Adjustably stiffenable convertible catheter assembly

• US 6,733,473 B1
• Filed: 07/09/1993
• Issued: 05/11/2004
• Est. Priority Date: 04/05/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Andersen, Erik, Tartaglino, Sandra G., Reifart, Nikolaus, Wheeler, Timothy W., Abele, John E.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/089,655
• Time in Patent Office: 3,959 Days
• Field of Search: 606/192-195, 604/93.01, 604/94.01, 604/95.01, 604/95.02, 604/95.03, 604/95.04, 604/95.05, 604/96.01, 604/102.01, 604/102.02, 604/102.03, 604/523, 604/524, 604/160, 604/767
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A stiffenable balloon catheter assembly capable of being converted from an “over-the-wire” mode with respect to a guidewire extending therethrough to a “rapid-exchange” mode with respect to a guidewire extending therethrough, and vice versa. The catheter has a plurality of lumens, one lumen however, having a side opening with an obstructable galp, the orientation of which, determines the utilization “mode” of the catheter assembly. Stiffening stylets may be adjustably locked into the lumens, depending upon the “mode”, to control the stiffness of the catheter assembly during its utilization within a patient.

Claims

1. A catheter assembly for insertion within a body vessel, said catheter assembly capable of being converted between an “

over-the-wire”

mode and a “

rapid-exchange-wire”

mode through a common lumen in said catheter assembly, comprising;

an elongated extruded flexible shaft having a proximal end and a distal end, said shaft having a balloon arranged about said distal end and a connector arranged at said proximal end;

a first and a second lumen arranged within said shaft, said second lumen being in fluid communication with the interior of said balloon for the enablement of inflation and deflation thereof; and

a third lumen extending between said proximal and

distal ends of said shaft, said third lumen having means therewith to facilitate oversion of said catheter between an “

over-the-wire”

mode and a “

rapid-exchange-wire”

mode with a guidewire arrangeable through at least a portion of said third lumen.

2. A catheter assembly for insertion within a vessel as recited in claim 1, wherein said first lumen has a closed distal end arranged within said shaft, said first lumen being arranged to receive a stiffening means therein.

3. A catheter assembly for insertion within a vessel as recited in claim 1, wherein said means to facilitate conversion of said catheter from the “

over-the-wire”

mode to the “

rapid-exchange-wire”

mode in said third lumen comprises a side opening disposed through the wall of said shaft, opening into said lumen to permit a guidewire to pass therethrough.

4. A catheter assembly for insertion within a vessel as recited in claim 3, wherein said side opening is disposed in said shaft at a location proximal to said balloon on said shaft.

5. A catheter assembly for insertion within a vessel as recited in claim 3, wherein said side opening has a resilient flap extending thereacross, and within said lumen, to act as a valve to minimize fluid leakage with respect to said lumen when said catheter is in said “

over-the-wire”

mode.

6. A catheter assembly for insertion within a vessel as recited in claim 2, wherein said stiffening means within said first lumen comprises a metal stiffening mandrel.

7. A catheter assembly for insertion within a vessel as recited in claim 6, wherein said stiffening mandrel is made from a metal wire selected from the group consisting of stainless steel or Nitinol.

8. A catheter assembly for insertion within a vessel as recited in claim 6, wherein said stiffening mandrel has a distalmost end which is emplaced within said catheter shaft, said stiffening mandrel extending adjacent said side opening distal to the position of said side opening in said catheter shaft, to minimize kinking within said shaft.

9. A catheter assembly for insertion within a vessel as recited in claim 8, wherein said stiffening mandrel is axially displaceable in said first lumen so as to effect the rigidity of said catheter shaft therealong.

10. A catheter assembly for insertion within a vessel as recited in claim 9, wherein said first lumen has a blocking means on its proximal end, to engage said stiffening mandrel and prevent axial displacement therewith.

11. A dilatation catheter made from a shaft of extrudable flexible material having proximal and distal ends, said catheter having an expandable elongated balloon disposed about its distal end;

a first lumen disposed in said shaft, extending from said proximal end of said shaft, and having a closed end near the distal end of said shaft;

a second lumen disposed in said shaft and having a distal end thereof which is in fluid communication with said expandable balloon on the distal end of the said shaft;

a third lumen disposed in said shaft comprising a tubular wall, extending from said proximal end of said shaft, through said balloon, said lumen having a terminal distal end which is open distally of said balloon;

a stiffening means disposed within said first lumen;

an obstructed opening arranged through said wall of said third lumen to provide access for a guidewire through the said lumen distally therepast.

12. A dilatation catheter as recited in claim 11 wherein said obstructed opening comprises a flexible flap, integral with said wall, disposed across said opening to permit said lumen to receive a guidewire through its full length thereof.

13. A dilatation catheter as recited in claim 12, wherein said opening is disposed through said lumen wall, at an acute angle with respect to the longitudinal axis of said shaft.

14. A dilatation catheter as recited in claim 11, wherein said third lumen is adaptable to receive a stiffening stylet and a guidewire therein, simultaneously.

15. A dilatation catheter as recited in claim 11, wherein said stiffening means in said first lumen comprises at least one stiffening mandrel extendable within said lumen.

16. A dilatation catheter as recited in claim 15, wherein said first lumen has a mandrel locking means at its proximal end thereof, to permit selective adjustment and engagement of said stiffening mandrel therein.

17. A dilatation catheter as recited in claim 15, wherein said closed end of said first lumen is disposed distally on said shaft, with respect to said obstructed opening, so that when said stiffening mandrel is fully emplaced therein, said mandrel provides stiffness and resistance to kinking of said shaft fully across said obstructed opening.

18. A dilatation catheter from a shaft of extrudable flexible material having a distal and a proximal end shaft, said having an elongated expandable balloon disposed about its distal end;

a first lumen disposed in said catheter shaft, open at said proximal end, and closed at said distal end, proximal of said balloon, said first lumen adapted to receive a stiffening mandrel therein;

a second lumen disposed in said catheter shaft, open at said proximal end, and having its distal end in fluid communication with said balloon; and

a third lumen disposed in said catheter shaft, said third lumen having a means for converting said dilatation catheter between an over-the-wire mode an da rapid-exchange-wire mode.

19. A dilatation catheter as recited in claim 18, wherein said third lumen is adaptable to receive a stiffening stylet and a separate guidewire therein, simultaneously.

20. A dilatation catheter as recited in claim 19, wherein said stiffening stylet and said separate guidewire are coaxial while both are in said third lumen.

21. A dilatation catheter as recited in claim 18, wherein said means for converting said catheter from an over-the-wire mode to a rapid-exchange mode comprises an acutely disposed opening arranged through the sidewall of said shaft, and in communication with said third lumen.

22. A dilatation catheter as recited in claim 18, wherein a plurality of orificci are arranged through the wall of said lumen, both proximally adjacent and distally adjacent said balloon at the distal end of said shaft.

23. A dilatation catheter as recited in claim 21, wherein said acutely disposed opening has a flexible flap arranged thereover and within said lumen, to provide an obstruction therewithin, said flap acting as a valve means with respect to said opening.

24. A dilatation catheter as recited in claim 18, wherein said means for converting said catheter between an “

over-the-wire”

mode and a “

rapid-exchange”

mode comprises an acutely disposed slit arranged through the sidewall of said catheter shaft, creating a flexible flap which is bendable to establish an opening in the wall for passage of a guidewire therethrough.

25. A dilatation catheter as recited in claim 18, wherein said means for converting said catheter between an “

over-the-wire”

mode and a “

rapid exchange”

mode comprises a longitudinal slot disposed through the sidewall of said catheter shaft, and into said third lumen, for passage of a guidewire therethrough when said slot is flexed apart.

26. A method of performing coronary angioplasty dilatation for opening a constriction in an artery of a patient, comprising the steps of:

providing an elongated guidewire having distal and proximal ends and a dilatation catheter comprising a shaft having a distal and a proximal end, with an elongated expandable balloon disposed about its distal end, a first lumen with a closed distal end arranged therein proximal to said balloon, a second lumen in said shaft open at its proximal end and in fluid communication at its distal end with said balloon, and a third lumen extending the length of said shaft and open at each end thereof, said third lumen having means for converting said catheter between an over-the-wire mode and a rapid-exchange mode, said means for converting said catheter comprising an obstructed opening through the side wall of said lumen proximal of said balloon, said first lumen having a stiffening mandrel therein, the distal end of which extends in said first lumen distal of said obstructed opening;

inserting said guidewire into the vessel system of a patient;

positioning said catheter over the proximal end of said guidewire so that said guide wire is in a sliding fit within said third lumen of said shaft;

advancing said guidewire proximally through said third lumen; and

bending said catheter shaft so to as lift said obstruction from said opening in the side of said third lumen to cause the proximal end of said guidewire to exit out the side of said third lumen and extend externally thereof to the proximal end of said catheter, while positioning said balloon within a vessel obstruction.

27. A method of performing coronary angioplasty dilatation as recited in claim 26, including the step of:

perfusing body fluid into said third lumen through a plurality of orificii adjacent said balloon, subsequently perfusing body fluid out of said third lumen on the other end of said balloon.

28. A method of performing coronary angioplasty dilatation as recited in claim 27, including the steps of:

withdrawing said catheter shaft from the patient sufficient to bring the proximal end of said guidewire into juxtaposed correspondence with the side opening in said third lumen;

straightening said catheter shaft at the location of said side opening in said third lumen; and

advancing the proximal end of said guidewire through the proximal balance of said third lumen while advancing said catheter shaft back into the vessel system of the patient.

29. A convertible dilatation catheter assembly suitable for performing dilatation procedures within a patient'"'"'s body comprising:

a) an elongated catheter body having proximal and distal end, a first lumen adapted to receive a guidewire and extending within the catheter body to the distal end thereof and a second lumen adapted to direct inflation fluid therethrough and extending within the catheter body to a distal portion thereof;

b) an inflatable member on a distal portion of the catheter body having an interior in fluid communication with the second lumen;

c) a first guidewire port in the catheter body being located at or near the proximal end of the catheter body and being in communication with said first lumen that is adapted to receive a guidewire;

d) a second guidewire port in the catheter body being spaced from the proximal end of the inflatable member that is on the distal portion of the catheter body and a substantial distance from the proximal end of the catheter body and being in communication with the first lumen that is adapted to receive a guidewire;

e) a third guidewire port in the distal end of the catheter body distal to the inflatable member which is in communication with the first lumen that is adapted to receive a guidewire;

f) a guidewire disposed in rapid exchange mode passing through said second guidewire port, such that a substantial portion of the length of said guidewire is located outside and alongside of said catheter body proximally of said second guidewire port and a portion of said guidewire extends inside said first lumen distally of said second guidewire port and emerges from said third guidewire port;

g) said first lumen being constructed to receive a guidewire in over-the-wire mode, extending from said first guidewire port to said third guidewire port, and

h) means on the proximal end of the catheter body to direct inflation fluid to the interior of the inflatable member through the inflation lumen.

30. The assembly of claim 29 wherein said guidewire port is located between about 15 to 35 cm from said inflatable member.

31. The dilation catheter assembly of claim 29 wherein said catheter is constructed as an angioplasty catheter and said guidewire is constructed as an angioplasty guidewire.

33. The method of claim 31 wherein said procedure performing formation is a dilatation balloon and said procedure is angioplasty dilatation for opening a constriction in a blood vessel.

32. A method of performing, with a guidewire and catheter, an intravascular procedure within a patient comprising:

(a) providing an intravascular catheter that is convertible between rapid exchange and over the wire modes of use which includes;

an elongated catheter body having proximal and distal ends, a guidewire-receiving inner lumen extending within the catheter body from the proximal end to the distal end thereof,

a procedure-performing formation disposed on the distal portion of the catheter body,

a first guidewire port in the catheter body being at the proximal end of the catheter body and being in communication with the guidewire-receiving inner lumen,

a second guidewire port in the catheter body spaced proximally of the procedure-performing device and a substantial distance from the proximal end and being in communication with the guidewire-receiving inner lumen, and

a third guidewire port in the distal end of the catheter body which is in communication with the guidewire-receiving inner lumen,

(b) positioning said convertible catheter and guidewire in the vascular system of a patient, with said guidewire disposed within the distal portion of the guidewire-receiving inner lumen and with the distal end thereof extending out the third guidewire port into the patient'"'"'s vascular system and the proximal portion of said guidewire extending out the second guidewire port and proximally along said catheter body.

34. The method of claim 32 comprising, during said procedure, converting said catheter to said over-the-wire mode.

35. The method of claim 32 comprising:

while leaving said guidewire within the vessel, removing said catheter from the body and exchanging for another catheter which is placed into said vessel over said guidewire.

37. The catheter of claim 35 wherein said flap is positioned to obstruct said opening.

38. The catheter of claim 35 wherein said flap is positioned to obstruct said guidewire lumen and cause diversion of a guidewire inserted in said distal end to cause it to exit through said opening.

39. The catheter of claim 37 wherein said one end of said flap is attached proximally of said opening.

40. The catheter of claim 38 wherein said flap is movable between a position to obstruct said guidewire lumen and cause diversion of a guidewire inserted in said distal end to cause it to exit through said opening and a position to obstruct said opening.

41. The catheter of claim 35 wherein said one end of said flap is attached distally of said opening and said free end is positionable outwardly to allow free passage through said opening.

52. The catheter of claim of 32 or 49 wherein said stiffening element is nitinol.

36. A catheter for performing an intravascular procedure within a patient, comprising:

a catheter body having a distal and a proximal end, with a procedure performing formation disposed about its distal end,

a guidewire lumen extending the length of said catheter body and open at proximal and distal ends thereof, said guidewire lumen having means for converting said catheter between an over-the-wire mode and a rapid exchange mode which comprises a guidewire receiving opening through the side wall of said lumen proximal of said procedure performing formation, and

a flap in the region of said opening having one end attached to said catheter body and a free end that can be positioned to produce an obstruction.

42. A catheter for performing a procedure in a blood vessel of a patient, said catheter bring convertible between rapid exchange and over the wire modes of use, said catheter comprising:

a shaft having a distal and a proximal end, with a procedure-performing formation disposed about its distal end,

a guidewire lumen within and extending the length of said shaft and open at each end thereof, said guidewire lumen having means for converting said catheter between and over-the wire mode and a rapid exchange mode which comprises a guidewire-passing opening through the side wall of said lumen proximal of said procedure performing formation,

said catheter further including a removable stiffening element disposed in said guidewire lumen and extending to a region proximal of said opening, said stiffening element being removable to convert said catheter for over-the-wire mode use.

43. The catheter of claim 42 wherein said stiffening element comprises a removable wire stylet.

44. The catheter of claim 42 in combination with a guidewire in the rapid exchange mode wherein said guidewire extends through said opening and occupies said guidewire lumen from said opening to said distal end of said catheter, and said removable stiffening element is a stylet in said guidewire lumen that extends to a position proximal of said opening.

45. The catheter of claim 42 including a further stiffening element extending past and beyond said opening and terminating proximal of said procedure-performing formation.

46. The catheter of claim 45 wherein said removable stiffening element comprises a wire stylet and said further stiffening element is a wire of smaller diameter than said wire stylet.

47. The catheter of claim 46 wherein said wire is positioned in a separate lumen, parallel to said guidewire lumen.

48. The catheter of claim 45 wherein said shaft comprises a multi-lumen extrusion including a substantially round lumen forming said guidewire lumen in which said removable stiffening element is disposed and a narrower lumen in which said further stiffening element in the shape of a wire is disposed.

50. The catheter of claim 48 or 49 wherein said narrower lumen is of crescent shape.

51. The catheter of claim 42 or 49 wherein said stiffening element is axially adjustable in the lumen in which it resides to vary stiffness along the length of said catheter.

49. A catheter for performing a procedure in a blood vessel of a patient, said catheter bring convertible between rapid exchange and over the wire modes of use, said catheter comprising:

a shaft having a distal and a proximal end, with a procedure-performing formation disposed about its distal end,

a guidewire lumen within and extending the length of said shaft and open at each end thereof, said guidewire lumen having means for converting said catheter between an over-the-wire mode and a rapid exchange mode which comprises a guidewire-passing opening through the side wall of said lumen proximal of said procedure performing formation,

said shaft comprising a multi-lumen extrusion including a substantially round lumen forming said guidewire lumen and a narrower lumen in which a stiffening element is disposed, said stiffening element extending past and beyond said opening and terminating proximal of said procedure-performing formation.

53. A readily exchangeable dilation catheter suitable for performing angioplasty procedures comprising:

a) an elongated catheter body having proximal and distal ends, a first lumen adapted to receive a guidewire and extending within the catheter body to the distal end thereof and a second lumen adapted to direct inflation fluid therethrough and extending within the catheter body to a distal portion thereof;

b) an inflatable member on a distal portion of the catheter body having an interior in fluid communication with said second lumen;

c) a first guidewire port in the catheter body being located at or near the proximal end of the catheter body and being in communication with said first guidewire-receiving lumen;

d) an elongated slot forming a flexible openable orifice serving as a second guidewire port in the catheter body and being in communication with said first guidewire-receiving lumen;

e) a third guidewire port in the distal end of the catheter body distal to the inflatable member, and in communication with the said first guidewire-receiving lumen; and

f) means on the proximal end of the catheter body to direct inflation fluid to the interior of the inflatable member through the inflation lumen.

54. The catheter of claim 53 in combination with

a guidewire disposed in rapid exchange mode passing through said second guidewire port, such that a substantial portion of the length of said guidewire is located outside and alongside of said catheter body proximally of said second guidewire port and a portion of said guidewire extends inside said first lumen distally of said second guidewire port and emerges from said third guidewire port, said first lumen being constructed to receive a guidewire in over-the-wire mode,

extending from said first guidewire port to said third guidewire port.

55. A method of performing, with a guidewire and catheter, an intravascular procedure within a patient comprising:

(a) providing an intravascular catheter that is convertible between rapid exchange and over the wire modes of use which includes;

an elongated catheter body having proximal and distal ends, a guidewire-receiving inner lumen extending within the catheter body from the proximal end to the distal end thereof,

a procedure-performing formation disposed on the distal portion of the catheter body,

a first guidewire port in the catheter body being at the proximal end of the catheter body and being in communication with the guidewire-receiving inner lumen,

a second guidewire port in the catheter body spaced proximally of the procedure-performing device and a substantial distance from the proximal end and being in communication with the guidewire-receiving inner lumen, and

a third guidewire port in the distal end of the catheter body which is in communication with the guidewire-receiving inner lumen,

(b) positioning said convertible catheter and guidewire in the vascular system of a patient, with said guidewire disposed within the distal portion of the guidewire-receiving inner lumen and with the distal end thereof extending out the third guidewire port into the patient'"'"'s vascular system and the proximal portion of said guidewire extending out the second guidewire port and proximally along said catheter body; and

(c) disposing said catheter in the patient'"'"'s body under conditions permitting perfusion of blood through said guidewire lumen past said procedure performing formation.

56. A dilatation catheter for performing angioplasty procedures within a patient'"'"'s coronary artery having a relatively long proximal section which is adapted to remain within a guiding catheter during the angioplasty procedure and a relatively short distal section which is adapted to extend out of the distal end of the guiding catheter during the angioplasty procedure, the dilatation catheter comprising:

a) an elongated catheter shaft which includes an elongated inner tubular structure which has a distal end, a distal guidewire port in the distal end and a guidewire receiving inner lumen extending within the inner tubular structure to the guidewire port in the distal end and an elongated outer tubular structure which is disposed about the inner tubular structure and defines therewith at least one further lumen;

b) an inflatable member on a distal portion of the catheter shaft having a distal end secured to the distal end of the inner tubular structure and an interior which is in fluid communication with a said further lumen between the inner and outer tubular structures;

c) a reinforcing mandrel disposed within a said further lumen between the inner and outer tubular structures which has a relatively long proximal section and a relatively short, distal section which has a smaller diameter than the diameter of the proximal section and which extends into the distal portion of the catheter but terminating proximal to the inflatable member.

57. The dilatation catheter of claim 56 including a guidewire slidably disposed within the guidewire receiving inner lumen.

58. The dilatation catheter of claim 56 wherein the catheter has a proximal end and the mandrel is secured within an adapter mounted on the proximal end of the catheter.

59. The dilatation catheter of claim 56 wherein said mandrel comprises nitinol.

60. The dilatation catheter of claim 56 wherein said mandrel comprises stainless steel.

61. The dilatation catheter of claim 56 wherein the distal section of said mandrel lies loosely within its respective lumen.

62. The dilatation catheter of claim 56 further comprising a guidewire-passing side port in the distal section of said catheter shaft communicating with the guidewire receiving lumen, wherein said mandrel extends from the proximal end of said dilatation catheter to a location past and beyond said side opening.

63. The dilatation catheter of claim 56 wherein there are two of said further lumens for respectively receiving said mandrel and communicating with said inflatable member for inflation.

64. The dilatation catheter of claim 63 wherein said lumen receiving said mandrel is closed immediately proximal of said inflatable member.

65. The dilatation catheter of claim 56 wherein said mandrel is adjustably locked in the vicinity of the proximal end of the catheter.