Implantable device as organ valve replacement

• US 7,510,574 B2
• Filed: 07/28/2004
• Issued: 03/31/2009
• Est. Priority Date: 07/29/2003
• Status: Expired due to Fees

• Current Assignee: Pfm Medical AG
• Original Assignee: Pfm Produkte Fur Die Medizin Aktiengesellschaft
• Inventors: Lê, Trong-Phi, Jung, Johannes
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/901,324
• Publication Number:
  US 20050060029A1
• Time in Patent Office: 1,707 Days
• Field of Search: 623 124- 412
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An implantable device for use in a human and/or animal body for replacement of an organ valve. The device has an elongate main body having a first end and a second end provided with openings, and a membrane element provided with at least one opening. The device has, in a first operating state (primary form), a large ratio of length to transverse extent along an axis, and, in a second operating state (secondary form), a smaller ratio of length to transverse extent along an axis. The device is reversibly convertible from the secondary form into the primary form by application of force against elastic material forces. At least one of the two ends of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel.

Claims

1. Implantable device for use in a human and/or animal body for replacement of an organ valve, comprising:

an expandable, elongate main body having a longitudinal axis and being substantially cylindrical in shape about said axis, said body including a first end and a second end each provided with an opening;

at least one outwardly protruding anchoring portion disposed proximate at least one of said first and second ends of said main body;

an expandable membrane element provided with at least one opening, said membrane element disposed within the main body and having a valve portion and a ring portion secured to the main body; and

said main body and said membrane element together movable between a first condition in which said main body and said membrane element together define a first cross sectional area, and a second, deployed condition in which said main body and said membrane element together define a second cross sectional area greater than said first cross sectional area.

2. Implantable device according to claim 1, wherein the protruding anchoring portion extends around the circumference of the main body.

3. Implantable device according to claim 1, wherein the device has areas of different stiffness.

4. Implantable device according to claim 3, wherein at least one area of lesser stiffness is arranged between at least two areas of greater stiffness.

5. Implantable device according to claim 4, wherein the at least one area of lesser stiffness is provided in the main body.

6. Implantable device according to claim 1, wherein at least one guide opening is provided for the passage of guide wires for the implantation of the device.

7. Implantable device according to claim 6, wherein the at least one guide opening is arranged near the membrane element.

8. Implantable device according to claim 6, wherein the at least one guide opening has a diameter substantially corresponding to the opening width of the origins of the coronary arteries to be covered by the device.

9. Implantable device according to claim 1, wherein the main body includes markings detectable by imaging techniques.

10. Implantable device according to claim 1, wherein one or more additional openings are provided in the area of the device covering the origins of the coronary arteries after implant of the device.

11. Implantable device according to claim 1, wherein the membrane element is made of a material selected from the group consisting of synthetic, biological, and polyurethane materials.

12. Implantable device according to claim 11, wherein the membrane element is provided with a coating for biostability.

13. Implantable device according to claim 1, wherein the membrane element is provided with a coating for biostability.

14. Implantable device according to claim 1, wherein the main body is made of a material selected from the group consisting of biocompatible material, a metal alloy, stainless steel, plastics, polycarbonate, a shape-memory material, and nitinol.

15. Implantable device according to claim 14, wherein the material of the main body is treated at least in one section by chemical and/or mechanical means, in particular by etching, electropolishing, microsectioning or otherwise, to produce different degrees of stiffness.

16. Implantable device according to claim 1, wherein the main body and the membrane element are connectable or connected to one another in a process selected from the group consisting of adhesive bonding, welding, sewing, melting, and immersion.

17. Implantable device according to claim 1, wherein the main body is substantially of one piece.

18. Implantable device according to claim 17, wherein the main body is cut and/or punched from a piece of material and/or separated therefrom by another method of separation.

19. Implantable device according to claim 1, wherein the main body is cut and/or punched from a piece of material and/or separated therefrom by another method of separation.

27. Method for producing an implantable device according to claim 1, comprising the steps of:

cutting and/or punching a main body from a piece of material;

bending the main body into a substantially cylindrical body;

inserting a membrane element into the substantially cylindrical main body and connected therewith; and

securing the ring portion to the main body, the ring portion connected to the valve portion associated with the membrane element.

28. Method according to claim 27, wherein the material cut is carried out so as to produce a continuous net structure of the substantially cylindrical main body, wherein the material includes at least partly different mesh sizes.

29. Method for implanting an implantable device according to claim 1 in the heart of a human or animal body, wherein guide wires are guided through guide openings of the main body, the guide wires being advanced by a probe to the site of implantation in the heart, the guide wires being at least partly pushed into the coronary vessels, the device then being advanced in the non-deployed configuration via a catheter into the body of the patient to the site of implantation in the heart, where the device is expanded and oriented with respect to the origins of the coronary vessels from the heart with the aid of the guide wires.

30. Method according to claim 29, wherein the device is pushed so far into the area of the cardiac valve, especially the aortic valve, that the natural valve is pressed against the wall of the vessel and is held there by the device.

31. Method according to claim 29, wherein the at least one guide wire and/or the implantable device is introduced into the body via the aorta carotis or arteria axillaris.

32. Method according to claim 29, wherein the main body of the device is oriented such that the protruding anchoring portion at the first end protrudes into the heart ventricle, especially the left heart ventricle, and the protruding anchoring portion at the second end is clamped to the wall of the vessel, especially the aortic wall.

33. Method according to claim 29, wherein the at least one guide wire is passed through the main body and/or arranged at the outside of the main body.

20. Implantable device for use in a human and/or animal body for replacement of an organ valve, comprising:

an elongate main body having a first end and a second end each provided with an opening; and

a membrane element provided with at least one opening, said device having a deployed configuration having a relatively larger cross sectional area, and a non-deployed configuration having a relatively smaller cross sectional area, said device convertible from the non-deployed configuration to the deployed configuration by application of force against elastic material forces of the main body, wherein at least one of the first end and the second end of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel;

wherein the main body is substantially of one piece;

wherein the main body is cut and/or punched from a piece of material and/or separated therefrom by another method of separation;

wherein the material section comprises parallel cuts and alternating subsequent cuts extending obliquely.

21. Implantable device according to claim 20, wherein cuts extending obliquely with respect to the parallel cuts are provided for producing areas of different stiffness.

22. Implantable device according to claim 20, wherein the main body comprises cut elements with widened and rounded ends for producing atraumatic ends of the main body.

24. Implantable device according to claim 20, wherein at least one hole is provided in the area of the obliquely extending cuts.

23. Implantable device for use in a human and/or animal body for replacement of an organ valve, comprising:

an elongate main body having a first end and a second end each provided with an opening;

a membrane element provided with at least one opening, said device having a deployed configuration having a relatively larger cross sectional area, and a non-deployed configuration having a relatively smaller cross sectional area, said device convertible from the non-deployed configuration to the deployed configuration by application of force against elastic material forces of the main body, wherein at least one of the first end and the second end of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel; and

a ring portion secured to the main body and connected to a valve portion, the valve portion associated with the membrane element and disposed within the main body;

wherein the main body comprises cut elements with widened and rounded ends for producing atraumatic ends of the main body.

25. Implantable device for use in a human and/or animal body for replacement of an organ valve, comprising:

an elongate main body having a first end and a second end each provided with an opening; and

a membrane element provided with at least one opening, said device having a deployed configuration having a relatively larger cross sectional area, and a non-deployed configuration having a relatively smaller cross sectional area, said device convertible from the non-deployed configuration to the deployed configuration by application of force against elastic material forces of the main body, wherein at least one of the first end and the second end of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel;

wherein the membrane element has a ring portion and, connected thereto, a valve portion;

wherein the valve portion comprises three sail elements.

26. Implantable device according to claim 25, wherein the membrane element is made of a material selected from the group consisting of synthetic, biological, and polyurethane material.

34. Implantable device for use in a human and/or animal body for replacement of an organ valve, comprising:

an elongate main body having a first end and a second end each provided with an opening; and

a membrane element provided with at least one opening, said device having a deployed configuration having a relatively larger cross sectional area, and a non-deployed configuration having a relatively smaller cross sectional area, said device convertible from the non-deployed configuration to the deployed configuration by application of force against elastic material forces of the main body, wherein at least one of the first end and the second end of the main body has an outwardly protruding anchoring portion for anchoring the device in the organ and/or a vessel;

wherein the membrane element has a ring portion and, connected thereto, a valve portion;

wherein the main body comprises cut elements with widened and rounded ends for producing atraumatic ends of the main body.