Medical systems, devices, and related methods

Abstract

A medical device includes a handle, an end cap, and a patch. The handle comprises a movable body and a fixed body. The movable body includes an actuating member. The end cap is configured to be coupled to the distal end of the mirror. The patch is movable relative to the end cap. The patch is coupled to the movable body via one or more control elements such that movement of the movable body extends the patch from the end cap. The patch is also coupled to the actuation member via one or more actuation elements such that movement of the actuation member extends, arcuates, or bends the one or more actuation elements to at least partially deploy the patch.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 379,324, filed Oct. 13, 2022, which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0003] 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, such as patches for hemostasis, via a medical device, such as an endoscope. BACKGROUND ART

[0004] Bleeding ulcers, e.g., in the gastrointestinal (GI) tract of a subject, are often difficult to treat 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, e.g., 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 accurate compared to minimally invasive surgery for positioning a patch at one or more ulcers. Thus, 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

[0005] The present invention includes medical systems and devices that include a biocompatible patch, and methods of using the same, e.g., methods of delivering the patch to a target site of a patient to, e.g., aid in healing an ulcer and / or perform hemostasis.

[0006] In one or more examples, the medical device may include a handle, an end cap, and a patch. The handle may include a movable body and a fixed body. The movable body may include an actuating member. The end cap may be configured to couple to a distal end of a scope. The patch may be movable relative to the end cap. The patch may be coupled to the movable body via one or more control elements such that movement of the movable body may cause the patch to extend from the end cap. The patch may also be coupled to the actuating member via one or more actuating elements such that movement of the actuating member may cause the one or more actuating elements to extend, arch, or bend to at least partially deploy the patch.

[0007] The medical device may include one or more of the following features. The actuating member may be movably positioned within a slot in the movable body of the handle. The end cap may include an outer cap and an inner cap, and the patch may be movably positioned between the outer cap and the inner cap. The inner cap may include tines that extend radially inwardly and are configured to abut the distal face of the lens. The medical device may further include a protective element positioned at the distal end of one or more actuating elements and configured to at least partially seal an opening between the outer cap and the inner cap.

[0008] The patch may include one or more retention grooves configured to receive a portion of one or more actuating elements to couple the patch to the one or more actuating elements. When the patch is in an undeployed configuration, the one or more retention grooves may be positioned on a radially outer portion of the patch. The end cap may include an end cap ring and at least a portion of the end cap may be transparent. One or more of the actuating elements may be formed from a shape memory material.

[0009] The medical device may further include one or more sheath elements coupling the handle to the end cap. Each of the one or more actuating elements may be movably positioned within one of the one or more control elements. Each of the one or more control elements may be movably positioned within one of the one or more sheath elements. Each of the one or more actuating elements may be formed from one or more wires, and each of the one or more control elements may be formed from one or more coils. The movable body of the handle may move within a slot in the fixed body of the handle. The movable body of the handle may include at least one peg. The fixed body of the handle may include at least one hole, and the at least one peg may be configured to engage the at least one hole to at least partially fix the position of the movable body on the fixed body. The position of the at least one hole on the fixed body may correspond to the position on the fixed body where the patch extends from the end cap. The patch may include a hemostatic agent.

[0010] In another aspect, a medical system may include an endoscope and a medical device. The endoscope may include a distal end that includes one or more visualization devices on the distal face. The medical device may include a handle, an end cap, and a patch. The handle may include a movable body and a fixed body. The movable body may include an actuating member. The end cap may be configured to couple to the radially outer portion of the distal end of the endoscope. The patch may be movable relative to the end cap. The patch may be coupled to the movable body via one or more control elements such that movement of the movable body causes the patch to extend from the end cap. The patch may also be coupled to the actuating member via one or more actuating elements such that movement of the actuating member at least partially deploys the patch.

[0011] The medical device may include one or more of the following features. The end cap may include an outer cap and an inner cap. The patch may be movably positioned between the outer cap and the inner cap. The inner cap may include tines that extend radially inward and are configured to abut the distal face of the endoscope. The medical system may further include a protective element positioned at the distal end of one or more actuation elements and configured to at least partially seal an opening between the outer cap and the inner cap. The patch may include one or more retention grooves configured to receive a portion of one or more actuation elements to couple the patch to the one or more actuation elements. Movement of the one or more actuation elements may cause the one or more actuation elements to extend radially outward, bow, or bend and disengage from the one or more retention grooves.

[0012] In yet another aspect, the medical device may include a handle, an end cap, and a patch. The handle may include a movable body and a fixed body. The movable body may include an actuation member that is movable within a slot in the movable body. The end cap may be configured to couple to the distal end of a second medical device. The end cap may include an outer cap and an inner cap. The patch may be movably positioned between the outer cap and the inner cap. The patch may be coupled to the movable body via one or more control elements such that distal movement of the movable body causes the patch to extend from the end cap. The patch may also be coupled to the actuation member via one or more actuation elements such that movement of the actuation member at least partially deploys the patch.

[0013] The inner cap may include tines that may extend radially inward and may be configured to abut the distal face of the second medical device. The patch may include one or more retention grooves that may be configured to receive a portion of one or more actuation elements to couple the patch to the one or more actuation elements. Movement of the one or more actuation elements may cause the one or more actuation elements to extend radially outward, bow, or bend and disengage from the one or more retention grooves, which may at least partially deploy the patch.

[0014] Any of the examples described herein may have any combination of any of these features.

[0015] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. As used herein, the terms "comprising," "containing," "including," or any other variant 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. The term "exemplary" is used in the sense of "example" rather than "model." The term "distal" refers to the direction away from the operator / toward the treatment site, and the term "proximal" refers to the direction toward the operator. The term "about" or similar terms (e.g., "substantially") includes values within + / - 10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

[0017] Figure 1 A perspective view depicting an exemplary medical system including an exemplary medical device and an endoscope.

[0018] Figure 2A and Figure 2B depicts Figure 1 a perspective view of the distal end of the exemplary medical device in Figure 2A depicting the distal end of an exemplary medical device coupled to the distal end of the endoscope.

[0019] Figure 3A and Figure 3B depicts Figure 1 a perspective view of some portions of the distal end of the exemplary medical device in

[0020] Figure 4A shows the actuation of the handle portion of the exemplary medical device in Figure 1 and Figure 4B shows Figure 1 the corresponding movement of the distal portion of the exemplary medical device in

[0021] Figure 5A shows the additional actuation of the handle portion of the exemplary medical device in Figure 1 and Figure 5B shows Figure 1 the corresponding movement of the distal portion of the exemplary medical device in DETAILED DESCRIPTION

[0022] Reference will now be made in detail to embodiments of the invention, aspects of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0023] Figure 1Illustrates a medical system 100, for example including an endoscope 102 and a medical device 104. As discussed in detail herein, the medical device 104 may include a patch delivery system or otherwise be coupled thereto, for example, to position and / or deliver a patch 106 to one or more tissue portions within a subject, which may assist in performing hemostasis within the subject. Additionally, the medical device 104 may be coupled to one or more portions of the endoscope 102, for example, to deliver one or more portions of the medical device 104 to a treatment site. For example, the medical device 104 may include an end cap 108. The end cap 108 may be coupled to the distal portion 102B (i.e., the distal end) of the endoscope 102 such that the end cap 108 and the distal portion 102B of the endoscope 102 may be delivered to the treatment site. Additionally, during delivery, the patch 106 may be positioned within or inside one or more portions of the end cap 108. In Figure 1 a portion of the end cap 108 is omitted to expose the patch 106 and other aspects of the medical device 104. The medical device 104 may include a handle 110, and manipulating one or more portions of the handle 110 may assist in manipulating, positioning, and / or repositioning, releasing or deploying, and / or delivering the patch 106, for example, to position the patch 106 on tissue at the treatment site.

[0024] The endoscope 102 may include a generally cylindrical tubular shape and may include a proximal portion 102A, a distal portion 102B, and an intermediate portion 102C. Although not shown, the proximal portion 102A may include a handle or otherwise be coupled to a handle, for example, including one or more ports, controls, rods, electrical or communication connectors, etc. Additionally, the endoscope 102 may include one or more lumens 112 or working channels, for example, longitudinally extending through the endoscope 102. In these aspects, the lumen 112 or working channel may extend through the proximal portion 102A, the intermediate portion 102C, and the distal portion 102B, for example, terminating distally at one or more distal openings (i.e., at the most distal end of the endoscope 102). As Figure 1 shown, when the medical device 104 including the patch 106 is coupled to the endoscope 102 (i.e., during delivery and positioning), the distal portions of the patch 106 and the medical device 104 may be coupled to the distal portion 102B of the endoscope, for example, coupled to the distal opening of the lumen 112 and / or extending distally beyond it.

[0025] The endoscope 102 (i.e., the distal portion 102B of the endoscope 102) may include a diameter of from about 9 mm to about 15 mm, for example, from about 10.5 mm to about 12 mm. The end cap 108 may include a size and / or shape configured to couple to (e.g., radially surround) the distal portion 102B of the endoscope 102. As mentioned, the endoscope 102 may include one or more lumens 112, for example, a working channel having a diameter of from about 2 mm to about 4 mm, for example, about 2.8 mm. Additionally, as Figure 2A shown, the endoscope 102, for example, the distal face 102D of the endoscope 102 may include one or more illumination devices 114 (e.g., one or more LEDs, optical fibers, and / or other illuminators) and / or one or more visualization devices 116 (e.g., one or more cameras, one or more image sensors, endoscope viewing elements, optical assemblies including one or more image sensors and one or more lenses, etc.).

[0026] Although not shown, the endoscope 102 may include one or more grooves, channels, cavities, and / or other features for movably receiving one or more of the control element 120, the actuation element 122, and / or the sheath element 124. Additionally, although not shown, one or more portions of the endoscope 102 (i.e., the distal portion 102B) may be deflectable, for example, via one or more knobs or other controls on the proximal handle. In these aspects, the distal portion 102B of the endoscope 102 may be manipulated when delivered to the treatment site and / or positioned relative to the treatment site, for example, in a retroflexed position, such as when the treatment site is in the esophagus, stomach, duodenum, colon, or other part of the GI tract of a subject.

[0027] Although the treatment site is discussed as being in the GI tract of a subject, the present invention is not limited thereto, as the treatment site may be any lumen or other tissue within the subject's body. 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] As Figure 1As shown, the medical device 104 includes a tip cap 108 and a handle 110. One or more control elements 120 and one or more actuation elements 122 may extend from one or more portions of the handle 110 to one or more portions of the tip cap 108. Each of the control elements 120 may be formed of a coil, a tube, a sheath, etc. Each of the actuation elements 122 may be formed of a wire, a coil, a rod, etc. Additionally, one or more sheath elements 124 may also extend from one or more portions of the handle 110 to one or more portions of the tip cap 108. Each of the sheath elements 124 may be formed of a coil, a tube, a sheath, etc. In these aspects, each control element 120 may be radially located within a corresponding sheath element 124. Further, each actuation element 122 may be radially located within a corresponding control element 120.

[0029] As mentioned above and discussed in detail below, the patch 106 may be movably coupled to the tip cap 108. For example, movement of one or more of the control elements 120 may cause the patch 106 to extend, retract, or otherwise be positioned relative to the tip cap 108. Additionally, in some aspects, movement of one or more of the actuation elements 122 may assist in releasing or deploying the patch 106 from the tip cap 108, e.g., to deliver the patch 106 to a treatment site, which may assist in performing hemostasis.

[0030] The handle 110 includes a first or stationary body 126 and a second or movable body 128. Movement of the movable body 128 relative to the stationary body 126 may control the movement (i.e., extension or retraction) of one or more of the control elements 120 and, thus, may control the movement (i.e., extension or retraction) of the patch 106. In some aspects, the handle 110 may include one or more biasing elements (not shown) such that distal movement of the movable body 128 relative to the stationary body 126 is biased proximally. In these aspects, when the user releases the distal pressure on the movable body 128, one or more biasing elements may cause the movable body 128 to move proximally, e.g., to the Figure 1 position shown.

[0031] Additionally, the handle 110 may include an actuation member 130 that is movable relative to a portion of the movable body 128. For example, the actuation member 130 may move within a slot 132 located within the movable body 128. The slot 132 may extend longitudinally through a portion of the movable body 128. Movement of the actuation member 130 relative to the movable body 128 may control movement of the actuation element 122 relative to the control element 120, for example, to facilitate release or deployment of the patch 106. In some aspects, the handle 110 may include one or more biasing elements (not shown) such that distal movement of the actuation member 130 relative to the movable body 128 is biased proximally. In these aspects, when the user releases distal pressure on the actuation member 130, the one or more biasing elements may move the actuation member 130 proximally, for example, to move to Figure 1 the position shown.

[0032] The fixed body 126 may include a handle body 134. The handle body 134 may include a distal portion 134A, a proximal portion 134B, and an intermediate portion 134C. The proximal portion 134B may include a first finger loop 136, for example, to receive the user's thumb. The distal portion 134A may include an end cap 138, for example, at the distal end of the handle body 134. The end cap 138 may at least partially surround the sheath element 124 and may facilitate coupling the medical device 104 to a portion of the endoscope 102 (e.g., to the insertion port). In this regard, the sheath element 124 may be fixedly coupled to the fixed body 126 of the handle body 134, for example, to the distal portion 134A.

[0033] The intermediate portion 134C may be generally cylindrical and may include a handle slot 140. The handle slot 140 may extend longitudinally through at least a portion of the intermediate portion 134C of the handle body 134. As discussed below, the movable body 128 may be coupled to the fixed body 126 such that the movable body 128 may move (i.e., longitudinally) over at least a portion of the intermediate portion 134C. For example, the movable body 128 may surround a portion of the intermediate portion 134C and a portion of the movable body 128 may at least partially extend into the handle slot 140. Additionally, at least a portion of the movable body 128 may be connected to the control element 120.

[0034] The movable body 128 may include one or more second finger loops 142, for example, two second finger loops 142. The second finger loops 142 may be coupled to receive two of the user's fingers such that movement of the fingers (i.e., relative to the user's thumb in the first finger loop 136) controls the position of the movable body 128 relative to the fixed body 126 and thus controls movement of the control element 120 and / or the patch 106. Although two second finger loops 142 are shown, the invention is not limited thereto and in some examples, the movable body 128 may include a single second finger loop 142.

[0035] In some aspects, the stationary body 126 (e.g., a portion of the middle portion 134C of the handle body 134) may include one or more holes 150, e.g., round holes formed in one side of the stationary body 126. Additionally, in some aspects, the movable body 128 may include one or more extensions or pins 152. In these aspects, one or more pins 152 may be at least partially aligned with one or more holes 150, e.g., when the movable body 128 is positioned at one or more positions on the stationary body 126. For example, the stationary body 126 may include two holes 150 disposed on generally opposite sides of the stationary body 126, and the movable body 128 may include two pins 152 disposed on generally opposite sides of the movable body 128 (e.g., adjacent to the second finger ring 142). When aligned with one or more holes 150, one or more pins 152 may be suspended and / or biased to enter one or more holes 150. For example, positioning one or more pins 152 in one or more holes 150 may help ensure the positioning of the movable body 128 relative to the stationary body 126. Securing the positioning of the movable body 128 relative to the stationary body 126 may help secure the patch 106 in the extended position, e.g., relative to the end cap 108. For example, when the user advances the movable body 128 distally, as the movement of the control element 120 causes the patch 106 to extend from the end cap 108, the pins 152 may at least partially engage with the holes 150( Figure 4A and Figure 4B ). Once the patch 106 has extended a predetermined distance from the end cap 108, e.g., via the movement of the movable body 128, the engagement between the holes 150 and the pins 152 may help prevent the movable body 128 from moving proximally relative to the stationary body 126 (e.g., via one or more biasing elements).

[0036] Figure 2A and Figure 2B Illustrate various features of the distal portion 102B of the endoscope 102 and the end cap 108. Figure 2A Illustrates the end cap 108 coupled to the endoscope 102, Figure 2B Illustrates the end cap 108 separated from the endoscope 102. As mentioned above, the distal portion 102B, e.g., the distal face 102D, may include one or more of the distal end of the cavity 112, one or more illumination devices 114, and one or more visualization devices 116.

[0037] The end cap 108 can be coupled to the distal portion 102B, for example, via a friction fit, an adhesive, a press fit, a crimp, or any other suitable coupling mechanism. Additionally, the end cap 108 can receive some portions of one or more of the control element 120 and the actuation element 122. For example, the end cap 108 can include an outer cap 160 and an inner cap 162, and the patch 106 can be movably positioned between the outer cap 160 and the inner cap 162. It should be noted that Figure 2A a portion of the outer cap 160 is removed to show a portion of the patch 106 between the outer cap 160 and the inner cap 162. Additionally, it should be noted that one or more portions or all of the end cap 108 can be transparent, which can assist a user in visualizing the treatment site and / or the patch 106, for example, using the visualization device 116 on the endoscope 102.

[0038] Additionally, the end cap 108 can include an end cap ring 164. For example, the end cap ring 164 can extend radially outward from the end cap 108, for example, between the proximal portion 108A and the distal portion 108B of the end cap 108 ( Figure 2B ). Additionally, one or more portions of the end cap ring 164 can include a radiopaque material (e.g., one or more markers, one or more gradients, etc.), or otherwise assist a user in visualizing the end cap ring 164 or other portions of the end cap 108. In some aspects, the sheath element 124 can be coupled (e.g., fixedly coupled) to the end cap 108, for example, to the end cap ring 164 (e.g., via a friction fit, an adhesive, a press fit, a crimp, or any other suitable coupling mechanism). Although not shown, the end cap ring 164 can include one or more cavities, for example, to movably receive one or more of the control element 120 and the actuation element 122.

[0039] In some aspects, the end cap 108 can include one or more tines 166. The one or more tines 166 can extend radially inward from a portion of the end cap 108, for example, from a portion of the inner cap 162. For example, the tines 166 can extend radially inward from the inner cap 162 at one or more positions proximal to the distal end of the inner cap 162. In these aspects, the tines 166 can abut a portion of the distal face 102D of the endoscope 102. In this regard, the tines 166 can help ensure proper positioning of the end cap 108 on the distal portion 102B of the endoscope 102, for example, by restricting proximal movement of the end cap 108 relative to the distal face 102D of the endoscope 102.

[0040] In addition, the end cap 108 may include a protective element 168, such as, for example, a washer, a buffer, a seal, etc. The protective element 168 may be positioned distally of the patch 106. The protective element 168 may help to at least partially cover, seal, or otherwise block the distal opening between the outer cap 160 and the inner cap 162. In this regard, the protective element 168 may help to protect the patch 106 (e.g., from body fluids, impacts, scratches, etc.) during the delivery and / or positioning of the medical system 100 (such as the distal portion 102B of the endoscope 102 and the end cap 108) to the treatment site. The protective element 168 may be at least partially circular or cylindrical and may span a portion of the circumference at the distal end of the patch 106. For example, the protective element 168 may span approximately 180 degrees of the distal end of the end cap 108. Similarly, when the patch 106 is coupled to the end cap 108 (e.g., positioned therein), the patch 106 may span a portion of the circumference of the inner cap 162, such as, for example, approximately 180 degrees of the circumference of the inner cap 162.

[0041] Although two control elements 120 are shown in the figures, the present invention is not limited thereto. For example, in some aspects, the medical device 104 may include two or more patches 106, such as, for example, movably coupled to the end cap 108. In these aspects, the medical device 14 may include two control elements 120 for each patch 106 (such as, for example, four control elements 120 for two patches 106, etc.), as well as a corresponding number of actuation elements 122 and sheath elements 124.

[0042] The patch 106 may be a biodegradable and / or biocompatible patch having any suitable shape and any suitable size, such as, for example, based on the nature of the target tissue site. The patch 106 may be flexible and may have any shape, such as, for example, approximately square, approximately rectangular, square with rounded corners, rectangular with rounded corners, oval, circular, and other possible shapes. In some examples, the thickness of the patch may be on the order of millimeters, such as, for example, 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 106 may be sized sufficiently to cover the target tissue and have a margin for excision. Thus, the patch 106 may have a variety of sizes to accomplish such a task. In some aspects, the patch 106 may be about 50 mm × 50 mm (i.e., about 2 inches × 2 inches).

[0043] Patch 106 can have any suitable color, including transparent. Patch 106 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 106 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 106 can consist of polypropylene, polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and / or silicone. Patch 106 can be adhered to the target tissue using materials well known in the art, such as, for example, fibrin glue, hydrogel, and / or cyanoacrylate. Alternatively or additionally, patch 106 can consist of a reagent and / or be administered with a reagent to prevent cell detachment from the target tissue or to treat the target site. In some aspects, patch 106 can include a therapeutic agent, e.g., an antibiotic and / or a hemostatic agent. Further, after delivering patch 106 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., through the working channel (e.g., lumen 112) of endoscope 102 or another medical device.

[0044] Figure 3A and Figure 3B Additional aspects of medical device 104 separated from endoscope 102 are shown. For example, Figure 3A and Figure 3B show the distal portion of patch 106 as well as control element 120 and actuation element 122. It should be noted that the sheath element 124 is omitted for clarity. As mentioned above, protection element 168 can be positioned distally of patch 106.

[0045] Additionally, patch 106 can include one or more retention grooves 170. As Figure 3A and Figure 3B shown, the groove 170 can be formed by reducing the thickness of patch 106, e.g., a semi-circular notch on one side of patch 106. When patch 106 is in the undeployed configuration, patch 106 can include one or more retention grooves positioned on the radially outer portion of patch 106. In some examples, patch 106 can include two grooves 170 on opposite sides of patch 106, e.g., longitudinally extending through the side end portions of patch 106. The groove 170 can longitudinally extend through the entire longitudinal length of patch 106. As discussed in detail below, the groove 170 can receive some portions of actuation element 122. For example, as Figure 3BAs shown, when the actuating element 122 is in a straight (e.g., unactuated) configuration, the actuating element 122 can be at least partially positioned within the recess 170.

[0046] In these respects, the actuating element 122 can help to hold the patch 106, e.g., when the patch 106 extends distally from the end cap 108 ( Figure 4B ). For example, the actuating element 122 can help to hold the patch 106 in a curved configuration ( Figure 3A ), and can also help to maintain control of or connection to the patch 106, e.g., to position and / or reposition the patch 106 (e.g., based on movement of the control element 120). However, when the actuating element 122 is actuated (i.e., advanced distally relative to the control element 120), the actuating element 122 can extend radially outwardly, bow, or curve, as Figure 3A shown. For example, the actuating element 122 can be formed of a shape memory material (e.g., nitinol) or braided wire such that when the actuating element 122 extends distally, the actuating element 122 can assume a radially outwardly extending, bowed, or curved configuration. When the actuating element 122 extends radially outwardly, bows, or curves, some portions of the actuating element 122 may no longer be positioned within one or more of the recesses 170. Thus, actuation of the actuating element 122 can release or deploy the patch 106, e.g., to apply the patch 106 to tissue at the treatment site.

[0047] Figure 4A and Figure 4B show some portions of the medical system 100 and corresponding movements that extend or retract the patch 106 from the end cap 108. As discussed above and as Figure 4A shown, a user can advance the movable body 128 distally relative to the stationary body 126 of the handle 110. Movement of the movable body 128 (e.g., distally) can, for example, advance the control element 120 distally within the corresponding sheath element 124. As discussed above and as Figure 4B shown, distal movement of the control element 120 can cause the patch 106 to extend distally, e.g., relative to the end cap 108. The actuating element 122 can be positioned within the recess 170 in the patch 106, e.g., to help hold the patch 106 during extension. Additionally, the protective element 168 can also move distally with the patch 106, e.g., to help prevent the patch 106 from inadvertently contacting tissue or other substances at the treatment site. The user can use one or more visualization devices 116 ( Figure 2A ) to position the patch 106 relative to the treatment site. Additionally, the user can further advance and / or retract the movable body 128 distally and / or proximally relative to the stationary body 126 to control the position of the patch 106 relative to the end cap 108.

[0048] Figure 5A and Figure 5B illustrates some portions of the medical system 100 and corresponding movements for releasing or deploying the patch 106 from the end cap 108. As discussed above and as Figure 5A shown, with the patch 106 in the desired position relative to the end cap 108 (and thus the movable body 128 in the desired position relative to the fixed body 126), the user may distally advance the actuation member 130, e.g., within the slot 132.

[0049] In some aspects, the movable body 128 may be positioned relative to the fixed body 126 such that the staple 152 ( Figure 1 ) may be positioned within the hole 150 or otherwise interact therewith, e.g., to thereby fix the position of the movable body 128 relative to the fixed body 126. As discussed above and as Figure 5B shown, distally advancing the actuation member 130 within the slot 132 may cause the actuation element 122, e.g., to extend relative to the control element 120. For example, in the case where the patch 106 extends from the end cap 108 (e.g., distally from the outer cap 160 and the inner cap 162), advancing the actuation element 122 may cause the distal portion of the actuation element 122 to extend radially outwardly, bow, or bend and move out of the recess 170, thereby releasing the patch 106. As mentioned, the actuation element 122 may be formed of a shape memory material (e.g., nitinol) or a braided wire such that when the actuation element 122 extends distally, the actuation element 122 may assume a radially outwardly extending, bowed, or bent configuration. The patch 106 may then be applied to the treatment site. In some aspects, one or more auxiliary medical devices (e.g., forceps, tweezers, etc.) may be delivered to the treatment site (e.g., via the lumen 112 of the endoscope 102) to assist in positioning the patch 106 at the treatment site. Additionally, as Figure 5B shown, the actuation element 122 may be connected to the protective element 168 at one or more connection points 180. In these aspects, the protective element 168 may remain coupled to the actuation element 122 even when the actuation element 112 assumes a radially outwardly extending, bowed, or bent configuration.

[0050] Once the patch 106 has been deployed and delivered to the treatment site, the user may retract the actuation element 122 and the control element 120, e.g., such that the protective element 168 abuts the end cap 108 (e.g., the outer cap 160 and the inner cap 162). Additionally, the user may inspect the patch 106 and the treatment site, e.g., using the visualization device 116 ( Figure 2A ). The user may reposition the patch 106, e.g., using one or more auxiliary medical devices as discussed above. Additionally, the user may apply a hemostatic agent (e.g., hemostatic powder) to the delivered patch 106, e.g., via one or more auxiliary medical devices delivered through the lumen 112.

[0051] Various aspects of the medical system 100, for example, the medical device 104 with the patch 106, the end cap 108, and the handle 110 can be of low cost and can be disposable (i.e., single-use devices). The medical device 104 can be coupled to any type of mirror to facilitate the delivery of one or more patches 106 to a treatment site (e.g., endoscopically), and the coupling of the end cap 108 to the distal end of the mirror can be quick and user-friendly. One or more patches 106 can be positioned within the end cap 108 (e.g., between the outer cap 160 and the inner cap 162) and are at least partially protected by the protective element 168, which can help protect one or more patches 106 from fluids, tissues, substances, etc. during the delivery of the endoscope 102 to the treatment site.

[0052] Additionally, the medical device 104 can allow the delivery of one or more patches 106 to a treatment site via minimally invasive surgery (e.g., endoscopically) without having to deliver one or more patches 106 through the working channel (e.g., the lumen 112) of the endoscope 102. In this regard, one or more patches 106 can be larger than patches that pass through the working channel. Moreover, one or more patches 106 can not interfere with the delivery of one or more auxiliary medical devices, the delivery of fluids, the application of aspiration, etc., which can be done through the working channel.

[0053] Furthermore, in some aspects, the patch 106 can be positioned and repositioned prior to deployment. For example, as discussed, the user can manipulate the movable body 128 relative to the fixed body 126 to position and reposition the patch 106 via the movement of the control element 120. This positioning and repositioning can be done under direct visualization, e.g., via the visualization device 116. When the patch 106 is coupled to the endoscope 102 via the end cap 108, the distal face 102D of the endoscope 102 can be substantially unobstructed. Additionally, in some aspects, the user can lock or otherwise fix the position of the movable body 128 relative to the fixed body 126, e.g., via the interaction of the hole 150 and the peg 152, or by other handle locking mechanisms.

[0054] Once the patch 106 is in the desired position, the user may release or deploy the patch 106, e.g., via movement of the actuation member 130 (e.g., distally) to control movement of the actuation element 122. As discussed, movement of the actuation element 122 (e.g., distally) may cause the actuation element 122 to radially extend outwardly, bow or bend, and move out of the recess 170, thereby releasing the patch 106. Moreover, one or more auxiliary medical devices may be used to position the patch 106 relative to the treatment site, and / or the user may inspect the position of the patch 106 at the treatment site, e.g., via the visualization device 116. The positioning and deployment of the patch 106 (e.g., via the actuation member 130 of the movable body 128 and the handle 110) may be direct and user-friendly, which may allow the user to be the surgical technician while the physician performs one or more other tasks during the surgery.

[0055] While the principles of the present invention are described with reference to illustrative examples directed to particular applications, it should be understood that the present invention is not limited thereto. Persons having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, and substitutions of equivalents that 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, wherein the handle includes a movable body and a fixed body, and wherein the movable body includes an actuating member; An end cap configured to be coupled to a distal end of a mirror; A patch, wherein the patch is movable relative to the end cap, wherein the patch is coupled to the movable body via one or more control elements such that movement of the movable body causes the patch to extend from the end cap, and wherein the patch is further coupled to the actuating member via one or more actuating elements such that movement of the actuating member causes the one or more actuating elements to extend, bow, or bend to at least partially deploy the patch.

2. The medical device according to claim 1, wherein the actuating member is movably positioned within a slot in the movable body of the handle.

3. The medical device according to any of the preceding claims, wherein the end cap includes an outer cap and an inner cap, and wherein the patch is movably positioned between the outer cap and the inner cap.

4. The medical device according to claim 3, wherein the inner cap includes fork teeth that extend radially inwardly and are configured to abut against the distal face of the lens.

5. The medical device according to claim 3 or 4, further comprising a protective element positioned at the distal end of the one or more actuating elements, the protective element being configured to at least partially seal an opening between the outer cap and the inner cap.

6. The medical device according to any of the preceding claims, wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuating elements to couple the patch to the one or more actuating elements.

7. The medical device according to claim 6, wherein when the patch is in an undeployed configuration, the one or more retention grooves are positioned on a radially outer portion of the patch.

8. The medical device according to any of the preceding claims, wherein the end cap includes an end cap ring, and wherein at least a portion of the end cap is transparent.

9. The medical device according to any of the preceding claims, wherein the one or more actuating elements are formed of a shape memory material.

10. The medical device according to any of the preceding claims, further comprising one or more sheath elements coupling the handle to the end cap, wherein each of the one or more actuating elements is movably positioned within one of the one or more control elements, and wherein each of the one or more control elements is movably positioned within one of the one or more sheath elements.

11. The medical device according to claim 10, wherein each of the one or more actuating elements is formed of one or more wires, and wherein each of the one or more control elements is formed of one or more coils.

12. The medical device according to any of the preceding claims, wherein the movable body of the handle is movable within a slot in the fixed body of the handle.

13. The medical device according to claim 12, wherein the movable body of the handle includes at least one peg, wherein the fixed body of the handle includes at least one hole, and wherein the at least one peg is configured to engage with the at least one hole to at least partially fix the position of the movable body on the fixed body.

14. The medical device according to claim 13, wherein the position of the at least one hole on the fixed body corresponds to the position of the movable body on the fixed body where the patch extends from the end cap.

15. The medical device according to any of the preceding claims, wherein the patch includes a hemostatic agent.

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