Expandable vascular closure plug
View Patent ↗Described are devices useful for providing hemostasis at a vascular access site, and related methods. Such devices can include first and second implant members cooperable when forced together to expand the first implant member in a tissue tract at the site. Such devices can also include an anchor member and a tether attached thereto. The anchor member can be deployed distally to the first implant member, within a vessel, and the tether can be tensioned to apply counterforce to the first implant member as the second implant member is forced into cooperative contact to expand the first implant member.
1. A device for providing hemostasis at a surgical site in a patient, where the surgical site includes a puncture in a vascular vessel and a tissue tract extending from the skin of the patient to the puncture, the device comprising:
a delivery cannula having at least a portion advanceable into the tissue tract and through the puncture;
an anchor member received in the delivery cannula, the anchor member configured to reside and anchor within the vascular vessel upon deployment from the delivery cannula and contact an inner surface of the vascular vessel;
a tether connected to the anchor member, the tether configured to extend through the puncture and tissue tract when the anchor member is received within the vascular vessel;
a first implant member for implantation in the tissue tract, the first implant member received in the delivery cannula proximal to the anchor member;
a second implant member for implantation in the tissue tract, the second implant member received in the delivery cannula proximal to the anchor member, wherein the first and second implant members are sized and configured such that movement of at least a portion of the second implant member against the first implant member causes the first implant member to expand; and
a pusher received in the delivery cannula for imparting a pushing force against the second implant member; wherein the first and second implant members are sized and configured such that said movement causes overlap of the first and second implant members with one another along a length of the device such that a portion of the first implant member and a portion of the second implant member co-extend along a length of the device.
2. The device of claim 1 , wherein the first and second implant members are sized and configured such that said movement causes the first and second implant members to frictionally couple to one another.
3. The device of claim 1 , wherein the first implant member defines a lumen and the second implant member defines at least a portion receivable within the lumen of the first implant member so as to expand the first implant member.
4. The device of claim 1 , wherein at least a portion of the second implant member is received in the delivery cannula proximal to the first implant member.
5. The device of claim 1 , wherein:
the first implant member has a lumen extending at least partially along a length of the first implant member,
the second implant member has at least a portion received outside of and movable into the lumen of the first implant member upon said movement; and
the tether and pusher are so constructed and arranged that the tether can be tensioned to cause the anchor member to provide proximally-directed counterforce while the pusher is advanced distally to cause said movement.
6. The device of claim 1 , wherein said first implant member comprises an extracellular matrix (ECM) material.
7. The device of claim 1 , wherein at least one of said first implant member and second implant member is comprised of a bioabsorbable material.
8. The device of claim 1 , wherein at least one of said first implant member and said second implant member is comprised of a sponge material.
9. The device of claim 1 , wherein the second implant member has a tapered outer surface.
10. The device of claim 1 , wherein the second implant member has a conically-shaped portion for receipt in a lumen of the first implant member.
11. The device of claim 1 , wherein the second implant member is more resistant to compression than the first implant member.
12. The device of claim 11 , wherein the second implant member is comprised of a synthetic biodegradable polymer and the first implant member is comprised of an extracellular matrix material.
13. The device of claim 1 , wherein the first implant member defines a lumen extending from a proximal end to a distal end of the first implant member and the second implant member defines a lumen extending from a proximal end to a distal end of the second implant member.
14. The device of claim 13 , wherein the tether extends through the lumen of the second implant member and the lumen of the first implant member.
15. The device of claim 1 , wherein the pusher defines a lumen.
16. The device of claim 15 , wherein the tether extends through the lumen of the pusher.
17. The device of claim 1 , wherein the first implant member has a generally cylindrical body having a longitudinal lumen extending at least partially along a length of the generally cylindrical body, and the second implant member has at least a conically-shaped portion for receipt in a lumen of the first implant member upon said movement.
18. A device for providing hemostasis at a surgical site in a patient, where the surgical site includes a puncture in a vascular vessel and a tissue tract extending from the skin of the patient to the puncture, the device comprising:
a first implant member sized for receipt in the tissue tract, the first implant member having a proximal end and a distal end;
a second implant member sized for receipt in the tissue tract, the second implant member having a proximal end and a distal end, wherein the first and second implant members are sized and configured such that movement of at least a portion of the second implant member against the first implant member causes frictional coupling of the first and second implant members and urges the first implant member to expand; and
at least one force-transmitting member for causing said movement;
wherein said at least one force transmitting member includes an anchor member residing distal of the distal end of the first implant member and a tether connected to the anchor member, the anchor member and tether arranged to apply proximally-directed force to the first implant member; wherein the first and second implant members are sized and configured such that said movement causes overlap of the first and second implant members with one another along a length of the device such that a portion of the first implant member and a portion of the second implant member co-extend along a length of the device.
19. The device of claim 18 , wherein said at least one force transmitting member includes a pusher arranged to apply distally-directed force to the second implant member.