Apparatus and methods for sealing a vascular puncture
View Patent ↗An apparatus for sealing a puncture communicating with a blood vessel includes an inner member slidable within an outer member, and a balloon coupled to distal ends of the inner and outer members. A proximal end of the outer member includes a port for delivering fluid into the balloon, and a cylinder that communicates with the port. A piston coupled to the inner member is slidable and biased to move distally within the cylinder. The apparatus is introduced into the puncture until the collapsed balloon is disposed within the vessel. Fluid is introduced into the port, moving the inner member proximally to shorten the balloon as it expands. The balloon is withdrawn to seal the puncture, and a hydrogel is introduced into the puncture. Fluid is removed via the port, moving the inner member distally to extend the balloon as it collapses, and the apparatus is withdrawn from the puncture.
1. An apparatus for sealing a puncture extending through tissue, comprising:
an outer member comprising proximal and distal ends defining a longitudinal axis therebetween, and a lumen extending between the proximal and distal ends;
an expandable member comprising proximal and distal ends, the proximal end of the expandable member being coupled to the distal end of the outer member such that an interior of the expandable member communicates with the lumen, the expandable member being expandable from a collapsed state to an expanded state when fluid is introduced into the interior;
an inner member slidably coupled to the outer member and comprising proximal and distal ends, the distal end being coupled to the distal end of the expandable member, the inner member being biased to move distally relative to the outer member for moving the distal end of the expandable member away from the proximal end of the expandable member to at least partially collapse the expandable member; and
an element coupled to the inner member and comprising a surface exposed to the lumen such that, when fluid is introduced into the lumen, fluid pressure from the fluid pushes against the surface, causing the inner member to move proximally relative to the outer member for moving the distal end of the expandable member towards the proximal end of the expandable member a cylinder extending from the proximal end of the outer member, the element coupled to the inner member comprising a piston slidable within the cylinder and coupled to the proximal end of the inner member.
2. The apparatus of claim 1 , wherein the element is configured for causing the inner member to move distally relative to the outer member for moving the distal end of the expandable member away from the proximal end of the expandable member when fluid is evacuated from the lumen.
3. The apparatus of claim 1 , wherein the outer member comprises a port on the proximal end, the port communicating with the lumen for connecting a source of fluid to the lumen.
4. The apparatus of claim 1 , wherein the surface comprises a distal surface of the piston.
5. The apparatus of claim 1 , wherein the piston divides the cylinder into proximal and distal chambers, the distal chamber communicating with the lumen.
6. The apparatus of claim 5 , further comprising a fluid within the proximal chamber, the fluid comprising a predetermined pressure for biasing the inner member distally relative to the outer member.
7. The apparatus of claim 6 , wherein the fluid comprises a gas at atmospheric pressure.
8. The apparatus of claim 6 , further comprising a source of fluid coupled to the port, the source of fluid configured for delivering fluid into the lumen at a pressure greater than the predetermined pressure for moving the inner member proximally relative to the outer member.
9. The apparatus of claim 1 , further comprising a spring within the cylinder for biasing the inner member distally relative to the outer member.
10. The apparatus of claim 1 , wherein the surface has a surface area that is substantially greater than a cross-sectional area of the lumen.
11. The apparatus of claim 1 , wherein the inner member comprises a wire.
12. The apparatus of claim 1 , wherein the outer member comprises a tubular member, and wherein the inner member is slidable within the outer member.
13. The apparatus of claim 12 , wherein the inner member extends through the lumen of the outer member, the inner member having a cross-section smaller than a cross-section of the lumen to allow fluid to flow through the lumen around the inner member.
14. The apparatus of claim 1 , wherein the expandable member comprises a balloon.
15. The apparatus of claim 1 , wherein the expandable member has a length in the collapsed state, and wherein, in the expanded state, a distance between the distal ends of the inner and outer members changes to shorten the length as the expandable member expands towards the expanded state.
16. The apparatus of claim 15 , wherein the length shortens such that the proximal and distal ends of the expandable member at least partially evert into the interior of the expandable member.
17. The apparatus of claim 1 , wherein, in the collapsed state, the inner member is biased distally to subject the expandable member to axial tension to minimize a profile of the expandable member.
18. The apparatus of claim 1 , wherein the outer member has an outer diameter of about 0.025 inch (0.625 mm) or less.
19. The apparatus of claim 1 , further comprising an elongate sheath comprising proximal and distal ends, and a lumen extending therebetween, the lumen having sufficient size for receiving the outer member therein when the expandable member is in the collapsed state.
20. The apparatus of claim 19 , further comprising a source of liquid sealing compound coupled to the proximal end of the sheath for delivering liquid sealing compound into the lumen between the sheath and the outer member.
21. The apparatus of claim 20 , wherein the liquid sealing compound comprises a hydrogel.