Devices and systems for flexible elongate members insertable into a body

Abstract

Devices, systems, and methods for use with a medical endoscope, or devices, systems, and methods for use with an elongated shaft of a medical endoscope. The device may be or may include a cap for the elongated shaft. The cap may include a proximal end, a distal end, a lumen extending between the proximal and distal ends, and a protrusion located between the proximal and distal ends. The proximal end of the cap may be configured to engage with the elongated shaft. The distal end of the cap may define a first diameter. The protrusion may define a second diameter, the second diameter being smaller than the first diameter. The protrusion may be configured to engage tissue received within the lumen through the distal end.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 595,547, filed November 2, 2023, the entire disclosure of which is hereby incorporated herein by reference for all purposes. Technical Field

[0002] This disclosure generally relates to cap devices, systems, and methods, and more specifically to caps for connection with flexible, elongated members that can be inserted into the body. Background Technology

[0003] Various in vivo medical devices and systems have been developed for medical applications, such as transluminal procedures. Some of these devices and systems include guidewires, catheters, catheter systems, transluminal instruments, etc. These devices and systems are manufactured using any of a variety of different methods and can be used according to any of these methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a continued need for alternative medical devices and systems, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0004] This disclosure provides alternatives for the design, materials, manufacturing methods, and uses of medical devices and systems. In a first example, a cap for a flexible elongated member insertable into the body may include: a proximal end configured to engage with the flexible elongated member; a distal end defining a first inner diameter; a lumen extending between the proximal and distal ends; and a protrusion located between the proximal and distal ends and defining a second inner diameter smaller than the first inner diameter, wherein the protrusion may be configured to engage tissue received within the lumen via the distal end.

[0005] As an alternative or additional embodiment to any of the above examples, the protrusion may be configured to be spaced distally from the distal end of the flexible elongated member when the proximal end is connected to the flexible elongated member.

[0006] As an alternative or additional option to any of the above examples, the protrusion may extend circumferentially around the lumen.

[0007] As an alternative or additional option to any of the above examples, the protrusion may define a non-circular end of the lumen.

[0008] As an alternative or additional option to any of the above examples, the protrusion may define the circular end of the lumen.

[0009] As an alternative or additional option to any of the above examples, the distal end can be made of a substantially transparent material.

[0010] In another example, an apparatus may include a medical endoscope having a proximal end and a distal end, and a cap configured to be coupled to the distal end of the medical endoscope, the cap including a proximal end, a distal end, and a protrusion having a distal surface configured to engage with tissue received through an opening at the distal end.

[0011] As an alternative or additional option to any of the above examples, when the cap is attached to the distal end of the medical endoscope, the protrusion may be spaced distally from the distal end of the medical endoscope.

[0012] As an alternative or additional embodiment to any of the above examples, the inner surface of the cap may define a lumen, and the first diameter of the lumen at its distal end is greater than the second diameter at the protrusion.

[0013] As an alternative or additional option to any of the above examples, the protrusion may extend circumferentially around the lumen.

[0014] As an alternative or additional option to any of the above examples, the protrusion may define a non-circular portion of the lumen.

[0015] As an alternative or additional option to any of the above examples, the protrusion may define a circular portion of the lumen.

[0016] As an alternative or supplement to any of the above examples, a medical endoscope may have a working channel and a suction channel.

[0017] As an alternative or additional option to any of the above examples, the distal surface of the protrusion and the distal end of the cap can be configured to contact the tissue when negative pressure is applied to the suction channel.

[0018] As an alternative or additional embodiment to any of the above examples, the device may further include a cutting device that extends through the working channel, wherein the cutting device may be configured to cut the surface of the tissue at a location between two portions of the distal surface that are engaged with the tissue.

[0019] In another example, a method of forming an incision through the first tissue to the second tissue may include: engaging the distal end of the cap and a protrusion of the cap with the first tissue, wherein the protrusion may be offset proximally from the distal end of the cap; and cutting through the first tissue to the second tissue at an axial position along the cap and near an axial position of the protrusion.

[0020] As an alternative or additional option to any of the above examples, the method may further include applying negative pressure to the first tissue through the lumen of the extended through-cap.

[0021] As an alternative or additional embodiment to any of the above examples, engaging the distal end of the cap and the protrusion of the cap with the first tissue may include engaging the distal end of the cap with the first tissue and applying negative pressure to the first tissue to draw the first tissue into the cap and engage it with the protrusion.

[0022] As an alternative or additional option to any of the above examples, the proximal end of the cap may be connected to the distal end of the medical endoscope, and the medical endoscope may have a working channel.

[0023] As an alternative or additional embodiment to any of the above examples, the method may further include extending the cutting device through the working channel to a position near the axial location of the protrusion.

[0024] These and other features and advantages of this disclosure will become readily apparent from the following detailed description, the scope of the claimed invention being set forth in the appended claims. Attached Figure Description

[0025] Various embodiments are illustrated in conjunction with the accompanying drawings, which are included and form part of this specification, and the drawings, together with the description, serve to explain the principles of this disclosure.

[0026] Figure 1 A schematic diagram depicting the components of an illustrative medical endoscope;

[0027] Figure 2 A schematic diagram depicts the distal end of an illustrative medical endoscope axis, which has a cap attached thereto and is adjacent to tissue.

[0028] Figure 3 A schematic diagram depicts the distal end of an illustrative medical endoscope axis, which has a cap attached thereto and is adjacent to tissue.

[0029] Figure 4 A schematic three-dimensional view of the distal end of a medical endoscope, with an illustrative cap attached thereto, is depicted.

[0030] Figure 5 A schematic three-dimensional view depicts the distal end of a medical endoscope, which has connections thereto. Figure 4 The illustrative cap depicted in the text and the adjacent tissues;

[0031] Figure 6 A schematic cross-sectional view of the illustrative cap is depicted;

[0032] Figure 7 A schematic cross-sectional view of the illustrative cap is depicted;

[0033] Figure 8 A schematic diagram depicting the view from the perspective of an illustrative cap positioned near the tissue;

[0034] Figure 9 A schematic diagram depicting the view from the perspective of an illustrative cap positioned near the tissue; and

[0035] Figures 10A to 10D A schematic diagram illustrating the use of a medical endoscope is shown, wherein the distal end of the endoscope has an illustrative cap that is attached thereto.

[0036] While this disclosure can be modified and alternatively made in various ways, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the invention is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0037] This disclosure will now be described with reference to illustrative medical systems that can be used in transluminal medical procedures. However, it should be noted that reference to such specific procedures is provided for convenience only and is not intended to limit the scope of this disclosure. This disclosure can be understood with reference to the following description and accompanying drawings, wherein the same elements are referred to by the same reference numerals.

[0038] All numerical values ​​herein are assumed to be modified by the word “about”, whether explicitly indicated or not. In the context of numerical values, the term “about” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(e.g., having the same function or result). In many cases, the term “about” may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term “about” (e.g., in contexts other than numerical values) may be assumed to have their common and conventional definitions, as understood from and consistent with the context of the specification.

[0039] The numerical ranges listed by endpoints include all numbers within that range (including the endpoints) (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art will understand, based on the teachings of this disclosure, that expected dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0040] As used in this specification and the appended claims, the singular forms “a” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its sense, including “and / or”, unless the content clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular form, even if those features may be plural or repeated within the disclosed embodiments. Each instance of a feature may include and / or be covered by the singular form of the disclosure, unless expressly stated otherwise. For simplicity and clarity, not all elements of this disclosure need to be shown in every drawing or discussed in detail below. However, it should be understood that the following discussion can equally apply to any and / or all components that exist in more than one number of parts, unless expressly stated otherwise. Furthermore, for clarity, not all instances of some elements or features may be shown in every figure.

[0041] It should be noted that references to "configuration," "some configurations," "other configurations," etc., in the specification indicate that the described configuration may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Further, when a specific feature, structure, or characteristic is described in conjunction with a configuration, whether or not it is explicitly described, that specific feature, structure, or characteristic can be implemented in combination with other configurations, unless explicitly stated otherwise. That is, the individual elements described below, even if not explicitly shown in a specific combination, are contemplated as being combinable or arrangeable to form other additional configurations or to supplement and / or enrich the described configuration, as will be understood by those skilled in the art.

[0042] For clarity, certain numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designations are not intended to be restrictive and are merely illustrative. In some embodiments, modifications and deviations from previously used numerical designations may be made for brevity and clarity. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or designation in each instance will be apparent to those skilled in the art.

[0043] The detailed embodiments are intended to illustrate, but not limit, the scope of this disclosure. Those skilled in the art will recognize that the various elements described can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed embodiments illustrate exemplary embodiments of the disclosure.

[0044] refer to Figure 1 The illustration depicts a medical endoscope 10, such as an endoscope, in a schematic three-dimensional view. The medical endoscope 10 may include an elongated tube or shaft 12 (e.g., a flexible elongated shaft or member) configured to be inserted into the body of a subject (e.g., a patient).

[0045] The medical endoscope 10 may include a proximal portion 14 and a distal portion 16. The distal portion 16 of the medical endoscope 10 may house an imager (e.g., a CCD or CMOS imager, not shown). In some cases, the light source of the medical endoscope system including the medical endoscope 10 may supply illumination light to the distal portion 16 of the medical endoscope 10.

[0046] The elongated shaft 12 may include a distal end 18 (e.g., a distal or end unit adapted for insertion into a patient's body cavity) disposed at and / or along a distal portion 16 of the shaft 12, and a flexible bend 20 proximal to the distal end 18, though other suitable configurations are contemplated. The flexible bend 20 may include a hinge joint (not shown) to assist in turning the distal end 18, but this is not required.

[0047] The distal end 18 of the medical endoscope 10 may include an end face (e.g., as shown in the image). Figure 4 The depicted end face 22). In some cases, the end face may have: a gas / lens cleaning nozzle for supplying gas to inflate the internal space at the patient's treatment area and for supplying water to clean the lens covering the imager; a flushing opening for supplying flushing fluid to the patient's treatment area (e.g., the target site); one or more illumination windows for transmitting illumination light to the treatment area; an opening leading to a suction channel extending along axis 12; and / or an opening leading to a working channel extending along axis 12 for passing tools to the treatment area. In some examples, the working channel may extend along axis 12 to an operating handle 26 (e.g., a proximal handle) positioned on or along the operating handle of the medical endoscope 10, at a proximal channel opening 24. A biopsy valve 28 may be used to seal the channel opening 24 to prevent unwanted fluid leakage. Further, a cap 19 may be located at or on the distal end 18 of the medical endoscope 10 and may extend distally from the distal end 18.

[0048] The operating handle 26 may be provided with one or more knobs 30 for turning the distal end 18 via a line connected to an articulated joint in the flexible bending portion 20, such as remote four-way steering (e.g., one knob controls up-and-down steering, while another knob controls left-and-right steering). Multiple video switches 32 for remotely operating the video processing unit may be arranged on the handle 26 at the proximal portion 14 of the medical endoscope 10.

[0049] Handle 26 may be configured with a dual-valve position 34. One of the valve positions 34 may have or receive a gas / water valve 36 for performing gas supply operations for injection and lens cleaning water supply operations. The gas supply line and the lens cleaning supply line may extend distally from the gas / water valve 36 along axis 12 and converge at distal end 18 near the gas / cleaning nozzle, but other suitable configurations are conceivable.

[0050] Another valve position 34 may have or receive a suction valve 38 for performing suction operations. A suction supply line may extend distally from the suction valve 38 along axis 12 to a junction in fluid communication with the working channel of the medical endoscope 10.

[0051] Despite about Figure 1 An illustrative medical endoscope 10 has been described, but other suitable configurations of the medical endoscope 10 are contemplated, and one or more other suitable delivery devices (e.g., endoscopes, tubes, shafts, etc.) may be used in conjunction with the cap configuration or concept discussed herein. In some examples, an illustrative configuration of the delivery device may include an elongated shaft 12 and a handle 26, as well as other suitable components for use of the delivery device (e.g., the medical endoscope 10 and / or one or more other suitable delivery devices) within a subject's body (e.g., within a patient's body).

[0052] The medical endoscope 10 and / or other delivery devices may be configured to perform and / or facilitate the performance of “third-space” surgeries and / or surgeries in other transluminal spaces of the subject that are difficult to access through the distal end 18 of the medical endoscope 10. The subject’s “third space” may be a space within the wall of the subject’s gastrointestinal (GI) tract, such as in or between the tissue mucosa and tissue submucosa. Exemplary third-space surgeries include, but are not limited to, peroral endoscopic myotomy (POEM), endoscopic submucosal dissection (ESD), Zenker diverticulum peroral endoscopic myotomy (ZPOEM), peroral endoscopic pyloric myotomy (GPOEM), endoscopic submucosal tunneling tumor resection (STER), and peroral endoscopic tunneling esophageal recanalization (POETRE), etc. These third-space surgeries and / or other suitable surgeries may be used to treat esophageal sphincters, pyloric sphincters, subepithelial tumors, and / or other anatomical structures.

[0053] Some third-space surgeries (such as POEM, STER, POETRE) may involve creating a tunnel into or into the subject's submucosal tissue layer and performing one or more additional surgical steps. To create the tunnel, an incision may be made extending from the tissue mucosa layer into or into the tissue submucosa layer, such that the diameter of the endoscope can be adapted to pass through the opening.

[0054] Creating an incision from the mucosal tissue layer down to or into the submucosal tissue layer can be challenging and time-consuming. In some cases, the access angle of the medical endoscope 10 and / or other delivery devices and cutting tools (such as electrosurgical scalpels and / or other suitable cutting tools) may affect the difficulty of creating an appropriate incision from the mucosal tissue layer down to or into the submucosal tissue layer.

[0055] A cap or lid 19, connected and / or attached to the distal end of the elongated shaft 12 of the medical endoscope 10 and / or other delivery device, can be used in third-space surgery to maintain visualization of the target and facilitate the formation of a tunnel up to and / or into the submucosal layer of the tissue. In some examples, the cap or lid 19 may be clear or transparent (e.g., the cap or lid 19 may be made of any suitable clear or transparent biocompatible material) and forms a space isolated from bodily fluids and / or non-target tissue distal to the distal end 18 of the medical endoscope 10.

[0056] The cap or lid 19 can be coupled to the distal end of the elongated shaft 12 in any suitable manner, including but not limited to via threaded connection, Luer lock connection, friction fit, keyway connection, ball-and-socket connection, and / or other suitable types of connection. In some cases, the coupling between the cap 19 and the elongated shaft 12 can be configured to prevent the cap 19 from being adjusted proximally, distally, and / or rotated relative to the elongated shaft 12 during surgery.

[0057] The cap 19 can overlap with the distal end of the elongated shaft 12, such as, for example Figure 2 As depicted. In some examples, the cap 19 may overlap the distal end of the elongated shaft 12 by any suitable distance, which may include, but is not limited to, a distance ranging from about one (1) millimeter (mm) to about twenty-five (25) millimeters.

[0058] The cap 19 can have a rigid length L when in use, which makes it difficult for the distal end 62 of the cap 19 to be flush with or perpendicular to the target surface 53 (e.g., the target surface of the tissue wall 52 in the gastrointestinal tract 54 and / or other suitable target sites). Figure 2Illustrative examples are depicted of non-zero or non-parallel angles A between a medical endoscope 10 (e.g., cap 19, cutting tool 56 (e.g., electrosurgical scalpel and / or other suitable cutting tool), distal end 18, etc., whose surfaces may be parallel or non-parallel to each other) and the tissue wall 52. A non-zero angle A or non-parallel relationship between the tissue wall 52 and one or more components of the medical endoscope 10 may increase the difficulty of forming straight and / or flat incisions using the cutting tool 56 up to or into the submucosa of the tissue. As the diameter of the body lumen narrows relative to the diameter or size of the medical endoscope 10 and / or cap 19, the angle A between the medical endoscope 10 and the tissue wall 52 can increase (thus reducing the ability of the distal end 18 of the medical endoscope 10 to bend to a position closer to parallel to the tissue wall 52). An example of a relatively narrow body lumen is the esophagus of a subject, but the use of the device disclosed herein in other narrower body lumens is conceivable.

[0059] The cap 19 may have a proximal end 60, a distal end 62, and a lumen 64 (e.g., a working channel or other suitable lumen) extending between or along the proximal and distal ends. In some examples, the lumen 64 may be formed by an inner surface 66 (e.g., in...). Figure 2 (Seen in dashed lines) is defined, and therefore its diameter is defined by the inner surface 66. The diameter of the lumen 64 may be constant or may vary with the length L of the cap 19. The distal end 62 of the cap 19 may include an opening 68 configured to allow tissue (e.g., soft tissue of the tissue wall 52) to be drawn into the lumen 64 of the cap 19 by means of suction or negative pressure (e.g., as shown in dashed lines). Figure 3 What is described will be discussed below.

[0060] The cap 19 can have any suitable shape to be configured to engage with the distal end 18 of the medical endoscope 10, facilitate passage through body cavities, and / or create space for the user to observe tissue by spacing tissue from the distal end 18 of the medical endoscope 10. In some examples, the cap 19 can have a cylindrical shape, but other suitable shapes are conceivable. Furthermore, the shape of the cap 19 can be constant or not in the circumferential direction along its length L.

[0061] For example in Figure 3 As depicted, suction or negative pressure 58 (e.g., represented by lines extending from distal end 18) at the distal end 18 and / or cap 19 can be used to reduce the angle between the medical endoscope 10 and / or cutting tool 56 and the target surface 53 at the tissue wall 52. In the example using suction or negative pressure 58, the tissue wall 52 can be drawn into the cap 19 (e.g., Figure 3The cap (as depicted) or toward the cap draws in to reduce the angle between the cutting tool 56 and at least a portion of the target surface 53. However, due to the bulge of the tissue wall 52, the draw may result in inconsistent or unpredictable capture of the tissue wall 52 within the lumen 64 of the cap 19, making it impossible to adequately control the incision location and / or depth in the tissue wall 52 at the target surface 53 by means of the cutting tool 56.

[0062] Suction or negative pressure 58 can be applied to the tissue wall 52 in any suitable manner. In some examples, the user may not be able to control, or at least not accurately control, the amount of negative pressure applied to the tissue wall 52 (e.g., the negative pressure may not be accurately adjustable). In some cases, the negative pressure may be predetermined and may not be adjustable except for being turned on or off. In other examples, the user is able to accurately adjust or control the amount of negative pressure applied to the tissue wall 52.

[0063] To facilitate the formation of a target surface 53 (on which a predictable incision can be made using the cutting tool 56, e.g., at a predictable or desired location, with a predictable or desired size and / or with a predictable and / or desired depth), one or more protrusions may be formed in the wall of the cap 19, and the protrusions are defined by an inner surface 66. In some examples, the protrusions may be configured to contact tissue drawn into the lumen 64 of the cap 19 to flatten the surface of the tissue and form a predictably configured target surface parallel or substantially parallel to the cutting surface of the cutting tool 56. Even when the distal end 62 of the cap 19 is not parallel to the tissue wall 52, the protrusions in the cap 19 may still contact the drawn-in tissue and form a tissue surface parallel or substantially parallel to the cutting tool 56 to facilitate the formation of a consistent or predictable incision in the tissue, which may allow the formation of an initial tunnel through the tissue wall 52 for use in third-space procedures and / or other suitable procedures.

[0064] Figure 4 An illustrative configuration of a cap 19 connected to the elongated shaft 12 of a medical endoscope 10 is schematically depicted, wherein the cap 19 includes a protrusion 70 (e.g., a radially inwardly guided protrusion, such as...). Figure 4 As shown, when viewed through cap 19, it is indicated by dashed lines and as... Figure 8(Seen in solid lines when viewed through the opening 68 at the distal end 62 of the cap 19). Similar to what has been discussed above, the cap 19 may be coupled to the distal end 18 of the elongated shaft 12. In some examples, the end face 22 of the elongated shaft 12 may face the lumen 64 of the cap 19. The end face 22 may include one or more openings. In some examples, the openings in the end face 22 may include, but are not limited to: openings for one or more working channels 72, openings for one or more suction / aspiration channels 74, openings for one or more flushing channels 76 (e.g., for delivering water, liquid, or gas to the lumen 64 of the cap 19), openings for one or more imaging or observation channels 78, openings for one or more light guide channels 80, and / or one or more other suitable channels.

[0065] As tissue is drawn into cap 19, it can abut against the distal end 62 of cap 19 and then further against protrusion 70 (e.g., further against the distal surface 82 of protrusion 70 and / or other suitable surface of protrusion 70) to limit the distance the tissue is drawn into cap 19 and to form a flat target surface 81 in which an incision can be formed, such as, for example Figure 5 As depicted. In some examples, the protrusion 70 may include a distal surface 82 configured to abut against tissue drawn into the cap 19 through the opening 68 and influence the shape of the target surface 81.

[0066] The cap 19 may include one or more protrusions 70. For example, the cap 19 may include a single protrusion 70 (e.g., as shown in the image). Figure 4 The depicted features include, for example, substantially continuous, circumferentially extending protrusions, two protrusions 70, three protrusions 70, five protrusions 70, and / or other suitable number of protrusions 70.

[0067] The protrusion 70 can be located at any suitable position within the lumen 64 of the cap 19. For example, the protrusion 70 can be recessed proximally from the distal end 62 of the cap 19 and / or distally from the proximal end 60 of the cap 19. In some examples, retracting the protrusion 70 from the distal end 62 proximally can help maintain the desired negative pressure at the opening 68 of the cap 19, because a reduction in the diameter of the lumen 64 at the distal end 62 could result in a higher pressure at the distal end than desired, which could hinder the formation of the desired surface for incision formation. In some examples, retracting the protrusion 70 distally from the proximal end 60 can help provide suitable space for instruments, imaging, illumination, suction, and / or other features within and and on the cap 19. Figure 4In one exemplary configuration of the depicted cap 19, when the cap 19 is coupled to the elongated shaft 12, the protrusion 70 may be positioned in the lumen 64 of the cap 19 at a location recessed proximally from the distal end 62 and distally from the end face 22 of the elongated shaft 12; however, other suitable configurations are contemplated. When multiple protrusions 70 are employed, all protrusions 70 may be located at the same longitudinal or axial position along the lumen 64 of the cap 19, or one or more protrusions 70 may be located at different longitudinal or axial positions along the lumen 64 of the cap 19.

[0068] When retracted, the protrusion 70 may retract from one or both of the proximal end 60 and the distal end 62 of the cap 19 by any desired or suitable distance. In some examples, the protrusion 70 is retracted proximally or spaced apart from the distal end 62 of the cap 19 by a suitable distance to draw a sufficient amount of tissue into the cap 19 to engage with the protrusion 70 and form a desired surface through which an incision may penetrate. Exemplary suitable distances for retracting the protrusion 70 from the distal end include, but are not limited to, distances ranging from about one (1) mm to about twenty-five (25) mm. Additionally or alternatively, the protrusion 70 may be spaced apart from or recessed distally from the proximal end 60 of the cap 19 and / or the distal end (e.g., end face 22) of the elongated shaft 12 by a suitable distance, which may include, but is not limited to: a distance from the end face 22 of the elongated shaft recessed distally by the protrusion 70 in the range of about four (4) mm to about fifteen (15) mm, a distance from the proximal end 60 of the cap 19 recessed distally in the range of about five (5) mm to about forty (40) mm, and / or one or more other suitable distances recessed distally.

[0069] The protrusion 70 may extend any suitable distance around the lumen 64. In some examples, a single protrusion 70 may extend circumferentially around the lumen 64 (e.g., extending over the entire inner circumference of the lumen 64). Alternatively, in some examples, one or more protrusions 70 may extend around the lumen 64, but less than the entire circumference of the lumen 64. In some examples, when multiple protrusions 70 are used, the protrusions may be spaced equidistantly or unequally around the circumference of the lumen 64. Further, in some examples, when multiple protrusions 70 are used and these protrusions are located at different longitudinal or axial positions along the cap 19, the protrusions 70 may or may not overlap in the circumferential direction.

[0070] The protrusion 70 may be defined by the inner surface 66 of the cap 19, may define the lumen 64 of the cap 19, and / or may have any suitable shape. In some examples, the shape of the protrusion may be, but is not limited to, pedestal-shaped, ridge-shaped, rectangular cross-sectional shape, circular cross-sectional shape, triangular cross-sectional shape, annular, circular, rectangular, oval, triangular, and / or other suitable shapes. As discussed, the shape of the protrusion 70 may form the distal surface 82 (e.g., the distally facing or towards the opening 68 surface at the distal end 62 of the cap 19). In one example, the cap 19 may include a single protrusion 70 extending circumferentially around the lumen 64, wherein the single protrusion 70 may have a ridge-shaped or pedestal-shaped configuration with a rectangular cross-section, but other suitable configurations are contemplated.

[0071] Figure 6 and Figure 7 A schematic cross-sectional view depicting the illustrative configuration of cap 19 is shown. (See attached image.) Figure 6 and Figure 7 The depicted lumen 64 at or near the opening 68 at the distal end 62 may have a first diameter D1 (e.g., a first inner diameter), and the lumen 64 at or near the distal surface 82 of the protrusion 70 may have a second diameter D2 (e.g., a second inner diameter), which is smaller than (e.g., smaller in size) the first diameter D1 (e.g., the first diameter D1 may be larger than the second diameter D2). This configuration may help allow a desired amount of tissue to enter the lumen 64 of the cap 19 (e.g., due to pressure at the distal end 62 and / or space at the opening 68), and allow the received tissue to engage with or near the distal surface 82 to create a flat or other desired surface for incision formation.

[0072] Figure 6A protrusion 70 is schematically depicted, which recesses proximally from the distal end 62 of the cap 19 and extends to the proximal end 60 of the cap 19. The protrusion 70 extending to the proximal end 60 of the cap 19 can be configured for any suitable purpose. In some examples, the protrusion 70 may extend to the proximal end 60 to facilitate engagement with the distal end 18 of the elongated shaft 12. In one example, the protrusion 70 at the proximal end 60 may be provided with a keyway to engage with the elongated shaft 12, such that the cap 19 can only be engaged with the elongated shaft 12 when it is in a desired position relative to the elongated shaft 12 (e.g., angular position, rotational position, axial position, etc.). Further, when configured to engage with the elongated shaft 12, the proximal surface or other suitable surface of the protrusion 70 may be configured to engage with a surface of the elongated shaft 12 (e.g., end face 22, distally facing surface, and / or other suitable surface) to prevent the cap 19 (e.g., due to suction and / or other suitable forces at the cap) from moving proximally relative to the elongated shaft 12. The shape and / or configuration of the protrusion 70 may be all the same at the proximal end 60 of the cap 19, at the distal surface 82, and at one or more locations between the proximal end 60 and the distal surface 82 of the cap 19, or its shape or configuration along the protrusion 70 may differ at one or more locations from that at one or more other locations.

[0073] Figure 7 A protrusion 70 is schematically depicted, which retracts proximally from the distal end 62 of the cap 19 and distally from the proximal end 60 of the cap 19. The distal spacing of the protrusion 70 from or from the proximal end 60 of the cap 19 facilitates connection of the cap 19 to the distal end 18 of the elongated shaft 12 and / or provides additional space (relative to the distance from the proximal end 60). Figure 6 The configuration of the cap 19 depicted herein is for the operation of a device or component of a medical endoscope 10 that extends through or along the elongated axis 12 and / or for performing functions at or within the cap 19 (e.g., cutting tissue, capturing images, applying negative pressure to the lumen 64, applying fluid to the lumen 64, etc.).

[0074] Furthermore, the cap 19 and / or the elongated shaft 12 may include a stop member configured to engage with another stop member in the cap 19 and / or the elongated shaft 12 to prevent longitudinal movement of the cap 19 relative to the elongated shaft 12 in a proximal direction (e.g., during suction and / or at other times). In some examples, the stop member may be incorporated into the protrusion 70 (e.g., when the protrusion extends to the proximal end 60 of the cap 19, the stop member may be a proximal-facing surface of the protrusion 70), but other suitable configurations are contemplated. In some examples, the stop member may be proximal-spaced from the protrusion 70 as the proximal end 60 of the cap 19 retracts distally, and may have a surface configured to engage with the elongated shaft 12. The stop member may be one or more elements extending around the inner circumference of the cap 19 and / or the outer circumference of the elongated shaft 12, extending the entire circumference or less than the entire circumference.

[0075] Figure 8 and Figure 9 A schematic diagram is depicted as a view taken from the proximal end 60 along the lumen 64 from the axial end of the cap 19, wherein the protrusion 70 defines a portion of the lumen 64. The protrusion 70 may define the size and / or shape of the lumen 64 in any suitable manner. In some examples, the protrusion 70 may define an inner surface 66 that forms a circular cross-section of the lumen 64, such as... Figure 8 As depicted. In some examples, the protrusion 70 may define a non-circular cross-section (e.g., oval, elliptical, etc.) for the inner surface 66 forming the lumen 64, such as... Figure 9 The depiction is shown. Other suitable configurations of the protrusion 70 can also be envisioned.

[0076] Figures 10A to 10D A schematic flow diagram illustrating the technique for using the cap 19 in third-space surgery is depicted. In some examples, third-space surgery may include forming an incision through a first tissue at least up to a second tissue.

[0077] Figure 10A The distal end 18 of the elongated shaft 12 of a medical endoscope 10 is schematically depicted, which is inserted through the gastrointestinal tract 54 into a target site along the tissue wall 52, wherein a tissue mucosa layer 84 defines the lumen of the gastrointestinal tract 54, and a submucosal layer 86 may be located beneath the tissue mucosa layer 84 in the tissue wall 52. In some examples, the medical endoscope 10 may include a cap 19 coupled to the distal end 18 of the elongated shaft 12. Figure 10A As depicted, due to the tight space of the gastrointestinal tract 54, the rigid nature of the cap 19 and / or other suitable factors, the distal end 62 of the cap 19 can engage with the tissue wall 52 and can form a non-zero angle relative to the tissue wall 52 (in a non-flush or non-parallel position and / or orientation).

[0078] Once at the target site, suction or negative pressure 58 can be applied to the tissue wall 52 and / or through the lumen 64 in the cap 19 (e.g., through the lumen in the elongated shaft 12, or through a tube extending through the lumen in the elongated shaft 12) to draw the tissue wall 52 into the lumen 64 through the opening 68. As the tissue wall 52 enters the lumen 64, the tissue mucosal layer 84 of the tissue wall 52 may engage with the cap 19 at or near the distal end 62 and at or near the distal surface 82 of the protrusion 70 to create a flat target surface 81 for forming the incision. In some examples, the distal end 62 of the cap 19 may engage with the tissue mucosal layer 84 before initiating suction or negative pressure 58, but this is not necessary. Figure 10C As depicted, the protrusion 70 can be recessed proximally from the distal end 62 of the cap 19. The cutting tool 56 (e.g., via the working channel of the elongated shaft 12 or other suitable channel) can be delivered to or otherwise positioned at and / or within the lumen 64 as needed before, during, or after the formation of the flat target surface 81.

[0079] Once a flat target surface 81 is formed, the cutting tool 56 can engage the flat target surface 81 at or near the location of the protrusion 70 along the axial direction of the cap 19 (e.g., at a location between two portions of the distal surface 82 of the protrusion 70 and / or at one or more other suitable locations), and form an incision in the tissue wall 52 at the flat target surface 81, such as... Figure 10C As depicted. In some examples, the cutting tool 56 may advance and / or retract along the flat target surface 81 in the direction of arrow A to form an incision with a predictable depth and length. In one example, the incision may reach the depth at which the submucosal tissue layer in the tissue wall 52 begins, but other suitable depths are conceivable.

[0080] After an incision of appropriate depth and length is made, the cutting tool 56 can be removed from the lumen 64, and the fluid delivery tool 88 can be inserted into the lumen 64, through the incision, and into the tissue wall 52, as shown. Figure 10D As depicted. Once the distal end of the fluid delivery tool 88 is inserted into the tissue wall 52, fluid 89 (e.g., gas and / or liquid) can be dispensed from the distal end of the fluid delivery tool 88 to apply pressure between the tissue mucosa layer 84 and the tissue submucosa layer 86, thereby separating the tissue mucosa layer 84 from the tissue submucosa layer 86 and forming a space 90 between them. One or more third-space procedures can be performed using the space between the tissue mucosa layer 84 and the tissue submucosa layer 86 as needed.

[0081] The fluid can be any suitable type of fluid. Exemplary suitable types of fluids include, but are not limited to, liquids, gases, combinations of liquids and gases, saline solutions, sodium hyaluronate, glycerol solutions, methylcellulose solutions, and / or other suitable fluids.

[0082] Although the fluid delivery tool 88 is discussed as delivering fluid 89, fluid 89 can be delivered to the tissue wall 52 by one or more other means. In some examples, fluid 89 can be delivered to the tissue wall 52 by a cutting tool 56 so that fluid 89 can be applied to the tissue wall 52 after an incision is formed using the cutting tool 56. Alternatively or additionally, a spacer tool can be used to form a space 90 in the tissue wall 52, which is inserted through an incision at a flat target surface 81 and adjusted between the tissue mucosa layer 84 and the tissue submucosa layer 86 to form the space 90.

[0083] It should be understood that this disclosure is illustrative in many respects. Changes in detail, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. This may include, to appropriate extent, using any feature of one example embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A cap for a flexible, elongated member that can be inserted into the body, the cap comprising: The proximal end is configured to connect with the flexible elongated member; The distal end defines a first inner diameter; A lumen that extends between the proximal end and the distal end; as well as A protrusion, located between the proximal end and the distal end and defining a second inner diameter, the second inner diameter being smaller than the first inner diameter, The protrusion is configured to engage with tissue received within the lumen via the distal end.

2. The cap as claimed in claim 1, wherein, The protrusion is configured to be spaced distally from the distal end of the flexible elongated member when the proximal end is connected to the flexible elongated member.

3. The cap as claimed in claim 1 or claim 2, wherein, The protrusion extends circumferentially around the lumen.

4. The cap as claimed in any one of claims 1 to 3, wherein, The protrusion defines a non-circular end of the lumen.

5. The cap as claimed in any one of claims 1 to 4, wherein, The protrusion defines the circular end of the lumen.

6. The cap as claimed in any one of claims 1 to 5, wherein, The distal end is made of a substantially transparent material.

7. An apparatus comprising: A medical endoscope having a proximal end and a distal end; as well as A cap, configured to connect distally to the medical endoscope, the cap comprising: Proximal end; remote; and A protrusion having a distal surface configured to engage with tissue received through an opening at the distal end.

8. The apparatus of claim 7, wherein, When the cap is connected to the distal end of the medical endoscope, the protrusion is spaced distally from the distal end of the medical endoscope.

9. The apparatus of claim 7 or claim 8, wherein, The inner surface of the cap defines a lumen, and the first diameter of the lumen at the distal end of the lumen is greater than the second diameter at the protrusion.

10. The apparatus of claim 9, wherein, The protrusion extends circumferentially around the lumen.

11. The apparatus of claim 9 or claim 10, wherein, The protrusion defines a non-circular portion of the lumen.

12. The apparatus according to any one of claims 9 to 11, wherein, The protrusion defines a circular portion of the lumen.

13. The apparatus according to any one of claims 7 to 13, wherein, The medical endoscope has a working channel and a suction channel.

14. The apparatus of claim 13, wherein, The distal surface of the protrusion and the distal end of the cap are configured to contact the tissue when negative pressure is applied to the suction channel.

15. The apparatus of claim 14, further comprising: A cutting device that extends through the working channel. The cutting device is configured to cut the surface of the tissue at a location between the two portions of the distal surface that are engaged with the tissue.

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