Expandable medical device with ductile hinges

• US 6,241,762 B1
• Filed: 10/29/1998
• Issued: 06/05/2001
• Est. Priority Date: 03/30/1998
• Status: Expired due to Term

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Shanley, John F.
• Primary Examiner(s): Millin, V.
• Assistant Examiner(s): Nguyen, Tram A.
• Application Number:
  US09/183,555
• Time in Patent Office: 950 Days
• Field of Search: 623/1, 623/11, 623/12, 623/1.11, 623/1.12, 623/1.15, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 623/1.27, 623/1.28, 623/1.3, 623/1.34, 606/108, 606/191, 606/194, 606/195
• US Class Current: 623/1.17
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An expandable tissue supporting device of the present invention employs ductile hinges at selected points in the expandable device. When expansion forces are applied to the device as a whole, the ductile hinges concentrate expansion stresses and strains in small well defined areas. The expandable medical device including ductile hinges provides the advantages of low expansion force requirements, relatively thick walls which are radio-opaque, improved crimping properties, high crush strength, reduced elastic recoil after implantation, and control of strain to a desired level. The expandable tissue supporting device includes a plurality of elongated beams arranged in a cylindrical device and connected together by a plurality of ductile hinges. Although many ductile hinge configurations are possible, the ductile hinges preferably have a substantially constant hinge cross sectional area which is smaller than a beam cross sectional area such that as the device is expanded from a first diameter to a second diameter, the ductile hinges experience plastic deformation while the beams are not plastically deformed.

Claims

1. An expandable medical device comprising:

a plurality of elongated beams, the plurality of elongated beams joined together to form a substantially cylindrical device which is expandable from a first diameter to a second diameter, the plurality of elongated beams each having a beam width in a circumferential direction; and

a plurality of ductile hinges connecting the plurality of beams together in the substantially cylindrical device, the ductile hinges having a hinge thickness and a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the hinge thickness and the hinge width is smaller than the beam width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the beams are not plastically deformed.

2. The expandable medical device according to claim 1, further comprising an abrupt transition between each of the elongated beams and each of the ductile hinges.

3. The expandable medical device according to claim 1, further comprising a plurality of axial slots between adjacent elongated beams and a plurality of circumferential slots, wherein the plurality of ductile hinges are each formed between an axial slot and a circumferential slot.

4. The expandable medical device according to claim 3, wherein the ductile hinges are formed at opposite ends of the circumferential slots.

5. The expandable medical device according to claim 1, wherein the ductile hinges are each in the shape of a curved prismatic beam.

6. The expandable medical device according to claim 1, wherein expansion of the substantially cylindrical device from the first diameter to the second diameter which is at least two times the first diameter results in substantially no axial contraction.

7. The expandable medical device according the claim 1, further comprising a geometric deflection limiting feature for limiting an amount of bending of the ductile hinges.

8. The expandable medical device according to claim 7, wherein the geometric deflection limiting feature is a V-shaped notch having side surfaces which contact each other when a maximum amount of bending is reached.

9. The expandable medical device according to claim 1, wherein the plurality of elongated beams extend substantially axially and a plurality of circumferential beams are each connected at first and second ends to one of the elongated beams by a ductile hinge.

10. The expandable medical device according to claim 1, wherein the hinge width is no greater than 60% of the hinge thickness.

11. The expandable medical device according to claim 1, wherein the hinge thickness is over 2 times larger than the hinge width.

12. The expandable medical device according to claim 1, wherein all of the ductile hinges have the same dimensions.

13. The expandable medical device according to claim 1, wherein the hinge width is at least 50% smaller than the beam width.

14. The expandable medical device according to claim 1, wherein the device is expandable by a balloon catheter pressurized by an inflation pressure of 1 to 5 atmospheres.

15. An expandable medical device comprising:

a plurality of elongated beams, the plurality of elongated beams joined together to form a substantially cylindrical device which is expandable from a first diameter to a second diameter, the plurality of elongated beams each having a beam width in a circumferential direction; and

a plurality of ductile hinges connecting the plurality of beams together in the substantially cylindrical device, the ductile hinges having a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the beam width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the beams are not plastically deformed, each of the ductile hinges being in the shape of a curved prismatic beam having first and second arcuate surfaces facing the same direction with the second arcuate surface being larger than the first arcuate surface, the curved prismatic beams being positioned such that during expansion tensile strain is distributed along the second arcuate surface of the curved prismatic beam.

16. An expandable medical device comprising:

a plurality of elongated beams, the plurality of elongated beams joined together to form a substantially cylindrical device which is expandable from a first diameter to a second diameter, the plurality of elongated beams each having a beam width in a circumferential direction; and

a plurality of ductile hinges connecting the plurality of beams together in the substantially cylindrical device, the ductile hinges having a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the beam width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the beams are not plastically deformed, the plurality of elongated beams being formed of wire and the plurality of ductile hinges being reduced diameter portions of the wire.

17. An expandable medical device comprising:

a cylindrical tube;

a plurality of axial slots formed in the cylindrical tube in a staggered arrangement to define a network of elongated struts, the elongated struts being axially displaced from adjacent struts and having a strut width in a circumferential direction; and

a plurality of ductile hinges formed between the elongated struts, the ductile hinges having a hinge thickness and a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the hinge thickness and the hinge width is smaller than the strut width such that as the device is expanded from a first diameter to a second diameter the ductile hinges experience plastic deformation while the struts are not plastically deformed, the ductile hinges allowing the cylindrical tube to be expanded from the first diameter to the second diameter by deformation of the ductile hinges, the ductile hinges being asymmetrically configured to reach a predetermined strain level upon a first percentage expansion and to reach the predetermined strain level upon a second percentage of compression, wherein the first percentage is larger than the second percentage.

18. The expandable medical device according to claim 17, wherein the hinge width is less than ⅔

the strut width.

19. The expandable medical device according to claim 18, wherein a transition between the cross sectional area of the struts and the cross sectional area of the ductile hinges is an abrupt transition which extends less than 10 percent of a length of a strut.

20. The expandable medical device according to claim 17, wherein the plurality of ductile hinges are curved prismatic beams having a convex side surface and a concave side surface.

21. The expandable medical device according to claim 17, wherein a ratio of a length of the ductile hinges to a length of the axial struts is 1:

6 or less.

22. The expandable medical device according to claim 17, further comprising a geometric deflection limiting feature for limiting an amount of bending of the ductile hinges.

23. The expandable medical device according to claim 17, wherein the ductile hinges are designed to deform plastically upon radial expansion or compression of the expandable medical device while the elongated struts experience no plastic deformation upon radial expansion or compression.

24. The expandable medical device according to claim 17, wherein the expandable medical device is formed of Nitinol, and the ductile hinges are designed to deform upon radial expansion or compression of the expandable medical device and can be returned to an original configuration by heating.

25. The expandable medical device according to claim 17, wherein the elongated struts include a beneficial agent for delivery to a patient.

26. An expandable medical device comprising:

a plurality of elongated beams having a substantially constant beam cross sectional area along a beam length and a beam width in a circumferential direction;

a plurality of ductile hinges connecting the plurality of beams together in a substantially cylindrical device which is expandable or compressible from a first diameter to a second diameter by plastic deformation of the ductile hinges, the ductile hinges having a hinge thickness and a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the hinge thickness and the hinge width is smaller than the beam width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the beams are not plastically deformed; and

a plurality of deflection limiting members positioned at a plurality of the ductile hinges to limit the deflection at the ductile hinges.

27. The expandable medical device according to claim 26, wherein the deflection limiting members include angled side walls on opposite sides of the ductile hinges which engage one another to limit deflection of the ductile hinges.

28. The expandable medical device according to claim 27, wherein the deflection limiting members are V-shaped notches.

29. An expandable medical device which is visible in x-ray and fluoroscope images, the device comprising:

a plurality of struts arranged to form an expandable cylindrical tube, the struts having a strut width in a circumferential direction; and

a plurality of ductile hinges connecting the plurality of struts, wherein the struts and ductile hinges have a thickness in a radial direction of the cylindrical tube of at least 0.003 inches (0.0762 mm), the ductile hinges having a hinge thickness and a substantially constant width in a circumferential dimension along a portion of a hinge length which is at least ⅓

a total hinge length, wherein the hinge width is smaller than the hinge thickness and the hinge width is smaller than the strut width such that as the device is expanded from a first diameter to a second diameter the ductile hinges experience plastic deformation while the struts are not plastically deformed.

30. The expandable medical device according to claim 29, wherein the device is formed of stainless steel.

31. The expandable medical device according to claim 29, wherein the thickness of the struts and ductile hinges is at least 0.005 inches (0.127 mm).