Drug delivery cuff

• US 8,808,255 B2
• Filed: 12/12/2008
• Issued: 08/19/2014
• 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.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/747,048
• Publication Number:
  US 20100268188A1
• Time in Patent Office: 2,076 Days
• Field of Search: 623 142- 146, 600/37, 604/288.01, 604/288.04
• US Class Current: 604/288.04
• 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, comprising:

a reservoir for holding a drug-containing solution;

a membrane between the reservoir and the graft, the membrane being microporous relative to the drug-containing solution;

a pump provided to introduce the drug-containing solution to the reservoir at an infusion rate no greater than 1.0 ml/day and produce a threshold pressure within the reservoir wherein upon application of the threshold pressure the membrane releases the drug-containing solution from the reservoir to bloodstream within a lumen of the graft in a relatively uniform manner around an inner circumference of the membrane; and

free ends that are configured to be engaged and disengaged from one another via a closure mechanism so as to respectfully attach and remove the cuff to and from the graft.

2. The cuff of claim 1, wherein the infusion rate is no greater than 0.2 ml/day.

3. The cuff of claim 1, wherein the infusion rate is no greater than 0.1 ml/day.

4. The cuff of claim 1, wherein the membrane is configured to be placed adjacent to the graft and is thereby in fluid communication with the graft.

5. The cuff of claim 1, wherein the membrane comprises pores that are about 10 nm to about 1000 nm in size.

6. The cuff of claim 1, wherein a microporous character of the membrane causes the delivery of the drug-containing solution from the reservoir through the graft to be by convective mass transport and limits diffusive transport.

7. The cuff of claim 1, wherein the membrane controls the uniform manner of drug-containing solution release and the pump defines a rate of drug-containing solution release.

8. The cuff of claim 1, wherein the closure mechanism comprises respective mateable features present on the 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 free ends and a second flange protrusion on a second of the 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 free ends and a protrusion on a second of the 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 free ends and a second overlapping protrusion on a second of the 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 free ends and a second looped protrusion having at least one loop on a second of the 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 free ends and the cuff around the graft.

16. The cuff of claim 15, wherein the at least two protrusions are configured to be sufficiently rigid to hold the cuff in place once the protrusions are coupled together.

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

18. A method of securing a cuff around a graft, comprising:

providing a cuff, the cuff comprising;

a reservoir for holding a drug-containing solution, a membrane between the reservoir and the graft, the membrane being microporous relative to the drug-containing solution, a pump provided to introduce the drug-containing solution to the reservoir at an infusion rate no greater than 1.0 ml/day and produce a threshold pressure wherein upon application of the threshold pressure the membrane releases the drug-containing solution from the reservoir to bloodstream within a lumen of the graft in a relatively uniform manner around an inner circumference of the membrane, at least two free ends that are configured to be engaged and disengaged from one another via a closure mechanism so as to respectfully attach and remove the cuff to and from the graft;

placing the cuff around the graft; and

impermanently securing the at least two free ends and the cuff around the graft utilizing the closure mechanism.

19. A method of delivering a drug to a graft, comprising:

providing a cuff, the cuff comprising;

a reservoir for holding a drug-containing solution, a membrane between the reservoir and the graft, the membrane being microporous relative to the drug-containing solution, a pump provided to introduce the drug-containing solution to the reservoir at an infusion rate no greater than 1.0 ml/day and produce a threshold pressure wherein upon application of the threshold pressure the membrane releases the drug-containing solution from the reservoir to bloodstream within a lumen of the graft in a relatively uniform manner around an inner circumference of the membrane, free ends that are configured to be engaged and disengaged from one another via a closure mechanism so as to respectfully attach and remove the cuff to and from the graft;

placing the cuff around the graft;

impermanently securing the free ends and the cuff around the graft utilizing the closure mechanism;

operating the pump to deliver the drug-containing solution to the reservoir at an infusion rate no greater than 1.0 ml/day and to supply the threshold pressure within the reservoir so that the membrane substantially uniformly delivers the drug-containing solution to the graft, wherein the threshold pressure at least exceeds a mean arterial pressure of the graft;

controlling the uniform manner of drug-containing solution release via the membrane and defining a rate of drug-containing solution release via the pump; and

controlling the delivery of the drug-containing solution from the reservoir to the graft to be by convective mass transport and limiting diffusive transport of the drug-containing solution from the reservoir to the graft using a microporous character of the inner membrane.

20. The method of claim 19, wherein the drug-containing solution is delivered to the reservoir at such a rate to delay reaching the threshold pressure and delivery of the drug-containing solution across the membrane by at least one day following the placing of the cuff around the graft.