Graft devices and methods of fabrication

• US 10,149,750 B2
• Filed: 02/16/2016
• Issued: 12/11/2018
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: Xeltis AG (Technische Universiteit Eindhoven)
• Original Assignee: Neograft Technologies, Inc.
• Inventors: Wagner, David, Soletti, Lorenzo, El-Kurdi, Mohammed S., McGrath, Jon, Garibotto, John T., Flaherty, J. Christopher
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): Lannu, Joshua D
• Application Number:
  US15/044,369
• Publication Number:
  US 20160157989A1
• Time in Patent Office: 1,029 Days
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 27/047 Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

A graft device is provided comprising a flow conduit and a surrounding covering. The graft device can connect a first body space and a second body space. In one embodiment, the flow conduit is a vein, such as a harvested saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided are methods of preparing a graft device and connecting the graft device between a first body space and a second body space, such as the aorta and a location on an occluded coronary artery, distal to the occlusion.

Claims

1. A graft device for a patient, comprising:

a tubular flow conduit comprising an inner wall, an outer wall, a proximal end, a distal end, and a lumen therethrough; and

a tubular covering, said tubular covering surrounding a length of the tubular flow conduit and having an elastically biased curvilinear geometry customized for an anatomical geometry of an area of said patient;

wherein said tubular covering is configured to impart an elastic curvilinear bias to the graft device, and

wherein the graft device is constructed and arranged for connection between a first body space and a second body space.

2. The graft device of claim 1, wherein the graft device comprises a varying geometry cross section from the proximal end to the distal end of the tubular flow conduit.

3. The graft device of claim 1, wherein said anatomical geometry of an area of said patient is determined from an image produced by an instrument selected from the group consisting of:

X-ray;

MRI;

Ct-Scan;

NMR;

Ultrasound;

CCD Camera;

film camera; and

any combinations thereof.

4. The graft device of claim 1, wherein the tubular flow conduit comprises a tissue structure.

5. The graft device of claim 4, wherein the tissue structure is selected from the group consisting of:

bone;

skin;

eustachian tube;

artery;

vein;

urethra;

lympathic duct;

nasal channel;

intestine;

esophagus;

ureter;

urethra;

trachea;

bronchi;

duct;

fallopian tube; and

combinations thereof.

6. The graft device of claim 4, wherein the tissue structure is selected from the group consisting of:

autologous tissue;

allogenic tissue;

xenogenic tissue; and

combinations thereof.

7. The graft device of claim 4, wherein the tissue structure comprises a hollow tissue structure.

8. The graft device of claim 7, wherein the hollow tissue structure is selected from the group consisting of:

eustachian tube;

artery;

vein;

urethra;

intestine;

esophagus;

ureter;

urethra;

trachea;

fallopian tube; and

combinations thereof.

9. The graft device of claim 4, wherein the tissue structure comprises a blood vessel.

10. The graft device of claim 4, wherein the tissue structure comprises cultured tissue.

11. The graft device of claim 10, wherein the cultured tissue is tissue grown proximate a tubular scaffold.

12. The graft device of claim 10, wherein the cultured tissue is tissue grown on a relatively flat plate.

13. The graft device of claim 10, wherein the cultured tissue is tissue grown in situ.

14. The graft device of claim 1, wherein the tubular flow conduit comprises an artificial conduit.

15. The graft device of claim 14, wherein the artificial conduit comprises material selected from the group consisting of:

PFFE;

ePTFE;

PVDF-HFP;

silicone; and

combinations thereof.

16. The graft device of claim 1, wherein the tubular flow conduit comprises an artificial conduit and a tissue.

17. The graft device of claim 1, wherein the tubular covering comprises a polymer.

18. The graft device of claim 17, wherein the tubular covering comprises an electrospun polymer.

19. The graft device of claim 1, wherein the tubular covering comprises a fiber form.

20. The graft device of claim 19, wherein the fiber form comprises an electrospun fiber.

21. The graft device of claim 19, wherein the fiber form comprises a spooled fiber.

22. The graft device of claim 1, wherein the tubular covering is constructed and arranged to resist radial expansion of the tubular flow conduit.

23. The graft device of claim 1, wherein the tubular covering comprises an elongated tube constructed and arranged to slidingly receive the tubular flow conduit.

24. The graft device of claim 23, wherein the tubular covering is constructed and arranged to be shrunk after placement around the tubular flow conduit.

25. The graft device of claim 1, wherein the tubular covering comprises a helical coil constructed and arranged to surround the tubular flow conduit.

26. The graft device of claim 23, wherein the tubular covering is constructed and arranged to be expanded prior to slidingly receiving the tubular flow conduit.

27. The graft device of claim 1, wherein the tubular covering is constructed and arranged to support an anastomotic connection.

28. The graft device of claim 1, wherein the tubular covering comprises a slit tube constructed and arranged to surround the tubular flow conduit.