BLOOD VESSEL BANDAGE

(BIODEGRADABLE POLYMER WRAP)

INTRODUCTION

Coronary heart disease is being the leading causes of death in the Western country. The numbers of heart by pass procedure to half a million each year in the United State. The operation involves transplanting of arteries or veins anywhere in the body to route blood around partially blocked areas of the coronary vessels that supply heart muscle.

A significant number of bypasses fail, because the wall of transplanted arteries becomes thickened, which result to restricted blood flow. Surgeon thinks this happens because of the stress of being transplanted and suddenly having to handle a different blood pressure and flow rate.

PATENTED BY

Mohammed El-Kurdi and colleagues at the University of Pittsburgh have designed a biodegradable polymer bandage to wrap around a transplanted blood vessel and take the strain for the first few hours or days after surgery.

DESCRIPTION

BLOOD VESSEL BANDAGING is a method of mechanically conditioning an arterial vein graft, or any tubular tissue (living cellular structure), typically, but not exclusively, in autologous, allogeneic xenogeneic transplantation procedures. Provided herein is a method of wrapping a tubular tissue, including, without limitation, a vein, artery, urethra, intestine, esophagus, trachea, bronchi, ureter and fallopian tube. The tubular tissue is wrapped with a restrictive fiber matrix of a bioerodible (also referred to as biodegradable or bioresorbable) polymer about a circumference of the tubular tissue. In one non-limiting embodiment, the matrix is deposited onto tubular tissue by electrospinning. In one particular non-limiting embodiment, the tubular tissue is a vein, such as a saphenous vein, that is used, for instance, in an arterial bypass procedure, such as a coronary arterial bypass procedure .

PROCEDURE

1. Drug is associated with the matrix

2. The drug is chosen from one or more of a non-steroidal anti-inflammatory drug

3. The drug is chosen from one or more of an NSAID

· Method of Preparing Tubular Graft

A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and the restrictive fiber matrix of a bioerodible polymer about a circumference of the vein.

1.The matrix is deposited by electrospinning and the tubular tissue is obtained from a vein.

2. The tubular tissue is obtained from a portion of a saphenous vein.

3. The device is prepared by electrospinning the polymer fibers onto the tubular tissue thus the fibers comprise a polymer chosen from one or more of: a polymer derived from an alpha-hydroxy acid, a polylactide, a poly(lactide-co-glycolide), a poly(L-lactide-co-caprolactone), a polyglycolic acid, …etc

4. The fibers comprise a polymer comprising ester and urethane linkages and the fibers comprise a poly(ester urethane)urea.

5. The tubular tissue is chosen from one or more of an artery, urethra, intestine, esophagus, ureter, trachea, bronchi, and fallopian tube.

6. The device is prepared by electrospinning the polymer fibers onto the tubular tissue, and the fibers comprise a polymer derived from an alpha-hydroxy acid.

7. The fibers comprise one or more polymer chosen from a polylactide, a poly(lactide-co-glycolide), a poly(L-lactide-co-caprolactone), a polyglycolic acid, a poly(dl-lactide-co-glycolide) and a poly(1-lactide-co-dl-lactide).

8. The fibers comprise a polymer comprising a lactone monomer and the fibers comprise a polycaprolactone.

9. The fibers comprise a polymer comprising carbonate linkages.

10. The fibers comprise one or more polymers chosen from polycarbonate, polyglyconate, poly(glycolide-co-trimethylene carbonate) and poly(glycolide-co-trimethylene carbonate-co-dioxanone).

11. The fibers comprise a polymer comprising urethane linkages.

12. The fibers comprise one or more polymers chosen from a polyurethane and a poly(ester urethane) urea elastomer.

13. The fibers comprise a poly(ester urethane) urea elastomer.

14.The fibers comprise a collagen.

15. The fibers comprise from about 25% wt. to about 75% wt. collagen.

16.The fibers further comprise elastin.

17. The matrix bioerodes in situ over a time period ranging from 12 hours to two weeks.

18. The fibers comprise from about 25% wt. to about 75% wt. of a mixture of collagen and elastin.

19. Elastin and collagen are present in the fibers in approximately equal amounts.

20.The fibers comprises ester linkages

21.The polyester is a polyalkanoate

22. Wherein the polyhydroxyalkanoate is chosen from one or more of a polyhydroxybutyrate, polyhydroxyvalerate and polydioxanone.

23.The polymer is polygalactin.

24.The fibers comprise a natural polymer.

25. The fibers comprise one or more natural polymers chosen from chitosan, collagen, elastin, alginate, cellulose, polyalkanoates, hyaluronic acid and gelatin.

26.The fibers comprise collagen.

27.The fibers comprise elastin.

28.The tubular tissue is a saphenous vein.

29. Further comprising prior to depositing the matrix on the tubular tissue, removing the tubular tissue from a patient, and subsequent to depositing the matrix on the tubular tissue, grafting the device into the patient.

30. Further comprising associating one or both of a cell or a therapeutic substance with the matrix.

31. One or more of cells chosen from stem cells, progenitor (precursor) cells, smooth muscle cells, skeletal myoblasts, myocardial cells, endothelial cells, endothelial progenitor cells, bone-marrow derived mesenchymal cells and genetically modified cells are associated with the matrix.

32. Growth factor is associated with the matrix.

33. Growth factor chosen from one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factors (IGF), transforming growth factor-beta pleiotrophin protein, midkine protein and IGF-1 is associated with the matrix.

34. A drug is associated with the matrix.

35. The drug is chosen from one or more of a non-steroidal anti-inflammatory drug

36. The drug is chosen from one or more of an NSAID

Advantage

Biodegradable polymer wrap may have significantly reduced Intimal Hyperplasia in the AVGs over injured femoral arties controls

Disadvantage

The 30-day duration of the implants was too short and unsafe to use for unilateral surgeries.