Medical devices incorporating SIM alloy elements

• US 5,190,546 A
• Filed: 04/09/1991
• Issued: 03/02/1993
• Est. Priority Date: 10/14/1983
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Raychem Corporation (TE Connectivity Limited)
• Inventors: Jervis, James E.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): ROONEY, KEVIN
• Application Number:
  US07/682,243
• Time in Patent Office: 693 Days
• Field of Search: 606/60, 606/62, 606/67, 606/68, 606/69-76, 606/78, 606/108, 128/833
• 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
• 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 from 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 method of forming an attachment to a bone, which comprises positioning in an aperture in the bone an element formed at least partially from a shape memory alloy which displays stress induced martensite behavior at body temperature, the element being so positioned that it is deformed by the walls of the aperture by the formation of stress-induced martensite, and thereby exerts a force outwardly on the walls of the aperture.

2. A method as claimed in claim 1, in which the aperture is formed before the element is positioned.

3. The method of claim 1 wherein the step of positioning takes place at a temperature greater than the A_S of the alloy.

4. The method of claim 1 wherein substantially all of the formation of martensite results from deformation of the element, and not from any change in temperature of the element.

5. A method for installing a bone attachment into a bone of a mammalian body such that the device is substantially at body temperature, the method comprising the steps of:

(a) providing a bone attachment device at least partly formed from a pseudoelastic shape-memory alloy, wherein the shape-memory alloy can display reversible stress-induced martensite at about body temperature such that the shape-memory alloy 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 stressed-induced martensitic state and (ii) a different unstressed shape when the allow is in its austenitic state;

(b) deforming the bone attachment device with a tool at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the bone attachment device in its deformed shape;

(c) inserting and positioning the bone attachment device into a channel in the bone at a temperature greater than the As of the alloy while the bone attachment remains in its deformed shape; and

(d) while maintaining the temperature of the bone attachment device above the As of the alloy, releasing the bone attachment device from the tool so that at least a portion of the alloy transforms from its stress-induced martensitic state so that the bone attachment device transforms from its deformed shape toward its unstressed shape to fill the bone channel and exert a constant force, wherein substantially all of the transformation occurs from releasing the bone attachment device from the tool and not from any change in temperature of the bone attachment device or the tool.

6. The method of claim 5 wherein the bone attachment device is a marrow nail.

7. The method of claim 5 or 6 comprising the additional steps, after step (d), of (e) deforming the device with the tool at a temperature greater than the As of alloy so that at least a portion of the alloy transforms from its austenitic state so that the bone attachment device transforms into its deformed shape;

and (f) withdrawing the deformed bone attachment device from the bone without changing the temperature of the device.

8. The method of claim 5 wherein the bone attachment device is a bone staple.

9. A method for installing an implant into a bone in a mammalian body comprising the steps of:

(a) drilling a channel in the bone;

(b) selecting a bone implant comprised of 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 bone implant having (i) an insertable shape suitable for insertion into the channel when the alloy is in its stress-induced martensitic state and (ii) a second different shape when the alloy is in its austenitic state, the bone implant being in its second shape; and

(c) inserting the bone implant into the channel and stressing the bone implant so that the alloy transforms toward its stress-induced martensitic state and the bone implant transforms to its insertable shape.

10. The method of claim 9 wherein the bone implant is inserted into the channel and stressed at a temperature greater than the A_S of the alloy.

11. The method of claim 9 wherein substantially all of the transformation of the bone implant to its insertable shape occurs from inserting and stressing the bone implant, and not from any change in temperature of the bone implant.

12. The method of claim 9 wherein the bone implant that is selected is a marrow nail.

13. The method of claim 9 comprising the additional step, after step (c), of:

(d) causing the stress on the implant to be released so that the alloy transforms toward its austenitic state and the implant transforms toward its second shape.

14. The method of claim 9 comprising the additional step, after step (c), of:

(d) causing the stress on the implant to be released so that the implant exerts constant force in the channel.

15. The method of claim 13 or 14 including the additional step, after step (d), of stressing the implant so that the alloy transforms toward its stress-induced martensitic state and the implant transforms toward its insertable shape, and thereafter withdrawing the installed implant from the channel.

16. The method of claim 15 wherein the implant is a marrow nail.

39. The method of claim 9 wherein the step of stressing of the bone implant is performed before placement of the bone implant into the channel in the bone.

17. A bone implant sized for insertion into a channel in a bone in a mammalian body, the bone implant being comprised of 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 bone implant having (i) an insertable shape for insertion into the bone when the alloy is in its stress-induced martensitic state and (ii) a second, different, non-insertable shape when the alloy is in its austenitic state.

18. The bone implant of claim 17 wherein the bone implant is a nail.

19. The bone implant of claim 18 wherein the nail has a tine.

20. A method for holding onto a bone in a mammalian body comprising the steps of:

(a) drilling a hole into the bone;

(b) selecting a bone-holding device comprised of 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 device having (i) a deformed 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 bone-holding device being in its unstressed shape; and

(c) inserting the device into the hole and deforming the device to its deformed shape so that the alloy transforms toward its stress-induced martensitic state.

21. The method of claim 20 wherein the device is a bone staple.

22. The method of claim 20 wherein the step of selecting comprises selecting a device having a tine.

23. The method of claim 20 wherein the step of inserting the device and deforming the device takes place at a temperature greater than the A_S of the alloy.

24. The method of claim 20 wherein substantially all of the transformation of the alloy results from inserting the device and deforming the device, and not from any change in temperature of the device.

25. The method of claim 20 wherein the bone holding device is a bone nail.

26. The method of claim 25 wherein the nail has a tine.

40. The method of claim 20 wherein the step of deforming the device is performed before the device is inserted into the hole.

27. A method for removing from a mammalian body a medical device comprising a memory alloy element at least partly formed 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 device having (i) a removable shape when the alloy is in its stress-induced martensitic state and (ii) a different non-removable shape when the alloy is in its austenitic state, the device being positioned in a mammalian body and being in its non-removable shape, the method comprising the steps of:

(a) stressing the device so that the alloy transforms toward its stress-induced martensitic state and the device transforms to its removable shape, without changing the temperature of the device; and

(b) withdrawing the transformed device from the mammalian body.

28. The method of claim 27 wherein both steps (a) and (b) take place at a temperature greater than the A_S of the alloy.

29. The method of claim 27 wherein the medical device is a bone implant.

30. The method of claim 29 wherein the medical device is a marrow nail.

31. The method of claim 29 wherein the medical device is a bone staple.

32. The method of claim 27 wherein the medical device is an intrauterine contraceptive device.

33. The method of claim 27 wherein the medical device is a filter for a blood vessel.

34. The method of claim 27 wherein the medical device is tubular.

35. The method of claim 34 wherein the medical device is a catheter.

36. The method of claim 35 wherein the medical device is tracheal catheter.

37. An article formed at least partially from a shape memory alloy which displays stress-induced martensite behavior at human body temperature, the article adapted to be positioned in an aperture in a bone of a human body so that the article is deformed by the walls of the aperture by the formation of stress-induced martensite, and thereby exerts a force outwardly on the wall of the aperture.

38. A bone plate for compressing two ends of a fractured mammalian bone together, the bone plate being 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 bone plate being (i) elongated when the alloy is in its stress-induced martensitic state and (ii) shortened when the alloy is in its austenitic state;

the bone plate being provided with means for securing the bone plate to both ends of a fractured bone.