Medical systems, devices, and related methods

Abstract

A medical device includes a handle including a main body and a movable body; a sheath element coupled to the handle; an actuating element disposed within the sheath element; a tip cap configured to be coupled to a distal end of another medical device; and a patch positioned on the end cap and coupled to the actuating element. The patch includes a mesh and an expandable structure coupled to the mesh. The expandable structure is configured to be coupled to the actuation element, and the expandable structure is further configured to retract and expand the mesh.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 379,796, filed on Oct. 17, 2022, under 35 U.S.C. § 119, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to systems, devices, and methods for delivering patches. More specifically, aspects of the present invention relate to systems, devices, and / or methods for delivering patches via a medical device, such as an endoscope, for example, for hemostasis. Background Art

[0003] Bleeding ulcers, for example, in the gastrointestinal (GI) tract of a subject, are generally difficult to manage and / or provide hemostasis. For example, common treatments for bleeding ulcers include injection therapy, thermal therapy, mechanical therapy, and hemostatic powders. Such therapies are often expensive and / or time-consuming. In addition, such therapies may not be able to treat a large surface area, such as a large ulcer in the GI tract. Additionally, a common treatment for chronic ulcers is gastric bypass surgery. Such surgery may be more difficult, time-consuming, expensive, and / or less effective / less precise compared to minimally invasive surgery for positioning a patch at one or more ulcers. Accordingly, there is a need for systems, devices, and / or methods for positioning and / or deploying one or more hemostatic patches on one or more parts of a subject. Summary of the Invention

[0004] The present invention includes medical systems and devices that include a biocompatible patch, and methods of use thereof, such as methods of delivering the patch to a target site of a patient to, for example, aid in healing an ulcer and / or perform hemostasis.

[0005] In one or more examples, a medical device can include a handle that includes a body and a movable body; a sheath element coupled to the handle; an actuation element disposed within the sheath element; a tip cap configured to couple to a distal end of another medical device; and a patch positioned on the tip cap and coupled to the actuation element. The patch can include a mesh, and an expandable structure can be coupled to the mesh. The expandable structure can be configured to couple to the actuation element, and wherein the expandable structure can also be configured to retract and expand the mesh.

[0006] Any of the medical devices described herein may include any of the following features. A release mechanism may be coupled to the expandable structure. The release mechanism may also be coupled to a pull wire radially disposed within the actuation element. The handle may include a portion configured to separate the pull wire from the actuation element such that the pull wire moves independently of the actuation element. The release mechanism may include a ball and yoke, where the ball may be coupled to the distal end of the pull wire and where the ball may be configured to fit within a slot disposed in the yoke. The ball may be configured to separate from the yoke to release the expandable structure from the actuation element. The expandable structure may include a star configuration. The star configuration may include at least four pointed segments. The expandable structure may include a shape memory material. The actuation element may be configured to move the patch from a first position to a second position. When the patch is in the first position, the patch may be positioned on the end cap, and where when the patch is in the second position, the patch may be located in a position distal to the distal end of the end cap. The patch may be configured to be in a retracted configuration when in the first position. The patch may be configured to expand to an expanded configuration when in the second position. The patch may also include a central opening. The patch may be at least partially transparent.

[0007] According to another example, a method of delivering a biocompatible patch to a target site of a patient may include introducing a medical system into a lumen of the patient, the medical system including an endoscope; a medical device including a handle having a movable body and a body; an end cap coupled to the distal end of the endoscope; a sheath element coupling the handle to the end cap; an actuation element disposed within the sheath element; and a patch including a biocompatible mesh and an expandable structure. A release mechanism may be coupled to each of the expandable structure and the actuation element. The method may also include positioning the distal end of the endoscope adjacent to the treatment site, moving the patch from a first position to a second position by moving the movable body of the handle distally relative to the medical device, and releasing the patch from the medical device, where releasing the patch from the medical device may include separating at least a portion of the release mechanism from the expandable structure.

[0008] Any of the methods described herein may include any of the following features. The medical device may further include a pull wire disposed within and coupled to the actuation element, where the pull wire may also be coupled to the release mechanism, where the handle may further include a separation portion configured to separate the pull wire from the actuation element such that the pull wire moves independently of the actuation element, and where releasing the patch from the medical device may include engaging the release mechanism by separating the pull wire from the actuation element and separating the pull wire from the release mechanism. The distal end of the endoscope may include a visualization device, and the method may further include visualizing the second position relative to the treatment site with the visualization device, moving the patch from the second position back to the first position, and repositioning the distal end of the endoscope adjacent to the target site.

[0009] According to another example, a medical device may include a handle disposed at a proximal end of the medical device. The handle may include a body, a movable body, and a separation mechanism. The medical device may further include a sheath element; an actuation element disposed within the sheath element and coupled to the separation mechanism; a pull wire disposed within the actuation element and coupled to the separation mechanism; an end cap configured to be coupled to a distal end of another medical device; and a patch positioned on the end cap. The patch may include a biocompatible mesh, an expandable structure coupled to the biocompatible mesh, and a release mechanism coupled to each of the expandable structure and the pull wire. The expandable structure may be configured to expand the patch.

[0010] Any one of the medical devices described herein may include any one of the following features. The release mechanism may include a yoke portion and a ball portion configured to fit within a slot of the yoke portion. The ball portion may extend from the pull wire.

[0011] Any one of the examples described herein may have any one of these features in any combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the invention and, together with the description, serve to explain the principles of the invention.

[0013] Figure 1A A perspective view depicting an exemplary medical system including an exemplary medical device and an endoscope, according to some embodiments.

[0014] Figure 1B Shows a perspective view of a distal portion of an exemplary medical system, according to some embodiments Figure 1A of.

[0015] Figure 2A A perspective view depicting a distal portion of an exemplary medical system, according to some embodiments.

[0016] Figure 2B A perspective view depicting a distal portion of an exemplary medical system, according to some embodiments Figure 2A of.

[0017] Figure 3 A top view depicting an exemplary patch, according to some embodiments.

[0018] Figure 4 A perspective view depicting an exemplary release mechanism of a medical device, according to some embodiments.

[0019] Figure 5 A perspective view depicting a ball portion of an exemplary release mechanism, according to some embodiments Figure 4 of.

[0020] Figure 6 depicts a perspective view of a yoke portion of an exemplary release mechanism in accordance with some embodiments Figure 4 of.

[0021] Figure 7 is a block diagram depicting an exemplary method of using an exemplary medical device to deliver a biocompatible patch in accordance with some embodiments

[0022] Figure 8 depicts a perspective view of a portion of a handle for manipulating a medical device in accordance with some embodiments DETAILED DESCRIPTION

[0023] Reference will now be made in detail to 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 like parts. The term "distal" refers to the portion that is farthest from the user when the device is introduced into a subject (e.g., a patient) body. Conversely, the term "proximal" refers to the portion that is closest to the user when the device is placed in the subject body

[0024] The foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "has," "including," or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include 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," "generally," and "approximate" are used to represent a possible variation of ±10% of the stated value or characteristic

[0025] Figure 1A depicts a perspective view of a medical system 100 that, for example, includes a medical device 110 and an endoscope 140 that may be coupled to the distal end of the medical device 110. As discussed in detail herein, the medical device 110 may include a patch delivery system or otherwise be coupled to a patch delivery system, for example, to position and / or deliver a patch 200( Figure 1B and Figure 2B as shown). The patch delivery system may be disposed on the distal end of the endoscope 140 such that the patch 200 may be positioned and / or delivered to one or more portions of tissue within a subject, which may assist in performing hemostasis within the subject. Additionally, the medical device 110 may be coupled to one or more portions of the endoscope 140, such as the distal portion 148 of the endoscope 140, to deliver one or more portions of the medical device 110 to a treatment site

[0026] The endoscope 140 may include a flexible tubular shaft 141. The flexibility of the shaft 141 may be sufficient to allow the shaft 141 to bend to facilitate navigating the shaft 141 through the tortuous anatomical passageways of a subject. The shaft 141 may terminate in a distal portion 148 and may have any suitable length. The endoscope 140 may also include one or more lumens extending therethrough and one or more openings in communication with the one or more lumens (such as, an opening, e.g., a working channel 143 at the distal face 149 of the endoscope 140, as Figure 2A shown).

[0027] Although the treatment site discussed herein is in the GI tract of a subject, the present invention is not limited thereto, as the treatment site may be any lumen, organ, cavity, or other tissue within the body of a subject. Additionally, although the endoscope is referenced herein, 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 ultrasound ("EUS") scope, colonoscope, bronchoscope, laparoscope, arthroscope, cystoscope, aspiration scope, sheath, or catheter.

[0028] Still referring to Figure 2A , the endoscope 140 may have a diameter of from about 9 mm to about 15 mm, e.g., from about 10.5 mm to about 12 mm. As mentioned, the endoscope 140 may include one or more lumens, e.g., a working channel 143 having a diameter of from about 2 mm to about 4 mm, e.g., about 2.8 mm. Additionally, the distal face 149 of the endoscope 140 may include one or more lighting devices 144 (e.g., one or more LEDs, optical fibers, and / or other illuminators) and / or one or more visualization devices 142 (e.g., one or more cameras, one or more image sensors, endoscopic viewing elements, optical assemblies including one or more image sensors and one or more lenses, etc.).

[0029] Returning to Figure 1A, the medical device 110 may include a handle assembly 120 and a tip cap 130. The tip cap 130 may be coupled to the distal portion 148 of the endoscope 140 at the distal end 104 of the medical system 100. For example, the tip cap 130 of the medical device 110 may be coupled to the distal portion 148 (e.g., the distal end) of the endoscope 140 and may have a size and / or shape configured to couple to (e.g., radially surround) the distal portion 148 of the endoscope 140. The tip cap 130 may be coupled to the endoscope 140 before inserting the endoscope 140 into a subject such that the tip cap 130 and the distal portion 148 of the endoscope 140 may be delivered to the treatment site. Then, the user may manipulate one or more portions of the handle assembly 120 to control (e.g., extend or retract) one or more portions of the tip cap 130. Additionally, although not shown, the endoscope 140 may include one or more proximal controls (dials, levers, buttons, etc.) to, for example, extend or retract, deflect, or otherwise control the position of the distal portion 148 of the endoscope 140 and thus control the position of the tip cap 130.

[0030] In some embodiments, the handle assembly 120 may be located at the proximal end 102 of the medical device 110 and may include a body 121 and a movable body 122. The body 121 may be generally cylindrical and may include a ring portion 123 at the proximal most end of the body 121. The ring portion 123 may be configured to receive one or more of the user's fingers to facilitate gripping the handle assembly 120. The body 121 may include one or more ridged portions 124, for example, configured to facilitate clamping the body 121. The body 121 may also include a slot 125, for example, extending longitudinally through a portion of the body 121. The slot 125 may be configured to movably receive a portion of the movable body 122. The distal portion 126 of the body 121 may include a coupler portion 127, which may be cylindrical and may assist in coupling the actuator assembly 112 to the body 121. The movable body 122 may be cylindrical, may be hourglass-shaped, and may be configured to receive one or more fingers to facilitate movement of the movable body 122 relative to the body 121.

[0031] The actuator assembly 112 may be configured to move proximally and distally through the coupler portion 127. The actuator assembly 112 may include a sheath element, such as an outer sheath 114, and an actuator element, such as an inner sheath 116, which is movably disposed within the outer sheath 114. The inner sheath 116 may be configured to move proximally and distally within the outer sheath 114 relative to the medical device 110 and may be coupled to a separation mechanism 128. The separation mechanism 128 may be disposed on the body 121, for example, distal to the movable body 122.

[0032] In some embodiments, the pull wire 118 can be disposed within and removably coupled to the inner sleeve 116 and can be configured to move simultaneously with the inner sleeve 116. The pull wire 118 can also be coupled to a detachment mechanism 128, and the detachment mechanism 128 can be manipulated to detach the pull wire 118 from the inner sleeve 116 to allow the pull wire 118 to move independently of the inner sleeve 116, as will be discussed in more detail below.

[0033] Although not shown, a lumen can extend through the body 121 and the coupling portion 127, for example, to allow the actuator assembly 112 to be positioned within and move within the body 121. The proximal end of the actuator assembly 112 can be coupled to the movable body 122. In these aspects, the longitudinal proximal and / or distal movement of the movable body 122 relative to the body 121 can cause the actuator assembly 112 to move proximally and / or distally, respectively. For example, the distal movement of the movable body 122 can cause the inner sleeve 116 to move distally at the same time.

[0034] Figure 1B , Figure 2A and Figure 2B Various aspects of the end cap 130, endoscope 140, and patch 200 are shown. However, it should be noted that Figure 2A The patch 200 is omitted in order to illustrate various aspects of the endoscope 140. Figure 2B As shown in FIG. 1 , in some embodiments, the patch 200 can be releasably coupled to the distal end 131 of the end cap 130. As discussed below, the patch 200 can be releasably coupled to the inner sleeve 116 ( Figure 8 ). The release mechanism can be fixed to the expandable structure 210 within the patch 200. In some examples, advancing the movable body 122 proximally relative to the body 121 can be configured to move the patch 200 from a first position, e.g., proximal to the distal end 131, e.g., Figure 1A and Figure 1B As shown, transitioning to a second position, for example, a position distal to the distal end 131 of the end cap 130 .

[0035] In some embodiments, the end cap 130 can be coupled to the distal portion 148 of the endoscope 140, for example, via a friction fit, adhesive, press fit, crimping, or any other suitable coupling mechanism. Additionally, the end cap 130 can receive the location of one or more of the sheath elements, for example, the outer sleeve 114 and the actuation element, for example, the inner sleeve 116.

[0036] Additionally, the end cap 130 can include an end cap ring 132. For example, the end cap ring 132 can extend radially outward from the end cap 130, e.g., between the proximal portion 133 of the end cap 130 and the distal end 131 of the end cap 130. Additionally, one or more portions of the end cap ring 132 can include radiopaque material (e.g., one or more markers, one or more gradients, etc.), or otherwise assist the user in visualizing the end cap ring 132 or other portions of the end cap 130. In some aspects, the outer sheath 114 can be coupled (e.g., fixedly coupled) to the end cap 130, e.g., to the end cap ring 132 (e.g., via friction fit, adhesive, press fit, crimping, or any other suitable coupling mechanism). In some embodiments, as Figure 2A and Figure 2B shown in, the distal end (not shown) of the outer coil 114 can be coupled to the end cap ring 132 within a corresponding through hole 134 that extends through the end cap ring 132. When the inner sheath extends through the outer sheath 114, the inner sheath 116 can extend through the through hole 134.

[0037] Figure 3 A top view of the patch 200 in the expanded configuration is shown, as described above. The patch 200 can be a biodegradable and / or biocompatible patch having any suitable shape and any suitable size, e.g., based on the nature of the target tissue site. The patch 200 can be flexible and can have any shape, such as approximately square, approximately rectangular, square with rounded corners, rectangular with rounded corners, oval, circular, and other possible shapes. In some embodiments, the patch 200 can be at least partially transparent.

[0038] In some examples, the thickness of the patch can be on the order of millimeters, e.g., in the range of about 0.1 mm to about 5.0 mm, or more specifically, about 0.7 mm to about 2.0 mm. The patch 200 can be sized sufficiently to cover the target tissue and have an edge for excision. Thus, the patch 200 can have a variety of sizes to accomplish such a task. In some aspects, the patch 200 can be about 50 mm × 50 mm (i.e., about 2 inches × 2 inches).

[0039] Patch 200 can have any suitable color, including transparent, and can be formed of any suitable material, e.g., a mesh, netting, cloth, gelatin, or polysaccharide (chitosan, cellulose, starch, alginate, etc.), which can be further modified with synthetic biocompatible materials (pHEMA, PGA, PLA, PCA, PEG, etc.). In some aspects, patch 200 can be formed of a bioadhesive material, e.g., a composite of chitosan, modified chitosan, cellulose, pHEMA, PVA, PEG, or one or more of these polymers. Additionally, for example, patch 200 can be composed of polypropylene, polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and / or silicone.

[0040] In some embodiments, patch 200 can be adhered to the target tissue using materials or fluids well known in the art, such as, for example, fibrin glue, hydrogel, and / or cyanoacrylate. Alternatively or additionally, patch 200 can be composed of a reagent and / or administered with a reagent to prevent cells from detaching from the target tissue or to treat the target site. In some aspects, patch 200 can include a therapeutic agent, e.g., an antibiotic and / or a hemostatic agent. Further, after patch 200 is delivered to the treatment site, a user can spray, apply, or otherwise deliver one or more hemostatic agents (e.g., one or more hemostatic powders), e.g., through the working channel 143 of the endoscope 140 or another medical device. Additionally, patch 200 can be adhered to the tissue within the treatment site using materials well known in the art, such as, for example, fibrin glue, hydrogel, and / or cyanoacrylate.

[0041] Still referring Figure 3 , patch 200 can include an expandable structure 210 coupled to a mesh 220. The expandable structure 210 can be coupled to the mesh 220 by an adhesive or by any other suitable securing mechanism. For example, in some embodiments, the expandable structure 210 can be intertwined with the mesh 220. Alternatively, in some embodiments, the expandable structure can be secured to the mesh 220 using cords or can be fixed to the mesh 220 using UV curing techniques. In some embodiments, the expandable structure 210 can include at least one narrowing section or tip section, e.g., tip sections 212A-D. In some embodiments, the expandable structure 210 can be formed in the shape of a four-pointed star and include at least four tip sections 212A-D. However, the expandable structure 210 can be formed in any shape and / or can include any number of tip sections, e.g., two, three, five, six, etc., e.g., as Figure 2B shown, where the expandable structure 210 includes seven tip sections 212A-G.

[0042] The expandable structure 210 can provide rigidity to the mesh 220 and can transition from a retracted state (e.g., as shown in Figure 1A and Figure 1B where the distal end of the inner cannula 116 only extends to the distal end 131 of the end cap 130) to a deployed or expanded state ( Figure 2B and Figure 3 ). In the retracted state, the expandable structure 210 can be configured to be adjacent to or otherwise positioned near the distal end 131 of the end cap 130. For example, as shown in Figure 1B , the expandable structure 210 can be positioned above the end cap 130, and the tip segments 212A-D can be in a bent or retracted position on the sidewall 135 of the end cap 130, thereby helping to ensure that the patch 200 remains flush with the end cap 130 before the patch 200 is delivered to the treatment site. However, when the patch is delivered to the treatment site, the expandable structure 210 can transition from the retracted state ( Figure 1A and Figure 1B ) to the expanded state ( Figure 2B ). In the expanded state, the expandable structure 210 can open radially such that the patch 200 can lie flat against the treatment site. By holding the expandable structure 210 in the retracted state against the end cap 130, the patch 200 can have a larger size than other mesh patches used to treat ulcers because the patch 200 does not need to travel through the working channel 143 of the endoscope 140. Thus, larger treatment sites can be treated using the patch 200. By being coupled to the end cap 130 and delivered to the treatment site rather than through the working channel 143 of the endoscope 140, the patch 200 does not pose a risk of jamming or otherwise damaging the working channel 143. In some embodiments, the expandable structure 210 can be made of a shape memory alloy or material, such as nitinol, which can assist the structure in expanding from the retracted state to the expanded state.

[0043] In some embodiments, the patch 200 can additionally include a central opening 214 that extends through a central portion of the mesh 220. The central opening 214 can include a diameter that is substantially equal to the diameter of the visualization device 142, is disposed on the distal face 149 of the endoscope 140, and can be positioned above the visualization device 142 such that the visualization device 142 is not blocked by the patch mesh 220.

[0044] As shown in Figures 4 to 6 , the medical device 110 can additionally include a release mechanism 400, e.g., which is configured to releasably couple the patch 200 to the medical device 110. Figure 4 A view of the release mechanism 400 in the coupled configuration is depicted, where the ball portion 401 shown in detail in Figure 5 is disposed in Figure 6within the yoke portion 404 shown in detail.

[0045] In some embodiments, the release mechanism 400 can assist in coupling the patch 200 to the end cap 130 while the expandable structure 210 is in the retracted position. The release mechanism 400 can also assist in releasing the patch 200 from the end cap 130 when the expandable structure 210 is in the extended position, e.g., when the patch 200 extends distally from the end cap 130 ( Figure 2B ) and is being delivered to the treatment site.

[0046] In some embodiments, the release mechanism 400 can include a ball portion 401 extending from the pull wire 118. The distal end of the ball portion 401 can include a ball 403. The pull wire 118 can be movably positioned within the inner cannula 116 and can extend to the handle assembly 120 ( Figure 1A ). The release mechanism 400 can also include a yoke portion 404, which can be configured to couple to the expandable structure 210 of the patch 200. The yoke portion 404 can be coupled to the expandable structure 210 via an opening 410 disposed in the distal portion 409 of the yoke portion 404. For example, the distal portion 409 can surround a portion 211 of the expandable structure 210. In some embodiments, the diameter of the opening 410 can be greater than the diameter of the portion 211 of the expandable structure 210, which can allow the release mechanism 400 to move or slide along the expandable structure 210 as the expandable structure 210 transitions from the retracted state to the expanded state.

[0047] The yoke portion 404 can additionally include a slot 406, e.g., in the proximal portion 405 of the yoke portion 404. The yoke portion 404 can be configured to receive the ball 403 of the ball portion 401. The slot 406 can additionally include a substantially circular opening 407 located at the distal end of the slot 406. The diameter of the opening 407 can be greater than the diameter of the ball 403 such that the ball 403 can be inserted into the slot 406 via the opening 407, but the ball 403 can then be fixed within the elongate portion 411 of the slot 406. The width of the elongate portion 411 can be approximately equal to the diameter of the ball 403. Thus, prior to release, the ball 403 can be snugly fitted within the elongate portion 411 of the slot 406, e.g., such that one or more portions of the ball 403 abut portions of the elongate portion 411. In some embodiments, the ball portion 401 can additionally include a tapered portion 402 extending from the pull wire 118 to the ball 403. The angle of the tapered portion 402 can facilitate insertion of the ball portion 401 into the opening 407 since the width of the tapered portion 402 can be less than the width of the elongate portion 411.

[0048] Additionally, the yoke portion 404 may further include a central portion 408 disposed between the proximal portion 405 and the distal portion 409. Each of the proximal portion 405 and the distal portion 409 may be coupled to the central portion 408. In some embodiments, the central portion 408 may be cylindrical or circular; however, the central portion 408 may be formed in any suitable shape.

[0049] As will be discussed in more detail below, for example with respect to Figure 7 and Figure 8 discussed, in some embodiments, the ball portion 401 may be separated or detached from the yoke portion 404 so as to separate the patch 200 from the end cap 130. For example, the ball portion 401 may be completely removed from the yoke portion 404. Alternatively, in some embodiments, the ball portion 401 may be configured to break at the tapered portion 402, thereby separating the ball portion 401 from the yoke portion 404.

[0050] As Figure 7 shown in the flowchart depicted in Figure 8 below, in some embodiments, the patch 200 may be positioned and repositioned prior to being deployed to the treatment site according to method 700. For example, as Figure 8 shown, the inner coil 116 may be connected to a separation mechanism 128, which may include, for example, a spool 119 including a knob 129. The end cap 130 may be delivered and positioned at the treatment site using the medical system 100 by introducing the medical device 110 into a patient's cavity, such as at step 702. Once the medical device 110 is introduced into the cavity, the user may move the patch 200 using the movable body 122 of the handle assembly 120, such as at step 704, which is achieved by pushing the movable body 122 in the distal direction. As the inner cannula 116 moves distally, the patch 200 may move distally away from the end cap 130 toward the treatment site, thereby transitioning the expandable structure 210 from the retracted position to the expanded position. Once the patch 200 has moved away from the end cap 130, the user may attach the patch 200 to tissue within the treatment site, such as at step 706. Once the patch 200 is attached to tissue within the treatment site, the user may evaluate the position of the patch 200, such as at step 708, since the visualization device 142 on the endoscope 140 may be unobstructed. If the user wishes to reposition the patch 200 once the position of the patch 200 has been determined, such as at step 710, the movable body 122 of the handle assembly 120 may be adjusted in the proximal direction to move the patch 200 proximally back toward the end cap 130. Alternatively, in some embodiments, the distal portion 148 of the endoscope 140 may be deflected in the proximal direction, the distal direction, the upward direction, the downward direction, the leftward direction, and / or the rightward direction by adjusting an articulating section (not shown) of the endoscope 140.

[0051] Once the patch 200 has been positioned in the desired location on the treatment site, it can be manipulated, e.g., by rotating the separation mechanism 128 via the knob 129 ( Figure 8 as shown in) to cause the separation mechanism 128 to transition from a first configuration ( Figure 1A and Figure 1B ) to a second configuration ( Figure 8 ). In the first configuration, the pull wire 118 and the inner cannula 116 can be configured to move together, while in the second configuration, the separation mechanism 128 can be configured to lock or fix the position of the inner cannula 116 relative to the movable body 122. Thus, at step 712, for example, the separation mechanism can be engaged such that it is manipulated into the second configuration, in which the position of the pull wire 118 can be adjusted independently of the inner cannula 116. For example, when transitioning the separation mechanism 128 into the second configuration, the user can pull on the end of the pull wire 118, and when the separation mechanism 128 is in the second configuration, the pull wire 118 can move independently of the inner cannula 116. As described above, the ball portion 401 of the release mechanism 400 can be coupled to the pull wire 118. Thus, when the pull wire 118 is pulled proximally with sufficient force relative to the medical device 110, the yoke portion 404 and the slot 406 and / or the proximal face of the central portion 408 of the yoke portion 404 can butt against the distal end of the inner cannula 116, and the ball portion 401 of the release mechanism 400 can break free from the yoke portion 404, thereby releasing or deploying the patch 200 onto the treatment site. Once released, the tip segments 212A-G as Figure 2B shown in can expand, causing the patch 200 to be placed flush against the treatment site.

[0052] After the patch 200 has been deployed to the treatment site, the patch 200 can optionally re-adhere to the tissue within the treatment site, e.g., at step 714, using materials well known in the art such as, for example, fibrin glue, hydrogel, and / or cyanoacrylate. Alternatively or additionally, after delivering the patch 200 to the treatment site, the user can spray, apply, or otherwise deliver one or more hemostatic agents (e.g., one or more hemostatic powders), e.g., via the working channel 143 of an endoscope 140 or another medical device.

[0053] Additionally, in some embodiments, one or more auxiliary medical devices can be used to position the patch 200 relative to the treatment site, and / or the user can, e.g., examine the position of the patch 200 at the treatment site via one or more visualization devices 142 on the endoscope 140. Once the patch 200 has been applied and secured to the treatment site, the medical device 110 can be removed from the patient's body.

[0054] The positioning and deployment of the patch 200 (e.g., via the movable body 122 of the handle assembly 120 and / or by means of the pull wire 118) can be straightforward and user-friendly, which can allow the user to be a surgical technician while the physician performs one or more other tasks during the surgery. Additionally, as discussed above, since the expandable structure 210 can be maintained in a retracted state against the end cap 130, there is no need to deliver the patch 200 to the treatment site via the working channel 143 of the endoscope 140 because it is already positioned on the distal end 131 of the end cap 130. Thus, the patch 200 can have a larger size than other mesh patches used for treating ulcers because there is no risk of the patch 200 getting stuck in the working channel 143 or otherwise damaging the working channel 143. Accordingly, larger treatment sites can be treated using the patch 200.

[0055] Additionally, the ability to position and reposition the patch 200 provides flexibility during the treatment of the patient. For example, if the physician or other operator does not position the patch 200 directly above the treatment site, he or she can simply reposition the patch 200 before deploying it. Further, the patch 200 can be positioned and repositioned via the endoscope 140 or the inner cannula 116, which can allow for enhanced precision in positioning the patch 200. Finally, since the patch 200 can be transparent or can include a central opening 214, the visualization device 142 on the distal face 149 of the endoscope 140 can remain unobstructed, thus facilitating visualization of the treatment site by the physician / operator during positioning and repositioning.

[0056] Although the principles of the present invention are described with reference to illustrative examples directed to a particular application, it should be understood that the present invention is not limited thereto. Persons of ordinary skill in the art and having access to the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Accordingly, the present invention should not be considered limited by the foregoing description.

Claims

1. A medical device, comprising: a handle including a body and a movable body; a sheath element coupled to the handle; an actuation element disposed within the sheath element; a end cap configured to be coupled to a distal end of another medical device; and a patch positioned on the end cap and coupled to the actuation element, the patch including: a mesh, and an expandable structure coupled to the mesh, wherein the expandable structure is configured to be coupled to the actuation element, and wherein the expandable structure is further configured to retract and expand the mesh.

2. The medical device according to claim 1, further comprising a release mechanism coupled to the expandable structure.

3. The medical device according to claim 2, wherein the release mechanism is further coupled to a wire radially disposed within the actuation element.

4. The medical device according to claim 3, wherein the handle includes a portion configured to separate the wire from the actuation element such that the wire moves independently of the actuation element.

5. The medical device according to claim 3 or 4, wherein the release mechanism includes a ball and a yoke, wherein the ball is coupled to a distal end of the wire, and wherein the ball is configured to fit within a slot provided in the yoke.

6. The medical device according to claim 5, wherein the ball is configured to separate from the yoke to release the expandable structure from the actuation element.

7. The medical device according to any one of claims 1 to 6, wherein the expandable structure includes a star configuration.

8. The medical device according to claim 7, wherein the star configuration includes at least four pointed segments.

9. The medical device according to any one of claims 1 to 8, wherein the expandable structure includes a shape memory material.

10. The medical device according to any one of claims 1 to 9, wherein the actuation element is configured to move the patch from a first position to a second position.

11. The medical device according to claim 10, wherein when the patch is in the first position, the patch is positioned on the end cap, and wherein when the patch is in the second position, the patch is located at a position distal to the distal end of the end cap.

12. The medical device according to claim 10 or 11, wherein the patch is configured to be held in a retracted configuration when in the first position.

13. The medical device according to any one of claims 10 to 12, wherein the patch is configured to expand to an expanded configuration when in the second position.

14. The medical device according to any one of claims 1 to 13, wherein the patch further includes a central opening.

15. The medical device according to any one of claims 1 to 14, wherein the patch is at least partially transparent.

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