Apparatus for delivery of pharmaceuticals to the cochlea

• US 7,571,012 B2
• Filed: 11/14/2001
• Issued: 08/04/2009
• Est. Priority Date: 11/14/2000
• Status: Expired due to Fees

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Gibson, Peter
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US10/416,634
• Publication Number:
  US 20040078057A1
• Time in Patent Office: 2,820 Days
• Field of Search: 607 55- 57, 607/120, 607136-137, 607 1- 3, 604/256, 604/890.1, 604/891.1, 604 11- 15, 604 19- 21, 604/164.01, 604/164.02, 604/164.05, 604/164.08, 604/164.09, 604/164.12, 604/164.13, 60416501-16504, 60416701-16706, 60417001-17003, 604/171, 604/172, 604/93.01, 604/244, 604/48, 604/246, 604263-265, 604/500, 604/514, 600/25, 600/379, 623/10, 623/23.64, 623/23.68, 623/23.75, 623 24- 25, 606/32, 606/34, 606/41, 606108-109, 606/129
• US Class Current: 607/137
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 2210/0675 Eustachian tube
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• 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: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36038 Cochlear stimulation
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling

Abstract

An implantable tissue-stimulating device, such as a cochlear implant, having a resiliently flexible elongate member (11) having a plurality of electrodes (12) positioned thereon. The elongate member (11) provides a means of delivering at least one bio-active substance to the implantee following implantation of the elongate member (11). The delivery means can comprise a lumen 21 containing the bio-active substance in a liquid form. The bio-active substance can comprise a steroid or can perform a function of reducing the resting neuron potential of neurons within the cochlea.

Claims

1. A cochlear implant electrode assembly device comprising:

a resiliently flexible elongate member having disposed therein a sealable reservoir configured to receive a bio-active substance;

a plurality of electrodes mounted on said elongate member configured to provide stimulation to a cochlea; and

a substance egress fluidically coupling said reservoir to the exterior of said elongate member, wherein said substance egress is configured to release said bio-active substance from said reservoir following implantation of said device, wherein said substance egress comprises an opening in said reservoir sealed with a layer of bioresorable material configured to dissolve following implantation of said device,

a stiffening member configured to bias said elongate member into a first configuration, and wherein said elongate member adopts a second configuration upon deactivation or removal of said stiffening member, wherein said stiffening member comprises a stiffening element extending through a lumen in said elongate member, said stiffening element made of a material relatively stiffer than said resiliently flexible material of said elongate member, and formed of a bioresorbable material which softens or dissolves on exposure to a cochlear fluid.

2. The device of claim 1, wherein said bioresorbable material of said stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).

3. The device of claim 1, wherein said bioresorbable material of said stiffening element is impregnated with one or more said bio-active substances.

4. A cochlear implant electrode assembly device comprising:

a resiliently flexible elongate member having disposed therein a sealable reservoir adapted to receive a bio-active substance;

a plurality of electrodes mounted on said elongate member configured to provide stimulation to a cochlea; and

a substance egress fluidically coupling said reservoir to the exterior of said elongate member, wherein said substance egress is configured to release said bio-active substance from said reservoir following implantation of said device, wherein said substance egress comprises;

a seal disposed at an opening in said reservoir to seal said reservoir; and

a suture through said reservoir and said seal, wherein at least partial removal of said suture at least partially opens said reservoir.

5. The device of claim 4, wherein said elongate member is impregnated with at least one bio-active substance that can leach from said elongate member following implantation.

6. The device of claim 5, wherein said device further comprises a closure configured to sealably close an opening of said lumen.

7. The device of claim 6, wherein said closure comprises a plug insertable in said lumen to form a seal therewith.

8. The device of claim 7, wherein said plug is formed from a resiliently flexible material selected from the group comprising a silicone and a polyurethane.

9. The device of claim 4, wherein said reservoir comprises a lumen extending through at least a portion of the length of said elongate member.

10. The device of claim 4, wherein said bio-active substance is carried in or comprises a fluid, and said at least one substance egress is a fluid egress.

11. The device of claim 10, wherein each said at least one fluid egress comprises a valve configured to allow a fluid to exit said elongate member and to substantially prevent fluid flow from external said elongate member into said elongate member.

12. The device of claim 4, further comprising an additional reservoir external to said elongate member in fluid communication with said reservoir.

13. The device of claim 12, further comprising a pump configured to transfer said bio-active substance from said additional reservoir into said reservoir for subsequent delivery to a site of implantation of said elongate member.

14. The device of claim 4, further comprising a ceramic or polymer pellet impregnated with said bio-active substance, wherein said pellet is disposed in said reservoir and is configured to release said bio-active substance at a desired rate.

15. The device of claim 4, wherein said bio-active substance comprises a steroid.

16. The device of claim 4, wherein said bio-active substance is configured to reduce the resting neuron potential of neurons within the cochlea.

17. The device of claim 4, further comprising a stiffening member configured to bias said elongate member into a first configuration, and wherein said elongate member adopts a second configuration upon deactivation or removal of said stiffening member in order to apply a desired tissue stimulation.

18. The device of claim 17, wherein said elongate member is configured to adopt at least one intermediate configuration between said first and second configurations.

19. The device of claim 17, wherein said stiffening member comprises:

a stiffening sheath that at least partially envelops said elongate member, said sheath made of a material that is relatively stiffer than said resiliently flexible material of said elongate member.

20. The device of claim 19, wherein said stiffening sheath further comprises a coating of a lubricious material partially overlaying said stiffening sheath.

21. The device of claim 17, wherein said second configuration of said elongate member is curved.

22. The device of claim 21, wherein said second configuration of said elongate member is a spiral configuration.

23. The device of claim 17, wherein said first configuration is at least substantially straight.

24. The device of claim 17, wherein said stiffening member comprises:

a stiffening element extending through a lumen in said elongate member, said stiffening element made of a material relatively stiffer than said resiliently flexible material of said elongate member, and formed of a bioresorbable material which softens or dissolves on exposure to a cochlear fluid.

25. The device of claim 24, wherein said bioresorbable material of said stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).

26. The device of claim 24, wherein said bioresorbable material of said stiffening element is impregnated with one or more said bio-active substances.

27. The device of claim 17, wherein said stiffening member comprises:

a stiffening element extending through a lumen in said elongate member, said stiffening element made of a material relatively stiffer than said resiliently flexible material of said elongate member, and formed of a non bioresorbable material selected from the group comprising a metallic stylet and a non metallic stylet.

28. The device of claim 4, wherein said elongate member further comprises a coating of lubricious material on at least a portion of the outer surface of said elongate member.

29. The device of claim 28, wherein said lubricious material is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).

30. The device of claim 28, wherein said lubricious material is impregnated with said bio-active substance.

31. The device of claim 4, wherein said elongate member is formed from a biocompatible material selected from the group comprising a silicone and a polyurethane.

32. The device of claim 4, wherein said device is configured to deliver said bio-active substance to a site of implantation of said elongate member for a desired period of time following implantation.

33. A cochlear implant electrode assembly device comprising:

a resiliently flexible elongate member having disposed therein a sealable reservoir adapted to receive a bio-active substance;

a plurality of electrodes mounted on said elongate member configured to provide stimulation to a cochlea;

a substance egress fluidically coupling said reservoir to the exterior of said elongate member, wherein said substance egress is configured to release said bio-active substance from said reservoir following implantation of said device, wherein said substance egress comprises a sealed opening, wherein said elongate member further comprises a coating of lubricious material on at least a portion of the outer surface of said elongate member; and

a stylet configured to puncture said sealed opening of said substance egress prior to insertion of said device.

34. The device of claim 33, wherein said lubricious material is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).

35. The device of claim 33, wherein said lubricious material is impregnated with said bio-active substance.

36. The device of claim 33, further comprising a stiffening member configured to bias said elongate member into a first configuration, and wherein said elongate member adopts a second configuration upon deactivation or removal of said stiffening member in order to apply a desired tissue stimulation, wherein said stiffening member comprises:

a stiffening sheath that at least partially envelops said elongate member, said sheath made of a material that is relatively stiffer than said resiliently flexible material of said elongate member.

37. The device of claim 36, wherein said stiffening sheath further comprises a coating of a lubricious material partially overlaying said stiffening sheath.

38. A cochlear implant electrode assembly device comprising:

a resiliently flexible elongate member having disposed therein a sealable reservoir adapted to receive a bio-active substance;

a plurality of electrodes mounted on said elongate member configured to provide stimulation to a cochlea; and

a substance egress fluidically coupling said reservoir to the exterior of said elongate member, wherein said substance egress is configured to release said bio-active substance from said reservoir following implantation of said device, wherein said substance egress comprises;

a sealed opening configured to be punctured by a stylet prior to insertion of said device,

a stiffening member configured to bias said elongate member into a first configuration, and wherein said elongate member adopts a second configuration upon deactivation or removal of said stiffening member in order to apply a desired tissue stimulation, wherein said stiffening member comprises a stiffening element extending through a lumen in said elongate member, said stiffening element made of a material relatively stiffer than said resiliently flexible material of said elongate member, and formed of a bioresorbable material which softens or dissolves on exposure to a cochlear fluid.

39. The device of claim 38, wherein said bioresorbable material of said stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).

40. The device of claim 38, wherein said bioresorbable material of said stiffening element is impregnated with one or more said bio-active substances.