Catheter with sealed hydratable hemostatic occlusion element

Inventors

Yassinzadeh, Zia

Assignees

Cardiva Medical Inc

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.

Core Innovation

The invention relates to an apparatus for sealing a blood vessel wall penetration disposed at an end of a tissue tract. The apparatus includes a shaft having a proximal end and a distal end, and an occlusion element disposed near the distal end of the shaft. A hydratable hemostatic implant is disposed over or adjacent to an exterior surface of the shaft proximal to the occlusion element, where the implant is hydratable to expand to occlude the tissue tract when exposed to body fluids within the tissue tract.

To manage exposure of the hydratable hemostatic implant, the apparatus includes a protective sleeve retractably disposed over an outer surface of the hemostatic implant and proximal to the occlusion element. A soluble plug is provided for inhibiting hydration of the hemostatic implant prior to retraction of the protective sleeve. The soluble plug is disposed under the protective sleeve when the protective sleeve is retractably disposed over the outer surface of the hydratable hemostatic implant, and the plug is positioned proximal to the occlusion element and distal to a distal end of the hemostatic implant.

Retraction of the protective sleeve first exposes the soluble plug followed by the hemostatic implant. In this sequence, the soluble plug dissolves and is resorbed into surrounding tissue, and then the hydratable hemostatic implant expands and occludes the tissue tract. The occlusion element can be provided as an expansible structure.

Claims Coverage

The independent claim defines five main inventive elements: a shaft with a distal occlusion element, a hydratable hemostatic implant, a retractable protective sleeve, a soluble plug arranged under the sleeve to inhibit hydration, and a cooperative release sequence in which sleeve retraction exposes the soluble plug before the implant.

Overall claim coverage centers on a shaft-mounted occlusion element combined with a hydratable hemostatic implant protected from premature hydration by a retractable protective sleeve and a soluble plug positioned under the sleeve to inhibit hydration until sleeve retraction. The cooperative sequence requires the soluble plug to be exposed first so it dissolves and is resorbed, followed by expansion of the hydratable hemostatic implant to occlude the tissue tract.

Stated Advantages

Documented Applications

No documented applications found