Assembly comprising a ring for attachment in a passage surrounded by body tissue as well as an applicator for fitting the ring in the passage

• US 8,366,766 B2
• Filed: 03/29/2005
• Issued: 02/05/2013
• Est. Priority Date: 03/26/2004
• Status: Expired due to Fees

• Current Assignee: Daidalos Solutions B.V.
• Original Assignee: Daidalos Solutions B.V.
• Inventors: Berreklouw, Eric
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US10/594,363
• Publication Number:
  US 20080281411A1
• Time in Patent Office: 2,870 Days
• Field of Search: 623/2.11, 623/2.13, 623/2.36, 623/2.37, 623/2.38, 606/142, 606/144, 606/151, 606/153, 606/155, 606/219
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/0028 cooled
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present invention relates to an assembly comprising: a ring having anchoring elements for attaching the ring in a passage surrounded by body tissue, in particular blood vessel tissue. An applicator for fitting the ring in the passage; in which the anchoring elements have an anchoring position in which they protrude with respect to the ring, and in which the anchoring elements comprise a memory material, such as a memory metal or memory polymer, and are designed so that they can be bent from an anchoring position counter to a spring force into a fitting position and can be frozen in this fitting position by a temperature treatment in order to bend the anchoring elements back from the fitting position by the effect of this spring force into the anchoring position when a predetermined threshold temperature is exceeded, and in which the applicator is provided distally with a carrier for carrying the ring. The assembly according to the invention is provided with an influencing system for influencing the temperature of the anchoring elements of the ring carried by the carrier in such a way that the anchoring elements bend back from the fitting position to the anchoring position by increasing the temperature of the anchoring elements to above the threshold temperature.

Claims

1. Heart valve prosthesis comprising:

a ring member for attachment to a valve annulus; and

a constriction system comprising anchoring pins for penetrating into the valve annulus,

wherein the anchoring pins have a straight first position and a second position;

wherein, in the first position, the anchoring pins extend in an axial direction;

wherein the anchoring pins are arranged around the circumference of the ring member and are adapted to move, after the anchoring pins have fully penetrated into the valve annulus from the first position in a radially inward direction with respect to the ring member, to the second position, to press the annulus correspondingly in the radially inward direction;

wherein the ring member comprises a lower flange which is bendable from a straight axial position to a radially outward position with respect to the ring member, and an upper flange having a radial outwardly extending position with respect to the ring member, and

wherein, when the lower flange is in the radially outward position, the anchoring pins are arranged between the upper and lower flange.

2. Prosthesis according to claim 1, wherein the anchoring pins are bent from the second position into the first position against a spring force and are fixed in the first position in a releasable manner such that upon release the anchoring pins return to the second position.

3. Prosthesis according to claim 2, wherein the constriction system further comprises a carrier, and wherein the anchoring pins are arranged on the carrier which is adapted to shorten such that the anchoring pins move in said radially inward direction.

4. Prosthesis according to claim 3, wherein the prosthesis comprises memory metal or memory plastic frozen in the first position to be released to go back to the second position when the temperature increases above a threshold temperature.

5. Prosthesis according to claim 3, wherein the carrier comprises a radial arm for each said anchoring pin, which radial arm can be shortened by memory effects of memory metal or memory plastic.

6. Prosthesis according to claim 3, wherein the carrier comprises a carrier ring adapted to be reduced in diameter by use of memory effects of a memory metal or memory plastic.

7. Prosthesis according to claim 2, wherein the prosthesis comprises memory metal or memory plastic frozen in the first position to be released to go back to the second position when the temperature increases above a threshold temperature.

8. Prosthesis according to claim 1, wherein the constriction system further comprises a carrier, and wherein the anchoring pins are arranged on the carrier which is adapted to shorten such that the anchoring pins move in said radially inward direction.

9. Prosthesis according to claim 8, wherein the carrier comprises a radial arm for each said anchoring pin, which radial arm can be shortened by memory effects of memory metal or memory plastic.

10. Prosthesis according to claim 8, wherein the carrier comprises a carrier ring adapted to be reduced in diameter by use of memory effects of a memory metal or memory plastic.

11. Prosthesis according to claim 8, wherein the carrier comprises a carrier ring adapted to be reduced in diameter by use of memory effects of a memory metal or memory plastic.

12. Prosthesis according to claim 1, wherein the constriction system comprises a constriction ring element separate from the ring member and adapted to lie around the ring member.

13. Prosthesis according to claim 12, wherein the anchoring pins are bent from the second position into the first position against a spring force and are fixed in the first position in a releasable manner such that upon release the anchoring pins return to the second position.

14. Prosthesis according to claim 13, wherein the prosthesis comprises memory metal or memory plastic frozen in the first position to be released to go back to the second position when the temperature increases above a threshold temperature.

15. Prosthesis according to claim 12, wherein the anchoring pins are arranged on the constriction ring element and wherein the constriction ring element is adapted to shorten such that the anchoring pins move in said radially inward direction.

16. Prosthesis according to claim 15, wherein the constriction ring comprises a radial arm for each said anchoring pin, which radial arm can be shortened by memory effects of memory metal or memory plastic.

17. Prosthesis according to claim 1, wherein the ring member is provided with a material enhancing ingrowth of tissue.

18. Prosthesis according to claim 1, wherein the upper flange comprises arm segments extending essentially radially with respect to the ring member and carrying at their ends the anchoring pins, wherein the arm segments are arranged to shorten by returning under influence of a shape memory effect to a shortened condition in which the arm segments have a zig-zag-like shape.

19. Prosthesis according to claim 1, wherein the prosthesis further comprises one, two or more valve leaflets arranged inside the ring-member.

20. Prosthesis according to claim 1,

wherein, in the first position, the anchoring pins extend from the upper flange in the direction of the lower flange.

21. Prosthesis according to claim 1,

wherein the upper flange is a radially outwardly extending flange provided with slots;

wherein the prosthesis further comprises axial fingers inserted through said slots;

wherein the anchoring pins are provided at the underside of the upper flange adjacent a said slot so that the anchoring pins, kept in the straight first position by the axial fingers inserted through said slots, are allowed to move to the second position upon withdrawal of the axial fingers.

22. Heart valve prosthesis comprising:

a ring member for attachment to a valve annulus, and

a constriction system having anchoring pins for penetrating into the valve annulus,

wherein the anchoring pins are arranged around the circumference of the ring member and adapted to move in a radially inward direction with respect to the ring member, after the anchoring pins have fully penetrated into the valve annulus, from a first position to a second position to press the annulus correspondingly in the radially inward direction; and

wherein the ring member comprises a lower flange which is bendable from a straight axial position to a radially outward position with respect to the ring member, and an upper flange having a radial outwardly extending position with respect to the ring member, wherein the upper flange comprises arm segments extending essentially radially with respect to the ring member and carrying at their ends the anchoring pins, wherein the arm segments are arranged to shorten by returning under the influence of a shape memory effect to a shortened condition in which the arm segments have a zig-zag-like shape.