WO2003096871A2 - Multipurpose fluid jet surgical device - Google Patents

Multipurpose fluid jet surgical device Download PDF

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Publication number
WO2003096871A2
WO2003096871A2 PCT/IL2003/000387 IL0300387W WO03096871A2 WO 2003096871 A2 WO2003096871 A2 WO 2003096871A2 IL 0300387 W IL0300387 W IL 0300387W WO 03096871 A2 WO03096871 A2 WO 03096871A2
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WO
WIPO (PCT)
Prior art keywords
fluid jet
surgical device
multipurpose
jets
jet surgical
Prior art date
Application number
PCT/IL2003/000387
Other languages
French (fr)
Other versions
WO2003096871A3 (en
Inventor
Adrian Paz
Original Assignee
Patent Max Q (P.M.Q) Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Patent Max Q (P.M.Q) Ltd. filed Critical Patent Max Q (P.M.Q) Ltd.
Priority to AU2003224409A priority Critical patent/AU2003224409A1/en
Publication of WO2003096871A2 publication Critical patent/WO2003096871A2/en
Publication of WO2003096871A3 publication Critical patent/WO2003096871A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3203Fluid jet cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/046Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in liquid form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0801Prevention of accidental cutting or pricking
    • A61B2090/08021Prevention of accidental cutting or pricking of the patient or his organs

Definitions

  • This invention concerns multipurpose medical instruments for diverse surgical fields.
  • the invention relates in particular to such surgical instruments which use high-pressure liquid jets.
  • a major problem in prior art devices is that, when cutting tissue with a liquid jet, it is sometimes hard to control the depth the jet penetrates the tissue. This is a major drawback, because the jet might penetrate the tissue way too deep and cause injuries to adjacent organs and blood vessels.
  • Another basic drawback of cutting and dissection by traditional instruments is the bleeding that has to be controlled by means of an additional hemostatic device, or by changing the instrument used for the dissection with a hemostatic device.
  • This drawback is particularly severe when working in narrow spaces or in difficult-to-access areas, such as occurs during endoscopic or laparoscopic procedures.
  • Methods that use electrosurgical, ultrasonic and laser tools partially overcome that drawback by performing hemostasis concomitantly with, or subsequently to, cutting, through conversion of electrical, vibratory, mechanical or laser energy, respectively, into thermal energy that seals bleeding vessels.
  • thermal energy may cause also inadvertent damage to the remaining normal tissue, resulting in the necrosis thereof at various depths.
  • application of electrosurgical energy to tissue for cutting and hemostasis may induce inadvertent thermal injury to the remaining tissue, and does not completely prevent bleeding. Therefore, a relatively significant blood loss may occur, which requires continuous postoperative bladder irrigation and might require blood transfusion.
  • the thermal injury inflicted on remaining tissue causes significant irritative lower urinary tract symptoms for weeks after the operation.
  • the use of such devices may also be associated with significant postoperative irritative urinary symptoms, due to thermal injury to the remaining prostatic tissue.
  • Methods of prostatic ablation by laser energy that do not remove the necrotic tissue during the operation, may result in postoperative urethral obstruction and in the need for prolonged bladder catheterization for several days and even for weeks.
  • thermal ablation methods of the prostate based on radio frequency or microwave energy, are relatively less effective in relieving urethral obstruction than electrosurgical resection of the prostate or laser prostate ablation. These thermal ablation methods are also associated with significant irritative symptoms, due to diffuse thermal injury to the remaining prostatic tissue. Furthermore, the ablation procedures, which generate tissue heating, induce local visceral pain, which requires mostly general or regional anesthesia.
  • a liquid lance cutter does not heat the tissue by its liquid jet, and inflicts less damage to adjacent tissue.
  • Liquid jet-based instruments cut tissue by dislodging small fragments of tissue by the kinetic energy of the high- pressure liquid jet, and separate the tissue along its path. Fluid jet instruments known in the art and used in surgery are devised for general surgery, for neuro-surgical interventions, ocular interventions and dental procedures.
  • a liquid jet may also be used for separating tissues along a relatively least resistance path represented by preformed or natural planes. There is minimal heating of the surrounding tissue during this process, and therefore the damage to remaining tissue is relatively minor.
  • Visceral organs have pain receptors that are mainly sensitive to intense heat and distension, but are less sensitive to sharp mechanical pressure, e.g., cutting or water jet dissection. Since heating by water jet dissection is relatively minimal, it results in less visceral pain, and it can be performed under local anesthesia combined with general sedation. During cutting and dissection using moderate pressure liquid jets, relatively small vessels are cut or torn, and most of them stop bleeding spontaneously, but larger vessels and harder structures like fibrous bands and fascia are spared.
  • fluids and tissue debris pooling at the operating site may obscure the incision site and necessitate the interruption of the procedure for reassessment or for suction.
  • back- splashing of potentially contaminated emulsified tissue to the surrounding normal tissue, to the viewing camera and to the operator team may occur.
  • Japanese Patent No. 262,528 discloses a laparoscopic surgical method and device that is used to improve the safety of surgery, by separating biological tissue after incising an organ serous membrane by passing a high frequency electrical current to the tip of a nozzle inserted into an abdominal cavity through a trocar, and inserting the tip of the nozzle from the incision and swelling the subserous layer by jetting a high pressure liquid of a specified pressure.
  • this instrument is directed to perform hydro dissection and not to cut tissues by fluid jet. Furthermore, since it is not deflectable it cannot reach difficult-to-access sites.
  • European Patent No. 280,972 discloses a hand piece for liquid-jet cutting apparatus from which a liquid jet emerges at high pressure via an end-piece.
  • the end-piece is designed as an active coagulation electrode of a high-frequency surgery apparatus.
  • the electrode can be either a mono-polar or a bipolar coagulation electrode.
  • the apparatus can cut tissues by the liquid jet as well as perform coagulation during the operation by the smooth nozzle.
  • the cutting of harder tissue and of more resilient structures like fibrous bands and coagulated blood vessels necessitate relatively higher pressures of the liquid jet, or significant energy from the electrosurgical unit.
  • US Patent No. 5,505,729 discloses a process and apparatus for high-pressure liquid cutting of organic tissue, in which a high-frequency electric current is transmitted through an electrically conducting liquid cutting jet, so that simultaneous coagulation of small vessels is possible during cutting with the liquid jet.
  • the apparatus is adapted to an air environment, and is not functional in a conductive liquid environment.
  • the transmitted thermal energy is low and insufficient to seal larger blood vessels.
  • the cutting of harder tissue and more resilient structures like fibrous bands and coagulated blood vessels requires relatively higher pressures of liquid jet. This can be a major drawback, in some endoscopic resections, where for safety reasons a fairly low liquid jet pressure is required in order to prevent injury to adjacent structures.
  • the apparatus does not have deflection ability, and therefore it may be difficult to introduce to certain regions while cutting and dissecting.
  • Other prior art patents may include the following:
  • liquid jet instruments and methods as described above do not provide satisfactory solutions to the problems inherent to cutting through harder tissue and more resilient structures, such as fibrous band and coagulated blood vessels. They do not achieve the goal of using liquid jet pressures that are safe and usually do not cause inadvertent injury to adjacent tissues and do not penetrate way to deep.
  • Another object of the invention is to provide a cutting instrument suitable for performing liquid jet dissection, cutting and abrading while providing a converging set of jets with controllable penetration of the tissue.
  • the use of a proper angle between the jets causes reciprocal jet neutralization or weaken significantly their energy beyond their meeting point.
  • Selective hemostasis is achieved by only applying heat for short time periods, when this is necessary.
  • the surgery itself is performed using cold liquid jets; immediately following the surgical procedure, hot jets are applied to achieve hemostasis.
  • the invention is related to a cutting, dissecting and/or abrading apparatus for surgery, comprising:
  • the jet neutralizing, deflecting or weakening means situated at the nozzle is generated by splitting the central channel, or channels in its distal end, or ends into two or more sub-channels, so that their corresponding longitudinal axis converge and meet at the same imaginary focal point to generate a combined and focused jet.
  • the angle between the sub-channels should be large enough to permit reciprocal neutralization or weakening of the jets' energy beyond the meeting point (focal region).
  • two or more pressure sources of liquid, and or gas may be connected each using a different working pressure.
  • these gas jets may cause dispersion and weakening of the liquid jets, beyond their meeting point.
  • the energy of the individual jets should be enough to be able of neutralize or weaken each other significantly.
  • the jets may be round, oval crescent like, sheet like, according to the shape of the emanating orifices.
  • the nozzle is provided with means to protect the jets from being interfered with or deflected by tissues or other instruments during most, or all of their trajectory up to the focal point. This means safeguard proper reciprocal neutralization or weakening of the jets distal to the focal region.
  • the shape of this protecting means may be for example but not limited to a circular, tron-conical, or other shaped collars at the distal end of the nozzle. This collar may be rigidly affixed to the nozzle, or it can be attached to it trough a flexible hinge region. This protecting means may be made of a rigid material or from a flexible material.
  • the focal region of the meeting jets is preferentially distal to the distal free margins of the protecting means, but it can be also proximal to these margins in some particular embodiments.
  • the jet neutralizing, deflecting or weakening means situated at the nozzle is designed as an extension designed as a plate for example, with its long axis parallel to the long axis of the shaft and connected to the nozzle by an elastic hinge.
  • the extension itself may be made of a rigid or an elastic material.
  • the tip of the nozzle is too close to the tissue, the extension will touch the tissue and will be deflected.
  • the jets will touch the plate and they will be deflected, too.
  • This setup permits cutting perpendicular to the tissue at a distance from the nozzle tip, or cutting and dissecting parallel and between tissue planes, reducing the chance of inadvertently perforating through the tissue planes .
  • the jet neutralizing, deflecting or weakening means situated at the nozzle is represented by a stop plate with a handle, which can be rotated from a position opposite the jet, or jets orifice/orifices to a position which is not opposite this or these orifice/orifices. Preferentially, this movement should be around an axis perpendicular to the long axis of the shaft.
  • the stop plate is not opposite the jet, or jets the instrument can be used to cut tissue that is not protuberant, and for hydro-dissection and mechanical blunt dissection along tissue planes without interference by the stop plate. After this initial phase, protuberant tissue is generated. Then the stop plate may be moved to a position opposite the jet, or jets and it can assist in dissecting the tissue, lifting it and in deflecting and neutralizing the jet, or jets after penetrating and cutting this tissue .
  • the apparatus of the present invention further includes (a) means for performing the operation of tissue- coagulation or tissue-cutting, and (b) an electrode activated by closing an electric circuit during tissue coagulation.
  • the operation of said means is determined according to the voltage setup of said means.
  • the apparatus of the present invention further includes evacuation means for evacuating residue, fluids and/or gas from the area centered by the contact zone of the combined fluid jets and a target tissue, and/or for partially preventing back-splashing.
  • the evacuation means comprises (a) a tube connected to a gas source at its proximal end for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the combined fluid jets, said nozzle is located near, or at the tip of the shaft; (b) suction tube and vacuum source for evacuating the residue, the fluids and/or the gas from said area and/or for preventing back-splashing, the opening of said suction tube is located near, or at the said tip; and (c) an umbrella-like cap for capturing residue, fluids and/or gas in said area by encircling said area when the concavity side of said cap is directed toward said area and said tip is within the concavity side of said cap.
  • the cap is made from an elastic material that is also transparent and may be distensible.
  • the apparatus of the present invention further includes means for deflecting the tip of the shaft.
  • the means for deflecting the tip of the shaft comprise pull-wires, an actuator for controlling the deflection, and at least two stiffening elements placed along the deflectable tip, for preventing deflection of the tip in an undesired direction.
  • the actuator has a wheel like shape, which protrudes over both the upper and lower surface of the handle of the apparatus of the present invention and the two stiffening elements are made of an elastic, but not distensible, material.
  • the means for deflecting the tip of the shaft of the present invention further includes an implement for adjusting and modifying the deflected tip to a required extent.
  • the adjusting and modifying implement is a slidable stiff sheath over the deflectable tip.
  • the adjusting and modifying implement is an advanced or withdrew stiff rod inside the shaft.
  • the fluid jet-forming means comprises a high-pressure fluid source, or sources and a connector, or connectors for connecting the high-pressure fluid source, or sources to the apparatus.
  • the tissue- coagulation and cutting implement is an electrode.
  • the shape of the electrode is selected from the group consisting of a circular ring surrounding the nozzle, a straight ribbon or band electrode, or a curvilinear, round, oval or an omega- shaped ridge.
  • the electrode is connected through a conductive wire to the hemostatic unit.
  • the apparatus of the present invention further includes an illuminating implement and an imaging implement that are attached externally, or through a specific channel along the shaft of the present invention.
  • the imaging implement is a video camera, or properly arranged optic fibers.
  • the apparatus of the present invention further includes two or more electrodes insulated from each other, for heating the electrically conducting fluid that passes between the electrodes, in which the electrodes are mounted on the inner area surface of the main irrigating channel.
  • the heated fluid stream, or steam jet, or jets are used to cause hemostasis.
  • the electrodes are located adjacent, or at the distal end of the channel, and are connected through insulated wires that extend through the shaft to a plug located on the handle, in which the plug is connected through a cable to hemostatic unit.
  • the apparatus of the present invention further includes a resistive element for heating the fluid.
  • the resistive element is electrically insulated by heat resistant element, by ceramic material, or by a coating material.
  • the resistive element comprises an incandescent element, which is preferably a tungsten wire.
  • the apparatus of the present invention further includes a resistive element for producing hemostasis and cutting the tissue by direct contact heating of the tissue with the incandescent element.
  • the apparatus of the present invention further includes an additional electrode suitable to be attached to the external body surface of a patient, when operating in mono-polar mode.
  • the jet-forming means of the present invention further includes one or more non-insulated ring-like electrodes which are attached to the inner surface of the irrigating channel and are connected through an insulated wire that extends through the shaft to a plug that is connected to a radio frequency source, for heating an electrically conducting irrigated liquid and for generating a hot fluid stream, or steam jet or jets that causes hemostasis.
  • a resistive element is wrapped around a region of the channel in the shaft for heating the fluid, or steam that flows through the channel.
  • the resistive element is electrically insulated by a heat-resistant element or by a suitable coating and is connected to an electric source.
  • the jet-forming means of the present invention further includes an external source of hot fluid, or heated steam connected to the channel through a side connector.
  • the jet-forming means of the present invention further includes an external source of local anesthetic solution connected to the channel through a side connector.
  • This local anesthetic solution is entrained by the irrigation fluid during jetting and induce local anesthesia at the operation site.
  • the apparatus of the present invention further includes a suitable channel that passes through the length of the shaft for introducing hemostatic implement of an external hemostatic unit.
  • the hemostatic implement is at least one electrode.
  • the hemostatic unit is selected from the group consisting of electrosurgical, radio frequency, hot liquid, steam, laser energy, ultrasonic waves, or any other suitable device that can perform hemostasis and/or cutting.
  • the apparatus of the present invention is incorporated into a multipurpose surgical or endoscopic device.
  • the multipurpose surgical or endoscopic device further includes forceps, graspers or clipping means.
  • the jet-forming means of the present invention further includes an active mono-polar electrode that transmits the electrical current through an ionized hot steam jet that flows through the irrigating cannel and impacts the tissue at the operation site.
  • This instrument is adequate for performing hemostasis by the hot steam jet and additionally by the electrosurgical effect of the transmitted current in gaseous environment.
  • the invention further relates to a method for the endoscopic prostatectomy with a cutting and dissection device of the apparatus of the present invention, comprising: (a) positioning the deflection tip part of the device within the prostatic urethra, through an endoscope sheath and under vision; (b) providing a high-pressure fluid jet, between the lateral lobes of the hyperplastic prostate and the middle lobe, for performing incisions; (c) dissecting retrogradely the lateral lobes and the middle lobes from the prostatic surgical capsule; and (d) performing continuously hemostasis of encountered bleeding vessels by tissue-coagulation implements.
  • the pressure of the fluid jet varies between 10 to 60 atmospheres.
  • Fig. 1 schematically illustrates a basic surgical device 1 for cutting and dissecting, according to one embodiment of the prior art
  • FIG. 2A schematically illustrates a fluid jet based surgical device for cutting, dissecting and/or abrading tissues, according to a preferred embodiment of the invention
  • Fig. 2B details the angle of the fluid jets as required for their mutual neutralization beyond the focus region
  • Fig. 2C illustrates jets momentum and preferred neutralizing angles.
  • Figs. 2D and 2E detail a front view of the tip of a device using two jets and four jets, respectively.
  • Figs. 2F and 2G illustrate a surgical device with an off-axis focus.
  • Fig. 2H schematically illustrates a collar for protecting the liquid jets.
  • Fig. 21 schematically illustrates an extension or plate for protecting the liquid jets.
  • Figs. 2J and 2K schematically illustrate jet neutralizing means using a rotatable plate.
  • FIG. 3A and 3B schematically illustrate the surgical device of Fig. 2A provided with tissue-coagulation means, according to another preferred embodiments of the invention
  • Fig. 3C details the block diagram of a precision temperature control system
  • FIG. 4A schematically illustrates the surgical device of Fig. 2A provided with evacuation means, according to another preferred embodiment of the invention
  • Fig. 4B schematically illustrates the profile of the tip region of the surgical device of Fig. 4A, in a cross section form
  • Fig. 5 schematically illustrates the surgical device of Fig. 3A provided with a deflection mechanism, according to another preferred embodiment of the invention
  • Fig. 6 schematically illustrates the deflection mechanism of device 10 of Fig. 5, according to one preferred embodiment of the invention
  • Figs. 7A to 7L schematically illustrate the use of device 10 of Fig. 5, during a prostate resection
  • Fig. 8A to 8C schematically illustrate an additional way to use device 10 of Fig. 5, during a prostate resection
  • Figs 9 schematically illustrate the use of device 10 of Fig. 5, during a knee arthroscopy
  • Figs. 10A and 10B schematically illustrates a device 10 of Fig. 5, provided with an adjustable length of the deflected part, according to another preferred embodiment of the invention
  • Fig. 11 schematically illustrates a device 10 of Fig. 5, provided with illuminating means and imaging means, according to another preferred embodiment of the invention
  • Fig. 12A schematically illustrates the tip region of the device 10, according to another preferred embodiment of the present invention
  • Fig. 12B is a cross-section taken along the B-B plane of Fig. 12A;
  • Fig. 13 schematically illustrates the device 10 of Fig. 2A, provided with ring-like electrodes for generating a hot fluid stream for local hemostasis, according to another preferred embodiment of the invention
  • Fig. 14 schematically illustrates the device 10 of Fig. 2A, provided with an external source container, according to another preferred embodiment of the invention
  • Fig. 15 schematically illustrates the device 10 of Fig. 2A, provided with an active mono-polar electrode adapted for gaseous environment, according to another preferred embodiment of the invention
  • Fig. 16 schematically illustrates the device 10 of Fig. 2A, provided with a detachable unit, according to another preferred embodiment of the invention
  • Fig. 17A schematically illustrates the tip region of device 10 provided with resistive element, according to another preferred embodiment of the present invention.
  • Fig. 17B is a cross-section taken along the B-B plane of Fig. 17A;
  • Fig. 18 schematically illustrates the device of Fig. 2A provided with an incandescent element, according to another preferred embodiment of the invention.
  • FIG. 19 schematically illustrates the device of Fig. 2A, according to another preferred embodiment of the invention. Modes for Carrying out the Invention
  • the surgical device of the present invention is used for cutting, dissecting and/or abrading tissues by utilizing relatively high-pressure liquid jets, which are provided with two or more orifices located at the distal end of that surgical apparatus.
  • Fig. 1 schematically illustrates a basic surgical device 10 for cutting and dissecting, according to one embodiment of the prior art.
  • the surgical device 10 comprises shaft 11 , channel 12 for directing the high-pressure liquid jet towards the incision area, handle 14 for holding and/or operating the surgical device 10 and connector 16 through which the fluid source is provided.
  • surgical devices such as device 10, use a fluid jet in a required pressure towards the tissue in order to perform the incision.
  • a problem in such devices is that the liquid jet might penetrate too deep into the tissue, more than it is desired, thereby causing injuries to other tissue and/or organs.
  • the surgical device can be used in various surgical procedures, for example: laparoscopic surgery, thoracoscopic surgery, neurosurgery, ophthalmology, corneal reshaping, lens surgery, orthopedic surgery, endoscopic surgery such as excision of gastric or colonic polyps, endoscopic urologic surgery such as endoscopic prostatectomy, endoscopic resection of bladder tumors, endoscopic lithotripsy (fragmentation of stones), endoscopic fragmentation of billiary stones, dental surgery, ear, nose and throat surgery, endoscopic sinus surgery, dermal abrasion, dermatology, debridment of chronic ulcers and pressure sores, plastic surgery, endoluminal vascular re-channeling, heart surgery, cosmetic surgery, gynecology (endoscopic resection of miomas) .
  • endoscopic surgery such as excision of gastric or colonic polyps
  • endoscopic urologic surgery such as endoscopic prostatectomy, endoscopic resection of bladder tumors
  • endoscopic lithotripsy fragmentation of stones
  • Fig. 2A schematically illustrates a surgical device 10 for cutting, dissecting and/or abrading tissues, according to a preferred embodiment of the invention.
  • the surgical device 10 comprises a shaft 11 , a handle 14, a connector 16 and a channel 12, that continues at its distal end with at least two sub-channels, such as 13a and 13d, so that their corresponding longitudinal axis meet at the same imaginary region 15.
  • the imaginary region 15 is the focal region of the converging jets that stream from the sub-channels 13a, 13d and preferably, the converging jets at region 15 may produce an ellipsoid-like form of negligible thickness.
  • the surgical device 10 comprises the basic elements for cutting, dissection and/or abrading tissues.
  • the pressure at the converging region of all the jets i.e., at the imaginary region 15
  • the pressure at a small distance 196 beyond focal region 15 drops significantly, due to reciprocal neutralization, or weakening of the jets beyond the focal region. Therefore, there will be no involuntary relatively deep penetration of the fluid jet into the tissue or other organs, and no resulting damage.
  • the device uses a liquid jets pressure between 10 and 150 atm.
  • the liquid jet diameter may be in the range 0.05 to 0.6 mm.
  • Fig. 2B details the angle of the fluid jets as required for their mutual neutralization beyond the focus region.
  • the novel cutting, dissecting and/or abrading apparatus 10 for surgery may thus include: (a) liquid jet-forming means for generating a high pressure fluid jet;
  • the liquid is a physiological liquid.
  • Fig. 2B details the angle 195 between the liquid jets 193, 194 as required for their mutual neutralization in the area 196 beyond the focus region 15.
  • the angle 195 between the jets is in the range 40 to 60 arc degrees.
  • the angle 195 between the jets is in the range 50 to 80 arc degrees.
  • the angle 195 between the jets is in the range 40 to 90 arc degrees.
  • angles range can be found that results in effective jets neutralization beyond the meeting point of the jets (the focus) .
  • the specific value of that angle 195 may depend on the number of jets being used, the specific liquid type, temperature, fluid pressure, orifice diameter, etc.
  • the device or its tip is disposable, and a plurality of such devices are available to the surgeon, each having a specific angle. The surgeon then chooses the instrument best suited for the task at hand.
  • a replaceable nozzle is mounted at the instrument's distal end.
  • Various nozzles may be provided, each with a different angle of the emerging liquid jets.
  • the jet neutralizing, deflecting or weakening means situated at the nozzle is generated by splitting the central channel, or channels in its distal end, or ends into two or more sub-channels such as illustrated with sub-channels 13a and 13d, or 13a to 13d (see Figs. 2D and 2E), so that their corresponding longitudinal axis converge and meet at the same imaginary focal point to generate a combined and focused jet.
  • the angle 195 between the sub-channels should be large enough to permit reciprocal neutralization or weakening of the jets' energy in the area 196 beyond the meeting point 15 (focal region).
  • This focal region may be along the long axis of the shaft, or it can be at an angle with this long axis of the shaft.
  • the present inventor has found that too small an angle between the jets may cause augmentation of the jets energy beyond their meeting point, which is to be prevented. Rather, by using a larger angle between the jets, the desired effect is achieved, that the jets neutralize or at least weaken each other past the focal region, see Fig. 2B.
  • the specific angle between the jets to be used may vary, according to various parameters such as type of liquid, working pressure, temperature, orifice diameter, etc.
  • Fig. 2C illustrates jets momentum and preferred neutralizing angles. This is the result of a simulation aimed at evaluating the effect of two jets neutralizing each other on impact, or at least weakening each other to a considerable extent.
  • the model used for the above simulation was a non-time-dependent model (equilibrium state), using a Star CD finite element flow simulation software. The model assumed that two water jets were ejected in water and meet at some point.
  • the momentum at the meeting point and beyond this point on the symmetry line between the jets has been calculated.
  • the relative momentum represents the quotient of the momentum at various distances from the meeting point and the momentum at the meeting point.
  • the parameters used were liquid pressure in the irrigating cannel, jet orifices diameter and half-angle (angle between each jet and the symmetry line between the jets) between the jets.
  • the optimal half-angle between two jets is chosen from a group of curves showing the decrease in relative momentum as a function of distance from the meeting point for various liquid pressures in the irrigating channel at a given orifice diameter.
  • the optimal angle is chosen as the smaller angle that its increment cause a small curve shift.
  • One of the graphs depicts the optimal half-angle as a function of various liquid pressures between 20 and 40 atm.
  • the second graph depicts the decrease of the relative momentum at various distances from the meeting point on the symmetry line between the jets, at a liquid pressure of 40 atm, and orifices diameter of 0.3 mm.
  • Figs. 2D and 2E detail, by way of example, two embodiments of the invention, including a front view of a device's tip using two jets and four jets, respectively.
  • the liquid jets are generated by the channels 13a and 13d as illustrated in Fig. 2D, or the channels 13a to 13d as illustrated in Fig. 2E.
  • the cross-sectional shape of the jets may be circular, oval, crescent-like, sheet-like, and as defined by the shape of the emanating orifices.
  • Figs. 2F and 2G illustrate a surgical device 10 with an off-axis focus 15.
  • the focal region 15 may be along the long axis 106 of the shaft, or it can be at an angle with this long axis of the shaft.
  • the jets do not have to meet on the axis of symmetry 106 of instrument 10.
  • the two liquid, high pressure jets 193, 194 are meeting at a point 15 which is located off the axis of symmetry 106 of the device 10.
  • each of the provided jets 193, 194 is at an angle with respect to the axis 106 of the apparatus, so that their corresponding longitudinal axes meet at the same point 15 (in the focal region).
  • the basic elements of the surgical device such as the channels that directs the jets towards the required meeting point where the two or more jets are converged, together with optional elements (if existing) are located within a shaft.
  • the shaft is used for housing those elements thus allowing them to function as a single unit.
  • FIG. 2H schematically illustrates a collar 61 for protecting the liquid jets 193, 194.
  • the nozzle is provided with means 61 to protect the jets 193, 194 from being interfered with or deflected by tissues or other instruments, during most, or all of their trajectory up to the focal point 15.
  • This protecting means 61 can safeguard proper reciprocal neutralization or weakening of the jets distal to the focal region.
  • the shape of this protecting means may be, for example but not limited to, a circular, tron-conical, or other shaped collars at the distal end of the nozzle.
  • the collar 61 may be rigidly affixed to the nozzle, or it can be attached to it trough a flexible hinge region.
  • This protecting means may be made of a rigid material or from a flexible material.
  • the focal region of the meeting jets is preferably distal to the distal free margins of the protecting means, but it can be also proximal to these margins in some particular embodiments.
  • Fig. 21 schematically illustrates an extension or plate for protecting the liquid jets.
  • the jet neutralizing, deflecting or weakening means situated at the nozzle further includes extension means shaped as a plate 62 for example, and connected to the nozzle by an elastic hinge 621 .
  • the plate 62 itself may be made of a rigid or an elastic material.
  • the stop plate 62 is fabricated from a strong plastic or from metal, that can sustain without damage the energy of the tissue cutting jets, when using liquid pressures of up to 150 atm.
  • the extension When the tip of the nozzle is too close to the tissue, the extension will touch the tissue and will be deflected. When deflected, the jets 193, 194 will touch the plate 62 and will be deflected, too.
  • This setup permits cutting perpendicular to the tissue at a distance from the nozzle tip, or cutting and dissecting parallel and between tissue planes, reducing the chance of inadvertently perforating through the tissue planes.
  • Figs. 2J and 2K schematically illustrate jet neutralizing means using a rotatable plate 63.
  • the jet neutralizing, deflecting or weakening means situated at the nozzle of device 10 include a stop plate 63 which can be rotated about by the surgeon, using a handle for example.
  • the plate 63 can be rotated from a position opposite the jet, or jets orifice/orifices (see Fig. 2J) to a position which is not opposite this or these orifice/orifices (see Fig. 2K) .
  • the movement can be around an axis 632 which is perpendicular to the long axis of the shaft of instrument 10.
  • Rod means 631 connects plate 63 with axis of rotation 632.
  • Other embodiments for a rotatable plate 63 are possible.
  • the instrument can be used to cut tissue that is not protuberant, and for hydro-dissection and mechanical blunt dissection along tissue planes without interference by the stop plate.
  • stop plate 63 may be moved to a position opposite the jet or jets and it can assist in dissecting the tissue, lifting it and in deflecting and neutralizing the jet, or jets after penetrating and cutting this tissue.
  • Gas jets may be used for neutralizing or weakening the liquid jet/jets used in surgery, by changing them to aerosols after the meeting point.
  • one or more liquid jets are used for surgery, with one or more gas jets being used to weaken or neutralize the liquid jet(s) beyond the focus.
  • the above structure may be used only in gaseous environments.
  • gas jets in addition to weakening the liquid jets, may also clear the incision site, improving the visibility there by preventing pooling of liquid.
  • the aerosols are entrapped by an elastic cup provided at the end of the instrument and are evacuated by the evacuation channel also provided.
  • the pressure required for the gas jets or steam jets should be up to a few Atm., and orifice diameter should be between 0.01 to 0.7 mm.
  • two or more pressure sources of liquid, or gas may be connected each using a different working pressure.
  • these gas jets may cause dispersion and weakening of the liquid jets, beyond their meeting point.
  • the energy of the individual jets should be enough to be able of neutralize or weaken each other significantly.
  • the surgical device 10 further includes elements for performing tissue-coagulation and/or cutting.
  • the tissue-coagulation or the tissue cutting operation of these elements is determined according to their applied voltage setup.
  • the tissue- coagulation and cutting means comprise at least one electrode means for physically performing the coagulation or the cutting of resilient tissue when placing its surface on the tissue, and additional electrode means for closing an electric circuit during tissue coagulation, thereby provides the electricity to the electrode that physically performs the tissue coagulation or cutting of resilient tissue.
  • Figs. 3A, 3B schematically illustrate the surgical device 10 with tissue- coagulation or cutting of resilient tissue means using bipolar electrodes, according to another preferred embodiment of the invention.
  • the surgical device 10 comprises, in addition to the aforementioned basic elements, active electrode 21 for physically performing the tissue-coagulation or cutting of resilient tissue and inactive electrode 22 for closing the electrical circuit. Both electrodes are wired (e.g., by conductive wire 221) to an external hemostasis unit, via connector 23 on handle 14.
  • the device 10 may operate in a mono-polar mode, implying that an inactive electrode (not shown), such as inactive electrode 22, is attached externally to the patient skin.
  • the active electrode 21 is a smooth or ridge-shaped electrode.
  • the active electrode 21 is used generally for stopping the flow of blood (i.e., hemostasis), while the high-pressure liquid jet is used for cutting and dissecting tissues. Cutting of resilient tissue can be performed also by the electrode using an adequate voltage setup. A closed positioned relationship of the fluid jet nozzle and the edge of electrodes 21 of the hemostatic unit permits the sealing of blood vessels as they are encountered during cutting and dissection with device 10. Hemostasis is obtained, for example, by a contact of the tip of active electrode 21 with the tissue and intense tissue heating by the high current densities generated by connecting the active electrode 21 to an electrosurgical unit. However, by increasing the provided voltage to the active electrode 21 , it may also perform tissue cutting. The cutting is obtained due to relatively high heat of the electrode 21 as a result of the increased voltage.
  • Selective hemostasis is achieved by only applying heat for short time periods, when this is necessary.
  • the surgery itself is performed using cold liquid jets; immediately following the surgical procedure, hot jets are applied to achieve hemostasis.
  • a hot jet is only used for less than 10% of operating time and only for stopping bleeding (hemostasis), whereas prior art devices use high temperature jets/instruments during the entire operation: during cutting and hemostasis.
  • the temperature used with hot jets is lower, usually less than 100 Centigrade.
  • Hemostasis is achieved by the fluid jet pressure that collapses blood vessels and by the heat conveyed by the hot jet to tissue that cause blood vessel sealing.
  • Steam jets may be used for hemostasis, both in a liquid or a gaseous environments. The jet is applied for 5 to 10 sec each time and causes hemostasis by the pressure of the jet and the sealing effect of the heat transmitted to the bleeding vessels.
  • a hot liquid jet can be converted to a steam jet by overheating the incoming liquid. The advantage of a steam jet over a liquid jet is that it can convey more heat to tissue compared to a liquid jet.
  • the jet When using a steam jet in a liquid environment for a short distance, the jet is not intended to cut tissue and even if it is loosing some of its coherence it may still apply enough pressure and transmit enough heat to bleeding vessels to cause hemostasis.
  • the steam jet temperature may be up to 150 centigrade, and its pressure up to a few atm.
  • the gas jets may be used only in a gaseous environment.
  • the surgical device 10 further includes evacuation means for evacuating residue, fluids and/or gas from the area centered by the contact zone of the converging fluid jets and/or for partially preventing back-splashing of potentially contaminating material to the operator or to the tissue.
  • Fig. 3C details the block diagram of a precision temperature control system, which may be used with various heater means, such as illustrated in the present disclosure.
  • the system has two basic functions: a. To maintain a precise temperature, as set by the surgeon; this is the hot liquid or steam temperature required for hemostasis. b. to apply the above hemostasis temperature for a limited time only, either allowing manual activation thereof, or automatic application at preset time intervals and duty cycles.
  • the temperature control system includes a controller 651 connected to an electrical mains power source 652 and electrical heater means 653.
  • the heater means 653 may include for example an electrodes pair, an incandescent element, resistive element, a source of ultrasonic or radio frequency energy, etc.
  • the controller receives temperature readings from a temperature sensor 654.
  • the temperature sensor 654 may be immersed in the liquid used to form the high pressure jets.
  • the sensor may comprise a thermistor or a solid state sensor, for example.
  • the controller applies electric power to the heater 653 or disconnects it, to keep the high pressure jets at the required temperature.
  • the closed loop is only activated at predefined time periods, otherwise the high pressure jets use a cool liquid (not heated).
  • the controller 651 further includes input means 661 for setting the required temperature.
  • the surgeon may set up the temperature before the operation.
  • Another input is the manual activation means 662, for immediate activation of the heating process when desired.
  • the surgeon by pressing a button for example, may initiate hemostasis after performing the surgery.
  • the hemostasis may be activated automatically using a timer 655 means.
  • the inputs to the timer 655 may include, for example, a cycle time control input 663 and a heating time interval input 664.
  • Indicator means 666 may be used to indicate to the surgeon when the heating is activated. This may include a visual and/or audio indicator means.
  • Fig. 4A schematically illustrates the surgical device 10 provided with evacuation means, according to another preferred embodiment of the invention.
  • the surgical device 10 further includes a tube 31 connected to a gas source 310 at its proximal end, for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the converging fluid jets, suction tube 33 and vacuum source 34.
  • the suction tube 33 and the vacuum source 34 are used for evacuating the residue, the fluids and/or the gas from the incision area and/or for preventing back-splashing.
  • an umbrella-like cap 35 is provided for capturing residue, fluids and/or gas in the incision area.
  • Cap 35 captures residue, fluids and/or gas by encircling and covering the incision area with the concave side of cap 35 is directed toward the incision area.
  • Cap 35 covers the orifices of the entire sub-channels nozzles 13a and 13d, the nozzle of tube 31 and the opening of the suction tube 33, as shown in Fig. 4B.
  • suction orifice and/or gas nozzles There may be more than one suction orifice and/or gas nozzles, and the shape and position of the gas nozzle and suction orifice can vary as known to those skilled in the art. Applying suction to tube 33 through vacuum source 34, either with or without the gas stream, will evacuate any existing residues (e.g., secretions and tissue debris), liquids and/or gas, thus improving the view and permitting a more precise application to the tissue of the fluid jet and, if provided, of the hemostatic means.
  • residues e.g., secretions and tissue debris
  • the evacuating operation allows cutting tissue and cleaning of this operated area at the same time, thus it is not necessary to stop the cutting in order to clean the area, as shown and described in Figs 4A and 4B. The residues will not get in the way during the cutting.
  • the pressure of the gas stream is lower than the pressure of the combined liquid jets at region 15. This difference in pressures is required in order to avoid interference of the gas stream with the pressure of the combined liquid jet.
  • the pressure of the combined fluid jets at region 15 varies between 10 and 120 atmospheres.
  • the gas jet/jets are directed at the liquid jet/jets and are intended to weaken the liquid jet/jets after their meeting point.
  • the instrument is designed for achieving only homeostasis by using hot liquid or steam jeVjets and dissection and cutting is performed by other instruments.
  • Channel 12 extends along shaft 11 , and eventually continues with sub-channels 13a and 13d, located at the tip section 20 of device 10.
  • Channel 12 and sub-channels 13a, 13d are used for delivering high-pressure fluid from a high-pressure fluid source 191 (shown in Fig. 19) to the incision area to which the region 15 is to be brought.
  • a high-pressure fluid source 191 shown in Fig. 19
  • two sub-channels are shown in this figure, a smaller or larger number of such sub-channels can be used, as will be appreciated by the skilled person.
  • the high- pressure fluid source 191 can be, for example, in form of an injector.
  • the high-pressure fluid source 191 (Fig. 19) can be connected to device 10 through high- pressure fluid connector 16.
  • the nozzle of each sub-channel may have a circular, a slit-like, crescent-like cross-section, the sub-channels may have screw like internal profile resulting in a helical jet, or can be of any other suitable shape, which may be envisioned by those skilled in the art.
  • the tip of shaft 11 may have an inverted conical shape 192 (Fig. 19), that may preserve the fluid jet energy and the tissue cutting efficacy of the fluid jet.
  • this design protects the jet from external interference, safeguarding their mutual neutralization or weakening at the focal region.
  • the high-pressure fluid is pumped or irrigated into channel 12 through connector 16, flows through it and out of the orifices of the sub-channels 13a-13d in the form of high-pressure fluid jets, each of which is directed toward the convergence point.
  • the fluid may be a physiologic saline solution or any other biocompatible solution, as will be apparent to persons skilled in the art.
  • the nozzle of each sub- channel 13a-13d preferably has a relatively small orifice (i.e., from 0.1 to 1.5 mm, preferably between 0.4 and 0.8 mm).
  • device 10 is used for diverse surgical applications in liquid, gaseous or air environments.
  • a preformed plane is the space between fascias.
  • a fascia is a film made of collagen fibers, that envelop tissue and that is stronger and more elastic than the enveloped tissue. Adjacent fascias are separated by softer tissue that can easily be removed by gentle pressure. Blood vessels are few and at predicted positions between adjacent fascias, whereas within a tissue enveloped by a fascia the blood vessels are more numerous and at unpredictable positions and directions.
  • the new liquid jet instrument has particular advantages since in addition to cutting at the meeting point of the liquid jets, it can perform dissection of the soft tissue between the fascia by the bulk of the moving liquid (hydrodissection). Since the fascial planes are not straight, this dissection by the fluid bulk, which can flow in any direction, is particularly advantageous. The result is a neat, anatomical dissection along preformed planes and not through them, thus causing minimal bleeding and tissue injury.
  • device 10 is used in a liquid environment, for endoscopic procedures, such as prostate resection, where, generally, it is introduced through the sheath of an endoscope.
  • device 10 is utilized, e.g. for open surgical and laparoscopic procedures, and for endoscopic procedures in a gaseous environment, such as in the gastrointestinal tract.
  • a gaseous environment such as in the gastrointestinal tract.
  • device 10 further includes a deflection mechanism which allows the deflection of a section of device 10 - preferably, but not limitatively, the tip area - in order to reach difficult-to-access areas during the incision.
  • Figs. 5 and 6 schematically illustrate the surgical device 10 of Fig. 2A provided with the deflection mechanism.
  • device 10 further comprise side bands 51 a and 51 b, actuator 52 and other required elements for performing the deflection, as will be described hereinafter.
  • the side bands 51 a, 52b are attached to device 10 along shaft 11 , preferably, from the tip of device 10 to band 22.
  • Band 22 can be located at any suitable place on shaft 11 , thus distancing the length of the deflective section.
  • the side bands 51 a and 51 b are preferably made of an elastic, but not distensible, material (e.g., plastic) and are diametrically opposed in a way that allows the deflection to take place only in a single axis, thus obtaining a relatively high stability while performing the deflection.
  • one or more of the side bands 51 a, 51 b can be removed from shaft 11 , thus allowing the deflection to take place along a plurality of axis.
  • Pull-wires e.g., 24a and 24b in Fig. 6
  • actuator 52 can be used to achieve the required deflection of device 10.
  • Fig. 6 schematically illustrates the deflection mechanism according to one preferred embodiment of the invention.
  • Actuator 52 has preferably a wheel-like shape, which can be manipulated with one hand. For example, upon turning actuator 52 clockwise, using the thumb, pull-wire 24b is wrapped around cylinder 152 and pull-wire 24a is released from cylinder 152, resulting in a deflection toward arrow 153. Pushing pin 151 into one of the holes 155 fixes the tip of device 10 in a specific deflected position.
  • Actuator mechanism 52 has a wheel-like structure which rotates freely within a suitable slot in handle 14 and protrudes at the upper and lower surfaces of handle 14 (see Fig. 5).
  • the deflection mechanism can be easily manipulated by a user, holding handle 14 in one hand and operating the pull wires actuator mechanism with the fingers of the same hand.
  • the wheel-like actuator 52 can be rotated with the thumb or the index finger and the sliding, blocking pin can be advanced to block the wheel by the index finger or thumb while handle 14 is held by the other fingers.
  • Protrusion of the wheel member of actuator 52 over both the upper and lower surfaces of handle 14 permits an easy manipulation by the left or right hand of the user, even following rotation of the instrument.
  • the deflected part of the shaft 11 is made of flexible a material (Fig. 5).
  • the shaft 11 may also be provided with a bendable coupling element (i.e., joint) while the deflected part of shaft 11 is made of a rigid material.
  • the length of the deflected part can be adjusted to the required extent and can be modified, e.g., by sliding a stiff sheath 110 over the deflectable part (as shown in Figs. 10A and 10B) , or by advancing or withdrawing a stiff rod into a channel that is embedded in shaft 11 .
  • the active flexion is preferably performed by pull-wires 24a and 24b, but may also be performed by memory elements or by other mechanisms that will be apparent to those skilled in the art.
  • device 10 may further comprise illuminating means and imaging means.
  • the illuminating means and the imaging means are used for providing streaming images of the internal cavities of the patient body during the surgical operation.
  • Illuminating means 11 1 and imaging means 112 can be attached to device 10 in several ways, for example, in parallel and externally to device 10 as shown in Fig. 11 , through a specific channel along shaft 11 in device 10, or in other ways that will be apparent to persons skilled in the art.
  • Device 10 may be also incorporated into other multipurpose surgical or endoscopic devices.
  • a laparoscopic multipurpose device can be introduced through a port and may incorporate a device according to the invention, and may also include forceps, or graspers, or clipping means.
  • the electrical current flows through the electrode 21 , creating a high density current and thermal effect at the target tissue in contact with the small surface of the tip of electrode 21 , and back through the electrically conducting liquid, e.g., physiologic saline or any other electrically conducting biocompatible liquid that surrounds the working site, to a larger area of the inactive electrode 22 where the current density is low and the heating effect of the surrounding electrically conducting liquid, or tissue that is in contact with the electrode, is negligible.
  • the hemostatic or an electrosurgical cutting operation using both electrodes 21 and 22 is thus called "bipolar mode".
  • electrode 21 may operate in mono-polar mode as well.
  • an additional electrode (not shown) has to be attached to the body of the patient in order to close an electrical circuit (i.e., to allow current to flow) and to perform the hemostatic or cutting operation by electrode 21 .
  • the hemostatic unit has control elements that permit electrical current to flow only during contact of most of the electrode 21 with tissue, and which limit or interrupt the current flow when there is no contact, or when there is reduced contact with the tissue.
  • the control elements prevent damage to the surrounding tissue, overheating of the liquid environment, or current short circuit across the electrodes and damage to the electrosurgical unit.
  • a few pairs of active electrodes may be located at various positions along shaft 11 and around its circumference, and each pair may be independently controlled by the aforementioned control elements. In such case, an electrical potential will be applied only to those active electrodes that are in contact with the tissue during the activation of the hemostatic unit.
  • the fluid jets used for surgery can also provide hemostasis, by using hot jets.
  • the temperature is in the range about 70 to 100 degrees Celsius. In another embodiment, the temperature range is about 80 to 90 degrees Celsius. In yet another embodiment, the temperature is in the range 100 to 120 degrees Celsius.
  • the jet may be saline or a physiological liquid.
  • Figs 12A and 12B schematically illustrate the tip section of device 10, according to another preferred embodiment of the present invention, wherein Fig. 12B is a cross- section taken along the B-B plane of Fig. 12A.
  • Channel 12 comprises two adjacent active electrodes 91 a and 91 b that permit the heating of an electrically conducting fluid that passes between them, or even generation of steam.
  • Channel 12 is completely electrically insulated except for the two opposing electrodes 91 a and 91 b.
  • the two electrodes 91 a and 91 b are mounted on the inner area surface of channel 12, which come into contact with the irrigating fluid.
  • electrodes 91 a and 91 b are located adjacent, or at the distal end of channel 12, but other suitable locations are of course also possible.
  • Electrodes 91 a and 91 b are also insulated from each other, and are connected via insulated wires 92a and 92b that extend through channels in shaft 11 to a plug located on handle 14 (not shown), which is connected through a cable to an external hemostatic unit.
  • Application of a high electrical potential to these opposing active electrodes will result in the heating of an electrically conducting fluid such as, but not limited to, physiological saline, which flows through channel 12 and generates a hot fluid jet, or a steam jet for a limited period of time.
  • This hot fluid jet or steam jet when directed to blood vessels, seals them by thermal effect. Control elements in the electrosurgical unit prevent damage to the unit by limiting current intensities.
  • the hot fluid or steam when directed toward severed vessels or tissue, cause tissue hemostasis.
  • one or more non-insulated ring-like electrodes such as electrodes 94a-94c (Fig. 13), are attached to the inner surface of the electrically-insulated channel 12, and are connected through an insulated wire 95 that extends through a channel in shaft 11 to a plug that is connected to a radio frequency source (not shown).
  • a radio frequency source not shown.
  • Application of radio frequency energy to the electrode or electrodes located on the inner surface of the irrigation channel 12 causes the heating of an electro-conductive liquid to take place, thus permitting the generation of a hot fluid stream that causes local hemostasis.
  • external source container 118 is provided with device 10 and is connected to channel 12 through connector 119 (as shown in Fig. 14).
  • the external source 118 may contain a hot fluid or solution for local anesthetic.
  • the anesthetic solution can be entrained by the irrigation fluid during jetting and induce local anesthesia at the operation site.
  • external control elements (not shown) permit the application of a high-pressure fluid jet at room temperature, for tissue cutting and dissection, or the application of a hot fluid jet for tissue hemostasis.
  • the device 10 of Fig. 5 is adapted for a gaseous environment.
  • An active mono-polar electrode 120 is located on the inner surface and near the distal end of the electrically insulated irrigation channel 12 (Fig. 15), through which steam flows, and comes in contact with the steam generated from heating an electrically-conducting fluid.
  • the steam is generated by an external source connected to channel 12 by a connector, or is generated within shaft 11 by the methods mentioned above, or by any other suitable method.
  • Active mono- polar electrode 120 is connected through insulated wire 121 , which in turn is connected to a plug included in the handle assembly that is connected to an external electrosurgical unit (not shown).
  • An inactive electrode is attached to a large skin area of the patient's body. Hemostasis is obtained by the steam being in contact with the tissue, or and by applying an electric potential to the active mono-polar electrode 120 during the flow of steam over it.
  • the presence of ions derived from the electrically conductive fluid in the gaseous steam jet allows the discharge of a high intensity current through the jet, which induces an electrosurgical effect at the impact site of the jet with the tissue.
  • tissue cutting or hemostasis are obtained by a combination of a jet pressure of 3 to 20 atmospheres and to an adequate voltage setup.
  • the hemostatic means of a hemostatic unit are not an integral part of device 10 and can be introduced into device 10 through a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes trough the length of shaft 11 and ends at the tip region.
  • a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes trough the length of shaft 11 and ends at the tip region.
  • hemostasis or cutting of resilient tissue may be obtained (by the hemostasis unit) using, for example, electrosurgical means, radio frequency energy, hot liquid flow, steam flow, laser energy, ultrasonic activated probes, or any other conventional devices that can cause hemostasis and/or cutting.
  • an additional mechanical implements such as scalpel, forceps, graspers or clipping means, is introduced into device 10 through a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes along the length of shaft 11 and ends at the tip region.
  • a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes along the length of shaft 11 and ends at the tip region.
  • the resistive element 42 may be wrapped around a segment of the electrically- insulated, but thermally conducting, irrigation channel, such as channel 12.
  • Figs. 17A and 17B schematically illustrate the tip section of device 10, according to a preferred embodiment of the invention.
  • Fig. 17B is a cross-section of the device of Fig. 17A, taken along the B-B plane.
  • Resistive element 42 which is electrically insulated by heat-resistant element, or by a suitable coating, may be wrapped around a region of channel 12, heating it and indirectly heating the fluid that flows through it, thus resulting in a hot fluid jet or a steam jet.
  • Wires 43 connect element 42 to an electric source.
  • the device 10 of Fig. 2A further includes an incandescent element 181 (Fig. 18) for producing hemostasis and cutting of the tissue by direct contact heating of said tissue with the incandescent element.
  • the incandescent element is electrically connected to a suitable electrical power source, for example, . via connector 182.
  • the incandescent element 181 is a tungsten wire.
  • hemostasis can be obtained by using a non-electrically insulated beak region that acts as an active electrode, of the insulated sheath of an endoscope through which device 10 is introduced. Positioning the tip of device 10 adjacent to the beak allows obtaining hemostasis together with fluid jet cutting and dissection. After cutting the tissue with the fluid jet, bleeding vessels may be sealed by the adjacent beak of the endoscope sheath, which acts as an active hemostatic electrode.
  • the method includes positioning the deflection tip part of device 10 within the prostatic urethra, through an endoscope sheath and under visual monitoring.
  • incisions are performed with a high- pressure fluid jet, using pressure levels between 10 to 60 atm. and preferentially between 15 and 40 atm., between the lateral lobes of the hyperplastic prostate and the middle lobes, and thereafter the lateral lobes and middle lobes are dissected retrogradely from the prostatic surgical capsule.
  • Hemostasis of encountered bleeding vessels is obtained continuously and selectively by the hemostatic means provided with device 10. Fibrous bands are severed by the high-pressure converging fluid jets and/or by the hemostatic unit and inadvertent injury to the surgical prostate capsule and adjacent organs is prevented by the special design of these converging jets that cause a significant pressure reduction of the combined fluid jet beyond the focal region. Additionally, a method of slice-like cutting of the prostatic tissue is described.
  • FIG. 7A to 7L An example of using device 10 for prostate resection is shown in Figs. 7A to 7L, which schematically illustrate a prostate resection in an endoscopic view of the prostate.
  • Fig. 7A schematically illustrates an endoscopic view of the prostate before the resection.
  • the prostate comprises the following elements: right lateral lobe 101a, left lateral lobe 101 b, middle lobe 102, veru-montanum 103 and urinary bladder neck opening 104.
  • the circle around the prostate refers to the prostatic surgical capsule 105.
  • device 10 is introduced through the urethra of a patient.
  • Fig. 7B shows the shaft of device 10 after being introduced into the prostate urethra, the tip of that device being deflected.
  • the resection is started by cutting and dissecting between the middle lobe 102 and the right lobe 101 a as shown, starting cutting from the bladder neck.
  • Fig. 7C shows the continuation of the incision distally to the veru-montanum 103.
  • Fig. 7D schematically illustrates the dissection of the right lobe 101a, using the fluid- jet from the prostate capsule, starting from the veru-montanum 103 towards the bladder neck 104.
  • Fig. 7E shows the continuation of the dissection of the right lobe 101a from the prostatic surgical capsule 105.
  • Fig. 7F it can be seen that the right lobe 101 a is almost completely detached from the prostatic capsule 105.
  • Fig. 7G shows the complete detachment of the right lobe 101a from the prostatic capsule 105.
  • the detached lobe is pushed through the bladder neck 104 into the bladder, wherein it is morcellated using a morcellator.
  • Cutting and dissection of tissue from the left lobe 101b require the same procedure as shown in Figs. 7D to 7G.
  • Fig. 7H schematically illustrates the cutting and dissection of the middle lobe 102, starting from the veru-montanum 103 towards the bladder neck 104.
  • Fig. 71 shows the creation of a plane between the middle lobe 102 and the prostatic capsule 105, with continued dissection of the middle lobe 102.
  • Fig. 7J the dissection of middle lobe 102 is continued towards the bladder neck 104.
  • Fig. 7K shows the detachment of the dissected middle lobe 102 from the remaining attachment to the bladder neck 104.
  • Fig. 7L shows the complete detachment of the dissected middle lobe 102, wherein the detached middle lobe 102 is pushed through the bladder neck 104 into the bladder, wherein it is morcellated using a morcellator.
  • FIGs. 8A to 8C Another example of using device 10 for prostate resection is shown in Figs. 8A to 8C, which schematically illustrate a prostate resection via the endoscopic route.
  • the resection is started by cutting the protruding prostatic tissue of the right lobe 101a, by engaging it into the concavity of the deflected device 10 and applying the water jet on the protruding prostatic tissue of the right lobe 101a.
  • Device 10 is pulled back while continuously applying the water jet, and the tissue is cut in a slice-like manner.
  • Resection is started at the bladder neck 104 and toward the veru-montanum 103, and as shown in Figs. 8A-8C, almost the entire right lobe 101a is detached from the surgical capsule.
  • the cutting and dissection of the left lobe 101 b is the same as described in Figs 8A to 8C regarding the right lobe 101a.
  • the device of the invention can also be used for cutting and dissecting during an orthopedic endoscopic procedure that is generally performed in a liquid environment, such as a physiological saline solution.
  • a liquid environment such as a physiological saline solution.
  • the following example will schematically illustrate the use of device 10 as shown by any of the Figs. 2 to 5 during a knee arthroscopy, when there is a torn meniscus.
  • the trocars 82a and 82b for the working elements, endoscope 81 and device 10 must be introduced into the knee articulation.
  • device 10 is introduced into the knee through one of the trocars, such as trocar 82b.
  • Fig. 9 schematically illustrates the right knee after the introduction of endoscope 81 and device 10.
  • the right knee consists of the following main elements: medial collateral ligament 83, articular cartilage 84, patella 85, PCL 86, femur 87, ACL 88, medial meniscus 89, tibia 90, fibula 91 , lateral meniscus 92 and lateral collateral ligament 93.
  • device 10 of Fig. 5 is used for dissecting and cutting a diseased ligament tissue or cartilage, such as medial meniscus 89, articular cartilage 84 etc., from the healthy tissue.
  • the flexibility and the deflection ability of the tip of device 10 permits to direct the fluid jet at an angle of approximately 90 degrees to the tissue, although the knee environment is relatively narrow and has an irregular articular space.
  • a fluid jet pressure of between 20 to 100 atmospheres is required, whereas normally a fluid jet pressure of 15 to 40 atmospheres would be sufficient for a prostate operation.
  • changing the approach angle to an acute angle of less than 60 degrees by a suitable deflection of device 10 will allow dissection of the diseased tissue from an adjacent healthy tissue.
  • the blood vessels that are encountered can be sealed by the hemostatic means of device 10 (i.e., by electrode 21 ).
  • device 10 of Fig. 2A can be used for tissue abrasion, such as on skin or on cartilage. Abrasion is obtained due to the ellipsoid-like shape that the converging jets create at the region 15.

Abstract

A multipurpose fluid jet device (10) for cutting, dissecting, abrading and/or hemostasis, comprising: (a) fluid jet forming means for generating a high pressure fluid jet used for performing the cutting, dissecting or abrading interventions; (b) one or more irrigation channels (12,13a, 13d) for directing said generated fluid from a nozzle located in a distal part of the apparatus; (c) a jet neutralizing or weakening means (193, 194) situated at the nozzle; (d) a shaft (11) for housing the fluid jet forming means and channel, or channels. A surgical method for cutting, dissecting or abrading, comprising; (a) forming one or more cutting jets using a high pressure liquid, being emitted from the distal end of a hand-held device (10) ; (b) forming additional jet or jets (193,194) for neutralizing or weakening the cutting jets.

Description

Multipurpose Fluid Jet Surgical Device
Technical Field
This invention concerns multipurpose medical instruments for diverse surgical fields. The invention relates in particular to such surgical instruments which use high-pressure liquid jets.
Background Art
Traditional instruments for tissue cutting and dissection, such as scalpels and scissors, which are frequently used by medical personnel, have various limitations and drawbacks.
A major problem in prior art devices is that, when cutting tissue with a liquid jet, it is sometimes hard to control the depth the jet penetrates the tissue. This is a major drawback, because the jet might penetrate the tissue way too deep and cause injuries to adjacent organs and blood vessels.
Another basic drawback of cutting and dissection by traditional instruments is the bleeding that has to be controlled by means of an additional hemostatic device, or by changing the instrument used for the dissection with a hemostatic device. This drawback is particularly severe when working in narrow spaces or in difficult-to-access areas, such as occurs during endoscopic or laparoscopic procedures. Methods that use electrosurgical, ultrasonic and laser tools partially overcome that drawback by performing hemostasis concomitantly with, or subsequently to, cutting, through conversion of electrical, vibratory, mechanical or laser energy, respectively, into thermal energy that seals bleeding vessels.
However, such methods, employing thermal energy, may cause also inadvertent damage to the remaining normal tissue, resulting in the necrosis thereof at various depths. For example, during endoscopic prostatectomy, application of electrosurgical energy to tissue for cutting and hemostasis may induce inadvertent thermal injury to the remaining tissue, and does not completely prevent bleeding. Therefore, a relatively significant blood loss may occur, which requires continuous postoperative bladder irrigation and might require blood transfusion. Additionally, the thermal injury inflicted on remaining tissue causes significant irritative lower urinary tract symptoms for weeks after the operation.
In prior art devices, high temperature levels are used during the entire operation, during cutting and hemostasis and the resulting burn is deep, extensive and painful. Moreover, when using electrical current for electrocautery, the passage of this current and the tissue heating are very painful. Furthermore, the temperature used with these is higher than 100 Centigrade.
A method that uses laser energy devices, based on various sources such as neodymium, yttrium, aluminum garnet or holmium, to resect, evaporate or ablate the obstructing prostatic tissue, generally results in better hemostasis than electrosurgical devices. However, the use of such devices may also be associated with significant postoperative irritative urinary symptoms, due to thermal injury to the remaining prostatic tissue. Methods of prostatic ablation by laser energy, that do not remove the necrotic tissue during the operation, may result in postoperative urethral obstruction and in the need for prolonged bladder catheterization for several days and even for weeks.
Other thermal ablation methods of the prostate, based on radio frequency or microwave energy, are relatively less effective in relieving urethral obstruction than electrosurgical resection of the prostate or laser prostate ablation. These thermal ablation methods are also associated with significant irritative symptoms, due to diffuse thermal injury to the remaining prostatic tissue. Furthermore, the ablation procedures, which generate tissue heating, induce local visceral pain, which requires mostly general or regional anesthesia.
Unlike the aforementioned methods, a liquid lance cutter does not heat the tissue by its liquid jet, and inflicts less damage to adjacent tissue. Liquid jet-based instruments cut tissue by dislodging small fragments of tissue by the kinetic energy of the high- pressure liquid jet, and separate the tissue along its path. Fluid jet instruments known in the art and used in surgery are devised for general surgery, for neuro-surgical interventions, ocular interventions and dental procedures. A liquid jet may also be used for separating tissues along a relatively least resistance path represented by preformed or natural planes. There is minimal heating of the surrounding tissue during this process, and therefore the damage to remaining tissue is relatively minor. Visceral organs have pain receptors that are mainly sensitive to intense heat and distension, but are less sensitive to sharp mechanical pressure, e.g., cutting or water jet dissection. Since heating by water jet dissection is relatively minimal, it results in less visceral pain, and it can be performed under local anesthesia combined with general sedation. During cutting and dissection using moderate pressure liquid jets, relatively small vessels are cut or torn, and most of them stop bleeding spontaneously, but larger vessels and harder structures like fibrous bands and fascia are spared.
Using relatively higher-pressure jets to cut more resilient or harder structures can be unsafe, due to possible bleeding from the larger vessels and inadvertent injury to the adjacent structures. Therefore, an assistant has to perform hemostasis, or the liquid lance has to be changed by the operator to another tool to seal larger vessels and to cut the remaining structures that still connect the separated tissue.
Another problem that may occur while working with a liquid jet: fluids and tissue debris pooling at the operating site may obscure the incision site and necessitate the interruption of the procedure for reassessment or for suction. In addition, back- splashing of potentially contaminated emulsified tissue to the surrounding normal tissue, to the viewing camera and to the operator team may occur.
These drawbacks and hazards may be alleviated when performing endoscopic procedures in a liquid environment. For example, in urological interventions, regular endoscopes employed are provided with continuous fluid irrigation and with means for the evacuation of the accumulated fluids, blood and tissue debris, thus permitting a clear view of the operation site. During operation in a gaseous environment, separate suction of the accumulated liquid may be required.
Cutting of tissue by a liquid jet is optimal when the jet is directed at an approximately right angle to the tissue, whereas separating tissues along preformed planes necessitates application of the jet parallel to that plane in order to avoid injury to the separated tissues. However, these requirements are particularly restrictive for the application of a liquid jet instrument through narrow and hardly accessible spaces.
Following is a list of prior art patents, with an indication of some of the drawbacks thereof.
Japanese Patent No. 262,528 discloses a laparoscopic surgical method and device that is used to improve the safety of surgery, by separating biological tissue after incising an organ serous membrane by passing a high frequency electrical current to the tip of a nozzle inserted into an abdominal cavity through a trocar, and inserting the tip of the nozzle from the incision and swelling the subserous layer by jetting a high pressure liquid of a specified pressure. However, this instrument is directed to perform hydro dissection and not to cut tissues by fluid jet. Furthermore, since it is not deflectable it cannot reach difficult-to-access sites.
European Patent No. 280,972 discloses a hand piece for liquid-jet cutting apparatus from which a liquid jet emerges at high pressure via an end-piece. The end-piece is designed as an active coagulation electrode of a high-frequency surgery apparatus. The electrode can be either a mono-polar or a bipolar coagulation electrode. The apparatus can cut tissues by the liquid jet as well as perform coagulation during the operation by the smooth nozzle. However, the cutting of harder tissue and of more resilient structures like fibrous bands and coagulated blood vessels necessitate relatively higher pressures of the liquid jet, or significant energy from the electrosurgical unit. This can be a major drawback in some resections, such as a prostate resection, where for safety reasons a relatively low liquid jet pressure and minimal electrosurgical energy are required to prevent injury to the adjacent structures. Furthermore, there is no control on the depth the jet might penetrate into the tissue or adjacent organs. The apparatus does not have deflection ability, and therefore it may be difficult to introduce into certain regions while cutting and dissecting.
US Patent No. 5,505,729 discloses a process and apparatus for high-pressure liquid cutting of organic tissue, in which a high-frequency electric current is transmitted through an electrically conducting liquid cutting jet, so that simultaneous coagulation of small vessels is possible during cutting with the liquid jet. However, the apparatus is adapted to an air environment, and is not functional in a conductive liquid environment. Furthermore, the transmitted thermal energy is low and insufficient to seal larger blood vessels. Moreover, the cutting of harder tissue and more resilient structures like fibrous bands and coagulated blood vessels requires relatively higher pressures of liquid jet. This can be a major drawback, in some endoscopic resections, where for safety reasons a fairly low liquid jet pressure is required in order to prevent injury to adjacent structures. Furthermore, there is no control on the depth the jet might penetrate into the tissue or adjacent organs. Moreover, the apparatus does not have deflection ability, and therefore it may be difficult to introduce to certain regions while cutting and dissecting. Other prior art patents may include the following:
US Patent No. 5,944,686 DE 3421390 (Germany) US Patent No. 4,898,574 US Patent No. 3,818,913 US 2002177802
Applicant believes the liquid jet instruments and methods as described above do not provide satisfactory solutions to the problems inherent to cutting through harder tissue and more resilient structures, such as fibrous band and coagulated blood vessels. They do not achieve the goal of using liquid jet pressures that are safe and usually do not cause inadvertent injury to adjacent tissues and do not penetrate way to deep.
Furthermore, prior art fluid jet instruments and methods as described above do not address the need for a multipurpose surgical liquid jet instrument having deflectability capabilities for endoscopic surgery.
It is an objective of the present invention to provide for a multipurpose liquid cutting instrument suitable for performing liquid jet dissection, cutting and abrading, with means for overcoming the abovedetailed deficiencies. Disclosure of Invention
It is an object of the present invention to provide for a multipurpose liquid cutting instrument suitable for performing liquid jet dissection, cutting and abrading.
This object is achieved by a cutting, dissecting and/or abrading apparatus for surgery, as disclosed in claim 1.
It is an object of the present invention to provide a multipurpose liquid cutting instrument that is provided at its distal end with means that cause neutralization or reduction of the energy of the cutting jets after a specific trajectory length, thus limiting the depth of tissue penetration. This increases significantly its safety.
Another object of the invention is to provide a cutting instrument suitable for performing liquid jet dissection, cutting and abrading while providing a converging set of jets with controllable penetration of the tissue. The use of a proper angle between the jets causes reciprocal jet neutralization or weaken significantly their energy beyond their meeting point.
Selective hemostasis is achieved by only applying heat for short time periods, when this is necessary. The surgery itself is performed using cold liquid jets; immediately following the surgical procedure, hot jets are applied to achieve hemostasis.
This prevents or decreases the extent of damage to adjacent tissue and the pain inflicted on the patient. It is another object of the present invention to provide a liquid cutting instrument suitable for performing tissue cutting, dissection and abrading, and which by being deflectable can direct the liquid jet at the necessary angle in difficult-to-access spaces.
It is a further object of the present invention to provide a fluid cutting instrument suitable for performing suctioning during the cutting, dissection and/or abrading with the instrument.
It is still a further object of the present invention to provide a fluid cutting instrument that can be used to perform selected endoscopic surgery with the patient under local anesthesia combined with sedation.
It is still another object of the present invention to provide a fluid jet cutting instrument that can be easily manipulated with one hand.
It is yet a further object of the present invention to provide a fluid cutting instrument that is disposable, thus eliminating the risk of contamination from one patient to another.
Other objects and advantages of the invention will become apparent as the description proceeds.
The invention is related to a cutting, dissecting and/or abrading apparatus for surgery, comprising:
(a) fluid jet-forming means for generating a high pressure fluid jet;
(b) an irrigation channel, or channels for directing said generated fluid jet;
(c) a jet neutralizing, deflecting or weakening means situated at the nozzle; and
(d) a shaft for housing said fluid jet forming means, said channel, or channels and said sub-channels.
In a preferred embodiment the jet neutralizing, deflecting or weakening means situated at the nozzle is generated by splitting the central channel, or channels in its distal end, or ends into two or more sub-channels, so that their corresponding longitudinal axis converge and meet at the same imaginary focal point to generate a combined and focused jet. The angle between the sub-channels should be large enough to permit reciprocal neutralization or weakening of the jets' energy beyond the meeting point (focal region).
The use of a too small angle between the jets may cause augmentation of the jets energy beyond their meeting point, which is to be prevented.
In case of two or more central channels, two or more pressure sources of liquid, and or gas may be connected each using a different working pressure. In case of using gas jet or jets in addition to liquid jets these gas jets may cause dispersion and weakening of the liquid jets, beyond their meeting point. However the energy of the individual jets should be enough to be able of neutralize or weaken each other significantly. The jets may be round, oval crescent like, sheet like, according to the shape of the emanating orifices.
In a preferred embodiment the nozzle is provided with means to protect the jets from being interfered with or deflected by tissues or other instruments during most, or all of their trajectory up to the focal point. This means safeguard proper reciprocal neutralization or weakening of the jets distal to the focal region. The shape of this protecting means may be for example but not limited to a circular, tron-conical, or other shaped collars at the distal end of the nozzle. This collar may be rigidly affixed to the nozzle, or it can be attached to it trough a flexible hinge region. This protecting means may be made of a rigid material or from a flexible material. The focal region of the meeting jets is preferentially distal to the distal free margins of the protecting means, but it can be also proximal to these margins in some particular embodiments.
According to another preferred embodiment, the jet neutralizing, deflecting or weakening means situated at the nozzle is designed as an extension designed as a plate for example, with its long axis parallel to the long axis of the shaft and connected to the nozzle by an elastic hinge. The extension itself may be made of a rigid or an elastic material. When the tip of the nozzle is too close to the tissue, the extension will touch the tissue and will be deflected. When deflected, the jets will touch the plate and they will be deflected, too. This setup permits cutting perpendicular to the tissue at a distance from the nozzle tip, or cutting and dissecting parallel and between tissue planes, reducing the chance of inadvertently perforating through the tissue planes .
In another preferred embodiment the jet neutralizing, deflecting or weakening means situated at the nozzle is represented by a stop plate with a handle, which can be rotated from a position opposite the jet, or jets orifice/orifices to a position which is not opposite this or these orifice/orifices. Preferentially, this movement should be around an axis perpendicular to the long axis of the shaft. When the stop plate is not opposite the jet, or jets the instrument can be used to cut tissue that is not protuberant, and for hydro-dissection and mechanical blunt dissection along tissue planes without interference by the stop plate. After this initial phase, protuberant tissue is generated. Then the stop plate may be moved to a position opposite the jet, or jets and it can assist in dissecting the tissue, lifting it and in deflecting and neutralizing the jet, or jets after penetrating and cutting this tissue .
According to one preferred embodiment of the invention, the apparatus of the present invention further includes (a) means for performing the operation of tissue- coagulation or tissue-cutting, and (b) an electrode activated by closing an electric circuit during tissue coagulation.
Preferably, the operation of said means is determined according to the voltage setup of said means.
According to one preferred embodiment of the invention, the apparatus of the present invention further includes evacuation means for evacuating residue, fluids and/or gas from the area centered by the contact zone of the combined fluid jets and a target tissue, and/or for partially preventing back-splashing.
Preferably, the evacuation means comprises (a) a tube connected to a gas source at its proximal end for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the combined fluid jets, said nozzle is located near, or at the tip of the shaft; (b) suction tube and vacuum source for evacuating the residue, the fluids and/or the gas from said area and/or for preventing back-splashing, the opening of said suction tube is located near, or at the said tip; and (c) an umbrella-like cap for capturing residue, fluids and/or gas in said area by encircling said area when the concavity side of said cap is directed toward said area and said tip is within the concavity side of said cap. Preferably, the cap is made from an elastic material that is also transparent and may be distensible.
According to a preferred embodiment of the invention, the apparatus of the present invention further includes means for deflecting the tip of the shaft. Preferably, the means for deflecting the tip of the shaft comprise pull-wires, an actuator for controlling the deflection, and at least two stiffening elements placed along the deflectable tip, for preventing deflection of the tip in an undesired direction. Preferably, the actuator has a wheel like shape, which protrudes over both the upper and lower surface of the handle of the apparatus of the present invention and the two stiffening elements are made of an elastic, but not distensible, material.
The means for deflecting the tip of the shaft of the present invention, further includes an implement for adjusting and modifying the deflected tip to a required extent. According to one embodiment of the invention the adjusting and modifying implement is a slidable stiff sheath over the deflectable tip. According to another embodiment of the invention, the adjusting and modifying implement is an advanced or withdrew stiff rod inside the shaft.
According to another preferred embodiment of the invention, the fluid jet-forming means comprises a high-pressure fluid source, or sources and a connector, or connectors for connecting the high-pressure fluid source, or sources to the apparatus.
According to still another preferred embodiment of the invention the tissue- coagulation and cutting implement is an electrode. Preferably, the shape of the electrode is selected from the group consisting of a circular ring surrounding the nozzle, a straight ribbon or band electrode, or a curvilinear, round, oval or an omega- shaped ridge.
Preferably, the electrode is connected through a conductive wire to the hemostatic unit.
According to yet another preferred embodiment of the invention, the apparatus of the present invention further includes an illuminating implement and an imaging implement that are attached externally, or through a specific channel along the shaft of the present invention. Preferably, the imaging implement is a video camera, or properly arranged optic fibers.
According to a preferred embodiment of the invention, the apparatus of the present invention further includes two or more electrodes insulated from each other, for heating the electrically conducting fluid that passes between the electrodes, in which the electrodes are mounted on the inner area surface of the main irrigating channel. The heated fluid stream, or steam jet, or jets are used to cause hemostasis.
Preferably, the electrodes are located adjacent, or at the distal end of the channel, and are connected through insulated wires that extend through the shaft to a plug located on the handle, in which the plug is connected through a cable to hemostatic unit.
According to still another preferred embodiment of the invention, the apparatus of the present invention further includes a resistive element for heating the fluid. Preferably, the resistive element is electrically insulated by heat resistant element, by ceramic material, or by a coating material. The resistive element comprises an incandescent element, which is preferably a tungsten wire.
According to another preferred embodiment of the invention, the apparatus of the present invention further includes a resistive element for producing hemostasis and cutting the tissue by direct contact heating of the tissue with the incandescent element.
According to another preferred embodiment of the invention, the apparatus of the present invention further includes an additional electrode suitable to be attached to the external body surface of a patient, when operating in mono-polar mode.
According to another embodiment of the invention, the jet-forming means of the present invention further includes one or more non-insulated ring-like electrodes which are attached to the inner surface of the irrigating channel and are connected through an insulated wire that extends through the shaft to a plug that is connected to a radio frequency source, for heating an electrically conducting irrigated liquid and for generating a hot fluid stream, or steam jet or jets that causes hemostasis.
According to a preferred embodiment of the invention, a resistive element is wrapped around a region of the channel in the shaft for heating the fluid, or steam that flows through the channel. Preferably, the resistive element is electrically insulated by a heat-resistant element or by a suitable coating and is connected to an electric source.
According to another preferred embodiment of the invention, the jet-forming means of the present invention further includes an external source of hot fluid, or heated steam connected to the channel through a side connector.
According to a further preferred embodiment of the invention, the jet-forming means of the present invention further includes an external source of local anesthetic solution connected to the channel through a side connector. This local anesthetic solution is entrained by the irrigation fluid during jetting and induce local anesthesia at the operation site.
According to still further preferred embodiment of the invention, the apparatus of the present invention further includes a suitable channel that passes through the length of the shaft for introducing hemostatic implement of an external hemostatic unit. Preferably, the hemostatic implement is at least one electrode.
Preferably, the hemostatic unit is selected from the group consisting of electrosurgical, radio frequency, hot liquid, steam, laser energy, ultrasonic waves, or any other suitable device that can perform hemostasis and/or cutting.
According to one preferred embodiment, the apparatus of the present invention is incorporated into a multipurpose surgical or endoscopic device. Preferably, the multipurpose surgical or endoscopic device further includes forceps, graspers or clipping means.
According to another preferred embodiment of the invention, the jet-forming means of the present invention further includes an active mono-polar electrode that transmits the electrical current through an ionized hot steam jet that flows through the irrigating cannel and impacts the tissue at the operation site. This instrument is adequate for performing hemostasis by the hot steam jet and additionally by the electrosurgical effect of the transmitted current in gaseous environment.
The invention further relates to a method for the endoscopic prostatectomy with a cutting and dissection device of the apparatus of the present invention, comprising: (a) positioning the deflection tip part of the device within the prostatic urethra, through an endoscope sheath and under vision; (b) providing a high-pressure fluid jet, between the lateral lobes of the hyperplastic prostate and the middle lobe, for performing incisions; (c) dissecting retrogradely the lateral lobes and the middle lobes from the prostatic surgical capsule; and (d) performing continuously hemostasis of encountered bleeding vessels by tissue-coagulation implements.
Preferably, the pressure of the fluid jet varies between 10 to 60 atmospheres.
Brief Description of Drawings
The invention will now be described by way of example and with reference to the accompanying drawings in which:
Fig. 1 schematically illustrates a basic surgical device 1 for cutting and dissecting, according to one embodiment of the prior art;
Fig. 2A schematically illustrates a fluid jet based surgical device for cutting, dissecting and/or abrading tissues, according to a preferred embodiment of the invention; Fig. 2B details the angle of the fluid jets as required for their mutual neutralization beyond the focus region
Fig. 2C illustrates jets momentum and preferred neutralizing angles.
Figs. 2D and 2E detail a front view of the tip of a device using two jets and four jets, respectively.
Figs. 2F and 2G illustrate a surgical device with an off-axis focus.
Fig. 2H schematically illustrates a collar for protecting the liquid jets.
Fig. 21 schematically illustrates an extension or plate for protecting the liquid jets.
Figs. 2J and 2K schematically illustrate jet neutralizing means using a rotatable plate.
Figs. 3A and 3B schematically illustrate the surgical device of Fig. 2A provided with tissue-coagulation means, according to another preferred embodiments of the invention;
Fig. 3C details the block diagram of a precision temperature control system
Fig. 4A schematically illustrates the surgical device of Fig. 2A provided with evacuation means, according to another preferred embodiment of the invention;
Fig. 4B schematically illustrates the profile of the tip region of the surgical device of Fig. 4A, in a cross section form;
Fig. 5 schematically illustrates the surgical device of Fig. 3A provided with a deflection mechanism, according to another preferred embodiment of the invention;
Fig. 6 schematically illustrates the deflection mechanism of device 10 of Fig. 5, according to one preferred embodiment of the invention;
Figs. 7A to 7L schematically illustrate the use of device 10 of Fig. 5, during a prostate resection;
Fig. 8A to 8C schematically illustrate an additional way to use device 10 of Fig. 5, during a prostate resection;
Figs 9 schematically illustrate the use of device 10 of Fig. 5, during a knee arthroscopy;
Figs. 10A and 10B schematically illustrates a device 10 of Fig. 5, provided with an adjustable length of the deflected part, according to another preferred embodiment of the invention;
Fig. 11 schematically illustrates a device 10 of Fig. 5, provided with illuminating means and imaging means, according to another preferred embodiment of the invention;
Fig. 12A schematically illustrates the tip region of the device 10, according to another preferred embodiment of the present invention; Fig. 12B is a cross-section taken along the B-B plane of Fig. 12A;
Fig. 13 schematically illustrates the device 10 of Fig. 2A, provided with ring-like electrodes for generating a hot fluid stream for local hemostasis, according to another preferred embodiment of the invention;
Fig. 14 schematically illustrates the device 10 of Fig. 2A, provided with an external source container, according to another preferred embodiment of the invention;
Fig. 15 schematically illustrates the device 10 of Fig. 2A, provided with an active mono-polar electrode adapted for gaseous environment, according to another preferred embodiment of the invention;
Fig. 16 schematically illustrates the device 10 of Fig. 2A, provided with a detachable unit, according to another preferred embodiment of the invention;
Fig. 17A schematically illustrates the tip region of device 10 provided with resistive element, according to another preferred embodiment of the present invention;
Fig. 17B is a cross-section taken along the B-B plane of Fig. 17A;
Fig. 18 schematically illustrates the device of Fig. 2A provided with an incandescent element, according to another preferred embodiment of the invention;
Fig. 19 schematically illustrates the device of Fig. 2A, according to another preferred embodiment of the invention. Modes for Carrying out the Invention
A preferred embodiment of the present invention will now be described by way of example and with reference to the accompanying drawings.
The above and other characteristics and advantages of the invention will be better understood through the following illustrative and non-limitative detailed description of preferred embodiments thereof, with reference to the appended drawings.
The surgical device of the present invention is used for cutting, dissecting and/or abrading tissues by utilizing relatively high-pressure liquid jets, which are provided with two or more orifices located at the distal end of that surgical apparatus.
Fig. 1 schematically illustrates a basic surgical device 10 for cutting and dissecting, according to one embodiment of the prior art. The surgical device 10 comprises shaft 11 , channel 12 for directing the high-pressure liquid jet towards the incision area, handle 14 for holding and/or operating the surgical device 10 and connector 16 through which the fluid source is provided. In the prior art, surgical devices, such as device 10, use a fluid jet in a required pressure towards the tissue in order to perform the incision. A problem in such devices is that the liquid jet might penetrate too deep into the tissue, more than it is desired, thereby causing injuries to other tissue and/or organs.
The surgical device according to the present invention can be used in various surgical procedures, for example: laparoscopic surgery, thoracoscopic surgery, neurosurgery, ophthalmology, corneal reshaping, lens surgery, orthopedic surgery, endoscopic surgery such as excision of gastric or colonic polyps, endoscopic urologic surgery such as endoscopic prostatectomy, endoscopic resection of bladder tumors, endoscopic lithotripsy (fragmentation of stones), endoscopic fragmentation of billiary stones, dental surgery, ear, nose and throat surgery, endoscopic sinus surgery, dermal abrasion, dermatology, debridment of chronic ulcers and pressure sores, plastic surgery, endoluminal vascular re-channeling, heart surgery, cosmetic surgery, gynecology (endoscopic resection of miomas) .
Fig. 2A schematically illustrates a surgical device 10 for cutting, dissecting and/or abrading tissues, according to a preferred embodiment of the invention. The surgical device 10 comprises a shaft 11 , a handle 14, a connector 16 and a channel 12, that continues at its distal end with at least two sub-channels, such as 13a and 13d, so that their corresponding longitudinal axis meet at the same imaginary region 15. The imaginary region 15 is the focal region of the converging jets that stream from the sub-channels 13a, 13d and preferably, the converging jets at region 15 may produce an ellipsoid-like form of negligible thickness.
In a preferred embodiment, the surgical device 10 comprises the basic elements for cutting, dissection and/or abrading tissues. The pressure at the converging region of all the jets (i.e., at the imaginary region 15) will be the pressure required to perform the cutting, dissecting and/or abrading of tissues. The pressure at a small distance 196 beyond focal region 15 drops significantly, due to reciprocal neutralization, or weakening of the jets beyond the focal region. Therefore, there will be no involuntary relatively deep penetration of the fluid jet into the tissue or other organs, and no resulting damage.
It is an object of the present invention to provide a multipurpose liquid cutting instrument that is provided at its distal end with means that cause neutralization or reduction of the energy of the cutting jets beyond a specific trajectory length, thus limiting the depth of tissue penetration. This increases significantly its safety.
This is achieved by providing a converging set of jets with controllable penetration of the tissue. The use of a proper angle between the jets causes reciprocal jet neutralization, or weakens significantly their energy beyond their meeting point. Thus the new device is akin a scalpel - a sharp instrument at its cutting edge, not affecting the patient's body beyond that point.
Preferably, the device uses a liquid jets pressure between 10 and 150 atm. The liquid jet diameter may be in the range 0.05 to 0.6 mm.
Accordingly, Fig. 2B details the angle of the fluid jets as required for their mutual neutralization beyond the focus region.
The novel cutting, dissecting and/or abrading apparatus 10 for surgery may thus include: (a) liquid jet-forming means for generating a high pressure fluid jet; The liquid is a physiological liquid.
(b) an irrigation channel, or channels for directing said generated liquid jet;
(c) a jet neutralizing, deflecting or weakening means situated at the nozzle; and
(d) a shaft for housing said liquid jet forming means, said channel, or channels and said sub-channels.
Fig. 2B details the angle 195 between the liquid jets 193, 194 as required for their mutual neutralization in the area 196 beyond the focus region 15. In one preferred embodiment, the angle 195 between the jets is in the range 40 to 60 arc degrees.
In another preferred embodiment, the angle 195 between the jets is in the range 50 to 80 arc degrees.
In yet another preferred embodiment, the angle 195 between the jets is in the range 40 to 90 arc degrees.
For each desired application, the angles range can be found that results in effective jets neutralization beyond the meeting point of the jets (the focus) . The specific value of that angle 195 may depend on the number of jets being used, the specific liquid type, temperature, fluid pressure, orifice diameter, etc.
In a preferred embodiment, the device or its tip is disposable, and a plurality of such devices are available to the surgeon, each having a specific angle. The surgeon then chooses the instrument best suited for the task at hand.
In another embodiment, a replaceable nozzle is mounted at the instrument's distal end. Various nozzles may be provided, each with a different angle of the emerging liquid jets.
In a preferred embodiment, the jet neutralizing, deflecting or weakening means situated at the nozzle is generated by splitting the central channel, or channels in its distal end, or ends into two or more sub-channels such as illustrated with sub-channels 13a and 13d, or 13a to 13d (see Figs. 2D and 2E), so that their corresponding longitudinal axis converge and meet at the same imaginary focal point to generate a combined and focused jet. The angle 195 between the sub-channels should be large enough to permit reciprocal neutralization or weakening of the jets' energy in the area 196 beyond the meeting point 15 (focal region). This focal region may be along the long axis of the shaft, or it can be at an angle with this long axis of the shaft.
The present inventor has found that too small an angle between the jets may cause augmentation of the jets energy beyond their meeting point, which is to be prevented. Rather, by using a larger angle between the jets, the desired effect is achieved, that the jets neutralize or at least weaken each other past the focal region, see Fig. 2B. The specific angle between the jets to be used may vary, according to various parameters such as type of liquid, working pressure, temperature, orifice diameter, etc.
Fig. 2C illustrates jets momentum and preferred neutralizing angles. This is the result of a simulation aimed at evaluating the effect of two jets neutralizing each other on impact, or at least weakening each other to a considerable extent.
The two graphs there show a preferred neutralizing angle (this is actually half of the angle and should be multiplied by 2 for obtaining the best angle between two jets at which the jets will neutralize each other at a given pressure) and a second graph that shows the change of jets momentum as a function of distance from nozzle tip for a given pressure of 40 atm. The model used for the above simulation was a non-time-dependent model (equilibrium state), using a Star CD finite element flow simulation software. The model assumed that two water jets were ejected in water and meet at some point.
The momentum at the meeting point and beyond this point on the symmetry line between the jets has been calculated. The relative momentum represents the quotient of the momentum at various distances from the meeting point and the momentum at the meeting point. The parameters used were liquid pressure in the irrigating cannel, jet orifices diameter and half-angle (angle between each jet and the symmetry line between the jets) between the jets.
The optimal half-angle between two jets is chosen from a group of curves showing the decrease in relative momentum as a function of distance from the meeting point for various liquid pressures in the irrigating channel at a given orifice diameter. The optimal angle is chosen as the smaller angle that its increment cause a small curve shift.
One of the graphs depicts the optimal half-angle as a function of various liquid pressures between 20 and 40 atm.
The second graph depicts the decrease of the relative momentum at various distances from the meeting point on the symmetry line between the jets, at a liquid pressure of 40 atm, and orifices diameter of 0.3 mm.
The model is similar to a device used for cutting in liquid environment using two water jets meeting at a focal point. The optimal angle will permit cutting at the meeting point and weakening of the jets beyond this point permitting safe tissue cutting. Figs. 2D and 2E detail, by way of example, two embodiments of the invention, including a front view of a device's tip using two jets and four jets, respectively. The liquid jets are generated by the channels 13a and 13d as illustrated in Fig. 2D, or the channels 13a to 13d as illustrated in Fig. 2E.
The cross-sectional shape of the jets may be circular, oval, crescent-like, sheet-like, and as defined by the shape of the emanating orifices.
Figs. 2F and 2G illustrate a surgical device 10 with an off-axis focus 15. The focal region 15 may be along the long axis 106 of the shaft, or it can be at an angle with this long axis of the shaft. The jets do not have to meet on the axis of symmetry 106 of instrument 10.
That is, the two liquid, high pressure jets 193, 194 are meeting at a point 15 which is located off the axis of symmetry 106 of the device 10.
According to this preferred embodiment of the invention, each of the provided jets 193, 194 is at an angle with respect to the axis 106 of the apparatus, so that their corresponding longitudinal axes meet at the same point 15 (in the focal region). The basic elements of the surgical device, such as the channels that directs the jets towards the required meeting point where the two or more jets are converged, together with optional elements (if existing) are located within a shaft. The shaft is used for housing those elements thus allowing them to function as a single unit.
This structure allows more maneuverability, for efficient surgery in difficult to reach places. Fig. 2H schematically illustrates a collar 61 for protecting the liquid jets 193, 194. Thus, the nozzle is provided with means 61 to protect the jets 193, 194 from being interfered with or deflected by tissues or other instruments, during most, or all of their trajectory up to the focal point 15.
These means 61 can safeguard proper reciprocal neutralization or weakening of the jets distal to the focal region. The shape of this protecting means may be, for example but not limited to, a circular, tron-conical, or other shaped collars at the distal end of the nozzle.
The collar 61 may be rigidly affixed to the nozzle, or it can be attached to it trough a flexible hinge region. This protecting means may be made of a rigid material or from a flexible material. The focal region of the meeting jets is preferably distal to the distal free margins of the protecting means, but it can be also proximal to these margins in some particular embodiments.
Fig. 21 schematically illustrates an extension or plate for protecting the liquid jets. In this preferred embodiment, the jet neutralizing, deflecting or weakening means situated at the nozzle further includes extension means shaped as a plate 62 for example, and connected to the nozzle by an elastic hinge 621 . The plate 62 itself may be made of a rigid or an elastic material.
Preferably, the stop plate 62 is fabricated from a strong plastic or from metal, that can sustain without damage the energy of the tissue cutting jets, when using liquid pressures of up to 150 atm. When the tip of the nozzle is too close to the tissue, the extension will touch the tissue and will be deflected. When deflected, the jets 193, 194 will touch the plate 62 and will be deflected, too. This setup permits cutting perpendicular to the tissue at a distance from the nozzle tip, or cutting and dissecting parallel and between tissue planes, reducing the chance of inadvertently perforating through the tissue planes.
Figs. 2J and 2K schematically illustrate jet neutralizing means using a rotatable plate 63. In this embodiment, the jet neutralizing, deflecting or weakening means situated at the nozzle of device 10 include a stop plate 63 which can be rotated about by the surgeon, using a handle for example.
The plate 63 can be rotated from a position opposite the jet, or jets orifice/orifices (see Fig. 2J) to a position which is not opposite this or these orifice/orifices (see Fig. 2K) . In one preferred embodiment, the movement can be around an axis 632 which is perpendicular to the long axis of the shaft of instrument 10. Rod means 631 connects plate 63 with axis of rotation 632. Other embodiments for a rotatable plate 63 are possible.
When the stop plate 63 is not opposite the jet(s) , the instrument can be used to cut tissue that is not protuberant, and for hydro-dissection and mechanical blunt dissection along tissue planes without interference by the stop plate.
After this initial phase, protuberant tissue is generated. Then the stop plate 63 may be moved to a position opposite the jet or jets and it can assist in dissecting the tissue, lifting it and in deflecting and neutralizing the jet, or jets after penetrating and cutting this tissue.
According to another aspect of the present invention, Gas jets may be used for neutralizing or weakening the liquid jet/jets used in surgery, by changing them to aerosols after the meeting point. Thus, one or more liquid jets are used for surgery, with one or more gas jets being used to weaken or neutralize the liquid jet(s) beyond the focus. The above structure may be used only in gaseous environments.
In such embodiments gas jets, in addition to weakening the liquid jets, may also clear the incision site, improving the visibility there by preventing pooling of liquid.
Then, the aerosols are entrapped by an elastic cup provided at the end of the instrument and are evacuated by the evacuation channel also provided. The pressure required for the gas jets or steam jets should be up to a few Atm., and orifice diameter should be between 0.01 to 0.7 mm.
In case of two or more central channels, two or more pressure sources of liquid, or gas, may be connected each using a different working pressure. In case of using gas jet or jets in addition to liquid jets these gas jets may cause dispersion and weakening of the liquid jets, beyond their meeting point. However, the energy of the individual jets should be enough to be able of neutralize or weaken each other significantly.
The gas or steam jets will not inflate the patient, since the working system has a passive or active evacuation means for gas and/or liquid. According to another preferred embodiment of the invention, the surgical device 10 further includes elements for performing tissue-coagulation and/or cutting. The tissue-coagulation or the tissue cutting operation of these elements is determined according to their applied voltage setup.
Preferably but not limitatively, the tissue- coagulation and cutting means comprise at least one electrode means for physically performing the coagulation or the cutting of resilient tissue when placing its surface on the tissue, and additional electrode means for closing an electric circuit during tissue coagulation, thereby provides the electricity to the electrode that physically performs the tissue coagulation or cutting of resilient tissue.
For example, Figs. 3A, 3B schematically illustrate the surgical device 10 with tissue- coagulation or cutting of resilient tissue means using bipolar electrodes, according to another preferred embodiment of the invention. In this embodiment, the surgical device 10 comprises, in addition to the aforementioned basic elements, active electrode 21 for physically performing the tissue-coagulation or cutting of resilient tissue and inactive electrode 22 for closing the electrical circuit. Both electrodes are wired (e.g., by conductive wire 221) to an external hemostasis unit, via connector 23 on handle 14. Alternatively, the device 10 may operate in a mono-polar mode, implying that an inactive electrode (not shown), such as inactive electrode 22, is attached externally to the patient skin.
Preferably, the active electrode 21 is a smooth or ridge-shaped electrode.
The active electrode 21 is used generally for stopping the flow of blood (i.e., hemostasis), while the high-pressure liquid jet is used for cutting and dissecting tissues. Cutting of resilient tissue can be performed also by the electrode using an adequate voltage setup. A closed positioned relationship of the fluid jet nozzle and the edge of electrodes 21 of the hemostatic unit permits the sealing of blood vessels as they are encountered during cutting and dissection with device 10. Hemostasis is obtained, for example, by a contact of the tip of active electrode 21 with the tissue and intense tissue heating by the high current densities generated by connecting the active electrode 21 to an electrosurgical unit. However, by increasing the provided voltage to the active electrode 21 , it may also perform tissue cutting. The cutting is obtained due to relatively high heat of the electrode 21 as a result of the increased voltage.
Selective hemostasis is achieved by only applying heat for short time periods, when this is necessary. The surgery itself is performed using cold liquid jets; immediately following the surgical procedure, hot jets are applied to achieve hemostasis.
This prevents or decreases the extent of damage to adjacent tissue and the pain inflicted on the patient.
In a preferred embodiment of the present invention, a hot jet is only used for less than 10% of operating time and only for stopping bleeding (hemostasis), whereas prior art devices use high temperature jets/instruments during the entire operation: during cutting and hemostasis.
Moreover, the temperature used with hot jets is lower, usually less than 100 Centigrade.
Hemostasis is achieved by the fluid jet pressure that collapses blood vessels and by the heat conveyed by the hot jet to tissue that cause blood vessel sealing. Steam jets may be used for hemostasis, both in a liquid or a gaseous environments. The jet is applied for 5 to 10 sec each time and causes hemostasis by the pressure of the jet and the sealing effect of the heat transmitted to the bleeding vessels. Actually a hot liquid jet can be converted to a steam jet by overheating the incoming liquid. The advantage of a steam jet over a liquid jet is that it can convey more heat to tissue compared to a liquid jet.
When using a steam jet in a liquid environment for a short distance, the jet is not intended to cut tissue and even if it is loosing some of its coherence it may still apply enough pressure and transmit enough heat to bleeding vessels to cause hemostasis.
The steam jet temperature may be up to 150 centigrade, and its pressure up to a few atm. The gas jets may be used only in a gaseous environment.
According to another preferred embodiment of the invention, the surgical device 10 further includes evacuation means for evacuating residue, fluids and/or gas from the area centered by the contact zone of the converging fluid jets and/or for partially preventing back-splashing of potentially contaminating material to the operator or to the tissue.
Fig. 3C details the block diagram of a precision temperature control system, which may be used with various heater means, such as illustrated in the present disclosure.
The system has two basic functions: a. To maintain a precise temperature, as set by the surgeon; this is the hot liquid or steam temperature required for hemostasis. b. to apply the above hemostasis temperature for a limited time only, either allowing manual activation thereof, or automatic application at preset time intervals and duty cycles.
The temperature control system includes a controller 651 connected to an electrical mains power source 652 and electrical heater means 653. The heater means 653 may include for example an electrodes pair, an incandescent element, resistive element, a source of ultrasonic or radio frequency energy, etc.
The controller receives temperature readings from a temperature sensor 654.
The temperature sensor 654 may be immersed in the liquid used to form the high pressure jets. The sensor may comprise a thermistor or a solid state sensor, for example.
According to the instantaneous actual temperature, the controller applies electric power to the heater 653 or disconnects it, to keep the high pressure jets at the required temperature.
The closed loop is only activated at predefined time periods, otherwise the high pressure jets use a cool liquid (not heated).
The controller 651 further includes input means 661 for setting the required temperature. The surgeon may set up the temperature before the operation. Another input is the manual activation means 662, for immediate activation of the heating process when desired. Thus, the surgeon, by pressing a button for example, may initiate hemostasis after performing the surgery. The hemostasis may be activated automatically using a timer 655 means. The inputs to the timer 655 may include, for example, a cycle time control input 663 and a heating time interval input 664.
Indicator means 666 may be used to indicate to the surgeon when the heating is activated. This may include a visual and/or audio indicator means.
Fig. 4A schematically illustrates the surgical device 10 provided with evacuation means, according to another preferred embodiment of the invention. In this embodiment, either with or without addition to the tissue-coagulation means and to the aforementioned basic elements, the surgical device 10 further includes a tube 31 connected to a gas source 310 at its proximal end, for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the converging fluid jets, suction tube 33 and vacuum source 34.
The suction tube 33 and the vacuum source 34 are used for evacuating the residue, the fluids and/or the gas from the incision area and/or for preventing back-splashing. According to this embodiment, an umbrella-like cap 35 is provided for capturing residue, fluids and/or gas in the incision area. Cap 35 captures residue, fluids and/or gas by encircling and covering the incision area with the concave side of cap 35 is directed toward the incision area. Cap 35 covers the orifices of the entire sub-channels nozzles 13a and 13d, the nozzle of tube 31 and the opening of the suction tube 33, as shown in Fig. 4B.
There may be more than one suction orifice and/or gas nozzles, and the shape and position of the gas nozzle and suction orifice can vary as known to those skilled in the art. Applying suction to tube 33 through vacuum source 34, either with or without the gas stream, will evacuate any existing residues (e.g., secretions and tissue debris), liquids and/or gas, thus improving the view and permitting a more precise application to the tissue of the fluid jet and, if provided, of the hemostatic means.
According to a preferred embodiment of the present invention, the evacuating operation allows cutting tissue and cleaning of this operated area at the same time, thus it is not necessary to stop the cutting in order to clean the area, as shown and described in Figs 4A and 4B. The residues will not get in the way during the cutting.
The pressure of the gas stream is lower than the pressure of the combined liquid jets at region 15. This difference in pressures is required in order to avoid interference of the gas stream with the pressure of the combined liquid jet. Preferably, the pressure of the combined fluid jets at region 15 varies between 10 and 120 atmospheres.
According to another embodiment, the gas jet/jets are directed at the liquid jet/jets and are intended to weaken the liquid jet/jets after their meeting point.
According to another embodiment, the instrument is designed for achieving only homeostasis by using hot liquid or steam jeVjets and dissection and cutting is performed by other instruments.
Channel 12 extends along shaft 11 , and eventually continues with sub-channels 13a and 13d, located at the tip section 20 of device 10. Channel 12 and sub-channels 13a, 13d are used for delivering high-pressure fluid from a high-pressure fluid source 191 (shown in Fig. 19) to the incision area to which the region 15 is to be brought. Of course, while two sub-channels are shown in this figure, a smaller or larger number of such sub-channels can be used, as will be appreciated by the skilled person.
The high- pressure fluid source 191 (Fig. 19) can be, for example, in form of an injector. The high-pressure fluid source 191 (Fig. 19) can be connected to device 10 through high- pressure fluid connector 16. The nozzle of each sub-channel may have a circular, a slit-like, crescent-like cross-section, the sub-channels may have screw like internal profile resulting in a helical jet, or can be of any other suitable shape, which may be envisioned by those skilled in the art. Furthermore, working in a fluid environment, in which the cavitation effect may reduce the kinetic energy of the jet, the tip of shaft 11 may have an inverted conical shape 192 (Fig. 19), that may preserve the fluid jet energy and the tissue cutting efficacy of the fluid jet.
Furthermore, this design protects the jet from external interference, safeguarding their mutual neutralization or weakening at the focal region.
A fluid pump or any other device that may supply fluid under high pressure, preferably between 10 and 200 atmospheres, can be used as the high-pressure fluid source. The high-pressure fluid is pumped or irrigated into channel 12 through connector 16, flows through it and out of the orifices of the sub-channels 13a-13d in the form of high-pressure fluid jets, each of which is directed toward the convergence point. The fluid may be a physiologic saline solution or any other biocompatible solution, as will be apparent to persons skilled in the art. The nozzle of each sub- channel 13a-13d preferably has a relatively small orifice (i.e., from 0.1 to 1.5 mm, preferably between 0.4 and 0.8 mm). According to a preferred embodiment of the present invention, device 10 is used for diverse surgical applications in liquid, gaseous or air environments.
A preformed plane is the space between fascias. A fascia is a film made of collagen fibers, that envelop tissue and that is stronger and more elastic than the enveloped tissue. Adjacent fascias are separated by softer tissue that can easily be removed by gentle pressure. Blood vessels are few and at predicted positions between adjacent fascias, whereas within a tissue enveloped by a fascia the blood vessels are more numerous and at unpredictable positions and directions.
Dissection along preformed planes between fascias is easier necessitating lesser pressure and causing less bleeding than cutting trough fascia.
The new liquid jet instrument has particular advantages since in addition to cutting at the meeting point of the liquid jets, it can perform dissection of the soft tissue between the fascia by the bulk of the moving liquid (hydrodissection). Since the fascial planes are not straight, this dissection by the fluid bulk, which can flow in any direction, is particularly advantageous. The result is a neat, anatomical dissection along preformed planes and not through them, thus causing minimal bleeding and tissue injury.
For example, device 10 is used in a liquid environment, for endoscopic procedures, such as prostate resection, where, generally, it is introduced through the sheath of an endoscope. In gaseous environments device 10 is utilized, e.g. for open surgical and laparoscopic procedures, and for endoscopic procedures in a gaseous environment, such as in the gastrointestinal tract. When working in a gaseous environment, it is better to use the embodiment of device 10 that comprises also the cleaning and evacuation means described above with reference to Fig. 4.
According to another preferred embodiment of the present invention device 10 further includes a deflection mechanism which allows the deflection of a section of device 10 - preferably, but not limitatively, the tip area - in order to reach difficult-to-access areas during the incision. Figs. 5 and 6 schematically illustrate the surgical device 10 of Fig. 2A provided with the deflection mechanism. In this particular embodiment device 10 further comprise side bands 51 a and 51 b, actuator 52 and other required elements for performing the deflection, as will be described hereinafter.
The side bands 51 a, 52b are attached to device 10 along shaft 11 , preferably, from the tip of device 10 to band 22. Band 22 can be located at any suitable place on shaft 11 , thus distancing the length of the deflective section. The side bands 51 a and 51 b are preferably made of an elastic, but not distensible, material (e.g., plastic) and are diametrically opposed in a way that allows the deflection to take place only in a single axis, thus obtaining a relatively high stability while performing the deflection. Of course, if required one or more of the side bands 51 a, 51 b can be removed from shaft 11 , thus allowing the deflection to take place along a plurality of axis.
Pull-wires (e.g., 24a and 24b in Fig. 6) or any other applicable bending members, which are controlled by actuator 52, can be used to achieve the required deflection of device 10. Fig. 6 schematically illustrates the deflection mechanism according to one preferred embodiment of the invention. Actuator 52 has preferably a wheel-like shape, which can be manipulated with one hand. For example, upon turning actuator 52 clockwise, using the thumb, pull-wire 24b is wrapped around cylinder 152 and pull-wire 24a is released from cylinder 152, resulting in a deflection toward arrow 153. Pushing pin 151 into one of the holes 155 fixes the tip of device 10 in a specific deflected position.
Actuator mechanism 52 has a wheel-like structure which rotates freely within a suitable slot in handle 14 and protrudes at the upper and lower surfaces of handle 14 (see Fig. 5). The deflection mechanism can be easily manipulated by a user, holding handle 14 in one hand and operating the pull wires actuator mechanism with the fingers of the same hand. The wheel-like actuator 52 can be rotated with the thumb or the index finger and the sliding, blocking pin can be advanced to block the wheel by the index finger or thumb while handle 14 is held by the other fingers.
Protrusion of the wheel member of actuator 52 over both the upper and lower surfaces of handle 14 permits an easy manipulation by the left or right hand of the user, even following rotation of the instrument.
According to a preferred embodiment of the invention, the deflected part of the shaft 11 is made of flexible a material (Fig. 5). The shaft 11 may also be provided with a bendable coupling element (i.e., joint) while the deflected part of shaft 11 is made of a rigid material.
According to another preferred embodiment of the invention, the length of the deflected part can be adjusted to the required extent and can be modified, e.g., by sliding a stiff sheath 110 over the deflectable part (as shown in Figs. 10A and 10B) , or by advancing or withdrawing a stiff rod into a channel that is embedded in shaft 11 . The active flexion is preferably performed by pull-wires 24a and 24b, but may also be performed by memory elements or by other mechanisms that will be apparent to those skilled in the art. This flexibility of the tip of device 10, together with the pivoting and translation movements, permits to introduce the instrument through narrow passages into difficult-to-access spaces, and to direct the high pressure fluid jet at an angle to the tissue, which permits to achieve effective cutting, dissection and hemostasis.
According to another preferred embodiment of the present invention, device 10 may further comprise illuminating means and imaging means. The illuminating means and the imaging means are used for providing streaming images of the internal cavities of the patient body during the surgical operation. Illuminating means 11 1 and imaging means 112 (Fig. 11) can be attached to device 10 in several ways, for example, in parallel and externally to device 10 as shown in Fig. 11 , through a specific channel along shaft 11 in device 10, or in other ways that will be apparent to persons skilled in the art.
Device 10 may be also incorporated into other multipurpose surgical or endoscopic devices. For example, a laparoscopic multipurpose device can be introduced through a port and may incorporate a device according to the invention, and may also include forceps, or graspers, or clipping means.
Looking at Fig. 3A, the electrical current flows through the electrode 21 , creating a high density current and thermal effect at the target tissue in contact with the small surface of the tip of electrode 21 , and back through the electrically conducting liquid, e.g., physiologic saline or any other electrically conducting biocompatible liquid that surrounds the working site, to a larger area of the inactive electrode 22 where the current density is low and the heating effect of the surrounding electrically conducting liquid, or tissue that is in contact with the electrode, is negligible. Performing the hemostatic or an electrosurgical cutting operation using both electrodes 21 and 22 is thus called "bipolar mode".
According to a preferred embodiment of the present invention, electrode 21 may operate in mono-polar mode as well. In mono-polar mode, an additional electrode (not shown) has to be attached to the body of the patient in order to close an electrical circuit (i.e., to allow current to flow) and to perform the hemostatic or cutting operation by electrode 21 .
Typically, the hemostatic unit has control elements that permit electrical current to flow only during contact of most of the electrode 21 with tissue, and which limit or interrupt the current flow when there is no contact, or when there is reduced contact with the tissue. The control elements prevent damage to the surrounding tissue, overheating of the liquid environment, or current short circuit across the electrodes and damage to the electrosurgical unit. Furthermore, a few pairs of active electrodes may be located at various positions along shaft 11 and around its circumference, and each pair may be independently controlled by the aforementioned control elements. In such case, an electrical potential will be applied only to those active electrodes that are in contact with the tissue during the activation of the hemostatic unit.
The fluid jets used for surgery can also provide hemostasis, by using hot jets. In one embodiment, the temperature is in the range about 70 to 100 degrees Celsius. In another embodiment, the temperature range is about 80 to 90 degrees Celsius. In yet another embodiment, the temperature is in the range 100 to 120 degrees Celsius. The jet may be saline or a physiological liquid.
Figs 12A and 12B schematically illustrate the tip section of device 10, according to another preferred embodiment of the present invention, wherein Fig. 12B is a cross- section taken along the B-B plane of Fig. 12A.
Channel 12 comprises two adjacent active electrodes 91 a and 91 b that permit the heating of an electrically conducting fluid that passes between them, or even generation of steam. Channel 12 is completely electrically insulated except for the two opposing electrodes 91 a and 91 b. The two electrodes 91 a and 91 b are mounted on the inner area surface of channel 12, which come into contact with the irrigating fluid. Preferably, electrodes 91 a and 91 b are located adjacent, or at the distal end of channel 12, but other suitable locations are of course also possible.
Electrodes 91 a and 91 b are also insulated from each other, and are connected via insulated wires 92a and 92b that extend through channels in shaft 11 to a plug located on handle 14 (not shown), which is connected through a cable to an external hemostatic unit. Application of a high electrical potential to these opposing active electrodes will result in the heating of an electrically conducting fluid such as, but not limited to, physiological saline, which flows through channel 12 and generates a hot fluid jet, or a steam jet for a limited period of time. This hot fluid jet or steam jet, when directed to blood vessels, seals them by thermal effect. Control elements in the electrosurgical unit prevent damage to the unit by limiting current intensities. The hot fluid or steam, when directed toward severed vessels or tissue, cause tissue hemostasis.
In another preferred embodiment of the invention, one or more non-insulated ring-like electrodes, such as electrodes 94a-94c (Fig. 13), are attached to the inner surface of the electrically-insulated channel 12, and are connected through an insulated wire 95 that extends through a channel in shaft 11 to a plug that is connected to a radio frequency source (not shown). Application of radio frequency energy to the electrode or electrodes located on the inner surface of the irrigation channel 12 causes the heating of an electro-conductive liquid to take place, thus permitting the generation of a hot fluid stream that causes local hemostasis.
Application of radio frequency current to this electrode within the irrigation channel 12 will heat the liquid that flows through it, permitting the application of a hot fluid jet or steam at the target tissue. Therefore, the application to tissue of a high pressure fluid jet through this channel permits tissue cutting and dissection, and the application of the fluid jet through the same channel, together with the application of the radio frequency energy to the electrode, results in hemostasis.
Various shapes and positions of the electrodes may be envisioned by those skilled in the art.
In another preferred embodiment of the invention, external source container 118 is provided with device 10 and is connected to channel 12 through connector 119 (as shown in Fig. 14). The external source 118 may contain a hot fluid or solution for local anesthetic. For example, the anesthetic solution can be entrained by the irrigation fluid during jetting and induce local anesthesia at the operation site. In another example, external control elements (not shown) permit the application of a high-pressure fluid jet at room temperature, for tissue cutting and dissection, or the application of a hot fluid jet for tissue hemostasis.
According to another preferred embodiment of the invention, the device 10 of Fig. 5 is adapted for a gaseous environment. An active mono-polar electrode 120 is located on the inner surface and near the distal end of the electrically insulated irrigation channel 12 (Fig. 15), through which steam flows, and comes in contact with the steam generated from heating an electrically-conducting fluid. The steam is generated by an external source connected to channel 12 by a connector, or is generated within shaft 11 by the methods mentioned above, or by any other suitable method. Active mono- polar electrode 120 is connected through insulated wire 121 , which in turn is connected to a plug included in the handle assembly that is connected to an external electrosurgical unit (not shown).
An inactive electrode is attached to a large skin area of the patient's body. Hemostasis is obtained by the steam being in contact with the tissue, or and by applying an electric potential to the active mono-polar electrode 120 during the flow of steam over it. The presence of ions derived from the electrically conductive fluid in the gaseous steam jet allows the discharge of a high intensity current through the jet, which induces an electrosurgical effect at the impact site of the jet with the tissue. As will be apparent to the skilled person, tissue cutting or hemostasis are obtained by a combination of a jet pressure of 3 to 20 atmospheres and to an adequate voltage setup.
According to another preferred embodiment of the present invention, the hemostatic means of a hemostatic unit (e.g., electrodes) are not an integral part of device 10 and can be introduced into device 10 through a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes trough the length of shaft 11 and ends at the tip region. Of course, hemostasis or cutting of resilient tissue may be obtained (by the hemostasis unit) using, for example, electrosurgical means, radio frequency energy, hot liquid flow, steam flow, laser energy, ultrasonic activated probes, or any other conventional devices that can cause hemostasis and/or cutting.
According to another preferred embodiment of the invention, an additional mechanical implements, such as scalpel, forceps, graspers or clipping means, is introduced into device 10 through a suitable channel provided therein (e.g., channel 55 in Fig. 16) that passes along the length of shaft 11 and ends at the tip region.
According to another preferred embodiment of the present invention, the resistive element 42 (Fig. 17A and 17B) may be wrapped around a segment of the electrically- insulated, but thermally conducting, irrigation channel, such as channel 12. Figs. 17A and 17B schematically illustrate the tip section of device 10, according to a preferred embodiment of the invention. Fig. 17B is a cross-section of the device of Fig. 17A, taken along the B-B plane. Resistive element 42, which is electrically insulated by heat-resistant element, or by a suitable coating, may be wrapped around a region of channel 12, heating it and indirectly heating the fluid that flows through it, thus resulting in a hot fluid jet or a steam jet. Wires 43 connect element 42 to an electric source.
Applying a voltage difference to this resistive element, results in intense heating of the resistive element that heats the irrigation channel and the fluid flowing through it, as well as in a hot fluid jet, or steam, for a limited period of time. This heats and coagulates the tissue by a direct thermal effect. The subsequent flow of fluid at room temperature through the irrigation channel 12, after cessation of electrical current, cools the irrigation channel 12 and results in a fluid jet at room temperature. According to a further preferred embodiment of the present invention, the device 10 of Fig. 2A, further includes an incandescent element 181 (Fig. 18) for producing hemostasis and cutting of the tissue by direct contact heating of said tissue with the incandescent element. The incandescent element is electrically connected to a suitable electrical power source, for example, . via connector 182. Preferably, the incandescent element 181 is a tungsten wire.
According to another preferred embodiment of the present invention, hemostasis can be obtained by using a non-electrically insulated beak region that acts as an active electrode, of the insulated sheath of an endoscope through which device 10 is introduced. Positioning the tip of device 10 adjacent to the beak allows obtaining hemostasis together with fluid jet cutting and dissection. After cutting the tissue with the fluid jet, bleeding vessels may be sealed by the adjacent beak of the endoscope sheath, which acts as an active hemostatic electrode.
For further exemplification, a procedure for the endoscopic prostatectomy performed by device 10 provided with additional elements from any of the Figs. 2 to 5 will be described hereinafter. The method includes positioning the deflection tip part of device 10 within the prostatic urethra, through an endoscope sheath and under visual monitoring. Using a proper tip deflection, incisions are performed with a high- pressure fluid jet, using pressure levels between 10 to 60 atm. and preferentially between 15 and 40 atm., between the lateral lobes of the hyperplastic prostate and the middle lobes, and thereafter the lateral lobes and middle lobes are dissected retrogradely from the prostatic surgical capsule. Hemostasis of encountered bleeding vessels is obtained continuously and selectively by the hemostatic means provided with device 10. Fibrous bands are severed by the high-pressure converging fluid jets and/or by the hemostatic unit and inadvertent injury to the surgical prostate capsule and adjacent organs is prevented by the special design of these converging jets that cause a significant pressure reduction of the combined fluid jet beyond the focal region. Additionally, a method of slice-like cutting of the prostatic tissue is described.
An example of using device 10 for prostate resection is shown in Figs. 7A to 7L, which schematically illustrate a prostate resection in an endoscopic view of the prostate.
Fig. 7A schematically illustrates an endoscopic view of the prostate before the resection. The prostate comprises the following elements: right lateral lobe 101a, left lateral lobe 101 b, middle lobe 102, veru-montanum 103 and urinary bladder neck opening 104. The circle around the prostate refers to the prostatic surgical capsule 105. In order to start the resection, device 10 is introduced through the urethra of a patient.
Fig. 7B shows the shaft of device 10 after being introduced into the prostate urethra, the tip of that device being deflected. In this example, the resection is started by cutting and dissecting between the middle lobe 102 and the right lobe 101 a as shown, starting cutting from the bladder neck. Fig. 7C shows the continuation of the incision distally to the veru-montanum 103.
Fig. 7D schematically illustrates the dissection of the right lobe 101a, using the fluid- jet from the prostate capsule, starting from the veru-montanum 103 towards the bladder neck 104. Fig. 7E shows the continuation of the dissection of the right lobe 101a from the prostatic surgical capsule 105. In Fig. 7F it can be seen that the right lobe 101 a is almost completely detached from the prostatic capsule 105. Fig. 7G shows the complete detachment of the right lobe 101a from the prostatic capsule 105. The detached lobe is pushed through the bladder neck 104 into the bladder, wherein it is morcellated using a morcellator. Cutting and dissection of tissue from the left lobe 101b require the same procedure as shown in Figs. 7D to 7G.
Fig. 7H schematically illustrates the cutting and dissection of the middle lobe 102, starting from the veru-montanum 103 towards the bladder neck 104. Fig. 71 shows the creation of a plane between the middle lobe 102 and the prostatic capsule 105, with continued dissection of the middle lobe 102. In Fig. 7J the dissection of middle lobe 102 is continued towards the bladder neck 104. Fig. 7K shows the detachment of the dissected middle lobe 102 from the remaining attachment to the bladder neck 104. Fig. 7L shows the complete detachment of the dissected middle lobe 102, wherein the detached middle lobe 102 is pushed through the bladder neck 104 into the bladder, wherein it is morcellated using a morcellator.
Another example of using device 10 for prostate resection is shown in Figs. 8A to 8C, which schematically illustrate a prostate resection via the endoscopic route. The resection is started by cutting the protruding prostatic tissue of the right lobe 101a, by engaging it into the concavity of the deflected device 10 and applying the water jet on the protruding prostatic tissue of the right lobe 101a. Device 10 is pulled back while continuously applying the water jet, and the tissue is cut in a slice-like manner. Resection is started at the bladder neck 104 and toward the veru-montanum 103, and as shown in Figs. 8A-8C, almost the entire right lobe 101a is detached from the surgical capsule. The cutting and dissection of the left lobe 101 b is the same as described in Figs 8A to 8C regarding the right lobe 101a.
The device of the invention can also be used for cutting and dissecting during an orthopedic endoscopic procedure that is generally performed in a liquid environment, such as a physiological saline solution. The following example will schematically illustrate the use of device 10 as shown by any of the Figs. 2 to 5 during a knee arthroscopy, when there is a torn meniscus. At first, the trocars 82a and 82b for the working elements, endoscope 81 and device 10, must be introduced into the knee articulation. In the next step, device 10 is introduced into the knee through one of the trocars, such as trocar 82b. Fig. 9 schematically illustrates the right knee after the introduction of endoscope 81 and device 10. The right knee consists of the following main elements: medial collateral ligament 83, articular cartilage 84, patella 85, PCL 86, femur 87, ACL 88, medial meniscus 89, tibia 90, fibula 91 , lateral meniscus 92 and lateral collateral ligament 93.
For example, device 10 of Fig. 5 is used for dissecting and cutting a diseased ligament tissue or cartilage, such as medial meniscus 89, articular cartilage 84 etc., from the healthy tissue. The flexibility and the deflection ability of the tip of device 10 permits to direct the fluid jet at an angle of approximately 90 degrees to the tissue, although the knee environment is relatively narrow and has an irregular articular space. In order to cut the diseased tissue of the knee, a fluid jet pressure of between 20 to 100 atmospheres is required, whereas normally a fluid jet pressure of 15 to 40 atmospheres would be sufficient for a prostate operation. Thereafter, changing the approach angle to an acute angle of less than 60 degrees by a suitable deflection of device 10, will allow dissection of the diseased tissue from an adjacent healthy tissue. During dissection, the blood vessels that are encountered can be sealed by the hemostatic means of device 10 (i.e., by electrode 21 ).
According to another example, device 10 of Fig. 2A can be used for tissue abrasion, such as on skin or on cartilage. Abrasion is obtained due to the ellipsoid-like shape that the converging jets create at the region 15.
The above examples and description have been provided only for the purpose of illustration, and are not intended to limit the invention in any way. As will be appreciated by the skilled person, the invention can be carried out in a great variety of ways, employing techniques other than those described above, all within the scope of the present invention.

Claims

Claims
1. A multipurpose fluid jet surgical device for cutting, dissecting, abrading and/or hemostasis, comprising:
(a) fluid jet-forming means for generating a high pressure fluid jet used for performing the cutting, dissecting or abrading interventions;
(b) one or more irrigation channels for directing said generated fluid from a nozzle located in a distal part of the apparatus;
(c) a jet neutralizing or weakening means situated at the nozzle; and
(d) a shaft for housing said fluid jet forming means, said channel, or channels.
2. The multipurpose fluid jet surgical device according to claim 1 , wherein the device is used in laparoscopic surgery, thoracoscopic surgery, neurosurgery, ophthalmology, corneal reshaping, lens surgery, orthopedic surgery, endoscopic surgery such as excision of gastric or colonic polyps, endoscopic urologic surgery such as endoscopic prostatectomy, endoscopic resection of bladder tumors, endoscopic lithotripsy (fragmentation of stones), endoscopic fragmentation of billiary stones, dental surgery, ear, nose and throat surgery, endoscopic sinus surgery, dermal abrasion, dermatology, debridment of chronic ulcers and pressure sores, plastic surgery, endoluminal vascular re-channeling, heart surgery, cosmetic surgery and/or gynecology (for example: endoscopic resection of miomas).
3. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means located at the nozzle, includes splitting the central channel, or channels at its distal end, or ends into two or more sub-channels, so that their corresponding longitudinal axes converge and met at the same imaginary focal point to generate a combined and focused jet, and wherein the angle between the sub-channels is such as to cause reciprocal neutralization or weakening of the jets' energy beyond the meeting point of the jets, and wherein the shaft further houses the sub-channels.
4. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means situated at the nozzle and designed as an extension connected to the nozzle by an elastic hinge, that when flexed, will deflect and neutralize the ejected fluid jet or jets.
5. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means located at the nozzle comprise a stop plate with rotating means, the rotating means comprising a handle connected to actuator means to allow the rotation of the plate between two position, a first position wherein the plate is located opposite the jet or close to the meeting point of the jets, and a second position wherein the plate is removed from the above location.
6. The multipurpose fluid jet surgical device according to claim 1 , further including means for evacuating residues of a surgery and means for preventing back-splashing.
7. The multipurpose fluid jet surgical device according to claim 6, wherein the means for evacuating residues of a surgery and means for preventing back-splashing comprise:
(e) a tube for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the combined fluid jets, said nozzle being located near or adjacent to the tip of the shaft and said tube being further connected to a gas source at its proximal end;
(f) suction tube and vacuum source for evacuating the residue, fluids and/or gas from said area and/or for preventing back-splashing, the opening of said suction tube being located near or adjacent to said tip;
(g) an umbrella-shaped cap for capturing residue, fluids and/or gas in said area by encircling said area when the concavity side of said cap is directed toward said area and said tip is within the concavity side of said cap.
8. The multipurpose fluid jet surgical device according to claim 7, wherein the gas stream is directed as jet/jets and meet the liquid jet/jets and weaken them.
9. The multipurpose fluid jet surgical device according to claim 1 , further including heating means for stopping bleeding as resulting from surgery (hemostasis).
10. The multipurpose fluid jet surgical device according to claim 10, wherein the heating means for stopping bleeding comprise means for heating the fluid jet or jets used for surgery.
11 . The multipurpose fluid jet surgical device according to claim 1 , further including mechanical means for cutting, grasping, dissecting, or clipping tissue.
12. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means include forming an angle between the fluid jets which is of a value that causes reciprocal neutralization or weakening of the jets' energy beyond the meeting point, and protective means around the emanating jets for preventing interference with any of the jets.
13. The multipurpose fluid jet surgical device according to claim 1 , further including means for introducing a local anesthetic solution.
14. The multipurpose fluid jet surgical device according to claim 1 , further including tip deflecting means.
15. The multipurpose fluid jet surgical device according to claim 1 , further including hemostatic means.
16. The multipurpose fluid jet surgical device according to claim 1 , further including hemostatic means and tip deflecting means.
17. The multipurpose fluid jet surgical device according to claim 15, wherein the hemostatic means comprise means for heating the fluid jet to temperatures sufficient to stop bleeding (hemostasis).
18. The multipurpose fluid jet surgical device according to claim 8, wherein the cap is made from an elastic material, optionally distensible, that is also transparent.
19. The multipurpose fluid jet surgical device according to claim 1 , further including a protective means around the emanating jets for preventing interference with any of the jets.
20. The multipurpose fluid jet surgical device according to claim 19, wherein the protective means is shaped as a collar.
21 . The multipurpose fluid jet surgical device according to claim 20, wherein a distal margin of the collar is proximal to the meeting point of the jets.
22. The multipurpose fluid jet surgical device according to claim 19, wherein a distal margin of the protective means is distal to the meeting point of the jets.
23. The multipurpose fluid jet surgical device according to claim 19, wherein the protective means is attached to the nozzle by an elastic hinge.
24. The multipurpose fluid jet surgical device according to claim 4, wherein the extension at the nozzle is shaped as a plate with means for allowing it to be deflected when touching the tissue.
25. The multipurpose fluid jet surgical device according to claim 4, wherein the deflected extension jet neutralizing means cause deflection and neutralization of the emanating jet or jets.
26. The multipurpose fluid jet surgical device according to claim 5, wherein stop plate can be rotated as it touches the tissue.
27. The multipurpose fluid jet surgical device according to claim 5, wherein stop plate can be rotated by an actuator located at the instrument handle.
28. The multipurpose fluid jet surgical device according to claims 1 to 16, further including means for performing the operation of tissue coagulation and/or tissue cutting at a preset temperature value.
29. The multipurpose fluid jet surgical device according to claims 1 to 16, further including means for performing the operation of tissue coagulation and/or tissue cutting, in which the operation of said means is determined according to the voltage setup of said means.
30. The multipurpose fluid jet surgical device according to claims 1 to 16, further including evacuation means for evacuating residue, fluids and/or gas from the area centered by the contact zone of the combined fluid jets and/or for preventing back-splashing.
31 . The multipurpose fluid jet surgical device according to claim 30, wherein the evacuation means comprises: a) a tube for directing a gas stream, through a nozzle at its distal end, to the area centered by the contact zone of the combined fluid jets, said nozzle being located near or adjacent to the tip of the shaft and said tube being further connected to a gas source at its proximal end; b) suction tube and vacuum source for evacuating the residue, fluids and/or gas from said area and/or for preventing back-splashing, the opening of said suction tube being located near or adjacent to said tip; and c) an umbrella-like cap for capturing residue, fluids and/or gas in said area by encircling said area when the concavity side of said cap is directed toward said area and said tip is within the concavity side of said cap.
32. The multipurpose fluid jet surgical device according to claim 31 , wherein the cap is made from an elastic material, optionally distensible, that is also transparent.
33. The multipurpose fluid jet surgical device according to claims 1 to 16, further including means for deflecting the tip of the shaft.
34. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the shaft is made of a rigid material.
35. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the shaft is made of a flexible material.
36. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the shaft is provided with a bendable coupling element.
37. The multipurpose fluid jet surgical device according to claim 33, wherein the means for deflecting the tip of the shaft comprise pull-wires, an actuator for controlling the deflection, and at least two stiffening elements placed along the deflectable tip, for preventing deflection of said tip in an undesired direction.
38. The multipurpose fluid jet surgical device according to claim 33, wherein the actuator has a wheel- like shape, which protrudes over both the upper and lower surface of the handle of said apparatus.
39. The multipurpose fluid jet surgical device according to claim 33, wherein further including means for adjusting and modifying the deflected tip to a required extent.
40. The multipurpose fluid jet surgical device according to claim 33, wherein the adjusting and modifying means comprises a slidable stiff sheath over the deflectable tip, or an advanced or withdrew stiff rod inside the shaft.
41 . The multipurpose fluid jet surgical device according to claim 33, wherein the two stiffening elements are made of a non distend able material.
42. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the jet-forming means comprise one or more high-pressure fluid and/or gas source/sources and a connector/connectors for connecting said high-pressure source/sources to the apparatus.
43. The multipurpose fluid jet surgical device according to claim 29, wherein the means for performing the tissue-coagulation and/or the tissue cutting include an active electrode and an inactive electrode that are connected through a conductive wire to hemostatic unit.
44. The multipurpose fluid jet surgical device according to claim 43, wherein the active electrode is a smooth or ridge shaped electrode.
45. The multipurpose fluid jet surgical device according to claim 44, wherein the shape of the active electrode is selected from the group consisting of a circular ring surrounding the nozzle, a straight ribbon or band electrode, or a curvilinear, round, oval or an omega-shaped ridge.
46. The multipurpose fluid jet surgical device according to claim 43, wherein the active electrode and the inactive electrode perform in a bipolar mode.
47. The multipurpose fluid jet surgical device according to claims 43 to 44, wherein the active electrode is used for cutting the tissue.
48. The multipurpose fluid jet surgical device according to claims 1 to 16, further including illuminating means and imaging means.
49. The multipurpose fluid jet surgical device according to claim 48, wherein the illuminating means and the imaging means are attached externally, or through a specific channel along the shaft.
50. The multipurpose fluid jet surgical device according to claim 48, wherein the imaging means comprise a video camera.
51 . The multipurpose fluid jet surgical device according to claim 48, wherein the imaging means comprise properly arranged optic fibers.
52. The multipurpose fluid jet surgical device according to claims 1 to 16, further including two or more electrodes insulated from each other, for heating the electrically conducting fluid that passes between said electrodes, in which said electrodes are mounted on the inner area surface of the channel.
53. The multipurpose fluid jet surgical device according to claims 1 to 16, further including heating means for heating the fluid so as to generate steam.
54. The multipurpose fluid jet surgical device according to claim 52, wherein the electrodes are located adjacent to, or at the distal end of the channel, and which are connected through insulated wires that extend through the shaft to a plug located on the handle, in which said plug is connected through a cable to hemostatic unit.
55. The multipurpose fluid jet surgical device according to claims 1 to 16, further including a resistive element for heating the fluid that flows through said apparatus.
56. The multipurpose fluid jet surgical device according to claim 55, wherein the resistive element is electrically insulated by heat resistant means, by a ceramic material, or by a coating material.
57. The multipurpose fluid jet surgical device according to claim 56, wherein the resistive element comprises an incandescent element.
58. The multipurpose fluid jet surgical device according to claims 1 to 16, further including a resistive element for producing hemostasis and for cutting of the tissue by direct contact heating of said tissue with the incandescent element.
59. The multipurpose fluid jet surgical device according to claim 56 or 57, wherein the resistive element is a tungsten wire.
60. The multipurpose fluid jet surgical device according to claim 43, wherein the active electrode acts as a mono- polar electrode and further including an inactive electrode suitable to be attached to the external body surface of a patient, when operating in mono- polar mode.
61. The multipurpose fluid jet surgical device according to claims 1 to 16, further including one or more non- insulated ring-like electrodes which are attached to the inner surface of the channel and are connected through an insulated wire that extends through the shaft to a plug that is connected to a radio frequency source, for heating the liquid and to generate a hot fluid stream that causes hemostasis.
62. The multipurpose fluid jet surgical device according to claim 55, wherein the resistive element is wrapped around a region of the channel in the shaft for heating the fluid that flows through the channel.
63. The multipurpose fluid jet surgical device according to claim 58, wherein the resistive element is electrically insulated by a heat-resistant element, or by a suitable coating.
64. The multipurpose fluid jet surgical device according to claim 55 or 57, wherein the resistive element is connected to an electric source.
65. The multipurpose fluid jet surgical device according to claims 1 to 16, further including an external source of hot fluid connected to the channel through a side connector.
66. The multipurpose fluid jet surgical device according to claims 1 to 16, further including an external source of anesthetic solution is connected to the channel through a side connector, said anesthetic solution being entrained by the fluid jet to induce local anesthesia at the operation site.
67. The multipurpose fluid jet surgical device according to claims 1 to 16, further including a suitable channel that passes trough the length of the shaft for introducing hemostatic and/or cutting implement of an external hemostatic unit.
68. The multipurpose fluid jet surgical device according to claim 67, wherein the hemostatic implement is one or more electrodes.
69. The multipurpose fluid jet surgical device according to claim 67, wherein the hemostatic unit is selected from the group consisting of electrosurgical, radio frequency, hot liquid, steam, laser energy, ultrasonic activated probes, or any other suitable device that can perform hemostasis and/or cutting.
70. The multipurpose fluid jet surgical device according to claims 1 to 16, further including mechanical implements.
7 . The multipurpose fluid jet surgical device according to claim 70, wherein the mechanical implements are scalpel, forceps, graspers or clipping means.
72. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the device is incorporated into a multipurpose surgical or endoscopic device.
73. The multipurpose fluid jet surgical device according to claim 72, wherein the multipurpose surgical or endoscopic device further includes forceps, graspers or clipping means.
74. The multipurpose fluid jet surgical device according to claim 29, further including an active mono-polar electrode situated on the inner surface of the irrigation channel, said active mono- polar electrode is connected through an insulated wire that extends through the shaft to a plug connected to an electrosurgical unit, said active mono-polar electrode transmitting the electrical current through an electrical conductive steam jet that is irrigated through the irrigation channel, for performing hemostasis in gaseous environment.
75. The multipurpose fluid jet surgical device according to claims 1 to 16, further including a non-electrically insulated beak region at the insulated sheath of the endoscopic device that acts as an active electrode, whenever positioning the tip adjacent to said beak, for obtaining hemostasis.
76. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the tip of the shaft has an inverted conical shape.
77. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means includes splitting the central channel, or channels in its distal end, or ends into two or more sub-channels, so that their corresponding longitudinal axis converge and meet at the same imaginary focal point to generate a combined and focused jet, and wherein the angle between the sub-channels is such as to achieve a reciprocal neutralization or weakening of the jets' energy beyond the meeting point (focal region).
78. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means situated at the nozzle is designed as an extension connected to the nozzle by an elastic hinge, that when flexed, deflects or neutralizes the ejected fluid jet or jets.
79. The multipurpose fluid jet surgical device according to claim 1 , wherein the jet neutralizing or weakening means situated at the nozzle, represented by a stop plate with a handle, which can be rotated from a position opposite the jet, or jets orifice/orifices to a position which is not opposite this or these orifice/orifices.
80. The multipurpose fluid jet surgical device according to claim 78, further including protective means around the emanating jets, for preventing interference with any of the jets.
81 . The multipurpose fluid jet surgical device according to claims 1 to 16, further including selective hemostasis means for only applying heat for short time periods, when this is necessary, whereas the surgery itself is performed using cold liquid jets.
82. The multipurpose fluid jet surgical device according to claim 81 , wherein the selective hemostasis means apply heat responsive to a manual input.
83. The multipurpose fluid jet surgical device according to claim 81 , wherein the selective hemostasis means apply heat automatically, at predefined time intervals and for predefined time periods.
84. The multipurpose fluid jet surgical device according to claim 81 , wherein the selective hemostasis means further include automatic control means for keeping the temperature, during the heat application stage, at a predefined value.
85. The multipurpose fluid jet surgical device according to claim 84, wherein the automatic control means include temperature sensor means for generating an electrical signal indicative of measured temperature, heater means for generating heat when supplied with electrical power, and electronic controller means for receiving the signal from the sensor, comparing the measured temperature with a preset value of desired temperature, and applying electrical power to the heater accordingly, to keep the actual temperature as close as possible to the preset temperature.
86. The multipurpose fluid jet surgical device according to claims 1 to 16, wherein the device is disposable, to eliminate the risk of contamination from one patient to another.
87. A surgical method for cutting, dissecting or abrading, comprising:
(a) forming one or more cutting jets using a high pressure liquid, being emitted from the distal end of a hand-held device;
(b) forming additional jet or jets for neutralizing or weakening the cutting jets.
88. The surgical method according to claim 87, further including activating a selective hemostasis procedure.
89. The surgical method according to claim 87, further including applying it in laparoscopic surgery, thoracoscopic surgery, neurosurgery, ophthalmology, corneal reshaping, lens surgery, orthopedic surgery, endoscopic surgery such as excision of gastric or colonic polyps, endoscopic urologic surgery such as endoscopic prostatectomy, endoscopic resection of bladder tumors, endoscopic lithotripsy (fragmentation of stones), endoscopic fragmentation of billiary stones, dental surgery, ear, nose and throat surgery, endoscopic sinus surgery, dermal abrasion, dermatology, debridment of chronic ulcers and pressure sores, plastic surgery, endoluminal vascular re-channeling, heart surgery, cosmetic surgery and/or gynecology (endoscopic resection of miomas).
90. The surgical method according to claim 87, wherein used for endoscopic prostatectomy, comprising: a) positioning the deflection tip part of said device within the prostatic urethra, through an endoscope sheath and under vision; b) providing a high-pressure fluid jet, between the lateral lobes of the hyperplastic prostate and the middle lobes, for performing incisions; c) dissecting retrogradely said lateral lobes and said middle lobes from the prostatic surgical capsule; and d) performing continuously hemostasis of encountered bleeding vessels by tissue-coagulation implements.
91 . The surgical method according to claim 87, wherein the pressure of the fluid jet is between 10 to 60 atm.
92. The surgical method according to claim 87, further including heating the surgery location for stopping bleeding as resulting from surgery (hemostasis).
93. The surgical method according to claim 92, wherein using an active electrode as the heating means for stopping bleeding and/or tissue cutting.
94. The surgical method according to claim 92, wherein using a hot liquid jet as the heating means for stopping bleeding.
95. The surgical method according to claim 92, wherein using a hot steam jet as the heating means for stopping bleeding.
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