Extracellular matrix encasement structures and methods

• US 9,066,993 B2
• Filed: 09/24/2012
• Issued: 06/30/2015
• Est. Priority Date: 05/10/2007
• Status: Active Grant

• Current Assignee: Elutia Med LLC
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G
• Primary Examiner(s): Chen, Shin Lin
• Application Number:
  US13/573,566
• Publication Number:
  US 20130023721A1
• Time in Patent Office: 1,009 Days
• Field of Search: 424/422, 424/490, 424/572, 427/2.24, 600/16
• US Class Current: 1/1
• 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 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/22 Urine; Urinary tract, e.g. kidney or bladder; Intraglomerular mesangial cells; Renal mesenchymal cells; Adrenal gland
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 38/005 Enzyme inhibitors protease inhibitors A61K38/55
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• 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 27/3679 Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3839 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 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

A remodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch having an internal region configured to receive a device therein, the bioremodelable material comprising an extracellular matrix (ECM) composition that includes an ECM scaffold component derived from a mammalian source and at least a bioactive component selected from the group consisting of a statin and a chitin derivative.

Claims

1. An implantable medical device, comprising:

a pacemaker comprising an outer surface having at least one coating comprising an extracellular matrix (ECM) composition disposed thereon, said ECM composition coating forming an ECM encasement structure,

said ECM composition comprising acellular ECM from a mammalian tissue source, said tissue source being selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS) and stomach submucosa (SS), said ECM composition further comprising a statin,

said coated pacemaker, when implanted in host tissue of a subject'"'"'s body, being configured to modulate heart rate of said subject and induce modulated healing, said modulated healing comprising modulation of inflammation of said host tissue, induced tissue proliferation and bioremodeling of said host tissue.

2. The encased medical device of claim 1, wherein said statin is selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.

3. The medical device of claim 1, wherein said pacemaker comprises a plurality of said ECM composition coatings, said plurality of ECM coatings forming a plurality of ECM layers.