Low profile catheter valve

• US 6,355,014 B1
• Filed: 03/13/1998
• Issued: 03/12/2002
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic PercuSurge, Inc. (Medtronic Plc)
• Inventors: Field, Jeffrey F., Marano-Ford, April A., Kim, Isaac J., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza, Bleam, Jeffrey C.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/039,110
• Time in Patent Office: 1,460 Days
• Field of Search: 604/96, 604/99, 604/49, 604/97, 604/98, 604/101, 604/52, 604/53, 604/167, 604/169, 604/264, 604/523, 604/532-37, 604/539, 606/194, 606/195, 251/4-5, 251/7, 251/89-89
• US Class Current: 604/99.02
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• 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 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Claims

1. A valve, comprising:

a flexible elongate tubular body having a proximal end and a distal end, and a lumen having a longitudinal axis extending between the proximal and distal end, the lumen having an opening at the proximal end;

an expandable member on the distal end of the tubular body, the expandable member being in fluid communication with the lumen;

an access opening on the tubular body, the access opening being in fluid communication with the lumen to permit the expandable member to be actuated by pressurizing the access opening;

a sealing member having a sealer portion which seals against a surface of the tubular body, said portion of the sealing member being movable along the longitudinal axis relative to said surface of the tubular body between two positions, one of the positions positioning the sealer portion in contact with said surface at a location which blocks the flow of fluid to and from the expandable member through the access opening to maintain actuation of the expandable member, the other of the positions positioning the sealer portion at a location which permits the flow of fluid to and from the expandable member through the access opening to permit actuation or deactuation of the expandable member.

2. The valve of claim 1, wherein the sealing member has a portion which extends from the proximal end of the tubular body, and wherein the application of a proximal longitudinal force on the extending portion results in proximal movement of the sealer portion within the lumen, and the application of a distal longitudinal force of the extending portion results in a distal movement of the sealer portion within the lumen.

3. The valve of claim 2, further comprising force-increasing structure which increases the longitudinal force which must be applied to the extending portion to move the sealer portion.

4. The valve of claim 1, wherein the sealer portion is formed from a polymeric material.

5. The valve of claim 1, wherein the sealer portion is capable of withstanding pressures up to 10 atmospheres while preventing substantially all fluid from passing to and from the balloon through the access opening when the sealer portion is positioned distal to the access opening.

6. The valve of claim 5, wherein the sealer portion is capable of undergoing 10 valve-opening and closing cycles and, at a pressure of ten atmospheres, still prevents substantially all fluid from passing to and from the balloon through the access opening when the sealer portion is positioned distal to the access opening.

7. The valve of claim 1, wherein at least a portion of the sealing member is formed of a metal selected from the group consisting of nitinol, stainless steel and combinations thereof.

8. The valve of claim 1, wherein the outer diameter of the tubular body is larger than the outer diameter of any portion of the sealing member or sealer portion.

9. The valve of claim 8, wherein the outer diameter of the tubular body is no greater than 0.038 inches.

10. The valve of claim 9, wherein the outer diameter of the tubular body is no greater than 0.020 inches.

11. The valve of claim 10, wherein the outer diameter of the tubular body is no greater than 0.014 inches.

12. The valve of claim 1, further comprising positive stops to prevent withdrawal of the sealing member from the opening.

13. The valve of claim 1, further comprising an inflation adaptor capable of receiving the valve, the inflation adaptor providing a fluid tight chamber for introduction of a pressurized fluid to expand the expandable member.

14. The valve of claim 1, wherein the access opening is the lumen opening.

15. The valve of claim 1, wherein the lumen has a cross section which is substantially constant from the proximal end to the distal end.

16. The valve of claim 1, wherein said one of the positions positioning the sealer portion in contact with said surface at a location which blocks the flow of fluid to and from the expandable member is distal to said other of the positions positioning the scaler portion at a location which permits the flow of fluid to and from the expandable member.

17. A valve, comprising:

a flexible elongate tubular body having a proximal end and a distal end, and a lumen extending between the proximal and distal end, the lumen having an opening at the proximal end;

an expandable member on the distal end of the tubular body, the expandable member being in fluid communication with the lumen;

an access opening on the tubular body, the access opening being in fluid communication with the lumen to permit the expandable member to be actuated by pressurizing the access opening, wherein the access opening comprises a side-access port positioned on the tubular body at a point proximal to the tubular body distal end; and

a sealing member having a sealer portion which seals against a surface of the tubular body, said portion of the sealing member being movable relative to said surface of the tubular body between two positions, one of the positions positioning the sealer portion in contact with said surface at a location which blocks the flow of fluid to or from the expandable member through the access opening to maintain actuation of the expandable member, the other of the positions positioning the sealer portion at a location which permits the flow of fluid to or from the expandable member through the access opening to permit actuation or deactuation of the expandable member.

18. An apparatus, comprising:

a hollow metallic guidewire having a central lumen and a side-access port in fluid communication with the lumen;

an inflatable balloon mounted on the guidewire, the inflatable balloon being in fluid communication with the central lumen, such that fluid introduced through the side-access port can be used to inflate the balloon;

a valve mounted to slide along a surface of the guidewire, said valve movable between first and second positions, one of said positions sealing the central lumen such that substantially no fluid may pass to or from the inflatable balloon by way of the side-access port.

19. The apparatus of claim 18, wherein the hollow guidewire has an outer circumference defining a first value, and wherein the movable valve has a circumference which is less than the first value.

20. The apparatus of claim 19, wherein the hollow guidewire has an outer circumference of 0.044 inches or less.

21. The apparatus of claim 18, wherein the movable valve has a diameter not substantially larger than that of the hollow guidewire, and wherein said valve seals against an interior surface of said hollow guidewire.

22. A low profile catheter valve, comprising:

a sealing member capable of being movably inserted through a proximal opening on a catheter into an inflation lumen of the catheter, the catheter having a side-access inflation port and an inflatable balloon in fluid communication with the side-access inflation port;

a sealer portion on the sealing member, the sealer portion being capable of forming a fluid tight seal with the entire circumference of a section of the lumen, such that substantially all fluid may not pass the sealer portion;

wherein when the sealer portion is positioned within the lumen proximally of the side-access inflation port, an unrestricted fluid pathway is established between the side-access inflation port and the balloon, and when the sealer portion is positioned within the lumen distally of the side-access inflation port, substantially all fluid may not pass to or from the balloon through the side-access inflation port.

23. The valve of claim 22, wherein the lumen has a cross section which is substantially constant from the proximal end to the distal end.

24. A method of inflating a catheter balloon, comprising the steps of:

providing a tube having a proximal end and a distal end, the proximal end having an inflation opening in fluid communication with an inflation lumen and the distal end having an inflatable balloon in fluid communication with the inflation lumen;

introducing a pressurized inflation fluid through the inflation opening to inflate the balloon;

sealing the inflation opening by moving a sealing member within the inflation lumen without reducing the pressure of the pressurized fluid, wherein the step of sealing is performed without deflating the inflated balloon; and

reducing the pressure of the pressurized fluid after completing the sealing step.

25. The method of claim 24, wherein the lumen has a cross section which is substantially constant from the proximal end to the distal end.

26. The method of claim 24, wherein the inflation opening comprises a side-access port.

27. A low profile catheter valve for use with an inflation adaptor, comprising:

a catheter having an inflatable member and an inflation opening for inflating the inflatable member, the inflatable member being in fluid communication with the inflation opening;

a sealing member movably mounted in the catheter for selectively blocking fluid flow between the inflation opening and the inflatable member;

indicia on at least one of said catheter and said sealing member, the position of the indicia being such that alignment of said indicia with corresponding indicia on the inflation adaptor causes the inflation opening to be disposed within a fluid tight inflation chamber of the inflation adaptor.

28. The low profile catheter valve of claim 27, wherein the lumen has a cross section which is substantially constant from the proximal end to the distal end.

29. The low profile catheter valve of claim 27, wherein the inflation opening comprises a side-access port.

30. A medical device apparatus, comprising:

a flexible elongate tubular body having a proximal end and a distal end, and a lumen having a longitudinal axis extending between the proximal end and the distal end, the lumen having an opening at the proximal end;

an expandable member on the distal end of the tubular body;

an elongate member having a portion which engages a surface of the tubular body within the lumen of the tubular body, said portion being movable along the longitudinal axis relative to said surface of the tubular body between two positions, one of the positions positioning the portion in contact with said surface at a location for maintaining actuation of the expandable member.

31. The apparatus of claim 30, wherein the expandable member is an inflatable balloon.

32. The apparatus of claim 30, wherein the elongate member includes a sealer portion that seals against a surface of the tubular body.

33. The apparatus of claim 30, wherein the outer diameter of the tubular body is larger than the outer diameter of any portion of the elongate member.

34. The apparatus of claim 30, wherein the elongate member includes waves that frictionally engage a surface of the tubular body within the lumen.

35. The apparatus of claim 30, wherein the lumen has a substantially constant cross-section from the proximal end to the distal end.

36. The apparatus of claim 30, wherein the elongate member extends proximal to the tubular body.