Medical systems, devices, and related methods

Abstract

The invention relates to a medical device which comprises a handle, and the handle comprises a movable body and a fixed body. An end cap comprising an inner cap and an outer cap wherein the inner cap is coupled to the movable body by a control element such that movement of the movable body relative to the fixed body extends the inner cap relative to the outer cap; and a patch disposed between the inner cap and the outer cap such that movement of the inner cap relative to the outer cap at least partially deploys the patch.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 416,054, filed on October 14, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention generally relates to medical systems, devices, and related methods for delivering patches. More specifically, at least some embodiments of the present invention relate to systems, devices, and / or methods for delivering patches, such as for hemostasis and the like. Background Art

[0003] Technological development enables users of medical systems, devices and methods to perform increasingly complex operations on subjects. A challenge in the field of minimally invasive surgery is associated with preventing or stopping bleeding, such as, for example, bleeding ulcers in a cavity, organ or cavity of a subject. Common treatments for bleeding ulcers include, for example, injection therapy, thermal therapy, mechanical therapy and hemostatic powders. Such therapies are typically expensive and / or time-consuming. In addition, such therapies may not be able to treat larger surface areas, for example, larger bleeding in the gastrointestinal tract (GI). Additionally, a common treatment for chronic ulcers is gastric bypass surgery. Compared with minimally invasive surgery in which a patch is positioned at one or more bleeding sites, such surgery may be more difficult, more time-consuming, more expensive and / or less effective / less accurate. Therefore, a system, device and / or method for positioning and / or deploying one or more hemostatic patches on one or more parts of a subject is needed. Summary of the invention

[0004] The present invention includes medical systems and devices including biocompatible patches, and methods of using the same, for example, to deliver the patch to a treatment site of a patient, for example, to help treat an ulcer and / or perform a method of stopping bleeding. Each of the examples disclosed herein may include one or more of the features described in conjunction with any of the other disclosed examples.

[0005] According to one aspect, a medical device may include a handle, an end cap, and a patch. The handle may include a movable body and a fixed body. The end cap may include an inner cap and an outer cap. The inner cap may be coupled to the movable body by a control element so that movement of the movable body relative to the fixed body causes the inner cap to extend relative to the outer cap. The patch may be disposed between the inner cap and the outer cap so that movement of the inner cap relative to the outer cap at least partially deploys the patch.

[0006] Any of the examples described herein can have any of the following features in any combination. The medical device can also include a support structure partially surrounding a portion of the inner cap, and distal movement of the inner cap relative to the outer cap can cause the support structure to expand. The support structure can include a woven shape memory material.

[0007] The inner cap may include a proximal wall and a distal wall extending radially outward from the inner cap. In a first configuration, the outer edge of the distal wall of the inner cap may abut the inner edge of the outer cap, and in a second configuration, the outer edge of the distal wall of the inner cap may be distal to the inner edge of the outer cap.

[0008] The control element may be movably disposed within the lumen of the sheath. The sheath may be coupled to the outer cap. The end cap may be removably coupled to the endoscope by one or more fasteners, adhesives, or a friction fit. The inner cap may include a lumen extending from the proximal end to the distal end. The patch may include an adhesive on a side of the patch facing away from the inner cap. At least a portion of the end cap may be transparent.

[0009] According to an alternative aspect, a medical device may include an end cap, an expandable structure, and a patch. The end cap may include an inner cap and an outer cap. The expandable structure may partially surround a portion of the inner cap. The patch may be positioned around the expandable structure. In a first configuration, the inner cap may be disposed within the outer cap, and the patch may be disposed between a portion of the inner cap and a portion of the outer cap. In a second configuration, at least a portion of the inner cap may be distal to the outer cap and the patch may be released.

[0010] Any of the examples described herein may have any of the following features in any combination. The medical device may also include a connector ring connected to the proximal side of the end cap by one or more sheaths. The end cap may move relative to the connector ring. The support structure may include a woven shape memory material. The inner cap may include a proximal wall and a distal wall extending radially outward from the inner cap. In a first form, the outer edge of the distal wall of the inner cap may be adjacent to the inner edge of the outer cap. In a second form, the outer edge of the distal wall of the inner cap may be distal to the inner edge of the outer cap. In a third form, the end cap may be distal to the distal end of the endoscope. At least a portion of the end cap may be transparent. The inner cap may include a cavity extending from the proximal end of the inner cap to the distal end of the inner cap.

[0011] Aspects of the present invention also include references to exemplary methods. The method may include delivering a medical system to a treatment site, extending an inner cap relative to an outer cap by moving a movable body relative to a fixed body, and releasing a patch. The medical system may include a mirror and a medical device. The medical device may include a handle having a movable body and a fixed body; an end cap removably coupled to the distal end of the mirror; an expandable structure at least partially surrounding a portion of the inner cap; and a patch disposed between the inner cap and the outer cap. The end cap may include an inner cap and an outer cap. The inner cap may be coupled to the movable body of the handle via one or more control elements.

[0012] The method may also include manipulating one or more portions of the handle to extend the end cap from the distal end of the scope prior to extending the inner cap relative to the outer cap. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

[0014] Figure 1 is a perspective view of an exemplary medical system including an exemplary medical device and a portion of an endoscope according to aspects of the present invention.

[0015] Figure 2A is connected to the distal end of the endoscope according to various aspects of the present invention Figure 1 A stereoscopic view of a portion of a distal end of a medical device.

[0016] Figure 2B According to various aspects of the present invention Figure 2A A cross-sectional view of the distal end is shown.

[0017] Figure 3A and Figure 3B are perspective views of the distal end of a medical device at various steps of an exemplary procedure in accordance with aspects of the present invention.

[0018] Figure 4 is a flow chart of an exemplary method according to aspects of the invention.

[0019] Figure 5A and Figure 5B According to various aspects of the present invention, the endoscope is in a retracted state ( Figure 5A ) and extended form ( Figure 5B ) is a stereoscopic view of the distal portion of an alternative exemplary medical device.

[0020] Fig. 6A and Figure 6B are perspective views of a distal portion of an alternative medical device at various steps of an exemplary procedure in accordance with aspects of the present invention. DETAILED DESCRIPTION

[0021] Reference will now be made in detail to various aspects of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion farthest from the user when the device is introduced into a subject (e.g., a patient). Conversely, the term "proximal" refers to the portion closest to the user when the device is placed in the subject.

[0022] The foregoing general description and the following detailed description are exemplary and explanatory only and are not limitations on the features, as claimed. As used herein, the terms "comprises," "including," "having," "comprising," or other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. In the present invention, relative terms such as, for example, "about," "substantially," "roughly," and "approximately" are used to indicate a possible variation of ±10% of a stated value or characteristic.

[0023] Although the treatment site discussed herein is in the GI tract of a subject, the present invention is not so limited, as the treatment site may be any lumen, organ, cavity, or other tissue in the subject's body. Additionally, although reference is made herein to an endoscope, it should be understood that the present invention encompasses any medical device having a working channel extending from a proximal end to a distal end, such as a ureteroscope, duodenoscope, gastroscope, endoscopic ultrasonography ("EUS") scope, colonoscope, bronchoscope, laparoscope, arthroscope, cystoscope, aspiration scope, sheath, or catheter.

[0024] Embodiments of the present invention may address one or more of the limitations in the art. However, the scope of the present invention is defined by the appended claims rather than by the ability to solve a specific problem.

[0025] Figure 1 A perspective view of a medical system 100 is depicted, which includes, for example, a medical device 102 and an endoscope 125. As discussed in detail herein, the medical device 102 can include a handle 103 and an end cap 130. The end cap 130 can be coupled to the distal end 106 of the medical device 102. During delivery of the endoscope 125 and the end cap 130 to a treatment site, the patch 140 can be positioned within or inside one or more portions of the end cap 130. For example, the end cap 130 of the medical device 102 can be coupled to a distal portion 125C (e.g., a distal end) of the endoscope 125. Prior to inserting the endoscope 125 into a subject, the end cap 130 can be coupled to the endoscope 125 so that the end cap 130 and the distal portion 125C of the endoscope 125 can be delivered to the treatment site. The user can then manipulate one or more portions of the handle 103 to control (e.g., extend or retract) one or more portions of the end cap 130 to position and / or deploy the patch 140. Additionally, although not shown, the endoscope 125 can include one or more proximal controls (dials, levers, buttons, etc.), for example, to extend or retract, deflect, or otherwise control the position of the distal portion 125C of the endoscope 125, and thus control the position of the end cap 130 prior to positioning and / or deploying the patch 140.

[0026] As mentioned, the proximal end 104 of the medical device 102 may include a handle 103. The handle 103 may include a proximal handle portion 103A, an intermediate handle portion 103B, and a distal handle portion 103C. The proximal handle portion 103A may include a finger ring 108, for example, to receive a user's thumb. Specifically, the finger ring 108 may be positioned on the proximal end of the proximal handle portion 103A. The distal handle portion 103C may include a first portion 114 and a second portion 116, and the second portion 116 may include one or more ridges or indentations, for example, to facilitate the user's grip on the handle 103.

[0027] The handle 103 additionally includes a first or movable body 110 and a second or fixed body 112. For example, movement of the movable body 110 relative to the fixed body 112 can control movement (e.g., extension or retraction) of one or more control elements 120, such as a control wire, and thus the control element 120 can control movement (e.g., extension or retraction) of one or more portions of the end cap 130. The movable body 110 can partially surround a portion of the fixed body 112, and a portion of the movable body 110 can at least partially extend into the handle slot 111. The handle slot 111 can extend longitudinally through at least a portion of the fixed body 112 of the handle 103. In some aspects, although not shown, the handle 103 can include one or more biasing elements (e.g., one or more springs), for example, such that distal movement of the movable body 110 relative to the fixed body 112 is biased proximally. In these aspects, when the user releases distal pressure or force on the movable body 110, the one or more biasing elements can bias the movable body 110 proximally, for example, to Figure 1 Furthermore, at least a portion of the movable body 110 can be coupled (eg, directly or indirectly) or otherwise connected to the control element 120 .

[0028] The movable body 110 may include one or more reduced diameter sections or grooves 110A, for example, between the proximal ridge 110B and the distal ridge 110C, which may help facilitate a user's grip on the movable body 110. For example, a user may place the movable body 110 between two fingers such that the user's fingers are positioned within the grooves 110A. Thus, movement of the user's fingers (i.e., relative to the user's thumb in the finger ring 108) controls the position of the movable body 110 relative to the fixed body 112, and thus controls movement of one or more portions of the control element 120 and / or the end cap 130.

[0029] In some aspects, the fixed body 112 (e.g., a portion of the middle handle portion 103B of the handle 103) and / or the movable body 110 may include one or more visual or physical indicators 109. The indicator 109 may include, for example, an indentation, a raised surface, a marking, etc. The indicator 109 may physically or visually indicate the actuation or extension of the end cap 130. For example, when the movable body 110 is advanced distally relative to the fixed body 112, thereby actuating the end cap 130, the movable body 110 may have to overcome, for example, the indicator 109. The indicator 109 may signal to the user that the end cap 130 has been actuated or that the end cap 130 is in an extended position. Additionally or alternatively, the user may utilize markings or other visual indicators on the handle 103 to determine the state, position, actuation state, etc. of one or more portions of the end cap 130.

[0030] Still reference Figure 1 , endoscope 125 may include a generally cylindrical tubular shape and may include a proximal portion 125A, a distal portion 125C, and an intermediate portion 125B. Although not shown, proximal portion 125A may include a handle or otherwise be coupled to a handle, for example, including one or more ports, controls, levers, buttons, electrical communication connections, etc. Additionally, endoscope 125 may include one or more lumens 127 ( Figure 2B Lumen 127 can extend longitudinally through endoscope 125, for example, through proximal portion 125A, middle portion 125B, and distal portion 125C.

[0031] The endoscope 125 (i.e., the distal portion 125C of the endoscope 125) can include an outer diameter of about 9 mm to about 20 mm, for example, an outer diameter of about 10.5 mm to about 12 mm. As mentioned, the endoscope 125 can include a lumen 127, for example, having a working channel with a diameter of about 2 mm to about 4 mm, for example, about 2.8 mm. One or more lumens 127 can terminate at the distal side 125D of the endoscope 125. Additionally, as Figure 2B As shown, the distal side 125D of the endoscope 125 may include one or more lighting devices 128 (e.g., one or more LEDs, optical fibers, and / or other illuminators). The distal side 125D may additionally or alternatively include one or more visualization devices 129 (e.g., one or more cameras, one or more image sensors, an endoscopic viewing element, an optical assembly including one or more image sensors and one or more lenses, etc.).

[0032] like Figure 1As shown, when the medical device 102 (including the end cap 130) is coupled to the endoscope 125 (i.e., during delivery and positioning), the end cap 130 and / or the distal portion of the medical device 102 can be coupled to the distal portion 125C of the endoscope 125. For example, the distal portion of the medical device 102 and / or the proximal portion of the end cap 130 can be attached to the outer surface of the distal portion 125C of the endoscope 125. For example, the proximal portion of the end cap 130 can include an inner diameter that is complementary to the outer diameter of the endoscope 125 and can receive the outer diameter of the endoscope 125. The end cap 130 can be attached to the distal portion 125C of the endoscope 125 by methods such as adhesives, mechanical fits, snap fits, press fits, welding, or any other coupling techniques well known in the art. Additionally or alternatively, the end cap 130 can be coupled to the distal opening of the lumen 127 and / or extend distally beyond the distal opening (e.g., Figure 2B Although not shown, a portion of the end cap 130 can extend proximally into the one or more cavities 127 and be coupled to an interior surface within the one or more cavities 127 via, for example, an adhesive, a mechanical fit, a snap fit, a press fit, a weld, or any other coupling technique well known in the art.

[0033] To provide additional stability of the medical device 102 relative to the endoscope 125, one or more portions of the medical device 102 may also be coupled to the endoscope 125 at other locations along the longitudinal length of the endoscope 125. For example, the proximal portion of one or more sheath elements 118 and / or the intermediate portion of the sheath element 118 may be coupled to, for example, the proximal portion 125A and / or the intermediate portion 125B, respectively, of the endoscope 125. One or more portions of the handle 103 may additionally or alternatively be coupled to one or more portions of the endoscope 125, such as, for example, at a handle (not shown) of the endoscope 125.

[0034] Although not shown, the endoscope 125 can include one or more grooves, channels, cavities, and / or other features to removably receive the control element 120 and / or the sheath element 118 of the medical device 102. The one or more grooves, channels, cavities, and / or other features can extend at least partially along the longitudinal length of the endoscope 125, inwardly (e.g., on the inner surface) or outwardly (e.g., on the outer surface). Alternatively or additionally, the system 100 can include an outer sheath (not shown) to assist in enclosing the endoscope 125, the sheath element 118, and / or the control element 120. Furthermore, although not shown, one or more portions of the endoscope 125 (e.g., the distal portion 125C) can be deflectable, for example, via one or more knobs, levers, buttons, or other controls on a proximal handle. In these aspects, the distal portion 125C of the endoscope 125 can be manipulated when delivered to and / or positioned relative to the treatment site, e.g., in a reflexed position, such as can be used when the treatment site is in the esophagus, stomach, duodenum, colon, or other portion of the GI tract of a subject. Thus, at least a portion of the medical device 102 can be flexible or semi-flexible, e.g., to facilitate manipulation with the endoscope 125.

[0035] Still reference Figure 1 , the control element 120 can extend from one or more portions of the handle 103 of the medical device 102 to one or more portions of the end cap 130. The control elements 120 can each be formed of a wire, a coil, a tube, etc. Additionally, one or more sheath elements 118 can extend from one or more portions of the handle 103 to one or more portions of the end cap 130. The sheath elements 118 can each be formed of a coil, a tube, a sheath, etc., and can have a lumen (not shown) extending longitudinally to receive the control element 120. In these aspects, each control element 120 can be radially located within a corresponding sheath element 118 (e.g., the control element 120 can be movably disposed within a lumen of the sheath element 118).

[0036] The sheath element 118 and / or the control element 120 can extend outwardly to the endoscope 125 (e.g., along the outer surface of the endoscope 125). In such a case, the end cap 130 can be fixedly or removably coupled to the control element 120. The end cap 130 can be coupled to the control element 120 by techniques such as, for example, adhesives, mechanical fits, snap fits, press fits, friction fits, welding, or any other techniques or fasteners well known in the art. Any combination of techniques for coupling the end cap 130 to the control element 120 is also permissible (e.g., adhesives and snap fits).

[0037] Alternatively, the sheath element 118 and / or the control element 120 can extend through the lumen 127 of the endoscope 125. In such a case, the end cap 130 can be removably coupled to the control element 120 to enable a user to introduce the sheath element 118 through the lumen 127 of the endoscope 125. In an alternative form, the end cap 130 can be fixedly coupled to the control element 120, and the control element can be removably coupled to the handle 103.

[0038] Figure 2A and Figure 2B 1 are different views of the end cap 130 in a first (eg, retracted) configuration. Specifically, Figure 2A is a perspective view of the end cap 130 in the first configuration, and Figure 2B 1 is a cross-sectional view of the end cap 130 in a first configuration. The end cap 130 can be in the first configuration, for example, during delivery of the endoscope 125 and the end cap 130 to a treatment site. As previously described, the end cap 130 can be coupled to the distal portion 125C of the endoscope 125. The end cap 130 can include a generally cylindrical shape (e.g., Figure 1 , Figure 2A and Figure 2B ), however, it should be understood that other shapes (eg, oval, square, rectangular, etc.) may also be utilized. In some aspects, the shape of the end cap 130 may correspond to the shape of the distal portion 125C of the endoscope 125.

[0039] The end cap 130 also includes an inner cap 134 and an outer cap 132. A patch 140, which will be described in further detail below, can be positioned within the outer cap 132, for example, on an outer surface of a support structure 142 surrounding a middle portion 131 of the inner cap 134. The inner cap 134 can include a middle portion 131 extending between a proximal wall 135 and a distal wall 136. The proximal wall 135 and the distal wall 136 can protrude radially outward from the middle portion 131. The support structure 142 can extend from the distal side of the proximal wall 135 to the proximal side of the distal wall 136 and at least partially surround the middle portion 131. Additionally, a cavity 138 extends from the proximal end to the distal end of the inner cap 134. As shown in FIG. Figure 2B As shown, the outer edge 133 of the distal wall 136 can be formed so that the inner cap 134 is more easily received by the outer cap 132. For example, the outer edge 133 can be rounded, chamfered or beveled. The outer edge 133 may help form a stop surface, for example, when the inner cap is retracted proximally. The outer edge 133 can alternatively form a gradually changing stop surface.

[0040] The support structure 142 can include any device having expandable and / or shape memory properties, such as, for example, a stent. Thus, the support structure 142 can be made of one or more flexible or semi-flexible materials, for example, materials including expandable and / or shape memory properties, such as, for example, plastic, nitinol, cobalt nitinol, stainless steel, or any material well known in the art. For example, the one or more materials can be woven or wrapped around the middle portion 131. Additionally or alternatively, the one or more materials can form a line extending longitudinally and / or laterally between the proximal wall 135 and the distal wall 136. In either case, in a first configuration, the support structure 142 can be positioned between the proximal wall 135 and the distal wall 136 in an unexpanded state, for example, such that the inner surface of the support structure 142 is adjacent to the radially outer surface of the middle portion 131.

[0041] The control element 120 can be coupled to a proximal portion of the inner cap 134, for example, to a proximal surface of the proximal wall 135. Additionally or alternatively, the control element 120 can extend into the proximal portion of the proximal wall 135, such as Figure 2B As shown, for example, to further secure the control element 120 to the inner cap 134. The control element 120 can be attached to the inner cap by, for example, adhesive, mechanical fit, snap fit, press fit, welding, or any other connection technology well known in the art. Figure 2B As shown, one or more sheath elements 118 can be coupled to the outer cap 132. For example, the outer surface of the sheath element 118 can be coupled to the inner surface of the outer cap 132. The sheath element 118 can be coupled to the inner surface of the outer cap 132 by, for example, adhesives, mechanical fits, snap fits, press fits, welding, or any other coupling techniques well known in the art. Coupling the sheath element 118 to the outer cap 132 and coupling the control element 120 to the inner cap 134 can enable a user to extend the inner cap 134 distally from the outer cap 132 and / or retract the inner cap 134 proximally relative to the outer cap 132. For example, when the control element 120 (and therefore the inner cap 134) is extended distally or retracted proximally, the sheath element 118 (and therefore the outer cap 132) can remain fixed.

[0042] The outer cap 132 also includes a cavity 137, such as Figure 2B As shown, for receiving the inner cap 134. For example, in the first form, the inner cap 134 is positioned in the cavity 137 of the outer cap 132, for example, so that the distal surface of the distal wall 136 of the inner cap 134 is adjacent to or proximal to the distal end 132A of the outer cap 132. Additionally, in such a form, the proximal surface of the proximal wall 135 of the inner cap 134 is adjacent to or distal to the proximal surface of the outer cap 132. Figure 2BAs shown, the inner edge 139 of the outer cap 132 can be formed to more easily accept the inner cap 134. For example, the inner edge 139 can be rounded, chamfered or beveled. Alternatively or additionally, one or more surfaces of the inner edge 139 can be complementary to the outer edge 133 of the distal wall 136 of the inner cap 134. For example, in the first form, the outer edge 133 can abut or touch the inner edge 139. For example, when the inner cap 134 is retracted, the inner edge 139 can gradually abut the outer edge 133. When the outer edge 133 abuts the inner edge 139, the user may experience tactile feedback on the handle. For example, when manipulating the movable body 110, the user may experience a sudden stop or feel an increase in friction when the outer edge 133 abuts the inner edge 139.

[0043] The outer cap 132 and the inner cap 134 can each be composed of a rigid or semi-rigid material (e.g., stainless steel, titanium, polypropylene plastic, high-density polyethylene plastic, acrylic resin, glass, etc.). In some embodiments, one or more portions (e.g., distal portions) of the outer cap 132 and / or the inner cap 134 can be transparent or at least partially transparent. In these aspects, the outer cap 132 and / or the inner cap 134 may not substantially interfere with the visualization device 129 and / or the lighting device 128 that visualizes and / or illuminates the treatment site. Additionally or alternatively, the inner cap 134 and / or the outer cap 132 may include markings (e.g., markings for fluoroscopy, radiopaqueness, etc.) to assist in visualizing the outer cap 132 and / or the inner cap 134 during, for example, a fluoroscopic procedure.

[0044] Additionally or alternatively, one or more surfaces of the outer cap 132 and / or the inner cap 134 can be at least partially coated with any biocompatible material well known in the art (e.g., silicone-based lubricants, coatings, gels, fluids, etc.). For example, coating one or more exterior surfaces or portions of the outer cap 132 and / or one or more exterior surfaces of the inner cap 134 (e.g., the distal side of the distal wall 136) can facilitate insertion, positioning, and / or removal of the end cap 130 into a subject. Similarly, coating one or more interior surfaces or portions of the inner cap 134 can facilitate insertion, positioning, and / or removal of the end cap 130 onto the distal portion 125C of the endoscope 125 (e.g., Figure 1 Additionally or alternatively, coating one or more inner surfaces or portions of the outer cap 132 and / or coating one or more outer surfaces or portions of the inner cap 134 may facilitate extending and / or retracting the inner cap 134 from the outer cap 132.

[0045] The longitudinal length of the inner cap 134 can range from about 1 cm to about 3 cm, for example, about 2 cm. Accordingly, the longitudinal length of the outer cap 132 can range from about 1 cm to about 3.5 cm, for example, about 2.2 cm. However, it should be understood that the outer cap 132 and the inner cap 134 can include various other shapes, sizes, and / or lengths other than those shown and described herein.

[0046] In some embodiments, the inner cap 134 may include a total outer diameter of about 10 mm to about 20 mm, for example, about 15 mm. The middle portion 131 of the inner cap 134 may have an outer diameter of about 9 mm to about 18 mm, for example, about 10 mm. Therefore, the proximal wall 135 and the distal wall 136 may extend radially outward from the middle portion 131 by about 1 mm to about 10 mm, for example, about 5 mm. In some aspects, the outer cap 132 and / or the inner cap 134 may have a transverse cross-sectional shape, such as, for example, an ellipse, a circle, a square, a rectangle, a star, or any shape well known in the art.

[0047] As mentioned above, the inner cap 134 also includes a cavity 138. The cavity 138 can be of sufficient size so that at least a portion of the lumen 127 of the endoscope 125 (e.g., Figure 2B 129 and / or one or more illuminators 128. By way of example only, but in some embodiments, the cavity 138 of the inner cap 134 may include an inner diameter of about 7 mm to about 15 mm, for example, about 10.5 mm to about 12 mm. The inner diameter of the cavity 138 may be the same along the entire longitudinal length of the inner cap 134. In an alternative example (not shown), the inner diameter of the cavity 138 may vary along the longitudinal length. For example, the inner diameter of the cavity 138 may increase along the longitudinal length so that the inner diameter is larger on the distal portion of the inner cap 134 compared to the distal portion of the cavity 138. Alternatively, the inner diameter of the cavity 138 may decrease along the longitudinal length so that the inner diameter is larger on the proximal portion of the inner cap 134 compared to the distal portion of the inner cap 134. In some aspects, cavity 138 can have a transverse cross-sectional shape such as, for example, oval, circular, square, rectangular, star-shaped, or any shape well known in the art.

[0048] In some embodiments, the outer cap 132 can include an overall outer diameter of about 12 mm to about 25 mm, for example, about 16 mm. The cavity 137 of the outer cap 132 can include an inner diameter of about 10 mm to about 22 mm, for example, about 15.5 mm. In some aspects, the outer cap 132 can have a transverse cross-sectional shape such as, for example, an oval, a circle, a square, a rectangle, a star, or any shape well known in the art.

[0049] Figure 3A and Figure 3B Perspective views of the end cap 130 are provided, wherein the end cap 130 is in various configurations. Figure 3A In the first form ( Figure 2A and Figure 2B ) and the second form ( Figure 3B ) when the end cap 130 is in an intermediate position. Figure 3B The end cap 130 is shown in the second configuration. To convert the end cap 130 from the first configuration to the second (eg, actuated or extended) configuration, the user may actuate the movable body 110 ( Figure 1 110A). For example, the user can move one or more fingers in the groove 110A distally to move the movable body 110 distally, and thereby convert the end cap 130 from the first form to the second form. Actuating the movable body 110 results in actuation or extension of the control element 120. Therefore, when the control element 120 is extended distally relative to the one or more sheath elements 118, the inner cap 134 can be extended distally relative to the outer cap 132. For example, the distal wall 136 of the inner cap 134 can extend distally beyond the distal end 132A of the outer cap 132. However, as Figure 3B As shown, in the second configuration, at least a portion of the proximal wall 135 can remain proximal to the distal end 132A of the outer cap 132. For example, in some embodiments, the outer cap 132 can include a feature (not shown) protruding radially inward from the surface of the cavity 137. The feature (not shown) can catch or abut the proximal wall 135, thereby helping to prevent the inner cap 134 (e.g., the proximal wall 135) from extending distally beyond the distal end 132A of the outer cap 132. The inner cap 134 can also be positioned in one or more intermediate positions. For example, the inner cap 134 can partially extend distally relative to the outer cap 132.

[0050] During and / or after transitioning from the first configuration to the second configuration, the lumen 127 of the endoscope 125 can remain in fluid communication with the lumen 138 of the inner cap 134. Similarly, during and / or after transitioning from the first configuration to the second configuration, neither the inner cap 134 nor the outer cap 132 covers or otherwise interferes with the one or more visualization devices 129 and / or the one or more illumination devices 128. Thus, a user may be able to visualize target tissue or other aspects of a treatment site throughout the procedure.

[0051] When the inner cap 134 extends distally relative to the outer cap 132, the patch 140 also extends distally. In addition, when the inner cap extends distally, the support structure 142 can expand or otherwise actuate. Due to the shape memory properties previously described, the support structure 142 can be at least partially expanded (e.g., radially outward). For example, when the inner cap 134 extends, the support structure 142 can no longer be limited by the wall of the cavity 137 that defines the outer cap 132. Therefore, the outer wall of the support structure 142 can be pushed radially outward or away from the inner cap 134. When the outer wall of the support structure 142 is pushed radially outward, the patch 140 can be pushed against or toward the target tissue and / or the patch 140 can be released or deployed to the treatment site from the end cap 130 in other ways. In an alternative form (not shown), once the patch is released or deployed from the end cap 130, one or more auxiliary medical devices can be delivered through the cavity 127 of the endoscope 125 to assist in positioning or repositioning the patch 140.

[0052] The inner cap 134 can also be retracted within the outer cap 132, for example, by retracting the control element 120. The control element 120 can be moved, for example, by moving one or more fingers in the groove 110A in the opposite direction to the previous direction, for example, proximally, as shown in FIG. Figure 1 The inner cap 134 can be retracted or returned to the first configuration, as shown. Figure 2A and Figure 2B Additionally, when the inner cap 134 is retracted within the outer cap 132, the support structure 142 can return to its original shape and / or size. For example, the support structure 142 can be retracted (e.g., radially inward) because the walls defining the cavity 137 of the outer cap 132 constrain the support structure 142.

[0053] Patch 140 can be a biodegradable and / or biocompatible patch with any suitable shape and any suitable size, for example, based on the properties of the target tissue site. Patch 140 can have any shape, such as, approximately square, approximately rectangular, rounded square, rounded rectangle, oval, circular and other possible shapes. In some examples, the thickness of the patch may be in the millimeter level, for example, ranging from about 0.1mm to 5.0mm, or more specifically, about 0.7mm to about 2.0mm. Patch 140 may have enough size to cover the target tissue, and have an edge for excision. Therefore, patch 140 can have a variety of sizes to achieve this task. In addition, patch 140 can have any suitable color, including transparent, and material, for example, net, cloth, polysaccharide (chitosan, cellulose, starch, alginate, etc.), which can be further modified with synthetic biocompatible materials (pHEMA, PGA, PLA, PCA, PEG, etc.). Additionally, for example, patch 140 can be made up of polypropylene, polyester, ePTFE and / or silicone. Patch 140 can use materials well known in the art, such as, for example, fibrin glue, hydrogel and / or cyanoacrylate to adhere to the target tissue. Alternatively or additionally, patch 140 can be made up of reagents or administered together with reagents to prevent cells from falling off from the target tissue or processing the treatment site. Alternatively or additionally, patch 140 can include one or more hemostatic materials or agents. In some forms, after patch 140 is connected or bonded to the target tissue, hemostatic materials or agents can be applied to patch 140.

[0054] The patch 140 can be flexible and bendable. For example, the patch 140 can be formed as a planar film, sheet or disc that can be folded, curled or otherwise manipulated into a temporary non-planar form within a confined space or when other forces act on the patch 140. For example, the patch 140 can be folded, bent or curled between the inner cap 134 and the outer cap 132 of the end cap 130 to be properly delivered to the target tissue. However, once at least a portion of the inner cap 134 extends distally beyond the outer cap 132, thereby actuating the support structure 142, the patch 140 can be released from the support structure 142. Therefore, the patch 140 can restore its original plane or other expanded form.

[0055] The patch 140 can be substantially dry during delivery to the treatment site. For example, one or more proximal portions of the outer cap 132 and the inner cap 134 and one or more distal portions of the outer cap 132 and the inner cap 134 can form a seal or liquid-tight barrier to prevent body fluids from contacting the patch 140 before delivery or deployment. In some examples herein, the patch 140 can be wetted during delivery or shortly after being released from the end cap 130. For example, the patch 140 can be exposed to water or another fluid via the cavity 127 of the endoscope 125 and / or by contacting with body fluids or moisture inside the subject's body. In some embodiments, for example, the cavity 127 of the endoscope 125 can be connected to a fluid supply connector (not shown) or a similar structure (e.g., port) fluid. When exposed to moisture, the patch 140 can absorb fluid, thereby causing the patch 140 to swell or expand. For example, the patch 140 may be substantially like paper when dry, and when wet, may present a consistency more like jelly. According to some aspects of the invention, moistening patch 140 may facilitate its application to tissue.

[0056] In some examples herein, the patch 140 includes an adhesive, for example, to assist in applying the patch to the tissue and / or to keep the patch in place after application, and / or to assist in delivering the patch 140 to the treatment site. The adhesive can be arranged on a surface or side of the patch 140, which is opposite to the surface or side of the patch 140 adjacent to the support structure 142. The adhesive can be arranged at certain discrete positions on the surface or side of the patch 140 or on the entire surface. The adhesive suitable for the present invention can be natural, for example, including natural polymers, or obtained from natural polymers, or synthetic. Exemplary adhesives include, but are not limited to, gelatin (including, for example, thrombin / gelatin), fibrin (for example, fibrin glue), cyanoacrylate, polyethylene glycol (PEG) and albumin (including, for example, albumin glutaraldehyde). The adhesive can be at least partially reabsorbed by the body of the subject.

[0057] The selection of adhesive can be based at least in part on the properties of the treatment site to which the patch 140 is applied, such as, for a patch 140 comprising an extracellular matrix (ECM), a relatively stronger adhesive may be required, compared to a patch 140 comprising chitosan having natural bioadhesive properties. In addition, for example, a patch 140 intended to be applied to a relatively large wound, tumor or defect site may include an adhesive to further help fix the patch 140 to tissue. The patch 140 according to the present invention may include an adhesive applied to one region or two or more regions, such as, the opposite ends of the patch 140. Alternatively or additionally, an adhesive may be applied to the periphery of the patch 140, leaving a central portion of the patch 140 without adhesive. In some examples, the patch 140 does not include an adhesive. Therefore, when the patch 140 is released from the supporting structure 142, the patch 140 may be adhered to the target tissue or otherwise positioned at the treatment site.

[0058] Figure 4 300 is a flow chart of an exemplary method 300 that one or more users can perform with any of the medical systems, devices, or parts of systems discussed herein, such as the medical system 100. In a first step 302 of the method 300, the medical system 100 (e.g., a distal portion of the medical system 100) can be inserted into a subject, for example, through a natural orifice or incision. The medical system 100 can include, for example, a medical device 102 and an endoscope 125. The medical device 102 can also include a handle 103 and an end cap 130. The first step 302 can also include coupling the end cap 130 to the distal portion 125C of the endoscope 125 before inserting the medical system 100 into the subject. The first step 302 can also include deflecting and / or positioning the distal portion 125C of the endoscope 125 (e.g., via a knob, lever, dial, etc.).

[0059] Once the medical system 100 is in the desired position, the second step 304 includes extending the inner cap 134 by manipulating the movable body 110 of the handle 103 relative to the fixed body 112 (e.g., manipulating distally relative to the fixed body 112). Moving the movable body 110 relative to the fixed body 112 can extend or otherwise actuate the inner cap 134 relative to the outer cap 132.

[0060] In optional step 306 of method 300, the user can retract or deactivate inner cap 134 and reposition end cap 130 within the subject, e.g., before releasing patch 140 from inner cap 134. For example, the user can move endoscope 125 proximally and / or move control element 120 via handle 103. Optional step 306 can also include deflecting and / or positioning distal portion 125C of endoscope 125 (e.g., via a knob, lever, dial, etc.).

[0061] In step 308, the inner cap 134 is fully extended or actuated, and the patch 140 is released from the inner cap 134. The inner cap 134 can be extended or actuated, for example, by advancing the movable body 110 distally relative to the fixed body 112. The movable body 110 can control the movement (e.g., extension or retraction) of the control element 120 coupled to the end cap 130. Thus, for example, when the control element 120 is advanced distally, the inner cap 134 is extended or actuated. The movable body 110 may include, for example, a visual or physical indicator. The indicator 109 may include, for example, a dent, a raised surface, a mark, etc. The indicator 109 may physically or visually indicate the actuation or extension of the end cap 130. The outer cap 132 may include a feature that protrudes radially inward to prevent the inner cap 134 from extending distally beyond the distal end 132A of the outer cap 132.

[0062] Once the patch 140 is released, the user can remove the medical system 100 from the subject in step 310. For example, the medical system 100 can be removed by pulling the endoscope 125 proximally through a natural orifice or incision. Once the medical system 100 is removed, the method 300 can be repeated, for example, with a second end cap 130 or the same end cap 130 with a new patch 140. Before, during, or after removing the medical system 100, the user can retract the inner cap 134 within the outer cap 132.

[0063] Figure 5A and Figure 5B shows that in a first, e.g., retracted configuration ( Figure 5A ) and second, for example, the extended form ( Figure 5B ) is a perspective view of an alternative medical system 200 in FIG. Medical system 200 can include a medical device 202 and an endoscope 225. Medical device 202 can include a handle 203 and an end cap 230. End cap 230 can have any of the properties of end cap 130, except as described below. Similarly, end cap 203 can have any of the properties of end cap 103, except as described below.

[0064] The handle 203 may include a first movable body 210 and a fixed body 212. For example, the movement of the first movable body 210 relative to the fixed body 212 may control one or more control elements 220 ( Figure 5B 203 ). The control element 220 may control the movement (e.g., extension or retraction) of one or more portions of the end cap 230. The first movable body 210 may partially surround a portion of the fixed body 212, and a portion of the first movable body 210 may at least partially extend into the handle slot 211. The handle slot 211 may extend longitudinally through at least a portion of the fixed body 212 of the handle 203. In some aspects, although not shown, the handle 203 may include one or more biasing elements (e.g., one or more springs), for example, such that the first movable body 210 is proximally biased relative to the distal movement of the fixed body 212. In these aspects, when the user releases distal pressure or force on the first movable body 210, the one or more biasing elements may bias the first movable body 210 proximally. In addition, at least a portion of the first movable body 210 may be coupled to (e.g., directly or indirectly) or otherwise connected to the control element 220.

[0065] The first movable body 210 may include one or more finger holes 210A extending radially outward from the first movable body 210. Thus, movement of a user's finger (i.e., relative to the user's thumb in the finger ring 208) may control the position of the first movable body 210 relative to the fixed body 212, and thus control movement of one or more portions of the control element 220 and / or the end cap 230. Additionally or alternatively, the first movable body 210 may be similar to Figure 1 For example, the first movable body 210 may include one or more sections or grooves with reduced diameters to facilitate the user's grip on the movable body 110.

[0066] The handle 203 may also include a second movable body 213, for example, movably mounted on the first movable body 210 or otherwise coupled to the first movable body 210. Movement of the second movable body 213 relative to the first movable body 210 may control, for example, movement (e.g., extension or retraction) of one or more actuation wires 222, and thus the actuation wires may control movement (e.g., extension or retraction) of one or more portions of the end cap 230. A portion of the second movable body 213 may at least partially extend into the handle slot 215. The handle slot 215 may extend longitudinally through at least a portion of the first movable body 210 of the handle 203. In some aspects, although not shown, one or more portions of the handle 203 (e.g., the first movable body 210) may include one or more biasing elements (e.g., one or more springs), for example, such that the second movable body 213 is proximally biased relative to distal movement of the first movable body 210. In these aspects, when the user releases distal pressure or force on the second movable body 213, the one or more biasing elements can bias the second movable body 213 proximally, for example, to Figure 5A In addition, at least a portion of the second movable body 213 can be coupled to (eg, directly or indirectly) or otherwise connected to the actuation wire 222 .

[0067] The second movable body 213 may include one or more lugs or features 213A that may help facilitate the user's grasping and / or movement of the second movable body 213. Thus, the movement of the user's fingers controls the position of the second movable body 213 relative to the first movable body 210, and thus controls the movement of one or more portions of the actuation wire 222 and / or the end cap 230. For example, the user may grasp and / or move the second movable body 213 using one or more fingers of the user's other hand.

[0068] Although not shown, the fixed body 212, the first movable body 210 and / or the second movable body 213 may include a Figure 1The indicator may include, for example, an indentation, a raised surface, a marking, etc. The indicator may physically or visually indicate the actuation or extension of the end cap 230. For example, when the first movable body 210 is advanced distally relative to the fixed body 212, thereby actuating at least a portion of the end cap 230, the first movable body 210 may have to overcome, for example, an indicator on the fixed body 212. The indicator on the fixed body 212 may signal to the user that the first portion of the end cap 230 has been actuated or that the first portion of the end cap 230 is in an extended position. Similarly, when the second movable body 213 is advanced distally relative to the first movable body 210, thereby actuating at least a second portion of the end cap 230, the second movable body 213 may have to overcome, for example, an indicator on the first movable body 210. Additionally or alternatively, the user may utilize markings or other visual indicators on the handle 203 to determine the state, position, actuation state, etc. of one or more portions of the end cap 230. An indicator on the first movable body 210 may signal to the user that the second portion of the end cap 230 has been actuated or is in the extended position.

[0069] Endoscope 225 can have any of the characteristics of endoscope 125. The connector ring 219 can be coupled to the outer surface of endoscope 225 by techniques such as, for example, adhesives, mechanical fit, snap fit, press fit, welding, or any other technique well known in the art. The connector ring 219 can, for example, provide an anchor for the end cap 230 to the endoscope 225. The connector ring 219 can be composed of a rigid or semi-rigid material (e.g., stainless steel, titanium, polypropylene plastic, high-density polyethylene plastic, acrylic resin, aluminum, brass, etc.). The connector ring 219 can be of a size large enough to receive, for example, the distal end 225C of the endoscope 225. In a first (e.g., retracted) configuration, as shown in FIG. Figure 5A As shown, the proximal side of the outer cap 232 can be adjacent to or touch the distal side of the coupler ring 219.

[0070] Similar to the previous embodiment, the end cap 230 may include an outer cap 232 and an inner cap 234 that is movable relative to the outer cap 232. The support structure 242 may extend partially or completely around a portion of the inner cap 234, for example, between the outer cap 232 and the inner cap 234. The inner cap 234 may include a cavity 238 that extends from the proximal end to the distal end of the inner cap 234. Although not shown, the inner cap 234 may include a proximal wall and / or a distal wall, similar to the proximal wall 135 and the distal wall 136 of the previous embodiment. The patch 240 may be positioned on the outer surface of the support structure 242. In the first form, the patch 240 may be confined between the inner cap 234 and the outer cap 232, for example, radially outside the support structure 242.

[0071] like Figure 5B As shown, the control element 220 can extend through the coupling ring 219 and be coupled to the proximal side 233 of the outer cap 232. The proximal side 233 can include an opening 221, for example, to Figure 5A The first configuration shown is configured to receive the distal portion of the endoscope 225 and / or to Figure 5B The second configuration shown allows fluid to flow through the cavity 238 of the outer cap 232 and the inner cap 234.

[0072] By moving the first movable body 210 distally in the handle 203, as shown in FIG. Figure 5A As shown, the control element 220 can be extended distally relative to the control sheath 218. Therefore, when the control element 220 is extended distally relative to the control sheath 218, the outer cap 232 and the inner cap 234 are extended distally relative to the distal end 225D of the endoscope 225. For example, in the second configuration, the outer cap 232 and the inner cap 234 extend beyond the distal end 225D by about 1 cm to about 4 cm, for example, about 2 cm. In the second configuration, the patch 240 can remain constrained between the inner cap 234 and the outer cap 232, for example, radially outside the support structure 242.

[0073] Fig. 6A and Figure 6B It is shown that in the third state ( Fig. 6A ) and the fourth form ( Figure 6B ) is a stereoscopic view of the medical system 200 in FIG. 2 . For example, in the third form, the inner cap 234 of the end cap 230 extends distally beyond the distal end of the outer cap 232. For example, in the third form, one or more activation wires 222 extend distally relative to the control element 220. The actuation wire 222 can be radial within the control element 220. The actuation wire 222 can be coupled to a proximal portion of the inner cap 234. Additionally or alternatively, the actuation wire 222 can be coupled to a middle portion and / or a distal portion of the inner cap 234. Thus, extending the actuation wire 222 distally beyond the control element 220 extends the inner cap 234 relative to the outer cap 232.

[0074] The extension of the actuation wire 222 can be achieved by, for example, enabling the second movable body 213, such as Figure 5A As shown, the inner cap 234 is moved distally relative to the first movable body 210. Therefore, extending the inner cap 234 relative to the outer cap 232 causes expansion or actuation of the support structure 242. The first movable body 210 can include one or more indicators, for example, adjacent to the slot 215, which corresponds to the position of the second movable body 213 in the slot 215. Therefore, the indicator can correspond to the position where the inner cap 234 is positioned relative to the outer cap 232, so that the support structure can expand radially outward.

[0075] The support structure 242 can expand in a manner similar to that described above with respect to the support structure 142 of the first embodiment. For example, when the inner cap 234 is extended, the support structure 242 can no longer be constrained by the inner wall of the outer cap 232. Therefore, the support structure 242 can be pushed radially outward or away from the inner cap 234. When the outer wall of the support structure 242 is pushed radially outward, the patch 240 can be pushed against the target tissue and / or otherwise released or deployed, such as Figure 6B shown.

[0076] like Figure 6B As shown, once the patch 240 is released or deployed, the inner cap 234 is retracted or pulled proximally within the outer cap 232, thereby retracting the actuation wire 222 within the control element 220. Additionally, the outer cap 232 is retracted or pulled proximally so that the proximal side 233 is adjacent to or touches the distal side of the coupling ring 219, similar to the first configuration. The distal portion of the endoscope 225 can be received by the opening 221 of the outer cap 232. In this configuration, the control element 220 can be retracted within the control sheath 218.

[0077] The medical system 200 may also be used to perform one or more steps of the method 300, except as described below. For example, once the medical system 200 is inserted into the body, additional steps may be required to extend the outer cap 232 and the inner cap 234 to the second configuration, such as Figure 5B Once in the desired position, the inner cap 234 can be extended to release the patch 240. Similar to the previous embodiment, before releasing the patch 240, the inner cap 234 and / or the endoscope 225 can be retracted or repositioned one or more times to reposition the inner cap 234 within the subject. However, once the patch 240 is released, the user can retract the inner cap 234 within the outer cap 232 and retract the outer cap 232 relative to the endoscope 225, as shown. Figure 6B The medical system 200 may then be removed from the subject.

[0078] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed apparatus without departing from the scope of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed invention. It is intended that the specification and examples be considered exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical device, include: A handle, wherein the handle comprises a movable body and a fixed body; an end cap, the end cap comprising an inner cap and an outer cap, wherein the inner cap is coupled to the movable body through a control element, so that movement of the movable body relative to the fixed body causes the inner cap to extend relative to the outer cap; as well as A patch is disposed between the inner cap and the outer cap such that movement of the inner cap relative to the outer cap at least partially deploys the patch.

2. The medical device of claim 1, further comprising a support structure partially surrounding a portion of the inner cap, and wherein distal movement of the inner cap relative to the outer cap causes the support structure to expand.

3. The medical device of claim 2, wherein the support structure comprises a woven shape memory material.

4. The medical device of any preceding claim, wherein the inner cap comprises a proximal wall and a distal wall extending radially outwardly from the inner cap, in, In a first configuration, an outer edge of the distal wall of the inner cap abuts an inner edge of the outer cap, and wherein in a second configuration, the outer edge of the distal wall of the inner cap is distal to the inner edge of the outer cap.

5. The medical device of any preceding claim, wherein the control element is movably disposed within the lumen of the sheath. The medical device of claim 5 , wherein the sheath is coupled to the outer cap.

7. The medical device of any preceding claim, wherein the end cap is removably coupled to the endoscope by one or more fasteners, adhesives, or a friction fit.

8. The medical device of any preceding claim, wherein the inner cap comprises a cavity extending from a proximal end to a distal end.

9. The medical device of any preceding claim, wherein the patch comprises an adhesive on a side of the patch facing away from the inner cap.

10. The medical device of any preceding claim, wherein the patch comprises a haemostatic agent.

11. The medical device of any preceding claim, wherein at least a portion of the end cap is transparent.

12. The medical device of any preceding claim, further comprising a coupler ring coupled to a proximal side of the end cap via one or more sheaths, wherein the end cap is movable relative to the coupler ring.

13. The medical device of claim 12, wherein the coupler ring is configured to couple to an outer surface of an endoscope.

14. The medical device of claim 13, wherein in a third configuration, the end cap is distal to the distal end of the endoscope.

15. The medical device of any preceding claim, wherein an outer edge of the inner cap forms a gradually changing stop surface.

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