Implantable device for access to a treatment site

• US 20030069541A1
• Filed: 07/26/2002
• Published: 04/10/2003
• Est. Priority Date: 03/09/1999
• Status: Abandoned Application

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Gillis, Edward M., Theeuwes, Felix
• Application Number:
  US10/206,280
• Publication Number:
  US 20030069541A1
• Time in Patent Office: Days
• US Class Current: 604/164.01
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

The present invention provides an implantable guide for access to a treatment site. The implantable guide comprises a proximal end, a distal end, and a guide body defining a lumen, and can optionally comprise a stable positioning element for stably positioning a drug delivery device within the guide. The guide can be provided in connection with a drug delivery device. In use, the guide is implanted within a subject so as to provide a conduit through which a drug delivery device can be retrievably introduced to facilitate delivery of drug to a treatment site within a subject at a site distal to an accessible implantation site. The drug delivery device is then positioned within the guide lumen to provide for delivery of drug from the drug delivery to the desired treatment site.

Claims

1. An implantable guide for facilitating repeated access to a treatment site in a subject, the guide comprising:

a proximal end, a distal end, and a guide body, wherein the guide body defines a lumen extending from the guide proximal end to the guide distal end; and

a stable positioning element for stably positioning at least a portion of a drug delivery device within the guide.

2. The implantable guide of claim 1, where at least a portion of the guide body is flexible.

3. The implantable guide of claim 1, wherein the guide comprises an openable valve.

4. The implantable guide of claim 1, wherein the guide comprises a sealing element positioned within the guide lumen.

5. The implantable guide of claim 1, wherein the guide body defines a plurality of lumen.

6. The implantable guide of claim 1, wherein the guide is adapted to accommodate at least two drug delivery devices.

7. The implantable guide of claim 1, wherein the guide further comprises a reinforcing element channel.

8. The implantable guide of claim 1, wherein the guide further comprises an anchoring element.

9. The implantable guide of claim 1, wherein the guide body comprises a material selected from the group consisting of:

a polymer, a metal, glass, a polyolefin, nylon, polyethylene terephtholate, silicon, urethane;

a liquid crystal polymer and a fluorenated polymer.

10. The implantable guide of claim 1, wherein the guide is shaped for implantation to a treatment to a site that is subcutaneous, intravenous, intrathecal, intraorbital, intraocular, intraaural, intratympanic, intramuscular, intra_arterial, intra_articular, intracavitary, intraductal, intraglandular, intravascular, intranasal, intraperitoneal, intraspinal, epidural, intracranial, intracardial, intrapericardial, peritumoral, or intratumoral.

50. A method for site-specific drug delivery, the method comprising:

implanting in a subject a guide of claim 1, said implanting providing for placement of the guide distal end at a treatment site;

inserting at least a portion of a drug delivery device into the implanted guide, said insertion providing for stable positioning of the drug delivery device at a proximal end of the guide; and

delivering a drug from the drug delivery device to the treatment site from the guide distal end.

51. The method of claim 50, wherein the drug delivery device comprises a drug release device and a drug delivery catheter, and wherein the drug release device is retained at the proximal end of the guide and the drug delivery catheter is positioned within the guide lumen.

52. The method of claim 50, wherein the treatment site is subcutaneous, intravenous, intrathecal, intraorbital, intraocular, intraaural, intratympanic, intramuscular, intra_arterial, intra_articular, intracavitary, intraductal, intraglandular, intravascular, intranasal, intraperitoneal, intraspinal, epidural, intracranial, intracardial, intrapericardial, peritumoral, or intratumoral.

53. A method of providing access to a treatment site, the method comprising:

implanting in a subject a guide of claim 1, said implanting providing for placement of the guide distal end at a treatment site;

wherein the guide defines a conduit for access to the treatment site.

11. An implantable guide for facilitating repeated access to a treatment site in a subject, the guide comprising:

a proximal end, a distal end, and a guide body, wherein the guide body defines a lumen extending from the guide proximal end to the guide distal end; and

a sealing element for providing a liquid-resistant seal with at least a portion of a drug delivery device positioned within the guide lumen.

12. The implantable guide of claim 11, wherein at least a portion of the guide body is flexible.

13. The implantable guide of claim 11, wherein the guide comprises an openable valve.

14. The implantable guide of claim 11, wherein the guide comprises a stable positioning element for stably positioning at least a portion of a drug delivery device within the guide.

15. The implantable guide of claim 11, wherein the guide body defines a plurality of lumen.

16. The implantable guide of claim 11, wherein the guide is adapted to accommodate at least two drug delivery devices.

17. The implantable guide of claim 11, wherein the guide further comprises a reinforcing element channel.

18. The implantable guide of claim 11, wherein the guide further comprises an anchoring element.

19. The implantable guide of claim 11, wherein the guide body comprises a material selected from the group consisting of:

a polymer, a metal, glass, a polyolefin, nylon, polyethylene terephtholate, silicon, urethane;

a liquid crystal polymer and a fluorenated polymer.

20. The implantable guide of claim 11, wherein the guide is shaped for implantation to a treatment to a site that is subcutaneous, intravenous, intrathecal, intraorbital, intraocular, intraaural, intratympanic, intramuscular, intra_arterial, intra_articular, intracavitary, intraductal, intraglandular, intravascular, intranasal, intraperitoneal, intraspinal, epidural, intracranial, intracardial, intrapericardial, peritumoral, or intratumoral.

21. A drug delivery device comprising:

a drug release device comprising a reservoir, and an orifice defined by a distal portion of the drug release device;

a substantially hollow drug delivery catheter comprising a drug delivery catheter proximal end and a drug delivery catheter distal end, wherein the drug delivery catheter proximal end is coupled to the drug release device to provide a drug flow pathway from the reservoir, through the orifice, and through a lumen of the drug delivery catheter; and

a stable positioning element for stably positioning at least a portion of the drug delivery device within a guide.

22. The drug delivery device of claim 21, wherein the stable positioning element comprises a recess for receiving a snap fit tab.

23. The drug delivery device of claim 21, wherein the drug delivery device further comprises a sealing element for providing a liquid-resistant seal with a guide.

24. The drug delivery device of claim 21, wherein the drug delivery catheter comprises a material selected from the group consisting of:

a polymer, a metal, glass, a polyolefin, nylon;

polyethylene terephtholate, silicone, urethane, a liquid crystal polymer, a fluorenated polymer, and nitinol.

25. The drug delivery device of claim 21, wherein the drug delivery catheter comprises nitinol.

26. The drug delivery device of claim 21, wherein the drug delivery catheter is coated with silver or an antimicrobial agent.

27. A drug delivery device comprising:

a drug release device comprising a reservoir, and an orifice defined by a distal portion of the drug release device;

a substantially hollow drug delivery catheter comprising a drug delivery catheter proximal end and a drug delivery catheter distal end, wherein the drug delivery catheter proximal end is coupled to the drug release device to provide a drug flow pathway from the reservoir, through the orifice, and through a lumen of the drug delivery catheter; and

a sealing element for providing a liquid-resistant seal with a guide.

28. The drug delivery device of claim 27, wherein the drug delivery device comprises a stable positioning element for stably positioning at least a portion of the drug delivery device within a guide.

29. The drug delivery device of claim 27, wherein the stable positioning element is a snap fit recess for mating with a snap fit tab.

30. The drug delivery device of claim 27, wherein the drug delivery catheter comprises a material selected from the group consisting of:

a polymer, a metal, glass, a polyolefin, nylon, polyethylene terephtholate, silicone, urethane, a liquid crystal polymer, a fluorenated polymer, and nitinol.

31. The drug delivery device of claim 27, wherein the drug delivery catheter comprises nitinol.

32. The drug delivery device of claim 27, wherein the drug delivery catheter is coated with silver or an antimicrobial agent.

33. A system for delivery of drug to a treatment site comprising:

an implantable guide comprising a proximal end, a distal end, and a guide body, wherein the guide body defines a lumen extending from the guide proximal end to the guide distal end;

a drug delivery device, wherein at least a portion of the drug delivery device is removably and stably positioned within the guide lumen; and

a stable positioning element that stably and removably associates the guide with the drug delivery device;

wherein the drug delivery device is positioned for delivery of drug from a drug reservoir of the drug delivery device and through the distal end of the guide lumen to the treatment site.

34. The system of claim 33, wherein the drug delivery device comprises:

a drug release device comprising a drug reservoir and a distal portion defining a drug delivery orifice; and

a drug delivery catheter comprising a drug delivery catheter proximal end and a drug delivery catheter distal end, wherein the drug delivery catheter proximal end is coupled to the drug release device to provide a drug delivery pathway from the drug reservoir, through the orifice, and through a lumen of the drug delivery catheter to the drug delivery catheter distal end.

35. The system of claim 34, wherein the drug release device is selected from the group consisting of a diffusion system, an osmotic pump, an electromechanical pump, an erodible drug-comprising polymer, an electrodiffusion pump, an electroosmotic pump, a piezoelectric pump, a vapor pressure pump, and an electrolytic pump.

36. The system of claim 34, wherein the drug delivery catheter distal end terminates within the guide body.

37. The system of claim 34, wherein the drug delivery catheter distal end terminates at a point distal to the guide distal end.

38. The system of claim 34, wherein the drug delivery catheter is at least partially filled with drug prior to implantation.

39. The system of claim 33, wherein the guide comprises an outer diameter of from about 0.1 mm to 3 mm.

40. The system of claim 34, wherein the drug delivery catheter comprises an inner diameter of from about 0.025 mm to 1.5 mm.

41. The system of claim 34, wherein the drug delivery catheter is stiff relative to the guide body of the guide.

42. The system of claim 33, wherein at least a portion of the guide body is flexible.

43. A system for delivery of drug to a treatment site comprising:

an implantable guide comprising a proximal end, a distal end, and a guide body, wherein the guide body defines a lumen extending from the guide proximal end to the guide distal end;

a drug delivery device, wherein at least a portion of the drug delivery device is removably and stably positioned within the guide lumen; and

a sealing element positioned between an inner wall of the guide lumen and an outer wall of the drug delivery device;

wherein the drug delivery device is positioned for delivery of drug from a drug reservoir of the drug delivery device and through the distal end of the guide lumen.

44. The system of claim 43, wherein the system further comprises a stable positioning element for associating the drug delivery device with the guide.

45. The system of claim 43, wherein the stable positioning element comprises a snap fit tab.

46. The system of claim 43, wherein the stable positioning element comprises a bayonet-style connector.

47. The system of claim 43, wherein the stable positioning element comprises a luer lock.

48. The system of claim 43, wherein the stable positioning element comprises a a threaded coupling member.

49. The system of claim 43, wherein the stable positioning element comprises a press-fit connection.