WO2008030547B1 - Intramyocardial patterning for global cardiac resizing and reshaping - Google Patents

Intramyocardial patterning for global cardiac resizing and reshaping

Info

Publication number
WO2008030547B1
WO2008030547B1 PCT/US2007/019496 US2007019496W WO2008030547B1 WO 2008030547 B1 WO2008030547 B1 WO 2008030547B1 US 2007019496 W US2007019496 W US 2007019496W WO 2008030547 B1 WO2008030547 B1 WO 2008030547B1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
heart
space
apex
base
Prior art date
Application number
PCT/US2007/019496
Other languages
French (fr)
Other versions
WO2008030547A1 (en
Inventor
Hani N Sabbah
Randall J Lee
Andrew G Hinson
Original Assignee
Symphony Medical Inc
Hani N Sabbah
Randall J Lee
Andrew G Hinson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Symphony Medical Inc, Hani N Sabbah, Randall J Lee, Andrew G Hinson filed Critical Symphony Medical Inc
Priority to AU2007293055A priority Critical patent/AU2007293055B2/en
Priority to CA002661624A priority patent/CA2661624A1/en
Priority to JP2009527418A priority patent/JP5522663B2/en
Priority to EP07837853A priority patent/EP2051661A1/en
Publication of WO2008030547A1 publication Critical patent/WO2008030547A1/en
Publication of WO2008030547B1 publication Critical patent/WO2008030547B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/20—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • A61L27/3839—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by the site of application in the body
    • A61L27/3873—Muscle tissue, e.g. sphincter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2002/249—Device completely embedded in the heart wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Informatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Neurosurgery (AREA)
  • Dispersion Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Prostheses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Cardiomyopathy may be treated by distributing space-occupying agent within the myocardium in a pattern about one or more chambers of the heart, such that the space-modifying agent integrates into and thickens at least part of the cardiac wall about the chamber so as globally to reduce wall stress and stabilize or even reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function. Over time the relief of wall stress reduces oxygen consumption and promotes healing. Moreover, various long-term therapeutic effects may be realized depending on the properties of the space-occupying agent, including combinations.with other therapeutic materials. Specific cardiac conditions treatable by these systems and methods include, for example, dilated cardiomyopathy (with or without overt aneurismal formations), congestive heart failure, and ventricular arrhythmias, myocardial infarctions, and mitral regurgitation.

Claims

AMENDED CLAIMS received by the International Bureau on 04 March 2008 (04.03.2008)
means for introducing biocompatible material into myocardial tissue of the heart in accordance with the pattern to form the intramyocardial supportive regions.
49. The kit of claim 48 wherein the chamber is elongated and the line extends generally circumferentially about at least a major part of the chamber.
50. The kit of claim 48 wherein the chamber is elongated and the line extends generally longitudinally along at least a major part of the chamber.
51. Use of a source of biocompatible space-occupying agent that is effective for thickening a myocardial wall, for the preparation of a medicament for globally treating a dilated chamber of a heart by delivery thereof in a therapeutically effective amount into a plurality of sites disposed in a therapeutically effective pattern within the myocardial wall of the chamber.
52. Use as in claim 51 wherein the chamber comprises a base portion near a base of the heart and an apex portion near the apex of the heart, and the pattern comprises a line generally extending circumferentially along a major portion of a free wall of the chamber between the base portion and the apex portion.
53. Use as in claim 51 wherein the chamber comprises a base portion near a base of the heart and an apex portion near the apex of the heart, and the pattern comprises a line generally extending longitudinally along a major portion of a free wall of the chamber from near the base portion to near the apex portion.
54. Use as in claim 51 wherein the space-occupying agent consists essentially of an injectable non-living material.
55. Use as in claim 51 wherein the space-occupying agent comprises a nonliving material in combination with living cells, growth factors, peptides, proteins, or any combination thereof.
56. Use as in claim 51 wherein the space-occupying agent comprises an implantable non-living material.
57. A source of biocompatible space-occupying agent that is effective for thickening a myocardial wall, for use as a medicament for globally treating a dilated chamber of a heart by delivery thereof in a therapeutically effective amount into a plurality of sites disposed in a therapeutically effective pattern within the myocardial wall of the chamber.
58. Use as in claim 57 wherein the chamber comprises a base portion near a base of the heart and an apex portion near the apex of the heart, and the pattern comprises a line generally extending circumferentially along a major portion of a free wall of the chamber between the base portion and the apex portion.
59. Use as in claim 57 wherein the chamber comprises a base portion near a base of the heart and an apex portion near the apex of the heart, and the pattern comprises a line generally extending longitudinally along a major portion of a free wall of the chamber from near the base portion to near the apex portion.
60. Use as in claim 57 wherein the space-occupying agent consists essentially of an injectable non-living material.
61. Use as in claim 57 wherein the space-occupying agent comprises a nonliving material in combination with living cells, growth factors, peptides, proteins, or any combination thereof.
62. Use as in claim 57 wherein the space-occupying agent comprises an implantable non-living material.
PCT/US2007/019496 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping WO2008030547A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2007293055A AU2007293055B2 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping
CA002661624A CA2661624A1 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping
JP2009527418A JP5522663B2 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global heart resizing and remodeling
EP07837853A EP2051661A1 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84347506P 2006-09-08 2006-09-08
US60/843,475 2006-09-08

Publications (2)

Publication Number Publication Date
WO2008030547A1 WO2008030547A1 (en) 2008-03-13
WO2008030547B1 true WO2008030547B1 (en) 2008-05-08

Family

ID=38921737

Family Applications (3)

Application Number Title Priority Date Filing Date
PCT/US2007/019581 WO2008030581A1 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for treating localized anomalies of the heart
PCT/US2007/019575 WO2008030578A2 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping
PCT/US2007/019496 WO2008030547A1 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping

Family Applications Before (2)

Application Number Title Priority Date Filing Date
PCT/US2007/019581 WO2008030581A1 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for treating localized anomalies of the heart
PCT/US2007/019575 WO2008030578A2 (en) 2006-09-08 2007-09-07 Intramyocardial patterning for global cardiac resizing and reshaping

Country Status (6)

Country Link
US (4) US9782258B2 (en)
EP (3) EP2051661A1 (en)
JP (3) JP2010502372A (en)
AU (3) AU2007292926A1 (en)
CA (3) CA2662169C (en)
WO (3) WO2008030581A1 (en)

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