Expandable annuloplasty ring and methods of use

• US 6,406,493 B1
• Filed: 07/28/2000
• Issued: 06/18/2002
• Est. Priority Date: 06/02/2000
• Status: Expired due to Fees

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Hosheng Tu, Rodolfo C. Quijano
• Inventors: Tu, Hosheng, Quijano, Rodolfo C.
• Primary Examiner(s): Snow, Bruce
• Application Number:
  US09/627,523
• Time in Patent Office: 690 Days
• Field of Search: 623/2.36, 623/2.37, 623/900, 623/2.14, 623/2.18, 623/1.17, 623/1.15
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

An expandable annuloplasty ring which may be enlarged in situ comprising essentially uniform ring distension in the circumferential direction. The expandable annuloplasty ring is usable in pediatric patients whose growth necessitates enlargement of the ring by application of shape-memory material by way of heat activation or other non-mechanical means to accommodate growth of the annulus. The invention includes a non-contact method for post-implantation enlargement of the annuloplasty ring via a magnetic circuit or an external heat source.

Claims

1. An expandable annuloplasty ring for implantation in a heart valve annulus configured for essentially uniform ring distension in a circumferential direction after an expansion process comprising a fabric sheath;

and a plurality of stenting elements mounted within said fabric sheath configured to form a ring, wherein a first of the plurality of stenting elements is made of a first shape-memory material having a preshape and a first shape-transition temperature, wherein the first shape-memory material expands to its preshape when said first shape-memory material is heated to above the first shape-transition temperature, wherein the plurality of stenting elements further comprises a second stenting element made of a second shape-memory material having a preshape and a second shape-transition temperature, wherein the second shape-memory material expands to its preshape when said second shape-memory material is heated to above the second shape-transition temperature.

2. The expandable annuloplasty ring according to claim 1, wherein the plurality of stenting elements further comprises a third stenting element made of a third shape-memory material having a preshape and a third shape-transition temperature, wherein the third shape-memory material expands to its preshape when said third shape-memory material is heated to above the third shape-transition temperature.

3. The expandable annuloplasty ring according to claim 1, wherein said fabric sheath is a distensible sheath.

4. The expandable annuloplasty ring according to claim 1, wherein said shape-memory material is selected from a group consisting of shape-memory Nitinol and shape-memory plastic.

5. The expandable annuloplasty ring according to claim 1, wherein said shape-memory material is embedded within a biocompatible substrate selected from a group consisting of silicone, polyurethane, expanded polytetrafluoroethylene, semi-permeable material, elastomer and mixture of said biocompatible substrate thereof.

6. A method for radially expanding an expandable annuloplasty ring implanted in an annulus of a heart valve of a patient, the method comprising steps of:

implanting within the annulus an expandable annuloplasty ring configured for essentially uniform ring distension in a circumferential direction after an expansion process having a fabric sheath and a plurality of stenting elements mounted within said fabric sheath configured to form a ring, wherein said at least one stenting element is made of shape-memory material, the shape-memory material having a preshape and a shape-transition temperature;

after a predetermined time duration, applying heat for radially expanding the annuloplasty ring to a size larger than the size at implantation, wherein the shape-memory material expands to its preshape when said shape-memory material is heated to above the shape-transition temperature, wherein the expandable annuloplasty ring further comprises a second stenting element made of shape-memory material, the second stenting element having a preshape and a second shape-transition temperature, the method further comprising applying heat for radially expanding the annuloplasty ring to a size larger than the size at first expansion, wherein the second stenting element expands to its preshape when said second stenting element is heated to above the second shape-transition temperature.