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1. (WO1993017750) CATHETER INTRAVASCULAIRE ET PROCEDE D'UTILISATION
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WE CLAIM:
1. A balloon catheter for use with a guide wire, said balloon catheter comprising:
an inflatable balloon;
an elongate shaft having a proximal portion and a distal portion, said inflatable balloon located at said distal portion and said elongate shaft having an inflation lumen for conveying fluid for inflation of said balloon;
a shaft extension located inside said balloon and extending from a proximal end of said balloon, said shaft extension having an opening therethrough
communicating with the inflation lumen; and
a sealing sleeve located inside said balloon and extending from a distal end of said balloon, said sealing sleeve and said shaft extension fitting
together one inside the other in a slidable, fluid-sealing relationship with each other.

2. The balloon catheter of Claim 1 in which said shaft extension is formed of a distal portion of said elongate shaft.

3. The balloon catheter of Claim 1 further comprising:
a guide wire lumen extending through said elongate shaft, said guide wire lumen adapted to receive a guide wire.

4. The balloon catheter of Claim 3 in which said inflation lumen is also adapted to receive the guide wire.

5. The balloon catheter of Claim 1 in which said sealing sleeve defines a guide lumen therethrough.

6. The balloon catheter of Claim 1 in which said sealing sleeve is received inside a distal end of said shaft extension.

7. The balloon catheter of Claim 1 further comprising:
a shoulder located on said sealing sleeve and adapted to be abutted by a distal end of said shaft extension for the transference of force from said shaft extension to said sealing sleeve.

8. The balloon catheter of Claim 1 in which said sealing sleeve defines a guide wire lumen
therethrough forming a fluid sealing fit with respect to a guide wire received therein.

9. The balloon catheter of Claim 3 further comprising:
a guide wire adapted to be received in said guide wire lumen, said guide wire having:
a distal portion having a profile greater than a distal guide wire opening of said balloon catheter.

10. The balloon catheter of Claim 1 further comprising:
a guide wire comprising:
a polymer jacket forming an exterior surface of said guide wire at a location along said guide wire that corresponding to the sealing sleeve of said catheter when said guide wire is positioned in said catheter during use.

11. A manifold for a catheter comprising: a manifold body having a manifold bore extending therethrough in communication with a lumen of the catheter,
a port on the manifold communicating with the manifold bore, said port sized and adapted to allow a guide wire to extend from a position outside the catheter, through said port, into the manifold boire, and into the catheter lumen;
a fluid seal in said port adapted to provide a fluid tight seal around a guide wire extending through said port to limit the passage of fluid around the guide wire between the manifold bore and a position outside the catheter;
a gripping apparatus adapted to restrict relative movement between said manifold body and a guide wire in said port; and
an actuator located at said port and adapted to operate said fluid seal and said gripping apparatus.

12. The manifold of Claim 11 in which actuation of said actuator is adapted to operate one of said fluid seal and said gripping apparatus and
continued actuation of said actuator is adapted to operate the other of said fluid seal and said gripping apparatus .

13. The manifold of Claim 11 in which said actuator is further adapted to operate said fluid seal and said gripping apparatus to open said fluid seal and to release said gripping apparatus.

14. The manifold of Claim 11 in which said fluid seal comprises a compression seal located around said manifold bore and adapted to seal down around a guide wire located in said bore upon application of force from said actuator.

15. The manifold of Claim 11 in which said gripping device comprises a collet defining a bore therethrough for receiving a guide wire that extends into the manifold bore and a collet seat defining a bore therethrough for receiving the guide wire, said collet adapted to be received into said collet seat upon application of force from said actuator.

16. The manifold of Claim 14 in which said gripping device comprises a collet defining a bore therethrough for receiving a guide wire that extends into the manifold bore and a collet seat defining a bore therethrough for receiving the guide wire, said collet adapted to be received into said collet seat upon application of force from said actuator, said collet and said collet seat adjacent of said
compression seal.

17. The manifold of Claim 16 in which said collet, said collet seat, and said compression seal are adapted to receive a force from said actuator.

18. The manifold of Claim 14 in which said manifold body comprises a shoulder against which said compression seal is compressed by an application of force from said actuator.

19. The manifold of Claim 11 in which said catheter is a balloon catheter and in which said lumen is adapted to both receive a guide wire and convey fluid for inflation of an inflatable balloon.

20. A method of operating a manifold on a catheter comprising the steps of:
providing a catheter having the manifold of Claim 11; and
rotating the actuator to grip the a guide wire received in said port and by the same act of rotation provide a fluid seal around said guide wire.

21. A manifold for a catheter comprising:
a manifold body having a manifold bore extending therethrough in communication with a lumen of the catheter,
a port on the manifold communicating with the manifold bore, said port sized and adapted to connect in a fluid tight sealing manner to a source of fluid for delivery of the fluid into the manifold bore and into the lumen of the catheter; and
a closure in said port operable to close said port to isolate the manifold bore from the ambient in the absence of a connection to said port, said closure operable
a. to open and provide communication between said port and the manifold bore upon connection of the source of fluid to the port; and
b. to close and isolate said port from the manifold bore upon disconnection of the source of fluid to the port.

22. The manifold of Claim 21 further
comprising:
a cap connected to said manifold body in a manner that permits relative movement between said cap and said manifold between first and second positions.

23. The manifold of Claim 22 in which said cap is adapted to receive fluid from said source, said cap having a bore that aligns with said manifold bore in the first position, said bore in said cap not aligned with said manifold bore when said cap is in the second position relative to said manifold body.

24. The manifold of Claim 22 further
comprising a venting bore, said venting bore
communicating with ambient, said source of fluid communicating with said venting bore when said cap is in said second position.

25. The manifold of Claim 22 in which said cap is adapted to connect to said source of fluid and to form a fluid tight seal with the source of fluid by said connecting in a manner of actuation, and further in which said cap adapted to be moved from one of said positions to another of said positions by said manner of actuation.

26. The manifold of Claim 25 in which said cap is moved from one of said positions to the other of said positions in response to a lower threshold of said actuation than needed to form said fluid tight seal.

27. The manifold of Claim 22 in which said cap is adapted to connect to said source of fluid by rotating said source of fluid with respect to said cap in a first rotational direction and to form a fluid tight seal with the source of fluid by tightly rotating said source of fluid onto said cap, and further in which said cap adapted to be moved from one of said positions to another of said positions by rotating said cap relative to said manifold body in said first rotational direction.

28. The manifold of Claim 26 in which said cap is adapted to disconnect from said source of fluid by rotating said source of fluid with respect to said cap in an opposite rotational direction and to release from the fluid tight seal with the source of fluid by rotating said source of fluid off of said cap, and further in which said cap adapted to be moved from the other of said positions to the one of said positions by rotating said cap relative to said manifold body to release said source of fluid.

29. The manifold of Claim 21 in which said catheter is a balloon catheter.

30. A method of operating a manifold on a catheter comprising the steps of:
providing a catheter having the manifold of Claim 22; and
engaging said cap with a source of fluid;
rotating said cap with respect to said manifold body to open said closure; and
rotating said source of fluid with respect to said cap to seal said source of fluid with respect to said manifold body.

31. A balloon catheter comprising:
an elongate shaft having an inflation lumen extending therethrough, said elongate shaft having a distal portion adapted for positioning intravascularly and a proximal portion adapted to extend outside of the body of a patient during use;

a dilation balloon connected to and located at the distal portion of said shaft and communicating with said lumen;
a small profile core wire extending through at least said dilation balloon and having a distal portion that extends distally thereof from a distal core wire opening located distally of said balloon, and further in which said core wire is movable relative to said elongate shaft to allow withdrawal of said
elongate shaft and said balloon while leaving said core wire positioned intravascularly; and
a tip member connected to the core wire in a region thereof distal of the location at which said core wire extends distally of the core wire opening, said tip member having a profile larger than said opening, and further in which said core wire has no connection at a proximal end thereof for coupling with an extension wire.

32. The balloon catheter of Claim 31 further comprising:
an inner tubular member extending through said balloon and defining a second lumen occupied by a portion of said core wire and in which said inner tubular member terminates distally at the distal core wire opening.

33. The balloon catheter of Claim 32 in which said inner tubular member extends proximally from the distal core wire opening within said elongate shaft to a proximal core wire opening located at a manifold at the proximal end of said elongate shaft.

34. The balloon catheter of Claim 32 in which said tubular member extends proximally from the distal core wire opening within said elongate shaft to a proximal core wire opening located at a portion of said elongate shaft normally within the body during intravascular use.

35. The balloon catheter of Claim 32 in which said elongate shaft further comprises:
a proximal relatively rigid portion; and
a distal relatively flexible portion
connected at a proximal end to a distal end of said proximal rigid portion and connected at a distal end to said balloon.

36. The balloon catheter of Claim 35 in which a proximal core, wire opening is located close to the connection of said proximal and distal portions of said elongate shaft.

37. The balloon catheter of Claim 35 in which a proximal core wire opening is located close to the connection of said distal portion of said elongate shaft to said balloon.

38. The balloon catheter of Claim 35 further comprising:
an inner tubular member extending through said balloon and defining a second lumen occupied by a portion of said core wire.

39. The balloon catheter of Claim 31 in which at least a portion of said elongate shaft is formed of a superelastic tubing.

40. The balloon catheter of Claim 31 in which said core wire is located at least in part in the inflation lumen of said elongate shaft.

41. The balloon catheter of Claim 40 further comprising:
an inner tubular member extending through said balloon and defining a second lumen occupied by a portion of said core wire, and further in which said inner tubular member extends proximally from the distal core wire opening through said balloon and terminates at a location distal of a manifold at the proximal end of said elongate shaft, and further in which said core wire is located in the inflation lumen of said elongate shaft between the proximal termination of said inner tubular member and said manifold.

42. An intravascular catheter comprising:
an elongate shaft having a distal portion adapted for positioning intravascularly and a proximal portion adapted to extend outside of the body of a patient during use, at least a portion of said elongate shaft formed of a superelastic tubing; and
an intravascular implement connected to and located at the distal portion of said shaft.

43. The intravascular catheter of Claim 42 in which said superelastic tubing is formed of a material selected from a group consisting of: nitinol and Tinel.

44. The intravascular catheter of Claim 42 in which said elongate shaft defines an outer wall of said intravascular catheter.

45. The intravascular catheter of Claim 42 in which said intravascular implement is an inflatable dilation balloon.

46. The intravascular catheter of Claim 42 in which said elongate shaft further comprises:
a proximal relatively rigid portion; and
a distal relatively flexible portion
connected at a proximal end to a distal end of said proximal rigid portion and connected at a distal end to said implement.

47. The intravascular catheter of Claim 46 in which said proximal portion is formed of the
superelastic tubing.

48. A method of performing a balloon
angioplasty procedure comprising the steps of:
providing a low profile balloon catheter, said low profile balloon catheter having an elongate shaft with an inflation lumen extending therethrough, said elongate shaft having a distal portion adapted for positioning intravascularly and a proximal portion adapted to extend outside of the body of a patient during use;
a dilation balloon connected to and located at the distal portion of said shaft and communicating with said lumen;
a small profile core wire extending through at least said dilation balloon and having a distal portion that extends distally thereof from a distal core wire opening located distally of said balloon, and further in which said core wire is movable relative to said elongate shaft to allow withdrawal of said elongate shaft and said balloon while leaving said core wire positioned intravascularly; and
a tip member connected to the core wire in a region thereof distal of the location at which said core wire extends distally of the core wire opening, said tip member having a profile larger than said opening;
securing a proximal portion of said core wire to the elongate shaft at a proximal portion of said core wire so that said core wire and said elongate shaft can be advanced together intravascularly;
advancing said low profile balloon
intravascularly in a person's body, and
withdrawing said elongate shaft and balloon while leaving said core wire and tip member in place in the person's body without holding onto a proximal portion of the core wire that extends the out of the person's body.

49. The method of Claim 48 further
comprising the step of:
performing an angioplasty procedure .at a stenosed vessel site by inflating the dilation balloon.

50. The method of Claim 48 further
comprising the step of:
exchanging said dilation catheter for a second intravascular device.

51. The method of Claim 48 further
comprising the steps of:
unsecuring said proximal portion of said core wire from said proximal portion of said elongate shaft;
securing a distal portion of said core wire within a guide catheter in which is located said distal portion of said core wire and a distal portion of said elongate shaft; and
withdrawing said elongate shaft from the person's body.

52. The method of Claim 51 further
comprising the steps of:
advancing a second intravascular device over said core wire; and
unsecuring said distal portion of said core wire from within said guide catheter.

53. A balloon catheter comprising:
an elongate shaft having an inflation lumen extending therethrough and a guide wire lumen, said elongate shaft having a distal portion adapted for positioning intravascularly and a proximal portion adapted to extend outside of the body of a patient during use;
a dilation balloon connected to and located at the distal portion of said shaft and communicating with said inflation lumen and said guide wire lumen;
a small profile core wire extending through said dilation balloon and having a distal portion that extends distally thereof from a distal core wire opening located distally of said balloon, and further in which said core wire is movable relative to said elongate shaft to allow withdrawal of said elongate shaft and said balloon while leaving said core wire positioned intravascularly; and
a tip member connected to the core wire in a region thereof distal of the location at which said core wire extends distally of the core wire opening, said tip member having a profile larger than said opening.

54. A balloon catheter comprising:
an elongate shaft having an inflation lumen extending therethrough, said elongate shaft having a distal portion adapted for positioning intravascularly and a proximal portion adapted to extend outside of the body of a patient during use;
a dilation balloon connected to and located at the distal portion of said shaft and communicating with said lumen;
a small profile core wire extending through at least said dilation balloon at which location said core wire has a distal profile and further said core wire having a distal portion that extends distally thereof from a distal core wire opening located
distally of said balloon, and further in which said core wire is movable relative to said elongate shaft to allow withdrawal of said elongate shaft and said balloon while leaving said core wire positioned
intravascularly; and
a tip member connected to the core wire in a region thereof distal of the location at which said core wire extends distally of the core wire opening, said tip member having a profile larger than said opening, and further in which said core wire has a profile proximal of said balloon that is not greater than said distal profile.