Endoluminal device and system and method for detecting a change in pressure differential across an endoluminal device

• US 7,189,256 B2
• Filed: 05/10/2002
• Issued: 03/13/2007
• Est. Priority Date: 05/10/2002
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Smith, John K.
• Primary Examiner(s): Woo; Julian W.
• Assistant Examiner(s): WEBB, SARAH K
• Application Number:
  US10/143,434
• Publication Number:
  US 20030212448A1
• Time in Patent Office: 1,768 Days
• Field of Search: 623 111- 154
• US Class Current: 623/1.34
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0013 for adjusting fluid pressure
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

An endoluminal device for deployment in a body lumen includes a radially expandable stent, a graft attached to the stent, and a plurality of indicator members affixed to the graft and adapted to form a normal pattern in response to a normal pressure differential and an abnormal pattern in response to an abnormal pressure differential across the graft. By forming different patterns at different pressure differentials, the indicator members enable the detection of a change in pressure which could be evidence of a leak. A system for detecting a change in pressure differential includes the endoluminal device and an imaging system for displaying the indicator members. A method for detecting a change in pressure includes the steps of identifying the normal pattern, implanting the device, imaging the indicator members, and comparing the imaged pattern with the normal pattern to determine whether the normal pressure or an abnormal pressure differential exists.

Claims

1. An endoluminal device for deployment in a body lumen, the device comprising:

a radially expandable stent;

a graft attached to said stent, wherein said graft defines a radially interior space having an internal pressure corresponding to systolic blood pressure and a radially exterior space having an external pressure corresponding to the pressure of an aneurysm sac; and

a plurality of indicator members affixed to said graft and adapted to form a normal pattern in response to a normal pressure differential between the internal pressure and the external pressure and an abnormal pattern in response to an abnormal pressure differential between the internal pressure and the external pressure wherein the normal pressure differential is the pressure differential between the radially interior space and the radially exterior space in the absence of leaks across the device.

2. The endoluminal device according to claim 1, wherein said stent comprises a metal wire defining a plurality of openings and said indicator members are positioned on said graft at regions corresponding to at least one of said openings.

3. The endoluminal device according to claim 1, wherein said stent has a portion defining a border of a first of said openings and said border comprises a plurality of edges intersecting at least one junction, and said graft is attached to said stent at the at least one junction.

4. The endoluminal device according to claim 1, wherein said stent has a portion defining a border of a first of said openings and said border comprises a plurality of edges, and said graft is attached to said stent along the length of said edges.

5. The endoluminal device according to claim 4, wherein said graft is disposed radially outside of said stent.

6. The endoluminal device according to claim 1, wherein said stent is adapted to provide a plurality of openings, each having the same size regardless of the value of the differential pressure across said device.

7. The endoluminal device according to claim 6, wherein said stent is laser cut or filamentary.

8. The endoluminal device according to claim 1, wherein said graft is disposed radially within said stent.

9. The endoluminal device according to claim 1, wherein said plurality of indicator members are made integral with said graft.

12. The endoluminal device according to claim 2, wherein said stent has a portion defining a border of a first of said openings and said border comprises a plurality of edges, and said normal pattern comprises at least one central line disposed within said first opening and parallel to a first of said edges and a plurality of outer curves bending outwards from the center of said first opening.

13. The endoluminal device according to claim 12, wherein said indicator members are affixed to said graft by forming, at no pressure differential across said graft, said at least one central line and said plurality of outer curves as substantially straight lines parallel to each other and to said first edge.

14. The endoluminal device according to claim 2, wherein said plurality of indicator members are dots adapted to be positioned at regularly spaced intervals at the normal pressure differential.

10. An endoluminal device for deployment in a body lumen, the device comprising:

a radially expandable stent comprising a metal wire defining a plurality of openings wherein said stent has a portion defining a border of a first of said openings and said border comprises a plurality of edges;

a graft attached to said stent, wherein said graft defines a radially interior space having an internal pressure and a radially exterior space having an external pressure; and

a plurality of indicator members affixed to said graft, positioned on said graft at regions corresponding to at least one of said openings, and adapted to form a normal pattern in response to a normal pressure differential between the internal pressure and the external pressure and an abnormal pattern in response to an abnormal pressure differential between the internal pressure and the external pressure, wherein said normal pattern comprises a plurality of lines disposed within said first opening and parallel to each other and to a first of said edges.

11. The endoluminal device according to claim 10, wherein said plurality of lines include at least one central line and at least one outer line and said lines are affixed to said graft by forming, at no pressure differential across said graft, said at least one central line substantially straight and said plurality of outer lines as curves bending towards the center of said first opening.