Angioplasty apparatus facilitating rapid exchanges

What is claimed is:

1. An elongated dilatation catheter which is adapted to be inserted over a guidewire through a patient's blood vessel to perform angioplasty procedures therein, comprising:

a) an elongated catheter body having an inner inflation lumen extending therethrough, a proximal portion which is adapted to extend out of the patient during angioplasty procedures and which has means to direct inflation fluid into the inner inflation lumen and a distal portion which is adapted to be disposed entirely within the patient's vascular system during angioplasty procedures and which has a transition region with a proximal port therein opening to the exterior of the catheter and located at least 10 cm proximally from a distal port in the distal tip of the catheter body and a substantial distance distally from the proximal portion of the catheter body which extends out of the patient during an angioplasty procedure;

b) an inflatable balloon on the distal portion of the catheter body which is distal to the proximal port and which has an interior in fluid communication with the inner inflation lumen therein; and

c) an open-ended tubular member fixed with respect to the catheter body and having an inner lumen which is substantially shorter than the catheter body, which is disposed essentially in its entirety within the distal portion of the catheter body and which extends proximally within the catheter body from the distal port at the distal tip of the catheter body, through the interior of the balloon, to the proximal port in the transition region, said inner lumen of the tubular member adapted to slidably receive a guidewire therein so that a distal portion of the guidewire extends distally out of the distal port and a proximal portion thereof extends proximally out of the proximal port to the exterior of the catheter body and generally parallel and exteriorly to the catheter body over most of the length of the guidewire and out of the patient.

2. The catheter of claim 1 including an additional sleeve disposed within the tubular member which extends from the interior of the balloon to the proximal extremity of the tubular member and which has a vent tube removably disposed therein.

3. In an elongated dilatation catheter assembly for performing angioplasty procedures within a patient's arterial system, which assembly includes a guiding catheter adapted to be positioned within a patient's arterial system with the proximal end thereof extending out of the patient during the angioplasty procedure, a balloon dilatation catheter adapted to be positioned within an inner lumen of the guiding catheter with the proximal end thereof extending out of the proximal end of the guiding catheter during the angioplasty procedure and a guidewire adapted to be positioned within an inner lumen of the dilatation catheter during the angioplasty procedure, an improvement in the dilatation catheter of the assembly, comprising:

a) an elongated catheter body having an inflation lumen which extends therein, a proximal portion which is adapted to extend out of the proximal end of the guiding catheter during angioplasty procedures and which has means to direct inflation fluid into the inflation lumen of the catheter body, and a distal portion which is adapted to extend partially out of the distal end of the guiding catheter into the patient's artery during angioplasty procedures and which has a distal port in the distal end thereof, a transition region in the distal portion which is adapted to remain within the inner lumen of the guiding catheter during angioplasty procedures and which has a proximal port therein disposed a substantial distance distally from the proximal portion which extends out the proximal end of the guiding catheter, and at least 10 cm proximally from the distal port;

b) a relatively short tubular member fixed with respect to the distal portion of the catheter body having an inner lumen which is adapted to slidably receive the guidewire therein and which extends through the interior of the distal portion of the catheter body between the proximal port and the distal port, with a distal portion of the guidewire extending out the distal port and a proximal portion of the guidewire extending out of the proximal port and generally parallel and exteriorly to the catheter body within the inner lumen of the guiding catheter; and

c) an inflatable balloon located on the distal portion of the catheter body distal to the proximal port having an interior which is in fluid communication with the inflation lumen in the catheter body.

4. A dilatation catheter assembly for performing an angioplasty procedure in a human patient, wherein the assembly is adapted to be disposed during the procedure within an inner lumen of an elongated guiding catheter which has a distal end inserted into an ostium of the patient's coronary artery and a proximal end extending out of the patient, said assembly comprising:

a) a dilatation catheter which is adapted to extend out of the distal end and the proximal end of the guiding catheter during the angioplasty procedure, said dilatation catheter comprising an elongated catheter body and an inflatable balloon on the distal portion thereof, the catheter body having a first, relatively long inner lumen for directing inflation fluid from the proximal end of the catheter body to the interior of the balloon and a second inner lumen, much shorter than the first inner lumen, which is defined at least in part by a tubular member fixed with respect to the catheter body and extends through the interior of the balloon between a distal port at the distal end of the catheter body and a proximal port disposed proximally from the balloon, at least 10 cm proximally from the distal port and a substantial distance distally from the portion of the dilatation catheter which extends out of the proximal end of the guiding catheter so that the proximal port is adapted to remain within the guiding catheter during the angioplasty procedure; and

b) an elongated guidewire which is disposed within the second inner lumen of the catheter body and which has a distal portion adapted to extend out of the distal port and a proximal portion adapted to extend out of the proximal port, generally parallel and exteriorly to the portion of the catheter body disposed within the guiding catheter and out the proximal end of the guiding catheter.

5. A dilatation catheter for performing coronary angioplasty procedures which facilitates the rapid exchange thereof with another catheter without the need for exchange wires or guidewire extensions, the catheter comprising:

a) an elongated catheter shaft having proximal and distal ends and a first inner lumen extending therein;

b) an inflatable balloon disposed at the distal end of the catheter shaft having an interior in fluid communication with the first inner lumen extending within the catheter shaft; and

c) a second inner lumen which is defined at least in part by a tubular member extending through the interior of the balloon, which is adapted to slidably receive a guidewire therein, which has a first port in the distal end thereof and which has a second port spaced at least about 10 cm proximally from the distal port and spaced distally a substantial distance from the proximal end of the catheter shaft.

6. A dilatation catheter assembly for performing an angioplasty procedure within a patient's coronary artery, comprising:

a) a guiding catheter having proximal and distal ends which is adapted to be disposed within a patient's cardiovascular system with the distal end seated within an ostium of the patient's coronary artery and the proximal end extending out of the patient;

b) a guidewire with proximal and distal ends which is adapted to be disposed within the guiding catheter with the distal end of the guidewire extending out the distal end of the guiding catheter into the coronary artery of the patient and the proximal end of guidewire extending out the proximal end of the guiding catheter which extends out of the patient;

c) a dilatation having an elongated catheter body with a proximal end adapted to extend out of the patient, a distal end and adapted to be advanced through a stenosis, an inflatable balloon on a distal portion of the catheter body, a first elongated inner lumen within the catheter body which is adapted to direct inflation fluid from the proximal end of the dilatation catheter to the interior of the inflatable balloon and a second much shorter inner lumen which is defined at least in part by a tubular member extending through the interior of the balloon and which is adapted to slidably receive the guidewire, the second inner lumen having a distal port located in the distal end of the catheter body and a proximal port located at least 10 cm from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body.

Description Submit all comments and votes

This invention relates to angioplasty apparatus facilitating rapid exchanges and a method for making rapid exchanges of angioplasty devices.

At the present time in practicing angioplasty, it is often necessary to exchange one dilatation catheter for another. In doing so, it has been necessary to utilize long exchange wires having a length of approximately 300 centimeters which typically requires two operators to perform the procedure. During this procedure, it is necessary that the operators communicate with each other which makes the procedure time consuming. In addition, since the exchange wire is so long it often is awkward to handle and for that reason may come in contact with the floor or become contaminated which necessitates removing the entire apparatus being utilized for the angioplasty procedure. There is therefore a need for a new and improved angioplasty apparatus which overcomes such difficulties.

In general, it is an object of the present invention to provide an angioplasty apparatus and a method which facilitates rapid exchanges of various types of devices.

Another object of the invention is to provide an angioplasty apparatus and method of the above character which greatly facilitates exchanges of dilatation catheters.

Another object of the invention is to provide an angioplasty apparatus and method of the above character which can be utilized for the positioning of flexible elongate members.

Another object of the invention is to provide an angioplasty apparatus and method of the above character which can be utilized with various types of devices utilizing flexible elongate members.

Another object of the invention is to provide an angioplasty apparatus and method in which dye injection and pressure measurements can be made.

Additional objects and features of the invention will appear from the following description in which the preferred embodiments are set forth in conjunction with the accompanying drawings.

FIG. 1 is a side elevational view of an angioplasty apparatus incorporating the present invention.

FIGS. 2A, 3A and 4A are partial cross sectional views of the shaft, transition and balloon regions of the balloon dilatation catheter utilized in the embodidment of the invention shown in FIG. 1.

FIGS. 2B, 3B and 4B are cross sectional views taken along the lines 2B--2B, 3B--3B and 4B--4B of FIGS. 2A, 3A and 4A respectively.

FIGS. 5A, 6A and 7A are cross sectional views corresponding to FIGS. 2A, 3A and 4A of another embodiment of a balloon dilatation catheter incorporating the present invention.

FIGS. 5B, 6B and 7B are cross sectional views taken along the lines 5B--5B, 6B--6B and 7B--7B of FIGS. 5A, 6A and 7A respectively.

FIGS. 8A and 9 are cross sectional views of the transition and balloon regions of another balloon dilatation catheter incorporating the present invention.

FIG. 8B is a cross sectional view taken along the line 8B--8B of FIG. 8A.

FIG. 10 is a side elevational view of a dedicated dye injection/pressure measurement catheter incorporating the present invention.

FIG. 11 is a side elevational view of a fiber optic cable incorporating the present invention.

FIG. 12 is a side elevational view of a dedicated dye injection/pressure measurement catheter incorporating the present invention and having specific guiding means for facilitating entering acute bends in arterial vessels.

FIG. 13 is a side elevational view of a bail out catheter incorporating the present invention.

FIG. 14 is a plan view of a holder utilized in connection with the present invention.

In general, the angioplasty apparatus of the present invention is designed for introduction into the vessel of a patient. It consists of a guiding catheter which is adapted to be inserted into the vessel of the patient. It also consists of a device which is adapted to be inserted into the guiding catheter. The device includes a flexible elongate member, a sleeve is secured to the flexible elongate member near the distal extremity thereof and extends from the distal extremity into a region spaced from the distal extremity of the flexible elongate member. The device also includes a guide wire which is adapted to extend through the sleeve from the distal extremity of the flexible elongate element, through the sleeve and rearwardly of the sleeve alongside of and exteriorally of the flexible elongate element.

More particularly as shown in FIGS. 1-4, the angioplasty apparatus 16 for facilitating rapid exchanges of dilatation catheters consists of a conventional guiding catheter 17 which is provided with a rotatable hemostatic adapter 18 mounted on a proximal end and a y or two-arm connector or adapter 19 which is mounted on the rotatable adapter 18. The y-connector 19 is provided with a knurled knob 21 which carries a threaded valve member 22 that carries an O-ring 23 which is adapted to be urged into sealing engagement with a balloon dilatation catheter 26 and a guide wire 27 extending through the y-adapter 19 and through the guiding catheter 17 as shown in FIG. 1.

The balloon dilatation catheter 26 is of a single lumen type and is provided with a flexible elongate tubular member 29 which has a lumen 31 extending therethrough. The flexible tubular member 29 can be formed of a suitable material such as plastic. A Luer-type fitting 32 is mounted on the proximal extremity of the flexible tubular member 29 and is adapted to be connected to a syringe or other type of instrument for introducing a radiographic contrast liquid into the flexible tubular member 29. A balloon 33 is mounted on the distal extremity of another flexible tubular member 36 which also is formed of a suitable material such as plastic. The distal extremity of the balloon 33 is bonded to the distal extremity of the flexible tubular member 36 to form an air-tight and liquid-tight seal with respect to the same. The balloon 33 is coaxial with the tubular member 36 or sleeve as shown in FIG. 4B. The flexible tubular member 36 is provided with a guide wire lumen 37 through which the guide wire 27 carrying its flexible tip 28 can extend.

Means is provided for forming a balloon inflation lumen 41 substantially concentric with the flexible tubular member 36 and extends toward the distal extremity of the flexible tubular member 36. As can be seen from FIGS. 3B and 4B, the balloon inflation lumen 41 is formed by a flexible tubular member 42 which can be formed integral with the balloon 33. The flexible tubular member 42 extends into a transition region 44 which overlies the distal extremity of the flexible tubular member 29 so that the lumen 31 therein is in communication with the balloon inflation lumen 41. As can be seen particularly from FIG. 3A, the flexible tubular member 36 makes a transition and extends out of the tubular member 42 and provides an opening 43. The proximal extremity of the tubular member 36 overlies the flexible tubular member 31. The guide wire 27 exits through the opening 43 and extends alongside and exteriorally of the flexible tubular member 29 from the proximal extremity of the flexible tubular member 36 to the proximal extremity of the flexible tubular member 29.

The transition region 44 should be positioned at least approximately 10-15 centimeters from the distal extremity of the balloon dilatation catheter 26. This is important for two reasons. One is that the transition region be kept at a point where when the balloon dilatation catheter 26 is utilized in a procedure, the transition region remains in the guiding catheter 17 and out of the coronary artery. The spacing from the distal extremity of the dilatation catheter for the transition region is also advantageous in that it permits the person performing the procedure to pull the balloon dilatation catheter 26 out of the guiding catheter 17 until the transition region 44 clears the y-connector 19 so that all of the portion of the guide wire 27 which is exterior of the balloon dilatation catheter 26 is proximal of the y-connector. While this is being done, the operator can then utilize the knurled nut 21 to again close the o-ring to form a hemostatic seal between the y-connector and the balloon dilatation catheter to minimize the loss of blood from the patient.

The flexible tubular member 42 can be formed of a suitable material such as a heat shrinkable plastic so that it can be shrunk onto the distal extremity of the flexible tubular member 29 and onto the proximal extremity of the flexible tubular member 36 to form liquid-tight and air-tight seals with respect to the same. From the construction shown it can be seen that the guide wire 27 exits from the balloon dilatation catheter 26 in a region which is relatively close to the distal extremity of the balloon dilatation catheter 26 and extends exteriorally of the balloon dilatation catheter to the proximal extremity of the same. As shown in FIG. 1, the guide wire 27 and the balloon dilatation catheter 26 extend outwardly from the y-connector 19.

A torquer 46 of a conventional construction is secured to the guide wire 27 for rotating the guide wire as hereinafter described.

Operation and use of the angioplasty apparatus shown in FIG. 1 may now be briefly described as follows. The guiding catheter 17 is inserted into the coronary artery in a conventional manner. The balloon dilatation catheter is prepared for insertion into the guiding catheter 17 in a conventional manner. The balloon 33 can be inflated outside the body by the use of a balloon flushing tube of the type described in U.S. Pat. No. 4,323,071 and inflated by introducing a radiopaque liquid through the fitting 32 into the lumen 31 and through the lumen 41 into the balloon 33 to flush all of the air in the balloon 33 through the balloon flushing tube to fully inflate the balloon. After the balloon 33 has been inflated, the balloon can be deflated by removing the radiopaque liquid from the balloon.

The guide wire 27 is then introduced into the balloon dilatation catheter 26 by a back loading technique. Without the torquer 46 on the guide wire, the proximal extremity of the guide wire 27 is inserted backwardly through the tip of the balloon dilatation catheter through the guide wire lumen 37. The guide wire is advanced rearwardly by holding the distal extremity of the balloon dilatation catheter in one hand and advancing the guide wire 27 rearwardly with the other hand until the guide wire 27 exits through the opening 43 at the transition region 44 of the dilatation catheter. As soon as the guide wire has cleared the opening 43, the guide wire can be grasped by the hand and pulled rearwardly paralleling the balloon dilatation catheter 26 until its proximal extremity is near the proximal extremity of the dilatation catheter and so that the distal extremity of the guide wire 27 with its flexible or floppy tip 28 protrudes at least partially from the distal extremity of the balloon dilatation catheter.

At this point in time, the O-ring 23 in the y-connector 19 is opened by operation of the knurled knob 21. The distal extremity of the balloon dilatation catheter 26 having the flexible tip protruding therefrom is then introduced to the y-connector past the opened o-ring 23 and slid down the guiding catheter 17. The balloon dilatation catheter 26 and the guide wire 27 are grasped between the fingers of a hand and are advanced parallel into the guiding catheter 17. This procedure is continued until a substantial portion of the balloon dilatation catheter is disposed in the guiding catheter 17.

The torquer 46 now can be attached to the guide wire 27 near the proximal extremity of the same. The guide wire 27 is then advanced ahead of the balloon dilatation catheter until it enters the arterial vessel of the patient. The balloon dilatation catheter 26 is held stable by the fingers of the hand while the guide wire 27 is being advanced. The positioning of the guide wire 27 in the desired arterial vessel can be observed under a fluoroscope by using x-ray techniques well known to those skilled in the art. As is well known to those skilled in the art, the torquer 46 can be utilized for rotating the guide wire 27 to facilitate positioning of the flexible tip 28 in the desired arterial vessel so that the distal extremity of the guide wire can be advanced into the stenosis which it is desired to open or enlarge.

As soon as the guide wire 27 is in the desired location, it can be held stationary by two fingers of the hand and at this point in time, the balloon dilatation catheter 26 is advanced over the guide wire until the deflated balloon 33 is across the desired lesion or stenosis. If any difficulty is encountered by the person conducting the procedure in introducing the balloon dilatation catheter so that the balloon 33 resists crossing the lesion or stenosis, the guide wire 27 can be retracted slightly. The person then can observe under the fluoroscope to see that the tip 28 of the guide wire is wiggling in the blood stream indicating that it is free to move in the blood stream. Then the person can grasp both the guide wire and the dilatation catheter in one hand and advance them as a unit so that they can cross the stenosis as a unit. It has been found by utilizing such a procedure, greater pushability can be obtained in advancing the balloon dilatation catheter across the stenosis. In other words, more force can be applied to the balloon to cause it to cross the stenosis or lesion in case the opening therein is very small.

After the balloon 33 has crossed the stenosis or lesion, the balloon 33 can be inflated in a conventional manner by introducing a radiopaque contrast liquid through the lumen 31. After the inflation has occurred and the desired operation has been performed by enlarging the opening in the stenosis, the balloon dilatation catheter 26 can be removed very rapidly by the person performing the procedure by grasping the guide wire 27 by two fingers immediately proximal of the y-connector 19 after the torquer 46 has been removed. The balloon dilatation catheter 26 can be removed in several seconds in comparison with the much longer time required for removing the balloon dilatation catheter utilizing prior art exchange wire procedures. As soon as the balloon dilatation catheter 26 has been removed from the guiding catheter 17, another injection of radiographic contrast liquid can be introduced through the guiding catheter 17 to observe whether or not the balloon dilatation procedure which has been performed on the lesion or stenosis has in fact opened the lesion or stenosis to the satisfaction of the person performing the procedure.

If it is ascertained by the person performing the procedure that additional dilation of the stenosis is desired and that a larger balloon should be inserted into the stenosis, this can be accomplished very rapidly by selecting the desired size of balloon dilatation catheter.

As the balloon dilatation catheter 26 is being retracted out of the guiding catheter 17 and as soon as the transition region 44 has cleared the y-adapter 19, the o-ring 23 can be tightened down to form a seal over the balloon dilatation catheter to minimize the loss of blood of the patient. Thereafter, if desired, the remainder of the balloon dilatation catheter 26 can be removed from the guiding catheter 17 until the proximal extremity of the guide wire passes through the opening 43 and passes through the end of the balloon dilatation catheter 26. As soon as this has been accomplished, a new balloon dilatation catheter can be loaded onto the guide wire in a rearward direction by introducing the proximal extremity of the guide wire 27 into the tip of the balloon dilatation catheter. As this is being done, the index finger of the hand performi