Bioerodible wraps and uses therefor

• US 9,333,068 B2
• Filed: 01/21/2015
• Issued: 05/10/2016
• Est. Priority Date: 01/30/2007
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: El-Kurdi, Mohammed S., Hong, Yi, Soletti, Lorenzo, Stankus, John J., Vorp, David A., Wagner, William R.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): HELM, CARALYNNE E
• Application Number:
  US14/601,523
• Publication Number:
  US 20150150673A1
• Time in Patent Office: 475 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C12N 2533/40 : Polyhydroxyacids, e.g. polymers of glycolic or lactic acid (PGA, PLA, PLGA); Bioresorbable polymers
• CPC Class Codes: C12N 5/0068 : General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: D01D 5/0007 : Electro-spinning non-woven fabrics produced by electro-spinning D04H1/728
• CPC Class Codes: D01D 5/0076 : characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid D01D5/0046 takes precedence
• CPC Class Codes: D10B 2331/10 : polyurethanes
• CPC Class Codes: D10B 2401/12 : biodegradable
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

Abstract

A tubular tissue graft device is provided comprising a tubular tissue and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft comprising depositing a fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and a restrictive fiber matrix of a bioerodible polymer about a circumference of the vein also is provided.

Claims

1. A method of forming a tubular tissue graft device for a patient, the method comprising:

inserting a mandrel inside a harvested vein segment; and

electrospinning one or more synthetic fibers about a circumferential outer surface of the harvested vein segment to form a restrictive fiber matrix that is in substantial contact with the circumferential outer surface and that restricts circumferential expansion of the resulting tubular tissue graft device when grafted.

2. The method of claim 1, wherein the harvested vein segment comprises a saphenous vein.

3. The method of claim 1, wherein the one or more synthetic fibers comprise one or more bioerodible synthetic fibers.

4. The method of claim 3, wherein the one or more bioerodible synthetic fibers are selected so that the restrictive fiber matrix bioerodes over a time period ranging from 12 hours to two weeks after an implantation of the tubular tissue graft device into the patient.

5. The method of claim 1, wherein the one or more synthetic fibers comprise at least one polymer comprising urethane linkages.

6. The method of claim 1, wherein the electrospinning comprises causing relative motion between an orifice of an electrospinning source and the mandrel while metering fluid comprising synthetic material to the orifice to deposit the one or more synthetic fibers about the circumferential outer surface of the harvested vein segment.

7. The method of claim 6, wherein causing the relative motion comprises at least one of linear motion or spinning.

8. The method of claim 6, wherein the electrospinning further comprises applying an electric field between the orifice and the mandrel while metering the fluid comprising the synthetic material to the orifice.

9. The method of claim 8, wherein the electric field comprises a voltage between 3 kV and 15 kV.

10. The method of claim 1, wherein the one or more synthetic fibers are electrospun from a fluid comprising between 1% and 15% polymer by weight.

11. The method of claim 1, wherein the restrictive fiber matrix is formed over less than the entire outer surface of the harvested vein segment.

12. The method of claim 1, wherein the restriction of circumferential expansion of the tubular tissue graft device provided by the restrictive fiber matrix decreases over time.

13. The method of claim 1, wherein the restrictive fiber matrix comprises a porous mesh of the one or more synthetic fibers.

14. The method of claim 1, wherein the electrospinning the one or more synthetic fibers comprises orienting the one or more synthetic fibers to provide anisotropy.

15. The method of claim 1, wherein the inserting the mandrel inside the harvested vein segment comprises inserting the mandrel into and through an inner lumen of the harvested vein segment.

16. A method of performing a vascular grafting procedure in a patient, the method comprising:

obtaining a tubular tissue graft device formed by the method of claim 1; and

implanting the tubular tissue graft device into the patient as a blood vessel to perform the vascular grafting procedure.

17. The method of claim 16, wherein the vascular grafting procedure comprises an arterial bypass grafting procedure.