Graft devices and methods of use

• US 10,239,071 B2
• Filed: 08/04/2016
• Issued: 03/26/2019
• Est. Priority Date: 07/19/2010
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: Neograft Technologies, Inc., University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Soletti, Lorenzo, El-Kurdi, Mohammed S., McGrath, Jon, Ziegler, Andrew, Flaherty, J. Christopher, Wagner, William R., Vorp, David
• Primary Examiner(s): Kuhlman, Catherine B
• Assistant Examiner(s): Lannu, Joshua D
• Application Number:
  US15/228,339
• Publication Number:
  US 20170043360A1
• Time in Patent Office: 964 Days
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• 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 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2002/046 Tracheae
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: B05B 5/0255 spraying and depositing by electrostatic forces only
• CPC Class Codes: B05B 5/12 specially adapted for coating the interior of hollow bodies
• CPC Class Codes: D01D 13/02 Elements of machines in combination
• CPC Class Codes: D01D 5/0084 Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses

Abstract

A cartridge device is provided for applying a fiber matrix to a tubular member such as a saphenous vein graft. The cartridge includes a housing, a tubular member holder, a rotational drive, and a polymer delivery assembly. The housing defines a chamber which surrounds the tubular member holder. The rotational drive rotates the tubular member during the fiber application process.

Claims

1. A cartridge device for applying a fiber matrix to a tubular member, the cartridge device comprising:

a housing that defines a chamber and comprises an attachment port;

a tubular member holder positioned within the chamber;

a rotation element operably connected to the tubular member holder;

a polymer delivery assembly configured to deliver the fiber matrix comprising at least one polymer onto the tubular member;

an inlet port; and

an outlet port,

wherein the attachment port is configured to (i) fluidly attach to a polymer reservoir comprising the at least one polymer and (ii) provide the at least one polymer to the polymer delivery assembly, and wherein at least one of the inlet port or the outlet port comprises a filtered port.

2. The device according to claim 1, wherein the inlet port, the outlet port, or a combination thereof comprises a membrane, wherein the membrane covers an opening of the inlet port, the outlet port, or the combination thereof.

3. The device according to claim 2, wherein the membrane is removably attached to the opening of the inlet port, the outlet port, or the combination thereof.

4. The device according to claim 2, wherein the membrane is configured to be punctured to uncover the opening of the inlet port, the outlet port, or the combination thereof.

5. The device according to claim 2, wherein the membrane comprises a resealable membrane.

6. The device according to claim 1, wherein the filtered port is configured to maintain sterility of the tubular member holder.

7. The device according to claim 1, wherein the filtered port is configured to provide ventilation of the housing.

8. The device according to claim 1, wherein the filtered port comprises a 0.2 micron filter.

9. The device according to claim 1, wherein the housing comprises a first portion, a mating second portion, and a seal therebetween.

10. The device according to claim 9, wherein the seal comprises a sterility barrier.

11. The device according to claim 1, wherein the polymer delivery assembly is configured to deliver a solvent, and wherein the device is configured to control a partial pressure of the solvent.

12. The device according to claim 11, wherein at least one of the inlet port or the outlet port attaches to an external environmental control device.

13. The device according to claim 12, wherein the external environmental control device is selected from the group consisting of:

a positive pressure source;

a vacuum source;

a heating unit;

a cooling unit;

a humidifier;

a dehumidifier;

an ionizing unit; and

any combination thereof.

14. The device according to claim 1, wherein the inlet port provides an inert gas to the device and controls one or more of:

an ambient pressure, a humidity, or a combination thereof within the device.

15. The device according to claim 14, wherein the inert gas comprises nitrogen.

16. The device according to claim 1, wherein the polymer delivery assembly further comprises a nozzle configured to deliver the fiber matrix onto the tubular member.

17. The device according to claim 16, wherein the nozzle is positioned at a top of the housing or at a bottom of the housing.

18. The device according to claim 16, wherein the nozzle moves in a manner selected from the group consisting of:

translation;

oscillation;

rotation; and

any combination thereof.

19. The device according to claim 1, wherein the tubular member comprises a harvested tissue.

20. The device according to claim 19, wherein the tubular member comprises the harvested tissue selected from the group consisting of:

a vein;

an artery;

a lymphatic duct;

a vas deferens;

a tear duct;

an intestine;

an esophagus;

a ureter;

a urethra;

a trachea;

a bronchi;

a duct tissue;

an Eustachian tube;

a fallopian tube; and

any combination thereof.