Endoscopic device removal system and method

Abstract

To provide systems and methods for non-traumatic removal of a variety of devices placed over or on either endoscopic instruments or endoscopes.SOLUTION: A device removal system includes a removal element for gripping a device, which includes a body with a central portion and adjacent gripping arms movably coupled to the central portion. The system also includes an insertion device coupled to the removal element, and an expanding instrument. The insertion device has an elongate shaft configured for advancement into an opening or channel within the device to be removed. The expanding instrument is configured for insertion into the insertion device to expand the shaft of the insertion device and obtain a firm grip on the device, thereby reducing the local pressure applied to any one portion of the device, which reduces the wear and tear on the instrument and minimizes damage to epoxy joints and other sealed areas.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 788,901, filed January 6, 2019, the entire disclosure of which is incorporated herein by reference for all purposes.

[0002] (Technical field) The present disclosure relates to systems and methods for detaching medical devices, instruments, accessories, or components attached to or on other medical devices, instruments, or components, and more particularly to systems and methods for detaching an endoscopic device from a medical device or endoscope. [Background technology]

[0003] Recent advances in optical imaging technology have enabled many medical procedures to be performed in a minimally invasive manner today. Advances in more sophisticated flexible scopes with enhanced visual capabilities have enabled access to deeper regions of the human body that were previously only achievable through invasive surgical intervention. This modern convenience has led to an increase in the demand for, and the number of, endoscopic, laparoscopic, arthroscopic, ophthalmoscopic, and other remote imaging visualization procedures performed annually in the United States. These procedures, while relatively safe, are not without risk.

[0004] An endoscope is a medical instrument used for visual examination of the interior of the body, including lumens, cavities, or various organs such as the heart, liver, pancreas, stomach, colon, bladder, reproductive system, and other parts of the body. A typical endoscope is long and thin and has illuminated optical features, allowing for easy introduction into a patient and visualization during procedures. Endoscopes can be used in conjunction with other medical devices, instruments, or components, such as cutting or cauterizing instruments, for treatment in addition to the examination of body cavities or organs. Some of these endoscopic combination devices or components can be positioned on or within the endoscope, such as endoscope caps, endoscope shields, sheaths, optical couplers, lenses, varicose vein banding devices, and endoscopic submucosal resection devices, to name a few. These devices further enhance the functionality of the endoscope and / or provide protection from contaminants. Summary of the Invention [Problem to be solved by the invention]

[0005] Mounting evidence indicates that the continued removal of these various devices from an endoscope over time can result in loosening of epoxy joints and other areas that are supposed to remain sealed to prevent contaminants from biological material during an endoscopic procedure, further exposing the endoscope to unnecessary wear and tear. Failure to maintain these seals can create areas where biological material can accumulate, making cleaning and reprocessing of the scope or instrument difficult and therefore prone to harboring pathogens that, in some cases, can colonize and lead to dangerous drug-resistant infections, leading to increased scope maintenance costs and a shortened useful life of the scope.

[0006] Therefore, it would be desirable to have an improved system for effectively detaching these endoscopic devices from an endoscope or medical instrument. [Means for solving the problem]

[0007] The present disclosure addresses a long-standing need for a detachment system for the accurate, predictable detachment of various endoscopic devices from instruments and endoscopes with minimal damage to the instrument or endoscope in which the device is incorporated. According to one aspect of the present disclosure, a system for detaching a device from an endoscopic instrument includes a detachment element for grasping the device and an insertion element coupled to the detachment element. The detachment element has a body including a central portion and first and second grasping arms movably coupled to the central portion to allow an operator to obtain a firm grip on the device. The insertion device has a protruding portion configured for advancement into an opening in the device. The insertion device provides the operator with a firm grip on the device. Additionally, the insertion device allows the operator to apply force from within the device to easily withdraw the device from the endoscopic instrument.

[0008] In certain embodiments, the protruding portion comprises an elongated shaft configured to pass through the opening and into the internal channel of the device. Preferably, the elongated shaft of the insertion device is collapsible so that at least a portion of the shaft has a small diameter for passage through the internal channel of the device. This facilitates advancement of the shaft into the device, and then allows the shaft to expand outward, creating a friction fit within the internal channel of the device and providing a firmer grip on the device. The friction fit also allows the user to apply force from the inside of the device when withdrawing. Applying force from the inside of the device distributes the application of force from the outside of the device (via the gripping arms) and from the inside via the insertion device. This reduces localized pressure on any one part of the device, resulting in precise and trauma-free removal, which reduces wear and tear on the instrument and minimizes damage to epoxy joints and other sealing areas.

[0009] In an exemplary embodiment, the shaft includes one or more slits extending substantially longitudinally to allow the shaft to collapse under external pressure from the internal channel of the device, facilitating advancement of the shaft into the device to be removed. In another exemplary embodiment, the shaft includes ridges on at least a portion of its outer surface to enhance the grip between the shaft and the device.

[0010] In certain embodiments, the removal system further includes an expander configured for insertion into the insertion device. Preferably, the expander has at least one portion with a diameter larger than the inner diameter of the insertion device (at least in its collapsed configuration). The expander expands the shaft of the insertion device relative to the internal channel of the device to be removed, further increasing the friction fit therebetween. In an exemplary embodiment, the expander includes an elongated shaft having an expander head on a distal end portion of the shaft. The expander head serves to expand the shaft of the insertion device as it is advanced through it. In an exemplary embodiment, the expander terminates in a tapered tip to facilitate advancement of the expander into the insertion device.

[0011] In certain embodiments, the first and second gripping arms are pivotally coupled to a central portion of the detachment element and configured to pivot from a substantially parallel orientation to a transverse or perpendicular orientation relative to the central portion. This design allows the operator to pivot the gripping arms relative to the device. In exemplary embodiments, the gripping arms further include one or more ridges on their inner surfaces to provide additional grip on the device. The gripping arms can also include finger gripping elements on their outer surfaces to facilitate handling of the gripping arms. In exemplary embodiments, the finger gripping elements include protrusions extending laterally outward from each of the gripping arms. The protrusions can include curved distal surfaces (distal being the surfaces facing away from the operator) that allow the operator to place their fingers against the curved surface. The finger gripping elements provide the operator with additional leverage, providing sufficient force to withdraw the detachment element and device away from the endoscopic instrument.

[0012] In some embodiments, the device to be removed is selected from the group consisting of an endoscope cap, an endoscope shield, a sheath, an optical coupler, a lens, a varicose vein banding device, and an endoscopic submucosal resection device. For example, the device to be removed can be an endoscopic device such as an optical coupler or an endoscope cap attached to the distal or proximal end of an endoscope.

[0013] In another aspect of the invention, a method for detaching a device from an endoscopic instrument includes grasping a portion of the device with a detachment element, inserting a protruding portion of the detachment element into an opening in the device, and applying a force to the detachment element to withdraw the device from the endoscopic instrument. In certain embodiments, the protruding portion includes an elongate shaft coupled to the detachment element. The elongate shaft advances through an internal channel in the device to be detached. In an exemplary embodiment, the elongate shaft collapses as it advances into the internal channel, facilitating insertion of the shaft into the device.

[0014] In certain embodiments, the method further includes expanding at least a portion of the elongate shaft after insertion into the channel or opening of the device. The shaft can be expanded by inserting an expansion instrument through an internal channel in the shaft. The expansion instrument can include an elongate shaft having an enlargement head that operates to expand the insertion device.

[0015] In certain embodiments, the method further includes contacting first and second sides of the device with first and second gripping arms of a detachment element. The gripping arms can be pivotally coupled to a central portion of the detachment element such that an operator pivots the gripping arms into position relative to the device. Applying a detachment force can include contacting the device to grip the first and second gripping arms and pulling the central portion of the detachment element away from the device to remove the device from the endoscopic instrument.

[0016] It is to be understood that both 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 practice of the present disclosure.

[0017] 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 disclosure. [Brief explanation of the drawings]

[0018] [Figure 1A] 1 illustrates an exterior isometric view of a removal element in an unfolded configuration in accordance with the present disclosure. [Figure 1B] 1B shows an inner isometric view of the removal element of FIG. 1A. [Figure 1C] 1B shows an overhead view of the detachment element of FIG. 1A in a folded configuration. [Figure 1D] 1D shows an inner isometric view of the removal element of FIG. 1C. [Figure 2] 1B shows an exploded view of the removal element of FIG. 1A. [Figure 3A] 10A-10C illustrate steps in a method for removing a device from an endoscopic instrument according to the present disclosure. [Figure 3B] 10A-10C illustrate a stage of securing an endoscopic device to a detachment system by inserting an insertion device. [Figure 3C] FIG. 16 is a medial isometric view of the removal system and endoscopic device ready for removal. DETAILED DESCRIPTION OF THE INVENTION

[0019] This description and the accompanying drawings illustrate exemplary embodiments and are not limiting, and the claims define the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of the present description and 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 reference numbers in two or more drawings represent the same or similar elements. Furthermore, elements and related aspects described in detail with reference to one embodiment may, when implemented, be included in other embodiments where they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment but not with reference to a second embodiment, the element can still be claimed to be included in the second embodiment. Furthermore, the description herein is for illustrative purposes only and does not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

[0020] It should be noted that, as used in this specification and claims, the singular forms "a," "an," "the," and the use of any singular form of any word include plural references unless clearly dictated otherwise. As used herein, the term "comprises" and its grammatical variations are intended to be open-ended, and the recitation of elements in a list does not exclude other similar elements that may be substituted for or added to the listed elements.

[0021] The present disclosure provides a system that allows for accurate, predictable, and minimally traumatic removal of various devices used in endoscopic procedures. Removable devices include, for example, endoscope caps, endoscope shields, sheaths, optical couplers, lenses, varicose vein banding devices, endoscopic submucosal resection devices, balloons, and other devices that can be positioned on, within, or relative to an endoscope or other device used in endoscopic, interventional, or other procedures in which instruments or other devices are inserted into the body. The present disclosure is particularly useful for removing devices from endoscopes, such as optical couplers and conductive optical elements that can be removably coupled to the distal end portion of an endoscope. For example, optical coupling devices suitable for removal using the systems and methods of the present invention are described in International Application Nos. PCT / US2016 / 043371, filed July 21, 2016, PCT / US2016 / 035566, filed June 2, 2016, and U.S. Patent No. 8,905,921, the entire disclosures of which are incorporated herein by reference for all purposes.

[0022] According to one exemplary embodiment shown in FIGS. 1A-1D, a detachment system 100 includes a detachment element 20 configured to atraumatically grasp and apply force to the exterior surface or edge of a device to be detached, allowing a user to grasp and apply force to a device targeted for removal from an endoscope or instrument. The detachment element 20 comprises an elongated body 22 having a central portion 24 flanked by adjacent tabs or gripping arms 26 a, 26 b, which couple to the central portion 24 at a notched region 29. A notched region 28 between the central portion 24 and the gripping arms 26 a, 26 b allows the gripping arms 26 a, 26 b to fold or pivot relative to the central portion 24, as shown in FIGS. 1C and 1D. Of course, other configurations are possible. For example, the gripping arms 26 a, 26 b can be pivotally coupled to the central portion 24 by a variety of different mechanisms, such as hinges or other suitable articulation mechanisms.

[0023] Surface protrusions, such as ridges 36 or other suitable gripping elements, can be provided on the inner surface 32 of the removal element 20, as shown in FIG. 1B, to improve gripping and application of force to grasp and remove the device to be removed. The removal element 20 or some other aspect of the system 100 can include finger gripping elements 38 on the outer surface 34, as shown in FIG. 1A, to improve the ergonomics of the system by making it easier to hold and apply force to the system 100. In one embodiment, the finger gripping elements 38 are protrusions extending outward from the gripping arms 26a, 26b. These protrusions preferably include a curved inner surface configured to contact the operator's fingers, allowing the operator to firmly grasp the gripping elements 38 while pulling the removal element 20 proximally (or away from the curved surface).

[0024] According to one embodiment of the present disclosure, as shown in FIG. 2 , the system 100 can further include an insertion device 40, which can be a collet or other suitable element that can be inserted into the working channel of an endoscope shield, optical coupler, endoscope cap, or other device to be removed that includes an internal channel. The insertion device 40 can be attachable to the removal element 20, such that the insertion device advances into the internal channel of the device to be removed. Alternatively, the insertion device 40 can be an integral part of the removal element 20 (i.e., manufactured together in the same mold). The insertion device 40 preferably includes an elongated shaft 42 having slits 44 or other suitable cutouts or design features that allow the insertion device 40 to collapse or otherwise reduce in diameter during insertion. This allows the insertion device 40 to easily advance through the internal channel of the device to be removed. Additionally, the insertion device 40 then naturally expands outward within the device, creating a friction fit between the insertion device 40 and the device to be removed. This friction fit allows the user to apply force from the inside of the device when pulling back. Applying force from the inside of the device distributes the force application so that it is applied from the outside of the device (via the gripping arms 26a, 26b) and from the inside via the insertion device 40. This reduces localized pressure on any one part of the device, resulting in precise and atraumatic removal.

[0025] Of course, it should be understood that detachment element 20 can be configured to apply radial pressure or force from within the device to be detached, or can be used to spread the ends and capture the device to be detached. In other words, detachment element 20 can be used to effectively grasp the device and pull it away from an attached instrument or endoscope by spreading the open ends and pulling the device toward the user.

[0026] In another embodiment, the insertion device 40 includes a protruding portion (not shown), such as a knob, flange, lip, extension, or other protrusion, that can be inserted into the opening of the device to be removed. In these embodiments, the protruding portion is configured to expand outward upon insertion into the opening to create a friction fit within the device. The protruding portion can include a flexible material that is biased outward, for example, by a spring or a natural composition of material. A user can apply force on the protruding portion to collapse the protruding portion and insert it into the opening, whereby the protruding portion then expands outward to create a friction fit. In one such embodiment, the protruding portion is configured to expand outward upon insertion into the opening, such that when the protruding portion is pulled back by the user, it applies a force to the proximal interior surface of the device. In these embodiments, the insertion device 40 can be used, for example, to remove a device that has an opening but no internal channel therein.

[0027] In some embodiments, the insertion device 40 can have one or more ridges 48 or other surface features or variations on its exterior surface to enhance adhesion or grip within the interior channel when the removal system 100 is applied to remove the device. The ridges 48 can be located, for example, on the exterior or distal surface of the shaft 42.

[0028] As shown in FIG. 2 , an expander instrument 60 can be provided for use with the removal system 100. According to another aspect of the exemplary embodiment, the insertion device 40 can include an opening 46 (see FIG. 3B ) that leads to an interior channel (not shown) of the elongate shaft 42 to receive the expander instrument 60. In some embodiments, the expander instrument 60 has an outer diameter that is larger than the inner diameter of the interior channel of the insertion device 40, such that the expander instrument 60 expands the insertion device 40. In some cases, the outer diameter of the expander instrument 60 is slightly larger than the collapsed inner diameter of the insertion device 40 (i.e., after being inserted into the device and collapsed via the slit 44 on the shaft 42). In other embodiments, the expander instrument 60 can include an enlarged head portion 62 and an elongate shaft 64 extending from the head portion 62. In these embodiments, the enlarged head portion 62 serves to expand the insertion device 40 (i.e., the outer diameter of the expander instrument 60 can be equal to or less than the inner diameter of the insertion device 40). In all of these embodiments, advancing the insertion device 40 through the opening 46 and into the internal channel of the insertion device 40 increases the diameter of the elongate shaft 42, resulting in an increase in the magnitude of the resistance and transmission forces when the insertion device 40 is used to remove the device being removed.

[0029] The elongate shaft 64 of the dilator 60 can terminate in a tip 66. In some embodiments, the tip 66 can be tapered, blunt, or sharp. The tip 66 serves to facilitate advancement of the dilator through the interior channel of the insertion device 40.

[0030] 3A-3C, an exemplary method for removing a representative device 200 mounted on an instrument or endoscope according to the present disclosure will be described. As shown in FIG. 3C, the insertion device 40 is advanced through the device's opening. The slit 44 allows the shaft 42 of the insertion device 40 to collapse, allowing the insertion device 40 to easily advance through the opening of the device 200. Next, as shown in FIG. 3A, the gripping arms 26a, 26b of the detachment element 20 can fold over the device 200. The ridges 36 on the inner surface 32 of the detachment element 20 can provide a secure grip when a user applies pressure with the finger gripping elements 38 to fold the detachment element 20 over the device 200 to be removed. Next, as shown in FIG. 3B, an expander instrument 60 can be inserted through the opening 46 of the insertion device 60. This expands the diameter of the elongated shaft 42 of the insertion device 40, as shown in FIG. 3C, further securing the device 200 in the detachment system. Once the insertion device 60 is inserted, the user can grasp the entire removal system 100 and pull the device 200 away from the instrument or endoscope, thereby removing the device 200 in a more precise, predictable, and less traumatic manner than current methods.

[0031] The components of the detachment system 100 can be made of any medical grade material including, but not limited to, elastomeric materials, rigid materials, or combinations of materials that achieve various performance elements that can include, for example, both elastic and rigid materials, including polypropylene, PET materials, PTFE materials, thermoplastic elastomers, polycarbonate, acrylic, and any other elastic or rigid medical grade material.

[0032] Of course, it should be understood that detachment system 100 can be sterilized using any acceptable method, or can be non-sterile. For example, detachment system 100 can be provided as a disposable or single-use system.

[0033] All issued patents, published patent applications, and non-patent literature mentioned in this specification 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.

[0034] 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 a true scope and spirit of the embodiments being indicated by the following claims.

[0035] (Embodiment 1) 1. A system for removing a device from an endoscopic instrument, comprising: a detachment element for grasping the device, the detachment element having a body including a central portion and first and second gripping arms movably coupled to the central portion; an insertion device coupled to the removal element and having a protruding portion configured to advance into an opening in the device; Including, the system. (Embodiment 2) 2. The system of embodiment 1, wherein the protruding portion is an elongated shaft configured to advance through an internal channel of the device. (Embodiment 3) 3. The system of embodiment 2, wherein the elongate shaft is collapsible such that the outer diameter of at least a portion of the elongate shaft decreases upon advancement of the device into the internal channel. (Embodiment 4) 3. The system of embodiment 2, further comprising an expansion instrument configured for insertion into the insertion device. (Embodiment 5) 5. The system of embodiment 4, wherein the insertion device includes an internal open channel for receiving the expansion instrument. (Embodiment 6) 6. The system of embodiment 5, wherein the insertion device is expandable by advancement of the expansion instrument into the internal open channel. (Embodiment 7) 5. The system of embodiment 4, wherein the insertion device comprises a slit along the elongate shaft that allows expansion of the elongate shaft. (Embodiment 8) 2. The system of embodiment 1, wherein the first and second gripping arms include ridges or finger gripping elements on an inner surface. (Embodiment 9) 2. The system of embodiment 1, wherein the insertion device comprises a ridge on the protruding portion. (Embodiment 10) 5. The system of embodiment 4, wherein the expansion instrument comprises an elongated shaft with an enlarged distal head and terminates in a tapered tip. (Embodiment 11) 1. A system for removing a device from an endoscopic instrument, comprising: a detachment element for grasping the device; an insertion device coupled to the removal element and having a protruding portion configured to advance into an opening in the device; an expansion tool configured to be inserted into the protruding portion such that the protruding portion expands within the device; Including, the system. (Embodiment 12) The system of embodiment 11, wherein the protruding portion comprises an elongated shaft configured to advance through an internal channel within the device. (Embodiment 13) 13. The system of embodiment 12, wherein the elongate shaft of the insertion device is collapsible such that the outer diameter of at least a portion of the elongate shaft can be reduced by advancing the device into the opening. (Embodiment 14) 12. The system of embodiment 11, wherein the insertion device includes an internal open channel for receiving the expansion instrument. (Embodiment 15) The system of embodiment 12, wherein the removal element has a body including a central portion and first and second gripping arms pivotally connected to the central portion, and the elongated shaft of the insertion device is expandable by advancement of the expansion instrument into an internal open channel for receiving the expansion instrument. (Embodiment 16) 13. The system of embodiment 12, wherein the insertion device includes a slit along the elongate shaft that allows expansion of the shaft. (Embodiment 17) 16. The system of embodiment 15, wherein the first and second gripping arms include ridges on their inner surfaces. (Embodiment 18) 16. The system of embodiment 15, wherein the first and second gripping arms include finger gripping elements on their outer surfaces. (Embodiment 19) 12. The system of embodiment 11, wherein the insertion device comprises a ridge on the protruding portion. (Embodiment 20) The system of embodiment 12, wherein the expansion instrument includes an elongated shaft having an enlarged distal head, the elongated shaft of the expansion instrument terminating in a tapered tip. [Explanation of symbols]

[0036] 20 Removal element 22 Long and slender body 24 Center part 26a, 26b Grasping arms 28 Notched Area 34 Exterior 38 Finger gripping element 40 Insertion Device 44 Slit 60 Extension Device 66 Tip 100 systems

Claims

1. A kit comprising: an accessory device configured to removably couple to the endoscopic device; a detachment device including a detachment element having a body including a central portion and first and second gripping arms movably coupled to the central portion for gripping the attachment device; and an insertion device coupled to the detachment element and having a protruding portion configured to advance into an opening in the lumen of the attachment device; A kit comprising:

2. 10. The kit of claim 1, wherein the accessory device is selected from the group consisting of an endoscope cap, an endoscope shield, a sheath, an optical coupler, a conductive optical element, a lens, a varicose vein banding device, and an endoscopic submucosal resection device.

3. The kit of claim 1 , wherein the protruding portion is an elongate shaft configured to advance through an internal channel of the device.

4. The kit of claim 3 , wherein the elongate shaft is collapsible such that an outer diameter of at least a portion of the elongate shaft decreases upon advancement of the device into the interior channel.

5. The kit described in claim 4, further comprising an expansion instrument configured to be inserted into the insertion device, the insertion device including an internal opening channel for receiving the expansion instrument.

6. The kit of claim 5 , wherein the insertion device is expandable by advancement of the expansion instrument into the interior open channel.

7. The kit of claim 6 , wherein the insertion device includes a slit along the elongate shaft that allows expansion of the elongate shaft.

8. A kit comprising: an endoscope having a distal end; an accessory device configured to removably couple to the distal end of the endoscope; a detachment element for grasping the attachment device; Equipped with the detachment element includes an insertion device coupled to the detachment element and having a protruding portion configured to advance into an opening in the device, and an expansion instrument configured to be inserted into the protruding portion such that the protruding portion expands within the attachment device.

9. 9. The kit of claim 8, wherein the accessory device is selected from the group consisting of an endoscope cap, an endoscope shield, a sheath, an optical coupler, a conductive optical element, a lens, a varicose vein banding device, and an endoscopic submucosal resection device.

10. The kit of claim 9 , wherein the protruding portion is an elongate shaft configured to be advanced through an internal channel of the accessory device.

11. 11. The kit of claim 10, wherein the elongate shaft is collapsible such that an outer diameter of at least a portion of the elongate shaft decreases upon advancement of the accessory device into the interior channel.

12. The kit of claim 11, further comprising an expansion tool configured to be inserted into the insertion device, the insertion device including an internal open channel for receiving the expansion tool.

13. The kit of claim 12 , wherein the insertion device is expandable by advancement of the expansion instrument into the interior open channel.

14. The kit of claim 13 , wherein the insertion device includes a slit along the elongate shaft that allows expansion of the elongate shaft.

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