Modular drug delivery system for minimizing trauma during and after insertion of a cochlear lead

• US 8,271,101 B2
• Filed: 07/31/2009
• Issued: 09/18/2012
• Est. Priority Date: 08/29/2007
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics (Sonova Holding AG)
• Inventors: Overstreet, Edward H., Xie, Jian, Colvin, Michael S., Faltys, Michael A.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US12/533,963
• Publication Number:
  US 20090292237A1
• Time in Patent Office: 1,145 Days
• Field of Search: 607/116, 607/119, 607/120, 607/137
• US Class Current: 607/137
• 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 a therapeutic agent to biological tissue comprising:

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

said coating releasing said therapeutic agent into said biological tissue, wherein said therapeutic agent comprises DXMb coupled to said surgically implantable lead, DEX salt deposited over said DXMb, wherein said DEX salt is configured to rapidly elute into said biological tissue when said surgically implantable lead is implanted and said DXMb is configured to more slowly elute into said biological tissue at a lower concentration than said DEX salt.

2. The system of claim 1, in which said coating of mixed DXMb and DEX salt comprises a polymer matrix with mixed DXMb and DEX salt particulates.

3. The system of claim 1, in which said coating of mixed DXMb and DEX salt comprises at least one of:

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

4. The system of claim 1, further comprising a permeable polymer coating 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.

5. The system of claim 1, in which said coating of mixed DXMb and DEX salt is hydrophobic.

6. The system of claim 1, in which said coating of mixed DXMb and DEN salt is hydrophilic.

7. The system of claim 1, in which said coating of mixed DXMb and DEX salt is more lubricious than silicone.

8. The system of claim 1, wherein the coating has a ratio of DXMb to DEX salt selected to have a release profile to achieve a biological benefit.

9. A system for delivering a therapeutic agent to biological tissue comprising:

a surgically implantable lead configured to be inserted into the biological tissue;

an inner layer comprising dexamethasone base (DXMb) deposited on the lead; and

an outer layer comprising dexamethasone salt (DEX salt) deposited on the inner layer wherein said DEX salt is configured to rapidly elute into surrounding tissue when the device is implanted and said DXMb is configured to more slowly elute into said surrounding tissue at a lower concentration than the DEX salt.

10. The system of claim 9, wherein the outer layer further comprises a lubricant, said lubricant configured to absorb an aqueous solution comprising DEX salt.

11. The system of claim 9, wherein the inner layer further comprises a polymer.

12. The system of claim 9, wherein the lead comprises a cochlear lead.