WO2017011535A1

WO2017011535A1 - Endoscope sheath assembly including an integrated elevator mechanism

Info

Publication number: WO2017011535A1
Application number: PCT/US2016/042062
Authority: WO
Inventors: Jason H. RAHIMZADEH; Leonardo S. TOMA; Robert KALINOWSKI
Original assignee: Cogentix Medical, Inc.
Priority date: 2015-07-16
Filing date: 2016-07-13
Publication date: 2017-01-19

Abstract

An elevator mechanism configured to direct instruments passed through an endoscope sheath toward a target area is provided. The elevator mechanism includes a sheath assembly configured to cover an endoscope, the endoscope having a longitudinal axis; an elevator mechanism including a main body for receiving an instrument, the elevator mechanism operably coupled to the sheath assembly; and at least one pull-wire operably coupled to the elevator mechanism for raising and lowering the elevator mechanism from a first position to a second position.

Description

ENDOSCOPE SHEATH ASSEMBLY INCLUDING AN INTEGRATED

ELEVATOR MECHANISM

FIELD OF THE INVENTION

[0001] The present invention relates generally to an endoscope sheath assembly having an integrated elevator mechanism.

BACKGROUND OF THE INVENTION

[0002] The use of endoscopes for minimally invasive diagnostic and therapeutic purposes to visualize the patient anatomy, diagnose various conditions, and deliver instrumentation to the treatment site is widespread. Devices are typically delivered via a working channel of the endoscope, which generally ranges from about 2.0 to 3.5 mm in diameter, and may be used to introduce catheters and other elongate devices, including forceps, scissors, brushes, snares, and baskets. Larger working channels of 5.0 mm in diameter are available in certain specialized endoscopes, and may be used to pass relatively large devices or provide capability for improved aspiration or decompression. The following discussion applies to all of these types of endoscopes but in particular to duodenoscopes.

[0003] Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, esophagus, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography— or ERCP— in the United States each year. ERCP is used when it is suspected that a person's bile or pancreatic ducts may be narrowed or blocked due to tumors, gallstones, inflammation due to trauma or illness, sphincters in the ducts that will not open properly, sclerosis or the ducts and pseudocysts or accumulations of fluid and tissue debris.

[0004] ERCP is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones treating or other conditions in these ducts. The duodenoscope is different than the endoscopes used for routine upper gastrointestinal endoscopy or colonoscopy. The complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize medical devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it. There is a known association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli, which has led to illness in patients and in several cases, death.

[0005] To deal with the foregoing risks, endoscopes are increasingly being used with sterile sheaths in lieu of germicidal immersion reprocessing. Sheaths are positioned over the insertion tube of the endoscope to create a sterile barrier and avoid cross- contamination and the possible communication of disease from one patient to another. The sheath also allows the device to be used at more frequent intervals, because the need for lengthy cleaning and disinfection and/or sterilization procedures is reduced. Generally, the sheath is comprised of a flexible, thin, resilient material, such as latex, or other similar materials, that fits over and surrounds the insertion tube of the endoscope so the insertion tube is completely isolated from contaminants. The sheath is generally further comprised of a "cap" portion at the distal end of the sheath, the cap typically having a side viewing window. The sheath and cap combination may include a plurality of internal channels, or lumens, through which biopsy samples or fluids may be either introduced or removed.

[0006] The aforementioned channels of endoscope sheaths may also be used for advancing medical devices into the anatomy of patients. Conventional sheaths, however, lack means for deflecting a medical device toward a selected target anatomy. Rather, the medical device exits the sheath statically. In particular, in hard to reach target areas, such as pancreatic and biliary ducts of a patient, when a medical device exits a conventional sheath it may not reach the targeted area at all and the medical device must be withdrawn and/or the endoscope manipulated to try and reach the targeted area. Other conventional sheaths, such as those disclosed in U.S. Pat. No. 8,696,550, provide a fixed-ramp mechanism that directs a medical device toward a targeted area at a fixed angle. Therefore, the medical device may still not reach the targeted area and the fixed ramp mechanism has to be changed to a different one having a different fixed angle and the process repeated.

[0007] Therefore, what is needed is a sheath assembly that acts as a microbial barrier and also includes an integrated elevator mechanism that permits deflection of a medical device toward a targeted patient anatomy at a variety of angles thus allowing the endoscope to provide its full intended functionality, while introducing a clean and sterile device into the patient and reducing the requirements for sterilization and reprocessing. BRIEF SUMMARY OF THE INVENTION

[0008] The problems outlined above are addressed by the endoscope and microbial barrier sheath having an integrated elevator mechanism in accordance with the invention.

[0009] The endoscope microbial barrier comprises a sheath assembly that broadly includes a distal end comprising a cap portion having integrated elevator mechanism and viewing windows therein, a shaft portion, and a proximal end comprising a connector portion for coupling the sheath assembly to an endoscope. The working length of the endoscope is covered by the sheath and the endoscope handle is covered by a handle cover portion. The connector portion may include an actuator mechanism for the integrated elevator and an open end for receiving the distal tip of an endoscope insertion tube. Alternatively, the actuator mechanism for actuating the elevator may be directly operably coupled to the endoscope handle.

[0010] In one aspect of the invention a side-viewing sterile, microbial barrier sheath assembly is provided.

[0011] In another aspect of the invention the sheath includes a working channel, irrigation means, insufflation and suction means.

[0012] In another aspect of the invention a discrete, removable cap portion includes an integrated elevator mechanism operably coupled thereto. The integrated elevator mechanism is pivotally moveable from an angle of approximately ten degrees to an angle of approximately one-hundred ten degrees offset from the longitudinal axis of the insertion portion of the endoscope housed within the sheath. [0013] In yet another aspect of the invention a self-cleaning side-viewing sheath assembly that uses irrigation to remove debris from the viewing window is provided.

[0014] In yet another aspect of the invention a multi-lumen channel in a non-round configuration (such as a D-shape in cross section) is provided as part of the sheath assembly. The non-round configuration helps to prevent channel wrap (in which the endoscope insertion tube becomes tangled in the channel(s) during the loading process) and facilitates loading of the endoscope.

[0015] In another aspect of the invention an endoscope adaptor is provided as part of the sheath assembly with an actuator and optional brake or locking mechanism. The locking mechanism permits the operator to fix the relative position of an instrument which exits the distal portion of the sheath and is deflected by the elevator mechanism.

[0016] In another aspect of the invention the elevator mechanism is actuated by an actuator coupled to the proximal end of the endoscope.

[0017] In another aspect of the invention an endoscope may be completely covered by a sterile, removable sheath. The system eliminates the potential hazards of traditional ERCP devices, namely patient cross-contamination via inadequately- cleaned equipment.

[0018] In another aspect of the invention, an endoscope with a detachably attaching feature that engages the elevator mechanism that is integrated into the disposable sheath assembly and, once engaged, allows manipulation of the elevator mechanism during surgical procedures. The detachably attaching feature may comprise part of the endoscope. [0019] In another aspect of the invention an elevator mechanism configured to direct instruments passed through an endoscope sheath toward a target area is provided. The elevator mechanism includes a sheath assembly configured to cover an endoscope, the endoscope having a longitudinal axis; an elevator mechanism including a main body for receiving an instrument, the elevator mechanism operably coupled to the sheath assembly; and at least one pull-wire operably coupled to the elevator mechanism for raising and lowering the elevator mechanism from a first position to a second position.

[0020] In another aspect of the invention, the elevator mechanism is configured to pivot from an angle of approximately ten degrees to an angle of approximately one- hundred ten degrees offset from the longitudinal axis of the endoscope.

[0021] In another aspect of the invention, the elevator mechanism main body includes two side walls defining a channel therewithin. In another aspect, the elevator mechanism main body includes a U-shaped notch configured to center the instrument in the main body.

[0022] In another aspect of the invention, the elevator mechanism main body is concave.

[0023] In another aspect of the invention, the elevator mechanism main body includes two pins for pivotally coupling the elevator mechanism to the sheath assembly.

[0024] In another aspect of the invention, the elevator mechanism includes first and second pull-wire attachment points coupled to the main body that operably couple first and second pull-wires. [0025] In another aspect of the invention, the sheath assembly comprises a connector portion for operably coupling the sheath assembly to the endoscope; a sheath portion having a proximal end coupled to the connector portion and a distal end; and an end cap portion coupled to the distal end of the sheath portion.

[0026] In another aspect the sheath assembly includes an actuator operably coupled to an endoscope handle or the connector portion of the sheath assembly.

[0027] In another aspect of the invention, the actuator comprises a fmger-actuatable trigger rotatably coupled to the connector portion by pivot pins and coupled to the pull-wire at an end thereof. The actuator is structured to be deployed toward a user to apply tension to the pull-wire to raise the elevator mechanism and structured to release tension from the pull-wire to lower the elevator mechanism when the trigger is released.

[0028] In another aspect, the actuator comprises a drum for receiving the at least one pull-wire; an axle for coupling the drum to the connector portion; and a finger- graspable knob coupled to the axle, the knob circumferentially surround by a plurality of knob teeth. The connector portion of the sheath assembly includes a lock lever having a tooth engageable with one of the plurality of knob teeth, the lock lever structured to hold the elevator mechanism in position at the target site. The knob is structured to apply tension to the pull-wire when rotated in a first direction to raise the elevator mechanism and further structured to release tension from the pull-wire when rotated in a second direction to lower the elevator mechanism.

[0029] In another aspect of the invention, actuator comprises a clutch disk for receiving the at least one pull-wire; an axle for coupling the clutch disk to the connector portion; a finger-graspable knob coupled to the axle; and a spring positioned between a wall of the connector portion and the knob. The spring is structured to bias the actuator away from the connector wall to cause the clutch disk to engage and prevent movement of the knob. The knob is structured to receive a downward applied force to cause the spring to compress and decouple the clutch disk to allow the knob to rotate.

[0030] In another aspect, the sheath assembly includes a front viewing window positioned on the distal cap portion.

[0031] Functions provided by the sheath in accordance with the invention would include proven viral-barrier protection of the endoscope, passage of illumination and visualization through a window, therapeutic access to the target site via a working channel, and a means of positioning the flexible working channel to guide instruments to the target site by pulling on a wire that is encapsulated in a second channel.

[0032] The sheath assembly may contain a third channel to flush the window clean during use, and the system as a whole may include a second visualization capability to provide forward-looking imaging to assist guidance of the system to the target site.

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:

[0034] FIG. 1 illustrates is a perspective view of the distal end of the sheath assembly with a fixed integrated elevator mechanism in accordance with the invention. [0035] FIG. 2 is a perspective view of the distal end of the sheath assembly with an alternative aspect of an integrated elevator mechanism in accordance with the invention.

[0036] FIG. 3 is a perspective view of one aspect of an actuator for the elevator mechanism in accordance with the invention.

[0037] FIG. 4A is a perspective view of the sheath assembly with integrated elevator mechanism showing a drum or knob for applying tension to an elevator pull wire to actuate the elevator mechanism.

[0038] FIG. 4B is a partially exploded view of the sheath assembly with integrated elevator mechanism of FIG. 4 A

[0039] FIG. 5 is a perspective view showing another aspect of a knob for applying tension to an elevator pull wire to actuate the elevator mechanism in accordance with the invention.

[0040] FIG. 6A is a perspective view showing details of the knob of FIG. 5.

[0041] FIG. 6B is a side view showing details of the knob of FIG. 5.

[0042] FIGS. 7 A and 7B are perspective views of the distal end of an endoscope insertion tube that mates with the sheath assembly and elevator mechanism in accordance with the invention.

[0043] FIG. 8 is a perspective view of one aspect of an elevator mechanism in accordance with the invention. [0044] FIG. 9A is a perspective cut-away view of the distal portion of the sheath assembly in accordance with the invention showing the elevator mechanism of FIG. 8 in a lowered position in which the deflection angle of an instrument being deployed is approximately ten to thirty degrees offset from the longitudinal axis of the endoscope insertion tube.

[0045] FIG. 9B is a perspective cut-away view of the distal portion of the sheath assembly showing the elevator mechanism in a raised position in which the deflection angle of an instrument being deployed is approximately ninety to one-hundred ten degrees offset from the longitudinal axis of the endoscope insertion tube.

[0046] FIG. 10 is a perspective view of another aspect of an elevator mechanism in accordance with the invention.

[0047] FIG. 11 is a perspective view of the D-shaped profile of an endoscope distal tip showing it inserted into the sheath distal tip including the elevator mechanism of FIG. 10.

[0048] FIG. 12A is a perspective view of an endoscope showing an actuator for actuating the elevator mechanism in accordance with the invention wherein the actuator is coupled to the sheath assembly.

[0049] FIG. 12B is an enlarged cutaway view of 12A showing the pull-wire inside the connector portion of the sheath assembly.

[0050] FIG. 13A is a perspective view of an endoscope showing a actuator for actuating the elevator mechanism in accordance with the invention wherein the actuator is coupled to the endoscope body. [0051] FIG. 13B is an enlarged view of the connector portion of the sheath assembly showing the pull-wire therewithin.

[0052] FIG. 13C is an exploded view of the endoscope operating knob showing the actuator for the pull-wire coupled to an endoscope.

DEFINITIONS

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0054] The terms ^Mcomprise(s)," "include(s)," "having," "has," "can," "contain(s)," and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. The present invention also contemplates other embodiments "comprising," "consisting of and "consisting essentially of," the embodiments or elements presented herein, whether explicitly set forth or not.

[0055] The term "biocompatible," as used herein, refers to a material that is substantially non-toxic in the in vivo environment of its intended use, and that is not substantially rejected by the patient's physiological system. A biocompatible structure or material, when introduced into a majority of patients, will not cause an undesirably adverse, long-lived or escalating biological reaction or response. Such a response is distinguished from a mild, transient inflammation which typically accompanies surgery or implantation of foreign objects into a living organism.

[0056] The term "distal," as used herein, refers to a direction that is generally towards a target site within a patient's anatomy during a medical procedure.

[0057] The term "proximal," as used herein, refers to a direction that is generally towards a physician during a medical procedure

DETAILED DESCRIPTION OF THE INVENTION

[0058] Referring now to the FIGS, the invention broadly includes a sheath assembly for positioning on the distal portion of an endoscope insertion tube. The sheath assembly comprises a proximal connector portion for coupling with an endoscope, an integral film-like, microbial barrier for covering the endoscope, and a distal cap portion with an integrated elevator mechanism. The proximal connector portion may include an actuator mechanism (as disclosed hereinbelow) coupled thereto for actuating the elevator mechanism as best seen in FIG. 12. Alternatively, the actuator mechanism may be operably coupled to the endoscope body as best seen in FIG. 13.

[0059] Referring now to FIG. 1 a sterile sheath assembly 10 for receiving the distal portion 14 of an endoscope insertion tube is provided. As shown in FIG. 1 , the sheath assembly 10 includes a proximal connector portion (not shown in FIG. 1) for coupling the sheath assembly 10 to an endoscope, a microbial barrier portion 12 and a distal cap portion 14 having an integrated elevator mechanism 16. The integrated elevator mechanism 16 as depicted in FIG. 1 comprises an opening 17 operably coupled to instrument channel 18 formed within the sheath assembly 10. Instrument channel 18 comprises a fixed, curved ramp at the distal end of the working channel of the sheath assembly 10 that guides instruments to the target site. Proximal connector portion (not shown in FIG. 1 but seen in FIG. 12 at reference numeral 1220) couples the sheath assembly 10 to the insertion portion of an endoscope. The system as a whole, including endoscope, includes the functionality of an endoscopic retrograde cholangiopancreatography endoscope (ERCP), which substantially eliminates the potential hazards of traditional ERCP devices, namely patient cross-contamination via inadequately-cleaned equipment. The connector portion 1220 of the sheath assembly 10 is adapted to receive the distal end of an endoscope insertion tube (as best seen in FIGS. 7 A and 7B at reference numeral 722). The sheath assembly 10 also includes one or more apertures or windows at the distal end thereof that are configured to accommodate the endoscope's visualization devices such as illumination 26 and optics 28. The sheath assembly 10 may also include a front-viewing window 30 that provides a second visualization capability for forward-looking imaging to assist guidance of the endoscope as it is passed to the target site. Optionally, the sheath assembly 10 may contain a third channel to flush the windows clean during use.

[0060] The endoscope sheath assembly may be constructed of biocompatible materials such as clear polycarbonate polymers or clear, translucent or opaque polymers such as polyurethane, acrylics or nylon. In other embodiments, the sheath assembly may comprise silicone.

[0061] A second aspect of a sheath assembly 200 in accordance with the invention is shown in FIG. 2. The sheath assembly 200 includes a shaft portion 212 and a distal cap portion 214 having an integrated elevator mechanism 216. The integrated elevator mechanism 216 as depicted in FIG. 2 comprises flexible tubing 218 forming an instrument channel therewithin having opening 217. Flexible tubing 218 is operably coupled to the distal end of pull- wire 219. The proximal end (not shown) of pull -wire 219 is operably coupled to any of the actuators, best seen in FIGS. 3-6 and 12-13. Pull- wire 219 is operably received in a channel 232 separate from the instrument channel of elevator mechanism 216. Flexible tubing 218 deflects instruments from the sheath assembly 200 through opening 217 in a plurality of different angles offset from the longitudinal axis of the endoscope insertion tube. Similar to the sheath assembly 10 of FIG. 1, the sheath assembly 200 also includes a proximal connector portion (not shown in FIG. 2 but seen in FIG. 12 at reference numeral 1220) for coupling the sheath assembly 200 to an endoscope. The system as a whole, including endoscope, includes the functionality of an endoscopic retrograde cholangiopancreatography endoscope (E CP), which substantially eliminates the potential hazards of traditional ERCP devices, namely patient cross-contamination via inadequately-cleaned equipment. The sheath assembly 200 also includes one or more apertures or windows at the distal end thereof that are configured to accommodate the endoscope's visualization devices such as illumination 226, camera 228, fiber-optic elements (not shown), working channels (not shown) and the like know to those of skill in the art. The sheath assembly 200 may also include a front-viewing window 230 that provides a second visualization capability for forward-looking imaging to assist guidance of the endoscope as it is passed to the target site. Optionally, the sheath assembly 200 may contain a third channel to flush the windows clean during use.

[0062] Referring now to FIGS. 3 through 6 a plurality actuator mechanisms for actuating the elevator mechanisms in accordance with the invention are depicted. FIG. 3 depicts a first actuator mechanism 300 for actuating the elevator mechanisms disclosed herein. Pull wire 310 is used to engage the elevator mechanism in the distal portion of sheath assembly. The wire 310 may be affixed to a finger-operable lever or trigger mechanism 312, which is operably coupled by opposing pins 314 to pivot axis 316 housed in the sheath assembly endoscope connector portion 320. A stop (not shown) may also be provided to prevent the lever mechanism 312 from being pulled past a certain point.

[0063] Referring now to FIGS. 4A and 4B another aspect of an actuator mechanism is depicted. Knob 400 includes fmger-graspable portion 412 for turning the knob 400 in a first direction and in a second opposite direction. The first direction may be clock-wise and the second direction may be a counter-clockwise direction. Alternatively, the first direction may be counter clock-wise and the second direction may be clock- wise. A plurality of teeth 414 surround the circumference 416 of knob 400. Drum 418 is operably coupled to knob 400 by axle 420, which is received in an axle receiving channel (not shown) on the inside of knob 400, the coupling of which is known to those of ordinary skill in the art. Release and lock lever 422 is moveably positioned within connector portion 420 and includes release and lock tooth 424 which ratchetably engages teeth 414. Drum 418 is positioned within connector body well 419 by shaft 420 while and knob 400 is fixed to shaft 420 with connector wall 421 in between drum 418 and 400 knob 400. Pull-wire 410 is operably coupled to drum 418 such that turning knob 400 in a first direction applies tension to wire 410 to raise the elevator mechanism while turning knob 400 in a second direction releases tension on wire 410 to lower the elevator mechanism. In operation, a user turns knob 400 to deflect the elevator mechanism and instrument to the target site. At the target site, lock tooth 424 engages one of the teeth 414 to hold the elevator mechanism and deployed instrument in position so that the user may manipulate the mstrument at the target site. When the user completes the task with the instrument, the user releases lock lever 422 allowing the knob 400 to be rotated counter-clockwise allowing the elevator to return to the neutral position. The instrument may then be withdrawn from the sheathed ERCP endoscope. The wire 410 may be contained in housing 430 which has enough compressive strength to counteract the applied tensile load of the wire 410. Housing 430 is operably coupled to the sheath assembly endoscope connector portion and the distal cap portion. This ensures that the user has sufficient leverage to activate the elevator mechanism without causing significant displacement of the endoscope insertion tube, and the pull wire 410 is fully integrated into the proximal connector portion 420 so it will not need to be loaded into the scope to be used.

[0064] FIGS. 5, 6A and 6B illustrate another aspect of an actuator for actuating the elevator mechanism in accordance with the invention. Knob 500 is positioned on a side of the sheath assembly at the proximal connector portion 520. Knob 500 includes a finger-graspable portion 512 and is rotatably coupled to rotatably, moveable clutch disk 514 by a shaft 517 having key element 518, as best seen in FIG. 6. Key element 518 is received through slot 513 of drum 514 and slot 512 of connector wall 521 to lock knob 500 to connector 520. Elevator pull wire 510 is housed in housing 530 and fixedly coupled at an end 522 thereof to clutch disk 514 and is wound around clutch disk 514 as shown. In alternative embodiments, pull-wire 510 may be coupled to shaft 517 or to an additional pulley (not shown) that rotates with clutch disk 514 allowing the position of pull-wire 510 to be adjusted. In the neutral or "locked" state, pull- wire 510 cannot be adjusted. In the neutral or "locked" state, wave spring 516 biases knob 500 away from the connector wall 521, which causes the clutch disk to engage thereby preventing movement of pull- wire 10 and the elevator mechanism. When engaged, the wave spring 516 prevents the clutch disk 514 from moving, and therefore the knob 500, from rotating freely. To rotate the knob 510 and actuate the elevator mechanism, a force must be applied downwards on the knob to compress wave spring 516 and decouple clutch disk 514. The downward force applied on the axis of the knob causes the spring to compress, which in turn allows the knob 500 to rotate freely.

[0065] FIG. 7 A illustrates one aspect for the distal portion 724 of an endoscope insertion tube 722 in accordance with the invention. The distal portion 724 may be made of metal, ceramic, molded plastic or a polymer material. FIG. 7A depicts a cross-section of the distal portion 724 with optics 728 and illumination 726 placed on the top side of the insertion tube 722. FIG. 7B depicts an endoscope 722 covered by the sheath assembly 700 in accordance with the invention where the illumination 726 and optics 728 are placed directed on a flat side of the D-shape cross-section. The optics and illumination windows of the endoscope insertion tube may be constructed from the same or different materials than the other portions of the distal portion 724 of the endoscope insertion tube but desirably should be optically clear. Irrigation and air channels (not shown) may be provided to facilitate cleaning of the optics window and illumination window. If provided, the irrigation and air channels are desirably pointed towards the optics and illumination. A working channel (not shown) may be included to facilitate passing of an instrument for therapeutic or diagnostic purposes. FIG. 7B depicts the endoscope insertion tube covered by the sheath assembly in accordance with the invention including the elevator mechanism of FIG. 10. Elevator pin mounting holes are included for the placement of the elevator.

[0066] The sheath assembly with integrated elevator mechanism in accordance with the invention is configured to slide over and cover an endoscope insertion tube. When the endoscope is fully seated in the sheath, the optics and illumination windows will seat flush against the surface. Thus, light may be transmitted through the optically transparent windows of the sheath assembly and an image may be obtained through the window. Tools may be inserted and deflected by the elevator mechanism. When the procedure is complete, the sheath may be removed and disposed of.

[0067] Another aspect of an elevator mechanism in accordance with the invention is depicted in FIG. 8. Elevator mechanism 800 includes a body 810 and two side portions 812, 814 defining an instrument channel 816 thereinbetween. Pull- wire 818 is covered with pull- wire housing 830 and operably connected to body 810. Body 810 is coupled to pivot element 820 having a receiving aperture 822 for receiving a pivot pin (not shown). Instrument channel 816 defines a U-shaped notch 824 at a distal end thereof, which is configured to maintain an instrument centered and prevent it from sliding laterally, which may reduce the operator's control over the instrument. Pivot pin (not shown) pivotally couples elevator mechanism to any of the actuator mechanisms disclosed herein for actuating the elevator mechanism allowing it to be moved from a raised configuration to a lowered configuration as best seen in FIGS. 9B and 9A, respectively. The elevator may be made of any biocompatible material as herein described.

[0068] FIG. 10 is a perspective view of another aspect of an elevator mechanism 1000 in accordance with the invention. FIG. 1 1 depicts the D-shaped profile of an endoscope distal tip showing it inserted into the sheath distal tip including the elevator mechanism 1000 of FIG. 10. The elevator mechanism 1000 includes a substantially concave or V-groove surface 1010 that is configured to accommodate an instrument that may be directed off-axis. The elevator mechanism 1000 includes a pair of pins 1012, 1014, which may be positioned opposite one another. Pins 1012, 1014 are positioned within cap portion of the sheath assembly and allow for rotation or pivoting about a pin axis 1020 as best seen in FIG. 1 1. The elevator mechanism 1000 includes pull wire attachment points 1016, 1018 for operably coupling to pull wires 1018', 1016' as best seen in FIG. 1 1. Attachment points 1016, 1018 are rotatably coupled to the elevator mechanism to facilitate application of linear force by way of wires 1018', 1016', which rotate the elevator mechanism about the pin axis 1020 of rotation.

[0069] FIG. 12A is a perspective view of an endoscope 1223 having a sheath assembly 1210 coupled thereto. Sheath assembly 1210 includes a proximal connector portion 1220, a microbial barrier portion 1212 for covering endoscope insertion portion 1222 and a distal end cap portion 1214 having an integrated elevator therein. The barrier is film-like and preferably integrally formed over the connector 1220. Those of skill in the art will appreciate, however, that the film-like barrier may comprise a separate flexible covering. Proximal connector portion 1 120 includes an actuator 1200 for actuating the elevator mechanism 1202 in accordance with any embodiments of the invention disclosed herein wherein the actuator 1200 is coupled on the connector portion 1220 of the sheath assembly 1210. Those of skill in the art will appreciate that actuator 1200 may be any of the actuators disclosed herein. FIG. 12B is a cutaway, exploded view of the actuator 1200 of FIG. 12A showing the pull- wire 1230 wound around drum 1218 inside the connector portion 1220 of the sheath assembly. Pull- wire 1230 is covered by pull-wire housing 1232 within sheath assembly 1210. Instrument channel 1234 for inserting instruments is also shown.

[0070] FIG. 13A is a perspective view of the sheath assembly 1310 with integrated elevator mechanism in accordance with the invention showing the pull-wire 1330 connected directly to actuator/control handle 1303. Sheath assembly includes a proximal connector portion 1320, a microbial barrier portion 1312 for covering endoscope insertion portion 1322 and a distal end cap portion 1314 having an integrated elevator therein. The barrier is film-like and preferably integrally formed over the connector. Those of skill in the art will appreciate, however, that the film- like barrier may comprise a separate flexible covering. The proximal connector portion 1320 of the sheath assembly 1310, as hereinbefore disclosed, is configured to receive the insertion tube 1322 of the endoscope 1323 and passed through to the distal cap portion 1314 of the sheath assembly 1310. One or more working channels may be affixed to the proximal side of the sheath assembly and the elevator mechanism may be actuated from the control handle 1303 of the endoscope, as shown. Pull- wire 1330 engages elevator mechanism 1302 located at the distal end 1314 of the sheath assembly 1310 and operably couples directly to control handle 1303 (best seen in FIG. 13C) of endoscope body 1323. This conveniently allows manipulation of the elevator mechanism 1302 during surgical procedures directly from the control handle 1303. Pull- wire 1330 may also detachably couple to actuator/control handle 1303. FIG. 13B is an enlarged view of the connector portion 1320 of the sheath assembly 1310 showing the pull-wire 1330 therewithin. Pull-wire 1330 is covered by pull- wire housing 1332 within sheath assembly 1310. Instrument channel 1334 for inserting instruments is also shown. FIG. 13C is an exploded view of the endoscope operating knob showing the pull- wire actuator/control handle 1303.

[0071] Although the present invention has been described with reference to certain aspects and embodiments, those of ordinary skill in the art will appreciate that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

CLAIMS:

1. An elevator mechanism configured to direct instruments passed through an endoscope sheath toward a target area comprising: a sheath assembly configured to cover an endoscope, the endoscope having a longitudinal axis; an elevator mechanism including a main body for receiving an instrument, the elevator mechanism operably coupled to the sheath assembly; at least one pull-wire operably coupled to the elevator mechanism for raising and lowering the elevator mechanism from a first position to a second position.

2. The elevator mechanism of claim 1 wherein elevator mechanism is configured to pivot from an angle of approximately ten degrees to an angle of approximately one-hundred ten degrees offset from the longitudinal axis of the endoscope.

3. The elevator mechanism of claim 1 wherein the elevator mechanism main body includes two side walls defining a channel therewithin.

4. The elevator mechanism of claim 1 wherein the main body includes a U- shaped notch configured to center the instrument in the main body.

5. The elevator mechanism of claim 1 wherein the main body is concave.

6. The elevator mechanism of claim 5 wherein the main body includes two pins for pivotally coupling the elevator mechanism to the sheath assembly.

7. The elevator mechanism of claim 5 further comprising first and second pull-wire attachment points coupled to the main body.

8. The elevator mechanism of claim 7 further comprising first and second pull-wires operably coupled to the first and second pull-wire attachment points, respectively.

9. The elevator mechanism of claim 1 wherein the sheath assembly comprises a connector portion for operably coupling the sheath assembly to the endoscope; a sheath portion having a proximal end coupled to the connector portion and a distal end; and an end cap portion coupled to the distal end of the sheath portion.

10. The elevator mechanism of claim 9 further comprising an actuator operably coupled to an endoscope handle or the connector portion of the sheath assembly.

1 1. The elevator mechanism of claim 10 wherein the actuator comprises a finger-actuatable trigger rotatably coupled to the connector portion by pivot pins and coupled to the pull-wire at an end thereof.

12. The elevator mechanism of claim 1 1 wherein the actuator is structured to be deployed toward a user to apply tension to the pull-wire to raise the elevator mechanism and structured to release tension from the pull-wire to lower the elevator mechanism when the trigger is released.

13. The elevator mechanism of claim 10 wherein the actuator comprises a drum for receiving the at least one pull-wire; an axle for coupling the drum to the connector portion; and a finger-graspable knob coupled to the axle, the knob circumferentially surround by a plurality of knob teeth.

14. The elevator mechanism of claim 13 wherein the connector portion includes a lock lever having a tooth engageable with one of the plurality of knob teeth, the lock lever structured to hold the elevator mechanism in position at the target site.

15. The elevator mechanism of claim 13 wherein the knob is structured to apply tension to the pull-wire when rotated in a first direction to raise the elevator mechanism and further structured to release tension from the pull-wire when rotated in a second direction to lower the elevator mechanism.

16. The elevator mechanism of claim 10 wherein the actuator comprises a clutch disk for receiving the at least one pull-wire; an axle for coupling the clutch disk to the connector portion; a finger-graspable knob coupled to the axle; and a spring positioned between a wall of the connector portion and the knob.

17. The elevator mechanism of claim 16 wherein the spring is structured to bias the knob away from the connector wall to cause the clutch disk to engage and prevent movement of the knob.

18. The elevator mechanism of claim 16 wherein the knob is structured to receive a downward force to compress the spring and decouple the clutch disk to allow the knob to rotate.

19. The elevator mechanism of claim 9 wherein the sheath assembly includes a front viewing window positioned on the distal cap portion.