Biomaterials for track and puncture closure

Patent metadata

Field	Value
Publication number	US-9463004-B2
Application number	US-77332610-A
Country	US
Kind code	B2
Filing date	May 4, 2010
Priority date	May 4, 2009
Publication date	Oct 11, 2016
Grant date	Oct 11, 2016

Abstract

Embodiments include coatings for adherence of biomaterials to a tissue. Systems and methods for adapting such coated materials to vascular access closure are further proved.

First claim

It is claimed:

1. An apparatus for treatment of a track and blood vessel large bore puncture comprising:
an applicator, a plug comprising a proximal and a distal end preloaded in the applicator, and first and second reactive precursors preloaded in the applicator,
with the applicator comprising a distal portion sized for placement in the track of the large bore puncture and having a distal opening and a lumen, and a pusher at least partially received in the lumen for pushing the plug out of the lumen through the distal opening,
with the plug being sized for placement in the track of the large bore puncture and disposed within the lumen, and
with the precursors disposed in the lumen at a position distal to the distal end of the plug for release into the track of the large bore puncture prior to expulsion of the plug from the lumen,
wherein the precursors are a powder in a dry state and react with physiological fluid after placement in the track to dissolve and form a matrix material that secures the plug within the puncture.

2. The apparatus of claim 1 wherein the first reactive precursor comprises electrophilic functional groups and the second reactive precursor comprises nucleophilic functional groups, wherein both of the precursors are polymers.

3. The apparatus of claim 1 wherein the plug comprises a rod, a tube, a rolled-up sheet, a twisted sheet, or a braided sheet.

4. The apparatus of claim 1 wherein the precursors dissolve in physiological fluid after placement in the track and undergo a covalent bonding reaction to form a matrix material that adheres to the plug and the track.

5. The apparatus of claim 1 comprising a plurality of the reactive precursors, wherein the precursors dissolve in physiological fluid after placement in the track and undergo a covalent bonding reaction to form a matrix material that adheres to the plug and the track.

6. The apparatus of claim 1 wherein the plug comprises a porous hydrogel.

7. The apparatus of claim 1 wherein the plug comprises a lyophilized hydrogel biomaterial.

8. The apparatus of claim 1 further comprising a buffer to increase a reaction rate of the precursors when exposed to fluid within the track.

9. The apparatus of claim 1 wherein the applicator comprises a sheath.

10. A method for treatment of a track and blood vessel puncture comprising:
placing a distal portion of an applicator into the track, the applicator preloaded with a plug having proximal and distal ends and first and second reactive precursors distally beyond the distal end of the plug, wherein the precursors are a powder in a dry state and react with physiological fluid to dissolve the precursors;
expelling the precursors from the applicator into at least a portion of the track, and subsequently expelling the distal end of the plug into the track, wherein the precursors react and form a matrix material adhesive to the track and the treatment substantially stops flow of blood into the track;
wherein the puncture is a large bore puncture.

11. The method of claim 10 wherein the plug is expelled into the track and pushed through at least a portion of the track that received the precursors.

12. The method of claim 10 wherein the precursors are expelled into the track and a distal portion of the applicator is passed through at least a portion of the track that received the reactive precursors, and the plug is expelled into the track.

13. The method of claim 10 wherein the first precursor comprises electrophilic functional groups and the second precursor comprises nucleophilic functional groups, wherein both of the precursors are polymers.

14. The method of claim 10 wherein the plug comprises a rod, a tube, a rolled-up sheet, a twisted sheet, or a braided sheet.

15. The method of claim 10 wherein the precursors dissolve in physiological fluid after placement in the track and undergo a covalent bonding reaction to form a matrix material that secures the plug within the track.

16. The method of claim 10 comprising a plurality of the reactive precursors, wherein the precursors dissolve in physiological fluid after placement in the track and undergo a covalent bonding reaction to form a matrix material that adheres to the plug and the track.

17. The method of claim 10 comprising melting the precursors, with the melted precursor material being located distal to the plug in the applicator.

18. The method of claim 10 wherein the plug comprises a porous hydrogel.

19. The method of claim 10 wherein the plug comprises a lyophilized hydrogel biomaterial.

20. The method of claim 10 further comprising a buffer to increase a reaction rate of the precursors when exposed to fluid within the track.

21. The method of claim 10 wherein the applicator comprises a sheath.

22. The method of claim 21 further comprising passing the sheath over an introducer wire.

23. The method of claim 10 , further comprising placing an elongate member including an expandable member into the track and expanding the expandable member within a body lumen adjacent the track, and wherein the precursors and plug are expelled from the applicator at a position around the elongate member and proximal the expanded expandable member.

24. The method of claim 23 , further comprising removing the expandable member and applicator from the track through the plug.

25. A method for treatment of a track and blood vessel puncture, comprising:
providing an applicator with a proximal end portion and a distal end portion preloaded with a plug having a proximal and a distal end and first and second reactive precursors distally beyond the distal end of the plug adjacent a distal end portion of the applicator, wherein the precursors are a powder in a dry state and react with physiological fluid to dissolve the precursors;
positioning the distal end portion of the applicator near an arteriotomy in a distal portion of the track; and
sequentially expelling the precursors and the plug from the distal end portion of the applicator into the track, wherein the precursors react and form a matrix material that secures the plug within the track relative to the arteriotomy,
wherein the puncture is a large bore puncture.

26. The method of claim 25 , wherein the plug is a lyophilized hydrogel biomaterial.

27. The method of claim 26 , wherein the first precursor comprises electrophilic functional groups and the second precursor comprises nucleophilic functional groups, wherein both of the precursors are polymers.

28. The method of claim 25 , further comprising introducing additional sealing material into all or a portion of the track.

Assignees

• Campbell Patrick
• Sawhney Amarpreet S
• Incept Llc

Inventors

• Campbell Patrick
• Sawhney Amarpreet S

Classifications

• A61B17/0057 Primary

  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 title

• A61L31/145

  Hydrogels or hydrocolloids · CPC title

• A61B2017/00654

  entirely comprised between the two sides of the opening · CPC title

• A61B2017/0065

  the implement being an adhesive · CPC title

• A61L31/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title