Apparatus and methods for delivering hemostatic materials for blood vessel closure
First Claim
1. A method for sealing a blood vessel penetration disposed at the end of a tissue tract, 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, the hemostatic implant having a first mass on a first lateral side of the shaft and a second mass on a second lateral side opposite the first lateral side, the first mass being greater than the second mass such that the hemostatic implant is asymmetrically mounted relative to the axis on the exterior surface 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 first mass of the hemostatic implant is greater than the second mass of the hemostatic implant such that the hemostatic implant hydrates and expands laterally to release from the first lateral side of the shaft, thereby facilitating withdrawal of the shaft and occlusion element past the expanded 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.
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Accused Products
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.
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Citations
19 Claims
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1. A method for sealing a blood vessel penetration disposed at the end of a tissue tract, comprising:
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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, the hemostatic implant having a first mass on a first lateral side of the shaft and a second mass on a second lateral side opposite the first lateral side, the first mass being greater than the second mass such that the hemostatic implant is asymmetrically mounted relative to the axis on the exterior surface 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 first mass of the hemostatic implant is greater than the second mass of the hemostatic implant such that the hemostatic implant hydrates and expands laterally to release from the first lateral side of the shaft, thereby facilitating withdrawal of the shaft and occlusion element past the expanded 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification