Steerable cannula

• US 5,345,937 A
• Filed: 07/28/1993
• Issued: 09/13/1994
• Est. Priority Date: 02/15/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Raychem Limited (TE Connectivity Limited)
• Inventors: Pyka, Walter R., Middleman, Lee M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/079,717
• Time in Patent Office: 412 Days
• Field of Search: 604/95, 604/96, 604/264, 604/280, 604/281, 604/164, 604/170, 606/108, 606/78, 128/657, 128/772, 128/45 M, 128/4
• US Class Current: 600/434
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A device suitable for insertion into a mammalian body comprises an elongated tube or cannula, an elastic member for bending the cannula, and a straightener preventing the elastic member from bending the cannula. The straightener and elastic member are capable of relative axial movement, so that the elastic straightener can be positioned to prevent or allow the elastic from bending the cannula. Preferably the elastic member is formed from a superelastic shape-memory alloy. Other versions of the device without a straightener are described.

Claims

1. An article of manufacture comprising:

(a) an elongated tube having an internal lumen, a peripheral wall, and including a hollow, bendable distal segment;

(b) an elastic member engaging the distal segment of the tube and incorporated into the peripheral wall of the tube, the elastic member having (i) a bent shape and (ii) a substantially straight shape, the elastic member being sufficiently stiff to cause the distal segment to bend when the elastic member is in its bent shape; and

(c) straightening means capable of preventing the elastic member from bending;

wherein the straightening means and the elastic member are capable of relative axial movement and wherein such relative axial movement transforms the elastic member from one shape to another for correspondingly bending or unbending the distal segment of the tube.

2. The article of claim 1 comprising a plurality of elastic members extending axially.

3. The article of claim 2 in which the elastic members are substantially equally spaced apart around the periphery of the tube.

4. The article of claim 1 wherein the elastic member is tubular.

5. The article of claim 4 wherein the straightening means is sized to fit within the elastic member.

6. An article of manufacture comprising:

(a) an elongated tube having an internal lumen, a peripheral wall, and including a hollow, bendable distal segment;

(b) an elastic member engaging the distal segment of the tube, the elastic member having (i) a bent shape and (ii) a substantially straight shape, the elastic member being sufficiently stiff to cause the distal segment to bend when the elastic member is in its bent shape; and

(c) straightening means capable of preventing the elastic member from bending the straightening means being within the lumen of the tube, tubular, concentric and coaxial with the tube, and axially slidable relative to the tube; and

wherein the straightening means and the elastic member are capable of relative axial movement and wherein such relative axial movement transforms the elastic member from one shape to another for correspondingly bending or unbending the distal segment of the tube.

7. The article of claim 6 in which the straightening means is exterior of the peripheral wall of the tube.

8. An article of manufacture comprising:

(a) an elongated tube having an internal lumen, a peripheral wall, and including a hollow, bendable distal segment;

(b) an elastic member engaging the distal segment of the tube, the elastic member having (i) a bent shape and (ii) a substantially straight shape, the elastic member being sufficiently stiff to cause the distal segment to bend when the elastic member is in its bent shape; and

(c) straightening means capable of preventing the elastic member from bending and incorporated into the wall of the tube;

wherein the straightening means and the elastic member are capable of relative axial movement and wherein such relative axial movement transforms the elastic member from one shape to another for correspondingly bending or unbending the distal segment of the tube.

10. The device of claim 8 wherein the elastic member is a memory alloy element formed at least partly from a superelastic 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 being in its substantially straight shape when the alloy is in its stress-induced martensitic state, and wherein the straightening means is capable of transforming the elastic member to and from its stress-induced martensitic state without changing the temperature of the elastic member.

9. A device suitable for insertion into a mammalian body comprising:

(a) a cannula having an internal lumen, a peripheral wall, and a hollow, bendable polymeric distal segment;

(b) an elongated elastic member inside the lumen of the cannula, the elastic member having a bent shape and a substantially linear shape, the elastic member being sufficiently stiff to cause the distal segment of the cannula to bend when the elastic member is in its bent shape, the distal segment of the cannula being sufficiently pliable that it can be straightened into a substantially straight shape;

(c) a straightener axially slidable in the lumen of the cannula, the straightener being sufficiently stiff that when located in the distal segment of the cannula the distal segment cannot be bent by the elastic member; and

(d) sliding means for axially sliding the straightener to and from the distal segment of the cannula for correspondingly unbending or bending the distal segment of the cannula.

11. The device of claim 9 wherein the cannula comprises a plurality of lumens with the elastic member in one lumen and the straightener in another lumen.

12. The device of claim 9 wherein the means for axially sliding the straightener comprises a wire attached to the straightener and extending to a proximal end of the cannula.

13. The device of claim 9 including a fiberoptic light guide.

24. A method for navigating a tortuous path in a mammalian body comprising the steps of:

(a) selecting the device claimed in claim 9;

(b) inserting the device into the mammalian body, the distal segment of the cannula being inserted first; and

(c) axial sliding the straightener to and from the distal segment with the sliding means for bending and unbending the distal segment of the cannula.

14. A device suitable for insertion into a mammalian body comprising:

(a) a cannula having an internal lumen, a peripheral wall, and a hollow, bendable distal segment;

(b) an elastic member engaging the distal segment of the cannula, the elastic member having a bent shape and being sufficiently stiff to cause the distal segment to bend when the elastic member is in its bent shape, the elastic member being capable of being deformed into a substantially straight shape;

(c) a tubular straightener sufficiently stiff to prevent the elastic member from bending the distal segment of the cannula when the straightener is proximate to the distal segment of the cannula; and

(d) means for moving the straightener along the cannula between a first position proximate to the distal segment of the cannula and a second position remote from the distal segment of the cannula for correspondingly unbending or bending the distal segment of the cannula, the distal segment of the cannula being substantially straight when the straightener is in its first position and the distal segment of the cannula being bent when the straightener is in its second position.

15. The device of claim 14 wherein the straightener is external of the cannula and slides along peripheral wall of the cannula.

16. The device of claim 14 wherein the straightener is inside the lumen of the cannula.

17. The device of claim 14 wherein the elastic member is imbedded in the wall of the cannula.

18. The device of claim 14 wherein the straightener is within the lumen of the cannula and is tubular, the elastic member is within the straightener, and the straightener is axially slidable along the elastic member.

19. The device of claim 14 in which the elastic member is secured to the cannula and is not movable relative thereto.

20. The device of claim 16 wherein the elastic member is helical and the stiffener is inside the helix.

25. A method for navigating a tortuous path in a mammalian body comprising the steps of:

(a) selecting the device claimed in claim 14;

(b) inserting the device into the mammalian body, the distal segment of the cannula being inserted first; and

(c) moving the straightener axially along the cannula between the first and second positions for bending and unbending the distal segment of the tube.

21. A device suitable for insertion into a mammalian body comprising:

(a) a cannula having an internal lumen, a peripheral wall, and a hollow, bendable distal segment;

(b) a hollow tubular elastic member internal of the cannula and engaging the distal segment of the cannula, the elastic member having a bent shape and a substantially straight shape, the elastic member being sufficiently stiff to cause the distal segment of the cannula to generally conform to the shape of the elastic member;

(c) a straightener capable of being inserted into the elastic member, the straightener being sufficiently stiff to prevent the elastic member from bending the distal segment of the cannula when the straightener is inside the elastic member; and

(d) means for moving the straightener inside the cannula from a first position inside the elastic member to a second position remote from the elastic member for transforming the distal segment of the cannula from a substantially straight shape when the straightener is in its first position to a bent shape when the straightener is in its second position.

22. The device of claim 21 in which the means for moving comprises a pull wire.

26. A method for navigating a tortuous path in a mammalian body comprising the steps of:

(a) selecting the device claimed in claim 21;

(b) inserting the device into the mammalian body, the distal segment of the cannula being inserted first; and

(c) moving the straightener from the first position to the second position for bending the distal segment of the tube.

23. A device suitable for insertion into a mammalian body comprising:

(a) a cannula having an internal lumen, a peripheral wall, and a hollow, bendable distal segment;

(b) an elastic member inside the cannula and axially slidable therein between a first position proximate to the distal segment and a second position remote from the distal segment, the elastic member having a bent shape and being sufficiently stiff to cause the distal segment to bend when the elastic member is in its bent shape, the elastic member being capable of being deformed into a substantially straight shape;

(c) a tubular, substantially straight stiffener within the cannula, the straightener having an internal lumen sized to receive the elastic member, the straightener being located remote from the distal segment of the cannula and being sufficiently stiff to transform the elastic member to its substantially straight shape; and

(d) means for moving the elastic member axially in the cannula between its first and second position, the elastic member in its first position bending the distal segment of the cannula and in its second position being within the straightener and thus substantially straight, thereby correspondingly bending and unbending the distal segment of the cannula.

27. A device suitable for insertion into a mammalian body comprising:

(a) a cannula having an internal lumen and a bendable distal segment;

(b) an elongated elastic member engaging the distal segment of the cannula, the elastic member being a memory alloy element formed at least partly from a superelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about body temperature such as it has a stress-induced martensitic state and austenitic state, the elastic member being sufficiently stiff to cause the distal segment to have a shape corresponding to the shape of the elastic member, the elastic member being in a substantially straight shape when the alloy is in its stressed-induced martensitic state and the elastic member being in a bent shape when the alloy is in its austenitic state; and

(c) stressing means coupled to the elastic member,

wherein tensioning the stressing means results in the alloy being transformed to its stress-induced martensitic state and the elastic member being in its substantially straight shape and the distal segment of the cannula being substantially straight, and release of the tension on the stressing means results in transformation of the alloy to its austenitic state and the elastic member being in its bent shape for bending the distal segment of the cannula.

28. The device of claim 27 wherein the elastic member is an elongated wire.

29. The device of claim 27 wherein the elastic member is a helical coil substantially coaxial with the cannula.

30. The device of claim 27 in which the elastic member has a zigzag shape along the longitudinal axis of the cannula.

31. A device comprising:

(a) a tube having an internal lumen and a bendable distal segment, the internal lumen comprising a distal portion of relatively large diameter and an adjoining portion of relatively small diameter;

(b) an elastic memory alloy member axially slidable in the lumen of the tube, the elastic member being formed at least partly from a superelastic 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 member being in a bent shape when the alloy is in its stress-induced martensitic state, the memory alloy member being substantially straight when the alloy is in its austenitic state, the memory alloy member being sufficiently stiff to cause the distal segment of the tube to conform to the shape of the memory alloy member,

wherein the diameter of the distal portion of the lumen is sufficiently large that the alloy is in its austenitic state when the memory alloy member is in the distal portion of the lumen and thus the memory alloy member and the tube are substantially straight, and

wherein the diameter of the adjoining portion of the lumen is sufficiently small that the alloy is in its stress-induced martensitic state when the memory alloy element is in the adjoining portion of the lumen, and thus the memory alloy member causes the distal segment of the tube to bend; and

(c) means for moving the memory alloy member from the distal portion to the adjoining portion of the lumen for unbending or bending the distal segment of the cannula.

32. A bendable device comprising:

(a) an elongated hollow tube having an open distal segment and an internal lumen, the distal segment being sufficiently flexible to be bent; and

(b) an elastic member sized to fit within the lumen of the tube and axially slidable in the tube and out of the open distal segment of the tube, the elastic member comprising two elongated substantially parallel segments forming a loop at the distal end of the elastic member,

wherein the elastic member when constrained bends to assume a bent position as a result of one segment of the elastic member tending to bend in a first direction and the other segment of the elastic member tending to bend in a second direction different from the first direction, bending of the elastic member resulting in the distal segment of the tube bending.

33. The device of claim 32 wherein the elastic member is a memory alloy element formed at least partly from a superelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about body temperature such that it has a stress-induced martensitic state containing relatively more martensite and an austenitic state containing relatively more austenite, the memory alloy element being in its bent shape when the alloy is in its stress-induced martensitic state.

34. An article comprising:

(a) a cannula having an internal lumen, and a hollow, bendable polymeric distal segment;

(b) a plurality of elongated bending members inside the lumen of the distal segment of the cannula, each bending member being capable of exerting a bending moment on the distal segment of the cannula, the distal segment of the cannula being sufficiently flexible that it can be bent by the bending members, and each bending member being rotatable along its longitudinal axis within the lumen to change the direction of the bending moment exerted by the bending members on the cannula; and

(c) means for rotating one or more of the bending members for straightening and bending the distal segment of the cannula.

36. The article of claim 34 wherein at least one of the bending members is a memory alloy element formed at least partly from a superelastic shape-memory alloy, the alloy displaying reversible stress-induced martensite at about human body temperature such that it has a stress-induced martensitic state containing relatively more martensite and an austenitic state containing relatively more austenite.

35. An article comprising:

(a) a cannula having an internal lumen, and a hollow, bendable distal segment;

(b) a plurality of elongated bending members inside the lumen of the cannula, each bending member being capable of exerting a bending moment on the cannula and the elongated members being movable axially in the lumen into and out of the distal segment for changing the direction and force of the bending moment on the distal segment; and

(c) means for moving the bending members in the lumen into and out of the distal segment for bending and straightening the distal segment.