Extendable balloon-on-a-wire catheter, system and treatment procedure

• US 5,338,301 A
• Filed: 08/26/1993
• Issued: 08/16/1994
• Est. Priority Date: 08/26/1993
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Diaz, Juan-Carlos
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Wilkens, Frank
• Application Number:
  US08/112,684
• Time in Patent Office: 355 Days
• Field of Search: 604/53, 604/96-103, 606/192, 606/194, 128/656-658
• US Class Current: 604/103.1
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/0905 extendable, e.g. mechanisms for extension
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An extendable balloon-on-a-wire catheter is provided which includes a telescoping exchange core wire mounted along the inside lumen of the longitudinal tube of the balloon-on-a-wire assembly. In the preferred embodiment, the exchange core wire is mounted within a hypodermic tube secured to the core wire of the balloon-on-a-wire assembly. A multiple component system includes this balloon-on-a-wire assembly together with an over-the-wire catheter which slidably passes over the elongated body of the balloon-on-a-wire assembly. Preferably, the relative sizing of these components of the system is such that the over-the-wire catheter does not pass over the balloon of the balloon-on-a-wire assembly. In a treatment procedure, the balloon-on-a-wire assembly achieves dilation of a lesion or a stenosis, after which it is moved somewhat distally to clear the stenosis. When the over-the-wire catheter is used, it is slidably moved over the balloon-on-a-wire assembly until its treatment location reaches the stenosis. During the procedure, the exchange core wire can be telescopically extended to a length such that the surgeon can readily grasp the balloon-on-a-wire assembly or its exchange core wire during manipulation of the over-the-wire catheter.

Claims

1. An extendable balloon-on-a-wire catheter, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, a longitudinally extending portion of said lumen of the elongated body defining an elongated passageway, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion of the balloon-on-a-wire assembly; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said hypodermic tube having a proximal end and a distal end, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated surface of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube in the proximal direction, and said exchange core wire being prevented from extending out of said hypodermic tube in the distal direction.

2. The extendable catheter in accordance with claim 1, wherein a portion of said exterior elongated surface of the hypodermic tube is adhered to said inside wall of the elongated body of the balloon-on-a-wire assembly.

3. The extendable catheter in accordance with claim 2, wherein said exterior elongated surface and said inside wall are adhered together with a metal adhesive.

4. The extendable catheter in accordance with claim 1, wherein said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction.

5. The extendable catheter in accordance with claim 4, wherein said movement-limiting section includes a diameter reduction area of said hypodermic tube in combination with a stop member of said exchange core wire.

9. The extendable catheter in accordance with claim 1, further including a steering device having a receptor opening at its distal portion which has a radial cross-section complementary in size and shape to a radial cross-section of a proximal end portion of said elongated body of the balloon-on-a-wire assembly, whereby said receptor opening holdingly receives said proximal portion of the elongated body.

6. An extendable balloon-on-a-wire catheter, comprising:

a fixed wire percutaneous transluminal angioplasty balloon-dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with the a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, a longitudinally extending portion of said lumen of the elongated body defining an elongated passageway, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion of the balloon-on-a-wire assembly;

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube; and

p1 a movement-limiting section is positioned at a proximal end portion of the hypodermic tube and at a distal end portion of the exchange core wire.

7. An extendable balloon-on-a-wire catheter, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, a longitudinally extending portion of said lumen of the elongated body defining an elongated passageway, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion of the balloon-on-a-wire assembly;

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube; and

said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction, said movement-limiting section includes a diameter reduction area of said hypodermic tube in combination with a stop of said exchange core wire, said diameter reduction area is at a proximal end portion of the hypodermic tube, and said stop is at a distal end portion of the exchange core wire.

8. An extendable balloon-on-a-wire catheter, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, a longitudinally extending portion of said lumen of the elongated body defining an elongated passageway, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion of the balloon-on-a-wire assembly;

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube; and

said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction, and said movement-limiting section includes a gradually tapered frusto-conical stop surface of said exchange core wire and a reduced diameter tapered surface of said hypodermic tube, the taper of said hypodermic tube reduced diameter tapered surface being steeper than the taper of said frusto-conical stop surface.

10. A multiple component balloon catheter system, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, an elongated passageway defined along said lumen and extending between said balloon member and said proximal end portion of the balloon-on-a-wire assembly, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said hypodermic tube having a proximal end and a distal end, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube in the proximal direction, and said exchange core wire being prevented from extending out of said hypodermic tube in the distal direction; and

an over-the-wire percutaneous transluminal catheter, said over-the-wire catheter having an elongated body with a treatment member at a distal end portion thereof, said elongated body of the over-the-wire catheter being a tubular member having a lumen for communicating treatment fluid between a proximal end portion of the over-the-wire catheter and its said treatment member, said lumen of the over-the-wire catheter exhibiting an inner diameter which is slightly larger than said outer diameter of the elongated body of the balloon-on-a-wire assembly, whereby said over-the-wire catheter is slidably inserted over the elongated body of the balloon-on-a-wire assembly.

11. The multiple component catheter system in accordance with claim 10, wherein said inner diameter of the over-the-wire catheter is sized whereby the over-the-wire catheter is not slidable over said balloon member of the balloon-on-a-wire assembly.

12. The multiple component catheter system in accordance with claim 10, wherein said balloon-on-a-wire assembly includes a steering device at a proximal end of said elongated body thereof, said steering device being removable after insertion of the balloon-on-a-wire assembly within a living body vessel in order to gain access to a proximal end of the exchange core wire to permit its slidable extension out of said hypodermic tube and out of said elongated body of the balloon-on-a-wire assembly.

14. The multiple component catheter in accordance with claim 10, wherein a portion of said exterior elongated surface of the hypodermic tube is adhered to said inside wall of the elongated body of the balloon-on-a-wire assembly.

15. The multiple component catheter in accordance with claim 10, wherein said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction.

16. The multiple component catheter in accordance with claim 14, wherein said movement-limiting section includes a diameter reduction area of said hypodermic tube in combination with a stop member of said exchange core wire.

13. A multiple component balloon catheter system, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, an elongated passageway defined along said lumen and extending between said balloon member and said proximal end portion of the balloon-on-a-wire assembly, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube; and

an over-the-wire percutaneous transluminal catheter, said over-the-wire catheter having an elongated body with a treatment member at a distal end portion thereof, said elongated body of the over-the-wire catheter being a tubular member having a lumen for communicating treatment fluid between a proximal end portion of the over-the-wire catheter and its said treatment member, said lumen of the over-the-wire catheter exhibiting an inner diameter which is slightly larger than said outer diameter of the elongated body of the balloon-on-a-wire assembly, and said inner diameter of the lumen of the over-the-wire catheter body is smaller than the external sizing of said balloon of the balloon-on-a-wire assembly when said balloon is deflated.

17. A multiple component balloon catheter system, comprising;

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, an elongated passageway defined along said lumen and extending between said balloon member and said proximal end portion of the balloon-on-a-wire assembly, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube;

an over-the-wire percutaneous transluminal catheter, said over-the-wire catheter having an elongated body with a treatment member at a distal end portion thereof, said elongated body of the over-the-wire catheter being a tubular member having a lumen for communicating treatment fluid between a proximal end portion of the over-the-wire catheter and its said treatment member, said lumen of the over-the-wire catheter exhibiting an inner diameter which is slightly larger than said outer diameter of the elongated body of the balloon-on-a-wire assembly, whereby said over-the-wire catheter is slidably inserted over the elongated body of the balloon-on-a-wire assembly; and

said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction, and said movement-limiting section is positioned at a proximal end portion of the hypodermic tube and at a distal end portion of the exchange core wire.

18. A multiple component balloon catheter system, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire; and

extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, an elongated passageway defined along said lumen and extending between said balloon member and said proximal end portion of the balloon-on-a-wire assembly, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within sand extendable out of said hypodermic tube;

an over-the-wire percutaneous transluminal catheter, said over-the-wire catheter having an elongated body with a treatment member at a distal end portion thereof, said elongated body of the over-the-wire catheter being a tubular member having a lumen for communicating treatment fluid between a proximal end portion of the over-the-wire catheter and its said treatment member, said lumen of the over-the-wire catheter exhibiting an inner diameter which is slightly larger than said outer diameter of the elongated body of the balloon-on-a-wire assembly, whereby said over-the-wire catheter is slidably inserted over the elongated body of the balloon-on-a-wire assembly; and

said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction, said movement-limiting section includes a diameter reduction area of sad hypodermic tube in combination with a stop of said exchange core wire, and said diameter reduction area is at a proximal end portion of the hypodermic tube, and said stop is at a distal end portion of the exchange core wire.

19. A multiple component balloon catheter system, comprising:

a fixed wire percutaneous transluminal angioplasty balloon dilation catheter assembly which is a balloon-on-a-wire assembly having an elongated body with a proximal end portion and with a balloon member at a distal portion thereof, said elongated body being a wire-like member having an inside wall defining a lumen, said elongated body having an outer diameter substantially the same as that of a catheter guidewire;

an extension assembly longitudinally positioned within said lumen of the elongated body of the balloon-on-a-wire assembly, an elongated passageway defined along said lumen and extending between said balloon member and said proximal end portion of the balloon-on-a-wire assembly, said elongated passageway communicating pressurized fluid between said balloon member and said proximal end portion; and

said extension assembly includes a hypodermic tube secured within said balloon-on-a-wire assembly, said elongated passageway being between an exterior elongated surface of the hypodermic tube and said lumen of the elongated body of the balloon-on-a-wire assembly, said extension assembly further including an exchange core wire slidably positioned within and extendable out of said hypodermic tube;

an over-the-wire percutaneous transluminal catheter, said over-the-wire catheter having an elongated body with a treatment member at a distal end portion thereof, said elongated body of the over-the-wire catheter being a tubular member having a lumen for communicating treatment fluid between a proximal end portion of the over-the-wire catheter and its said treatment member, said lumen of the over-the-wire catheter exhibiting an inner diameter which is slightly larger than said outer diameter of the elongated body of the balloon-on-a-wire assembly, whereby said over-the-wire catheter is slidably inserted over the elongated body of the balloon-on-a-wire assembly; and

said hypodermic tube and said exchange core wire have a movement-limiting section which resists movement of the exchange core wire in a proximal direction, and said movement-limiting section includes a gradually tapered frusto-conical stop surface of said exchange core wire and a reduced diameter tapered surface of said hypodermic tube, the taper of said hypodermic tube reduced diameter tapered surface being steeper than the taper of said frusto-conical stop surface.

20. A transluminal percutaneous procedure for treating a stenosis and the like within a living body vessel, comprising the steps of:

inserting into a living body vessel a fixed wire percutaneous transluminal angioplasty balloon dilation catheter which is a balloon-on-a-wire assembly having an elongated body with a balloon member at a distal end portion thereof and having a steering device at a proximal end portion thereof;

locating the balloon member within a stenosis of the living body vessel, inflating the balloon member to predilate the stenosis, and deflating the balloon member;

moving the balloon-on-a-wire assembly distally within the body vessel to a location such that the balloon member is closely distally spaced from the stenosis which has been predilated;

removing the steering device from the proximal end portion of the balloon-on-a-wire assembly in order to gain access to an exchange core wire telescopingly positioned within the elongated body of the balloon-on-a-wire assembly;

slidably inserting an over-the-wire percutaneous transluminal catheter into the body vessel and over the elongated body of the balloon-on-a-wire assembly until the over-the-wire catheter is located at the stenosis which had been predilated;

treating the predilated stenosis by manipulation of the over-the-wire catheter;

removing the over-the-wire catheter from the body vessel; and

removing the balloon-on-a-wire assembly from the body vessel.

21. The procedure in accordance with claim 20, wherein said step of removing the over-the-wire catheter is preceded by extending the exchange core wire in a telescoping manner from out of the elongated body of the balloon-on-a-wire assembly, said telescopic extension step including extending the exchange core wire to have a length, when combined with a proximal portion of the elongated body of the balloon-on-a-wire assembly that is outside of the body, which is longer than the length of the proximal portion of the over-the-wire catheter, thereby permitting grasping of the proximal portion of the balloon-on-a-wire catheter and/or its extended exchange core wire during the entirety of said step of slidably inserting the over-the-wire catheter.

22. The procedure in accordance with claim 20, wherein said slidably inserting step is carried out without passing any portion of the over-the-wire catheter over the balloon member of the balloon-on-a-wire assembly.

23. The procedure in accordance with claim 20, wherein said slidably inserting step includes preventing passage of the over-the-wire catheter over the balloon member of the balloon-on-a-wire assembly by relative sizing of a lumen of the over-the-wire catheter and of the balloon member of the balloon-on-a-wire assembly whereby the balloon member will not pass through the lumen, even when the balloon member is deflated.