Catheter with sealed hydratable hemostatic occlusion element

Abstract

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 . Apparatus for sealing a blood vessel wall penetration disposed at an end of a tissue tract, said apparatus comprising:
 a shaft having a proximal end and a distal end;   a hemostatic implant disposed over or adjacent to an exterior surface of the shaft proximal to the occlusion element, said hemostatic implant being hydratable to expand to occlude the tissue tract when exposed to body fluids within the tissue tract;   a protective sleeve retractably disposed over the hemostatic implant; and   means for inhibiting hydration of the hemostatic implant prior to retraction of the protective sleeve.   
     
     
         2 . Apparatus as in  claim 1 , wherein the hydration inhibiting means comprises a soluble plug disposed at one end of the hemostatic implant to prevent fluid intrusion through an open end of the protective sleeve. 
     
     
         3 . Apparatus as in  claim 2 , wherein the soluble plug comprises a resorbable biopolymer. 
     
     
         4 . Apparatus as in  claim 3 , wherein the resorbable biopolymer comprises hyaluronic acid. 
     
     
         5 . Apparatus as in  claim 1 , further comprising an occlusion element near the distal end of the shaft, said occlusion element being shiftable 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. 
     
     
         6 . Apparatus as in  claim 1 , wherein the protective sleeve comprises an outer sleeve and a separately retractable inner release sheath. 
     
     
         7 . Apparatus as in  claim 6 , wherein the inner release sleeve is split to relieve constraint on the occlusion element after the outer sleeve is retracted over the inner release sleeve. 
     
     
         8 . Apparatus as in  claim 1 , further comprising a latch and a key element, wherein the latch is disposed on the shaft and engages the protective sleeve and wherein the key shifts the latch between a locking configuration which immobilizes the sleeve and an open configuration which allows the sleeve to be proximally retracted, wherein the latch is spring-loaded to deflect radially outwardly from the shaft to engage the sleeve and wherein the key element can radially depress the latch to release the sleeve, and further comprising a back stop on the shaft, wherein the back stop engages the hemostatic implant to immobilize the implant while the sleeve is being proximally retracted, over the implant and the contracted occlusion element is being withdrawn past the implant. 
     
     
         9 . Apparatus as in  claim 1 , wherein the shaft comprises an outer tube and an inner rod and wherein the occlusion element has a distal end connected to a distal end of the rod and a proximal end connected to a distal end of the tube so that proximal retraction of the rod relative to the tube effects radial expansion of the occlusion element and distal advancement of the rod relative to the tube effects radial contraction of the occlusion element, wherein the occlusion element comprises a braided mesh covered by an elastic membrane. 
     
     
         10 . Apparatus as in  claim 1 , wherein the hemostatic implant comprises a body which circumscribes the shaft. 
     
     
         11 . Apparatus as in  claim 1 , wherein the hemostatic implant comprises a body which is configured to open laterally from the shaft. 
     
     
         12 . Apparatus as in  claim 1 , wherein the hydratable hemostatic implant comprises a biodegradable polymer selected from the group consisting of polyethylene glycols, collagens, and gelatins. 
     
     
         13 . Apparatus as in  claim 1 , wherein the hemostatic implant comprises an active agent which comprises an anti-proliferative agent selected from the group consisting of sirolimus and paclitaxel, or an anticoagulant selected from the group consisting of thrombin and tissue factor. 
     
     
         14 . A method for sealing a blood vessel penetration disposed at the end of a tissue tract,
 providing an apparatus including a shaft, a hydratable hemostatic implant disposed on an exterior surface of the shaft, and a protective sleeve covering an outer surface of the hemostatic implant;   introducing the shaft through the tissue tract to position the hemostatic implant within the tissue tract, wherein the hydratable hemostatic implant is covered by the protective sleeve and a distal end of the hydratable implant is covered by a soluble plug disposed under the protective sleeve while the shaft is being introduced;   retracting the protective sleeve to expose the hydratable hemostatic implant and the soluble plug wherein the soluble plug dissolves and is resorbed into surrounding tissue while the hydratable implant expands and occludes the tissue track;   withdrawing the shaft past the expanded hemostatic implant which remains in the tissue tract.   
     
     
         15 . A method as in  claim 14 , wherein the soluble plug comprises a resorbable biopolymer. 
     
     
         16 . A method as in  claim 15 , wherein the resorbable biopolymer comprises hyaluronic acid. 
     
     
         17 . A method as in  claim 14 , 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. 
     
     
         18 . A method as in  claim 14 , wherein the protective sleeve is latched to the shaft while the shaft is introduced, further comprising unlatching the sleeve before retracting the sleeve, wherein unlatching comprises distally advancing a key over a latch on the shaft. 
     
     
         19 . A method as in  claim 14 , 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. 
     
     
         20 . A method as in  claim 14 , 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. 
     
     
         21 . A method as in  claim 14 , wherein the hemostatic implant comprises a cylindrical body which circumscribes the shaft. 
     
     
         22 . A method as in  claim 14 , wherein the hemostatic implant comprises a body which is configured to open laterally and release from the shaft after the protective sleeve is withdrawn. 
     
     
         23 . A method as in  claim 14 , 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. 
     
     
         24 . A method as in  claim 23 , wherein the biodegradable polymer comprises a material selected from the group consisting of polyethylene glycols, collagens, and gelatins. 
     
     
         25 . A method as in  claim 14 , wherein the hydratable hemostatic implant comprises an active agent comprising an anti-proliferative agent selected from the group consisting of sirolimus, paclitaxel, wherein the active agents are incorporated in a degradable carrier comprising a material selected from the group consisting of polylactic acid, and poly(lactide-co-glycolide). 
     
     
         26 . A method as in  claim 25 , wherein the hemostatic implant comprises an active agent which comprises an anti-proliferative agent selected from the group consisting of sirolimus and paclitaxel, or an anticoagulant selected from the group consisting of thrombin and tissue factor. 
     
     
         27 . A method as in  claim 14 , wherein at least a portion of the hemostatic implant or tube 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.