Intravascular catheter with distal guide wire lumen and transition member

• US 5,425,711 A
• Filed: 02/16/1994
• Issued: 06/20/1995
• Est. Priority Date: 02/29/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Ellis, Louis G., Ressemann, Thomas V., Keith, Peter T.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/197,169
• Time in Patent Office: 489 Days
• Field of Search: 604/96, 604/264, 604/265, 604/280, 604/101-104, 606/191, 606/192, 606/194, 128/657, 128/658, 128/772
• US Class Current: 604/103.1
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An over-the-wire balloon dilatation catheter of the short guide wire lumen type has a stainless steel hypotube catheter shaft section, a distal plastic shaft section attached to the hypotube and a balloon connected to the distal plastic shaft section. A relatively short guide wire lumen extends throughout the length of the balloon. The distal shaft section includes a reinforcing and kink-resistant transition member extending throughout the length of the distal shaft section. The transition member allows the proximal guide wire lumen aperture to be placed distally from the distal end of the hypotube. This configuration permits the length of the guide wire lumen to be minimized.

Claims

1. An intravascular catheter comprising:

a main shaft segment defined by a metallic tube, the main shaft segment having a proximal end and a distal end;

a balloon;

a plastic shaft segment connected between the distal end of the main shaft segment and the balloon, the plastic shaft segment being more flexible than the main shaft segment;

the main shaft segment and the plastic shaft segment having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member attached to the main shaft segment and extending distally into the plastic shaft segment, the transition member being less rigid than the main shaft segment;

a guide wire lumen extending from a location proximal of the balloon to a location distal of the balloon; and

a guide wire lumen inlet spaced distally from the distal end of the main shaft segment and communicating with the guide wire lumen; and

the transition member extending into the plastic shaft segment distally at least partially across the guide wire lumen inlet.

2. The intravascular catheter of claim 1 wherein the transition member comprises a solid core wire.

3. The intravascular catheter of claim 2 wherein the guide wire lumen is at least as long as the balloon.

4. The intravascular catheter of claim 2 wherein the balloon includes a proximal balloon neck and the guide wire lumen inlet is disposed adjacent the proximal balloon neck.

5. The intravascular catheter of claim 2 wherein the guide wire lumen inlet is disposed at least 5 cm from the distal end of the metallic tube.

6. The intravascular catheter of claim 5 wherein the length of the guide wire lumen is at least as long as the balloon.

7. The intravascular catheter of claim 2 wherein the guide wire lumen inlet is disposed about 5 cm from the distal end of the metallic tube.

8. The intravascular catheter of claim 1 wherein the transition member comprises a solid core wire having multiple sections of differing outside diameters.

9. The intravascular catheter of claim 8 wherein the diameter of each section of the core wire is smaller than the diameter of a next proximal section.

10. The intravascular catheter of claim 1 wherein the transition member extends at least between the distal end of the metallic tube and the guide wire lumen inlet.

11. A catheter comprising:

a relatively stiff main shaft section, the relatively stiff main section having a proximal end and a distal end;

a balloon;

a relatively flexible distal shaft section connected between the distal end of the relatively stiff main shaft section and the balloon;

the main and distal shaft sections having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member comprising a core member, the core member having multiple sections of decreasing outer diameter in a distal direction, the transition member attached to and extending distally from the relatively stiff main shaft section into the distal shaft section; and

a guide wire lumen extending from a location proximal of the balloon to a location distal of the balloon, the guide wire lumen having an inlet and an outlet, and the inlet of the guide wire lumen being spaced distally from the distal end of the relatively stiff main shaft section; and

the transition member extending distally into the relatively flexible distal shaft section at least partially across the guide wire lumen inlet.

12. The intravascular catheter of claim 11 wherein the transition member comprises a wire.

13. The intravascular catheter of claim 11 wherein the transition member extends at least between the distal end of the main shaft section and the guide wire lumen inlet.

14. The intravascular catheter of claim 13 wherein the guide wire lumen inlet is disposed adjacent a proximal end of the balloon.

15. The intravascular catheter of claim 11 wherein a length of the guide wire lumen is equal to at least a length of the balloon.

16. The intravascular catheter of claim 11 wherein a length of the guide wire lumen is 5 centimeters or less.

17. The intravascular catheter of claim 11 wherein the guide wire lumen inlet is disposed at least 5 cm from the distal end of the main shaft segment.

18. A balloon dilatation catheter comprising:

a metallic tube defining a proximal shaft section, the metallic tube having a proximal end and a distal end;

a distal shaft section disposed distally of the proximal shaft section, the distal shaft section being more flexible than the metallic tube;

the proximal and distal shaft sections having an inflation lumen defined therethrough which extends to a distal end of the distal shaft section;

a dilatation balloon attached to the distal end of the distal shaft section, the dilatation balloon being in fluid communication with the inflation lumen such that inflation pressure may be provided to the balloon therethrough;

a guide wire tube extending from a location proximal the balloon to a location distal of the balloon, the guide wire tube defining a second lumen separate from and shorter than the inflation lumen, the second lumen having a guide wire lumen inlet at its proximal end and a guide wire lumen outlet at its distal end, wherein the guide wire tube receives a guide wire therein such that the catheter may be slidably moved on the guide wire, and the guide wire lumen inlet being spaced distally from the distal end of the metallic tube; and

a transition member comprising a core wire disposed between the distal end of the metallic tube and the guide wire lumen inlet, the core wire having a plurality of tapers to define a plurality of core wire sections, each core wire section having an outer diameter less than the next proximal core wire section to provide increasing flexibility in the distal direction; and

the transition member extends distally at least partially across the guide wire lumen inlet.

19. An intravascular catheter comprising:

a relatively stiff main shaft section, the relatively stiff main shaft section having a proximal end and a distal end;

an intravascular interoperative element;

a relatively flexible distal shaft section connected between the distal end of the relatively stiff main shaft section and the intravascular interoperative element;

a transition member comprising a core member, the core member having multiple sections of decreasing outer diameter in the distal direction, the transition member attached to and extending distally from the relatively stiff main shaft section into the relatively flexible distal shaft section; and

a guide wire lumen extending from a location proximal of the intravascular interoperative element to a location distal of the intravascular interoperative element, the guide wire lumen having an inlet and an outlet, the inlet of the guide wire lumen spaced distally from the distal end of the relatively stiff main shaft section; and

the transition member extending distally at least partially across the guide wire lumen inlet.

20. An intravascular catheter comprising:

a main shaft segment, the main shaft segment having a proximal end and a distal end;

a balloon;

a trackable plastic shaft segment connected between the distal end of the main shaft segment and the balloon, the plastic shaft segment being more flexible than the main shaft segment;

the main shaft segment and the trackable plastic shaft segment having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member attached to the main shaft segment extending distally into the trackable plastic shaft segment, the transition member being less rigid than the main shaft segment;

a guide wire lumen extending from a location proximal of the balloon to a location distal of the balloon; and

a guide wire lumen inlet spaced distally from the distal end or the main shaft segment and communicating with the guide wire lumen; and

the transition member extending distally at least partially across the guide wire lumen inlet.

21. A catheter comprising:

a relatively stiff main shaft section, the relatively stiff main section having a proximal end and a distal end;

a balloon;

a relatively flexible trackable distal shaft section connected between the distal end of the relatively stiff main shaft section and the balloon;

the main and trackable distal shaft sections having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member comprising a core member, the core member having multiple sections of decreasing outer diameter in a distal direction, the transition member attached to and extending distally from the relatively stiff main shaft section into the trackable distal shaft section; and

a guide wire lumen defined through the balloon, the guide wire lumen having an inlet and an outlet, and the inlet of the guide wire lumen being spaced distally from the distal end of the relatively stiff main shaft section; and

the transition member extending distally at least partially across the guide wire lumen inlet.

22. A balloon dilatation catheter comprising:

a proximal shaft section having a proximal end and a distal end;

a trackable distal shaft section disposed distally of the proximal shaft section, the trackable distal shaft section being more flexible than the proximal shaft section;

the proximal and trackable distal shaft sections having an inflation lumen defined therethrough which extends to a distal end of the trackable distal shaft section;

a dilatation balloon attached to the distal end of the trackable distal shaft section, the dilatation balloon being in fluid communication with the inflation lumen such that inflation pressure may be provided to the balloon therethrough;

a guide wire tube extending through an interior of the balloon, the guide wire tube defining a second lumen separate from and shorter than the inflation lumen, the second lumen having a guide wire lumen inlet at its proximal end and a guide wire lumen outlet at its distal end, wherein the guide wire tube receives a guide wire therein such that the catheter may be slidably moved on the guide wire, and the guide wire lumen inlet being spaced distally from the distal end of the proximal shaft section; and

a transition member comprising a core wire disposed between the distal end of the proximal shaft section and the guide wire lumen inlet, the core wire having a plurality of tapers to define a plurality of core wire sections, each core wire section having an outer diameter less than the next proximal core wire section to provide increasing flexibility in the distal direction; and

the transition member extending distally at least partially across the guide wire lumen inlet.

23. An intravascular catheter comprising:

a main shaft segment having a proximal end and a distal end;

a balloon;

a plastic shaft segment connected between the distal end of the main shaft segment and the balloon, the plastic shaft segment being more flexible than the main shaft segment;

the main shaft segment and the plastic shaft segment having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member extending distally from the main shaft segment to the plastic shaft segment, the transition member being less rigid than the main shaft segment for providing a smooth transition of flexibility between the main shaft segment and the plastic shaft segment;

a guide wire lumen defined through the plastic shaft segment and the balloon; and

a guide wire lumen inlet spaced distally from the distal end of the main shaft segment and communicating with the guide wire lumen; and

the transition member extending distally at least partially across the guide wire lumen inlet.

24. A catheter comprising:

a relatively stiff main shaft section, the relatively stiff main shaft section having a proximal end and a distal end;

a balloon;

a relatively flexible distal shaft section connected between the distal end of the relatively stiff main shaft section and the balloon;

the main and distal shaft sections having an inflation lumen defined therethrough to provide inflation pressure to the balloon;

a transition member extending distally from the relatively stiff main shaft section into the distal shaft section;

the transition member being less stiff than the relatively stiff main shaft section;

a guide wire lumen defined through the balloon, the guide wire lumen having an inlet and an outlet, and the inlet of the guide wire lumen being spaced distally from the distal end of the main shaft section; and

the transition member extending distally at least partially across the guide wire lumen inlet.

25. A balloon dilatation catheter comprising:

a proximal shaft section having a proximal end and a distal end;

a distal shaft section disposed distally of the proximal shaft section, the distal shaft section being more flexible than the proximal shaft section;

the proximal and distal shaft sections having an inflation lumen defined therethrough which extends to a distal end of the distal shaft section;

a dilatation balloon attached to the distal end of the distal shaft section, the dilatation balloon being in fluid communication with the inflation lumen such that inflation pressure may be provided to the balloon therethrough;

a guide wire tube extending through an interior of the balloon, the guide wire tube defining a second lumen separate from and shorter than the inflation lumen, the second lumen having a guide wire lumen inlet at its proximal end and a guide wire lumen outlet at its distal end, wherein the guide wire tube receives a guide wire therein such that the catheter may be slidably moved on the guide wire, and the guide wire lumen inlet being spaced distally from the distal end of the proximal shaft section;

a transition member attached to the proximal shaft section and extending distally into the distal shaft section, the transition member being less rigid than the proximal shaft section to provide increasing flexibility in the distal direction; and

the second lumen and the transition member extending through the distal shaft section such that the second lumen is along side of the transition member.

26. An intravascular catheter comprising:

a relatively stiff main shaft section, the relatively stiff main shaft section having a proximal end and a distal end;

an intravascular interoperative element;

a relatively flexible distal shaft section connected between the distal end of the relatively stiff main shaft section and the intravascular interoperative element;

a transition member attached to and extending distally from the relatively stiff main shaft section into the relatively flexible distal shaft section;

the transition member being less rigid than the relatively stiff main shaft section;

a guide wire lumen defined through the intravascular interoperative element, the guide wire lumen having an inlet and an outlet, the inlet of the guide wire lumen spaced distally from the distal end of the relatively stiff main shaft section; and

the transition member extending distally at least partially across the guide wire lumen inlet.