CA2559320A1 - Ventricular partitioning device - Google Patents

Ventricular partitioning device Download PDF

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Publication number
CA2559320A1
CA2559320A1 CA002559320A CA2559320A CA2559320A1 CA 2559320 A1 CA2559320 A1 CA 2559320A1 CA 002559320 A CA002559320 A CA 002559320A CA 2559320 A CA2559320 A CA 2559320A CA 2559320 A1 CA2559320 A1 CA 2559320A1
Authority
CA
Canada
Prior art keywords
ribs
patient
membrane
component
heart
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002559320A
Other languages
French (fr)
Other versions
CA2559320C (en
Inventor
Hugh Sharkey
Alexander Khairkhahan
Serjan D. Nikolic
Branislav Radovancevic
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CardioKinetix Inc
Original Assignee
Cardiokinetix, Inc.
Hugh Sharkey
Alexander Khairkhahan
Serjan D. Nikolic
Branislav Radovancevic
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 Cardiokinetix, Inc., Hugh Sharkey, Alexander Khairkhahan, Serjan D. Nikolic, Branislav Radovancevic filed Critical Cardiokinetix, Inc.
Publication of CA2559320A1 publication Critical patent/CA2559320A1/en
Application granted granted Critical
Publication of CA2559320C publication Critical patent/CA2559320C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection
    • 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
    • A61F2/2487—Devices within the heart chamber, e.g. splints

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

This invention is directed to a partitioning device (10) for separating a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a reinforced, expandable membrane (11) which separates the productive and non-productive portions of the heart chamber aid a support (13) or spacing member extending between the reinforced membrane and the wall of the patient's heart chamber. The support or spacing member has a non-traumatic distal end (19) to engage the ventricular wall.

Claims (51)

1. A device for increasing the ejection fraction of a patient's heart chamber, comprising:
a. a reinforced membrane component which has a proximal face and a distal face and which is configured to partition the patient's heart chamber into a main operational portion and a secondary, non-operational portion; and b. a support component which is disposed in the non-productive portion of the heart chamber defined in part by the distal face of the reinforced membrane and which is configured to extend from the reinforced membrane to a region of the heart wall defining in part the heart chamber.
2. The device of claim 1 wherein reinforced membrane has a contracted configuration about a center line axis and an expanded configuration in which the membrane periphery is radially expanded away from the center line axis.
3. The device of claim 1 wherein the support component is at least in part an elongated stem.
4. The device of claim 1 wherein the support component has a distal extremity which is configured to non-traumatically engage a region of the patient's ventricular wall defining in part the secondary non-operational portion of the heart chamber.
5. The device of claim 4 wherein the distal extremity of the support component has at least one J-shaped bumper element.
6. The device of claim 4 wherein the distal extremity has from two to four J-shaped elements.
7. The device of claim 4 wherein the distal extremity has a coil shaped element.
8. The device of claim 1 including a hub secured to a central location of the reinforced membrane.
9. The device of claim 8 wherein the membrane is reinforced by a frame which is radially expandable at a proximal extremity thereof.
10. The device of claim 9 wherein the radially expandable frame has a plurality of ribs.
11. The device of claim 10 wherein the ribs have distal ends secured to the central hub.
12. The device of claim 11 wherein the distal ends of the ribs are secured to the central hub to facilitate abduction of the free proximal ends away from a centerline axis to facilitate expansion of the reinforced membrane component.
13. The device of claim 12 wherein the ribs have free proximal ends configured to engage the heart wall and secure the device within the heart chamber.
14. The device of claim 13 wherein the free proximal ends of the ribs have tissue penetrating tips.
15. The device of claim 9 wherein the membrane is secured to the ribs on a proximal side of the expandable frame.
16. The device of claim 9 wherein the reinforced membrane component restricts the radial expansion of the free proximal ends of the ribs to an angle of about 60° to about 90° from a center line axis.
17. The device of claim 16 wherein the radial expansion of the free proximal ends of the ribs are about 30° to about 60°.
18. The device of claim 3 wherein the stem is configured to extend to the ventricular wall.
19. The device of claim 1 wherein the support component is at least in part an inflatable member.
20. The device of claim 1 wherein the membrane has radial dimensions from a center line axis of about 10 to about 160 mm.
21. The device of claim 1 wherein the member has radial dimensions from a center line axis of about 5 to about 80 mm.
22. The device of claim 9 wherein the frame has about 3 to about 30 ribs.
23. The device of claim 9 wherein the frame has about 6 to about 16 ribs.
24. The device of claim 9 wherein the expandable frame is self expanding.
25. The device of claim 9 wherein the frame is formed of superelastic NiTi alloy which is in an austenite phase when unstressed.
26. The device of claim 9 wherein the frame is in a stress maintained martensite phase when delivered through the patient's vasculature to the patient's heart chamber.
27. The device of claim 1 wherein the membrane is formed at least in part of expanded fluoropolymer.
28. The device of claim 27 wherein the expanded fluoropolymer is polytetrafluoroethylene.
29. The device of claim 1 wherein the membrane is at least in part formed of a foraminous sheet.
30. A partitioning apparatus for treating a patient's heart, comprising:
a. a central hub component;

b. an expandable frame component having a plurality of ribs with free proximal ends and distal ends secured to the central hub;
c. a membrane component secured to the expandable frame ribs which limits the radial expansion of the free proximal ends of the ribs to less than about 90° from a center line axis; and d. a support component extending from a distal side of the frame for non-traumatically engaging a region of the patient's ventricular wall defining in part the heart chamber being partitioned.
31. The partitioning apparatus of claim 30 wherein the support component is an elongated stem.
32. The partitioning apparatus of claim 31 wherein a distal extremity of the stem has at least one resilient member to non-traumatically engage the region of the patient's ventricular wall.
33. The partitioning apparatus of claim 32 wherein the at least one resilient member has a J-shape.
34. The partitioning apparatus of claim 32 wherein the at least one resilient member has a helical coil shape.
35. The partitioning apparatus of claim 30 wherein the support component is an inflatable member.
36. The partitioning apparatus of claim 30 wherein the membrane component is secured to the proximal side of the ribs.
37. The partitioning apparatus of claim 30 wherein the membrane component is secured to the distal side of the ribs.
38. A device for treating a patient by partitioning a heart chamber thereof, comprising:

a. ~a central hub component;

b. ~an expandable frame component having a plurality of ribs with distal ends secured to the central hub component and free proximal ends and distal ends secured to the central hub component;

c. ~a membrane component secured to the ribs of the expandable frame;
and d. ~a support component which extends from the distal side of the expandable frame component, which is configured to space the expandable frame component from a ventricular wall and which has sufficient give to provide non-traumatic engagement with a weakened portion of the ventricular wall.
39. ~The device of claim 38 wherein the ribs of the expandable frame component limit the radial expansion of the free proximal ends of the ribs to less than 90°.
40. ~The device of claim 38 wherein the support component has a proximal end secured to the central hub component and a distal end provided with a flexible bumper for non-traumatic engagement of the ventricular wall.
41. ~The device of claim 40 wherein the flexible bumper of the support component has a J-shape.
42. ~The device of claim 40 wherein the distal end of the support component has a plurality of J-shape bumpers.
43. ~A system for treating a patient's heart, comprising:
a. ~a reinforced membrane;
b. ~means for positioning the reinforced membrane within a chamber of the patient's heart;

c. ~means to secure a peripheral edge of the reinforced membrane to a wall defining at least in part the patient's heart chamber; and d. ~means for spacing a central portion of the reinforced membrane from the heart wall.
44. ~The system of claim 43 including means to deliver the reinforced membrane in a folded configuration.
45. ~The system of claim 43 including means to expand the reinforced membrane in position within the patient's heart wall.
46. ~The system of claim 44 wherein the reinforced membrane is positioned within an inner lumen of an elongated catheter which is configured to be percutaneously introduced into the patient's vasculature and advanced therein to the patient's heart chamber.
47. ~The system of claim 46 including means to discharge the reinforced membrane from the catheter into the patient's heart chamber.
48. ~The system of claim 44 including anchoring means for securing the peripheral edge of the reinforced membrane to the heart wall defining at least in part the heart chamber.
49. ~The system of claim 43 wherein the reinforced membrane is self expanding.
50. ~A device for treating a patient by partitioning a heart chamber thereof, comprising:
a. ~a central hub means;
b. ~a frame means having a plurality of ribs with distal ends secured to the central hub means and free proximal ends and distal ends secured to the central hub means;

c. ~a membrane means secured to the ribs of the frame means; and d, ~a support means which extends from the distal side of the expandable frame, which is configured to space the expandable frame from a ventricular wall and which has sufficient give to provide non-traumatic engagement with a weakened portion of the ventricular wall.~
51. ~A system for treating a patient with congestive heart failure, comprising the steps of:

a. ~a reinforced membrane;

b. ~means to position the reinforced membrane within a chamber of the patient's heart with a peripheral edge of the reinforced membrane secured to a wall defining at least in part the patient's heart chamber;
and c. ~means for spacing a central portion of the reinforced membrane from the heart wall.
CA2559320A 2004-01-09 2005-01-05 Ventricular partitioning device Expired - Fee Related CA2559320C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/754,182 2004-01-09
US10/754,182 US7399271B2 (en) 2004-01-09 2004-01-09 Ventricular partitioning device
PCT/US2005/000264 WO2005070330A1 (en) 2004-01-09 2005-01-05 Ventricular partitioning device

Publications (2)

Publication Number Publication Date
CA2559320A1 true CA2559320A1 (en) 2005-08-04
CA2559320C CA2559320C (en) 2012-10-09

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Family Applications (1)

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CA2559320A Expired - Fee Related CA2559320C (en) 2004-01-09 2005-01-05 Ventricular partitioning device

Country Status (5)

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US (2) US7399271B2 (en)
EP (1) EP1708642B1 (en)
JP (1) JP4519858B2 (en)
CA (1) CA2559320C (en)
WO (1) WO2005070330A1 (en)

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