Intravascular catheter and method for use thereof

• US 5,484,409 A
• Filed: 02/26/1993
• Issued: 01/16/1996
• Est. Priority Date: 08/25/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Robinson, David, Atkinson, Robert, Schmaltz, Dale, Ellis, Louis G., Keith, Peter
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/023,950
• Time in Patent Office: 1,054 Days
• Field of Search: 604/96-98, 604/122, 604/118-119, 604/192-194, 604/236, 606/191-192
• US Class Current: 604/103.03
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• 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 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular catheter, such as a balloon catheter, and a method for use thereof, the catheter comprising an elongate shaft having an inflation lumen extending therethrough, an implement, such as a dilation balloon, connected to and located at the distal portion of the shaft and communicating with the lumen, a small profile core wire extending through at least the dilation balloon and having a distal portion that extends distally from the dilation balloon through a distal core wire opening located distally of the balloon, and further in which the core wire is movable relative to the elongate shaft to allow withdrawal of the elongate shaft and the balloon while leaving the core wire positioned intravascularly, and a tip member connected to the core wire in a region thereof distal of the location at which the core wire extends distally of the core wire opening, the tip member having a profile larger than the opening. Also, a manifold is provided adapted to both form a fluid seal around a guide wire received in a port and spatially fix the position of the guide wire in the manifold. Also, the manifold automatically closes a fluid port upon disconnection of a source of fluid from the fluid port.

Claims

1. A balloon catheter system comprising:

a. an elongate shaft having a proximal and a distal end with a lumen extending therethrough;

b. an inflatable balloon having a proximal end and a distal end with an interior volume defined therein, said proximal end of said balloon affixed to said elongate shaft proximate the distal end thereof;

c. means for fluid communication between said interior volume of said balloon and said lumen of said elongate shaft;

d. a sealing sleeve having a proximal end and a distal end and a lumen extending therethrough, said lumen of said sealing sleeve axially aligned with said lumen of said elongate shaft, wherein said proximal end of said sealing sleeve is distal of said means for fluid communication; and

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e. a guide wire slidably received through said lumen of said elongate shaft and said lumen of said sealing sleeve, said guide wire including a sleeved portion forming an exterior surface of said guide wire at a location along said guide wire corresponding to the sealing sleeve of said catheter when said guide wire is positioned in said catheter during use, wherein a close tolerance between said sleeved portion of said guide wire and said sealing sleeve forms a seal therebetween during inflation of said inflatable balloon while said guide wire remains slidably received within said lumens.

2. The balloon catheter system of claim 1 wherein said sealing sleeve is a tubular member having sufficient radial strength so that the walls thereof do not collapse onto said guide wire during inflation of said inflatable balloon.

3. The balloon catheter system of claim 2, wherein said sealing sleeve is manufactured from a polymeric material.

4. The balloon catheter system of claim 1, wherein said sleeved portion of said guide wire extends proximally from proximate the distal end thereof.

5. The balloon catheter system of claim 4, wherein said sleeved portion of said guide wire is manufactured from a polymeric material.

6. The balloon catheter system of claim 5, wherein said polymeric material is heat shrunk onto said guide wire.

7. The balloon catheter system of claim 5, wherein said sleeve portion is approximately 6.5 inches in length.

8. The balloon catheter system of claim 1, wherein said proximal end of said sealing sleeve is slidably received within the distal end of said elongate shaft.

9. The balloon catheter system of claim 8, wherein said elongate shaft comprises multiple segments.

10. The balloon catheter system of claim 1, wherein said elongate shaft includes a distal segment which extends distally into the interior volume of said inflatable balloon.

11. The balloon catheter system of claim 10, wherein said means for fluid communication comprise said distal segment having holes through the wall thereof within the interior volume of said inflatable balloon.

12. A balloon catheter system comprising:

a. an elongate shaft having a proximal and a distal end with a lumen extending therethrough;

b. an inflatable balloon having a proximal end and a distal end, said proximal end of said balloon affixed to said elongate shaft proximate the distal end thereof and having an interior volume in fluid communication with said lumen of said elongate shaft;

c. a sealing sleeve having a proximal end and a distal end and a lumen extending therethrough, said sealing sleeve having the distal end of said inflatable balloon affixed thereto and extending proximally through at least a portion of the interior volume of said inflatable balloon, wherein said lumen of said sealing sleeve is axially aligned with said lumen of said elongate shaft; and

,

d. a guide wire slidably received through said lumen of said elongate shaft and said lumen of said sealing sleeve, said guide wire including a sleeved portion forming an exterior surface of said guide wire at a location along said guide wire corresponding to the sealing sleeve of said catheter when said guide wire is positioned in said catheter during use, wherein a close tolerance between said sleeved portion of said guide wire and said sealing sleeve forms a seal therebetween during inflation of said inflatable balloon while said guide wire remains slidably received within said lumen of said elongate shaft and said lumen of said sealing sleeve.

13. The balloon catheter system of claim 12, wherein said sealing sleeve is a tubular member having sufficient radial strength so that the walls thereof do not collapse onto said guide wire during inflation of said inflatable balloon.

14. The balloon catheter system of claim 13, wherein said sealing sleeve is manufactured from a polymeric material.

15. The ball on catheter system of claim 12, wherein said sleeved portion of said guide wire extends proximally from proximate the distal end thereof.

16. The balloon catheter system of claim 15, wherein said sleeved portion of said guide wire is manufactured from a polymeric material.

17. The balloon catheter system of claim 16, wherein said polymeric material is heat shrunk onto said guide wire.

18. The balloon catheter system of claim 16, wherein said sleeve portion is approximately 6.5 inches in length.

19. The balloon catheter system of claim 12, wherein said proximal end of said sealing sleeve is slidably received within the distal end of said elongate shaft.

20. The balloon catheter system of claim 19, wherein said elongate shaft comprises multiple segments.

21. The balloon catheter system of claim 12, wherein said elongate shaft includes a distal segment which extends distally into the interior volume of said inflatable balloon.

22. The balloon catheter system of claim 21, wherein said distal segment includes holes through the wall thereof within the interior volume of said inflatable balloon to provide said fluid communication.