Apparatus and methods for delivering hemostatic materials for blood vessel closure

• US 9,439,637 B2
• Filed: 11/14/2014
• Issued: 09/13/2016
• Est. Priority Date: 12/13/2005
• Status: Active Grant

• Current Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Original Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Inventors: Yassinzadeh, Zia, Pelayo, Delfin
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/542,066
• Publication Number:
  US 20150073472A1
• Time in Patent Office: 669 Days
• Field of Search: 606/213
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

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.

Claims

1. An apparatus for sealing a blood vessel penetration disposed at the end of a tissue tract, the apparatus comprising:

a shaft having a proximal end and a distal end;

a radially expandable occlusion element at a distal end of the shaft;

a hemostatic implant disposed over and in contact with an exterior surface at the distal end of the shaft; and

a retractable outer sleeve constraining the hemostatic implant on the shaft to maintain the hemostatic implant in a position between the retractable outer sleeve and the exterior surface at the distal end of the shaft;

wherein the hemostatic implant is configured to remain stationary on the shaft while the outer sleeve is being retracted, and

wherein the constrained hemostatic implant has a first mass on a first lateral side of the shaft and a second mass on a second lateral side of the shaft opposite the first side, the first mass being greater than the second mass so that the hemostatic implant hydrates and expands asymmetrically to open laterally to release from the first lateral side of the shaft after the outer sleeve is fully retracted from over the implant.

2. An apparatus as in claim 1, further comprising a back stop on the shaft wherein the backstop is configured to prevent the hemostatic implant from being displaced proximally while the outer sleeve is retracted.

3. An apparatus as in claim 1, wherein the apparatus further includes an inner release sheath inside of the outer sleeve and covering the implant, wherein the release sheath inhibits sticking between the outer sleeve and the hemostatic implant as the outer sleeve is retracted.

4. An apparatus as in claim 3, wherein the inner release sheath is split so that it opens over the hemostatic implant after the outer sleeve is retracted.

5. An apparatus as in claim 3, wherein the outer sleeve is configured to couple to and retract the inner release sheath to expose and release the hemostatic implant as the outer sleeve is retraced.

6. An apparatus as in claim 3, wherein the inner release sheath is configured to be retracted separately from the outer sleeve.

7. An apparatus as in claim 1, wherein the hemostatic implant comprises a cylindrical body which circumscribes the shaft and having at least one axial split along its length.

8. An apparatus as in claim 1, wherein the hemostatic implant has a crescent-shaped cross-section.

9. An apparatus as in claim 1, wherein the hemostatic implant comprises a wrapped sheet which is axially split and which partially or fully circumscribes the shaft.