WO2023150083A1

WO2023150083A1 - Venous sealing apparatus and method of closing a venous access

Info

Publication number: WO2023150083A1
Application number: PCT/US2023/011876
Authority: WO
Inventors: Greg A. WALTERS
Original assignee: Walters Greg A
Priority date: 2022-02-02
Filing date: 2023-01-30
Publication date: 2023-08-10

Abstract

A venous puncture sealing apparatus includes a deployment assembly that is configured for insertion into the channel of the procedural outer sheath by a push rod that is detachably attachable to the deployment assembly. The system has a first configuration, where the push rod and deployment assembly are coupled together and translatable together in the channel, and a second configuration, where the push rod is decoupled from the deployment assembly when the procedural outer sheath is removed. The deployment assembly includes a release tube with a delivery tube configured therein to push a sealing unit out from a release aperture in the distal end of the release tube. The sealing unit includes an anchor configured to extend within the lumen over a venous puncture and a plug member configured to extend over the outer wall of a vein and over said venous puncture.

Description

VENOUS SEALING APPARATUS AND METHOD OF CLOSING A VENOUS

ACCESS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S Provisional Patent Application No 63/305,716, filed on February 2, 2022.

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

[0002] The present invention is directed to a venous sealing apparatus and related methods.

BACKGROUND

[0003] Structural heart interventions require access, via arteries or veins. In most cases, access requires a puncture for insertion of procedural devices. Closure is required to achieve hemostasis within a reasonable time. In venous access interventions, closure is achieved via sutures or clips, or just manual pressure.

SUMMARY OF THE INVENTION

[0004] There is a need for improved venous puncture closure system employing a venous puncture sealing apparatus. An embodiment of the present disclosure is a venous puncture closure system for use with a procedural outer sheath, such as a venous access sheath having a channel. The venous puncture sealing apparatus includes a push rod insertable into the channel of the procedural outer sheath. The venous puncture sealing apparatus includes a deployment assembly that is removably coupled to the push rod, such that, the push rod and deployment assembly are translatable together into the channel. The venous puncture sealing apparatus also includes a sealing unit carried by the deployment assembly and configured to be ejected therefrom, wherein de-coupling of the push rod from the deployment assembly permits the sealing unit to be ejected from the deployment assembly. The sealing unit includes an anchor configured to be retained along the interior wall of the vein and over the venous puncture and a plug member configured to be retained on the exterior wall of the vein and over the venous puncture to seal the venous puncture.

[0005] An exemplary venous puncture sealing apparatus includes a push rod insertable into the channel of the procedural outer sheath. The system further includes a deployment assembly that is removably coupled to the push rod. The system has a first configuration, where the push rod and deployment assembly are coupled together and translatable together in the channel, and a second configuration, where the push rod is decoupled from the deployment assembly when the push rod and deployment assembly are not inside the channel of the procedural outer sheath. The venous puncture sealing apparatus, including the push rod and the deployment assembly, may have a length that is at least twice the length of the procedural outer sheath, to allow insertion through the procedural outer sheath and then removal of the procedural outer sheath over the venous puncture sealing apparatus. The procedural outer sheath is typically about 30cm in length and therefore, the length of the venous puncture sealing apparatus, may be about 60cm or more, about 70cm or more, or even 80cm or more.

[0006] An exemplary venous puncture sealing apparatus for use with a procedural outer sheath having a channel includes a sealing unit that includes a suture, a plug member, such as a collagen plug coupled to the suture, and an anchor also coupled to the suture. An exemplary plug member is a planar strip that is folded one or more times, such as two times to produce three layers of the planar strip. The exemplary plug member has plug apertures for the suture to extend therethrough and the folded configuration provides points of engagement with the suture. The folded configuration may have plug apertures in each layer of the fold and when the suture is pulled tight, the suture knot may press the folded layers together to form a tight configuration, wherein the layers are squeezed against each other.

[0007] The anchor has a suture end, an extended end opposite the suture end, a length that extends from the suture end to the extended end along an anchor axis, and a plurality of suture apertures that extends through the anchor through which the suture extends. Each one of the pluralities of suture apertures are positioned between the suture end and a midline of the anchor, wherein the midline is substantially equidistant between the first and the extended end of the anchor. The anchor may be made out of a bioresorbable material to enable endothelial cells to grow thereover. The bioresorbable material may have a composition to enable it to substantially retain structure for about 75 days or more, about 90 days or more, about 100 day or more and any range between and including the time periods provided.

Substantially retain structure means that the anchor retains at least 80% or more of an original mass over the specified timeframe.

[0008] The summary of the invention is provided as a general introduction to some of the embodiments of the invention, and is not intended to be limiting. Additional example embodiments including variations and alternative configurations of the invention are provided herein

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[0009] The foregoing summary, as well as the following detailed description of illustrative embodiments of the present application, will be better understood when read in conjunction with the appended drawings, which are described below. For the purposes of illustrating the present application, there is shown in the drawings illustrative embodiments of the disclosure. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown.

[0010] Figure 1 shows a side view of a procedural outer sheath, such as a venous access sheath having a valve configured proximal to the access end, or proximal end, and a conduit extending from said access end to the venous end, or distal end.

[0011] Figure 2 show a side view of a deployment assembly including a push rod coupled with a release tube.

[0012] Figure 3 shows a side view of the sealing unit being deployed out from the delivery aperture of the delivery tube.

[0013] Figure 4 shows a side view of the connection of the push rod with the delivery tube with the release tube configured over delivery tube.

[0014] Figure 5 shows the hub of the release tube coupled with the push rod.

[0015] Figure 6 shows a side view of the sealing unit including the anchor and plug member, coupled together by the suture, being pushed out from the delivery aperture of the delivery tube.

[0016] Figure 7A shows a side view of the sealing unit with an anchor and plug member fully released and ejected from the release tube and the tamper tube extending down over the suture to hold the knot as suture and knot are tighten.

[0017] Figure 7B shows an exemplary plug member having two folds to create three layers of the plug pad.

[0018] Figure 8 shows a side view of the sealing unit with the anchor configured along the interior wall of the vein and the plug member configured on the exterior wall of the vein with the suture securing the anchor and plug member to the venous wall in a sealing configuration. [0019] Figure 9 shows a side view sealing unit configured over a venous puncture in the vein wall.

[0020] Figure 10 shows a perspective view of a venous puncture sealing apparatus being inserted into a venous access sheath.

[0021] Figure 11 shows a perspective view of the venous puncture sealing apparatus inserted through the venous access sheath, shown in FIG. 10, and into the vein.

[0022] Figure 12 shows a perspective view of the procedural outer sheath, such as a venous access sheath, being removed from the vein by pulling it over the delivery tube shown in FIG. 11, and the release tube of the venous puncture sealing apparatus extending out from the vein.

[0023] Figure 13 shows a perspective view of the venous puncture sealing apparatus shown in FIG. 12 now configured within the vein with the venous access sheath, shown in FIG. 12, removed.

[0024] Figure 14 shows a perspective view of the venous puncture sealing apparatus shown in FIG. 13, with the push rod removed and with the delivery tube being used to push the sealing unit out from the release aperture of the release tube.

[0025] Figure 15 shows a perspective view of the sealing unit deployed from the deployment assembly shown in FIG. 14.

[0026] Figure 16 shows a perspective view of the release tube being pulled out from the venous puncture to expose the delivery tube.

[0027] Figure 17 shows a perspective view of the closure and deployment systems shown in FIG. 16, with the delivery tube being held or pushed into the venous puncture as the release tube is being pulled back and away from the venous puncture.

[0028] Figure 18 shows a side view of an anchor of the sealing unit configured along the interior wall of the vein to cover the venous puncture.

[0029] Figure 19 shows a perspective view of the anchor shown in Figure 18 with a suture extending down through the suture apertures and also through the torque apertures.

[0030] Corresponding reference characters indicate corresponding parts throughout the several views of the figures. The figures represent an illustration of some of the embodiments of the present invention and are not to be construed as limiting the scope of the invention in any manner. Some of the figures may not show all of the features and components of the invention for ease of illustration, but it is to be understood that where possible, features and components from one figure may be included in the other figures. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0031] Certain exemplary embodiments of the present invention are described herein and are illustrated in the accompanying figures. The embodiments described are only for purposes of illustrating the present invention and should not be interpreted as limiting the scope of the invention. Other embodiments of the invention, and certain modifications, combinations and improvements of the described embodiments, will occur to those skilled in the art and all such alternate embodiments, combinations, modifications, improvements are within the scope of the present invention.

[0032] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Also, use of "a" or "an" are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.

[0033] Embodiments of the present disclosure include systems and methods for sealing a puncture in a large bore vein. The system may include an outer sheath, which may be a procedural sheath, a push rod, a deployment assembly that is removably coupled to the push rod, a sealing unit carried by the deployment assembly, and a tamping device.

[0034] As shown in FIG. 1, an exemplary procedural outer sheath 24, such as a venous access sheath, has a valve 25 proximal to the proximal end or access end 26, and a length 27 from said access end to the distal end 28 or end that is inserted through the venous puncture and into the lumen of a vein.

[0035] Referring now to FIGS. 2 to 8, a venous puncture closure system 11, employs a venous puncture sealing apparatus 10 that is configured to deliver a sealing unit 60 through a procedural outer sheath 24, such as a venous access sheath, and seal a venous puncture 18 in a vein 12. As shown in FIG. 2, a deployment assembly 30 includes a push rod 40 coupled with a delivery tube 31 and a release tube 50 having a sealing unit retained therein.

[0036] The push rod 40 has a length 47 from the proximal end 46 to the distal end 48, and a sheath marker 42 that indicates when the distal end of the deliver tube 31 is pushed out from the distal end 28 of the procedural outer sheath 24, and into the vein 12. A hub 35 retains the push rod 40 to the delivery tube 31. As shown best in FIGS. 4 and 5, the push rod is configured with a retained portion 44 in a hub slot 34, such that the push rod can be detached from the delivery tube 31 after the sealing unit 60 is released into the vein. The retained portion of the push rod 40 is smaller in cross-sectional dimension than an extended portion extending from the hub 35 to the proximal end 46 and an insert portion 45 configured within the delivery tube 31. The delivery tube 31 has a push-rod slot 33 that extend from the hub 35 or proximal end 36 of the delivery tube toward the distal end 38 of the delivery tube. This push-rod slot allows the push rod to be removed after the procedural outer sheath is pulled off of the venous puncture sealing apparatus 10, over the push rod. The push rod 40 has a release-tube stop 43 that extends radially out through the push-rod slot 33 in the delivery tube 31 to engage with and prevent the release tube 50 from sliding up over this stop during insertion of the deployment assembly 30 through the procedural outer sheath, through the venous puncture 18 in the vein wall 17 and into the lumen 13 of the vein 12.

[0037] A tamping device 65 is coupled with the suture, such as being a cylinder configured around the suture. The tamping device may be extended out from the delivery tube 31 and by manually manipulated to apply compression on the knot 98. The tamping device is pushed against the knot 98 while the tension is applied to the suture 96 to tighten the suture to retain the anchor 70 and plug member 90 in place over the venous puncture 18. As shown, the suture extends through the tamping device.

[0038] The delivery tube 31 extends into the release tube 50 and the sealing unit 60 is configured within the release tube. The release tube has a release aperture 52 on the distal end 58 to allow the sealing unit to be released, or pushed out by pushing the delivery tube 31 into the release tube 50. The delivery tube 31 has a length from the proximal end 36 to the distal end 38, shown in FIG. 3, which is longer than the length of the release tube 50, from a proximal end 56 to a distal end 58. The venous puncture sealing apparatus 10 has a length 37 that is greater than the length 27 of the procedural outer sheath 24 shown in FIG. 1. The length of the venous puncture sealing apparatus may be twice that of the length of the procedural outer sheath, to allow for insertion through the venous access sheath and then removal of the procedural outer sheath by pulling the procedural outer sheath over the release tube 50, and the push rod 40.

[0039] As shown in FIG. 3, the sealing unit 60 is released or push out of the release aperture 52 of the release tube 50 by the distal end 38 of the delivery tube 31. The sealing unit includes the anchor 70 coupled to the suture 96

[0040] As shown in FIG. 4, the hub 35 of the delivery tube 31 is coupled with the push rod 40, as described herein. Note that the hub slot extends down at least a release offset distance 39, a distance required to release the sealing unit 60 from the release tube 50 by pushing the delivery tube 31 into the release tube. The release offset distance 39 may also be the length of the insert portion 45 of the push rod 40, from the hub 35 to the distal end of the release tube stop 43.

[0041] As shown in FIG. 5, the hub 35 has a hub slot 34 to enable the push rod 40 to be detached from the delivery tube 31. The insert portion 45 and the extended portion 41 of the push rod are larger in cross-sectional dimension than the retained portion 44 in the hub slot 34.

[0042] As shown in FIG. 6, the sealing unit 60 includes an anchor 70 and plug member 90, coupled together by the suture 96. The sealing unit is being pushed out from the release aperture 52 of the release tube 50 by the delivery tube 31. The anchor has a suture end 76 and an extended end 78. The suture extends through suture apertures 71 in the anchor and the suture apertures may be more proximal to the suture end than the extended end.

[0043] Referring now to FIGS. 7A and 7B, the sealing unit 60 is fully release or ejected from the release tube 50 and configured with a plug pad 92 type plug member 90 having plug apertures 93 for retaining the suture 96 to the plug member. The plug pad may be a planar material, and may be a collagen plug 94, that is folded one or more times to produce a plurality of plug apertures through separate folds, as shown in FIG. 7B. The plug pad 92 has two folds to create three layers of the plug member.

[0044] As shown in FIG. 8, the sealing unit 60 is configured with the anchor 70 configured along the interior wall 14 of the vein 12 and the plug member 90 configured on the exterior wall 16 of the vein wall with the suture 96 securing the anchor and plug member to the vein wall in a sealing configuration. The anchor has a length from the suture end 76 to the extended end 78. The sutures extend from the anchor and through the venous puncture 18 in the vein wall from a position more proximal to the suture end, or offset an offset distance from center. The flow of blood is indicated by the bold arrow within the vein and this direction of flow will push the extended end of the anchor up against the interior wall 14 of the vein 12.

[0045] As shown in FIG. 9, the sealing unit 60 shown in FIG. 8 is configured over the venous puncture 18 in the vein wall 17.

[0046] Referring now to FIGS. 10 to 17, a venous puncture sealing apparatus 10 is inserted through a procedural outer sheath 24 and the delivery tube 31 deploys the sealing unit 60 having an anchor 70, that is configured within the vein 12 along the interior wall 14 of the vein and a plug member 90 over the exterior wall 16 and over the venous puncture 18.

[0047] As shown in FIGS. 10 and 11, the venous puncture closure system 11 employs a venous puncture sealing apparatus 10 that is inserted through the access end 26 of procedural outer sheath 24, through the valve 25 and into the vein 12.

[0048] As shown in FIG. 12, the procedural outer sheath 24 is being removed from the venous puncture sealing apparatus 10 and from the vein 12 by pulling it over the release tube 50 and the proximal end of the delivery tube 31 and also over the push rod 40. Note that the release tube 50 is held in place by the release-tube stop 43 shown in FIG. 4.

[0049] As shown in FIG. 13, the venous puncture sealing apparatus 10 shown in FIG. 12 is now configured within the vein 12 with the procedural outer sheath 24, shown in FIG. 12, removed. The distal end of the release tube 50 is configured within the lumen 13 of the vein 12.

[0050] Referring now to FIGS. 14 and 15, the venous puncture sealing apparatus 10 shown in FIG. 13 is released into the lumen 13 of the vein. As shown in FIG. 14, the push rod 40 is removed. The push rod is detached from the hub 35 by pulling it out of the hub slot, as detailed in FIG. 4. The delivery tube 31 is being pushed into the release tube 50 as indicated by the two arrows pointing toward each other. The release tube may be held in position and the delivery tube may be pushed into the release tube to push the sealing unit 60 out of the distal end 58 of the release tube 50. The distal end of the release tube 50 pushes the anchor 70 out from the delivery aperture 32 of the delivery tube 31. As shown in FIG. 15, the anchor 70 is configured in the lumen 13 of the vein 12. [0051] As shown in FIG. 16, the anchor 70 is deployed from the deployment assembly 30 shown in FIG. 15 and the release tube 50 and delivery tube 31 are retraced out from the lumen of the vein 12. The anchor 70 is retained along the interior wall 14 of the vein 12 as the release tube 50 and delivery tube 31 are retraced. The sutures 96 retain the anchor to the release tube 50 delivery system 30 and extend up through the venous puncture 18. The anchor allows the plug member 90 to be released from the release aperture on the exterior wall 16 of the vein 12.

[0052] As shown in FIG. 17, the release tube 50 and delivery tube 31 are pulled from the venous puncture 18, to deploy the plug member 90 on the exterior wall 16 of the vein 12. The plug member 90, such as a collagen plug 94, are retained by the suture 96. The delivery tube 31 is being pushed down against the suture knot 98, such as a self-tightening knot, to tighten the suture between the plug member 90 and the anchor 70. A tamping device may be coupled with the suture to further tighten the suture and secure the anchor and plum member. The plug member 90, a collagen plug 94, is configured on the exterior wall 16 of the vein 12 and is retained the suture.

[0053] Referring now FIGS. 18 and 19, an exemplary anchor 90 is configured along an interior wall 14 of a vein 12 and has a geometry to enable the anchor to be pulled tight against the interior wall. The anchor has a length 77 from a suture end 76 to an extended end 78 and a midline 85 configured equidistance between the two ends along the anchor axis 87. The anchor has suture apertures 71, that are aligned with the venous puncture 18 and wherein the suture 96 extends from the venous puncture directly into the suture apertures. The suture apertures are positioned between the midline 85 and the suture end of the anchor to provide torque on the anchor when tension is applied to the suture. The suture may be coupled with the anchor more proximal to the suture end, as shown by the suture loop extending through the torque apertures 72. Also, the anchor may have a torque protrusion that the suture is coupled to, such as extending thereover or being attached to, to create a torque on the anchor 70 when the suture is pulled up through the venous puncture. The suture may extend toward the suture end 76 of the anchor such that tension on the suture applies a force on the torque protrusion to rotate the extended end 78 of the anchor up toward the interior wall 14 of the vein wall 13. As shown, the suture 96 extends around the torque protrusion and up through torque apertures 72 in the anchor. The torque protrusion extends away from the wall side 74 of the anchor, or is a protrusion from the lumen side 75 of the anchor. Put another way, the torque anchor extends radially inward into the lumen of the vein. The anchor also comprises a plurality of ingrowth apertures 73 that are different than the plurality of suture apertures 71, wherein the plurality of ingrowth apertures are configured for tissue in-growth

[0054] It will be apparent to those skilled in the art that various modifications, combinations and variations can be made in the present invention without departing from the scope of the invention. Specific embodiments, features and elements described herein may be modified, and/or combined in any suitable manner. Thus, it is intended that the present invention cover the modifications, combinations and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

CLAIMS:

1. A venous puncture closure system for use with a procedural outer sheath having a channel, the system comprising: a venous puncture sealing apparatus comprising: a push rod insertable into the channel of the procedural outer sheath; a deployment assembly that is removably coupled to the push rod, such that, the push rod and deployment assembly are translatable together into the channel; and a sealing unit carried by the deployment assembly and configured to be ejected therefrom, wherein de-coupling of the push rod from the deployment assembly permits the sealing unit to be ejected from the deployment assembly.

2. A venous puncture closure system for use with a procedural outer sheath having a channel, the system comprising: a venous puncture sealing apparatus comprising: a push rod insertable into the channel of the procedural outer sheath; and a deployment assembly that is removably coupled to the push rod, wherein the system has a first configuration, where the push rod and deployment assembly are coupled together and translatable together in the channel, and a second configuration, where the push rod is decoupled from the deployment assembly when the push rod and deployment assembly are not inside the channel; and a sealing unit carried by the deployment assembly.

3. A venous puncture closure system for use with a procedural outer sheath having a channel, the system comprising: a venous puncture sealing apparatus comprising: a deployment assembly; a sealing unit carried by the deployment assembly and configured to be ejected therefrom, the sealing unit having a suture, a collagen plug coupled to the suture, and an anchor, wherein the anchor has a suture end, an extended end opposite the suture end, a length that extends from the suture end to the extended end along an anchor axis, and a plurality of suture apertures that extends through the anchor through which the suture extends, wherein each one of the plurality of suture apertures are positioned between the suture end and a midline of the anchor, wherein the midline is substantially equidistant between the first and the extended end of the anchor.

4. The system of claim 1 or claim 2, wherein the sealing unit includes a suture, a collagen plug coupled to the suture, and an anchor.

5. The system of claim 4, wherein the anchor has a suture end, an extended end opposite the suture end, a length that extends from the suture end to the extended end along an anchor axis, and a plurality of suture apertures that extends through the anchor through which the suture extends, wherein each one of the plurality of suture apertures are positioned between the suture end and a midline of the anchor, wherein the midline is substantially equidistant between the first and the extended end of the anchor.

6. The system of claim 5, wherein the plurality of suture apertures are aligned along a lateral axis that is perpendicular to the anchor axis and substantially parallel to the midline, such that the anchor is rotatable about a connection region where the suture is coupled to the anchor at the plurality of suture apertures.

7. The system of claim 6, wherein the anchor further comprises a plurality of ingrowth apertures that are different than the plurality of suture apertures, wherein the plurality of ingrowth apertures are configured for tissue in-growth.

8. The system of claim 7, wherein the anchor has a lower surface, an upper surface, and a thickness that extends from lower surface to the upper surface along a direction that is perpendicular to the anchor axis, the lower surface defining a ridge proximate the plurality of suture apertures, such that a portion of the suture along the lower surface is in position adjacent to the ridge.

9. The system of claim 5, wherein the suture has a suture body, a first suture end, and a second suture end, wherein the suture body extends through the first plurality of suture apertures of the anchor with the first suture end forming a self-tightening knot with the suture body.

10. The system according to any one of the claims 1 to 9, wherein the deployment assembly comprises: a release tube having an internal channel, the release tube having a proximal end and distal end, the distal end of the release tube defining an opening through which the sealing unit can exit the deployment assembly; and a delivery tube positioned in the internal channel having a rear hub spaced proximally with respect to the proximal end of the release tube, and a forward end positioned within the internal channel, wherein the sealing unit is carried within an internal space defined between the forward end of the delivery tube and the proximal end of the release tube; and a tamping device coupled to the suture.

11. The system of claim 10, further comprising an outer sheath having a channel that extends therethrough, wherein the release tube and pushrod assembly are insertable into the channel.

12. The system of claim 3, further comprising a push rod insertable into the channel of the procedural outer sheath, wherein the deployment assembly is removably coupled to the push rod, such that, the push rod and deployment assembly are translatable together into the channel, and wherein de-coupling of the push rod from the deployment assembly permits the sealing unit to be ejected from the deployment assembly.

13. A venous puncture sealing system for use with a procedural outer sheath having a channel, the system comprising: a venous puncture sealing apparatus comprising: a push rod insertable into the channel of the procedural outer sheath; a deployment assembly insertable into the channel of the procedural outer sheath by said push rod, wherein the deployment assembly is removably coupled to the push rod, such that, the push rod and deployment assembly are translatable together into the channel; and a sealing unit carried by the deployment assembly and configured to be ejected therefrom, the sealing unit comprising: a suture; a collagen plug coupled to the suture; and an anchor; wherein de-coupling of the push rod from the deployment assembly permits the sealing unit to be ejected from the deployment assembly; wherein the system has a first configuration, where the push rod and deployment assembly are coupled together and translatable together in the channel, and a second configuration, where the push rod is decoupled from the deployment assembly when the push rod and deployment assembly are not inside the channel.

14. The system of claim 13, wherein the anchor has a suture end, an extended end opposite the suture end, a length that extends from the suture end to the extended end along an anchor axis, and a plurality of suture apertures that extends through the anchor through which the suture extends, wherein each one of the plurality of suture apertures are positioned between the suture end and a midline of the anchor.

15. The system of claim 14, wherein the anchor further comprises a torque protrusion that extends from a lumen side of the anchor and wherein the suture is coupled thereto, whereby tension applied on the suture produces a torque on the anchor to pull the extended end up against an interior wall of a vein.

16. The system of claim 15, wherein the anchor further comprises a torque aperture that is configured more proximal to the suture end than the plurality of suture apertures and wherein the suture extends from the plurality of suture aperture through the torque aperture.

17. The system of claim 16, comprising a plurality of torque apertures and wherein the suture is looped through the plurality of torque apertures.

18. The system of claim 15, wherein the torque protrusion is at least a 1mm protrusion.

19. The system of claim 13, wherein the delivery tube comprises hub and a push-rod slot extending from said hub, said hub comprising a hub slot, wherein the push rod is configured to be coupled to the delivery tube within the hub slot and the push-rod slot.

20. The system of claim 19, wherein the push rod comprises a release tube stop that extends from the push rod through the push-rod slot in the delivery tube to prevent the release tube from moving over the release tube stop.

21. The system of claim 20, wherein the release tube stop engages with the release tube to force the release tube into the channel during insertion of the deployment assembly into the channel of the procedural outer sheath.

22. The system of claim 19, wherein the push rod is detachably attachable to the delivery tube through the hub slot and the push-rod slot.

23. The system of claim 22, wherein the push rod comprises a tapered portion that is retained in the hub slot, wherein a distal portion of the push rod is retained in the push-rod slot of the delivery tube.

24. A method of using a system according to any one of the claims 1 to 12, for sealing a puncture in a vein.

25. A method of assembling the system according to any one of the claims 1 to 12.