Catheter with sealed hydratable hemostatic occlusion element
Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an optional occlusion element, a hydratable hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element optionally occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hydratable hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus by retracting the protective sleeve and left in place to enhance closure of the vascular wall penetration with minimum scarring. The hydratable implant will be protected from premature hydration and swelling by a soluble plug covering the implant's distal end prior to sleeve retraction.
1. A method for sealing a blood vessel penetration disposed at the end of a tissue tract, the method comprising:
providing an apparatus including a shaft, a hemostatic implant disposed on an exterior surface of the shaft, a soluble plug for inhibiting hydration of the hemostatic implant and disposed on the exterior surface of the shaft, and a protective sleeve covering outer surfaces of the hemostatic implant and the soluble plug, wherein the soluble plug is positioned distal to a distal end of the hemostatic implant to function cooperatively with a distal end of the protective sleeve to inhibit hydration of the hemostatic implant;
introducing the shaft through the tissue tract to position the hemostatic implant within the tissue tract, wherein the hemostatic implant and the soluble plug are covered by the protective sleeve while the shaft is being introduced;
retracting the protective sleeve to first expose the soluble plug followed by the hemostatic implant such that the soluble plug dissolves and is resorbed into surrounding tissue while the hydratable implant expands and occludes the tissue track; and
withdrawing the shaft past the expanded hemostatic implant which remains in the tissue tract.
2. A method as in claim 1 , wherein the soluble plug is configured to seal against and prevent fluid ingress through an open end of the protective sleeve.
3. A method as in claim 1 , wherein the soluble plug comprises a resorbable biopolymer.
4. A method as in claim 3 , wherein the resorbable biopolymer comprises hyaluronic acid.
5. A method as in claim 1 , wherein the apparatus further includes an occlusion element and the method further comprises deploying the occlusion element to inhibit blood flow from the blood vessel into the tissue tract.
6. A method as in claim 5 , wherein deploying the occlusion element comprises shifting the occlusion element between a radially contracted configuration for passage through the tissue tract and a radially expanded configuration for deployment within the blood vessel to occlude the penetration.
7. A method as in claim 5 , wherein at least a portion of the hemostatic implant or the shaft is radiopaque, wherein the method further comprises observing the occlusion element to determine that it has a correct orientation before the protective sleeve is retracted.
8. A method as in claim 1 , wherein the protective sleeve is latched to the shaft while the shaft is introduced, and the method further comprises unlatching the sleeve before retracting the sleeve, wherein unlatching comprises distally advancing a key over a latch on the shaft.
9. A method as in claim 1 , wherein the hemostatic implant is prevented from being displaced proximally by a back stop on the shaft while the sleeve is retracted and while the shaft is withdrawn.
10. A method as in claim 1 , wherein the protective sleeve comprises an outer sleeve and an inner release sheath, wherein the outer sleeve is retracted first while the protective sheath inhibits sticking between the outer sleeve and the hemostatic implant.
11. A method as in claim 1 , wherein the hemostatic implant comprises a cylindrical body which circumscribes the shaft.
12. A method as in claim 1 , wherein the hemostatic implant comprises a body which is configured to open laterally and release from the shaft after the protective sleeve is withdrawn.
13. A method as in claim 1 , wherein the hydratable hemostatic implant comprises a swellable, biodegradable polymer, wherein the polymer is not fully hydrated when covered by the protective sleeve and hydrates when exposed by retracting the protective sleeve.
14. A method as in claim 13 , wherein the biodegradable polymer comprises a material selected from the group consisting of polyethylene glycols, collagens, and gelatins.
15. A method as in claim 14 , wherein the hydratable hemostatic implant comprises an active agent selected from the group consisting of:
(i) an anti-proliferative agent selected from the group consisting of sirolimus and paclitaxel;
(ii) an anticoagulant selected from the group consisting of thrombin and tissue factor; and
(iii) combinations thereof,
wherein the active agent is incorporated in a degradable carrier comprising a material selected from the group consisting of poly lactic acid, and poly(lactide-co-glycolide).