Modular Drug Delivery System for Minimizing Trauma During and After Insertion of a Cochlear Lead

• US 20130079749A1
• Filed: 11/14/2012
• Published: 03/28/2013
• Est. Priority Date: 08/29/2007
• Status: Abandoned Application

• Current Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Original Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Inventors: Overstreet, Edward H., Xie, Jian, Colvin, Michael S., Faltys, Michael A.
• Application Number:
  US13/676,310
• Publication Number:
  US 20130079749A1
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• 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: A61N 1/0541 Cochlear electrodes

Abstract

A modular capsule includes a first therapeutic agent having a first solubility in biological fluids in an implanted environment and a second therapeutic agent having a second lower solubility in the biological fluids. The modular capsule is configured such that dissolution of the first therapeutic agent increases a rate of dissolution of the second therapeutic agent.

Claims

1. A modular capsule comprising:

a first therapeutic agent with a first solubility in biological fluids in an implanted environment;

a second therapeutic agent with a second lower solubility in the biological fluids;

in which dissolution of the first therapeutic agent increases a rate of dissolution of the second therapeutic agent.

2. The modular capsule of claim 1, wherein the first therapeutic agent is interposed between the second therapeutic agent and the biological environment.

3. The modular capsule of claim 1, further comprising:

a wall surrounding the first therapeutic agent and the second therapeutic agent; and

an aperture through the wall exposing a surface of the first therapeutic agent.

4. The modular capsule of claim 3, wherein a layer of the first therapeutic agent is interposed between the aperture and a layer of the second therapeutic agent.

5. The modular capsule of claim 3, wherein the aperture is covered by a permeable membrane.

6. The modular capsule of claim 1, first therapeutic agent is contained within a metal foam exposed to biological fluids on a first side, wherein the second therapeutic agent is disposed adjacent to a second side of the metal foam.

7. The modular capsule of claim 6, wherein dissolution of the first therapeutic agent opens pores in the metal foam.

8. The modular capsule of claim 1, wherein dissolution of the first therapeutic agent exposes a surface area of the second therapeutic agent to the biological fluids, the surface area remaining substantially constant as the second therapeutic agent dissolves.

9. The modular capsule of claim 1, wherein the first therapeutic agent comprises a matrix and the second therapeutic agent comprises particulates embedded in the matrix, wherein dissolution of the matrix exposes the particulates to the biological fluids.

10. The modular capsule of claim 1, wherein the second therapeutic agent comprises a matrix and the first therapeutic agent comprises particulates in embedded in the matrix, wherein dissolution of the first therapeutic agent exposes a larger area of the second therapeutic agent to the biological fluids, thereby increasing the rate of dissolution of the second therapeutic agent.

11. The modular capsule of claim 1, wherein the first therapeutic agent forms a core and the second therapeutic agent forms a shell around the core, in which dissolution of the core exposes an inner surface of the shell to the biological fluids.

12. The modular capsule of claim 11, wherein a substantially constant area of the core is exposed to the biological fluids during dissolution of the core and a substantially constant area of the shell is exposed to the biological fluids during dissolution of the shell after the core has dissolved.

13. The modular capsule of claim 1, wherein the modular capsule is placed in a cavity in an implant such that the modular capsule has a single surface exposed to the biological fluids.

14. The modular capsule of claim 1, in which the first therapeutic agent comprises a higher concentration of DEX salt than the second therapeutic agent.

15. The modular capsule comprising:

a first side configured to be exposed when the modular capsule is disposed within a preformed cavity of surgically implantable lead, the first side comprising a first therapeutic agent having a first solubility in biological fluids; and

a second side configured to be covered when the modular capsule is disposed within a preformed cavity, the second side comprising a second therapeutic agent having a second solubility in biological fluids.

16. A kit for delivering therapeutic treatment to biological tissue comprising:

a surgically implantable lead comprising at least one preformed cavity; and

a plurality of modular capsules configured to be retained in the at least one preformed cavity comprising;

at least one dummy capsule;

a first capsule comprising a first therapeutic agent, the first capsule configured to elute into biological tissue at a first concentration; and

a second capsule comprising a second therapeutic agent, the second capsule configured to elute into biological tissue at a second concentration.

17. The kit of claim 16, further comprising an insertion tool to insert a modular capsule into the preformed cavity.

18. The kit of claim 17, in which the modular capsule is preloaded into the insertion tool.

19. The kit of claim 16, further comprising adhesive to bond the modular capsule into the preformed cavity.

20. A method for implantation of a surgically implantable lead with a preformed cavity comprising:

evaluating medical characteristics of a specific patient to be implanted with the lead,

obtaining a kit comprising a plurality of modular capsules, each capsule configured to be retained in the preformed cavity;

selecting at least one of the modular capsules based on medical characteristics of the patient;

inserting the selected capsule into the preformed cavity of the lead; and

implanting the lead into the patient.

21. The method of claim 20, wherein obtaining the kit comprises:

separately ordering the surgically implantable lead; and

ordering the plurality of modular capsules after evaluating the medical characteristics of the patient, in which the modular capsules in the kit are selected according to the medical characteristics of the patient.