Apparatus and method for deployment of radially expandable stents by a mechanical linkage

• US 5,443,477 A
• Filed: 02/10/1994
• Issued: 08/22/1995
• Est. Priority Date: 02/10/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Stentco Incorporated
• Inventors: Marin, Michael L., Marin, Ralph
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/196,278
• Time in Patent Office: 558 Days
• Field of Search: 606/152, 606/108, 606/153, 606/191, 606/195, 606/198, 606/200, 604/53, 604/104, 604/105, 604/106, 604/107, 623/1, 623/11, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The invention provides a method and apparatus for intraluminal delivery and deployment of an expandable prosthesis at a site within a body lumen. The apparatus for intraluminal delivery and deployment includes a support for supporting the expandable prosthesis while being delivered to the site within the body lumen, and a radially displaceable mechanical linkage connected to the support for radially displacing the support. The linkage is adapted to deploy the expandable prosthesis when it is displaced radially outward. The linkage permits continuous fluid flow within the body lumen while the expandable prosthesis is being deployed. The present invention can also be used without stents for expanding a body lumen. The present method comprises the steps of transmitting a radially, outwardly directed displacement force to the support from a control mechanism, the support being displaced radially outwardly to an expanded stance such that the prosthesis contacts the body passageway, and transmitting a radially, inwardly directed displacement force to the support from a control mechanism, the support being displaced radially inwardly to a recoiled stance less than the diameter of the body passageway while leaving the prosthesis in contact the body passageway. Fluid flow is permitted throughout the delivery and deployment process.

Claims

1. In combination with an expandable prosthesis, an apparatus for intraluminal delivery and deployment of the expandable prosthesis at a site within a body lumen, comprising:

a support for supporting the expandable prosthesis while being delivered to the site within the body lumen; and

a radially displaceable mechanical linkage connected to said support for radially displacing said support, said linkage adapted to deploy the expandable prosthesis when said linkage is displaced radially outward, said linkage permitting continuous fluid flow within the body lumen while the expandable prosthesis is being deployed.

2. An apparatus as in claim 1, further comprising axially moveable control means coupled to said linkage for remotely controlling said linkage.

3. An apparatus as in claim 2, further comprising means to normally bias said control means in an axially distal position such that said linkage is normally in a recoiled stance for delivery and withdrawal of said apparatus from the lumen, said axially moveable control means transmitting one of an expansion and compression force to said linkage.

4. In combination with a stem, an apparatus at a predetermined location on a catheter for intraluminally deploying the stent, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end fixedly coupled to said member for axially moving said member with respect to the catheter;

a plurality of wings surrounding said member to form a support surface for the stent; and

a linkage for linking said wings to said member and the catheter, said linkage causing said wings to displace radially outward when said member is moved axially by said deployment wire in a first direction and displace radially inward when said member is moved axially by said deployment wire in a second direction.

5. An apparatus as in claim 4, further comprising a rigid portion axially mounted with respect to said guide wire, said rigid portion being coupled to said wings.

6. An apparatus as in claim 5, further comprising a plurality of first and second arms, each of said wings being linked to said member by at least one of said first arms and to said rigid portion by at least one of said second arms.

7. An apparatus as in claim 6, wherein each of said wings is pivotally linked to said member by at least one of said first arms and to said rigid portion by at least one of said second arms.

8. An apparatus as in claim 6, wherein said wings have a stepped surface opposite said support surface, said stepped surface permitting the apparatus to assume a compact radial profile.

9. An apparatus as in claim 6, further comprising initiating means axially movably mounted with respect to the guide wire for initiating displacement of said wings.

10. An apparatus as in claim 9, further comprising an initiating wire fixedly coupled to said initiating means for axially moving said initiating means with respect to the guide wire.

11. An apparatus as in claim 10, further comprising an actuator coupled to said initiating wire such that movement of said actuator causes said initiating means to move axially in one of said first and second directions.

12. An apparatus as in claim 9, wherein each of said second arms has a distal portion free of contact of said initiating means and a proximal portion that engages said initiating means when said initiating means moves axially in said first direction.

13. An apparatus as in claim 12, wherein said proximal portion of each of said second arms has a sloped edge which gradually engages said initiating means when said initiating means moves axially in said first direction, whereby each of said wings is radially displaced from said member and the stent supported on said wings is radially expanded.

14. An apparatus as in claim 13, wherein said sloped edge is 15°

.

15. An apparatus as in claim 5, further comprising a steering wire fixedly coupled at a distal end to said rigid portion.

16. An apparatus as in claim 15, further comprising a steering control coupled to a proximal end of said steering wire.

17. An apparatus as in claim 5, further comprising a catheter shaft articulately mounted at a distal end thereof to said rigid portion.

18. An apparatus as in claim 17, wherein said articulately mounted rigid portion is universally connected to said catheter shaft.

19. An apparatus as in claim 17, wherein said articulately connected rigid portion is hingeably connected to said catheter shaft.

20. An apparatus as in claim 17, further comprising a trigger mechanism, said catheter shaft being rotatably mounted at a proximal end thereof to said trigger mechanism, said trigger mechanism being coupled to a proximal end of said deployment wire.

21. An apparatus as in claim 20, further comprising a trigger housing and a peg for insertion into said housing, said housing and peg defining the movement of said mechanism, said trigger mechanism being movable within said housing from a rest position to said peg, said wings displacing radially outward as said trigger mechanism moves toward said peg.

22. An apparatus as in claim 21, wherein said housing has a plurality of holes for receiving said peg, each of said holes corresponding to a calibrated relative displacement of said wings.

23. An apparatus as in claim 22, wherein said calibrated relative displacement of said wings is predetermined.

24. An apparatus as in claim 4, wherein said deployment wire is terminated at a proximal end with a slotted portion.

25. An apparatus as in claim 24, further comprising a trigger mechanism, said trigger mechanism engaging said slotted portion such that movement of said trigger mechanism causes said member to move axially with respect to the guide wire in one of said first and second directions and causes each of said wings to displace radially.

26. An apparatus as in claim 25, further comprising a trigger housing and a peg for insertion into said housing, said housing and peg defining the movement of said mechanism, said trigger mechanism being movable within said housing from a rest position to said peg, said wings displacing radially outward as said trigger mechanism moves toward said peg.

27. An apparatus as in claim 26, wherein said housing has a plurality of holes for receiving said peg, each of said holes corresponding to a calibrated relative displacement of said wings.

28. An apparatus as in claim 27, wherein said calibrated relative displacement of said wings is predetermined.

29. In combination with a stent, an apparatus at a predetermined location on a catheter for intraluminally deploying the stent, comprising:

a member, said member being movably mounted with respect to the catheter;

a wire having a distal end coupled to said member for axially moving said member with respect to the catheter;

a plurality of first and second arms;

a plurality of wings surrounding said member to form a support surface for the stent, each of said wings being pivotally linked to said member by at least one of said first arms; and

a rigid portion connected to the catheter, each of said wings being pivotally linked to said rigid portion by at least one of said second arms, whereby a force applied to said wire causes said wings displace radially outward when said member is moved axially by said wire in a first direction and displace radially inward when said member is moved axially by said wire in a second direction.

30. An apparatus as in claim 29, further comprising initiating means axially movably mounted with respect to the guide wire for initiating displacement of said wings.

31. An apparatus at a predetermined location on a catheter for expanding a graft, stent, or stenosed body lumen or the like, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end coupled to said member for axially moving said member with respect to the catheter;

a plurality of wings surrounding said member;

a linkage for linking said wings to said member and the catheter and for providing a force sufficient to expand the graft, stent, stenosed body lumen or the like;

initiating means axially movably mounted with respect to the catheter for initiating displacement of said wings; and

an initiating wire fixedly coupled to said initiating means for axially moving said initiating means with respect to the catheter.

32. An apparatus as in claim 31, further comprising an actuator coupled to said initiating wire such that movement of said actuator causes said initiating means to move axially with respect to the catheter.

33. An apparatus at a predetermined location on a catheter for expanding a graft, stem, or stenosed body lumen or the like, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end coupled to said member for axially moving said member with respect to the catheter;

a plurality of wings surrounding said member;

a linkage for linking said wings to said member and the catheter and for providing a force sufficient to expand the graft, stent, stenosed body lumen or the like;

a rigid portion axially mounted with respect to said catheter, said rigid portion being coupled to said wings; and

a plurality of first and second arms, each of said wings being linked to said member by at least one of said first arms and to said rigid portion by at least one of said second arms.

34. An apparatus as in claim 33, further comprising initiating means axially movably mounted with respect to the catheter for initiating displacement of said wings, each of said second arms having a distal portion free of contact of said initiating means and a proximal portion that engages said initiating means when said initiating means moves axially in said first direction.

35. An apparatus at a predetermined location on a catheter for expanding a graft, stent, or stenosed body lumen or the like, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end coupled to said member for axially moving said member with respect to the catheter;

a plurality of wings surrounding said member;

a linkage for linking said wings to said member and the catheter and for providing a force sufficient to expand the graft, stent, stenosed body lumen or the like;

a rigid portion axially mounted with respect to said catheter, said rigid portion being coupled to said wings; and

a steering wire fixedly coupled at a distal end to said rigid portion.

36. An apparatus as in claim 35, further comprising a steering control coupled to a proximal end of said steering wire.

37. An apparatus at a predetermined location on a catheter for expanding a graft, stent, or stenosed body lumen or the like, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end coupled to said member for axially moving said member with respect to the catheter;

a plurality of wings surrounding said member;

a linkage for linking said wings to said member and the catheter and for providing a force sufficient to expand the graft, stent, stenosed body lumen or the like;

initiating means axially movably mounted with respect to the catheter for initiating displacement of said wings; and

a rigid portion axially mounted with respect to said catheter, said rigid portion being coupled to said wings;

wherein said rigid portion is articulately mounted at a distal end of the catheter.

38. An apparatus as in claim 37, further comprising a trigger mechanism, said catheter being rotatably mounted at a proximal end thereof to said trigger mechanism, said trigger mechanism being coupled to a proximal end of said deployment wire.

39. An apparatus at a predetermined location on a catheter for expanding a graft, stem, or stenosed body lumen or the like, comprising:

a member, said member being movably mounted with respect to the catheter;

a deployment wire having a distal end coupled to said member for axially moving said member with respect to the catheter and a proximal end terminated with a slotted portion;

a plurality of wings surrounding said member; and

a linkage for linking said wings to said member and the catheter and for providing a force sufficient to expand the graft, stent, stenosed body lumen or the like.

40. An apparatus as in claim 39, further comprising a trigger mechanism, said trigger mechanism engaging said slotted portion such that movement of said trigger mechanism causes said member to move axially with respect to the catheter in one of said first and second directions and causes each of said wings to displace radially.

41. A method for intraluminally implanting a prosthesis disposed on a mechanical support at a predetermined location on a catheter which has been inserted into a body passageway, comprising the steps of:

transmitting a radially, outwardly directed displacement force substantially instantaneously to the support from a control mechanism, said support being displaced radially outwardly to an expanded stance such that the prosthesis contacts the body passageway;

transmitting a radially, inwardly directed displacement force substantially instantaneously to the support from a control mechanism, said support being displaced radially inwardly to a recoiled stance less than the diameter of the body passageway while leaving the prosthesis in contact the body passageway; and

permitting fluid flow while transmitting either of said radially, outwardly directed displacement force or said radially, inwardly directed displacement force.

42. A method as in claim 41, wherein each of the steps of transmitting a radially directed displacement force includes the step of directly translating an axial force from the control mechanism into a radial force at the distal end of the catheter.

43. A method as in claim 41, wherein each of the transmitted displacement forces is calibrated to the displacement of the support such that a prosthesis is expanded to a predetermined diameter.

44. A method as in claim 41, including the additional step of guiding the prosthesis upon the support to a designated site within the body passageway.

45. A method as in claim 41, including the additional step of disposing the prosthesis upon a mechanical support.