Medical systems, devices, and related methods

Abstract

The medical device includes a handle having a primary actuator and one or more secondary actuators, an end cap configured to be coupled to the distal end of another medical device and including a fixed portion and a movable portion, 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 extending 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 actuators 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

[Technical Field]

[0001] The present disclosure relates generally to systems, devices, and methods for delivering patches. More specifically, aspects of the present disclosure relate to systems, devices, and / or methods for delivering patches via a medical device, such as an endoscope, for example, for hemostasis. [Background technology]

[0002] Bleeding ulcers, for example in the gastrointestinal (GI) tract of a subject, are often difficult to manage and / or provide hemostasis to. For example, common treatments for bleeding ulcers include injection therapy, heat therapy, mechanical therapy, and hemostatic powders. Such therapies are often expensive and / or time-consuming. Furthermore, such therapies may not be able to treat larger surface areas (e.g., larger ulcers in the GI tract). Furthermore, a common treatment for chronic ulcers is gastric bypass. Such procedures may be more difficult, more time-consuming, more expensive, and / or less effective / precise than minimally invasive procedures for positioning a patch on one or more ulcers. 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 portions of a subject. Summary of the Invention

[0003] The present disclosure includes medical systems and devices including biocompatible patches, and methods of use thereof, e.g., methods of delivering the patch to a target site in a subject to, for example, aid in the healing of an ulcer and / or to achieve hemostasis. Each of the embodiments disclosed herein may include one or more of the features described in connection with any of the other disclosed embodiments.

[0004] In one or more examples, the medical device may include a handle, an end cap, one or more patches, one or more control elements, and one or more actuation elements. The handle may include a primary actuator and one or more secondary actuators. The end cap may be configured to be coupled to a distal end of another medical device, and the end cap may include a fixed portion and a movable portion. The one or more patches may be coupled to the movable portion of the end cap. The one or more control elements may couple the primary actuator to the movable portion of the end cap. The one or more actuation 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 move the movable portion of the end cap relative to the fixed portion of the end cap. 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.

[0005] The medical device may include one or more of the following features: The 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 the one or more control elements and the one or more actuation elements. The handle body may include a lumen through which the primary actuator and the one or more secondary actuators are movable. The primary actuator may include a proximal face that is larger than a proximal opening of the lumen of the handle body. Each of the one or more secondary actuators may include a marking or protrusion configured to interact with the handle body at a position corresponding to deployment of the one or more patches.

[0006] The medical device may further include one or more sheath elements. The one or more actuating elements may be positioned within a corresponding one of the one or more control elements. The one or more control elements may be positioned within a corresponding one of the one or more sheath elements. The stationary portion of the end cap may include one or more first through-holes. The one or more sheath elements may be coupled to the stationary portion of the end cap adjacent to a corresponding one of the one or more first through-holes of the stationary portion of the end cap. The at least one control element and the at least one actuating element may extend through a corresponding one of the one or more first through-holes of the stationary portion of the end cap. The movable portion of the end cap may include a proximal ring at a proximal end. The proximal ring may include one or more second through-holes. The 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. The 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 within the proximal groove. Another portion of the one or more patches may be positioned within the distal groove. A distal portion of the one or more actuating elements may be positioned within the distal groove. The one or more actuating elements may be formed from one or more wires. The one or more control elements may be formed from one or more coils or one or more tubes.

[0007] At least a portion of the end cap may be transparent. The one or more actuating elements may be formed from 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.

[0008] In another aspect, a medical system may include an endoscope having 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 a 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. The one or more patches may be coupled to a movable portion of the end cap between the proximal ring and the distal ring. The 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 move the movable portion of the end cap relative to the fixed portion of the end cap and relative to the endoscope. Movement of the one or more secondary actuators may cause one or more patches to at least partially deploy from the movable portion of the end cap.

[0009] The medical system may include one or more of the following features. The medical system may further include a sheath. The sheath may movably surround one or more portions of the end cap and the endoscope. The proximal ring may include one or more through-holes. The one or more control elements may be coupled to a movable portion of the end cap adjacent a corresponding one of the one or more through-holes in the proximal ring. At least one actuating element may extend through a corresponding one of the one or more through-holes in 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 within the proximal groove. Another portion of the one or more patches may be positioned within the distal groove. A distal portion of the one or more actuating elements may be positioned within the distal groove.

[0010] In yet another embodiment, 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 be coupled to a 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 and distal rings. 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. A 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.

[0011] The medical device may include one or more of the following features: The one or more actuators may be secondary actuators; The handle may further include a primary actuator configured to control the position of the end cap relative to the distal end of another medical device; The secondary actuators may be movable within respective channels formed by one or more wings on the primary actuator.

[0012] Any of the examples described herein can have any of these features in any combination. It will be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the claimed invention. As used herein, the terms "comprises," "comprising," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or device that includes 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 device. The term "exemplary" is used to mean "example" rather than "ideal." 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 "about" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value.

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0014] [Figure 1] 1 shows a perspective view of an exemplary medical device. [Figure 2A] 1 illustrates a perspective view of an exemplary control element. [Figure 2B] 2 shows a side view of the distal end of the exemplary medical device of FIG. 1, including an exemplary control element. [Figure 3A] 2 shows a perspective view of a portion of the distal end of the exemplary medical device of FIG. 1. [Figure 3B] 2 shows a perspective view of a portion of the distal end of the exemplary medical device of FIG. 1. [Figure 3C] 2 shows a cross-sectional view of a portion of the distal end of the exemplary medical device of FIG. 1. [Figure 4] 2 shows a perspective view of the distal end of the exemplary medical device of FIG. 1 coupled to an endoscope and in an operative configuration. DETAILED DESCRIPTION OF THE INVENTION

[0015] Reference will now be made in detail to examples of the present disclosure, 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. Among other aspects, embodiments of the present disclosure aim to improve a user's ability to position and / or deploy a patch within a subject's body during a medical procedure, help reduce the need to remove and reintroduce an endoscope or other medical device into a subject's body, help achieve hemostasis within a subject, and reduce overall procedure time.

[0016] FIG. 1 illustrates a medical device 104. As shown in FIGS. 2B and 4 , one or more portions of the medical device 104 may be coupled to another or second medical device, such as an endoscope 102, to form a medical system 100. As discussed in detail herein, the medical device 104 may include or otherwise be coupled to a patch delivery system to, for example, position and / or deliver one or more patches 106 to one or more portions of tissue within a subject, which may help to achieve hemostasis within the subject. Additionally, the medical system 100 may include a sheath or other protective element 112 ( FIG. 4 ). The sheath 112 may be movably 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 may be retracted proximally to expose the one or more patches 106, and one or more portions of the medical device 104 may be actuated to position and / or deploy the one or more patches 106.

[0017] 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. Furthermore, it should be noted that one or more portions or the entire end cap 108 may be transparent, which may aid a user in visualizing the treatment site and / or the patch 106, for example, using one or more visualization devices on the endoscope 102.

[0018] The medical device 104 may include a handle 110, manipulation of one or more portions of the handle 110 may serve to steer, position and / or reposition, release or deploy, and / or deliver one or more patches 106, for example, to position the one or more patches 106 on tissue at a treatment site. As discussed below, the handle 110 may 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.

[0019] The endoscope 102 may include a generally cylindrical, tubular shape and may include a proximal portion (not shown) and a distal portion 102B. While not shown, the proximal portion may include or otherwise be coupled to a handle that may include, for example, one or more ports, controls, levers, electrical or communication connections, etc. Additionally, the endoscope 102 may include, for example, one or more internal lumens or working channels extending longitudinally through the endoscope 102. In these embodiments, the internal lumens or working channels may extend through the proximal and distal portions 102B and terminate distally, for example, at one or more distal openings (i.e., the distal-most end of the endoscope 102). As shown in FIG. 1, when the medical device 104 including the patch 106 is coupled to the endoscope 102 (i.e., during delivery and positioning), the distal portion of the patch 106 and medical device 104 is coupled to the distal portion 102B of the endoscope 102, e.g., coupled to the distal opening of the internal lumen and / or may extend distally beyond the distal opening of the internal lumen.

[0020] The endoscope 102 (i.e., the distal portion 102B of the endoscope 102) may include a diameter of about 9 mm to about 15 mm, e.g., about 10.5 mm to about 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 described above, the endoscope 102 may include one or more internal lumens, e.g., a working channel having a diameter of about 2 mm to about 4 mm, e.g., about 2.8 mm. Additionally, the endoscope 102, e.g., the distal end face (not shown) of the endoscope 102, may include one or more illumination devices (e.g., one or more LEDs, optical fibers, 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.).

[0021] Although not shown, endoscope 102 may include one or more grooves, channels, lumens, or other features to movably receive one or more of control element 120, actuation element 122, and / or sheath element 124. Additionally, although not shown, one or more portions of endoscope 102 (i.e., distal portion 102B) may be deflectable, for example, via one or more knobs or other controls on the proximal handle. In these embodiments, distal portion 102B of endoscope 102 may be delivered to a treatment site and / or manipulated while positioned relative to the treatment site in a retroflex position, which may be used, for example, when the treatment site is within the subject's esophagus, stomach, duodenum, colon, or other portion of the GI tract.

[0022] Although the treatment site is discussed as being within the GI tract of a subject, the present disclosure is not so limited, as the treatment site may be any internal lumen or other tissue within a subject. Additionally, although an endoscope is referenced herein, it will be understood that the present disclosure encompasses any medical device having a working channel extending from a proximal to a distal end, such as a ureteroscope, duodenoscope, gastroscope, endoscopic ultrasound ("EUS") scope, colonoscope, bronchoscope, laparoscope, arthroscope, cystoscope, suction scope, sheath, or catheter.

[0023] Additionally, in some embodiments, the medical system 100 may include a sheath 112, e.g., an outer sheath (FIG. 4). The sheath 112 may be movable and may 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 may serve to cover the one or more patches 106 during delivery of the endoscope 102 and the end cap 108 to the treatment site. For example, as shown in FIG. 4, the sheath 112 may be retracted proximally to expose the one or more patches 106 once the endoscope 102 and the end cap 108 are positioned at the treatment site.

[0024] The patch 106 may be a biodegradable and / or biocompatible patch of any suitable shape and any suitable dimensions, based, for example, on the nature of the target tissue site. The patch 106 may be flexible and have any shape, such as, for example, a generally square, a generally rectangular, a rounded square, a rounded rectangular, an oval, or a circle, among other possible shapes. In some examples, the thickness of the patch may be on the order of millimeters, for example, from about 0.1 mm to about 5.0 mm, or more specifically, from about 0.7 mm to about 2.0 mm. The patch 106 may be sized sufficiently to cover the target tissue with a margin for excision. Thus, the patch 106 may be provided in many sizes to accomplish such a task. In some embodiments, the patch 106 may be approximately 50 mm x 50 mm (i.e., approximately 2 inches x 2 inches).

[0025] The patch 106 may be any suitable color, including transparent. The patch 106 may be formed from any suitable material, such as netting, mesh, cloth, gelatin, or polysaccharides (chitosan, cellulose, starch, alginate, etc.), which may be further modified with synthetic biocompatible materials (e.g., pHEMA, PGA, PLA, PCA, PEG, etc.). In some embodiments, the patch 106 may be formed from a bioadhesive material, such as chitosan, modified chitosan, cellulose, pHEMA, PVA, PEG, or a composite of one or more of these polymers. Additionally, for example, the patch 106 may be comprised of polypropylene, polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and / or silicone. The patch 106 may be adhered to the target tissue using materials commonly known in the art, such as, for example, fibrin glue, hydrogels, and / or cyanoacrylates. Alternatively, or in addition, patch 106 may comprise and / or be medicated with a drug to prevent cell shedding from the target tissue or to treat the target site. In some embodiments, patch 106 may include a therapeutic agent, e.g., an antibiotic and / or a hemostatic agent. Furthermore, after patch 106 is delivered to the treatment site, a user may 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., an internal lumen) of endoscope 102 or another medical device.

[0026] As shown in FIG. 1 , the medical device 104 includes an end cap 108 and a handle 110. One or more sheath elements 118 may 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. Each of the sheath elements 118 may be formed by a coil, a tube, a sheath, or the like. Additionally, one or more control elements 120 and one or more actuating elements 122 may extend from one or more portions of the handle 110 to one or more portions of the end cap 108. Each of the control elements 120 may be formed by a coil, a tube, a sheath, or the like. Each of the actuating elements 122 may be formed by a wire, a coil, a tube, a rod, or the like. In these embodiments, as shown in FIG. 2A , each control element 120 may be radially inward of a respective sheath element 118. Furthermore, each actuating element 122 may be radially inward of a respective control element 120.

[0027] As shown in FIGS. 1 and 2B, the end cap 108 may include a fixed portion 126 and a scaffolding or movable portion 128. FIG. 2B shows the end cap 108 without one or more patches 106 to illustrate the interior features of the end cap 108. The fixed portion 126 may be coupled to the distal portion 102B of the endoscope 102 (FIG. 2B). The fixed portion 126 may be cylindrical and / or ring-shaped, with a lumen 130 extending longitudinally through the fixed portion 126. The fixed portion 126 may be configured to be coupled to the radially outward-facing or outer surface 114 of the endoscope 102 (FIG. 2B). The fixed portion 126 may be coupled to the distal portion 102B of the endoscope 102 via, for example, a friction fit, adhesive, a press fit, crimping, or any other suitable coupling mechanism.

[0028] Further, stationary portion 126 may include one or more through-holes 132 extending longitudinally through a portion of stationary portion 126 (i.e., radially outward of lumen 130). In some embodiments, each of sheath elements 118 may be coupled to a corresponding through-hole 132. In addition, control element 120 (and actuating element 122) may extend longitudinally through a corresponding through-hole 132. In these embodiments, control element 120 (and actuating element 122) may move longitudinally (i.e., proximally and / or distally) relative to stationary portion 126 through a corresponding through-hole 132 to control, for example, the position of movable portion 128 relative to stationary portion 126 and / or endoscope 102 (FIG. 2B).

[0029] Although not shown, fixed portion 126 (and / or movable portion 128) may include one or more radiopaque markers, protrusions, or indicators configured to facilitate visualization of fixed portion 126 (and / or movable portion 128), for example, via x-ray, CT scan, or the like, or other external visualization techniques.

[0030] The movable portion 128 may be generally cylindrical and may include a lumen 134 ( FIG. 2B ) extending longitudinally therethrough. Additionally, 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 a 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 embodiments, one or more patches 106 may be positioned between the proximal ring 136 and the distal ring 138, as shown in FIG. 1 and discussed in detail with respect to FIGS. 3A-3C .

[0031] Additionally, the movable portion 128 may include one or more through-holes 142 extending longitudinally through a portion of the movable portion 128 (i.e., radially outward of the lumen 130). In some embodiments, each of the control elements 120 may be coupled to a corresponding through-hole 142. Additionally, the actuating elements 122 may extend longitudinally through a corresponding through-hole 142. The distal ends of the actuating elements 122 may be coupled to or otherwise abut the distal ring 138. In these embodiments, movement of the control element 120, e.g., via one or more actions relative to the handle 110, may control the position of the movable portion 128 relative to the stationary portion 126 and / or the distal portion 102B of the endoscope 102, as described in detail below. Additionally, movement of the actuating elements 122, e.g., via one or more different actions relative to the handle 110, may control the position and / or deployment of one or more patches 106.

[0032] As previously described, the handle 110 may be coupled to the end cap 108 via the sheath element 118, the control element 120, and / or the actuation element 122. Additionally, with reference to FIG. 1 , the handle 110 may include a handle body 150 including an internal lumen (not shown). In some embodiments, the proximal end of the sheath element 118 may be coupled to a distal end or portion of the handle body 150. The handle body 150 may include a main body portion 150A, which may be generally tubular or cylindrical (as shown) or may have another suitable shape. The main body portion 150A may be configured to be held within a handle and / or between a user's 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 embodiments, the extension portion 150B may be generally oval. Although not shown, extension portion 150B may be circular, rectangular, or another suitable shape. Main body portion 150A and extension portion 150B may help enable a user to grasp handle body 150 with, for example, one hand while allowing the user to actuate or otherwise manipulate one or more other portions of handle 110 with, for example, the same hand.

[0033] Further, in some embodiments, 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 may be movable within an internal lumen of the handle body 150. The primary actuator 152 may be coupled to the control element 120. For example, a distal portion of the primary actuator 152 may be coupled to a proximal end of the control element 120, e.g., within the internal lumen of the handle body 150. The distal portion of the primary actuator 152 may be coupled to the proximal end of the control element 120 via, e.g., a friction fit, adhesive, a press fit, a crimp, or any other suitable coupling mechanism. In this embodiment, movement of the primary actuator 152 relative to the handle body 150 (i.e., proximal or distal movement) may control extension or retraction of the control element 120 relative to the sheath element 118, and thus, extension or retraction of the movable portion 128 relative to the fixed portion 126 (FIG. 2B).

[0034] Additionally, one or more secondary actuators 154 may be coupled to the actuating elements 122. For example, a distal portion of each secondary actuator 154 may be coupled to a proximal end of a corresponding actuating element 122, e.g., within an internal lumen of the handle body 150. The distal portion of each secondary actuator 154 may be coupled to a proximal end of a corresponding actuating element 122, e.g., via a friction fit, adhesive, press fit, crimping, or any other suitable coupling mechanism. In this embodiment, movement (i.e., proximal or distal movement) of each secondary actuator 154 relative to the handle body 150 controls the extension or retraction of the actuating element 122 relative to the control element 120, and thus may control the position and / or deployment of one or more patches 106.

[0035] In these embodiments, the end cap 108 may include multiple patches 106. For example, the end cap 108 may include four patches 106 spaced circumferentially around the body portion 140 of the movable portion 128. Alternatively, the end cap 108 may include one, two, three, five, six, seven, eight, etc. patches 106. The patches 106 may be evenly or unevenly spaced around the body portion 140 of the movable portion 128. The handle 110 may include a number of secondary actuators 154 corresponding to the number of patches 106 on the end cap 108. As described above, the medical device 104 may include a number of sheath elements 118, control elements 120, and actuating elements 122 corresponding to the number of patches 106. Furthermore, the medical device 104 may include twice (or more) the number of sheath elements 118, control elements 120, and actuating elements 122 corresponding to 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 .

[0036] Further, although not shown, the handle 110 may include one or more springs or biasing elements, for example, within an internal lumen of the handle body 150, to bias movement of one or more of the primary actuators 152 and / or secondary actuators 154. For example, the one or more springs or biasing elements may bias proximally movement of one or more of the primary actuators 152 and / or secondary actuators 154. In these embodiments, a user may advance one or more of the primary actuators 152 and / or secondary actuators 154 distally relative to the handle body 150, but when distal pressure from the user is removed, the one or more biasing elements may urge the one or more of the primary actuators 152 and / or secondary actuators 154 proximally. Additionally or alternatively, one or more portions of the handle 110 may include a locking mechanism, for example, to selectively and / or releasably secure the position of one or more of the primary actuators 152 and / or secondary actuators 154.

[0037] The primary actuator 152 may include a proximal surface 156. The proximal surface 156 may 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 surface 156 may include a textured surface, which may aid a user in manipulating the primary actuator 152. In some embodiments, the proximal surface 156 may include a size (e.g., diameter or circumference) that is larger than the internal lumen of the handle body 150. For example, the proximal surface 156 may help to control and / or limit the movement (e.g., extension) of the movable portion 128 relative to the fixed portion 126.

[0038] The primary actuator 152 may also include one or more radially extending portions or wings 158 (e.g., at a mid-portion of the primary actuator 152), for example, that form one or more channels 160. For example, a plurality of wings 158 may extend radially away from a central portion 162 of the primary actuator 152. The outer portions of the wings 158 may be angularly or circumferentially spaced from adjacent wings 158 to form the channels 160. For example, in one embodiment, the primary actuator 152 may include four wings 158 spaced circumferentially at approximately 90-degree intervals and forming four channels 160. In these embodiments, each of the channels 160 may be sized and / or shaped to movably receive one of the secondary actuators 154. For example, each of the secondary actuators 154 may be wedge-shaped, and each of the channels 160 may be formed by two wings 158 spaced approximately 90 degrees apart.

[0039] As described above, the handle 110 may include one secondary actuator 154 for each actuation element 122. For example, if the medical device 104 includes four actuation elements 122 (as shown), the handle 110 may include four secondary actuators 154, with each secondary actuator 154 coupled to a corresponding actuation element 122. For example, the distal end of each secondary actuator 154 may be coupled to the proximal end of the corresponding actuation element 122, e.g., within the interior of the handle body 150. Each secondary actuator 154 may include a proximal surface 166. The proximal surface 166 may 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 surface 166 may include a textured surface, which may aid a user in manipulating the secondary actuators 154.

[0040] Each of the secondary actuators 154 may include a different color, pattern, indicia (e.g., letters, numbers, symbols, etc.), which may help a user distinguish between different secondary actuators 154. Additionally, although not shown, one or more of the patches 106 or one or more portions of the end cap 108 may include corresponding colors, patterns, indicia (e.g., letters, numbers, symbols, etc.), which may be visible via a visualization element on the endoscope 102, a separate internal or external visualization element, etc. In these aspects, a user may associate which secondary actuator 154 to activate or otherwise manipulate in order to position and / or deploy the appropriate patch 106.

[0041] 1 , one or more of the secondary actuators 154 may include one or more protrusions and / or markings 164. For example, the one or more protrusions and / or markings 164 may indicate to a user when the one or more secondary actuators 154 are in a position corresponding to extension of the actuating element 122 to deploy one or more patches 106. In some examples, the one or more protrusions and / or markings 164 may interact with the handle body 150 (e.g., a ridge or bump that may require additional proximal force for the secondary actuator 154 to overcome) and / or provide an audible click when the secondary actuator 154 reaches a position to deploy the patch 106. In other examples, the one or more protrusions and / or markings 164 may signal or otherwise indicate to a user that the actuating element 122 has reached a position to deploy the patch 106 when the one or more protrusions and / or markings 164 on the secondary actuator 154 are aligned with or distal to the proximal end of the handle body 150. In some examples, not shown, the handle body 150 may include a recess configured to receive one or more protrusions and / or markings 164. In this example, the one or more protrusions and / or markings 164 may snap or otherwise fit into the recess when the secondary actuator 154 is positioned relative to the handle body 150 such that the actuating element 122 reaches a position to deploy the patch 106.

[0042] 3A-3C illustrate additional features of the movable portion 128 of the end cap 108. FIGS. 3A and 3B are different perspective views of the movable portion 128 extending from the fixed portion 126 (not shown), and FIG. 3C is a longitudinal cross-sectional view of the movable portion 128. As previously described, the movable portion 128 includes one or more through-holes 132, e.g., coupled to the control element 120, for movably receiving the actuation element 122. Additionally, the movable portion 128 includes a lumen 134. Furthermore, one or more patches 106 may be positioned between the proximal ring 136 and the distal ring 138, e.g., such that the one or more patches 106 are radially outward of and / or adjacent to the body portion 140.

[0043] As shown in FIGS. 3A-3C , the distal ring 138 may include a distal groove 170. Additionally, in some embodiments, as shown in FIGS. 3A and 3C , the proximal ring 136 may include a proximal groove 172. As shown in cross-sectional views, the distal groove 170 and / or the proximal groove 172 may extend parallel to the longitudinal axis of the movable portion 128, for example, through portions of the distal ring 138 and the proximal ring 136, respectively. In these embodiments, the distal groove 170 and / or the proximal groove 172 may extend circumferentially around the longitudinal axis of the movable portion 128, for example, through portions of the distal ring 138 and the proximal ring 136, respectively. For example, the distal groove 170 may extend distally through the proximal surface of the distal ring 138. Similarly, the proximal groove 172 may extend proximally through the distal surface of the proximal ring 136. Additionally, a distal portion of one or more patches 106 may be positioned within distal groove 170, and a proximal portion of one or more patches 106 may be positioned within proximal groove 172. In these embodiments, grooves 170, 172 may help to retain one or more patches 106, for example, during delivery and / or positioning of one or more patches 106.

[0044] Additionally, as shown in Figures 3B and 3C, the actuating elements 122 may extend radially inward of one or more patches 106. Note that only one patch 106 is shown in Figure 3B, and the control element 120 is omitted from Figure 3C for clarity. For example, the actuating elements 122 may extend through respective through-holes 132 (e.g., in the proximal ring 136) and terminate in the distal groove 170. Each actuating element 122 may extend radially inward of an intermediate or central portion of a respective patch 106.

[0045] 4 illustrates movement of the movable portion 128 of the end cap 108 relative to the fixed portion 126 and the distal portion 102B of the endoscope, and also illustrates the positioning and deployment of the patch 106. In operation, a user may first couple the medical device 104 to an insertion device, such as the endoscope 102, for example, by coupling the end cap 108 to the distal portion 102B of the endoscope 102. The user may then use one or more visualization devices, illumination devices, etc. (not shown) at the distal tip of the endoscope 102 to manipulate and navigate the endoscope 102 to a treatment site within the subject's body.

[0046] As shown, once the distal portion 102B and end cap 108 of the endoscope 102 are positioned at the treatment site, the user may retract the sheath 112 proximally, e.g., to expose the movable portion 128 and one or more patches 106 coupled to the movable portion 128. Note that the sheath 112 may extend proximally, e.g., to the handle 110, the proximal end of the endoscope 102, etc., although for clarity, only a portion of the sheath 112 is shown in FIG. 4 . Alternatively, or in addition, the movable portion 128 may extend from the fixed portion 126. As described above, the user may operate (e.g., advance distally) the primary actuator 152 ( FIG. 1 ) to extend the movable portion 128. For example, operating the primary actuator 152 may distally advance the control element 120, thereby distally advancing the movable portion 128. Control element 120 may move relative to sheath element 118 through fixed portion 126, for example, through respective through-holes 132. Primary actuator 152 may be moved further distally and / or retracted proximally to reposition movable portion 128 relative to the treatment site. In some embodiments, endoscope 102 may include one or more visualization devices (not shown), which can assist a user in visualizing the treatment site and / or the position of movable portion 128 relative to endoscope 102 and / or treatment site. Once movable portion 128 is positioned relative to endoscope 102 and / or treatment site, a user may lock the position of primary actuator 152.

[0047] With the movable portion 128 positioned, a user may manipulate (e.g., advance distally) one of the secondary actuators 154 ( FIG. 1 ) to advance a selected actuating element 122. For example, a user may select one of the secondary actuators 154 to control the positioning and / or deployment of one patch 106. As shown in FIG. 4 , the distal end of the actuating element 122 is secured or otherwise positioned within the distal groove 170. Additionally, the position of the movable portion 128 may be secured, for example, by a user's hand or finger on the primary actuator 152, via one or more locking mechanisms, frictional engagement with the handle body 150, or the like. Thus, when the actuating element 122 is advanced distally, a portion of the actuating element 122 extends radially outward, bows, bends, or otherwise moves, for example, away from the body portion 140 of the movable portion 128, as shown in FIG. 4 . For example, the actuating element 122 may be formed from a shape memory material (e.g., nitinol) or braided wire, such that when the actuating element 122 is extended distally, the actuating element 122 may assume a radially outwardly extended, bowed, or bent configuration.

[0048] Because the actuating element 122 is positioned radially inward of the patch 106, or otherwise between the body portion 140 and the patch 106, movement of the actuating element 122 urges the patch 106 radially outward. For example, a first movement of the actuating element 122 may partially extend the patch 106 radially outward away from the body portion 140 (e.g., at least partially unfold the patch 106), e.g., with respective portions of the patch 106 retained within the distal and proximal grooves 170, 172. Then, further movement of the actuating element 122 (e.g., such that the markings 164 are aligned with the proximal end of the handle body 150) may further extend the patch 106 radially outward away from the body portion 140, e.g., so that respective portions of the patch 106 are no longer retained within the distal and proximal grooves 170, 172.

[0049] Once patch 106 is deployed and delivered to the treatment site, the user may inspect patch 106 and the treatment site, for example, using one or more visualization devices, illumination devices, etc. of endoscope 102. The user may reposition patch 106 using one or more ancillary medical devices, such as, for example, graspers or other ancillary medical devices (e.g., delivered to the treatment site through the working channel of endoscope 102). Additionally, the user may apply a hemostatic agent (e.g., hemostatic powder) to the delivered patch 106, for example, via one or more ancillary medical devices delivered through the working channel of endoscope 102.

[0050] Additionally, the user may reposition the movable portion 128, for example, via movement of the primary actuator 152, and may operate another secondary actuator 154 to position and / or deploy another patch 106. Another patch 106 may be delivered to the treatment site, for example, adjacent to the first patch, to help cover and / or heal a large ulcer. Alternatively, or in addition, another patch 106 may be delivered to another location on the treatment site. The user may repeat these steps as many times as necessary to deploy the desired number of patches 106 at the treatment site and / or to deploy all of the patches 106 on the end cap 108. Multiple patches 106 may be deployed at the treatment site without removing the medical system 100, including the endoscope 102 and end cap 108, from the subject.

[0051] Various aspects of the medical system 100, such as the medical device 104 having the patches 106, end cap 108, and handle 110, may have low cost and may be disposable (i.e., a single-use device). The medical device 104 may be coupled to any type of scope to facilitate delivery (e.g., endoscopic) of the one or more patches 106 to a treatment site, and coupling the end cap 108 to the distal end of the scope may be quick and user-friendly. The one or more patches 106 may be positioned on the end cap 108 (e.g., radially around the body portion 140 of the movable part 128). Additionally, the sheath 112 and / or distal ring 138 may help protect the one or more patches 106 from fluids, tissue, materials, etc. during delivery of the endoscope 102 to the treatment site.

[0052] Additionally, the medical device 104 may allow the 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., an internal lumen) of the endoscope 102. In this embodiment, the one or more patches 106 may be larger than patches that pass through the working channel. Furthermore, the one or more patches 106 and the end cap 108 may not interfere with the delivery of one or more auxiliary medical devices, delivery of fluids, application of suction, etc., that may occur through the working channel.

[0053] Furthermore, in some embodiments, the patch 106 may be positioned and repositioned prior to deployment. For example, as described above, a user can position and reposition the patch 106 via movement of the control element 120 by manipulating the primary actuator 152 relative to the handle body 150. The user may also position and reposition the distal portion 102B of the endoscope 102. This positioning and repositioning may be performed 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, a distal end face of the endoscope 102 is substantially unobstructed. Additionally, in some embodiments, a user may lock or otherwise secure the position of the primary actuator 152 relative to the handle body 150 via one or more handle locking mechanisms.

[0054] Once the patch 106 is in the desired position, the user may release or deploy the patch 106, for example, via movement (e.g., distal movement) of the secondary actuator 154 to control the movement of the actuating element 122. As discussed, movement (e.g., distal movement) of the actuating element 122 may cause the actuating element 122 to extend, bow, or bend radially outward, thus pushing the patch 106 radially outward such that portions of the patch 106 are no longer positioned within the distal and proximal grooves 170, 172. Alternatively, or in addition, the patch 106 may first be coupled (e.g., adhered using glue, epoxy, or other adhesive) to one or more actuating elements 122. In this embodiment, distal movement of the actuating element 122, which causes the actuating element 122 to extend, encircle, or bend radially outward, can also overcome the coupling between the patch 106 and the actuating element 122 and thus release or deploy the patch 106. Additionally, patch 106 may be positioned relative to the treatment site using one or more auxiliary medical devices, and / or the user may inspect the position of patch 106 at the treatment site, for example, via one or more visualization devices on endoscope 102. Positioning and deployment of patch 106 (e.g., via primary actuator 152 and secondary actuator 154 of handle 110) may be straightforward and user-friendly, which may allow the user to be a surgical technician while the physician performs one or more other tasks during the procedure.

[0055] While the principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, and equivalent substitutions, all within the scope of the examples described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. a handle including a primary actuator and one or more secondary actuators; an end cap configured to be coupled to a distal end of another medical device, the end cap including a fixed portion and a movable portion; one or more patches coupled to the movable portion of the end cap; one or more control elements coupling the primary actuator to the movable portion of the end cap; one or more actuating elements extending from the one or more secondary actuators to a location between a portion of the one or more patches and the movable portion of the end cap; Movement of the primary actuator causes the movable portion of the end cap to move relative to the fixed portion of the end cap; The medical device, wherein movement of the one or more secondary actuators causes the one or more patches to at least partially deploy 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. 2. The medical device of claim 1, wherein the handle includes a handle body, and both the primary actuator and the one or more secondary actuators are movable relative to the handle body to control movement of the one or more control elements and the one or more actuating elements.

4. 4. The medical device of claim 3, wherein the handle body includes a lumen, the primary actuator and the one or more secondary actuators are movable through the lumen, and the primary actuator includes a proximal face that is larger than a proximal opening of the lumen 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 location corresponding to deployment of the one or more patches.

6. 6. The medical device of claim 1, 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 the one or more control elements are positioned within a corresponding one of the one or more sheath elements.

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

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

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

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

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

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

13. The medical device of any one of claims 1 to 12, wherein at least a portion of the end cap is transparent.

14. The medical device of any one of claims 1 to 13, wherein the one or more actuating elements are formed from a shape memory material.

15. 15. The medical device of any one of claims 1-14, wherein the one or more secondary actuators comprise four secondary actuators, the one or more control elements comprise four control elements, the one or more actuation elements comprise four actuation elements, and the one or more patches comprise four patches.

Images