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Catheter system having tubular radiation source

Imported: 24 Feb '17 | Published: 13 Jan '04

Michael J. Urick, Timothy G. J. Ehr, Roger N. Hastings

USPTO - Utility Patents

Abstract

A radiation source for inhibiting restenosis including a radiation delivery tube having a radioactive distal region, the tube being adapted to slide over a guide wire within a radiation delivery catheter. One tube has radioactive material incorporated into the tube wall material. Another tube has radioactive material secured to the tube surface. One radiation delivery balloon catheter includes a common inflation and radiation delivery lumen, the lumen being sealed distally and having a radiation source guide wire within the lumen. The lumen is sealed from contact with bodily fluids and is filled with inflation fluid during use. In use, the catheter balloon is advanced to a site to be treated, the balloon inflated, and the radioactive tube advanced over the radiation source guide wire within the lumen.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary, longitudinal cross-sectional view of a radiation delivery tube having a radioactive distal region disposed over a radiation source guide wire and disposed within a radiation shielding vault coupled to a transfer tube;

FIG. 2 is a fragmentary, longitudinal cross-sectional view of the vault, transfer tube, radiation delivery tube, and radiation source guide wire of FIG. 1 coupled to a radiation delivery catheter proximal end;

FIG. 3 is a fragmentary, longitudinal cross-sectional view of a fixed wire radiation delivery balloon catheter having the radioactive region of the radiation delivery tube of FIG. 1 inserted within the balloon;

FIG. 4 is a schematic cross section of a preferred catheter management system including a vault having a tubular radiation source path therethrough including multiple bends to shield against radiation exposure in both a radial and longitudinal direction and a reel assembly which contains the non-radioactive portion of the tubular body;

FIG. 5 is a plan view of a preferred radioactive tubular body construction incorporating a guide wire slot extending from the proximal end of the tubular body to a point proximate the radioactive portion of the tubular body and also incorporating a plurality of cutouts to increase flexibility of the distal portion of the tubular body;

FIG. 6 schematically depicts a two-piece tubular radiation source which includes a detachable distal portion having the radioactive source thereon and a long proximal member for attachment thereto;

FIG. 7 is a fragmentary, longitudinal cross-sectional view of the balloon of FIG. 3;

FIG. 8 is a fragmentary, longitudinal view of the balloon portion of a single operator exchange catheter embodiment having a catheter guide wire disposed within a distal guide wire lumen;

FIG. 9 is a fragmentary, longitudinal cross-sectional view of a radiation delivery balloon catheter having a radiation delivery tube disposed within an inner tube which is in turn disposed within an outer inflation tube;

FIG. 10 is a fragmentary, longitudinal cross-sectional view of a delivery catheter incorporating a separate radiation delivery lumen, a separate inflation lumen and a combination perfusion lumen and single operator exchange guide wire lumen;

FIG. 11 is a fragmentary cross-sectional view of a manifold assembly for use in conjunction with the catheter of FIG. 10 depicting the core wire extending proximally from the proximal end of the manifold;

FIG. 12 is a cross section of the catheter of FIG. 10 at line

12

12;

FIG. 13 is a cross section of the proximal shaft portion of the catheter of FIG. 10 at line

13

13;

FIG. 14 is a cross section of an alternative proximal shaft portion similar to that of FIG. 13 incorporating a dual lumen extrusion for the proximal shaft; and

FIG. 15 is a cross section of an alternative proximal shaft portion similar to FIG. 13 which depicts the use of multiple separate tubular shafts which are bundled to form the proximal shaft portion.

Claims

1. A radiation source for inhibiting restenosis comprising:

2. A radiation source as recited in claim 1 wherein said tube is formed of metal.

3. A radiation source as recited in claim 1 wherein said tube has tube walls and said tube distal radioactive region includes radioactive material incorporated in said tube walls.

4. A radiation source as recited in claim 1 wherein said tube has a surf ace and said tube distal radioactive region includes radioactive material secured to said distal region surface.

5. A radiation source as recited in claim 1 wherein said tube has an exterior surface and said tube distal radioactive region includes radioactive wire wound about said distal region exterior surface.

6. A radiation source as recited in claim 1 wherein said tube is formed of metal and said tube distal radioactive region is formed of radioactive metal.

7. A radiation source as recited in claim 1 wherein said tube has a tube wall and a longitudinal slit through said tube wall, such that the guide wire is slidable through said longitudinal slit.

8. A radiation source as recited in claim 7 wherein said slit does not extend through at least a portion of said tube distal region.

9. A radiation source as recited in claim 1 wherein said tube distal region has a proximal guide wire port.

10. A radiation source as recited in claim 1 further comprising a shaft having a distal region, wherein said tube is disposed on said shaft distal region.

11. A catheter system for inhibiting restenosis comprising:

12. A catheter system as recited in claim 11 wherein said balloon includes a plurality of lobes.

13. A catheter system as recited in claim 11 wherein said balloon includes a plurality of tubular balloon segments disposed transversely about said radiation source guide wire.

14. A catheter system as recited in claim 11 wherein said radiation source is Ru/Re

106.

15. A catheter system as recited in claim 11 wherein said radiation delivery tube is formed from Nitinol.

16. A catheter system as recited in claim 11 wherein said radiation delivery tube is a polymeric tube formed from polyethylene.

17. A catheter system for inhibiting restenosis comprising:

18. A catheter system for inhibiting restenosis comprising:

19. A method for inhibiting restenosis comprising:

20. A method for inhibiting restenosis as recited in claim 19 further comprising the steps: