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 20080281411A1
• Filed: 03/29/2005
• Published: 11/13/2008
• Est. Priority Date: 03/26/2004
• Status: Active Grant

• Current Assignee: Daidalos Solutions B.V.
• Original Assignee: Daidalos Solutions B.V.
• Inventors: Berreklouw, Eric
• Granted Patent: US 8,366,766 B2
• Time in Patent Office: Days
• 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. 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 outwardly 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 is exceeded; and

in which the applicator is provided distally with a carrier for carrying the ring;

characterized in that,

the assembly 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.

2. Assembly according to claim 1, wherein the influencing system comprises a cooling device for cooling the anchoring elements to a temperature below the threshold temperature.

3. Assembly according to claim 1, wherein the influencing system comprises a heating device for heating the anchoring elements to a temperature above the threshold temperature.

4. Assembly according to claim 1, wherein the part of the carrier contacting the ring is made of a metal, and wherein, the influencing system is connected in a heat-exchanging manner to that part of the carrier contacting the ring or forms part of the carrier.

5. Assembly according to claim 1, wherein the influencing system comprises a Peltier element.

6. Assembly according to claim 1, wherein the influencing system comprises a channel for supplying a fluid, such as a liquid or gas, to the carrier.

7. Assembly according to claim 6, wherein the channel comprises at least one free outlet for bringing the fluid into contact with the anchoring elements or the ring.

8. Assembly according to claim 1, wherein the influencing system comprises a source for generating an alternating electromagnetic field, and wherein the carrier and/or the anchoring elements are designed in such a manner that they are sensitive to heating by the alternating electromagnetic field.

9. Assembly according to claim 8, wherein the source comprises at least one electrically conductive loop which can be connected to an alternating current source.

10. Assembly according to claim 9, wherein the loop surrounds a passage of a size such that the ring can be accommodated therein with play, the size of the passage being at least 1.2 times larger than that of the ring.

11. Assembly according to claim 1, wherein the carrier comprises gripper parts which can be moved between a position gripping the ring and a position releasing the ring.

12. Assembly according to claim 1, wherein the applicator comprises a sleeve which can slide along the applicator between a position overlapping the ring provided on the carrier and a position exposing the ring provided on the carrier.

13. Assembly according to claim 12, wherein the sleeve comprises a distal part which tapers in the distal direction to form a diameter which is smaller than that of the ring, and the distal part consists of axial fingers which can bend radially outwards from the tapering position in such a manner that the tapering part of the sleeve can be displaced over the ring.

14. Assembly according to claim 12, wherein the sleeve is provided at its distal end with axial fingers and the ring is provided at its distal end with the anchoring elements, a space being left between neighbouring axial fingers and wherein the axial fingers are provided in such a manner that, when the ring is accommodated in the sleeve, each axial finger overlaps a respective distal anchoring element.

15. Assembly according to claim 14, wherein the ring is provided at its proximal end with a flange which extends radially outwards for interaction with the distal anchoring elements, and wherein the flange is provided with passages for those axial fingers.

16. Assembly according to claim 14, wherein the ring is provided with the anchoring elements at its proximal end, and wherein the proximal and distal anchoring elements are provided in a staggered manner with respect to each other, seen in the tangential direction of the ring, in such a manner that the axial fingers can overlap with the distal anchoring elements when they protrude through the proximal anchoring elements.

17. Assembly according to claim 1, wherein the composition of the material of the anchoring elements is chosen such that the threshold temperature is around or below the human body temperature.

18. Assembly according to claim 17, wherein the threshold temperature is in the range ≦

37.5°

C.

19. Assembly according to claim 17 wherein the threshold temperature is in the range 19°

C. to 37°

C.

20. Assembly according to claim 1, wherein the influencing system is designed to be able to raise the temperature of the anchoring elements to at least 5 to 10°

C. above the threshold temperatures.

21. Assembly according to claim 1, wherein the influencing system is designed to maintain the temperature of the anchoring elements approximately 10 to 28°

C. below the threshold temperature.

22. Assembly according to claim 1, wherein the ring is provided with a valve prosthesis.

23. Assembly according to claim 22, wherein the valve prosthesis comprises one, two or more valve leaflets, and wherein the carrier is provided with a longitudinal member extending in the longitudinal direction, against which longitudinal member the valve leaflets of the valve prosthesis supported by the carrier rest in their open position.

24. Assembly according to claim 1, wherein the ring is a ring provided with further anchoring elements for attaching a valve prosthesis therein.

25. Assembly according to claim 1, wherein the ring is a valve reconstruction ring.

26. Assembly according to claim 1, wherein the ring is an anastomosis attachment ring.

27. Assembly according to claim 1, wherein the ring is provided with further anchoring elements for attaching a cannula and/or port and/or operating channel.

28. Assembly according to claim 1, wherein the assembly is fitted with one or more sensors and/or one or more marks distally, in particular near the carrier.

38. Assembly according to claim 9, wherein the loop surrounds a passage of a size such that the ring can be accommodated therein with play, the size of the passage being at least 1.5 times larger than that of the ring.

39. Assembly according to claim 18, wherein the threshold temperature is in the range of 24°

C. to 34°

C.

40. Assembly according to claim 18, wherein the ring is provided with a heart valve prosthesis.

29. (canceled)

30. (canceled)

31. Heart valve prosthesis comprising:

a ring member for attachment to body tissue surrounding said ring;

one, two, or more valve leaflets arranged inside the ring-member; and

a constriction system having anchoring pins for penetrating into the body tissue, the anchoring pins being arranged around the circumference of the ring member and adapted to move, when the pins have fully penetrated into the body tissue, the pins from a first penetrated position in a radial inward direction to a second penetrated position to constrict the body tissue.

32. Prosthesis according to claim 31, wherein the pins are bent from the second penetrated position into the first penetrated position against a spring force and are fixed in the first penetrated position in a releasable manner such that upon release the pins return to the second penetrated position.

33. Prosthesis according to claim 31, wherein the pins are arranged on a carrier adapted to shorten such that the pins move in radially inward direction.

34. Prosthesis according to claim 31, wherein the constriction system comprises a ring element adapted to lie around the ring member.

35. Prosthesis according to claim 32, wherein the pins are arranged on a carrier adapted to shorten such that the pins move in a radially inward direction.

36. Prosthesis according to claim 32, wherein the pins are bent from the second penetrated position into the first penetrated position against a spring force and are fixed in the first penetrated position in a releasable manner such that upon release the pins return to the second penetrated position.

37. Prosthesis according to claim 33, wherein the pins are arranged on a carrier adapted to shorten such that the pins move in a radially inward direction.