Apparatus and method for tissue ligation

Abstract

To provide, in general, medical devices, ligators and methods for deploying ligation bands around a portion of tissue.SOLUTION: In some embodiments, a medical device may include a plunger biasable within a first tube, the first tube including a band along a first tube distal end. The medical device may further include a second tube surrounding the first tube, the second tube comprising a second tube proximal end opposite a second tube distal end, where the second tube distal end includes an engagement member operable to dispense the band from the first tube in response to axial movement of the first and second tubes relative to one another.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to medical ligating devices, and more particularly, to an apparatus and method for tissue ligation using a tissue band dispenser.

Background Art

[0002] Hemorrhoids are an event that occurs in many adults, especially with aging. One method for treating and / or removing hemorrhoids is ligation in which a constricting element such as an elastic band surrounds and blocks the tissue of the hemorrhoid. Over time, due to insufficient blood flow, the ligated hemorrhoid eventually withers and falls off.

[0003] For medical professionals such as surgeons, it may be difficult both to position the ligation device at the ligation site and to place the elastic band on the target tissue. It is a common technique for a physician to move his or her guiding hand away from the patient end of the ligation device in order to place the band, and there is a possibility of losing the position. Therefore, it is desirable to have a device that allows a surgeon to move the ligation device using only one hand while simultaneously activating the release of the elastic band.

Summary of the Invention

[0004] This disclosure relates, in various embodiments, to medical devices, ligators, and methods for deploying a ligation band around a portion of tissue, such as a hemorrhoid. In one or more embodiments, the medical device may include a plunger movable within a first tube. The first tube includes a band along its distal end. The medical device may further include a second tube for receiving the first tube. The second tube includes a proximal end opposite to the distal end of the second tube, and the distal end of the second tube includes an engaging member operable to release the band from the first tube in response to relative axial movement of the first and second tubes. In some embodiments, the plunger may include a shaft extending between the proximal and distal ends of the plunger. The shaft has a first channel extending into the distal end of the plunger. The plunger may include a sealing member extending around the shaft. The sealing member engages with the inner surface of the first tube. In some embodiments, the first tube may include a first portion on which the band extends around an external surface, and a second portion connected to the first portion, including a user engagement feature and containing a sealing member. The first diameter of the first portion is smaller than the second diameter of the second portion. In some embodiments, the second tube may include a distal portion connected to a proximal portion. The proximal portion extends around the second portion of the first tube, and the distal portion extends around the first portion of the first tube. In some embodiments, the engagement member may include a fixed end connected to the distal portion of the second tube and a free end extending axially from the fixed end. The free end includes a flange extending radially toward the first tube. The flange may include an inclined surface that can operate to overlap and pass over the band as the distal end of the first tube and the distal end of the second tube move axially away from each other, and a flat surface that can operate to engage with the band as the distal end of the first tube and the distal end of the second tube move axially toward each other. In some embodiments, the free end terminates proximal to 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 arranged around the distal end of the second tube, the engaging members and the one or more additional engaging members being separated from each other by slots.In some embodiments, the slot extends axially along the distal portion of the second tube. In some embodiments, the medical device further includes an applicator that can engage with a band loader, the band loader comprising a first tube and a second tube, the applicator may include a third tube surrounding a plunger and a fourth tube surrounding the third tube, the third tube extending into a second channel of the first tube to receive a band surrounding the first tube, and the fourth tube including a distal end of the fourth tube that is operable to pull the band out of the third tube and advance it as the third and fourth tubes move axially relative to each other.

[0005] In one or more embodiments, the ligator may include a plunger positioned within a first tube, the first tube including a plurality of bands surrounding the distal end of the first tube. The ligator may further include a second tube for receiving the first tube. The second tube includes a proximal end opposite to the distal end of the second tube, the distal end of the second tube including a plurality of engaging members that, in response to axial movement of the first tube relative to the second tube, engage with each of the plurality of bands and operate to retain each of the plurality of bands from the first tube. In some embodiments, the plunger may include a shaft extending between the proximal end and the distal end of the plunger, and a sealing member extending around the shaft. The sealing member engages with the inner surface of the first tube, creating a vacuum within the first tube. In some embodiments, the plurality of engaging members may include a fixed end connected to the distal portion of the second tube, and a free end extending axially from the fixed end. The free end includes a flange extending radially toward the first tube. The flange may include an inclined surface that can operate to overlap and pass over a plurality of bands as the distal ends of the first and second tubes move axially away from each other, and a flat surface that can operate to engage with the plurality of bands as the distal ends of the first and second tubes move axially towards each other. In some embodiments, the free end terminates proximal to the most distal point of the distal end of the second tube. In some embodiments, the ligator may further include a slot provided within the distal end of the second tube, the slot separating two adjacent engaging members of a plurality of engaging members.

[0006] In one or more embodiments, the method may include acting on a plunger positioned within the first tube to draw target tissue into the first tube, wherein the first tube includes a band along its distal end, and providing a second tube around the first tube. The second tube may include a proximal end opposite the distal end of the second tube, the distal end of the second tube including an engaging member. The method may further include biasing the first tube and the second tube toward each other to engage with the band and to retain the band away from the distal end of the first tube. In some embodiments, the method may further include biasing the second tube in a first axial direction toward the proximal end of the first tube until the flange of the second tube passes over the band, and biasing the second tube in a second axial direction away from the proximal end of the first tube until the flat surface of the flange engages with the band and retains it. In some embodiments, the method may further include biasing the second tube in a first axial direction toward the proximal end of the first tube until the flange of the second tube passes over the second band, and biasing the second tube in a second axial direction away from the proximal end of the first tube until the flat surface of the flange engages with the second band and it is in place. In some embodiments, the method may further include providing a protective area at the distal end of the second tube, the protective area located between the engaging member and the most distal point of the distal end of the second tube to protect the free end of the engaging member when the second tube is inserted into the patient. In some embodiments, the method may further include engaging an applicator with a band loader, the applicator including a third tube surrounded by a fourth tube, and the band loader including the first and second tubes. The method may further include biasing the second tube relative to the first tube to transfer the band from the first tube to the third tube. In some embodiments, the method may further include biasing the third and fourth tubes toward each other in order to transfer the band from the third tube to the target tissue.

[0007] One or more of the features outlined above may be replaced, exchanged, combined, or substituted with other features outlined above for use in relation to the medical systems and methods outlined above, and in the embodiments described in more detail below and otherwise within the scope of this disclosure.

[0008] Non-limiting embodiments of this disclosure are described, by example, with reference to accompanying drawings not intended to be drawn to scale. In the drawings, each identical or substantially identical component shown is typically represented by a single number. For clarity, not all components are referenced in all drawings, nor are all components of each embodiment shown where explanation is unnecessary for those skilled in the art to understand this disclosure. Furthermore, some of the drawings include section views in the form of “slices” or “myopic” sections, omitting certain background lines or features that would be visible in a “true” section view for illustrative purposes. [Brief explanation of the drawing]

[0009] [Figure 1] A perspective view of a medical device according to an embodiment of the present disclosure. [Figure 2] An exploded perspective view of the medical device shown in Figure 1, according to an embodiment of the present disclosure. [Figure 3A] Figure 1 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 3B] Figure 1 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 3C] Figure 1 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 4A] This figure shows a method for implanting one or more bands of the medical device shown in Figure 1 according to an embodiment of the present disclosure. [Figure 4B] This figure shows a method for implanting one or more bands of the medical device shown in Figure 1 according to an embodiment of the present disclosure. [Figure 4C] This figure shows a method for implanting one or more bands of the medical device shown in Figure 1 according to an embodiment of the present disclosure. [Figure 4D]This figure shows a method for implanting one or more bands of the medical device shown in Figure 1 according to an embodiment of the present disclosure. [Figure 5A] A diagram showing another medical device according to an embodiment of the present disclosure. [Figure 5B] A diagram showing another medical device according to an embodiment of the present disclosure. [Figure 6] A perspective view of a medical device according to an embodiment of the present disclosure. [Figure 7] An exploded perspective view of the medical device according to an embodiment of the present disclosure, shown in Figure 6. [Figure 8A] Figure 6 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 8B] Figure 6 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 8C] Figure 6 shows the operation of the medical device according to an embodiment of the present disclosure. [Figure 9A] This figure shows a method for implanting one or more bands of the medical device shown in Figure 6 according to an embodiment of the present disclosure. [Figure 9B] This figure shows a method for implanting one or more bands of the medical device shown in Figure 6 according to an embodiment of the present disclosure. [Figure 9C] This figure shows a method for implanting one or more bands of the medical device shown in Figure 6 according to an embodiment of the present disclosure. [Figure 9D] This figure shows a method for implanting one or more bands of the medical device shown in Figure 6 according to an embodiment of the present disclosure. [Figure 10A] A diagram showing another medical device according to an embodiment of the present disclosure. [Figure 10B] A diagram showing another medical device according to an embodiment of the present disclosure. [Figure 11] A perspective view of a medical device according to an embodiment of the present disclosure. [Figure 12A] This figure shows a method for implanting one or more bands of the medical device shown in Figure 11 according to an embodiment of the present disclosure. [Figure 12B] This figure shows a method for implanting one or more bands of the medical device shown in Figure 11 according to an embodiment of the present disclosure. [Figure 12C] This figure shows a method for implanting one or more bands of the medical device shown in Figure 11 according to an embodiment of the present disclosure. [Figure 12D] A diagram showing a method of placing one or more bands of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 12E] A diagram showing a method of placing one or more bands of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 13] A perspective view of the plunger of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 14] A flowchart of a method according to an embodiment of the present disclosure.

Mode for Carrying Out the Invention

[0010] The present disclosure is not limited to the specific embodiments described herein. The terms used herein are for the purpose of merely describing specific embodiments and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which the present disclosure pertains.

[0011] Disclosed herein are a medical device, a ligator, and a method for placing a ligating band around a target tissue such as a hemorrhoid. As described above, it is desirable to have a device that enables a medical professional to more easily both manipulate a medical device (e.g., a ligator) to a predetermined position around a hemorrhoid and initiate the release of an elastic band therefrom. The medical device, ligator, and method of the present disclosure advantageously provide a simplified operator interface that includes a plurality of pre-loaded bands that can be advanced, placed / discharged using one or more engagement members.

[0012] In some embodiments, the medical devices and ligators disclosed herein may include an applicator that can engage with a band loader to transfer one or more bands onto an applicator. The band loader may include a first tube surrounded by a second tube, with the bands positioned along the outside of the first tube. Once the applicator and band loader are coupled together, the bands can be transferred from the first tube to the applicator for subsequent placement around a hemorrhoid.

[0013] Referring here to Figures 1 and 2, a medical device 100 (e.g., a ligator) according to an embodiment of the present disclosure will be described in more detail. As shown in the figures, the medical device (hereinafter, "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, while 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. The plunger 106, the first tube 102, and the second tube 104 may be arranged concentrically around a central axis 114 that penetrates the device 100. In some embodiments, the plunger 106, the first tube 102, and the second tube 104 may be made from flexible materials such as thermoplastic elastomers, including silicone, polyamide and polyether backbone blocks, and polyurethane, in order to allow the scope to bend. In other embodiments, one or more components of the device 100 may be made from rigid materials such as polycarbonate and acrylonitrile butadiene styrene (ABS) to provide a more direct positioning response.

[0014] 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. The proximal plunger end 118 may have a plunger engagement component 122, such as a flange or handle, which can be grasped by an operator to move the plunger 106 axially along the central axis 114 relative to the first tube 102. The distal plunger end 120 is a tip, which may be angled to prevent tissue from being pinched between the outer surface of the distal plunger end 120 and the inner surface of the first tube 102. This angle may be greater than 25 degrees, but is not limited to this angle. One or more sealing members 124, such as a gasket, may surround the shaft 116. The sealing members 124 are operable to engage with the inner surface of the first tube 102 and form an airtight seal at the interface between the inner surface and the sealing member 124.

[0015] The first tube 102 may include a first portion 126 connected to a second portion 127. As shown, multiple bands 130 may extend around the outer surface 131 of the first portion 126. In some embodiments, the bands 130 may be partially seated in corresponding recesses (not shown). As will be described in more detail below, the bands 130 may be elastic bands that stretch into an elongated shape to fit around the outer surface 131 of the first tube 102 and maintain their position until implantation. During operation, one or more of the bands 130 may roll or be pushed away from the first distal end 134 of the first tube 102 and then contract around target tissue (not shown). Once implanted, the bands 130 may block blood flow to the target tissue so that the tissue shrinks, dies, and eventually separates from the surrounding tissue. By using multiple bands 130, the device 100 can be repositioned and further tissue can be captured without withdrawing the device 100 from the patient, and the continuous placement of the multiple bands 130 allows the clinician to complete the procedure more efficiently without having to reload the device 100.

[0016] As further illustrated, the first tube 102 may include one or more user engagement features 136, such as tabs or flanges, extending radially from the second portion 127. The user engagement features 136 may be located at the first proximal end 137 of the first tube 102. In some embodiments, as better shown in Figure 2, the first diameter "D1" of the first portion 126 is smaller than the second diameter "D2" of the second portion 127. Reducing the diameter of the first portion 126 relative to the second portion 127 may increase patient comfort. When the device 100 is assembled, the plunger 106 may be located within a second channel 110, which penetrates through the first portion 126 and the second portion 127 of the first tube 102.

[0017] It will be understood that the inner diameter of the second portion 127 is approximately equal to the outer diameter of the sealing member 124. In some embodiments, the inner diameter of the second portion 127 may be slightly smaller than the outer diameter of the sealing member 124 in order to ensure an airtight seal between the second portion 127 and the sealing member 124.

[0018] As further illustrated, the second portion 127 may include one or more ridges, indicators, or protrusions 138 along its outer surface 141. The protrusions 138 may engage with corresponding recesses, grooves, or stoppers (not shown) along the inner surface of the second tube 104, or with a proximal end ridge. The protrusions 138 can 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, which may indicate, for example, how many bands 130 have been placed. In some embodiments, the inner surface of the second tube 104 may include a series of ridges or protrusions, and the second portion 127 may include recesses or grooves. Furthermore, in some embodiments, the inner surface of the second portion 127 and / or the second tube 104 may include one or more cantilevered cutout tabs for engaging with engagement features on an opposing surface. It will be understood that any number or configuration of protrusions 138 is possible.

[0019] The second tube 104 may include a distal portion 132 connected to a proximal portion 133. The proximal portion 133 may extend roughly around the second portion 127 of the first tube 102, and the distal portion 132 may extend roughly around the first portion 126 of the first tube 102. The area between the distal portion 132 and the proximal portion 133 is the shoulder region 139. The shoulder region 139 may gradually slope and / or curve to increase patient comfort. As shown, the diameter of the distal portion 132 may be smaller than the diameter of the proximal portion 133. In some embodiments, the second tube 104 may include a biasing tab 140 extending radially from the proximal end 143 of the second tube.

[0020] As further illustrated, 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 with or connected to the distal portion 132 and a free end 148 extending axially from the fixed end 147. As described in more detail herein, the free ends 148 of one or more engaging members 145 may include flanges extending radially toward the first tube 102 for engaging with and retaining one or more bands. Adjacent engaging members 145 may be separated from each other by gaps or slots 152. As illustrated, each slot 152 may extend substantially axially along the distal portion 132 of the second tube 104. The slots 152 can provide flexibility to each of the engaging members 145, thus allowing the free end 148 to move substantially radially with respect to the central axis 114.

[0021] The operation of the apparatus 100 according to embodiments of the present disclosure will now be described with reference to Figures 3A to 3C. During use, the operator of the apparatus 100 can target hemorrhoidal tissue, for example, by viewing through an endoscope camera. In other embodiments, a camera is not used. Suction can then be applied by biasing the plunger 106 to draw the target hemorrhoidal tissue into the first tube 102. Specifically, as shown in Figure 3A, the plunger engagement component 122 of the plunger 106 can be moved axially (for example, along the y-direction) away from the proximal end 137 of the first tube 102, as indicated by the arrow 150. A sealing member 124 (Figure 2) in contact with the inner surface of the first tube 102 creates a vacuum chamber for drawing the target hemorrhoidal tissue into the apparatus 100.

[0022] Next, as shown in Figure 3B, 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 most distal band 130A of the multiple bands 130.

[0023] Next, as shown in Figure 3C, the second tube 104 can be biased axially again relative to the first tube 102. In this case, the second tube 104 moves away from the proximal end 137 of the first tube 102, engaging the distal end 146 of the second tube 104 with the distal band 130A and disengaging the distal band 130A from the first tube 102. The distal band 130A can then constrict around the target hemorrhoidal tissue (not shown).

[0024] In some embodiments, the suction may then be released by moving the plunger 106 toward the distal end 146 of the second tube, and the proper positioning of the most distal band 130A is confirmed, for example, by visualizing the site with an endoscope camera. In other embodiments, the suction may be maintained, and another band of the multiple bands 130 is placed around the target hemorrhoidal tissue.

[0025] Figures 4A to 4D further illustrate the placement of multiple bands 130 from the apparatus 100 according to embodiments of the present disclosure. As shown, the first tube 102 is located within the third channel 112 of the second tube 104. A plunger 106 may be located within the second channel 110 of the first tube 102, although this is not shown. Each of the multiple bands 130A to 130C may be located within one or more corresponding recesses 155 of the first tube 102. In some embodiments, instead of recesses 155, multiple projections extending outward from the first tube 102 may separate the multiple bands 130A to 130C. Each engaging member 145 may include a flange 158 at its free end 148, the flange 158 extending inward toward the first tube 102. In some embodiments, the flange 158 may be located at the most distal point of the distal end 146 of the second tube.

[0026] In some embodiments, the flange 158 may include an inclined surface 161 extending to a point 162. As shown in Figure 4A, the point 162 can initially engage with the outer surface 131 of the first tube 102. In the initial position, the flange 158 is positioned between the distal end 134 of the first tube and the band 130A. As shown in Figure 4B, as the distal end 146 of the second tube begins to move away from the distal end 134 of the first tube, the inclined surface 161 passes over / along the band 130A, bending the free ends 148 of each engaging member 145 radially away from the first tube 102.

[0027] As shown in Figure 4C, the second tube 104 continues to move axially relative to the first tube 102 until the flange 158 passes through band 130A. At this position, the flange 158 may engage with or abut against the outer surface 131 of the first tube 102 in the region between bands 130A and 130B. In some embodiments, auditory and / or tactile feedback regarding the position of the second tube 104 relative to the first tube 102 is provided to the operator of the device 100 as the flange 158 re-engages with the outer surface 131. If the operator hears an audible click, for example, the operator can stop moving the second tube 104 away from the first tube 102.

[0028] To initiate the removal of band 130A from the first tube 102, the distal end 146 of the second tube may reverse direction and move toward the distal end 134 of the first tube, as shown in Figure 4D. Point 162, along with the flat surface 164 of the flange 158, may engage with band 130A and remove it from the recess 155. Point 162 may act as a wedge to remove band 130A from the recess 155. The flat surface 164 may continue to push band 130A toward the distal end 134 of the first tube as the second tube 104 moves downward. Finally, band 130A moves beyond the distal end 134 of the first tube and slides around the target hemorrhoidal tissue 168 that has been drawn into the second channel 110 of the first tube.

[0029] In some embodiments, once band 130A is in place, the second tube 104 may again move axially upward until flange 158 passes through band 130B and is positioned between band 130B and band 130C. Band 130B may then be in place in a similar manner to band 130A, followed by band 130C. In other embodiments, it will be understood that more or fewer bands may be in place.

[0030] Figures 5A and 5B illustrate various non-limiting alternatives to the first tube 102 and the second tube 104 according to embodiments of the present disclosure. As illustrated, the user engagement feature 136 may be one or more loops 169 extending from or around the first tube proximal end 137 of the first tube 102. Each loop 169 may receive an operator's finger to improve the operation of the device 100. As further shown in Figure 5A, the second tube 104 may include a series of grip elements 173 along an outer surface 171 at the second tube proximal end 143. The series of grip elements 173 may replace or complement the biasing tab 140 shown in the device 100 of Figure 5B.

[0031] Referring here to Figures 6 and 7, a medical device (e.g., a ligator) 200 according to embodiments of the present disclosure will be described in more detail. The medical device (hereinafter, the "device") 200 may be similar in many respects to the device 100 described herein. Therefore, for the sake of simplification, only specific aspects of the device 200 may be described hereafter. As shown in the figures, 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 that houses the plunger 206 therein, and the second tube 204 may be a hollow, elongated member that surrounds 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. The plunger 206, the first tube 202, and the second tube 204 may be arranged concentrically around a central axis 214 that runs lengthwise through the apparatus 200.

[0032] The plunger 206 may include a rigid or semi-rigid shaft 216 extending between the proximal end 218 and the distal end 220 of the plunger. A plunger engagement component 222, such as a flange or handle, may be located at the proximal end 218 of the plunger, which can be grasped by an operator to move the plunger 206 axially relative to the first tube 202, for example along the y-direction. A sealing member 224, such as a gasket, may surround the shaft 216. The sealing member 224 is operable to engage with the inner surface of the first tube 202 and create an airtight seal at the interface between them.

[0033] The first tube 202 may include a first section 226 connected to a second section 227, with multiple bands 230 extending around the outer surface 231 of the first section 226. In some embodiments, the bands 230 may be partially seated within corresponding recesses of the first tube 202. As will be described in more detail below, the bands 230 may be elastic bands that stretch to a stretched shape, fit around the outer surface 231, and maintain their position until implantation. During operation, one or more of the bands 230 may be rolled or pushed away from the first distal end 234 of the first tube 202 and subsequently contract around the target tissue (not shown). Using more than one band 230 may allow the device 200 to be repositioned to capture further tissue by successive implantation of multiple bands 230 without the need to withdraw the device 200 from the patient.

[0034] The first tube 202 may include, but is not limited to, one or more user engagement features 236, such as tabs or flanges, extending radially from the second portion 227. The user engagement features 236 may be located at the proximal end 237 of the first tube 202. When the device 200 is assembled, the plunger 206 may be located within a second channel 210 defined by the internal surfaces of the first portion 226 and the second portion 227 of the first tube 202.

[0035] As further illustrated, the second portion 227 may include one or more indicators 238 along its outer surface 241. The indicators 238 can 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, how many bands 230 have been implanted. It will be understood that a variety of indicators 238 may be used.

[0036] The second tube 204 may include a distal portion 232 connected to a proximal portion 233. The proximal portion 233 may extend roughly around a second portion 227 of the first tube 202, and the second portion 227 may include a biasing tab 240 extending radially from the proximal end 243 of the second tube. The area between the distal portion 232 and the proximal portion 233 is the shoulder region 239. The shoulder region 239 may gradually slope and / or curve to increase patient comfort. For similar reasons, the diameter of the distal portion 232 is smaller than the diameter of the proximal portion 233.

[0037] As further illustrated, the second tube 204 may include one or more engaging members 245 positioned along the distal portion 232. In this embodiment, the engaging member 245 is positioned proximal to the distal end 246 of the second tube 204. The engaging member 245 may include a fixed end 247 integrally formed with or connected to the distal portion 232, and a free end 248 extending axially from the fixed end 247. As described in more detail herein, the free end 248 of one or more engaging members 245 may include a flange for engaging with and retaining a plurality of bands 230 extending radially toward the first tube 202. In some embodiments, the engaging member 245 may be surrounded by one or more slots 252 to give flexibility to the free end 248.

[0038] As further illustrated, 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 ring or cylinder that is connected around almost its entire circumference and is provided between the free end 248 of the engaging member 245 and the most distal point 249 of the distal end 246 of the second tube. That is, in order to increase the rigidity of the distal end 246 of the second tube, the protective region 244 may be made without any slots or gaps. Thus, the protective region 244 can prevent or reduce the deflection of the free end 248 when the distal end 246 of the second tube is inserted into the patient.

[0039] The operation of the apparatus 200 according to embodiments of the present disclosure will now be described with reference to Figures 8A to 8C. During use, the operator of the apparatus 200 can target hemorrhoidal tissue, for example, by viewing it through an endoscope camera. Suction can then be applied by creating a vacuum and biasing the plunger 206 to draw the target hemorrhoidal tissue into the first tube 202. Specifically, as shown in Figure 8A, the plunger engagement component 222 of the plunger 206 can be moved axially (for example, along the y-direction) away from the proximal end 237 of the first tube 202, as indicated by the arrow 250. The sealing member 224 (Figure 7) in contact with the inner surface of the first tube 202 creates a vacuum chamber for drawing the target hemorrhoidal tissue into the apparatus 200.

[0040] Next, as shown in Figure 8B, 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 most distal band 230A of the multiple bands 230.

[0041] Next, as shown in Figure 8C, the second tube 204 can be biased again against the first tube 202. In this case, the second tube 204 is moved axially away from the first proximal end 237 of the first tube 202, as indicated by arrow 253, thereby engaging the engaging member 245 of the second tube 204 with the distal band 230A and disengaging the distal band 230A from the first distal end 234 of the first tube 202. The distal band 230A may then constrict around the target hemorrhoidal tissue (not shown).

[0042] In some embodiments, the suction may then be released by moving the plunger 206 toward the distal end 246 of the second tube, and the proper positioning of the most distal band 230A is confirmed, for example, by visualizing the site with an endoscope camera. In other embodiments, the suction may be maintained, and another band of the multiple bands 230 is placed around the target hemorrhoidal tissue.

[0043] Figures 9A to 9D further illustrate the placement of multiple bands 230 from the apparatus 200 according to embodiments of the present disclosure. As shown, the first tube 202 is located within the third channel 212 of the second tube 204. A plunger 206 may be located within the second channel 210, although not shown. Each of the multiple bands 230A to 230C may be located within one or more corresponding recesses 255 of the first tube 202. Each engaging member 245 may include a flange 258 at its free end 248, the flange 258 extending inward toward the first tube 202. As shown, the flange 258 at the free end 248 terminates proximal to the most distal point 249 of the distal end 246 of the second tube.

[0044] In some embodiments, the flange 258 may include an inclined surface 261 extending to point 262. As shown in Figure 9A, point 262 can initially engage with the outer surface 231 of the first tube 202. At this position in the device 200, the flange 258 is positioned between the distal end 234 of the first tube and the band 230A. As shown in Figure 9B, as the distal end 246 of the second tube begins to move away from the distal end 234 of the first tube, the inclined surface 261 engages with the band 230A, and the free ends 248 of each engaging member 245 can bend radially outward from the first tube 202.

[0045] As shown in Figure 9C, the second tube 204 continues to move axially relative to the first tube 202 until the flange 258 passes through the band 230A. At this position, the flange 258 may engage with or abut against the outer surface 231 of the first tube 202 in the region between bands 230A and 230B. To remove band 230A from the first tube 202, the second tube 204 may then reverse direction and move toward the distal end 234 of the first tube. As shown in Figure 9D, the point 262, together with the flat surface 264 of the flange 258, may engage with the band 230A and remove it from the recess 255. The point 262 may act as a wedge for removing band 230A from the recess 255. The flat surface 264 may be used to push the band 230A toward the distal end 234 of the first tube as the second tube 204 moves downward until the band 230A is positioned around the target hemorrhoidal tissue 268. As shown, once positioned, the band 230A constricts around the target hemorrhoidal tissue 268.

[0046] In some embodiments, once band 230A is in place, the second tube 204 may again move axially upward until flange 258 passes through band 230B and is positioned between band 230B and band 230C. Band 230B may then be in place in a similar manner to band 230A, followed by band 230C. In other embodiments, it will be understood that more or fewer bands may be in place.

[0047] Figures 10A and 10B illustrate various non-limiting alternatives to the first tube 202 and the second tube 204 according to embodiments of the present disclosure. As shown in Figure 10A, the user engagement feature 236 may include one or more loops 269 extending from or around the first tube proximal end 237 of the first tube 202. The second tube 204 may further include a series of grip elements 273 along the outer surface 271 at the second tube proximal end 243. The series of grip elements 273 may replace or complement a biasing tab, such as the biasing tab 240 shown in Figure 10B. The device 200 in Figure 10B may further include a pair of tabs 269 extending radially from a second portion 227 of the first tube 202. The pair of tabs 269 may be located distal to the first tube proximal end 237, but is not limiting. A pair of tabs 269 may include an inclined upper surface 272 and a flat lower surface 274 to improve operator ergonomics.

[0048] Referring to Figure 11, a medical device (e.g., a ligator) 300 according to an embodiment of the present disclosure will be described. As shown in the figure, the medical device (hereinafter, the "device") 300 may include an applicator 301 that can engage with a band loader 303. The applicator 301 is for transferring one or more bands 330 onto the applicator 301. The band loader 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 arranged concentrically around the band loader axis 307. The first tube 302 may include a distal end 334 that accommodates bands along its outer surface 331.

[0049] As further illustrated, the second tube 304 may include a biasing surface 340, which allows an operator to move the second tube 304 axially relative to the first tube 302, for example, along the band loader axis 307, to secure the band 330. In some embodiments, the biasing surface 340 is roughened and / or includes one or more gripping elements (e.g., ridges) to enhance engagement with the operator's thumb. The second tube 304 may further include one or more engaging members 345, including a fixed end 347 opposite a free end 348. As described in more detail herein, the free end 348 of one or more engaging members 345 may include a flange 358 extending radially toward the first tube 302 for engaging with and disengaging the band 330. In some embodiments, each engaging member 345 may be separated from each other by a gap to give it radial flexibility.

[0050] 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 arranged concentrically around the applicator axis 383. The plunger 306 may include one or more user engagement features 336, such as tabs or flanges, extending radially from the proximal end 318 of the plunger. The user engagement features 336 allow the plunger 306 to be biased along the applicator axis 383 relative to the third tube 380. As shown, the user engagement features 336 of the plunger 306 may slide within an opening or slot 384 at the proximal end 385 of the third tube 380. In some embodiments, the fourth tube 381 may include a biasing tab 341 extending radially from the proximal end 343 of the fourth tube, the biasing tab 341 enabling the fourth tube 381 to actuate relative to the third tube 380.

[0051] Figures 12A to 12E illustrate the transfer of multiple bands 330 from a band loader 303 to an applicator 301 according to embodiments of the present disclosure. As shown, the band loader 303 includes a first tube 302 located within a second channel 310 of a second tube 304. Each of the multiple bands 330A to 330C may be located within one or more corresponding recesses of the first tube 302. Each engaging member 345 may include a flange 358 at its free end 348, the flange 358 extending inward toward the first tube 302. As shown, the flange 358 may be located between band 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 toward a point 362, which engages with the outer surface 331 of the first tube 302. As shown in Figure 12A, the applicator 301 and the band loader 303 can initially be separated from each other.

[0052] As shown in Figure 12B, when the applicator 301 and the band loader 303 are engaged, the first tube 302 may be positioned to overlap the third tube 380. For example, the inner surface 387 of the first tube 302 may be close to and / or in physical contact with the outer surface 388 of the third tube 380. As shown, a gap 389 may be provided between the distal end 329 of the first tube 302 and the distal end 390 of the fourth tube 381 to allow for the acceptance of multiple bands 330A to 330C around the third tube 380 during implantation.

[0053] Next, as shown in Figure 12C, the second tube 304 may be retracted relative to the first tube 302 to guide the flange 358 between bands 330A and 330B. The inclined surface 361 allows the flange 358 to overlap band 330A and pass through more easily. Subsequently, the second tube 304 may be moved toward the distal end 329 of the first tube 302 until the flat surface 364 of the flange 358 engages with band 330A. As shown in Figure 12D, the point 362 and the flat surface 364 may push the band 330A toward the applicator 301 until the band 330A is released from the recess 355 and passed over the distal end 329 of the first tube 302 onto the third tube 380.

[0054] As shown in Figure 12E, once the band 330A is positioned around the third tube 380, the band loader 303 can be disengaged from the applicator 301. (Not shown) The third tube 380 of the applicator 301 can then be moved to a position around the target hemorrhoidal tissue. The band 330A can be positioned by biasing the distal end 390 of the fourth tube 381 relative to the band 330A until the band 330A passes over the distal end 396 of the fourth tube 380 and slides or is pressed onto the target hemorrhoidal tissue. (Not shown) The fourth tube 381 may include one or more flanges, such as the flanges 158, 258 described above, configured to engage with and position the band 330A.

[0055] In some embodiments, the band loader 303 and applicator 301 may remain engaged until all bands 330A-330C are deposited on the third tube 380. It will be understood that bands 330B and 330C may be deposited in a similar manner to band 330A. Furthermore, it will be understood that in other embodiments, more or fewer bands may be deposited.

[0056] Referring now to Figure 13, the plunger 306 of the apparatus 300 according to an embodiment of the present disclosure will be described in more detail. As shown, the plunger 306 may include a rigid or semi-rigid shaft 316 extending into the third tube 380. The proximal end 318 of the plunger has one or more user engagement features 336, such as tabs or flanges 393, extending radially therefrom. The flanges 393 may extend into an opening 384 at the 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, creating an airtight seal at the interface between them.

[0057] During use, the proximal end 385 of the third tube 380 may be positioned in the palm of the operator's hand, and when the user engages the user engagement feature 336 toward the proximal end 385 of the third tube with their fingers, the vacuum pressure within the third tube 380 increases. In this way, the device 300 enables one-handed operation. It will be understood that similar engagement features may be incorporated into the devices 100 and 200 described herein instead of the plunger engagement component 122 and the plunger engagement component 222, respectively.

[0058] Once the target hemorrhoidal tissue is drawn into the third tube 380 and the band 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 relief component 398 that can be operated by an operator. The relief component 398 may be a button for controlling a valve (not shown) within the plunger 306. When the button is activated, the valve opens, breaking the vacuum seal created by the plunger 306 and the third tube 380. In some embodiments, the relief component 398 may extend into a relief opening 399 of the third tube 380 for operator access.

[0059] Figure 14 is a flowchart of Method 400 according to an embodiment of the present disclosure. In block 401, Method 400 may include acting a plunger positioned within a first tube to draw target tissue into a first tube, wherein the first tube includes a band along its distal end. In some embodiments, a vacuum is created within the first tube using a sealing member of the plunger engaged with the inner surface of the first tube to draw in the target tissue. In some embodiments, the sealing member is an annular gasket. In some embodiments, the plunger includes a rigid or semi-rigid shaft extending between a proximal end and a distal end. The proximal end of the plunger may have a plunger engagement component, such as a flange or handle, which can be grasped by an operator to move the plunger, for example, axially relative to the first tube.

[0060] In block 402, method 400 may include providing a second tube around a first tube, the second tube including a proximal end opposite to the distal end of the second tube, and the distal end of the second tube including an engaging member. In some embodiments, the plunger, the first tube, and the second tube may be arranged concentrically around a central axis passing through the device.

[0061] In block 403, method 400 may include biasing the first tube and the second tube toward each other in order to engage an engaging member with the band and to implant the band away from the first tube. In some embodiments, the method may include biasing the second tube in a first axial direction toward the proximal end of the first tube until the flange of the second tube passes over the band, and then biasing the second tube in a second axial direction away from the proximal end of the first tube until the flat surface of the flange engages with the band. The second tube may continue to be biased until the band is implanted beyond the proximal end of the first tube. In some embodiments, the band may be implanted around target tissue. In some embodiments, the band may be implanted around the shaft of an applicator and then inserted into a patient.

[0062] In some embodiments, the first and second tubes are part of a band loader that operates with the applicator to load one or more bands onto the third tube of the applicator. During use, the applicator and band loader may be combined such that the inner surface of the first tube is in physical contact with the outer surface of the third tube. In some embodiments, a gap may be provided between the distal end of the first tube 302 and the distal end of the fourth tube surrounding the third tube. The gap may be provided to allow the band to be received around the third tube during placement. Subsequently, the second tube of the band loader may be biased relative to the first tube to place the band from the first tube onto the third tube of the applicator.

[0063] In some embodiments, the method may include engaging and disengaging the band loader from the applicator once the band is positioned around the third tube. The third tube of the applicator may then be moved to a position around the target tissue, and the band may be positioned by biasing the distal end of the fourth tube relative to the band until the band slides or is pressed onto the target tissue beyond the distal end of the fourth tube of the third tube.

[0064] In some embodiments, a physician may operate the medical device described herein by inserting the medical device into the patient's rectum. The physician may then engage the medical device with target tissue within the patient and implant one or more bands by biasing the outer tube against the inner tube. As a result, one or more bands are implanted on the target tissue.

[0065] 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 used solely for identification purposes to aid the reader's understanding of this disclosure and are not limited in any way to the location, orientation, or use of this disclosure. However, as used herein in reference to Device 100 and Device 200, the term “proximal” may refer to the part of the device closest to the operator during use, and the term “distal” may refer to the part of the device initially inserted into the patient.

[0066] Some embodiments may be described using the terms “coupled” and “connected,” along with their derivatives. These terms are not intended to be synonymous with each other. For example, some embodiments may be described using the terms “connected” and / or “coupled” to indicate that two or more elements are in direct physical or electrical contact with one another. However, the term “coupled” may also mean that two or more elements are not in direct contact with one another but still cooperate or interact with one another.

[0067] As used herein, the singular forms "a," "an," and "the" are intended to include the plural form unless otherwise specified in the context. Furthermore, as used herein, the terms "comprises" and / or "comprising" or "includes" and / or "including" indicate the presence of the described features, areas, process elements, and / or components, but do not preclude the presence or addition of one or more other features, areas, integers, processes, operations, elements, components, and / or groups thereof.

[0068] Furthermore, the terms “substantial” or “substantially” and “approximate” or “approximately” can be used interchangeably in some embodiments and may be described using any relative scale acceptable to those skilled in the art. For example, these terms can serve as a comparison to a reference parameter to indicate a deviation that still provides the intended function. The deviation from the reference parameter may be, but is not limited to, quantities such as less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, or less than 20%.

[0069] While specific embodiments have been illustrated and described herein, it should be understood that any configuration that is presumed to achieve the same objective may be used instead of the specific embodiments shown. This disclosure is intended to encompass all adapted or modified forms of the various embodiments. It should be understood that the above description is illustrative and not limiting. Combinations of the above embodiments with other embodiments not specifically described herein will be apparent to those skilled in the art upon consideration of the above description. Accordingly, the scope of the various embodiments includes any other uses in which the above compositions, structures, and methods are used.

[0070] Furthermore, although the exemplary method 400 is described above as a series of actions or events, the disclosure is not limited by the order of such actions or events unless otherwise expressly indicated. For example, some actions may occur in a different order and / or simultaneously with other actions or events not illustrated and / or described herein in accordance with the disclosure. In addition, not all actions or events shown may be necessary to implement the methodology provided by the disclosure.

[0071] (Note) As a preferred embodiment, the technical concept that can be understood from the above embodiment is described below. [Item 1] It is a medical device, The medical device comprises a plunger that is movable within a first tube, and the first tube includes a band positioned on the distal end of the first tube. The medical device comprises a second tube for receiving the first tube, the second tube having a proximal end opposite to the distal end of the second tube, and the distal end of the second tube including an engaging member operable to release the band from the first tube in response to the relative axial movement of the first and second tubes. Medical device. [Item 2] The plunger is A shaft extending between the proximal end and the distal end of the plunger, A sealing member extending around the shaft and engaging with the inner surface of the first tube, A medical device as described in item 1, comprising the features described in item 1. [Item 3] The first tube is, The band comprises a first portion that extends around the outer surface, A second portion is connected to the first portion, includes user engagement features, and has the sealing member located inside; A medical device as described in item 2, comprising the features described in item 2. [Item 4] The medical device according to item 3, wherein the first diameter of the first part is smaller than the second diameter of the second part. [Item 5] The medical device according to item 3 or 4, wherein the second tube includes a distal portion connected to a proximal portion, the proximal portion extending around the second portion of the first tube, and the distal portion extending around the first portion of the first tube. [Item 6] The aforementioned engaging member is A fixed end connected to the distal portion of the second tube, A free end having a flange extending axially from the fixed end and radially toward the first tube, A medical device as described in item 5, which includes the following: [Item 7] The aforementioned flange is As the distal end of the first tube and the distal end of the second tube move away from each other in the axial direction, an inclined surface is provided that is capable of moving over and passing over the band, A flat surface that can operate to engage with the band as the distal end of the first tube and the distal end of the second tube move toward each other in the axial direction, A medical device as described in item 6, comprising the features described therein. [Item 8] The medical device according to item 6 or 7, wherein the second tube has a protective area between the distal end of the second tube and the engaging member. [Item 9] The medical device according to any one of items 6 to 8, wherein the free end terminates proximal to the most distal point of the distal end of the second tube. [Item 10] The medical device according to any one of items 1 to 9, further comprising one or more additional engaging members positioned around the distal end of the second tube. [Item 11] The medical device according to item 8, wherein the engaging member and the one or more additional engaging members are separated from each other by slots. [Item 12] The medical device according to item 11, wherein the slot extends axially along the distal portion of the second tube. [Item 13] The medical device further comprises an applicator that can engage with a band loader, the band loader comprising the first tube and the second tube, and the applicator is A third tube surrounding the plunger, A fourth tube surrounding the third tube, A medical device as described in item 1, comprising the features described in item 1. [Item 14] The medical device according to item 13, wherein the third tube is positioned within the first tube to receive the band from the first tube. [Item 15] The medical device according to item 13 or 14, wherein the fourth tube includes a distal end of the fourth tube that is operable to pull the band out of the third tube and advance it as the third tube and the fourth tube move axially relative to each other. While the subject matter has been described in language specific to structural features and / or methodological actions, it should be understood that the subject matter defined in the attached claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are disclosed as exemplary forms of carrying out the claims.

Claims

1. It is a medical device, The medical device comprises a first tube, the first tube including a first band positioned on the distal end of the first tube and a second band separated proximally from the first band by a predetermined gap. The medical device includes a plunger that is movable within the first tube, The medical device comprises a second tube configured to receive the first tube, the second tube having a proximal end opposite to the distal end of the second tube, and the distal end of the second tube includes at least one engaging member operable to be positioned in the gap between the first band and the second band in response to the relative axial movement of the first tube and the second tube and to separate from the second band and allow the first band to exit the first tube, The distal end of the first tube and the distal end of the second tube are configured to engage with each other to provide the operator of the medical device with auditory or tactile feedback regarding the position of the second tube relative to the first tube when the second tube moves into the gap between adjacent bands. Medical device.

2. The plunger is A shaft extending between the proximal end and the distal end of the plunger, A sealing member extending around the shaft and engaging with the inner surface of the first tube, A medical device according to claim 1, comprising:

3. The first tube is, Both the first band and the second band comprise a first portion that extends around the outer surface, A second portion is connected to the first portion, includes user engagement features, and the sealing member is disposed inside the second portion, The medical device according to claim 2, comprising:

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

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

6. The at least one engaging member is, A fixed end connected to the distal portion of the second tube, A free end having a flange extending axially from the fixed end and radially toward the first tube, The medical device according to claim 5, comprising:

7. The flange mentioned above is As the distal end of the first tube and the distal end of the second tube move away from each other in the axial direction, an inclined surface is provided that is capable of overlapping and passing over the first band, A flat surface that can operate to engage with the first band as the distal end of the first tube and the distal end of the second tube move toward each other in the axial direction, The medical device according to claim 6, comprising:

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

9. The medical device according to any one of claims 5 to 8, further comprising one or more additional engaging members disposed around the distal end of the second tube.

10. The medical device according to claim 9, wherein the engaging member and the one or more additional engaging members are separated from each other by slots.

11. The medical device according to claim 10, wherein the slot extends axially along the distal portion of the second tube.

12. The aforementioned at least one engaging member consists of a plurality of engaging members, and the plurality of engaging members are A fixed end connected to the distal portion of the second tube, A free end extending axially from the fixed end and Equipped with, The free end includes a flange extending radially toward the first tube, The flange mentioned above is An inclined surface that can move so as the distal end of the first tube and the distal end of the second tube move away from each other in the axial direction, When the distal end of the first tube and the distal end of the second tube move toward each other in the axial direction, a flat surface which is operable to engage with the plurality of bands A medical device according to claim 1, comprising:

13. The medical device according to claim 12, wherein at least two adjacent engaging members among the plurality of engaging members are separated by slots.

14. The medical device according to claim 1, wherein the free end of the at least one engaging member terminates at a predetermined point.

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