Endoscopic combination device having a locking element

Abstract

The endoscope combination or coupler device includes a proximal end configured to attach to the working end of an endoscope and a visualization section that allows for viewing of tissue. The coupler device includes an instrument channel, such as a working channel extension or open passageway, with an open distal end and a proximal end configured to align with the working channel of the endoscope. The coupler device is configured to restrain and / or secure an instrument passed through the instrument channel to ensure the instrument remains in place at the target site and / or to facilitate instrument exchange. The coupler device also provides a protective cover to reduce the ingress of debris, fluids, bacteria, or other unwanted materials from the working end of the endoscope, which can lead to infection and reduced scope performance.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 007,461, filed April 9, 2020, the entire disclosure of which is incorporated herein by reference as if copied and pasted for all purposes.

[0002] The present disclosure relates to a combination or coupling device for covering and at least partially sealing the optical elements of an endoscope, and a mechanism for restraining and / or locking an instrument from exiting a working channel of the endoscope. [Background technology]

[0003] Recent advances in optical imaging technology have made it possible for many medical procedures to be performed minimally invasively today. The evolution of more sophisticated flexible scopes with advanced visual capabilities has enabled access to deeper regions within the human body that were previously achievable only through invasive surgical intervention. This modern convenience has led to an increase in the demand for and number of endoscopies, laparoscopies, arthroscopies, ophthalmoscopy, and other remote imaging visualization procedures performed annually in the United States and around the world. While these procedures are relatively safe, they are not without risks.

[0004] For example, endoscopy is a procedure in which an illuminated visualization device called an endoscope is inserted into a patient's body to view the inside of a body cavity, lumen, organ, or a combination thereof for the purposes of examination, diagnosis, or treatment. The endoscope may be inserted through a small incision or through a natural orifice of the patient. In bronchoscopy, the endoscope is inserted through the mouth, while in sigmoidoscopy, the endoscope is inserted through the rectum. Unlike most other medical imaging devices, endoscopes are inserted directly into organs, body cavities, or lumen.

[0005] Today, most endoscopes are reused. This means that after an endoscopy, the endoscope undergoes cleaning, disinfection or sterilization, and reprocessing procedures so that it can be returned to the site for use in another endoscopy on another patient. In some cases, endoscopes are reused several times a day on several different patients.

[0006] Although cleaning, disinfection, and reprocessing procedures are rigorous, there is no guarantee that an endoscope will be completely cleaned and free of any form of contamination. Modern endoscopes have sophisticated and complex optical visualization components inside a very small, flexible tubular body, features that allow these scopes to be as effective in diagnosing or treating patients. However, the trade-off for this comfort is that they are difficult to clean due to their small size and numerous components. These scopes are introduced deep into areas of the body, which exposes the surfaces of these scopes to elements that may become trapped within or adhere to the surface of the scope, such as bodily fluids, blood, and even tissue, increasing the risk of infection with each repeated use.

[0007] Endoscopes used in the digestive tract, such as forward-viewing endoscopes, endoscopic ultrasound (EUS) scopes, and duodenoscopes with side-viewing capabilities, present an added complication in that they are located in a bacterial-rich environment. Typical gastroscopes, colonoscopes, duodenoscopes, and EUS scopes have a camera lens, lighting, and a working channel with a distal opening exposed to the patient environment. All of these elements of the scope create cleaning challenges, including the risk of bacteria entering the working channel and other hard-to-clean locations on the scope. This provides an opportunity for bacteria to colonize and become drug-resistant, creating significant morbidity and even mortality risks for patients. This infection risk also exists in the cable mechanisms used to articulate instruments passing through the working channel and in other aspects of existing scope designs. Furthermore, in addition to the health risks posed by bacterial contamination and patient-to-patient cross-contamination, the accumulation of fluids, debris, bacteria, particulates, and other unwanted materials in these hard-to-clean areas of the scope also impacts performance and shortens the useful life of these reusable scopes.

[0008] Another drawback with many existing endoscopes is that although instruments passed therethrough can be articulated to reach a desired target area within a patient, they are not fixed in place as they pass through the distal end of the endoscope. In particular, flexible instruments, such as guidewires, have a tendency to shift position during a procedure, i.e., not remain at the desired target area. In addition, instrument exchange can be difficult and time-consuming because it requires the operator to reposition a second instrument or guidewire, for example, if the operator wishes to exchange an instrument over the guidewire. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Provisional Patent Application No. 62 / 949,238 [Patent Document 2] U.S. Provisional Patent Application No. 63 / 003,656 [Patent Document 3] U.S. Patent Application Serial No. 16 / 717,202 [Patent Document 4] U.S. Patent Application Serial No. 16 / 717,804 Summary of the Invention [Problem to be solved by the invention]

[0010] It is therefore desirable to provide a device that serves as a convenient accessory to existing endoscopes to reduce the risk of contamination and infection while also improving the performance of the endoscope. It would be particularly desirable to provide an accessory or companion device for an endoscope that allows a user to protect the working end from bacterial contamination, allow instruments to exit the working end of the scope at different angles, and constrain or secure these instruments in place after they have been advanced to specific target sites within a patient. [Means for solving the problem]

[0011] The present disclosure provides a coupler device for use with an endoscope having a proximal end configured to attach to the working end of the endoscope and a visualization section to enable viewing of tissue or other material. The coupler device includes an instrument channel that operates adjacent to a working or biopsy channel within the endoscope when the proximal end is attached to the endoscope. The coupler device is configured to constrain and / or secure an instrument to ensure it remains in place at the target site and / or to facilitate instrument exchange. The coupler device also provides a protective cover to reduce the ingress of debris, fluids, bacteria, or other unwanted materials from the working end of the endoscope, which can lead to infection and reduced scope performance.

[0012] The instruments may include guidewires, endoscopic mucosal resection instruments, needle injectors, Foley catheters, bipolar or monopolar electrosurgical or ultrasound devices, snares, endoscopic staplers and other fastening or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, and any other devices configured to penetrate and / or navigate within the body. The instruments may be configured to advance through the working channel of the endoscope and the instrument channel of the coupler device.

[0013] In one aspect of the present invention, the instrument channel of the coupler device is a working channel extension having an open distal end and a proximal end configured to attach to a working or biopsy channel in an endoscope. The coupler device is configured to secure the instrument in place after it passes through the working channel extension so that it does not move around the target site within the patient. This novel feature of the present disclosure can be used by the operator to secure the instrument while another instrument is exchanged over the guidewire and / or to secure the guidewire.

[0014] In other embodiments, the instrument channel may be an open passageway, cavity, or channel within the optical coupler that allows an instrument to pass through the coupler device to the surgical site. In these embodiments, the coupler device includes a mechanism for securing the instrument within the passageway. Additionally, the instrument can be articulated by a variety of suitable means, such as a cable, elevator, piezoelectric material, micromotor, organic semiconductor, electroactive polymer, or other energy or power source located within the coupler device, on or within the endoscope, or external to both and appropriately coupled to the instrument.

[0015] In certain embodiments, the coupler device is configured to fix the instrument at a specific angle relative to the endoscope shaft while allowing longitudinal movement of the instrument at a fixed angle. This ensures that the instrument is advanced at a fixed angle relative to the optical coupler and endoscope. Alternatively, the instrument may be removed and replaced with another instrument that can be easily and quickly advanced to the same location within the patient, for example, a guidewire or instrument exchange.

[0016] In one embodiment, the optical coupler device or endoscope can include an actuator coupled to a portion of the working channel extension. The actuator is configured to compress at least a portion of the working channel extension to reduce its inner diameter and constrain an instrument passing therethrough. In a preferred embodiment, the actuator translates or articulates the working channel extension relative to another fixed portion of the coupler device, thereby compressing at least a portion of the working channel extension. Alternatively, the actuator can comprise an elongated component, such as, for example, a cable or rod, attached to the working channel extension and configured to translate longitudinally to push or pull against one side of the working channel extension, thereby compressing its inner diameter.

[0017] In certain embodiments, the coupler device can include a stop member positioned to engage a portion of the working channel extension, such that the working channel extension is configured to at least partially compress upon engagement with the stop member, thereby reducing the inner diameter of the working channel extension and restraining an instrument passing therethrough. The stop member can translate and / or articulate relative to the working channel extension, or the working channel extension can translate and / or articulate relative to the stop member. Alternatively, the working channel extension can articulate relative to the stop member such that the working channel is at least partially compressed when it engages the stop member.

[0018] In certain embodiments, the working channel extension of the coupler device can be angularly adjustable by an elevator or cable that passes through the endoscope. Alternatively, the coupler device may include its own actuator, such as an elevator, cable, or similar actuation means, for adjusting the working channel extension and thereby articulating an instrument that passes through the endoscope. The actuator can be powered by any suitable energy source, such as a motor. The energy source can be coupled to the actuator directly through the scope or indirectly through a magnetic, electrical, or some other energy source. The energy source can be located within the coupler device, or it can be external to the coupler device (i.e., located on the proximal end of the scope or external to the patient).

[0019] In one particular embodiment, the coupler device further comprises a locking element on the outer surface of the main body. An elevator (or other actuator) is configured to articulate the instrument and / or working channel extension relative to the locking element to secure the instrument in place. The locking element can comprise an elongate body projecting from the outer surface of the main body and extending transversely to the longitudinal axis of the main body. The instrument and / or working channel is articulated generally longitudinally relative to the elongate body of the locking element. The elongate body can further include one or more protrusions extending therefrom to define a groove for securing the instrument. In certain embodiments, the locking element can include multiple locations or grooves for securing more than one instrument thereto.

[0020] In another aspect of the invention, the endoscope is a side-viewing scope, such as a duodenoscope or an endoscopic ultrasound scope (EUS). The side-viewing scope includes a working channel, a light source, and a camera. The scope can further include an actuator for adjusting the angle of the working channel extension of the optical coupler. In one embodiment, the actuator includes an elevator disposed within the distal end portion of the scope. In another embodiment, the actuator includes a cable extending through the scope. In these embodiments, the coupler device is configured to cooperate with the actuator or cable of the scope to articulate an instrument through the coupler device. In other embodiments, the coupler device includes its own actuator for articulating the instrument, eliminating the need for a scope with an elevator or cable actuator.

[0021] In one preferred embodiment, the coupler device includes an elevator for articulating the working channel extension, the elevator configured to move the working channel extension relative to a fixed portion of the coupler device, thereby compressing a portion of the working channel extension to secure an instrument thereto.

[0022] The articulation aspect of the coupler device can include a locking feature or function that fixes the exit angle within the working channel extension at a particular angle. For example, the particular exit angle can be aimed at a particular point within the GI tract, such as the bile duct or pancreatic duct, or the exit angle can be fixed to temporarily prevent the advancement of a wire or other instrument inside the working channel, temporarily locking the instrument in place to aid in instrument exchange or temporarily improve instrument navigation.

[0023] In another aspect of the invention, the working channel extension or coupler device elevator includes a groove at or near its distal end for receiving an instrument therein. The groove is preferably shaped to facilitate securing the instrument to the working channel extension or elevator. In certain embodiments, the groove includes a substantially V-shape. In other embodiments, the groove can define other shapes, such as a U-shape, a square, a rectangle, a triangle, or a cone.

[0024] In certain embodiments, the working channel extension or elevator further includes one or more protrusions, such as bevels, ridges, folds, or other protrusions extending into the elevator or working channel extension. The protrusions can comprise, for example, a pair of ridges that form a groove at the open distal end of the working channel extension or elevator. The protrusions can also serve to squeeze or narrow the working channel extension toward its distal end to guide an instrument into the groove. The groove can be configured to secure an instrument, such as a guidewire, in place relative to the optical coupler and / or the distal end portion of the endoscope. In certain embodiments, the groove has a surface material or shape designed to utilize the reaction force of the guidewire to secure the guidewire within the locking element.

[0025] The protrusions and / or grooves can be integrally formed with the working channel extension or elevator, or they can be part of a separate component coupled to the inner surface of the working channel extension or elevator. In certain embodiments, the protrusions and / or grooves comprise removable components that can be coupled to the working channel extension or elevator for a certain portion of a procedure and then removed when no longer needed.

[0026] In another aspect of the invention, a kit for use in a procedure on a patient includes an endoscope having a working channel for receiving a light, a camera lens, and an instrument, and a coupler device. The coupler device includes a main body having a visualization section for permitting endoscopic viewing of tissue and a proximal end configured to attach to a distal end portion of the endoscope. The coupler further includes a passage within the body for permitting passage of an instrument from the endoscope working channel to a target site within the patient. The coupler device is configured to restrain and / or secure an instrument passing through the passage.

[0027] In certain embodiments, the kit further includes an endoscopic device configured to advance into a patient through an opening. For purposes of this disclosure, opening refers to a natural orifice opening through any existing natural opening into the patient, such as the mouth, sinuses, ear, urethra, vagina, or anus, or any access port provided through the patient's skin into a body cavity, internal lumen (i.e., blood vessel), or the like, or through an incision and port-based opening in the patient's skin, cavity, skull, joint, or other medically indicated entry point. Similarly, the endoscopic device can be configured to advance through a working channel or biopsy channel within the endoscope (i.e., through the same access port as the endoscope) and through other passageways, including working channel extensions or alternative joint working elements of a coupler device. Alternatively, the endoscopic device can be configured to advance through an opening separate from the endoscopic access point.

[0028] In certain embodiments, the endoscopic instrument is a guidewire for use with an endoscope and a coupler device. The guidewire preferably includes an elongate shaft sized for advancement through the working channel of the endoscope and the working channel extension or other articulating element of the coupler device. The guidewire includes a distal tip sized for advancement into a relatively narrow body cavity of a patient, such as the pancreaticobiliary duct or other body cavity. The orientation of the guidewire can be adjusted by actuating the working channel extension or other articulating element of the coupler device relative to the endoscope shaft. Alternatively, the guidewire can be adjusted through a separate actuator on the proximal end of the guidewire, on or within the endoscope or coupler device, or external to both. In all of these embodiments, the coupler device is configured to secure the guidewire after it has been articulated to a desired position.

[0029] A coupler device can be provided as a single-use, disposable accessory to an endoscope that alters the exit angle of a device advanced from the working channel of the endoscope and provides a user with the ability to secure the device in place without exposing the distal end of the scope to bacteria, debris, fluids, and particulate matter. In some embodiments, the coupler device includes a working channel extension having an open distal end and a proximal end configured to attach to a working channel or biopsy channel in the endoscope. The working channel extension can provide a seal against the scope working channel so that instruments can be advanced back and forth through the scope working channel and out of the working channel extension of the coupler device without allowing fluids and bacteria to enter areas outside the scope working channel. This seal, in some embodiments, is achieved by an extension of the device working channel into the scope working channel, by a gasket at the end of the working channel extension, by the use of temporary adhesives, by pressure and sealing of the entire device against the distal end of the scope, by selection of a resilient and elastomeric material, and other suitable and alternative means.

[0030] The working channel extension of the coupler device can be made of one or more materials having elastic properties. The materials can include biocompatible materials when the device is intended for medical use, including, without limitation, elastic and elastomeric materials, as well as combinations of rigid and flexible materials, including silicone bonded to polycarbonate and other materials bonded to biocompatible metals.

[0031] In some embodiments, the working channel extension of the coupler device can include a resilient biocompatible material that reduces friction associated with threading a device through the working channel extension, which is bonded to the biocompatible metal such as a coil spring, hypotube, or braid that has additional resilient material bonded to it to increase flexibility, reduce kinking, and assist in sealing the working channel of the device against the working channel of the endoscope.

[0032] In some embodiments, the device allows the endoscope user to articulate the working channel of the device in a preferred direction, so that a wire, catheter, or other instrument being advanced along the working channel of the endoscope can be directed in a preferred direction that is different from the angle at which the instrument would exit the endoscope if the coupler device was not in place or if the in-scope elevator were not used. This redirection of the instrument has the advantage of aiding in device navigation without introducing fluids, debris, particulate matter, bacteria, and other unwanted elements into hard-to-clean areas of the endoscope, particularly the distal tip of the endoscope.

[0033] Benefits of the present invention include the ability for a physician to modify the exit angle so that one or more devices can be redirected to enter specific body cavities such as the bile duct or pancreatic duct or other hard-to-reach areas, including non-medical procedures, and the ability to secure the instrument in place after reaching a specific body cavity or area while sealing the distal end of the scope to prevent infection and the ingress of debris and particulate matter into the inner elements of the scope that are difficult to access for subsequent cleaning.

[0034] In some embodiments, the device can be formed with an optically transparent material that covers and seals the end of the endoscope, allowing visualization by the endoscopic camera without the device obscuring the view. Similarly, the optically transparent material covers the light guide of the endoscope, allowing light projected by the endoscope to illuminate the field of view of the endoscope. In some embodiments, the optically transparent material can include navigational markers to guide a user when visualizing tissue, such as markers to identify the relative position of the scope when the user visualizes tissue through the optically transparent material.

[0035] In embodiments, the optically transparent material may also include other markers to guide the user in verifying correct placement of the optically transparent material over the endoscope's camera and, if applicable, over the endoscope's light guide.

[0036] In some embodiments, the device allows for the articulation of an instrument through the device by a cable in a sealed sheath attached to a flexible working channel extension in the coupler device, allowing the user to advance and retract the cable to move the working channel extension or other articulating element back and forth and change the exit angle from the flexible working channel to orient the instrument in a desired direction.

[0037] In some embodiments, the device has multiple cables, and therefore the exit angle can be articulated in multiple directions, including different quadrants, unlike existing endoscopic elevators that can only deflect or redirect the instrument in a single axial direction due to the limited travel of the endoscopic elevator, which can only move up or down but cannot move side to side or articulate into other quadrants. In some embodiments, the cables can be attached directly to the working channel extension or to other devices that can be articulated to cause the working channel extension to change its exit angle, including, for example, a dowel housed within the device that is below the working channel extension but can move back and forth as the cables advance and retract. In some embodiments, the articulation function of the coupler device can be generated by an elevator embedded in the coupler device, which is disposable and therefore discarded after the procedure.

[0038] The articulation of the coupler device may occur using cable-free elements, including, for example, piezoelectric materials, micromotors, organic semiconductors, and electroactive polymers. In some embodiments, the articulation of the coupler device may occur using force transmission to the working channel extension or embedded elevator through force-transmitting interlocking connectors, stranded wires, slidable sheaths, and shape-memory alloys that change shape through the transfer of temperature. In some embodiments, the device includes a power connector or motor that delivers energy, including electromagnetic energy, to the device to effect force transmission and change the exit angle from the coupler device when or prior to passing an instrument through the device. This force transmission may include rotating the device as it exits the working channel extension. The device may be navigated and articulated by a user directly or as part of a robotic system in which user input is translated through the system through a variety of means, including cables, power connectors, motors, electromagnetic energy, slidable sheaths, haptics, computer guidance, and guided input, and other means to guide and direct the device to its intended location, including remote locations desired for specific diagnostic and therapeutic purposes on a patient or in non-medical applications.

[0039] In some embodiments, the device may be integrated into the scope and configured to be removable and reusable for separate cleaning, including manual cleaning in autoclaves, ETO sterilizers, gamma sterilizers, and other sterilization methods.

[0040] The device can include a disposable or reusable control mechanism attached to the endoscope for articulating the distal end of the coupler device to change the exit angle from the working channel extension of the coupler device. In some embodiments, the control mechanism can also lock the exit angle of the working channel extension, or the working channel extension can be locked through an element within the endoscope itself, such as an element that articulates an elevator on the endoscope.

[0041] In some embodiments, the coupler device may cover the entire distal tip of the endoscope, or may cover only the hard-to-clean areas. In some embodiments, the coupler device may cover the distal tip of the endoscope or a portion thereof, or it may include a sheath attached to the coupler device that covers the entire scope that is exposed to fluids, debris, particulate matter, bacteria, and other unwanted elements.

[0042] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. Additional features of the present disclosure will be set forth in part in the description which follows, or may be learned by the practice of the present disclosure.

[0043] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0044] [Figure 1] 1 is a partial cross-sectional view of a proximal portion of an exemplary endoscope in accordance with the present disclosure. [Figure 2] 1 is a perspective view of a distal end portion of a side-viewing endoscope in accordance with the present disclosure; [Figure 3A] FIG. 1 is an isometric view of an exemplary embodiment of a coupler device of the present disclosure for use with a duodenoscope. [Figure 3B] FIG. 1 is an isometric view of an exemplary embodiment of a coupler device of the present disclosure for use with a duodenoscope. [Figure 4A] FIG. 3B is a partial cutaway view of the coupler device and duodenal scope of FIG. 3A. [Figure 4B] FIG. 3C is a partial cutaway view of the coupler device and duodenal scope of FIG. 3B. [Figure 5] FIG. 3C is another partial cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B. [Figure 6]FIG. 3C is yet another partial cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B. [Figure 7] FIG. 3C is a partial cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B in a first position. [Figure 8] FIG. 3C is a partial cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B in a second position. [Figure 9] FIG. 3C is a partial cutaway view of the coupler device and duodenoscope of FIGS. 3A and 3B in a third position. [Figure 10] FIG. 3C is an enlarged side view of an actuation channel extension with a membrane of the coupler device of FIGS. 3A and 3B. [Figure 11] FIG. 3C is a top view of the coupler device of FIGS. 3A and 3B. [Figure 12] FIG. 10 is a cutaway view of another exemplary embodiment of a coupler device of the present disclosure. [Figure 13] FIG. 13 is a cutaway side view of the coupler device of FIG. 12. [Figure 14] FIG. 13 is a cutaway side view of the coupler device of FIG. 12 for use with a duodenoscope. [Figure 15] FIG. 10 is an enlarged side view of an exemplary embodiment of a working channel extension of the present disclosure. [Figure 16] FIG. 16 is another enlarged side view of the working channel extension of FIG. 15. [Figure 17A] FIG. 16 is a perspective view of the working channel extension of FIG. 15. [Figure 17B] FIG. 17B shows the working channel extension of FIG. 17A in use with an instrument. [Figure 18] FIG. 4 is a perspective top view of the coupler device of FIG. 3 having a locking feature. [Figure 19] FIG. 10 is a perspective view of another exemplary embodiment of a working channel extension of the present disclosure. [Figure 20] FIG. 10 is a cross-sectional side view of a working channel extension having grooves for restraining and / or securing an instrument. [Figure 21]21 is a cutaway side view of an alternative embodiment of a coupler device for use with the working channel extension of FIG. 20. [Figure 22A] 10A-10C show a portion of a coupler device having an elevator with a groove for restraining and / or securing an instrument therein. [Figure 22B] 10A-10C show a portion of a coupler device having an elevator with lateral stop members for restraining and / or securing an instrument. [Figure 23] 10 is a cutaway side view of an alternative embodiment of a coupler device for use with a cable to secure an instrument within a working channel extension. [Figure 24A] 10A-10C illustrate an embodiment of a coupler device having locking elements on the exterior surface of the main body. [Figure 24B] 10A-10C illustrate an embodiment of a coupler device having locking elements on the exterior surface of the main body. [Figure 25A] 10A-10C illustrate another embodiment of a locking element for a coupler device in accordance with the present disclosure. [Figure 25B] 10A-10C illustrate another embodiment of a locking element for a coupler device in accordance with the present disclosure. [Figure 26A] 10A-10C illustrate yet another embodiment of a locking element for a coupler device in accordance with the present disclosure. [Figure 26B] 10A-10C illustrate yet another embodiment of a locking element for a coupler device in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0045] The present specification and the accompanying drawings illustrate illustrative embodiments and should not be construed as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational modifications are possible without departing from the scope of the present disclosure and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the present disclosure. Like numbers in more than one figure represent the same or similar elements. Furthermore, elements and their related aspects described in detail with respect to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, when an element is described in detail with respect to one embodiment and not with respect to a second embodiment, the element can still be claimed as being included in the second embodiment. Furthermore, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the inventive system or the illustrated components.

[0046] It should be noted that as used in this specification and claims, the singular forms "a," "an," and "the," and the use of any singular of any word, include plural referents unless expressly and unambiguously limited to one referent. As used herein, the term "comprises" and its grammatical variations are intended to be open-ended, such that the enumeration of items in a list does not exclude other similar items that may replace or add to the listed items.

[0047] Although the following disclosure is directed primarily to coupler devices for optical imaging endoscopes, it should be understood that the features of the kits described herein can be readily adapted for use with a variety of reusable or disposable endoscopic scopes, instruments, and devices.

[0048] The term "endoscope" in this disclosure generally refers to any scope relating to or used in medical applications involving the body (human or otherwise), including, for example, laparoscopes, duodenoscopes, endoscopic ultrasound scopes, arthroscopes, colonoscopes, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, cardioscopes, and saphenous vein harvesters with scopes, whether robotic or not.

[0049] A variety of scopes are used during interventions to remotely visualize the inside of a patient's body. The scope used depends on the extent to which the physician needs to navigate within the body, the type of surgical instruments used for the procedure, and the level of invasiveness appropriate for the type of procedure. For example, visualization within the digestive tract involves the use of endoscopes in the form of flexible gastroscopes and colonoscopes, endoscopic ultrasound scopes (EUS), and specialized duodenal scopes that can be several feet long and over one centimeter in diameter. These scopes can be turned, articulated, or steered by the physician as they navigate within the patient's body. Many of these scopes contain one or more working channels for passing and supporting instruments, fluid and irrigation channels for irrigating tissue and cleaning the scope, an insufflation channel for insufflation to improve navigation and visualization, and one or more light guides for illuminating the scope's field of view.

[0050] Smaller, less flexible or rigid scopes, or a combination of flexible and rigid scopes, are also used in medical applications. For example, smaller, thinner, and much shorter scopes are used when examining joints and performing arthroscopic procedures, such as shoulder or knee surgery. When a surgeon performs an arthroscopic repair of a torn meniscus in the knee, they typically insert a shorter, more rigid scope through a small incision on one side of the knee to visualize the wound, while passing instruments through an incision on the other side of the knee. The instruments can wash over the scope inside the knee to maintain visualization and manipulate the tissue to complete the repair.

[0051] Other scopes can be used for diagnosis and treatment using less invasive endoscopic procedures, including, but not limited to, the use of scopes to examine and treat abnormalities of the lungs (bronchoscope), mouth (enteroscope), urethra (cystoscope), abdominal and peritoneal cavity (laparoscope), nose and sinuses (laryngoscope), anus (sigmoidoscope), chest and thoracic cavity (thoracoscope), and heart (cardioscope). Additionally, robotic medical devices rely on scopes for remote visualization of the area they are evaluating and treating.

[0052] These and other scopes can be inserted through natural orifices (such as the mouth, sinuses, ears, urethra, anus, and vagina) and through incisions and port-based openings in a patient's skin, cavities, skull, joints, or other medically indicated entry points. Examples of diagnostic applications of visualized endoscopy using these medical scopes include investigating symptoms of disease such as digestive system disorders (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), or confirming diagnoses (e.g., by taking biopsies for anemia, bleeding, inflammation, and cancer), or surgically treating disease (such as removing a ruptured appendix or cauterizing intragastric bleeding).

[0053] Referring now to FIG. 1 , the devices, systems, and methods of the present disclosure can include optical viewing endoscopes of the type described above. An exemplary endoscope 100 used in the present disclosure includes a proximal handle 112 adapted for manipulation by a surgeon or clinician coupled to an elongated shaft 114 adapted for insertion through a natural orifice or for endoscopic or percutaneous penetration into a patient's body cavity. The endoscope 100 further includes a fluid delivery system 116 coupled to the handle 112 via a universal cord 115. The fluid delivery system 116 can include several different tubes coupled to an internal lumen within the shaft 114 for delivery of fluids such as water and air, suction, and other functions a clinician may desire to remove fluids, blood, debris, and particulate matter from the field of view, thereby providing a better view of underlying tissue or material for evaluation and treatment. In an exemplary embodiment, the fluid delivery system 116 includes a water jet connector 118, a water bottle connector 120, a suction connector 122, and an air pipe 124. The water jet connector 118 is coupled to an inner water jet lumen 126 that extends through the handle 112 and elongated shaft 114 to the distal end of the endoscope 100. Similarly, the water jet connector 118, water bottle connector 120, suction connector 122, and air pipe 124 are each coupled to inner lumens 128, 130, 132, and 134 that extend through the shaft 114 to the distal end of the endoscope 100.

[0054] The endoscope 100 may further include a working channel (not shown) for passing instruments therethrough. The working channel allows for the passage of instruments down the shaft 114 of the endoscope 100 for the evaluation and treatment of tissue and other material. Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniscopes, baskets, snares, and other devices for use with a scope within a lumen.

[0055] The proximal handle 112 can include various controls for a surgeon or clinician to operate the fluid delivery system 116. In an exemplary embodiment, the handle 112 includes a suction valve 135, an air / water valve 136, and a biopsy valve 138 for extracting tissue samples from a patient. The handle 112 will also include an eyepiece (not shown) coupled to an image capture device (not shown), such as a lens and optical transmission system. As used herein, the term "image capture device" need not refer to a device having only a lens or other light-guiding structure. Instead, for example, the image capture device can be any device capable of capturing and relaying an image, such as (i) a relay lens between the objective lens and eyepiece at the distal end of the scope, (ii) an optical fiber, (iii) a charge-coupled device (CCD), or (iv) a complementary metal-oxide semiconductor (CMOS) sensor. Similarly, the image capture device can be simply a chip for sensing light and generating an electrical signal for communication corresponding to the sensed light, or other technology for transmitting an image. An image capture device can have a viewing end, which is where light is captured. Generally, an image capture device can be any device that can view an object, capture an image, and / or capture video.

[0056] In some embodiments, the endoscope 100 includes some form of positioning assembly (e.g., manual) attached to the proximal end of the shaft to allow the operator to steer the scope. In other embodiments, the scope is part of a robotic element that achieves steerability and positioning of the scope relative to the desired investigation point and focuses the scope.

[0057] Referring now to FIG. 2 , the distal end portion of a side-viewing endoscope 150 (e.g., a duodenoscope or EUS) will now be described. As shown, the scope 150 includes an elongated, flexible shaft 151 having a distal end portion 152 with a viewing region 154 and an instrument region 156, both of which are oriented laterally, i.e., lateral to the longitudinal axis of the shaft 151. The viewing region 154 includes an air nozzle port 158, a camera lens 160, and a light source 162 to provide a view of a surgical site within a patient. The instrument region 156 includes an opening 164 coupled to a working channel (not shown) in the shaft 151 of the scope 150. The opening 164 is configured to allow passage of an instrument from the working channel of the scope 150 to the surgical site. The scope 150 also preferably includes an articulation mechanism for adjusting the angle at which the instrument passes through the opening 164. In the exemplary embodiment, the articulation mechanism includes an elevator 166, but those skilled in the art will recognize that the articulation mechanism may include various other components designed to articulate the instrument angle, such as, for example, a cable extending through shaft 151.

[0058] 3A and 3B illustrate an exemplary embodiment of a coupler device 10 of the present disclosure. The coupler device 10 functions as an accessory component to an existing endoscope. The device seals and covers vulnerable areas of the scope, preventing the entry of debris, fluids, or other unwanted substances that can lead to bacterial contamination and reduced scope performance.

[0059] In certain embodiments, the coupler device 10 provides a flexible working channel for inserting instruments into the scope. The flexible working channel can be easily angled. As shown, in a preferred embodiment, the coupler device 10 can be used with a duodenoscope 40 or other side-viewing scope instrument. Of course, the coupler device 10 can be similarly adapted for use with end-viewing scopes. Furthermore, the coupler device 10 of the present disclosure can be used with any type of scope for a variety of medical applications. The duodenoscope 40 shown here is for illustrative purposes only.

[0060] Of course, it will be appreciated that instruments passing through the scope can be articulated with a variety of different mechanisms. For example, in some embodiments, because the device has multiple cables, the exit angle can be articulated in multiple directions, including different quadrants, unlike existing endoscopic elevators that deflect and therefore redirect instruments in a single axial direction due to the limited travel of the endoscopic elevator, which can only move up or down but cannot move left or right or articulate into other quadrants. In some embodiments, the cables can be attached directly to the working channel extension or to other devices that can be articulated to allow the working channel extension to change its exit angle, including, for example, a dowel housed within the device that is below the working channel extension but can move back and forth as the cable advances and retracts to move the working channel extension. In some embodiments, the articulation function of the coupler device can be generated by an elevator embedded in the coupler device, which is disposable and therefore discarded after the procedure.

[0061] The actuation function of the coupler device may also occur with cable-less elements, including, for example, piezoelectric materials, micromotors, organic semiconductors, and electroactive polymers. In some embodiments, the actuation function of the coupler device may occur using force transmission to the working channel extension or embedded elevator through force-transmitting interlocking connectors, stranded wires, slidable sheaths, and shape-memory alloys that change shape upon temperature transmission. In some embodiments, the device includes a power connector or motor that delivers energy, including electromagnetic energy, to the device to effect force transmission and change the exit angle from the coupler device when or prior to passing an instrument through the device. This force transmission may include rotating the device as it exits the working channel extension. The device may be navigated and actuated by a user directly or as part of a robotic system where user input is translated through the system by a variety of means, including cables, power connectors, motors, electromagnetic energy, slidable sheaths, haptics, computer guidance, and guided input, and by other means to point and guide the device to its intended location for specific diagnostic and therapeutic purposes at the patient or in non-medical applications, or to a desired remote location.

[0062] 3A and 3B, the coupler device 10 can include a main body 12, proximal and distal ends 14 and 16, a lower surface 18, and an upper surface 20. The proximal end 14 mounts over and extends the working end of a duodenoscope 40. The upper surface 20 can include a lens and light guide 24 and a scope irrigator opening 28, which can be used to force fluid over the scope camera to flush debris from the camera and also to force air over the camera to dry it and insufflate the patient's digestive tract. The upper surface 20 can also include open areas above the lens and light guide 24 and the scope irrigator opening 28 to improve visualization of the surgical site and to allow for the release of fluid into the surgical site through the scope irrigator opening 28 (and / or the release of air that can pass over the light guide 24 to dry the camera or that can enter the surgical site and insufflate portions of the site). Additionally, top surface 20 includes a flexible actuation channel region 30 that includes a flexible actuation channel extension 34 surrounded by a flexible membrane 38. This flexible membrane 138 acts as a protective hood or cover for the actuation end of coupler device 10, providing flexible articulation actuation while keeping out debris, fluids, bacteria, or other unwanted materials.

[0063] As shown in Figures 4A and 4B, duodenoscope 40 can include a light guide 44, a lens 46, and an irrigator opening 48. Coupler device 10 cooperates with each of these components of scope 40 to provide a fully functional scope. Coupler device 10 reduces the risk of contamination with each use without interfering with the scope's ability to deliver a clear image. This benefit is achieved by providing coupler device 10 that attaches to the working end component of scope 40 and seals around the working end.

[0064] Coupler device 10 may include one or more optical layers configured to reduce the amount of light reflected from surfaces and / or inhibit the condensation of water droplets on the visualization section. Reducing glare and / or fogging of the visualization section significantly improves the surgeon's view of the target site through coupler device 10. A more complete description of optical layers suitable for use with the present invention can be found in U.S. Provisional Patent Application No. 62 / 949,238, filed December 17, 2019, the complete disclosure of which is hereby incorporated by reference as if copied and pasted into this specification in its entirety.

[0065] Coupler device 10 can further include one or more sensors on or within the exterior surface of its main body. The sensors are configured to detect physiological parameters of tissue surrounding the exterior surface of the coupler device main body. The physiological parameters can include, for example, tissue temperature, tissue size, tissue depth, tissue topography, tissue biomarkers, tissue bioimpedance, temperature, pH, histological parameters, or another parameter that can be used to diagnose a medical condition. Coupler device 10 can be part of an overall system for analyzing, diagnosing, monitoring, treating, and / or predicting the condition of tissue by detecting and objectively quantifying images and physiological parameters within a patient's body, such as overall tissue size, depth, and topography, tissue biomarkers, tissue bioimpedance, temperature, pH, histological parameters, lesions or ulcers, bleeding, strictures, pathogens, abnormal or diseased tissue, and cancerous or precancerous tissue. A more complete description of such a system can be found in U.S. Provisional Patent Application No. 63 / 003,656, filed April 1, 2020, assigned to the assignee of the present invention, the complete disclosure of which is hereby incorporated by reference herein as if copied and pasted in its entirety into this specification.

[0066] As further shown in Figures 3A, 3B, 4A, 4B, 5, and 6, coupler device 10 provides an extension of the scope's working channel 42. The working channel extension 34 of coupler device 10 of Figure 3 is flexible and can contact the scope's working channel 42 via a sealed connection at the working channel extension's proximal end 34a, as shown in Figure 6. The distal end 34b of working channel extension 34 serves as an exit for instruments to pass through scope 40 to access various areas of the body.

[0067] Additionally, coupler device 10 provides an additional seal around the scope's elevator 50. Because coupler device 10 seals elevator 40, the risk of debris ingress, fluid, bacteria, and other material buildup behind the elevator and working channel is significantly reduced. Such debris, bacteria, and other material ingress is believed to be a cause of drug-resistant infections with existing scopes today. While preventing ingress, coupler device 10 advantageously maintains flexibility for movement of working channel extension 34.

[0068] During use, the scope's working channel extension 34 allows instruments to be passed down the scope's working channel 42 and through and exit the working channel extension 34 of the device 40 for evaluation and treatment of tissue and other materials. Such instruments can include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniscopes, baskets, snares, and other devices for use with the scope within a lumen. The working channel extension 34 is flexible enough to allow the elevator 50 of the scope 40 to raise and lower the working channel extension 34 so that instruments can be advanced out of the working channel extension distal end (or exit) 34b of the scope 40 at various angles or raised and lowered by a cable or other means to articulate the working channel extension 34.

[0069] As Figures 7-9 show, during use, when the elevator 50 of the scope 40 is actuated, the flexible working channel extension 34 of the coupler device moves or adjusts relative to this actuation along direction AA. In Figure 7, the elevator 50 rises slightly, creating a hinged ramp or shoulder that pushes the working channel extension 34 a corresponding angle, shifting the exit or distal end 34b of the working channel extension 34 to the left. In Figure 8, the elevator has risen higher than in Figure 7, similarly shifting the distal end 34b of the working channel extension 34 further to the left compared to Figure 7, while Figure 9 shows that the elevator 50 has risen even higher, moving the distal end 34b of the working channel extension 34 further to the left compared to Figures 7 and 8.

[0070] 10 , the ability of distal end 34b of actuation channel extension 34 to shift along the width of working channel region 30 of coupler device 10 is due in part to the fact that distal end 34b is itself attached to flexible membrane 38. This flexible membrane 38 includes a plurality of loose folds or creases that allow excess material to stretch and flex as elevator actuation flexes and shifts the actuation channel extension accordingly. Additionally, flexible membrane 38 acts as a protective cover or hood for working channel region 38, preventing fluids, debris, or other unwanted matter from entering the interior of scope 40 and causing bacterial contamination or the injection of other unwanted fluids, debris, or particulate matter.

[0071] It is contemplated that the coupler device 10 of the present disclosure can be configured for single-use disposable use, or it can be configured for reuse. The coupler device 10 can be fabricated from any biocompatible material, such as, for example, silicone or another elastomeric or polymeric material. Additionally, the material can be transparent. As shown in FIG. 11, the coupler device 10 can provide a transparent cover for the scope camera and light source, thereby allowing unobstructed performance of the scope 40.

[0072] 12-14 illustrate another exemplary embodiment of the coupler device 10 of the present disclosure. In this embodiment, the coupler device 10 is adapted for use with a cable-actuated scope, eliminating the need for an elevator component. As shown, the coupler device 10 maintains the same structural features as described above, but now further includes a disposable outer sheath 60 capable of receiving the scope's inner actuation cable 54. This cable 54 can be detached from the elevator and reattached to the flexible working channel extension 34 of the coupler device 10. Because actuation of the cable results in movement of the working channel extension 34, an elevator is no longer required in this embodiment. The outer sheath 60 can be configured to attach directly to the scope 40, for example, by wrapping it around the outside of the scope or by a friction-fit connection. In embodiments, multiple cables can be placed within one or more sheaths to achieve articulation in quadrants other than the single-axis articulation with the elevator in existing duodenoscopes.

[0073] In other embodiments, coupler device 10 can include a reclosable port (i.e., self-sealing) that allows for the injection of anti-adhesive, anti-bacterial, anti-inflammatory, or other medicinal or injectable substances that prevent bacterial adhesion or colonization on the scope. An applicator can be provided that is integrated into coupler device 10 and has a port for delivering the injectable substance. Alternatively, the applicator can be separate from coupler device 10 and applied to the distal end of scope 40. Injectable substances can include forms of silver, platinum, copper, other anti-adhesive, anti-bacterial, anti-inflammatory, or other medicinal or injectable substances in a gel or other solution that is compatible with the materials of the scope and coupler device and biocompatible for patient use.

[0074] In one exemplary embodiment, the device includes an anti-infective material. In another exemplary embodiment, the device includes an anti-infective coating. In yet another embodiment, the device includes a coating that is hydrophobic. In yet another embodiment, the device is superhydrophobic. In yet another embodiment, the device is both anti-infective and hydrophobic. In yet another embodiment, the device is both anti-infective and superhydrophobic. In yet another exemplary embodiment, an anti-inflammatory coating is incorporated into the device. In other embodiments, the anti-inflammatory coating can be hydrophilic.

[0075] In one exemplary embodiment, device 10 can include a silver ion coating. In other embodiments, device 10 can have a silver hydrogel applied, injected into, or made part of the device 10 in the area covering or extending around the scope elevator. In addition to having antibacterial properties, silver can also conduct electricity. Thus, in yet another embodiment, device 10 can include electrical wires or other electrical transmission points that allow for the creation of an electric field across the silver ion coating to improve the silver ion coating's ability to prevent infection. In some embodiments, the electrical wires or other electrical transmission points can also be loaded with other antibacterial and electrically conductive materials, including platinum and copper.

[0076] 15 and 16 illustrate other embodiments of the working channel extension 234 of the present disclosure. As envisioned, the working channel extension can include a combination of different materials. For example, as shown in FIG. 15, the working channel extension 234 can be formed from multiple elastic materials bonded to a biocompatible metal. In some embodiments, one of the elastic materials can be PTFE, and another elastic material can be a biocompatible elastic material covering the biocompatible metal. In the example of FIG. 15, the working channel extension 234 can include an inner elastic material 210 and an outer elastic material. The exterior of the working channel extension 234 can include a biocompatible metal 230, which can take the form of a coil or winding 232. In one embodiment, the biocompatible metal can be wrapped with one or more of the elastic materials.

[0077] In FIG. 16, the outer biocompatible elastic material 220 is formed to create a gasket 222 that seals the proximal end of the working channel extension 234 against the working channel of the endoscope, creating a seal that prevents unwanted bacteria, biological material, and other substances from entering this sealed area.

[0078] Figure 17A shows working channel extension 234 as including an adjustable exit angle θ for locking instrument 200 in place. In this embodiment, adjusting the exit angle creates a compressive force on working channel 234, locking instrument 200 in place, as shown in Figure 17B. This can be used to secure an instrument while advancing a wire through it, or to secure a wire while exchanging a second instrument over the wire.

[0079] 18 illustrates an alternative embodiment for locking the instrument 200 in place. In this embodiment, the working channel extension 234 is raised to a point where the instrument 200 within the working channel extension 234 is compressed against the lock 180 on the device 100, causing a change in the exit angle of the working channel extension 234 and locking the instrument 200 in a fixed position within the working channel extension 234.

[0080] FIG. 19 shows an alternative embodiment of the actuation channel extension 234 including a flange 268 for attaching the actuation channel extension to the membrane material 38 that is part of the device 10 .

[0081] 20 illustrates an alternative embodiment of a working channel extension 234 for a coupler device that includes a recess or groove 306 in a distal open end 308 for receiving an instrument (not shown) passing through the internal lumen 304 of the working channel extension 234. The groove 306 is sized to restrain and / or secure the instrument in place after it passes through the working channel extension 234, so that it does not move around at the target site within the patient. The groove 306 can be used by an operator, for example, to secure an instrument while another instrument is exchanged over the guidewire and / or to secure the guidewire.

[0082] The instruments can include guidewires, endoscopic mucosal resection instruments, needle injectors, Foley catheters, bipolar or monopolar electrosurgical or ultrasonic devices, snares, staplers and other fastening or sealing instruments for endoscopes, arterial lines, drainage catheters, peripherally inserted central catheters, and other devices that penetrate and / or are navigated within the body, etc. The instruments can be configured to pass through the working channel of the endoscope and the working channel extension or other passageway of the coupler device.

[0083] As shown, groove 306 preferably forms a substantially V-shape, although one skilled in the art will recognize that other shapes are contemplated. For example, groove 306 may be beveled or angled or may form a partial cylinder, cone, square, triangular, U-shape, or other suitable shape. Groove 306 provides a firmer grip on the instrument to lock it in place within working channel extension 234.

[0084] Groove 306 may be formed directly in working channel extension 234. Alternatively, groove 306 may be formed by a separate component attached to the distal end of working channel extension 234. In this latter embodiment, groove 306 may be formed by a biocompatible component that may be removably attached to working channel extension 234, for example, before or during a procedure on a patient.

[0085] In one embodiment, working channel extension 234 optionally includes one or more bevels, protrusions, or projections 302 that extend into inner lumen 304 to narrow or constrict the passageway distally and further define groove 306. Protrusions 302 form a bevel within inner cavity 304 of working channel extension 234 to guide instruments into groove 306. Protrusions 302 can extend the entire circumference of inner lumen 304, or can form only a portion of inner lumen 304. For example, protrusions 302 can form a quasi-hemisphere around a portion of lumen 304.

[0086] The protrusions 302 can be formed directly into the working channel extension 234 during manufacturing by various techniques known in the art. Alternatively, the protrusions 302 can be separate components that are attached to the working channel extension 234. The protrusions 302 and grooves 306 can be formed together or can be separate components that can be removably attached to the working channel extension 234 so that they can be used when needed during a procedure and then removed if no longer desired. Alternatively, the protrusions 302 and / or grooves 306 can be permanently fixed to the working channel extension 234. In certain embodiments, the protrusions 302 and grooves 306 are formed from a metal, such as stainless steel or titanium, or a plastic material, such as PMMA, polycarbonate, polyethylene, or any other suitable biocompatible material.

[0087] The surfaces of the protrusions 302 can be formed of a material that increases friction with the instrument to facilitate gripping therebetween. Alternatively, the inner surfaces of the protrusions 302 can include surface features, such as an abrasive surface or a roughened surface, that utilize the reaction force of the guidewire to secure the guidewire in the working channel extension 234.

[0088] 21 , coupler device 300 may include an elevator 310 for articulating working channel extension 234 (alternatively, the elevator may be part of scope 40). Similarly, working channel extension 234 may include grooves 306 in its open distal end 308, as shown in FIG. 20. In this embodiment, working channel extension 234 does not include any protrusions within the internal lumen of working channel extension 234, although such protrusions may be included as described in FIG. 20 .

[0089] During use, when the elevator 310 is actuated, the flexible actuation channel extension 234 of the coupler device moves or adjusts relative to this actuation along direction AA, as described above. As the elevator 310 moves across the flexible actuation channel extension 234, it slightly compresses the inner diameter of the actuation channel extension 234 to secure an instrument within the groove 306 or to secure an instrument within the actuation channel extension 234. Alternatively, the coupler device 300 may further include a stop member 340 (not shown) within the main body positioned such that the actuation channel extension 234 engages the stop member when the elevator 310 moves across the actuation channel extension 234. This engagement slightly compresses one of the walls of the actuation channel extension 234, reducing its inner diameter and securing an instrument therein. Alternatively, the stop member may be coupled to an actuator configured to translate or advance the stop member relative to the actuation channel extension 234. In this latter embodiment, the instrument may be secured within working channel extension 234 at any location that allows movement along direction AA.

[0090] Alternatively, coupler device 300 may be included without protrusions 302 or grooves 306. In this embodiment, elevator 310 articulates a flexible working channel extension relative to another fixation member of coupler device 300 to secure an instrument therein.

[0091] 22A and 22B illustrate another embodiment in which a coupler device according to the present disclosure includes an elevator 310 for articulating an instrument, such as a guidewire 320. The remainder of the coupler device 300 is not shown in these figures. In this embodiment, the coupler device 300 may or may not include a working channel extension. For example, the coupler device 300 may include an open area or passageway between the distal end of the working channel of the scope 40 and the elevator 310. This open area or passageway allows an instrument to be advanced from the scope working channel to the elevator 310. The elevator 310 can be rotated to articulate the instrument and change its exit angle from the coupler device 300. As described above, the elevator 310 can be rotated by a variety of different actuators.

[0092] As shown in FIG. 22A , elevator 310 includes a groove 332 near its distal end for receiving an instrument (e.g., guidewire 320). As with the previous embodiment, groove 332 may be substantially V-shaped or have any other suitable shape, allowing guidewire 320 to be secured therein. Elevator 310 may be articulated to engage stop member 340, which may be part of the main body of coupler device 300 or may be a separate component of device 300. Alternatively, elevator 310 may be designed to engage a distal end portion of a scope, in which case the coupler device would not include stop member 340. When elevator 310 engages stop member 340 or the distal end of the scope, guidewire 320 is secured within groove 332.

[0093] 22B illustrates an alternative feature of the coupler device of the present disclosure. As shown, an instrument, such as a guidewire 320, can be advanced along the side 312 of the elevator 310. Stop members 342 can be provided on the sides of the elevator 310 to secure the guidewire 320 between the side 312 and the stop members 342. The lateral stop members 342 can be translated or articulated into position to engage the guidewire 320 therebetween. Alternatively, the elevator 310 can be designed to articulate into position so that the guidewire 320 is secured between the side and the lateral stop members 342. In yet another embodiment, the coupler device 300 does not include the lateral stop members 342, and the guidewire 320 is secured between the elevator 310 and a side wall (not shown) of the coupler device 300. In this embodiment, the coupler device 300 can simultaneously secure two separate instruments (i.e., one in the groove 332 and the other along the side 312).

[0094] FIG. 23 illustrates yet another embodiment of a coupler device 400 in accordance with the present disclosure. As shown, the coupler device includes a working channel extension 234 having a proximal end configured to couple to the distal end of a working channel of an endoscope and an open distal end 234b. In this embodiment, the coupler device 400 or endoscope may or may not include a separate elevator 310 for articulating the working channel extension 234. A cable 406 extends through an outer sheath 408 and has a distal end 412 coupled to a portion of the working channel extension 234. The cable 406 is configured to advance distally to compress that portion of the working channel extension 234, thereby reducing its inner diameter and immobilizing an instrument passing therethrough. Alternatively, the cable 406 can remain stationary, as the elevator 310 moves the working channel extension 234 relative to the cable 406, thereby compressing the portion of the working channel extension 234. Working channel extension 234 may or may not include one or more protrusions or grooves in its internal lumen to facilitate instrument anchoring.

[0095] 24A and 24B illustrate another embodiment of a coupler device 500 having a locking element 502 in accordance with the present disclosure. As shown, the coupler device 500 includes a main body 504 having a proximal end 506 configured to mount over the working end of an endoscope (not shown), thereby extending the working end of the scope. As with the previous embodiment, the main body 504 has an upper surface 508 that can include a lens and light guide and a scope irrigator opening. The upper surface 508 can also include an open area above the lens and light guide and scope irrigator opening to facilitate visualization of the surgical site and to allow for the release of fluids from the scope irrigator opening into the surgical site (and / or the release of air that can pass over the light guide to dry the camera or that can enter the surgical site and insufflate a portion of the site).

[0096] Additionally, upper surface 508 includes a flexible working channel region having a proximal end (not shown) configured to attach to the working channel of an endoscope and a distal opening 512 for passing an instrument 514, such as a guidewire, through working channel extension 510 and into a patient. As with the previous embodiment, coupler device 500 may further include an elevator or other mechanism for articulating working channel extension 510 to vary the angle at which instrument 514 exits distal opening 512. Alternatively, coupler device 500 may be configured to cooperate with an elevator on an endoscope, as described above.

[0097] As shown, the coupler device 500 further includes a locking element 502 positioned on the upper surface 508 for restraining and / or locking the instrument 514 in place. The locking element 502 includes an elongate body 522 extending transversely or substantially perpendicular to the longitudinal axis of the main body 504. The locking element 502 further includes a central projection 524 extending outwardly from the elongate body 522, which is positioned to lock the instrument 514 between the elongate body 522 and the working channel extension 510 or to bias the instrument 514 to the side of the central projection 524 (as shown in FIG. 24B ). The locking element 502 can comprise any suitable biocompatible material that is rigid or at least semi-rigid, such as bare plastic, polycarbonate, or acrylic. Alternatively, the locking element 502 can comprise a more elastic material, such as a thermoplastic elastomer (TPE).

[0098] In use, the working channel extension 510 is articulated in a direction generally parallel to the longitudinal axis of the main body 504 so that the instrument 514 is compressed against the elongate body 522 on one side of the central protrusion 524 of the locking element 502. In one embodiment, raising the elevator causes the working channel extension 510 to temporarily compress and lock the instrument 514. Alternatively, as the elevator is raised, the TPE above the elevator can directly contact the instrument 514, compressing the instrument 520 against the locking element 502. In certain embodiments, multiple instruments can be locked on either side of the central protrusion 524.

[0099] 25A and 25B illustrate another embodiment of a locking element 540 for coupler device 500. As shown, locking element 540 includes an elongate body 542 having two protrusions 544, 546 defining a central groove 548 therebetween. In this embodiment, with working channel extension 510 compressed against locking element 540, instrument 514 is locked into central groove 548. As with the previous embodiment, groove 548 may be substantially V-shaped or any other suitable shape that facilitates securing instrument 514 therein.

[0100] 26A and 26B illustrate yet another embodiment of a locking element 550 for coupler device 500. As shown, locking element 550 includes an elongate body 542 that extends transversely to the longitudinal axis of endoscope and coupler device 500. In this embodiment, locking element 550 does not include any protrusions extending from elongate body 542. In use, an elevator rises to articulate working channel extension 510 such that instrument 514 is locked relative to elongate body 542.

[0101] The coupler devices and endoscopes of the present disclosure can be used in a variety of different kits that include other medical devices, instruments, accessories, balloons, endoscopic positioning systems, guidewires, dilation catheters, cannulas, cutting devices (e.g., sphincterotomes or papillotomes), choledochoscopes, stone capture and extraction devices, polyp or tissue removal devices, snares, stents (e.g., biliary stents), disposable valves, bite blocks, anatomical support bands, or other devices. A more complete description of kits for use with the present disclosure is set forth in commonly assigned and currently pending U.S. patent application Ser. Nos. 16 / 717,202 and 16 / 717,804, both filed Dec. 17, 2019, the complete disclosures of which are hereby incorporated by reference herein for all purposes.

[0102] All issued patents, published patent applications, and non-patent literature referenced herein are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual issued patent, published patent application, or non-patent literature was specifically and individually indicated to be incorporated by reference.

[0103] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the embodiments being indicated by the following claims. [Explanation of symbols]

[0104] 100 Endoscope 112 Proximal Handle 114 Thin Shaft 115 Universal Code 116 Fluid Delivery System

Claims

1. 1. A device for use with an endoscope, comprising: a main body having a visualization section that allows tissue to be viewed by the endoscope and a proximal end configured to be attached to a distal end portion of the endoscope; an instrument channel within the main body configured for operation adjacent a working channel within the endoscope when the proximal end of the main body is attached to the distal end portion of the endoscope; and Equipped with the instrument channel defines a groove at the distal end to restrain an instrument passing through the instrument channel; one or more protrusions extending into the instrument channel; and an actuator for compressing the instrument channel to secure the instrument within the groove; the protrusion is removably coupled to the instrument channel; A device characterized by:

2. 10. The device of claim 1, wherein the instrument channel is a working channel extension within the main body, the working channel extension having an open distal end and a proximal end configured to attach to the working channel of the endoscope.

3. The device of claim 2 , wherein the device is configured to compress a portion of the working channel extension against the instrument to secure the instrument in place within the working channel extension.

4. 3. The device of claim 2, wherein the open distal end is angled relative to the longitudinal axis of the endoscope working channel, the device being configured to lock the instrument in place at the angle.

5. The device of claim 4 configured to allow movement of the instrument while fixing the instrument at the angle.

6. 10. The device of claim 1 further comprising an elevator within said main body for angular adjustment of said instrument channel.

7. further comprising a locking element on an outer surface of the main body; the elevator is configured to secure an instrument relative to the locking element; 7. The device of claim 6.

8. the locking element includes a main body extending transversely to a longitudinal axis of the working channel; The locking element further comprises one or more protrusions extending from the main body and defining a groove for securing the instrument.

8. The device according to claim 7 .

9. 7. The device of claim 6, wherein the elevator is configured to compress a portion of the instrument channel to lock the instrument in place during the angular adjustment.

10. The device of claim 1 , wherein the groove has a substantially V-shape.

11. 10. The device of claim 1, further comprising a mechanism for articulating an instrument passing through the endoscope.

12. 3. The device of claim 2, wherein the working channel extension is flexible and angularly adjustable by actuation of the endoscope.

13. a stop member positioned to engage a portion of the working channel extension; the actuation channel extension is configured to be partially compressed upon engagement with the stop member; the working channel extension is configured to engage the stop member upon angular adjustment of the working channel extension.

13. The device of claim 12.

14. 3. The device of claim 2, further comprising an actuator coupled to a portion of the working channel extension and configured to compress the portion to reduce a diameter of the working channel extension.

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