Fluoroscopically-visible flexible graft structures

• US 6,048,362 A
• Filed: 01/12/1998
• Issued: 04/11/2000
• Est. Priority Date: 01/12/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Cardiovascular Group Incorporated
• Inventors: Berg, Todd Allen
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/005,533
• Time in Patent Office: 820 Days
• Field of Search: 623/1, 623/12, 623/1.34
• US Class Current: 623/1.34
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A fluoroscopically-visible graft structure is provided. The graft structure may be formed from a tubular metal wire mesh coated with an elastomeric material. The graft structure is flexible and distensible like natural body organ tubing and is suitable for repairing or replacing body organ tubing such as vascular tubing (e.g., arteries and veins). A radiopaque filler compound may be provided throughout a substantial portion of the graft structure or throughout the entire graft structure, so that a physician can determine the size and location of the graft structure during implantation of the graft structure in the body of a patient. The radiopacity of the graft structure also allows the physician to monitor status of the graft structure after installation. The radiopacity of the graft structure is preferably sufficient to allow the graft structure to be clearly viewable on a fluoroscope, but is not so great that the radiopacity of the graft obscures radiopaque dyes introduced into the patient and passed through the graft.

Claims

1. A fluoroscopically-visible flexible graft structure for installation in the body of a patient, comprising:

a flexible elastic tubular structure having a frame and an elastic fluid-retaining coating that covers the frame; and

a radiopaque substance distributed throughout a substantial portion of the coating so that the elastic tubular structure is fluoroscopically visible when the graft is inside the body of the patient.

2. The graft structure defined in claim 1 wherein the frame comprises a metal mesh frame for supporting the elastic tubular structure.

3. The graft structure defined in claim 2 wherein the metal mesh frame further comprises a nitinol mesh frame.

4. The graft structure defined in claim 2 wherein the coating comprises an elastic coating on the metal mesh frame.

5. The graft structure defined in claim 2 wherein the coating comprises a silicone coating on the metal mesh frame.

6. The graft structure defined in claim 1 wherein radiopaque dye is introduced into the elastic tubular structure, the graft structure further comprising a quantity of the radiopaque substance that allows the graft structure to be fluoroscopically viewed without obscuring the radiopaque dye.

7. The graft structure defined in claim 1 wherein the radiopaque substance comprises a radiopaque filler compound containing a metal selected from the group consisting of:

barium, bismuth, and tungsten.

8. The graft structure defined in claim 1 wherein the radiopaque substance is distributed substantially throughout the entire coating.

9. A method for using a fluoroscopically-visible flexible graft structure inside the body of a patient, comprising the steps of:

installing a flexible graft structure in the body of the patient that has a flexible elastic tubular structure having a frame and an elastic fluid-retaining coating that covers the frame with a radiopaque substance distributed throughout a substantial portion of the coating; and

fluoroscopically viewing the flexible graft structure when the flexible graft structure is inside in the body of the patient.

10. The method defined in claim 9 wherein the step of installing the flexible graft structure having a frame and an elastic fluid-retaining coating that covers the frame further comprises the step of installing a flexible graft structure having a metal mesh frame that supports the elastic tubular structure.

11. The method defined in claim 10 wherein the step of installing the flexible graft structure having the metal mesh frame further comprises the step of installing a flexible graft structure having a nitinol mesh frame that supports the elastic tubular structure.

12. The method defined in claim 10 wherein the step of installing the flexible graft structure having the metal mesh frame further comprises the step of installing a flexible graft structure having an elastic tubular structure with an elastic coating formed on the metal mesh frame.

13. The method defined in claim 10 wherein the step of installing the flexible graft structure having the metal mesh frame further comprises the step of installing a flexible graft structure having an elastic tubular structure with a silicone coating formed on the metal mesh frame.

14. The method defined in claim 9 further comprising the steps of:

introducing radiopaque dye into the flexible graft structure; and

fluoroscopically viewing the radiopaque dye within the flexible graft structure without obscuring the radiopaque dye with the graft structure.

15. The method defined in claim 9 wherein the step of installing the flexible graft structure further comprises the step of installing a flexible graft structure having a radiopaque filler compound containing a metal selected from the group consisting of:

barium, bismuth, and tungsten.

16. The method defined in claim 9 wherein the step of installing the flexible graft structure that has a flexible elastic tubular graft structure having a frame and an elastic fluid-retaining coating that covers the frame further comprises the step of installing a flexible graft structure having an elastic tubular structure in which the radiopaque substance is distributed substantially throughout the entire coating.