Drug eluting patch for the treatment of localized tissue disease or defect

• US 9,532,943 B2
• Filed: 12/16/2011
• Issued: 01/03/2017
• Est. Priority Date: 12/20/2010
• Status: Active Grant

• Current Assignee: Elutia Med LLC
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert
• Primary Examiner(s): Zhang, Yanzhi
• Application Number:
  US13/328,287
• Publication Number:
  US 20120156255A1
• Time in Patent Office: 1,845 Days
• Field of Search: 424/400, 514/275, 514/277, 514/311
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/046 Tracheae
• 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: A61L 2300/21 Acids
• CPC Class Codes: A61L 2300/232 Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: C08L 67/02 : Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

A polymeric matrix for delivery of an HMG CoA reductase inhibitor such as a statin to tissue such as cardiac tissue in need thereof for the treatment or prevention of a disease or defect such as atrial fibrillation has been developed. In the preferred embodiment, a statin is delivered by means of a patch sutured to cardiac tissue at the time of cardiothoracic surgery. In the most preferred embodiment, the patch is a biodegradable material providing controlled or sustained release over a prolonged period of time, such as a week. Suitable materials include extracellular matrix, or other biodegradable hydrogels or polymeric materials providing sustained or controlled release of statin at the site of application.

Claims

1. A patch for treating a cardiac disorder, comprising:

a matrix comprising acellular extracellular matrix (ECM); and

a HMG CoA reductase inhibitor comprising cerivastatin, said cerivastatin comprising in the range of 10 μ

g/cm²-10 mg/cm² of said ECM matrix,

said ECM matrix being capable of modulating inflammation of post-operative cardiac tissue when administered thereto, said inflammation modulation comprising inhibiting localized expression of monocyte chemoattractant protein 1 (MCP-1) and C-C chemokine receptor type 2 (CCR2).

2. The patch of claim 1, wherein said HMG CoA reductase inhibitor is dispersed within said ECM matrix.

3. The patch of claim 1, wherein said ECM matrix is in the form of a graft.

4. The patch of claim 1, wherein said ECM matrix is configured to be applied as a spray.

5. The patch of claim 1, wherein said ECM matrix is configured to be applied as a biological glue.

6. The patch of claim 1, wherein said ECM matrix further includes a pharmacological agent component comprising an anti-thrombotic agent.

7. The patch of claim 1, wherein said ECM matrix is in the form of a hydrogel.

8. The patch of claim 1, wherein said ECM matrix is in the form of a woven matrix.

9. The patch of claim 1, wherein said ECM matrix is in the form of a non-woven matrix.

10. A method for treating tissue injury or defect comprising administering to or near the patch the device of claim 1.

11. The method of claim 10 wherein the tissue injury or defect is caused by ischemia.

12. The method of claim 10 wherein the tissue is cardiac tissue and the defect is atrial fibrillation.

13. The method of claim 10 wherein the patch is administered during surgery.

14. The method of claim 10 wherein the patch is administered through a catheter or as part of a stent.