Prosthesis anchoring and deploying device

• US 8,337,543 B2
• Filed: 11/05/2004
• Issued: 12/25/2012
• Est. Priority Date: 11/05/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jordan, Gary, Leanna, Gary J., Molloy, Dean, Norton, Paul K.
• Primary Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/982,465
• Publication Number:
  US 20060100688A1
• Time in Patent Office: 2,972 Days
• Field of Search: 604/93.01, 604/96.01, 623 111- 135, 623 149- 154, 606/194, 606/108, 606/195, 606/200
• US Class Current: 623/1.12
• 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, comprising:

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

the radially self-expanding prosthesis contained in the distal wall segment and thereby maintained in the reduced-radius delivery state, said prosthesis including a plurality of helically wound strands interbraided to define an open tubular frame structure having a proximal end and a distal end, wherein the strands at the distal end are formed into a plurality of bends and wherein the strands at the proximal end are formed into a plurality of axially elongated loops having a strand crossing point and having a greater longitudinal extent than a distance between adjacent strand crossings within the frame structure of the prosthesis to define a linking structure at the proximal end of the prosthesis thereat, each of the plurality of axially elongated loops having spaced apart longitudinal sections formed from a monofilament strand, wherein each of said plurality of axially elongated loops includes two of said plurality of helically wound strands integrated into said monofilament strand of each of said longitudinal sections;

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 comprising a cylindrical body having an annular outside surface, said annular outside surface having a plurality of recesses directed radially inward from the annular outside surface to form axially directed recess segments having recess walls, wherein the recess walls of pairs of the axially directed recess segments substantially surround said monofilament strand of the spaced apart longitudinal sections of the axially elongated loops of the prosthesis such that medial portions of the cylindrical body between the pairs of axially directed recess segments extend into the elongate loops, wherein only said monofilament strand of said longitudinal sections extends within the recess walls of the pairs of the axially directed recess segments, the cylindrical body being 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, and

a thrust feature disposed along the control member and surrounding said 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.

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 end region relative to the outer catheter.

5. The device of claim 1 wherein:

said control feature is formed as a unitary member.

6. The device of claim 1 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.

7. The device of claim 6 wherein:

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

8. 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.

9. A prosthesis delivery and deployment device, comprising:

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

said radially self-expanding prosthesis contained in the distal wall segment and thereby maintained in the reduced-radius delivery state, said prosthesis including a plurality of helically wound strands interbraided to define an open tubular frame structure having a proximal end and a distal end, wherein the strands at the distal end are formed into a plurality of bends and wherein the strands at the proximal end are formed into a plurality of axially elongated loops having a strand crossing point and having a greater longitudinal extent than a distance between adjacent strand crossings within the frame structure of the prosthesis to define a linking structure at the proximal end of the prosthesis thereat, each of the plurality of axially elongated loops is formed from a monofilament strand, said monofilament strand having spaced apart longitudinal sections;

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; and

a control feature comprising a cylindrical body having an annular outside surface, said annular outside surface having a plurality of recesses directed radially inward from the annular outside surface to form axially directed recess segments having recess walls a medial portion extends from each of said plurality of recesses, wherein only said monofilament strand extends between said recess wall and said medial portion, the cylindrical body being 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;

wherein said medial portions are elongate axially directed fins, said fins being tapered wherein a width of each of said fins decrease as the fins extend radially outward and thereby positioned to effect a releasable engagement with the proximal-end linking structure of the radially self-expanding prosthesis and to engage opposite sides of the plurality of the axially elongated loops when in the delivery position and with the prosthesis so contained.

10. The device of claim 9 further including:

a thrust feature mounted to the control member proximally of the control feature 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.

11. The device of claim 10 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.

12. The device of claim 11 wherein:

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

13. The device of claim 9 wherein:

said recesses are directed inwardly a distance greater than a radial thickness dimension of the loop.

14. The device of claim 9 wherein:

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

15. The device of claim 9 wherein:

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

16. The device of claim 15 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.

17. The device of claim 9 wherein:

the cylindrical body comprises a centrally located axial opening therethrough adapted to receive the control member and facilitate a mounting of the control feature in surrounding relation to the control member.

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

providing a radially self-expanding prosthesis comprising a plurality of helically wound strands interbraided to define an open tubular frame structure having a proximal end and a distal end, wherein the strands at the distal end are formed into a plurality of bends and wherein the strands at the proximal end are formed into a plurality of axially elongated loops having a strand crossing point and having spaced apart longitudinal sections and having a greater longitudinal extent than a distance between adjacent strand crossings within said frame structure of the prosthesis to define a proximal-end linking structure of the radially self-expanding prosthesis thereat, wherein each of said plurality of axially elongated loops includes two of said plurality of helically wound strands integrated into a monofilament strand defining each of said longitudinal sections;

positioning the radially self-expanding prosthesis along and in surrounding relation to a distal end region of an elongate prosthesis control member, wherein the control member comprises a cylindrical body having an annular outside surface, said annular outside surface having a plurality of recesses directed radially inward from the annular outside surface to form axially directed recess segments having recess walls, wherein the recess walls of pairs of the axially directed recess segments substantially surround said monofilament strand of each of the spaced apart longitudinal sections of the axially elongated loops of the prosthesis such that medial portions of the cylindrical body between the pairs of axially directed recess segments extend into the elongate loops, wherein said monofilament strand of said each of said longitudinal sections extends within each of the recess walls of the pairs of the axially directed recess segments; and

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,

wherein a width of said each of said plurality of axially elongated loops between said at least two of said plurality of helically wound strands is at least about twice a width of the medial portions of the cylindrical body.

19. The process of claim 18 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.