WO2016018457A1

WO2016018457A1 - Surgical endoscopic cutting system

Info

Publication number: WO2016018457A1
Application number: PCT/US2015/011011
Authority: WO
Inventors: Graham Smith
Original assignee: Smith & Nephew, Inc.
Priority date: 2014-07-31
Filing date: 2015-01-12
Publication date: 2016-02-04

Abstract

An endoscopic cutting system includes a housing assembly adapted to engage and support the cutting blade of an endoscopic cutting device within the working channel of an endoscope in order to provide one handed operation of the endoscopic cutting system. The housing assembly can include an actuator mechanism that connects a lever to the endoscopic cutting device such that when a user applies pressure on or moves the lever, the cutting blade moves axially within the working channel of the endoscope. The cutting blade can include two cutting elements, a first cutting element including a side cutting window adapted for surgically removing individual segments of tissue and a second cutting element located distally of the first cutting element adapted for incising or piercing tissue.

Description

SURGICAL ENDOSCOPIC CUTTING SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit under 35 U.S.C. § 119(e) of the U.S.

Provisional Application No. 62/031345, filed July 31, 2014, the contents of which are incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] Not Applicable.

REFERENCE TO MICROFICHE APPENDIX

[0003] Not Applicable

BACKGROUND

Technical Field of the Invention

[0004] The present invention relates to a hand-held surgical endoscopic cutting system that can be used to resect tissue from within the body, for example to remove prostate tissue to treat Benign Prostatic Hyperplasia.

Description of the Prior Art

[0005] Benign Prostatic Hyperplasia (BPH) is a disease that affects the majority of men in the latter part of their life. The disease is a natural process of aging and has been linked to the decrease in testosterone, and subsequent increase in DHT. The result is slow, benign, growth of the male prostate. The prostate serves both glandular and muscular function; it surrounds the male urethra between the bladder neck and penis. Due to the sensitive anatomy, this growth has significant impact on the patient's quality of life. Some symptoms of BPH include; urgency to urinate, trouble emptying bladder, erectile dysfunction, nocturnal urination, and can lead to serious illness within the kidneys. SUMMARY

[0006] The present invention is directed to an apparatus or system adapted for use in performing a surgical procedure for endoscopically removing tissue, such as portions of the prostate gland. The surgical procedure includes inserting an endoscopic cutting device into the lumen of the urethra whereby the cutting end is adjacent to the portion of the prostate to be removed. An incision can be made in the urethra wall using a cutting blade or sharpened edge on the outer distal end of the endoscopic cutting device to enable at least a portion of the endoscopic cutting device to access the prostate tissue without removing portions of urethra wall. The sharpened edge can be a separate cutting element mounted on the cutting blade or provided as a retractable outer sheath of the cutting blade or the endoscope. The small incision allows the urethra to heal more quickly providing faster recovery. The cutting end of endoscopic cutting device can pass through the incision and can remove portions of the prostate tissue. In some embodiments of the invention, the endoscopic cutting device can be configured to include an electro-cautery electrode (e.g., either bipolar or monopolar) to cauterize some of the cut tissue of the prostate. In some embodiments of the invention, the endoscopic cutting device can include a loop electrode (e.g., either bipolar or monopolar) to cut tissue using RF energy, either without the need for mechanical cutting or in addition to mechanical cutting. The endoscopic cutting system can include an endoscope that enables the surgeon to visualize the cutting end of the endoscopic cutting device as it extends beyond the distal end of the endoscope. The endoscope can include a working channel or lumen that provides a path for the endoscopic cutting device to approach the prostate through the urethra.

[0007] The endoscope can be inserted into the urethra and the distal end of the endoscope can be positioned adjacent to the portion of the prostate to be removed. The endoscopic cutting blade can be positioned within the working channel or lumen of the endoscope such that the distal end of the cutting blade does not extend beyond the distal end of the endoscope to prevent the cutting blade from cutting the urethra during insertion. After the distal end of the endoscope is positioned adjacent to the portion of the prostate to be removed, the distal end of the endoscopic cutting device can be adjustably positioned by the user to project beyond the distal of the endoscope. The distal end of the endoscopic cutting blade can include two cutting elements, a first cutting element adapted to excise tissue and a second cutting element adapted for creating an incision in the wall of the urethra to provide access to the prostate. The incision can be made parallel to the longitudinal axis of the urethra or transverse to the longitudinal axis of the urethra (e.g., along the circumference of the urethra wall). The second cutting element can be used to create an incision in the wall of the urethra and the distal end of the endoscopic cutting device can be inserted through the incision into the prostate. The distal end of the endoscopic cutting blade can include a first cutting element adapted for removing portions of the prostate. The first cutting element can be advanced through the incision into the prostate to position it against the prostate tissue to be removed. The first cutting element can be actuated by actuating the drive unit to rotate the cutting blade to cut and remove prostate tissue. In some embodiments, the first cutting element can include a stationary outer tube that includes a side facing cutting window and an inner rotating cutting blade that slices tissue that projects into the cutting window.

[0008] In accordance with the invention, the endoscopic cutting system can include a handle assembly that can include a housing that engages and supports the endoscope and the endoscopic cutting device in a predefined configuration. In accordance with some embodiments of the invention, the housing can be adapted to position the endoscopic cutting device at various positions along the longitudinal axis of the working channel of endoscope to facilitate one or more surgical procedures. In accordance with some embodiments of the invention, the housing can be adapted to position the endoscopic cutting device within the working channel of the endoscope whereby the distal end of the endoscopic cutting device does not extend beyond the end of the endoscope. The handle assembly can further include an actuation mechanism coupled to the endoscopic cutting device that can move and position the endoscopic cutting device with respect to the endoscope. The actuation mechanism can include a lever or trigger that can be operated by the surgeon to control the motion and position of the endoscopic cutting device relative to the endoscope.

[0009] The handle assembly can be adapted to receive a conventional endoscope and a conventional endoscopic cutting device, enabling the endoscope and the endoscopic cutting device to be separately sterilized or disposable. In accordance with some embodiments of the invention, the distal end of the endoscopic cutting device can be inserted into the working channel of the endoscope whereby the distal end of the endoscopic cutting device does not extend beyond the distal end of the endoscope and with each of the endoscope and the endoscopic cutting device separately coupled to the handle assembly. In accordance with some embodiments of the invention, the housing of the handle assembly can be assembled around the endoscope and the endoscopic cutting device to position them relative to each other. The endoscopic cutting device can be coupled to a carriage that can be part of the actuation mechanism that is adapted to move the endoscopic cutting device relative to the endoscope.

[0010] The handle assembly can include a handle that enables a surgeon to hold and operate the device with one hand to extend and retract the endoscopic cutting blade within the endoscope. The actuation mechanism can include a trigger or lever that can be actuated by squeezing to cause the endoscopic cutting device to extend and a return spring can be provided to return the endoscopic cutting device to the retracted position as the trigger or lever is released.

[0011] In accordance with some embodiments of the invention the housing of the handle can be integrated in to the endoscope. In some embodiments, the housing and the endoscope can be integral parts of the same component or assembly (e.g., a monolithic component or assembly) or the endoscope can be permanently affixed to the handle, such as by welding, adhesive bonding or over molding the housing on to the endoscope.

[0012] In accordance with some embodiments of the invention, the housing of the handle can be integrated into the endoscopic cutting device. In some embodiments, the housing and the endoscopic cutting device can be integral parts of the same component or assembly (e.g., a monolithic component or assembly) or the endoscopic cutting device can be permanently affixed to the housing, such as by welding, adhesive bonding or over molding the handle on to the endoscopic cutting device. In these embodiments of the invention, the endoscope can be coupled to a carriage that is part of the actuation mechanism that is adapted to move the endoscope relative to endoscopic cutting device.

[0013] These and other capabilities of the invention, along with the invention itself, will be more fully understood after a review of the following figures, detailed description, and claims. BRIEF DESCRIPTION OF THE FIGURES

[0014] The accompanying drawings, which are incorporated into this

specification, illustrate one or more exemplary embodiments of the inventions and, together with the detailed description, serve to explain the principles and applications of these inventions. The drawings and detailed description are illustrative, and are intended to facilitate an understanding of the inventions and their application without limiting the scope of the invention. The illustrative embodiments can be modified and adapted without departing from the spirit and scope of the inventions.

[0015] FIGS. 1A and IB show diagrammatic side views of endoscopic cutting systems according to some embodiments of the invention.

[0016] FIG. 1C shows a diagrammatic side view of an electrosurgical endoscopic cutting system according to some embodiments of the invention.

[0017] FIG. ID shows a diagrammatic view of an electrosurgical endoscopic cutting blade according to some embodiments of the invention.

[0018] FIG. 2 is a diagrammatic side view of a handle assembly of an endoscopic cutting system according to some embodiments of the invention.

[0019] FIG. 3 is a diagrammatic side view of an endoscopic cutting system according to some embodiments of the invention.

[0020] FIGS. 4-7, 8 A, 8B, 9A and 9B are is a diagrammatic views of various embodiments of the distal end of an endoscopic cutting blade according to some embodiments of the invention.

[0021] FIGS. 10A, 10B, and IOC show a diagrammatic view of an endoscopic cutting system according to some embodiments of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0022] The present invention is directed to an endoscopic cutting system 100 that a surgeon can use to remove tissue during an endoscopic surgical procedure using a single hand to control the location and motion of the cutting blade. Figures 1A, IB, 1C and 3 show an illustrative example of an endoscopic cutting system 100 according to some embodiments of the invention with a portion of the housing 122 removed. The endoscopic cutting system 100 can include a handle assembly 120, and endoscopic cutting device 140 and an endoscope 150. The endoscope 150 can be fitted with an optional sheath or insertion tube 190 as shown in Fig. 1A. Fig. IB shows the endoscopic cutting system 100 with sheath 190 removed. Fig. 1C shows the endoscopic cutting system 100 configured to use an electrosurgical cutting blade that can provide mechanical cutting and electro -cautery at the same time or in sequence.

[0023] As shown in Figs. 1A, IB and 3, the endoscopic cutting device 140 can include a drive unit 142 and a tubular cutting blade 144 that is coupled to the drive unit 142. The drive unit 142 can include a motor that can be energized to cause the cutting blade to rotate about a longitudinal axis. The motor can be an electric or non-electric (e.g., pneumatic or hydraulic) motor. In accordance with some embodiments, the motor of the drive unit 142 can be connected to a power source (not shown) and a control unit (not shown) by a power/control cable 143. The cutting blade 144 can rotate continuously in one direction or can periodically change direction, either before or after having made at least one complete revolution. In accordance with some embodiments of the invention, the cutting blade 144 can include a stationary outer tubular member 144 A and a rotatable inner tubular cutting blade 144B as shown in Figs. 4 - 9B. The stationary outer tubular member 144 A includes a cutting window and the inner tubular cutting blade 144B includes a cutting window that is configured to move across the cutting window of the stationary outer tubular member 144 A to cut tissue that enters into the cutting window of the stationary outer tubular member 144 A. The inner tubular cutting blade 144B can include a lumen that extends into the drive unit 142 and can be coupled to the aspiration port 145. The aspiration port 145 can be connected to a vacuum source that enables fluid and cut tissue to be aspirated through the cutting blade 144B. In accordance with some embodiments, the aspiration port 145 can be connected to an aspiration control valve 145 A that can control the application of suction or negative pressure to the distal end 146 of cutting blade 144B.

[0024] The cutting blade 144 can also be provided with a retractable outer sheath or tube 148. The outer sheath 148 can include one or more cutting edges on the outer surface or distal end of the outer sheath 148. The outer sheath 148 can be configured to move axially along its longitudinal axis relative to the cutting blade 144 enabling the distal end of the outer sheath 148 to extend beyond the distal end of the endoscope 150 to make an incision in tissue. In addition, the cutting blade 144 can be configured to move axially along the longitudinal axis relative to the outer sheath 148 enabling a portion of the distal tip 146 of the cutting blade 144 to extend beyond the distal end of the outer sheath 148 to excise tissue.

[0025] The endoscopic cutting device 140 can also include an aspiration channel that enables cut tissue and fluid to be aspirated from the surgical site. The cutting blade can include a lumen that extends from the distal end to the proximal end of the cutting blade and can be connected to the aspiration channel. A source of vacuum (e.g. negative pressure) can be applied to the proximal end of aspiration channel to cause cut tissue and fluid to be aspirated from the surgical site at the distal end of the cutting blade to the proximal end of the aspiration channel. A collection reservoir can be connected to the proximal end of the aspiration channel to facilitate the collection the cut tissue and fluid.

[0026] In accordance with some embodiments of the invention, the endoscopic cutting device 140 can include an electrosurgical cutting device such as that disclosed in commonly owned U.S. Patent No. 7,150,747 entitled Electrosurgical Cutter, which is herein incorporated by reference in its entirety. Figures 1C and ID show embodiments of invention that include an endoscope cutting system that includes an electrosurgical cutting device.

[0027] Fig. 1C shows an illustrative example of an endoscopic cutting system 100 according to some embodiments of the invention wherein the handle assembly 120 is adapted to receive an electrosurgical endoscopic cutting device 140 which includes an RF power cord 143 A. The electrosurgical cutting device 140 can be used to apply electrocautery to tissue and/or cut tissue as needed for treatment. The cutting blade of electrosurgical cutting device 140 can include a second cutting element that can also be electrically connected for electro-cautery cutting as well.

[0028] As shown in Fig. ID, the endoscopic cutting device 140 can be fitted with an electro-blade 142 A that includes an RF power cord 143 A and connector 143B adapted to be connected to either an RF generator or a footswitch connected to an RF generator to provide a supply path and a return path for the RF signal. The electro-blade 142A can be configured for bipolar or monopolar operation. The stationary outer tubular member 144 A and the inner tubular cutting blade 144B can be electrically connected to the supply path of the RF signal to apply the RF signal to tissue as it is being cut to cauterize the tissue at the site where it is being cut.

[0029] In accordance with some embodiments of the invention, the endoscopic cutting device 140 can include an electrocautery cutting loop (e.g., with or without the inner and outer tubular cutting blades). The electrocautery cutting loop can be electrically connected to the RF supply which enables the cutting loop to cut tissue. The optional inner and outer tubular cutting blades can be used to chop the larger pieces of cut tissue into small pieces to facilitate aspiration through the inner tubular cutting blade. Where the tubular cutting blades are not used, an aspiration tube can be provided to remove the fluid and/or cut tissue.

[0030] The endoscope 150 enables the user (e.g. surgeon) to view the surgical site inside the body. As shown in Figs. 1A and IB, the endoscope 150 can extend from a proximal end 152 to a distal end 154 along the longitudinal axis of the endoscope 150. The endoscope 150 can include a visualization system 160 and an illumination system 170. The visualization system 160 and the illumination system 170 can be enclosed within an elongated tubular component 158 of the endoscope 150. The visualization system 160 can extend from the proximal end 152 to the distal end 154 and an

illumination system 172 can extend from the proximal end 152 to the distal end 154. The distal end 154 of the endoscope can be inserted into the body of the subject to enable the user to illuminate and remotely observe the surgical site and the surgical procedure. The visualization system 160 can include an observation lens 162 at the distal end 154, a camera port 164 at the proximal end and one or more rod lenses and/or one or more optical fibers for transferring images from the distal end 152 to the proximal end 154 of the endoscope 150. The camera port 164 can be adapted to be coupled to a camera that can be used to reproduce the images of the surgical site on a display screen (not shown). Alternatively, the visualization system 160 can include one or more cameras located at the distal end 154 that covey images over wires, optical fibers, or wirelessly to a receiver or display screen connected at the proximal end 152. The illumination system 170 can include one or more optical fibers connected to a light source (no shown) by light port 172 at the proximal end 152 to transmit light to the distal end 154. The endoscope 150 can also include one or more working channels that are adapted to receive the cutting blade 144 and, optionally, the outer sheath 148. In accordance with some embodiments of the invention, the endoscope 150 can be a unitary device in which the visualization system and the illumination system can be integral parts that are permanently affixed within device. In accordance with some embodiments of the invention, the endoscope 150 can be an assembly device in which the visualization system 160 and the illumination system 170 can be component parts that can be removed from the device.

[0031] In accordance with some embodiments of the invention, the endoscope

150 can include an insertion portion 156 which can be adapted to be inserted into the body by providing the insertion portion 156 with a predefined diameter sufficient to be inserted, for example into an incision, an orifice or a lumen of an organ. In accordance with some embodiments, the diameter of the insertion portion of the endoscope can be less than 10 mm, less than 9 mm, less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, or less than 4 mm. The length of the insertion portion 156 can be determined as a function of the distance from the surgical site to the entry point in the body of the subject. In accordance with some embodiments, the insertion portion of the endoscope can be at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, or at least 30 mm. In accordance with some embodiments of the invention, the diameter of the endoscope lumen can be less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, less than 4 mm or less than 3 mm. In accordance with some embodiments of the invention, the outer diameter of the outer sheath can be less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, less than 4 mm or less than 3 mm.

[0032] The handle assembly 120 is shown in Figs. 1 - 3. The handle assembly

120 operatively connects that endoscope 150 and the endoscope cutting device 140 in to an assembly that can be operated with one handle. The handle assembly 120 can include an actuation mechanism 130 that can be manipulated by the user to control the position of the cutting blade 144 within the working channel of the endoscope 150. The handle assembly 120 can also include a sheath control mechanism 180 that enables the user to control the position of the outer sheath 148 with respect to the cutting blade 144, for example, to extend the sheath 148 for cutting.

[0033] Figure 2 shows a side view (with the left side housing removed) of an embodiment of the handle assembly 120 without the endoscope 150 and the endoscopic cutting device 140. The handle assembly 120 can include a housing 122 which can be formed from one or more pieces. The handle assembly 120 can also include a drive housing 124 and an endoscope engaging portion 126. In accordance with some embodiments of the invention, the endoscope engaging portion 126 is adapted to engage and support at least a portion of the endoscope 150 such that the endoscope 150 does not move axially and the drive unit 142 can be contained within the drive housing 124 of the housing assembly.

[0034] The handle assembly 120 can also include a handle or hilt 128 that can be adapted to be grasped by the user. The actuation mechanism 130 can be mounted within or adjacent to the hilt 128 to enable the user to grasp the handle assembly 120 and operate the endoscopic cutting system 100 with a single hand. The actuation mechanism 130 can include a lever or trigger 132 connected to a carriage 134 by a linkage 136. The carriage 134 can be adapted to engage and support the drive unit 142 of the endoscopic cutting device 140.

[0035] As shown in Figs. 2 and 3, the linkage 136 can be formed by linkage elements 136A and 136B which connect the lever 132 to the carriage 134. In accordance with some embodiments of the invention, the lever 132 can be mounted on a pivot 132P that enables the lever 132 pivot with respect to the housing 122. A portion of the lever 132 can be coupled to linkage element 136B which can be coupled to linkage element 136A. The linkage element 136A can be mounted on pivot pin 136P to enable linkage element 136A to pivot relative to the housing 122. Linkage element 136A can also be coupled between the carriage 134 and linkage element 136B such that pivoting the lever 132 causes the linkage 136A to pivot and move the carriage 134 in a controlled manner. Linkage 136A can be coupled to the carriage 134 by pin 134P and return spring 139 (e.g. a tension spring or compression spring) can be coupled to the carriage 134, the pin 134P or the linkage element 136A to bias the cutting blade 144 into the retracted position. Other similar mechanisms, such as 3 bar mechanisms, 4 bar mechanisms and slider crank mechanisms can also be used to enable the lever 132 to cause the carriage 134 to move.

[0036] In accordance with some embodiments of the invention, the cutting blade 144 of the endoscope cutting device 140 can be inserted into a working channel of the endoscope 150 as shown in Figs. 1A and IB. In this configuration, the longitudinal axis of the cutting blade 144 can be substantially parallel and aligned with the longitudinal axis of the endoscope and the cutting blade 144 can move axially within the working channel of the endoscope 150. The assembly (formed by the endoscope 150 and the endoscopic cutting device 140) can be mounted to the handle assembly 120 as shown in Figs. 1A and IB. In this embodiment, the handle assembly 120 holds the endoscope 150 substantially fixed with respect to the housing 122 and drive unit 142 can be mounted to the carriage 134 which can be moveable by actuation of the lever 132. In operation, the user actuates the lever 132 which causes the carriage 134 and the drive unit 142 to move relative to the drive housing 124 (and the endoscope 150) by operation of the linkage 136. A return spring 139 can be connected between the carriage 134 and the drive housing 124 to bias the carriage 134 in to the retracted position toward the proximal end of the system.

[0037] In the retracted position, the carriage 134 and the housing 122 can be configured to position the cutting blade 144 within the working channel such that the distal end 146 of the cutting blade 144 can be flush with or slightly recessed within (and therefor does not extend beyond) the distal end 154 of the endoscope 150. Upon operation of the lever 132, the user can control the amount of extension (e.g., distal movement) of the distal end 146 of the cutting blade 144 beyond the distal end 154 of the endoscope 150 to enable the cutting blade 144 to cut tissue. When the user releases the pressure on the lever 132, the return spring 193 can bias the cutting blade 144 to the retracted position.

[0038] In accordance with some embodiments of the invention, the housing 122 of the handle assembly 120 can be integrated as part of the endoscope, for example, the endoscope 150 can include the drive housing 124, and the handle 128 (e.g., which supports the actuation mechanism 130) as an integrated or monolithic part of the proximal end 152 of the endoscope 150. In this embodiment, the proximal end 152 of the endoscope 150 includes the handle 120 as a monolithic component or as a permanently attached component of the endoscope. In accordance with some embodiments, the housing 122 of the handle assembly 120 can be permanently attached to the proximal end 152 of the endoscope 150, such as by welding, brazing, or adhesives. In accordance with some embodiments of the invention, the housing 122 of the handle assembly 120 can be over-molded onto the proximal end 152 of the endoscope 150 forming an integrated unit and the actuation mechanism 130 can be added to the handle 128.

[0039] In accordance with some embodiments of the invention, the housing 122 of the handle assembly 120 can be integrated as part of the drive unit 142 of the endoscopic cutting device, for example the drive unit 142 can include the endoscope engaging portion 126, and the handle 128 (e.g., which supports the actuation mechanism 130) as an integrated or monolithic part of the drive unit 142, such as the drive unit housing. In accordance with some embodiments, the housing 122 of the handle 120 can be permanently attached to the drive unit 142, such as by welding, brazing, or adhesives. In accordance with some embodiments of the invention, the housing 122 of the handle 120 can be over-molded onto the drive unit 142 forming an integrated unit. In this embodiment, the actuation mechanism 130 can be configured to engage the endoscope and move the endoscope relative to the endoscopic cutting device. The endoscope can be mounted to a carriage (e.g., carriage 1346) that is coupled to lever 132 at pin 132P (which is not fixed to the housing 122), which can be configured to pivot on linkage element 136B, such that actuating the lever 132 causes the carriage and the endoscope to move proximally. In this configuration, a return spring 139 (e.g., a compression or tension spring) can be used to bias the endoscope 150 toward its initial position.

[0040] In an alternative embodiment, the lever 132 can be connected to the carriage 134 by a rack and pinion or a gear train whereby the lever 132 pivots and drives a pinion gear that can be either directly or indirectly coupled to the rack that can be coupled to the carriage 134 (or directly attached to the drive unit 142). The user can control the axial motion of the cutting blade 144 by actuating the lever 132. A spring 139 can be used to bias the carriage toward the retracted position.

[0041] In an alternative embodiment, the actuation mechanism 130 can be configured whereby the spring 139 biases the drive unit 142 and the cutting blade 144 in the extended position (e.g., where the cutting blade 144 extends beyond the distal end 154 of the endoscope 150 or where the endoscope 150 is in the retracted position) and the lever 132 can be configured to move the cutting blade 144 in to the retracted position. This can, for example, be accomplished by exchanging the positions of the spring 139 and the lever 132 as shown in Fig. 2. Thus, the spring 139 can be connected between the endoscope engaging portion 126 and the carriage 134 to bias the carriage 134 toward the extended position and the lever 132 can be pivotally connected to the proximal end of the housing 122 (where spring 139 is shown in Fig. 2) and connected to linkage 136A by a linkage similar to 136B. In operation, moving the lever 132 in the distal direction will cause the drive unit 142 and the cutting blade 144 to retract against the force of the spring 139 and releasing the lever 132 will enable the cutting blade 144 to return to the extended position under the force of the spring 139.

[0042] Fig. 4 shows a diagrammatic view of the distal end 154 of the endoscope

150 and the cutting blade 144 extending through the working channel 155 of endoscope 150. In accordance with some embodiments of the invention, the cutting blade 144 can include a first cutting element that includes a stationary outer tube 144 A and a rotatable inner tube 144B. Both the outer tube 144 A and the inner tube 144B can include overlapping side cutting windows 143 A and 143B such that as the inner tube 144B rotates any tissue that extends into the cutting window of the outer tube 144 A and the cutting window of the inner tube 144B can be sheared apart by the overlapping edges of the windows. Cutting can be performed by pressing the side window 143 A of the cutting blade 144 against the tissue such that the tissue enters the cutting window 143 A of the outer tube 144A can is cut by the rotating window 143B of the inner tube 144B. The longitudinal edges 143A-1 and 143B-2 of one or both cutting windows can be sharpened and/or provided with teeth to facilitate cutting.

[0043] In accordance with some embodiments of the invention, the cutting windows 143 A and 143B can be formed by removing a section of the outer tube 144 A and/or the inner tube 144B. In accordance with some embodiments of the invention, the distal end of the outer tube 144 A and optionally the distal end of the inner tube 144B can be closed and can be flat, rounded or pointed. In accordance with some embodiments of the invention, the cutting windows 143 A and 143B can be formed by slicing the outer tube 144A and/or the inner tube 144B along a plane that is parallel to or transverse to the longitudinal axis of the cutting blade 144.

[0044] In accordance with some embodiments of the invention, the cutting blade

144 can include a second cutting element 145 located distally of the cutting window. As shown in Fig. 4, the outer tube 144A can be provided with a sharpened or pointed tip 145 to enable the cutting blade to pierce or slice through tissue, such as the lining of the urethra. The pointed tip 145 can form a sharp edge along the plane of the cutting window wall of an organ to enable the cutting blade 144 to reach tissue on the other side of the wall.

[0045] Figs 5, 6 and 7 show alternative embodiments of the second cutting element according to the invention. Fig. 5 shows a cutting edge 145 formed on the outer tube 144 A extending along the plane of the cutting window 143 A. Fig. 6 shows a cutting edge 145 formed on the outer tube 144 A extending along a plane that is offset or displaced from the plane of the cutting window 143 A. Fig. 7 shows a cutting edge 145 formed on the outer tube 144A extending along a plane that is transverse to the plane of the cutting window 143 A. While each of these second cutting elements 145 is shown positioned distally from the cutting window 143 A, the second cutting element 145 can also be provided on the side of the outer tube 144 A proximal of the cutting window 143A.

[0046] Figs. 8A, 8B, 9A, and 9B show an alternative embodiment of the invention wherein an outer sheath 148 is provided around the cutting blade 144. The outer sheath 148 can include a cutting edge 145 A that can be advanced (Figs. 8 A and 9 A) and retracted (Figs. 8B - partially retracted and 9B - fully retracted) separately from the cutting blade 144. In operation, the endoscope 150 can be advanced into position with the sheath 148 and the cutting blade 144 safely retracted against the cutting blade 144 or into the working channel of the endoscope 150. After the endoscope is positioned appropriately, the sheath 148 can be advanced to extend beyond the distal end 154 of the endoscope 150 and used to create an incision in the tissue adjacent the distal end 154 of the endoscope 150. After the incision is completed, sheath 148 can be retraced (Figs. 8B and 9B) and the endoscope 150 can be advanced through the incision and the cutting blade 144 can be extended beyond the distal end 154 of the endoscope 150 to cut and remove tissue.

[0047] While Figs. 8 A and 8B show a cutting blade 144 having teeth similar to that shown in Figs. 4 - 7, Figs. 9 A and 9B show a cutting blade 144 A according to an alternative embodiment of the invention. In accordance with this embodiment of the invention, the cutting blade 144C can include an inner tube 144B that rotates and translates axially to cut tissue as described in commonly owned U.S. Patent No.

7,226,459 which is hereby incorporated by reference. [0048] In accordance with some embodiments of the invention, the actuation mechanism 130 can include a sheath control extension mechanism 180 that can be adapted to advance and retract the outer sheath 148 relative to the position of the drive unit 142. Figs. 10A, 10B and IOC show an embodiment of an extension mechanism 180 according to some embodiments of the invention. The an extension mechanism 180 can include an extension element 182 that can be coupled between the carriage 134 and the outer sheath 148, such that actuating the actuation mechanism 130 causes the outer sheath 148 to extend beyond the distal end 154 of the endoscope 150. The extension mechanism 180 can also include an extendable coupling 184 that connects the extension element 182 to the outer sheath 148 can causes the length of the extension element 182 to increase or decrease. In accordance with some embodiments of the invention, as shown in Figs. 10A, 10B and IOC, the extendable coupling 184 can include a rotatable cam 186 that includes at least two selectable positions and is adapted to slide in a slot formed in the housing 122. The extendable coupling 184 can connect the extension element 182 to sheath coupling element 188 and the sheath coupling element 188 can be fastened or coupled to the outer sheath 148.. In accordance with some embodiments the rotatable cam 186 can serve to position the sheath coupling element 188 at two or more predefined distances with respect to the extension element 182 which also serves to move the sheath 148 with respect to the cutting blade 144.

[0049] Fig. 10A shows the actuation mechanism 130 in the retracted position whereby the cutting blade 144 and the outer sheath 148 does not extend beyond the distal end 154 of the endoscope 150. However, the extendable coupling 184 of the extension mechanism 180 is in the extended position whereby the outer sheath 148 extends beyond the distal end of the cutting blade 144 as shown in Figs. 8 A and 9A. When the actuation mechanism 130 is operated as shown in Fig. 10B, the distance that the sharpened distal end of the outer sheath 148 extends beyond the distal end 154 of the endoscope 150 can be controlled by the user. The outer sheath 148 can be used to create an incision or opening through which the endoscope 150 can be inserted. After the endoscope 150 is inserted, the outer sheath 148 can be retracted by placing the extendable coupling 184 of the extension mechanism 180 in the retracted position as shown in Fig. IOC, 8B (partially retracted) and 9B.

[0050] Other embodiments are within the scope and spirit of the invention. For example, due to the nature of software, functions described above can be implemented using software, hardware, firmware, hardwiring, or combinations of any of these.

Features implementing functions may also be physically located at various positions, including being distributed such that portions of functions are implemented at different physical locations.

[0051] Further, while the description above refers to the invention, the description may include more than one invention.

Claims

CLAIMS What is claimed is:

1. An endoscopic cutting system adapted for one handed operation comprising:

a housing assembly engaging an endoscope and an endoscopic cutter;

the housing assembly further including an actuator adapted to engage and move the endoscopic cutter relative to the housing assembly;

the endoscope being substantially coupled to the housing assembly whereby actuating the actuator causes the endoscopic cutter to move relative to the endoscope.

2. The endoscopic cutting system according to claim 1 wherein the endoscope includes a working channel extending from a distal end to a proximal end of the endoscope and the endoscopic cutter includes a cutting blade extending into the working channel.

3. The endoscopic cutting system according to claim 2 wherein actuating the actuator causes the cutting blade to extend from the distal end of the endoscope.

4. The endoscopic cutting system according to claim 2 wherein the actuator moves the cutting blade between an extended position and a retracted position and the housing assembly further comprises a spring adapted for biasing the cutting blade into the retracted position.

5. The endoscopic cutting system according to claim 1 wherein the actuator includes a lever coupled to the endoscopic cutter by a linkage and moving the lever causes the endoscopic cutter to move relative to the housing.

6. The endoscopic cutting system according to claim 1 wherein the endoscopic cutter includes a cutting blade extending along a longitudinal axis that includes a first cutting element and a second cutting element, the second cutting element being positioned distally with respect to the first cutting element.

7. The endoscopic cutting system according to claim 6 wherein the second cutting element includes a substantially pointed tip.

8. The endoscopic cutting system according to claim 6 wherein the second cutting element includes a substantially sharpened edge.

9. The endoscopic cutting system according to claim 6 wherein the second cutting element includes an outer sheath over the cutting blade, the outer sheath being movable along the longitudinal axis.

10. The endoscopic cutting system according to claim 9 further comprising an extension mechanism adapted to position the sheath along the longitudinal axis.

11. The endoscopic cutting system according to claim 1 wherein the endoscopic cutter includes a cutting blade and the cutting blade includes a monopolar electro-blade adapted to be connected to an RF signal generator.

12. The endoscopic cutting system according to claim 1 wherein the endoscopic cutter includes a cutting blade and the cutting blade includes a bipolar electro- blade adapted to be connected to an RF signal generator.

13. The endoscopic cutting system according to claim 1 wherein the endoscopic cutter includes a cutting element and the cutting element includes a monopolar electric loop adapted to be connected to an RF signal generator.

14. The endoscopic cutting system according to claim 1 wherein the endoscopic cutter includes a cutting element and the cutting element includes a bipolar electric loop adapted to be connected to an RF signal generator.

15. An endoscopic cutting system adapted for one handed operation comprising: a housing assembly engaging an endoscope and an endoscopic cutter;

the housing assembly further including an actuator adapted to engage and move the endoscope to the housing assembly;

the endoscopic cutter being substantially coupled to the housing assembly whereby actuating the actuator causes the endoscope to move relative to the endoscopic cutter.

16. The endoscopic cutting system according to claim 15 wherein the endoscope includes a working channel extending from a distal end to a proximal end of the endoscope and the endoscopic cutter includes a cutting blade extending into the working channel.

17. The endoscopic cutting system according to claim 16 wherein actuating the actuator causes the cutting blade to extend from the distal end of the endoscope.

18. The endoscopic cutting system according to claim 16 wherein the actuator moves the endoscope between an extended position and a retracted position and the housing assembly further comprises a spring adapted for biasing the endoscope into the extended position.

19. The endoscopic cutting system according to claim 15 wherein the actuator includes a lever coupled to the endoscope and moving the lever causes the endoscope to move relative to the housing.

20. The endoscopic cutting system according to claim 15 wherein the endoscopic cutter includes a cutting blade extending along a longitudinal axis that includes a first cutting element and a second cutting element, the second cutting element being positioned distally with respect to the first cutting element.

21. The endoscopic cutting system according to claim 20 wherein the second cutting element includes a substantially pointed tip.

22. The endoscopic cutting system according to claim 20 wherein the second cutting element includes a substantially sharpened edge.

23. The endoscopic cutting system according to claim 20 wherein the second cutting element includes an outer sheath over the cutting blade, the outer sheath being movable along the longitudinal axis.

24. The endoscopic cutting system according to claim 23 further comprising an extension mechanism adapted to position the sheath along the longitudinal axis.

25. The endoscopic cutting system according to claim 15 wherein the endoscopic cutter includes a cutting blade and the cutting blade includes a monopolar electro-blade adapted to be connected to an RF signal generator.

26. The endoscopic cutting system according to claim 15 wherein the endoscopic cutter includes a cutting blade and the cutting blade includes a bipolar electro- blade adapted to be connected to an RF signal generator.

27. The endoscopic cutting system according to claim 15 wherein the endoscopic cutter includes a cutting element and the cutting element includes a monopolar electric loop adapted to be connected to an RF signal generator.

28. The endoscopic cutting system according to claim 15 wherein the endoscopic cutter includes a cutting element and the cutting element includes a bipolar electric loop adapted to be connected to an RF signal generator.

29. A method for performing an endoscopic procedure comprising:

providing an endoscopic cutting device, the device including an endoscope and a motor driven cutter, each coupled to a housing, the housing including an actuator whereby actuating the actuator causes the motor driven cutter to move relative to the endoscope; the endoscope including a working channel adapted for receiving a cutting blade of the motor driven cutter, the working channel extending from a distal end to a proximal end of the endoscope;

positioning the cutting blade in the working channel of the endoscope; inserting the distal end of the endoscope into an opening in the body with the cutting blade in the working channel; and

positioning a distal end of the cutting blade to extend beyond the distal end of the endoscope by actuation of the actuator.

30. The method of claim 29 further comprising positioning the distal end of the cutting blade against tissue in the body and operating the cutter to cut tissue in the body.

31. The method of claim 30 further comprising actuating the actuator to move the cutter while the cutter is operatively cutting the tissue.

32. The method of claim 29 wherein the endoscope is coupled to a first portion of a handle and the motor driven cutter is coupled to a second portion of the handle and actuating the actuator causes the motor driven cutter to move relative to the endoscope.

33. The method of claim 29 wherein the cutting blade includes a first cutting element and second cutting element positioned distally with respect to first cutting element, and the method includes using the second cutting element to make an opening in tissue in the body.

34. The method of claim 33 wherein the second cutting element makes an opening large enough for the distal end of the endoscope to pass through.

35. The method of claim 33 wherein the second cutting element includes an outer sheath over the cutting blade and the method further includes moving a distal end of the second cutting element to extend beyond the distal end of the cutting blade.

36. A method for performing an endoscopic procedure comprising:

positioning the cutting blade in the working channel of the endoscope; inserting a distal end of a sheath into an opening in the body; inserting the distal end of the endoscope into the sheath with the cutting blade positioned within the working channel of the endoscope; and

37. The method of claim 36 further comprising positioning the distal end of the cutting blade against tissue in the body and operating the cutter to cut tissue in the body.

38. The method of claim 37 further comprising actuating the actuator to move the cutter while the cutter is operatively cutting the tissue.

39. The method of claim 36 wherein the endoscope is coupled to a first portion of a handle and the motor driven cutter is coupled to a second portion of the handle and actuating the actuator causes the motor driven cutter to move relative to the endoscope.

40. The method of claim 36 wherein the cutting blade includes a first cutting element and second cutting element positioned distally with respect to first cutting element, and the method includes using the second cutting element to make an opening in tissue in the body.

41. The method of claim 40 wherein the second cutting element makes an opening large enough for the distal end of the endoscope to pass through.

42. The method of claim 40 wherein the second cutting element includes an outer sheath over the cutting blade and the method further includes moving a distal end of the second cutting element to extend beyond the distal end of the cutting blade.