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

• US 20090292237A1
• Filed: 07/31/2009
• Published: 11/26/2009
• Est. Priority Date: 08/29/2007
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Inventors: Xie, Jian, Faltys, Michael A., Overstreet, Edward H., Colvin, Michael S.
• Granted Patent: US 8,271,101 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• 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: A61N 1/0541 Cochlear electrodes

Abstract

A system for delivering therapeutic agents to biological tissue includes a surgically implantable lead configured to be inserted into the biological tissue, the surgically implantable lead including a preformed cavity; and a modular capsule containing a therapeutic agent which includes dexamethasone base; the modular capsule being secured within the preformed cavity; the modular capsule releasing the therapeutic agent into the biological tissue. A method of delivering therapeutic agents to biological tissue includes obtaining a surgically implantable lead with a preformed cavity; obtaining a modular capsule containing a therapeutic agent comprising dexamethasone base and securing it within the preformed cavity; and inserting the surgically implantable lead into the biological tissue.

Claims

1. A system for delivering therapeutic agents to biological tissue comprising:

a surgically implantable lead configured to be inserted into said biological tissue, said surgically implantable lead comprising a preformed cavity; and

a modular capsule containing a therapeutic agent comprising dexamethasone base (DEXb);

said modular capsule being configured to be secured within said preformed cavity after manufacture of said surgically implantable lead is complete;

said modular capsule releasing said therapeutic agent into said biological tissue.

2. The system of claim 1, wherein said surgically implantable lead is an electro-stimulator designed for long term implantation.

3. The system of claim 2, wherein said surgically implantable lead is a cochlear lead.

4. The system of claim 1, wherein said modular capsule further comprises a permeable membrane.

5. The system of claim 4, wherein said permeable membrane has a pore size smaller than approximately 0.2 microns.

6. The system of claim 4, wherein said permeable membrane is at least one of porous polytetrafluoroethylene, a silicone membrane, fluorinated ethylene propylene, or cellulose acetate.

7. The system of claim 1, wherein said therapeutic agent comprises genetically engineered cells, said genetically engineered cells being sustained by said biological tissue and generating a biologically active substance which elutes from said modular capsule.

8. The system of claim 1, wherein said therapeutic agent is DXMb.

9. The system of claim 1, wherein said therapeutic agent is dispensed using a micro-osmotic pump.

10. The system of claim 1, wherein said therapeutic agent is a powder.

11. The system of claim 10, wherein said powder comprises a combination of DXMb and dexamethasone salt (DEX salt).

12. The system of claim 11, wherein said therapeutic agent has a release profile, said release profile being modified by at least one of:

altering a proportion of two or more powdered drugs;

adjusting particle size; and

distribution of powder mixture within the modular capsule.

13. The system of claim 1, wherein said modular capsule comprises a solid tablet.

14. The system of claim 1, wherein said solid tablet comprises DXMb and DEX salt.

15. The system of claim 1, wherein said surgically implantable lead comprises a plurality of preformed cavities configured to receive said modular capsule.

16. The system of claim 1, wherein said preformed cavity is filled with a silicone blank.

17. The system of claim 1, wherein said modular capsule is secured using a biocompatible adhesive.

20. The method of claim 17, further comprising securing a membrane over an aperture of said preformed cavity.

18. A method of delivering therapeutic agents to biological tissue comprising:

obtaining a surgically implantable lead, said surgically implantable lead having a preformed cavity;

obtaining a modular capsule containing a therapeutic agent comprising DEXb;

securing said modular capsule within said preformed cavity; and

inserting said surgically implantable lead into said biological tissue.

19. The method of claim 18, further comprising

evaluating medical needs of a patient;

and

selecting at least one modular capsule configured to deliver at least one therapeutic agent comprising DEXb to meet said medical needs.

21. A system for delivering therapeutic agents to biological tissue comprising:

a surgically implantable lead configured to be inserted into said biological tissue, said surgically implantable lead comprising a coating of mixed DXMb and DEX salt;

said coating of mixed DXMb and DEX salt releasing said therapeutic agent into said biological tissue.

22. The system of claim 21, in which said coating of mixed DXMb and DEX salt comprises a polymer matrix with mixed DXMb and DEX salt particulates.

23. The system of claim 21, in which said coating of mixed DXMb and DEX salt at least one of:

a dip coating, a brush coating, and a spray coating.

24. The system of claim 21, further comprising a permeable polymer coating is applied over said coating of mixed DXMb and said DEX salt;

said DXMb and said DEX salt eluting through said polymer coating and into said biological tissue at a controlled rate.

25. The system of claim 21, in which said coating of mixed DXMb and DEX salt is hydrophobic.

26. The system of claim 21, in which said coating of mixed DXMb and DEX salt is hydrophilic.

27. The system of claim 21, in which said coating of mixed DXMB and DEX salt is more lubricious than silicone.