Devices and methods for tissue ligation

Abstract

This invention generally relates to medical devices, ligators, and methods for deploying ligatures around a portion of tissue. In some embodiments, the medical device may include a plunger biasable within a first tube, the first tube including a ligature along a distal end of the first tube. The medical device may also include a second tube surrounding the first tube, the second tube including a proximal end of the second tube opposite to the distal end of the second tube, wherein the distal end of the second tube includes an engaging member operable to dispense a ligature from the first tube in response to axial movement of the first and second tubes relative to each other.

Description

[0001] Cross-reference to related applications

[0002] This application is a non-provisional application filed on March 12, 2020, under U.S. Provisional Application Serial No. 62 / 988,479, which claims priority under 35 U.S. SC § 119, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to medical ligation devices, and more particularly to apparatus and methods for performing tissue ligation using a tissue ligation dispenser. Background Technology

[0004] Hemorrhoids are a problem many adults experience, especially as they age. One method used to treat and / or remove hemorrhoids is ligation, where a binding element, such as an elastic bandage, surrounds and isolates the hemorrhoid tissue. Over time, due to lack of blood flow, the ligated hemorrhoids will eventually shrink and fall off.

[0005] For medical professionals, such as surgeons, simultaneously positioning the ligation device at the ligation site and deploying the elastic band onto the target tissue can be challenging. The typical practice is for a physician to remove his or her guiding hand from the patient end of the ligation device to deploy the band, which can lead to mispositioning. Therefore, a device is desired that allows surgeons to move the ligation device while simultaneously releasing the elastic band with only one hand. Summary of the Invention

[0006] The present invention generally relates, in its various embodiments, to medical devices, ligators, and methods for deploying a ligation band around a portion of tissue, such as hemorrhoids. In one or more embodiments, the medical device may include a plunger movable within a first tube, the first tube including a ligation band along a distal end of the first tube. The medical device may also include a second tube for receiving the first tube, the second tube including a proximal end of the second tube opposite to the distal end of the second tube, wherein the distal end of the second tube includes an engagement member operable to dispense the ligation band from the first tube in response to axial movement of the first and second tubes relative to each other. In some embodiments, the plunger may include a shaft extending between the proximal and distal ends of the plunger, wherein a first channel extends through the distal end of the plunger; and a sealing member extending around the shaft, wherein the sealing member engages an inner surface of the first tube. In some embodiments, the first tube may include a first segment, wherein the ligation band extends around an outer surface of the first segment; and a second segment connected to the first segment, wherein the second segment includes a user engagement feature, wherein the sealing member is disposed within the second segment, and wherein a first diameter of the first segment is smaller than a second diameter of the second segment. In some embodiments, the second tube may include a distal segment connected to a proximal segment, wherein the proximal segment extends around a second segment of the first tube, and wherein the distal segment extends around a first segment of the first tube. In some embodiments, the engaging member may include a fixed end connected to the distal segment of the second tube; and a free end extending axially from the fixed end, the free end including a flange extending radially toward the first tube. The flange may include a sloped surface operable to pass over a cable tie when the distal ends of the first and second tubes move axially away from each other; and a flat surface operable to engage the cable tie when the distal ends of the first and second tubes move axially toward each other. In some embodiments, the free end terminates proximally at the most distal point of the distal end of the second tube. In some embodiments, the medical device may further include one or more additional engaging members disposed around the distal end of the second tube, wherein the engaging member and one or more additional engaging members are separated from each other by a slot. In some embodiments, the slot extends axially along the distal segment of the second tube. In some embodiments, the medical device further includes an applicator operable to a cable tie loader, wherein the cable tie loader includes the first and second tubes. The applicator may include a third tube surrounding the plunger; and a fourth tube surrounding the third tube, wherein the third tube extends within a second channel of the first tube to receive a cable tie surrounding the first tube, and wherein the fourth tube includes a distal end operable to remove and advance the cable tie from the third tube as the third and fourth tubes move axially relative to each other.

[0007] In one or more embodiments, the ligator may include a plunger disposed within a first tube, the first tube including a plurality of cable ties surrounding a distal end of the first tube. The ligator may also include a second tube for receiving the first tube, the second tube including a proximal end of the second tube opposite the distal end of the second tube, wherein the distal end of the second tube includes a plurality of engaging members operable to engage and deploy each of the plurality of cable ties originating from the first tube in response to axial movement of the first tube relative to the second tube. In some embodiments, the plunger may include a shaft extending between the proximal and distal ends of the plunger, and a sealing member extending around the shaft, wherein the sealing member engages an inner surface of the first tube to create a vacuum within the first tube. In some embodiments, the plurality of engaging members may include a fixed end connected to a distal segment of the second tube; and a free end extending axially from the fixed end, wherein the free end includes a flange extending radially toward the first tube. The flange may include an inclined surface operable to pass over the plurality of cable ties as the distal ends of the first and second tubes move axially away from each other; and a flat surface operable to engage the plurality of cable ties as the distal ends of the first and second tubes move axially toward each other. In some embodiments, the free end terminates proximally at the farthest point of the distal end of the second tube. In some embodiments, the ligator may further include a slot disposed through the distal end of the second tube, the slot separating two adjacent engaging members among a plurality of engaging members.

[0008] In one or more embodiments, a method may include actuating a plunger disposed within a first tube to draw target tissue into the first tube, the first tube including a cable tie along a distal end of the first tube; and providing a second tube around the first tube. The second tube may include a proximal end of a second tube opposite to the distal end of the second tube, wherein the distal end of the second tube includes an engaging member. The method may further include biasing the first and second tubes relative to each other to engage and deploy the cable tie originating from the distal end of the first tube. In some embodiments, the method may further include biasing the second tube toward the proximal end of the first tube in a first axial direction until a flange of the second tube passes the cable tie; and biasing the second tube away from the proximal end of the first tube in a second axial direction until a flat surface of the flange engages and deploys the cable tie. In some embodiments, the method may further include biasing the second tube toward the proximal end of the first tube in a first axial direction until a flange of the second tube passes the second cable tie; and biasing the second tube away from the proximal end of the first tube in a second axial direction until a flat surface of the flange engages and deploys the second cable tie. In some embodiments, the method may further include providing a protective region at the distal end of the second tube, wherein the protective region is located between the most distal points of the engagement member and the second tube to protect the free end of the engagement member when the second tube is inserted into the patient. In some embodiments, the method may further include an engagement applicator and a ligature loader, wherein the applicator includes a third tube surrounded by a fourth tube, and wherein the ligature loader includes a first tube and a second tube. The method may further include biasing the second tube relative to the first tube to transfer a ligature from the first tube to the third tube. In some embodiments, the method may further include biasing the third and fourth tubes relative to each other to transfer a ligature from the third tube to target tissue.

[0009] One or more of the various features outlined above may be interchanged, exchanged, combined, or substituted with other features outlined above to be used in conjunction with the medical systems and methods outlined above, as well as embodiments described in more detail below and other embodiments within the scope of the invention. Attached Figure Description

[0010] Referring to the accompanying drawings, which are not intended to be drawn to scale, non-limiting embodiments of the invention are described by way of example. In the drawings, each identical or nearly identical component shown is generally represented by a single number. For clarity, not every component is labeled in every drawing, and not every component of every embodiment is shown where it is not necessary for a person of ordinary skill in the art to understand the invention. Furthermore, some drawings include cross-sectional views in the form of "slices" or "near-view" cross-sectional views, where certain background lines or features otherwise visible in the "true" cross-sectional view are omitted for clarity. In the drawings:

[0011] Figure 1 This is a perspective view of a medical device according to an embodiment of the present invention;

[0012] Figure 2 According to the embodiments of the present invention, Figure 1 Exploded 3D diagram of a traditional Chinese medicine device;

[0013] Figures 3A to 3C The present invention describes an embodiment of the present invention. Figure 1 Operation of traditional Chinese medicine devices;

[0014] Figures 4A to 4D A method for deployment according to an embodiment of the present invention is described. Figure 1 One or more ligatures used in traditional Chinese medicine devices;

[0015] Figures 5A to 5B An alternative medical device according to an embodiment of the present invention is described;

[0016] Figure 6 This is a perspective view of a medical device according to an embodiment of the present invention;

[0017] Figure 7 According to the embodiments of the present invention, Figure 6 Exploded 3D diagram of a traditional Chinese medicine device;

[0018] Figures 8A to 8C The present invention describes an embodiment of the present invention. Figure 6 Operation of traditional Chinese medicine devices;

[0019] Figures 9A to 9D A method for deployment according to an embodiment of the present invention is described. Figure 6 One or more ligatures used in traditional Chinese medicine devices;

[0020] Figures 10A to 10B An alternative medical device according to an embodiment of the present invention is described;

[0021] Figure 11 This is a perspective view of a medical device according to an embodiment of the present invention;

[0022] Figures 12A to 12E A method for deployment according to an embodiment of the present invention is described. Figure 11 One or more ligatures used in traditional Chinese medicine devices;

[0023] Figure 13 According to the embodiments of the present invention, Figure 11 A three-dimensional diagram of the plunger in a traditional Chinese medicine device; and

[0024] Figure 14 This is a flowchart of a method according to an embodiment of the present invention. Detailed Implementation

[0025] This invention is not limited to the specific embodiments described herein. The terminology used herein is for describing specific embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise specified, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0026] This document discloses medical devices, ligators, and methods for deploying ligatures around target tissues, such as hemorrhoids. As described above, it is desirable to have a device that allows medical professionals to more easily manipulate a medical device (e.g., a ligator) to a location around the hemorrhoid and activate the release of an elastic ligature from it. The medical devices, ligators, and methods of the present invention advantageously provide a simplified operator interface, including multiple preloaded ligatures that can be advanced and deployed / distributed using one or more engagement members.

[0027] In some embodiments, the medical device and ligator disclosed herein may include an applicator that engages with a ligator to transfer one or more ligatures onto the applicator. The ligator may include a first tube surrounded by a second tube, wherein the ligature is disposed along the outside of the first tube. Once the applicator and the ligator are coupled together, the ligature can be transferred from the first tube to the applicator for subsequent deployment around the hemorrhoid.

[0028] Turn now Figures 1 to 2 The medical device 100 (e.g., a ligator) according to embodiments of the present invention will be described in more detail below. As shown, the medical device (hereinafter referred to as the “device”) 100 may include a first tube 102, a second tube 104, and a plunger 106. The first tube 102 may be a hollow elongated member for receiving the plunger 106 therein, and the second tube 104 may be a hollow elongated member for receiving the first tube 102. The plunger 106 may define a first channel 108, the first tube 102 may define a second channel 110, and the second tube 104 may define a third channel 112. Although not limiting, the plunger 106, the first tube 102, and the second tube 104 may be concentrically arranged about a central axis 114 extending through the device 100. In some embodiments, the plunger 106, the first tube 102, and the second tube 104 may be made of flexible materials, such as silicone, thermoplastic elastomers including polyamide and polyether backbone blocks, polyurethane, etc., to allow for mirror flexure. In other embodiments, one or more components of device 100 may be made of rigid materials, such as polycarbonate, acrylonitrile butadiene styrene (ABS), etc., to provide a more direct positioning response.

[0029] The plunger 106 may include a rigid or semi-rigid shaft 116 extending between a proximal plunger end 118 and a distal plunger end 120. At the proximal plunger end 118 may be a plunger engagement member 122, such as a flange or handle, which can be gripped by an operator to move the plunger 106 axially relative to the first tube 102 along a centerline shaft 114. At the distal plunger end 120 is a tip that may be angled to prevent tissue from becoming trapped between the outer surface of the distal plunger end 120 and the inner surface of the first tube 102. While not limiting, this angle may be greater than 25 degrees. One or more sealing members 124, such as gaskets, may surround the shaft 116. The sealing members 124 are operable to engage the inner surface of the first tube 102 to create an airtight seal at the interface therebetween.

[0030] The first tube 102 may include a first segment 126 connected to the second segment 127. As shown, a plurality of cable ties 130 may extend around the outer surface 131 of the first segment 126. In some embodiments, the cable ties 130 may be partially located within a corresponding notch (not shown). As will be described in more detail below, the cable ties 130 may be elastic cable ties that stretch to an expanded shape to assemble around and remain positioned around the outer surface 131 of the first tube 102 until deployment. During operation, one or more of the cable ties 130 may roll out or push out from the first distal end 134 of the first tube 102 and then contract around the target tissue (not shown). Once deployed, the cable ties 130 may cut off blood flow to the target tissue, causing the tissue to contract, die, and eventually separate from the surrounding tissue. Using more than one cable tie 130 allows the device 100 to be repositioned to capture additional tissue by subsequently deploying multiple cable ties 130 without having to remove the device 100 from the patient, thus allowing clinicians to perform procedures more efficiently without reloading the device 100.

[0031] As further shown, the first tube 102 may include a user engagement feature 136, such as one or more lugs or flanges, extending radially from the second segment 127. The user engagement feature 136 may be located at the first tube proximal end 137 of the first tube 102. In some embodiments, such as Figure 2 As better illustrated, the first diameter 'D1' of the first segment 126 may be smaller than the second diameter 'D2' of the second segment 127. Reducing the diameter of the first segment 126 relative to the second segment 127 provides increased patient comfort. Once the device 100 is assembled, the plunger 106 can be positioned within the second channel 110, which extends through the first segment 126 and the second segment 127 of the first tube 102.

[0032] It should be understood that the inner diameter of the second segment 127 is approximately equal to the outer diameter of the sealing member 124. In some embodiments, the inner diameter of the second segment 127 may be slightly smaller than the outer diameter of the sealing member 124 to ensure an airtight seal therebetween.

[0033] As further shown, the second segment 127 may include one or more ridges, indicators, or protrusions 138 along its outer surface 141. The protrusions 138 may engage a corresponding notch, groove, or pawl (not shown) along the inner surface of the second tube 104 or on a proximal ridge. The protrusions 138 may provide the operator of the device 100 with visual, auditory, and / or tactile feedback regarding the position of the second tube 104 relative to the first tube 102, indicating, for example, that several cable ties 130 have been deployed. In some embodiments, the inner surface of the second tube 104 may include a series of ridges or protrusions, while the second segment 127 includes notches or grooves. Furthermore, in some embodiments, the second segment 127 and / or the inner surface of the second tube 104 may include one or more cantilevered, cut-out lugs for engaging with engagement features on opposing surfaces. It should be understood that any number or configuration of protrusions 138 is possible.

[0034] The second tube 104 may include a distal segment 132 connected to the proximal segment 133. The proximal segment 133 may generally extend around the second segment 127 of the first tube 102, and the distal segment 132 may generally extend around the first segment 126 of the first tube 102. Between the distal segment 132 and the proximal segment 133 is a shoulder region 139. The shoulder region 139 may be gradually tilted and / or flexed to increase patient comfort. As shown, the diameter of the distal segment 132 may be smaller than the diameter of the proximal segment 133. In some embodiments, the second tube 104 may include an offset lug 140 extending radially from the proximal end 143 of the second tube.

[0035] As further shown, the second tube 104 may include one or more engaging members 145 extending axially at the distal end 146 of the second tube. Each engaging member 145 may include a fixed end 147 integrally formed or connected to the distal segment 132, and a free end 148 extending axially from the fixed end 147. As will be described in more detail herein, the free end 148 of one or more engaging members 145 may include a flange extending radially toward the first tube 102 for engaging and deploying one or more cable ties. Adjacent engaging members 145 may be separated from each other by a gap or slot 152. As shown, each slot 152 may generally extend axially along the distal segment 132 of the second tube 104. The slot 152 may provide flexibility to each engaging member 145, thereby allowing the free end 148 to move substantially radially relative to the central axis 114.

[0036] Turn now Figures 3A to 3C The operation of the device 100 according to an embodiment of the present invention will be described. During use, the operator of the device 100 can aim at the hemorrhoidal tissue by, for example, observation via an endoscopic camera. In other embodiments, no camera is used. Suction can then be applied by biasing the plunger 106 to bring the target hemorrhoidal tissue into the first tube 102. Specifically, as Figure 3AAs shown, the plunger engagement member 122 of the plunger 106 is axially movable away from the first tube proximal end 137 of the first tube 102 (e.g., along the y-direction), as indicated by arrow 150. The sealing member 124 abuts against the inner surface of the first tube 102 ( Figure 2 A vacuum chamber is created to pull the target hemorrhoid tissue into the device 100.

[0037] Next, as Figure 3B As shown, the second tube 104 can be biased relative to the first tube 102. For example, the second tube 104 can be pulled axially toward the proximal end 137 of the first tube 102, as indicated by arrow 151. As a result, the distal end 146 of the second tube moves away from the distal end 134 of the first tube, exposing the farthest cable ties 130A among the plurality of cable ties 130.

[0038] Next, as Figure 3C As shown, the second tube 104 can again be axially biased relative to the first tube 102. In this case, the second tube 104 is moved away from the first tube proximal end 137 of the first tube 102, so that the second tube distal end 146 of the second tube 104 engages the distal ligature 130A and removes it from the first tube 102. The distal ligature 130A can then be tightened around the target hemorrhoid tissue (not shown).

[0039] In some embodiments, suction can then be released by moving the plunger 106 toward the distal end 146 of the second tube, for example, by properly locating the identified distal ligature 130A by visualizing the site with an endoscopic camera. In other embodiments, suction can be maintained, and another ligature of the plurality of ligatures 130 is deployed around the target hemorrhoidal tissue.

[0040] Figures 4A to 4D Further illustration is provided of the deployment of a plurality of cable ties 130 originating from device 100 according to an embodiment of the present invention. As shown, a first tube 102 is disposed within a third channel 112 of a second tube 104. Although not shown, a plunger 106 may be disposed within a second channel 110 of the first tube 102. Each of the plurality of cable ties 130A to 130C may be disposed in one or more corresponding notches 155 of the first tube 102. In some embodiments, instead of notches 155, a plurality of protrusions extending outward from the first tube 102 may separate the plurality of cable ties 130A to 130C. Each engaging member 145 may include a flange 158 at its free end 148, wherein the flange 158 extends inward toward the first tube 102. In some embodiments, the flange 158 may be positioned at the furthest point of the distal end 146 of the second tube.

[0041] In some embodiments, flange 158 may include an inclined surface 161 extending to point 162. For example... Figure 4AAs shown, point 162 can initially engage with the outer surface 131 of the first tube 102. In the initial position, flange 158 is positioned between the distal end 134 of the first tube and cable tie 130A. As the distal end 146 of the second tube begins to move away from the distal end 134 of the first tube, as... Figure 4B As shown, the inclined surface 161 passes over / along the cable tie 130A, causing the free end 148 of each coupling member 145 to flex radially away from the first tube 102.

[0042] like Figure 4C As shown, the second tube 104 continues to move axially relative to the first tube 102 until the flange 158 passes the cable tie 130A. At this position, the flange 158 may engage or abut the outer surface 131 of the first tube 102 in the region between the cable ties 130A and 130B. In some embodiments, when the flange 158 re-engages with the outer surface 131, auditory and / or tactile feedback is provided to the operator of the device 100 regarding the position of the second tube 104 relative to the first tube 102. For example, once the operator hears an audible click, the operator can stop the movement of the second tube 104 away from the first tube 102.

[0043] To begin removing cable ties 130A from the first tube 102, as follows Figure 4D As shown, the distal end 146 of the second tube can be reversed and moved toward the distal end 134 of the first tube. Point 162, together with the flat surface 164 of the flange 158, can engage the cable ties 130A, thereby removing them from the notch 155. Point 162 can act as a wedge to remove the cable ties 130A from the notch 155. As the second tube 104 moves downward, the flat surface 164 can continue to push the cable ties 130A toward the distal end 134 of the first tube. Ultimately, the cable ties 130A will slide past the distal end 134 of the first tube and around the target hemorrhoid tissue 168 that has been sucked into the second channel 110 of the first tube 102.

[0044] In some embodiments, once cable tie 130A is deployed, the second tube 104 can move upward axially again until the flange 158 passes cable tie 130B and is positioned between cable ties 130B and 130C. Cable tie 130B can then be deployed in a similar manner to cable tie 130A, followed by cable tie 130C. It should be understood that in other embodiments, more or fewer cable ties may be deployed.

[0045] Figures 5A to 5B Various non-limiting alternatives to the first tube 102 and the second tube 104 according to embodiments of the present invention are illustrated. As shown, the user engagement feature 136 may be one or more rings 169 extending from or surrounding the proximal end 137 of the first tube 102. Each ring 169 may receive an operator's finger to enhance the operation of the device 100. Figure 5AAs further shown, the second tube 104 may include a set of gripping elements 173 along the outer surface 171 at the proximal end 143 of the second tube. This set of gripping elements 173 may replace or supplement the... Figure 5B The bias lug 140 is shown in the device 100.

[0046] Turn now Figures 6 to 7 The medical device (e.g., a ligator) 200 according to embodiments of the present invention will be described in more detail below. The medical device (hereinafter referred to as the “device”) 200 may be similar to the device 100 described herein in many respects. For this purpose, only certain aspects of the device 200 will be discussed below for the sake of brevity. As shown, the device 200 may include a first tube 202, a second tube 204, and a plunger 206. The first tube 202 may be a hollow elongated member including the plunger 206, and the second tube 204 may be a hollow elongated member surrounding the first tube 202. The plunger 206 may define a first channel 208, the first tube 202 may define a second channel 210, and the second tube 204 may define a third channel 212. Although not limiting, the plunger 206, the first tube 202, and the second tube 204 may be concentrically arranged about a central axis 214 extending longitudinally through the device 200.

[0047] The plunger 206 may include a rigid or semi-rigid shaft 216 extending between a proximal plunger end 218 and a distal plunger end 220. At the proximal plunger end 218 may be a plunger engagement member 222, such as a flange or handle, which can be gripped by an operator to move the plunger 206 axially relative to the first tube 202, for example, in the y-direction. A sealing member 224, such as a gasket, may surround the shaft 216. The sealing member 224 is operable to engage the inner surface of the first tube 202 to create an airtight seal at the interface therebetween.

[0048] The first tube 202 may include a first segment 226 connected to the second segment 227, wherein a plurality of straps 230 extend around the outer surface 231 of the first segment 226. In some embodiments, the straps 230 may be partially located within corresponding notches of the first tube 202. As will be described in more detail below, the straps 230 may be elastic straps that are stretched into an expanded shape to fit around the outer surface 231 and remain positioned until deployment. During operation, one or more of the straps 230 may roll out or be pushed out from the first distal end 234 of the first tube 202 and subsequently contract around target tissue (not shown). Using more than one strap 230 allows the device 200 to be repositioned to capture additional tissue by subsequently deploying the plurality of straps 230 without having to remove the device 200 from the patient.

[0049] Although not limiting, the first tube 202 may include a user engagement feature 236, such as one or more lugs or flanges, extending radially from the second segment 227. The user engagement feature 236 may be located at the first tube proximal end 237 of the first tube 202. Once the device 200 is assembled, the plunger 206 may be positioned within the second channel 210, which is defined by the inner surfaces of the first segment 226 and the second segment 227 of the first tube 202.

[0050] As further shown, the second segment 227 may include one or more indicators 238 along its outer surface 241. The indicators 238 may provide the operator of the device 200 with visual, auditory, and / or tactile feedback regarding the position of the second tube 204 relative to the first tube 202, which may further indicate, for example, that several cable ties 230 have been deployed. It should be understood that various indicators 238 may be used.

[0051] The second tube 204 may include a distal segment 232 connected to the proximal segment 233. The proximal segment 233 may extend substantially around a second segment 227 of the first tube 202, wherein the second segment 227 may include an offset lug 240 extending radially from the proximal end 243 of the second tube. Between the distal segment 232 and the proximal segment 233 is a shoulder region 239. The shoulder region 239 may be gradually tilted and / or flexed to increase patient comfort. For similar reasons, the diameter of the distal segment 232 may be smaller than the diameter of the proximal segment 233.

[0052] As further shown, the second tube 204 may include one or more engaging members 245 disposed along the distal segment 232. In this embodiment, the engaging member 245 is positioned proximal to the second distal end 246 of the second tube 204. The engaging member 245 may include a fixed end 247 integrally formed or connected to the distal segment 232, and a free end 248 extending axially from the fixed end 247. As will be described in more detail herein, the free end 248 of one or more engaging members 245 may include a flange extending radially toward the first tube 202 to engage and deploy a plurality of cable ties 230. In some embodiments, the engaging member 245 may be surrounded by one or more slots 252 to provide flexibility to the free end 248.

[0053] As further shown, the second tube 204 may include a protective region 244 at the distal end 246 of the second tube. The protective region 244 may include a generally solid ring or column disposed between the free end 248 of the engaging member 245 and the distalmost point 249 of the distal end 246 of the second tube. That is, the protective region 244 may not have any slots or gaps to increase the rigidity of the distal end 246 of the second tube. In this respect, the protective region 244 may prevent or reduce the deflection of the free end 248 when the distal end 246 of the second tube is inserted into the patient.

[0054] Now turning Figures 8A to 8CThe operation of the device 200 according to an embodiment of the present invention will be described. During use, the operator of the device 200 can aim at hemorrhoidal tissue, for example, by observation using an endoscopic camera. Suction can then be applied by biasing the plunger 206 to create a vacuum and bring the target hemorrhoidal tissue into the first tube 202. Specifically, as Figure 8A As shown, the plunger engagement member 222 of the plunger 206 is axially movable away from the first tube proximal end 237 of the first tube 202 (e.g., in the y-direction), as indicated by arrow 250. The sealing member 224 abuts against the inner surface of the first tube 202... Figure 7 A vacuum chamber is created to pull the target hemorrhoid tissue into the device 200.

[0055] Next, as Figure 8B As shown, the second tube 204 can be biased relative to the first tube 202. For example, the second tube 204 can be pulled axially toward the proximal end 237 of the first tube 202, as indicated by arrow 251. The movement of the distal end 246 of the second tube 204 relative to the first tube 202 exposes the distal end 234 of the first tube and the farthest cable tie 230A of the plurality of cable ties 230.

[0056] Next, as Figure 8C As shown, the second tube 204 can again be biased relative to the first tube 202. In this case, the second tube 204 can be axially moved away from the proximal end 237 of the first tube 202, as indicated by arrow 253, thereby causing the engaging member 245 of the second tube 204 to engage the distal ligature 230A and remove it from the distal end 234 of the first tube 202. The distal ligature 230A can then be tightened around the target hemorrhoidal tissue (not shown).

[0057] In some embodiments, suction can then be released by moving the plunger 206 toward the distal end 246 of the second tube, for example, by properly locating the identified distal ligature 230A by visualizing the site with an endoscopic camera. In other embodiments, suction can be maintained, and another of the plurality of ligatures 230 can be deployed around the target hemorrhoid tissue.

[0058] Figures 9A to 9D Further illustration is provided of the deployment of a plurality of cable ties 230 originating from device 200 according to an embodiment of the invention. As shown, a first tube 202 is disposed within a third channel 212 of a second tube 204. Although not shown, a plunger 206 may be disposed within the second channel 210. Each of the plurality of cable ties 230A to 230C may be disposed in one or more corresponding notches 255 of the first tube 202. Each engaging member 245 may include a flange 258 at its free end 248, wherein the flange 258 extends inward toward the first tube 202. As shown, the flange 258 of the free end 248 terminates proximally at the distal end 249 of the distal end 246 of the second tube.

[0059] In some embodiments, flange 258 may include an inclined surface 261 extending to point 262. Point 262 may initially engage with the outer surface 231 of the first tube 202, such as Figure 9A As shown. In this position of device 200, flange 258 is positioned between the distal end 234 of the first tube and cable tie 230A. When the distal end 246 of the second tube begins to move away from the distal end 234 of the first tube, as... Figure 9B As shown, the inclined surface 261 can engage the cable tie 230A, causing the free end 248 of each engagement member 245 to flex radially outward from the first tube 202.

[0060] like Figure 9C As shown, the second tube 204 continues to move axially relative to the first tube 202 until the flange 258 passes the cable tie 230A. At this position, the flange 258 can engage or abut against the outer surface 231 of the first tube 202 in the region between the cable ties 230A and 230B. To remove the cable tie 230A from the first tube 202, the second tube 204 can then be reversed and moved toward the distal end 234 of the first tube. Point 262, together with the flat surface 264 of the flange 258, can engage the cable tie 230A, thereby removing it from the notch 255, as... Figure 9D As shown, point 262 can be used as a wedge to remove cable ties 230A from notch 255. As the second tube 204 moves downward, the flat surface 264 can be used to push cable ties 230A toward the distal end 234 of the first tube until cable ties 230A are deployed around the target hemorrhoid tissue 268. As shown, once deployed, cable ties 230A are tightened around the target hemorrhoid tissue 268.

[0061] In some embodiments, once cable tie 230A is deployed, the second tube 204 can move upward axially again until the flange 258 passes cable tie 230B and is positioned between cable ties 230B and 230C. Cable tie 230B can then be deployed in a similar manner to cable tie 230A, followed by cable tie 230C. It should be understood that in other embodiments, more or fewer cable ties may be deployed.

[0062] Figures 10A to 10B Various non-limiting alternatives to the first tube 202 and the second tube 204 according to embodiments of the present invention are shown. For example... Figure 10A As shown, the user engagement feature 236 may include one or more rings 269 extending from or surrounding the first tube proximal end 237 of the first tube 202. The second tube 204 may also include a set of gripping elements 273 along the outer surface 271 at the second tube proximal end 243. This set of gripping elements 273 may replace or supplement bias lugs, such as… Figure 10B The offset lug 240 is shown. Figure 10BThe device 200 may also include a pair of lugs 269 extending radially from the second segment 227 of the first tube 202. Although not limiting, the pair of lugs 269 may be positioned distal to the proximal end 237 of the first tube. The pair of lugs 269 may include an inclined upper surface 272 and a flat lower surface 274 to improve operator ergonomics.

[0063] Turn Figure 11 A medical device (e.g., a ligator) 300 according to an embodiment of the present invention will be described. As shown, the medical device (hereinafter referred to as the "device") 300 may include an applicator 301 that can engage with a ligator 303 to transfer one or more ligatures 330 thereon. The ligator 303 may include a first tube 302 surrounded by a second tube 304. The first tube 302 and the second tube 304 may be hollow elongated members concentrically arranged about an axis 307 of the ligator. The first tube 302 may include a distal end 334 that contains a ligature along its outer surface 331.

[0064] As further shown, the second tube 304 may include a biasing surface 340 that allows an operator to move the second tube 304 axially relative to the first tube 302 along, for example, a cable loader axis 307 to deploy the cable ties 330. In some embodiments, the biasing surface 340 is textured and / or includes one or more gripping elements (e.g., ridges) to enhance engagement with the operator's thumb. The second tube 304 may also include one or more engagement members 345, which include a fixed end 347 opposite a free end 348. As will be described in more detail herein, the free end 348 of one or more engagement members 345 may include a flange 358 extending radially toward the first tube 302 to engage and disengage the cable ties 330. In some embodiments, each engagement member 345 may be separated from each other by a gap to provide radial flexibility to it.

[0065] The applicator 301 may include a third tube 380 surrounding a plunger 306 and a fourth tube 381 surrounding the third tube 380. As shown, the plunger 306, the third tube 380, and the fourth tube 381 may be hollow, elongated members concentrically arranged about an applicator axis 383. The plunger 306 may include a user engagement feature 336, such as one or more lugs or flanges, extending radially from a proximal end 318 of the plunger. The user engagement feature 336 allows the plunger 306 to be biased relative to the third tube 380 along the applicator axis 383. As shown, the user engagement feature 336 of the plunger 306 may slide within an opening or slot 384 at a proximal end 385 of the third tube 380. In some embodiments, the fourth tube 381 may include a biasing lug 341 extending radially from a proximal end 343 of the fourth tube, the biasing lug 341 allowing actuation of the fourth tube 381 relative to the third tube 380.

[0066] Figures 12A to 12EThis illustration demonstrates the transfer of multiple cable ties 330 from a cable tie loader 303 to an applicator 301 according to an embodiment of the invention. As shown, the cable tie loader 303 includes a first tube 302 disposed within a second channel 310 of a second tube 304. Each of the multiple cable ties 330A to 330C may be disposed in one or more corresponding notches in the first tube 302. Each engagement member 345 may include a flange 358 at its free end 348, wherein the flange 358 extends inward toward the first tube 302. As shown, the flange 358 may be positioned between the cable tie 330A and the most distal point 329 of the first tube 302. In some embodiments, the flange 358 may include an inclined surface 361 extending to point 362, wherein point 362 engages with the outer surface 331 of the first tube 302. Figure 12A As shown, the applicator 301 and the cable tie loader 303 can initially be separated from each other.

[0067] When the applicator 301 and the cable tie loader 303 are engaged, as Figure 12B As shown, the first tube 302 may be positioned above the third tube 380. For example, the inner surface 387 of the first tube 302 may abut and / or physically contact the outer surface 388 of the third tube 380. As shown, a gap 389 may be provided between the farthest point 329 of the first tube 302 and the farthest point 390 of the fourth tube 381 to allow for the reception of multiple cable ties 330A to 330C around the third tube 380 during deployment.

[0068] Next, as Figure 12C As shown, the second tube 304 can retract relative to the first tube 302 so that the flange 358 is positioned between cable ties 330A and 330B. The inclined surface 361 allows the flange 358 to pass more easily over the cable tie 330A. The second tube 304 can then be moved toward the farthest point 329 of the first tube 302 until the flat surface 364 of the flange 358 engages the cable tie 330A. Figure 12D As shown, point 362 and flat surface 364 allow cable tie 330A to be removed from notch 355, pushing cable tie 330A toward applicator 301 until cable tie 330A passes the farthest point 329 of the first tube 302 onto the third tube 380.

[0069] like Figure 12EAs shown, once the cable tie 330A is deployed around the third tube 380, the cable tie loader 303 can be disengaged from the applicator 301. Although not shown, the third tube 380 of the applicator 301 can then be brought to a position around the target hemorrhoidal tissue. The cable tie 330A can be deployed by biasing the distal end 390 of the fourth tube 381 against the cable tie 330A until the cable tie 330A slides or pushes the distal end 396 of the fourth tube beyond the third tube 380 onto the target hemorrhoidal tissue. Although not shown, the fourth tube 381 may include one or more flanges configured to engage and deploy the cable tie 330A, such as the flanges 158, 258 described above.

[0070] In some embodiments, the cable tie loader 303 and the applicator 301 may remain engaged until all cable ties 330A to 330C have been deployed onto the third tube 380. It should be understood that cable ties 330B and 330C may be deployed in a similar manner to cable ties 330A. It should also be understood that in other embodiments, more or fewer cable ties may be deployed.

[0071] Turn now Figure 13 The plunger 306 of the device 300 according to an embodiment of the present invention will be described in more detail. As shown, the plunger 306 may include a rigid or semi-rigid shaft 316 extending within a third tube 380. At the proximal end 318 of the plunger are user engagement features 336 extending radially therefrom, such as one or more lugs or flanges 393. The flange 393 may extend through an opening 384 at a proximal end 385 of the third tube 380. Although not shown, a sealing member such as a gasket may surround the shaft 316 and engage with the inner surface of the third tube 380 to create an airtight seal at the interface therebetween.

[0072] During use, the proximal end 385 of the third tube 380 can be positioned within the operator's palm, while his / her fingers pull the user engagement feature 336 toward the proximal end 385 of the third tube, increasing the vacuum pressure within the third tube 380. In this way, the device 300 allows for one-handed operation. It should be understood that similar engagement features can be incorporated into the devices 100 and 200 described herein, replacing the plunger engagement components 122 and 222, respectively.

[0073] Once the target hemorrhoid tissue is pulled into the third tube 380 and a ligature is deployed from the third tube 380, the suction created by the plunger 306 and the third tube 380 can be released. In some embodiments, the plunger 306 may include a venting component 398 actuated by an operator. Although not limiting, the venting component 398 may be a button for controlling a valve (not shown) within the plunger 306. Once the button is actuated, the valve opens, which breaks the vacuum seal created by the plunger 306 and the third tube 380. In some embodiments, the venting component 398 may extend through a venting opening 399 in the third tube 380 for operator access.

[0074] Figure 14 This is a flowchart of method 400 according to an embodiment of the present invention. At block 401, method 400 may include actuating a plunger disposed within a first tube to draw target tissue into the first tube, the first tube including a cable tie along a distal end of the first tube. In some embodiments, to draw in the target tissue, a vacuum is created within the first tube using a sealing member that engages the plunger with the inner surface of the first tube. In some embodiments, the sealing member is a circular gasket. In some embodiments, the plunger includes a rigid or semi-rigid shaft extending between a proximal end and a distal end of the plunger. At the proximal end of the plunger may be a plunger engagement member, such as a flange or handle, which can be gripped by an operator to move the plunger relative to the first tube, for example, in an axial direction.

[0075] At block 402, method 400 may include providing a second tube surrounding the first tube, the second tube including a proximal end of the second tube opposite to the distal end of the second tube, wherein the distal end of the second tube includes a engaging member. In some embodiments, the plunger, the first tube, and the second tube may be concentrically arranged about a central axis extending through the device.

[0076] At block 403, method 400 may include biasing the first and second tubes relative to each other to engage the ligature of the first tube with an engaging member and deploy the ligature. In some embodiments, the method may include biasing the second tube toward the proximal end of the first tube in a first axial direction until the flange of the second tube passes the ligature; then biasing the second tube away from the proximal end of the first tube in a second axial direction until the flat surface of the flange engages the ligature. The biasing of the second tube may continue until the ligature is deployed beyond the proximal end of the first tube. In some embodiments, the ligature may be deployed around target tissue. In some embodiments, the ligature may be deployed around an axis of an applicator that can then be inserted into a patient.

[0077] In some embodiments, the first and second tubes are part of a cable tie loader, which can be operated by an applicator to load one or more cable ties onto a third tube of the applicator. During use, the applicator and the cable tie loader can be brought together such that the inner surface of the first tube makes physical contact with the outer surface of the third tube. In some embodiments, a gap may be provided between the farthest point of the first tube 302 and the farthest point of the fourth tube surrounding the third tube. The gap may be provided to allow reception of cable ties around the third tube during deployment. The second tube of the cable tie loader can then be biased relative to the first tube to deploy cable ties from the first tube onto the third tube of the applicator.

[0078] In some embodiments, once the cable tie has been deployed around the third tube, the method may include disengaging the cable tie loader from the applicator. The third tube of the applicator may then be brought to a position around the target tissue, and the cable tie may be deployed by biasing the farthest point of the fourth tube against the cable tie until the cable tie slides or by pushing the far end of the fourth tube beyond the third tube onto the target tissue.

[0079] In some embodiments, a physician may operate the medical device described herein by inserting it into the patient's rectum. The physician may then engage the target tissue within the patient's body with the medical device and deploy one or more ligatures by biasing the outer tube relative to the inner tube. As a result, one or more ligatures are deployed onto the target tissue.

[0080] All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are for illustrative purposes only to aid the reader in understanding the invention and do not constitute limitation, particularly in terms of location, orientation, or use of the invention. While not restrictive, as used herein with respect to devices 100 and 200, the term “proximal” may refer to the portion of the device closest to the operator during use, while the term “distal” may refer to the portion of the device initially inserted into the patient.

[0081] The terms “connection” and “link” and their derivatives may be used to describe some embodiments. These terms are not intended to be synonymous with each other. For example, the terms “connection” and / or “link” may be used to describe some embodiments to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term “link” may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0082] As used herein, the singular forms “a” and “the” are intended to also include the plural forms unless the context clearly indicates otherwise. It should also be understood that, when used herein, the terms “comprising” or “including” indicate the presence of the stated feature, region, step, element, and / or component, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0083] Furthermore, the terms "substantially" or "generally" and the terms "approximately" or "roughly" are used interchangeably in some embodiments and can be described using any relevant measurement acceptable to a person skilled in the art. For example, these terms can be used as comparisons with reference parameters to indicate deviations from the intended function. While not limiting, deviations from reference parameters can be, for example, amounts less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc.

[0084] Although specific embodiments have been shown and described herein, it should be understood that any arrangement derived for achieving the same purpose may replace the specific embodiments shown. The invention is intended to cover any and all adaptive changes or variations of the various embodiments. It should be understood that the above description is illustrative and not restrictive. Upon review of the above description and in conjunction with the foregoing embodiments, other embodiments not specifically described herein will be apparent to those skilled in the art. Therefore, the scope of the various embodiments includes any other application in which the foregoing components, structures, and methods are used.

[0085] Furthermore, although the illustrative method 400 is described above as a series of actions or events, the invention is not limited to the shown order of these actions or events unless specifically stated otherwise. For example, according to the invention, some actions may occur in a different order and / or simultaneously with other actions or events other than those shown and / or described herein. Moreover, not all illustrated actions or events require implementation according to the method of the invention.

[0086] Although the subject matter has been described in language specific to structural features and / or methodological behavior, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or behaviors described above. Rather, the specific features and behaviors described above are disclosed as exemplary forms for implementing the claims.

Claims

1. A medical device comprising: A first tube, the first tube including a cable tie disposed at the distal end of the first tube; A plunger that can move within the first tube; as well as A second tube for receiving the first tube, the second tube including a second tube proximal end opposite a distal end of the second tube, wherein the distal end of the second tube includes a engagement member operable to dispense the cable tie from the first tube in response to axial movement of the first tube and the second tube relative to each other; as well as An applicator that can engage with a cable tie loader, wherein the cable tie loader includes the first tube and the second tube, and wherein the applicator includes: A third tube surrounding the plunger; as well as The fourth tube that surrounds the third tube.

2. The medical device according to claim 1, wherein the plunger comprises: A shaft extending between the proximal and distal ends of the plunger; as well as A sealing member extending about the axis, wherein the sealing member engages the inner surface of the first tube.

3. The medical device according to claim 2, wherein the first tube comprises: The first segment, wherein the cable tie extends around the outer surface of the first segment; as well as A second segment connected to the first segment, wherein the second segment includes a user engagement feature, and wherein the sealing member is disposed within the second segment.

4. The medical device according to claim 3, wherein the first diameter of the first segment is smaller than the second diameter of the second segment.

5. The medical device of claim 3 or 4, wherein the second tube includes a distal section connected to a proximal section, wherein the proximal section extends around a second section of the first tube, and wherein the distal section extends around a first section of the first tube.

6. The medical device of claim 5, wherein the engaging member comprises: A fixed end connected to the distal section of the second tube; as well as A free end extending axially from the fixed end, the free end including a flange extending radially toward the first tube.

7. The medical device of claim 6, wherein the flange comprises: An inclined surface, operable to pass over the cable tie as the distal ends of the first tube and the second tube move axially away from each other; as well as A flat surface operable to engage the cable tie when the distal ends of the first tube and the second tube move axially toward each other.

8. The medical device according to claim 6 or 7, wherein the second tube includes a protective region between the distal end of the second tube and the engagement member.

9. The medical device according to claim 6 or 7, wherein the free end terminates proximally at the most distal point of the second tube distal end.

10. The medical device according to any one of claims 1 to 4, further comprising one or more additional engagement members disposed around the distal end of the second tube.

11. The medical device of claim 10, wherein the engaging member and one or more of the additional engaging members are separated from each other by a slot.

12. The medical device of claim 11, wherein the slot extends axially along the distal segment of the second tube.

13. The medical device of claim 1, wherein the third tube is positioned within the first tube to receive the cable tie originating from the first tube.

14. The medical device of claim 1 or 13, wherein the fourth tube includes a distal end operable to remove from the third tube and advance the ligature as the third tube and the fourth tube move axially relative to each other.

15. A ligation device, comprising: A plunger disposed within a first tube, the first tube including a plurality of cable ties surrounding a distal end of the first tube, wherein each of the plurality of cable ties is disposed within one or more corresponding notches in the first tube, or wherein a plurality of protrusions extending outward from the first tube are disposed from the plurality of cable ties. and A second tube for receiving the first tube, the second tube including a proximal end of the second tube opposite to the distal end of the second tube, wherein the distal end of the second tube includes a plurality of engaging members operable to engage and deploy each of the plurality of ties originating from the first tube in response to axial movement of the first tube relative to the second tube, wherein the plunger is configured to be biased to apply suction, thereby bringing the target hemorrhoid tissue into the first tube.

16. The ligator of claim 15, wherein the plunger comprises: A shaft extending between the proximal and distal ends of the plunger; and A sealing member extending around the axis, wherein the sealing member engages the inner surface of the first tube to create a vacuum within the first tube.

17. The ligator of claim 15, wherein each of the plurality of engaging members comprises: A fixed end connected to the distal section of the second tube; and The free end extending axially from the fixed end, The free end includes a flange extending radially toward the first tube, and The flange includes: An inclined surface, operable to pass over the plurality of cable ties as the distal ends of the first tube and the second tube move axially away from each other; and A flat surface operable to engage the plurality of cable ties when the distal ends of the first tube and the distal ends of the second tube are axially moved toward each other.

18. The ligator of claim 17, wherein the free end terminates proximally at the most distal point of the second tube distal end.

19. The ligator of claim 15, further comprising a slot disposed at the distal end of the second tube, the slot separating two adjacent coupling members among the plurality of coupling members.

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