Device and method for improving the function of a heart valve

• US 10,195,029 B2
• Filed: 08/04/2015
• Issued: 02/05/2019
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Keranen, Olli
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/818,163
• Publication Number:
  US 20150335428A1
• Time in Patent Office: 1,281 Days
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A device for improving the function of a heart valve comprises: a support member formed from a shape memory material, and a restraining member providing a restraining action on a course of the support member. The support member may abut one side of the valve conforming to the shape of the valve annulus upon said shape memory material assuming an activated shape while the restraining member restrains the course of the support member. The restraining action is removable for allowing the support member to assume a desired, altered course. The restraining member may be biodegradable to be degraded within a patient or may be detachable from the support member to be withdrawn. The support member according to another embodiment presents a shape change in that an increased cross-section is associated with a shortened length of the support member. The support member according to yet another embodiment has a first and a second activated shape.

Claims

1. A method for improving the function of a heart valve comprising:

obtaining a support member, wherein the support member is comprised of a first segment and a second segment;

inserting said first segment to abut a superior or inferior side of the valve and to substantially conform along a first course of said first segment to a shape of at least part of an annulus of the valve and inserting said second segment to abut an opposite inferior or superior side of the valve and to substantially conform along a first course of said second segment to a shape of at least part of the valve annulus at said opposite side;

fixating a position of the support member relative to the valve;

changing the shape of the support member into an altered course of reduced diameter by expanding a cross-section of the support member such that a length of the support member is shortened so as to remodel the heart valve;

wherein said fixating step is performed prior to said changing step.

2. The method according to claim 1, wherein said expanding said cross-section includes inflating a balloon against at least a part of said support member.

3. The method according to claim 1, wherein the first and second segments are formed from a mesh-like structure.

4. The method according to claim 1, wherein said fixating comprises trapping valve tissue between said first and second segments.

5. The method according to claim 1, wherein said changing the shape of the support member further comprises changing the shape of both the first and second segment into said altered course.

6. The method according to claim 1, wherein said inserting further comprises

introducing a first end of the first segment through a portion of the valve tissue,

rotating the support member so that the first segment is on said superior or inferior side of the valve, and

positioning the second segment on said opposite superior or inferior side of the valve.

7. The method according to claim 1, wherein the step of inserting further comprises introducing said support member into a patient inside a catheter.

8. The method according to claim 1, wherein said changing the shape further comprises allowing said first and second segment to change into a memory induced shape.

9. The method according to claim 1, wherein the first and second segments are belt-shaped.

10. The method according to claim 1, wherein the first and second segments have a U-shaped cross-section.

11. The method according to claim 1, wherein the first and second segments are tubular.

12. The method according to claim 1, wherein the first segment is continuous with the second segment to form a coil-shape.

13. A method for improving the function of a heart valve comprising:

obtaining a support member,

inserting said support member to abut one side of the valve and to substantially conform along a first course of said support member to a shape of at least part of an annulus of the valve,

fixating a position of the support member relative to the valve,

changing the shape of the support member into an altered course of reduced diameter so as to remodel the heart valve by expanding a cross-section of the support member such that a length of the support member is shortened;

wherein said fixating step is performed prior to said changing step;

wherein the support member is arranged to assume a reduced radius of curvature in said altered course.