Biomaterials for track and puncture closure

Patent metadata

Field	Value
Publication number	US-2016367235-A1
Application number	US-201615254643-A
Country	US
Kind code	A1
Filing date	Sep 1, 2016
Priority date	May 4, 2009
Publication date	Dec 22, 2016
Grant date	—

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

1 . An apparatus for treatment of a track and blood vessel puncture comprising
an applicator and a plug, with the applicator comprising a distal sheath portion sized for placement in the track and having a distal opening and a lumen, and a pusher received by the lumen for pushing the plug out of the lumen through the sheath distal opening, with the plug being sized for placement in the track and comprising
a coated portion with a substantially dry coating, wherein the coating comprises at least one precursor that dissolves in physiological fluid after placement in the track and undergoes a covalent bonding reaction to form a matrix material that adheres the plug to the track and/or blood vessel, and
an uncoated portion that exposes a porous portion of the plug to blood in the track, with the porous portion at least partially dehydrating the blood in the track.

2 . The apparatus of claim 1 wherein a proximal portion of the plug comprises the uncoated portion of the plug and a distal portion of the plug comprises the coated portion of the plug.

3 . The apparatus of claim 1 wherein the coating comprises a plurality of discrete blebs or discrete stripes separated by the uncoated portion.

4 . The apparatus of claim 1 wherein the uncoated portion comprises a plurality of discontinuous subportions that are separated from each other by the coating.

5 . The apparatus of claim 1 wherein the coated portion covers no more than about 60 % of the plug surface area.

6 . The apparatus of claim 1 wherein the puncture is a vascular access site.

7 . The apparatus of claim 1 comprising a plurality of the precursors, wherein a first precursor comprises electrophilic functional groups and a second precursor comprises nucleophilic functional groups, wherein both of the precursors are polymers.

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

9 . The apparatus of claim 1 further comprising a release agent disposed on at least a portion of the coating.

10 . The apparatus of claim 1 wherein the adherence of the coating to the tissue exceeds the strength of the plug, as testable by the plug failing before disadhering from the tissue.

11 . The apparatus of claim 1 wherein the plug is readily compressible by manual tamponade.

12 . The apparatus of claim 1 wherein the plug further comprises an axial lumen.

13 . The apparatus of claim 1 wherein the plug comprises a dehydrated hydrogel.

14 . The apparatus of claim 1 wherein the plug comprises a polylactide matrix.

15 . A method for treatment of a track and blood vessel puncture comprising percutaneously introducing a porous plug into the track through an applicator having a lumen terminating in a distal opening, the plug comprising a dry coating on a distal portion of the plug and being free of the coating on a proximal portion of the plug, wherein the coating comprises at least a first precursor that dissolves in physiological fluid after placement in the track and undergoes a covalent bonding reaction to form a matrix material that adheres the plug to tissue of the track and/or blood vessel, with the coating promoting adhesion at or near the puncture and the uncoated portion of the plug at least partially dehydrating blood in the track to reduce flow of blood into the track.

16 . The method of claim 15 wherein the first precursor comprises electrophilic functional groups and further comprising a second precursor that comprises nucleophilic functional groups, wherein both of the precursors are polymers.

17 . The method of claim 16 wherein the coating is formed by applying the precursors in a melted state to the plug or by applying the precursors in a liquid solution to the plug and evaporating solvent from the solution.

Assignees

• Incept Llc

Inventors

• Campbell Patrick
• Sawhney Amarpreet S

Classifications

• A61L31/145

  Hydrogels or hydrocolloids · CPC title

• A61B2017/00654

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

• 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

• A61L31/148

  Materials at least partially resorbable by the body · CPC title

• A61B2017/00557

  inflatable (A61B2017/22051 takes precedence) · CPC title