WO1999065399A1

WO1999065399A1 - Suturing instrument with integral imaging device and method for use thereof

Info

Publication number: WO1999065399A1
Application number: PCT/US1999/013692
Authority: WO
Inventors: Inbae Yoon
Original assignee: Inbae Yoon
Priority date: 1998-06-17
Filing date: 1999-06-17
Publication date: 1999-12-23
Also published as: AU4574599A

Abstract

An instrument (30) and method for suturing anatomical tissue with a suture needle carrying suture material includes a barrel (32) having one or more needle holders (40 and 50) therein which can be manipulated from a proximal end of the barrel (32) to cause the needle and suture material to pass through tissue. A viewing device (33) is disposed in the barrel (32) to permit the entire suturing procedure to be viewed from a proximal end of the instrument.

Description

SUTURING INSTRUMENT WITH INTEGRAL IMAGING DEVICE AND METHOD FOR USE THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS This Application is related to applicant's copending applications Serial No.

08/758,648, Serial No. 08/847,182, Serial No. 08/847,254, Serial No. 08/847,252, Serial

No. 08/899,710, Serial No. 08/847,189, Serial No. 08/758,648, Serial No. 905,215,

Serial No. 904,767, Serial No. 08/902,311 , Serial No. 08/847,253, Serial No.

08/877,764, Serial No. 08/904,764, Serial No. 60/083,521 , and 60/085,242, the

disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Field of the Invention:

The present invention pertains to suturing of bodily or anatomical tissue and, more particularly, to an apparatus and method for suturing anatomical tissue with suture material attached to a needle and viewing the suturing procedure with a single instrument.

Discussion of the Related Art:

Suturing of bodily tissue, that is, the practice of using lengths of suture material to

ligate or approximate tissue, is a time consuming part of most surgical procedures

including open surgery, microsurgery and minimally invasive surgery. "Open surgery"

refers to surgery wherein the surgeon gains access to the surgical site by a relatively large

incision and "minimally invasive surgery" refers to any type of surgery, such as endoscopic

surgery or "mini-lap" surgery, wherein the surgeon gains access to the surgical site via one or more portals or small incisions through which instruments, such as forceps, cutters, needle holders, imaging scopes, and the like, are introduced to the surgical site.

In the past, suturing has been accomplished with the use of a sharp suture needle carrying a length of suture material, the suture needle being caused to penetrate and pass through the tissue, at a precise location, pulling the suture material through the tissue. Once the suture material has been pulled through the tissue one or more times, the surgeon ties a knot in the suture material. The knot tying procedure allows the surgeon to adjust the tension on the suture material to accommodate the particular tissue being sutured and to control approximation, occlusion, attachment or other conditions of the tissue.

The process of tissue penetration and tying a knot in the suture material can be time consuming and tedious work, particularly when performed in connection with microsurgery and minimally invasive surgery and can unduly prolong the duration of surgery and therefore the period in which the patient is under anesthesia. Nevertheless, minimally invasive surgery is preferred over open surgery due to the greatly reduced trauma and wound healing time for the patient and due to cost savings associated with shorter hospital stays and performing surgery in non-hospital or out-patient surgery sites. Accordingly, there has been much effort to develop techniques to replace the suturing normally performed by use of a suture needle and a length of suture material. Alternative techniques include electrical coagulation, mechanical devices such as clips, clamps and staples, and lasers. However, no alternative technique has yet been well accepted by surgeons to produce the results obtained by suturing and knot tying. Thus, there is a great need for suturing and knot tying techniques useful in minimally invasive surgery, open surgery, and microsurgery to permit surgeons to suture anatomical tissue with suture material attached to a needle and tie a knot in the suture material in a time efficient consistent, and precise manner.

The performance of a minimally invasive procedure typically involves creation of one or more puncture sites through a wall of an anatomical cavity using a penetrating instrument including an obturator, such as a trocar, disposed within a portal sleeve. After the penetrating instrument has penetrated into the anatomical cavity, the obturator is withdrawn leaving the sleeve in place to form a portal in the cavity wall for the introduction of instruments having scissors, forceps, needle holders, and the like, into the anatomical cavity. The portal sleeve can be omitted and instruments can be inserted directly through a small incision. Suturing is typically performed with a needle holding instrument, or needle holder, having a needle holding member, such as a pair of jaw members adapted to hold the body of a suture needle. The jaw members of the needle holding instrument are inserted into the cavity through a portal sleeve or incision and are positioned at the operative site by manipulation of a handle at the proximal end of the instrument outside the body. A viewing instrument, such as an endoscope, is inserted into the cavity through a separate portal sleeve or incision for viewing the suturing procedure. With a suture needle held between the jaw members of the needle holding instrument, the handle is manipulated to cause a tip of the needle to be pushed through the tissue being sutured. Once the tip of the suture needle has been pushed through the tissue, the jaw members of the needle holding instrument must be opened to release the suture needle so that the tip of the needle can be grasped and pulled through the tissue therewith, or, after opening the jaw members, a second needle holding instrument must be introduced at the operative site through another portal to grasp the tip of the suture needle after it has emerged from the tissue being sutured.

The former technique requires difficult manipulation and further adjustment of the suture needle within the jaw members of the needle holder before another stitch can be made. While use of a second needle holding instrument for pulling the needle through the anatomical tissue allows the first needle holding instrument to grasp the body of the suture needle in the manner required to make additional stitches, a second puncture site is required to permit insertion of the second instrument. In either case, a separate puncture site is required for the viewing instrument. It is generally desirable to minimize the number of puncture sites created for performing a particular minimally invasive procedure.

With conventional instruments, viewing is accomplished by a viewing device inserted through a separate portal sleeve or incision. This increases the required number of portal sleeves or incisions and thus increases patient trauma. In addition to conventional endoscopes which use an objective lens and a light transmission element, such as a fiber optical bundle, endoscopes have included a variety of transducers such as vidicons (i.e., closed circuit television camera tubes) and solid-state Charge Coupled Devices (CCDs) for converting image light into electrical image signals for transmission to a viewing screen. CCD solid-state image sensors provide the benefits of small size and flexibility in image sensor placement, but are relatively difficult and expensive to implement in medical instruments, since CCD sensor signals require processing through complex and expensive ancillary equipment, if a usable image is to be displayed. It is often difficult to position a separate endoscope proximate the distal end of a suturing instrument to view an entire suturing procedure. U.S. Patent No. 5,037,433 to Wilk et al. is representative of a suturing instrument and an optical imaging device in a single instrument. The imaging device is utilized to locate the wound prior to suturing and to visually detect presence of the needle between jaws of forceps used to pull the needle through tissue.

In view of the precision required during a suturing procedure, it is desirable to be able to view the entire procedure, particularly the step of pushing, or driving, the needle through the tissue. In particular, the surgeon must be able to view the tissue being sutured at the precise point of entry of the sharp tip of the needle to ensure that the needle penetrates the tissue at a desired position having adequate thickness. It is important to be able to view the needle and the tissue as the needle is driven through the tissue to determine if the tissue is torn, or otherwise damaged, by the needle. Viewing the step of pulling the needle through the tissue is desirable for the same reason.

SUMMARY OF THE INVENTION Accordingly, it is a primary object of the present invention to overcome the above- mentioned disadvantages of the prior art and to improve suturing instruments and methods. An object of the invention is to facilitate positioning of a viewing device during suturing procedures by providing a suturing instrument with an integral viewing device.

An additional object of the present invention is to minimize the number of puncture sites required for performing suturing of anatomical tissue by inserting a suturing instrument and integral viewing device through a single puncture site or incision. A further object of the invention is to facilitate viewing of an entire suturing process, including the entire steps of driving a needle into tissue and pulling the needle through tissue.

The present invention is generally characterized in a surgical instrument including a housing, an elongate outer shaft or barrel having a proximal end coupled to the housing and a distal end, and at least one needle holder having a portion that extends from the distal end of the barrel. The needle holder is moveable to permit a needle to be driven into tissue and pulled through the tissue. A viewing device is disposed in the barrel and includes an objective disposed proximate a distal end of the instrument, a viewing screen proximate a proximal end of the instrument, and a transmission member coupling the objective to the viewing screen. The instrument can include more than one needle holder operative in a cooperating manner. Another aspect of the present invention is generally characterized in a method of performing a suturing procedure in an anatomical cavity including the steps of introducing a surgical instrument having an elongate barrel and a viewing device in the barrel into an area proximate tissue to be sutured, the surgical instrument including at least one needle holder extending at least partially from the distal end of the barrel, grasping a needle having suture material attached thereto in the needle holder, and moving the needle holder to cause the needle to penetrate the tissue and viewing the procedure with the viewing device. The suturing procedure can be viewed without the need for a separate viewing instrument and other operative steps can be performed by moving the needle holder. Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view, broken longitudinally, of a surgical instrument according to the present invention.

Fig. 2 is a perspective view of the barrel of the instrument of Fig. 1 ; Fig. 3 is a top view of the needle holders removed from the barrel; Fig. 4 is a sectional view of the housing of the instrument of Fig. 1 taken along line 4-4 of Fig. 1; Fig. 5 is a detailed sectional view of the cylindrical member;

Fig. 6 is a sectional view taken along line 6-6 of Fig. 5; Fig. 7 is a perspective view of another instrument according to the invention; Figs. 8-13 are perspective views illustrating a suturing procedure using the instrument of Fig. 1 ;

Fig. 14 is a side view, in partial section, of another instrument according to the invention; and Fig. 15 is a side view, in partial section, of the instrument of Fig. 14 with the viewing device in a deflected position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The suturing instrument of the present invention can be utilized to suture any type of anatomical tissue. Accordingly, while the instrument is described hereinafter for use in minimally invasive procedures, such as endoscopic procedures, the instrument can be used in open surgery and with catheters and other small and large diameter tubular or hollow cylindrical members providing access to small cavities, such as veins and arteries, as well as large cavities, such as the abdomen. For example, the instrument can be used in microsurgery, eye surgery, or minilap procedures. Also, the instrument can be used in open surgical procedures. The term "suturing" as defined herein refers to passing a needle through or around tissue one or more times while suture material is attached to the needle to pull the suture material through or around the tissue. The term "needle" as used herein refers to any member having suture attached thereto and which can be passed through or around tissue. The phrase "viewing device", as used herein, refers to any device which permits viewing, from a proximal end of an instrument, a procedure being conducted at a distal end of the instrument. A suturing instrument according to the present invention is illustrated at 30 in Fig. 1 and includes cylindrical barrel (or outer shaft) 32, needle driver 40, and needle catcher 50. Needle driver 40 and needle catcher 50 are substantially contained within cylindrical barrel 32 as is described in detail below. The terms "needle driver" and "needle catcher" are used herein to describe, in terms of their function, elements that may be structurally similar in the preferred embodiment. However, the function of these two elements herein is interchangeable. Also, these elements are sometimes referred to generically as "needle holders" herein. Needle driver 40 and needle catcher 50 optionally can be moved proximally and distally in barrel 32. As shown in Fig. 2, barrel 32 has channels 38a-d and suture material passage 37 extending longitudinally therethrough. Barrel 32 can have additional channels for receiving one or more additional instruments to be introduced in the abdominal cavity or barrel 32 can have fewer channels as needed. Optical fibers can extend through barrel 32 to transmit light from a proximal light source to the body cavity of a patient. Channels 38a-d can be formed by thin wall, tubular sleeves extending longitudinally through barrel 32 or by any other means. Needle driver 40 is substantially disposed in channel 38a and needle catcher 50 is substantially disposed in channel 38c, as shown in Fig. 1. Viewing device 33 extends through channel 38b, as shown in Fig. 1, and is described in greater detail below. Fig. 3 illustrates needle driver 40 and needle catcher 50 removed from barrel 32 for illustrative purposes. Needle driver 40 includes elongated, tubular outer member 42 and elongated tubular inner member 44 disposed within outer member 42. Outer member 42 and inner member 44 define a shaft that extends through channel 38a, as indicated above and is rotatable in barrel 32. Outer member 42 has a proximal end on which beveled gear 46 is disposed. Projection 47 extends from outer member 42. The function of beveled gear 46 and projection 47 is described in detail below. Aperture 53 permits a channel to be defined through inner member 44 from a proximal end of instrument 30 to a distal end thereof. Arms 51 A and 51 B serve as connecting members between jaw members 50A and

50B and inner member 44 and can be made entirely or partly of resilient, flexible or spring materials, or materials having shape memory. Jaw members 50A and 50B serve as a needle holding member and are biased to be normally disposed in an open position wherein the jaw members have a gap defined therebetween, as illustrated in Fig. 3. This permits the shank of a suture needle to be placed between jaw members 50A and 50B and to be grasped thereby. Of course, the inner surfaces of jaw members 50A and 50B can be shaped to correspond to the needle shank, or any other appropriate way, to firmly grasp the needle when the jaw members 50A and 50B are in a closed position, which position is shown in Fig. 8. Cam surfaces 52A and 52B are formed on arms 51 A and 51 B respectively. Movement of outer member 42 in a distal direction with respect to inner member 44 causes outer member 42 to push over cam surfaces 42A and 42B to close jaw members 50A and 50B. Needle driver 40 can be designed in various known ways permitting jaw members 50A and 50B to be movable between the closed position and the open position. The opening and closing movement of jaw members 50A and 50B is described in more detail below.

Needle catcher 50 includes elongated, tubular outer member 42' and elongated tubular inner member 44' disposed within outer member 42'. Outer member 42' and inner member 44' define a shaft that extends through channel 38c and is rotatable in barrel 32. Outer member 42 has a proximal end on which beveled gear 46' is disposed. Projection 47' extends from outer member 42. The function of beveled gear 46' and projection 47' is described in detail below.

Arms 51 A' and 51 B' serve as connecting members between jaw members 50A and 50B' and inner member 44' and can be made entirely or partly of resilient, flexible or spring materials, or materials having shape memory. Jaw members 50A and 50B' serve as a needle holding member and are biased to be normally disposed in an open position wherein the jaw members have a gap defined therebetween, as illustrated in Fig. 3. This permits the shank of a suture needle to be placed between jaw members 50A and 50B' and to be grasped thereby. Of course, the inner surfaces of jaw members 50A and 50B' can be shaped to correspond to the needle shank, or any other appropriate way, to firmly grasp the needle when jaw members 50A and 50B' are in a closed position, which position is shown in Fig. 9. Cam surfaces 52A and 52B' are formed on arms 51 and 51 B' respectively. Movement of outer member 42' in a distal direction with respect to inner member 44' causes outer member 42' to push over cam surfaces 42A and 42B' to close jaw members 50A' and 50B'. Needle catcher 50 can be designed in various known ways permitting jaw members 50A and 50B' to be movable between the closed position and the open position. The opening and closing movement of jaw members 50A and 50B' is described in more detail below. Aperture 53' permits a channel to be defined through inner member 44' from a proximal end of instrument 30 to a distal end thereof.

Needle driver 40 and needle catcher 50 can be of any configuration which permits selective grasping of the needle and relative motion between the needle driver and needle catcher, and can include needle holding members such as pivoting jaw members, slots and keepers, moveable flanges, and resilient fork-like members. For example, the needle driver and needle catcher can have any of the configurations disclosed in the related applications noted above, the disclosures of which are incorporated herein by reference.

As illustrated in Figs. 1 and 4, proximal controls 60 of instrument 30 include a set of scissor type handles 62 and 64 extending out of housing 79 disposed on a proximal end of barrel 32. Handle 62 can be pivoted towards handle 64 to cause movement of the shafts of needle driver 40 and needle catcher 50, and jaw members 50A and 50B and jaw members 50A and 50B', in a coordinated manner as is discussed in detail below. Specifically, handle 62 is coupled to both needle driver 40 and needle catcher 50 in a manner which causes the desired rotation of the shafts of needle driver 40 and needle catcher 50 and the opening and closing operation of the respective jaw members necessary for passing the needle between needle driver 40 and needle catcher 50 merely by squeezing and releasing handles 62 and 64 once or multiple times. The mechanism coupling handles 62 and 64 to needle driver 40 and needle catcher 50 can be designed to accomplish any stitching or tying function, such as the function disclosed in detail below, or any other appropriate motion. Such an automatic mechanism facilitates suturing by minimizing fatigue on the surgeon and reducing the possibility of operational errors.

Figs. 4-6 illustrate an internal mechanism of proximal controls 60 in detail. Handle 64 is fixedly connected to housing 79. Handle 62 is movable and extends through a slot in housing 79 to be mounted on rotatable shaft 120 to cause shaft 120 to rotate when handle 62 is pivoted towards handle 64. Beveled gears 122 and 124 are also mounted on shaft 120 to rotate with shaft 120. Biasing member 126, shown as a coiled spring, biases handle 62 away from handle 64 to the illustrated position. Beveled gears 122 and 124 are coupled respectively to beveled gears 46 and 46' that are mounted on outer member 42 and outer member 42' respectively. Note that beveled gears 46 and 46' are axially slidable with respect to outer members 42 and 42' respectively, but are fixed rotationally on the outer members by keys 49 and 49'. Beveled gear 124 is coupled directly to beveled gear 46' and beveled gear 122 is coupled to beveled gear 46 through beveled gear 130. Accordingly, rotation of shaft 120 causes outer member 42 to rotate in a first direction and causes outer member 42' to rotate in a second direction opposite to the first direction. The corresponding inner members are configured to rotate with the outer members. The inner members are coupled to proximal ports by a rotational coupling, or the like, to permit rotation of the inner members without rotating the proximal ports.

Projection 47 extends from outer member 42. A free end of projection 47 slides in cam groove 136 formed in cylindrical member 170 fixed to housing 79. Similarly, projection 47' extends from outer member 42' and slides in cam groove 138 formed in cylindrical member 172, as illustrated in Figs. 5 and 6. The cam grooves are shaped to cause the respective outer members to move axially, in distal and proximal directions, after the inner members rotate through a predetermined angle.

In operation, a needle is grasped in jaws of needle driver 40 with proximal controls 60 in the position illustrated in Fig. 4. When the surgeon squeezes handle 62 towards handle 64, shaft 120 rotates to cause needle driver 40 to rotate in a counter clockwise direction, as viewed from the distal end, and to cause needle catcher 50 to rotate in a clockwise direction, as viewed from the distal end. This results in the needle being pushed through tissue and into the jaws of needle holder 50, as described in greater detail below, at which time cam grooves 136 and 138 cause outer members 42 and 42' members to move relative to inner members 44 and 44' respectively in a manner to open jaws of needle driver 40 and close jaws of needle catcher 50.

Specifically, as outer member 42 rotates counter-clockwise, projection 47 enters the curved portion of cam groove 136 to cause outer member 42 to move distally with respect to inner member 44. Therefore, a distal end of outer member 42 moves off of cam surfaces 42A and 42B to allow jaw members 50A and 50B to open. Similarly, the interaction between projection 47' and cam groove 138 causes outer member 42' to move distally and close jaw members 50A and 50B' around the needle. Releasing handles 62 and 64 permits needle holder 40 and needle catcher 50 to rotate in opposite directions due to the force of biasing member 126 as projections 47 and 47' continue in the same direction through cam grooves 136 and 138. Now handles 62 and 64 can be compressed again to transfer the needle back to needle driver 40 for another stitch or for tying a knot in the manner described below with the appropriate jaws operating in a coordinated manner. Note that handles 62 and 64 are configured to be grasped while the surgeon's fingers pass through openings in the handles or while the surgeon's fingers are wrapped around outer portions of the handles to increase comfort and adaptability.

It will be appreciated that the jaw members of needle driver 40 and needle catcher 50 can be of different configurations, such as those described in the related applications incorporated herein, dependent upon procedural use and other considerations. Also, cutting elements 53 and 53' can be provided on the jaw members as needed to cut suture material or tissue, as illustrated in Fig. 3. It can be seen that pressing handle 62 towards handle 64 moves the jaw members of the needle driver toward the needle catcher and releasing handle 62 moves the jaw members of the needle driver away from the needle catcher. Once the needle has been pulled through the tissue, the mechanism can reverse the process so that, for example, if the handles are squeezed again, the mechanism will cause the jaw members of the needle catcher to move toward the needle driver while also causing the jaw members of the needle catcher to open and the jaw members of the needle driver to close, thereby transferring the suture needle back to the needle driver for continued suturing. This same automatic motion of the needle holders can be used for tying a knot merely by manipulating the distal end of the instrument in the manner disclosed below in copending application Serial No. 60/083,521 , incorporated herein by reference.

Suture material channel 37 extends to a proximal aperture (not illustrated) through which suture material S is supplied. Excess suture material may be stored on a spool or in a container. The surgeon can grasp proximal portions of suture material S to retract suture material S and fix proximal portions of suture material S. Also, a knot can be tied in the suture material extending from a proximal aperture and the knot can be pushed through suture material channel 37 with a knot pusher. Suture material S is attached to needle N loaded in jaw members 50A and 50B of needle driver 40. Suture material S can be inserted through suture material passage 37, prior to a suturing procedure, with a rigid guide tool or the like.

As illustrated in Fig. 1 , viewing device 33 includes objective (or image receiving element) 34, in the form of a lens, disposed at a distal end of barrel 32 and transmission member 35, in the form of optical fibers, extending through channel 38b from objective 34 to proximal viewing screen 36 which includes a display, such as an LCD display, and any required circuitry for driving the display and processing the image or signal transmitted by transmission member 35. A suturing procedure can be viewed on the display by virtue of an image defined by objective 34 and transmitted by transmission member 35. Viewing screen 36 is coupled to housing 79 by an articulated member to permit the orientation of viewing screen 36 to be adjusted for optimum viewing. Viewing device 33 can be inserted into channel 38b through proximal aperture 91 or can be formed integrally with other portions of instrument 30. In instrument 30, viewing device 33 is disposed substantially in tubular member 31 defining channel 38b and is coupled to viewing screen 36 by optical connector 39 and an unillustrated optical cable. Viewing device 33 can have a passage formed therein to permit aspiration or irrigation through proximal port 91 and channel 38b or viewing device 33 can be removable to permit channel 38b to be used for other purposes, such as the insertion of instruments. Fig.7 illustrates another instrument 130 according to the invention. Instrument 130 is similar to instrument 30 of Fig. 1 and like elements are labeled with identical reference numerals. However instrument 130 includes objective 134 that is a CMOS image sensor. The phrase "CMOS image sensor" as used herein means a solid-state image sensor fabricated using the well known, economical CMOS process, i.e., the Integrated Circuit (IC) fabrication technology usually combining either or both of enhancement mode N-channel (NMOS) and P-channel (PMOS) Field Effect Transistors (FETs), preferably on a single substrate to form logic gates, memory cells, or image sensors. CMOS image sensors are fabricated using the CMOS process and preferably incorporate, on a single substrate (or chip), all of the required image signal processing circuitry. The CMOS image sensor preferably has a plurality of MOS pixel circuits integrated onto a substrate or chip, and is preferably mounted on the distal end of barrel 32. In instrument 130, transmission member 135, in the form of an electrical conductor or conductors, is coupled to objective 134 and viewing screen 136.

A suturing procedure utilizing instrument 30 is described below. A procedure using instrument 130 is conducted similarly.. In use, instrument 30 is inserted into a body cavity using known techniques. Note that the entire device can be inserted through a single puncture site. Also, jaw members 50A and 50B and 50A' and 50B' as well as needle N, which can be initially grasped by needle driver 40, can be disposed within the diametrical dimension of barrel 32 by positioning needle driver 40 and needle catcher 50 appropriately. By grasping proximal controls 60, the distal end of suturing instrument 30 is guided to the operative site through a portal sleeve positioned in the wall of an anatomical cavity. The portal sleeve can be positioned in the anatomical cavity wall using any suitable penetrating technique, including those creating puncture sites by means of a removable obturator, such as a trocan, and can include a valve housing, if desired, to prevent loss of pneumoperitoneum during insertion and withdrawal of the instrument. Further, a retractable sheath can be provided to facilitate insertion through a portal sleeve valve by protecting needle driver 40 and needle catcher 50. Visualization of the endoscopic procedure can be accomplished with viewing device 33 incorporated into channel 38b. Prior to insertion through a portal sleeve or the like, needle N is held tightly between jaw members 50A and 50B of needle driver 40. Alternatively, needle N can be introduced into the body cavity by a separate instrument through a separate puncture sight or through an operating channel of instrument 30. In the illustrated embodiment, needle N is curved. However, needle N can be straight or of any other appropriate shape.

Figs. 8-13, illustrate a suturing procedure using instrument 30 after insertion of the distal end of instrument 30 into a body cavity. Note that the entire procedure can be viewed on viewing screen 36 and objective 35 can be formed to provide the desired field of view and magnification. Significantly, the field of view can be adjusted to encompass the paths of motion of both the needle driver and needle catcher and then permit viewing of the step of driving the needle through tissue in its entirety. This permits the surgeon to precisely place the needle in the tissue and drive the needle through the tissue without tearing the tissue.

As illustrated in Fig. 8, needle N, having suture material S attached thereto, is grasped between jaw members 50A and 50B of needle driver 40. The distal end of instrument 30 is then manipulated, while the procedure is viewed on viewing screen 36, to place a particular portion of tissue T (to be sutured) between a tip of needle N and jaw members 50A and 50B' of needle catcher 50 with precision. Handle 62 is then pressed toward handle 64 and thus the shaft of needle holder 40 is rotated in a counter-clockwise direction, as viewed in Figs. 8 -13, to cause a tip of needle N to penetrate and pass through a portion of tissue T while a shaft of needle catcher 50 is rotated in a clockwise direction. Once again, this step is viewed on viewing screen 36 to ensure precision of needle placement and motion as needle N passes through tissue T. Therefore, jaw members 50A and 50B push needle N through tissue T and into jaw members 50A' and 50B', as illustrated in Fig. 9. Jaw members 50A and 50B open due to movement in the proximal direction of outer member 42, as described above, and jaw members 50A' and 50B' close due to movement in the distal direction of outer member 42', as described above. With needle N positioned in needle catcher 50, handle 62 is released with needle

N grasped between jaw members 50A and 50B' and the shaft of needle catcher 50 is rotated in a counter-clockwise direction to pull needle N and thus suture material S attached to needle N, through tissue T, as illustrated in Fig. 10 while viewing the procedure on viewing screen 36. As shown in Fig. 11 , after needle N has been pulled through tissue T, the distal end of instrument 30 can then be moved away from tissue T (upwards in the drawing) and handle 62 can be compressed again so needle catcher 50 is rotated clockwise and needle driver 40 is rotated in a counter clockwise direction to place needle N between jaws 50A and 50B and needle N is grasped again with jaw members 50A and 50B, as shown in Fig. 12. This step also is viewed on viewing screen 36 to ensure that tissue is not damaged. In this state a single stitch has been made and upon releasing handle 62 instrument 30 is ready to make subsequent stitches, if needed, as shown in Fig. 13. Of course, the suturing procedure can be conducted by manipulating needle driver 40 and needle catcher 50 in any appropriate manner, such as the suturing procedures disclosed in the related applications incorporated herein. For example, the needle can have sharp tips on each end and can be passed back and forth through tissue in a shuttle manner.

Once the desired number of stitches have been made in the tissue in the manner described above, the surgeon can begin a knot tying procedure. A knot can be formed in ends of suture material S extending out of a proximal end of instrument 30 and can be pushed through channel 37 and tightened on tissue T while viewing the procedure on viewing screen 36. The knot can comprise any number of hitches, preferably two or more. Cutting elements 53 can be used to cut suture material S, by manipulating the appropriate jaw members, to permit withdrawal of instrument 30 and needle N. Alternatively, a knot can be tied by manipulating the needle holders in the manner described in copending application Serial No. 60/083,521, incorporated herein by reference.

Because the objective is disposed on a distal end of the instrument, the barrel in the preferred embodiment, the objective is always precisely positioned to view the needle holders and the tissue. The field of view is adjusted or set to view the needle holders and the tissue. The field of view and magnification of the viewing device can be preset or can be adjustable. For example, the proximal controls can include a zooming control or the viewing device can be movable in axial directions in channel 38b to move the objective closer to or further from the needle during a suturing procedure. Needle N can be straight or curved. Suture S can be connected to any portion of needle N and needle N can be stored in an operating channel prior to suturing. Further, the suturing motion can be accomplished by rotating barrel 32 in its entirety with the needle holders temporarily locked in position relative to barrel 32. At any point during the operative procedure, channel 38d can be used for irrigation or aspiration, can serve as a space for holding suture material S and/or needle N or as a portal for the introduction of other instruments such as, forceps, cutting members, ligators, or cautery devices. Also, channels 38a and 38c can be used for irrigation, aspiration, insertion of an instrument or the like by utilizing passages through inner member 44 of needle driver 40 and/or through inner member 44' of needle catcher 50. Proximal apertures 90 - 93 are provided for access to operating channels 38a-38d respectively.

Fig. 14 illustrates another instrument according to the invention which facilitates viewing of a suturing procedure. Instrument 230 includes viewing device 233 which is slidably disposed in barrel 32. A proximal end of viewing device 233 is coupled to knob 240. Movement of knob 240 in proximal and distal directions causes a distal end of viewing device 233 to move between the illustrated extended position in which the distal end extends from the distal end of a barrel 32 and a retracted position in which the distal end is disposed inside barrel 32. A distal end of viewing device 233 is resiliently flexible. In Fig. 14, viewing device 233 is in an undeflected position

Deflecting member 210 is disposed in the distal end of barrel 32 and is pivotably attached to barrel 32 at one end thereof. Tether 212 is coupled to a free end of deflecting member 210 at one end thereof and is coupled to lever 214 at the other end of thereof. Accordingly, pivoting lever 214 to the position illustrated in Fig. 15 will cause tether 212 to pull on deflecting member 210 thereby causing deflecting member 210 to deflect the distal end of viewing device 233 to the position illustrated in Fig. 15. A slot is formed in the distal end of barrel 32 to permit deflection of the distal end of viewing device to 233 to be deflected outside of the confines of barrel 32. In the deflected position of Fig. 15, objective 234 disposed on a distal end of viewing device 233 is offset from a longitudinal axis of barrel 32 and a thus provides a better viewing angle of the suturing procedure conducted with needle driver 40 and needle catcher 50.

The amount of deflection of the distal end of viewing device 233 can be adjusted by adjusting the position of lever 214, and the degree of extension of the distal end of viewing device 233 can be adjusted by moving knob 240, to provide optimal imaging position and angle. Deflection of the distal end of viewing device 233 can be accomplished by any appropriate mechanism, such as tethers, or the like. Alternatively, the distal end of the viewing device at 233 can have a naturally curved configuration to assumed a deflected position when advanced out of channel 38b.

The needle holders can be modified to suture anatomical tissue with straight or slightly curved suture needles by shaping the jaw members appropriately to receive and hold the needle. Also, the jaw members can be rotatable on the arms to accept needle N more smoothly. Further, needle N can be held between jaw members 50A and 50B or 50A' and 50B' while extending along the lengthwise direction of instrument 30 during insertion. In this case needle N can be seated in grooves formed along grasping surfaces of jaw members 50A and 50B or jaw members 50A' and 50B'.

While the needle driver and the needle catcher have been described herein as being controlled in concert, separate operating mechanisms, such as knobs and handles, can be used to provide independent control of the needle driver and the needle catcher. The needle holders need only be movable relative to one another to pass the needle. Therefore, one of the needle holders can be fixed. The needle holders can be operated by servo-motors or the like in response to actuation of a button or switch.

Any appropriate proximal controls can be used to accomplish the disclosed movement. For example, any of the proximal controls disclosed in applicant's copending applications incorporated herein by reference can be used. The needle holders can be moved toward and away from each other simultaneously or one after the other, i.e. in seriatim. Also, the instrument can include only one needle holder, or more than two needle holders. In the case of one needle holder, the needle is driven through tissue, released, and the needle holder can be moved to the other side of the tissue to regrasp the needle and pull the needle through the tissue. The needle holders can be of the same design or of different designs as long as one is capable of grasping and releasing a needle. Also, the needle holders can be disposed in various portions of the barrel. For example, the instrument can have any of the configurations disclosed in the copending applications incorporated herein. Further, the function of the needle driver and the needle catcher can be interchanged and suturing can be accomplished in the opposite direction depending on whether the surgeon is right- handed or left-handed, or other practical considerations.

The viewing device can be an optical device, a CCD and associated circuitry, a CMOS chip, or any other device for transmitting the image from the distal end of the proximal end of the instrument. The viewing screen can be mounted on a bendable, articulated, or pivoting member to permit adjustment of the angle thereof for optimum viewing. The viewing screen can be mounted separate from the housing and coupled to the transmission member by appropriate wiring and circuitry, and the like. An eyepiece or other type of viewing apparatus can be used for viewing in place of the screen. The transmission member can be any means for transmitting an image or signal, including electrical conductors, optical conductors, or a radio transmitter and receiver.

One or more lengths of suture material can be attached to the suture needle at any desirable location along the body or tip of the needle including, but not limited to, the proximal end of the needle, intermediate or medial portions of the needle body, or locations adjacent the tip of the needle. It will also be appreciated that the instrument according to the present invention can be used with any type of standard suturing needle including, but not limited to, needles having sharp or blunt tissue penetrating tips, and needles having tissue penetrating tips at opposite axial ends of a needle body. The holding mechanisms of the needle holders shown and described herein are merely exemplary of the types of needle holding mechanisms that can be used according to the present invention. Accordingly, the needle holders can have any suitable configuration for cooperatively grasping needles to suture anatomical tissue including, but not limited to, configurations wherein jaw members or other elements pivot, slide or otherwise move relative to one another to capture and release a needle. The jaw members can, for example, be of straight, curved or angled configuration and can be provided with ribs, grooves, slots and/or holes along grasping surfaces to assure a positive grip. The jaw members can also carry cutting members, such as slots with sharp edges or protruding blades, and can have opposed arcuate or concave portions for clamping tubular objects, such as organs, without compressing the objects.

The mechanisms for moving the needle catcher and needle driver relative to one another are merely exemplary of the types of mechanisms that can be used to perform these functions and other mechanisms can be used. The particular length and curvature of the suture needles shown and described herein as well as any angular displacements of the needle holders shown and described herein are merely exemplary, and it will be appreciated that other needle lengths and angular displacements can be used. For example, the needle holders can be flexible and can be drawn into the barrel proximally to be placed in an insertion position. Also, the needle holders can move rotationally, arcuately, linearly or through any appropriate path to accomplish suturing and knot tying.

One of the needle holders can be used as forceps, to grasp the tissue, during suturing or can contain a clip applicator. Therefore, the invention can be used for pickup and cutting, pickup and clipping, pickup and suturing, or lysis of adhesion procedures. Alternatively, a forceps device can be inserted through the operating channel formed in the shaft of one of the needle holders or another operating channel. The jaw members can be used as unipolar or bipolar cautery electrodes by being electrically insulated from other portions of the instrument and being coupled to an electrical power source by connector 110. Also, a button can be provided to switch the electric power from one set of jaw members to the other. Further, tissue can be clamped between adjacent needle holders or tissue can be retracted by placing adjacent needle holders between tissue portions and moving the needle holders apart. The suture tying procedure can be varied to accomplish tying of any desirable knot.

The components of the instrument of the present invention can be made of any suitable, medical grade materials to permit sterilization for reuse. The instrument can be reusable, disposable or disposable in part. The components can be made of multiple parts of various configurations and materials to reduce cost. The invention can have various valves, stop-cocks and seals therein to control the flow of fluid and medical devices through the suturing instrument. The tubular members, including the barrel, can have any appropriate cross-sectional shape, such as circular, square, triangular, or polygonal.

In as much as the present invention is subject to many variations, modifications and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and not be construed as limiting the scope of the invention defined by the appended claims.

Claims

WHAT IS CLAIMED IS: 1. A suturing instrument for causing a needle having suture material attached thereto to pass through anatomical tissue to suture the tissue while permitting the suturing procedure to be viewed, said instrument comprising: an elongated barrel having a distal end and a proximal end; a needle driver having a needle holding member extending from said distal end of said barrel; controls coupled to said proximal end of said barrel, said controls including means for manipulating said needle driver to pass the needle through the anatomical tissue; and a viewing device including an objective disposed proximate a distal end of said instrument.

2. An instrument as recited in claim 1 further comprising a needle catcher having a needle holding member extending from said distal end of said barrel, said means for manipulating further manipulating said needle catcher.

3. An instrument as recited in claim 1 wherein said objective is disposed on a distal end of said barrel, said viewing device including a transmission member coupled to said objective and extending to a proximal end of said barrel and screen means disposed proximate said proximal end of said barrel and coupled to said transmission member.

4. An instrument as recited in claim 3 wherein said screen means comprises a display.

5. An instrument as recited in claim 5 wherein said transmission member extends through said barrel.

6. An instrument as recited in claim 5 wherein said objective is an optical lens and said transmission member is an optical conductor.

7. An apparatus as recited in claim 5 wherein said objective is a CCD and said transmission member is an electrical conductor.

8. An instrument as recited in claim 3 wherein said objective is a CMOS chip and said transmission member is an electrical conductor.

9. An instrument as recited in claim 1 , further comprising means for deflecting said objective to a position that is offset from a longitudinal axis of said barrel.

10. A method of suturing anatomical tissue using a length of suture material attached to a needle while viewing the suturing procedure, said method comprising the steps of: a) introducing a distal end of an instrument having a barrel and a needle driver extending from the barrel into an area proximate the anatomical tissue; b) grasping the needle with the needle driver; c) positioning the anatomical tissue proximate a tip of the suture needle; d) manipulating the needle driver to cause a tip of the needle to penetrate the anatomical tissue; and e) viewing penetration of the tip of the needle into the tissue during said step (d) with a viewing device disposed in the barrel.

11. A method of suturing as recited in claim 10 wherein said viewing step further comprises viewing said steps (a) - (c) with the viewing device.

12. A method as recited in claim 11 wherein the viewing device used in said step (e) comprises an objective disposed on a distal end of the barrel, a transmission member coupled to the objective and extending to a proximal end of the barrel, and a viewing screen disposed proximate the proximal end of the barrel and coupled to the transmission member.

13. A method as recited in claim 12 wherein the viewing screen comprises a display.

14. A method as recited in claim 12 wherein the transmission member extends through said barrel.

15. A method as recited in claim 12 wherein the objective is an optical lens and the transmission member is an optical conductor.

16. A method as recited in claim 12 wherein the objective is a CCD and the transmission member is an electrical conductor.

17. A method as recited in claim 10 wherein the objective is a CMOS chip and the transmission member is an electrical conductor.

18. A method as recited in claim 12 further comprising the step of deflecting the objective to a position that is offset from a longitudinal axis of the barrel.

19. A suturing instrument for causing a needle having suture material attached thereto to pass through anatomical tissue to suture the tissue while viewing the suturing procedure, said instrument comprising: an elongated barrel having a distal end and a proximal end; a needle driver having a needle holding member extending from said distal end of said barrel; controls coupled to said proximal end of said barrel, said controls including means for manipulating said needle driver to pass the needle through the anatomical tissue; and a viewing device including an objective disposed proximate said distal end of said barrel, said viewing device having a field of view which permits viewing the needle as the needle is driven into the tissue.

20. An instrument as recited in claim 19 wherein said objective is disposed on a distal end of said barrel, said viewing device further comprising a transmission member coupled to said objective and extending to a proximal end of said barrel, and a viewing screen disposed proximate said proximal end of said barrel and coupled to said transmission member.

21. An instrument as recited in claim 20 wherein said viewing screen comprises a display.

22. An instrument as recited in claim 20 wherein said transmission member extends through said barrel.

23. An instrument as recited in claim 20 wherein said objective is an optical lens and said transmission member is an optical conductor.

24. An apparatus as recited in claim 20 wherein said objective is a CCD and said transmission member is an electrical conductor.

25. An instrument as recited in claim 20 wherein said objective is a CMOS chip and said transmission member is an electrical conductor.