Medical systems, devices, and related methods

Abstract

A medical device includes a handle with a primary actuator and one or more secondary actuators; an end cap configured to be coupled to a distal end of another device and including fixed and movable portions; one or more patches coupled to the movable portion; one or more control elements coupling the primary actuator to the movable portion; and one or more actuating elements. The one or more actuation elements extend from the one or more secondary actuators to a position between a portion of the one or more patches and the movable portion of the end cap. Movement of the primary actuator moves the movable portion of the end cap relative to the fixed portion of the end cap, and movement of the one or more secondary actuators at least partially deploys the one or more patches from the movable portion of the end cap.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application No. 63 / 379,781, filed on October 17, 2022, 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, heat therapy, mechanical therapy, and hemostatic powders. Such therapies are generally expensive and / or time-consuming. In addition, such therapies may not be able to treat larger surface areas, for example, larger ulcers in the GI tract. Additionally, a common treatment for chronic ulcers is gastric bypass surgery. Compared to minimally invasive surgery in which a patch is positioned at one or more ulcers, such surgery may be more difficult, more time-consuming, more expensive, and / or less effective / less accurate. Therefore, 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 including biocompatible patches, and methods of using the same, e.g., to deliver the patch to a target site in a subject, e.g., to aid in healing an ulcer and / or to achieve hemostasis. Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0005] In one or more examples, a medical device may include a handle, an end cap, one or more patches, one or more control elements, and one or more actuating elements. The handle may include a primary actuator and one or more secondary actuators. The end cap may be configured to couple to a distal end of another device, and the end cap may include a fixed portion and a movable portion. One or more patches may be coupled to the movable portion of the end cap. One or more control elements may couple the primary actuator to the movable portion of the end cap. The one or more actuating elements may extend from the one or more secondary actuators to a position between a portion of the one or more patches and the movable portion of the end cap. Movement of the primary actuator may cause the movable portion of the end cap to move relative to the fixed portion of the end cap. Movement of the one or more secondary actuators may deploy the one or more patches at least partially from the movable portion of the end cap.

[0006] The medical device may include one or more of the following features. One or more secondary actuators may be movably positioned within one or more channels in the primary actuator. The handle may include a handle body. Both the primary actuator and the one or more secondary actuators may be movable relative to the handle body to control movement of one or more control elements and one or more actuating elements. The handle body may include a cavity through which the primary actuator and the one or more secondary actuators are movable. The primary actuator may include a proximal side that is larger than the proximal opening of the cavity of the handle body. Each of the one or more secondary actuators may include a marking or protrusion that is configured to interact with the handle body at a position corresponding to the deployment of the one or more patches.

[0007] The medical device may further include one or more sheath elements. One or more actuating elements may be positioned within a corresponding one of the one or more control elements. One or more control elements may be positioned within a corresponding one of the one or more sheath elements. The fixed portion of the end cap may include one or more first through-holes. One or more sheath elements may be coupled to the fixed portion of the end cap adjacent to a corresponding one of the one or more first through-holes of the fixed portion of the end cap. At least one control element and at least one actuating element may extend through a corresponding one of the one or more first through-holes of the fixed portion of the end cap. The movable portion of the end cap may include a proximal ring at the proximal end. The proximal ring may include one or more second through-holes. One or more control elements may be coupled to the movable portion of the end cap adjacent to a corresponding one of the one or more second through-holes of the proximal ring. At least one actuating element may extend through a corresponding one of the one or more second through-holes of the proximal ring. The movable portion of the end cap may further include a distal ring at the distal end. One or more patches may be positioned between the proximal ring and the distal ring. The proximal ring may include a proximal groove. The distal ring may include a distal groove. A portion of the one or more patches may be positioned in the proximal groove. Another portion of the one or more patches can be positioned in the distal recess. A distal portion of the one or more actuator elements can be positioned in the distal recess. The one or more actuator elements can be formed from one or more wires. The one or more control elements can be formed from one or more cannulas or one or more tubes.

[0008] At least a portion of the end cap may be transparent. The one or more actuating elements may be formed of a shape memory material. The one or more secondary actuators may include four secondary actuators. The one or more control elements may include four control elements. The one or more actuating elements may include four actuating elements. The one or more patches may include four patches.

[0009] In another aspect, a medical system may include an endoscope with a distal end and a medical device. The medical device may include a handle, an end cap, one or more patches, one or more control elements, and one or more actuating elements. The handle may include a primary actuator and one or more secondary actuators. The one or more secondary actuators may be movably positioned within one or more channels in the primary actuator. The end cap may be coupled to the distal end of the endoscope. The end cap may include a fixed portion and a movable portion. The movable portion may include a proximal ring and a distal ring. One or more patches may be coupled to the movable portion of the end cap located between the proximal ring and the distal ring. One or more control elements may couple the primary actuator to the movable portion of the end cap. The one or more actuating elements may extend from the one or more secondary actuators to a position located between a portion of the one or more patches and the movable portion of the end cap. Movement of the primary actuator may cause the movable portion of the end cap to move relative to the fixed portion of the end cap and relative to the endoscope. Movement of the one or more secondary actuators may at least partially deploy the one or more patches from the movable portion of the end cap.

[0010] The medical device may include one or more of the following features. The medical system may also include a sheath. The sheath may be removably disposed around one or more portions of the endoscope and the end cap. The proximal ring may include one or more through-holes. One or more control elements may be coupled to the removable portion of the end cap adjacent to a corresponding one of the one or more through-holes of the proximal ring. At least one actuating element may extend through a corresponding one of the one or more through-holes of the proximal ring. The proximal ring may include a proximal groove. The distal ring may include a distal groove. A portion of the one or more patches may be positioned in the proximal groove. Another portion of the one or more patches may be positioned in the distal groove. A distal portion of the one or more actuating elements may be positioned within the distal groove.

[0011] In yet another aspect, a medical device may include a handle, an end cap, one or more patches, and one or more actuating elements. The handle may include one or more actuators. The end cap may be configured to couple to the distal end of another medical device. The end cap may include a proximal ring including a proximal groove; a distal ring including a distal groove; and a body portion between the proximal ring and the distal ring. The one or more patches may be coupled to the end cap such that a portion of each of the one or more patches may be positioned within the proximal groove, and another portion of each of the one or more patches may be positioned within the distal groove. The one or more actuating elements may extend from the one or more actuators to a position between a portion of the one or more patches and the body portion of the end cap. The distal portion of each of the one or more actuating elements may be positioned within the distal groove. Movement of the one or more actuators may at least partially deploy the one or more patches from the end cap.

[0012] The medical device may include one or more of the following features. One or more actuators may be secondary actuators. The handle may also include a primary actuator configured to control the position of the end cap relative to the distal end of another medical device. The secondary actuator may be movable within a corresponding channel formed by one or more wings in the primary actuator.

[0013] Any of the examples described herein can have any of these features in any combination.

[0014] It will be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limitations of the invention, as claimed. As used herein, the terms "comprises," "comprising," "including," "comprising," or any other variations thereof, are intended to encompass 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. The term "exemplary" is used in the sense of "example" rather than "model." The term "distal" refers to a direction away from the operator / toward the treatment site, and the term "proximal" refers to a direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values of + / - 10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying 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.

[0016] Figure 1 A perspective view of an exemplary medical device is depicted.

[0017] Figure 2A depicts a perspective view of an exemplary control element, and Figure 2B Depicts Figure 1 A side view of the distal end of an exemplary medical device including an exemplary control element.

[0018] Figures 3A to 3C Depicts Figure 1 A perspective or cross-sectional view of a portion of the distal end of an exemplary medical device.

[0019] Figure 4 Depicts a device coupled to an endoscope and in an actuated configuration. Figure 1 A perspective view of the distal end of an exemplary medical device. DETAILED DESCRIPTION

[0020] Reference will now be made in detail to examples of the present invention, various aspects of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

[0021] Embodiments of the present invention seek to improve a user's ability to position and / or deploy a patch within a subject during a medical procedure, help reduce the need to remove and reintroduce an endoscope or other medical device into a subject, help perform hemostasis within a subject, and reduce overall surgical time, among other things.

[0022] Figure 1 A medical device 104 is shown. Figure 2B and Figure 4 As shown, one or more portions of the medical device 104 can be coupled to another or a second medical device, such as an endoscope 102, to form a medical system 100. As discussed in detail herein, the medical device 104 can include or otherwise be coupled to a patch delivery system, for example, to position and / or deliver one or more patches 106 to one or more tissue portions within a subject, which can assist in performing hemostasis within the subject. Additionally, the medical system 100 can include a sheath or other protective element 112 ( Figure 4 ). The sheath 112 can be removably positioned radially outward of the one or more patches 106, for example, during delivery of one or more portions of the medical system 100 to a treatment site. The sheath 112 can be retracted proximally to expose the one or more patches 106, and one or more portions of the medical device 104 can be actuated to position and / or deploy the one or more patches 106.

[0023] The medical device 104 can be coupled to one or more portions of the endoscope 102, for example, to facilitate delivery of the one or more portions of the medical device 104 to a treatment site. For example, the medical device 104 can include an end cap 108. The end cap 108 can 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 can be delivered to the treatment site. Furthermore, 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 one or more visualization devices on the endoscope 102.

[0024] The medical device 104 can include a handle 110, and manipulating one or more portions of the handle 110 can facilitate manipulation, positioning and / or repositioning, releasing or deploying and / or delivering the one or more patches 106, for example, to position the one or more patches 106 over tissue at a treatment site. As discussed below, the handle 110 can be coupled to the end cap 108 via one or more sheath elements 118, one or more control elements 120, and one or more actuation elements 122.

[0025] The endoscope 102 may include a generally cylindrical tubular shape and may include a proximal portion (not shown) and a distal portion 102B. Although not shown, the proximal portion may include a handle or otherwise be coupled to a handle, e.g., include one or more ports, controls, levers, electrical or communication connections, etc. Additionally, the endoscope 102 may include one or more lumens or working channels, e.g., extending longitudinally through the endoscope 102. In these aspects, the lumens or working channels may extend through the proximal portion and the distal portion 102B, e.g., terminating distally at one or more distal openings (i.e., at the distal-most end of the endoscope 102). Figure 1 As shown, when the medical device 104 including the patch 106 is coupled to the endoscope 102 (i.e., during delivery and positioning), the patch 106 and the distal portion of the medical device 104 can be coupled to the distal portion 102B of the endoscope 102, for example, to the distal opening of the lumen and / or extending distally beyond it.

[0026] The endoscope 102 (i.e., the distal portion 102B of the endoscope 102) may include a diameter of approximately 9 mm to approximately 15 mm, for example, approximately 10.5 mm to approximately 12 mm. One or more portions of 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, for example, a working channel having a diameter of approximately 2 mm to approximately 4 mm, for example, approximately 2.8 mm. Additionally, the endoscope 102, for example, a distal face (not shown) of the endoscope 102 may include one or more illumination devices (e.g., one or more LEDs, fiber optics, and / or other illuminators) and / or one or more visualization devices (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.).

[0027] Although not shown, the endoscope 102 can include one or more grooves, channels, cavities, and / or other features to movably receive 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) can be deflectable, for example, via one or more knobs or other controls on a proximal handle. In these aspects, the distal portion 102B of the endoscope 102 can be manipulated when delivered to and / or positioned relative to a treatment site, for example, in a flexed position, which can be used, for example, when the treatment site is in the esophagus, stomach, duodenum, colon, or other portion of the GI tract of a subject.

[0028] Although the treatment site is discussed as being in the GI tract of a subject, the present invention is not so limited, as the treatment site can be any lumen 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 ultrasound ("EUS") scope, colonoscope, bronchoscope, laparoscope, arthroscope, cystoscope, aspiroscope, sheath, or catheter.

[0029] Additionally, in some aspects, the medical system 100 may include a sheath 112, such as an outer sheath ( Figure 4 ). The sheath 112 can be removable and can surround one or more portions of the endoscope 102 and the medical device 104, for example, during delivery of the endoscope 102 (distal portion 102B) and the end cap 108 to the treatment site. The sheath 112 can help cover one or more patches 106 during delivery of the endoscope 102 and the end cap 130 to the treatment site. For example, Figure 4 As shown, once the endoscope 102 and end cap 108 are positioned at the treatment site, the sheath 112 may be retracted proximally, exposing the one or more patches 106 .

[0030] Patch 106 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 106 can be flexible and 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 order, for example, ranging from about 0.1mm to about 5.0mm, or more specifically, about 0.7mm to about 2.0mm. Patch 106 may have enough size to cover the target tissue and have an edge for excision. Therefore, patch 106 can have multiple sizes to achieve this task. In some aspects, patch 106 can be about 50mm×50mm (that is, about 2 inches×2 inches).

[0031] Patch 106 can have any suitable color, comprises transparent.Patch 106 can be by any suitable material, for example, and net, mesh, cloth, gelatin or polysaccharide (chitosan, cellulose, starch, alginate etc.) are formed, and this material can be further modified with synthetic biocompatible material (pHEMA, PGA, PLA, PCA, PEG etc.).In some respects, patch 106 can be by bioadhesive material, for example, such as, one or more composite materials in chitosan, modified chitosan, cellulose, pHEMA, PVA, PEG or these polymers are formed.Additionally, for example, patch 106 can be made up of polypropylene, polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) and / or silicone resin.Patch 106 can use material well known in the art, such as, for example, fibrin glue, hydrogel and / or cyanoacrylate and adhere to target tissue. Alternatively or additionally, the patch 106 can be composed of and / or administered with an agent to prevent cells from being shed from the target tissue or to treat the target site. In some aspects, the patch 106 can include a therapeutic agent, such as an antibiotic and / or a hemostatic agent. In addition, after the patch 106 is delivered to the treatment site, the user can spray, apply, or otherwise deliver one or more hemostatic agents (e.g., one or more hemostatic powders), for example, through a working channel (e.g., lumen) of an endoscope 102 or another medical device.

[0032] like Figure 1 As shown, the medical device 104 includes an end cap 108 and a handle 110. One or more sheath elements 118 can extend between the handle 110 and the end cap 108, for example, from one or more portions of the handle 110 to one or more portions of the end cap 108. The sheath elements 118 can each be formed from a cannula, tube, sheath, etc. Additionally, one or more control elements 120 and one or more actuation elements 122 can each extend from one or more portions of the handle 110 to one or more portions of the end cap 108. The control elements 120 can each be formed from a cannula, tube, sheath, etc. The actuation elements 122 can each be formed from a wire, cannula, tube, rod, etc. In these aspects, as Figure 2A As shown in FIG, each control element 120 can be radially located within the corresponding sheath element 118. Additionally, each actuation element 122 can be radially located within the corresponding control element 120.

[0033] like Figure 1 and Figure 2B As shown in , the end cap 108 may include a fixed portion 126 and a bracket or movable portion 128 . Figure 2B The end cap 108 is shown without the one or more patches 106 in order to illustrate the internal features of the end cap 108. The fixing portion 126 can be coupled to the distal portion 102B ( Figure 2B The fixing portion 126 may be cylindrical and / or annular with a lumen 130 extending longitudinally through the fixing portion 126. The fixing portion 126 may be configured to couple to a radially outwardly facing surface or outer surface 114 ( Figure 2B The securing portion 126 can be coupled to the distal portion 102B of the endoscope 102, for example, via a friction fit, an adhesive, a press fit, a crimp, or any other suitable coupling mechanism.

[0034] In addition, the fixed portion 126 can include one or more through-holes 132 that extend longitudinally through a portion of the fixed portion 126 (i.e., radially outward from the cavity 130). In some aspects, each of the sheath elements 118 can be coupled to a corresponding through-hole 132. Additionally, the control element 120 (and the actuation element 122) can extend longitudinally through a corresponding through-hole 132. In these aspects, the control element 120 (and the actuation element 122) can be moved longitudinally (i.e., proximally and / or distally) relative to the fixed portion 126 through the corresponding through-hole 132, for example, to control the position of the movable portion 128 relative to the fixed portion 126 and / or the endoscope 102 ( Figure 2B ).

[0035] Although not shown, the fixed portion 126 (and / or the movable portion 128) can include one or more radiopaque markers, protrusions, or indicators. The one or more radiopaque markers, protrusions, or indicators can, for example, be configured to facilitate visualization of the fixed portion 126 (and / or the movable portion 128), for example, via X-ray, CT scan, or other external visualization techniques.

[0036] The movable portion 128 may be generally cylindrical and may include a cavity 134 ( Figure 2B ). In addition, the movable portion 128 may include a proximal ring 136 and a distal ring 138. The proximal ring 136 and the distal ring 138 may each extend radially away from the body portion 140 of the movable portion 128. For example, the proximal ring 136 and the distal ring 138 may include a greater thickness or radial width than the body portion 140 of the movable portion 128. In these aspects, as Figure 1 As shown and as related to Figures 3A to 3C As discussed in detail, one or more patches 106 may be positioned between the proximal ring 136 and the distal ring 138 .

[0037] Additionally, the movable portion 128 can include one or more through-holes 142 that extend longitudinally through a portion of the movable portion 128 (i.e., radially outward from the lumen 130). In some aspects, each of the control elements 120 can be coupled to a corresponding through-hole 142. Additionally, the actuation element 122 can extend longitudinally through a corresponding through-hole 142. The distal end of the actuation element 122 can be coupled to or otherwise abut the distal ring 138. In these aspects and as described in detail below, the control element 120, for example, via movement of one or more actions of the handle 110, can control the position of the movable portion 128 relative to the fixed portion 126 and / or the distal portion 102B of the endoscope 102. Furthermore, the actuation element 122, for example, via movement of one or more different actions of the handle 110, can control the position and / or deployment of one or more patches 106.

[0038] As mentioned above, the handle 110 can be coupled to the end cap 108 via the sheath element 118, the control element 120, and / or the actuation element 122. Figure 1 , the handle 110 may include a handle body 150, which includes an inner cavity (not shown). In some aspects, the proximal end of the sheath element 118 may be coupled to the distal end or distal portion of the handle body 150. The handle body 150 may include a main body portion 150A, which may be roughly tubular or cylindrical (as shown), or may be another suitable shape. The main body portion 150A may be configured to be held in the user's handle and / or between the fingers. The handle body 150 may also include an extension portion 150B, for example, extending radially outward from the proximal end of the main body portion 150A. In some aspects, the extension portion 150B may be roughly oval. Although not shown, the extension portion 150B may be circular, rectangular, or another suitable shape. The main body portion 150A and the extension portion 150B can help the user, for example, hold the handle body 150 with one hand, while also allowing the user, for example, to actuate or otherwise manipulate one or more other parts of the handle 110 with the same hand.

[0039] Additionally, in some aspects, the handle 110 includes a primary actuator 152 and one or more secondary buttons or actuators 154. The primary actuator 152 and the one or more secondary actuators 154 can be movable within the lumen of the handle body 150. The primary actuator 152 can be coupled to the control element 120. For example, a distal portion of the primary actuator 152 can be coupled to the proximal end of the control element 120, for example, within the lumen of the handle body 150. The distal portion of the primary actuator 152 can be coupled to the proximal end of the control element 120, for example, via a friction fit, an adhesive, a press fit, a crimp, or any other suitable coupling mechanism. In this aspect, movement of the primary actuator 152 relative to the handle body 150 (i.e., proximal or distal movement) can control extension or retraction of the control element 120 relative to the sheath element 118, and thereby control extension or retraction of the movable portion 128 relative to the fixed portion 126 (i.e., distal movement). Figure 2B ).

[0040] Additionally, one or more secondary actuators 154 can be coupled to the actuating element 122. For example, a distal portion of each secondary actuator 154 can be coupled to the proximal end of a corresponding actuating element 122, e.g., within the lumen of the handle body 150. The distal portion of each secondary actuator 154 can be coupled to the proximal end of the corresponding actuating element 122, e.g., via a friction fit, adhesive, press fit, crimp, or any other suitable coupling mechanism. In this regard, movement of each secondary actuator 154 relative to the handle body 150 (i.e., proximally or distally) can control the extension or retraction of the actuating element 122 relative to the control element 120, and thereby control the position and / or deployment of one or more patches 106.

[0041] In these aspects, the end cap 108 can include a plurality of patches 106. For example, the end cap 108 can include four patches 106 that are circumferentially spaced around the body portion 140 of the movable portion 128. Alternatively, the end cap 108 can include one, two, three, five, six, seven, eight, etc. patches 106. The patches 106 can be evenly or unevenly spaced around the body portion 140 of the movable portion 128. The handle 110 can include a plurality of secondary actuators 154 that correspond to the number of patches 106 on the end cap 108. As mentioned, the medical device 104 can include a plurality of sheath elements 118, control elements 120, and actuation elements 122 that correspond to the number of patches 106. Furthermore, the medical device 104 can include twice as many (or more) sheath elements 118, control elements 120, and actuation elements 122 as the number of patches 106. In this manner, two (or more) actuation elements 122 may control the position and / or deployment of corresponding patches 106 .

[0042] Furthermore, although not shown, the handle 110 can include one or more springs or biasing elements, e.g., within a lumen of the handle body 150, to bias the movement of one or more of the primary actuator 152 and / or the secondary actuator 154. For example, the one or more springs or biasing elements can bias the movement of one or more of the primary actuator 152 and / or the secondary actuator 154 proximally. In these aspects, a user can advance one or more of the primary actuator 152 and / or the secondary actuator 154 distally relative to the handle body 150, but once the distal pressure from the user is removed, the one or more biasing elements can urge the one or more of the primary actuator 152 and / or the secondary actuator 154 proximally. Additionally or alternatively, one or more portions of the handle 110 can include a locking mechanism, e.g., to selectively and / or releasably secure the position of one or more of the primary actuator 152 and / or the secondary actuator 154.

[0043] The primary actuator 152 can include a proximal side 156. The proximal side 156 can be flat, e.g., perpendicular to the longitudinal axis of the handle 110 and / or the longitudinal axis of the medical device 104. Additionally, the proximal side 156 can include a textured surface, which can assist a user in manipulating the primary actuator 152. In some aspects, the proximal side 156 can include a dimension (e.g., a diameter or circumference) that is larger than the inner cavity of the handle body 150. For example, the proximal side 156 can assist in controlling and / or limiting movement (e.g., extension) of the movable portion 128 relative to the fixed portion 126.

[0044] The primary actuator 152 can also include one or more radial extensions or wings 158 (e.g., in a middle portion of the primary actuator 152), for example, to form one or more channels 160. For example, a plurality of wings 158 can extend radially away from a center portion 162 of the primary actuator 152. The outer portions of the wings 158 can be angularly or circumferentially spaced apart from adjacent wings 158, thereby forming the channels 160. For example, in one aspect, the primary actuator 152 can include four wings 158 that are circumferentially spaced approximately 90 degrees apart and form four channels 160. In these aspects, each of the channels 160 can be sized and / or shaped to movably receive one of the secondary actuators 154. For example, each of the secondary actuators 154 can be wedge-shaped, and each of the channels 160 can be formed by two wings 158 that are spaced approximately 90 degrees apart.

[0045] As mentioned, the handle 110 can include one secondary actuator 154 for each actuating element 122. For example, if the medical device 104 includes four actuating elements 122 (as shown), the handle 110 can include four secondary actuators 154, where each secondary actuator 154 is coupled to a corresponding actuating element 122. For example, the distal end of each secondary actuator 154 can be coupled to the proximal end of the corresponding actuating element 122, e.g., within the interior of the handle body 150. Each secondary actuator 154 can include a proximal side 166. The proximal side 166 can be flat, e.g., perpendicular to the longitudinal axis of the handle 110 and / or the longitudinal axis of the medical device 104. Additionally, the proximal side 166 can include a textured surface, which can help a user manipulate the secondary actuator 154.

[0046] Each of the secondary actuators 154 can include a different color, pattern, or indication (e.g., a letter, number, symbol, etc.), which can help a user distinguish between the different secondary actuators 154. Furthermore, although not shown, one or more of the patches 106 or one or more portions of the end cap 108 can include a corresponding color, pattern, or indication (e.g., a letter, number, symbol, etc.), which can be visualized via a visualization element on the endoscope 102, a separate internal or external visualization element, etc. In these aspects, a user can associate which secondary actuator 154 to actuate or otherwise manipulate in order to position and / or deploy the appropriate patch 106.

[0047] In addition, if Figure 1As shown, one or more of the secondary actuators 154 can include one or more protrusions and / or markings 164. For example, the one or more protrusions and / or markings 164 can indicate to the user when the one or more secondary actuators 154 are in a position corresponding to extending the actuation element 122 to deploy the one or more patches 106. In some examples, the one or more protrusions and / or markings 164 can interact with the handle body 150 (e.g., a ridge or bump that may be needed to overcome additional proximal force on the secondary actuator 154) and / or provide an audible click when the secondary actuator 154 reaches a position where the patch 106 will be deployed. In other examples, when the one or more protrusions and / or markings 164 on the secondary actuator 154 are aligned with the proximal end of the handle body 150 or aligned distally therewith, the one or more protrusions and / or markings 164 can signal or otherwise indicate to the user that the actuation element 122 has reached a position where the patch 106 will be deployed. In some examples, although not shown, the handle body 150 can include a recessed portion configured to receive one or more projections and / or indicia 164. In this example, when the secondary actuator 154 is in a position relative to the handle body 150 such that the actuation element 122 has reached a position to deploy the patch 106, the one or more projections and / or indicia 164 can snap or otherwise fit into the recessed portion.

[0048] Figures 3A to 3C Additional features of the removable portion 128 of the end cap 108 are shown. Figure 3A and Figure 3B is a different perspective view of the movable portion 128 extending from the fixed portion 126 (not shown), and Figure 3C is a longitudinal cross-sectional view of the movable portion 128. As mentioned, the movable portion 128 includes one or more through-holes 132, for example, which are coupled to the control element 120 and are used to movably receive the actuation element 122. Additionally, the movable portion 128 includes a cavity 134. Moreover, one or more patches can be positioned between the proximal ring 136 and the distal ring 138, for example, such that the one or more patches 106 are located radially outwardly of and / or adjacent to the body portion 140.

[0049] like Figures 3A to 3C As shown in , the distal ring 138 may include a distal groove 170. Additionally, in some aspects and as Figure 3A and Figure 3CAs shown in FIG, the proximal ring 136 may include a proximal groove 172. As shown in the cross-sectional view, the distal groove 170 and / or the proximal groove 172 may extend parallel to the longitudinal axis of the movable portion 128, e.g., through respective portions of the distal ring 138 and the proximal ring 136. In these aspects, the distal groove 170 and / or the proximal groove 172 may extend circumferentially around the longitudinal axis of the movable portion 128, e.g., through respective portions of the distal ring 138 and the proximal ring 136. For example, the distal groove 170 may extend distally through the proximal side of the distal ring 138. Similarly, for example, the proximal groove 172 may extend proximally through the distal side of the proximal ring 136. Additionally, the distal portion of one or more patches 106 may be positioned within the distal groove 170, and the proximal portion of one or more patches 106 may be positioned within the proximal groove 172. In these aspects, the grooves 170 , 172 can help retain the one or more patches 106 , for example, during transport and / or positioning of the one or more patches 106 .

[0050] Additionally, if Figure 3B and Figure 3C As shown, the actuator element 122 can extend distally within one or more patches 106. It should be noted that Figure 3B Only one patch 106 is shown in FIG, and for clarity, Figure 3C For example, the actuation elements 122 can extend through corresponding through-holes 132 (e.g., in the proximal ring 136) and terminate within the distal recess 170. The corresponding actuation elements 122 can extend radially within the middle or center portion of the corresponding patch 106.

[0051] Figure 4 Movement of the movable portion 128 of the endcap 108 relative to the fixed portion 126 and distal portion 102B of the endoscope is shown, and positioning and deployment of the patch 106 are also shown. During operation, a user may first couple the medical device 104 to an insertion device, such as the endoscope 102, for example, by coupling the endcap 108 to the distal portion 102B of the endoscope 102. The user may then manipulate the endoscope 102 using one or more visualization devices, lighting devices, etc. (not shown) at the distal tip of the endoscope 102 to navigate to a treatment site within a subject.

[0052] As shown, once the distal portion 102B of the endoscope 102 and the end cap 108 are positioned at the treatment site, the user can retract the sheath 112 proximally, for example, to expose the movable portion 128 and one or more patches 106 coupled to the movable portion 128. It should be noted that the sheath 112 can extend proximally, for example, to the handle 110, the proximal end of the endoscope 102, etc., but for clarity, the sheath 112 is shown proximally. Figure 4 Only a portion of the sheath 112 is shown in FIG. Alternatively or additionally, the movable portion 128 can extend from the fixed portion 126. As mentioned above, the user can manipulate (e.g., advance distally) the primary actuator 152 ( Figure 1 ) to extend the movable portion 128. For example, manipulating the primary actuator 152 can distally advance the control element 120 to distally advance the movable portion 128. The control element 120 can be moved relative to the sheath element 118 and through the fixed portion 126, for example, through the corresponding through-hole 132. The primary actuator 152 can be further moved distally and / or retracted proximally to reposition the movable portion 128 relative to the treatment site. In some aspects, the endoscope 102 can include one or more visualization devices (not shown) that can assist a user in visualizing the treatment site and / or the position of the movable portion 128 relative to the endoscope 102 and / or the treatment site. Once the movable portion 128 is positioned relative to the endoscope 102 and / or the treatment site, the user can lock the position of the primary actuator 152.

[0053] With the movable portion 128 positioned, the user can manipulate (e.g., distally advance) a secondary actuator 154 ( Figure 1 ) to advance the selected actuating element 122. For example, a user may select one of the secondary actuators 154 to control the positioning and / or deployment of a patch 106. Figure 4 As shown, the distal end of the actuating element 122 is fixed or otherwise positioned within the distal recess 170. In addition, the position of the movable portion 128 can be fixed, for example, with a user's hand or finger on the primary actuator 152, via one or more locking mechanisms, frictional engagement with the handle body 150, etc. Thus, when the actuating element 122 is advanced distally, a portion of the actuating element 122 extends radially outward, arches, bends, or otherwise moves, for example, away from the body portion 140 of the movable portion 128, as shown. Figure 4 For example, the actuation element 122 can be formed from a shape memory material (eg, Nitinol) or a braided wire such that when the actuation element 122 extends distally, the actuation element 122 can adopt a radially outwardly extending, arched, or curved configuration.

[0054] Because the actuation element 122 is positioned radially within or otherwise between the body portion 140 and the patch 106, movement of the actuation element 122 pushes the patch 106 radially outward. For example, a first movement of the actuation element 122 can partially extend the patch 106 radially outward away from the body portion 140 (e.g., at least partially deploy the patch 106), e.g., with corresponding portions of the patch 106 retained within the distal recess 170 and the proximal recess 172. Subsequently, additional movement of the actuation element 122 (e.g., such that the marking 164 is aligned with the proximal end of the handle body 150) can further extend the patch 106 radially outward away from the body portion 140, e.g., such that corresponding portions of the patch 106 are no longer retained within the distal recess 170 and the proximal recess 172.

[0055] Once the patch 106 is deployed and delivered to the treatment site, the user can inspect the patch 106 and the treatment site, for example, using one or more visualization devices, lighting devices, etc. of the endoscope 102. The user can reposition the patch 106, for example, using one or more auxiliary medical devices, such as a grasper or other auxiliary medical device (e.g., which is delivered to the treatment site through the working channel of the endoscope 102). In addition, the user can apply a hemostatic agent (e.g., hemostatic powder) to the delivered patch 106, for example, via one or more auxiliary medical devices delivered through the working channel of the endoscope 102.

[0056] In addition, the user can reposition the movable portion 128, for example, via movement of the primary actuator 152, and can manipulate another secondary actuator 154 to position and / or deploy another patch 106. Another patch 106 can be delivered to the treatment site, for example, in the vicinity of the first patch to help cover and / or heal a large ulcer. Alternatively or in addition, another patch 106 can be delivered to another location on the treatment site. The user can repeat these steps as many times as needed to deploy a desired number of patches 106 at the treatment site, and / or deploy all of the patches 106 on the end cap 108. Multiple patches 106 can be deployed to the treatment site without removing the medical system 100, including the endoscope 102 and the end cap 108, from the subject.

[0057] Various aspects of the medical system 100, such as the medical device 104 with the patch 106, the end cap 108, and the handle 110, can be low-cost and disposable (i.e., a one-time-use device). The medical device 104 can be coupled to any type of scope to facilitate delivery of one or more patches 106 to a treatment site (e.g., endoscopically), and coupling the end cap 108 to the distal end of the scope can be quick and user-friendly. The one or more patches 106 can be positioned on the end cap 108 (e.g., radially around the body portion 140 of the movable portion 128). Additionally, the sheath 112 and / or the distal ring 138 can help protect the one or more patches 106 from fluids, tissues, materials, etc. during delivery of the endoscope 102 to the treatment site.

[0058] Additionally, the medical device 104 can allow one or more patches 106 to be delivered to a treatment site in a minimally invasive procedure (e.g., endoscopically) without having to deliver the one or more patches 106 through a working channel (e.g., lumen) of the endoscope 102. In this regard, the one or more patches 106 can be larger than a patch that passes through the working channel. Furthermore, the one or more patches 106 and the end cap 108 can not interfere with the delivery of one or more auxiliary medical devices, the delivery of fluids, the application of suction, etc., which can be accomplished through the working channel.

[0059] In addition, in some aspects, the patch 106 can be positioned and repositioned prior to deployment. For example, as discussed, the user can manipulate the primary actuator 152 relative to the handle body 150 to position and reposition the patch 106 via movement of the control element 120. The user can also position and reposition the distal portion 102B of the endoscope 102. Such positioning and repositioning can be accomplished under direct visualization, for example, via one or more visualization devices on the endoscope 102. Because the patch 106 is coupled to the endoscope 102 via the end cap 108, the distal face of the endoscope 102 can be substantially unobstructed. Additionally, in some aspects, the user can lock or otherwise fix the position of the primary actuator 152 relative to the handle body 150 via one or more handle locking mechanisms.

[0060] Once the patch 106 is in the desired position, the user can release or deploy the patch 106, for example, by moving the secondary actuator 154 (e.g., distally) to control the movement of the actuating element 122. As discussed, the movement of the actuating element 122 (e.g., distally) can cause the actuating element 122 to extend, bow, or bend radially outward, thereby pushing the patch 106 radially outward so that portions of the patch 106 are no longer positioned within the distal recess 170 and the proximal recess 172. Alternatively or additionally, the patch 106 can initially be coupled to one or more actuating elements 122 (e.g., adhered using glue, epoxy, or other adhesives). In this regard, the distal movement of the actuating element 122, which causes the actuating element 122 to extend, bow, or bend radially outward, can also overcome the coupling between the patch 106 and the actuating element 122, thereby releasing or deploying the patch 106. Furthermore, one or more auxiliary medical devices can be used to position the patch 106 relative to the treatment site, and / or the user can inspect the position of the patch 106 at the treatment site, for example, via one or more visualization devices on the endoscope 102. Positioning and deployment of the patch 106 (e.g., via the primary actuator 152 and the secondary actuator 154 of the handle 110) can be straightforward and user-friendly, which can allow the user to be a skilled surgical technician while the physician performs one or more other tasks during the procedure.

[0061] Although the principles of the present invention are described with reference to illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skill in the art and access to the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device comprising: a handle, wherein the handle includes a primary actuator and one or more secondary actuators; an end cap configured to couple to a distal end of another medical device, wherein the end cap comprises a fixed portion and a movable portion; one or more patches, wherein the one or more patches are coupled to the removable portion of the end cap; one or more control elements coupling the primary actuator to the movable portion of the end cap; as well as one or more actuation elements, wherein the one or more actuation elements extend from the one or more secondary actuators to a position between a portion of the one or more patches and the movable portion of the end cap, wherein movement of the primary actuator causes the movable portion of the end cap to move relative to the fixed portion of the end cap, and Wherein movement of the one or more secondary actuators at least partially deploys the one or more patches from the movable portion of the end cap.

2. The medical device of claim 1, wherein the one or more secondary actuators are movably positioned within one or more channels in the primary actuator.

3. The medical device of claim 1 , wherein the handle comprises a handle body, and wherein both the primary actuator and the one or more secondary actuators are movable relative to the handle body to control the movement of the one or more control elements and the one or more actuating elements.

4. The medical device of claim 3, wherein the handle body includes a cavity through which the primary actuator and the one or more secondary actuators are movable, and wherein the primary actuator includes a proximal side that is larger than a proximal opening of the cavity of the handle body.

5. The medical device of claim 3, wherein each of the one or more secondary actuators includes a marking or protrusion configured to interact with the handle body at a position corresponding to deployment of the one or more patches.

6. The medical device of any preceding claim, further comprising one or more sheath elements, wherein the one or more actuation elements are positioned within a corresponding one of the one or more control elements, and wherein the one or more control elements are positioned within a corresponding one of the one or more sheath elements.

7. The medical device of claim 6 , wherein the fixed portion of the end cap comprises one or more first through holes, wherein the one or more sheath elements are adjacent to a corresponding one of the one or more first through holes of the fixed portion of the end cap, are coupled to the fixed portion of the end cap, and wherein the at least one control element and the at least one actuating element extend through the corresponding one of the one or more first through holes of the fixed portion of the end cap.

8. A medical device according to claim 7, wherein the movable portion of the end cap includes a proximal ring at the proximal end, wherein the proximal ring includes one or more second through holes, wherein the one or more control elements are adjacent to a corresponding one of the one or more second through holes of the proximal ring, connected to the movable portion of the end cap, and wherein the at least one actuating element extends through the corresponding one of the one or more second through holes of the proximal ring.

9. The medical device of claim 8, wherein the removable portion of the end cap further comprises a distal ring at a distal end, and wherein the one or more patches are positioned between the proximal ring and the distal ring.

10. The medical device of claim 9, wherein the proximal ring comprises a proximal groove, wherein the distal ring comprises a distal groove, wherein a portion of the one or more patches is positioned in the proximal groove, and wherein another portion of the one or more patches is positioned in the distal groove.

11. The medical device of claim 10, wherein a distal portion of the one or more actuation elements is positioned within the distal recess.

12. The medical device of claim 11, wherein the one or more actuation elements are formed from one or more wires, and wherein the one or more control elements are formed from one or more cannulas or one or more tubes.

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

14. The medical device of any preceding claim, wherein the one or more actuation elements are formed from a shape memory material.

15. A medical device according to any preceding claim, wherein the one or more secondary actuators include four secondary actuators, wherein the one or more control elements include four control elements, wherein the one or more actuating elements include four actuating elements, and wherein the one or more patches include four patches.

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