Catheter system having tubular radiation source

• US 6,676,590 B1
• Filed: 12/08/1997
• Issued: 01/13/2004
• Est. Priority Date: 03/06/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Ehr, Timothy G. J., Hastings, Roger N., Urick, Michael J.
• Primary Examiner(s): Lacyk; John P.
• Application Number:
  US08/984,490
• Time in Patent Office: 2,227 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

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.

Claims

1. A radiation source for inhibiting restenosis comprising:

a tube, said tube having a lumen and a distal region, said distal region being radioactive, wherein said lumen is adapted to receive a core wire, said tube being slidable over the core wire, and wherein said tube has an outer surface adapted to slide within a balloon catheter.

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:

an elongate tubular shaft having a lumen, a proximal region and a distal region;

an inflatable balloon disposed about said shaft distal region, said balloon having a distal region, said balloon defining a balloon interior and exterior, said balloon interior being sealed with respect to fluid communication with said balloon exterior;

a radiation source guide wire extending through said shaft lumen and through said balloon to said balloon distal region, said radiation source guide wire being operably attached to said balloon distal region; and

an elongate radiation delivery tube, said delivery tube having a lumen to receive said radiation source guide wire and a distal region, said delivery tube distal region being radioactive, said delivery tube being slidable over said radiation source guide wire,

such that said balloon is inflatable by infusing said tubular shaft lumen with inflation fluid,

such that said radiation delivery tube is advancable over said radiation source guide wire, within said tubular shaft lumen, and into said balloon interior.

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/Re₁₀₆.

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:

an elongate outer tube having a lumen, a proximal region and a distal region;

an inflatable balloon disposed proximate said outer tube distal region, said balloon defining a balloon, interior and exterior, said balloon interior being sealed with respect to fluid communication with said balloon exterior;

an elongate inner tube having a lumen, a proximal port, a distal region, and a closed distal end, said inner tube being disposed within said outer tube, said inner tube distal region being disposed inside said balloon;

an inflation lumen defined between said inner and outer tubes, said inflation lumen being in fluid communication with said-balloon interior;

a radiation source guide wire extending through said inner tube lumen and being fixed in said inner tube distal region; and

an elongate radiation delivery tube, said delivery tube having a lumen to receive said radiation source guide wire and a distal region, said delivery tube distal region being radioactive, said delivery tube being slidable over said radiation source guide wire,

such that said balloon is inflatable by infusing said inflation lumen with inflation fluid,

such that said radiation delivery tube is advancable over said radiation source guide wire, within said inner tube lumen, and into said balloon interior.

18. A catheter system for inhibiting restenosis comprising:

an elongate tubular shaft having a lumen, a proximal region and a distal region;

an inflatable balloon disposed proximate said shaft distal region, said balloon having a distal region, said balloon defining a balloon interior and exterior, said balloon interior being sealed with respect to fluid communication with said balloon exterior;

a radiation source guide wire extending through said shaft lumen and through said balloon, said radiation source guide wire being operably attached to said balloon distal region; and

an elongate radiation delivery tube, said delivery tube having a lumen to receive said radiation source guide wire and a distal region, said delivery tube distal region being radioactive, said delivery tube being slidable over said radiation source guide wire,

such that said balloon is inflatable by infusing said tubular shaft lumen with inflation fluid,

such that said radiation delivery tube is advancable over said radiation source guide wire, within said tubular shaft lumen, and into said balloon interior.

19. A method for inhibiting restenosis comprising:

providing a radiation delivery catheter including an elongate tubular shaft having a lumen, a proximal region and a distal region,

an inflatable balloon disposed proximate said shaft distal region, said balloon defining a balloon interior and exterior, said balloon interior being sealed with respect to fluid communication with said balloon exterior, a radiation source guide wire extending through said shaft lumen and through said balloon to said balloon distal region, said radiation source guide wire being operably attached to said balloon distal region;

providing an elongate radiation delivery tube, said delivery tube having a lumen and a distal region, said delivery tube distal region being radioactive, said delivery tube being slidable over said radiation source guide wire, such that said balloon can be inflated by infusing said tubular shaft lumen with inflation fluid, such that said radiation delivery tube is advancable over said radiation source guide wire, within said tubular shaft lumen, into said balloon interior;

inserting said catheter distal region into the vascular system of a patient;

advancing said catheter distal region to a site to be treated;

inserting said radiation source guide wire into said. radiation delivery tube lumen;

advancing said radiation delivery tube over said radiation. source guide wire and within said tubular shaft lumen;

further advancing said radiation delivery tube within said balloon interior;

inflating said balloon;

exposing said treatment site to radiation;

deflating said balloon; and

retracting said catheter and radiation delivery tube from said patient.

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

providing a radiation shielding vault having a channel therethrough;

housing said radiation delivery tube distal region in said vault channel prior to use; and

advancing said radiation delivery tube distal region into said catheter lumen.