Temporary radioisotope stent

• US 6,013,019 A
• Filed: 04/06/1998
• Issued: 01/11/2000
• Est. Priority Date: 04/06/1998
• Status: Expired due to Fees

• Current Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Original Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/055,484
• Time in Patent Office: 645 Days
• Field of Search: 600/3, 600/11, 604/93, 604/96, 604/97, 604/280, 604/101, 604/104, 606/194, 606/108, 606/198, 606/191, 606/192
• US Class Current: 600/3
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

The temporary radioisotope stent catheter system of the present invention includes a temporary radioisotope stent that is situated at a distal portion of two, co-axially situated, thin-walled tubes. The catheter system can be delivered into a vessel of a human body either as a stand-alone device or it can be used in conjunction with an elongated cylindrical sheath which is a form of delivery catheter. If used as a stand-alone device, the temporary radioisotope stent is first percutaneously advanced through a guiding catheter and is then placed at the site of a stenotic dilatation. An operating means located at a proximal portion of the catheter system is then used to increase the diameter of the temporary radioisotope stent to be approximately equal to the inside diameter of the dilated stenosis. The temporary radioisotope stent is then retained at that position for an irradiation time period that is determined by the level of radioactivity of the stent, by the diameter of the dilated stenosis, and by the dose of radiation that is prescribed for application to that portion of the artery. At the conclusion of the irradiation time period, the operating means at the proximal portion of the catheter system is used to decrease the diameter of the temporary radioisotope stent to its minimum value, and then the catheter system is removed from the patient'"'"'s body.

Claims

1. A temporary radioisotope stent catheter system for applying radiation at the site of a dilated stenosis within a vessel of the human body, the catheter system comprising:

an elongated, cylindrical, inner shaft having a proximal end and a distal end;

an elongated, cylindrical, thin-walled outer shaft having a proximal end and a distal end, the outer shaft being situated coaxially around the inner shaft and being adapted to move slideably relative to the inner shaft;

a temporary radioisotope stent having a multiplicity of longitudinal struts, each longitudinal strut including a radioactive source, the radioactive source having the capability for irradiating the tissue of the dilated stenosis when the longitudinal struts are deployed radially outward so that at least one of the struts is in contact with the inner surface of the dilated stenosis, the temporary radioisotope stent also having a proximal end that is fixedly attached to the distal end of the outer shaft and a distal end that is fixedly attached to the distal end of the inner shaft; and

a temporary radioisotope stent operating means that is adapted to move the inner shaft in a longitudinal direction relative to the outer shaft, the temporary radioisotope stent being deployed radially outward when the inner shaft is moved in a proximal direction relative to the outer shaft and the temporary radioisotope stent being retracted radially inward when the inner shaft is moved in a distal direction relative to the outer shaft.

2. The catheter system of claim 1 wherein the inner shaft is a solid wire.

3. The catheter system of claim 1 wherein there are at least eight longitudinal struts.

4. The catheter system of claim 1 wherein there are at least four longitudinal struts.

5. The catheter system of claim 1 wherein the radioactive source is a beta particle emitter.

6. The catheter system of claim 5 wherein the beta particle emitter is strontium-90.

7. The catheter system of claim 5 wherein the beta particle emitter is yttrium-90.

8. The catheter system of claim 5 wherein the beta particle emitter is phosphorous-32.

9. The catheter system of claim 1 wherein the radioactive source is a low energy x-ray emitter.

10. The catheter system of claim 1 wherein at least that part of the longitudinal strut that contains the radioactive source is a thin-walled cylinder.

11. The catheter system of claim 1 wherein the radioactive source has a proximal end and a distal end and has one radiopaque marker placed at the source'"'"'s proximal end and a second radiopaque marker placed at the source'"'"'s distal end.

12. The catheter system of claim 1 wherein there is one radiopaque marker band placed at the proximal end of the temporary radioisotope stent and one radiopaque marker band placed at the distal end of the temporary radioisotope stent.

13. The catheter system of claim 1 wherein the catheter system includes a tapered distal tip to enhance insertion through the vascular system of the human body.

14. The catheter system of claim 1 wherein the distal tip has a through hole for insertion over a guide wire for over-the-wire insertion of the catheter system.

15. The catheter system of claim 1 wherein the distal tip has a proximal guide wire exit port by means of which rapid exchange capability is obtainable for the catheter system.

16. The catheter system of claim 1 wherein each longitudinal strut consists of a multiplicity of comparatively rigid sections and a multiplicity of flexible sections and a central section which is comparatively rigid, these sections being adapted to cause radial expansion of the central section when the inner shaft is longitudinally displaced in a proximal direction relative to the outer shaft.

17. The catheter system of claim 1 wherein the operating means includes an inner shaft distal screw to which is joined a holding nut.

18. The catheter system of claim 1 wherein the operating means includes a threaded outer shaft adjustment screw and a threaded adjustment nut.

19. The catheter system of claim 18 wherein the outer shaft adjustment screw includes a stent diameter indicator scale that indicates the diameter to which the temporary radioisotope stent has been radially expanded.

20. The catheter system of claim 18 wherein the longitudinal position of the inner shaft is adjustable relative to the outer shaft by means of the threaded adjustment nut.

21. The catheter system of claim 20 wherein the threaded adjustment nut has a leading edge and the diameter of the temporary radioisotope stent is indicated by the position of the leading edge of the threaded adjustment nut relative to a stent diameter indicator scale that is fixedly attached to the proximal end of the outer shaft.

22. The catheter system of claim 1 wherein the inner shaft and the outer shaft are each thin-walled metal tubes.

23. The catheter system of claim 22 wherein the metal of the metal tubes is stainless steel.

24. The catheter system of claim 22 wherein the metal of the metal tubes is Nitinol.

25. The catheter system of claim 22 wherein at least one of the metal tubes is cut through in such a manner as to increase the longitudinal flexibility of that tube.

26. The catheter system of claim 22 wherein the metal tube forming the inner shaft and the metal tube forming the outer shaft are both cut through in such a manner as to increase longitudinal flexibility.

27. The catheter system of claim 22 wherein at least one of the metal tubes is cut through in such a manner that the more distal sections of that tube have a greater longitudinal flexibility as compared to the flexibility of a more proximal section of the at least one tube.

28. A temporary radioisotope stent catheter system for the treatment of a dilated stenosis in a vessel of a human body, the catheter system having a proximal portion that is adapted to be placed external to the human body and a distal portion that is adapted to be placed within the vessel of the human body at the site of the dilated stenosis, the distal portion of the catheter system including a radioactive, radially expandable, temporary radioisotope stent, the proximal portion of the catheter system having an operating means adapted to radially expand the temporary radioisotope stent, the operating means including a stent diameter indicator scale that indicates the diameter to which the operating means has expanded the temporary radioisotope stent.

29. The catheter system of claim 28 wherein the temporary radioisotope stent includes a beta particle emitting isotope.

30. The catheter system of claim 29 wherein the isotope is strontium-90.

31. The catheter system of claim 29 wherein the isotope is yttrium-90.

32. The catheter system of claim 29 wherein the isotope is phosphorous-32.

33. The catheter system of claim 28 wherein the catheter system includes a tapered distal tip having a proximal end and a distal end and a lumen through which a guide wire can be slideably placed, the distal tip also including a distal guide wire exit port located at the distal end of the distal tip through which the guide wire exits from the catheter system.

34. The catheter system of claim 33 wherein the guide wire lumen is centrally located and extends throughout the entire length of the distal tip thereby providing an over-the-wire capability for the catheter system.

35. The catheter system of claim 33 wherein the guide wire lumen in the distal tip has a proximal guide wire exit port located at the side of the distal tip near the proximal end of the distal tip thus providing a rapid exchange capability for the catheter system.

36. A temporary radioisotope stent catheter system for the irradiation of a dilated stenosis in a vessel of a human body, the catheter system comprising:

a flexible guide wire;

a sheath in the form of an elongated, cylindrical, hollow, elastomer tube; and

a temporary radioisotope stent catheter system having a proximal portion and a distal portion, the proximal portion being adapted to remain exterior to the human body and the distal portion being adapted to be placed through the sheath and into the vessel of the human body, the catheter system having a radioactive temporary radioisotope stent located at the distal portion of the catheter system, the temporary radioisotope stent being adapted to be advanced through the sheath and into the vessel of the human body, the catheter system also being adapted to place the temporary radioisotope stent at the site of the dilated stenosis within the vessel, the proximal portion of the catheter system having an operating means that is adapted to cause the radial expansion of the temporary radioisotope stent to a specific, pre-determined diameter that is approximately equal to the inside diameter of the dilated stenosis.

37. A method for irradiating a dilated stenosis in a vessel of a human body, the method comprising the following steps:

(a) advancing a temporary radioisotope stent that is located at a distal portion of a catheter system until the temporary radioisotope stent is situated at the site of the dilated stenosis in the vessel of the human body, the position of the temporary radioisotope stent being determined from one radiopaque marker band located proximal to the temporary radioisotope stent and one radiopaque marker band located just distal to the temporary radioisotope stent;

(b) actuating an operating means located at the proximal portion of the catheter system so as to expand the temporary radioisotope stent radially outward until the inside diameter of the temporary radioisotope stent is approximately equal to the diameter of the dilated stenosis;

(c) allowing a radioactive source which is formed as part of the temporary radioisotope stent to remain situated at the site of the dilated stenosis until a predetermined radiation dose has been received by the tissue of the dilated stenosis;

(d) adjusting the operating means at the proximal portion of the catheter system so as to cause the temporary radioisotope stent to be radially contracted; and

(e) removing the catheter system from the vessel of the human body.

38. A temporary radioisotope stent catheter system for applying radiation at the site of a dilated stenosis within a vessel of the human body, the catheter system comprising:

an elongated catheter having a proximal portion and a distal portion and having a radially expandable temporary radioisotope stent situated at the distal portion of the catheter and a temporary radioisotope stent operating means situated at the proximal portion of the catheter, the operating means being adapted to radially increase and radially decrease the diameter of the temporary radioisotope stent; and

an elongated perfusion sheath situated co-axially around the elongated catheter, the sheath having a proximal portion and a distal portion and also having an expandable section located at the distal portion of the sheath, the expandable section of the sheath having a pre-expanded state and an expanded state, the expandable section when in its expanded state being adapted to allow blood flow through the vessel at the site of the expandable section of the sheath.

39. The catheter system of claim 38 wherein the sheath forms an enclosure that prevents the blood from making contact with the catheter.

40. The catheter system of claim 38 wherein the expandable section of the sheath when in its expanded state allows blood to flow between the outer surface of the expandable section and the inner surface of the dilated stenosis.

41. The catheter system of claim 38 wherein the expandable section of the sheath includes at least one distal hole and one proximal hole which holes allow blood to pass through the expandable section so as to perfuse tissue that is located distal to the site of the expandable section of the sheath.

42. A radioisotope stent in the form of a thin-walled cylindrical structure, the radioisotope stent being adapted to irradiate a dilated stenosis in a vessel of a human body, the dilated stenosis having an interior, generally cylindrical surface, the radioisotope stent consisting of a multiplicity of metal struts that are placed in close proximity to the inner surface of the dilated stenosis, the struts including a radioactive source which radioactive source does not come in direct contact with the inner surface of the dilated stenosis.

43. The radioisotope stent of claim 42 wherein a metal structure prevents the radioactive source from being in contact with the inner surface of the dilated stenosis.

44. The radioisotope stent of claim 42 wherein an elastomer material is situated between the radioactive source of the radioisotope stent and the interior, generally cylindrical surface of the dilated stenosis thereby preventing the radioactive source from making direct contact with the inner surface of the dilated stenosis.