Systems and devices for treating tissue

Abstract

A tissue treatment device includes a balloon and first and second clip arms each having a proximal end received within the balloon for movement between an open configuration and a closed configuration. A tissue retention feature extends radially inward from each arm to grip tissue in the tissue gripping configuration and release the tissue in the open configuration. The retention feature is coupled to the arm via a curved portion. The second clip arm includes a second tissue retention feature extending radially inward from the first portion of the second clip arm toward the longitudinal axis.

Description

This application is a divisional application of Chinese application No. 202080099690.4, entitled "System and apparatus for processing tissues". Technical Field

[0001] This invention relates to an apparatus, system, and method for treating tissue. In particular, this invention relates to a compression clamp, a system, and a method for delivering the clamp via an endoscope to a target site for hemostasis along blood vessels in the gastrointestinal tract. Background Technology

[0002] Diseases of the gastrointestinal (GI) system, bile tree, vascular system, and other body cavities and hollow organs are often treated endoscopically, many of which require hemostasis to control bleeding. Hemostatic clips grasp the tissue around the wound and temporarily hold the wound edges together to allow the natural healing process to permanently close the wound. Specialized endoscopic clamping devices are used to deliver the clip to the desired location within the body, after which the clip delivery device is withdrawn, leaving the clip in place. In addition to providing hemostasis, endoscopic clamping devices can also be used, for example, to provide endoscopic marking and closure of cavity perforations, from endoscopic procedures involving access to internal tissues by passing the device through the wall of a natural body cavity.

[0003] The opening width of a clip typically determines the maximum size of the defect it can close. Several complex closure techniques have been developed to close defects larger than the maximum clip opening width, often requiring the additional use of snares, figure-eight loops, or other devices. As an alternative to these advanced and technically challenging methods, a novel defect closure technique uses a technique commonly known as "hold and drag," which makes it possible to close fairly large defects using only conventional clips. This technique simplifies the closure of large defects and reduces the time required for surgery. However, the biggest challenge in using this technique is the significant risk of tissue slippage if the clip is reopened. Therefore, it is not uncommon for multiple attempts to successfully close the defect when applying this technique. Summary of the Invention

[0004] The present invention relates to an apparatus for processing tissue, comprising a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough along a longitudinal axis; and first and second clamping arms, each extending from a proximal end to a distal end, the proximal end being received within the channel of the capsule to move between an open tissue receiving mode and a closed tissue clamping mode, wherein in the open tissue receiving mode the distal ends of the clamping arms are separated from each other, and in the closed tissue clamping mode the distal ends of the clamping arms are moved toward each other.

[0005] The first clamping arm includes a first portion that, in a tissue clamping configuration, extends substantially parallel to the first portion of the second arm and parallel to the longitudinal axis. The first clamping arm includes a first tissue holding feature extending radially inward from the first portion of the first clamping arm toward the longitudinal axis. The first tissue holding feature is configured to clamp target tissue in the tissue clamping configuration and subsequently release the target tissue when the first and second clamping arms move toward an open tissue receiving configuration. The first holding feature is coupled to the first portion of the first clamping arm via a first curved portion. The second clamping arm includes a second tissue holding feature extending radially inward from the first portion of the second clamping arm toward the longitudinal axis. The second tissue holding feature is configured to clamp target tissue in the tissue clamping configuration and subsequently release the target tissue when the first and second clamping arms move toward an open tissue receiving configuration. The second holding feature is coupled to the first portion of the second clamping arm via a second curved portion.

[0006] In one embodiment, the first tissue retention feature includes a first tooth extending radially inward from the first curved portion, and the second tissue retention feature includes a second tooth extending radially inward from the second curved portion toward the longitudinal axis.

[0007] In one embodiment, the first retaining feature has a different number of teeth than the second retaining feature.

[0008] In one embodiment, the first retaining feature includes a first protective member positioned and shaped to project a sharp tip of the second tooth such that the sharp tip of the second tooth is located proximal to the first protective member and closer to the longitudinal axis than the lateral edges of the first and second clamping arms when the first and second clamping arms are in a tissue clamping configuration.

[0009] In one embodiment, the second retaining feature includes a second guard positioned and shaped to protrude the sharp tip of the first tooth such that the sharp tip of the first tooth is located proximal to the second guard and closer to the longitudinal axis than the lateral edges of the first and second clamping arms when the first and second clamping arms are in a tissue clamping configuration.

[0010] In one embodiment, the first retaining feature extends at a first angle of 30 to 100 degrees relative to a first portion of the first clamping arm, and the second retaining feature extends at a second angle of 30 to 100 degrees relative to a first portion of the second clamping arm.

[0011] In one embodiment, the first angle is equal to the second angle.

[0012] In one embodiment, the first retaining feature includes a first sharp tip extending radially inward therefrom, and the second retaining feature includes a second sharp tip extending radially inward therefrom.

[0013] In one embodiment, the shape of the first sharp tip and the second sharp tip is one of a triangle, a circle, or a rectangle.

[0014] In one embodiment, the first retaining feature includes a first plurality of barbs extending radially inward therefrom, and the second retaining feature includes a second plurality of barbs extending radially inward therefrom.

[0015] The present invention also relates to a reloadable clip system comprising: an applicator including a catheter and a control member extending therethrough, the control member extending from a proximal end to a distal end and being longitudinally movable relative to the applicator; and at least one clip assembly coupled to the applicator. Each clip assembly includes: a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough along a longitudinal axis; and first and second clip arms, each extending from a proximal end to a distal end, the proximal end being received within the channel of the capsule body to move between an open tissue receiving configuration and a closed tissue clamping configuration, wherein in the open tissue receiving configuration, the distal ends of the clip arms are separated from each other, and in the closed tissue clamping configuration, the distal ends of the clip arms are moved toward each other.

[0016] The first clamping arm includes a first portion that, in a tissue clamping configuration, extends substantially parallel to the first portion of the second arm and parallel to the longitudinal axis. The first clamping arm includes a first tissue holding feature extending radially inward from the first portion of the first clamping arm toward the longitudinal axis. The first tissue holding feature is configured to clamp target tissue in the tissue clamping configuration and subsequently release the target tissue when the first and second clamping arms move toward an open tissue receiving configuration. The first holding feature is coupled to the first portion of the first clamping arm via a first curved portion. The second clamping arm includes a second tissue holding feature extending radially inward from the first portion of the second clamping arm toward the longitudinal axis. The second tissue holding feature is configured to clamp target tissue in the tissue clamping configuration and subsequently release the target tissue when the first and second clamping arms move toward an open tissue receiving configuration. The second holding feature is coupled to the first portion of the second clamping arm via a second curved portion.

[0017] In one embodiment, the first tissue retention feature includes a first tooth extending radially inward from the first curved portion, and the second tissue retention feature includes a second tooth extending radially inward from the second curved portion toward the longitudinal axis.

[0018] In one embodiment, the first retaining feature includes a first protective member positioned and shaped to project a sharp tip of the second tooth such that the sharp tip of the second tooth is located proximal to the first protective member and closer to the longitudinal axis than the lateral edges of the first and second clamping arms when the first and second clamping arms are in a tissue clamping configuration.

[0019] In one embodiment, the first retaining feature extends at a first angle of 30 to 100 degrees relative to a first portion of the first clamping arm, and the second retaining feature extends at a second angle of 30 to 100 degrees relative to a first portion of the second clamping arm.

[0020] In one embodiment, the second retaining feature includes a second guard positioned and shaped to protrude the sharp tip of the first tooth such that the sharp tip of the first tooth is located proximal to the second guard and closer to the longitudinal axis than the lateral edges of the first and second clamping arms when the first and second clamping arms are in a tissue clamping configuration.

[0021] Additionally, the present invention relates to a method for processing tissue, comprising: inserting a first clamp assembly into a target site within a living organism via a working channel of an endoscope, the first clamp assembly including a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough along a longitudinal axis, and first and second clamping arms slidably received within the capsule to move between an open configuration and a closed configuration, wherein in the open configuration the distal ends of the clamping arms are separated from each other, and in the closed configuration the distal ends of the clamping arms are pulled toward each other; positioning the clamping arms in contact with a first target tissue; moving the first clamping arm from the open configuration to the closed configuration such that a first tissue holding feature extending radially inward from a first portion of the first clamping arm toward the longitudinal axis and a second tissue holding feature extending radially inward from a first portion of the second clamping arm toward the longitudinal axis pierce the first target tissue; moving the first clamping arm from the closed configuration to the open configuration such that the first tissue holding feature releases the first target tissue while holding the first target tissue thereon; positioning the clamping arm in contact with a second target tissue; and moving the first clamping arm from the open configuration to the closed configuration to clamp the first and second target tissues between the first and second clamping arms.

[0022] In one embodiment, the first tissue retention feature includes a first tooth extending radially inward from a first curved portion of a first portion of a first clamping arm, and the second tissue retention feature includes a second tooth extending radially inward from a second curved portion of a first portion of a second clamping arm.

[0023] In one embodiment, the first retaining feature includes a first protective member positioned and shaped to project a sharp tip of the second tooth such that the sharp tip of the second tooth is located proximal to the first protective member and closer to the longitudinal axis than the lateral edges of the first and second clamping arms when the first and second clamping arms are in a tissue clamping configuration.

[0024] In one embodiment, the method further includes loading the first clamp assembly onto the applicator by coupling a control member of the applicator to the proximal end of the clamp arm.

[0025] In one embodiment, the method further includes releasing the clamp assembly from the applicator; and loading the second clamp assembly onto the applicator by coupling a control member of the applicator to the proximal end of the clamp arm. Attached Figure Description

[0026] Figure 1 A top plan view of a clamp system according to an exemplary embodiment of the present invention is shown.

[0027] Figure 2 It shows Figure 1 Front view of the clip components of the clip system.

[0028] Figure 3 It shows Figure 1 A three-dimensional view of the distal end of the clamp arm of the clamp component of the clamp system.

[0029] Figure 4 It shows Figure 1 A three-dimensional view of the clip components of the clip system.

[0030] Figure 5 A top plan view of a clamp system according to a second exemplary embodiment of the present invention is shown.

[0031] Figure 6 It shows Figure 5 Front view of the clip components of the clip system.

[0032] Figure 7 A top plan view of a clamp system according to a third exemplary embodiment of the present invention is shown.

[0033] Figure 8 It shows Figure 7 Front view of the clip components of the clip system.

[0034] Figure 9 It shows Figure 7 A three-dimensional view of the distal end of the clamp arm of the clamp component of the clamp system.

[0035] Figure 10 A top plan view of a clamp system according to a fourth exemplary embodiment of the present invention is shown.

[0036] Figure 11 It shows Figure 10 Front view of the clip components of the clip system.

[0037] Figure 12 It shows Figure 10 A side view of the distal end of the clamp arm of the clamp component of the clamp system.

[0038] Figure 13 It shows Figure 1 The first step in using the clip system.

[0039] Figure 14 It shows Figure 1 The second step in the method of using the clip system.

[0040] Figure 15 It shows Figure 1 The third step in using the clip system.

[0041] Figure 16 It shows Figure 1 The fourth step in using the clip system.

[0042] Figure 17 A top plan view of a clamp system according to a fifth exemplary embodiment of the present invention is shown.

[0043] Figure 18 It shows Figure 17 A three-dimensional view of the clamp arm of the clamp component of the clamp system.

[0044] Figures 19A to 19B It shows Figure 17 A three-dimensional view of the distal end of the clamp arm of the clamp component of the clamp system.

[0045] Figure 20 It shows Figure 17 A three-dimensional view of the clip components of the clip system.

[0046] Figure 21A It shows Figure 17 A three-dimensional view of the distal end of the clamp arm of the clamp component of the clamp system.

[0047] Figure 21B It shows Figure 17 Front view of the first clamp arm of the clamp assembly of the clamp system.

[0048] Figure 21C It shows Figure 17 Front view of the second clamping arm of the clamping component of the clamping system.

[0049] Figure 22 It shows Figure 17 Front view of the distal end of the clamp arm of the clamp assembly of the clamp system.

[0050] Figure 23 It shows that according to Figure 17 A front view of the distal end of the clamp arm of a clamp assembly in another embodiment of the clamp system.

[0051] Figure 24 It shows that according to Figure 17 A front view of the distal end of the clamp arm of a clamp assembly in another embodiment of the clamp system.

[0052] Figure 25 A top plan view of a clamp system according to a sixth exemplary embodiment of the present invention is shown.

[0053] Figure 26A It shows Figure 25 A three-dimensional view of the distal end of the clamp arm of the clamp component of the clamp system.

[0054] Figure 26B It shows Figure 25 Front view of the first clamp arm of the clamp assembly of the clamp system.

[0055] Figure 26C It shows Figure 25 Front view of the second clamping arm of the clamping component of the clamping system. Detailed Implementation

[0056] The invention can be further understood with reference to the following description and accompanying drawings, wherein like elements are designated by like reference numerals. The present invention relates to a clamping system, and more particularly to a single-use or reloadable endoscopic clamping system for treating tissue perforations, defects, and / or bleeding. Exemplary embodiments of the invention describe a hemostatic clip having invasive clamping or holding features to improve attachment to target tissue when the clip is at least partially in an open configuration. In particular, exemplary embodiments describe a hemostatic clip having clamping arms with pins, hooks, barbs, and other geometries as clamping features to allow tissue to be grasped and held by a single clamping arm. It should be noted that, as used herein, the terms “proximal” and “distal” are intended to refer to the user facing (proximal) and away (distal) from the device.

[0057] like Figure 1 As shown, a system 100 according to an exemplary embodiment of the present invention includes a clamp assembly 102 that can be inserted into a living body to a target tissue for treatment, for example, through the working channel of an endoscope. The clamp assembly 102 is flexible enough to allow it to traverse a tortuous path through the body—for example, through the working channel of a flexible endoscope inserted through a natural body cavity via a natural body orifice.

[0058] In an exemplary embodiment, the clamp assembly 102 may be loaded onto a distal portion of the applicator 104 before being inserted into the living body to clamp target tissue. The applicator 104 and the clamp assembly 102 are configured such that after the clamp assembly 102 has been deployed in the living body, a new clamp assembly 102 can be loaded onto the applicator 104, such that the same applicator 104 can be used to deliver a new clamp assembly 102 to a second portion of the target tissue in the living body. The applicator 104 may include a catheter (not shown) and a control member 108 extending therethrough. The clamp assembly 102 includes first and second clamping arms 110, 112 slidably received within a longitudinal channel 114 of the capsule 116.

[0059] The first and second clamping arms 110, 112 are movable between an open tissue receiving mode and a closed tissue holding mode. In the open tissue receiving mode, the distal ends 120, 122 of the clamping arms 110, 112 are separated from each other to receive target tissue therebetween. In the closed tissue holding mode, the distal ends 120, 122 of the clamping arms 110, 112 move toward each other to hold the target tissue therebetween. The clamping arms 110, 112 are movable between the open and closed modes via a control member 108 extending into the capsule 116. The proximal end (not shown) of the control member 108 is connected to an actuator positioned on a handle outside the body. In this embodiment, the distal end of the control member 108 is coupled to the proximal end of the clamping arms 110, 112.

[0060] like Figure 1 As further shown, the clamping arms 110, 112 of the exemplary embodiment of the present invention extend from a proximal end (not shown) to a distal end 120, 122. As those skilled in the art will understand, the arms 110, 112 of this embodiment are biased toward an open tissue receiving position in which the distal ends 120, 122 are separated from each other to receive tissue. That is, the arms 110, 112 are configured to spring open to the tissue receiving position when they are displaced distally from the constraint of the capsule 116. However, as those skilled in the art will understand, the clamp assembly 102 may include a separate member, as a supplement to or alternative to this bias, which pushes the clamping arms 110, 112 away from each other.

[0061] In an exemplary embodiment, the clamping arms 110, 112 may include locking lugs (not shown) at their proximal ends for engaging distal components within the pouch body 116 when the clamp assembly 102 has been deployed. The locking lugs (not shown) may also form a mechanical lock after the clamp has been deployed, with windows formed on the sides of the pouch body 116. However, those skilled in the art will understand that any of the various known mechanisms for releasably coupling the clamp assembly 102 (e.g., the pouch body including the clamping arms) to the insertion device may be employed without departing from the scope of the invention.

[0062] As described above, the clamping arms 110, 112 are biased toward the open configuration such that when the clamping arms 110, 112 move distally past the distal end 126 of the capsule 116, the distal ends 120, 122 of the clamping arms 110, 112 separate from each other into the open configuration. When the clamping arms 110, 112 are pulled proximally into the capsule 116, contact with the capsule 116 pulls the clamping arms 110, 112 toward each other into the closed configuration. During deployment, the clamping arms 110, 112 are locked within the capsule 116, which holds them in the closed position, as will be understood by those skilled in the art. As described above, the clamping arms 110, 112 move between the open and closed configurations via a control member 108, which moves proximally and distally relative to the capsule 116 via an actuator held externally at a handle.

[0063] In an exemplary embodiment, one or both of the clamping arms 110, 112 may include a pin 128 extending from the inside of the distal tip 130 of the clamping arms 110, 112. Figures 2 to 3 As shown, the first clamping arm 110 has a single pin 128, while the second clamping arm 112 has two pins 128. The pins 128 extend radially inward from the inner surface of the clamping arms 110, 112 substantially perpendicularly toward the other of the clamping arms 110, 112.

[0064] In an exemplary embodiment, the stud 128 is designed to pierce or at least engage tissue, such that tension in the tissue (from pulling it across the defect) creates further engagement between the stud 128 and the tissue. For example, a fishhook shape demonstrates this engagement once it pierces the tissue: applying additional force in the same direction pushes the tissue further upward on the hook, whereas the direction of the force must be reversed to remove the hook.

[0065] like Figure 3 As can be seen, the pins 128 on the opposing arms 110 and 112 are offset from each other longitudinally, making it impossible for them to prevent the clamping arms 110 and 112 from completely closing around the tissue defect. For example, as Figure 3 As shown, when the clamp assembly 102 is in the closed position, the pins 128 of the first clamping arm 110 are positioned distally or proximally to the two pins 128 on the second clamping arm 112. Furthermore, as... Figure 4 As shown, the pins of the first and second clamping arms 110 and 112 are laterally offset from each other, such that the pin 128 of the first clamping arm 110 is received between the pins 128 of the second clamping arm 112 without any interference.

[0066] In an alternative embodiment, the pins 128 are configured to extend in different planes to be received by the opposing arms without interference from the pins 128 of the other arm. For example, the pins 128 of the first clamping arm 110 are positioned such that when the clamp assembly 102 is in a closed configuration, it is fitted between the two pins 128 of the second clamping arm 112. In another embodiment, the two pins 128 are configured to extend in substantially the same plane such that when the arms 110, 112 are in a closed configuration, the ends of the pins 128 originating from the opposing arms 110, 112 touch each other.

[0067] As those skilled in the art will understand, the spike 128 is sharp enough to pierce and hook into tissue. In one embodiment, the spike 128 of the second clamping arm 112 is at a greater angle relative to the rest of the clamping arm 112, such that the spike 128 remains hooked within the target tissue when the clamping assembly 102 moves to an open configuration to capture another portion of the tissue. Specifically, the spike 128 may also extend from the inner surface of the clamping arm 112 at various angles between 20 and 90 degrees relative to the longitudinal axis L of the clamping arm 112, to allow the spike 128 to continue to grip the tissue when the clamping arms 110, 112 are in the open configuration.

[0068] In use, the operator orients the clamp arms 110 and 112 such that the second clamp arm 112 is outside the tissue defect and the first clamp arm 110 is inside the tissue defect. Next, the operator closes the clamp assembly 102 at the edge of the tissue defect, and the pin 128 pierces the mucosal layer to hold the tissue inside the clamp arms 110 and 112. When the clamp assembly 102 is dragged to the opposite edge of the tissue defect and gently reopened, the tissue flap remains hooked on the second clamp arm 112 but is released from the first arm 110. That is, the direction of the force on the first clamp arm 110 is reversed, causing the tissue to release from the first clamp arm 110 while remaining on the second clamp arm 112.

[0069] The first clamping arm 110 can then be used to pull the opposing edges of the defect within the clamp assembly 102. The pins 128 on the two jaws 110, 112 ensure a secure hold of the defect edges and prevent slippage when the clamps are closed and deployed. Once the two opposing edges of the tissue defect are joined by the clamp assembly 102, the clamp assembly 102 is released from the applicator 104, and additional clamps can be placed along the tissue defect to complete the closure, as described in further detail below.

[0070] In another exemplary embodiment, such as Figures 5 to 6 As shown, system 200 is substantially the same as system 100, except as described herein. System 200 includes a clamp assembly 202 having first and second clamping arms 210, 212. In this embodiment, clamping arms 210, 212 use a combination of hooks and pins to hold a first tissue edge on one arm while a second arm drags a second tissue edge toward the first edge. Specifically, as Figure 5 As shown, the first arm 210 includes two pins 228, similar to the pins 128 of the clamp assembly 102, which extend radially inward from the inner surface of the clamp arm 210 substantially perpendicularly toward the second clamp arm 212. The second arm 212 has a hook-shaped distal end 222 with a sharp distal tip 230 configured to pierce and hold tissue thereon.

[0071] In an exemplary embodiment, the distal tip 230 forms an angle of approximately 90 to 180 degrees relative to the remainder of the clamp arm 212. For example, in one embodiment, the distal end 222 of the second clamp arm 212 may be bent rearward toward the clamp assembly 202 such that the distal tip 230 is substantially parallel to the remainder of the clamp arm 212. This embodiment provides a high degree of tissue retention once the distal tip 230 has pierced the tissue defect. In another example, the distal end 222 may have a bend greater than 90 degrees such that the distal tip is substantially perpendicular to the proximal portion of the clamp arm 212. This embodiment allows the tissue defect to be pierced more easily by the distal tip 230.

[0072] In use, as discussed above, the hook-shaped distal end 222 of the second clamping arm 212 is designed to adhere to the tissue and hold the first edge of the tissue defect within the clamping arms 210, 212, while the pin 228 of the first clamping arm 210 is designed to release the first edge of the tissue defect and pull in the opposite second edge of the tissue defect when the clamp assembly 202 is reopened. This combination of invasive features has proven particularly effective for the "hold and drag" technique.

[0073] In another exemplary embodiment, such as Figures 7 to 9 As shown, system 300 is substantially the same as systems 100 and 200, except as described herein. System 300 includes a clamp assembly 302 having first and second clamping arms 310, 312. In this embodiment, the first clamping arm 310 includes one or more barbs 332 attached to the inner surface 334 of the distal portion of the first clamping arm 310. The clamping arm with barbs is particularly effective if the operator can force the barbed arm to lie flat against the target tissue. This positioning of the arm to lie flat against the tissue allows each of the barbs 332 to pierce the submucosal tissue layer and forces the tissue to remain attached to the clamping arm even under high tension.

[0074] like Figures 8 to 9 As shown, the first clamping arm 310 of this embodiment includes four barbs 332 that extend radially inward from the inner surface 334 of the first clamping arm 310 substantially perpendicularly toward the second clamping arm 312. It should be understood that while this embodiment includes four barbs 332, any number of barbs can be used. The barbs 334 can also extend from the inner surface 334 at various angles between 20 and 90 degrees relative to the longitudinal axis L of the clamping arm 310, and more specifically at 45 degrees, to allow the barbs 332 to grasp tissue when the clamping arms 310, 312 are in an open configuration. That is, the barbs 332 can extend outward from the inner surface 334 of the first clamping arm 310 in a plane substantially perpendicular to the plane containing the inner surface 334 of the first clamping arm 310, or they can extend at an angle and thus lie in a plane not perpendicular to the plane containing the inner surface 334 of the clamping arm 310.

[0075] In one embodiment, such as Figures 8 to 9 As shown, the barbs 332 are positioned in pairs, substantially parallel to each other, on the inner surface 334. However, it should be understood that the barbs 332 can be in any configuration, such as, for example, longitudinally staggered pairs, a single longitudinal line along the central longitudinal axis of the clamping arm 310, etc. As can be seen in the figure, the second arm 312 has a flat profile along its length.

[0076] In addition to nails, hooks, and barbs, other geometries can be used to improve the attachment of the clamp to the target tissue defect. For example, in another exemplary embodiment, such as Figures 10 to 12 The clamp assembly 402 of the shown clamp system 400 includes a tooth 440 located at the distal tip 430 of at least one of the first and second clamp arms 410, 412. For example, as Figures 11 to 12 As shown, the first clamping arm 410 includes three teeth 440 located on the inner surface of the distal tip 430 of the first clamping arm 410. It should be noted that while this embodiment includes three teeth, any number of teeth may be used, as those skilled in the art will understand. The teeth 440 have sharp tips to allow tissue puncture and retention. Additionally, the distal tip 430 of the first clamping arm 410 may be at approximately a 90-degree angle relative to the remainder of the clamping arm 410 to allow tissue retention when the clamping arms 410, 412 are reopened.

[0077] The method of using system 100 according to an exemplary embodiment is as follows: Figures 13 to 16The process is described in the diagram. Initially, a clamp assembly 102 is inserted into the working channel of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body cavity) to the site of the target defect 10 adjacent to the tissue to be clamped and closed. The clamp assembly 102 is inserted into the target tissue in a closed configuration to allow it to pass through the working channel. Upon reaching the site of the target tissue defect, the clamp assembly 102 is pushed out of the distal end of the working channel of the endoscope, and the clamp arms 110, 112 extend out of the capsule 116 to move the clamp arms 110, 112 into an open tissue receiving configuration.

[0078] Once the first edge 12 of the target tissue defect has been received between the clamping arms 110, 112, the clamping arms 110, 112 move toward a closed configuration, causing the pins 128 to pierce the first edge 12 of the tissue defect, thus clamping the first edge 12 between the distal ends of the clamping arms 110, 112. The clamping arms 110, 112 are moved toward a tissue clamping configuration by pulling a control member proximally relative to the capsule 116. Once the clamping assembly 102 is in the closed tissue clamping configuration, the first edge 12 is pulled toward the second edge 14 of the defect via the applicator 104 through the clamping assembly 102. When the first and second edges 12, 14 of the tissue defect are adjacent to each other, the clamping arms 110, 112 are gently reopened. When the clamping arms 110, 112 reopen, the first arm 110 releases the first edge 12 of the tissue defect, but the two pins 128 of the second clamping arm 112 retain the first edge 12 attached to the second clamping arm 112. The clamp arms 110, 112 then reclose at the two edges 12, 14 of the tissue defect, and the first clamp assembly 102 is deployed from the dispenser 104 via an actuator. Additional clamp assemblies 102 can be placed along the tissue edges to close the defect.

[0079] In another exemplary embodiment, such as Figures 17 to 24 As shown, system 500 is similar to systems 100, 200, 300, and 400, except as described herein. System 500 includes a clamp assembly 502 having first and second clamping arms 510, 512. Figure 17 As shown, the clamp assembly 502 is configured such that when the target tissue 10 is processed in a substantially perpendicular manner (i.e., the longitudinal axis L of the clamping assembly 502 is oriented substantially perpendicular to the surface of the tissue 10 to be clamped), the distal end of the clamp arm in the open tissue receiving configuration extends at a predetermined angle relative to the surface of the tissue 10, as will be described in more detail below.

[0080] As those skilled in the art will understand, although Figure 17The surface tissue 10 is shown as a basic plane, but with a plane perpendicular to the approach angle of the clamps of the system 500. This arrangement illustrates the configuration of the various components of the system 500, which can be used to clamp tissues of any shape with tissue surfaces from any desired approach angle.

[0081] The first clamping arm 510 has a distally curved portion 514 and a first tissue holding feature 518 extending laterally inward toward the axis L. Similarly, the second clamping arm 512 has a distally curved portion 516 and a second tissue holding feature 520 extending laterally inward toward the axis L. In an exemplary embodiment, each of the first and second tissue holding features 518, 520 includes one or more teeth, which in this embodiment are integrally formed from the curved portions of each of the first and second clamping arms 510, 512, respectively, located at the curved portions 514, 516, to extend toward the axis L. The holding features 518, 520 are angled inward toward the axis L at a selected angle such that when the first and second clamping arms 510, 512 are pulled toward each other into a tissue clamping configuration, the tissue received between the clamping arms 510, 512 is held by the first and second tissue holding features 518, 520.

[0082] like Figure 18 As shown, the curved portion 514 of the first clamping arm 510 defines an angle α between the outer side 511 of the first clamping arm 510 and the outer side 513 of the retaining feature 518. In this embodiment, the angle α can range from 30° to 100°, however, a preferred range is between 60° and 90°. In this embodiment, the configuration of the second clamping arm 512 is essentially a mirror image of the first clamping arm 510. When the angle α is too sharp, tissue may adhere to the clamping arm 510 before the user has decided to deploy and lock the clamp onto the target tissue. This can make it difficult to release the tissue and reposition the clamp without tearing the tissue. Furthermore, if the angle α is too blunt, the tissue gripping ability of the clamping assembly 502 may be affected, potentially leading to puncture or tearing of the tissue and / or premature release of the target tissue held by the clamping assembly 502.

[0083] As described above, the first and second clamping arms 510, 512, when released, separate from each other to move into an open tissue receiving configuration, such that each forms an angle δ relative to the axis L. In this embodiment, the angle δ is the same for the first clamping arm 510 as for the second clamping arm 512. Figure 19A and 19BAs shown, when the system 500 is positioned such that the axis L is perpendicular to the surface of the tissue 10 in the open tissue receiving configuration, the first clamping arm 510 forms an angle β relative to the surface of the tissue 10. The angle β is measured between the outer side 513 of the retaining feature 518 and the surface of the tissue 10. The angle β can have a range of -20° to 40°; however, in this embodiment, the range is preferably between 0° and 20°. Figure 19A In the middle, the first clamping arm 510 forms a positive angle β (e.g., 20°) with respect to the surface of the tissue 10, while Figure 19B In this case, the clamp arm 510 forms a negative angle β (e.g., -20°) relative to the surface of the tissue 10.

[0084] In other words, such as Figure 20 As seen in the diagram, the clamping arm 510 forms an angle δ with the longitudinal axis L of the clamp assembly 502. In this embodiment, the angle δ has a range of 50° to 110°; however, in this embodiment, the angle δ may preferably be between 70° and 90°. As those skilled in the art will understand, angles α, β, and δ are proportionally related to each other. Furthermore, in this embodiment, the first and second clamping arms 510, 512 are formed as approximately mirror images of each other with respect to angles α, β, and δ. However, those skilled in the art will understand that any of these angles can vary from one clamping arm to the other within the exemplary range as needed.

[0085] In an exemplary embodiment, retaining features 518, 520 are designed to be aligned with each other such that when the clamping assembly 502 is inserted in a closed configuration through the working channel of the endoscope, the sharp edges of the retaining features 518, 520 are protected to prevent any edge of either retaining feature from protruding beyond the external limits of the clamping arms 510, 512 (i.e., no edge of either retaining feature 518, 520 protrudes further toward the wall of the cylindrical cavity into which the clamping assembly 502, rather than the smooth radial outer surface of the clamping arms 510, 512, is received). This shielding reduces the risk that any sharp edge of the clamping arms 510, 512 will engage and damage any portion of the working channel through which the clamping assembly 502 is deployed. Additionally, the shielding reduces the risk, for example, that a bag storing the product will be torn by any of these sharp surfaces that could compromise the product's sterility.

[0086] like Figures 21A to 21CAs shown, in this embodiment, the retaining features 518 and 520 correspond to each other such that when they are pulled together into a tissue clamping configuration, each of the teeth of the first clamping arm 510 faces a gap of a corresponding size between the teeth of the second clamping arm 512, causing them to nest together, as described below. In this embodiment, each of the retaining features 518 has a sharp tip 522, while each of the retaining features 520 has a sharp tip 524 to facilitate piercing and retaining the engaged tissue. In an exemplary embodiment, the retaining feature 518 includes a first tooth 518a having a first sharp tip 522a and a second tooth 518b having a second sharp tip 522b, as... Figure 21B As shown.

[0087] For retaining feature 518, a first tooth 518a is positioned near a first lateral edge 521a of clamping arm 510, while a second tooth 518b is positioned more centrally and separated from the first tooth 518a at a first gap 525, the first gap 525 having a width substantially corresponding to the width of the second sharp tip 524b of clamping arm 512 (across the sharp tip from the first lateral edge to the second lateral edge of the corresponding clamping arm). The second tooth 518b is spaced apart from the second lateral edge 521b by a distance substantially corresponding to the width of the first sharp tip 524a of the second clamping arm 512. Retaining feature 518 also includes a first circular protrusion 526 adjacent to the second tooth 518b, the first protrusion 526 serving as a protective element against the first sharp tip 524a. The first protrusion 526 extends distally from the curved portion 514 a portion of the length of the second tooth 518b.

[0088] Similar to retaining feature 518, retaining feature 520 includes a first tooth 520a having a first pointed tip 524a and a second tooth 520b having a second pointed tip 522b, as shown below. Figure 21C As shown. For the retaining feature 520, a first tooth 520a is positioned near the first lateral edge 523a of the clamping arm 512, while a second tooth 520b is positioned more centrally, separated from the first tooth 520 by a gap 527 having a width substantially corresponding to the width of the second sharp tip 522b of the first clamping arm 510. The second tooth 520b is spaced apart from the second lateral edge 523b by a distance substantially corresponding to the width of the first sharp tip 522a of the first clamping arm 510. The retaining feature 520 also includes a second circular protrusion 528 adjacent to the second tooth 520b, which serves as a protective element against the first sharp tip 522a. The second protrusion 528 extends distally from the curved portion 516 a portion of the length of the second tooth 520b.

[0089] As those skilled in the art will understand, the width of the first clamping arm 510 (i.e., the distance from the first lateral edge 521a to the second lateral edge 521b) is substantially similar to the width of the second clamping arm 512 (i.e., the distance from the first lateral edge 523a to the second lateral edge 523b), such that a tooth in one of the clamping arms is always protected by the opposing clamping arm. That is, where the number of teeth in one of the clamping arms is the same as the number of teeth on the opposing arm, or where the teeth are offset from the center positioning of the clamping arm, the distal portion of each clamping arm will have a selected width to extend laterally in the closed configuration at least to the distance required to protect all the teeth of the opposing clamping arm.

[0090] This configuration allows the second pointed tip 522b to be received in the gap 527 between the first and second teeth 520a, 520b in the closed configuration, while the first pointed tip 522a is received below the second protrusion 528. Similarly, in the closed configuration, the second pointed tip 524b is received in the gap 525 between the first and second teeth 518a, 518b, while the first pointed tip 524a is received below the first protrusion 526 of the first clamping arm 510, as shown below. Figure 21A As shown. This configuration provides protection so that the sharp tips 522, 524 of features 518, 520 do not extend beyond the lateral edges 523a, 523b of the second clamping arm 512 and the lateral edges 521a, 521b of the first clamping arm 510.

[0091] The sharpness of features 518 and 520 is determined by their sharp tips 522 and 524. In an exemplary embodiment, the sharp tips 522 and 524 are typically triangular. Figure 22 As shown, the second tooth 518b and the second pointed tip 522b are substantially similar to the first tooth 518a and the first pointed tip 522a. The sharpness of the first tooth 518a (and teeth 518b, 520a, and 520b) can be expressed as a first ratio between the width W of the tooth 518a and the length T of the tooth 518a. As those skilled in the art will understand, the length V of the first pointed tip 522a is a portion of the length T of the tooth 518a. The first ratio (T / W) is expressed as the ratio of length T to width W.

[0092] The first ratio in this embodiment has an exemplary range of 0.5 to 6; however, the preferred range is between 2 and 4. Furthermore, the sharpness of the tooth 518a can be expressed as a second ratio between the width W and the length V, where the length V is a portion of the length T of the tooth 518a. The second ratio (V / W) is expressed as the ratio of length V to width W. In this embodiment, the second ratio has an exemplary range of 0.5 to 6 and a preferred range between 2 and 3. In the exemplary embodiment, the sharp tips 522, 524 are triangular in shape; however, the sharp tips 522, 524 can have various other shapes (e.g., circular, rectangular, etc.), such as... Figure 23 As shown. Additionally, as... Figure 24 As shown, retaining features 518, 520 can be formed as multiple barbs 532a, 532b, instead of sharp tips 522, 524. It should be noted that although these embodiments include two teeth on each clamping arm, the number of teeth on each clamping arm can be changed as needed.

[0093] In another exemplary embodiment, such as Figures 25 to 26C As shown, system 600 is substantially the same as systems 100, 200, 300, 400, and 500, except as described herein. Similar to system 500, system 600 includes a clamp assembly 602 having first and second clamping arms 610, 612. Figure 25 As shown, the first clamping arm 610 has a curved portion 614 and a first tissue holding feature 618 extending distally therefrom. Similarly, the second clamping arm 612 has a curved portion 616 and a second tissue holding feature 620 extending distally therefrom. The holding features 618, 620 are configured to grasp target tissue therebetween when the clamp assembly 602 is moved into a closed configuration.

[0094] like Figures 26A to 26C As shown, similar to the retaining features 518, 520 of clamping assembly 502, the retaining features 618, 620 of clamping assembly 602 are designed to be consistent with each other. When clamping assembly 602 is inserted through the working channel of endoscope in a closed configuration, retaining features 618, 620 are protected to prevent any edge of retaining features 618, 620 from protruding beyond the external limits of clamping arms 610, 612 (i.e., no edge of either retaining feature 618, 620 protrudes further toward the wall of the cylindrical cavity into which clamping assembly 602, rather than the smooth radial outer surface of clamping arms 610, 612, is received), thereby reducing the risk that any sharp edge will engage and damage any portion of the working channel of endoscope through which clamping assembly 602 is deployed.

[0095] The clamping assembly 602 differs from the clamping assembly 502 in that the retaining feature 618 is different from the retaining feature 620, while the retaining feature 518 is substantially similar to the retaining feature 520. Specifically, each of the retaining features 518 and 520 has the same number of teeth (e.g., retaining feature 518 has two teeth and retaining feature 520 has two teeth), while the retaining feature 618 has a different number of teeth than the retaining feature 620 (e.g., retaining feature 618 has one tooth and retaining feature 620 has two teeth), as described below. Thus, the retaining feature 618 has a single sharp tip 622, while the retaining feature 620 has two sharp tips 624 for piercing and retaining the tissue engaged by the retaining features 618 and 620. As those skilled in the art will understand, any of the various configurations of the retaining features described herein can be employed with a clamping arm having any of the aforementioned angles α, β, and δ.

[0096] In an exemplary embodiment, the sharpness of retaining features 618 and 620 is determined by sharp tips 622 and 624, and the sharpness of retaining features 618 and 620 is determined similarly to that of retaining features 518 and 520. Furthermore, in an exemplary embodiment, the sharp tips 622 and 624 are triangular in shape; however, the sharp tips 622 and 624 can have various other shapes (e.g., circular, rectangular, etc.), similar to... Figures 22 to 24 The sharp tips 522 and 524 are located in the clamping assembly 602. When the clamping assembly 602 is in the closed configuration, the sharp tips 622 and 624 are protected, as described below.

[0097] In an exemplary embodiment, retaining feature 618 includes a single tooth 618a having a single sharp tip 622a, such as Figure 26B As shown. For the retaining feature 618 in this embodiment, the tooth 618a is centered relative to the side of the first clamping arm 610 at the distal end of the curved portion 614. The retaining feature 618 also includes a first circular protrusion 626 serving as a guard to protect the second sharp tip 624b of the clamping arm 612, and a second circular protrusion 628 serving as a guard to protect the first sharp tip 624a of the second clamping arm 612.

[0098] A first protrusion 626 is located between the first lateral edge 621a of the first clamping arm 610 and the tooth 618a, while a second protrusion 628 is located between the second rear edge 621b of the clamping arm 610 and the tooth 618a. The first and second protrusions 626 and 628 extend distally from the curved portion 614 a portion of the length of the tooth 618. The first protrusion 626 has a width substantially corresponding to the width of the second pointed tip 624b (in a direction across the pointed tip from the first lateral edge to the second lateral edge of the corresponding clamping arm). Similarly, the second protrusion 628 has a width substantially corresponding to the width of the first pointed tip 624a.

[0099] In an exemplary embodiment, the retaining feature 620 includes a first tooth 620a having a first sharp tip 624a and a second tooth 620b having a second sharp tip 624b, such as Figure 26C As shown. For retaining feature 620, the first tooth 620a is positioned near the first lateral edge 623a of the second clamping arm 612, while the second tooth 620b is positioned near the second lateral edge 623b. The first tooth 620a and the second tooth 620b are separated from each other by a gap 625 having a width substantially corresponding to the width of the sharp tip 622a of the first clamping arm 610.

[0100] As those skilled in the art will understand, the width of the first clamping arm 610 (i.e., the distance from the first lateral edge 621a to the second lateral edge 621b) is substantially similar to the width of the second clamping arm 612 (i.e., the distance from the first lateral edge 623a to the second lateral edge 623b), such that a tooth in one of the clamping arms is always protected by the opposing clamping arm. That is, in the case where the number of teeth in one of the clamping arms is less than the number of teeth on the opposing arm, or where the teeth are offset from the center positioning of the clamping arm, the distal portion of each clamping arm will have a selected width to extend laterally in the closed configuration at least to the distance required to shield all teeth of the opposing clamping arm. This configuration allows the sharp tip 624a to be received below the second protrusion 628 in the closed configuration to prevent the sharp tip 624a from extending beyond the first clamping arm 610.

[0101] Similarly, the pointed tip 624b is received below the first protrusion 626 to prevent the pointed tip 624b from extending beyond the first clamping arm 610. Furthermore, the pointed tip 622a is received in the gap 625 located between the first and second teeth 620a and 620b to prevent the pointed tip 622a from extending beyond the second clamping arm 612, as... Figure 26A As shown. This configuration provides protection so that the sharp tips 622, 624 of features 618, 620 do not extend beyond the lateral edges 623a, 623b of the second clamping arm 612 and the lateral edges 621a, 621b of the first clamping arm 610.

[0102] As those skilled in the art will understand, although these embodiments include clamping arms with one tooth and clamping arms with two teeth, each of the clamping arms can have any number of teeth, as long as the number of teeth on each of the clamping arms is different. The methods of use of systems 500 and 600 are substantially the same as those described above for system 100. Those skilled in the art will understand that changes can be made to the above embodiments without departing from the concept of the invention. It should also be understood that structural features and methods associated with one of the embodiments can be incorporated into other embodiments.

[0103] Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but modifications are also covered within the scope of the invention as defined by the appended claims.

Claims

1. An apparatus for processing tissue, comprising: A first clamping arm and a second clamping arm are configured to move between an open tissue receiving configuration and a closed tissue clamping configuration. In the open tissue receiving configuration, the distal ends of the first and second clamping arms are separated from each other; in the closed tissue clamping configuration, the distal ends of the first and second clamping arms move toward each other. The first clamping arm includes a first tooth extending radially inward from its distal portion toward the longitudinal axis. The second clamping arm includes a second tooth extending radially inward from its distal portion toward the longitudinal axis; and Wherein, the second tooth is laterally offset relative to the first tooth, and the first clamping arm includes a first protective member extending laterally outward from the first tooth, such that when the first clamping arm and the second clamping arm are in the tissue clamping configuration, the first protective member protrudes from the second tooth, such that the sharp tip of the second tooth is located near the first protective member and closer to the longitudinal axis than the lateral edge of the first protective member.

2. The apparatus according to claim 1, wherein, The first tooth is connected to the distal portion of the first clamping arm via a first curved portion, and the second tooth is connected to the distal portion of the second clamping arm via a second curved portion.

3. The apparatus according to claim 1, wherein, The number of teeth on the first clamping arm is different from the number of teeth on the second clamping arm.

4. The apparatus according to claim 1, wherein, The second clamping arm includes a second protective member laterally offset from the second tooth. The second protective member is positioned and shaped to protrude the sharp tip of the first tooth such that when the first clamping arm and the second clamping arm are in the tissue clamping configuration, the sharp tip of the first tooth is located proximal to the second protective member and closer to the longitudinal axis than the lateral edge of the second protective member.

5. The apparatus according to claim 1, wherein, The first tooth extends at a first angle of 30 to 100 degrees relative to the distal portion of the first clamping arm, and the second tooth extends at a second angle of 30 to 100 degrees relative to the distal portion of the second clamping arm.

6. The apparatus according to claim 5, wherein, The first angle is equal to the second angle.

7. The apparatus according to claim 1, wherein, The first tooth and the second tooth each include a plurality of sharp tips extending radially inward therefrom.

8. The apparatus according to claim 7, wherein, Each of the pointed tips is shaped like a triangle, a circle, or a rectangle.

9. The apparatus according to claim 1, wherein, The first tooth includes a first plurality of barbs extending radially inward therefrom, and the second tooth includes a second plurality of barbs extending radially inward therefrom.

10. A reloadable clip system comprising: An applicator, the applicator including a conduit and a control member extending therethrough, the control member extending from a proximal end to a distal end and being longitudinally movable relative to the applicator; At least one clip assembly is coupled to the applicator, each clip assembly comprising: A first clamping arm and a second clamping arm are configured to move between an open tissue receiving configuration and a closed tissue clamping configuration; in the open tissue receiving configuration, the distal ends of the first and second clamping arms are separated from each other; in the closed tissue clamping configuration, the distal ends of the first and second clamping arms move toward each other. The first clamping arm includes a first tooth extending radially inward from its distal portion toward the longitudinal axis. The second clamping arm includes a second tooth extending radially inward from its distal portion toward the longitudinal axis, and Wherein, the second tooth is laterally offset relative to the first tooth, and the first clamping arm includes a first protective member extending laterally outward from the first tooth, such that when the first clamping arm and the second clamping arm are in the tissue clamping configuration, the first protective member protrudes from the second tooth, such that the sharp tip of the second tooth is located near the first protective member and closer to the longitudinal axis than the lateral edge of the first protective member.

11. The system according to claim 10, wherein, The second tooth includes a second guard that is positioned and shaped to protrude from the sharp tip of the first tooth such that when the first and second clamping arms are in the tissue clamping configuration, the sharp tip of the first tooth is located proximal to the second guard and closer to the longitudinal axis than the lateral edge of the second guard.

12. The apparatus according to claim 10, wherein, The first tooth extends at a first angle of 30 to 100 degrees relative to the distal portion of the first clamping arm, and the second tooth extends at a second angle of 30 to 100 degrees relative to the distal portion of the second clamping arm.

13. The system according to claim 10, wherein, The first tooth is connected to the distal portion of the first clamping arm via a first curved portion, and the second tooth is connected to the distal portion of the second clamping arm via a second curved portion.

14. The system according to claim 10, wherein, The first tooth includes a first plurality of barbs extending radially inward therefrom, and the second tooth includes a second plurality of barbs extending radially inward therefrom.

15. The system according to claim 10, wherein, The first tooth and the second tooth each include a plurality of sharp tips extending radially inward therefrom.

16. An apparatus for processing tissue, comprising: A first clamping arm and a second clamping arm are configured to move between an open tissue receiving configuration and a closed tissue clamping configuration. In the open tissue receiving configuration, the distal ends of the first and second clamping arms are separated from each other; in the closed tissue clamping configuration, the distal ends of the first and second clamping arms move toward each other. The first clamping arm includes a first tissue puncture element extending radially inward from its distal portion toward the longitudinal axis, and a second tissue puncture element extending radially inward from the distal portion of the second clamping arm toward the longitudinal axis. Wherein, the first tissue puncture element is a first nail, which is configured to release the previously punctured tissue when the first clamp arm and the second clamp arm move from a closed state to an open state, and the second tissue puncture element is configured to remain embedded in the previously punctured tissue when the first clamp arm and the second clamp arm move from a closed state to an open state.

17. The apparatus according to claim 16, wherein, The first pin extends from the distal portion of the first clamp arm at a first angle relative to the longitudinal axis of the first clamp arm, and wherein the second tissue puncture element includes a second pin that extends radially inward from the distal portion of the second clamp arm toward the longitudinal axis of the second clamp arm at a second angle greater than the first angle and between 20 and 90 degrees relative to the longitudinal axis of the second clamp arm.

18. The apparatus according to claim 16, wherein, The second tissue puncture element includes a hook with a sharp, distal tip.

19. The apparatus according to claim 18, wherein, The farthest tip extends at an angle between 90 and 180 degrees relative to the longitudinal axis of the second clamping arm.

20. The apparatus according to claim 16, wherein, The second tissue puncture element includes a pair of barbs.

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