Endoluminal prostheses having position indicating markers

• US 6,203,568 B1
• Filed: 07/24/1998
• Issued: 03/20/2001
• Est. Priority Date: 04/05/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lombardi, Sylvie, Evans, Michael A., Lenker, Jay A., Gittings, Darin C., Will, Allan R., Kim, Steven W.
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/122,337
• Time in Patent Office: 970 Days
• Field of Search: 623/1.13, 623/1.16, 623/1.23, 623/1.35, 600/36, 606/194
• US Class Current: 623/1.13
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped
• 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: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers

Abstract

The present invention provides an endoluminal prosthesis for deployment in a body lumen of a patient body, the prosthesis comprising a tubular fabric liner and a radially expandable frame supporting the liner. A plurality of imagable bodies are attached to the liner, the imagable bodies providing a sharp contrast so as to define a pattern which indicates the prosthesis position when the prosthesis is imaged within the patient body. Preferably, each imagable body comprises a plate having first and second opposed major surfaces and a passage therebetween to facilitate stitching the imagable body to the liner. Advantageously, the imagable bodies can be aligned with the openings of a perforate frame structure so that at least some of the imagable bodies are visible through associated openings, but need not actually be attached to the frame directly. Such imagable bodies are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but will not interfere with the radial expansion of the frame during deployment.

Claims

1. An endoluminal prosthesis for deployment in a body lumen of a patient body, the prosthesis comprising:

a tubular fabric liner having a proximal end, a distal end, and a lumen therebetween;

a radially expandable frame supporting the liner; and

a plurality of radiopaque marker elements, each marker element comprising a plate having at least one passage therethrough and stitched through the passage to the liner, the marker elements indicating a position of the prosthesis when the prosthesis is imaged within the body lumen, wherein the marker elements are not directly attached to the frame.

2. A prosthesis as in claim 1, wherein the marker elements are not in contact with the frame when the frame is radially expanded.

3. A prosthesis as in claim 1, wherein the plates comprise a material selected from the group consisting of tantalum, platinum, and gold.

4. An endoluminal prosthesis for deployment in a body lumen of a patient body, the prosthesis comprising:

a radially expandable tubular body having a proximal port, a distal port, and a lumen therebetween, the lumen defining a centerline; and

a plurality of marker elements which define a pattern when the prosthesis is imaged within the patient body, wherein each marker element comprises a high contrast plate and the pattern includes a gate disposed adjacent to the distal or proximal port, the gate comprising radially separated marker elements on opposed sides of the centerline when the prosthesis is properly orientated so as to facilitate deployment of a secondary prosthetic module within the adjacent port of the prosthesis.

5. A prosthesis as claimed in claim 4, wherein the pattern includes two axially separated gates defining an allowable prosthetic overlap region therebetween.

6. A prosthesis as claimed in claim 4, wherein the pattern includes at least one marker element that is rotatably alignable with the centerline within the body lumen.

7. A prosthesis as claimed in claim 6, wherein the pattern includes two marker elements which are roughly radially opposed relative to the centerline, wherein the two marker elements are axially offset.

8. A prosthesis as claimed in claim 4, wherein the prosthesis comprises a bifurcated tubular body having a trunk portion, a first branch portion, and a branch port for receiving a second branch portion, and wherein the pattern includes at least one marker element adjacent the distal end of the prosthesis which indicates the orientation of the branch port before deployment of the branch port.

9. An endoluminal body lumen marker for use in positioning a later deployed endoluminal prosthesis in a body lumen of a patient high contrast plate, the lumen marker comprising a body which produces a sharp contrast when imaged within the body lumen, and a support structure which maintains a position of the lumen marker within the body lumen until the prosthesis is positioned and deployed across the lumen marker.

10. A body lumen marker as claimed in claim 9, wherein the support structure comprises a barbed protrusion for attaching the plate to the lumenal wall.

11. A body lumen marker as claimed in claim 9, wherein the deployed marker has an axial length of less than about 2 cm.

12. A body lumen marker as claimed in claim 9, wherein the support structure comprises a radially expandable radiopaque band which engages the surrounding body lumen and which marks an axial target location for an end of the prosthesis.

13. A body lumen marker as claimed in claim 12, wherein the band comprises a helical coil before radial expansion.

14. A body lumen marker as claimed in claim 12, further comprising a conformable tubular gasket which expands with the band and which seals between the prosthesis and the surrounding body lumen when an end of the prosthesis is deployed within the axial target location.

15. A body lumen marker as claimed in claim 14, further comprising a hook extending from the imagable body roughly opposite the barbed protrusion to anchor the prosthesis deployed over the imagable body.

16. An endoluminal stent-graft comprising:

a tubular liner having a lumen which defines an axis; and

a tubular frame supporting the liner, the frame having a plurality of marker elements integrally formed with the tubular Frame, the marker elements defining a pattern which indicates a position of the prosthesis when the prosthesis is imaged within the body lumen.

17. A stent-graft as claimed in claim 16, wherein the frame comprises a radiopaque material, and wherein the marker elements comprise portions that are wider than adjacent expandable structural elements of the frame to provide an enhanced radiographic contrast.

18. A method for assembling an endoluminal prosthesis at a target location of a body lumen, the method comprising:

introducing a first tubular endoluminal prosthetic module into the body lumen;

positioning the first module adjacent to the target location;

radially expanding the first module to deploy the module adjacent to the target location, the expanded first module having first and second marker elements disposed adjacent to a port, wherein each marker element comprises a high contrast plate;

introducing a second tubular prosthetic module into the body lumen; and

positioning the second module within the port of the first module by imaging the first module and axially advancing the second module between the first and second marker elements.

19. A method as claimed in claim 18, wherein the second module positioning step further comprises axially advancing the second module within the port beyond the first and second marker elements while the images of the first and second marker elements are visible on opposite sides of the second module.

20. A method as claimed in claim 19, wherein the second module positioning step further comprises axially positioning an element of the second module within the port between an axial position of the first and second marker elements and an axial position of third and forth marker elements of the first module.

21. A method for positioning a tubular endoluminal prosthesis at a target location of a body lumen, the method comprising:

introducing a guidewire through the body lumen and advancing the guidewire beyond the target location;

advancing the prosthesis over the guidewire so that the guidewire passes through a lumen of the prosthesis;

radially orienting the prosthesis by imaging the prosthesis within the body lumen and aligning an image of a marker element of the prosthesis with an image of the guidewire, wherein, the marker element comprises a high contrast plate.

22. A method for positioning a tubular endoluminal prosthesis at a target location of a body lumen, the method comprising:

introducing the prosthesis into the body lumen;

positioning the prosthesis adjacent to the target location;

radially orienting the prosthesis by imaging the prosthesis within the body lumen and aligning an image of a first marker element of the prosthesis with an image of a second marker element of the prosthesis, wherein the first and second marker elements each comprise a high contrast plate and are axially offset from each other.

23. A method for verifying the radial orientation of a port of a branching tubular endoluminal prosthesis within a body lumen, the method comprising:

introducing the prosthesis into the body lumen;

radially orienting the prosthesis;

deploying an end of the prosthesis which is separated from the port by axially withdrawing a surrounding sheath and allowing the prosthesis end to expand resiliently; and

imaging at least one port orientation indicating marker element disposed on the expanded end of the prosthesis while the prosthesis adjacent the port remains compressed, wherein the marker element comprises a high contrast plate.

24. A method for deploying an endoluminal prosthesis, the method comprising:

introducing a marker element into a body lumen and deploying the marker element so as to mark a target location of the body lumen;

introducing the prosthesis into the body lumen;

aligning the prosthesis with the deployed marker element; and

deploying the aligned prosthesis within the body lumen.

25. A method as claimed in claim 24, further comprising imaging the marker element and prosthesis in the body lumen to determine changes in their relative positions.

26. An endoluminal prosthesis comprising:

a frame comprising a high-strength material; and

a marker element comprising a high-contrast imagable material

wherein the high-strength and high-contrast materials have similar electromotive force characteristics to avoid corrosion.

27. A prosthesis as claimed in claim 26, wherein the high-strength material comprises a shape memory alloy, and wherein the high-contrast material comprises tantalum.