Composite drug delivery catheter

• US 6,368,315 B1
• Filed: 06/23/1999
• Issued: 04/09/2002
• Est. Priority Date: 06/23/1999
• Status: Expired due to Term

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Gillis, Edward M., Theeuwes, Felix
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/339,465
• Time in Patent Office: 1,021 Days
• Field of Search: 604/264, 604/96, 604/71, 604/101, 604/523, 604/524, 604/525, 604/526, 604/527, 604/528, 604/529, 604/530, 604/532, 604/533, 604/534, 604/535, 606/191-194
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Abstract

The present invention features a composite catheter comprising an elongate outer member and an elongate inner member positioned within the outer member so that the inner and outer members define an interstitial space. The outer member has a size and other characteristics that facilitate handling and implantation of the composite catheter, while the inner diameter of the inner member has the size and other characteristics suitable for delivery of a drug through a lumen of the inner member. The interstitial space imparts flexibility to the composite catheter by, for example, removing material from the cross-sectional area that would otherwise provide additional stiffness to the catheter, and/or by accommodating movement of the outer member relative to the inner member.

Claims

1. A composite catheter comprising:

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen, wherein the outer member body comprises a substantially biocompatible material selected from the group consisting of silicone, polyethylene, an ethylene vinyl acetate copolymer, a polyvinylchloride, polymethylmethacrylate, polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate, ethylene dimethacrylate, hydroxymethyl methacrylate, polyurethane, polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, a polycarbonate, polyamides, a fluoropolymers, a polystyrene, a styrene acrylonitrile homopolymer, a styrene acrylonitrile copolymer, cellulose acetate, an acrylonitrile butadiene styrene homopolymer, acrylonitrile butadiene styrene copolymer, polyvinylchloride, silicone rubber, polymethylpentene, a polysulfone, a polyester, a polyimide, polyisobutylene, polymethylstyrene, a polyvinyl chloride elastomer, a polyolefin homopolymeric elastomer, a polyolefine copolymeric elastomer, a urethane-based elastomer, a natural rubber, and a synthetic rubber; and

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end.

2. The composite catheter of claim 1, wherein the inner member defines at least two drug delivery conduits.

3. The composite catheter of claim 1, wherein the catheter comprises at least two inner members.

4. The composite catheter of claim 1, wherein the interstitial space comprises an antimicrobial agent.

5. The composite catheter of claim 1, wherein the catheter further comprises an distal extension at a distal end of the catheter.

6. The composite catheter of claim 5, wherein the distal extension is flexible relative to a proximal portion of the catheter.

7. The composite catheter of claim 5, wherein the distal extension is an extension of the outer member distal end.

8. The composite catheter of claim 5, wherein the distal extension is substantially hollow, and wherein the inner member lumen and a lumen defined by the distal extension form a drug delivery conduit.

9. The composite catheter of claim 5, wherein the distal extension defines an opening that provides a drug delivery outlet.

10. The composite catheter of claim 5, wherein the inner member lumen terminates in a drug delivery outlet at a sidewall of the distal extension.

11. The catheter of claim 1, wherein the inner member lumen is suitable for delivery of drug at a low volume rate.

12. The catheter of claim 1, wherein the inner diameter of the inner member lumen is from about 0.001″

to 0.025″

.

13. The catheter of claim 1, wherein the catheter has an outer diameter of from about 0.030″

to 0.060″

.

14. The catheter of claim 1, wherein the catheter further comprises a radiopaque marker.

15. The catheter of claim 1, wherein the catheter comprises a valve at a catheter distal end.

16. The catheter of claim 1, wherein the catheter comprises an attachment element for attaching a drug delivery device to the catheter.

17. A composite catheter comprising:

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen; and

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, wherein the inner member body comprises a substantially impermeable material selected from the group consisting of a polymer, metal, glass, a polyolefin, nylon, polyethylene terephthalate, urethane, a fluorenated polymer, poly(methyl)methacrylate, polyvinylidine chloride, laminous hydrophilic polymer, laminous hydrophobic polymer, acrylonitrile, nickel titanium, superelastic nickel titanium, and laminates of hydrophilic and hydrophobic polymers, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end.

18. A composite catheter comprising:

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen;

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end; and

a support member positioned within the interstitial space, wherein the support member comprises a material selected from the group consisting of metal, a metal alloy, carbon fiber, a polycarbonate, a polymer, plexiglass, stainless steel, parylene-coated stainless steel, Teflon-coated stainless steel, and nickel titanium.

19. The composite catheter of claim 18, wherein the support member is a compression support member.

20. The composite catheter of claim 19, wherein the compression support member is slidable within the interstitial space.

21. The composite catheter of claim 18, wherein the support member is a tensile support member.

22. A drug delivery system comprising:

a composite catheter comprising;

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen; and

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, and wherein the inner member lumen defines a drug delivery conduit suitable for deliver a drug from the inner member proximal end to the inner member distal end; and

a drug delivery device

wherein the drug delivery device is attached to the catheter to facilitate delivery of a drug from the drug delivery device and through the inner member lumen of the composite catheter, and wherein the drug delivery device facilitates controlled release of drug at a volume rate of from about 0.01 μ

l/day to about 200 μ

l/day.

23. The drug delivery system of claim 22, wherein the catheter is detachably attached to the drug delivery device.

24. The drug delivery system of claim 22, wherein the drug delivery device is a convective drug delivery device.

25. The drug delivery system of claim 22, wherein the drug delivery device is a diffusive drug delivery device.

26. The drug delivery system of claim 22, wherein the inner member defines at least two drug delivery conduits.

27. The drug delivery system of claim 22, wherein the catheter comprises at least two inner members.

28. The drug delivery system of claim 22 wherein the interstitial space comprises an antimicrobial agent.

29. The drug delivery system of claim 22, wherein the catheter further comprises a distal extension at a distal end of the catheter.

30. The drug delivery system of claim 29, wherein the distal extension is flexible relative to a proximal portion of the catheter.

31. The drug delivery system of claim 29, wherein the distal extension is an extension of the outer member distal end.

32. The drug delivery system of claim 29, wherein the distal extension is substantially hollow, and wherein the inner member lumen and a lumen defined by the distal extension form a drug delivery conduit.

33. The drug delivery system of claim 29, wherein the distal extension defines an opening that provides a drug delivery outlet.

34. The drug delivery system of claim 29, wherein the inner member lumen terminates in a drug delivery outlet at a sidewall of the catheter proximal to the distal extension.

35. The drug delivery system of claim 22, wherein the inner member lumen is suitable for delivery of drug at a low volume rate.

36. The drug delivery system of claim 22, wherein the inner diameter of the inner member lumen is from about 0.001″

to 0.025″

.

37. The drug delivery system of claim 22, wherein the catheter has an outer diameter of from about 0.030″

to 0.060″

.

38. The drug delivery system of claim 22, wherein the catheter further comprises a radiopaque marker.

39. The drug delivery system of claim 22, wherein the catheter comprises a valve at a catheter distal end.

40. The drug delivery system of claim 22, wherein the catheter comprises an attachment element for attaching the drug delivery device to the catheter.

41. The drug delivery system of claim 40, wherein the catheter is detachably attached to the drug delivery device.

42. The drug delivery system of claim 22, wherein the drug delivery device is a convective drug delivery device.

43. The drug delivery system of claim 22, wherein the drug delivery device is a diffusive drug delivery device.