DRUG DELIVERY CUFF

• US 20100268188A1
• Filed: 12/12/2008
• Published: 10/21/2010
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Oregon Health & Science University
• Original Assignee: Oregon Health & Science University
• Inventors: Hanson, Stephen R.
• Granted Patent: US 8,808,255 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

Embodiments provide a drug delivery cuff including a drug reservoir. In an embodiment, an integrated drug pump may be provided. A drug delivery cuff in accordance with an embodiment may be placed around any suitable vascular graft (e.g., ePTFE) or directly around any natural tissue conduit (e.g., perivascularly), at any position along the graft/conduit or overlapping a graft and conduit, either at the time of graft surgical placement or separate therefrom.

Claims

1. A cuff for the local delivery of a substance to a graft or natural tissue conduit, comprising:

an outer membrane and an inner membrane defining a reservoir therebetween;

two free ends forming an open configuration of the cuff when the cuff is disengaged from the graft or natural tissue conduit; and

a closure mechanism to secure the two free ends and the cuff around the graft or natural tissue conduit.

2. The cuff of claim 1, wherein the cuff is further coupled to a drug pump and wherein the drug pump is in fluid contact with the reservoir.

3. The cuff of claim 2, wherein the drug pump is in fluid contact with the reservoir via a connecting tube.

4. The cuff of claim 1, wherein the inner membrane is configured to be adjacent to the graft or conduit and has a first surface, an opposite second surface, and an intermediate porous portion that communicates the second surface with the first surface.

5. The cuff of claim 4, wherein the intermediate porous portion is a microporous portion.

6. The cuff of claim 4, wherein the reservoir is capable of fluid communication with the graft or conduit via the intermediate porous portion of the inner membrane such that, when in use, a substance in the reservoir may be delivered to the graft or conduit.

7. The cuff of claim 1, wherein the outer membrane comprises a substantially non-porous biocompatible material.

8. The cuff of claim 1, wherein the closure mechanism comprises mateable features present on the two free ends.

9. The cuff of claim 8, wherein the mateable features are configured to be coupled together using sutures, staples, or adhesive.

10. The cuff of claim 8, wherein the mateable features comprise a first flange protrusion on a first of the two free ends and a second flange protrusion on a second of the two free ends, the first flange protrusion and the second flange protrusion being mateable.

11. The cuff of claim 8, wherein the mateable features comprise a slot on a first of the two free ends and a protrusion on a second of the two free ends, the slot and the protrusion being mateable.

12. The cuff of claim 8, wherein the mateable features comprise a first overlapping protrusion on a first of the two free ends and a second overlapping protrusion on a second of the two free ends, the first overlapping protrusion and the second overlapping protrusion being mateable.

13. The cuff of claim 8, wherein the mateable features comprise a first protrusion on a first of the two free ends and a second looped protrusion having at least one loop on a second of the two free ends, the first protrusion and the second looped protrusion being mateable.

14. The cuff of claim 13, wherein the second looped protrusion has a plurality of loops.

15. The cuff of claim 1, wherein the closure mechanism comprises at least two protrusions that are configured to be coupled together to secure the two free ends and the cuff around the graft or natural tissue conduit.

16. The cuff of claim 15, wherein the protrusions are configured to be coupled together using sutures, staples, or adhesive.

17. The cuff of claim 1, further comprising a spacer insertable between and couplable to the two free ends of the cuff.

18. A method of securing a cuff around a graft or natural tissue conduit, comprising:

providing a cuff, the cuff having an outer membrane and an inner membrane defining a reservoir therebetween, two free ends forming an open configuration of the cuff when the cuff is disengaged from the graft or natural tissue conduit, and a closure mechanism to secure the two free ends and the cuff around the graft or natural tissue conduit;

placing the cuff around the graft or natural tissue conduit; and

impermanently securing the two free ends and the cuff around the graft or natural tissue conduit utilizing the closure mechanism.

19. A method of delivering a drug to a graft or natural tissue conduit, comprising:

providing a cuff, the cuff having an outer membrane and an inner membrane defining a reservoir therebetween, two free ends forming an open configuration of the cuff when the cuff is disengaged from the graft or natural tissue conduit, a closure mechanism to secure the two free ends and the cuff around the graft or natural tissue conduit; and

a pump containing a drug and in fluid communication with the reservoir;

placing the cuff around the graft or natural tissue conduit;

impermanently securing the two free ends and the cuff around the graft or natural tissue conduit utilizing the closure mechanism;

operating the pump to deliver the drug to the reservoir and to deliver the drug across the inner membrane to the graft or natural tissue conduit when pressure in the reservoir exceeds intraluminal pressure of the graft or natural tissue conduit.

20. The method of claim 19, wherein the drug is delivered to the reservoir at such a rate to delay delivery of the drug across the inner membrane by 1-3 days until such time as the pressure in the reservoir exceeds the intraluminal pressure of the graft or natural tissue conduit.