Systems and devices for treating tissue - Patents.com

Abstract

To provide improvement in a device, a system and a method for treating a tissue.SOLUTION: A tissue treating device includes a capsule and first and second clip arms each having a proximal end received within the capsule for a movement between an open configuration and a closed configuration. A tissue retention feature extends radially inward from each arm to grip a tissue in a tissue clipping configuration and release the tissue in the open configuration. Retention features are coupled to the arms via curved portions. The second clip arm includes a second tissue retention feature extending radially inward from a first portion of the second clip arm toward a longitudinal axis line.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to devices, systems and methods for treating tissue. In particular, the present disclosure relates to compression clips, systems and methods for delivering the clips through an endoscope to a target site to effect hemostasis of blood vessels along the gastrointestinal tract. [Background technology]

[0002] Pathologies of the gastrointestinal (GI) tract, biliary system, vasculature, and other body lumens and hollow organs are often treated by endoscopic surgery, many of which require hemostasis to control bleeding. Hemostatic clips capture tissue around the wound and temporarily hold the wound edges together allowing the natural healing process to permanently close the wound. Certain endoscopic clipping devices are used to deliver the clip to a desired location within the body, after which the clip delivery device is withdrawn leaving the clip within the body. In addition to providing hemostasis, endoscopic clipping devices may be used to provide, for example, endoscopic marking and closure of luminal perforations by endoscopic procedures that require access to medial tissue, for example, by passing the device through the wall of a natural body lumen.

[0003] The clip opening width usually determines the maximum size of the wound that can potentially be closed. Several advanced closure techniques have been developed that often require the additional use of snares, "8-rings" or other devices to close wounds larger than the maximum clip opening width. As an alternative to these advanced and technically challenging methods, a novel technique for wound closure uses a technique colloquially known as "hold and pull" that allows for large wounds to be closed using only traditional clips. This technique simplifies the closure of large wounds and reduces the time required for surgery. However, the biggest challenge in using this technique is the high risk of tissue coming out if the clip reopens. As a result, it is not uncommon that multiple attempts are required to successfully close the wound when applying this technique. Summary of the Invention

[0004] The present disclosure relates to an apparatus for treating tissue including a capsule extending longitudinally from a proximal end to a distal end 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 ends being received within the channel of the capsule and moved between an open, tissue-receiving configuration in which the distal ends of the clip arms are spaced apart from one another and a closed, tissue-clipping configuration in which the distal ends of the clip arms are moved towards one another.

[0005] The first clip arm includes a first portion extending substantially parallel to the first portion of the second arm and parallel to the longitudinal axis in the tissue clipping configuration, the first clip arm including a first tissue retaining structure extending radially inward from the first portion of the first clip arm toward the longitudinal axis, the first tissue retaining structure configured to grip the target tissue in the tissue clipping configuration and subsequently release the target tissue when the first and second clip arms are moved to the open, tissue receiving configuration. The first retaining structure is coupled to the first portion of the first clip arm by a first curved portion, and the second clip arm includes a second tissue retaining structure extending radially inward from the first portion of the second clip arm toward the longitudinal axis. The second tissue retaining structure is configured to grip the target tissue in the tissue clipping configuration and subsequently release the target tissue when the first and second clip arms are moved to the open, tissue receiving configuration. The second retaining structure is coupled to the first portion of the second clip arm by a second curved portion.

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

[0007] In an embodiment, the first retaining structure has a different number of teeth than the number of teeth of the second retaining structure. In an embodiment, the first retention structure includes a first guard positioned and configured to overlie a sharp tip of the second tine, the sharp tip of the second tine being proximal to the first guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than the outer edges of the first and second clip arms.

[0008] In an embodiment, the second retention structure includes a second guard positioned and configured to overlie the sharp tip of the first tine, the sharp tip of the first tine being proximal to the second guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than the outer edges of the first and second clip arms.

[0009] In an embodiment, the first retaining structure extends at a first angle of between 30 degrees and 100 degrees relative to the first portion of the first clip arm, and the second retaining structure extends at a second angle of between 30 degrees and 100 degrees relative to the first portion of the second clip arm.

[0010] In an embodiment, the first angle is equal to the second angle. In an embodiment, the first retention structure includes a first prong extending radially inward therefrom and the second retention structure includes a second prong extending radially inward therefrom.

[0011] In an embodiment, the first and second prongs are one of a triangular, circular, or rectangular shape. In an embodiment, the first retention structure includes a first plurality of barbs extending radially inward therefrom, and the second retention structure includes a second plurality of barbs extending radially inward therefrom.

[0012] The present disclosure also relates to a reloadable clip system including a catheter and an applicator including a control member extending therethrough, the control member extending from a proximal end to a distal end and longitudinally movable relative to the applicator, and at least one clip assembly coupled to the applicator, each clip assembly including a capsule extending longitudinally from a proximal end to a distal end, the capsule including a channel extending through the capsule along a longitudinal axis, and first and second clip arms, each clip arm extending from a proximal end to a distal end, the proximal ends being received within the channels of the capsule and moved between an open, tissue-receiving configuration in which the distal ends of the clip arms are spaced apart from one another, and a closed, tissue-clipping configuration in which the distal ends of the clip arms are moved towards one another.

[0013] The first clip arm includes a first portion extending substantially parallel to the first portion of the second arm and parallel to the longitudinal axis in the tissue clipping configuration, the first clip arm including a first tissue retaining structure extending radially inward from the first portion of the first clip arm toward the longitudinal axis. The first tissue retaining structure is configured to grip the target tissue when in the tissue clipping configuration and subsequently release the target tissue when the first and second clip arms are moved to the open, tissue receiving configuration, the first retaining structure is coupled to the first portion of the first clip arm by a first curved portion, and the second clip arm includes a second tissue retaining structure extending radially inward from the first portion of the second clip arm toward the longitudinal axis. The second tissue retaining structure is configured to grip the target tissue when in the tissue clipping configuration and subsequently release the target tissue when the first and second clip arms are moved to the open, tissue receiving configuration. The second retaining structure is coupled to the first portion of the second clip arm by a second curved portion.

[0014] In an embodiment, the first tissue retaining structure includes a first tooth extending radially inward from the first curved portion and the second tissue retaining structure includes a second tooth extending radially inward from the second curved portion toward the longitudinal axis.

[0015] In an embodiment, the first retention structure includes a first guard positioned and configured to overlie the sharp tip of the second tine such that the sharp tip of the second tine is proximal to the first guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than the outer edges of the first and second clip arms.

[0016] In an embodiment, the first retaining structure extends at a first angle of between 30 degrees and 100 degrees relative to the first portion of the first clip arm, and the second retaining structure extends at a second angle of between 30 degrees and 100 degrees relative to the first portion of the second clip arm.

[0017] In an embodiment, the second retention structure includes a second guard positioned and configured to overlie the sharp tip of the first tine, the sharp tip of the first tine being proximal to the second guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than the outer edges of the first and second clip arms.

[0018] Additionally, the present disclosure relates to a method for treating tissue comprising inserting a first clip assembly via a working channel of an endoscope to a target location within a living body, the first clip assembly including a capsule extending longitudinally from a proximal end to a distal end including a channel extending therethrough along a longitudinal axis, and first and second clip arms slidably received within the capsule, the first and second clip arms movable between an open configuration in which the distal ends of the clip arms are spaced apart from one another and a closed configuration in which the distal ends of the clip arms are drawn towards one another, positioning the clip arms against a first target tissue, and pressing the first clip arm against the first target tissue. moving the first clip assembly from an open configuration to a closed configuration such that a first tissue retaining structure extending radially inward toward the longitudinal axis from the first portion of the clip arm and a second tissue retaining structure extending radially inward toward the longitudinal axis from the first portion of the second clip arm penetrate the first target tissue, moving the first clip assembly from the closed configuration to the open configuration such that the first tissue retaining structure releases the first target tissue while the second tissue retaining structure holds the first target tissue thereon, positioning the clip arms against the second target tissue, and moving the first clip assembly from the open configuration to the closed configuration such that the first and second target tissues are clipped between the first and second clip arms.

[0019] In an embodiment, the first tissue retaining structure includes a first tooth extending radially inward from a first curved portion connecting the first retaining structure to the first portion of the first clip arm, and the second tissue retaining structure includes a second tooth extending radially inward toward the longitudinal axis from a second curved portion connecting the second retaining structure to the first portion of the second clip arm.

[0020] In an embodiment, the first retention structure includes a first guard positioned and configured to overlie the sharp tip of the second tine such that the sharp tip of the second tine is proximal to the first guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than the outer edges of the first and second clip arms.

[0021] In an embodiment, the method further includes mounting the first clip assembly on the applicator by coupling a control member of the applicator to a proximal end of the clip arm. In embodiments, the method further includes releasing the clip assembly from the applicator and mounting a second clip assembly onto the applicator by coupling a control member of the applicator to a proximal end of the clip arm. [Brief description of the drawings]

[0022] [Figure 1] 1 illustrates a top view of a clip system according to an exemplary embodiment of the present disclosure. [Diagram 2] FIG. 2 shows a front view of a clip assembly in the clip system of FIG. 1; [Diagram 3] 2 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 1; [Figure 4] FIG. 2 shows a perspective view of a clip assembly in the clip system of FIG. 1; [Diagram 5] 1 illustrates a top view of a clip system according to a second exemplary embodiment of the present disclosure. [Figure 6] 6 shows a front view of the clip assembly in the clip system of FIG. 5. [Figure 7] 13 illustrates a top view of a clip system according to a third exemplary embodiment of the present disclosure. [Figure 8] 8 shows a front view of the clip assembly in the clip system of FIG. 7. [Figure 9] 8 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 7. [Figure 10] 13 illustrates a top view of a clip system according to a fourth exemplary embodiment of the present disclosure. [Figure 11] 11 shows a front view of the clip assembly in the clip system of FIG. 10. [Figure 12]11 shows a side view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 10. [Figure 13] 2 shows a first step in a method of using the clip system of FIG. 1. [Figure 14] 2 shows a second step in a method of using the clip system of FIG. 1; [Figure 15] 3 shows a third step in the method of using the clip system of FIG. 1 . [Figure 16] 4 shows a fourth step in the method of using the clip system of FIG. 1 . [Figure 17] 13 illustrates a top view of a clip system according to a fifth exemplary embodiment of the present disclosure. [Figure 18] 18 shows a perspective view of a clip arm of a clip assembly in the clip system of FIG. 17. [Figure 19A] 18 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 17. [Figure 19B] 18 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 17. [Figure 20] 18 shows a perspective view of a clip assembly in the clip system of FIG. 17. [Figure 21A] 18 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 17. [Figure 21B] 18 shows a front view of a first clip arm of a clip assembly in the clip system of FIG. 17. [Figure 21C] 18 shows a front view of a second clip arm of the clip assembly in the clip system of FIG. 17. [Figure 22] 18 shows a front view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 17. [Diagram 23] 18 shows a front view of a distal end of a clip arm of a clip assembly according to a further embodiment of the clip system of FIG. 17. [Figure 24]18 shows a front view of a distal end of a clip arm of a clip assembly according to a further embodiment of the clip system of FIG. 17. [Diagram 25] 13 illustrates a top view of a clip system according to a sixth exemplary embodiment of the present disclosure. [Figure 26A] 26 shows a perspective view of a distal end of a clip arm of a clip assembly in the clip system of FIG. 25. [Figure 26B] 26 shows a front view of a first clip arm of the clip assembly in the clip system of FIG. 25. [Figure 26C] 26 shows a front view of a second clip arm of the clip assembly in the clip system of FIG. 25. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. The present disclosure relates to a clipping system, and in particular to a disposable or reloadable endoscopic clipping system for treating tissue perforations, wounds, and / or bleeding. Exemplary embodiments of the present disclosure describe hemostatic clips having positive gripping or holding structures for improving attachment to target tissue when the clip is in at least a partially open configuration. In particular, exemplary embodiments describe hemostatic clips having clip arms with spikes, hooks, barbs, and other shapes as gripping structures to enable capturing and holding tissue by a single clip arm. It is noted that the terms "proximal" and "distal" as used herein are intended to indicate toward (proximal) and away from (distal) the user of the device.

[0024] 1, a system 100 according to an exemplary embodiment of the present disclosure includes a clip assembly 102 that is insertable within a living body, for example through a working channel of an endoscope to a target tissue to be treated. The clip assembly 102 is sufficiently flexible to allow the clip assembly 102 to travel a tortuous path through the body, for example through the working channel of a flexible endoscope inserted through a natural body lumen accessed via a natural body orifice.

[0025] In an exemplary embodiment, the clip assembly 102 can be loaded onto a distal portion of the applicator 104 prior to inserting the clip assembly 102 into the living body for clipping of the target tissue. The applicator 104 and clip assembly 102 are configured such that a new clip assembly 102 can be loaded onto the applicator 104 after placing the clip assembly 102 in the living body, such that the same applicator 104 may be used to deliver a new clip 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 clip assembly 102 includes first and second clip arms 110, 112 that are slidably received within a longitudinal channel 114 of a capsule 116.

[0026] The first and second clip arms 110, 112 are movable between an open, tissue-receiving configuration in which the distal ends 120, 122 of the clip arms 110, 112 are spaced apart from one another to receive target tissue therebetween, and a closed, tissue-grasping configuration in which the distal ends 120, 122 of the clip arms 110, 112 are moved toward one another to grasp target tissue therebetween. The clip arms 110, 112 are movable between the open and closed configurations by a control member 108 that extends into the capsule 116. A proximal end (not shown) of the control member 108 is coupled to an actuator on a handle that is disposed outside the human body. In this embodiment, the distal end of the control member 108 is coupled to the proximal ends of the clip arms 110, 112.

[0027] 1, clip arms 110, 112 according to an exemplary embodiment of the present disclosure extend from a proximal end (not shown) to distal ends 120, 122. As one of ordinary skill in the art would appreciate, the arms 110, 112 in this embodiment are biased toward an open, tissue-receiving position in which the distal ends 120, 122 are spaced apart 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 can be appreciated by one of ordinary skill in the art, the clip assembly 102 may include a spacing member that additionally or alternatively biases the clip arms 110, 112 apart from one another.

[0028] In an exemplary embodiment, the clip arms 110, 112 may include locking tabs (not shown) at the proximal ends of the clip arms 110, 112 for engaging distal components within the capsule 116 when the clip assembly 102 is deployed. The locking tabs (not shown) may form a mechanical lock with a window formed on the side of the capsule 116 after the clip is deployed. However, one of ordinary skill in the art will appreciate that any of a variety of known mechanisms for releasably coupling the clip assembly 102 (e.g., a capsule including clip arms) to an insertion device may be used without departing from the scope of the present invention.

[0029] As shown above, the clip arms 110, 112 are biased toward the open configuration such that the distal ends 120, 122 of the clip arms 110, 112 are spaced apart from one another into the open configuration when the clip arms 110, 112 are moved distally beyond the distal end 126 of the capsule 116. When the clip arms 110, 112 are drawn proximally into the capsule 116, contact with the capsule 116 draws the clip arms 110, 112 toward one another into the closed configuration. Once deployed, as will be understood by one of ordinary skill in the art, the clip arms 110, 112 are secured within the capsule 116 which retains the clip arms 110, 112 in the closed position. As described above, the clip arms 110, 112 are moved between the open and closed configurations by a control member 108 which is moved proximally and distally relative to the capsule 116 by an actuator at a handle held outside the body.

[0030] In an exemplary embodiment, one or both of the clip arms 110, 112 may include a spike 128 extending from an inner side of a distal end 130 of the clip arm 110, 112. As shown in Figures 2-3, the first clip arm 110 has one spike 128 while the second clip arm 112 has two spikes 128. The spikes 128 extend substantially perpendicularly from the inner surface of the clip arm 110, 112 radially inward toward the other of the clip arms 110, 112.

[0031] In typical embodiments, spike 128 is designed to penetrate or at least engage tissue such that tension in the tissue (by pulling the tissue across the wound) creates further engagement between spike 128 and the tissue. For example, a fish hook type will exhibit engagement once it has penetrated the tissue. Applying additional force in the same direction will force the tissue further up the hook, and the direction of the force must be reversed to disengage the hook.

[0032] As seen in Fig. 3, the spikes 128 on the opposing arms 110, 112 are offset from one another longitudinally so that the spikes 128 do not impede complete closure of the clip arms 110, 112 about the tissue wound. For example, as shown in Fig. 3, the spike 128 of the first clip arm 110 is disposed either distal or proximal to the two spikes 128 on the second clip arm 112 when the clip assembly 102 is in the closed configuration. Additionally, as shown in Fig. 4, the spikes of the first and second clip arms 110, 112 are offset from one another laterally so that the spike 128 of the first clip arm 110 is received between the spikes 128 of the second clip arm 112 without any interference.

[0033] In alternative embodiments, the spikes 128 are configured to extend in different planes and are received by the opposing arms without interference from the spikes 128 of the other arm. For example, the spike 128 of the first clip arm 110 is positioned to fit between two spikes 128 of the second clip arm 112 when the clip assembly 102 is in the closed configuration. In another embodiment, both spikes 128 are configured to extend in substantially the same plane such that the ends of the spikes 128 from the opposing arms 110, 112 contact each other when the arms 110, 112 are in the closed configuration.

[0034] As will be appreciated by one of ordinary skill in the art, the spikes 128 are sufficiently sharp to penetrate tissue and the hooks therein. In an embodiment, the spikes 128 of the second clip arm 112 are angled significantly relative to the remainder of the clip arm 112 so that the spikes 128 remain latched within the target tissue when the clip assembly 102 is moved to the open configuration to capture another portion of tissue. In particular, the spikes 128 may further extend from the inner surface of the clip arm 112 at various angles between 20 degrees and 90 degrees relative to the longitudinal axis L of the clip arm 112 to allow the spikes 128 to continue to capture tissue when the clip arms 110, 112 are in the open configuration.

[0035] In use, the operator will orient the clip arms 110, 112 so that the second clip arm 112 is on the outside of the tissue wound and the first clip arm 110 is on the inside of the tissue wound. The operator will then close the clip assembly 102 over the edge of the tissue wound and the spikes 128 will penetrate the mucosal layer to hold the tissue inside the clip arms 110, 112. As the clip assembly 102 is drawn to the opposite edge of the tissue wound and gradually reopened, the tissue piece will remain trapped on the second clip arm 112 but will be released from the first arm 110. That is, the direction of force on the first clip arm 110 is reversed so that the tissue is released from the first clip arm 110 while still being held on the second clip arm 112.

[0036] The first clip arm 110 may then be used to draw opposing edges of the wound inside the clip assembly 102. The spikes 128 on both jaws 110, 112 ensure that both edges of the wound are securely captured and will not back out when the clip is closed and deployed. When the two opposing edges of the tissue wound are joined by the clip assembly 102, the clip assembly 102 may be released from the applicator 104 and the clip may be further positioned along the tissue wound to finish the closure, as described in more detail below.

[0037] In another exemplary embodiment, as shown in Figures 5-6, system 200 is substantially similar to system 100 except as described herein. System 200 includes a clip assembly 202 having first and second clip arms 210, 212. In this embodiment, clip arms 210, 212 use a combination of hooks and spikes to hold a first tissue edge on one arm while simultaneously drawing a second tissue edge toward the first edge with the second arm. In particular, as shown in Figure 5, first arm 210 includes two spikes 228, similar to spikes 128 of clip assembly 102, that extend substantially perpendicularly from an inner surface of clip arm 210 radially inward toward second clip arm 212. Second arm 212 has a hooked distal end 222 with a sharp distal-most tip 230 configured to penetrate tissue and hold tissue thereon.

[0038] In an exemplary embodiment, the distal tip 230 is angled from about 90 degrees to about 180 degrees relative to the remainder of the clip arm 212. For example, in an embodiment, the distal end 222 of the second clip arm 212 may be bent back toward the clip assembly 202 so that the distal tip 230 is approximately parallel to the remainder of the clip arm 212. This embodiment provides a high degree of tissue retention once the distal tip 230 penetrates the tissue wound. In another example, the distal end 222 may have a bend of 90 degrees or more so that the distal tip is substantially perpendicular to the proximal portion of the clip arm 212. This embodiment allows the tissue wound to be more easily penetrated by the distal tip 230.

[0039] In use, the barbed distal end 222 of the second clip arm 212 is designed to adhere to the tissue and hold a first edge of the tissue wound inside the clip arms 210, 212, as described above, while the spike 228 of the first clip arm 210 is designed to release the first edge of the tissue wound and draw together a second, opposing edge of the tissue wound when the clip assembly 202 is reopened. This combination of positive structures has proven particularly effective for a "hold and draw" technique.

[0040] In another exemplary embodiment, as shown in Figures 7-9, system 300 is substantially similar to systems 100, 200 except as described herein. System 300 includes a clip assembly 302 having first and second clip arms 310, 312. In this embodiment, the first clip arm 310 includes one or more barbs 332 attached to an inner surface 334 of a distal portion of the first clip arm 310. Clip arms having barbs are particularly effective if an operator can press the barbed arm plane against the target tissue. This positioning of the arm plane against the tissue allows each of the barbs 332 to penetrate the mucosal tissue layer and allow the tissue to remain attached to the clip arm even under high tension.

[0041] As shown in Figures 8-9, the first clip arm 310 of this embodiment includes four barbs 332 extending radially inwardly from an inner surface 334 of the first clip arm 310 substantially perpendicularly towards the second clip arm 312. It will be understood that while this embodiment includes four barbs 332, any number of barbs may be used. The barbs 334 may further extend from the inner surface 334 at various angles between 20 degrees and 90 degrees, and more specifically 45 degrees, relative to the longitudinal axis L of the clip arm 310 to allow the barbs 332 to capture tissue when the clip arms 310, 312 are in the open configuration. That is, the barbs 332 may extend outwardly from the inner surface 334 of the first clip arm 310 in a plane that is substantially perpendicular to the plane that includes the inner surface 334 of the first clip arm 310, or may extend at an angle and therefore in a plane that is not perpendicular to the plane that includes the inner surface 334 of the clip arm 310.

[0042] 8-9, the barbs 332 are disposed on the inner surface 334 in a substantially parallel pair. However, it is understood that the barbs 332 may take any configuration, such as, for example, a longitudinally staggered pair, a single longitudinal line along a central longitudinal axis of the clip arm 310, etc. As can be seen in the figures, the second arm 312 has a planar profile along its length.

[0043] In addition to spikes, hooks, and barbs, other shapes may be used to improve attachment of the clip arms to the target tissue wound. For example, in another exemplary embodiment, the clip assembly 402 of the clip system 400 shown in FIGS. 10-12 includes sharp teeth 440 at the distal tip 430 of at least one of the first and second clip arms 410, 412. As seen, for example, in FIGS. 11-12, the first clip arm 410 includes three teeth 440 disposed on the inner surface of the distal tip 430 of the first clip arm 410. It is noted that while this embodiment includes three teeth, any number of teeth may be used, as can be understood by one of ordinary skill in the art. The teeth 440 have sharp tips to provide tissue penetration and retention. Additionally, the distal tip 430 of the first clip arm 410 may be angled at approximately 90 degrees relative to the remainder of the clip arm 410 to provide tissue retention when the clip arms 410, 412 are reopened.

[0044] A method of use of the system 100 according to an exemplary embodiment is illustrated in Figures 13-16. Initially, the clip 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 lumen) to a location adjacent the target tissue wound 10 to be clipped closed. The clip assembly 102 is inserted into the target tissue in a closed configuration to facilitate movement through the working channel. Once at the location of the target tissue wound, the clip assembly 102 is advanced out the distal end of the working channel of the endoscope and the clip arms 110, 112 are extended out of the capsule 116 to move the clip arms 110, 112 into an open, tissue-receiving configuration.

[0045] Once a first edge of the tissue wound target tissue is received between the clip arms 110, 112, the clip arms 110, 112 are moved to a closed configuration such that the spikes 128 penetrate the first edge 12 of the tissue wound so that the first edge 12 is grasped between the distal ends of the clip arms 110, 112. The clip arms 110, 112 are moved to a tissue grasping configuration by drawing the control member proximally relative to the capsule 116. Once the clip assembly 102 is in the closed tissue grasping configuration, the first edge 12 is drawn by the applicator 104 through the clip assembly 102 toward the second edge of the wound. When the first and second edges 12, 14 of the tissue wound are adjacent one another, the clip arms 110, 112 are gradually reopened. When the clip arms 110, 112 are reopened, the first arm 110 releases the first edge 12 of the tissue wound while the two spikes 128 of the second clip arm 112 hold the first edge 12 attached to the second clip arm 112. The clip arms 110, 112 are then reclosed over both edges 12, 14 of the tissue wound and the first clip assembly 102 is deployed from the applicator 104 by the actuator. Additional clip assemblies 102 may be placed along the tissue edges to close the wound.

[0046] In another exemplary embodiment, as shown in Figures 17-24, system 500 is similar to systems 100, 200, 300 and 400, except as described herein. System 500 includes a clip assembly 502 having first and second clip arms 510, 512. As shown in Figure 17, clip assembly 502 is configured to extend at a predetermined angle relative to the surface of tissue 10 when distal ends of the clip arms are in an open, tissue-receiving configuration when addressing target tissue 10 in a substantially vertical approach (i.e., an approach in which the longitudinal axis L of clipping assembly 502 is oriented substantially perpendicular to the surface of tissue 10 to be clipped), as described in more detail below.

[0047] As can be appreciated by one of ordinary skill in the art, although FIG. 17 illustrates the surface tissue 10 as being substantially planar, this arrangement of a plane perpendicular to the angle of approach of the clips of system 500 is used to illustrate the configuration of the various components of system 500, while system 500 may be used to clip tissue of any of a variety of shapes on a tissue surface from any desired angle of approach.

[0048] The first clip arm 510 has a distal curved portion 514 and a first tissue retaining structure 518 extending laterally inwardly therefrom toward the axis L. Similarly, the second clip arm 512 has a distal curved portion 516 and a second tissue retaining structure 520 extending laterally inwardly therefrom toward the axis L. In an exemplary embodiment, each of the first and second tissue retaining structures 518, 520 each includes one or more teeth that in this embodiment are integrally formed by bending in each of the first and second clip arms 510, 512, respectively, and extend toward the axis L at the curved portions 514, 516, respectively. The retaining structures 518, 520 are angled inwardly toward the axis L at a selected angle such that tissue received between the clip arms 510, 512 is grasped by the first and second tissue retaining structures 518, 520 as the first and second clip arms 510, 512, respectively, are drawn toward one another into the tissue clipping configuration.

[0049] As shown in FIG. 18, the curved portion 514 of the first clip arm 510 defines an angle α between the outer surface 511 of the first clip arm 510 and the outer surface 513 of the retaining structure 518. The angle α in this embodiment may range from 30° to 100°, however, a preferred angle is between 60° and 90°. The configuration of the second clip arm 512 is substantially a mirror image of the first clip arm 510 in this embodiment. When the angle α is too acute, tissue may become stuck to the clip arm 510 before the user decides to place and secure the clip on the target tissue. This may make it difficult to release the tissue and reposition the clip without potentially tearing the tissue. Furthermore, when the angle α is too obtuse, the tissue capture ability of the clipping assembly 502 may be compromised, potentially resulting in rupture or tearing of the tissue and / or premature release of the target tissue grasped by the clipping assembly 502.

[0050] As described above, as the first and second clip arms 510, 512 move away from one another when released to the open, tissue-receiving configuration, they each form an angle δ with respect to the axis L, which in this embodiment is the same as the angle δ with respect to the second clip arm 512 and the angle with respect to the first clip arm 510. 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, as shown in FIGS. 19A and 19B, the first clip arm 510 forms an angle β with respect to the surface of the tissue 10. The angle β is measured between the outer surface 513 of the retaining structure 518 and the surface of the tissue 10. The angle β may have a typical range of -20° to 40°, however, in this embodiment the range is preferably between 0° and 20°. In FIG. 19A, the first clip arm 510 forms a positive angle β (e.g., 20°) with the surface of the tissue 10, while in FIG. 19B, the clip arm 510 forms a negative angle β (e.g., −20°) with the surface of the tissue 10.

[0051] Additionally, as seen in FIG. 20, the clip arm 510 forms an angle δ with the longitudinal axis L of the clip 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 can be understood by one of ordinary skill in the art, the angles α, β, and δ are proportionally related to one another. Furthermore, in this embodiment, the first and second clip arms 510, 512 are formed as substantially mirror images of one another with respect to the angles α, β, and δ. However, one of ordinary skill in the art will understand that any of these angles may be varied from one clip arm to another within the typical range as desired.

[0052] In an exemplary embodiment, the retaining structures 518, 520 are designed to mate with one another so that when the clipping assembly 502 is inserted into the working channel of the endoscope in the closed configuration, the sharp edges of the retaining structures 518, 520 are protected from protruding beyond the outer boundary of the clip arms 510, 512 from any edge of any of the retaining structures (i.e., no edge of any of the retaining structures 518, 520 protrudes further toward the wall of the cylindrical lumen through which the clip assembly 502 is received than the smooth radially outer surface of the clip arms 510, 512). This protection reduces the risk that any sharp edges of the clip arms 510, 512 will engage and damage any portion of the working channel of the endoscope through which the clipping assembly 502 is deployed. Additionally, the protection reduces the risk that, for example, a pouch in which a product is stored will be torn by any of these sharp surfaces, potentially compromising the sterility of the product.

[0053] 21A-21C, the retaining structures 518, 520 in this embodiment correspond to one another so that when they are drawn together into the tissue clipping configuration, each tooth of the first clip arm 510 faces a correspondingly sized gap between the teeth of the second clip arm 512 to nest with one another as described below. In this embodiment, each retaining structure 518 has a sharp tip 522, while each retaining structure 520 has a sharp tip 524 to facilitate penetration and retention of engaged tissue. In an exemplary embodiment, as shown in FIG. 21B, the retaining structure 518 includes a first tooth 518a having a first sharp tip 522a and a second tooth 518b having a second sharp tip 522b.

[0054] For the retaining structure 518, the first tooth 518a is located adjacent the first outer edge 521a of the clip arm 510, while the second tooth 518b is further centrally located and spaced from the first tooth 518a by a first gap 525 having a width substantially corresponding to the width of the second tine 524b of the clip arm 512 (in a direction across the tine from the first outer edge to the second outer edge of the corresponding clip arm). The second tooth 518b is spaced from the second outer edge by a distance substantially corresponding to the width of the first tine 524a of the second clip arm 512. The retaining structure 518 further includes a first circular overhang 526 adjacent the second tooth 518b, the first overhang 526 acting as a guard to protect the first tine 524a. The first overhang 526 extends distally from the curved portion 514 a partial length of the second tooth 518b.

[0055] Similar to the retaining structure 518, as shown in FIG. 21C, the retaining structure 520 includes a first tooth 520a having a first sharp tip 524a and a second tooth 520b having a second sharp tip 522b. For the retaining structure 520, the first tooth 520a is disposed adjacent to a first outer edge 523a of the clip arm 512, while the second tooth 520b is further centrally disposed and spaced from the first tooth 520a by a gap 527 having a width substantially corresponding to the width of the second sharp tip 522b of the clip arm 510. The second tooth 520b is spaced from the second outer edge 523b by a distance substantially corresponding to the width of the first sharp tip 522a of the first clip arm 510. The retaining structure 520 further includes a second circular overhang 528 adjacent to the second tooth 520b, which acts as a guard to protect the first sharp tip 522a. A second overhang 528 extends distally from curved portion 516 a partial length of second tooth 520b.

[0056] As one skilled in the art would understand, the width of the first clip arm 510 (i.e., the distance from the first outer edge 521a to the second outer edge 521b) is substantially similar to the width of the second clip arm 512 (i.e., the distance from the first outer edge 523a to the second outer edge 523b), so that the teeth of one clip arm are always protected by the opposing clip arm. That is, if the number of teeth on one of the clip arms is the same as for the opposing arm, or where the teeth are located off-center on the clip arms, the distal portion of each clip arm will have a width selected to extend laterally apart at least as far as required to protect all of the teeth of the opposing clip arm in the closed configuration.

[0057] This configuration allows the second prong 522b in the closed configuration to be received within the gap 527 between the first and second tines 520a, 520b while the first prong 522a is received under the second overhang 528. Similarly in the closed configuration, the second prong 524b is received within the gap 525 between the first and second tines 518a, 518b while the first prong 524a is received under the first overhang 526 of the first clip arm 510 as shown in FIG. 21A. This configuration provides protection such that the prongs 522, 524 of the retention structures 518, 520 do not extend beyond the outer edges 523a, 523b of the second clip arm 512 and the outer edges 521a, 521b of the first clip arm 510.

[0058] The sharpness of the retention structures 518, 520 is determined by the sharp tips 522, 524. In an exemplary embodiment, the sharp tips 522, 524 are generally triangular. As shown in FIG. 22, 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 (and teeth 518b, 520a and 520b) may 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 one of ordinary skill in the art, the length V of the first sharp tip 522a is a portion of the length T of the tooth 518a. The first ratio (T / W) is expressed as the length T over the width W.

[0059] The first ratio in this embodiment has a typical range of 0.5 to 6, but a preferred range is between 2 and 4. Additionally, the sharpness of the tooth 518a may be expressed as a second ratio between the width W and the length V, which is a portion of the length T of the tooth 518a. The second ratio (V / W) is expressed as the length V over the width W. The second ratio in this embodiment has a typical 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, but as in FIG. 23, the sharp tips 522, 524 may be various other shapes (e.g., circular, rectangular, etc.). Additionally, instead of the sharp tips 522, 524, the retention structures 518, 520 may be formed as a plurality of barbs 532a, 532b as shown in FIG. 24. Note that while these embodiments include two teeth on each clip arm, the number of teeth per clip arm may be varied as desired.

[0060] In another exemplary embodiment, as shown in FIGS. 25-26C, system 600 is substantially similar to systems 100, 200, 300, 400, and 500, except as described herein. Similar to system 500, system 600 includes a clip assembly 602 having first and second clip arms 610, 612. As shown in FIG. 25, first clip arm 610 has a curved portion 614 and a first tissue retaining structure 618 extending distally therefrom. Similarly, second clip arm 612 has a curved portion 616 and a second tissue retaining structure 620 extending distally therefrom. Retaining structures 618, 620 are configured to grasp target tissue therebetween when clip assembly 602 is moved to a closed configuration.

[0061] 26A-26C, similar to the retaining structures 518, 520 of the clipping assembly 502, the retaining structures 618, 620 of the clipping assembly 602 are designed to mate with one another. When the clipping assembly 602 is inserted through the working channel of the endoscope in the closed configuration, the retaining structures 618, 620 are protected to avoid any edges of the retaining structures 618, 620 protruding beyond the outer boundaries of the clip arms 610, 612 (i.e., no edge of any of the retaining structures 618, 620 protrudes further toward the wall of the cylindrical lumen through which the clip assembly 602 is received) to reduce the risk of any sharp edges engaging and damaging any portion of the working channel of the endoscope through which the clipping assembly 602 is positioned.

[0062] Clipping assembly 602 differs from clipping assembly 502 in that retaining structure 618 differs from retaining structure 620, while retaining structure 518 is substantially similar to retaining structure 520. In particular, while each retaining structure 518, 520 has the same number of teeth (retaining structure 518 has two teeth and retaining structure 520 has two teeth), the number of teeth of retaining structure 618 differs from the number of teeth of retaining structure 620, as described below (e.g., retaining structure 618 has one tooth and retaining structure 620 has two teeth). Thus, retaining structure 618 has one sharp tip 622, while retaining structure 620 has two sharp tips 624 to facilitate penetration and retention of tissue engaged by retaining structures 618, 620. As can be appreciated by one of ordinary skill in the art, any of the various forms of retaining structures described herein may be used with clip arms having any of the angles α, β, and δ described above.

[0063] In an exemplary embodiment, the sharpness of the retention structures 618, 620 is determined by the sharp tips 622, 625, similar to the sharpness of the retention structures 518, 520. Additionally, in an exemplary embodiment, the sharp tips 622, 624 are triangular, however, the sharp tips 622, 624 may be a variety of other shapes (e.g., circular, rectangular, etc.) similar to the sharp tips 522, 524 of Figures 22-24. When the clipping assembly 602 is in the closed configuration, the sharp tips 622, 624 are protected as described below.

[0064] 26B, the retaining structure 618 includes one tooth 618a having one sharp tip 622a. For the retaining structure 618 in this embodiment, the tooth 618a is centrally located relative to the side of the first clip arm 610 on the distal end of the curved portion 614. The retaining structure 618 further includes a first circular overhang 626 that acts as a guard to protect the second sharp tip 624b of the clip arm 612, and a second circular overhang 628 that acts as a guard to protect the first sharp tip 624a of the second clip arm 612.

[0065] The first overhang 626 resides between the first outer edge 621a of the first clip arm 610 and the tooth 618a, while the second overhang 628 resides between the second outer edge 621b of the clip arm 610 and the tooth 618a. The first and second overhangs 626, 628 extend distally from the curved portion 614 a partial length of the tooth 618. The first overhang 626 has a width that substantially corresponds to the width of the second sharp tip 624b (in a direction across the sharp tip from one of the first outer edges to the second outer edge of the corresponding clip arm). Similarly, the second overhang 628 has a width that substantially corresponds to the width of the first sharp tip 624a.

[0066] In an exemplary embodiment, as shown in FIGURE 26C, the retaining structure 620 includes a first tooth 620a having a first sharp tip 624a and a second tooth 620b having a second sharp tip 624b. For the retaining structure 620, the first tooth 620a is disposed adjacent a first outer edge 623a of the second clip arm 612, while the second tooth 620b is disposed adjacent an outer edge 623b. The first tooth 620a and the second tooth 620b are spaced apart from one another by a gap 625 having a width substantially corresponding to a width of the sharp tip 622b of the clip arm 610.

[0067] As one skilled in the art would understand, the width of the first clip arm 610 (i.e., the distance from the first outer edge 621a to the second outer edge 621b) is substantially similar to the width of the second clip arm 612 (i.e., the distance from the first outer edge 623a to the second outer edge 623b), so that one tooth of the clip arm is always protected by the opposing clip arm. That is, if one of the clip arms has fewer teeth than the opposing arm, or as here, if the teeth are located off-center on the clip arms, the distal portion of each clip arm will have a width selected such that in the closed configuration it extends laterally at least as far apart as required to protect all of the teeth of the opposing clip arm. This configuration allows the sharp tip 624a in the closed configuration to be received under the second overhang 628, preventing the sharp tip 624a from extending beyond the first clip arm 610.

[0068] Similarly, the sharp tip 624b is received under the first overhang 626, preventing the sharp tip 624b from extending beyond the first clip arm 610. Additionally, as shown in FIGURE 26A, the sharp portion 622a is received in a gap 625 between the first and second tines 620a and 620b, preventing the sharp tip 622a from extending beyond the second clip arm 612. This configuration provides protection so that the sharp tips 622, 624 of the retention structures 618, 620 do not extend beyond the outer edge 623a of the second clip arm 612 and the outer edges 621a, 621b of the first clip arm 610.

[0069] As can be appreciated by those skilled in the art, although these embodiments include clip arms with one tooth and clip arms with two teeth, each clip arm may have any number of teeth, so long as the number of teeth on each clip arm is different. The methods of use of systems 500 and 600 are substantially the same as those described above for system 100. It will be appreciated by those skilled in the art that changes may be made to the above-described embodiments without departing from these inventive concepts. It will be further appreciated that structural features and methods associated with one of the embodiments may be incorporated into other embodiments.

[0070] Therefore, it is to be understood that the disclosure is not to be limited to the specific embodiments disclosed, but rather that modifications are intended to be included within the scope of the present invention as defined by the appended claims.

Claims

1. 1. A device for treating tissue, comprising: a capsule extending longitudinally along a longitudinal axis from a proximal end to a distal end; including first and second clip arms having proximal ends received within the capsule, the first and second clip arms being moved between an open, tissue-receiving configuration in which the distal ends of the first and second clip arms are spaced apart from one another and a closed, tissue-clipping configuration in which the distal ends of the first and second clip arms are moved toward one another; the first clip arm includes a first portion extending parallel to the first portion of the second clip arm and parallel to the longitudinal axis in the tissue clipping configuration, the first clip arm having a first tooth extending radially inward from the first portion of the first clip arm toward the longitudinal axis, and the second clip arm includes a second tooth extending radially inward from the first portion of the second clip arm toward the longitudinal axis; the second tines are partial and laterally offset relative to the first tines, and the first clip arm includes a first guard extending laterally outward from the first tines, such that when the first and second clip arms are in the tissue clipping configuration, the first guard overlies the second tines such that a sharp tip of the second tine is proximal to the first guard and closer to the longitudinal axis than outer edges of the first and second clip arms.

2. 2. The device of claim 1, wherein the first tine is coupled to the first portion of the first clip arm via a first curved portion and the second tine is coupled to the first portion of the second clip arm via a second curved portion.

3. The device of claim 1 , wherein the first clip arm has a number of teeth that is different than a number of teeth of the second clip arm.

4. 2. The device of claim 1, wherein the second clip arm includes a second guard laterally offset from the second tine and positioned and configured to overlie a sharp tip of the first tine, such that the sharp tip of the first tine is proximal to the second guard when the first and second clip arms are in the tissue clipping configuration and is closer to the longitudinal axis than outer edges of the first and second clip arms.

5. 5. The device of claim 1, wherein the first tines extend at a first angle of 30 to 100 degrees relative to the first portion of the first clip arm, and the second tines extend at a second angle of 30 to 100 degrees relative to the first portion of the second clip arm.

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

7. The apparatus of any one of claims 1 to 6, wherein each of the first tines and the second tines includes a plurality of sharp tips extending radially inwardly from the first tines and the second tines.

8. The device of claim 7 , wherein each of the sharp tips is one of a triangular, circular, or rectangular shape.

9. 9. The apparatus of claim 1, wherein the first tine includes a first plurality of barbs extending radially inward from the first tine and the second tine includes a second plurality of barbs extending radially inward from the second tine.

10. an applicator including a catheter and a control member extending through the catheter, the control member extending from a proximal end to a distal end and longitudinally movable relative to the applicator; and at least one clip assembly coupled to the applicator, each clip assembly comprising: a capsule extending longitudinally along a longitudinal axis from a proximal end to a distal end; first and second clip arms each extending from a proximal end to a distal end; the proximal ends of the first and second clip arms are received within the capsule such that the first and second clip arms are movable between an open, tissue-receiving configuration in which the distal ends of the first and second clip arms are spaced apart from one another and a closed, tissue-clipping configuration in which the distal ends of the first and second clip arms are moved toward one another; the first clip arm has a first portion extending parallel to a first portion of the second clip arm and parallel to the longitudinal axis in the tissue clipping configuration, the first clip arm including a first tooth extending radially inward from the first portion of the first clip arm toward the longitudinal axis, and the second clip arm including a second tooth extending radially inward from the first portion of the second clip arm toward the longitudinal axis; a first clip arm including a first guard extending laterally outward from the first tooth such that the first guard overhangs the second tooth when the first and second clip arms are in the tissue clipping configuration such that a sharp tip of the second tooth is proximal to the first guard and closer to the longitudinal axis than outer edges of the first and second clip arms.

11. 11. The system of claim 10, wherein the second tine includes a second guard positioned and configured to overlie a sharp tip of the first tine such that the sharp tip of the first tine is proximal to the second guard when the first and second clip arms are in the tissue clipping configuration and closer to the longitudinal axis than outer edges of the first and second clip arms.

12. 11. The system of claim 10, wherein the first tine extends at a first angle of 30 degrees to 100 degrees relative to the first portion of the first clip arm and the second tine extends at a second angle of 30 degrees to 100 degrees relative to the first portion of the second clip arm.

13. 11. The system of claim 10, wherein the first tine is coupled to the first portion of the first clip arm via a first curved portion and the second tine is coupled to the first portion of the second clip arm via a second curved portion.

14. 11. The system of claim 10, wherein the first tine includes a first plurality of barbs extending radially inward from the first tine and the second tine includes a second plurality of barbs extending radially inward from the second tine.

15. The system of claim 10 , wherein each of the first tines and the second tines includes a plurality of sharp tips extending radially inward from the first tines and the second tines.

Images