Device for maintaining colonic air distension

Abstract

A device for maintaining colonic air distension is disclosed. The device includes a body having opposing first and second edge structures. The first and second edge structures are selectively engageable with one another to circumferentially surround a portion of a colonoscope and position the body in a use configuration. From the use configuration, the first and second edge structures are selectively disengageable from one another to position the body in an open position and permit removal from the colonoscope. A proximal end portion of the body includes a diaphragm that extends radially outwardly from a longitudinal axis of the body and is shaped to conform to at least one of an anus or a stoma of a subject.

Description

DEVICE FOR MAINTAINING COLONIC AIR DISTENSIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of the filing date of U.S. Provisional Patent Application No. 63 / 649,091, filed May 17. 2024, the entirety of which is hereby incorporated by reference herein.FIELD

[0002] This disclosure relates generally to devices for use in a colonoscopy.BACKGROUND

[0003] Achieving adequate air distention of the colon during colonoscopy has been described in the literature as one of the core measures that lead to effective adenoma detection, leading to an overall decrease in colorectal cancer. Gas escape is particularly problematic in a patient who is sedated with propofol, or for those with an incompetence sphincter muscle, and in those procedures performed through an ostomy. As of now, manual pressure performed by technicians and nursing staff on the patient’s buttocks is one maneuver that is used to prevent gas escape, although this is usually a futile measure in maintaining colonic distention, and most often leads to staff fatigue. The patient can also be rotated off of the left side in order to allow for more adequate distention in order to improve adenoma detection, although this may lead to injury to the endoscopy workers, as the patients are too sedated to assist. Additionally, there is a risk of aspiration when patients are rotated to the supine position do to a relatively unprotected airway.

[0004] Air distention of the colon is also important when performing diagnostic and therapeutic colonoscopies in patients with lower bleeding or where lesions need to be removed when there is colonic narrowing due to spasm.

[0005] Applicant’s previously issued patent, U.S. Patent No. 11,690,508, which is hereby incorporated herein by reference in its entirety', describes a device that maintains colonic distention. However, the disclosed device must have the colonoscope received therethrough before insertion into an anal sphincter or stoma. If the device is needed after the colonoscope is already inserted, the colonoscope must be fully removed and re-inserted. Similarly, toremove the device that maintains colonic distention, the colonoscope must be removed from the anal sphincter or stoma.

[0006] As further described herein, the disclosed devices are configured to be selectively attachable to and detachable from a colonoscope to allow clinicians to selectively provide air distension without the need for removal of the colonoscope from an anus or stoma.SUMMARY

[0007] Disclosed herein, in one aspect, is a device for maintaining colonic air distension. The device includes a body having a longitudinal axis, opposing proximal and distal ends spaced apart along the longitudinal axis, and opposing first and second edge structures positioned between the proximal and distal ends. The first and second edge structures are selectively engageable with one another to circumferentially surround a portion of a colonoscope and position the body of the device in a use configuration. From the use configuration, the first and second edge structures are selectively disengageable from one another to position the body in an open position and disengage or permit removal from the colonoscope. In the use configuration, the body defines an inner surface, an outer surface, a proximal end portion comprising the proximal end, and an opposed distal end portion comprising the distal end, the distal end portion being spaced from the proximal end portion relative to the longitudinal axis. In the use configuration, the inner surface of the body defines a central bore surrounding the longitudinal axis and extending through and between the proximal end portion and the distal end portion of the body, wherein the central bore is configured to receive a portion of a length of the colonoscope; and the proximal end portion of the body forms or comprises a diaphragm that extends radially outwardly from the longitudinal axis of the body, wherein the diaphragm is shaped to conform to at least one of an anus or a stoma of a subject.

[0008] Also disclosed herein are systems and methods of using the device.

[0009] Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. 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 invention, as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] These and other features of the preferred embodiments of the invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:

[0011] FIG. 1 A is a partial sagittal sectional view of a device for maintaining colonic air distension as disclosed herein; FIG. IB is a partial perspective view of the device of FIG. 1A; FIG. 1C is a partial side view' of a projection of an edge structure of a body of the device of FIG. 1 A; FIG. ID is an underside view of the projection of FIG. 1C.

[0012] FIG. 2A is a perspective view of an exemplary device in an open position. FIG. 2B is a perspective view of the device of FIG. 2A in a closed position. FIG. 2C is a perspective view of a system having a device as disclosed herein with a segment of a scope extending therethrough.

[0013] FIG. 3 is a cross-sectional view' of an exemplary' projection and corresponding groove profile.

[0014] FIG. 4 is a cross-sectional view of an exemplary' projection and corresponding groove profile.

[0015] FIG. 5 is a cross-sectional view of an exemplary projection and corresponding groove profile.

[0016] FIG. 6 is a top view of an exemplary device as disclosed herein.

[0017] FIG. 7A is an end view' of an exemplary device as disclosed herein in an open position, showing engagement features projecting from an edge structure of the device. FIG. 7B is an end view of the device of FIG. 7A in a closed position.

[0018] FIG. 8A is a perspective view of an exemplary device having axially extending engagement features in an open position. FIG. 8B is a sectional perspective view' of the device of FIG. 8A in a closed position.

[0019] FIG. 9A is a perspective view of an exemplary device having axially extending engagement features in an open position. FIG. 9B is a sectional perspective view' of the device of FIG. 9A in a closed position.

[0020] FIG. 10A is a perspective view of an exemplary device as disclosed herein, the device having radially extending engagement features. FIG. 1 OB is a perspective view of the device of FIG. 10A in a closed position.

[0021] FIG. 11 is a cross-section of a portion of a body of an exemplary device, showing a diaphragm with a rounded outer profile.

[0022] FIG. 12A is a perspective view of an exemplary device as disclosed herein in an open position, with a detail view of a portion of the engagement features of the exemplary device. FIG. 12B is a perspective view of the device of FIG. 12A in a closed position.

[0023] FIG. 13A is a perspective view of an exemplary device as disclosed herein in an open position, with a detail view of a portion of the engagement features of the exemplary device. FIG. 13B is a perspective view of the device of FIG. 13 A in an open position. FIG. 13C is an end view of the exemplary device of FIG. 13 A in the open position. FIG. 13D is an end view of the exemplar^' device of FIG. 13 A in the closed position.

[0024] FIG. 14A is a perspective view of an exemplary device as disclosed herein in an open position, with a detail view of a portion of the engagement features of the exemplary device. FIG. 14B is a perspective view of the device of FIG. 14A in a closed position. FIG. 14C is another perspective view of the device of FIG. 14A in the open position.

[0025] FIG. 15A is a perspective view of an exemplary device as disclosed herein in a closed position. FIG. 15B is a cross-sectional view of the device of FIG. 15 A taken in a plane including the longitudinal axis.

[0026] FIG. 16A is a perspective view of an exemplary device as disclosed herein in a closed position, with a detail view of a portion of the engagement features of the exemplary device including an adhesive. FIG. 16B is a cross-sectional view of the device of FIG. 16A taken in a plane through the liner, with the device shown partially transparent to illustrate both outer and inner features.

[0027] FIG. 17A is a perspective view' of an exemplary device as disclosed herein in an open position. FIG. 17B is another perspective view of the device of FIG. 17A in the open position.

[0028] FIG. 18A is a perspective view of an exemplary device as disclosed herein in a closed position. FIG. 18B is a side view of the device of FIG. 18A.

[0029] FIG. 19A is a perspective view of an exemplary device as disclosed herein in an open position, with a detail view of a portion of the engagement features of the exemplary device. FIG. 19B is another perspective view of the device of FIG. 19A in the open position, with a detail view of a portion of the engagement features of the exemplary device. FIG. 19C is a cross-sectional of the device of FIG. 19A taken in a plane perpendicular to the longitudinal axis of the device.

[0030] FIG. 20 is a schematic diagram of a device as disclosed herein having an inflatable portion formed by a diaphragm.

[0031] FIG. 21 is a schematic diagram of a device as disclosed herein having an inflatable portion on a patient-facing side of a diaphragm.DETAILED DESCRIPTION

[0032] The disclosed system and method may be understood more readily by reference to the following detailed description of particular embodiments and the examples included therein and to the Figures and their previous and following description.

[0033] It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention which will be limited only by the appended claims.

[0034] It must be noted that as used herein and in the appended claims, the singular forms “a,” "an." and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, unless context clearly dictates otherwise, reference to “an engagement feature” constitutes disclosure of a single engagement feature as well as disclosure of two or more such engagement features, and so forth.

[0035] “Optional” or “optionally” means that the subsequently described event, circumstance, or material may or may not occur or be present, and that the description includes instances where the event, circumstance, or material occurs or is present and instances where it does not occur or is not present.

[0036] Ranges may be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, also specifically contemplated and considered disclosed is the range from the one particular value and / or to the other particular value unless the context specifically indicates otherwise. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another, specifically contemplated embodiment that should be considered disclosed unless the context specifically indicates otherwise. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint unless the context specifically indicates otherwise. Finally, it should be understood that all of the individual values and subranges of values contained within an explicitly disclosed range are also specifically contemplated and should be considered disclosed unless the context specifically indicates otherwise. The foregoing applies regardless of whether in particular cases some or all of these embodiments are explicitly disclosed.

[0037] Optionally, in some aspects, when values are approximated by use of the antecedents “about,” “substantially,” or “generally,” it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of the particularly stated value or characteristic can be included within the scope of those aspects.

[0038] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed apparatus, system, and method belong. Although any apparatus, systems, and methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present apparatus, system, and method, the particularly useful methods, devices, systems, and materials are as described.

[0039] Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps. In particular, in methods stated as comprising one or more steps or operations it is specifically contemplated that each step comprises what is listed (unless that step includes a limiting term such as “consisting of”), meaning that each step is not intended to exclude, for example, other additives, components, integers or steps that are not listed in the step.

[0040] As used herein, “proximal'’ refers to a patient-facing portion, surface, side, or end of the device, and “distal” refers to a portion, surface, side, or end of the device configured to face away from the patient (e.g., facing the clinician).

[0041] Disclosed herein is an attachable / detachable device for maintaining colonic air distension. One advantage of having an attachable / detachable device that achieves this goal of maintaining air distention is that the colonoscope does not have to be removed from the patient in order to attach the device, therefore decreasing the possibility’ of potentially not reidentifying a lesion or a bleeding site. This ability’ to attach the device on demand allows one to maintain position within the colon. This can also decrease procedure time in the time the patient is under anesthesia.

[0042] Referring to FIGS. 1A-2C, an exemplar}' a device 10 for maintaining colonic air distension is shown. The device 10 can comprise a body 12 having a longitudinal axis 14, opposing proximal and distal ends 16. 18 spaced apart along the longitudinal axis 14. The body 12 can have opposing first and second edge structures 20, 22 positioned between the proximal and distal ends 16, 18. The first and second edge structures 20, 22 can be selectively engageable with one another to circumferentially surround (and optionally engage) a colonoscope 100 and position the body 12 in a use configuration (FIG. 2B). From the use configuration, the first and second edge structures 20, 22 can be selectively disengageable from one another to position the body 12 in an open position (see FIG. 2 A) and disengage or otherwise permit removal from the colonoscope 100. In the use configuration, the body 12 can define an inner surface 30. an outer surface 32, a proximal end portion 36 comprising the proximal end 16, and an opposed distal end portion 38 comprising the distal end 18, the distal end portion being spaced from the proximal end portion relative to the longitudinal axis. In the use configuration, the inner surface 30 of the body 12 can define a central bore 40 surrounding the longitudinal axis 14 and extending through and between the proximal end portion 36 and the distal end portion 38 of the body 12. The central bore 40 can be configured to receive a portion of a length of the colonoscope. The proximal end portion 36 of the body 12 can form a diaphragm 42 that extends radially outwardly from the longitudinal axis of the body. The diaphragm 42 can be shaped to conform to at least one of an anus or a stoma of a subject. In some aspects, the first and second edge structures 20. 22 can extend continuously between the proximal and distal ends 16, 18. In other aspects, the first and second edge structures 20, 22 can extend only a portionof the length of the device between the proximal and distal ends 16, 18. That is, the first and second edge structures 20, 22 need not contact each other along an entire length of the device, although they may. Optionally, when the first and second edge structures 20, 22 do not contact each other along the entire length of the device, it is contemplated that the remaining portions of the device (along which first and second edge structures are not provided) can form a sleeve for receiving a portion of the colonoscope or, alternatively, can define respective edges that do not engage with each other (and remain spaced from each other during use).

[0043] Referring to FIGS. 1-18B, the first and second edge structures 20, 22 of the body 12 can comprise respective engagement features 50. The engagement features 50 of the first edge structure 20 can be complementary to (e.g., matching) the engagement features 50 of the second edge structure 22. Referring to FIGS. 1 A-5, the engagement features 50 of the first and second edge structures 20, 22 can comprise alternating grooves 52 and projections 54. The grooves 52 of the first edge structure 20 can be configured to receive corresponding projections 54 of the second edge structure 22, and the grooves 52 of the second edge structure 22 can be configured to receive corresponding projections 54 of the first edge structure 20. In some aspects, and as illustrated in FIGS. 1A-4, the grooves and projections 52, 54 can have a rounded or substantially rounded profile. Optionally, referring to FIGS.I A- ID. at least one groove 52 of the first edge structure 20 can comprise a recessed ledge 56 and a bottom portion 58 that is at least partially surrounded by the recessed ledge. At least one projection 54 of the second edge structure 22 can comprise an outer portion 62 having a first thickness that is configured to rest on the recessed ledge 56 when the body 12 is in the use configuration and a center portion 64 surrounded by the outer portion and having a second thickness that is greater than the first thickness, wherein the center portion is configured to be received in the bottom portion of the at least one groove. Referring to FIGS. 3 and 4, the grooves and projections 52, 54 can have an end portion that has a profile corresponding or substantially corresponding to a curvilinear triangle. In other aspects, the grooves and projections 52, 54 can have complementary polygonal profiles. For example, the grooves and projections 52, 54 can have pentagonal or substantially pentagonal profiles. Referring to FIG. 5, in other aspects, the grooves and projections 52, 54 can have non- complementary profiles. For example, the grooves and projections 52, 54 can have mismatched shapes so that the projections 54 do not have the same shape as the corresponding grooves 52. In this way, the projections 54 can apply non-uniform radialforces to the grooves. For example, the grooves 52 can be circular, whereas projections 54 can be non-circular (e.g., triangular with rounded edges). Accordingly, the body 12 at the projections 54 and / or groove 52 has to resiliently deform to permit engagement therebetween.

[0044] In some aspects, and with reference to FIGS. 8A-9B the engagement feature 50 of the first edge structure 20 can comprises an axial projection 70 (e.g., a projection extending longitudinally along the device), and the engagement feature 50 of the second edge structure 22 can comprise an axial slot 72 (e.g., a slot extending longitudinally along the device) that is configured to complementarily receive the axial projection. For example, the axial projection 70 and axial slot 72 can each have a profile that is generally consistent along the longitudinal axis 14 in planes perpendicular thereto. In some aspects, the axial projection can comprise a head and a neck that is narrow than the head (e g. having a mushroom shape in cross-section). The axial slot can be deformable to receive the head therein. As shown in cross section in FIGS. 8A-9B, the engagement feature 50 of the second edge structure 22 can be moved radially relative to the engagement feature 50 of the first edge structure 20 to that one hooks over the top of the other.

[0045] As shown in FIG. 10A and 10B, in some aspects, the engagement features 50 of the first structure 20 can comprise radial projections 80, and the engagement features 50 of the second edge structure 22 can comprise openings 82 to receive the radial projections. Optionally, the radial projections 80 can each have a head and a neck that is narrower than the head so that the heads retains the respective projection within the opening. In exemplary- aspects, the openings 82 can each be provided in respective flaps so that each flap can be independently decoupled from the corresponding projection 80. In other aspects, the openings 82 can be provided in a single flap.

[0046] The device 10 can comprise at least one latch that is configured to secure the first and second edge structures together in the use position. As shown in FIG. 1A, the diaphragm 42 can comprise one or more engagement features 60 (e.g., mating male and female structures) so that opposite sides of the diaphragm 42 can be coupled to each other. For example, in some aspects, and with reference to FIGS. 7A and 7B, the engagement features 60 can comprise one or a plurality of projections 66 that extend from a first side of the body 12 and are each receivable into a respective socket 68. In some aspects, the projection(s) 66 can be receivable into the socket(s) 68 so that the projections are not visible when the device is in the closed position. For example, the socket(s) 68 can be embedded in the diaphragm 42. Insome aspects, the projection(s) 66 and / or the socket(s) 68 can be configured to resiliency deform to permit coupling and decoupling. For example, the projection(s) 66 can have a head and a nanowed neck. The head can be larger than an opening of the socket to retain the head within the socket.

[0047] Referring to FIGS 12A and 12B. in some optional aspects, the first and second edge structures 20, 22 can comprise complementary structures that engage without inhibiting separation from each other. For example, the first and second edge structures 20, 22 can comprise wavy or undulating surfaces. In this way, the first and second edge structures 20, 22 can interlock to inhibit relative movement therebetween while permitting separation when desired. The first and second edge structures 20, 22 can further comprise surfaces that interlock radially to inhibit movement of one edge structure radially relative to the other. Optionally, in these aspects, the first edge structure can comprise a protrusion 74 (e.g., a longitudinally extending protrusion) that is receivable into a groove 76, the groove inset relative to surfaces radially inwardly and outwardly (above and below, in the figures) said groove.

[0048] Referring to FIGS. 14A and 14B, in some aspects, the mating edge structures 20, 22 can comprise a slot 84 that extends along the edge structures and a projection 86 that is receivable within the slot. For example, the slot 84 can be defined by a recess that is inset from a perimeter of the mating edge structure 22. The projection 86 can be complementary to the slot 84. In some aspects, the projection 86 can have a consistent radial dimension along the longitudinal axis 14.

[0049] In further aspects, and with reference to FIGS. 15A and 15B, an adhesive can secure the first and second edge structures 20, 22 together. For example, in some aspects, the adhesive 88 can be positioned on an interior of the slot 84 or an exterior of the projection 86. In further aspects, a liner 90 can be disposed over the adhesive 88. In this way, the liner 90 can inhibit adhesion between the first and second edge structures 20, 22 until adhesion is desirable. The adhesive can be medical grade with high instant tack properties. Exemplary adhesives include acrylic, silicone, hydrocolloid, rubber or a combination thereof.

[0050] In further aspects, and with reference to FIGS. 16, the adhesive 88 can be sufficient that the first and second edge structures 20, 22 need not have interlocking features. For example, the first and second edge structures 20, 22 can comprise planar surfaces (optionally,planar surfaces that are parallel to or coplanar with a plane containing the longitudinal axis 14 and a radial axis that extends outwardly from the longitudinal axis). The liner 90 in FIG. 16 projects radially outwardly of the outer surface of the body 12 to provide a gripping portion for removal from the adhesive 88.

[0051] Referring to FIGS. 18A-18B, in some aspects, the device can further comprise adhesive 92 on a patient-facing side end of the device. For example, the adhesive 92 can be provided on the diaphragm 42. In this way, the adhesive 92 can enhance sealing against the anatomy of the patient. A release liner 93 can be provided over the adhesive 92.

[0052] As further illustrated in FIGS. 18A-18B. the device 10 can have a length suitable for the desired purpose. For example, the device 10 can have a relatively shorter length to improve flexibility of the scope positioned within the device 10. In various aspects, the device 10 can have a length from about 1 inch to about 6 inches, or from about 1.5 inches to about 5 inches, or from about 2 inches to about 4 inches, or from about 3 inches to about 5 inches. In use, it is contemplated that the device 10 can be compatible with a variety of colonoscope sizes, including, for example and without limitation, colonoscopies having outer diameters ranging from 9.5 mm to 12.9 mm.

[0053] Referring to FIGS. 19A-C, in some aspects, the first and second edge structures can comprise reverse drafts 110 that are configured to engage each other. For example, the body 12 can be compressed to deflect a lip 112 of the first edge structure 20 over a ridge 114 of the second edge structure 22 to thereby provide disengagement between the first and second edge structures and move the device to the open position. The body 12 can resiliently return to its undeflected form to provide engagement between the first and second edge structures 20, 22 (in the closed, use position).

[0054] As shown herein, in some aspects, the body 12 can be unitary. For example, the body 12 can be formed as a monolithic structure. In other aspects, and with reference to FIGS.13A -13D, the body 12 can comprise two or more portions that are configured to couple together. For example, the body 12 can comprise a first portion 12a that is separable from a second portion 12b. Optionally, in these aspects, the body 12 can comprise two pairs of mating edge structures 20, 22. In some aspects, the pairs of mating edge structures 20, 22 can be on opposite sides of the body 12 about the circumference of the body. Optionally, one or both of the pairs of mating structures can include an adhesive 88 (FIG. 16A).

[0055] Referring also to FIGS. 17A and 17B, the body can comprise first and second portions 12a, 12b. wherein one or both of the first and second portions can be flexible to receive the other portion. Optionally, in these aspects, the first portion can define more than half of a cylinder and the second portion can also define more than half of a cylinder, wherein the first portion receives the second portion therein. Accordingly, the first portion or the second portion can resiliently deform to receive the other. For example, the first portion (e.g., the outer / female portion) can comprise a rigid material (e.g., optionally, polycarbonate), and the second portion (e.g., the inner / male portion) can comprise a flexible material (e.g., silicone or nitrile butadiene rubber (NBR)). In some aspects, the first and second portions 12a, 12b can have complementary outer surfaces so that the first and second portions cooperate to form a continuous outer surface (e.g., cylindrical surface) when joined together. For example, the sections of the second portion 12b that are not covered by the first portion 12a can extend radially outwardly by a distance equal to (or substantially equal to) a thickness of the first portion 12a covering the second portion 12b.

[0056] Optionally, the first and second edge structures 20, 22 can extend axially parallel to the longitudinal axis. In other aspects, and with reference to FIG. 6, the first and second edge structures can extend helically around the body. In this way, the body can be deformed to bend around the colonoscope, and the edge structures can then come together with the colonoscope received therein. In further aspects, the first and second edge structures 20. 22 can extend in a wavy, zig-zag, switchback, or along any other non-axial profile.

[0057] In some aspects, the body can have a longitudinal length that is less than 15 cm. For example, the body can have a longitudinal length ranging from about 4 cm to about 15 cm.

[0058] In some aspects, the body 12 can comprise a pliable material (e.g., silicone, rubber, neoprene, nitrile, an elastomer, or other pliable polymer material). More generally, the device 10 can comprise any suitable material. For example, in some aspects, the device 10 can comprise at least one thermoplastic. The thermoplastic can be, for example, polyethylene, polypropylene, polystyrene. PVC, nylon, PET, or combinations thereof. Such materials can have a low melting point and can, therefore, be easily molded into a desirable shape. In additional or alternative aspects, the device 10 can comprise a thermoset. Thermosets can have high strength and resilience to heat and chemicals. The thermoset can include, for example, epoxy, phenolic, melamine resin, or combinations thereof. In additional or alternative aspects, the device 10 can comprise an elastomer. Elastomers canhave a high elasticity and can be stretched and bent without breaking. The elastomer can be. for example and without limitation, silicone rubber, neoprene, polyurethane, or combinations thereof. In additional or alternative aspects, the device 10 can comprise a composite material. For example, the device (e.g., the body 12) can comprise fiber-reinforced polymer and / or a metal matrix composite. Optionally, the body 12 can comprise foam. Optionally, the body 12 can have a Shore-A durometer from about 35 to about 65, or from about 50 to about 65, or from about 58-62, or about 60. In additional aspects, the device 10 can comprise a plurality of materials. For example, the plurality of materials can be separate materials that are coupled together or overmolded materials.

[0059] In some aspects, the diaphragm 42 can have an outer diameter that decreases moving in a proximal direction (towards the patient). For example, the diaphragm 42 can have an outer surface with a convex curvature. Optionally, in these aspects, and with reference to FIG. 11, the diaphragm 42 can have a rounded profile. For example, in cross sectional planes parallel to the longitudinal axis 14, the portions of the outer surface of the diaphragm can be arcuate (optionally, having consistent radii therealong). In additional aspects, the diaphragm 42 can be inwardly tapered in a proximal direction. More generally, the diaphragm 42 can have any suitable geometry' for forming a seal against the anatomy (e.g., anus) of the patient. In exemplary aspects, the diaphragm can have a longitudinal length ranging from about 5 mm to about 30 mm. The diaphragm can have a maximum outer diameter ranging from about 2 cm to about 6 cm. Optionally, the central bore of the body has a diameter ranging from about 9 mm to about 40 mm, or from about 12 mm to about 18 mm. In some aspects, the diaphragm 42 can comprise a pliable material (e.g., silicone, rubber, neoprene, nitrile, an elastomer, or other pliable polymer material).

[0060] Further, referring to FIGS. 20 and 21, in some aspects, the device 10 can comprise an inflatable portion 44 on the proximal (patient-facing) end 16 of the device. The inflatable portion 44 can conform to the anatomy of the patient to thereby provide a seal. For example, in some aspects, and as shown in FIG. 20, the diaphragm 42 can be inflatable so that the diaphragm 42 forms or comprises the inflatable portion 44. In other aspects, and with reference to FIG. 21, the device can comprise an inflatable end portion 44 on a patient-facing side of the diaphragm 42. Accordingly, in this example configuration, the inflatable end portion 44 can conform to the anatomy of the patient, and the diaphragm 42 can provide a structure to push against the inflatable end portion 44 and / or to contact the anatomy of thepatient to achieve an effective seal. The device 10 can further comprise a conduit 46. The device 10 can have an inlet 48 for providing fluid (e.g., air or gas). The inlet 48 can comprise a hose fitting, an opening, or any suitable connecting structure for engaging a fluid source. The fluid source can be, for example, medical gas provided within a medical facility or a compressed gas tank.

[0061] In some aspects, a coating can be provided on the inner surface 30 of the body 12. The coating can be configured to facilitate movement between the body 12 and the colonoscope.

[0062] In some aspects, the device 10 can comprise one or more internal sealing surfaces 94 (e g., gaskets). In exemplary aspects, the one or more internal sealing surfaces 94 can have a width along the longitudinal axis 14 from 1 mm to 20 mm. Further, the one or more internal sealing surfaces 94 can have an inner diameter ranging from about 1 mm to about 20 mm. In some aspects, the sealing surfaces can be configured to engage, and, optionally, seal against, the colonoscope. For example, the device can comprise a first sealing surface 94a on a patient-facing side of the device (e.g., within the diaphragm 42). In further aspects, the device 10 can comprise a second sealing surface on an outer end of the device, opposite the patient-facing side. In further aspects, the device 10 can comprise one or more sealing surfaces 94c between the patient-facing side and outer end. The sealing surface(s) 94c (gaskets) can each be defined by a respective internally projecting rib. In alternative aspects, the device can contact the colonoscope along an entire length of the device, or substantially an entire length of the device (e.g., at least 90%), or a majority of the length of the device.

[0063] In some aspects, the body 12 can be resiliently biased toward the open position. For example, the body 12 can, in a relaxed state, be in the open position. In this way, decoupling of the engagement structures 50 can permit the body to resiliently move to the open position. In other aspects, the body 12 can be resiliently biased toward the closed position.

[0064] Referring to FIG. 13B, in some aspects, the device 10 can comprise one or more gripping features. For example, the device can comprise one or more circumferential outer ribs 96. In additional aspects, the device can comprise one or more longitudinally extending ribs. In additional aspects, the device can comprise a textured outer surface.

[0065] A colonoscopy system can comprise the device 10 and a colonoscope. The first and second edge structures 20, 22 of the body 12 of the device 10 can be selectively engageablewith one another to circumferentially surround (and optionally, engage) a portion of the colonoscope and position the body in the use configuration. Optionally, it is contemplated that the device 10 and the colonoscope can be provided together as a kit, which can optionally include packaging and instructions for use.

[0066] A method of using the device 10 can include positioning a colonoscope within an anus or a stoma of a subject. With the device 10 in the open position, the device can circumferentially surround a portion of the colonoscope. The first and second edge structures 20, 22 of the body 12 of the device 10 can be selectively engaged with one another to circumferentially surround (and optionally, engage) a portion of the colonoscope and position the body in the use configuration. The diaphragm 42 of the body 12 of the device 10 can be positioned against the anus or stoma and avoid entry into the body of the patient. Optionally, before positioning the device against the anus or stoma, the device can be moved distally toward the controller associated with the colonoscope. Then, during colon collapse, the device can be selectively closed and opened and moved back and forth in and out of contact with the anus or stoma to make and break a seal against the anus or stoma as needed to reduce air escape and / or reverse colonic distention, thereby providing improved visibility during performance of the colonoscopy.

[0067] More particularly, in exemplary aspects, the first and second edge structures 20, 22 of the body 12 of the device 10 can be disengaged from one another to position the body of the device in an open position without removing the colonoscope from the anus or stoma, thereby allowing a clinician to quickly and reversibly break the seal between the device and the patient. Optionally, the first and second edge structures can again be re-engaged with one another to surround the colonoscope and permit reestablishment of a seal against the anus or stoma.

[0068] Optionally, prior to use of the device, the interior surfaces of the device can be lubricated to promote movement of the device relative to the colonoscope.

[0069] Optionally, the device can be a single-use device that is discarded after use. Alternatively, it is contemplated that the device can be configured for sterilization following use.EXEMPLARY ASPECTS

[0070] In view of the described products, systems, and methods and variations thereof, herein below are described certain more particularly described aspects of the invention. These particularly recited aspects should not however be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language literally used therein.

[0071] Aspect 1. A device for maintaining colonic air distension, comprising: a body having a longitudinal axis, opposing proximal and distal ends spaced apart along the longitudinal axis, and opposing first and second edge structures positioned between the proximal and distal ends, wherein the first and second edge structures are selectively engageable with one another to surround and engage a colonoscope and position the body in a use configuration, and wherein from the use configuration, the first and second edge structures are selectively disengageable from one another to position the body in an open position and disengage the colonoscope, wherein in the use configuration: the body defines an inner surface, an outer surface, a proximal end portion comprising the proximal end, and an opposed distal end portion comprising the distal end, the distal end portion being longitudinally spaced from the proximal end portion along the longitudinal axis, wherein the inner surface of the body defines a central bore surrounding the longitudinal axis and extending through and between the proximal end portion and the distal end portion of the body, wherein the central bore is configured to receive a portion of a length of the colonoscope; and the proximal end portion of the body comprises a diaphragm that extends radially outwardly from the longitudinal axis of the body, wherein the diaphragm is shaped to conform to at least one of an anus or a stoma of a subject.

[0072] Aspect 2. The device of aspect 1, wherein the first and second edge structures of the body each comprise at least one respective engagement feature, and wherein the at least one engagement feature of the first edge structure is complementary to the at least one engagement feature of the second edge structure.

[0073] Aspect 3. The device of aspect 2, wherein the at least one engagement feature of the first and second edge structures comprises alternating grooves and projections, wherein the grooves of the first edge structure are configured to receive corresponding projections of the second edge structure, and wherein the grooves of the second edge structure are configured to receive corresponding projections of the first edge structure.

[0074] Aspect 4. The device of aspect 3, wherein the grooves and projections have a rounded or substantially rounded profile.

[0075] Aspect 5. The device of aspect 4, wherein at least one groove of the first edge structure comprises a recessed ledge and a bottom portion that is at least partially surrounded by the recessed ledge, and wherein at least one projection of the second edge structure comprises: an outer portion having a first thickness that is configured to rest on the recessed ledge when the body is in the use configuration; and a center portion surrounded by the outer portion and having a second thickness that is greater than the first thickness, wherein the center portion is configured to be received in the bottom portion of the at least one groove.

[0076] Aspect 6. The device of aspect 3, wherein the grooves and projections have an end portion that has a profile corresponding or substantially corresponding to a curvilinear triangle.

[0077] Aspect 7. The device of aspect 3, wherein the grooves and projections have complementary polygonal profiles.

[0078] Aspect 8. The device of aspect 7, wherein the grooves and projections have pentagonal or substantially pentagonal profiles.

[0079] Aspect 9. The device of any one of aspects 2-8, wherein the at least one engagement feature of the first edge structure comprises a longitudinally extending projection, and wherein the at least one engagement feature of the second edge structure comprises a longitudinally extending slot that is configured to complementarily receive the axial projection.

[0080] Aspect 10. The device of any one of aspects 2-9. further comprising at least one latch that is configured to secure the first and second edge structures together in the use position.

[0081] Aspect 11. The device of any one of the preceding aspects, wherein the body has a longitudinal length that is less than 15 cm.

[0082] Aspect 12. The device of any one of the preceding aspects, wherein the body has a longitudinal length ranging from about 4 cm to about 15 cm.

[0083] Aspect 13. The device of any one of the preceding aspects, wherein the diaphragm has an outer diameter that decreases moving in a proximal direction.

[0084] Aspect 14. The device of aspect 13, wherein the diaphragm has an outer surface with a convex curvature.

[0085] Aspect 15. The device of aspect 13, wherein the diaphragm is inwardly tapered in a proximal direction.

[0086] Aspect 16. The device of aspect 13, wherein the diaphragm has a longitudinal length ranging from about 5 mm to about 30 mm.

[0087] Aspect 17. The device of aspect 13, wherein the diaphragm has a maximum outer diameter ranging from about 2 cm to about 6 cm.

[0088] Aspect 18. The device of any one of the preceding aspects, wherein the central bore of the body has a diameter ranging from about 12 mm to about 18 mm.

[0089] Aspect 19. The device of any one of the preceding aspects, wherein the diaphragm comprises a pliable material.

[0090] Aspect 20. The device of any one of the preceding aspects, further comprising at least one gasket positioned within the central bore of the body.

[0091] Aspect 21. The device of any one of the preceding aspects, wherein the body is sufficiently deformable to receive the colonoscope therein.

[0092] Aspect 22. The device of any one of the preceding aspects, wherein the body comprises two separable structures.

[0093] Aspect 23. The device of aspect 22, wherein the body further comprises opposing third and fourth edge structures positioned between the proximal and distal ends, wherein the third and fourth edge structures are selectively engageable with one another.

[0094] Aspect 24. The device of aspect 23, wherein the opposing first and second edge structures and the opposing third and fourth edge structures are on opposite sides of the body about a circumference of the body.

[0095] Aspect 25. The device of any one of the preceding aspects, further comprising a coating on the inner surface of the body.

[0096] Aspect 26. The device of any one of the preceding aspects, further comprising an adhesive on one or both of the first and second edge structures.

[0097] Aspect 27. The device of any one of the preceding aspects, further comprising an adhesive on a surface of the diaphragm configured to contact the patient.

[0098] Aspect 28. The device of any one of the preceding aspects, further comprising: an inflatable portion on the proximal end portion of the device; and a conduit extending from, and providing fluid communication between, the inflatable portion and the distal end of the device.

[0099] Aspect 29. The device of aspect 28, wherein the diaphragm comprises the inflatable portion.

[0100] Aspect 30. The device of any one of the preceding aspects, wherein the opposing first and second edge structures extend continuously from the proximal end to the distal end.

[0101] Aspect 31. The device of any one of aspects 1-29, wherein the opposing first and second edge structures extend only a partial length of the device from the proximal end to the distal end

[0102] Aspect 32. A colonoscopy system comprising: the device as recited in any one of the preceding aspects; and a colonoscope,wherein the first and second edge structures of the body of the device are selectively engageable with one another to circumferentially surround a portion of the colonoscope and position the body in the use configuration.

[0103] Aspect 33. A method comprising: positioning a colonoscope within an anus or a stoma of a subject; with the device as recited in any one of aspects 1-31 in the open position, selectively engaging the first and second edge structures of the body of the device with one another to circumferentially surround a portion of the colonoscope and position the body in the use configuration; and positioning the diaphragm of the body of the device against the anus or stoma.

[0104] Aspect 34. The method of aspect 33, further comprising disengaging the first and second edge structures of the body of the device from one another to position the body of the device in an open position without removing the colonoscope from the anus or stoma.

[0105] Aspect 35. The method of aspect 34, further comprising removing the device from the colonoscope without removing the colonoscope from the anus or stoma.

[0106] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, certain changes and modifications may be practiced within the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A device for maintaining colonic air distension, comprising: a body having a longitudinal axis, opposing proximal and distal ends spaced apart along the longitudinal axis, and opposing first and second edge structures positioned between the proximal and distal ends, wherein the first and second edge structures are selectively engageable with one another to surround and engage a colonoscope and position the body in a use configuration, and wherein from the use configuration, the first and second edge structures are selectively disengageable from one another to position the body in an open position and disengage the colonoscope. wherein in the use configuration: the body defines an inner surface, an outer surface, a proximal end portion comprising the proximal end, and an opposed distal end portion comprising the distal end, the distal end portion being longitudinally spaced from the proximal end portion along the longitudinal axis, wherein the inner surface of the body defines a central bore surrounding the longitudinal axis and extending through and between the proximal end portion and the distal end portion of the body, wherein the central bore is configured to receive a portion of a length of the colonoscope; and the proximal end portion of the body comprises a diaphragm that extends radially outwardly from the longitudinal axis of the body, wherein the diaphragm is shaped to conform to at least one of an anus or a stoma of a subject.

2. The device of claim 1, wherein the first and second edge structures of the body each comprise at least one respective engagement feature, and wherein the at least one engagement feature of the first edge structure is complementary to the at least one engagement feature of the second edge structure.

3. The device of claim 2, wherein the at least one engagement feature of the first and second edge structures comprises alternating grooves and projections, wherein the grooves of the first edge structure are configured to receive corresponding projections of the second edge structure, and wherein the grooves of the second edge structure are configured to receive corresponding projections of the first edge structure.

4. The device of claim 3, wherein the grooves and projections have a rounded or substantially rounded profile.

5. The device of claim 4, wherein at least one groove of the first edge structure comprises a recessed ledge and a bottom portion that is at least partially surrounded by the recessed ledge, and wherein at least one projection of the second edge structure comprises: an outer portion having a first thickness that is configured to rest on the recessed ledge when the body is in the use configuration; and a center portion surrounded by the outer portion and having a second thickness that is greater than the first thickness, wherein the center portion is configured to be received in the bottom portion of the at least one groove.

6. The device of claim 3, wherein the grooves and projections have an end portion that has a profile corresponding or substantially corresponding to a curvilinear triangle.

7. The device of claim 3, wherein the grooves and projections have complementary polygonal profiles.

8. The device of claim 7, wherein the grooves and projections have pentagonal or substantially pentagonal profiles.

9. The device of claim 2, wherein the at least one engagement feature of the first edge structure compnses a longitudinally extending projection, and wherein the at least one engagement feature of the second edge structure comprises a longitudinally extending slot that is configured to complementarily receive the axial projection.

10. The device of claim 2, further comprising at least one latch that is configured to secure the first and second edge structures together in the use position.

11. The device of claim 1, wherein the body has a longitudinal length that is less than 15 cm.

12. The device of claim 1, wherein the body has a longitudinal length ranging from about 4 cm to about 15 cm.

13. The device of claim 1, wherein the diaphragm has an outer diameter that decreases moving in a proximal direction.

14. The device of claim 13, wherein the diaphragm has an outer surface with a convex curvature.

15. The device of claim 13, wherein the diaphragm is inwardly tapered in a proximal direction.

16. The device of claim 13, wherein the diaphragm has a longitudinal length ranging from about 5 mm to about 30 mm.

17. The device of claim 13, wherein the diaphragm has a maximum outer diameter ranging from about 2 cm to about 6 cm.

18. The device of claim 1, wherein the central bore of the body has a diameter ranging from about 12 mm to about 18 mm.

19. The device of claim 1, wherein the diaphragm comprises a pliable material.

20. The device of claim 1, further comprising at least one gasket positioned within the central bore of the body.

21. The device of claim 1, wherein the body is sufficiently deformable to receive the colonoscope therein.

22. The device of claim 1, wherein the body comprises two separable structures.

23. The device of claim 22, wherein the body further comprises opposing third and fourth edge structures positioned between the proximal and distal ends, wherein the third and fourth edge structures are selectively engageable with one another.

24. The device of claim 23, wherein the opposing first and second edge structures and the opposing third and fourth edge structures are on opposite sides of the body about a circumference of the body.

25. The device of claim 1, further comprising a coating on the inner surface of the body.

26. The device of claim 1, further comprising an adhesive on one or both of the first and second edge structures.

27. The device of claim 1, further comprising an adhesive on a surface of the diaphragm configured to contact the patient.

28. The device of claim 1, further comprising: an inflatable portion on the proximal end portion of the device; and a conduit extending from, and providing fluid communication between, the inflatable portion and the distal end of the device.

29. The device of claim 28, wherein the diaphragm comprises the inflatable portion.

30. The device of claim 1, wherein the opposing first and second edge structures extend continuously from the proximal end to the distal end.

31. The device of claim 1 , wherein the opposing first and second edge structures extend only a partial length of the device from the proximal end to the distal end.

32. A colonoscopy system comprising: the device as recited in any one of the preceding claims; and a colonoscope, wherein the first and second edge structures of the body of the device are selectively engageable with one another to circumferentially surround a portion of the colonoscope and position the body in the use configuration.

33. A method comprising: positioning a colonoscope within an anus or a stoma of a subject; with the device as recited in any one of claims 1-31 in the open position, selectively engaging the first and second edge structures of the body of the device with one another to circumferentially surround a portion of the colonoscope and position the body in the use configuration; and positioning the diaphragm of the body of the device against the anus or stoma.

34. The method of claim 33, further comprising disengaging the first and second edge structures of the body of the device from one another to position the body of the device in an open position without removing the colonoscope from the anus or stoma.

35. The method of claim 34, further comprising removing the device from the colonoscope without removing the colonoscope from the anus or stoma.

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