Prosthesis anchoring and deploying device

• US 20060100688A1
• Filed: 11/05/2004
• Published: 05/11/2006
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Leanna, Gary J., Norton, Paul K., Jordan, Gary, Molloy, Dean
• Granted Patent: US 8,337,543 B2
• Time in Patent Office: Days
• US Class Current: 623/1.120
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A system for intraluminally delivering and deploying stents and other prostheses includes an outer catheter, an inner catheter movable axially relative to the outer catheter, and an anchoring device mounted to a distal end region of the inner catheter. The anchoring device includes one or more control features that interact with a linking structure proximally disposed on the prosthesis, preferably including one or more loops. The control features and loops interact by surface engagement to anchor the prosthesis relative to the inner catheter in a nonfrictional manner, thus to maintain lower axial prosthesis deployment and retraction forces. In one version of the anchor, the control features extend radially outward from a sleeve. In another version, the control features are formed in respective recesses which also receive the loops or other linking structure.

Claims

1. A device for effecting an intraluminal delivery and controlled deployment of a body implantable prosthesis, including:

an elongate prosthesis delivery member having a distal wall segment adapted to contain a radially self-expanding prosthesis in a reduced-radius delivery state against an internal restoring force;

a radially self-expanding prosthesis contained in the distal wall segment and thereby maintained in the reduced-radius delivery state, said prosthesis including a linking structure near a proximal end of the prosthesis;

an elongate prosthesis control member mounted for axial travel relative to the delivery member, toward and away from a delivery position in which a distal end region of the control member extends along the distal wall segment of the delivery member and is disposed radially inwardly of the prosthesis;

a control feature disposed along the distal end region of the control member and extending radially outwardly from the control member beyond a radial midpoint of the linking structure when in the delivery position with the prosthesis so contained, thereby being positioned to allow limited distal travel of the delivery member and prosthesis relative to the control member, and to effect a substantially non-frictional surface engagement with the linking structure upon said distal travel, to anchor the prosthesis against further distal travel relative to the control member.

2. The device of claim 1 wherein:

the distal end region is surrounded by the prosthesis when in said delivery position.

3. The device of claim 1 wherein:

the delivery member comprises an elongate outer catheter having a lumen running substantially the entire length of the outer catheter.

4. The device of claim 3 wherein:

the control member comprises an elongate inner catheter disposed in said lumen, wherein a proximal region of the inner catheter extends proximally beyond a proximal end of the outer catheter to facilitate use of the proximal region to control a position of the distal region relative to the outer catheter.

5. The device of claim 1 wherein:

the control feature comprises a plurality of control features angularly spaced apart from one another about the control member distal region.

6. The device of claim 5 wherein:

said control features have proximal end surfaces aligned in a plane substantially normal to the axial direction.

7. The device of claim 5 wherein:

a proximal end surface of each of the control features is aligned with respect to the control member to define an angle, relative to the axial direction, other than 90 degrees.

8. The device of claim 5 wherein:

each of the control features has a proximal end surface including a concavity in the proximal direction.

9. The device of claim 5 further including:

a sleeve supporting said control features and mounted in surrounding relation to the control member along the distal end region.

10. The device of claim 9 wherein:

said sleeve and control features are formed as a unitary member.

11. The device of claim 1 further including:

a thrust feature disposed along the control member, spaced apart proximally from the control feature, and positioned to allow limited proximal travel of the delivery member and prosthesis relative to the control member when in the delivery position with the prosthesis so contained, and to engage the proximal end of the prosthesis responsive to said limited proximal travel and thereby prevent further proximal travel of the prosthesis relative to the control member.

12. The device of claim 11 wherein:

the linking structure has an axial dimension along a portion thereof disposed between the thrust feature and the control feature when the prosthesis is so contained, and an axial spacing between the thrust feature and the control feature is selected to determine a range, for axial travel of the prosthesis relative to the control member, of 3.3 to 6.7 times said axial dimension.

13. The device of claim 12 wherein:

said range for axial travel is at least about 0.7 mm and at most about 1.7 mm.

14. The device of claim 1 wherein:

the linking structure defines at least one linking aperture, and the control feature is disposed to extend into the linking aperture.

15. The device of claim 14 wherein:

the linking structure defines a plurality of linking apertures near the proximal end of the prosthesis;

the control feature comprises a plurality of the control features, each adapted to extend into a different one of the linking apertures.

16. The device of claim 14 wherein:

the control feature extends through the linking aperture, to a location radially outwardly of the linking structure.

17. The device of claim 5 wherein:

the control features comprise hooks.

18. The device of claim 5 wherein:

the control features comprise pins.

19. The device of claim 5 wherein:

the control features comprise elongate axially extended fins.

20. The device of claim 5 wherein:

the control features have radially outward ends cooperating to define a control feature outer diameter less than an inside diameter of the distal wall segment.

21. The device of claim 20 wherein:

a radial spacing between the radially outward ends of the control features and the distal wall segment of the delivery member is less than half of a radial thickness dimension of the prosthesis.

22. The device of claim 1 wherein:

a radial self-expansion of the prosthesis upon its release from the delivery member carries the linking structure radially outward beyond the control feature, thus to disengage the prosthesis from the control member.

23. The device of claim 1 wherein:

the linking structure comprises an elongate linking strand formed into a loop to provide a linking aperture.

24. The device of claim 23 wherein:

the control feature comprises a first component contained within the loop, and a second component disposed outside of the loop, spaced apart from the first component, and cooperating with the first component to form a first recess to releasably contain a first segment of said linking strand.

25. The device of claim 24 wherein:

said control feature further includes a third component disposed outside the loop on a side of the loop opposite the second component, and spaced apart from the first component to define a second recess for releasably containing a second segment of said strand.

26. The device of claim 25 wherein:

said first and second recesses extend substantially in the axial direction.

27. The device of claim 23 wherein:

the linking structure comprises a plurality of loops, and the control feature comprises a plurality of the control features, wherein each of the control features is associated with a different one of the loops.

28. The device of claim 23 wherein:

the prosthesis is an open frame tubular structure formed of a plurality of elongate strands, including said linking strand.

29. A prosthesis delivery and deployment device, including:

an elongate prosthesis delivery member having a distal wall segment adapted to contain a radially self-expanding prosthesis in a reduced-radius delivery state against an internal restoring force;

an elongate control member mounted for axial travel relative to the delivery member, toward and away from a delivery position in which a distal end region of the control member extends along the distal wall segment of the delivery member; and

a prosthesis anchor mounted to the distal end region and comprising at least one elongate axially directed control feature extending radially outwardly from the control member and thereby positioned to effect a releasable engagement with a proximal-end linking structure of a radially self-expanding prosthesis when in the delivery position and with the prosthesis so contained;

wherein the anchor, when in said engagement with the linking structure, is operable to anchor the prosthesis against distal travel relative to the control member.

30. The device of claim 29 further including;

a self-expanding prosthesis including a proximally disposed linking structure and contained by said distal wall segment in the reduced-radius delivery state.

31. The device of claim 30 further including:

a thrust feature mounted to the control member proximally of the anchor and operable, through proximal travel of the delivery member relative to the control member with the prosthesis so contained, to establish surface contact with the linking structure to anchor the prosthesis against further proximal movement relative to the control member.

32. The device of claim 31 wherein:

the linking structure has an axial dimension along a portion thereof disposed between the control feature and the thrust feature when the prosthesis is so contained; and

an axial spacing between the control feature and the thrust feature is selected to determine a range, for axial travel of the prosthesis relative to the control member, of 3.3 to 6.7 times the axial dimension.

33. The device of claim 32 wherein:

said range is at least about 0.7 mm and at most about 1.7 mm.

34. The device of claim 30 wherein:

the linking structure includes an elongate linking strand formed into an elongate axially directed loop, and the control feature when so positioned extends into the loop.

35. The device of claim 34 wherein:

the anchor includes an anchoring body with a recess directed inwardly from an outside surface of the anchoring body and adapted to receive the loop, and the control feature is disposed in the recess and extends radially outward through the loop when the loop is in the recess; and

said recess includes first and a second recess segments on opposite sides of the control feature.

36. The device of claim 35 wherein:

the elongate linking strand includes opposed, substantially axially directed parallel first and second loop segments, and the first and second recess segments extend axially to contain the first and second loop segments, respectively.

37. The device of claim 35 wherein:

an inside diameter of the distal wall segment is larger than an outside diameter of the anchoring body, by an amount less than a radial thickness dimension of the loop.

38. The device of claim 37 wherein:

said recess is directed inwardly a distance greater than said radial thickness dimension of the loop.

39. The device of claim 29 wherein:

the anchor comprises a plurality of the elongate radially directed control features positioned to effect said releasable engagement with the linking structure.

40. The device of claim 39 wherein:

the proximal-end linking structure comprises a plurality of elongate axially directed loops, each associated with a different one of the control features.

41. The device of claim 29 wherein:

the distal end region is surrounded by the prosthesis when in said delivery position.

42. The device of claim 29 wherein:

the delivery member comprises an elongate outer catheter having a lumen running substantially the entire length of the outer catheter.

43. The device of claim 42 wherein:

the control member comprises an elongate inner catheter disposed in said lumen, with a proximal region of the inner catheter extending proximally beyond a proximal end of the outer catheter to facilitate use of the proximal region to control a position of the distal region relative to the outer catheter.

44. The device of claim 29 wherein:

the anchor includes a cylindrical anchoring body with a centrally located axial opening therethrough adapted to receive the control member and facilitate a mounting of the anchor in surrounding relation to the control member.

45. The device of claim 30 wherein:

the proximal-end linking structure comprises a plurality of elongate axially directed loops angularly spaced apart from one another about the prosthesis; and

said anchor comprises a plurality of the elongate axially directed control features angularly spaced apart from one another about the control member, and each of the control features is positioned to releasably engage a different one of the loops.

46. The device of claim 45 wherein:

the number of control features equals the number of loops.

47. The device of claim 45 wherein:

the number of loops is an integral multiple of the number of control features.

48. A prosthesis anchoring device adapted for fixation to a prosthesis deployment member, the anchoring device including:

a generally cylindrical anchoring sleeve having a central opening extending axially therethrough to facilitate a slideable installation of the anchoring sleeve onto an elongate prosthesis deployment member for fixation along a distal end region of the deployment member; and

a control feature extended radially outwardly from the anchoring sleeve and adapted to extend radially into a proximal-end linking structure of a radially self-expanding prosthesis when the prosthesis is maintained in a reduced-radius state against an internal restoring force and selectively axially aligned with said distal end region;

whereby the control feature, with the anchoring sleeve fixed to a deployment member and when so extending into a proximal-end linking structure of a radially self-expanding prosthesis so maintained and aligned, is adapted to engage the linking structure to prevent any substantial distal movement of the prosthesis relative to the deployment member.

49. The device of claim 48 wherein:

the control feature is elongate, directed axially, and adapted to extend into a proximal-end linking structure in the form of an elongate, axially extended loop.

50. The device of claim 49 wherein:

the control feature, when surrounded by the loop, prevents any substantial axial movement of the loop relative to the anchoring body.

51. The device of claim 48 wherein:

the anchoring sleeve and the control feature are formed as a unitary member.

52. The device of claim 48 including:

a plurality of the control features angularly spaced apart from one another about the anchoring body.

53. The device of claim 48 wherein:

the anchoring body includes a recess containing the control feature, adapted to receive a prosthesis proximal-end linking structure, and having a depth in the radial direction larger than a radial thickness of the linking structure.

54. The device of claim 53 wherein:

the recess includes first and second recess segments disposed on opposite sides of the control feature for containing opposite sides of a prosthesis proximal-end linking structure in the form of a loop disposed in the recess.

55. A process for loading a radially self-expanding prosthesis for subsequent deployment in a body lumen, including:

positioning a radially self-expanding prosthesis along and in surrounding relation to a distal end region of an elongate prosthesis control member with a proximal end linking structure of the prosthesis disposed near axially spaced apart first and second features that extend radially outwardly from the control member;

with the prosthesis so positioned, radially contracting the prosthesis to a reduced-radius delivery state against an internal elastic restoring force to move the linking structure into a delivery position between the first and second features whereby the first and second features cooperate to limit axial travel of the prosthesis relative to the control member to a predetermined range so long as the prosthesis is maintained in the delivery state; and

selecting an axial dimension of the linking structure with respect to an axial spacing between the first and second features whereby the predetermined range is at least twice the axial dimension of the linking structure.

56. The process of claim 55 wherein:

radially contracting the prosthesis comprises progressively advancing a prosthesis delivery member over the prosthesis to contain the prosthesis in the delivery state within a lumen of the delivery member.