Drug-delivery accessory for an implantable medical device

• US 9,101,732 B2
• Filed: 12/17/2013
• Issued: 08/11/2015
• Est. Priority Date: 05/24/2010
• Status: Active Grant

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Dadd, Fysh, Rapsey, Jane, Gibson, Peter, Schuller, Peter, Newbold, Carrie
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/108,809
• Publication Number:
  US 20140180195A1
• Time in Patent Office: 602 Days
• Field of Search: 604/57
• US Class Current: 1/1
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0046 Ear
• 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 31/002 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: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

An implantable drug-delivery sleeve for an elongate component of an implantable medical device. The sleeve includes a tubular substrate having a lumen configured to receive the elongate component so as to allow relative displacement of the substrate and the elongate component, wherein the substrate is shaped so as to be retained stationary at a desired position along the elongate component, and a drug releasably carried by the substrate.

Claims

1. An implantable medical device comprising:

an elongate component that is at least partially implantable in a cochlear of a recipient; and

a drug-delivery sleeve releasably carrying at least one drug and having a lumen configured to receive the elongate component so as to allow relative displacement of the sleeve and the elongate component, wherein the sleeve is manually compressible to the elongate component such that the sleeve is retained stationary relative to the elongate component at an intra-cochlear region of the elongate component, wherein the sleeve includes an attachment frame having a length extending between first and second ends of the sleeve, and a plurality of rings each connected to the attachment frame, wherein the rings are aligned along the length of the attachment frame such that the elongate component is positionable in respective lumens of each of the rings concurrently, and wherein the attachment frame comprises a plurality of severable regions at which the rings may be severed from each other.

2. The device of claim 1, wherein the implantable medical device is a cochlear implant and the elongate component is an elongate carrier member having a plurality of electrodes longitudinally spaced along the carrier member.

3. The device of claim 2, wherein the sleeve is resorbable and at least partially covers each of the plurality of the electrodes.

4. The device of claim 2, wherein the sleeve is a ring having a length that is less than or equal to a distance between two adjacent electrodes of the plurality of electrodes.

5. The device of claim 1, wherein the elongate component includes an extra-cochlear region, wherein the lumen is configured so as to allow relative displacement of the sleeve relative to the intra-cochlear and extra-cochlear regions, and wherein the sleeve is manually compressible to the intra-cochlear and extra-cochlear regions such that the sleeve is retained stationary relative to the elongate component.

6. The device of claim 1, wherein the sleeve comprises at least one mechanical weakness at which a first portion of the sleeve may be detached from a second portion of the sleeve.

7. The device of claim 1, wherein the elongate component is tapered and a diameter of the elongate component at a desired position is greater than or equal to a diameter of the lumen at the desired position.

8. The device of claim 1, wherein the sleeve is configured to substantially surround a circumference of the elongate component when the elongate component is disposed in the lumen.

9. The device of claim 8, wherein the sleeve comprises a gap along its length such that the sleeve surrounds less than all of a circumference of the elongate component when the elongate component is disposed in the lumen.

10. The device of claim 1, further comprising a second drug-delivery sleeve releasably carrying at least one drug and having a lumen configured to receive the elongate component so as to allow relative displacement of the sleeve and the elongate component.

11. An implantable medical device comprising:

an elongate tapered electrode carrier member that is implantable in a recipient;

a tubular substrate having a lumen extending between first and second ends of the substrate, wherein the lumen is configured to receive the electrode carrier member so as to allow relative displacement of the substrate and the electrode carrier member, wherein the substrate is shaped so as to be retained stationary at a desired position along the electrode carrier member at an intra-cochlear region of the electrode carrier member, wherein the lumen has a first diameter at the first end and a second diameter at the second end that is smaller than the first diameter, and wherein the substrate is positioned on the electrode carrier member such that the first diameter of the lumen is disposed at the desired position and the second diameter of the lumen is disposed at a portion of the electrode carrier member having a diameter that is greater than or equal to the second diameter of the lumen, and wherein the diameter of the electrode carrier member at the desired position is greater than or equal to the diameter of the lumen at the desired position; and

a drug releasably carried by the substrate.

12. The device of claim 11, wherein an outer surface of the substrate comprises one or more suture-retention elements configured to prevent relative displacement of the substrate and the electrode carrier member when a suture is positioned around the substrate with sufficient tightness in or between the one or more suture-retention elements.

13. The device of claim 12, wherein the one or more suture-retention elements are two ribs disposed at lease partially around the substrate and configured to retain a suture between the two ribs, or a channel disposed around the substrate and configured to receive the suture.

14. The device of claim 11, wherein the substrate is configured to substantially surround a circumference of the electrode carrier member when the electrode carrier member is disposed in the lumen.

15. The device of claim 14, wherein the substrate comprises a gap along its length such that the substrate surrounds less than all of a circumference of the electrode carrier member when the electrode carrier member is disposed in the lumen.

16. The device of claim 15, further comprising:

an ionic solution disposed within the substrate such that the substrate is electrically conductive.

17. The device of claim 15, wherein the substrate is configured such that, when inserted into a cochlea of a recipient, the substrate absorbs ions from the recipient'"'"'s cochlear fluid.

18. The device of claim 11, wherein the implantable medical device is a cochlear implant.

19. The device of claim 11, wherein the electrode carrier member has a plurality of electrodes longitudinally spaced along the carrier member.

20. The device of claim 19, wherein the substrate at least partially covers each of a plurality of the electrodes.

21. The device of claim 19, wherein the substrate is a ring having a length that is less than or equal to a distance between two adjacent electrodes of the plurality of electrodes.