Fixing device, in particular for fixing to vascular wall tissue

• US 7,524,330 B2
• Filed: 04/13/2004
• Issued: 04/28/2009
• Est. Priority Date: 05/25/1999
• Status: Expired due to Fees

• 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:
  US10/822,682
• Publication Number:
  US 20040193261A1
• Time in Patent Office: 1,841 Days
• Field of Search: 606/153, 623/1.14, 623/1.24, 623/1.36, 623/2.1, 623/2.11, 623/2.14, 623/2.17, 623/2.18, 623/2.23, 623 236- 24, 623/900
• US Class Current: 623/1.36
• 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

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. 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 the 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 the resilient force.

Claims

1. An assembly comprising a valve prosthesis and a prosthesis fixing device, comprising:

a tubular element providing a lumen therethrough and intended to lie, when the prosthesis fixing device is in an implanted position, with an outside in contact with a wall part of the circulatory system and to accommodate said valve prosthesis inside the lumen of said tubular element, the tubular element having pins distributed around a periphery of the tubular element, said pins having pointed ends for penetrating the peripheral wall when the prothesis fixing device is in the implanted position,

wherein the pointed ends face in radially outward direction of the tubular element, and each pin is angularly arranged on an arm which, via a bend line, is fixed by one end to the tubular element in a manner which permits swinging around said bend line, and

wherein the arms and pins are movable, by swinging about the bend line, from an insertion position, in which the arms and pins are located inside the exposed lumen of the tubular element, into the implanted position in which at least the pins, viewed in the radial direction, project from the outside of the tubular element,

the valve prosthesis comprising a cylindrical outer body fitting in the lumen of said tubular element, wherein the arms and pins are located within the longitudinal boundaries of the tubular element in the insertion position and in that the tubular element is provided with radial passages, viewed in radial direction of the tubular element, located alongside the pins and arms, such that, on swinging from the insertion position into the implanted position, the pins emerge through these passages and the arms are located within the passages.

2. The assembly according to claim 1, wherein the arms, viewed in the longitudinal direction of the tubular element, extend essentially in said longitudinal direction.

3. The assembly according to claim 1, wherein the arms extend in tangential direction of the tubular element.

4. The assembly according to claim 1, wherein each arm has at least two pins.

5. The assembly according to claim 1, wherein in the insertion position, the anus viewed from the bend line point away from the outside of the tubular element.

6. The assembly according to claim 1, wherein the tubular element has a bottom and/or top flange extending in the circumferential direction of the tubular element, which flange, at least in the inserted position, projects outwards with respect to the tubular element in order to come into contact with, or at least to overlap, the bottom or, respectively, the top of surrounding vascular wall tissue.

7. The assembly according to claim 6, wherein the bottom or, respectively, top flange has a number of flange fingers separated from one another by incisions, cut-outs or folds and distributed around the periphery of the tubular element.

8. The assembly according to claim 7, wherein the ends of the flange fingers each carry a said pin, and in that said fingers form said arms.

9. The assembly according to claim 1, wherein the tubular element is provided with a lower limit in order to prevent a prosthesis placed in the tubular element after implantation of the prosthesis fixing device from detaching from the tubular element in the downward direction and/or with a top closure in order to prevent a prosthesis placed in the tubular element after implantation of the prosthesis fixing device from detaching from the tubular element in the upward direction.

10. The assembly according to claim 9, wherein the lower limit comprises a stop arranged inside the tubular element at the bottom thereof.

11. The assembly according to claim 9, wherein the top closure comprises resilient snap-fit lips.

12. The assembly according to claim 1, wherein the arms and pins are arranged at least partially in accordance with a sine wave-like pattern in the peripheral direction of the tubular element.

13. The assembly according to claim 12, wherein the sine wave path has a length of three sine periods together spanning the periphery of the tubular element.

14. The assembly according to claim 1, wherein the tubular element is a sine-wave-shaped ring or sine-wave-shaped cylindrical element with three sine wave periods.

15. The assembly according to claim 1, wherein the arms provided with pins are bendable against a resilient force from the implanted position into the insertion position and are fixable in said insertion position in such a way that the fixing can be automatically released in order to cause the arms provided with pins to bend back toward the implanted position under the influence of the resilient force.

16. The assembly according to claim 1, wherein at least part of the external surface of the tubular element is concave.

17. The assembly according to claim 1, wherein the tubular element is provided with two or more rows of arms, provided with pins, running in the peripheral direction.

18. The assembly according to claim 1, wherein the radial passages are slit-shaped and extend in the longitudinal direction of the arms.

19. The assembly according to claim 1, wherein the prosthesis fixing device is made of one piece as an integral whole.

20. The assembly according to claim 1, wherein the prosthesis fixing device is made from one part as an integral whole.

21. An assembly comprising a valve prosthesis and a prosthesis fixing device, comprising:

a tubular element providing a lumen therethrough and intended to lie, when the prosthesis fixing device is in an implanted position, with an outside in contact with a wall part of the circulatory system and to accommodate said valve prosthesis inside the lumen of said tubular element, the tubular element having pins distributed around a periphery of the tubular element, said pins having pointed ends for penetrating the peripheral wall when the prothesis fixing device is in the implanted position,

wherein the pointed ends face in radially outward direction of the tubular element, and each pin is angularly arranged on an arm which, via a bend line, is fixed by one end to the tubular element in a manner which permits swinging around said bend line, and

wherein the arms and pins are movable, by swinging about the bend line, from an insertion position, in which the arms and pins are located inside the exposed lumen of the tubular element, into the implanted position in which at least the pins, viewed in the radial direction, project from the outside of the tubular element,

the valve prosthesis comprising a cylindrical outer body fitting in the lumen of said tubular element,

wherein each arm extends from said one end to an other end;

said other end bearing a said pin pointing in radially outward direction; and

said one end being fixed to the tubular element and defining the bend line, wherein the arms and pins are located within the longitudinal boundaries of the tubular element in the insertion position and in that the tubular element is provided with radial passages, viewed in radial direction of the tubular element, located alongside the pins and arms, such that, on swinging from the insertion position into the implanted position, the pins emerge through these passages and the arms are located within the passages.

22. The assembly according to claim 21, wherein, in the insertion position and viewed along each arm from the tubular element to the pin carried on said arm, the arm extends obliquely, in radially inwards direction, into the lumen.

23. The assembly according to claim 21, wherein, in the insertion position as well as the fixing position, the pin approximately extends at right angles to the arm bearing said pin.