Enhanced radioactive stent for reduction of restenosis

• US 6,179,789 B1
• Filed: 05/03/1999
• Issued: 01/30/2001
• Est. Priority Date: 05/03/1999
• Status: Expired due to Fees

• Current Assignee: Irvine Biomedical, Inc. (Abbott Laboratories)
• Original Assignee: Hosheng Tu, Lily Chen Tu
• Inventors: Tu, Lily Chen, Tu, Hosheng
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/304,598
• Time in Patent Office: 638 Days
• Field of Search: 600/585, 600/433, 600/434, 600/436, 600/1, 600/2, 606/108, 606/194, 606/195, 606/198
• US Class Current: 600/585
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00154 containing and delivering drugs
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

An ablation apparatus system for treating tissues or atherosclerosis on a patient having a stent or a metallic implant, wherein said stent or metallic implant comprises a coating layer including a carrier composed of a biocompatible material and having dispersed therein a radioactive substance, the ablation apparatus system comprising an electrical conducting wire that is coupled to an external radiofrequency generator for delivering the radiofrequency current to the stent or the metallic implant for the purposes of thermally enhanced irradiation capability for tissue therapeutic treatment.

Claims

1. An ablation apparatus system comprising:

a vascular stent, wherein the vascular stent comprises a non-radioactive elongated metallic tube having open ends, and a sidewall containing a multiplicity of openings therethrough to allow said stent to be expanded radially for deployment in a blood vessel subjected to angioplasty so as to maintain the lumen of blood vessel open;

wherein a thin coating on an exterior surface of the tube, said coating including a carrier composed of a biocompatible material and having dispersed therein a radioactive substance;

detachable conducting wire means for detachably contacting said tube, said detachable conducting wire means having a wire distal end and a wire proximal end, wherein the wire distal end is to contact the elongated metallic tube and the wire proximal end is coupled to a radiofrequency current source; and

a radiofrequency current generating means for generating radiofrequency current and for generating heat within the tissue, wherein the radiofrequency current is transmitted to the vascular stent through the detachable conducting wire means so that the radioactive substance diffuses more quickly into the heated tissue for prolonged radiotherapy for tissue treatment.

2. The ablation apparatus system of claim 1, wherein the biocompatible material for the coating is a biodegradable material.

3. The ablation apparatus system as in claim 1 further comprising at least one temperature sensor, wherein the temperature sensor is disposed at close proximity of the wire distal end.

4. The ablation apparatus system as in claim 1 further comprising at least one temperature sensor, wherein the temperature sensor is disposed on the elongated metallic tube.

5. The apparatus system as in claim 3 or 4 further comprising temperature control means for controlling a temperature sensed from the at least one temperature sensor, wherein the temperature measured from the temperature sensor is relayed to the temperature control means and is adapted to effect the radiofrequency current delivery to the vascular stent.

6. The ablation apparatus system of claim 1, wherein the radiofrequency current is within the range of 50 to 2,000 kHz.

7. The ablation apparatus system of claim 1, wherein the detachable conducting wire means is selected from the group consisting of a guidewire, a spiral wire, a catheter wire, a catheter probe having an electrical conducting wire, and a combination thereof.

8. The ablation apparatus system of claim 1, wherein the biocompatible material for the coating is a thermally degradable material.

9. A method of preventing restenosis of a blood vessel which has undergone angioplasty to open a restricted region of a lumen of the vessel, the method comprising inserting a stent into the blood vessel and deploying the stent to contact the vessel wall at the site of the restricted region;

irradiating the tissue in the wall at said site with a radioactive substance in a coated layer which is coated to an exterior surface of the stent; and

providing radiofrequency current from a radiofrequency current generator to the stent and heat to the surrounding vessel wall through an electrical conducting wire so that the radioactive substance diffuses more quickly into the heated tissue for prolonged radiotherapy.

10. The method of preventing restenosis of a blood vessel as in claim 9, the method further comprising the stent having a coated layer composed of thermally degradable material so that the radioactive substance is being embedded in the tissue in the wall.

11. The method of preventing restenosis of a blood vessel as in claim 9, the method further comprising the electrical conducting wire having a temperature sensor, wherein the temperature sensor is disposed at a distal end of the electrical conducting wire.

12. The method of preventing restenosis of a blood vessel as in claim 10, the method further comprising the radiofrequency current generator having a temperature control means, wherein a temperature measured from the temperature sensor is relayed to the temperature control means and adapted to effect the radiofrequency current delivery to the stent.

13. The method of preventing restenosis of a blood vessel as in claim 9, the method further comprising the radiofrequency current generator having the radiofrequency current within the range of 50 to 2,000 kHz.

14. The method of preventing restenosis of a blood vessel as in claim 9, wherein the electrical conducting wire is selected from the group consisting of a guidewire, a spiral wire, a catheter wire, a catheter probe having an electrical conducting wire, and a combination thereof.

15. A method for treating tissues of a patient having a metallic implant, said metallic implant having a thin coating on an exposed surface of said implant and said coating including a carrier composed of a biocompatible material and having dispersed therein a radioactive substance that diffuses readily in contact with heated tissue;

the method comprising the steps of;

(a) inserting detachable conducting wire means for detachably contacting said metallic implant, said detachable conducting wire means having a wire distal end and a wire proximal end, wherein the wire distal end is to contact the metallic implant and the wire proximal end is to be coupled to a radiofrequency current source; and

(b) applying radiofrequency current from a radiofrequency current generating means to the metallic implant through the detachable conducting wire means so that the radioactive substance diffuses more quickly into the heated tissue for prolonged radiotherapy.

16. The method for treating tissues of a patient having a metallic implant as in claim 15, wherein the metallic implant is a stent.

17. The method for treating tissues of a patient having a metallic implant as in claim 15, wherein the metallic implant has a coated layer composed of thermally degradable material so that the radioactive substance is being embedded in the tissue.

18. The method for treating tissues of a patient having a metallic implant as in claim 15, wherein the detachable conducting wire means comprises a temperature sensor disposed at a distal end of the detachable conducting wire means.

19. The method for treating tissues of a patient having a metallic implant as in claim 15, wherein the radiofrequency current generating means comprises temperature control means, wherein a temperature measured from the temperature sensor is relayed to the temperature control means and adapted to effect the radiofrequency current delivery to the metallic implant.

20. The method for treating tissues of a patient having a metallic implant as in claim 15, wherein the radiofrequency current generating means has the radiofrequency current within the range of 50 to 2,000 kHz.