Apparatus for delivery of pharmaceuticals to the cochlea

• US 8,401,674 B2
• Filed: 08/04/2009
• Issued: 03/19/2013
• 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
• Application Number:
  US12/535,374
• Publication Number:
  US 20090292329A1
• Time in Patent Office: 1,323 Days
• Field of Search: 607/3, 607136-137, 604/256, 604/265
• 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;

a stiffening member configured to bias the elongate member into a first configuration, wherein the elongate member adopts a second configuration upon deactivation or removal of the stiffening member, and wherein the stiffening member extends through a lumen in the elongate member, the stiffening member made of a material relatively stiffer than the resiliently flexible material of the elongate member, and formed from one of;

a bioresorbable material which softens or dissolves on exposure to a cochlear fluid, and a non bioresorbable material selected from the group comprising a metallic stylet and a non metallic stylet; and

a substance egress configured to fluidically couple said reservoir to an exterior of said elongate member, wherein said substance egress is configured to release said bio-active substance from said reservoir, wherein said substance egress comprises an opening in said reservoir, wherein said opening is sealed, and wherein said opening is configured to be unsealed following implantation of said device.

2. The device of claim 1, wherein said elongate member further comprises a coating of lubricious material on at least a portion of the outer surface of said elongate member.

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

4. The device of claim 2, wherein said lubricious material is impregnated with said bio-active substance.

5. The device of claim 1, wherein at least said substance egress is sealed with a layer of bioresorable material configured to dissolve following implantation of said device to unseal the sealed opening.

6. The device of claim 1, wherein said elongate member is impregnated with at least one bio-active substance, and wherein said elongate member is configured to permit said at least one bio-active substance to leach from said elongate member following implantation.

7. The device of claim 1, wherein said reservoir comprises a lumen extending through at least a portion of the length of said elongate member.

8. The device of claim 7, wherein said lumen extends parallel to a direction of mounting of the plurality of electrodes.

9. The device of claim 1, wherein said opening is configured to be manipulated to seal and unseal said opening.

10. The device of claim 1, 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 1, wherein said device further 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.

12. The device of claim 1, wherein said stiffening member is formed of a bioresorbable material which softens or dissolves on exposure to a cochlear fluid.

13. The device of claim 1, wherein said stiffening member is formed of a non bioresorbable material selected from the group comprising a metallic stylet and a non metallic stylet.

14. 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 substance egress comprising a sealed opening in the reservoir that is configured to be unsealed following implantation of the device to fluidically couple said reservoir to an exterior of said elongate member thereby releasing the bio-active substance from the reservoir; and

a substance ingress, separate from said substance egress, configured to fluidically couple said reservoir to an exterior of said elongate member, wherein said substance ingress is configured to receive said bio-active substance from outside said reservoir prior to implantation of said device.

15. The device of claim 14, further including a plug configured to be inserted in said substance ingress to seal said substance ingress.

16. The device of claim 14, wherein a lumen extends from said substance ingress to said substance egress, and wherein said fluid reservoir comprises said lumen.

17. The device of claim 16, wherein said lumen extends parallel to a longitudinal axis of said elongate member.