Devices and methods 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] FIELD OF THE DISCLOSURE The present disclosure relates to medical ligation devices and, more particularly, to devices and methods for tissue ligation using a tissue band dispenser. [Background technology]

[0002] Hemorrhoids are an occurrence for many adults, especially as they age. One method for treating and / or removing hemorrhoids is ligation, where a tightening element, such as an elastic band, surrounds and blocks the hemorrhoidal tissue. Over time, due to lack of blood flow, the ligated hemorrhoid will eventually wither and fall off.

[0003] It can be difficult for medical professionals, such as surgeons, to both position the ligation device at the ligation site and place the elastic band on the target tissue. It is common practice for physicians to move their guiding hand away from the patient end of the ligation device to place the band, which can lead to loss of position. It would therefore be desirable to have a device that allows a surgeon to use only one hand to both move the ligation device and simultaneously actuate the release of the elastic band. Summary of the Invention

[0004] The present disclosure, in its various embodiments, generally relates to medical devices, ligators, and methods for placing 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 a first tube distal end. The medical device may further include a second tube for receiving the first tube. The second tube includes a second tube proximal end opposite the second tube distal end, the second tube distal end including an engagement member operable to eject the band from the first tube in response to axial movement of the first and second tubes relative to one another. In some embodiments, the plunger may include a shaft extending between the plunger proximal end and the plunger distal end. The shaft has a first channel extending into the plunger distal end. The plunger may include a sealing member extending around the shaft. The sealing member engages an inner surface of the first tube. In some embodiments, the first tube may include a first portion with the band extending around an exterior surface thereof and a second portion connected to the first portion, including a user engagement feature, and having a sealing member disposed therein. A first diameter of the first portion is smaller than a second diameter of the second portion. In some embodiments, the second tube may include a distal portion connected to the 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 angled surface operable to pass over the band as the first tube distal end and the second tube distal end move axially away from one another, and a flat surface operable to engage the band as the first tube distal end and the second tube distal end move axially toward one another. In some embodiments, the free end terminates proximal to a distal-most point of the second tube distal end. In some embodiments, the medical device may further include one or more additional engagement members disposed about the second tube distal end, the engagement member and the one or more additional engagement members being separated from one another by a slot.In some embodiments, the slot extends axially along a distal portion of the second tube. In some embodiments, the medical device further includes an applicator engageable with the band loader, the band loader comprising the first tube and the second tube, the applicator may include a third tube surrounding the plunger and a fourth tube surrounding the third tube, the third tube extending into the second channel of the first tube to receive the band surrounding the first tube, the fourth tube including a fourth tube distal end operable to retrieve and advance the band from the third tube as the third tube and the fourth tube move axially relative to one another.

[0005] In one or more embodiments, the ligator may include a plunger disposed within a first tube, the first tube including a plurality of bands surrounding the first tube distal end. The ligator may further include a second tube for receiving the first tube. The second tube includes a second tube proximal end opposite the second tube distal end, the second tube distal end including a plurality of engagement members operable to engage and retain each of the plurality of bands 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 plunger proximal end and the plunger distal end and a sealing member extending around the shaft. 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 engagement members may include a fixed end connected to a 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 can include an angled surface operable to pass over the plurality of bands as the first and second tube distal ends move axially away from one another and a flat surface operable to engage the plurality of bands as the first and second tube distal ends move axially toward one another. In some embodiments, the free end terminates proximal to a distal-most point of the second tube distal end. In some embodiments, the ligator can further include a slot in the second tube distal end separating two adjacent engagement members of the plurality of engagement members.

[0006] In one or more embodiments, the method may include actuating a plunger disposed within a first tube to draw the target tissue into the first tube, the first tube including a band along a first tube distal end, and providing a second tube around the first tube. The second tube may include a second tube proximal end opposite the second tube distal end, the second tube distal end including an engagement member. The method may further include biasing the first tube and the second tube toward one another to engage and deploy the band from the first tube distal end. In some embodiments, the method may further include biasing the second tube in a first axial direction toward the first tube proximal end of the first tube until a flange of the second tube passes over the band, and biasing the second tube in a second axial direction away from the first tube proximal end until a flat surface of the flange engages and deploys the band. In some embodiments, the method may further include biasing the second tube in a first axial direction toward the first tube proximal end of the first tube until a flange of the second tube passes over the second band, and biasing the second tube in a second axial direction away from the first tube proximal end until a flat surface of the flange engages and deploys the second band. In some embodiments, the method may further include providing a protective region at the second tube distal end, the protective region being located between the engagement member and a distal-most point of the second tube distal end to protect the free end of the engagement member as the second tube is inserted into the patient. In some embodiments, the method may further include engaging the applicator with a band loader, the applicator including a third tube surrounded by a fourth tube, the band loader including the first tube and the second tube. The method may further include biasing the second tube against 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 tube and the fourth tube relative to one another to transfer the band from the third tube to the target tissue.

[0007] Various one or more of the features outlined above may be interchanged, exchanged, combined, or substituted for other features outlined above for use in connection with the medical systems and methods outlined above, as well as in connection with embodiments described in more detail below and otherwise within the scope of the present disclosure.

[0008] Non-limiting embodiments of the present disclosure are described, by way of example, with reference to the accompanying figures, which are not intended to be drawn to scale. In the figures, each identical or nearly identical component shown is typically represented by a single numeral. For clarity, not every component is labeled in every figure, and not every component of every embodiment is shown unless explanation is necessary for a person skilled in the art to understand the disclosure. Furthermore, some of the figures include cross-sectional views in the form of "slices" or "myoscopic" cross-sectional views that omit certain background lines or features that would be visible in a "true" cross-sectional view for clarity of illustration. [Brief description of the drawings]

[0009] [Figure 1] 1 is a perspective view of a medical device according to an embodiment of the present disclosure. [Diagram 2] 2 is an exploded perspective view of the medical device of FIG. 1 in accordance with an embodiment of the present disclosure. [Figure 3A] 2 illustrates the operation of the medical device of FIG. 1 in accordance with an embodiment of the present disclosure. [Figure 3B] 2 illustrates the operation of the medical device of FIG. 1 in accordance with an embodiment of the present disclosure. [Figure 3C] 2 illustrates the operation of the medical device of FIG. 1 in accordance with an embodiment of the present disclosure. [Figure 4A] 2A-2C illustrate a technique for deploying one or more bands of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 4B] 2A-2C illustrate a technique for deploying one or more bands of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 4C] 2A-2C illustrate a technique for deploying one or more bands of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 4D]2A-2C illustrate a technique for deploying one or more bands of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 5A] 1 illustrates another medical device according to an embodiment of the present disclosure. [Figure 5B] 1 illustrates another medical device according to an embodiment of the present disclosure. [Figure 6] 1 is a perspective view of a medical device according to an embodiment of the present disclosure. [Figure 7] 7 is an exploded perspective view of the medical device of FIG. 6 according to an embodiment of the present disclosure. [Figure 8A] 7A-7C illustrate the operation of the medical device of FIG. 6 in accordance with an embodiment of the present disclosure. [Figure 8B] 7A-7C illustrate the operation of the medical device of FIG. 6 in accordance with an embodiment of the present disclosure. [Figure 8C] 7A-7C illustrate the operation of the medical device of FIG. 6 in accordance with an embodiment of the present disclosure. [Figure 9A] 7A-7C illustrate a technique for deploying one or more bands of the medical device of FIG. 6 according to an embodiment of the present disclosure. [Figure 9B] 7A-7C illustrate a technique for deploying one or more bands of the medical device of FIG. 6 according to an embodiment of the present disclosure. [Figure 9C] 7A-7C illustrate a technique for deploying one or more bands of the medical device of FIG. 6 according to an embodiment of the present disclosure. [Figure 9D] 7A-7C illustrate a technique for deploying one or more bands of the medical device of FIG. 6 according to an embodiment of the present disclosure. [Figure 10A] 1 illustrates another medical device according to an embodiment of the present disclosure. [Figure 10B] 1 illustrates another medical device according to an embodiment of the present disclosure. [Figure 11] 1 is a perspective view of a medical device according to an embodiment of the present disclosure. [Figure 12A] 12A-12C illustrate a method for deploying one or more bands of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 12B] 12A-12C illustrate a method for deploying one or more bands of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 12C] 12A-12C illustrate a method for deploying one or more bands of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 12D] 12A-12C illustrate a method for deploying one or more bands of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 12E] 12A-12C illustrate a method for deploying one or more bands of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 13] 12 is a perspective view of a plunger of the medical device of FIG. 11 in accordance with an embodiment of the present disclosure. [Figure 14] 1 is a flowchart of a method according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present disclosure is not limited to the specific embodiments described herein. The terms used herein are merely for 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 belongs.

[0011] Disclosed herein are medical devices, ligators, and methods for placing ligation bands around target tissues such as hemorrhoids. As noted above, it is desirable to have a device that allows a medical professional to more easily both manipulate a medical device (e.g., a ligator) into position around a hemorrhoid and activate the release of an elastic band therefrom. The medical devices, ligators, and methods of the present disclosure advantageously provide a simplified operator interface that includes multiple pre-loaded bands that can be advanced and placed / removed using one or more engagement members.

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

[0013] 1-2, a medical device 100 (e.g., a ligator) according to an embodiment of the present disclosure will now be described in more detail. As shown, 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 therein, 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. Without limitation, 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, first tube 102, and second tube 104 may be made from a flexible material, such as a thermoplastic elastomer including silicone, polyamide and polyether backbone blocks, polyurethane, etc., to allow for bending of the scope. In other embodiments, one or more components of the device 100 may be made from a rigid material, such as polycarbonate, acrylonitrile butadiene styrene (ABS), etc., to provide a more direct positioning response.

[0014] The plunger 106 may include a rigid or semi-rigid shaft 116 extending between a plunger proximal end 118 and a plunger distal end 120. At the plunger proximal end 118 may be a plunger engagement component 122, such as a flange or handle, that may be grasped by an operator to move the plunger 106 axially along the central axis 114 relative to the first tube 102. At the plunger distal end 120 is a tip that may be angled to prevent tissue from being pinched between the outer surface of the plunger distal end 120 and the inner surface of the first tube 102. Without limitation, the angle may be greater than 25 degrees. One or more sealing members 124, such as a gasket, may surround the shaft 116. The sealing members 124 are operable to engage the inner surface of the first tube 102 and form an airtight seal at the interface therebetween.

[0015] The first tube 102 may include a first portion 126 connected to a second portion 127. As shown, a plurality of bands 130 may extend around an exterior surface 131 of the first portion 126. In some embodiments, the bands 130 may be partially seated within corresponding recesses (not shown). As described in more detail below, the bands 130 may be elastic bands that expand into an extended configuration to fit around the exterior surface 131 of the first tube 102 and maintain position until deployment. In operation, one or more of the bands 130 may be rolled or pushed off the first tube distal end 134 of the first tube 102 and then contract around the target tissue (not shown). Once deployed, the bands 130 may block blood flow to the target tissue such that the tissue shrinks, dies, and eventually separates from the surrounding tissue. The use of multiple bands 130 may allow the device 100 to be repositioned to capture additional tissue without having to withdraw the device 100 from the patient through sequential deployment of multiple bands 130, thus allowing the clinician to complete the procedure more efficiently without having to reload the device 100.

[0016] As further shown, the first tube 102 may include a user engagement feature 136, such as one or more tabs or flanges extending radially from the second portion 127. The user engagement feature 136 may be disposed at a first tube proximal end 137 of the first tube 102. In some embodiments, as better shown in FIG. 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 disposed within the second channel 110, which extends through the first portion 126 and the second portion 127 of the first tube 102.

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

[0018] As further shown, the second portion 127 may include one or more ridges, indicators, or protuberances 138 along its exterior surface 141. The protuberances 138 may engage corresponding indentations, grooves, or detents (not shown) along the inner surface of the second tube 104, or proximal ridges. The protuberances 138 may provide visual, audio, and / or tactile feedback to the operator of the device 100 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 deployed. In some embodiments, the inner surface of the second tube 104 may include a series of ridges or protuberances, and the second portion 127 includes indentations or grooves. Additionally, in some embodiments, the inner surface of the second portion 127 and / or the second tube 104 may include one or more cantilevered cut-out tabs for engaging with engagement features on opposing surfaces. It will be understood that any number or configuration of protuberances 138 is possible.

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

[0020] As further shown, the second tube 104 can include one or more engagement members 145 extending axially at the second tube distal end 146. Each engagement member 145 can include a fixed end 147 integral 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 end 148 of the one or more engagement members 145 can include a flange extending radially toward the first tube 102 to engage and retain one or more bands. Adjacent engagement members 145 can be separated from one another by gaps or slots 152. As shown, each slot 152 can extend generally axially along the distal portion 132 of the second tube 104. The slots 152 can provide flexibility to each of the engagement members 145, thus allowing the free ends 148 to move generally radially relative to the central axis 114.

[0021] 3A-3C, the operation of the device 100 according to an embodiment of the present disclosure will now be described. In use, an operator of the device 100 can target hemorrhoidal tissue, for example, by looking through an endoscopic camera. In other embodiments, a camera is not used. Suction can then be applied by biasing the plunger 106 to drive the targeted hemorrhoidal tissue into the first tube 102. Specifically, as shown in FIG. 3A, the plunger-engaging component 122 of the plunger 106 can be moved axially (e.g., along the y-direction) away from the first tube proximal end 137 of the first tube 102, as indicated by arrow 150. The sealing member 124 (FIG. 2) abutting the inner surface of the first tube 102 creates a vacuum chamber for drawing the targeted hemorrhoidal tissue into the device 100.

[0022] 3B, the second tube 104 may then be urged against the first tube 102. For example, the second tube 104 may be pulled axially toward the first tube proximal end 137 of the first tube 102, as indicated by arrow 151. As a result, the second tube distal end 146 moves away from the first tube distal end 134, exposing the distal-most band 130A of the plurality of bands 130.

[0023] 3C, the second tube 104 may again be axially biased relative to the first tube 102. In this case, the second tube 104 moves away from the first tube proximal end 137 of the first tube 102, thereby engaging the second tube distal end 146 of the second tube 104 with the distal-most band 130A and removing the distal-most band 130A from the first tube 102. The distal-most band 130A may then be clamped around the targeted hemorrhoidal tissue (not shown).

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

[0025] 4A-4D further illustrate the placement of the plurality of bands 130 from the device 100 according to an embodiment of the present disclosure. As shown, the first tube 102 is disposed within the third channel 112 of the second tube 104. Although not shown, the plunger 106 may be disposed within the second channel 110 of the first tube 102. Each of the plurality of bands 130A-130C may be disposed within one or more corresponding recesses 155 of the first tube 102. In some embodiments, instead of recesses 155, a plurality of protrusions extending outwardly from the first tube 102 may separate the plurality of bands 130A-130C. Each engagement member 145 may include a flange 158 at its free end 148, the flange 158 extending inwardly toward the first tube 102. In some embodiments, the flange 158 may be disposed at a distal-most point of the second tube distal end 146.

[0026] In some embodiments, the flange 158 can include a sloped surface 161 that extends to a point 162. As shown in FIG. 4A, the point 162 can initially engage the exterior surface 131 of the first tube 102. In the initial position, the flange 158 is disposed between the first tube distal end 134 and the band 130A. As shown in FIG. 4B, as the second tube distal end 146 begins to move away from the first tube distal end 134, the sloped surface 161 passes over / along the band 130A, bending the free ends 148 of each engagement member 145 radially away from the first tube 102.

[0027] 4C, the second tube 104 continues to move axially relative to the first tube 102 until the flange 158 passes band 130A. At this position, the flange 158 may engage or abut the exterior surface 131 of the first tube 102 in the area between bands 130A and 130B. In some embodiments, as the flange 158 re-engages the exterior surface 131, audio 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. When the operator hears an audible click, for example, the operator may stop moving the second tube 104 away from the first tube 102.

[0028] To begin removing the band 130A from the first tube 102, the second tube distal end 146 may reverse direction and move toward the first tube distal end 134, as shown in FIG. 4D. The point 162, along with the flat surface 164 of the flange 158, may engage and remove the band 130A from the recess 155. The point 162 may act as a wedge to remove the band 130A from the recess 155. The flat surface 164 may continue to push the band 130A toward the first tube distal end 134 as the second tube 104 moves downward. Eventually, the band 130A slides over the first tube distal end 134 and around the targeted hemorrhoidal tissue 168 aspirated into the second channel 110 of the first tube 102.

[0029] In some embodiments, once band 130A is deployed, second tube 104 may again be moved axially upward until flange 158 passes band 130B and is disposed between bands 130B and 130C. Band 130B may then be deployed in a similar manner as band 130A, followed by band 130C. It will be appreciated that in other embodiments, more or fewer bands may be deployed.

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

[0031] 6 and 7, a medical device (e.g., ligator) 200 according to an embodiment of the present disclosure will be described in more detail. The medical device (hereinafter, "device") 200 may be similar in many respects to the device 100 described herein. Thus, hereinafter, for simplicity, only certain aspects of the device 200 may be described. 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 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. Without limitation, the plunger 206 , the first tube 202 , and the second tube 204 may be concentrically arranged about a central axis 214 that extends lengthwise through the device 200 .

[0032] The plunger 206 may include a rigid or semi-rigid shaft 216 extending between a plunger proximal end 218 and a plunger distal end 220. At the plunger proximal end 218 there may be a plunger engagement component 222, such as a flange or handle, that may be grasped by an operator to move the plunger 206 axially relative to the first tube 202, e.g., 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 an inner surface of the first tube 202 and create an airtight seal at the interface therebetween.

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

[0034] The first tube 202 may include a user engagement feature 236, such as, without limitation, one or more tabs or flanges extending radially from the second portion 227. The user engagement feature 236 may be disposed at a first tube proximal end 237 of the first tube 202. When the device 200 is assembled, the plunger 206 may be disposed within a second channel 210 defined by the interior surfaces of the first portion 226 and the second portion 227 of the first tube 202.

[0035] As further shown, the second portion 227 may include one or more indicators 238 along its exterior surface 241. The indicators 238 may provide visual, audio, and / or tactile feedback to an operator of the device 200 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 deployed. 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 generally around the second portion 227 of the first tube 202, which may include a biasing tab 240 extending radially from the second tube proximal end 243. Between the distal portion 232 and the proximal portion 233 is a shoulder region 239. The shoulder region 239 may be gradually tapered and / or curved 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 shown, the second tube 204 can include one or more engagement members 245 disposed along the distal portion 232. In this embodiment, the engagement member 245 is disposed proximal to the second tube distal end 246 of the second tube 204. The engagement member 245 can include a fixed end 247 integral 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 the one or more engagement members 245 can include a flange for engaging and retaining the plurality of bands 230 extending radially toward the first tube 202. In some embodiments, the engagement member 245 can be surrounded by one or more slots 252 to provide flexibility to the free end 248.

[0038] As further shown, the second tube 204 may include a protective region 244 at the second tube distal end 246. The protective region 244 may include a generally circumferentially connected ring or cylinder disposed between the free end 248 of the engagement member 245 and a distal-most point 249 of the second tube distal end 246. That is, the protective region 244 may be devoid of any slots or gaps to increase the rigidity of the second tube distal end 246. Thus, the protective region 244 may prevent or reduce deflection of the free end 248 when the second tube distal end 246 is inserted into a patient.

[0039] 8A-8C, the operation of the device 200 according to an embodiment of the present disclosure will now be described. In use, an operator of the device 200 can target hemorrhoidal tissue, for example, by viewing through an endoscopic camera. Suction can then be applied by biasing the plunger 206 to create a vacuum and force the targeted hemorrhoidal tissue into the first tube 202. Specifically, as shown in FIG. 8A, the plunger-engaging component 222 of the plunger 206 can be moved axially (e.g., along the y-direction) away from the first tube proximal end 237 of the first tube 202, as indicated by arrow 250. The sealing member 224 (FIG. 7) abutting the inner surface of the first tube 202 creates a vacuum chamber for drawing the targeted hemorrhoidal tissue into the device 200.

[0040] 8B, the second tube 204 may then be urged relative to the first tube 202. For example, the second tube 204 may be pulled axially toward the first tube proximal end 237 of the first tube 202, as shown by arrow 251. The movement of the second tube distal end 246 of the second tube 204 relative to the first tube 202 exposes the first tube distal end 234 and the distal-most band 230A of the plurality of bands 230.

[0041] 8C, the second tube 204 may then be again biased against the first tube 202. In this case, the second tube 204 may be moved axially away from the first tube proximal end 237 of the first tube 202, as indicated by arrow 253, to engage the engagement member 245 of the second tube 204 with the distal-most band 230A and disengage the distal-most band 230A from the first tube distal end 234 of the first tube 202. The distal-most band 230A may then be clamped around the targeted hemorrhoidal tissue (not shown).

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

[0043] 9A-9D further illustrate the placement of the plurality of bands 230 from the device 200 according to an embodiment of the present disclosure. As shown, the first tube 202 is disposed within the third channel 212 of the second tube 204. Although not shown, the plunger 206 may be disposed within the second channel 210. Each of the plurality of bands 230A-230C may be disposed within one or more corresponding recesses 255 of the first tube 202. Each engagement member 245 may include a flange 258 at its free end 248 that extends inwardly toward the first tube 202. As shown, the flange 258 of the free end 248 terminates proximal to a distal-most point 249 of the second tube distal end 246.

[0044] In some embodiments, the flange 258 can include an angled surface 261 that extends to a point 262. As shown in FIG. 9A, the point 262 can initially engage the exterior surface 231 of the first tube 202. In this position of the device 200, the flange 258 is disposed between the first tube distal end 234 and the band 230A. As shown in FIG. 9B, as the second tube distal end 246 begins to move away from the first tube distal end 234, the angled surface 261 can engage the band 230A and bend the free end 248 of each engagement member 245 radially outward from the first tube 202.

[0045] As shown in FIG. 9C, the second tube 204 continues to move axially relative to the first tube 202 until the flange 258 passes the band 230A. In this position, the flange 258 may engage or abut the exterior surface 231 of the first tube 202 in the area between the bands 230A and 230B. To remove the band 230A from the first tube 202, the second tube 204 may then reverse direction and move toward the first tube distal end 234. As shown in FIG. 9D, the point 262, along with the flat surface 264 of the flange 258, may engage and remove the band 230A from the recess 255. The point 262 may act as a wedge to remove the band 230A from the recess 255. The flat surface 264 can be used to push the band 230A towards the first tube distal end 234 as the second tube 204 moves downward until the band 230A is placed around the target hemorrhoidal tissue 268. As shown, once placed, the band 230A tightens around the target hemorrhoidal tissue 268.

[0046] In some embodiments, once band 230A is deployed, second tube 204 may again be moved axially upward until flange 258 passes band 230B and is disposed between bands 230B and 230C. Band 230B may then be deployed in a similar manner as band 230A, followed by band 230C. It will be appreciated that in other embodiments, more or fewer bands may be deployed.

[0047] 10A-10B illustrate various non-limiting alternatives for the first tube 202 and the second tube 204 according to embodiments of the present disclosure. As shown in FIG. 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 gripping elements 273 along an exterior surface 271 at the second tube proximal end 243. The series of gripping elements 273 may replace or complement a biasing tab, such as the biasing tab 240 shown in FIG. 10B. The device 200 of FIG. 10B may further include a pair of tabs 269 extending radially from the second portion 227 of the first tube 202. Without limitation, the pair of tabs 269 may be located distal to the first tube proximal end 237. The pair of tabs 269 may include a sloped upper surface 272 and a flat lower surface 274 to improve operator ergonomics.

[0048] 11, a medical device (e.g., ligator) 300 according to an embodiment of the present disclosure will be described. As shown, the medical device (hereinafter, "device") 300 can include an applicator 301 engageable with a band loader 303 for transferring one or more bands 330 thereon. The band loader 303 can include a first tube 302 surrounded by a second tube 304. The first tube 302 and the second tube 304 can be hollow elongated members arranged concentrically about a band loader axis 307. The first tube 302 can include a first tube distal end 334 that receives the band along its exterior surface 331.

[0049] 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, for example along the band loader axis 307, to deploy 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 engagement members 345 including a fixed end 347 opposite a free end 348. As described in more detail herein, the free end 348 of the one or more engagement members 345 may include a flange 358 extending radially toward the first tube 302 to engage and release the band 330. In some embodiments, each engagement member 345 may be separated from one another by a gap to provide radial flexibility thereto.

[0050] The applicator 301 may include a third tube 380 surrounding the 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 about an applicator axis 383. The plunger 306 may include a user engagement feature 336, such as one or more tabs or flanges extending radially from the plunger proximal end 318. The user engagement feature 336 allows the plunger 306 to be biased along the applicator axis 383 relative to the third tube 380. As shown, the user engagement feature 336 of the plunger 306 may slide within an opening or slot 384 in the third tube 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 fourth tube proximal end 343, which enables actuation of the fourth tube 381 relative to the third tube 380.

[0051] 12A-12E illustrate the transfer of a plurality of bands 330 from a band loader 303 to an applicator 301, according to an embodiment of the present disclosure. As illustrated, the band loader 303 includes a first tube 302 disposed within a second channel 310 of a second tube 304. Each of the plurality of bands 330A-330C may be disposed within one or more corresponding recesses of the first tube 302. Each engagement member 345 may include a flange 358 at its free end 348, the flange 358 extending inwardly toward the first tube 302. As illustrated, the flange 358 may be disposed between the band 330A and a distal-most point 329 of the first tube 302. In some embodiments, the flange 358 may include an angled surface 361 extending to a point 362, which engages the exterior surface 331 of the first tube 302. As shown in FIG. 12A, the applicator 301 and the band loader 303 may initially be separated from one another.

[0052] 12B, upon engagement of the applicator 301 and band loader 303, the first tube 302 may be positioned over the third tube 380. For example, an inner surface 387 of the first tube 302 may be adjacent to and / or in physical contact with an outer surface 388 of the third tube 380. As shown, a gap 389 may be provided between a distal-most point 329 of the first tube 302 and a distal-most point 390 of the fourth tube 381 to allow for reception of multiple bands 330A-330C around the third tube 380 during deployment.

[0053] 12C, the second tube 304 may then be retracted relative to the first tube 302 to guide the flange 358 between band 330A and band 330B. The angled surface 361 allows the flange 358 to pass over band 330A more easily. The second tube 304 may then be moved toward the distal-most point 329 of the first tube 302 until the flat surface 364 of the flange 358 engages band 330A. The point 362 and flat surface 364 may remove the band 330A from the recess 355 and push the band 330A toward the applicator 301 until the band 330A is passed over the distal-most point 329 of the first tube 302 and over the third tube 380, as shown in FIG.

[0054] 12E, once the band 330A is positioned around the third tube 380, the band loader 303 can be disengaged from the applicator 301. Although not shown, the third tube 380 of the applicator 301 can then be moved into position around the target hemorrhoidal tissue. The band 330A can be positioned by biasing the distal-most point 390 of the fourth tube 381 against the band 330A until the band 330A passes over the fourth tube distal end 396 of the third tube 380 and is slid or pushed onto the target hemorrhoidal tissue. Although not shown, the fourth tube 381 can include one or more flanges, such as the flanges 158, 258 described above, configured to engage and position the band 330A.

[0055] In some embodiments, band loader 303 and applicator 301 may remain engaged until all bands 330A-330C have been placed onto third tube 380. It will be appreciated that bands 330B and 330C may be placed in a similar manner as band 330A. Additionally, it will be appreciated that in other embodiments, more or fewer bands may be placed.

[0056] 13, the plunger 306 of the device 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 plunger proximal end 318 has a user engagement feature 336, such as one or more tabs or flanges 393 extending radially therefrom. The flanges 393 may extend into an opening 384 in the third tube 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 the inner surface of the third tube 380 to create an airtight seal at the interface therebetween.

[0057] During use, the third tube proximal end 385 of the third tube 380 may be placed in the palm of an operator's hand and the user engagement feature 336 is pulled with one's fingers towards the third tube proximal end 385, increasing the vacuum pressure within the third tube 380. In this manner, the device 300 allows for one-handed operation. It will be appreciated that similar engagement features may be incorporated into the devices 100 and 200 described herein in place of the plunger engagement component 122 and plunger engagement component 222, respectively.

[0058] Once the targeted hemorrhoidal tissue has been drawn into the third tube 380 and the band has been deployed from the third tube 380, the suction created by the plunger 306 and the third tube 380 may be released. In some embodiments, the plunger 306 may include a relief component 398 that is actuable by an operator. Without limitation, the relief component 398 may be a button to control a valve (not shown) in the plunger 306. When the button is actuated, 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 in the third tube 380 for access by the operator.

[0059] FIG. 14 is a flow chart of a method 400 according to an embodiment of the present disclosure. In block 401, the method 400 may include actuating a plunger disposed within a first tube, the first tube including a band along a first tube distal end, to draw target tissue into the first tube. In some embodiments, a vacuum is created within the first tube using a sealing member of the plunger engaged with an 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 plunger proximal end and a plunger distal end. The plunger proximal end may have a plunger engagement component, such as a flange or handle, that may be grasped by an operator to move the plunger, e.g., axially, relative to the first tube.

[0060] At block 402, the method 400 may include providing a second tube about the first tube, the second tube including a second tube proximal end opposite the second tube distal end, the second tube distal end including the engagement 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.

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

[0062] In some embodiments, the first tube and the second tube are part of a band loader operable with the applicator to load one or more bands onto a third tube of the applicator. In use, the applicator and band loader may be assembled such that an inner surface of the first tube is in physical contact with an outer surface of the third tube. In some embodiments, a gap may be provided between the most distal point of the first tube 302 and the most distal point of a fourth tube that surrounds the third tube. The gap may be provided to allow reception of the band around the third tube during deployment. The second tube of the band loader may then be urged against the first tube to deploy the band from the first tube onto the third tube of the applicator.

[0063] In some embodiments, the method can include disengaging the band loader from the applicator once the band is positioned about the third tube. The third tube of the applicator can then be moved into position about the target tissue and the band can be positioned by urging a distal-most point of the fourth tube against the band until the band is slid or pushed past the fourth tube distal end of the third tube and onto the target tissue.

[0064] In some embodiments, a physician may operate a medical device described herein by inserting the medical device into a patient's rectum. The physician may then engage a target tissue within the patient with the medical device and place one or more bands by forcing the outer tube against the inner tube, resulting in placement of one or more bands 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 for identification purposes only to aid in the reader's understanding of this disclosure and are not intended to be limiting as to the location, orientation, or use of the present disclosure in particular. Without limitation, when used herein with respect to device 100 and device 200, the term "proximal" may refer to the portion of the device closest to the operator during use and the term "distal" may refer to the portion of the device that is first 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 as synonyms for 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 each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0067] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, the terms "comprises" and / or "comprising" or "includes" and / or "including," as used herein, are understood to specify the presence of stated features, regions, step elements, and / or components, but not to exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups.

[0068] Additionally, the terms "substantial" or "substantially" as well as "approximate" or "approximately" can be used interchangeably in some embodiments and can be described using any relative measure acceptable to one of ordinary skill 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. Without limitation, the deviation from the reference parameter can be, for example, an amount of less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc.

[0069] Although specific embodiments have been illustrated and described herein, it should be understood that any configuration that is expected to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any adaptations or variations of the various embodiments. It should be understood that the above description is made in an illustrative manner and is not limiting. Combinations of the above embodiments with other embodiments not specifically described herein will be apparent to one of ordinary skill in the art upon reviewing the above description. Thus, the scope of the various embodiments includes any other applications in which the above compositions, structures, and methods are used.

[0070] Further, although the exemplary method 400 is described above as a series of acts or events, the present disclosure is not limited by the order of such acts or events shown, unless expressly stated otherwise. For example, some acts may occur in different orders and / or simultaneously with other acts or events other than those illustrated and / or described herein in accordance with the present disclosure. In addition, not all acts or events shown may be required to implement a methodology in accordance with the present disclosure.

[0071] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

Claims

1. 1. A medical device, comprising: The medical device comprises a plunger movable within a first tube, the first tube including a band disposed on a distal end of the first tube; the medical device comprising a second tube for receiving the first tube, the second tube having a second tube proximal end opposite the second tube distal end, the second tube distal end including an engagement member operable to eject the band from the first tube in response to axial movement of the first tube and the second tube relative to one another. Medical equipment.

2. The plunger is a shaft extending between a plunger proximal end and a plunger distal end; a sealing member extending around the shaft and engaging an inner surface of the first tube; The medical device of claim 1 .

3. The first tube is a first portion of the band extending around an exterior surface thereof; a second portion connected to the first portion and including a user engagement feature, the second portion having the sealing member disposed therein; The medical device of claim 2 .

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

5. 5. The medical device of 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 engaging member is a fixed end connected to the distal portion of the second tube; a free end including a flange extending axially from the fixed end and extending radially toward the first tube; The medical device of claim 5 .

7. The flange is a ramp operable to pass over the band as the first tube distal end and the second tube distal end move axially away from one another; a flat surface operable to engage the band as the first tube distal end and the second tube distal end move axially toward one another; The medical device of claim 6 .

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

9. The medical device of any one of claims 6 to 8, wherein the free end terminates proximal to a distal-most point of the second tube distal end.

10. The medical device of any one of claims 1 to 9, further comprising one or more additional engagement members disposed about the second tube distal end.

11. The medical device of claim 8 , wherein the engagement member and the one or more additional engagement members are separated from one another by a slot.

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

13. The medical device further comprises an applicator engageable with a band loader, the band loader comprising the first tube and the second tube, and the applicator comprising: a third tube surrounding the plunger; a fourth tube surrounding the third tube; The medical device of claim 1 .

14. The medical device of claim 13 , wherein the third tube is positionable within the first tube to receive the band from the first tube.

15. 15. The medical device of claim 13 or 14, wherein the fourth tube includes a fourth tube distal end operable to retrieve and advance the band from the third tube upon axial movement of the third tube and the fourth tube relative to one another.

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