Apparatus and methods for delivering hemostatic materials for blood vessel closure

• US 10,327,747 B2
• Filed: 08/15/2016
• Issued: 06/25/2019
• 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 M
• Application Number:
  US15/237,493
• Publication Number:
  US 20160345946A1
• Time in Patent Office: 1,044 Days
• Field of Search: 606213
• 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, resorptive for implantable prostheses A61F2210/0004
• 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. 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.

2. 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 sleeve.

3. A method as in claim 2, wherein unlatching comprises distally advancing a key over a latch on the shaft.

4. A method as in claim 3, 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 sleeve are performed by direct manipulation with a user'"'"'s hands.

5. A method as in claim 4, 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.

6. A method as in claim 4, wherein the key couples to the protective sleeve and the sleeve is retracted by retracting the key.

7. A method as in claim 1, wherein the protective sleeve comprises an outer sleeve and an inner release sheath, wherein the outer sleeve is retracted first while the inner release sheath inhibits sticking between the outer sleeve and the hemostatic implant.

8. A method as in claim 7, wherein the inner release sheath is split so that the inner release sheath opens over the hemostatic implant as the outer sleeve is retracted.

9. A method as in claim 1, wherein the 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.

10. A method as in claim 9, wherein the biodegradable polymer comprises a material selected from the group consisting of polyethylene glycols, collagens, and gelatins.

11. A method as in claim 1, wherein the hemostatic implant comprises an active agent comprising an anti-proliferative agent selected from the group consisting of sirolimus and 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).

12. A method 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 a coagulant selected from the group consisting of thrombin and tissue factor.

13. A method as in claim 12, wherein the active agent is incorporated in a nanoparticle.

14. A method as in claim 13, wherein the nanoparticles have an average size in the range from 10 nm to 100 μ

m.

15. 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.

16. A method as in claim 1, wherein the shaft is advanced through an introducer sheath which is present in the tissue tract.

17. A method as in claim 16, further comprising removing the introducer sheath over the apparatus after the shaft has been introduced therethrough.

18. A method as in claim 16, wherein the shaft is introduced without a guidewire.

19. A method as in claim 1, wherein the hemostatic implant comprises a wrapped sheet at least partially circumscribing the shaft.