Graft devices and methods of use

• US 9,445,874 B2
• Filed: 07/19/2011
• Issued: 09/20/2016
• 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): Matthews, Christine H
• Assistant Examiner(s): Lannu, Joshua D
• Application Number:
  US13/811,206
• Publication Number:
  US 20140005470A1
• Time in Patent Office: 1,890 Days
• US Class Current: 1/1
• 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;

a tubular member holder positioned within the chamber;

a rotation element operably connected to the tubular member holder;

a polymer delivery assembly comprising one or more polymers, one or more solvents and a polymer injection reservoir comprising;

a first compartment comprising the one or more polymers, a second compartment comprising the one or more solvents, and a mixing element that mixes the one or more polymers and the one or more solvents; and

a sterile barrier between an internal portion and an exterior surface of the cartridge device.

2. The cartridge device of claim 1, further comprising an equipotential surface surrounding the tubular member holder.

3. The cartridge device of claim 1, wherein the cartridge device is constructed and arranged to maintain the tubular member holder in a controlled environment.

4. The cartridge device of claim 3, wherein the controlled environment comprises one or more of the following:

a controlled temperature;

a controlled humidity;

a controlled pressure;

or any combination thereof.

5. The cartridge device of claim 3, wherein the cartridge device controls the partial pressure of the one or more solvents.

6. The cartridge device of claim 3, further comprising an inlet port, an outlet port, or combination thereof.

7. The cartridge device of claim 3, further comprising one or more ports operably connected to one or more external environmental control devices comprising a positive pressure source, a vacuum source, a heating unit, a cooling unit, a humidifier, a dehumidifier, an ionizing unit, or any combination thereof.

8. The cartridge device of claim 1, wherein the cartridge device is configured to apply the fiber matrix to two or more tubular members simultaneously.

9. The cartridge device of claim 1, wherein the housing further comprises a transparent portion, wherein the transparent portion allows an optical measurement device to measure a parameter of the tubular member, the fiber matrix, or combination thereof.

10. The cartridge device of claim 1, wherein the housing comprises a door that provides access to the tubular member holder;

a recess;

a projection;

a longitudinally expandable portion;

a filtered access port;

an electrical plug;

an attachment port that fluidly attaches to a polymer reservoir;

a first portion, a mating second portion, and a seal therebetween;

a profile that approximates a flight path of an electrospun polymer;

or any combination thereof.

11. The cartridge device of claim 10, wherein the housing comprises a recess operably connectable to a mating projection of an electrospinning device.

12. The cartridge device of claim 10, wherein the housing comprises a projection operably connectable to a recess of an electrospinning device.

13. The cartridge device of claim 1, further comprising a nozzle attachment orifice, a nozzle, or combination thereof.

14. The cartridge device of claim 13, comprising at least two of the nozzle attachment orifices or the nozzles.

15. The cartridge device of claim 13, wherein the nozzle attachment orifice, the nozzle, or combination thereof moves in a manner selected from the group consisting of translation, oscillation, rotation, and combinations thereof.

16. The cartridge device of claim 1, wherein the tubular member comprises harvested tissue.

17. The cartridge device of claim 16, wherein the harvested tissue is selected from the group consisting of vein, artery, lymphatic duct, vas deferens, tear duct, intestine, esophagus, ureter, urethra, trachea, bronchi, duct tissue, Eustachian tube, fallopian tube, and combinations thereof.

18. The cartridge device of claim 1, wherein the tubular member comprises an artificial conduit.

19. The cartridge device of claim 1, wherein the tubular member comprises a conductive material element, an element comprising a first portion and a second portion, or any combination thereof.

20. The cartridge device of claim 19, wherein the tubular member comprises a first end portion, a mid portion, and a second end portion, wherein the conductivity of the first end portion is different than the mid portion.

21. The cartridge device of claim 1, wherein the tubular member holder comprises a first portion and a second portion slidingly received by the first portion.

22. The cartridge device of claim 1, wherein the rotation element comprises a mechanical drive element, a magnetic drive element, a rotation element that electrically connects the tubular member holder to an electrical power supply, or any combination thereof.

23. The cartridge device of claim 1, wherein the polymer delivery assembly further comprises a pump assembly.

24. The cartridge device of claim 1, further comprising a second reservoir.

25. The cartridge device of claim 1, wherein the housing further comprises one or more sensors.

26. The cartridge device of claim 25, wherein the one or more sensors are selected from the group consisting of:

a temperature sensor;

a pressure sensor;

a humidity sensor;

a sensor that senses at least one of;

a polymer thickness, an airborne solvent parameter, or a force used to control tension of the tubular member holder;

a sensor that measures at least one of;

a fiber matrix thickness, a solvent parameter, a polymer parameter, an electrospinning parameter, a velocity, a diameter, an electric field strength, or an electric field direction; and

combinations thereof.

27. The cartridge device of claim 1, wherein the polymer delivery assembly is integral to the housing or attachable thereto.

28. The cartridge device of claim 1, wherein the cartridge device is capable of being sterilized one or more times.