Adjustably stiffenable convertible catheter assembly
First Claim
Patent Images
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.
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Accused Products
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.
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Citations
65 Claims
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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 anddistal 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.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- over-the-wire”
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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;
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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. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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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;
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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. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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26. A method of performing coronary angioplasty dilatation for opening a constriction in an artery of a patient, comprising the steps of:
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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. - View Dependent Claims (27, 28)
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.
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28. A method of performing coronary angioplasty dilatation as recited in claim 27, including the steps of:
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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.
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29. A convertible dilatation catheter assembly suitable for performing dilatation procedures within a patient'"'"'s body comprising:
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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. - View Dependent Claims (30, 31, 33)
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32. A method of performing, with a guidewire and catheter, an intravascular procedure within a patient comprising:
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(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. - View Dependent Claims (34, 35, 37, 38, 39, 40, 41, 52)
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.
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37. The catheter of claim 35 wherein said flap is positioned to obstruct said opening.
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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.
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39. The catheter of claim 37 wherein said one end of said flap is attached proximally of said opening.
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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.
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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.
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52. The catheter of claim of 32 or 49 wherein said stiffening element is nitinol.
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36. A catheter for performing an intravascular procedure within a patient, comprising:
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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.
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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:
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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. - View Dependent Claims (43, 44, 45, 46, 47, 48, 50, 51)
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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:
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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.
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53. A readily exchangeable dilation catheter suitable for performing angioplasty procedures comprising:
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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. - View Dependent Claims (54)
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.
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55. A method of performing, with a guidewire and catheter, an intravascular procedure within a patient comprising:
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(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.
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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:
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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. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64, 65)
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Specification