System and method for assembling an endoluminal prosthesis

• US 6,165,213 A
• Filed: 05/21/1999
• Issued: 12/26/2000
• Est. Priority Date: 02/09/1994
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Hudson, John, Mialhe, Claude, Goicoechea, George
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/317,102
• Time in Patent Office: 585 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.23, 623/1.27, 623/1.34, 623/1.35
• US Class Current: 623/1.34
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• 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: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: Y10S 623/903 : Blood vessel
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A system is provided for assembling an endoluminal prosthesis within a body lumen and for indicating the rotational orientation of a segment of the endoluminal prosthesis during insertion thereof into the body lumen. The system includes prosthesis segments configured for engagement to one another to form the endoluminal prosthesis in the body lumen. The system also includes radiographic indicia defined on at least one of the prosthesis segments and having different radiopacity from the prosthesis segment, wherein the composite radiographic image of the radiographic indicia varies with the rotational orientation of the prosthesis segment in the body lumen. The rotational orientation of the prosthesis segment in the body lumen is indicated by the radiographic image for optional adjustment of the rotational orientation.

Claims

1. A system for assembling an endoluminal prosthesis within a body lumen and for indicating the rotational orientation of a segment of said endoluminal prosthesis during insertion thereof into the body lumen, said system comprising:

prosthesis segments configured for engagement to one another to form said endoluminal prosthesis in the body lumen;

radiographic indicia defined on at least one of said prosthesis segments and having different radiopacity from said prosthesis segment, wherein the composite radiographic image of said radiographic indicia varies with the rotational orientation of said prosthesis segment in the body lumen;

wherein the rotational orientation of said prosthesis segment in the body lumen is indicated by said radiographic image for optional adjustment of the rotational orientation.

2. The system recited in claim 1 wherein at least one of said radiographic indicia is a substantially straight line.

3. The system recited in claim 2 wherein each of said radiographic indicia is a substantially straight line.

4. The system recited in claim 3 wherein said radiographic indicia together form a "V" shape, each radiographic indicium being a leg of said "V" shape.

5. The system recited in claim 4 wherein said radiographic image varies with the rotational orientation of said prosthesis segment between said "V" shape and a substantially straight line.

6. The system recited in claim 4 wherein said "V" shape is oriented in a direction along an axis of said prosthesis segment.

7. The system recited in claim 1 wherein at least one of said radiographic indicia comprises a radiopaque marker.

8. The system recited in claim 7 wherein each of said radiographic indicia comprises a radiopaque marker.

9. The system recited in claim 1 wherein said radiographic indicia are aligned in relation to one another upon rotational orientation of said at least one prosthesis segment in the body lumen.

10. The system recited in claim 9 wherein said radiographic indicia, when aligned, are oriented in a direction corresponding to an axis of said at least one prosthesis segment.

11. The system recited in claim 9 wherein when said radiographic indicia are aligned, one of said radiographic indicia is positioned substantially behind another one of said radiographic indicia in said radiographic image.

12. The system recited in claim 10 wherein said radiographic indicia are positioned at an end portion of said prosthesis segment.

13. The system recited in claim 1, at least one of said prosthesis segments including a stent configured for radial expansion in the body lumen and a graft at least partially supported by said stent.

14. The system recited in claim 13, said stent extending along the length of said prosthesis segment.

15. The system recited in claim 13, said stent providing support along the length of said prosthesis segment.

16. The system recited in claim 15, said graft being fully supported by said stent.

17. A method for assembling an endoluminal prosthesis within a body lumen and for determining the rotational orientation of a segment of said endoluminal prosthesis during insertion thereof into the body lumen, said method comprising the steps of:

(a) providing a first prosthesis segment with radiographic indicia having different radiopacity from the first prosthesis segment, wherein the composite radiographic image of the radiographic indicia varies with the rotational orientation of the first prosthesis segment in the body lumen;

(b) inserting the first prosthesis segment into the body lumen;

(c) detecting the radiographic image;

(d) determining the rotational orientation of the first prosthesis segment in the lumen based on the radiographic image and optionally adjusting the rotational orientation of the first prosthesis segment based on the radiographic image, and

(e) inserting a second prosthesis segment into the body lumen for engagement with the first prosthesis segment to form the endoluminal prosthesis in the body lumen.

18. The method recited in claim 17 wherein said providing step further comprises applying at least one radiopaque marker to said first prosthesis segment to provide said radiographic indicia.

19. The method recited in claim 17 wherein said providing step further comprises providing a prosthesis segment selected from the group consisting of a stent, a graft, and a stent-graft combination.

20. The method recited in claim 17 wherein said providing step further comprises configuring said radiographic indicia having said different radiopacity in a "V" shape.

21. The method recited in claim 17 further comprising providing the second prosthesis segment with radiographic indicia having different radiopacity from the second prosthesis segment.

22. The method recited in claim 21, wherein the composite radiographic image of the radiographic indicia varies with the rotational orientation of the second prosthesis segment in the body lumen, said method further comprising determining the rotational orientation of the second prosthesis segment in the lumen based on the radiographic image and optionally adjusting the rotational orientation of the second prosthesis segment based on the radiographic image.

23. The method recited in claim 17 further comprising aligning the first and second prosthesis segments with respect to one another using the radiographic indicia to facilitate proper alignment of the first and second prosthesis segments.

24. A system for assembling an endoluminal prosthesis within the vasculature of a body, said system comprising:

prosthesis segments configured for insertion into the vasculature of the body, wherein said prosthesis segments are configured for engagement with one another to form said endoluminal prosthesis in the vasculature;

wherein a portion of at least one of said prosthesis segments has a different radiopacity, said portion of different radiopacity facilitating proper alignment of said prosthesis segments with respect to one another during said engagement of said prosthesis segments.

25. The system recited in claim 24 wherein a portion of each of said prosthesis segments has a different radiopacity.

26. The system recited in claim 24 wherein a radiopaque marker provides said different radiopacity.

27. The system recited in claim 24 wherein at least one of said prosthesis segments is selected from the group consisting of a stent, a graft, and a stent with a graft at least partially supported by said stent.

28. The system recited in claim 27, at least one of said prosthesis segments comprising a stent extending along the length of said prosthesis segment.

29. The system recited in claim 28, said prosthesis segment comprising a stent and a graft fully supported by said stent.

30. A method for assembling an endoluminal prosthesis within the vasculature of a body, the method comprising the steps of:

providing prosthesis segments for insertion into the vasculature of the body, one of the prosthesis segments being adapted for engagement with another one of the prosthesis segments;

providing a portion of at least one of said proximal segments with a different radiopacity;

aligning the prosthesis segments with respect to one another using the portion of different radiopacity to facilitate proper alignment of the prosthesis segments;

engaging the prosthesis segments to form the endoluminal prosthesis in the vasculature.

31. The method recited in claim 30 wherein said step of providing a portion of different radiopacity comprises applying a radiopaque marker to at least one of the prosthesis segments.

32. The method recited in claim 30 wherein said step of providing prosthesis segments comprises providing at least one prosthesis segment selected from the group consisting of a stent, a graft, and a stent-graft combination.

33. The method recited in claim 30 wherein said step of providing a portion of different radiopacity comprises configuring the portion of different radiopacity in a "V" shape.