Medical devices incorporating SIM alloy elements

• US 5,597,378 A
• Filed: 10/02/1992
• Issued: 01/28/1997
• Est. Priority Date: 10/14/1983
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Raychem Limited (TE Connectivity Limited)
• Inventors: Jervis, James E.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): KENEALY, DAVID
• Application Number:
  US07/956,653
• Time in Patent Office: 1,579 Days
• Field of Search: 606/78, 606/76, 606/77, 623/11, 604/281, 604/280, 604/282, 604/283
• US Class Current: 606/78
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• 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 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61C 2201/007 using shape memory effect
• CPC Class Codes: A61C 7/12 Brackets; Arch wires; Combinations thereof; Accessories therefor
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 6/14 intra-uterine type
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 31/022 Metals or alloys

Abstract

Medical devices which are currently proposed to use elements made form shape memory alloys may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.

Claims

1. A medical device which comprises:

(a) an element for use within a human body or in such proximity to a human body that the device is substantially at human body temperature, the element comprising a shape memory alloy which displays a stress-induced martensite behavior at body temperature; and

(b) a restraint holding the shape memory alloy element in a deformed configuration at a temperature less than the body temperature of the human for positioning the shape memory alloy element within or in proximity to the human body in its deformed configuration, the deformation occurring through the formation of stress-induced martensite;

wherein the shape memory alloy element is sufficiently deformed that when the shape memory alloy element is at human body temperature removal of the restraint from the shape memory alloy element, without change in temperature of the device, releases at least a portion of the shape memory alloy element from its deformed configuration.

2. A device as claimed in claim 1, in which the restraint is hollow, and the shape memory alloy element is positioned at least partially within the restraint.

3. A device as claimed in claim 2, in which the restraint is a catheter.

4. A device as claimed in claim 2, in which the shape memory alloy element is an intrauterine contraceptive device.

5. A device as claimed in claim 2, in which the shape memory alloy element is a filter for a blood vessel.

6. A device as claimed in claim 1, in which the shape memory alloy element is tubular, and the restraint is positioned within the shape memory alloy element to deform it.

7. A device as claimed in claim 2, in which the shape memory alloy element has a transverse dimension and a longitudinal dimension, and wherein the shape memory alloy element is deformed by its transverse dimension being reduced, and wherein the restraint prevents transverse expansion of the element.

8. The device of claim 1, wherein the shape memory alloy element is sufficiently deformed that removal of the restraint from the shape memory alloy releases at least a portion of the shape memory alloy element from its deformed configuration without change in state of the restraint.

9. A medical device suitable for placement within or proximate to a mammalian body for treatment of the mammalian body, the device comprising:

(a) a memory alloy element formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensitic state and an austenitic state, the memory alloy element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape; and

(b) restraining means engaging and stressing the memory alloy element at a temperature less than the body temperature of a human and greater than the As of the alloy for positioning the memory alloy element within or in proximity to the mammalian body while the memory alloy element is in its deformed shape;

wherein the alloy is selected so that removal of the restraining means from the memory alloy element at a temperature greater than the As of the alloy when the device is placed within or proximate to the human body, transforms at least a portion of the alloy from its stress-induced martensitic state so that the memory alloy element transforms from its deformed shape toward its unstressed shape, without any change in temperature of the restraining means or the memory alloy element being required for the transformation of the alloy.

19. The invention of claim 9 wherein the transformation of the alloy occurs without any change in the state of the restraining means.

24. The medical device of claim 9 wherein the removal of the restraining means from the memory alloy element causes at least a portion of the alloy to transform to its austenitic state.

26. The device of claim 24 wherein the alloy is selected so that engaging the restraining means with the memory alloy element after removal results in the memory alloy element transforming toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state.

10. A medical device for treatment of a mammalian body, the device comprising:

(a) a memory alloy element formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human temperature such that it has a stress-induced martensitic state and an austenitic state, the memory alloy element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape; and

(b) a hollow restraining member with the memory alloy element being within the restraining member, the restraining member engaging and stressing the memory alloy element at a temperature less than the body temperature of the human and greater than the As of the alloy for positioning the memory alloy element within or in proximity to the mammalian body while the memory alloy element is in its deformed shape;

wherein the restraining member and the memory alloy element are movable relative to each other to transform at least a portion of the alloy from its stress-induced martensitic state at a temperature greater than the As of the alloy so that the memory alloy element transforms from its deformed shape toward its unstressed shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the restraining member or the memory alloy element.

11. The medical device of claim 10 wherein the restraining member is a tube and the memory alloy element is axially slidable within the tube, and wherein the memory alloy element is sufficiently long that relative axial movement between the tube and the memory alloy element extends at least a portion of the memory alloy element beyond the tube and thereby transforms the memory alloy element toward its austenitic state.

12. The device of claim 11 wherein the memory alloy element can be extruded completely out of the tube for deployment in the mammalian body.

20. The invention of claim 10, 13 or 15 wherein the transformation of the alloy occurs without any change in the state of the restraining member.

22. The invention of claim 9, 10 or 13 wherein the memory alloy element exerts constant stress during its transformation.

25. The medical device of claim 10, 13, 15 wherein relative movement of the restraining member and the memory alloy element causes at least a portion of the alloy to transform to its austenitic state.

27. The device of claim 25 wherein (i) the restraining member can be completely disengaged and separated from the memory alloy element, and (ii) the alloy is selected so that engaging the restraining member with the memory alloy element after separation results in the memory alloy element transforming towards its deformed shape by reversion to its stress-induced martensitic state.

13. A medical device for treatment of a mammalian body, the device comprising (i) a restraining member and (ii) a hollow memory alloy element formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about body temperature such that it has a stress-induced martensitic state and an austenitic state, the memory alloy element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape;

the restraining member being within the hollow memory alloy element and engaging and stressing the memory alloy element at a temperature greater than the As of the alloy so that the memory alloy element is in its deformed shape;

wherein the restraining member and the memory alloy element are movable relative to each other to transform at least a portion of the alloy from its stress-induced martensitic state at a temperature greater than the As of the alloy so that the memory alloy element transforms from its deformed shape toward its unstressed shape, and wherein the alloy is selected that the transformation can occur without any change in temperature of the restraining member or the memory alloy element.

14. The device of claim 13 wherein the memory alloy element is a tube and the restraining member is axially slidable within the tube, and wherein the tube is sufficiently long that relative axial movement between the tube and the restraining members extends at least a portion of the tube beyond the restraining means and thereby transforms the tube toward its austenitic shape.

15. A medical device for insertion into a human body, the device comprising (i) a restraining member and (ii) a hollow catheter formed at least party from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state and an austenitic state, the catheter having (i) an easily inserted shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic state;

the restraining member engaging and stressing the catheter at a temperature greater than the As of the alloy so that the catheter is in its easily inserted shape so that the catheter can be inserted into the mammalian body;

wherein disengagement of the restraining member from the catheter at a temperature greater than the As of the alloy transforms at least a portion of the alloy from its stress-induced martensitic state to its austenitic state so that the catheter transforms from its easily inserted shape toward its unstressed shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the restraining member or the catheter.

16. The medical device of claim 15 wherein the catheter is a cannula.

23. The invention of claim 15 or 17 wherein the catheter exerts constant stress during its transformation.

28. The device of claim 15 wherein (i) the restraining member can be completely disengaged and separated from the catheter, and (ii) the alloy is selected so that reengaging the restraining member with the catheter after separation results in the catheter transforming toward its easily inserted shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state.

31. The medical device of claim 15 wherein the restraint externally engages the catheter.

32. The medical device of claim 15 wherein the restraint internally engages the catheter.

17. A medical device for insertion into a human body, the device comprising (i) a straight pin and (ii) a catheter formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state and an austenitic state, the catheter having (i) a straight shape when the alloy is in its stress-induced martensitic state and (ii) a curved unstressed shape when the alloy is in its austenitic state;

the straight pin engaging and stressing the inside of the catheter at a temperature greater than the As of the alloy so that the catheter is in its straight shape;

wherein withdrawal of the pin from the catheter at a temperature greater than the As of the alloy transforms at least a portion of the alloy from its stress-induced martensitic state to its austenitic state so that the catheter transforms from its straight shape to its curved shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the pin or the catheter.

18. The medical device of claim 17 wherein the catheter is a tracheal insertion catheter.

21. The invention of claim 17 wherein the transformation of the alloy occurs without any change in the state of the pin.

29. The device of claim 17 wherein (i) the pin can be completely disengaged and separated from the catheter, and (ii) the alloy is selected so that reengaging the restraining means with the memory alloy element after separation results in the catheter transforming toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state.

33. A medical device suitable for placement within or proximate to a mammalian body for treatment of the mammalian body, the device comprising (i) a restraint, and (ii) an element formed at least partly from a pseudoelastic shape-memory alloy,

the alloy displaying reversible stress-induced martensite by virtue of being above its A_s and above its M_s and below its M_d at about body temperature;

such that it has a stress-induced martensitic state and an austenitic state, the element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape;

wherein the restraint is (i) stressing the element at a temperature less than the body temperature of the mammal for placement of the element in its deformed shape in or in proximity to the mammalian body and (ii) is capable of being at least partially removed from the element while the device is within or proximate to the body at the body temperature and the element is therefore at an operating temperature greater than the A_s and M_s and below the M_d of the alloy,

such removal of the restraint causing at least a portion of the alloy to transform from its stress-induced martensitic state to its austenitic state so that the element spontaneously transforms from its deformed shape toward its unstressed shape,

and such transformation can occur without a change in temperature of the restraint or of the element from the operating temperature.

34. A medical device for treatment of a human body, the device comprising:

(a) a memory alloy element formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state and an austenitic state, the memory alloy element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape; and

(b) a hollow tubular restraining member with the memory alloy element being within the restraining member, the restraining member engaging and stressing the memory alloy element at a temperature greater than the As of the alloy so that the memory alloy element is in its deformed shape;

wherein the memory alloy element is axially slidable within the tube, and wherein the memory alloy element can be extruded completely out of the tube for deployment in the mammalian body to transform at least a portion of the alloy from its stress-induced martensitic state towards its austenitic state at a temperature greater than the As of the alloy so that the memory alloy element transforms from its deformed shape toward its unstressed shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the restraining member or the memory alloy element.

39. The invention of claim 34, 36 or 37 wherein the transformation of the alloy occurs without any change in the state of the restraining member.

35. A medical device which comprises:

(a) a tubular element for use within a human body or in such proximity to a human body that the device is substantially at human body temperature, the tubular element comprising a shape memory alloy which displays stress-induced martensite behavior at body temperature; and

(b) a restraint within the tubular element holding and deforming the tubular shape memory alloy element in a deformed configuration to allow it to be positioned within or in proximity to a human body, the deformation occurring through the formation of stress-induced martensite;

wherein the tubular element is sufficiently deformed that removal of the restraint from the tubular shape memory alloy element, without change in temperature of the device, releases at least a portion of the tubular element from its deformed configuration.

36. A medical device for treatment of a human body, the device comprising (i) a restraining member and (ii) a hollow memory alloy element formed at least partly from a pseudoelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state and an austenitic state, the memory alloy element having (i) a deformed shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape;

the restraining member being within the hollow memory alloy element and engaging and stressing the memory alloy element at a temperature less than the body temperature of the human and greater than the As of the alloy for positioning the memory alloy element within or in proximity to the human body while the memory alloy element is in its deformed shape;

wherein the restraining member and the memory alloy element are movable relative to each other to transform at least a portion of the alloy from its stressed-induced martensitic state at a temperature greater than the As of the alloy so that the memory alloy element transforms from its deformed shape toward its unstressed shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the restraining member of the memory alloy element.

30. The device of claim 36 wherein (i) the placement device can be completely disengaged and separated from the catheter, and (ii) the alloy is selected so that reengaging the placement device with the catheter after separation results in the catheter transforming toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state.

37. The device of claim 36 wherein the memory alloy element is a tube and the restraining member is axially slidable within the tube, and wherein the tube is sufficiently long that relative axial movement between the tube and the restraining member extends at least a portion of the tube beyond the restraining member and thereby transforms the tube toward its austenitic shape.

38. A medical device for insertion into a human body, the device comprising (i) a restraining member and (ii) a hollow catheter formed at least partly from a pseudoelastic shape-memory allow, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state and an austenitic state, the catheter having (i) an easily inserted shape when the alloy is in its stress-induced martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic state;

the restraining member engaging and stressing the catheter at a temperature less than the body temperature of the human and greater than the As of the alloy so that the catheter is in its easily inserted shape for inserting the catheter into the human body; and

wherein disengagement of the restraining member from the catheter at a temperature greater than the As of the alloy transforms at least a portion of the alloy from it stress-induced martenistic state to its austenitic state so that the catheter transforms from its easily inserted shape toward its unstressed shape, and wherein the alloy is selected so that the transformation can occur without any change in temperature of the restraining member or the catheter.

40. The device of claim 38 wherein the device is adapted so that (i) the restraining member can be completely disengaged and separated from the catheter, and (ii) re-engaging the restraining member with the catheter after separation results in the catheter transforming toward its easily inserted shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state.