Endoscopic patch delivery

Abstract

A medical device includes: a first handle coupled to a first sheath; a second handle coupled to a second sheath, wherein at least a portion of the first sheath is disposed within a cavity of the second sheath; and a patch. In a first configuration, the first handle and the second handle may be separated by a first distance, and the patch may be disposed between a distal portion of the first sheath and a distal portion of the second sheath. In a second configuration, the first handle and the second handle may be in contact with each other or may be separated by a second distance, where the second distance is less than the first distance, and where the distal-most end of the second sheath is proximal to the proximal end of the patch.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 394,651, filed on August 3, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention generally relates to medical devices and related methods of making and using the same. More specifically, the present invention includes devices that can be used in endoscopic medical procedures, such as applying a patch to tissue for resection. More particularly, embodiments of the present invention relate to minimally invasive devices and methods for full-thickness endoscopic mucosal resection. The present invention also relates to methods of using such devices. Background Art

[0003] Colorectal cancer is the second leading cause of cancer death in the United States. Current treatment options for removing colorectal lesions (including cancerous and precancerous lesions) include endoscopic treatment or surgery. Examples of endoscopic treatments include endoscopic mucosal resection ("EMR") or endoscopic full-thickness resection ("EFTR"). EMR can be used to remove superficial lesions of the colorectum (e.g., lesions confined to the mucosa or submucosa). EFTR can be used to treat colorectal lesions that extend to deeper layers of colorectal tissue. However, EFTR is traditionally associated with the risk of intra-abdominal hypertension, insufflation, and / or cancer cell implantation. Since endoscopic resection performed in an outpatient setting is likely to significantly reduce hospital stays, as well as the morbidity and mortality associated with surgical resection, there is an unmet need for endoscopic tissue dissection of malignant and precancerous lesions, including lesions that extend deeper than those treatable with EMR. Summary of the invention

[0004] The present invention includes medical devices and systems including biocompatible patches, and methods of using the same, for example, methods of delivering the patches to a target site in a patient to safely resect target tissue.

[0005] In one example, a medical device may include: a first handle coupled to a first sheath; and a second handle coupled to a second sheath. At least a portion of the first sheath may be disposed within a cavity of the second sheath. The medical device may also include a patch. In a first configuration, the first handle and the second handle may be separated by a first distance, and the patch may be disposed between a distal portion of the first sheath and a distal portion of the second sheath. In a second configuration, the first handle and the second handle may contact each other or may be separated by a second distance, wherein the second distance is less than the first distance, and wherein the distal-most end of the second sheath is proximal to a proximal end of the patch.

[0006] Any of the examples described herein may have any of the following features in any combination. The first handle of the medical device may include a proximal opening configured to receive the distal portion of the handle of the endoscope. The first handle of the medical device may include features configured to accommodate the features of the endoscope. The patch of the medical device may include at least one pull line. At least one pull line may be arranged within the periphery of the patch and conform to the shape of the periphery of the patch. Each of the at least one pull line may terminate in two free ends extending from the same edge of the patch. The first handle of the medical device may include an actuator configured to move at least one pull line in a proximal direction. The distal portion of the first sheath may include a balloon coupled to the outer surface of the first sheath. In the first form, the balloon may be disposed between the first sheath and the patch. In the third form, the balloon may be inflated and the patch may be disposed on the inflated balloon. In the fourth form, the balloon and the patch may be separated. The patch may include an adhesive on the side of the patch away from the first sheath. The patch may be exposed to the liquid via a fluid channel. The medical device may be removably coupled to the endoscope by means of one or more fasteners, adhesives, or a friction fit.The first sheath may include a lumen for receiving a shaft of the endoscope.

[0007] In additional or alternative configurations, a medical device may include: a first sheath and a second sheath. The first sheath may be disposed within a cavity of the second sheath. The medical device may also include a balloon and a patch. In at least one configuration of the medical device, at least a portion of the patch may be disposed between the second sheath and at least a portion of the balloon, and at least a portion of the balloon may be disposed between at least a portion of the patch and the first sheath. The patch may also include at least one pull wire disposed within the periphery of the patch and conforming to the shape of the periphery of the patch. At least one configuration may be a first configuration, and in a second configuration, the second sheath may be retracted relative to the first sheath, and the balloon may be inflated.

[0008] In an additional or alternative example, a medical method may include: deploying a patch above a lesion in a body cavity; pulling a pull line of the patch in a proximal direction so that the patch surrounds at least a portion of the lesion and pulls together a first tissue portion on a first side of the lesion and a second tissue portion on a second side of the lesion; and removing the patch and the lesion from the body cavity. The method may also include: before deploying the patch, introducing a distal portion of a medical device into the body cavity; and after introducing the distal portion of the medical device into the body cavity, moving a second handle of the medical device proximally relative to a first handle of the medical device, thereby moving a second sheath of the medical device proximally relative to a first sheath of the medical device, and exposing the patch at the distal portion of the medical device.

[0009] It will be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not limitations of the present invention, as claimed. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to encompass non-exclusive inclusions such that a process, method, article, or device that includes a list of elements includes not only those elements, but may include other elements that are not explicitly listed or that are inherent to such a process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "exemplary." The term "distal" refers to the direction away from the operator / toward the treatment site, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present invention and, together with the description, serve to explain the principles of the present invention.

[0011] Figure 1 A perspective view of a medical device assembly according to aspects of the present invention is depicted.

[0012] Figure 2 Exemplary patches according to aspects of the invention are depicted.

[0013] Figures 3A to 3G Depicts deployment according to aspects of the present invention Figure 2 The patch Figure 1 device.

[0014] Figure 4A and Figure 4B Depicted is a schematic diagram of an open configuration ( Figure 4A ) and closed forms ( Figure 4B ) in an exemplary device.

[0015] Figure 5A and Figure 5B Depicted is a schematic diagram of an open configuration ( Figure 5A ) and closed forms ( Figure 5B ) in the alternative device.

[0016] Figure 6 Alternative arrangements according to aspects of the invention are depicted. DETAILED DESCRIPTION

[0017] 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.

[0018] Figure 1A perspective view of a medical device assembly 100 including a scope 110 and a medical device 120 is depicted. Although the term scope may be used herein, it should be understood that the term encompasses a variety of devices, including but not limited to endoscopes, duodenoscopes, colonoscopes, ureteroscopes, bronchoscopes, or laparoscopes, as well as other devices, including but not limited to sheaths, catheters, or any other suitable delivery devices or medical devices that may be used in conjunction with the devices of the present invention. Scope 110 includes a handle 101 (which may be retained outside the body of a subject) and an insertion sheath 139 (i.e., a shaft) (which may be inserted or introduced into a body cavity of a subject).

[0019] The handle 101 may include one or more control mechanisms 102. The control mechanism 102 may enable the steerable section 135 of the distal portion of the insertion sheath 139 to deflect / steer to allow the operator to navigate the insertion sheath 139 through tortuous anatomical structures and / or toward a site of interest. The handle 101 may include a port 103, which may be in fluid communication with one or more lumens (e.g., a working channel) of the insertion sheath 139. The scope 110 may also include an umbilicus 105 extending from the handle 101 for connecting the scope 110 / handle 101 to, for example, a source of air, water, suction, electricity, etc., as well as image processing and / or viewing equipment (not shown).

[0020] Insertion sheath 139 extends from the distal portion of handle 101 to distal end 140 of scope 110. Insertion sheath 139 may include one or more lumens (e.g., working channel, air / water lumen, wire / cable lumen, etc.). For example, the working channel of insertion sheath 139 may terminate in distal opening 137 at distal end 140 (e.g., Figure 3A As described above, the distal portion of the insertion sheath 139 can include a steerable section 135. The steerable section 135 can include, for example, an articulated joint. The insertion sheath 139 can be sufficiently flexible to maneuver through various anatomical structures, including portions of the gastrointestinal system. The insertion sheath 139 and the steerable section 135 can include various structures that are or may be known in the art. For example, the distal end 140 of the scope 110 can include a distal tip having an imaging device (e.g., a camera) and an illumination source (e.g., an LED or fiber optic) ( Figure 1 not shown).

[0021] The medical device 120 may include a primary or first handle 122 and a secondary or second handle 130. The primary handle 122 may include a fluid supply connector 126 and one or more actuators 124 (e.g., knobs), which will be described in further detail below. The primary handle 122 is approximately cylindrical in shape and surrounds the distal portion of the handle 101. The primary handle 122 may feature one or more features of the handle 101 of the scope 110 with various cutouts or contours. For example, the primary handle 122 may include a cutout 123 for receiving a portion of the port 103 of the handle 101.

[0022] The inner sheath 128 extends from the distal portion of the primary handle 122. The inner sheath 128 can extend around the insertion sheath 139 (e.g., the insertion sheath 139 can be disposed within the lumen of the inner sheath 128). The outer sheath 132 extends from the distal portion of the secondary handle 130. The inner sheath 128 extends through the central opening of the secondary handle 130 and through the central lumen of the outer sheath 132 to the distal end 138 of the medical device 120. The outer sheath 132 has a shorter overall length than the inner sheath 128. The inner sheath 128 and the outer sheath 132 can be coated with or made of a lubricious material to assist in loading or unloading the medical device 120 onto or from the scope 110 (as discussed below) and / or to assist in the movement of the outer sheath 132 relative to the inner sheath 128. The outer sheath 132 and the inner sheath 128 can be composed of a flexible biocompatible material so as not to hinder or otherwise limit the flexibility of the insertion sheath 139 of the scope 110. Portions of the outer sheath 132 and the inner sheath 128 can include different materials or different thicknesses of the same material to create variability in flexibility along the length of the sheath. Additionally or alternatively, the outer sheath 132 can be composed of one material and the inner sheath 128 can be composed of a second material different from the outer sheath 132.

[0023] The outer sheath 132 and the inner sheath 128 may also include additional lumens to assist in the delivery and / or removal of additional medical devices or fluids (i.e., air, water). For example, the outer sheath 132 or the inner sheath 128 may include one or more additional lumens extending proximally or distally along the length of the respective sheath to facilitate the use of one or more additional medical devices, such as wires, forceps, baskets, meshes, guidewires, or any other devices commonly used in the art. Additionally or alternatively, one or more lumens of the inner sheath 128 may be coupled to the fluid supply connector 126 and may be used to facilitate expansion or contraction of the balloon 134, as described in more detail below. A separate lumen (not shown) or a shared lumen may be used to facilitate ...) within the patch 136 ( Figure 1 and Figure 3A Not visible in , but in Figure 3B142a, 142b (discussed in detail below) and the actuator 124 of the main handle 122.

[0024] In the first form, Figure 1 and Figure 3A As shown, the primary handle 122 and the secondary handle 130 are separated by a first distance, or are not in contact. More specifically, the secondary handle 130 is positioned distally along the inner sheath 128 compared to the primary handle 122, such that a gap is formed between the distal end of the primary handle 122 and the proximal end of the secondary handle 130. In this configuration (also in Figure 3A ), the deflated balloon 134 and the patch 136 (in Figure 1 and Figure 3A Not visible in , but in Figure 3B ) can be positioned between the outer surface of the inner sheath 128 and the inner surface of the outer sheath 132 toward the distal end 138 of the medical device 120. FIG. 3A to FIG. 3C This arrangement is shown in more detail in FIG. Figure 3B As shown in more detail in FIG. 1 , the patch 136 can be positioned around the deflated balloon 134 (radially outward of the balloon 134 compared to the central longitudinal axis of the inner sheath 128). In addition, in the first configuration, the distal-most end of the inner sheath 128 can be aligned with the distal-most end of the outer sheath 132 at the distal end 138 of the medical device 120. For at least this reason, the distal-most end of the inner sheath 128 is aligned with the distal-most end of the outer sheath 132 at the distal end 138 of the medical device 120. Figure 3A Not visible in, or close to Figure 1 The distal end 138.

[0025] In the first configuration, the distal-most ends of the inner sheath 128 and the outer sheath 132 terminate proximal to the steerable or articulating section 135 of the scope 110. In an alternative arrangement of the medical device 120 in the first configuration, the distal portion 141 of the medical device 120 (e.g., the inner sheath 128 and / or the outer sheath 132 in the first configuration of the medical device 120) may terminate distal to the steerable or articulating section 135 of the scope 110, proximal to the distal end 140. In such an embodiment, the patch 136 and the balloon 134 may still be positioned proximal to the steerable or articulating section 135 of the scope 110 so as not to interfere with the articulation or steerability of the scope 110.

[0026] Figure 3B The distal portion 141 of the medical device 120 is shown in the second configuration. In the second configuration, the secondary handle 130 is pulled proximally (i.e., Figure 1 ), so that the primary handle 122 and the secondary handle 130 are closer to each other and / or contact each other ( Figure 1130). For example, the primary handle 122 and the secondary handle 130 can be separated by a second distance. The second distance can be less than the first distance, as discussed above with reference to the first configuration. In the second configuration, the primary handle 122 can be embedded in the proximal opening of the secondary handle 130. In the second configuration, when the secondary handle 130 is pulled upward, the outer sheath 132 is also pulled proximally while the inner sheath 128 remains stationary, thereby exposing the deflated balloon 134 and the patch 136.

[0027] like Figure 3C As shown and described in further detail below, in the third configuration of the medical device assembly 100, the balloon 134 can then be used to Figure 1 The fluid of the fluid supply connector 126 shown is inflated. A cavity or tube (not shown) can extend the length of the inner sheath 128 and be fluidically connected with the balloon 134 so that the balloon 134 is inflated. Alternatively, the cavity or tube communicated with the balloon 134 and the fluid supply connector 126 can extend through the other parts of the medical device 120. The fluid supply connector 126 can be connected to an external source, such as a fluid source or an air source. Various materials can be used to inflate the balloon 134, including but not limited to saline, water, air, etc. The inflation of the balloon 134 can then move the patch 136 radially outward. The patch 136 can conform to the shape of the balloon 134. In this form, the patch 136 can be applied to the target tissue 202 (i.e., lesions). For example, as discussed below, the balloon 134 can press the patch 135 against the target tissue 202. The balloon 134 may be made of any material well known in the art and used for balloons, such as, for example, polyurethane, Pebax, TM and / or silicone resin.

[0028] In an alternative configuration, the balloon 134 can be replaced by an expandable element, such as an expandable basket or cage (not shown). The expandable basket or cage can be configured to be in an open or expanded configuration or biased in an open or expanded configuration. For example, when the outer sheath 132 is pulled proximally, the basket or cage will automatically expand, much like a balloon is inflated. Such an alternative expandable element can have the same or similar effect on the patch 136, thereby facilitating the application of the patch 136 to the target tissue 202.

[0029] The medical device 120 may be attached to the distal portion of the handle 101 of the scope 110 by post-loading the medical device 120 onto the scope 110, much like an arm in a cannula, such that the handle of the scope 110 nests within a proximal opening of the medical device 120 (such as the proximal opening of the main handle 122), and the insertion sheath 139 of the scope 110 is positioned within the lumen of the inner sheath 128 of the medical device 120. The medical device 120 may be held in place on the scope 110 by means of a friction fit, one or more fasteners, an adhesive, or any other method well known in the art.

[0030] Figure 2 Depicted is an exemplary patch 136. Patch 136 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 136 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 5.0mm, or more specifically, about 0.7mm to about 2.0mm. Patch 136 may have enough size to cover the target tissue and have an edge for excision. Therefore, patch 136 can have a variety of sizes to achieve this task. In addition, patch 136 can have any suitable color, including transparent, and materials, for example, mesh, cloth, polysaccharides (chitosan, cellulose, starch, alginate, etc.), which can be further modified with synthetic biocompatible materials (pHEMA, PGA, PLA, PCA, PEG, etc.). Additionally, for example, patch 136 can be composed of polypropylene, polyester, ePTFE and / or silicone. Patch 136 can be adhered to the target tissue using materials well known in the art, such as, for example, fibrin glue, hydrogel and / or cyanoacrylate. Alternatively or additionally, patch 136 can be composed of or administered with an agent to prevent cells from falling off the target tissue or to treat the target site.

[0031] One or more pull wires 142a, 142b may be disposed on one or more surfaces of the patch 136 (e.g., Figure 2 The pull wires 142a, 142b may be positioned within the perimeter of the patch 136 on the upper / top surface 146 (depicted in the figure) and mimic or conform to the overall shape of the patch 136. The pull wires 142a, 142b may be positioned within one or more cavities on or within the patch 136 to allow for the movability of the pull wires 142a, 142b relative to the patch 136 (e.g., relative to the cavity of the patch 136). In an alternative configuration, the pull wires 142a, 142b may be positioned on the lower / bottom surface of the patch 136 (not shown in the figure). Figure 2142a and opposite to the top surface 146) or between the layers of the patch 136. Any combination is also allowed. For example, the pull wire 142a can be positioned between the layers of the patch 136, and the pull wire 142b can be positioned on the upper / top surface 146 or vice versa. The pull wires 142a, 142b can form an approximately straight line along the edge of the patch 136, or can be oriented to form various curves or geometric shapes. For example, as Figure 2 As shown, the pull wires 142a, 142b may have a square shape or a rounded square shape. Additionally or alternatively, the pull wires 142a, 142b may form a circle on the square or rectangular patch 136.

[0032] The number of pull wires 142a, 142b is not limited to two, as there may be additional pull wires or fewer pull wires. In addition, the pull wires 142a, 142b do not need to mimic each other's geometry and may have any suitable shape. For example, the pull wire 142a may form a circle and the pull wire 142b may form a square surrounding the circle. It should be understood that other geometric shapes may also be allowed. The pull wires 142a, 142b may be made of any suitable material, including metal, thread, suture material, etc. The pull wires 142a, 142b may also be coated with any desired biocompatible material to assist in reducing the amount of force required to pull the pull wires 142a, 142b. The pull wires 142a, 142b may have any suitable length. For example, the pull wires 142a, 142b may be long enough to be connected to Figure 1 The actuator 124 of the medical device 120 (i.e., the pull wire can extend the entire length of the inner sheath 128 of the medical device 120). Alternatively, the pull wires 142a, 142b can be shortened so that when the patch 136 is positioned in the body cavity, an auxiliary tool (not shown) can be used to pull the pull wires 142a, 142b. In an example, the pull wires 142a, 142b can extend through the pull wire sheath 148 ( Figures 3D to 3F ), which in turn can extend through a lumen of the medical device 120 (e.g., a lumen of the outer sheath 132 or the inner sheath 128) or through a space between the outer sheath 132 and the inner sheath 128.

[0033] Pull wires 142a, 142b may have one or two free ends extending from patch 136. Figure 2 As shown, the free ends of the pull wires 142a, 142b can extend from the same side of the patch 136, or can extend from opposite sides of the patch 136. For example, the free end of the pull wire 142a can extend from one side of the patch 136, and the free end of the pull wire 142b can extend from the opposite or opposing side of the patch 136.

[0034] The patch 136 may also include holes 144 extending through one or more layers of the patch material. The shape and size of the holes 144 are designed so that a grasper (not shown) can be passed through the holes 144 to help the user manipulate or adjust the target tissue contained within the patch 136.

[0035] The patch 136 can be flexible and bendable. For example, the patch 136 can be formed as a planar film, sheet, or disc that can be folded, curled, or otherwise manipulated into a temporary non-planar form within a confined space or when other forces act on the patch 136. For example, the patch 136 can be folded, bent, or curled between the inner sheath 128 and the outer sheath 132 of the medical device 120 for proper delivery via the mirror 110. Alternatively, the patch 136 can be folded, bent, curled, or otherwise manipulated to fit within the cavity of the mirror 110. However, once the balloon 134 is inflated or once the patch 136 is released from the balloon, the patch 136 can return to its original plane or other expanded form.

[0036] The patch 136 may be substantially dry during delivery to the target site. In some examples herein, the patch 136 may be wetted during delivery or shortly after being released from the delivery device. For example, the patch 136 may be exposed to water or another liquid via the fluid channel of the medical device 120 or the mirror 110 and / or by contacting with body fluids or moisture in the body. The fluid channel (not shown) of the medical device 120 may be fluidly connected to the fluid supply connector 126 or similar structure (i.e., port). When exposed to moisture, the patch 136 may absorb fluid, thereby causing the patch 136 to swell or expand. For example, the patch 136 may be substantially like paper when dry, and when wet, may present a consistency more like jelly. According to some aspects of the present invention, the moistened patch 136 may help to apply it to the tissue.

[0037] In some examples herein, patch 136 includes adhesive, for example, to assist in applying the patch to tissue and / or to keep the patch in place after application, and / or to assist in delivering patch 136 to a target site. Adhesive can be arranged on the surface of patch 136 relative to the surface of patch 136 with pull lines 142a, 142b. Adhesive can be arranged at certain discrete positions on the bottom surface (relative to top surface 146) of patch 136 or on the entire bottom surface. Adhesive suitable for the present invention can be natural, for example, including natural polymers, or obtained from natural polymers, or synthetic. Exemplary adhesives include, but are not limited to, gelatin (including, for example, thrombin / gelatin), fibrin (for example, fibrin glue), cyanoacrylate, polyethylene glycol (PEG) and albumin (including, for example, albumin glutaraldehyde). Adhesive can be at least partially reabsorbed by the body of the subject.

[0038] The selection of adhesive can be based at least in part on the properties of the target site to which the patch 136 is applied, such as, compared with the patch 136 comprising chitosan with natural bioadhesive properties, for the patch 136 comprising extracellular matrix (ECM), a relatively stronger adhesive may be required. In addition, for example, the patch 136 intended to be applied to a relatively large wound, tumor or defective part may include adhesive to further help fix the patch 136 to tissue. The patch 136 according to the present invention may include an adhesive applied to a region or two or more regions, such as the opposite end of the patch 136. Alternatively or additionally, adhesive may be applied in the periphery of the patch 136, thereby leaving the center portion of the patch 136 without adhesive. In some examples, the patch 136 does not include adhesive.

[0039] Figures 3A to 3G Depicts deployment in body cavities Figure 2 Patch 136 Figure 1 Medical device 120. Figure 3A The distal portion 141 of the medical device 120 is depicted, wherein the medical device 120 is in a first configuration, as described in further detail above. Figure 3A In the embodiment of the present invention, the distal end 140 of the insertion sheath 139 of the scope 110 is inserted or introduced into the body cavity 200. The distal end 140 of the scope 110 is positioned beyond (distal to) the target tissue 202 (e.g., a tumor) so that the distal portion of the outer sheath 132 is positioned above (i.e., aligned with) the target tissue 202.

[0040] Figure 3B The distal portion 141 of the medical device 120 is depicted in the second configuration. Figure 3B , the secondary handle 130 has been pulled proximally ( Figure 1 )(exist Figure 1134 and the insert sheath 139). The distal portion of the inner sheath 128 is then positioned so that the patch 136 and the balloon 134 are aligned with the target tissue 202. The proximal and distal ends of the balloon 134 / patch 136 can extend beyond the target tissue 202 so that there is a margin around the target tissue for adequate resection. In an example, the patch 136 and balloon 134 can be positioned so that it is approximately centered with respect to the target tissue 202.

[0041] Figure 3C The distal portion 141 of the medical device 120 is depicted in the third configuration, as described above. Figure 3C In the embodiment of the present invention, the balloon 134 is inflated, for example, via the fluid supply connector 126 ( Figure 1 ). As discussed above, the fluid supply connector 126 can be in fluid communication with the balloon 134 via a cavity or channel to enable the balloon 134 to be inflated and / or deflated. As discussed above, the balloon 134 can be inflated with the aid of one or more fluids (i.e., saline or water) or gases. Once inflated, the balloon 134 can press the patch 135 against the target tissue 202. The patch 136 can adhere to the tissue. The balloon 134 can then be deflated to release the patch 136, or the balloon 134 can be pulled away from the patch 136, thereby leaving the patch 136 in place, attached to the target tissue 202, as described above. Figure 3D shown.

[0042] Figure 3D The distal portion of the sheath 139 is depicted inserted when the patch 136 is positioned within the cavity 200. In this configuration, the balloon 134 (not shown) Figure 3D shown in FIG. 3A to FIG. 3C 136 ) may have been deflated, and the insertion sheath 139 may have been pulled proximally (i.e., toward the operator), thereby allowing the user to visualize the patch 136 using an imaging device of the scope 110 at the distal end 140 of the insertion sheath 139. Alternatively or additionally, portions of the medical device 120 (e.g., the outer sheath 132 and / or the inner sheath 128) may be removed from the body cavity 200 and / or from the scope 110. Figure 3D As shown, the patch 136 may be secured to the target tissue 202 (eg, via an adhesive of the patch 136, as discussed above).

[0043] like Figure 3E As shown, once the patch 136 is in place, it can be opened by rotating it clockwise or counterclockwise. Figure 1 The actuator 124 is used to pull one or two pull wires 142a, 142b proximally (e.g., through a pull wire sheath 148). In some embodiments, the actuator 124 may include multiple actuators that are used to independently control each of the pull wires 142a, 142b. For example, one of the actuators 124 can be rotated to pull the pull wire 142a, and a second actuator (not shown) can be used to pull the pull wire 142b. Alternatively or additionally, an auxiliary tool (e.g., tweezers) can be used to pull the pull wires 142a, 142b. Because the patch is adhered to the tissue, tensioning or pulling one or more pull wires 142a, 142b brings together relative portions of the healthy segment of the tissue wall, thereby tightening the patch 136 and creating a small bag or a bag of tissue, including the target tissue 202. This creates a polyp-like shape, enabling the user to use auxiliary tools to more easily extract the target tissue 202 within the patch 136, similar to a polypectomy, as described below. This process reduces the chance of implantation when the tumor is removed because the tumor is contained and confined within the patch.

[0044] Auxiliary tool 150 can be used to assist in positioning target tissue 202 in the small bag or bag created by patch 136. Auxiliary tool 150 can include forceps, guide wire, net, grasper or any other tool well known in the art. Auxiliary tool 150 can be inserted through the cavity of insertion sheath 139 of mirror 110. In the alternative, auxiliary tool 150 can be inserted outside of mirror 110, as shown. For example, auxiliary tool 150 can be an element of medical device assembly 100. Auxiliary tool 150 can extend, for example, through the space between outer sheath 132 and inner sheath 128, or through the cavity defined by one or more walls of outer sheath 132 or inner sheath 128. Alternatively, auxiliary tool 150 can extend through the space between inner sheath 128 and insertion sheath 139.

[0045] exist Figure 3F1, the snare 147 and the basket 149 coupled to the snare 147 are positioned above the patch 136 and the target tissue 202 contained therein. The snare 147 can be inserted through the lumen of the insertion sheath 139 of the scope 110. Alternatively, as shown, the snare 147 can be inserted into the body cavity 200 on the scope or via the medical device assembly 100, as described above for the auxiliary tool 150. One or more pull wires 142a, 142b can be maintained in a tightened configuration to create stability of the snare 147, hold the target tissue 202 within the pocket or pouch created by the patch 136, reduce blood flow to the target tissue and / or reduce tumor implantation.

[0046] like Figure 3G As shown, the snare 147 can be closed or used to cut (e.g., via an electric current) or separate the target tissue 202 from the surrounding healthy tissue. The snare 147 can also be used to cut or separate a portion of the patch 136 from the pull wires 142a, 142b. For example, when the patch 136 is in a flat configuration ( Figure 2 ) and a portion of the patch 136 that protrudes away from the periphery of the patch 136 when it forms a pocket or pouch around the target tissue 202 can be removed. The basket 149 of the cannula 147 contains and limits the excised portion of the target tissue 202 and the cut portion of the patch 136. In an alternative form, the snare 147 can cauterize the target tissue 202 to separate it from the surrounding healthy tissue. One or more pull wires 142a, 142b can be maintained in place and / or tightened around the base of where the target tissue 202 was located, for example, to reduce bleeding or prevent implantation. The target tissue can now be removed by pulling the snare 147 and basket 149 out of the body cavity 200 (e.g., by pulling the entire scope 110 proximally out of the body cavity 200). The user can use a clip or band to further secure the closure (not shown). Additionally or alternatively, another medical device (not shown) can be used to cut the pull wires 142a, 142b.

[0047] In an alternative embodiment, the patch 136 is positioned over the target tissue 202 without the use of the medical device 120. In such an alternative, the patch 136 can be delivered from the insertion sheath 139 of the scope 110 by crimping, folding, bending, or otherwise manipulating to fit to the outer surface of the insertion sheath 139 of the scope 110. In such an embodiment, one or more pull wires (having any of the properties of the pull wires 142a, 142b) can be advanced the entire length of the insertion sheath 139 of the scope 110 through a pull wire sheath (having any of the properties of the pull wire sheath 148) positioned outside or near the insertion sheath 139. The distal ends of the pull wires can be free or can be coupled to one or more actuators, similar to Figure 1actuator 124. In alternative embodiments, the patch 136 can be delivered through the lumen of the insertion sheath 139, and a pull wire and / or pull wire sheath (having any of the properties of the pull wires 142a, 142b and the pull wire sheath 148, respectively) can be positioned in the lumen of the insertion sheath 139, with the proximal end of the pull wire extending through, for example, a port of the handle 101. Alternatively, the user may be able to feed the pull wire sheath 148 through the working channel of the scope 110. This can be achieved by loading the pull wire sheath 148 and one or more pull wires 142 through the working channel of the insertion sheath 139. In any of the above alternatives, in order to close the patch 136, one or more pull wires can be pulled proximally (i.e., toward the operator) through the pull wire sheath. This pulls the sides of the patch 136 together, and therefore pulls the relative portions of the healthy tissue surrounding the target tissue together, thereby creating a pouch or bag similar to a polyp, as described above. Similar steps to those described above may be taken to remove part or all of the target tissue and patch 136.

[0048] Figure 4A and Figure 4B An alternative medical device 520 is shown. Figure 4A The medical device 520 is shown in an open configuration. The medical device 520 may include a sheath 576 and a wire forming a loop 578 extending from the sheath 576. The medical device 520 may be biased to Figure 5A The ring 578 can be moved relative to the sheath 576. For example, in a first configuration, the ring 578 can be completely disposed within the sheath 576. In a second configuration, the ring 578 can extend beyond the distal portion of the sheath 576 and expand to the configuration shown.

[0049] Two or more tubes 580 (e.g., hypotubes) (which may define a lumen) are distributed along the length of the ring 578, through which the ring 578 may be received. The two or more tubes 580 may be independently movable relative to the ring 578. For example, the tube 580 may rotate relative to the ring 578, or may be movable along the length (e.g., circumference) of the ring 578. The tube 580 may be made of one or more biocompatible materials, such as stainless steel or one or more plastics (i.e., acrylonitrile-butadiene-styrene or ABS). The struts 582 extend from each of the tubes 580 toward a central pivot point 584 positioned near the center of the ring 578. One or more struts 582 may be straight and rigid enough to resist bending. The patch 586 extends across the center of the ring 578 and may be attached to one or more struts 582 at various points along the length of the stent 582. Alternatively, the patch 586 may be attached to two or more opposing tubes 580. Patch 586 may be comprised of any of the materials previously described with respect to previous embodiments.

[0050] Figure 4B The medical device 520 is shown in a closed configuration. To achieve such a configuration, the wire forming the loop 578 can be pulled proximally (i.e., toward the user). Additionally or alternatively, the loop 578 can be attached to a separate pull wire (not shown) that can be pulled proximally. This movement causes the struts 582 to pivot about the central pivot point 584 while the tube 580 remains stationary relative to the loop 578. The struts 582 and / or the patch 586 can include barbs or adhesive material to assist in adhering to the target tissue and pulling the tissue into or against the patch 586 as the patch 586 begins to form a basket when the medical device 520 is converted to the closed configuration. When converted to or in the closed configuration, as shown in FIG. Figure 4B As shown, struts 582 may be bent such that struts 582 are transverse to the plane defined by the lines forming loop 578. Struts 582 may be oriented transverse to the axis defined by sheath 576, thereby creating a pyramid or cone shape with patch 586 forming a basket in the center of the pyramid or cone shape.

[0051] During use, the medical device 520 is used in a manner similar to the previous embodiments. For example, the medical device 520 is positioned above the target tissue in an open configuration, such as Figure 4A As shown. Patch 586 can be adhered to the target tissue as described above. Once the medical device 520 is in the appropriate position and the target tissue is surrounded by patch 586, the wire forming loop 578 is pulled proximally (i.e., toward the user). The proximal movement of loop 578 causes loop 578 to contract, thereby applying force to tube 580 and then to strut 582, causing strut 582 to pivot about central pivot point 584. Tube 580 can be fixed to loop 578. When strut 582 pivots, patch 586 forms a basket that surrounds the target tissue. When forming the basket, the opposite ends of the tissue around the target tissue are gathered together. Similar to Figures 1 to 3G 58, a polypoid pocket or pouch of tissue is formed within the basket formed by patch 586. The polypoid pocket or pouch of tissue may now be removed by, for example, utilizing an auxiliary tool (not shown) and / or energizing the wire forming loop 578 or otherwise cutting tissue with loop 578.

[0052] Figure 5A and Figure 5B Shown in open configuration ( Figure 5A ) and closed forms ( Figure 5B) in an alternative medical device 620. The medical device 620 includes a sheath 676 and a wire forming a loop 678, similar to a snare. A serrated surface 688 (i.e., a plurality of teeth) can be positioned on a portion of the loop 678 that faces the center. The serrated surface 688 can face radially inward, toward the center of the loop 678, and can be composed of any suitable material well known in the art, including metal or plastic. In some embodiments, the serrated surface 688 may not extend around the entirety of the loop 678 and / or may be patterned within any suitable period. For example, the serrated surface 688 may be disposed between segments of the loop 678 that do not have serrations. Additionally or alternatively, the serrated surface 688 may be disposed along a distal portion of the loop 678 so that when the loop 678 is pulled proximally into the sheath, the serrated surface 688 is not pulled into the sheath 676. This may be desirable to avoid damaging the sheath 676.

[0053] The patch 686 can be coupled to the outermost edge of the ring 678 and form a basket. For example, the patch 686 can extend away from the plane of the ring 678. The patch 686 can be made of any material previously described with respect to the previous embodiments. Additionally or alternatively, the patch 686 can include one or more conductive paint rings (not shown) such that when electrical energy is supplied to the conductive paint of the patch 686, the target tissue 202 is resected. The one or more conductive paint rings (not shown) can be oriented transversely or longitudinally relative to the plane formed by the ring 678. Figures 1 to 5B Any of the patches described may include such a conductive paint.

[0054] In an alternative, the medical device 620 may resemble a bag and may include a string or cord along the edge of the patch 686 instead of the loop 678. When the string or cord is pulled, the cord may become knotted so that the patch 686 remains in a closed bag or pouch-like configuration, with the tissue held in the pouch.

[0055] Any of the patches described herein (including patch 686) may include one or more needles (not shown) on the inner wall of patch 686 (the wall facing the tissue when patch 686 is deployed). One or more needles can act as a grasper and pierce the target tissue (e.g., target tissue 202) to hold it in place. One or more needles can be serrated or barbed to adequately hold the target tissue 202 in place within patch 686.

[0056] The medical device 620 may also include a locking mechanism 690. The locking mechanism 690 may be similar to those found on cable ties or cable ties. For example, the ring 678 may include a notched surface so that when the ring 678 is closed or tightened (e.g., Figure 5B), the ring 678 can be maintained in a tightened configuration using a locking mechanism 690. This may be desirable, for example, to maintain the target tissue 202 in place and within the patch 686 during surgery.

[0057] Figure 5B The medical device 620 is shown in a closed configuration. In this configuration, using any of the methods described above for actuating the medical device 620, the wire forming the loop 678 is pulled proximally, thereby forcing the serrated surface 688 to abut against and / or enter the target tissue 202, thereby cutting the target tissue 202 and / or reducing the size of the loop 678. When cutting the target tissue 202, the excised portion is limited by the patch 686 to prevent it from traveling through the body or implanting. As previously described, the locking mechanism 690 can be used to hold or lock the loop 678 in a tightened or closed configuration. As discussed above with respect to other examples, the patch 686 and the excised tissue contained therein can then be removed from the body.

[0058] Figure 6 A medical device 720 is depicted having two or more cutting blades 704 and a patch 786 forming a basket. The medical device 720 can have any of the properties of the medical device 620, as described above. The patch 786 can be coupled to the outer edge of the cutting blade 704 at one or more locations. The patch 786 can include or contain the elements and / or properties described with respect to the patch or basket of the previous embodiments. For example, the inner surface of the patch 786 can include needles and / or an adhesive surface.

[0059] The cutting blades 704 are oriented such that the cutting edges 706 of the cutting blades 704 face each other (i.e., inwardly) and toward the tissue to be captured within the patch 786. The distal points of each of the cutting blades 704 meet at a distal point 707 of the medical device 720. One or more wires 742 (i.e., wires) may be coupled to the proximal end of each of the cutting blades 704 and extend proximally.

[0060] In the first configuration, the cutting blade 704 can be slightly curved to form a circular or oval shape. The cutting blade 704 can be offset in the first configuration. In the second configuration (not shown), the wire 742 can be pulled proximally so that the cutting blade 704 is straightened and the cutting edges 706 of the opposing cutting blades 704 meet. When the cutting blades 704 meet, they can cut tissue and / or capture target tissue in a small pocket or bag formed by the patch 786 and / or the cutting blade 704.

[0061] The medical device 720 can be used in a manner similar to the previously described embodiments. For example, the medical device 720 can be used to excise target tissue (not shown), confine or contain the excised tissue within the patch 786, and remove the excised tissue from the body cavity.

[0062] Figure 2 and FIG. 4A to FIG. 6 The example patch and / or basket depicted in C may additionally or alternatively include one or more threads (i.e., wires, threads, etc.) that surround the patch / basket. Once the target tissue is excised or cut, the one or more threads may be used to tighten (i.e., close) the patch / basket, thereby confining the excised tissue to the interior of the patch / basket. In some embodiments, the one or more threads may be used to form a knot.

[0063] Although the principle of the present invention is described with reference to the illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skills in the art and who can obtain the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the above description.

Claims

1. A medical device comprising: a first handle coupled to the first sheath; a second handle coupled to a second sheath, wherein at least a portion of the first sheath is disposed within the lumen of the second sheath; as well as Patch; wherein, in a first configuration, the first handle and the second handle are separated by a first distance, and the patch is disposed between a distal portion of the first sheath and a distal portion of the second sheath; and Wherein, in a second configuration, the first handle and the second handle are in contact with each other or separated by a second distance, wherein the second distance is smaller than the first distance, and wherein the distalmost end of the second sheath is proximal to the proximal end of the patch. 2 . The medical device of claim 1 , wherein the first handle comprises a proximal opening configured to receive a distal portion of a handle of an endoscope.

3. The medical device of any preceding claim, wherein the first handle comprises features configured to accommodate features of an endoscope.

4. The medical device of any preceding claim, wherein the patch comprises at least one draw wire.

5. The medical device of claim 4, wherein the at least one pull wire is disposed within a perimeter of the patch and conforms to a shape of the perimeter of the patch.

6. The medical device of claim 4, wherein each of the at least one pull wire terminates in two free ends extending from the same edge of the patch.

7. The medical device of any preceding claim, wherein the first handle comprises an actuator configured to move at least one pull wire in a proximal direction.

8. The medical device of any preceding claim, wherein the distal portion of the first sheath comprises a balloon coupled to an outer surface of the first sheath.

9. The medical device of claim 8, wherein in the first configuration, the balloon is disposed between the first sheath and the patch.

10. The medical device of claim 8 or 9, wherein in a third configuration, the balloon is inflated and the patch is disposed on the inflated balloon.

11. The medical device of claim 10, wherein in a fourth configuration, the balloon and the patch are detached.

12. The medical device of any preceding claim, wherein the patch comprises an adhesive on a side of the patch facing away from the first sheath.

13. The medical device of any preceding claim, wherein the patch is exposed to the liquid via a fluid channel.

14. The medical device of any one of claims 2 to 13, wherein the medical device is removably coupled to the endoscope by means of one or more fasteners, adhesives, or a friction fit.

15. The medical device of any preceding claim, wherein the first sheath comprises a lumen for receiving a shaft of an endoscope.

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