Drug-delivery accessory for an implantable medical device

• US 8,617,097 B2
• Filed: 05/24/2010
• Issued: 12/31/2013
• Est. Priority Date: 05/24/2010
• Status: Expired due to Fees

• 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:
  US12/786,313
• Publication Number:
  US 20110288468A1
• Time in Patent Office: 1,317 Days
• Field of Search: 604/57
• US Class Current: 604/57
• 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. A kit of implantable drug-delivery sleeves for a tapered elongate component of an implantable medical device, the kit comprising:

one or more first drug-delivery sleeves; and

one or more second drug-delivery sleeves, wherein each of the first and second sleeves comprises a substrate releasably carrying at least one drug and having a lumen configured to receive the elongate component so as to allow relative displacement of the substrate and the elongate component, and wherein the substrate is shaped so as to be retained stationary at a desired position along the elongate component; and

wherein the first and second sleeves differ in one or more characteristics selected from the group comprising;

the at least one drug releasably carried by the sleeves;

a dosage of the at least one drug;

resorbability; and

lumen diameter.

2. The kit of claim 1, wherein for each of the first sleeves, the substrate releasably carries a first drug and the substrate is shaped so as to be retained stationary near a distal tip of the elongate component, and for each of the second sleeves, the substrate releasably carries a second drug different than the first drug and the substrate is shaped so as to be retained stationary near a proximal end of the elongate component.

3. The kit of claim 1, wherein for each of the first and second sleeves, the substrate is configured to be retained stationary at a desired position along the elongate component, wherein the diameter of the elongate component at the desired position is greater than or equal to the diameter of the lumen at the desired position.

4. The kit of claim 3, wherein for each of the first and second sleeves, the lumen extends between first and second ends of the substrate, a first diameter of the lumen is the diameter of the lumen at the first end, a second diameter of the lumen at the second end is smaller than the first diameter, and when the sleeve is positioned on the elongate component such that the first diameter is disposed at the desired position, the second diameter of the lumen is disposed at a portion of the elongate component having a diameter that is greater than or equal to the second diameter of the lumen.

5. The kit of claim 4, wherein the first diameter of the lumen of each of the first sleeves is different than the first diameter of the lumen of each of the second sleeves.

6. The kit of claim 1, wherein each of the first sleeves releasably carries a different drug, and each of the second sleeves releasably carries a different drug.

7. The kit of claim 1, wherein each of the first sleeves releasably carries a different dosage of the at least one drug, and wherein each of the second sleeves releasably carries a different dosage of the at least one drug.

8. The kit of claim 1, wherein one of the first sleeves is resorbable and another of the first sleeves is non-resorbable.

9. The kit of claim 1, wherein the first and second sleeves are resorbable.

10. The sleeve of claim 1, 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 one or more second drug-delivery sleeves with sufficient tightness in or between the one or more suture-retention elements.

11. The kit of claim 10, wherein the one or more suture-retention elements are two ribs disposed at least partially around the sleeve and configured to retain a suture between the two ribs, or a channel disposed around the sleeve and configured to receive the suture.

12. The kit of claim 1, wherein the one or more first and second sleeves are each configured to substantially surround a circumference of an electrode carrier member when the electrode carrier member is disposed in the lumen.

13. The kit of claim 12, wherein at least one of the one or more first and second sleeves each comprise a gap along its length such that the sleeve surrounds less than all of a circumference of an electrode carrier member when the electrode carrier member is disposed in the lumen.

14. The sleeve kit of claim 1, wherein at least one of the one or more first and second drug-delivery sleeves is electrically conductive.

15. The kit of claim 14, further comprising:

an ionic solution disposed within the at least one electrically conductive sleeve such that the sleeve is electrically conductive.

16. The kit of claim 14, wherein the at least one electrically conductive drug-delivery sleeve is configured such that, when inserted into a cochlea of a recipient, the sleeve absorbs ions from the recipient'"'"'s cochlear fluid.

17. The device kit of claim 1, wherein at least one of the first and second sleeves comprises a plurality of mechanical weaknesses at which a first portion of the sleeve may be detached by hand from a second portion of the sleeve.

18. The kit of claim 1, wherein at least one of the first and second sleeves comprises:

an attachment frame having a length extending between first and second ends of the sleeve; and

a plurality of rings each unitary with or connected to the attachment frame, wherein the rings are aligned along the length of the attachment frame such that an elongate component is positionable in the respective lumens of each of the rings concurrently, and wherein the attachment frame comprises a plurality of severable regions at which a first portion of the sleeve may be severed by hand from a second portion of the sleeve.

19. The kit of claim 1, wherein the first and second sleeves are non-resorbable.