heart clip

Abstract

Cardiac conditions such as valve regurgitation can be treated using implantable clip devices. Some clip devices include two or more separate clips, which are individually attached to the natural valve leaflets and then connected to each other. The completed placement can serve to maintain the valve leaflets held in close or near-close contact with each other by the clips.

Description

Background Art

[0001] The present disclosure relates to medical devices and surgical methods. More particularly, the present invention relates to a clip implantable in a patient's heart. The mitral valve maintains unidirectional blood flow between the left atrium and the left ventricle. The tricuspid valve maintains unidirectional blood flow between the right atrium and the right ventricle. Mitral regurgitation and tricuspid regurgitation occur when the valve leaflets do not coapt (seal) properly. Valve regurgitation often leads to heart failure and in some cases can lead to death.

[0002] Percutaneous correction of mitral and tricuspid regurgitation by implanting valve clips (Abbott's MitraClip® and Edwards Lifesciences' PASCAL) has become the standard treatment for patients at high risk of open-chest corrective procedures. Such clip implantation procedures are performed through a guiding catheter inserted into the femoral vein. One or more clips can be delivered and implanted through the guiding catheter to bring the valve leaflets closer together again. This procedure is often referred to as "edge-to-edge" repair.

[0003] Current clips are a single structure with four clip arms that extend at a 180° angle. One limitation of "edge-to-edge" repair is the ability of the clip to reach both valve leaflets. In some cases, the valve leaflets may be too far apart to be reached simultaneously by both arms of the clip. Another limitation of "edge-to-edge" repair is that current clips can apply torque to the valve leaflets if they are not positioned exactly perpendicular to the valve plane opening. This torque on the valve leaflets creates a situation called "pinwheeling" of the valve. This "pinwheeling" can cause problems such as residual valve regurgitation and the possibility of clip detachment.

[0004] For a more detailed description of the embodiments of this disclosure, the accompanying drawings are referenced herein. By convention, drawings are sometimes not drawn to scale for clarity. [Brief explanation of the drawing]

[0005] [Figure 1] This is a schematic diagram of a clip according to one embodiment, in which the clip is screwed into a delivery sheath and is fully housed within a small-diameter, maneuverable guide. [Figure 2] Figure 1 is a schematic diagram of the clip, in which the clip is advanced outward from a small-diameter, operable guide, and the main arm of the clip is extended. [Figure 3] Figure 1 is a schematic diagram of the clip, where the tether wire is partially released, allowing the clip's gripper arm to deploy. [Figure 4] Figure 1 is a schematic diagram of the clip, which allows the tether wire to be further released, enabling the gripper arm to close relative to the main arm. [Figure 5] Figure 1 shows a schematic diagram of the two clips, which are joined in a parallel configuration by a connecting collar. [Figure 6] A schematic diagram of two clips and their associated delivery sheaths, adapted to be joined in a cross configuration according to one embodiment, in which a connecting collar is advanced over the associated delivery sheath using a collar delivery catheter. [Figure 7] Figure 6 shows a schematic diagram of the two clips, with a connecting collar joining the two clips together. [Figure 8] This is a schematic diagram of two clips and their associated delivery sheaths adapted to be joined in a parallel configuration according to one embodiment, in which the main arm and gripper arm have different stationary positions. [Figure 9] Figure 8 shows a schematic diagram of the two clips, with a connecting collar joining the two clips together. [Figure 10] This is a schematic diagram of two clips attached to a delivery shaft, with the clips having an outward spread. [Figure 11] Figure 10 shows a schematic diagram of two clips, each of which is housed within a delivery sheath having a tether wire or gripper line, and both delivery sheaths are housed within the lumen of a maneuverable guide. [Figure 12] Figure 10 shows a schematic diagram of two clips, each of which is housed within a delivery sheath having a tether wire or gripper line, and both delivery sheaths are housed within the lumen of a maneuverable guide. [Figure 13] Figure 10 shows a schematic diagram of the two clips, illustrating the effect of sequentially releasing the tension on the tether wire. [Figure 14] Figure 10 shows a schematic diagram of the two clips, illustrating the effect of sequentially releasing the tension on the tether wire. [Figure 15] Figure 10 shows a schematic diagram of the two clips, illustrating the removal of both the delivery sheath and the tether wire or gripper line. [Figure 16] Figure 10 shows schematic diagrams of two clips, illustrating the control of the degree of outward spreading of the clips using a steerable guide. [Figure 17] Figure 10 shows schematic diagrams of two clips, illustrating the control of the degree of outward spreading of the clips using a steerable guide. [Figure 18] Figure 10 shows a schematic diagram of the two clips, in which the connecting collar with a skirt is locked in place before the clip delivery shaft is retrieved. [Modes for carrying out the invention]

[0006] It should be understood that the following disclosure describes several exemplary embodiments for carrying out various different features, structures, or functions of the present invention. For the sake of brevity of this disclosure, exemplary embodiments of components, arrangements, and configurations are described below. However, these exemplary embodiments are provided merely as examples and are not intended to limit the scope of the present invention.

[0007] implants This disclosure describes a preferred embodiment of an implant comprising two or more clips. Each clip comprises a shaft, a single relatively more rigid main arm, and a single relatively more flexible gripper arm located above the main arm. The main arm and / or gripper arm are attached to the shaft via a hinge region. Each clip can move independently of the other clip and grip a valve leaflet. Once all clips have properly gripped the valve leaflet, the clips can be joined together to form a single structure. The implant may also allow for the separation of the clips at a later date if necessary.

[0008] For example, the implant also includes a connecting collar (e.g., a stent, tube) that is movable along the clip toward the main arm / gripper arm. The connecting collar may house two halves joined to each other in a locking manner and a central lumen. The distal end of the connecting collar may have a skirt, funnel, or umbrella that spreads over the atrial surface of the heart valve as the connecting collar moves toward the heart valve. The valve leaflets are joined to each other by pulling the clip together with the connecting collar. The proximal end of each shaft has a locking groove or locking protrusion. These locking grooves or protrusions can fix the connecting collar in the appropriate position and join two or more clips. For example, the connecting collar includes complementary locking grooves or protrusions that can lock into each other with the locking grooves or protrusions on each shaft. The connecting collar can join two or more clips to each other in either a parallel or cross configuration. The connecting collar may optionally have a central lumen. To separate previously joined clips, a coronary angioplasty balloon can be placed in the central lumen of the connecting collar. When the balloon is inflated, the two halves of the connecting collar are unjoined, and the clips are separated.

[0009] Alternatively, the clips can be joined or separated from one another using nuts and bolts that can be screwed into and unscrewed from the clips. Alternatively, the clip may be isolated by applying energy, such as electrical energy, to the implant.

[0010] The clip preferably has a nitinol structure. The shafts of the clips can be flattened or chamfered on one side to ensure that the orientation of the arms of the clips coincides when two or more clips are joined together. The side that is flattened or chamfered depends on whether the two or more clips are joined together in a parallel configuration or in an intersecting configuration. However, it is preferable that the shafts of the clips be rounded. This allows the shafts to rotate inside the connecting collar even when the connecting collar is moved to a fixed position to engage with the locking grooves or protrusions on each shaft. This configuration can reduce the occurrence of valve "pinwheeling".

[0011] In the static configuration of the clip, it is preferable that the arms are closed to each other and at an angle of 90 degrees or less from the vertical shaft of the clip. For example, the clip can be configured with the arms angled upward, which may improve tissue adhesion.

[0012] Delivery kit This disclosure describes three preferred embodiments of a delivery kit for implanting clips. Each clip is releasably connected (e.g., screwed) to a corresponding delivery shaft, the delivery shaft being inserted into a delivery sheath housing the delivery shaft. The delivery sheath and / or delivery shaft may have a slightly outward angle, resulting in outward spreading of the clip. Each delivery sheath also houses a tether wire that can be used to raise and lower the gripper arm of the clip. The tether wire extends through the delivery sheath to the tip of the gripper arm. A connecting collar can advance along the delivery shaft after the delivery sheath and tether wire have been removed.

[0013] To ensure that each clip has the ability to extend sufficiently to grasp a non-contacting valve leaflet, the delivery kit may include multiple small-bore operable guides, typically two guides, one for each clip.

[0014] A large-bore steerable catheter can accommodate all clips, their delivery sheaths, and their small-bore steerable guides. The combination of two steerable guides (a large-bore steerable guide and a smaller-bore steerable guide inside it) can impart high flexibility and controllability for directing the clip.

[0015] After removing the small-bore steerable guide from the large-bore steerable catheter, the large-bore steerable catheter may accommodate a collar delivery catheter having a connection collar provided at its distal end. The collar delivery catheter and the connection collar surround the delivery shaft.

[0016] In an alternative embodiment, the delivery kit may include fewer, sometimes only one, small-bore steerable guide. Multiple, sometimes all, clips can be housed and delivered by the small-bore steerable guide. Typically, the small-bore guide can accommodate two clip delivery shafts. In this case, each of the delivery sheath and / or the delivery shaft preferably has a slightly outward angle that provides an outward spread of the clip.

[0017] The collar is delivered inside a small-bore steerable guide at the end of the collar delivery catheter (e.g., at the distal tip of the collar delivery catheter). The collar can lock onto the clip as described above.

[0018] In yet another alternative embodiment, the clip may be delivered to the valve by using only the large-bore guide. In this alternative, no small-bore guide is required. Treatment This disclosure describes three preferred embodiments of a surgical treatment.

[0019] First, each clip is connected to the distal end of the delivery shaft, which is then inserted into the delivery sheath. Each delivery sheath houses a tether wire for controlling the position of the clip's gripper arm. The tether wire is looped through a passage within the delivery sheath and is attached to the distal end of the gripper arm. Each clip and its delivery shaft / sheath are optionally housed individually or collectively in a small-bore, maneuverable guide. The delivery shaft / sheath, and the small-bore, maneuverable guide (if provided), are housed in a large-bore, maneuverable catheter.

[0020] In mitral valve procedures, a large-bore, maneuverable catheter is used to traverse the atrial septum and orient the implant downward toward the mitral valve. Therefore, the large-bore, maneuverable catheter is positioned across the atrial septum and angled downward toward the mitral valve.

[0021] In one embodiment, each clip and delivery shaft / sheath may be housed individually within a small-diameter, maneuverable guide. When housed within a small-diameter, maneuverable guide, the main arm is vertical in the downward position and the gripper arm is vertical in the upright position.

[0022] Once positioned in the heart valve plane, each individual clip and its corresponding small-bore maneuverable guide are sequentially advanced outward from the large-bore maneuverable catheter. Next, as the first clip is advanced outward from the small-bore maneuverable guide, the main arm comes to a 90-degree position. The small-bore maneuverable guide can be used to control the degree of outward spreading of the clip (e.g., to flatten the delivery sheath and / or delivery shaft). Next, the main arm is lifted toward the ventricular side of the valve lobule. The small-bore maneuverable guide is then pulled back further, thereby releasing the gripper arm of the clip. The tether wire holds the gripper arm in the retracted position until the clip is finally repositioned. The tether wire is then partially released, thereby closing the gripper arm toward the atrial side of the valve. Preferably, the tether wire is fully released and retrieved together with the delivery sheath later in the procedure, as described below. The other clip is deployed in the same manner as the first clip.

[0023] The clips can be repositioned until the tether wire is released. Therefore, it is preferable that the tether wire is not fully released until the proper positioning of all clips is confirmed. Once the tether wire is released, the delivery sheath can be retrieved from around the delivery shaft.

[0024] Once all clips are in place, the small-bore, maneuverable guide is removed. This step leaves only the clip delivery shaft in the lumen of the large-bore, maneuverable catheter. Next, a connecting collar is applied, which joins two or more clips together. The connecting collar is housed at the distal end of the color delivery catheter. The color delivery catheter and connecting collar are advanced inside the large-bore maneuverable catheter over two or more delivery shafts, advanced downwards to the clips, and exit from the end of the large-bore maneuverable catheter. By pulling the clips together with the connecting collar, the valve leaflets are joined to each other or brought closer together.

[0025] The release of the clips does not need to be completed until the connecting collar can be advanced downward over the delivery sheath. Once the connecting collar is in position, the delivery shafts can be released from the clips. When the clips are joined to each other by the connecting collars and still housed within the colored delivery catheter, each of the delivery shafts is unscrewed from its clip. At this point, the collars and clips are locked together and the implant can then be pushed out from the distal end of the large-bore, maneuverable guide. Once these delivery shafts are unscrewed and still housed within the colored delivery catheter, they can be advanced relative to the connecting collars to release the connecting collars from the colored delivery catheter (for example, in a plunger-like manner).

[0026] At the end of the procedure, the clip is joined, applied to the valve leaflet, and released from the collar delivery catheter. In tricuspid valve procedures, a large-bore, maneuverable catheter is used solely for implant delivery. Clips can be applied to the tricuspid valve in a similar manner without requiring septal transposition.

[0027] In another embodiment, the clips and their delivery shafts / sheaths may be collectively housed within a small-bore maneuverable guide. When housed within the small-bore maneuverable guide, the main arms of each clip are vertical in a downward position, and the gripper arms are vertical in an upright position. The large-bore maneuverable guide catheter typically remains in the atrium, and the small-bore maneuverable guide is advanced through the large-bore maneuverable guide catheter.

[0028] In this embodiment, the small-bore maneuverable guide may not need to be removed from the large-bore maneuverable catheter. The clip delivery sheath and gripper line may also be removed to allow delivery of the collar. The collar may slide down on the clip delivery shaft. The collar may descend through the small-bore maneuverable guide. Once the collar is engaged, the collar delivery catheter can be used as a plunger to push the clip and collar out of the small-bore guide catheter.

[0029] In yet another embodiment, the clip may be delivered to the valve by using only a large-diameter guide. If the clips need to be separated at a later date, the connecting collar can be separated in half using a balloon. This action releases the clips. Each clip can remain on an individual valve leaflet.

[0030] Figures 1 to 4 show the sequence of clip deployment. When in use, two or more clips are deployed as shown in Figures 1 to 4. Each clip moves independently of the other clip and can grip the valve leaflet. Once all clips have properly gripped the valve leaflet, the clips can be joined together to form a single structure.

[0031] After the steps shown in Figure 4, the tether wire and clip delivery sheath are retrieved. Figure 5 shows two clips deployed as shown in Figures 1-4 and joined by a connecting collar. In this example, the connecting collar houses two halves and a central lumen, joined to each other in a locking mechanism. To separate previously joined clips, a coronary angioplasty balloon can be placed inside the central lumen of the connecting collar. When the balloon is inflated, the two halves of the connecting collar are released, and the clips are separated.

[0032] Figures 6 and 7 illustrate an exemplary sequence for joining two clips having clip shafts arranged in a cross configuration relative to each other. Each clip shaft naturally has a non-linear shape. The clip shafts are positioned on opposite sides of each other (e.g., approximately 180 degrees opposite each other) so that when unconstrained, they extend radially outward and away from each other.

[0033] Each clip shaft can be fabricated from an elastically flexible material (e.g., Nitinol tubing) shaped to have a naturally curved or angled form. As a result, the clip shaft (and the clip attached to its distal end) has a natural tendency to spread radially outward (as shown in Figure 6) when not constrained by the sheath and / or collar. However, by sliding the collar and / or sheath distally to trap the curved portion of the clip shaft within the collar and / or sheath, the clip shaft becomes more linear, and the clips are moved radially inward toward each other (as shown in Figure 7). The outward spreading of the clip shaft and the resulting distance between clips can be controlled by the distal placement of the delivery sheath or collar on the non-linear portion of the clip shaft.

[0034] To ensure proper orientation of the clip shaft and clip, in some embodiments, the flattened or chamfered side of the clip shaft is on the same side as the clip (not the opposite side in the previous figure). Thus, the flattened or chamfered surfaces of the clip shaft can come into contact with each other, resulting in the crossed arrangement shown.

[0035] Furthermore, in this example, as best shown in Figure 7, the distal end of the connecting collar has a funnel or umbrella that spreads over the atrial surface of the heart valve as the connecting collar moves toward the heart valve (towards the clip). In some embodiments, this umbrella consists of a wire framework (e.g., shaped Nitinol, stainless steel, etc.) to which a flexible, impermeable membrane coating material (e.g., ePTFE, PTFE, polyester, Dacron, metal foil, etc.) is attached. The wire framework can be shaped to naturally spread radially outward when not constrained by the sheath (as shown in Figure 7).

[0036] The umbrella can serve multiple purposes. In some cases, it functions as an occluder to reduce the backflow of blood through the clipped valve leaflets (valve regurgitation). Alternatively or additionally, in some cases, the umbrella functions as a funnel to retrieve the clips into the sheath when recapture and removal of the clips are desired.

[0037] In some embodiments, the umbrella has a circular cross-sectional shape. In some embodiments, the umbrella has an elongated elliptical cross-sectional shape (e.g., elliptical, oblong, egg-shaped, D-shaped, etc.). In some such embodiments, the principal axis of the elongated elliptical cross-sectional shape may be oriented to extend along the line of contact of the natural valve leaflets. Thus, the aforementioned closure performance of the umbrella can be optimized in such orientation.

[0038] Figures 8 and 9 show another exemplary embodiment and the sequence for joining two clips in a parallel configuration. The clip shafts of this embodiment also have a naturally curved or angled shape (similar to the clip shafts of the embodiments described above with reference to Figures 6 and 7). However, this embodiment differs from the embodiments of Figures 6 and 7 in that the clip shafts do not intersect each other. Each clip shaft is curved / angled so as to extend radially away from the other clip shaft rather than intersecting each other. The embodiments of Figures 8 and 9 may include a collar and an umbrella attached to the distal end of the collar.

[0039] Furthermore, the static configuration of the clip has its arms closed to each other. Compared to the previous figure, the arms are angled upward at an angle of less than 90 degrees from the clip's shaft. This static configuration may improve tissue adhesion.

[0040] After the steps shown in Figure 7 or Figure 9, the delivery shaft (clip shaft) is disconnected from the clip and removed / recovered. Figures 11-18 show the sequence of implant deployment. Unlike the previous figures, both clips are housed together within a single small-bore maneuverable guide (or catheter). The small-bore maneuverable guide is not retrieved before collar delivery, and the collar slides within the small-bore maneuverable guide rather than within a large-bore catheter.

[0041] Figures 11-18 do not show all controllable guides; additional controllable guides can be placed further up in the figures. For simplification, valve leaflets are shown only in Figure 18.

[0042] In Figure 11, the clip delivery sheath houses a clip delivery shaft that is detachable from the clip, and a tether wire or gripper line. In Figure 15, the gripper line or tether wire is released and the delivery sheath is retrieved.

[0043] In Figures 16 and 17, the outward spread of the clip delivery shaft and the distance between clips can be controlled by how far above or below the distal end of the small-diameter, maneuverable guide is on the spread portion of the clip delivery shaft and / or the clip shaft itself. The outward spread may be provided on the clip delivery shaft only (as illustrated), on the clip shaft only, or on both the clip shaft and the delivery shaft.

[0044] In Figure 18, the collar allows for a certain degree of rotation of the clip itself. The clip shaft is rounded and optionally has a horizontal ridge that loosely engages with a horizontal ridge on the inside of the collar lumen.

[0045] In addition, this disclosure also intends to include at least the following embodiments. Embodiment 1 Embodiment 1 is an implant for bringing the leaflets of a patient's heart valve closer together. The implant comprises two or more clips and a connecting collar.

[0046] Each clip comprises a shaft, a main arm, and a gripper arm. The main arm and / or gripper arm are attached to the shaft via a hinge region. The gripper arm is positioned above the main arm on the same side of the shaft as the main arm. Each clip can move independently of the other clip and grip a valve leaflet.

[0047] The connecting collar (e.g., stent, tube) is movable along the clip toward the main arm / gripper arm to connect two or more clips.

[0048] Embodiment 2 Embodiment 2 is the implant described in Embodiment 1, wherein each clip comprises a single main arm and a single gripper arm.

[0049] Embodiment 3 Embodiment 3 is the implant according to Embodiment 1 or 2, wherein a locking groove or protrusion is present at the proximal end of each shaft. These locking grooves or protrusions can secure a connecting collar in the appropriate position and join two or more clips.

[0050] Embodiment 4 Embodiment 4 is an implant according to any one of Embodiments 1 to 3, wherein the shaft of each clip is flattened or chamfered on the side opposite to the main arm and gripper arm, so that two or more clips can be joined in a parallel configuration.

[0051] Embodiment 5 Embodiment 5 is an implant according to any one of Embodiments 1 to 3, wherein the shaft of each clip is flattened or chamfered on the same side as the main arm and gripper arm, so that two or more clips can be joined in a cross configuration.

[0052] Embodiment 6 Embodiment 6 is an implant according to any of Embodiments 1 to 5, wherein the shafts of each clip can rotate inside the connecting collar even when the connecting collar is moved to a fixed position so as to engage with the locking grooves or protrusions on each shaft.

[0053] Embodiment 7 Embodiment 7 is an implant according to any one of Embodiments 1 to 6, wherein the connecting collar includes two parts that are releasably locked together.

[0054] Embodiment 8 Embodiment 8 is a kit for delivering the implant described in any of Embodiments 1 to 7. The kit comprises two or more sheaths, each sheath containing a delivery shaft and a tether wire. The delivery shaft of each sheath can be connected to the shaft of a clip. The tether wire is looped within a passage in the sheath. The tether wire is releasably attached to the gripper arm of the clip, and the gripper arm can be displaced.

[0055] Embodiment 9 Embodiment 9 is the kit described in Embodiment 8, further comprising two or more maneuverable guides, each capable of housing a sheath to which a clip is attached.

[0056] Embodiment 10 Embodiment 10 is the kit described in Embodiment 8, further comprising at least one maneuverable guide capable of accommodating two or more sheaths.

[0057] Embodiment 11 Embodiment 11 is a kit according to any of Embodiments 8 to 10, wherein the delivery sheath and / or delivery shaft have a slightly outward angle that causes the clip to spread outward.

[0058] Embodiment 12 Embodiment 12 is a kit according to any one of embodiments 8 to 11, further comprising a maneuverable catheter capable of housing a maneuverable guide.

[0059] Embodiment 13 Embodiment 13 is a kit according to any one of Embodiments 8 to 12, further comprising a color delivery catheter capable of holding a connecting collar and sized to surround two or more delivery shafts.

[0060] Embodiment 14 Embodiment 14 is a method for implanting an implant described in any of Embodiments 1 to 7 into a patient's heart using a kit described in any of Embodiments 8 to 13, wherein each clip is moved independently of the other clip and can grasp the valve leaflet. Once all the clips have properly grasped the valve leaflet, the clips can be joined together to form a single structure.

[0061] Embodiment 15 Embodiment 15 is the same as Embodiment 14, in which the valve leaflets are brought closer together by pulling the clip together with the connecting collar.

[0062] Embodiment 16 Embodiment 16 is a method according to Embodiment 14 or 15, further comprising allowing the shafts or each clip to rotate inside the connecting collar when the connecting collar is engaged with the locking grooves or protrusions on each shaft.

Claims

1. An implantable heart valve leaflet clip system, A delivery sheath that defines the lumen, A first clip device slidably disposed within the lumen, comprising a first shaft and a first leaflet clip releasably connected to the distal end of the first shaft, A second clip device slidably disposed within the lumen, comprising a first shaft and a first valve leaflet clip releasably connected to the distal end of the first shaft, A collar is slidably disposed within the lumen and slidably disposed around the first shaft and the second shaft. A system equipped with these features.

2. The system according to claim 1, wherein the collar comprises an expandable umbrella portion having a naturally widened shape that appears when the collar is pushed distally from the lumen.

3. The system according to claim 2, wherein the extended shape has a circular cross-sectional shape.

4. The system according to claim 2, wherein the extended shape has an elongated elliptical cross-sectional shape.

5. The system according to claim 4, wherein the cross-sectional shape of the elongated ellipse is oblong or elliptical.

6. The system according to claim 2, wherein the umbrella portion includes a flexible film-like material attached to a shaped metal frame.

7. The system according to claim 1, wherein the first shaft and the second shaft each naturally have a non-linear, curved, or angled shape, and the shape such that the clip is positioned radially outward from the first shaft and the second shaft when the first shaft and the second shaft are not radially constrained by the delivery sheath and the collar.

8. The system according to claim 7, wherein the first shaft and the second shaft intersect each other.

9. The system according to claim 8, wherein the first shaft and the second shaft have flat surfaces that contact each other.

10. The system according to claim 7, wherein the first shaft and the second shaft do not intersect each other.

11. The system according to claim 10, wherein the first shaft and the second shaft have flat surfaces that contact each other.

12. The system according to claim 1, wherein the first valve leaf clip and the second valve leaf clip are releasably connected to the first shaft and the second shaft, respectively, by screw connections.

13. The system according to claim 1, wherein the first valve leaflet clip and the second valve leaflet clip are releasably connected to the first shaft and the second shaft, respectively, by removable sutures.

14. The system according to claim 1, wherein the first shaft and the second shaft are tubes.

15. The system according to claim 1, wherein the system is configured to adjust the distance between the first clip and the second clip by positioning the distal end of the delivery sheath or the collar at various positions along the first shaft and the second shaft.

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