Closure device for sealing percutaneous opening in a vessel
Closure systems, kits and methods for sealing a percutaneous puncture or other opening in a blood vessel wall, body cavity or biopsy tract are disclosed. A closure system can comprise an implant assembly, a delivery assembly, and an introducer sheath. The closure system can further comprise a valve bypass and a dilator. The implant assembly can include an inner member, a sealing membrane, and an outer member, each of which can be delivered by the delivery assembly. The inner member can be extended through the puncture or opening and positioned adjacent an inner tissue surface. The outer member can be positioned adjacent an outer tissue surface. The sealing membrane can have a distal end attached to the inner member, a proximal end including an opening configured to receive the outer member, and a mid-region therebetween. The outer member, when expanded from a delivery configuration to a sealing configuration, can urge the mid-region of the sealing membrane radially outward such that its outer surface can contact and conform to a perimeter edge of the puncture or opening.
1. A method for sealing a hole that extends between an inner vessel surface and an outer vessel surface, comprising:
inserting an inner member including a bioabsorbable material through the hole and into a lumen of a vessel, wherein the inner member is attached to a distal end of a sealing membrane and a proximal end of the sealing membrane defines an opening and extends outside of the vessel;
pulling the inner member against the inner vessel surface , including arranging such that a portion of a connecting member, which is coupled on its distal end to the inner member, to extend to the extends outside of the vesselon its proximal end;
inserting positioning an outer member including a bioabsorbable material in a delivery configuration over the proximal end of slidably along the connecting member to a position adjacent the outer vessel surface opposite and spaced from the inner member such that the distance between the outer member and the inner member is adjustable, wherein the outer member is received within a the opening defined by the proximal end of the sealing membrane; and
applying a compressive force to the outer member, including expanding the outer member from the delivery configuration to a sealing configuration within the sealing membrane such that its outer surface contacts and conforms to an edge of the hole and the expanded outer member urges a mid-region of the sealing member membrane radially outward and enables an outer surface of the sealing membrane to contact and conform to an edge of the hole.
2. The method of claim 1 , wherein inserting the inner member through the hole and into the lumen of the vessel includes positioning an enlarged region of the inner member adjacent to the hole.
3. The method of claim 1 , wherein pulling the inner member against the inner vessel surface includes conforming the inner member to a shape of the inner vessel surface.
4. The method of claim 1 , wherein pulling the inner member against the inner vessel surface includes activating a hinge at an intersection of the inner member and the connecting member.
5. The method of claim 4 , wherein activating the hinge includes allowing the connecting member to bend or reorientate with respect to the inner member.
6. The method of claim 1 , wherein pulling the inner member against the inner vessel surface includes maintaining tension on the proximal end of the connecting member.
7. The method of claim 1 , wherein inserting the outer member over the connecting member to the position adjacent the outside of the vessel includes advancing the outer member along the connecting member until it contacts the outer vessel surface.
8. The method of claim 1 , wherein inserting positioning the outer member over including the bioabsorbable material in the delivery configuration slidably along the connecting member to the position adjacent the outer vessel surface includes advancing the outer member along the connecting member until it contacts a stop member placed on the connecting member.
9. The method of claim 1 , wherein inserting positioning the outer member over including the bioabsorbable material in the delivery configuration slidably along the connecting member includes inserting first and second outer members over the connecting member in a stacking arrangement.
10. The method of claim 9 , wherein expanding the outer member from the delivery configuration to the sealing configuration includes expanding the first and second outer members from the delivery configuration to the sealing configuration.
11. The method of claim 1 , wherein expanding the outer member from the delivery configuration to the sealing configuration includes expanding the outer member to a circumference greater than a perimeter of the hole.
12. The method of claim 1 , wherein expanding the outer member from the delivery configuration to the sealing configuration includes causing the outer member to assume a longitudinally-compressed and transversely-expanded configuration.
13. The method of claim 1 , wherein expanding the outer member from the delivery configuration to the sealing configuration includes causing a plurality of struts, defined by parallel slits through a wall of the outer member, to move from an orientation substantially perpendicular to the inner member toward an orientation substantially parallel to the inner member.
14. The method of claim 1 , further comprising securing a position of the inner member against the inner vessel surface and the expansion of the outer member in the sealing configuration, including engaging a locking member with a portion of the connecting member.
15. The method of claim 14 , wherein the locking member includes an engagement portion configured to allow the connecting member to be slid with respect to the locking member in a first direction, but precluding the connecting member from sliding with respect to the locking member in a second, opposite direction.
16. The method of claim 14 , further comprising changing a circumference of the outer member in the sealing configuration by adjusting a position of the locking member relative to the connecting member.
17. The method of claim 14 , further comprising shearing portions of the connecting member proximal of the locking member and removing the portions from an area near the vessel.
18. The method of claim 1 , further comprising viewing an encapsulated pocket of radiopaque material in each longitudinal an end of the inner member using fluoroscopy.
19. The method of claim 1 , further comprising viewing an encapsulated pocket of a water soluble, radiopaque material in the inner member using fluoroscopy.
20. The method of claim 1 , further comprising viewing an encapsulated pocket of iodine in the inner member using fluoroscopy.