Method of inserting medical devices incorporating SIM alloy elements

• US 5,067,957 A
• Filed: 09/27/1988
• Issued: 11/26/1991
• Est. Priority Date: 10/14/1983
• Status: Expired due to Term

• 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): ROONEY, KEVIN
• Application Number:
  US07/252,019
• Time in Patent Office: 1,155 Days
• Field of Search: 623/2, 606/60, 606/67, 606/69-76, 606/78, 606/108, 128/833
• US Class Current: 606/108
• 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: A61C 2201/007 using shape memory effect
• CPC Class Codes: A61C 7/12 Brackets; Arch wires; Combinations thereof; Accessories therefor
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 27/04 Metals or alloys
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: Y10S 606/911 Memory material

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 medical treatment of a mammal which comprises the steps of:

(a) providing a device comprising an element which comprises a shape memory alloy which displays stress induced martensite behavior at body temperature of the mammal, the element being restrained in a deformed configuration, the restraining means stressing the element thereby inducing stress induced martensite in the alloy;

(b) positioning the device so that the shape memory alloy element is within a mammalian body or in such proximity to a mammalian body that the element and the restraining means are substantially at body temperature; and

(c) at least partially removing the restraining means from the element thereby transforming the element from the deformed configuration, the transformation occurring with the element and the restraining means being substantially at body temperature.

2. A method as claimed in claim 1, in which transformation of the shape memory alloy element causes one or more parts of the body in contact with the element to be displaced.

3. The method of claim 1 wherein the step of removing the restraining means transforms the element without change in state of the restraining means.

4. The method of claim 1 wherein the shape memory alloy element is a catheter.

38. The invention of claim 1, 5, 10, 14, 16, or 30 wherein the memory alloy element exerts essentially constant stress during its transformation.

5. A method for installing a medical device within or proximate to a mammalian body such that the device is substantially at body temperature, the method comprising the steps of:

(a) providing a medical device comprising a memory alloy element 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 stress-induced martensitic state and (ii) a different unstressed shape;

(b) engaging the memory alloy element with a restraining means at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the memory alloy element in its deformed shape and subsequently positioning the medical device within or proximate to the body at a temperature greater than the As of the alloy while the memory alloy element remains in its deformed shape; and

(c) while maintaining the temperature of the memory alloy element above the As of the alloy, disengaging the restraining means from the memory alloy element so that at least a portion of the alloy transforms from its stress-induced martensitic state so that the memory alloy element spontaneously transforms from its deformed shape toward its unstressed shape, wherein substantially all of the transformation occurs from removing the restraining means and not from any change in temperature of the device or the restraining means.

6. The method of claim 5 wherein the step of engaging comprises directly contacting the memory alloy element with the restraining means, and the step of disengaging comprises separating the restraining means from the memory alloy element.

7. The method of claim 5 wherein the step of disengaging results in at least a portion of the alloy transforming from its stress-induced martensitic state to its austenitic state.

8. The method of claim 7 including the additional step after step (c) of re-engaging the memory alloy element with the restraining means so that the memory alloy element transforms toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state, wherein the step of re-engaging occurs while maintaining the temperature of the device above the As of the alloy.

9. The method of claim 7 wherein when the memory alloy element is in its unstressed shape, the shape-memory alloy is in its austenitic state, and the step of disengaging causes the memory alloy element to transform completely to its unstressed shape.

10. A method for installing a medical device within or proximate to a mammalian body such that the device is substantially at body temperature, the method comprising the steps of:

(a) providing a medical device comprising a memory alloy element 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 stress-induced martensitic state and (ii) a different unstressed shape;

(b) placing the memory alloy element within a hollow restraining member at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the memory alloy element in its deformed shape, and positioning the medical device within or proximate to the body at a temperature greater than the As of the alloy while the memory alloy element remains in its deformed shape; and

(c) while maintaining the temperature of the memory alloy element above the As of the alloy, causing relative movement between the hollow restraining member and the memory alloy element so that at least a portion of the alloy transforms from its stress-induced martensitic state so that the memory alloy element spontaneously transforms from its deformed shape toward its unstressed shape, wherein substantially all of the transformation occurs from the relative movement and not from any change in temperature of the device or the restraining means.

11. The method of claim 10 wherein the hollow member is a tube and the memory alloy element is axially slidable within the tube, and wherein the step of causing relative movement comprises causing relative axial movement between the tube and the memory alloy element so that at least a portion of the memory alloy element extends out of the tube and thereby spontaneously transforms toward its unstressed shape.

12. The method of claim 10 wherein the step of causing relative movement comprises completely separating the hollow member from the memory alloy element, and wherein at least a portion of the alloy transforms from its stress-induced martensitic state to its austenitic state.

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

40. The method of claim 10 or 14 wherein the step of causing relative movement results in at least a portion of the alloy transforming from its stress-induced martensitic state to its austenitic state.

41. The method of claim 40 wherein the step of causing relative movement comprises disengaging the restraining means from the memory alloy element, the method including the additional step after step (c) of directly contacting the memory alloy element with the restraining means so that the memory alloy element transforms toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state, wherein the step of directly contacting occurs while maintaining the temperature of the device above the As of the alloy.

14. A method for installing a medical device within or proximate to a mammalian body such that the device is substantially at body temperature, the method comprising the steps of:

(a) providing a medical device comprising a hollow memory alloy element 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 stress-induced martensitic state and (ii) a different unstressed shape;

(b) placing a restraining means in the hollow memory alloy element at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the memory alloy element in its deformed shape and positioning the medical device within or proximate to the body at a temperature greater than the As of the alloy while the hollow memory alloy element remains in its deformed shape; and

(c) while maintaining the temperature of the memory alloy element above the As of the alloy, causing relative movement between the restraining means and the memory alloy element so that at least a portion of the alloy transforms from its stress-induced martensitic state so that the memory alloy element spontaneously transforms from its deformed shape toward its unstressed shape, wherein substantially all of the transformation occurs from the relative movement and not from any change in temperature of the device or the restraining means.

15. The method of claim 14 wherein the hollow member is a tube and the restraining means is axially slidable within the tube, and wherein the step of causing relative movement comprises causing relative axial movement between the memory alloy element and the restraining means so that at least a portion of the memory alloy element extends beyond the restraining means and thereby spontaneously transforms toward its unstressed shape.

37. The invention of claim 5, 14, or 16 wherein the transformation of the alloy occurs without any change in the state of the restraining means.

16. A method for inserting a medical device into a mammalian body comprising the steps of:

(a) providing a medical device comprising (i) a restraining means and (ii) a memory alloy element at least partly formed from a pseudoelastic shape-memory alloy, wherein the alloy can display reversible stress-induced martensite at about human body temperature such that the 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 stress-induced martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic state;

(b) directly contacting the memory alloy element with the restraining means at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and deforming the memory alloy element into its deformed shape; and

(c) after step (b), while maintaining the temperature of the device above the As of the alloy, inserting the memory alloy element into the human body and at least partly separating the restraining means from the memory alloy element so that at least a portion of the alloy transforms from its stress-induced martensitic state to its austenitic state so that the memory alloy element spontaneously transforms from its deformed shape toward its unstressed shape, wherein substantially all of the transformation occurs from disengaging the restraining means and not from any change in temperature of the device or the restraining means.

17. The method of claim 16 including the additional step after step (c) of re-engaging the memory alloy element with the restraining means so that the memory alloy element transforms toward its deformed shape by reversion of at least a portion of the alloy from its austenitic state to its stress-induced martensitic state, wherein the step of re-engaging occurs while maintaining the temperature of the device above the As of the alloy.

18. A method for inserting a catheter into a mammalian body comprising the steps of:

(a) providing a catheter at least partly formed from a pseudoelastic shape-memory alloy, wherein the alloy can display reversible stress-induced martensite at about body temperature such that the alloy has a stress-induced martensitic state and an austenitic state, the catheter having (i) an easy insertion shape when the alloy is in its stressed-induced martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic state;

(b) stressing the catheter with a restraint at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the memory alloy element in its deformed easy insertion shape;

(c) after step (b), inserting the catheter into the mammalian body at a temperature greater than the As of the alloy; and

(d) after step (c), at least partly disengaging the restraint from the catheter so that at least a portion of the alloy transforms from its stress-induced martensitic state to its austenitic state so that the catheter spontaneously transforms from its easy insertion shape to its unstressed shape, wherein substantially all of the transformation occurs from disengaging the restraint and not from any change in temperature of the catheter or the restraint.

19. The method of claim 18 including the additional steps after step (d) of (e) stressing the catheter with the restraint at a temperature greater than the As of the alloy for placing the alloy in its stressed-induced martensitic state and the memory alloy element in its easily inserted shape, and (f) removing the easily inserted catheter from the body.

20. The method of claim 18 wherein a catheter is stressed with an internal restraint.

21. The method of claim 18 wherein the catheter is a cannula.

22. The method of claim 18 wherein the step of disengaging comprises removing the restraint from the catheter.

23. The method of claim 18 wherein the restraint is a pin axially slidable within the catheter.

24. The invention of claim 18 wherein the transformation of the alloy occurs without any changes in state of the restraint.

39. The invention of claim 18 or 25 wherein the catheter exerts essentially constant stress during its transformation.

25. A method for inserting a catheter into a mammalian body such that the catheter is substantially at body temperature, the method comprising the steps of:

(a) providing a medical device comprising a catheter at least partly formed from a pseudoelastic shape-memory alloy, wherein the alloy can display reversible stress-induced martensite at about body temperature such that the catheter has a stress-induced martensitic state and an austenitic state, the catheter being (i) straightened when the alloy is in its stress-induced martensitic state and (ii) curved when the alloy is in its austenitic state;

(b) sliding a straight pin down the catheter axis at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and straightening the catheter; and

(c) after step (b), while maintaining the temperature of the catheter above As, inserting the catheter into the body and withdrawing the pin from the catheter so that at least a portion of the alloy transforms from its stress-induced martensitic state to its austenitic state so that the catheter spontaneously transforms from being straightened to being curved, wherein substantially all of the transformation occurs from withdrawing the pin from the catheter and not from any change in temperature of the catheter or the pin.

26. The invention of claim 25 wherein the transformation of the alloy occurs without any change in the state of the pin.

27. The method of claim 25 wherein the catheter is a tracheal puncture catheter, and the step of inserting the catheter into the body comprises inserting the catheter into the trachea.

28. The method of claim 25 or 27 comprising the additional steps, after step (c), of (d) inserting the pin into the catheter so that at least a portion of the alloy transforms from its austenitic state to its stress-induced martensitic state so that the catheter spontaneously transforms from being curved to being straight for permitting easy withdrawal of the catheter from the body;

and (e) withdrawing the straightened catheter from the body.

29. The method of claim 25 wherein the step of withdrawing the pin comprises removing the pin from the catheter.

30. A method for inserting a medical device into a mammalian body such that the device is substantially at body temperature, the method comprising:

(a) providing a medical device comprising a memory alloy element at least partly formed from a pseudoelastic shape-memory alloy, wherein the shape-memory alloy displays 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 straightened shape when the alloy is in its stressed-induced martensitic state and (ii) a different unstressed shape when the alloy is in its austenitic state;

(b) placing the memory alloy element into a hollow placement device at a temperature greater than the As of the alloy for placing the alloy in its stress-induced martensitic state and the memory alloy element in its straightened shape; and

(c) while maintaining the temperature of the memory alloy element above the As of the alloy, extruding the memory alloy element from the placement device into the body so that at least a portion of the alloy transforms from its stress-induced martensitic state so that the memory alloy element spontaneously transforms from being straightened to being in its unstressed shape, wherein substantially all of the transformation occurs from disengaging the restraining means and not from any change in temperature of the device or the placement device.

31. The invention of claim 30 wherein the transformation occurs without any change in the state of the placement device.

32. The method of claim 30 wherein the memory alloy element is an intrauterine contraceptive device, and the step of extruding the memory alloy element from the placement device into the body comprises extruding the device into the uterus.

33. The method of claims 30 or 32 including the additional steps, after step (c), of (d) withdrawing the memory alloy element into the placement device for placing the alloy in its stress-induced martensitic state and thus straightening the memory alloy element;

and (e) withdrawing the placement device and the straightened memory alloy element from the body.

34. The method of claim 30 wherein the memory alloy element is a stent graft, and the unstressed shape of the stent graft is a tubular coiled shape, and the step of extruding the memory alloy element into the body comprises extruding it into a vessel of the body.

35. The method of claim 30 wherein the memory alloy element is a filter for trapping blood clots, and the step of extruding the memory alloy element into the body comprises extruding the filter into the vena cava.

36. The method of claim 30, 32, 34, or 35 wherein the step of extruding comprises completely removing the memory alloy element from the placement device.