Independently-manufactured drug delivery module and corresponding receptacle in an implantable medical device

• US 8,133,215 B2
• Filed: 08/13/2008
• Issued: 03/13/2012
• Est. Priority Date: 08/13/2007
• Status: Active Grant

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Gibson, Peter
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/191,302
• Publication Number:
  US 20090048580A1
• Time in Patent Office: 1,308 Days
• Field of Search: 604/11, 604285-287, 604/514, 604/890.1, 604/891.1, 604/288.01, 424/437, 514/956
• US Class Current: 604/891.1
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• 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 1/36038 Cochlear stimulation
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

A drug delivery system for an implantable medical device and methods for making and using the same. Embodiments include a housing of an implantable component of the medical device and one or more at least quasi-solid drug-delivery modules that retain an at least quasi-solid state if not a solid state. The drug-delivery modules and component housing are physically distinct, and as such, may be manufactured independently of each other. The independently-manufacturable drug delivery modules each carry a drug, while the component housing has an exterior surface with one or more recesses formed therein. Associated module(s) and recess(es) are correspondingly dimensioned so that each module may be securely retained within an associated recess via, for example, an interference fit such as by physical interlocking or by friction fit. When so retained in a housing recess, the drug-delivery module and surrounding exterior surface of the housing form a contiguous component surface.

Claims

1. A drug delivery system for an implantable medical device comprising:

a housing of an implantable component of the medical device having an exterior surface with one or more recesses formed therein; and

a drug-delivery module that retains at least a quasi-solid state and releasably carries at least one drug,

wherein the module and housing are physically distinct, and the module and recess are correspondingly dimensioned such that a dimension of the module is sized slightly larger than a corresponding dimension of the recess, thereby securing the module within the recess.

2. The drug delivery system of claim 1, wherein the dimension of the module and the dimension of the recess form an interference fit which comprises physical interlocking of the drug-delivery module in the recess.

3. The drug delivery system of claim 1, wherein the dimension of the module and the dimension of the recess form an interference fit which comprises the drug-delivery module having a friction fit in the recess.

4. The drug delivery system of claim 1, wherein the medical device is a cochlear implant and further wherein the implantable component is a stimulator/receiver device of the cochlear implant.

5. The drug delivery system of claim 1, wherein the drug delivery modules and recesses may be configured in a wide range of sizes and shapes depending on the particular application.

6. The drug delivery system of claim 1, further comprising a tool to remove a drug delivery module from the recess.

7. The drug delivery system of claim 1, wherein the module and recess are configured such that, when a drug-delivery module is inserted into an associated recess, the exposed surface(s) of the drug-delivery module is/are substantially contiguous with the exterior surface of the component housing.

8. The drug delivery system of claim 1, wherein the drug-delivery module is a cartridge.

9. The drug delivery system of claim 1, wherein the drug-delivery module is a tablet.

10. The drug delivery system of claim 1, wherein the drug deliver system has a single drug delivery module per recess.

11. A drug delivery system for an implantable medical device comprising:

a housing of an implantable component of the medical device having an exterior surface with one or more recesses formed therein; and

a drug-delivery module that retains at least a quasi-solid state and releasably carries at least one drug,

wherein the module and housing are physically distinct, and the module and recess are correspondingly dimensioned such that an opening of the recess is more narrow than a corresponding dimension of the module.

12. The drug delivery system of claim 11, wherein wherein when the drug-delivery module is retained in the recess, a surface of the drug-delivery module and a portion of the exterior surface of the housing surrounding the recess form a contiguous component housing surface.

13. The drug delivery system of claim 11, wherein the corresponding dimension is a width of the module.

14. A drug delivery system for an implantable medical device comprising:

a housing of an implantable component of the medical device having an exterior surface with one or more recesses formed therein; and

a drug-delivery module that retains at least a quasi-solid state and releasably carries at least one drug,

wherein the module and housing are physically distinct, and the module and recess are correspondingly dimensioned such that the module may be securely retained within the recess, and

wherein the housing is a hermetically-sealed, biocompatible rigid housing having mounted therein operational components of the medical device.

15. A drug delivery system for an implantable medical device comprising:

a housing of an implantable component of the medical device having an exterior surface with one or more recesses formed therein; and

a drug-delivery module that retains at least a quasi-solid state and releasably carries at least one drug,

wherein the module and housing are physically distinct, and the module and recess are correspondingly dimensioned such that the module may be securely retained within the recess,

wherein the recess has a dimension that is slightly larger than the corresponding dimension of the drug delivery module thereby forming a gap in the recess after insertion of the drug-delivery module, the gap providing access to a removal tool to facilitate removal of the module from the recess, and

wherein the drug delivery system has an a single drug delivery module per recess.

16. A method for implanting a drug delivery system in connection with an implantable medical device, comprising:

obtaining a drug-delivery module that releasably carries at least one drug;

producing, independently of the drug-delivery module, a housing for the implantable medical device component, the housing having an exterior surface with at least one recess formed therein, wherein the module(s) and recess(es) are correspondingly configured such that a dimension of the module is sized slightly larger than a corresponding dimension of the recess; and

inserting the drug-delivery module into the recess subsequent to the device'"'"'s manufacture such that the module is secured in the recess as a result of the dimension of the module being sized slightly larger that the corresponding dimension of the recess.

17. The method of claim 16, wherein the action of inserting the module into the recess includes moving the module from outside the recess and outside the housing into the recess.

18. The method of claim 17, wherein the action of inserting the module into the recess includes snapping the module into the recess.

19. The method of claim 17, wherein the action of inserting the module into the recess includes inserting the module into the recess such that a surface of the drug-delivery module and a portion of the exterior surface of the housing surrounding the recess form a contiguous component housing surface.

20. The method of claim 17, wherein the medical device is a cochlear implant and further wherein the implantable component is a stimulator/receiver device of the cochlear implant.

21. The method of claim 17, wherein the housing is a hermetically-sealed, biocompatible rigid housing having mounted therein operational components of the medical device.

22. The method of claim 17, wherein the action of inserting the module into the recess includes inserting only one module into one recess such that upon completion of the method, the drug delivery system has a single drug delivery module per recess.

23. The method of claim 17, further comprising the action of removing the drug delivery module from the recess utilizing a tool.

24. A method for implanting a drug delivery system in connection with an implantable medical device, comprising:

obtaining a drug-delivery module that releasably carries at least one drug;

obtaining a housing for the implantable medical device component, the housing having an exterior surface with at least one recess formed therein, wherein the module(s) and recess(es) are correspondingly configured such that a dimension of the module is sized slightly larger than a corresponding dimension of the recess,; and

inserting the drug-delivery module into the recess subsequent to the device'"'"'s manufacture such that the module is secured in the recess as a result of the dimension of the module being sized slightly larger that the corresponding dimension of the recess.