Valve prosthesis implantation techniques

• US 8,348,996 B2
• Filed: 03/23/2007
• Issued: 01/08/2013
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/726,889
• Publication Number:
  US 20080071362A1
• Time in Patent Office: 2,118 Days
• Field of Search: 623/1.24, 623/2.38, 623 21- 219
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A method is provided, including providing a semilunar valve prosthesis, and implanting the prosthesis without using any imaging techniques. Another method is provided, including providing a semilunar valve prosthesis, placing the prosthesis in a body of a subject, and determining a correct rotational disposition of the prosthesis with respect to a semilunar valve site based on tactile feedback. Other embodiments are also described.

Claims

1. An apparatus comprising:

a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, wherein the prosthesis includes a valve prosthesis support having exactly three engagement arms that meet one another at three respective junctures, wherein the junctures are located at a downstream end of the prosthesis when the prosthesis is implanted in a native valve complex, and wherein each engagement arm extends between two junctures,

wherein the native valve complex has three native leaflets, three native commissures, and three semilunar sinuses, each respective semilunar sinus being located between two adjacent native commissures and between a floor of the native valve complex and a distal end of the two adjacent native commissures,

wherein the prosthesis is configured such that each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses upon implantation,

wherein the prosthesis is configured such that the junctures between the engagement arms are downstream of a respective one of the native commissures in the direction of intended bloodflow upon implantation,

wherein the prosthesis is configured such that a correct rotational disposition of the prosthesis with respect to the native semilunar valve can be determined based on tactile feedback between the engagement arm and an adjacent native commissure,

wherein the prosthesis is configured to position the native leaflets between the engagement arms and a valve prosthesis attached to the valve prosthesis support, and

wherein adjacent engagement arms meet one another at their respective juncture at a downstream end of the prosthesis such that the prosthesis is configured to allow a respective native commissure to be disposed between the adjacent engagement arms when the prosthesis is implanted in a native valve complex wherein the engagement arms are sized such that the engagement arms are configured to contact the floor of the respective semilunar sinuses at a contact point upon implantation.

2. The apparatus of claim 1, wherein each of the three engagement arms includes a trough complex.

3. The apparatus of claim 2, wherein the prosthesis is configured such that each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses upon implantation.

4. The apparatus of claim 1, wherein each of the engagement arms is shaped to define a length, parallel to a longitudinal axis of the prosthesis, between the respective juncture and the contact point of the respective engagement arm, wherein the length is greater than 6 mm.

5. The apparatus of claim 1, wherein the engagement arms are shaped so as to define three peak complexes at the three respective junctures.

6. The apparatus of claim 1, wherein the prosthesis is configured such that the three respective junctures are in rotational alignment with a respective one of the semilunar sinuses when the prosthesis is implanted at a native semilunar valve.

7. The apparatus of claim 1, wherein the prosthesis is configured to apply a radial force of less than 0.5 pounds outwardly against the native semilunar valve.

8. An apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising:

a valve support member configured to extend at least partially downstream of the native semilunar valve in the direction of bloodflow when the prosthesis is implanted in the native semilunar valve,

wherein the native semilunar valve includes native leaflets, three native commissures, and three semilunar sinuses, each respective semilunar sinus being located between two adjacent native commissures and between a floor of the native valve complex and a distal end of the two adjacent native commissures,

wherein the valve support member includes three engagement arms that meet one another at three respective junctures, wherein the junctures are located at a downstream end of the prosthesis when the prosthesis is implanted in a native valve complex,

wherein each engagement arm extends between two junctures, wherein the prosthesis is configured such that the junctures between the engagement arms are downstream of a respective one of the native commissures in the direction of bloodflow upon implantation, wherein the prosthesis has a central longitudinal axis, and wherein the engagement arms are configured to extend from a downstream end of the valve support member at an angle between about ten degrees and about sixty degrees upon implantation,

wherein the prosthesis is configured to position the native leaflets between the engagement arms and a valve prosthesis attached to the valve prosthesis support,

wherein adjacent engagement arms meet one another at their respective juncture at a downstream end of the prosthesis such that the prosthesis is configured to allow a respective native commissure to be disposed between the adjacent engagement arms when the prosthesis is implanted in a native valve complex, and

wherein the prosthesis is configured such that a correct rotational disposition of the prosthesis with respect to the native semilunar valve can be determined based on tactile feedback between the engagement arm and an adjacent native commissure wherein the engagement arms are sized such that the engagement arms contact the floor of the respective one of the semilunar sinuses at a contact point upon implantation.

9. The apparatus of claim 8, wherein the engagement arms are shaped so as to define three peak complexes at the three respective junctures and three trough complexes, wherein one trough complex is between each two of the peak complexes.

10. The apparatus of claim 9, wherein the prosthesis is configured such that each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses upon implantation.

11. The apparatus of claim 8, wherein each of the engagement arms is shaped to define a length, parallel to a longitudinal axis of the prosthesis, between the respective juncture and the contact point of the respective engagement arm, wherein the length is greater than 6 mm.

12. The apparatus of claim 8, wherein the engagement arms extend from the downstream end of the valve support member at an angle of twenty five degrees.

13. The apparatus of claim 12, wherein the prosthesis further includes a valve member attached to the valve support member.

14. An apparatus comprising:

a prosthesis for implantation at a native semilunar valve site having three native leaflets, three native commissures, and three semilunar sinuses, each respective semilunar sinus being located between two adjacent native commissures and between a floor of the native valve complex and a distal end of the two adjacent native commissures,

wherein the prosthesis includes a valve prosthesis support having exactly three engagement arms that meet one another at three respective junctures,

wherein the junctures are located at a downstream end of the prosthesis when the prosthesis is implanted in a native valve complex, and wherein each engagement arm extends between two junctures, wherein the prosthesis is configured such that each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses upon implantation, and wherein the prosthesis is configured such that the junctures between the engagement arms are downstream of the respective one of the native commissures in the direction of intended bloodflow upon implantation,

wherein the prosthesis is configured to position the native leaflets between the engagement arms and a valve prosthesis attached to the valve prosthesis support,

wherein adjacent engagement arms meet one another at their respective juncture at a downstream end of the prosthesis such that the prosthesis is configured to allow a respective native commissure to be disposed between the adjacent engagement arms when the prosthesis is implanted in a native valve complex, and

wherein the prosthesis is configured such that a correct rotational disposition of the prosthesis with respect to the native semilunar valve can be determined based on tactile feedback between the engagement arm and an adjacent native commissure wherein the engagement arms are sized such that the engagement arms are configured to contact the floor of the respective semilunar sinuses at a contact point upon implantation.

15. The apparatus of claim 14, wherein native leaflets of the native semilunar valve site are removed prior to implantation of the prosthesis.

16. The apparatus of claim 14, wherein the native semilunar valve site is a diseased native semilunar valve site.