WO2016073870A1

WO2016073870A1 - Vascular closure device with force responsive components

Info

Publication number: WO2016073870A1
Application number: PCT/US2015/059501
Authority: WO
Inventors: Greg A. WALTERS; Todd D. Sorzano; Jason D. KEISER; Joseph T. GRINTZ
Original assignee: Essential Medical, Inc.
Priority date: 2014-11-07
Filing date: 2015-11-06
Publication date: 2016-05-12

Abstract

A vascular closure device including a sealing plug, a toggle, and a suture connecting the toggle and plug, and including force responsive components to provide gradual but controlled separation between the sealing plug and toggle during the encapsulation and healing process. This separation hastens subsequent healing which reduces long-term forces on the toggle that might otherwise lead to longitudinal bending of the toggle after implantation.

Description

VASCULAR CLOSURE DEVICE WITH FORCE RESPONSIVE COMPONENTS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of U.S. Provisional Application No. 62/077,013, filed November 7, 2014, the entire contents of which are incorporated by reference herein.

TECHNICAL FIELD

[0002] The present disclosure relates to vascular closure devices, and in particular to sealing devices that that include one or more force responsive components.

BACKGROUND

[0003] During an interventional cardiovascular procedure a puncture may be made in the femoral artery. Vascular closure devices composed of an absorbable intra-arterial toggle, an extra-vascular folding sealing plug, and a connecting suture, such as a filament, have been developed and may be used to seal these punctures. These devices function by compressing the intra and extra-arterial components together around the puncture, with sufficient tension within the connecting suture. However, as the size of percutaneous sheaths become larger to accommodate larger cardiovascular devices, the size of the resulting puncture increases. Larger punctures are harder to seal because of the larger vessel wall defect or puncture. In the case of sealing blood pressure with an external plug, larger defects expose the plug to increased forces, which must be supported through the connecting suture by the intra-arterial toggle.

SUMMARY

[0004] An embodiment of the present disclosure is a vascular closure device configured to seal a puncture in a vessel wall. The vascular closure device includes a suture, a toggle connected to the suture, and a plug disposed along the suture in a proximal direction relative to the toggle. The plug has an initial configuration where the plug is slidable along the suture and a locked configuration where the plug is fixed to the suture relative to the toggle. The vascular closure devices includes at least one force responsive component configured such that application of tension along a portion of the suture disposed between the plug and the toggle when the plug is in the locked configuration causes relative movement between the plug and the toggle body. The force responsive component can be at least one of A) a portion of the toggle, and B) a portion of the suture disposed between the toggle and the plug. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The foregoing summary, as well as the following detailed description of an exemplary embodiments of the application, is better understood when read in conjunction with the appended figures. The figures illustrate exemplary embodiments for the purposes of illustration. It should be understood, however, that the application is not limited to the precise arrangements and systems shown.

[0006] Figure 1 A is a perspective view of a vascular closure device in accordance with an embodiment of the present disclosure.

[0007] Figure IB is a partial cut-away view of the vascular closure device shown in Figure 1A.

[0008] Figure 1C is a perspective view of a sealing device associated with the vascular closure device in Figure 1A.

[0009] Figure 2A is an exploded view of the sealing device illustrated in Figures 1A-

1C.

[0010] Figure 2B is a schematic, partial sectional view of the sealing device in a sealing position over a puncture of a vessel.

[0011] Figures 3A, 3B, and 3C are side, top, and end views, respectively of a toggle of the sealing device illustrated in Figures 2A and 2B.

[0012] Figures 4A, 4B, and 4C are side, top, and end views, respectively of a toggle according to another embodiment of the present disclosure.

[0013] Figure 4D is a schematic, partial sectional view of the sealing device including the toggle illustrated in Figures 4A-4C.

[0014] Figure 5 is a schematic, partial sectional view of a sealing device according to another embodiment of the present disclosure.

[0015] Figures 6A-6C are rear perspective views of the vascular closure device with portions of the device removed for clarity. [0016] Figure 6D is a cross-sectional view of the vascular closure device shown in Figure 6A, taken along line 6D-6D.

[0017] Figure 6E is a perspective view of the release component, delivery component and tensioner of the vascular closure device shown in Figure 1A.

[0018] Figure 6F is a perspective cross-sectional view of the a release component, delivery component and a tensioner of the vascular closure device shown in Figure 6E, taken along line 2-4.

[0019] Figure 7 is a perspective view of the delivery component and tensioner of the vascular closure device shown in Figure 6E.

[0020] Figures 8 and 9 are perspective and top views, respectively, of the release component of the vascular closure device shown in Figure 1A.

[0021] Figure 10A is a schematic showing an access sheath partially disposed within a vessel through a puncture site in the vessel.

[0022] Figure 10B is a schematic showing the closure device of Figure 1A translated into an access channel of the access sheath such that a distal end of the toggle is positioned distal to a distal end of the access sheath and over a guidewire.

[0023] Figure IOC is a schematic showing the access sheath and closure device combination pulled in a proximal direction such that the toggle is proximate to the puncture site.

[0024] Figure 10D is a schematic showing actuation of the actuator to release the toggle and apply a tension to a filament.

[0025] Figure 10E is a schematic showing the deployment device being pulled in a proximal direction such that the toggle abuts the vessel wall.

[0026] Figure 10F is a schematic showing deployment of a plug of the closure device.

[0027] Figure 10G is a schematic showing deployment of the a locking member against the plug.

[0028] Figure 10H is a schematic showing the locking member being tamped against the plug with a tamper. [0029] Figure 101 is a schematic showing the deployment of the sealing device fully sealing the puncture site.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0030] Certain terminology is used in the following description for convenience only and is not limiting. The words "right", "left", "lower" and "upper" designate directions in the drawings to which reference is made. The words "proximally" and "distally" generally refer to directions toward and away from, respectively, the individual operating the devices, unless noted otherwise. The terminology includes the above-listed words, derivatives thereof and words of similar import.

[0031] Referring to Figures 1A and IB, a vascular closure device 10 in accordance with an embodiment of the present disclosure include a sealing device or implantable unit 100 at least partially disposed within a deployment device 14. The vascular closure device 10 can be configured such that after the deployment device 14 is inserted into a vessel through a puncture site of the vessel, the sealing device 100 is deployed to thereby seal or otherwise close the puncture site of the vessel. The deployment device 14 is further explained below.

[0032] As shown in Figure 1C-2B, the sealing device 100 includes an intra-arterial toggle 104, a sealing plug 108, a suture 112 connecting the toggle 104 and plug 108. The toggle 104, suture 1 12, or both the toggle 104 and the suture 112 may include one or more force responsive components 120 for purposes described below. Specifically, the present inventors have recognized that when a sealing device 100 seals a puncture, toggles fabricated of known absorbable plastics may exhibit plastic creep or deformation until such time as the puncture is healed. Creep or deformation may result in a change of shape or outright failure of the toggle. It is believed that after the vascular closure device is in the sealing position against the puncture, the force responsive components may gradually cause the vascular closure device to expose the defect to full vessel pressure. It is further believed that gradual exposure to full vessel pressure may encourage faster defect healing while maintaining preferable alignment of toggle against the interior vessel wall where it can be readily encapsulated by cellular growth. Embodiments of the present disclosure utilize force responsive components 120, 320, 320 at or near the point where the suture 1 12 is attached to the toggle 104. A force responsive component 120 is a component or portion of the toggle 104 or suture 1 12 that will deform or move in response to a force level that is not sufficient to cause other portions of the toggle 104 or the suture 112 to move or deform. The force responsive components 120 are configured to permit gradual separation of the sealing closure device components, which, in turn, gradually exposes the puncture to full vessel pressure. The force responsive components 120 isolate forces applied to the sealing device 100 to allow for the separation but also minimize deformation in areas where rigidity is needed most, e.g., along a length of toggle 104. The can maintain alignment of the toggle 104 against a surface of the vessel as the sealing device separates, as further described below. Embodiments of the present disclosure include sealing devices with force responsive components 120 configured as a portion of the toggle 104, such as a moveable attachment member 126 illustrated in Figures 1C- 3C, and force response components 320 configured as a moveable attachment member 326 of toggle 304 illustrated in Figures 4A-4C. The present disclosure also include a force responsive component 420 configured as a deformable portion 426 of the suture 112 illustrated in Figure 5.

[0033] The sealing device 100 as described herein is formed with materials suitable for surgical procedures. For instance, the toggle 104 can be made of any biocompatible material. For example, the toggle 104 can be made of a polylactic-coglycolic acid or other synthetic absorbable polymer that degrades in the presence of water into naturally occurring metabolites. In other examples, the toggle 104 can be made of stainless steel, biocorrodible iron, and biocorrodible magnesium. It should be appreciated, however, that the toggle 104 can be made of other materials and can have other configurations so long as it can be seated inside the vessel against the vessel wall. The plug 108 can comprise a strip of compressible, resorbable, collagen foam and can be made of a fibrous collagen mix of insoluble and soluble collagen that is cross linked for strength. The suture 112 can be any elongate member, such as, for example a filament, thread, or braided. In certain examples, a portion of the suture 1 12 is configured to deform when the sealing device is in the sealing position, as further discussed below.

[0034] Turning to Figures 1C-2B, the sealing device 100 includes the toggle 104 connected to the suture 1 12, a plug 108 coupled to the suture 112 and spaced from the toggle 104 in a proximal direction 4, and a locking member 116 proximal to the plug 108. The suture 1 12 is extends through the apertures in the plug 108 as illustrated such that an end of the suture 1 12 is formed into a slidable knot 1 18. The knot 1 18 is slidable along the suture 1 12 between the plug 108 and the locking member 1 16. When the sealing device 100 is in an implanted, sealing configuration, the toggle 104 is adjacent an inner surface of the vessel and the locking member 1 16 compresses the plug 108 against the outer surface vessel toward the toggle 104 while pulling the toggle 104 along a proximal direction 4 so that the toggle 104 is firmly position over the puncture opposite the plug 108. A guide lumen 15 may extend through one or more components of the sealing device 100 and is configured to receive a guide wire 98 as will be discussed below.

[0035] Referring to Figures 2A-3C, the toggle 104 includes a toggle body 122, an opening 124 that extends through the toggle body 122, and at least one force responsive component 120 that extends from the toggle body 122 at least partially into the opening 124. The force responsive component 120 can be an attachment member 126 that includes one or more attachment points 128 that are connected to or receive the suture 1 12. The attachment member 126 is configured to move relative to the toggle body 122 in response to application of tension along the suture 1 12 when the sealing device 100 is in the sealing position. The toggle body opening 124 is also sized to receive a guidewire 98 and guide lumen 15 therethrough adjacent to the force responsive components 120. However, the deployment device 14 can be configured so that the guidewire 98 and guide lumen 15 extends along the side of the toggle 104.

[0036] Continuing with Figures 2A-3C, the toggle body 122 is elongate along a toggle longitudinal axis 8a and includes a distal end 41d (or first end) and a proximal end 41p (or second end) opposed to the distal end 41d along the longitudinal axis 8a . The toggle body 122 further defines a first side 42a and a second side 42b spaced from the first side 42a along a lateral axis 8b that is perpendicular to and intersects the longitudinal axis 8a. The first and second sides 42a and 42b can be curved to define wing portions (not numbered) disposed about equidistant with respect to the first and second ends 41d and 41p. The winged portions expand the coverage area along the vessel proximate the puncture. The toggle body 122 further defines a first surface 43a, a second surface 43b opposed to the first surface 43a along a transverse axis 8c that is perpendicular to the longitudinal and lateral axes 8a and 8b. The first surface 43a may be referred to as the proximal surface and the second surface may be referred to as the distal surface. When in the sealing positions(Fig. 2B), the proximal surface 43 a of the body 122 is opposed to a distal surface of the plug 108. Furthermore, the toggle body 122 can define a length 9a that extends from the first end 41d to the second end 41p, a width 9b that extends from the first side 42a to the second side 42b along the lateral axis 8b, and thickness 9c that extends from first body surface 43a to the second body surface 43b. The toggle body 122 can be curved along the width 9c to conform to the vessel wall and can be linear or flat along the length 9a. Other shapes or profiles are possible. As illustrated, the toggle body length 9a is greater than the width 9b, and the width 9b is greater than the thickness 9c. It should be appreciated that in alternative embodiments, the length 9a and the width 9b could be about equal to each other to define a more circular shaped toggle body.

[0037] In accordance with the embodiment illustrated in Figures 3A-3C, the attachment member 126 extends from the toggle body 122 into the opening 124 along a direction that is oblique to the thickness 9c. This angle positions the attachment points 128 within the opening 124 and places terminal ends (not numbered) of the attachment member at or below a plane that contains the distal surface 43b of the toggle body 122. This can provide for a longer travel path for the attachment points 128 as tension applied to the suture 112 causes the attachment member 126 bend relative to the toggle body 122. The result can be a more extensive separation of the sealing device 100 over time. In the example shown, the attachment member 126 is elongate along an axis that is perpendicular to the longitudinal axis 8a and is also angularly offset with respect to the lateral axis 8b and the transverse axis 8c (or thickness 9c as described above). However, it should be appreciated that the attachment member 126 can have any number of configurations and orientations with respect to the toggle body 122 that can facilitate its movement with respect to the toggle body 122. For example, the attachment member 126 can extend from the toggle body into the opening 124 along a direction that is perpendicular to the thickness 9c. Furthermore, in the example shown in Figures 4A-4C and discussed below, the attachment member 326 is elongate along an axis that is perpendicular to the lateral axis 8b and is angled with respect to the longitudinal axis 8a.

[0038] Continuing with Figures 3A-3C, the toggle 104 includes a first attachment member 126a and a second attachment member 126b that extend into the opening 124. The first and second attachment members 126a and 126b include first and second attachment points 128a and 128b, respectively, each of which are connected to the suture 112. Reference number 126 is used interchangeably with reference number 126a and 126b to refer to attachment members, unless noted otherwise. Reference number 128 is used interchangeably with reference number 128a and 128b to refer to attachment points unless note otherwise.

[0039] Continuing with Figures 3A-3C, each attachment member 126 can be a bendable tab and a hinge disposed along the toggle body 122. In accordance with the illustrated embodiment, the first attachment member 126a is a first bendable tab 130a and a first hinge 132a. The second attachment member 126b is a second bendable tab 130b and a second hinge 132b. The first and second bendable tabs 130a and 130b extend from and bend about first and second hinges 132a and 132b, respectively. As illustrated, the attachment points 128a and 128b are first and second apertures, respectively. The first and second apertures extend through the first and second tabs 130a and 130b, respectively. Each aperture is sized to receive the suture 1 12. The attachment members 126a, 126b are intended to flex, bend or creep over a period of time once the sealing device 100 is transitioned into the sealing position and the plug 108 is locked in place along the suture 1 12. This function may be facilitated with hinges 132a, 132b. The hinges 132a, 132b may be a thinned, intentionally weakened area configured to permit bending. The stiffness of the attachment members 126a, 126b may be tuned by varying the depth of hinges 132a, 132b to achieve the desired bending desired during tensioning the sealing device 100 in position. The bending may also be modified by varying the thickness of the attachment member 126a, 126b, varying the depth of the hinge point, or utilizing some other alternate geometry of the hinge 132a, 132b.

[0040] Continuing with Figures 1C- 2B, the plug 108 is disposed along the suture 112 proximally with respect to the toggle 104. The plug 108 is configured to transition between an initial or deployment configuration where the plug 108 is slidable along the suture 112 and a locked configuration where the plug 108 is fixed to the suture 1 12. When the plug 108 is in the initial configuration, the plug 108 is a generally elongate and may be housed in with the deployment device 14, as shown in Figure 1C. In the initial configuration, the plug 108 can slide along the suture 112 to toward the toggle 104 in the distal direction 2 to abut the outer surface of the vessel wall. The plug 108 is further configured to transition or compress into a folded structure as illustrated in Figure 2B via a tamper 234 (Fig. 10G) .

[0041] Referring to Figure 2B, when the plug 108 is in the locked configuration, the knot 118 and locking member 1 16 lock the plug 108 in place along the suture 1 12 and compress the plug 108 against the vessel wall 204. In the locked configuration, the plug 108 defines a distal surface 140 that is opposed to and faces the proximal surface 43 a of the toggle 104. It should be appreciated, however, that the plug 108 could be any structure that can cover the puncture and is not limited to a plug the folds down when compressed and locked in place.

[0042] Continuing with Figure 1C-2B, one end of the suture 112 is woven through the sealing plug 108, through first aperture 128a, through the second aperture 128b, back through the plug 108 and is tied off into knot 118. Suture knot 118 may be made to slide or otherwise tighten the loop formed by the tied suture 1 12, which upon tensioning will apply the compression needed to close the vessel puncture with the plug 108 and toggle 104. The locking member 116 can secure the plug 108 in place and maintain tension between a locking point, where locking member 1 16 and knot 1 18 contact the plug 108, and the attachment point 128, where the suture 1 12 is connected to the toggle 104. It can be seen in Figure 2B that when the plug 108 is in the locked configuration, the plug 108 is fixed to the suture 1 12 relative to the toggle body 122 by a distance D (Figure 2B). The distance D extends from the distal surface 140 of the plug 108 to the proximal surface43a of the toggle body 104 along a distal direction 2. Tension along a portion between plug 108 and toggle 104 cause relative movement between the attachment member 126 and the toggle body 122, which increases the distance D. Depending on the force components, the attachment members 126 may remain stationary while toggle body 122 moves with respect to the attachment points 128. Alternatively, the toggle body 122 may remain stationary while the attachment member 126 moves with respect to toggle body 122. In also possible that both toggle body 122 and the attachment members 126 may move relative to each other to increase the distance D.

[0043] Continuing with to Figure 2B, the vessel puncture 200 in an artery wall 204 may be sealed by the sealing device 100 with the toggle 104 and sealing plug 108, which are connected by the suture 1 12. As noted above, the suture 112 applies sufficient compression between the toggle 104 and plug 108 to withstand intra-vessel pressure. The advantage of the sealing device with the force responsive components 120 (e.g. attachment member 126) described above may be better appreciated after a short description of the how a puncture is created and the healing process that occurs after the puncture is sealed. During access to the vessel, a hollow needled is inserted into the vessel, through which a guidewire is passed into the vessel lumen. The needle is removed, leaving the guidewire passing from the outside of the patient through the skin and subcutaneous tissue and into the vessel, and along the interior of the vessel lumen. The puncture in the vessel wall at this stage is generally round, and somewhat tight fitting to the needle. Subsequent steps in vessel access involve inserting sequentially larger catheters over the guidewire to enlarge the puncture to the point at which a sufficiently large sheath may be placed in the vessel to provide a port or passageway for the intended percutaneous tools (stents, PTCA catheters, stent valves, etc.). Once the vessel puncture is stretched open beyond 5-6F (2 mm), depending upon vessel character, the vessel tears across the length, that is, laterally. This lateral tear can be difficult to close or otherwise provide a difficult site for hemostasis management. For large bore punctures, generally greater than 18F, this lateral tear can be as large as 8 mm or more. Further, once the vessel is breached, blood pressure continually works to keep the puncture site open. As puncture sizes get larger, so too, does the stress acting upon any member employed in closure, assuming that the seal is complete without leakage. A larger puncture requires a larger size seal, and a large seal (more exposed area) requires greater force to seal. This force is greatest initially when a sealing member is applied, and reduces over time as the puncture heals and supporting tissue grows over and within the puncture to heal the vessel wall. Thus, initially a seal must support full blood pressure, but over time, less and less force is required. As the vessel begins to assume more and more pressure, the healing can progress rapidly. Similar to bone, long term shielding of the puncture is not recommend, and full healing is facilitated by gradual uptake of the vessel wall to full vessel pressure, in a timeframe appropriate for healing.

[0044] Continuing with Figure 2B, after sealing device is deployed into the sealing position as shown, the sealing device 100 is compressed on either side of the puncture, with the sealing plug 108 holding back blood pressure. The force of the blood pressure is borne by the suture 112, which is ultimately connected to the toggle 104 and locking member 116 and knot 1 18. Thus, the toggle 104 and specifically the toggle body 122 distribute this force along the inside of the vessel. In the case of a polymer toggle, and more specifically an absorbable polymer toggle, this force can creep, or steadily deform the toggle body 122 over time. In the worst case, this may lead to the toggle body 122 being ejected from the puncture, pulled out by the force acting on the sealing plug 108. More commonly, it has been observed that the toggle body may bend slightly at the point of attachment. Absorbable polymers are generally non- thrombogenic and well tolerated in blood flow and a bent toggle body may not present difficulties with the healing puncture. However, too much bending slows down the cellular encapsulation process. It is preferred that the toggle body 122 stays flat on the vessel wall 204 to minimize encapsulation time. Suture attachment members 126 (See Figure 2A and 3B) accomplish this by gradually bending from the forces applied to the sealing plug 108 and toggle 104 over a time relevant to healing. This allows the healing vessel defect to be exposed to blood pressure gradually, while allowing the specific deformation, or movement of the toggle 104 at a point where the toggle body 122 is not affected by the needed deformation. In other words, the attachment members 126 permit a localized deformation or movement of a portion of the toggle 104 while not causing an overall deformation of the entire toggle body 122. Thus, the sealing plug 108 may be displaced relative to the toggle bodyl22 by about 1.0 to about 2.0 mm (or more) without bending the toggle body 122. While the above description refers to sealing device 100, the advantages would apply to alternative sealing devices 300 and 400 discussed below and illustrated in figures 4A-5. [0045] Figures 4A-4D illustrate an alternative embodiment of a sealing device 300 that includes toggle 304 with a force responsive component 320. Similar reference numbers are used for features that are common between sealing device 300 illustrated in Figures 4A-4D and sealing device 100 illustrated in Figures 1A-3C. In accordance with the illustrated embodiment, the sealing device 300 includes a suture 112, a toggle 304 connected to the suture 1 12 at an attachment point 328, and a plug 108 disposed along the suture 1 12. Figure 4D illustrates the sealing device 300 in a sealing position on vessel wall 204 and the plug 108 in the locked configuration. The toggle 304 includes a toggle body 322, an opening 324 that extends through the toggle body 322, and at least one force responsive component 320 that extends from the toggle body 322 at least partially into the opening 324 and that is connected to the suture 112 (Figure 4D). The force responsive component 320 can be an attachment member 326 that includes one or more attachment points 328. The attachment member 326 is configured to move relative to the toggle body 322 in response to application of tension along the suture 1 12 when the plug 108 is in the locked configuration as illustrated in Figure 4D.

[0046] Continuing with Figures 4A-4C, in accordance with the illustrated embodiment, the attachment member 326 extends from the toggle body 322 into the opening 324 along a direction that is oblique to the thickness 9c. This angle positions the attachment points 328 within the opening 324 and places the attachment member terminal ends 334 at or below a plane that contains the distal surface 43b of the toggle body 322. This can provide for a more extensive path of travel when tensions is applied to suture 112 and the attachment member 326 bends relative to the toggle body 322, which, in turn permits more extensive separation of the sealing device 300. In the example shown the attachment member 326 is elongate along an axis that perpendicular to the lateral axis 8b and oblique with respect to the transverse axis 8c (or thickness 9c). However, it should be appreciated that the attachment member 326 can have any number of configurations and orientations with respect to the toggle body 322 that can facilitate its movement with respect to the toggle body 322. For example, the attachment member 326 can extend from the toggle body 322into the opening 324 along a direction that is perpendicular to the transverse axis 8c.

[0047] Continuing with Figures 4A-4C, the attachment member 326 can be a bendable tab 330 having a base 332 disposed at the toggle body 322 and a terminal end 334 opposed to the base 332 and disposed at least partially within the opening 324. As illustrated, the bendable tab 330 is extends from the body 322 along a direction that is oblique with respect to the thickness 9c of the toggle body 322. The underside of the bendable tab defines an attachment point 328 configured as a groove 338 that receives the suture 1 12. The attachment point 328 could be an aperture as well. The toggle body 322 includes first and second attachment points 128a and 128 configured as first and second apertures, respectively. The first and second apertures extend through the body 322 along the thickness 9c and are further disposed on opposite sides of the bendable tab 330. The suture 1 12 is woven through the first aperture 328a, along the groove 338 of the bendable tab 330, and through the second aperture 328b and tied into a knot 118. Tension applied to the suture 112 causes the bendable tab 330 to bend relative to the toggle body 322.

[0048] Continuing with Figures 4A-4D, when the sealing device 300 is deployed and in the sealing position, tension along the suture 1 12 between the locking member 1 16 on the plug 108 and the attachment point 328 cause the eventual deflection (or creep) of the bendable tab 330 with respect to toggle body 322. Movement of the bendable tab 330 permits separation of the plug 108 and toggle 304 such that the distance D2 between the plug distal surface 140 and proximal surface 43a of the toggle body 322 increases. When in sealing position as shown in Figure 4D, the toggle body 322 remains aligned along the vessel wall 204 while the force responsive component 320 (illustrated as the attachment member 326) moves relative to the toggle body322 due to applied tension along a portion of the suture 1 12 between the plug 108 and the toggle 304. It should be appreciated that there are many arrangements of a tab, cantilever, or other attachment methods that would result in intentional creep or deflection such as to protect the toggle body from sustained bending forces during the puncture healing process.

[0049] An alternative embodiment of a sealing device 400 as illustrated in Figure 5 will now be described. Similar reference numbers will be used for features that are common between the sealing device 100 illustrated in Figures 1A to 3C and the sealing device 400 illustrated in Figure 5. In accordance with the illustrated embodiment, the sealing device 400 includes a force responsive component 420 disposed along suture 1 12, a toggle 404 connected to the suture 112 at one or more attachment points (not shown), and a plug 108 disposed along the suture 1 12 in a proximal direction 4 relative to the toggle 404. Figure 5 illustrates the sealing device 400 in a sealing position on the vessel wall 204 and the plug 108 in the locked configuration. The toggle 404 includes a toggle body 422 that defines the one or more attachment points 128. In the sealing device 400, the force control component 420 is configured as a deformation portion 426 of the suture 1 12. As illustrated, the deformation portion 426 extends between the plug 108 to the toggle body 422. The deformation portion 426 may include one or all of the legs of the loop that connects the toggle 404 to the plug 108.

[0050] Continuing with Figure 5, when the sealing device 400 is in sealing position over a puncture, tension applied to the sealing device 400 causes the eventual elongation of the deformation portion 426 of the suture 112. The deformation or creep of the suture 112 between the plug 108 and toggle 404 increases the distance D2 between the plug distal surface 140 and proximal surface 43a of the toggle body 422. Increasing the distance, D3 separates the sealing device 400. As the sealing device 400 separates, i.e. the plug 108 and toggle 404 move away from each other, the toggle body 422 remains aligned along the vessel wall 204 while the force responsive component 420 (illustrated as the deformation portion 426 of the suture 1 12) deforms. Thus, the force responsive component 420 can localize deformation away from areas where rigidity and stiffness are needed most over the course healing— in this case away from toggle body 422.

[0051] The sealing devices 100, 300 and 400 described above can be inserted into the puncture using deployment device 14. Referring to Figures 1A to 1C, the deployment device 14 is configured to implant the sealing device 100 at the puncture to form a seal. The deployment device controls orientation of the toggle 104 of the sealing device 100 during deployment of the sealing device 100. In accordance with the illustrated embodiment, the deployment device 14 includes a release component 22 (shown in dashed lines in Figures 1A and IB) that restrains the toggle 104, a delivery component 26 (also shown in dashed lines in Figure 1A and IB), the suture 112, and one or more actuators 38 coupled to the release component 22. The release component 22 is operatively associated with the suture 112 such that actuation of the actuator 38 causes the release component 22 to 1) release the toggle 104, and 2) apply tension to the suture 1 12, which urges the toggle 104 against the delivery component 26 and orients the toggle 104 in the sealing position in the vessel.

[0052] Continuing with Figures 1A, IB and 1C, the deployment device 14 is elongate along a longitudinal direction L and includes a proximal end 16p and a distal end 16d spaced from the proximal end 16p along an axis 6 that is aligned with the longitudinal direction L. The longitudinal direction L can include and define a distal direction 2 that extends from the proximal end 16p toward the distal end 16d. Further, the longitudinal direction L can include and define a proximal direction 4 that is opposite the distal direction 2 and that extends from distal end 16d toward the proximal end 16p. The deployment device 14 is configured to insert the toggle 104 into the vessel along an insertion direction I. The longitudinal direction L is aligned with the insertion direction I during a portion of the sealing procedure.

[0053] Turning to Figures 1A and IB, in accordance with the illustrated embodiment, the deployment device 14 includes a handle member 20, the release component 22 supported by the handle manner 20 and extending from handle member 20 in the distal direction 2, the delivery component 26 also supported by the handle member 20 and extending along the distal direction 2, and a tensioner 28 supported by the handle member 20 and positioned adjacent to the release component 22. A portion of delivery component 26 is shown in dashed lines in Figure 1A and IB. The actuator 38 is coupled to both the handle member 20 and the release component 22. As noted above the actuator 38 is configured to 1) cause the release component 22 to move in the proximal direction 4 from a first or initial position relative to the delivery component 26 into a second or releasing position relative to the delivery component 26, and 2) apply a tensile force to the suture 1 12 during or subsequent to movement of the release component 22 from the initial position into the release position. The description below refers to the release component 22 being moveable relative to the delivery component 26. But the deployment device 14 can be configured so that the delivery component 26 is moveable relative to the release component 22. The deployment device 14 also includes the guide lumen 15 that extends through the deployment device 14, and an optional outer sheath 23 that contains and supports portions of the release component 22 and delivery component 26.

[0054] Continuing with Figures 1 A and IB, the handle member 20 includes a housing 21a, a sheath hub 21b and a cavity 21c defined at least partly by housing 21a and sheath hub 21b. The cavity 21c is sized to contain a portion of the release and delivery components 22 and 26 and the tensioner 28. The optional outer sheath 23 extends from the sheath hub 21b in the distal direction 2 along the release and delivery components 22 and 26. The sheath hub 21b mates the access sheath 208 (Figures 10A).

[0055] Turning to Figures IB, 8 and 9, the release component 22 is elongate along a first or longitudinal direction L defines a distal end 25 d and a proximal end 25p spaced from the distal end 25 d along the longitudinal direction L. In accordance with the illustrated embodiment, the release component 22 includes a release hub 24 and a release tube 46 that is fixed to the release hub 24 extends from the release hub 24 in the distal direction 2. The release hub 24 includes a pair of tabs 29a, 29b disposed at the proximal end 25p of the release component 22. A pulley 60 is coupled to the tabs 29a, 29b and defines a curved track that receives the suture 1 12 as will be explained below. The hub 24 defines a slot 47 that is elongate along the longitudinal direction L and is aligned with the release tube 46. The slot 47 is sized to receiver a coupler 30 of the tensioner 28.

[0056] Referring to Figures 6D-6F, the release tube 46 includes a release tube body 48 that is elongate along the longitudinal direction L. The release tube body 48 defines a release tube channel 52 (Figures 6D, 6F) that extends along the longitudinal direction L from the hub 24 toward the proximal end 25p. In the illustrated embodiment, the release tube channel 52 (Figure 6D) extends completely through the release tube body 48 from the hub 24 to the distal end 25d. Furthermore, in the illustrated embodiment the release tube body 48 is cylindrical such that the release tube channel 52 is radially enclosed. It should be appreciated, however, that the release tube channel 52 can extend partially through the release tube body 48 as desired and that the release tube body 48 can have other configurations as desired. For example, the release tube body 48 can be U-shaped such that the release tube channel 52 is partially radially open. As best shown in Figure 6F, the release tube channel 52 is sized to slidably receive a portion of the delivery component 26 such that the release component 22 is movable relative to the delivery component 26.

[0057] Referring to Figures 6A, 6B, 6D, and 9, the pulley 60 is disposed at the proximal end 25p of the release component 22. As shown, the suture 1 12 extends around the pulley 60 along the guide track and into the tensioner 28. As the release component 22 is pulled in the proximal direction 4, the pulley 60 pulls the suture 112 in proximal direction 4 thereby applying a tensile force to the toggle 104. In such an embodiment, the tensioner 28 is positioned alongside the release component 22. It should be appreciated, however, that in some embodiments, the tensioner 28 is positioned proximal to the release tube and is in-line with the release component 22 such that the suture 1 12 extends through the release tube and into the tensioner 28 along the first direction L.

[0058] With continued reference to 6A, 6B, 6D, and 9, the release component 22 can include at least one mating member 64 that mates with a corresponding mating member 68 of the actuator 38 to thereby transfer the motion of the actuator 38 to the release component 22. In the illustrated embodiment, the release component mating member 64 is a pair of slots 65a and 65b defined by the respective pair of tabs 29a and 29b. Each slot 65a and 65b is elongate along a direction a vertical direction V that is perpendicular to the first direction L. The actuator 38 mating member 68 can be operatively engaged with elongate slots 65a and 65b of release component 22 such that actuation of the actuator 38 causes the release component 22 to translate along the first direction L. It should be appreciated, however, that the mating member 64 can have any configuration as desired. For example, the mating member 64 can be bore having a diameter that is equal to that of the pin such that translation of the actuator 38 along the first direction L causes the release component 22 to translate along the first direction L.

[0059] As shown in Figures IB, 6D-7, the delivery component 26 is coupled to the tensioner 28 and extends along the release component 22 toward the distal end 16d of the deployment device 14. In accordance with the illustrated embodiment, because the tensioner 28 is fixed to the housing 21a, the delivery component 26 is fixed to the housing 21a and thus the handle member 31. The delivery component 26 includes a delivery tube body 80 that is elongate along the first direction L and defines a distal end 27d and a proximal end 27p spaced from the distal end 27d in the first direction L. The delivery tube body 80 defines an inner surface 81, which in turns defines a delivery tube channel 84 that extends at least partially through the delivery tube body 80 along the first direction L. As illustrated, the delivery tube channel 84 extends completely through the delivery tube body 80 from the proximal end 27p to the distal end 27d. However, the channel 84 can extend along a portion of the delivery tube body 80. Furthermore, in the illustrated embodiment the delivery tube body 80 is cylindrical such that the delivery tube channel 84 is radially enclosed. It should be appreciated, however, that the delivery tube channel 84 can extend partially through the delivery tube body 80 as desired and that the delivery tube body 80 can have other configurations as desired. For example, the delivery tube body 80 can be U-shaped such that the delivery tube channel 84 is partially radially open. As illustrated, the proximal end 27p of delivery component is fixed to the tensioner 28 and the distal end 27d of delivery component is configured to hold at least a portion of the sealing device 100, 300, 400(Figure 1C).

[0060] The delivery tube channel 84 is sized to retain at least a portion of the sealing device 100, 300, 400. In particular, the plug 108 and locking member 116 are retained within the delivery tube channel 84, while the toggle 104 is configured to be initially trapped between the delivery component 26 and the release component 22. For instance, the distal end 25d of the release tube 48 defines an offset surface 49, which can be angled with respect to the longitudinal axis 6. The offset surface 49 and inner surface 81 of the delivery tube 80 define a cavity 51 that receives the proximal end 41p of the toggle 104 when the release component 22 is in the initial position (as shown in Figure 1C). The angle of the offset surface 49 can define the orientation of the toggle 104 in this initial position, whereby the distal end 41 d of the toggle 104 is spaced some distance in the distal direction 2 beyond the distal ends 25d and 27d of the release and delivery components 22 and 26, respectively. The suture 112 extends from the toggle 104 through the delivery tube channel 84, through the proximal end 27p (Figure 6D) around the pulley 60 along the guide track and is coupled to the tensioner 28. The guide lumen 15 extends through the channel 84 and exits the distal end 16d of the vascular closure device 10. When the actuator 38 is actuated as will be further detailed below, the release component 22 moves in the proximal direction 4 thereby releasing the proximal end 41p of the toggle 104 from between the release component 22 and the delivery component 26. As the release component 22 moves in the proximal direction 4, the suture 1 12 will be pulled in the proximal direction 4 to thereby place the suture 1 12 in tension and urge the toggle 104 against the distal end 27d of the delivery component 26. At this point, the toggle 104 is oriented in the sealing position (see Figure 10D). In the sealing position, the toggle 104 has been repositioned so that the toggle 104 is placed against the distal end 27d of the delivery component 26 and is oriented more transversely with respect to the axis 6 compared to the position when the toggle 104 is restrained by the release component 22.

[0061] As shown in Figures 6D-6F and 7, the tensioner 28 disposed on the delivery component 26 and is positioned alongside the release component 22 to receive the suture 112 as noted above. In accordance with the illustrated embodiment, the tensioner 28 includes a tensioner housing 90, a coupler 30 that extends from the housing 90 and is attached to the delivery component 22, and a drag member 94 disposed within the tensioner housing 90. The suture 112 extends into the tensioner housing 90 through the drag member 94 and such that a frictional force is applied to the suture 112 by the drag member 94. The tensioner housing 90 is coupled to the housing 21a. The coupler 30 as illustrated is a tubular component that receives the proximal end 27p of the delivery tube body 80. As illustrated, the delivery tube body 80 is fixed to the coupler 30, which indirectly fixes the delivery component 26 to the housing 21a. The suture 112 extends from the proximal end 27p of the delivery tube body 80, through the coupler 30, around the pulley 60, and into the drag member 94 for spooling within the tensioner housing 90 (not shown). Spooling the suture 1 12 in the tension housing 90 allows suture 112 to dispense from the deployment device 14 when the deployment device 14 is pulled is proximal direction 2 to thereby deploy the sealing device 100, 300, 400 (see Figures 10E and 10F). The frictional force applied to the suture 112 by the drag member 94 can be high enough to maintain the suture 1 12 in tension after the actuator 38 has been actuated and the toggle 104 has been urged against the distal end 27d of the delivery component 26. At the same time, the frictional force applied to the suture 1 12 by the drag member 94 can be low enough to allow the suture 1 12 to dispense from the tensioner housing 90 when the deployment device 14 is pulled in a proximal direction 4 relative to the toggle 104. In the illustrated embodiment, the drag member 94 is a silicon member that pinches the suture 1 12. The tensioner 90 and drag member 94 can be similar the tensioner described in U.S. Patent Application Publication No. 2013/0178895. It should be appreciated, however, that the drag member 94 can have other configurations as desired.

[0062] Turning to Figures 6A-6D, the deployment device 14 can include one or more actuators. The actuators are configured to A) transition the release component 22 into a releasing position, and B) cause a tension to be applied to suture 112 when toggle 104 is released from the release component 22 as described above. As noted above, the actuator 38 can include the mating member 68 that operatively engages the mating member 64 of the release component 22 such that motion of the actuator 38 relative to the handle member 20 causes the release component to translate in the proximal direction 4 and further applies a tension to the filament.

[0063] In accordance with the illustrated embodiment, the actuator 38 can be configured as a lever that is rotatably coupled to the handle member 20. The actuator 38 or lever can include a pair of side members 71 rotatably coupled to each side of the housing 21a, a first leg 39 that extends from one of the side members 71, a second leg 37 that extends from the other side member 71, and a transverse member 114 that connects the first leg 39 to the second leg 37. The actuator 38 is configured to pivot about a pivot axis AP that is perpendicular to the axis 6. The pivot axis AP may or may not intersect axis 6. The housing 21a defines a curved housing slot 67 that is curved with respect to the pivot axis AP. The curved housing slot 67 has a first end 69a (Fig. 6D) and second end (not numbered) spaced apart from the first end along the proximal direction 4. The mating member 68 of the actuator 38 can be a pin 68 that is coupled to and extends between the side members 71 at a location that is offset from the pivot axis AP. The pin 68 extends through curved housing slot 67 and through the elongate slots 64a and 64a of the hub 24 of the release component 22 such that the actuator 38 is operatively coupled to the release component 22. As the actuator 38 pivots about the pivot axis AP, the pin 68 moves from the first end 69a the curved housing slot 67 toward the second end of the curved housing slot 67, and also moves along the slots 64a and 64b along the vertical direction V. Because the release component 22 is moveable relative to housing 21a, as pin 68 moves along the curved housing slot 67, the pin 68 advances the hub 24 of the release component 22 in the proximal direction 4. The result in accordance with the illustrated embodiment is that rotation of the actuator 38 causes the release component 22 to translate in the longitudinal direction L. It should be appreciated, however, that the actuator 38 can have other configurations as desired and is not limited to the disclosed lever.

[0064] In operation, the deployment device 14 is initially configured to insert the toggle 104 into the vessel. When the actuator 38 is actuated, the release component 22 moves in the proximal direction 4 relative to the delivery component 26 into the releasing position (not illustrated) thereby releasing the proximal end 41p of the toggle 104 from between the release component 22 and the delivery component 26. As the release component 22 moves in the proximal direction 4, the suture 112 will be pulled in the proximal direction 4 to thereby place the suture 1 12 in tension and urge the toggle 104 against the distal end 27d of the delivery component 26. At this point, the toggle 104 is oriented in the sealing position (see Figure 10D). Accordingly, the release component 22 is configured to restrain the toggle 104 of the sealing device 100, 300, 400 during insertion of the vascular closure device 10 into the vessel and subsequently release the toggle 104 so that the toggle 104 can be oriented for the sealing procedure.

[0065] The release component 22 is in communication with the suture 1 12 via the pulley 60 such that when the actuator 38 is actuated the release component 22 pulls the suture 1 12 in the proximal direction placing the suture 1 12 in tension. Application of tension along the suture 112 urges the toggle 104 against the distal end 27d of the delivery component 26 and orients the toggle 104 into the sealing position. In the illustrated embodiment, the actuator 38 and release component 22 are configured such that continuous movement of the actuator 38 relative to the housing 21a will move the release component 22 in the proximal direction 4, thereby releasing the toggle 104 from the release component 22 and subsequently apply tension to the suture 1 12. It should be appreciated, however, that in some embodiments the suture 1 12 can be tensioned as the toggle 104 is being released. It should further be appreciated that in some embodiments, the device 14 can include a first actuator to release the toggle 104 and a second actuator that tensions the suture 1 12.

[0066] The release component and delivery components 22 and 26 are described above has having tubular shaped bodies. It should be appreciated that the release and delivery components can have other configurations. For instance, the release component can be elongate rod, or an elongate rod with a tubular ring coupled to its distal end. The delivery component can be configured such that only a portion thereof has a tubular shape.

[0067] Embodiments of the present disclosure will now be described with respect to exemplary large bore procedures that utilize the vascular closure device 10 and sealing devices 100, 300, 400 to seal the puncture. After the relevant procedure is completed, the puncture site in the artery created by the bore needle during percutaneous access of the artery may be closed. The vascular closure device 10 may be used to seal the puncture site. Figures 10A-10H show schematic views of the vascular closure device 10 during the process of closing the puncture site 200 in a vessel (e.g. artery) wall 204.

[0068] Now in reference to Figure 10A, to deliver the vascular closure device 10 to the puncture site 200 so that the closure device 10 can seal the puncture site 200, the

introducer/procedure sheath set is replaced with a closure access sheath 208. For example, as shown in Figure 10A, the procedure sheath is exchanged for the closure access sheath 208 by removing the procedure sheath from the patient, leaving the guide wire 98 in place, and subsequently moving the closure access sheath 208 along the guide wire 98 or otherwise positioning the access sheath 208, such that a portion of the access sheath 208 is disposed within the vessel through the puncture site 200. As shown in Figure 10A, the access sheath 208 defines a distal end DA, a proximal end PA, and an access channel 212 that extends from the proximal end PA to the distal end DA along an insertion direction I. The access sheath 208 further includes a sheath hub 216 at its proximal end PA. The sheath hub 216 is configured to couple to the vascular closure device 10 when the vascular closure device 10 is inserted into the access channel 212 along the insertion direction I.

[0069] As shown in Figure 10B, the vascular closure device 10 can be positioned by translating the vascular closure device 10 into the access channel 212 along the insertion direction I such that the toggle 104 protrudes from the distal end DA of the access sheath 208 and into the vessel. Once fully inserted, the vascular closure device 10 can couple to the sheath hub 216. As shown in Figure 10B, a proximal end the toggle 104 is trapped within the release component 22 between the release component 22 and the delivery component 26 while the vascular closure device 10 is being moved into the vessel through the puncture site 200 of the vessel. While the proximal end of the toggle 104 is trapped, the toggle 104 is oriented in a pre- sealing position whereby at least the proximal end of the toggle 104 is prevented from dragging against the vessel wall during positioning of the toggle 104 within the vessel. [0070] Once the vascular closure device 10 is properly positioned within the access sheath 208, the toggle 104, and in particular, the entire access sheath 208 and vascular closure device 10 combination can be moved proximally such that the toggle 104 is adjacent the puncture site 200. While the toggle 104 is being positioned adjacent the puncture site 200 the toggle 104 is in the pre-sealing position as shown in Figure IOC. And once the toggle 104 is in position, the actuator 38 is actuated to thereby release the toggle 104 from the release tube and subsequently apply a tension to the suture 1 12 so as to pull the toggle 104 against the distal end of the delivery component 26 as shown in Figure 10D. At this point, the toggle 104 will be oriented in a sealing position as shown in 10D.

[0071] With the toggle 104 in the sealing position as shown in Figure 10E, the deployment device 14 along with the access sheath 208 can together be pulled proximally such that the toggle 104 abuts the vessel wall 204. As shown in Figure 10F, further pulling of the device 14 and sheath 208 will cause the sealing device 100, 300, 400, including the toggle 104, plug 108, a locking member 1 16, suture 1 12, and a tamper 234, are fully withdrawn from the delivery component 26. By pulling on the suture 112 in a direction away from the vessel (i.e. in a direction opposite the insertion direction I) the suture 112 is tensioned and the toggle 104 is moved fully into position against an inner surface of the vessel wall at the puncture site 200. The tension in the suture 1 12 also pulls the plug 108 into the puncture site 200, and causes the plug 108 to substantially fill the puncture site 200 as shown in Figure 10G. After the plug 108 is in contact with blood or other fluids within the puncture site 200, the plug 108 will expand and fill the remainder of the puncture site 200.

[0072] After the user has pulled the suture 1 12 to cause tension in the suture 1 12 and to cause the plug 108 to enter the puncture site 200, the user advances the tamper 234 along the guide wire 98 and the suture 112. As shown in Figure 10H, the tamper 234 contacts the locking member 1 16 and advances the locking member 116 along the suture 1 12 until the locking member 1 16 contacts the plug 108 and presses the plug 108 against an outer surface of the vessel. As the plug 108 is compressed by the tamper 234 the plug 108 folds over the top of and inside the puncture site 200. It should be appreciated, however, that in some embodiments, the delivery component 26 is pulled such that the plug 108 is removed from the delivery component 26 within the release component 22 and the tamper 234 is employed within the release component 22. In such an embodiment, the release component 22 helps control the plug 108 as it is being tamped against the puncture site. [0073] As shown in Figures 10H, the locking member 116, together with the plug 108 and the toggle 104 effect a seal of the puncture site 200. As shown in Figure 10H, tension is maintained on the suture 112 throughout the deployment of the plug 108 from the delivery component 26. After the puncture site 200 is sealed, the guide wire 98 can be removed as shown in Figure 101. As the guide wire 98 is removed, the suture 1 12 remains in tension and the user can re-compress the plug 108 with the tamper 234 as desired to confirm a proper seal of the puncture site 200. the suture 112 can be cut so that the remaining suture 112, tamper 234, and other components of the sealing device 100, 300, 400 can be removed from the puncture site 200, as shown in Figure 101. Once properly sealed, remaining portions of the sealing device 100, 300, 400, including the toggle 104, plug 108, portion of suture 1 12, and locking member 1 16 (depending on material used) will resorb into the body of the patient over time.

[0074] More specifically, when implanting sealing devices 100 and 300 with force response component s 120, 320, the plug 108 I locked in place along the suture 112 with the locking member 116 so that the sealing device 100,300 is fixed in the sealing position. Tension applied along the suture 112 can cause the force response component s 120, 320 to move relative to the toggle body 122,322, which causes relative movement between plug 108 and the toggle 104, 304. When the plug 108 is in the locked configuration, the plug 108 is fixed to the suture 1 12 relative to the toggle body 122, 322 a distance D, Dl (Figure 2B, 4D). Tension applied along the suture 112 causes relative movement between the force responsive component 120, 320 and the toggle body 122, 322. This relative movement increases the distance D, Dl between the plug 108and the toggle body 122,322. Increasing the distance D, Dl between the plug 108 and toggle body 122,322 after placing the sealing device 100,300 in the sealing position facilitates the gradual uptake of the vessel wall to full vessel pressure.

[0075] In the example where the sealing device 400 used to seal the puncture, the plug 108 is locked in place along the suture 1 12 and the locking member 1 16 compressed against the plug 108 so that the device 400 is in the sealing position. Tension applied along the suture deforms the deformation portion 426 of the suture 112, thereby causing the plug and toggle body to separate. More specifically, when the plug is in the locked configuration, the plug 108 is fixed to the suture relative to the toggle body by a distance D2 (Figure 5). Tension applied along the suture causes the suture to elongate, which increases the distance between the plug and the toggle body. Increasing the distance between the plug and toggle body after placing the sealing device 400 in the sealing position facilitates the gradual uptake of the vessel wall to full vessel pressure. [0076] Embodiments of the present disclosure include sealing devices with force responsive components 120, 320, 420 that are configured to facilitate gradual separation of the plug from the toggle. The force responsive components are configured to permit the gradual separation of the sealing device about the puncture. The force responsive components can be bendable tabs with hinges, tabs configured as cantilevers, or any other configuration or device that allows an attachment point where the suture is connected to the toggle to be displaced relative to the toggle body. The force responsive components can tabs, projections, levers, or other segments that can move in response to tension, as well as portions of the suture that can elongate under tension, over the course of typical healing time of a sealing device. Such bending may occur within a few weeks of implantation. The force responsive components permit relative movement between the toggle and the plug to cause gradual separation of the sealing device while still maintaining a flat toggle body against the vessel wall, which as noted above, encourages rapid healing and encapsulation within the vessel wall.

[0077] It will be appreciated by those skilled in the art that various modifications and alterations of the present disclosure can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be apparent to those skilled in the art.

Claims

We claim:

1. A vascular closure device configured to seal a puncture in a vessel wall, comprising: a suture;

a toggle that includes a toggle body and at least one attachment member that is moveable with respect to the toggle body, the at least one attachment member being connected to the suture; and

a plug disposed along the suture in a proximal direction relative to the toggle, the plug having an initial configuration where the plug is slidable along the suture and a locked configuration where the plug is fixed to the suture relative to the toggle,

wherein application of tension along a portion of the suture disposed between the plug and the toggle when the plug is in the locked configuration causes relative movement between the at least one attachment member and the toggle body.

2. The vascular closure device of claim 1, wherein relative movement between the at least one attachment member and the toggle body causes the plug and the toggle body to move apart relative to each other.

3. The vascular closure device of claim 1 or 2, wherein in the locked configuration, the plug is fixed to the suture relative to the toggle body a distance, wherein relative movement of the at least one attachment member and the toggle body increases the distance between the plug and the toggle body.

4. The vascular closure device of claim 3, wherein the distance extends from a distal surface of the plug to a proximal surface of the toggle body that is opposed to the distal surface when the plug is in the locked configuration.

5. The vascular closure device according to any one of the claims 1 to 4, wherein the toggle body defines an opening and the at least one attachment member extends at least partially into the opening such that the at least one attachment member is moveable at least partially in the opening.

6. The vascular closure device according to any of the claims 1 to 5, wherein the at least one attachment member includes a bendable tab.

7. The vascular closure device according to claim 6, wherein the at least one attachment member includes a hinge disposed at the toggle body such that bendable tab bends relative to the toggle body about the hinge.

8. The vascular closure device according to any one of the claims 1 to 9, wherein the toggle body includes a proximal surface, a distal surface opposed to the proximal surface, and a thickness that extends from the proximal surface to the distal surface, wherein the at least one attachment member extends from the toggle body into the opening along a direction that is oblique to the thickness.

9. The vascular closure device according to any of the claims 1 to 7, wherein the toggle includes one or more attachment points that receive the suture.

10. The vascular closure device according to claim 8, wherein each attachment point is an aperture or a groove.

1 1. The vascular closure device according to any one of the claims 6 to 10, wherein the bendable tab is a first bendable tab, and the toggle includes a second bendable tab opposed to the first bendable tab, wherein tension applied to the portion of the suture causes the first and second bendable tabs to bend relative to the toggle body.

12. The vascular closure device according to claim 1 1, wherein the first and second bendable tabs extend from first and second hinges, respectively, the first and second hinges disposed along the toggle body.

13. The vascular closure device according to any one of the claims 9 to 12, wherein the at least one attachment member includes the one or more attachment points that receive the suture.

14. The vascular closure device according to claim 13, wherein the one or more attachment points of the first and second bendable tabs are first and second apertures, respectively, wherein the suture is looped through the first and second apertures, such that, tension applied along the portion of the suture causes the first and second bendable tabs to bend relative to the toggle body.

15. The vascular closure device according to any one of the claims 6 to 10, wherein the bendable tab has a base disposed at the toggle body and a terminal end spaced from the base along a direction that is oblique with respect to a thickness of the toggle body, wherein the bendable tab is configured such that the terminal end is moveable relative to the toggle body.

16. The vascular closure device according to any one of the claims 9 to 10 and 15, wherein the toggle body defines the one or more attachment points that receive the suture.

17. The vascular closure device according to any one of the claims 9, 10, 15 and 16, wherein the one or more attachment points are first and second apertures that are disposed on opposite sides of the bendable tab, and the suture is received by the first aperture, the bendable tab, and the second aperture, such that, tension applied to the portion of the suture causes the bendable tab to bend relative to the toggle body.

18. The vascular closure device according to any one of the claim 17, wherein the bendable tab defines a groove that receives the suture.

19. The vascular closure device according to any one of the claims 1 to 19, further comprising a locking member disposed on the suture relative to the plug in the proximal direction, the locking member configured to lock the plug in place along the suture.

20. A vascular closure device configured to seal a puncture in a vessel wall, comprising: a suture;

a toggle that includes a toggle body and at least one attachment member, the at least one attachment member being connected to the suture; and

wherein a portion of the suture that extends between the plug and the toggle is configured to deform so as to cause relative movement between the plug and the toggle body when the plug is in the locked configuration.

21. The vascular closure device of claim 20, wherein deformation of the portion of the suture elongates the portion of the suture such that that plug and the toggle body move away from each other.

22. The vascular closure device of claim 20 or 21, wherein in the locked configuration, the plug is fixed to the suture relative to the toggle body a distance, wherein deformation of the portion of the suture increases the distance between the plug and the toggle body.

23. The vascular closure device of claim 22, wherein the distance extends from a distal surface of the plug to a proximal surface of the toggle body that is opposed to the distal surface when the plug is in the locked configuration.

24. A deployment instrument configured to deploy the vascular closure device according to any one of the claims 1 to 23.

25. The deployment instrument of claim 24, further comprising a delivery assembly that carries the vascular closure device, the delivery assembly configured to be actuated from an initial configuration where the toggle is fixed with respect to the delivery assembly into a deployed configuration where toggle is released from the delivery assembly.

26. The deployment instrument of claims 24 or 25, wherein the delivery assembly includes a delivery component and a release component that are moveable relative to each other, wherein an end of the toggle is captured between the delivery component and the release component in the initial configuration.