Guidewire inflation system

• US 6,050,972 A
• Filed: 11/20/1997
• Issued: 04/18/2000
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular (Medtronic Plc)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Leguidleguid, Roy, Kim, Isaac J., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza, Field, Jeffrey F., Bleam, Jefferey C., Marano-Ford, April A., Patel, Mukund, Tsai, George
• Primary Examiner(s): HAYES, MICHAEL J
• Assistant Examiner(s): Gring, Kent
• Application Number:
  US08/975,723
• Time in Patent Office: 880 Days
• Field of Search: 604/96, 604/97, 604/98, 604/99, 604/65, 604/95, 606/194, 606/191
• US Class Current: 604/97.01
• 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. Also disclosed herein is an inflation adaptor for moving the sealer portion within the catheter to establish or close the fluid pathway between the inflation port and the inflatable balloon.

Claims

1. An intravascular guidewire inflation system, comprising:

a hollow metallic body having distal and proximal portions, said body having a central lumen formed therein with distal and proximal ports in fluid communication with said lumen;

an expandable member mounted on said distal portion of said body and adapted to be in fluid communication with said distal port of said central lumen, such that fluid introduced through said proximal port will cause actuation of said expandable member;

a valve movably inserted with respect to said proximal port of said body, said valve movable between a first position to seal said central lumen to prevent deactuation of said expandable member and a second position to unseal said central lumen to allow actuation or deactuation of said expandable member; and

a valve adaptor which may be removably mounted on said proximal portion of said body, said adaptor having an auxiliary lumen adapted to be in fluid communication with said proximal port of said central lumen and further adapted to receive a fluid delivery device for selectively actuating or deactuating said expandable member, said adaptor having a first seal to engage said metallic body at a point distal to said proximal port, and a second seal to engage said valve, such that when said first and second seals are engaged on said distal point and said valve, a fluid tight sealing chamber is established surrounding said proximal port.

2. The guidewire inflation system of claim 1, wherein said metallic body comprises nitinol.

3. The guidewire inflation system of claim 1, wherein said expandable member comprises a balloon formed from an elastomeric material selected from the group consisting of C-Flex, silicones, latex and polyurethanes.

4. The guidewire inflation system of claim 2, wherein said metallic body has an outer diameter of from about 0.010 inches to about 0.032 inches.

5. The guidewire inflation system of claim 4, wherein said metallic body has an outer diameter of from about 0.014 inches to about 0.018 inches.

6. A surgical guidewire inflation system, comprising:

a hollow metallic body having distal and proximal portions, said body having a central lumen formed therein with distal and proximal ports in fluid communication with said central lumen;

an inflatable member mounted on said distal portion of said body in fluid communication with said distal port of said central lumen, such that fluid introduced through said proximal port will cause inflation of said inflatable member;

a valve movably inserted with respect to said proximal port of said body, said valve movable between a first position to seal said central lumen to prevent deflation of said inflatable member and a second position to unseal said central lumen to allow inflation or deflation of said inflatable member; and

a valve adaptor which may be removably mounted on said proximal portion of said body, said adaptor having an auxiliary lumen adapted to be in fluid communication with said proximal port of said central lumen and further adapted to receive a fluid delivery device for selectively inflating or deflating said inflatable device, said adaptor having a seal to engage said metallic body, thereby creating a fluid tight seal between said auxiliary lumen and said proximal port.

7. The guidewire inflation system of claim 6, wherein said metallic body comprises nitinol.

8. The guidewire inflation system of claim 6, wherein said inflatable member comprises a balloon formed from an elastomeric material selected from the group consisting of C-Flex, silicones, latex and polyurethanes.

9. The guidewire inflation system of claim 7, wherein said metallic body has an outer diameter of from about 0.010 inches to about 0.032 inches.

10. The guidewire inflation system of claim 6, wherein said metallic body has an outer diameter of from about 0.014 inches to about 0.018 inches.

11. The guidewire inflation system of claim 6, wherein said distal portion of said hollow metallic body comprises a coil at the distal tip of said body.

12. The guidewire inflation system of claim 11, wherein said central lumen has a core wire inserted therein at a distal opening, and said core wire extends distally from said distal opening within said coil.

13. The guidewire inflation system of claim 6, wherein said valve comprises a metallic rod slidably inserted into said central lumen.

14. The guidewire inflation system of claim 13, wherein the diameter of a first portion of said metallic rod is less than the internal diameter of said central lumen and the diameter of a second portion of said metallic rod is greater than the diameter of said central lumen.

15. The guidewire inflation system of claim 14, wherein the diameter of said second portion of said metallic rod is about 0.014 inches or less.

16. A method of inflating a balloon mounted on a hollow surgical guidewire during a medical procedure, comprising the steps of:

providing a hollow guidewire having a proximal end and a distal end with a central lumen extending therethrough, and a proximal opening and a distal opening, said distal opening being in fluid communication with said central lumen, said guidewire further having an inflatable balloon mounted near said distal end, said inflatable balloon being in fluid communication with said distal opening and said lumen, said central lumen further having a valve member inserted therein at said proximal end, said valve member being movable to at least a first position and a second position, and wherein said proximal opening is in fluid communication with said distal opening when said valve member is in the second position but not when said valve member is in the first position;

introducing said guidewire into a patient;

attaching a releasably securable inflation adaptor to said proximal end of said guidewire such that said proximal opening is contained within a sealing member of said inflation adaptor;

forming a fluid tight inflation chamber over said proximal opening by closing said sealing member about said proximal end; and

introducing a pressurized inflation fluid into said fluid tight inflation chamber, wherein said inflation fluid enters said proximal opening and said central lumen and inflates said balloon.

17. The method of claim 16, further comprising moving said valve member to said first position and detaching said adaptor from said proximal end, wherein said balloon remains inflated.

18. The method of claim 17, further comprising deflating said balloon comprising the further steps of:

attaching said adaptor to said proximal end;

forming said fluid tight inflation chamber over said proximal opening by closing said sealing member over said proximal end; and

moving said valve member from said first position to said second position, such that inflation fluid may exit said balloon through said proximal opening.

19. The method of claim 18, further comprising securing a vacuum apparatus to said adaptor and applying negative pressure to said fluid tight inflation chamber to deflate said balloon.

20. A surgical guidewire inflation system, comprising:

an elongate hollow body having distal and proximal portions, said body having a lumen formed therein with distal and proximal openings in fluid communication with said lumen;

an inflatable member mounted on said distal portion of said body in fluid communication with said distal opening of said lumen, such that fluid introduced through said proximal opening causes inflation of said inflatable member;

a movable sealing member for sealing said proximal opening of said hollow body; and

an adaptor having an inflation inlet for inflating said inflatable member, said adaptor being removably mountable on said proximal portion of said body such that fluid introduced into said inflation inlet flows into said proximal opening to inflate said balloon, said sealing member being movable within said adaptor to seal said proximal opening and maintain inflation of said inflatable member upon removal of said adaptor from said proximal portion of said body.