Apparatus and Methods for Delivering Hemostatic Materials for Blood Vessel Closure

Abstract

Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an occlusion element, a hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element temporarily occluding the vascular wall penetration and inhibiting backbleeding therethrough. The 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 and left in place to enhance closure of the vascular wall penetration with minimum scarring. The implant may be radiopaque to allow observation before release.

What is claimed is: 
     
         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 having an axis, an occlusion element, and a hemostatic implant disposed over and in contact with an exterior surface of at a distal end of the shaft;   introducing the shaft through the tissue tract to concurrently position both the occlusion element and the hemostatic implant in a lumen of the blood vessel, wherein the hemostatic implant is maintained in a position between a protective sleeve and the exterior surface of the shaft while the shaft is being introduced;   deploying the occlusion element;   retracting the apparatus to seat the deployed occlusion element against the blood vessel penetration to inhibit blood flow from the blood vessel into the tissue tract and to position the hemostatic implant within the tissue tract;   retracting the protective sleeve to expose the hemostatic implant, wherein the protective sleeve comprises a retractable sleeve and a release sheath positioned inside of the retractable sleeve, wherein the retractable sleeve is retracted first while the release sheath inhibits sticking between the retractable sleeve and the hemostatic implant;   collapsing the occlusion element; and   withdrawing the shaft and collapsed occlusion element past the hemostatic implant which remains in the tissue tract to completely biodegrade therein over a period of time to leave no material behind, wherein the shaft and the hemostatic implant have been advanced through the tissue tract prior to deploying the occlusion element.   
     
     
         2 . A method as in  claim 1 , wherein the release sheath is split so that the release sheath opens over the hemostatic implant as the retractable sleeve is retracted. 
     
     
         3 . A method as in  claim 1 , wherein the protective sleeve is latched to the shaft while the shaft is introduced, further comprising unlatching the sleeve before retracting the protective sleeve. 
     
     
         4 . A method as in  claim 3 , wherein unlatching comprises distally advancing a key over a latch on the shaft. 
     
     
         5 . A method as in  claim 4 , wherein the key and a proximal end of the sleeve lie proximally of the tissue tract when the occlusion element is deployed in the blood vessel lumen, wherein unlatching the latch and retracting the protective sleeve are performed by direct manipulation with a user's hands. 
     
     
         6 . A method as in  claim 5 , wherein the hemostatic implant is prevented from being displaced proximally by a back stop on the shaft while the protective sleeve is retracted and while the shaft is withdrawn. 
     
     
         7 . A method as in  claim 5 , wherein the key couples to the protective sleeve and the sleeve is retracted by retracting the key. 
     
     
         8 . A method as in  claim 1 , wherein at least a portion of the hemostatic implant or shaft is radiopaque, wherein the method further comprises observing the hemostatic implant to determine that the hemostatic implant has a correct orientation before the protective sleeve is retracted. 
     
     
         9 . A method as in  claim 1 , wherein the shaft is advanced through an introducer sheath which is present in the tissue tract. 
     
     
         10 . A method as in  claim 9 , further comprising removing the introducer sheath over the apparatus after the shaft has been introduced therethrough. 
     
     
         11 . A method as in  claim 9 , wherein the shaft is introduced without a guidewire. 
     
     
         12 . 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 having an axis, an occlusion element, and a hemostatic implant;   introducing the shaft through the tissue tract to concurrently position both the occlusion element and the hemostatic implant in a lumen of the blood vessel, wherein the hemostatic implant is covered by a protective sleeve while the shaft is being introduced, and wherein the protective sleeve is latched to the shaft while the shaft is introduced;   deploying the occlusion element;   retracting the apparatus to seat the deployed occlusion element against the blood vessel penetration to inhibit blood flow from the blood vessel into the tissue tract and to position the hemostatic implant within the tissue tract;   unlatching the sleeve by distally advancing a key over a latch on the shaft;   retracting the protective sleeve after unlatching the sleeve to expose the hemostatic implant;   collapsing the occlusion element; and   withdrawing the shaft and collapsed occlusion element past the hemostatic implant which remains in the tissue tract to completely biodegrade therein over a period of time to leave no material behind, wherein the shaft and the hemostatic implant have been advanced through the tissue tract prior to deploying the occlusion element.   
     
     
         13 . The method of  claim 12 , wherein the key and a proximal end of the sleeve lie proximally of the tissue tract when the occlusion element is deployed in the blood vessel lumen, and wherein unlatching the latch and retracting the sleeve are performed by direct manipulation with a user's hands.