IP Library Granted Patent US 9,737,590
Granted Patent B2
US 9,737,590 · App. 13/955,226 · Granted Aug 22, 2017

Self-assembly of collagen fibers from dermis, fascia and tendon for tissue augmentation and coverage of wounds and burns

Inventor: Theodore I. Malinin (Key Biscayne, FL)
Assignee: Vivex Biomedical, Inc.
A61K38/39A61K35/32A61K35/36Y10T428/2982
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Quick Facts
Patent No.
US 9,737,590
App. No.
13/955,226
Granted
Aug 22, 2017
Kind
B2
Abstract

The present invention is a composition of a self-assembly of collagen fibers made from a plurality of sized pieces of a source material. The source material made from animal or human tissue selected from one of dermis, tendon, fascia or dura mater. The self-assembly occurring by induction of a magnetic field in a liquid medium.

Claims (30)

1. A composition comprising sheets of segregated collagenous tissue pieces, wherein said sheets are formed by a process comprising:

preparing a plurality of segregated sized pieces of a source material made from unaltered animal or human collagenous tissue selected from the group consisting of dermis, tendon, fascia, and dura mater;

dehydrating the plurality of segregated sized pieces of source material;

rehydrating the dehydrated pieces in a liquid medium selected from the group comprising Trypsin-Versene liquid medium, a balanced salt solution, Hanks' balanced salt solution, lactated Ringer's solution, and phosphate buffered saline and saline;

exposing the rehydrated pieces in the liquid medium to a magnetic field under conditions sufficient to induce the rehydrated pieces to form connecting bridges, without being treated with acid hydrolysis or enzymes, wherein the connecting bridges extend from one source piece to connect another source piece so as to form a self-assembly of collagen fibers as an interconnected collagen structure, whereby the segregated collagenous tissue pieces are coalesced into single collagenous malleable soft structures; and

forming the collagenous malleable soft structures into sheets having a thickness of one millimeter or greater.

2. The composition of claim 1 wherein the shape of the plurality of sized pieces of source material is circular, oval, rectangular, rhomboid, multiangular, triangular or other 2 dimensional shaped piece.

3. The composition of claim 1 wherein the interconnected collagen structure magnetically adheres to a Teflon-coated magnetic bar.

4. The composition of claim 1 wherein dehydration is achieved by hypothermic dehydration.

5. The composition of claim 1 wherein the plurality of sized pieces has particle sizes from 50 to 1000 microns.

6. The composition of claim 1 wherein the source material is non-viable human tissue of dermis, tendon or fascia and dura mater.

7. The composition of claim 1 wherein the magnetic field is generated by utilization of stationary or rotating magnets and magnetic bars to produce magnetic fields inducing the plurality of sized pieces to induce the formation of new connecting bridges.

8. The composition of claim 7 wherein the plurality of sized segregated pieces exposed to the magnetic field induces the formation of the new connecting bridges between separate pieces into self-assembles of a single collagenous, malleable and soft structures.

9. The composition of claim 7 molding of segregated collagenous tissues into gelatinous masses, producing jelly, putty or paste consistency without resorting to chemical or harsh physical treatment at normothermic or moderately hypothermic temperatures.

10. The composition of claim 1 wherein the magnetic field strength is low to medium.

11. The composition of claim 10 wherein the magnetic field strength is less than 38 gauss.

12. The composition of claim 11 wherein the magnetic field strength is 17 to 27 gauss over a 24 hour exposure.

13. A method of making a composition comprising sheets of segregated collagenous tissue pieces, wherein said method comprises:

preparing a plurality of segregated sized pieces of a source material made from unaltered animal or human collagenous tissue selected from the group consisting of dermis, tendon, fascia, and dura mater;

dehydrating the plurality of segregated sized pieces of source material;

rehydrating the dehydrated pieces in a liquid medium selected from the group comprising Trypsin-Versene liquid medium, a balanced salt solution, Hanks' balanced salt solution, lactated Ringer's solution, and phosphate buffered saline and saline;

exposing the rehydrated pieces in the liquid medium to a magnetic field under conditions sufficient to induce the rehydrated pieces to form connecting bridges, without being treated with acid hydrolysis or enzymes, wherein the connecting bridges extend from one source piece to connect another source piece so as to form a self-assembly of collagen fibers as an interconnected collagen structure, whereby the segregated collagenous tissue pieces are coalesced into single collagenous malleable soft structures; and

forming the collagenous malleable soft structures into sheets having a thickness of one millimeter or greater.

14. The method of claim 13 wherein the liquid is Trypsin-Versene.

15. The method of claim 13 wherein the liquid is Hanks' balanced salt solution or other balanced salt solutions, including lactated Ringer's solution, phosphate buffered saline and saline.

16. The method of claim 13 wherein the liquid is water.

17. The method of claim 13 wherein dehydration is achieved by hypothermic dehydration.

18. The method of claim 13 wherein the plurality of sized pieces have particle sizes from 50 to 1000 microns.

19. The method of claim 13 wherein preparing the plurality of pieces further comprises cutting or slicing the pieces into sizes from 50 microns to 2×2 cm.

20. The method of claim 19 wherein said cutting comprises cutting the pieces into one or more shapes selected from circular, oval, rectangular, rhomboid, ultiangular, triangular or other 2 dimensional shaped pieces.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Dec 12, 2019
From: HERITAGE BANK OF COMMERCE
To: VIVEX BIOMEDICAL, INC.; UMTB BIOMEDICAL, INC; ADVANCED NUMED TECHNOLOGIES, LTD.; VIVEX BIOMEDICAL INTERNATIONAL, INC.
Reel/Frame 051282/0653 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2017
From: VIVEX BIOMEDICAL, INC.
To: MALININ, THEODORE I.
Reel/Frame 043354/0012 →
RELEASE OF SECURITY INTEREST Recorded Mar 28, 2017
From: SILICON VALLEY BANK
To: VIVEX BIOMEDICAL, INC.
Reel/Frame 042103/0686 →
SECURITY INTEREST Recorded Feb 22, 2017
From: VIVEX BIOMEDICAL, INC.; UMTB BIOMEDICAL, INC.; ADVANCED NUMED TECHNOLOGIES, LTD.; VIVEX BIOMEDICAL INTERNATIONAL, INC.
To: HERITAGE BANK OF COMMERCE
Reel/Frame 041782/0452 →
SECURITY INTEREST Recorded Jan 5, 2016
From: VIVEX BIOMEDICAL, INC.
To: SILICON VALLEY BANK
Reel/Frame 037413/0089 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 12, 2014
From: MALININ, THEODORE I
To: VIVEX BIOMEDICAL, INC.
Reel/Frame 032418/0015 →
Continuity (1)
Related Publication 20150037432A1 · Feb 5, 2015