Fixing device, in particular for fixing to vascular wall tissue

• US 6,790,229 B1
• Filed: 03/08/2002
• Issued: 09/14/2004
• Est. Priority Date: 05/25/1999
• Status: Expired due to Term

• Current Assignee: Daidalos Solutions B.V.
• Original Assignee: Eric Berreklouw
• Inventors: Berreklouw, Eric
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US09/979,668
• Time in Patent Office: 921 Days
• Field of Search: A61/F.224, 623/2.1, 623/2.36, 623/2.37, 623/2.38, 623/2.4, 623/900, 623/1.24, 623/2.14, 623/2.17, 623/2.18, 606/151, 606/153
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

The invention relates to a cardiac prosthesis fixing device made up of a tubular element that can be accommodated inside a valve annulus of a heart and is provided with a bottom flange and top flange, between which the valve annulus can be accommodated. According to the invention the bottom flange is bent, or can be bent, reversibly, against a resilient force, from a first outward-pointing position into a second position in which the projection of the bottom flange on a radial transverse surface of the tubular element is located essentially on and/or within the periphery of the tubular element and the bottom flange is fixed or can be fixed in said second position in such a way that the fixing can be released in order to bend back the bottom flange towards the first position under the influence of said resilient force.

Claims

1. A cardiac prosthesis assembly comprising:

a valve or ring cardiac prosthesis; and

a tubular element arranged and adapted to hold said prosthesis and to clamp a heart valve annulus,

said tubular element having a bottom flange extending from a first peripheral edge of said tubular element and a top flange extending from a second peripheral edge of said tubular element, said bottom and top flanges being at rest in a first position in which said bottom and top flanges extend radially outward to clamp a valve annulus, and said bottom flange being resiliently deformable to a second position in which said bottom flange is on or within an external periphery of said tubular element.

2. The assembly of claim 1, wherein a diameter of said tubular element is unchangeable.

3. The assembly of claim 1, wherein said tubular element is a continuous band.

4. The assembly of claim 1, wherein said prosthesis is held within said tubular element at a same time when said bottom flange is in the second position.

5. The assembly of claim 1, wherein said top flange is also resiliently deformable to a second position in which said top flange is on or within an external periphery of said tubular element.

6. The assembly of claim 1, wherein said top flange is rigid and unmovable from the first position.

7. The assembly of claim 1, wherein distal ends of said top and bottom flanges extend toward each other when in the first position.

8. The assembly of claim 1, wherein at least one of said top and bottom flanges comprises plural fingers spaced from each other.

9. The assembly of claim 1, wherein when said top and bottom flanges are in the first position, an axial spacing between distal ends of said top and bottom flanges is less than a thickness of a heart valve annulus to which said tubular element is clamped.

10. The assembly of claim 1, wherein said tubular element is integral with said prosthesis.

11. The assembly of claim 1, wherein said tubular element has interior limits to bar axial movement of said prosthesis positioned in said tubular element.

12. The assembly of claim 11, wherein at least one of said limits is a radially inward rib extending around an interior periphery of said tubular element.

13. The assembly of claim 11, wherein an upper one of said limits comprises one of a screw ring, a snap-fit ring, and a resilient lip.

14. The assembly of claim 11, further comprising means for rotating said prosthesis in said tubular element along a longitudinal axis of said tubular element when said prosthesis is held within said tubular element, and a twist lock that fixes said tubular element and said prosthesis in a desired position with respect to each other.

15. The assembly of claim 1, wherein said bottom and top flanges are in a sinusoidal pattern in a peripheral direction of said tubular element.

16. The assembly of claim 15, where said sinusoidal pattern includes three sine periods spanning circumference of said tubular element.

17. The assembly of claim 1, wherein said tubular element is a sine wave-shaped element with three sine periods.

18. The assembly of claim 1, wherein said top and bottom flanges each comprise plural flange elements following a sine pattern on a exterior of said tubular element.

19. The assembly of claim 1, wherein an exterior surface of said tubular element is concave.

20. The assembly of claim 1, wherein at least one of said top and bottom flanges includes anchoring means for anchoring in an annulus.

21. The assembly of claim 1, further comprising fixing means for releasably fixing said bottom flange in the second position.

22. The assembly of claim 21, wherein said fixing means comprises a sleeve that surrounds said bottom flange when said bottom flange is in the second position.

23. The assembly of claim 22, wherein said top flange is also resiliently deformable to a second position in which said top flange is on or within an external periphery of said tubular element, and wherein said sleeve also surrounds said top flange when said top flange is in the second position, said sleeve being retractable when said tubular element is clamped to an annulus.

24. The assembly of claim 21, wherein said fixing means comprises a removable suture that surrounds said bottom flange and holds said bottom flange in the second position.

25. A cardiac prosthesis assembly comprising:

a valve or ring cardiac prosthesis; and

a continuous band of unchangeable diameter that is arranged and adapted to hold said prosthesis and to clamp a heart valve annulus,

wherein said band has a bottom flange extending from a first peripheral edge thereof and a top flange extending from a second peripheral edge thereof,

said bottom and top flanges naturally assuming a first position in which said bottom and top flanges extend radially outward to clamp a valve annulus, and said bottom flange being resiliently deformable from the first position to a second position in which said bottom flange is on or within an external periphery of said band, and

wherein said prosthesis is held within said band at a same time when said bottom flange is in the second position.