COMPLEMENTARY DRUG DELIVERY SHEATH FOR AN IMPLANTABLE MEDICAL DEVICE

• US 20110098813A1
• Filed: 07/07/2008
• Published: 04/28/2011
• Est. Priority Date: 07/06/2007
• Status: Abandoned Application

• Current Assignee: Cochlear Americas Corporation (Cochlear Limited)
• Original Assignee: Cochlear Limited
• Inventors: Gibson, Peter
• Application Number:
  US12/668,003
• Publication Number:
  US 20110098813A1
• Time in Patent Office: Days
• US Class Current: 623/10
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

A complementary drug delivery sheath for implantable medical devices. The complementary drug delivery sheath is covered, impregnated or otherwise carries one or more drugs. The complementary drug-delivery sheaths are manufactured separately from to the implantable device and are operationally combined with one or more components subsequent to the device'"'"'s manufacture and/or sterilization.

Claims

1. A kit implantable in a recipient, comprising:

an implantable medical device component;

a implantable drug-delivery sheath physically separate from the component, and comprising;

at least one pannicular substrate configured to be operably positioned adjacent to one or more surfaces of the component subsequent to the component'"'"'s manufacture, and

at least one drug carried on the at least one substrate so as to be released into the recipient.

2. The kit of claim 1, wherein the at least one substrate is configured in the form of a pouch having interior dimensions that enable the pouch to receive and to partially or completely envelop the component.

3. The kit of claim 1, wherein the at least one drug comprises one or more of the group consisting of:

an anti-inflammatory drug; and

an antibiotic.

4. The kit of claim 1, wherein the implantable component is an implantable component of a cochlear implant.

5. The kit of claim 4, wherein the implantable component of the cochlear implant is a receiver/stimulator unit, and wherein the drug-delivery sheath is configured to be disposed between the recipient'"'"'s skin and the receiver/stimulator unit when the receiver/stimulator unit is implanted in a recessed portion of the recipient'"'"'s mastoid bone.

6. The kit of claim 4, wherein the implantable component of the cochlear implant is an electrode assembly, and wherein the drug-delivery sheath is configured to be disposed about at least a portion of the electrode assembly.

7. The kit of claim 1, wherein the drug-delivery sheath comprises:

a first substrate configured to configured to be operably positioned adjacent a first surface of the component; and

a second substrate configured to configured to be operably positioned adjacent a second surface of the component.

8. The kit of claim 7, wherein the first and second substrates are joined to each other to form a pouch dimensioned to receive the device.

9. The kit of claim 1, wherein the sheath is sufficiently flexible that the sheath may be manually urged to physically conform to a surface of the device.

10. The kit of claim 1, wherein one or more exterior dimensions of the drug-delivery sheath approximate a corresponding exterior dimension of the implantable medical device.

11. The kit of claim 1, wherein the drug-delivery sheath further comprises:

one or more securing mechanisms each configured to attach the drug-delivery sheath to one or more of the implantable component, a second implantable component or anatomical structure.

12. The kit of claim 11, wherein the one or more securing mechanisms are configured to be attached using one or more of sutures, staples and adhesives.

13. The kit of claim 11, wherein the securing mechanisms comprise one or more of the group consisting of:

tabs;

loops; and

hooks.

14. The kit of claim 9, wherein the surface is on a side of the implantable medical device determined based on one or more factors such as therapeutic benefits of the drugs, ease of implantation, long-term effects, and desired migration path of the drug.

15. The kit of claim 1, wherein the drug-delivery sheath further comprises a plurality of pannicular substrates adhered together.

16. The kit of claim 15, wherein two or more of the substrates carry different drugs.

17. The kit of claim 11, wherein the pannicular substrate is constructed of a polymeric material in which components of the drug are disposed within the chemical structure of the substrate.

18. The kit of claim 1, wherein the pannicular substrate is constructed of a resorbable material.

36. The kit of claim 1, further comprising:

a second implantable component; and

a second implantable drug-delivery sheath physically separate from the component.

37. The kit of claim 36, wherein the second drug-delivery sheath comprises:

one or more pannicular substrates configured to be operably positioned adjacent to one or more surfaces of the second component subsequent to the second component'"'"'s manufacture, and

at least one drug carried on the one or more substrates so as to be released into the recipient.

38. The kit of claim 36, wherein the first implantable component comprises a receiver/stimulator unit of a cochlear implant, and wherein the second implantable component comprises an electrode array of the cochlear implant.

19. A complementary drug-delivery sheath for implantation into a recipient of an implantable component comprising:

a pannicular substrate having dimensions which enable the sheath to be implanted proximate to one or more surfaces of the component; and

at least one drug carried in the substrate for release into the body of the recipient.

20. The sheath of claim 19, wherein the at least one substrate is configured in the form of a pouch having interior dimensions that enable the pouch to receive and to partially or completely envelop the implantable component.

21. The sheath of claim 19, wherein the at least one drug comprises one or more of the group consisting of:

an anti-inflammatory drug; and

an antibiotic.

22. The sheath of claim 19, wherein the implantable component is an implantable component of a cochlear implant.

23. The sheath of claim 22, wherein the implantable component of the cochlear implant is a receiver/stimulator unit, and wherein the drug-delivery sheath is configured to be disposed between the recipient'"'"'s skin and the receiver/stimulator unit when the receiver/stimulator unit is implanted in a recessed portion of the recipient'"'"'s mastoid bone.

24. The sheath of claim 22, wherein the implantable component of the cochlear implant is an electrode assembly, and wherein the drug-delivery sheath is configured to be disposed about at least a portion of the electrode assembly.

25. The sheath of claim 19, wherein the drug-delivery sheath comprises:

a first substrate configured to configured to be operably positioned adjacent a first surface of the component; and

a second substrate configured to configured to be operably positioned adjacent a second surface of the component.

26. The sheath of claim 25, wherein the first and second substrates are joined to each other to form a pouch dimensioned to receive the component.

27. The sheath of claim 19, wherein the sheath is sufficiently flexible that the sheath may be manually urged to physically conform to a surface of the device.

28. The sheath of claim 19, wherein one or more exterior dimensions of the drug-delivery sheath approximate a corresponding exterior dimension of the implantable medical device.

29. The sheath of claim 19, wherein the drug-delivery sheath further comprises:

one or more securing mechanisms each configured to attach the drug-delivery sheath to or more one of the implantable component, a second implantable component or anatomical structure.

30. The sheath of claim 29, wherein the one or more securing mechanisms are configured to be attached using one or more of sutures, staples and adhesives.

31. The sheath of claim 29, wherein the securing mechanisms comprise one or more of the group consisting of:

tabs;

loops; and

hooks.

32. The sheath of claim 19, wherein the drug-delivery sheath further comprises a plurality of pannicular substrates adhered together.

33. The sheath of claim 32, wherein two or more of the substrates carry different drugs.

34. The sheath of claim 19, wherein the the pannicular substrate is constructed of a polymeric material in which components of the drug are disposed within the chemical structure of the substrate.

35. The sheath of claim 19, wherein the pannicular substrate is constructed of a resorbable material.