Endoluminal prostheses having position indicating markers

• US 5,824,042 A
• Filed: 04/05/1996
• Issued: 10/20/1998
• 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: Evans, Michael A., Lenker, Jay A., Gittings, Darin C., Will, Allan R., Lombardi, Sylvie, Kim, Steven W.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Black, John M.
• Application Number:
  US08/628,797
• Time in Patent Office: 928 Days
• Field of Search: 623/12, 606/194, 606/195, 606/198
• 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 imagable bodies attached to the liner, each imagable body comprising a plate having at least one passage therethrough to facilitate attaching the imagable body 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.

2. A prosthesis as claimed in claim 1, wherein the frame comprises a frame material, and wherein the plates comprise an high-contrast material which is different than the frame material.

3. A prosthesis as claimed in claim 2, wherein the frame material and the high-contrast material have a similar electromotive force to avoid corrosion in the body lumen.

4. A prosthesis as claimed in claim 3, wherein the frame material comprises a shape memory alloy, and wherein the high-contrast material comprises tantalum.

5. A prosthesis as claimed in claim 2, wherein the plates are sized and positioned on the liner so that the radially expanded frame is not in contact with the imagable bodies.

6. A prosthesis as claimed in claim 2, wherein the frame and imagable bodies are disposed outside the liner.

7. A prosthesis as claimed in claim 6, wherein the frame self-expands within the body lumen, and wherein the imagable bodies are disposed entirely within the frame when the frame is radially compressed in a delivery catheter so as to avoid interfering with radial compression of the frame.

8. A prosthesis as claimed in claim 1, wherein the frame comprises a tube defining a plurality of radial openings when expanded, and wherein images of at least some of the imagable bodies are visible through associated openings of the expanded frame.

9. A prosthesis as claimed in claim 1, wherein each imagable body comprises first and second opposed major surfaces, wherein the passage extends between the major surfaces, and wherein the first major surface is disposed adjacent the liner.

10. A prosthesis as claimed in claim 9, wherein each plate has two passages therethrough, and wherein the plate is stitched to the liner.

11. A prosthesis as claimed in claim 1, wherein the imagable bodies are radiopaque.

12. A prosthesis as claimed in claim 1, wherein the imagable bodies provide enhanced ultrasound images.

13. An endoluminal prosthesis system including the prosthesis of claim 1 and further comprising a delivery catheter sheath slidably disposable over the prosthesis, wherein the imagable bodies produce distinct images when the frame is compressed within the catheter and the prosthesis is imaged within the body lumen.

14. A prosthesis as claimed in claim 1, wherein each imagable body is formed from sheet stock by selectively removing material from around the plate and within the opening.

15. A prosthesis as claimed in claim 1, wherein each plate has a thickness, a width, and a length, wherein the width and the length of each plate are larger than the thickness, and wherein the plates contiguously enclose the openings without a joint.

16. A prosthesis as claimed in claim 15, wherein the thickness of the plate is at least about 0.002 inches.

17. 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, the frame comprising a tube defining a plurality of radial openings when expanded; and

a plurality of imagable bodies 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;

wherein the imagable bodies are visible through and appear substantially within associated openings of the expanded frame when the expanded prosthesis is imaged within the patient body.

18. A method for fabricating a position indicating endoluminal prosthesis for use in a body lumen of a patient body, the method comprising:

affixing a radially expandable frame to a tubular liner so that the frame supports the liner; and

attaching a plurality of marker elements to the liner so that the marker elements define a pattern, the marker elements comprising plates of a material capable of producing a sharp contrast when imaged so that the pattern indicates a position of the prosthesis when the prosthesis is imaged within the patient body wherein the expanded frame holds the liner such that the plates do not contact the frame within the body lumen.

19. A method as claimed in claim 18, wherein the attaching step comprises stitching through at least one opening in each marker element.

20. A method as claimed in claim 18, further comprising selecting the high contrast material to match an electromotive force of the frame so as to avoid corrosion in the body lumen.

21. A method as claimed in claim 18, further comprising cutting a plurality of the imagable bodies from sheet stock of the high contrast material.

22. A method as claimed in claim 21, further comprising removing material from the sheet stock to define an opening through the plate for attaching the plate to the liner.

23. A method as claimed in claim 22, further comprising rounding edges of the plates, wherein the attaching step comprises stitching the plates to the liner.

24. A method as claimed in claim 21, wherein the cutting step comprises laser cutting.

25. A method as claimed in claim 21, wherein the cutting step comprises die cutting.

26. A method as claimed in claim 21, wherein the cutting step defines a chain of the plates connected by detachable tabs.