Radioactive catheter

• US 5,199,939 A
• Filed: 02/23/1990
• Issued: 04/06/1993
• Est. Priority Date: 02/23/1990
• Status: Expired due to Term

• Current Assignee: Bruce Hedger, Michael D. Dake, Stephen Oesterle
• Original Assignee: Bruce Hedger, Michael D. Dake, Stephen Oesterle
• Inventors: Dake, Michael D., Oesterle, Stephen, Hedger, Bruce
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Lacyk, J.
• Application Number:
  US07/484,117
• Time in Patent Office: 1,138 Days
• Field of Search: 600/1-8, 128/656-659
• US Class Current: 600/3
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1025 Wires
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A method for preventing restenosis after angioplasty comprises internally radiating the treated portion of the lumen to prevent restenosis of the enlarged lumen portion. A device useful for radiating the treated portion comprises an elongated flexible catheter with radioactive means located in a distal section of the carrier. Stiffening elements are located along the length of the catheter to enable the catheter to be pushed through the tortuous segments of coronary or peripheral vasculature without crimping.

Claims

1. A device suitable for endoluminal radiation treatment of a portion of a coronary artery in humans, the device comprising:

(a) an elongated, flexible carrier having a proximal section and a distal section; and

(b) radioactive means positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive portion,

wherein the carrier is sized and has sufficient stiffness and flexibility to navigate a human coronary artery so that the radioactive segment can be placed in a selected portion of a human coronary artery, the radioactive means when so placed providing sufficient radiation in less than 30 minutes to prevent restenosis in the selected portion after angioplasty.

2. The device of claim 1 wherein the radioactive means provides from about 50 to about 500 millicuries per centimeter length of the radioactive portion.

3. The device of claim 1 wherein the radioactive means provides from about 100 to about 10,000 rads per hour measured at 3 millimeters from the longitudinal central axis of the carrier.

4. The device of claim 3 wherein the radioactive means provides from about 500 to about 5000 rads per hour measured at 3 millimeter from the longitudinal central axis of the carrier.

6. The device of claim 1 or 5 wherein the radioactive means provides from about 100 to about 1000 rads per hour along the length of the radioactive segment measured at 3 mm from the longitudinal axis of the carrier.

8. The device of claim 1 or 5 wherein the length of the radioactive segment is about equal to the length of the portion of the coronary artery to be treated.

40. The device of claim 1 or 5 wherein the carrier has an outer diameter of less than about 1 mm.

41. The device of claim 40 wherein the length of the carrier is at least about 90 cm.

5. The device suitable for treatment of a portion of a lumen in mammals, the device comprising:

(a) an elongated, flexible carrier having a proximal section, an intermediate section, and a distal section; and

(b) at least three separate stiffening elements immovably located along the length of the carrier so that the proximal section of the carrier is the stiffest section of the carrier and the distal section of the carrier is the most flexible section of the carrier so that the intermediate section of the carrier has a stiffness intermediate the stiffness of the proximal section and the stiffness of the distal section, so that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the carrier; and

(c) radioactive means positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment,

wherein the carrier is sized and has sufficient stiffness and flexibility to navigate a human coronary artery so that the radioactive portion can be placed in a selected portion of a human coronary artery, the radioactive means when so placed providing sufficient radiation in less than 30 minutes to prevent restenosis in the selected portion after angioplasty.

7. The device of claim 5 wherein the carrier has a substantially constant outer diameter, a substantially constant inner diameter, and is composed of a material whose composition does not vary along the length of the carrier.

9. The device of claim 5 including an introducing catheter through which the carrier is pushed, the inner diameter of the introducing catheter being larger than the outer diameter of the carrier and the length of the carrier being greater than the length of the introducing catheter.

10. The device of claim 5 wherein the radioactive means comprises a plurality of radioactive beads in the radioactive segment of the carrier, the beads being sufficiently spaced apart from each other that the radioactive segment is sufficiently flexible to navigate tortuous turns in the lumen by pushing on the proximal section without crimping of the carrier, the stiffening element in the distal section of the carrier not extending into the radioactive segment.

11. A device suitable for endoluminal radiation treatment of a portion of lumen in a mammal, the device comprising:

(a) a hollow, elongated flexible tube having an axial passage, the tube having a proximal section, a distal section, and an intermediate section between the proximal and distal sections, the distal section including a distal end, the tube having a substantially constant outer diameter, a substantially constant inner diameter, and being composed of a material whose composition does not vary along the length of the carrier;

(b) radioactive means positioned in a radioactive segment of the distal section of the tube proximate to the distal end, the radioactive means providing sufficient radiation, in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment, that when the radioactive portion is placed in the portion of the lumen for an exposure time less than 30 minutes, restenosis in the portion of the lumen is prevents; and

(c) at least three separate stiffening elements immovably and serially located within the tube and extending longitudinally along the axial passage of the tube for differentially stiffening the proximal, intermediate, and distal sections of the tube, the stiffening elements being selected so that the proximal section of the tube is the stiffest section of the tube, the distal section of the tube is the most flexible section of the tube, and the intermediate section of the tube has a stiffness intermediate the stiffness of the proximal section and the stiffness of the distal section so that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the tube.

12. The device of claim 11 wherein the stiffening element in the distal section is a hollow tube stiffener element formed of the same material as the hollow tube.

13. The device of claim 11 wherein the axial passage of the tube is circular in cross-section and the stiffening elements are circular in transverse cross section and have a sufficiently large outer diameter that they are in frictional engagement with the inner wall of the tube.

14. The device of claim 11 wherein each stiffening element has substantially the same flexibility along its length.

15. The device of claim 11 wherein the radioactive means comprises a plurality of radioactive beads in the radioactive segment of the tube, the beads being sufficiently spaced apart from each other that the radioactive segment is sufficiently flexible to navigate tortuous turns in the lumen by pushing on the proximal section without crimping of the tube, the stiffening element in the distal section of the tube not extending into the radioactive segment.

16. The device of claim 7, 11, or 13 wherein each stiffening element has a substantially constant wall thickness.

18. The device of claim 11 or 17 wherein the length of the tube is at least about 90 cm, and wherein the length of the proximal stiffening element is from about 30 cm to about 60 cm, the length of the intermediate stiffening element is from about 65 cm to about 90 cm, and the length of the distal stiffening element is from about 5 cm to about 15 cm.

19. The device of claim 11 or 17 wherein the radioactive beads are spaced part by about 1 mm.

22. The device of claim 11 or 17 wherein the length of the distal stiffening element in the distal section of the tube terminates proximally to the position of the radioactive beads.

23. The device of claim 11 or 17 wherein the distal section is sufficiently flexible that the radioactive segment can enter the human coronary artery.

17. A device for endoluminal radiation treatment of a portion of a lumen in human beings, the device comprising:

(a) a hollow elongated flexible tube of outer diameter of less than about 1 mm, the tube having a proximal section, a distal section and an intermediate section between the proximal and distal sections, the distal section including a distal end;

(b) a plurality of radioactive beads positioned in a radioactive segment within the distal section of the tube proximate to the distal end of the tube, the radioactive beads providing sufficient radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment, that when the radioactive segment is placed in a selected portion of a human lumen for less than 30 minutes, restenosis in the selected portion of lumen is prevented;

(c) at least three separate stiffening elements immovably and serially located within the tube and extending longitudinally along the axial passage of the tube for differentially stiffening sections of the tube, the stiffening elements comprising a proximal stiffening element in a proximal section of the tube, a distal stiffening element in a distal section of the tube, and an intermediate stiffening element in an intermediate section of the tube between the distal and proximal sections, wherein the proximal stiffening element is the stiffest stiffening element, the distal stiffening element is the least stiff stiffening element, and the intermediate stiffening element has a stiffness intermediate the stiffness of the proximal and distal stiffening elements;

(d) means for maintaining radioactive beads spaced apart from each other so that the radioactive segment of the tube is flexible; and

wherein the distal stiffening element is sufficiently flexible and the beads are sufficiently spaced apart from each other that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the tube and that the radioactive segment of the tube can navigate tortuous turns in the lumen.

20. The device of claim 17 wherein the total activity of the radioactive beads is about 50 to about 500 millicuries per centimeter of length of the radioactive segment.

21. The device of claim 17 wherein the length of the radioactive segment is about 2 centimeters.

24. A method for preventing stenosis of a selected portion of a lumen in a mammal comprising the steps of:

(a) introducing a flexible, elongated carrier having a radioactive segment carrying radioactive elements into the lumen so that the radioactive elements are in the selected section of the lumen;

(b) irradiating the selected section of lumen with the radioactive elements for no more than about 45 minutes, the amount of radiation delivered to the selected section of lumen being at least about 25 rads per cm length of the selected section of the lumen; and

(c) withdrawing the carrier.

25. The method of claim 24 wherein at least about 100 rads per cm length of the selected section of the lumen are delivered.

26. The method of claim 24 or 25 wherein the step of irradiating comprises delivering up to about 1000 rads per centimeter length of the radioactive segment.

27. The method of claim 24 wherein the amount of radiation delivered is up to about 2500 rads per centimeter length of the selected section of the lumen.

28. The method of claim 24 wherein the step of irradiating comprises irradiating the selected section for no more than 30 minutes.

29. A method for enlarging the luminal cross-section of a selected portion of a mammalian lumen and preventing stenosis of the enlarged portion, the method comprising the steps of:

(a) enlarging the selected portion of the lumen with an endoluminal treatment apparatus having an outer diameter sufficiently small that the apparatus fits in the lumen;

(b) inserting a device having a radioactive segment comprising radioactive means into the enlarged portion of the lumen so that the radioactive means is proximate to the enlarged portion of the lumen;

(c) leaving the device in the lumen with the radioactive means proximate to the enlarged portion of the lumen for internally radiating the enlarged portion of the lumen with sufficient radioactivity in an amount from about 25 to about 2500 rads per centimeter length of the radioactive segment to prevent stenosis of the enlarged lumen portion; and

(d) thereafter withdrawing the device from the lumen.

30. The method of claim 29 wherein the step of leaving the device in the lumen comprises radiation the enlarged portion for less than about 30 minutes.

32. The method of claim 29 wherein the section of vasculature is a coronary artery.

33. The method of claim 29 wherein the step of enlarging the selected portion of the lumen comprises dilating the lumen using a balloon inside the lumen.

34. The method of claim 29 wherein the device comprises:

an elongated, flexible carrier having a proximal section and a distal section; and

wherein the radioactive means is positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing from about 0.01 to 100,000 millicuries per centimeter length of the radioactive segments.

35. The method of claim 29 wherein the device provides from about 100 to about 1000 rads per hour per centimeter length of radioactive segment measured at 3 mm from the outer circumferential surface of the device.

36. The method of claim 29 wherein the device comprises:

(a) an elongated, flexible carrier having a proximal section, a distal section and an intermediate section between the proximal and distal sections;

and wherein the radioactive means is positioned in a radioactive segment of the distal section of the carrier; and

(b) at least three separate stiffening elements immovably located along the length of the carrier for differentially stiffening the proximal, intermediate, and distal sections of the carrier, the stiffening elements being selected so that the proximal section of the carrier is the stiffest section of the carrier, the distal section of the carrier is the most flexible section of the carrier, and the intermediate section of the carrier has a stiffness intermediate the stiffness of the proximal section and the stiffness of the distal section so that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the carrier.

37. The method of claim 29 wherein the step of inserting the device in the lumen comprises the steps of:

(a) inserting a guide wire into the lumen;

(b) inserting a probing catheter into the guide wire; and

(c) inserting the device into the introducing catheter so that the distal section of the device extends beyond the distal end of the introducing catheter such that the radioactive segment is placed proximate to the enlarged portion of the lumen.

38. The method of claim 29 wherein the step of inserting the device into the lumen is accomplished from about 1 minute to about 10 minutes after the step of enlarging the selected portion of the lumen.

39. The method of claim 29 wherein the step of leaving the device in the lumen comprises leaving the device in the lumen a sufficient time to deliver from about 100 to about 1000 rads per centimeter length of the enlarged lumen.

31. The method of claim 31 wherein the lumen comprises a section of the vasculature of a human.