Support catheter assembly

• US 5,439,445 A
• Filed: 06/27/1994
• Issued: 08/08/1995
• Est. Priority Date: 08/07/1992
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Kontos, Stavros B.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/267,037
• Time in Patent Office: 407 Days
• Field of Search: 604/96, 604/95, 604/53, 604/280, 604/281, 604/282, 604/283, 604/101-104, 606/191-194
• US Class Current: 604/103.1
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A support catheter assembly for facilitating medical procedures includes a tubular body and a continuous lumen from its proximal end to its distal end. A manipulating member is connected to the tubular body for inserting, advancing, withdrawing and maneuvering the body during a medical procedure. The manipulating member may be a wire or a manipulating tube. The tubular body also may be provided with a funnel shaped lumen opening at its proximal end to facilitate insertion of devices therethrough, and radiopaque markers for subcutaneously detecting the location of the device during a medical procedure and, more particularly, for detecting its location relative to other devices used in the medical procedure. A method also is disclosed for using the tube assembly to facilitate insertion of a PTCA catheter into a stenotic region and for holding open the lumen through that region after angioplasty has been performed.

Claims

1. An angioplasty device for use in a vascular procedure in which a balloon dilatation catheter is advanced by a physician into the vasculature of a patient through a previously inserted guiding catheter and beyond the distal end of the guiding catheter into a coronary artery of the patient to the region of a stenotic lesion to be dilated, said device comprising:

a tubular body having a base portion disposed at a proximal end thereof, and having a continuous lumen therethrough from a proximal end to a distal end thereof, said lumen having a cross-section and a length, the cross-section of said lumen being large enough to permit passage therethrough of a balloon of the balloon dilatation catheter, said tubular body being configured to be advanced over the balloon dilatation catheter and to pass through the guiding catheter to the region of the coronary lesion; and

a proximal member connected to said tubular body and extending proximally therefrom for providing communication between said tubular body and a region outside of the body of the patient;

wherein said tubular body is further constructed and arranged to be advanced beyond the distal end of the guiding catheter, inserted into a dilated area of the stenotic lesion and maintained in place to inhibit restenosis of the region.

2. A device as recited in claim 1, wherein said device is constructed and arranged to remain in the region of the lesion while the balloon catheter is withdrawn, to facilitate the exchange of one dilatation balloon catheter for another.

3. A device as recited in claim 1, wherein the base portion of said body has an eccentric cross-section.

4. A device as recited in claim 1, wherein said tubular body is constructed and arranged to provide a blood flow passage to the dilated area of the stenotic lesion.

5. A device as recited in claim 4, wherein said device is constructed and arranged so that said tubular body extends outside of the distal end of the guiding catheter, while said tubular body is within the dilated area of the stenotic lesion, said tubular body thereby maintaining a substantially unrestricted blood flow passage through the dilated area.

6. A device as recited in claim 1, wherein said proximal member is a manipulation wire.

7. A device as recited in claim 1, wherein said tubular body is sized so that the physician can hold the proximal portion of the dilatation catheter at a location spaced from the proximal end of the dilatation catheter while said tubular member is being advanced over the proximal end of the dilatation catheter and so that the physician can hold the proximal end of the dilatation catheter once the proximal portion of said tubular body has advanced over the proximal end of the dilatation catheter, thereby enabling the physician to maintain control of the dilatation catheter at all times during the PTCA procedure.

8. A device as recited in claim 7, wherein the length of said lumen is at least as long as the length of the balloon of the dilatation catheter.

9. A device as recited in claim 7, wherein the length of said lumen is at least eight times as long as the length of the balloon of the dilatation catheter.

10. A device as recited in claim 7, wherein said body is about 12 inches long.

11. A device as recited in claim 1, wherein said body is at least about twelve inches long.

12. A device as recited in claim 1, wherein said proximal member is at least about 50 inches long.

13. A device as recited in claim 1, further comprising a tip member disposed at the distal end of said body wherein said tip member is soft and flexible.

14. A device as recited in claim 13, wherein said tip member is composed of a copolymer of polyethylene and ethylvinylalcohol.

15. A device as recited in claim 1, further comprising marker means for detecting the location of said body during the vascular procedure.

16. A device as recited in claim 1, wherein the wall portions of said tubular body have perforations for facilitating fluid flow to the area of the stenotic lesion.

17. The device recited in claim 1 wherein said tubular body includes an enlarged opening at the proximal end thereof.

18. The device as recited in claim 17, wherein the enlarged opening is funnel-shaped.

24. The device of claim 1 wherein said device is constructed to permit the physician to maintain control of the dilatation catheter at all times during the vascular procedure.

19. An angioplasty device for use in a vascular procedure in which a balloon dilatation catheter is advanced by a physician into the vasculature of a patient through a previously inserted guiding catheter and beyond the distal end of the guiding catheter into a coronary artery of the patient to the region of a stenotic lesion to be dilated, said device comprising:

a tubular body having a base portion disposed at a proximal end thereof, and having a continuous lumen therethrough from a proximal end to a distal end thereof, said lumen having a cross-section and a length, the cross-section of said lumen being large enough to permit passage therethrough of a balloon of the balloon dilatation catheter, said tubular body being short relative to the balloon catheter and being configured to be advanced over the balloon dilatation catheter and to pass through the guiding catheter to the region of the lesion, said device being constructed to permit the physician to maintain control of the dilatation catheter at all times during the PTCA procedure; and

a proximal member that is thin relative to said tubular body and is connected to said tubular body and extends proximally therefrom for providing communication between said tubular body and a region outside of the body of the patient,

wherein said tubular body is further sized and constructed to be inserted into a dilated area of the stenotic lesion and maintained in place to inhibit restenosis of the lesion.

20. A device as recited in claim 19, wherein said device is constructed and arranged to remain in the region of the lesion while the balloon catheter is withdrawn.

21. A device as recited in claim 19, wherein said device is constructed and arranged so that a proximal portion of said tubular body remains within the guiding catheter while said tubular body extends to the region of the lesion.

22. A device as recited in claim 19, wherein said proximal member is constructed and arranged to facilitate insertion of said tubular body to the region of the stenotic lesion.

23. A device as recited in claim 19, wherein said proximal member is a manipulation wire.

25. The device of claim 19 further sized and constructed to be advanced beyond the distal end of the guiding catheter and into the dilated region.

26. A method for treating a patient having a restricted stenotic region in a coronary artery, said method comprising the steps of:

inserting into the patient a guiding catheter having a distal end and positioning the guiding catheter so that the distal end of the guiding catheter is positioned in the vicinity of the ostium of the patient;

inserting a PTCA balloon catheter through the guiding catheter to the vicinity of the restricted region of the patient'"'"'s coronary artery;

dilating the restricted stenotic region with the PTCA balloon catheter;

inserting a device beyond the distal end of the guiding catheter and into a selected site in the dilated region of the coronary artery to prevent restenosis of the dilated region at that site, said device comprising

a tubular body having a base portion disposed at a proximal end thereof, and having a continuous lumen therethrough from a proximal end to a distal end thereof, said lumen having a cross-section and a length, the cross-section of said lumen being large enough to permit passage therethrough of the balloon of the balloon dilatation catheter, said tubular body being short relative to the balloon catheter and being configured to be advanced over the balloon dilatation catheter and to pass through the guiding catheter to the region of the lesion, said device being constructed to permit the physician to maintain control of the dilatation catheter at all times during the PTCA procedure, and

a proximal member that is thin relative to said tubular body and is connected to said tubular body and extends proximally therefrom for providing communication between said tubular body and a region outside of the body of the patient.

27. The method of claim 26 wherein said device is inserted through said guiding catheter over said PTCA balloon catheter.

28. The method of claim 26 wherein, prior to dilation of the restricted stenotic region, at least the balloon of said PTCA balloon catheter is disposed within the tubular body of said device and said balloon catheter and said device are advanced as a unit through said guiding catheter and beyond the distal end of said guiding catheter to the vicinity of the stenotic region of the patient'"'"'s coronary artery.

29. The method of claim 28 wherein said stenotic region is dilated by advancing the balloon of said PTCA balloon catheter beyond the distal end of the tubular body of said device and into the stenotic region, and by expanding the balloon once the balloon is positioned in a selected site in the stenotic region.

30. The method of claim 29 further comprising the steps of

withdrawing said PTCA balloon catheter from the dilated region, and

leaving the tubular body of said device positioned in the stenotic region to prevent restenosis of the previously restricted region and to maintain an unrestricted flow passage therethrough.

31. The method of claim 30 further comprising the step of withdrawing said guiding catheter from the patient.

32. The method of claim 26 wherein said proximal member of the device that is inserted into the patient is constructed and arranged to facilitate insertion of said tubular body to the region of the stenotic lesion.

33. The method of claim 32 wherein the proximal member of the device that is inserted into the patient is a manipulation wire.