Medical instrument, ring prosthesis, stent and stented valve

• US 10,137,019 B2
• Filed: 03/23/2011
• Issued: 11/27/2018
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Daidalos Solutions B.V.
• Original Assignee: Daidalos Solutions B.V.
• Inventors: Berreklouw, Eric
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): Ton, Martin T
• Application Number:
  US14/006,804
• Publication Number:
  US 20140039599A1
• Time in Patent Office: 2,806 Days
• Field of Search: 623 111, 623 115
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

The medical instrument includes: a first rod; a second rod which extends along the first rod; a longitudinal center line defined by the rods; and a manipulator. The manipulator includes a plurality of fingers, each with a first finger end and a second finger end. The second finger ends are free ends. The first finger ends are supported on the second rod in such a way that the fingers are operable, by moving the second rod in relation to the first rod, in order to be displaced from a first position to a second position. The distance from the free ends of the fingers to the longitudinal center line in the first position is different compared with the second position. A stent, a ring prosthesis and a prosthesis device are also described.

Claims

1. A stent, comprising:

a tubular element with an open grid structure which is radially expandable from a compressed condition to an expanded condition, and which has a proximal and distal end; and

a ring structure provided around the tubular element,

wherein the tubular element and ring structure are interconnected,

wherein the ring structure is a variable-diameter ring structure with distal and proximal flange feet,

wherein the ring structure has an axial direction and a radial direction disposed transverse to the axial direction,

wherein the ring structure is constructed from a series of elongated closed loops lying next to one another which, in each case, at the midpoint of the longitudinal sides of the loops, are attached laterally to one another via a junction to form the ring structure, in such a way that a) an imaginary center line through all junctions forms a closed ring and divides each loop into a distal flange foot of said distal flange feet and a proximal flange foot of said proximal flange feet, and b) the ring structure is expandable,

wherein the distal and proximal flange feet each have a fixed end arranged at the imaginary center line and a free end pointing away from the imaginary center line,

wherein the distal and proximal flange feet have a radial position, in which the free ends of the flange feet point in the radial direction,

wherein the distal and proximal flange feet have an extended position, in which the distal and proximal flange feet extend in the axial direction,

wherein the distal flange feet and the proximal flange feet lie in a longitudinal direction of the tubular element when the tubular element is in the compressed condition and the distal and proximal flange feet are in the extended position,

wherein the distal and proximal flange feet, when in the extended position, are under a pre-tension, which, upon release, bends the distal and proximal flange feet from the extended position to the radial position,

wherein, in the extended position, the free ends of the distal flange feet point in the distal direction whilst the free ends of the proximal flange feet point in the proximal direction such that, after the distal and proximal flange feet have bent from the extended position to the radial position, the distal and proximal flange feet interact to clamp surrounding tissue between the distal and proximal flange feet, and

wherein the distal flange feet, at the fixed ends of the distal flange feet, have a concave-curved part including a hollow side facing toward the proximal flange feet, and in the hollow side of the concave-curved part, a filling is provided that is configured to increase a clamping force with which the distal and proximal flange feet clamp the tissue in situ when the distal and proximal flange feet are in the radial position.

2. The stent according to claim 1, wherein the separate distal flange feet have an unequal shape and/or length and/or width in relation to one another, and/or angle in relation to the longitudinal direction, and/or fillings.

3. The stent according to claim 1, wherein the tubular element has a first and second zone, wherein the diameter in the first zone is smaller than in the second zone, and wherein the proximal and/or distal flange feet may be provided in the first and/or second zone.

4. The stent according to claim 1, wherein the stent further comprises a heart valve provided in the tubular element.

5. The stent according to claim 1, wherein the fillings of the separate distal flange feet have, in relation to one another, an unequal shape and/or length and/or width and/or consistency and/or material properties.

6. The stent according to claim 1, wherein the fillings of the separate distal flange feet extend beyond the circumference of the respective flange feet and/or in a lateral and/or radial direction therefrom.

7. The stent according to claim 1, wherein the fillings of the separate distal flange feet are interconnected in such a way that a continuity arises between all or a number of fillings of the distal flange feet.

8. The stent according to claim 1, wherein the fixed ends of the distal flange feet are located at a distance from the distal end of the tubular element whilst the fixed ends of the proximal flange feet are located at a distance from the proximal end of the tubular element.

9. An assembly, comprising a stent according to claim 1 and an applicator,

wherein the applicator comprises:

a rod system having a first rod and a second rod which extends along the first rod;

a longitudinal centre line defined by the direction in which the first rod and the second rod extend; and

a manipulator,

wherein the manipulator comprises a first and second plurality of fingers, each with a first finger end and a second finger end,

wherein the second finger ends are free ends,

wherein the first finger ends of said pluralities of fingers are supported on the rod system in such a way that the fingers of said plurality of fingers, by moving rods of the rod system in relation to each other, are operable to be displaced from a first position to a second position,

wherein the distance from the free ends of the fingers to the longitudinal centre line is in the first position smaller than in the second position, and

wherein the free, second ends of the first plurality of fingers point towards the free second ends of the second plurality of fingers and the first ends of the first plurality of fingers face in a direction opposite to the first ends of the second plurality of fingers.

10. An assembly comprising a stent according to claim 1, further comprising:

a manipulator for releasing the stent,

wherein the distal and proximal flange feet, if they are in the extended position, are under a pre-tension, which, when released, bends the flange feet from the extended position to the radial position, and

wherein the manipulator comprises

a plurality of U-shaped obstacle elements with a first leg and a second leg, the free ends of which point in the distal direction,

an operating element, and

for each obstacle element, a cord, one end of which is attached to the obstacle element and the other end of which is connected to the operating element in such a way that, when the operating element is displaced in the proximal direction, the obstacle elements are retracted in the proximal direction.

11. A method for implanting a stent according to claim 1, the method comprising the following steps:

bringing the stent to its location in the body of the patient, whilst the tubular element is in the compressed condition and the distal and proximal flange feet are in the extended position;

allowing the tubular element to expand whilst maintaining the distal and proximal flange feet in the extended position; and

after the tubular element has been expanded, releasing the distal and proximal flange feet from the extended position to pivot into the radial position.

12. A method for removing or repositioning an expanded stent, comprising the following steps:

providing an assembly according to claim 9;

allowing the stent to expand by displacing the first and second plurality of fingers from the first to the second position;

following said expansion of the stent, compressing the stent by displacing the first and second plurality of fingers; and

subsequently removing the stent from the body of the patient or repositioning the stent in the body of the patient.

13. A stent, comprising:

a tubular element with an open grid structure which is radially expandable from a compressed condition to an expanded condition, and which has a proximal and distal end; and

a ring structure provided around the tubular element,

wherein the tubular element and ring structure are interconnected,

wherein the ring structure is a variable-diameter ring structure with distal and proximal flange feet,

wherein the ring structure has an axial direction and a radial direction disposed transverse to the axial direction,

wherein the ring structure is constructed from a series of elongated closed loops lying next to one another which, in each case, at the midpoint of the longitudinal sides of the loops, are attached laterally to one another via a junction to form the ring structure, in such a way that a) an imaginary center line through all junctions forms a closed ring and divides each loop into a distal flange foot of said distal flange feet and a proximal flange foot of said proximal flange feet, and b) the ring structure is expandable,

wherein the distal flange feet and the proximal flange feet each have a fixed end arranged at the imaginary center line and a free end pointing away from the imaginary center line,

wherein the distal and proximal flange feet have a radial position, in which the free ends of the flange feet point in the radial direction,

wherein the distal and proximal flange feet have an extended position, in which the distal and proximal flange feet extend in the axial direction,

wherein the distal flange feet and proximal flange feet lie in a longitudinal direction of the tubular element when the tubular element is in the compressed condition and the distal and proximal flange feet are in the extended position,

wherein the distal and proximal flange feet, when in the extended position, are under a pre-tension, which, upon release, bends the distal and proximal flange feet from the extended to the radial position,

wherein, in the extended position, the free ends of the distal flange feet point in the distal direction whilst the free ends of the proximal flange feet point in the proximal direction such that, after the distal and proximal flange feet have bent from the extended position to the radial position, the distal and proximal flange feet interact to clamp surrounding tissue between the distal and proximal flange feet, and

wherein the proximal flange feet, at the fixed ends of the proximal flange feet, have a concave-curved part including a hollow side facing toward the distal flange feet, and provided in the hollow side of the concave-curved part is a filling which is configured to increase the clamping force with which the distal and proximal flange feet clamp the tissue in situ when the distal and proximal flange feet are in the radial position.

14. The stent according to claim 13, wherein the tubular element and the ring structure are formed of a single piece of material.

15. The stent according to claim 13, wherein the tubular element and the ring structure are separate components, which are subsequently interconnected.

16. The stent according to claim 15, wherein the tubular element and the ring structure are interconnected by welds.

17. The stent according to claim 15, wherein the tubular element and the ring structure are interconnected by sutures.

18. The stent according to claim 15, wherein one or more of said junctions are provided with one or more radial bores.

19. The stent according to claim 13, wherein the ring structure is formed of a memory material.

20. The stent according to claim 19, wherein the memory material is a memory metal.

21. The stent according to claim 13,

wherein the ring structure is expandable from a first condition to a second condition, and

wherein the ring structure, when in the first condition, is under a radial pre-tension, which, upon release, causes the ring structure to expand in the direction of the second condition.

22. The stent according to claim 13, wherein the distal flange feet, when in the radial position, show a bulge facing towards the proximal flange feet.

23. The stent according to claim 22, wherein the bulges are provided in halves of the distal flange feet adjacent to the junction.

24. The stent according to claim 13, wherein the proximal flange feet, when in the radial position, show a bulge facing towards the distal flange feet.

25. The stent according to claim 24, wherein the bulges are provided in halves of the proximal flange feet adjacent to the junction.

26. The stent according to claim 13, wherein the distal flange feet, at the fixed ends of the distal flange feet, have a concave-curved part including a hollow side facing toward the proximal flange feet, and provided in the hollow side of the concave-curved part is a filling which is configured to increase the clamping force with which the distal and proximal flange feet clamp the tissue in situ when the distal and proximal flange feet are in the radial position.

27. The stent according to claim 13, wherein the ring structure is formed of a memory material.

28. The stent according to claim 13, wherein the stent further comprises a heart valve provided in the tubular element.

29. The stent according to claim 13, wherein the fillings of the separate proximal flange feet have, in relation to one another, an unequal shape and/or length and/or width and/or consistency and/or material properties.

30. The stent according to claim 13, wherein the fillings of the separate proximal flange feet extend beyond the circumference of the respective flange feet and/or in a lateral and/or radial direction therefrom.

31. The stent according to claim 13, wherein the fillings of the separate proximal flange feet are interconnected in such a way that a continuity arises between all or a number of fillings of the proximal flange feet.

32. The stent according to claim 13, wherein the fixed ends of the distal flange feet are located at a distance from the distal end of the tubular element whilst the fixed ends of the proximal flange feet are located at a distance from the proximal end of the tubular element.

33. The stent according to claim 13, wherein the fillings of the proximal flange feet are made from a material other than the material from which the tubular element, the distal flange feet and the proximal flange feet are made.

34. The stent according to claim 13, wherein, viewed in the radial direction and radial position, the concave-curved part of the proximal flange feet, on a side of the concave curved part facing towards the free ends of the proximal flange feet, changes to a straight part.

35. The stent according to claim 13, wherein the separate proximal flange feet have an unequal shape and/or length and/or width in relation to one another, and/or angle in relation to the longitudinal direction, and/or fillings.

36. A method for implanting a stent according to claim 13, the method comprising the following steps:

bringing the stent to its location in the body of the patient, whilst the tubular element is in the compressed condition and the distal and proximal flange feet are in the extended position;

allowing the tubular element to expand whilst maintaining the distal and proximal flange feet in the extended position; and

after the tubular element has been expanded, releasing the distal and proximal flange feet from the extended position to pivot into the radial position.