Valve fixation member having engagement arms

• US 8,876,895 B2
• Filed: 03/23/2007
• Issued: 11/04/2014
• 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): PREBILIC, PAUL B
• Application Number:
  US11/726,915
• Publication Number:
  US 20080071369A1
• Time in Patent Office: 2,783 Days
• Field of Search: 623 124- 126, 623 214- 219, 623 238- 241
• US Class Current: 623/2.18
• 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

Apparatus is provided including a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses, the prosthesis including a valve prosthesis support, which includes a support structure including at least two engagement arms. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses. A shape of at least one of the engagement arms is generally characterized by a function z″(r)>=0, where z is a height of any given point on the at least one engagement arm measured along a longitudinal axis of the prosthesis, and r is a distance from the longitudinal axis to the given point. Other embodiments are also described.

Claims

1. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses, the prosthesis comprising:

a collapsible and expandable valve prosthesis support comprising a support structure having exactly three engagement arms and a longitudinal axis,

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

wherein each of the engagement arms comprises an upwardly concave portion, wherein the upwardly concave portion is shaped so as to curve outwards from the longitudinal axis in a lateral direction when the valve prosthesis support is in an expanded state.

2. The apparatus according to claim 1, wherein the valve prosthesis support includes a downstream section and an upstream section, wherein the engagement arms include a downstream end and an upstream end, and wherein the engagement arms extend from the downstream section of the valve prosthesis support towards the upstream section of the valve prosthesis support.

3. The apparatus according to claim 1, wherein the native semilunar valve includes a native aortic valve of the subject, wherein the semilunar sinuses include respective aortic sinuses, and wherein, upon implantation of the prosthesis, each of the engagement arms is configured to be disposed at least partially within the respective one of the aortic sinuses.

4. The apparatus according to claim 1, wherein the native semilunar valve includes a native pulmonary valve of the subject, wherein the semilunar sinuses include respective pulmonary sinuses, and wherein, upon implantation of the prosthesis, each of the engagement arms is configured to be at least partially disposed within the respective one of the pulmonary sinuses.

5. The apparatus according to claim 1, wherein each of the engagement arms comprises an extension element that extends from the engagement arm, wherein the extension element is configured to engage a sinus floor of the respective one of the semilunar sinuses upon implantation of the prosthesis.

6. The apparatus according to claim 2, wherein, when the valve prosthesis support is in an expanded state, the radial distance between the engagement arms and the longitudinal axis generally increases moving from the upstream end to the downstream end of the engagement arms.

7. The apparatus according to claim 1, wherein the prosthesis is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve.

8. The apparatus according to claim 1, wherein the valve prosthesis support is configured such that, upon implantation of the prosthesis, the valve prosthesis support does not fold over leaflets of the native semilunar valve.

9. The apparatus according to claim 1,

wherein the support structure is configured to serve as a distal fixation member,

wherein the valve prosthesis support comprises a proximal fixation member, and

wherein the proximal fixation member and the engagement arms of the distal fixation member are configured to axially sandwich the native valve complex from ventricular and downstream sides thereof, respectively, upon implantation of the prosthesis.

10. The apparatus according to claim 1, wherein each of the engagement arms is configured to engage a respective one of the semilunar sinuses upon implantation of the prosthesis.

11. The apparatus according to claim 10, wherein each of the engagement arms is shaped so as to define at least one extension element that extends from the engagement arm, and wherein each of the engagement arms and its respective at least one extension element are configured such that the engagement arm engages, via the at least one extension element, a sinus floor of the respective one of the semilunar sinuses upon implantation of the prosthesis.

12. The apparatus according to claim 10, wherein the longitudinal length of each of the engagement arms, as measured along a line parallel to a longitudinal axis of the prosthesis, is greater than 6 mm.

13. The apparatus according to claim 1, wherein the prosthesis further comprises a prosthetic valve comprising one or more prosthetic leaflets, wherein at least a portion of each of the prosthetic leaflets is configured to assume a closed position during diastole and an open position during systole, and wherein the at least a portion is not directly coupled to any of the engagement arms.

14. The apparatus according to claim 13, wherein the prosthetic valve is coupled to the support structure such that at least 50% of an axial length of the prosthetic leaflets is distal to native valve leaflets of the native semilunar valve, upon implantation of the prosthesis.

15. The apparatus according to claim 1, wherein the engagement arms are configured to touch respective floors of the respective semilunar sinuses, upon implantation of the prosthesis.

16. The apparatus according to claim 15, wherein the engagement arms are configured to firmly engage the respective semilunar sinuses, upon implantation of the prosthesis.

17. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses, the prosthesis comprising:

a collapsible and expandable valve prosthesis support comprising a support structure comprising at least two engagement arms, wherein the valve prosthesis support includes a downstream section and an upstream section, wherein the engagement arms extend from the downstream section of the valve prosthesis support towards the upstream section of the valve prosthesis support,

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

wherein each of the engagement arms comprises an upwardly concave portion, wherein the upwardly concave portion is shaped so as to curve outwards from the longitudinal axis in a lateral direction when the valve prosthesis support is in an expanded state.