Balloon catheter

• US 6,656,153 B1
• Filed: 03/08/2000
• Issued: 12/02/2003
• Est. Priority Date: 09/12/1997
• Status: Expired due to Fees

• Current Assignee: Nippon Zeon Co., Ltd. (BASF SE)
• Original Assignee: Nippon Zeon Co., Ltd. (BASF SE)
• Inventors: Iida, Takahiro, Sakai, Kouichi, Toyokawa, Tetsuo
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/508,193
• Time in Patent Office: 1,364 Days
• Field of Search: 604/99.04, 604/264, 604/523, 604/528, 604/164.13, 604/533, 604/96.01, 604/1, 604/167-1-1, 600/488, 600/585, 606/192-194
• US Class Current: 604/99.04
• CPC Class Codes: A61M 25/0075 Valve means
• 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 25/1006 Balloons formed between concentric tubes

Abstract

A balloon catheter of the present invention has an outer tube having a first lumen inside it. At the distal end of the outer tube is connected the proximal end of the balloon portion so that a balloon space is formed inside it, the distal end of the balloon portion is joined to a cylindrical front tip portion, and pressurized fluid is introduced into and released from the balloon space through the first lumen of the outer tube so as to make the balloon portion expand or contract. Inside the first lumen of the outer tube is arranged an inner tube having a second lumen freely slidable in the axial direction. The distal end of the inner tube projects out from the distal end of the outer tube and is detachably attached to the front tip portion. The balloon catheter of the present invention may have a guidewire detachably attached to the front tip portion rather than providing the inner tube.

Claims

1. A balloon catheter comprising:

an outer tube having a first lumen inside the outer tube,

a balloon portion having a proximal end joined to a distal end of the outer tube and a distal end of the balloon portion joined to a tubular shaped front tip portion axially spaced from said distal end of said outer tube, said front tip portion having a valve element sealing the balloon space inside the balloon portion from the outside of the balloon portion and being formed of a resilient material and operative to normally close the balloon portion in order to form a balloon space inside the balloon portion, into which a pressurized fluid is introduced and released through the first lumen of the outer tube to give an expanded and contracted state, an inner tube having a second lumen therein, said inner tube extending inside the first lumen of the outer tube and being mounted therein to freely slide in the axial direction, projecting out from the distal end of the outer tube, and said inner tube penetrating said front tip portion and being detachably attached thereto and effective to close said tip portion upon withdrawal of said inner tube therefrom to thereby close said balloon portion, wherein a distal end of the inner tube is detachably attached to the valve element for closing the valve element when the inner tube is withdrawn therefrom, wherein the valve element is formed with a tight-fit hole, a clearance with the inner tube is sealed in a state in which a distal end of the inner tube is inserted into the tight-fit hole, and the tight-fit hole being closeable upon withdrawal of said distal end of the inner tube to enable the balloon space at an inside of the balloon portion to be sealed from outside of the balloon portion in the state in which the inner tube, when detached from the tight-fit hole, closes the tight-fit hole to seal the balloon space, wherein a maximum outer diameter of the valve element is larger than an inside diameter of the front tip portion in a state before the valve element is attached to an inside of the front tip portion and wherein the valve element is compressed and elastically deformed to the inside of the front tip portion and is attached in the state with the tight-fit hole closed, wherein an extra clearance space for elastic deformation of the valve element in the axial direction is formed inside the front tip portion in order to widen the tight-fit hole in a state in which a distal end of the inner tube is inserted into the tight-fit hole of the valve element, and wherein the front tip portion has stopper members positioned at both sides of the valve element in the axial direction to create the extra clearance space inside the front tip portion and the stopper members are constructed to allow passage of the inner tube.

3. The balloon catheter as set forth in claim 1, wherein the valve element has a breaking elongation of 300 to 1000%.

4. The balloon catheter as set forth in claim 1, wherein the valve element has a compression modulus of elasticity of 0.01 to 0.30.

5. The balloon catheter as set forth in claim 1, wherein the front tip portion is comprised of a member which can elastically deform outwardly in the radial direction.

6. The balloon catheter as set forth in claim 1, wherein the front tip portion is provided with a pressure sensor.

7. The balloon catheter as set forth in claim 1, further comprising a supporting rod member having a distal end joined to the front tip portion and extending inside the balloon portion and the outer tube in the axial direction separate from the inner tube.

8. The balloon catheter as set forth in claim 7, wherein the supporting rod member is comprised of a tube and inside the tube is passed or buried wiring from the pressure sensor.

9. The balloon catheter as set forth in claim 1, wherein the proximal end of the outer tube is connected to a connector and the proximal end of tie guidewire is detachably attached to the connector.

10. The balloon catheter as set forth in claim 9, wherein the proximal end of the supporting rod member is connected to the connector.

11. A method of using the balloon catheter constructed according to claim 1 wherein the catheter is used for intra aortic balloon pumping (IABP).

2. The balloon catheter as set fort in 1, wherein the valve element has a Shore A hardness of not more than 30.

12. A balloon catheter comprising;

an outer tube having a first lumen inside the outer tube,

a balloon portion having a proximal end joined to a distal end of the outer tube and a distal end of the balloon portion joined to a tubular shaped front tip portion which is axially spaced from the distal end of the outer tube, the front tip portion capping the distal end of the balloon portion in order to form a balloon space inside the balloon portion, into which a pressurized fluid is introduce into, and released from, through the first lumen of the outer tube to give the balloon portion an expanded and contracted state, and

a guidewire extending inside the first lumen of the outer tube to be freely slidable in the axial direction,

the front tip portion providing a valve element through which the guidewire is passed in a detachable manner, the valve element being separate from said tip portion and being attached thereto so as to maintain an inside of the balloon portion sealed in both a state in which the guidewire is attached and a state in which the guidewire is not attached to the valve element,

wherein the valve element is formed with a tight-fit hole, a clearance between the guidewire and said hole in the valve element when the distal end of the guidewire is inserted into the tight-fit hole, and the tight-fit hole closes to enable the balloon space at an inside of the balloon portion to be sealed from outside of the balloon portion when the guidewire is a detached from the tight-fit hole,

wherein the valve element is formed of a resiliently compressable material having a maximum outer diameter larger than an inside diameter of the front tip portion in a state before the valve element is attached to an inside of the front tip portion, and wherein the valve element is compressed and elastically deformed to the inside of the front tip portion to be attached in a state in which the tight-fit bole is closed, and

wherein an extra clearance space for elastic deformation of the valve element in the axial direction is formed inside the front tip portion in order to widen the tight-fit hole in a state in which a distal end of the guidewire is inserted into the tight-fit hole of the valve element wherein the front tip portion has stopper members positioned at both sides of the valve element in the axial direction to create the extra clearance space inside the front tip portion, the stopper members being constructed to allow passage of the guidewire.

13. The balloon catheter as set forth in claim 12, wherein the valve element has a Shore A hardness of not more than 30.

14. The balloon catheter as set forth in claim 12, wherein the valve element has a breaking elongation of 300 to 1000%.

15. The balloon catheter as set forth in claim 12, wherein the valve element has a compression modulus of elasticity of 0.01 to 0.30 kg/cm².

16. The balloon catheter as set forth in claim 12, wherein the front tip portion is comprised of a member which can elastically deform outwardly in the radial direction.

17. The balloon catheter as set forth in claim 12, wherein the front tip portion is provided with a pressure sensor.

18. The balloon catheter as set forth in claim 12, further comprising a supporting rod member having a distal end joined to the front tip portion and extending inside the balloon portion and the outer tube in the axial direction separate from the inner tube.

19. The balloon catheter as set forth in claim 18, wherein the supporting rod member is comprised of a tube and inside the tube is passed or buried wiring from the pressure sensor.

20. The balloon catheter as set forth in claim 12, wherein the proximal end of the outer tube is connected to a connector and the proximal end of the guidewire is detachably attached to the connector.

21. The balloon catheter as set forth in claim 20, wherein a proximal end of a supporting rod member is connected to the connector.

22. A method of using the balloon catheter constructed according to claim 12, wherein the catheter is used for intra aortic balloon pumping (LABP).