Mechanical apparatus and method for dilating and irradiating a site of treatment

• US 6,059,752 A
• Filed: 11/13/1997
• Issued: 05/09/2000
• Est. Priority Date: 12/09/1994
• Status: Expired due to Fees

• Current Assignee: Radiovascular Systems, LLC
• Original Assignee: Jerome Segal
• Inventors: Segal, Jerome
• Primary Examiner(s): WEISS, JOHN
• Application Number:
  US08/969,220
• Time in Patent Office: 908 Days
• Field of Search: 604/104, 604/202, 604/53, 604/107, 604/106, 604/19, 606/194, 600/1, 600/3
• US Class Current: 604/107
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A mechanical dilatation and irradiation device for enlarging a flow passage of a vessel by dilating and irradiating an obstruction in the vessel. The present invention comprises a substantially cylindrically shaped expansion member and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration to diametrically expanded configuration. A radioisotope is place either inside the expansion member, alloyed into the metal from which the expansion member is constructed, coated onto the expansion member'"'"'s exterior surface or alternately, the non-radioactive metal or alloy of the expansion member can be irradiated so that it has become radioactive, i.e. it is then a radioisotope. The present method comprises the steps of advancing the radioactive expansion member or radioactive catheter to the obstruction in a vessel and applying opposed forces on said expansion member in an axial direction to move the expansion member to an expanded configuration wherein the expansion member dilates the obstruction and the catheter/expansion member assembly irradiates the obstruction.

Claims

1. A catheter for dilating and irradiating an obstruction within a vascular segment or a body passageway which comprises:

said catheter having a distal end and a proximal end;

a substantially cylindrical shaped expansion member located on said distal end, said expansion member having a first end and a second end, said first end being a distance from said second end;

an altering means engagable to said first end and said second end of said expansion member for altering said distance there between to move said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter, wherein said expansion member is adapted to allow blood to flow through said expansion member while said expansion member is in said second configuration; and

a radioactive source located at said distal end.

2. The catheter as recited in claim 1 wherein said expansion member comprises a first plurality of flexible elongate elements helically wound in a first direction of rotation and a second plurality of flexible elongate elements helically wound in a second direction of rotation to form a braid.

3. The catheter as recited in claim 2 wherein each flexible elongate element has a circular cross section defined by a diameter and said diameter is in a range of approximately 0.001 to 0.010 inches.

4. The catheter as recited in claim 1 further comprising said radioactive source employing material that emits radiation from a radioisotope.

5. The catheter as recited in claim 4 further comprising said radioisotope is located within a structural material of said expansion member.

6. The catheter as recited in claim 4 further comprising said radioisotope being incorporated into the structural material of said expansion member.

7. The catheter as recited in claim 4 further comprising said radioisotope is fixed to a surface of said expansion member.

8. The catheter as recited in claim 4 further comprising said radioisotope is alloyed into a structural material of at least one band surrounding an inner tubular member on distal end of said catheter.

9. The catheter as recited in claim 4 further comprising said radioisotope is alloyed into the material comprising an inner tubular member of said catheter.

10. The catheter as recited in claim 4 further comprising said radioisotope is alloyed into a structural material used to fabricate at least one flexible elongate element of the expansion member.

11. The catheter as recited in claim 4 further comprising said radioisotope is either a solid, liquid or gaseous material contained within a lumen of at least one flexible elongate element of the expansion member.

12. The catheter as recited in claim 4 further comprising said radioisotope is a coating affixed to at least a portion of the outer surface of at least one flexible elongate element of the expansion member.

13. The catheter as recited in claim 1 further comprising said radioactive source consists of a non-radioactive material that is activated to become radioactive.

14. The catheter as recited in claim 1 further comprising said radioactive source is a beta particle emitting radioisotope.

15. The catheter as recited in claim 1 further comprising said radioactive source is a gamma emitting radioisotope.

16. The catheter as recited in claim 1 further comprising said radioactive source is an alpha emitting radioisotope.

17. The catheter as recited in claim 1 further comprising said radioactive source as having any combination of alpha, beta or gamma emitting radioisotope.

18. The catheter as recited in claim 1 further comprising said radioactive source having a half-life of less than 100 days.

19. The catheter as recited in claim 1 further comprising said radioactive source being substantially centered within a vessel segment to uniformly expose said segment with radiation.

20. A mechanical dilatation and irradiation catheter comprising:

said catheter having a distal end and a proximal end, said catheter having an inner member and an outer member;

an expandable mesh positioned on said distal end adapted to dilate an obstruction in a vessel, said mesh having a first contracted diameter and a second expanded diameter, said second expanded diameter being larger than said first contracted diameter;

said mechanical dilatation and irradiation catheter being adapted to dilate said obstruction and expose said obstruction to radiation;

said expandable mesh adapted to allow blood perfusion while said mesh is in said second expanded diameter; and

said mechanical dilatation and irradiation catheter having a radioactive source located at said distal end.

21. The catheter as recited in claim 20 further comprising said radioactive source employing material that emits radiation from a radioisotope.

22. The catheter as recited in claim 21 further comprising said radioisotope is located with the structural material of said expandable mesh.

23. The catheter as recited in claim 21 further comprising said radioisotope is fixed to a surface of said expandable mesh.

24. The catheter as recited in claim 21 further comprising said radioisotope is alloyed into the material of at least one band surrounding said inner member of said catheter.

25. The catheter as recited in claim 21 further comprising said radioisotope is alloyed into the material comprising said inner member of said catheter.

26. The catheter as recited in claim 21 further comprising said radioisotope is alloyed into the material used to fabricate at least one flexible elongate element of the expansion member.

27. The catheter as recited in claim 21 further comprising said radioisotope is either a solid, liquid or gaseous material contained within a lumen in at least one flexible elongate element of the expansion member.

28. The catheter as recited in claim 21 further comprising said radioisotope is a coating affixed to at least a portion of the outer surface of at least one flexible elongate element of the expansion member.

29. The catheter as recited in claim 20 further comprising said radioactive source consists of a non-radioactive material that is activated to become radioactive.

30. The catheter as recited in claim 20 further comprising said radioactive source is a beta particle emitting radioisotope.

31. The catheter as recited in claim 20 further comprising said radioactive source is a gamma emitting radioisotope.

32. The catheter as recited in claim 20 further comprising said radioactive source is an alpha emitting radioisotope.

33. The catheter as recited in claim 20 further comprising said radioactive source as having any combination of alpha, beta, gamma emitting radioisotope.

34. The catheter as recited in claim 20 further comprising said radioactive source having a half-life of less than 100 days.

35. The catheter as recited in claim 20 further comprising said radioactive source being substantially centered within a vessel segment to uniformly expose said segment to radiation.

36. A method for dilating and irradiating an obstruction in a body passageway which comprises the steps of:

exposing an expansion member of a catheter to a radiation activation mechanism such that some portion or all of said expansion member becomes radioactive;

placing said radioactive expansion member within a vessel or body passageway, said expansion member being moveable between a first contracted configuration wherein said member is defined by a first dimension extending in a radial direction of said catheter, and a second expanded configuration wherein said member is defined by a second dimension extending in said radial direction;

advancing said radioactive expansion member to a predetermined site in the vessel or body passageway in said contracted configuration;

applying a force on said radioactive expansion member in an axial direction of said catheter to move said expansion member between said first contracted configuration to said second expanded configuration wherein said expansion member dilates and irradiates an obstruction within said predetermined site while allowing blood to flow through said expansion member.

37. A method as recited in claim 36 which further comprises the step of positioning a guidewire in the body passageway, and wherein said advancing step is accomplished by threading said expansion member over said guidewire.

38. A method as recited in claim 36 which further comprises the step of allowing said expansion member to be in said second expanded configuration for a predetermined period of time to further expose said obstruction to radiation.

39. A method for dilating and irradiating an obstruction in a vessel or body passageway which comprises the steps of:

placing a catheter within a vessel or body passageway, said catheter having an expansion member being moveable between a first contracted configuration wherein said member is defined by a first dimension extending in a radial direction, and a second expanded configuration wherein said member is defined by a second dimension extending in said radial direction, said catheter also containing a radioactive source located at a distal end of said catheter;

advancing said catheter with radioactive source to a predetermined site in the vessel or body passageway in said contracted configuration;

applying a force on said expansion member in an axial direction of said catheter to move said expansion member between said first contracted configuration to said second expanded configuration wherein said obstruction is dilated and irradiated; and

allowing blood to flow through said expansion member while said expansion member is in said expanded configuration.

40. A method as recited in claim 39 which further comprises the step of positioning a guidewire in the body passageway, and wherein said advancing step is accomplished by threading said catheter over said guidewire.

41. A method as recited in claim 39 which further comprises the step of allowing said expansion member to be in said second expanded configuration for a predetermined period of time to further expose said obstruction to radiation.