Systems and apparatus for processing tissue

Abstract

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

Description

Technical Field

[0001] The present invention relates to a device, system, and method for treating tissue, and more particularly, to a compression clip, a system, and a method for endoscopically delivering the clip to a target site for hemostasis of blood vessels along the gastrointestinal tract. Background Art

[0002] Lesions of the gastrointestinal (GI) system, biliary tree, vascular system, and other body cavities and hollow organs are often treated through endoscopic procedures, many of which require hemostasis to control bleeding. A hemostatic clip grasps the tissue surrounding a wound and temporarily holds the wound edges together to allow the natural healing process to permanently close the wound. A specialized endoscopic clamping device is used to deliver a clip at a desired location in the body, after which the clip delivery device is withdrawn, thereby leaving the clip in the body. In addition to providing hemostasis, endoscopic clamping devices can also be used to provide endoscopic marking and closure of, for example, cavity perforations, for example, from endoscopic procedures that involve accessing internal tissue by passing the device through the wall of a natural body cavity.

[0003] The width of the clip's opening generally determines the maximum size of the defect it can close. To close defects larger than the maximum clip opening width, several complex closure techniques have been developed that often require the additional use of snares, "figure-of-eight" loops, or other devices. As an alternative to these advanced and technically challenging methods, a new defect closure technique uses a technique commonly known as "hold and drag," which makes it possible to close fairly large defects using only traditional clips. This technique simplifies the closure of large defects and reduces the time required for the procedure. However, the greatest challenge with 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 a device for treating tissue, which includes a capsule that extends longitudinally from a proximal end to a distal end and includes a channel extending therethrough along a longitudinal axis; and first and second clamping arms, each extending from a proximal end to a distal end, with the proximal end received within the channel of the capsule to move between an open tissue receiving configuration and a closed tissue clamping configuration, in which the distal ends of the clamping arms are separated from each other and in which the distal ends of the clamping arms are moved toward each other in the closed tissue clamping configuration.

[0005] The first clamp 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 clamp arm including a first tissue retention feature extending radially inward from the first portion of the first clamp arm toward the longitudinal axis, the first tissue retention feature being configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first and second clamp arms are moved toward an open tissue receiving configuration. The first retention feature is coupled to the first portion of the first clamp arm via a first curved portion, and the second clamp arm includes a second tissue retention feature extending radially inward from the first portion of the second clamp arm toward the longitudinal axis. The second tissue retention feature is configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first and second clamp arms are moved toward the open tissue receiving configuration. The second retention feature is coupled to the first portion of the second clamp arm via a second curved portion.

[0006] In one embodiment, the first tissue retention feature includes first teeth extending radially inward from the first curved portion, and the second tissue retention feature includes second teeth 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 retention feature includes a first guard positioned and shaped to protrude from the sharp tips of the second teeth such that the sharp tips of the second teeth are proximal to the first guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the tissue clamping configuration.

[0009] In one embodiment, the second retention feature includes a second guard positioned and shaped to protrude from the sharp tips of the first teeth such that the sharp tips of the first teeth are 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 the tissue clamping configuration.

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

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

[0012] In one embodiment, the first retention feature includes a first sharpened tip extending radially inwardly therefrom, and the second retention feature includes a second sharpened tip extending radially inwardly 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 retention feature includes a first plurality of barbs extending radially inwardly therefrom, and the second retention feature includes a second plurality of barbs extending radially inwardly 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 comprises: a capsule extending longitudinally from a proximal end to a distal end and including a passage extending therethrough along a longitudinal axis; and first and second clamp arms, each extending from a proximal end to a distal end, a proximal end received within the passage of the capsule for movement between an open, tissue-receiving configuration in which distal ends of the clamp arms are separated from one another, and a closed, tissue-clamping configuration in which the distal ends of the clamp arms are moved toward one another.

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

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

[0018] In one embodiment, the first retention feature includes a first guard positioned and shaped to protrude from the sharp tips of the second teeth such that the sharp tips of the second teeth are proximal to the first guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the tissue clamping configuration.

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

[0020] In one embodiment, the second retention feature includes a second guard positioned and shaped to protrude from the sharp tips of the first teeth such that the sharp tips of the first teeth are 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 the tissue clamping configuration.

[0021] In addition, the present invention relates to a method for treating tissue, which includes: inserting a first clamp assembly into a target site in a living body through a working channel of an endoscope, the first clamp assembly including a capsule that extends longitudinally from a proximal end to a distal end and includes a channel extending therethrough along a longitudinal axis, and first and second clamp arms that are slidably received in the capsule to move between an open configuration and a closed configuration, wherein the distal ends of the clamp arms are separated from each other in the open configuration and the distal ends of the clamp arms are pulled toward each other in the closed configuration; positioning the clamp arms in contact with a first target tissue; moving the first clamp arm from the open configuration to the closed configuration so that a first tissue retention feature extending radially inward from a first portion of the first clamp arm toward the longitudinal axis and a second tissue retention feature extending radially inward from a first portion of the second clamp arm toward the longitudinal axis pierce the first target tissue; moving the first clamp arm from the closed configuration to the open configuration, wherein the first tissue retention feature releases the first target tissue while the second tissue retention feature retains the first target tissue thereon; positioning the clamp arms in contact with the second target tissue; and moving the first clamp arm from the open configuration to the closed configuration to clamp the first and second target tissues between the first and second clamp arms.

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

[0023] In one embodiment, the first retention feature includes a first guard positioned and shaped to protrude from the sharp tips of the second teeth such that the sharp tips of the second teeth are proximal to the first guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the 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 clip assembly from the applicator; and loading a second clip assembly onto the applicator by coupling a control member of the applicator to the proximal end of the clip arm. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0027] Figure 2 Shown Figure 1 Front view of the clip assembly of the clip system.

[0028] Figure 3 Shown Figure 1 A perspective view of the distal end of a clamp arm of a clamp assembly of a clamp system.

[0029] Figure 4 Shown Figure 1 A perspective view of a clip assembly of a clip system.

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

[0031] Figure 6 Shown Figure 5 Front view of the clip assembly of the clip system.

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

[0033] Figure 8 Shown Figure 7 Front view of the clip assembly of the clip system.

[0034] Figure 9 Shown Figure 7 A perspective view of the distal end of a clamp arm of a clamp assembly of a clamp system.

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

[0036] Figure 11 Shown Figure 10 Front view of the clip assembly of the clip system.

[0037] Figure 12 Shown Figure 10 A side view of the distal end of a clip arm of a clip assembly of a clip system.

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

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

[0040] Figure 15 Shown Figure 1 The third step of the method of using the clip system.

[0041] Figure 16 Shown Figure 1 The fourth step of the method of using the clip system.

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

[0043] Figure 18 Shown Figure 17 A perspective view of a clamp arm of a clamp assembly of a clamp system.

[0044] Figures 19A to 19B Shown Figure 17 A perspective view of the distal end of a clamp arm of a clamp assembly of a clamp system.

[0045] Figure 20 Shown Figure 17 A perspective view of a clip assembly of a clip system.

[0046] Figure 21A Shown Figure 17 A perspective view of the distal end of a clamp arm of a clamp assembly of a clamp system.

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

[0048] Figure 21C Shown Figure 17 Front view of the second clamp arm of the clamp assembly of the clamp system.

[0049] Figure 22 Shown Figure 17 A front view of the distal end of the clamp arm of the clamp assembly of the clamp system.

[0050] Figure 23 Shown according to Figure 17 A front view of the distal end of a clip arm of a clip assembly of another embodiment of a clip system.

[0051] Figure 24 Shown according to Figure 17 A front view of the distal end of a clip arm of a clip assembly of another embodiment of a clip system.

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

[0053] Figure 26A Shown Figure 25 A perspective view of the distal end of a clamp arm of a clamp assembly of a clamp system.

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

[0055] Figure 26C Shown Figure 25 Front view of the second clamp arm of the clamp assembly of the clamp system. DETAILED DESCRIPTION

[0056] The present invention may be further understood with reference to the following description and accompanying drawings, in which like elements are designated by like reference numerals. The present invention relates to a clamping system, and in particular to a disposable or reloadable endoscopic clamping system for treating tissue perforations, defects and / or hemorrhages. Exemplary embodiments of the present invention describe a hemostatic clip having an aggressive clamping or retaining feature 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 clamp arms having spikes, hooks, barbs, and other geometries as clamping features to allow tissue to be grasped and held by a single clamp arm. It should be noted that the terms "proximal" and "distal" as used herein are intended to refer toward (proximal) and away from (distal) a user of the device.

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

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

[0059] The first and second clamp arms 110, 112 are movable between an open tissue-receiving configuration, in which distal ends 120, 122 of the clamp arms 110, 112 are separated from each other to receive target tissue therebetween, and a closed tissue-gripping configuration in which distal ends 120, 122 of the clamp arms 110, 112 are moved toward each other to clamp target tissue therebetween. The clamp arms 110, 112 are movable between the open and closed configurations 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 on a handle positioned external to the body. In this embodiment, the distal end of the control member 108 is coupled to the proximal ends of the clamp arms 110, 112.

[0060] like Figure 1 As further shown, the clamp arms 110, 112 according to an exemplary embodiment of the present invention extend from proximal ends (not shown) to distal ends 120, 122. As will be appreciated by those skilled in the art, 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 one another to receive tissue. That is, the arms 110, 112 are configured to spring open to the tissue-receiving position when they are moved distally out of the confines of the capsule 116. However, as will be appreciated by those skilled in the art, the clamp assembly 102 may include a separate component that, in addition to or in lieu of this bias, urges the clamp arms 110, 112 away from one another.

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

[0062] As described above, the clamp arms 110, 112 are biased toward the open configuration such that when the clamp arms 110, 112 are moved distally past the distal end 126 of the capsule 116, the distal ends 120, 122 of the clamp arms 110, 112 separate from each other to the open configuration. When the clamp arms 110, 112 are drawn proximally into the capsule 116, contact with the capsule 116 pulls the clamp arms 110, 112 toward each other to the closed configuration. Upon deployment, the clamp 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 clamp arms 110, 112 are moved between the open and closed configurations via the control member 108, which is moved proximally and distally relative to the capsule 116 via an actuator at the handle, which is retained outside the body.

[0063] In an exemplary embodiment, one or both of the clamp arms 110, 112 may include a spike 128 extending from the inner side of the distal tip 130 of the clamp arms 110, 112. Figures 2 to 3 As shown, the first clamp arm 110 has a single spike 128, while the second clamp arm 112 has two spikes 128. The spikes 128 extend radially inwardly from the inner surfaces of the clamp arms 110, 112 substantially perpendicularly toward the other of the clamp arms 110, 112.

[0064] In an exemplary embodiment, staples 128 are designed to penetrate or at least engage tissue such that tension in the tissue (from pulling it through the defect) creates more engagement between staples 128 and the tissue. For example, a fishhook shape demonstrates this engagement once the tissue has been penetrated: applying additional force in the same direction pushes the tissue further up on the hook, and the direction of the force must be reversed to remove the hook.

[0065] like Figure 3 As can be seen in FIG, the pins 128 on the opposing arms 110, 112 are longitudinally offset from one another so that they do not prevent the clamp arms 110, 112 from completely closing around the tissue defect. Figure 3 As shown, when the clip assembly 102 is in the closed configuration, the spike 128 of the first clip arm 110 is positioned distally or proximally of the two spikes 128 on the second clip arm 112. Figure 4 As shown, the pegs of the first and second clamp arms 110 , 112 are laterally offset from one another such that the pegs 128 of the first clamp arm 110 are received between the pegs 128 of the second clamp arm 112 without any interference.

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

[0067] As will be appreciated by those skilled in the art, the spikes 128 are sharp enough to penetrate tissue and become lodged therein. In one embodiment, the spikes 128 of the second clamp arm 112 are angled more deeply relative to the rest of the clamp arm 112 so that when the clamp assembly 102 is moved to the open configuration to capture another portion of tissue, the spikes 128 remain lodged within the target tissue. Specifically, the spikes 128 can also extend from the inner surface of the clamp arm 112 at various angles between 20 and 90 degrees relative to the longitudinal axis L of the clamp arm 112 to allow the spikes 128 to continue to grip tissue when the clamp arms 110, 112 are in the open configuration.

[0068] In use, the operator will orient the clamp arms 110, 112 so 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 will close the clamp assembly 102 on the edge of the tissue defect, and the staples 128 will pierce the mucosal layer to retain the tissue inside the clamp arms 110, 112. When the clamp assembly 102 is dragged to the opposite edge of the tissue defect and gently reopened, the tissue flap will remain hooked to the second clamp arm 112 but released from the first arm 110. That is, the direction of the force of the first clamp arm 110 is reversed, causing the tissue to release from the first clamp arm 110 while being retained by the second clamp arm 112.

[0069] The first clamp arm 110 can then be used to pull the opposing edges of the defect inside the clip assembly 102. The staples 128 on the two jaws 110, 112 will ensure that the edges of the defect are securely captured and do not slip out when the clip is closed and deployed. When the two opposing edges of the tissue defect are connected by the clip assembly 102, the clip assembly 102 can be released from the applicator 104 and additional clips can be placed along the tissue defect to complete the closure, as described in further detail below.

[0070] In another exemplary embodiment, 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 clamp arms 210, 212. In this embodiment, the clamp arms 210, 212 use a combination of hooks and staples to hold a first tissue edge on one arm while simultaneously dragging a second tissue edge toward the first edge with the second arm. Specifically, as shown in FIG. Figure 5 As shown, the first arm 210 includes two spikes 228, similar to the spikes 128 of the clip assembly 102, extending radially inwardly from the inner surface of the clip arm 210 substantially perpendicularly toward the second clip arm 212. The second arm 212 has a hooked distal end 222 with a sharp distal-most tip 230 configured to penetrate tissue and retain the tissue thereon.

[0071] In an exemplary embodiment, the distal tip 230 is angled 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 can be bent rearwardly 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 penetrated the tissue defect. In another example, the distal end 222 can 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 more easily penetrated by the distal tip 230.

[0072] In use, as discussed above, the hooked distal end 222 of the second clamp arm 212 is designed to adhere to tissue and hold a first edge of the tissue defect within the clamp arms 210, 212, while the spike 228 of the first clamp arm 210 is designed to release the first edge of the tissue defect and pull in an opposing 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, Figures 7 to 9 As shown, system 300 is substantially identical to systems 100 and 200, except as described herein. System 300 includes a clamp assembly 302 having first and second clamp arms 310 and 312. In this embodiment, first clamp arm 310 includes one or more barbs 332 attached to an inner surface 334 of a distal portion of first clamp arm 310. Barbed clamp arms are particularly effective if the operator can force the barbed arms to lie flat against the target tissue. This positioning of the arms flat against the tissue allows each of the barbs 332 to penetrate the submucosal tissue layer and force the tissue to remain attached to the clamp arm even under high tension.

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

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

[0076] In addition to pins, hooks, and barbs, other geometries may be used to improve the attachment of the clamp arm to the target tissue defect. For example, in another exemplary embodiment, as Figures 10 to 12 The clip assembly 402 of the illustrated clip system 400 includes a tine 440 located at the distal tip 430 of at least one of the first and second clip arms 410, 412. Figures 11 to 12 As shown, the first clamping arm 410 includes three teeth 440 located at 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 will be understood by those skilled in the art. The teeth 440 have sharp tips to allow for tissue penetration and retention. Additionally, the distal tip 430 of the first clamping arm 410 may be angled approximately 90 degrees relative to the remainder of the clamping arm 410 to allow for tissue retention when the clamping arms 410, 412 are reopened.

[0077] The method of using the system 100 according to an exemplary embodiment is Figures 13 to 16Initially, the clip assembly 102 is inserted through a working channel of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body cavity) to a location adjacent to a target defect 10 of tissue to be clamped closed. The clip assembly 102 is inserted into the target tissue in a closed configuration to facilitate its passage through the working channel. Upon reaching the location of the target tissue defect, the clip assembly 102 is pushed out of the distal end of the working channel of the endoscope and the clamp arms 110, 112 are extended out of the capsule 116 to move the clamp arms 110, 112 to an open, tissue-receiving configuration.

[0078] Once the first edge 12 of the target tissue of the tissue defect has been received between the clamp arms 110, 112, the clamp arms 110, 112 are moved toward the closed configuration, causing the staples 128 to pierce the first edge 12 of the tissue defect, thereby clamping the first edge 12 between the distal ends of the clamp arms 110, 112. The clamp arms 110, 112 are moved toward the tissue-clamping configuration by pulling the control member proximally relative to the balloon 116. Once the clamp 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 clamp assembly 102. When the first and second edges 12, 14 of the tissue defect are adjacent to each other, the clamp arms 110, 112 are gently reopened. When the clamp arms 110, 112 reopen, the first arm 110 releases the first edge 12 of the tissue defect, but the two staples 128 of the second clamp arm 112 retain the first edge 12 attached to the second clamp arm 112. The clamp arms 110, 112 are then reclosed over the two edges 12, 14 of the tissue defect, and the first clip assembly 102 is deployed via the actuator from the applier 104. Additional clip assemblies 102 may be placed along the tissue edges to close the defect.

[0079] In another exemplary embodiment, 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 clamp arms 510, 512. Figure 17 As shown, the clamp assembly 502 is configured such that when the target tissue 10 is treated in a substantially vertical approach (i.e., a approach in which 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 ends of the clamp arms when in the open tissue receiving configuration extend at a predetermined angle relative to the surface of the tissue 10, as will be described in more detail below.

[0080] As will be appreciated by those skilled in the art, although Figure 17Surface tissue 10 is shown as being substantially planar, but with the planes perpendicular to the angle of approach of the clamps of system 500 being arranged to illustrate the configuration of the various components of system 500, which can be used to clamp tissue having any of a variety of shapes of tissue surfaces from any desired angle of approach.

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

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

[0083] As described above, the first and second clamping arms 510, 512 separate from each other when released to move into the open tissue receiving configuration such that each forms an angle δ with respect to the axis L, which in this embodiment 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 so that the axis L is perpendicular to the surface of the tissue 10 in the open tissue receiving configuration, the first clamp 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 FIG. 5 , the first clamp arm 510 forms a positive angle β (eg, 20°) relative to the surface of the tissue 10, and Figure 19B In the embodiment shown in FIG. 5 , the clamping arm 510 forms a negative angle β (eg, −20°) relative to the surface of the tissue 10 .

[0084] Additionally, if Figure 20 As seen in FIG. 5 , the clamp 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 will be appreciated by those skilled in the art, the angles α, β, and δ are proportionally related to one another. Furthermore, in this embodiment, the first and second clamp arms 510, 512 are formed as substantially mirror images of one another with respect to the angles α, β, and δ. However, as will be appreciated by those skilled in the art, any of these angles may vary from one clamp arm to another within the exemplary ranges as desired.

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

[0086] like Figures 21A to 21CAs shown, the retaining features 518, 520 in this embodiment correspond to each other so that when they are pulled together into the tissue clamping configuration, each of the teeth of the first clamping arm 510 faces a correspondingly sized gap between the teeth of the second clamping arm 512 so that they 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 engaged tissue. In the 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 shown in FIG. Figure 21B shown.

[0087] With respect to the retention feature 518, the first tooth 518a is positioned near the first lateral edge 521a of the clamp arm 510, while the second tooth 518b is positioned more centrally and separated from the first tooth 518a by a first gap 525. The first gap 525 has a width (in a direction transverse to the sharpened tip from the first lateral edge to the second lateral edge of the corresponding clamp arm) that substantially corresponds to the width of the second sharpened tip 524b of the clamp arm 512. The second tooth 518b is spaced apart from the second lateral edge 521b by a distance that substantially corresponds to the width of the first sharpened tip 524a of the second clamp arm 512. The retention feature 518 also includes a first circular protrusion 526 adjacent to the second tooth 518b. The first protrusion 526 serves as a guard for the first sharpened tip 524a. The first protrusion 526 extends distally from the curved portion 514 for a portion of the length of the second tooth 518b.

[0088] Similar to the retaining feature 518, the retaining feature 520 includes a first tooth 520a having a first sharp tip 524a and a second tooth 520b having a second sharp tip 522b. Figure 21C As shown. With respect to retention feature 520, first tooth 520a is positioned near first lateral edge 523a of clamp arm 512, while second tooth 520b is positioned more centrally, separated from first tooth 520 by gap 527 having a width substantially corresponding to the width of second sharpened tip 522b of first clamp arm 510. Second tooth 520b is spaced apart from second lateral edge 523b by a distance substantially corresponding to the width of first sharpened tip 522a of first clamp arm 510. Retention feature 520 also includes a second circular protrusion 528 adjacent to second tooth 520b, which serves as a guard for first sharpened tip 522a. Second protrusion 528 extends distally from curved portion 516 for a portion of the length of second tooth 520b.

[0089] As will be appreciated by those skilled in the art, the width of the first clamp 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 clamp arm 512 (i.e., the distance from the first lateral edge 523a to the second lateral edge 523b) such that the teeth of one of the clamp arms are always guarded by the opposing clamp arm. That is, where the number of teeth in one of the clamp arms is the same as the number of teeth on the opposing arm, or, as herein, where the teeth are positioned off-center of the clamp arms, the distal portion of each clamp arm will have a width selected to extend laterally in the closed configuration at least the distance required to guard all of the teeth of the opposing clamp arm.

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

[0091] The sharpness of the retaining features 518, 520 is determined by the sharp tips 522, 524. In the exemplary embodiment, the sharp tips 522, 524 are generally triangular in shape. Figure 22 As shown, the second tooth 518b and the second sharp tip 522b are substantially similar to the first tooth 518a and the first sharp tip 522a. The sharpness of the first tooth 518a (as well as 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 will be understood by those skilled in the art, the length V of the first sharp tip 522a is a fraction of the length T of the tooth 518a. The first ratio (T / W) is expressed as the ratio of the length T to the width W.

[0092] The first ratio in this embodiment has an exemplary range of 0.5 to 6, however, a preferred range is between 2 and 4. In addition, the sharpness of the tooth 518a can be expressed as a second ratio between the width W and the length V, and 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 the length V to the 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 shape of the sharp tips 522, 524 is triangular, however, the sharp tips 522, 524 can have various other shapes (e.g., circular, rectangular, etc.), such as Figure 23 In addition, as Figure 24 As shown, the retaining features 518, 520 may be formed as a plurality of barbs 532a, 532b rather than sharp tips 522, 524. It should be noted that while these embodiments include two teeth on each clamp arm, the number of teeth per clamp arm may vary as desired.

[0093] In another exemplary embodiment, 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 clamp arms 610, 612. Figure 25 As shown, the first clamp arm 610 has a curved portion 614 and a first tissue-retaining feature 618 extending distally therefrom. Similarly, the second clamp arm 612 has a curved portion 616 and a second tissue-retaining feature 620 extending distally therefrom. The retaining features 618, 620 are configured to grasp the target tissue therebetween when the clamp assembly 602 is moved into the closed configuration.

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

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

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

[0097] In an exemplary embodiment, the retaining feature 618 includes a single tooth 618a having a single sharp tip 622a, as shown in FIG. Figure 26B For the retaining feature 618 in this embodiment, the tooth 618a is centrally located 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 that serves as a guard to protect the second sharp tip 624b of the clamping arm 612, and a second circular protrusion 628 that serves as a guard to protect the first sharp tip 624a of the second clamping arm 612.

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

[0099] In an exemplary embodiment, the retention feature 620 includes a first tooth 620a having a first sharp tip 624a and a second tooth 620b having a second sharp tip 624b. Figure 26C As shown in FIG. 6 , the first tooth 620 a is positioned near the first lateral edge 623 a of the second clamping arm 612 , while the second tooth 620 b is positioned near the second lateral edge 623 b of the second clamping arm 612 . The first tooth 620 a and the second tooth 620 b are separated from each other by a gap 625 having a width that substantially corresponds to the width of the sharp tip 622 a of the first clamping arm 610 .

[0100] As will be appreciated by those skilled in the art, the width of the first clamp 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 clamp arm 612 (i.e., the distance from the first lateral edge 623a to the second lateral edge 623b), such that the teeth of one of the clamp arms are always shielded by the opposing clamp arm. That is, in situations where the number of teeth in one clamp arm is less than the number of teeth on the opposing arm, or as herein, where the teeth are positioned off-center in the clamp arms, the distal portion of each clamp arm will have a width selected to extend laterally at least the distance required to shield all teeth of the opposing clamp arm in the closed configuration. This configuration allows the sharp tip 624a to be received beneath the second protruding portion 628 in the closed configuration, preventing the sharp tip 624a from extending beyond the first clamp arm 610.

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

[0102] As will be understood by those skilled in the art, although these embodiments include a clamp arm with one tooth and a clamp arm with two teeth, each of the clamp arms can have any number of teeth, as long as the number of teeth on each clamp arm 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-described embodiments without departing from the concepts of the present invention. It should also be understood that structural features and methods associated with one embodiment can be incorporated into other embodiments.

[0103] Therefore, it is to be understood that this invention is not to be limited to the particular embodiments disclosed but modifications are intended to be included within the scope of the present invention as defined by the appended claims.

Claims

1. A device for treating tissue, comprising: a balloon extending longitudinally from a proximal end to a distal end and including a passage extending therethrough along a longitudinal axis; as well as a first clamp arm and a second clamp arm, each extending from a proximal end to a distal end, the proximal ends being received within the passageway of the balloon for movement between an open tissue-receiving configuration in which the distal ends of the first clamp arm and the second clamp arm are separated from each other, and a closed tissue-clamping configuration in which the distal ends of the first clamp arm and the second clamp arm are moved toward each other, 18. The foldable clamping device of claim 17, wherein the first clamping arm and the second clamping arm are configured to extend radially inwardly from the first portion of the second clamping arm toward the longitudinal axis in the tissue clamping configuration, the first clamping arm comprising a first tissue retaining feature extending radially inwardly from the first portion of the first clamping arm toward the longitudinal axis, the first tissue retaining feature being configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first clamping arm and the second clamping arm are moved toward the open tissue receiving configuration, the first tissue retaining feature being coupled to the first portion of the first clamping arm via a first curved portion, and the second clamping arm comprising a second tissue retaining feature extending radially inwardly from the first portion of the second clamping arm toward the longitudinal axis, the second tissue retaining feature being configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first clamping arm and the second clamping arm are moved toward the open tissue receiving configuration, wherein the first tissue retention feature comprises first teeth extending radially inward from the first curved portion, and the second tissue retention feature comprises second teeth extending radially inward from the second curved portion toward the longitudinal axis; and The first tissue retention feature includes a first guard positioned and shaped to protrude from the sharp tips of the second teeth such that the sharp tips of the second teeth are proximal to the first guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the tissue clamping configuration.

2. The device of claim 1, wherein the first tissue retention feature has a different number of teeth than the second tissue retention feature.

3. The device of claim 1 , wherein the second tissue retention feature comprises a second guard positioned and shaped to protrude from the sharp tip of the first tooth such that the sharp tip of the first tooth is proximal to the second guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the tissue clamping configuration.

4. The device of any one of claims 1 to 3, wherein the first tissue retention feature extends at a first angle of 30 to 100 degrees relative to the first portion of the first clamp arm, and the second tissue retention feature extends at a second angle of 30 to 100 degrees relative to the first portion of the second clamp arm. The device of claim 4 , wherein the first angle is equal to the second angle.

6. The device of any one of claims 1 to 3, wherein the first tissue retention feature comprises a first sharpened tip extending radially inwardly therefrom, and the second tissue retention feature comprises a second sharpened tip extending radially inwardly therefrom. 7 . The device of claim 6 , wherein the shape of the first sharp tip and the second sharp tip is one of a triangle, a circle, or a rectangle.

8. The device of any one of claims 1 to 3, wherein the first tissue retention feature comprises a first plurality of barbs extending radially inwardly therefrom, and the second tissue retention feature comprises a second plurality of barbs extending radially inwardly therefrom.

9. A reloadable clip system comprising: an applicator comprising 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; at least one clip assembly coupled to the applicator, each clip assembly comprising: a balloon extending longitudinally from a proximal end to a distal end and including a passage extending therethrough along a longitudinal axis; and a first clamp arm and a second clamp arm, each extending from a proximal end to a distal end, the proximal ends being received within the passageway of the balloon for movement between an open tissue-receiving configuration and a closed tissue-clamping configuration, wherein the distal ends of the first and second clamp arms are separated from each other in the open tissue-receiving configuration and the distal ends of the first and second clamp arms are moved toward each other in the closed tissue-clamping configuration, 18. The foldable clamping device of claim 17, wherein the first clamping arm and the second clamping arm are configured to extend radially inwardly from the first portion of the second clamping arm toward the longitudinal axis in the tissue clamping configuration, the first clamping arm comprising a first tissue retaining feature extending radially inwardly from the first portion of the first clamping arm toward the longitudinal axis, the first tissue retaining feature being configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first clamping arm and the second clamping arm are moved toward the open tissue receiving configuration, the first tissue retaining feature being coupled to the first portion of the first clamping arm via a first curved portion, and wherein the second clamping arm comprises a second tissue retaining feature extending radially inwardly from the first portion of the second clamping arm toward the longitudinal axis, the second tissue retaining feature being configured to clamp target tissue when in the tissue clamping configuration and subsequently release the target tissue when the first clamping arm and the second clamping arm are moved toward the open tissue receiving configuration, wherein the first tissue retention feature comprises first teeth extending radially inward from the first curved portion, and the second tissue retention feature comprises second teeth extending radially inward from the second curved portion toward the longitudinal axis; and The first tissue retention feature includes a first guard positioned and shaped to protrude from the sharp tips of the second teeth such that the sharp tips of the second teeth are proximal to the first guard and closer to the longitudinal axis than lateral edges of the first and second clamping arms when the first and second clamping arms are in the tissue clamping configuration.

10. The system of claim 9, wherein the first tissue retention feature extends at a first angle of 30 to 100 degrees relative to the first portion of the first clamp arm, and the second tissue retention feature extends at a second angle of 30 to 100 degrees relative to the first portion of the second clamp arm.

11. The system of any one of claims 9 to 10, wherein the second tissue retention feature comprises a second guard positioned and shaped to protrude from the sharp tip of the first tooth such that the sharp tip of the first tooth is proximal to the second guard and closer to the longitudinal axis than lateral edges of the first and second clamp arms when the first and second clamp arms are in the tissue clamping configuration.

Images