WO1995016487A1

WO1995016487A1 - Sliding receptacle catheter systems

Info

Publication number: WO1995016487A1
Application number: PCT/US1994/014585
Authority: WO
Inventors: G. David Jang
Original assignee: Jang G David
Priority date: 1993-12-17
Filing date: 1994-12-19
Publication date: 1995-06-22
Also published as: AU1374095A

Abstract

This invention is a catheter system having diagnostic and/or therapeutic applications that include a receptacle (114) which has an elongate tubular shaft (115) of a substantially constant diameter that has a receptacle lumen (120) extending longitudinally therethrough from a proximal end (116) to a distal end (118), having a first diagnostic or therapeutic means mounted on the distal end (118) of the receptacle (114), and an inner catheter (100) extending through the receptacle lumen (120), having a proximal end (103) and a distal end (105), the catheter (100) and the receptacle (114) each adapted to slide longitudinally with respect to each other, the inner catheter (100) having a second diagnostic or therapeutic means mounted on the distal end (105) of the inner catheter (100).

Description

SLIDING RECEPTACLE CATHETER SYSTEMS

BACKGROUND OF THE INVENTION

1. Field of the Invention The present invention relates to a system for permitting rapid removal and reinsertion of catheters, particularly catheters having diagnostic or therapeutic means mounted thereon. In particular, the invention is useful in connection with fixed wire and over-the-wire coronary balloon angioplasty catheters. The invention also relates to the use of multiple diagnostic or therapeutic means mounted on receptacle catheter systems.

2. Discussion of the Prior Art

Percutaneous transluminal coronary angioplasty (PTCA) has gained widespread acceptance as a significantly less- invasive alternative to coronary bypass surgery. A similar technique, peripheral angioplasty, is useful in treatment of peripheral vascular disease. Unlike bypass surgery, PTCA does not require general anesthesia, cutting of the chest wall, extracorporeal profusion, or transfusion of blood.

During PTCA and other balloon angioplasty procedures, a catheter bearing an angioplasty balloon at the distal end is threaded into a stenosis (restriction of the artery) under fluoroscopic observation. Contrast agent is injected during the positioning process in order to permit real time imaging of the vasculature into which the catheter is inserted.

Once the catheter is in place in the stenosis, the angioplasty balloon is inflated, dilating the stenosis.

It is important that the inflated diameter of the balloon be matched to the native diameter of the stenotic vessel. A balloon that is too small will produce suboptimal dilation, while a balloon that is too large could result in arterial wall damage.

There are numerous occasions in which removal of the angioplasty catheter and reinsertion of another catheter maybe required during PTCA. For example, where a balloon is unmatched to the native vessel size. Alternatively, dilation of one vessel may result in restriction of another, adjacent stenotic vessel. Furthermore, dissection of the arterial wall may occur during angioplasty. In each of the latter two events, placement of a perfusion catheter through the stenotic region may be of utmost importance.

Where the balloon chosen by the physician is unmatched to the native vessel size, removal of the angioplasty catheter and reinsertion of a different angioplasty catheter of larger or smaller size may be necessary. One type of angioplasty catheter in widespread use is the over the wire catheter. This catheter has a guidewire lumen through which a steerable guidewire may be advanced. The guidewire (which extends distally beyond the distal end of the angioplasty catheter) is typically first positioned in the stenosis. Next, the catheter is advanced over the guidewire into the stenosis. If catheter exchange is necessary, the catheter may be removed from the patient leaving the guidewire in place, and a new catheter may be rapidly advanced over the positioned guidewire into the stenosis.

Another type of angioplasty catheter in widespread use is the fixed wire catheter. In this catheter, the distal end of the angioplasty balloon is actually bonded to the guidewire. Thus, the guidewire is "fixed" with respect to the location of the balloon. A major advantage of the fixed wire catheter is the elimination of the guidewire lumen extending through the balloon, permitting the deflated fixed wire balloons to have an extremely low profile. However, a significant disadvantage of the fixed wire catheter is the inability to rapidly remove the catheter and reinsert a different catheter into the same vasculature location. When the fixed wire catheter is removed, the guidewire is removed at the same time. Insertion of a new catheter is somewhat time consuming, requiring additional injection of contrast material and fluoroscopic observation during positioning of the second catheter. In essence, replacing a catheter with a second fixed-wire catheter is like starting the procedure all over again. Accordingly, there is a substantial need for a system for bailing out fixed wire angioplasty catheters; that is, a system for permitting the removal of the fixed wire catheter and rapid and assured reinsertion of a second catheter into the same vascular location. Similarly, there is a need for a method for accomplishing that result.

SUMMARY OF THE INVENTION One aspect of the present invention provides a sliding receptacle catheter system for performing an intravascular diagnostic or therapeutic procedure, comprising a receptacle comprising an elongate tubular shaft (preferably of a substantially constant diameter) and having a receptacle lumen extending longitudinally therethrough from a proximal end to a distal end and having a first diagnostic or therapeutic means mounted on the distal end of the receptacle, and an inner catheter extending through the receptacle lumen, having a proximal end and a distal end, the catheter and the receptacle each adapted to slide longitudinally with respect to each other, the inner catheter having a second diagnostic or therapeutic means mounted on the distal end of the inner catheter.

In one embodiment the first means comprises an angioplasty balloon and the receptacle additionally comprises a balloon inflation lumen in operative communication with the balloon for inflating and deflating the balloon. Optionally, the second means comprises an angioplasty balloon and the inner catheter additionally comprises a balloon inflation lumen in operative communication with the balloon for inflating and deflating the balloon.

In another embodiment of the system, the first and second means comprise respective first and second angioplasty balloons and each of the receptacle and the inner catheter additionally comprise respective first and second balloon inflation lumens in operative communication with the respective first and second balloons for inflating and deflating the balloon.

In a preferred embodiment, the receptacle is positioned within and extends longitudinally through a guiding catheter. This is preferred for cardiac use; for peripheral use, no guiding catheter is usually necessary.

All of the systems of the present invention may optionally include a guidewire extending through the receptacle but outside of the inner catheter, and/or a guidewire extending through the inner catheter. The guidewire may be used in a manner that will be readily understood for placing and exchanging the inner catheter, the receptacle, or both. In another preferred embodiment, one of the first or second means is an inflatable angioplasty balloon and the other of the first or second means is a stent placement balloon with an implantable vascular stent concentrically mounted thereover. Either the inner catheter or the receptacle may carry the stent. The "free" balloon may be used to predilate a stenosis, and then the stent-carrying balloon may be advanced into the stenosis and dilated to implant the stent.

In yet another embodiment, one of the first or second means is an ultrasound transducer and the other is a balloon. When the ultrasound transducer is mounted on the receptacle, it is preferably annular in configuration. In any event, the balloon may be used to dilate the stenosis and then the transducer may be immediately advanced into the stenosis to image the stenosis.

In a different embodiment, one of the first and second means is adapted to emit therapeutic laser radiation and the other is a balloon. The balloon may be used to dilate a stenosis either before or after laser treatment to ablate the stenosis.

In still another embodiment, both the first and the second means comprise a balloon. In this case, one or both of the balloons may be a relatively inelastic angioplasty balloon having a substantially fixed predetermined working diameter. Preferably, the first balloon and the second balloon are both angioplasty balloons, each having a different predetermined working diameter. These dual sized balloons may permit predilation and dilation of a stenosis

(with the smaller then the larger balloon) , or treatment of multiple stenoses in differently sized vessels in the same procedure, without requiring a catheter exchange. Alternatively, one or both of the balloons is elastic, and may be used in tandem for isolating a particular region of a vessel.

The invention also includes methods for using the system. One is a method for stent placement, comprising positioning a system having both an angioplasty balloon and a stent-carrying balloon in a patient with the angioplasty balloon in a stenosis in a vessel, inflating and deflating the angioplasty balloon to dilate the stenosis, inserting the stent into the dilated stenosis and inflating and deflating its associated balloon to expand the stent and position the stent in the dilated stenosis. It is contemplated to use a system where the stent is positioned on the receptacle, or where the stent is positioned on the inner catheter.

The invention further comprises a method for isolating a region of interest in a vessel, comprising positioning a system of the present invention having two balloons in a region of interest in a vessel, such that the first balloon is on a first side of the region of interest and the second balloon is on a second side of the region of interest, and inflating the first and second balloons to contact the vessel wall on the first and second side of the region of interest to isolate the region of interest. The region of interest may be, for example, a region having an injury, disease, stenosis, or thrombus. Then, one may infuse a drug selected from the group consisting of a clot inhibiting or reducing drug and a drug that inhibits restenosis through the receptacle to the stenosis, or may infuse recombinant DNA or mRNA encoding a therapeutic polypeptide into the area or any other appropriate drug for treating the area. The proximal or distal balloon may be deflated during infusion, permitting the infused liquid to substantially or entirely displace the entire blood volume in the area, thereby providing for concentrated delivery of drug to the vessel.

Moreover, the invention includes a method for performing an intravascular diagnostic or therapeutic procedure, comprising providing the system of the invention, positioning the system at a location in a vessel that is in need of diagnosis or therapy, with one of the first or the second diagnostic or therapeutic means in proximity to the location, actuating the one of the first or second diagnostic or therapeutic means, moving the system so that the other of the first or second diagnostic or therapeutic means is in proximity to the location, and actuating the other of the first or second diagnostic or therapeutic means. Imaging transducers, cameras, ultrasound transducers, optical fibers, pressure monitors, atherectomy devices, radiopaque materials or injectors of such materials, temperature monitors, laser emitters, vessel isolating balloons, angioplasty balloons, stents, and the like are a few examples of the types of therapeutic and diagnostic devices that can be used.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side elevation of the system of the present invention, comprising a bailout receptacle with a fixed-wire balloon angioplasty catheter extending therethrough.

Figure 2 corresponds to Figure 1, but further illustrates a guidewire removing means for removing a guidewire laterally through the wall of the receptacle.

Figure 3 is a longitudinal cross section of the receptacle of Figure 1.

Figure 4 is a longitudinal cross section of the system of Figure 1, illustrating both the angioplasty catheter and the bailout receptacle in longitudinal cross section.

Figure 5 is a longitudinal cross section of the bailout system of the present invention with a bailout guidewire extending through the receptacle along side the angioplasty catheter, with the entire system being positioned inside a guiding catheter.

Figure 6 corresponds to Figure 5, and illustrates the proximal removal of the bailout receptacle and the angioplasty catheter while maintaining the bailout guidewire in place.

Figure 7, corresponds to Figure 6, except that the bailout system comprising the bailout receptacle and the angioplasty catheter have been completely removed from the guiding catheter and the bailout guidewire.

Figure 8, Panels A-D, illustrate one method of the present invention.

Figure 9, Panels A-D, illustrate a second method for practicing the present invention. Figure 10, Panels A-D, illustrate yet another method for practicing the present invention.

Figure 11, Panels A-D, illustrate still another method for practicing the present invention.

Figure 12, Panels A-D, illustrate the method of the present invention in use in a bifurcation lesion in a patient .

Figure 13 is a side elevation of the system of the present invention, comprising a bailout receptacle having an angioplasty balloon mounted thereon with an over-the- wire balloon angioplasty catheter extending therethrough.

Figure 13a is a transverse cross section of the system of Figure 13 taken along line A-A.

Figure 14 is a longitudinal cross section of the receptacle of Figure 13. Figure 15 is a longitudinal cross section of the system of Figure 13 taken along line 15-15.

Figure 16 is another longitudinal cross section of the system of Figure 13 taken along line 15-15 further showing a guidewire extending through the receptacle inside a guiding catheter.

Figure 16a is a transverse cross section of the system of Figure 16 taken along line A-A.

Figure 17 shows the system of Figure 13 with a stent mounted on the balloon of the receptacle. Figure 18 shows the system of Figure 13 with a stent

■ .mounted on the balloon of the inner catheter.

Figure 19 is a series of drawings illustrating a method of use of the system of Figure 17.

Figure 20 illustrates an alternative embodiment of the system of Figure 13 where the inner balloon catheter is replaced with an laser catheter.

Figure 21 illustrates an alternative embodiment of the system of Figure 13 where the inner balloon catheter is replaced with a catheter having a high speed rotating atherectomy head.

Figure 22 illustrates an alternative embodiment of the system of Figure 13 where the inner balloon catheter is replaced with an ultrasound transducer imaging catheter. Figure 23 illustrates a method of use of the system of

Figure 13. In Figures 23a and 23b, the use of the system for the isolation of an area of interest is illustrated. In Figure 23c, isolation of an area of interest is shown with perfusion capability.

DETAILED DESCRIPTION OF THE INVENTION In the present invention, there is provided a coaxial bailout system comprising a small caliber receptacle in the form of a hollow catheter with a balloon catheter inside of the receptacle. Unlike the larger caliber guiding catheter used in angioplasty procedures, the receptacle of the present invention has a diameter much closer to the diameter of a balloon angioplasty catheter. An angioplasty catheter, such as a fixed-wire or over-the-wire angioplasty balloon catheter (or other alternative angioplasty catheters) , extending through the bailout receptacle may slide longitudinally in the distal and proximal directions through the receptacle.

With reference now to Figure 1, the bailout system 10 of the present invention comprises an angioplasty catheter

12 extending through a bailout receptacle 14. The angioplasty catheter 12 may be a catheter of any suitable design for performing coronary angioplasty or peripheral angioplasty. However, the angioplasty catheter 12 is preferably a fixed wire balloon angioplasty catheter or a low profile over-the-wire catheter.

The angioplasty catheter 12 comprises a catheter shaft 16 having a proximal end 20 and a distal end 22. An inflatable/deflatable angioplasty balloon of conventional design is mounted on the distal end 22 of the catheter shaft 16. If the angioplasty catheter is a conventional fixed wire coronary angioplasty catheter, the balloon 24 has a proximal end attached to the distal end 22 of the catheter shaft 16. A fixed guidewire 26 extends through the balloon 24, and the distal end of the balloon 24 is attached securely to the fixed guidewire 26. The guidewire tip 30 may advantageously be a shapeable tip of conventional design. The bailout receptacle 14 comprises a elongated cylindrical shaft 32 with a proximal end 34 and a distal end 36. A proximal fitting 40, preferably of molded plastic, is provided on the proximal end 34 of the receptacle 14. A lumen 42 extends through the receptacle 14 from the proximal end 34 to the distal end 36. The receptacle lumen 42 is sized only slightly larger than the diameter of the angioplasty catheter 12, and is sized so that the angioplasty catheter 12 can slide proximally and distally through the receptacle lumen 42. In one preferred embodiment, the diameter of the receptacle shaft 32 is 3.9 French or smaller (e.g., in the case of a bailout system for coronary use) . The receptacle shaft will be larger for peripheral angioplasty.

In one preferred embodiment of the system 10, a proximal side port 44 is provided, extending through the wall 46 of the receptacle shaft 32. The proximal side port 44 is sized to permit insertion and removal of a distally- extending movable guidewire (not shown in Figure 1) .

In a preferred embodiment, as illustrated in Figure 2, the wall 46 of the receptacle shaft 32 is provided with a guidewire removing means 50 extending distally from the general vicinity of the proximal end 34 of the receptacle shaft 32. In the embodiment illustrated in Figure 2, the guidewire removing means 50 extends distally from the proximal side port 44. The guidewire removing means 50 can

^■ . extend distally any desired distance; however, in a preferred embodiment, the guidewire removing means 50 extends distally to within about 40 cm of the distal end 36 of the receptacle 14; preferably to within about 30, 25, or 20 cm, and more preferably to within about 10 or 5 cm of the distal end 36 of the receptacle 14, In one preferred embodiment, the guidewire removing means 50 extends all the way to the distal end 36 of the receptacle 14. The guidewire removing means illustrated in Figure 2 comprises a simple slit. It will be understood, however, that the guidewire removing means 50 may comprise any other type of structure that will permit removal of a guidewire laterally through the wall 46 of the receptacle 14. Thus, for example, the guidewire removing means 50 may comprise not only a fully formed slit, but an inchoate slit (e.g., a weakened area that readily may be ruptured or slit to permit lateral removal of the guidewire) . Alternatively, the guidewire removing means may comprise an interrupted or perforated slit, a tear-away strip, parallel weakened lines or parallel interrupted slits to permit removal of a strip, and other similar structures.

In a preferred embodiment, the bailout receptacle 14 (like the angioplasty catheter 12) is formed of molded or extruded polymer material. Without intending to limit the invention, polymer materials having suitable characteristics may be selected from polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate, polysiloxane, and other well known polymer materials.

Figure 3 illustrates a longitudinal cross section of one preferred embodiment of the bailout receptacle 14 of the present invention. As illustrated in Figure 3, the bailout receptacle 14 has a fitting 40 molded to or otherwise attached to the proximal end 34 of the receptacle shaft 32. The fitting 40 is preferably annular, and is advantageously formed of relatively rigid material to permit the physician to securely grip and hold the proximal end 34 of the receptacle 14 at the fitting 40. Figure 3 more clearly illustrates the lumen 42 extending longitudinally from the proximal end 34 to the distal end 36 of the receptacle 14. The wall 46 of the receptacle 14 has a proximal side port 44 formed therein, permitting access from a point normally outside the patient through -li¬ the outside wall 46 of the receptacle 14 into the lumen 42 of the receptacle 14.

In the embodiment illustrated in Figure 3, the receptacle shaft 32 includes a proximal segment 52 and a distal segment 54. The proximal segment 52 and the distal segment 54 may advantageously be made of different materials. Specifically, it is advantageous to form the proximal segment 52 of a more rigid material, and to form the distal segment 54 of a more pliable material. Alternatively, the wall thicknesses of the receptacle shaft 32 may be adjusted so that the distal segment 54 is more pliable or flexible than the proximal segment 52.

One advantage of having a 2-segment receptacle 14 is that the stiffer proximal segment can provide pushability, whereas the distal segment is sufficiently pliable to easily permit negotiation of coronary arteries without undo rigidity and without causing damage to the arteries. In practice, the distal segment may advantageously comprise the portion of the receptacle 14 extending distally from the guiding catheter (not shown in figure 3) and may, therefore, be between about 1 cm and 20 cm in length, preferably between about 3 cm and about 10 or 15 cm in length.

Figure 4 is another longitudinal section of the receptacle 14, this time also showing the angioplasty catheter 12 in cross section inside the receptacle 14.

In Figure 4, the angioplasty catheter 12 is a composite catheter, in which the proximal end 20 of the catheter shaft is formed of a rigid material (such as stainless steel hypotube) , and the distal end 22 of the catheter shaft is formed of a more flexible material, such as extruded polymer. The fixed guidewire 26 in Figure 4 is bonded to the proximal hypotube end 20 of the catheter shaft, and extends distally from the hypotube through the balloon 24.

Figure 4 illustrates that, deflated, the balloon 24 is sized to fit easily within the receptacle lumen 42 in sliding engagement therewith. The proximal-pointing arrow A and the distal-pointing arrow B indicate that the receptacle 14 may be advanced distally (in the direction of arrow B) over the balloon 24, as illustrated in phantom, or alternatively that the balloon 24 may be withdrawn inside the receptacle 14. Similarly, the receptacle 14 may be moved proximally in the direction of arrow A with respect to the angioplasty catheter 12.

In one particularly preferred embodiment of the invention, the bailout system 10 includes a bailout guidewire 60 inserted into the lumen 42 of the receptacle 14. Figure 5 illustrates the bailout system 10 of the present invention in place in a guiding catheter 62 of conventional design. The guiding catheter 62 includes a proximal fitting 64 at the proximal end 66 of the guiding catheter, and a distal opening 70 at the distal end 72 of the guiding catheter 62.

With the bailout system 10 of the present invention in place in a patient, the angioplasty catheter 12 extending through the bailout receptacle 14, and the bailout receptacle 14 extending distally into the guiding catheter 62, one may desire to advance a bailout guidewire 60 distally inside the bailout receptacle 14. In this embodiment, the receptacle lumen 42 of the receptacle 14 is of sufficient size to permit proximal and distal sliding motion of the bailout guidewire 60 and the angioplasty catheter 12 with respect to the bailout receptacle 14, while at the same time the bailout receptacle 14 is sufficiently small (e.g., 3.9 French or smaller for coronary use) to fit easily within a conventional guiding catheter. As illustrated in Figure 5, when the balloon 24 of the angioplasty catheter is extending distally from the distal opening 70 of the guiding catheter 62 (presumably having been positioned e.g., within a coronary artery in a patient) , the bailout guidewire 60 may be advanced distally alongside the balloon 24 and the fixed guidewire 26. The arrow B in Figure 5 indicates distally directed motion of the bailout guidewire 60.

With the bailout system 10 of the present invention in place in a patient, the bailout receptacle 14 may be advanced over the angioplasty catheter 12 to a desired position, the angioplasty catheter 12 may be removed from the patient, and a new catheter (such as a balloon angioplasty catheter) may be reinserted through the bailout receptacle 14 to the same position. Alternatively, if a bailout guidewire 60 has been inserted through the bailout receptacle 14 alongside the fixed wire angioplasty catheter 12, one may remove both the angioplasty catheter 12 and the bailout receptacle 14 from the patient while leaving the bailout guidewire 60 in place. Figure 6 illustrates the removal of the angioplasty catheter 12 and the bailout receptacle 14 while maintaining a bailout guidewire 60 in place in the patient.

In the embodiment illustrated in Figure 6, the bailout receptacle has a guidewire removing means 50 extending distally from the proximal sideport 44. As illustrated in Figure 6, the bailout receptacle 14 and angioplasty catheter 12 are removed proximally in the direction of arrow A. Arrow C illustrates that the bailout guidewire 60 is maintained in a fixed position (and does not move proximally with the remainder of the system 10) . By holding the bailout guidewire 60 stationary, the bailout guidewire 60 is passed laterally outward through the guidewire removing means 50. Figure 7 illustrates the completion of the removal process, in which the angioplasty catheter 12 and the receptacle 14 continue to move proximally in the direction of arrow A, while the bailout guidewire 60 is held in a fixed position as illustrated by arrow C. The guidewire removing means 50 in Figure 7 extends to the distal end of the bailout receptacle 14, so that the bailout receptacle 14 may be removed completely off of the bailout guidewire 60.

Figures 8-12 illustrate different methods for using the bailout system 10 of the present invention.

In the scenario illustrated in the four panels (A-D) of Figure 8, the guiding catheter 62 extends through the aorta to the coronary artery system, with the bailout receptacle 14 extending distally from the guiding catheter 62. The deflated angioplasty catheter 12 extends distally from the bailout receptacle and is positioned so that the deflated angioplasty balloon 24 is positioned within an arterial lesion 74. In panel B, the angioplasty balloon 24 is inflated to dilate the stenosis or lesion 74. Panel C illustrates the bailout guidewire 60 being advanced from the distal end of the bailout receptacle 14, past the deflated balloon 24 and through the dilated lesion 74. The angioplasty balloon 24 in Panel C is deflated prior to advancing the bailout guidewire 60 past the balloon 24. In Panel D, the angioplasty catheter 12 has been withdrawn into the bailout receptacle 14 and may be removed from the patient, leaving the bailout guidewire 60 in place in the lesion 74 in the event another catheter should need to be positioned inside the lesion 74 rapidly and securely.

Figure 9 is similar to Figure 8, except that the bailout guidewire 60 is advanced through the lesion prior to insertion of the angioplasty balloon 24 in the lesion 74. Thus, in Panel A, the bailout guidewire crosses the lesion 74; in Panel B, the balloon 24 of the angioplasty balloon catheter 12 is positioned inside the lesion 74; in Panel C, the balloon 24 is inflated in the stenosis or lesion 74, with the bailout guidewire 60 also extending through the lesion 74 outside of the balloon 24; and in Panel D, the receptacle 14 and the catheter 12 have been removed, leaving the bailout guidewire 60 in place in the stenosis 74.

Figure 10 illustrates yet another embodiment of the method of the present invention. In Panel A, the stenosis has already been dilated by the balloon 24, and the balloon 24 has been deflated. In Panel B, the angioplasty catheter 12 and the receptacle 14 are advanced as a unit through the dilated lesion 74, and then the bailout guidewire 60 is advanced through the bailout receptacle 14. Next, in Panel C, the receptacle 14 and the angioplasty catheter 12 are withdrawn proximally while the bailout guidewire 60 is maintained in its position within the lesion 74. Finally, in Panel D, the guidewire 60 is in place in the artery while the angioplasty catheter 12 (and, optionally, the bailout receptacle 14) have been removed proximally out of the patient . Another catheter may then be advanced over the guidewire 60 through the lesion.

In the scenario of Figure 11, the fixed-wire balloon angioplasty catheter 12 is positioned with the angioplasty balloon 24 inside the stenosis 74 and the receptacle 14 extending to within close proximity of the balloon 24. The balloon 24 is then inflated in the stenosis 74 to dilate the stenosis 74. In Panel B, the balloon is deflated, and in Panel C, the receptacle 14 is advanced through the dilated lesion 74 and over the balloon of the angioplasty catheter 12. The bailout guidewire 60 is then advanced through the bailout receptacle 14, extending through the dilated lesion 74. The balloon catheter 12 and the bailout receptacle 14 are then withdrawn, as shown in Panel D, leaving the bailout guidewire 60 extending through the dilated lesion 74.

Figure 12 illustrates use of the present invention in a bifurcation double lesion. In a patient suffering from bifurcation/double lesion coronary disease, the patient has lesions near the branching point of a coronary artery. The scenario of Figure 12 is a particularly difficult scenario for balloon angioplasty, because dilation of a first lesion 76 may tend to close the second lesion 80, and vice versa. Thus, before attempting angioplasty on the double lesions 76, 80, the physician must provide a guidewire through the lesion not being dilated at that moment as a safety precaution.

With reference to Panel A in Figure 12, the deflated balloon 24 is placed in the first lesion 76, with the bailout guidewire 60 positioned through the second lesion 80. Then, as shown in Panel B, the balloon 24 is inflated to dilate the first stenosis 76, with the bailout guidewire extending out of the distal end of the bailout receptacle 14 and through the second lesion 80.

The positions of the angioplasty balloon 24 and the bailout guidewire 60 are then switched, so that the bailout guidewire 60 extends through the dilated first lesion 76, and the angioplasty balloon is positioned in the second stenosis 80, as shown in Panel C. The balloon 24 is inflated to dilate the second stenosis. The angioplasty catheter 12 may then be withdrawn with the receptacle 14, leaving the bailout guidewire 60 in the first vessel extending through the first lesion 76.

It will be appreciated that the method of the invention may also be practiced without a bailout guidewire 60 by positioning the bailout receptacle 14 inside the dilated site (as illustrated in Panel B of Figure 10) . The angioplasty catheter 12 is then withdrawn from the patient and a new catheter may be inserted through the bailout receptacle 14 and through the lesion 74 of Figure 10, Panel B.

Although the apparatus and method of the present invention have been described in the context of particular embodiments, it will be appreciated that the present invention may be practiced with catheters other than balloon angioplasty catheters. It will also be appreciated that the catheter reinserted into the patient utilizing the present invention may be any suitable type of catheter, including another balloon angioplasty catheter (either fixed wire or over-the-wire) , an atherectomy catheter, a laser catheter, a perfusion catheter, other vascular catheter. Accordingly, in another embodiment of the invention, there is provided an alternative design of a catheter/receptacle system. In this embodiment, the receptacle is constructed with an inflatable or deflatable angioplasty balloon or other diagnostic or therapeutic means mounted on the distal portion of the catheter shaft. As will be appreciated, the invention is uniquely suited to use in a variety of applications.

For example, the balloons may be designed to allow isolation of a stenosis or other region of interest within a vessel. This is accomplished through locating the catheter system so that the balloon on the inner catheter and the balloon on the receptacle are on each side of the stenosis or other region of interest. Thereafter, both the balloon on the inner catheter and the balloon on the receptacle can be simultaneously inflated, thereby isolating the stenosis or other area of interest.

This embodiment is particularly suited to drug infusion applications. There are several clot dissolving drugs and other drugs that appear to have efficacy in dissolving clots or in preventing restenosis in vessels. For example, tissue plasminogen activator ("t-PA" or "TPA"), streptokinase, and others. Local drug delivery would be especially desirable if new drugs designed to inhibit restenosis are developed. Local delivery of such drugs during an angioplasty procedure would directly effect the local area of intervention.

In other preferred embodiments, the invention may be used for stent placement. In such embodiments, a stent may be mounted on one or the other of the inner catheter or the receptacle and the free balloon can be used for dilation of the stenosis. For example, where the stent is mounted on the receptacle, the balloon on the inner catheter is used to predilate the stenosis and the balloon on the receptacle is utilized to deploy the stent. Alternatively, where the stent is mounted on the inner catheter, another catheter is first used to dilate the stenosis, the sliding receptacle system is moved into position and the stent is deployed using the balloon on the inner catheter, and thereafter, the free balloon on the stent can be used for additional expansion of the stent. It will be appreciated this eliminates the need for use of multiple catheters in a single stent placement procedure.

It will also be appreciated that the invention is not limited to use with balloon catheter designs. Rather, "hybrid" catheters can be fashioned. For example, "hybrid" systems with angioplasty balloons and laser, ultrasound, and other diagnostic and therapeutic apparatus. Similarly, the invention is not limited to use of balloons on the catheters. Rather, the use of many varieties of diagnostic and/or therapeutic means is contemplated.

Further objects, advantages, and applications of the catheter system of the invention will be discussed and/or will become apparent in the following discussions. A preferred embodiment of the catheter system of the invention is illustrated in Figure 13. The system consists of an inner catheter 100 and a receptacle 114. The inner catheter 100 has an elongate catheter shaft 102 (FIG. 15) with a proximal end 103 in a proximal portion 104 and a distal end 105 in a distal portion 106. The inner catheter 100 has a proximal opening 107 in the proximal portion 104 and a distal opening 108 in the distal end 105. An angioplasty balloon 109 is mounted on the distal portion 106, proximal of the distal end 105.

On transverse cross section (FIG. 13a) , it will be seen that the inner catheter 100 has a guidewire lumen 110, a balloon inflation lumen 111, for inflating and deflating the balloon 109 (FIG. 13) , and an outer wall 112 in the guidewire lumen 110. The guidewire lumen 110 is adapted to permit insertion of a guidewire 113 from the proximal opening 107 to the distal opening 108 (FIG. 13) .

The inner catheter 100 is adapted freely slide within the receptacle 114, at least upon deflation of the balloon 109. Further, in a preferred embodiment, the inner catheter 100 is adapted to freely slide within the receptacle 114 when a guidewire is also extending through the receptacle.

Referring now to Figure 14, the bailout receptacle 114 comprises an elongated cylindrical shaft 115 with a proximal end 116 on a proximal portion 117 and a distal end 118. A proximal fitting 119, preferably of molded plastic, is provided on the proximal portion 117 of the receptacle 114. A lumen 120 extends through the receptacle 114 from the proximal end 116 to the distal end 118. The receptacle lumen 120 is sized only slightly larger than the diameter of the inner catheter 100, and is sized so that the inner catheter 100 can slide proximally and distally through the receptacle lumen 120. In one preferred embodiment, the diameter of the receptacle shaft 115 is 3.9 French or smaller (e.g., in the case of a bailout system for coronary use) . The receptacle shaft will be larger for peripheral angioplasty.

In one preferred embodiment of the system, a proximal side port 121 is provided, extending through the outer wall 122 of the receptacle shaft 115. The proximal side port 121 is sized to permit insertion and removal of a distally- extending movable guidewire (not shown in Figures 13-15) . In a preferred embodiment, as illustrated in Figure 2

(which illustrates a fixed wire catheter as the inner catheter) , the wall 46 of the receptacle shaft 32 is provided with a guidewire removing means 50 extending distally from the general vicinity of the proximal end 34 of the receptacle shaft 32. In the embodiment illustrated in Figure 2, the guidewire removing means 50 extends distally from the proximal side port 44. The guidewire removing means 50 can extend distally any desired distance; however, in a preferred embodiment, the guidewire removing means 50 extends distally to within about 40 cm of the distal end 36 of the receptacle 14; preferably to within about 30, 25, or 20 cm, and more preferably to within about 10 or 5 cm of the distal end 36 of the receptacle 14. In one preferred embodiment, the guidewire removing means 50 extends all the way to the distal end 36 of the receptacle 14.

The guidewire removing means illustrated in Figure 2 comprises a simple slit. It will be understood, however, that the guidewire removing means 50 may comprise any other type of structure that will permit removal of a guidewire laterally through the wall 46 of the receptacle 14. Thus, for example, the guidewire removing means 50 may comprise not only a fully formed slit, but an inchoate slit (e.g., a weakened area that readily may be ruptured or slit to permit lateral removal of the guidewire) . Alternatively, the guidewire removing means may comprise an interrupted or perforated slit, a tear-away strip, parallel weakened lines or parallel interrupted slits to permit removal of a strip, and other similar structures. Referring back to Figure 14, in a preferred embodiment, the bailout receptacle 114 (like the inner catheter 100) is formed of molded or extruded polymer material. Without intending to limit the invention, polymer materials having suitable characteristics may be selected from polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate, polysiloxane, and other well known polymer materials. Figure 14 illustrates a longitudinal cross section of a preferred embodiment of the bailout receptacle 114 of the present invention. As illustrated in Figure 14, the bailout receptacle 114 has a fitting 119 molded to or otherwise attached to the proximal end 116 of the receptacle shaft 115. The fitting 119 is preferably annular, and is advantageously formed of relatively rigid material to permit the physician to securely grip and hold the proximal end 116 of the receptacle 114 at the fitting 119. Figure 14 more clearly illustrates the lumen 120 extending longitudinally from the proximal end 116 to the distal end 118 of the receptacle 114. The outer wall 122 of the receptacle 114 has a proximal side port 121 formed therein, permitting access from a point normally outside the patient through the outer wall 122 of the receptacle 114 into the lumen 120 of the receptacle 114. A s discussed above, in connection with Figure 2, in a preferred embodiment the outer wall 122 of the receptacle shaft 115 may be provided with guidewire removing means that extends distally from the general vicinity of the proximal end 116 of the receptacle shaft 115. The guidewire removing means is adapted to permit a guidewire extending through the lumen to be removed laterally through the outer wall. As will be appreciated, in this manner, a catheter may be rapidly exchanged without requiring an extension wire.

In Figure 16, the complete system of a preferred embodiment of the invention is illustrated. There, the inner catheter 100 is depicted extending through the lumen 120 of the receptacle 114, which, in turn, is extending through a lumen 123 in a guiding catheter 124. The

^■ .guidewire 113 extends through the guidewire lumen 110 (not shown) of the inner catheter 100. A bailout guidewire 125 shown inserted in the proximal side port 121 of the receptacle 114 and extending distally through the lumen 120 of the receptacle 114 (FIGS. 16 and 16a) . The bailout guidewire 125 is illustrated extending beyond the distal end 105 of the inner catheter 100, so as to extend into and through a stenosis, for example, to allow removal of the inner catheter 100 without losing the guidewire position in the stenosis.

Where, as is illustrated in Figures 13-16, the receptacle includes an angioplasty or other balloon mounted on the exterior of the distal portion of the receptacle shaft as the diagnostic and therapeutic means, the receptacle additionally comprises an inflation side arm 127 in the connector 119. The inflation side arm is in communication with a balloon inflation lumen 128 (FIGS. 14- 16) that extends from the proximal portion of the receptacle shaft to, and terminating in, the receptacle balloon 129. The receptacle balloon 129 is mounted on the exterior of a distal portion 130 of the receptacle shaft 115.

As illustrated in Figures 13-15, the receptacle 114 in a preferred embodiment can be provided with an apparatus for performing a diagnostic or therapeutic procedure (herein, "diagnostic or therapeutic means") . Such means can be an angioplasty or other balloon, lasers, ultrasound transducers, balloons for placing stents, and the like. The importance of this unique function is that a user is now capable of performing a variety of diagnostic and therapeutic procedures with a single catheter, where, in the prior art, more than one catheter was required.

Further, where angioplasty or other balloons are employed as the diagnostic and therapeutic means in the catheter/receptacle system of the invention, an operator may undertake consecutively larger dilations of a single or multiple stenoses with a single catheter system without the need to exchange catheters or guidewires. Also, the use of a balloon on the receptacle and a balloon on the inner catheter allows a user to isolate areas of interest in a vessel, by blocking proximal and distal boundaries of the area through inflation of both balloons and adjusting the distance between the two balloons, in either order.

Moreover, the system is advantageously used in stent placement and dilation. A stent is piggybacked on one or the other balloon (i.e., on the balloon on the inner catheter or the balloon of the receptacle) . This balloon is used to place and initially dilate the stent, through inflating the balloon. Thereafter, the second balloon is used to further dilate the stent into its fully dilated position. It will be appreciated that in stent placement procedures, the stenosis must be predilated prior to deployment of the stent. Where the stent is mounted on the receptacle balloon, predilation of the stenosis can be accomplished with the balloon on the inner catheter. Alternatively, where the stent is mounted on the balloon of the inner catheter, the balloon on the receptacle is available for additional expansion of the stent or additional dilations in the vessel.

Two alternative designs of a stent placement catheter system of the present invention are illustrated in Figures 17-19. In Figure 17, it will be seen that the stent placement system 130 is assembled on the receptacle, with an angioplasty balloon catheter as the inner catheter 100 inside of the receptacle 114. In the illustrated embodiment, the inner catheter 100 is an over-the-wire catheter with a guidewire 113. The inner catheter can, however, be a fixed wire catheter. The stent 131 is mounted on the receptacle balloon 129. The balloon 109 on the inner catheter 100 is free for and used for predilation of a stenosis before stent deployment.

Similarly, in Figure 18, the stent 131 is positioned on the balloon 109 of the inner catheter 100, and the receptacle balloon 129 on the receptacle 114 is free for additional expansion of the stent in the stenosis or for dilating a new lesion.

In stent placement, referring to Figure 17, the system 130 is positioned in proximity to a stenosis 132 in a vessel 133 (FIG. 19a) . The system 130 can either be moved into position as a unit or the inner catheter 100 can first be slid into position and used to predilate the lesion and then the receptacle 114 is advanced into position. The balloon 109 is positioned in the stenosis 132 (FIG. 19a) and the stenosis 132 is dilated through inflating and deflating the balloon 109 (FIG. 19b) . The dilation can be performed successively until the lesion is adequately dilated.

Thereafter, the stent 131 mounted on the receptacle balloon 129 is positioned in the predilated stenosis 134 (FIG. 19c) . The receptacle balloon 129 is inflated to expand the stent 131 inside the dilated stenosis 134 (FIG. 19d) . Inflation of the receptacle balloon can be repeated until the stent 131 is adequately expanded and the vessel 133 is of desired diameter. At this time the procedure is complete and the system

130 could be removed. Advantageously, the receptacle 114 can be removed out of the vessel, but the inner catheter left inside the coronary vessel for additional dilations as are necessary. Referring back to Figure 18, where the stent is mounted on the inner catheter balloon 109, the stenosis must be predilated. Predilation is accomplished with another catheter, followed by insertion of the inner catheter 100 with the stent 131 mounted on the balloon 109. The receptacle 114 may be already in position, concurrently positioned, or positioned after insertion of the inner catheter 100. Once the inner catheter is in position in the predilated stenosis, the stent 131 is deployed by inflating the balloon 109. The balloon 129 on the receptacle is then available for additional expansion of the stent, if necessary, or for dilating other lesions.

It will be understood that the present invention is highly advantageous in vessels where the diameter of the vessel decreases rapidly just distal to the stenosis. For example, with the invention the inner catheter 100 can be withdrawn inside, or partially inside, of the receptacle 114 to ease the insertion of the receptacle balloon 129 into the stenosis. Further, if sufficient dilation of the stenosis is not achieved so that the stent bearing receptacle cannot be inserted into the stenosis, the inner catheter can be removed, leaving the receptacle positioned in proximity to the stenosis for a quick reinsertion of a new inner catheter with a larger balloon for successful completion of the stenting.

In Figure 20, a hybrid system of the invention is illustrated, where the diagnostic and/or therapeutic means in the system includes a combination of a balloon and a laser device. In a preferred embodiment, the balloon/laser angioplasty system 135 includes a laser head 135 on the distal end 105 of the inner catheter and a balloon 129 on the receptacle 114. It will be appreciated that the location of the laser head 135 and the balloon can be reversed without departing from the scope of the invention. In use, a variety of procedures can be accomplished with the system 135. For example, the laser head 135 on the inner catheter 100 can be used to lase and cut away atherosclerotic plaque of a stenosis and thereafter, the balloon on the receptacle can be used to finish off the procedure.

In Figure 21, another hybrid system is illustrated. In this system, the diagnostic and/or therapeutic means include a balloon and a rotating cutting head. In a preferred embodiment, the balloon/rotating atherectomy head system 137 includes a rotating atherectomy head 138 on the inner catheter 100. The drill head is preferably of diamond sand construction and typically rotates at speeds around and/or exceeding 20,000 revolutions per minute. Other types of atherectomy heads are also contemplated in accordance with the invention. The receptacle 114 includes a balloon 129 for either pre- or post-dilating a stenosis in connection with rotational atherectomy of the stenosis with the rotating head 138.

In use, the system 137 is substantially similar to the laser/balloon system in Figure 21, except that cutting of the stenosis is accomplished by the rotating head 138 instead of through use of a laser.

In Figure 22, another hybrid system of the invention is illustrated. In this embodiment, the diagnostic and/or therapeutic means includes a combination of a balloon and an ultrasound imaging head. In a preferred embodiment, the balloon/ultrasound imaging system 139 includes an ultrasound imaging head 140 on the distal end 105 of the inner catheter 100 and an angioplasty balloon 129 on the receptacle 114.

Through ultrasound imaging the internal vessel wall structure with the imaging head 140, the anatomy of the stenoses can be accurately accessed. This is useful both prior to and after dilation. For example, in a preferred embodiment, the imaging head 140 on the inner catheter 100 can be advanced into the stenosis and the stenosis imaged. The receptacle 114 can be advanced over the inner catheter 100 so that the balloon 129 on the receptacle 114 is positioned in the stenosis. The balloon 129 can be inflated and deflated and withdrawn to expose the stenosis which can then be imaged with the imaging head 140 to determine if sufficient dilation has been accomplished. The procedure can be repeated successively until adequate dilation is achieved.

As will be appreciated, however, the location of the balloon 129 and the ultrasound imaging head 140 can be reversed without departing from the scope of the invention.

As was previously discussed, the system of the invention can also be used for isolating an area of interest in a vessel. This application is illustrated in Figure 23 which shows a preferred embodiment of the system inserted through a stenosis 132 in a vessel 133. In Figure 23a, the inner catheter 100 extends through the stenosis 132 so that the balloon 109 on the inner catheter 100 is positioned on the distal side of the stenosis 132. The balloon 129 on the receptacle 114 is positioned on the proximal side of the stenosis 132.

In Figure 23b, each of the balloons 109 and 129 are inflated. Inflation will stop the flow of blood through the vessel 133, and a drug, for example, can be injected through the lumen in the receptacle 114 (not shown) . Since the blood will not be flowing past the stenosis 132, the drug will have a greater opportunity for contact with the stenosis 132 .

In another embodiment, as is illustrated in Figure 23c, the system can be used in isolating areas of interest, with the additional advantage of perfusion. In the Figure, a distal portion of the receptacle 114 and the inner catheter 100 is shown in longitudinal cross section. The balloon 109 on the inner catheter 100 and the receptacle balloon 129 on the receptacle 114 are inflated on each side of a stenosis 132 in a vessel 133. A guidewire 113 and 113a (in phantom) extends through the guidewire lumen of the inner catheter 100. Each of the receptacle 114 and the inner catheter 100 are provided with side ports 140 and 141 respectively that may be sized to allow insertion of a guidewire therethrough or may be sized so as to merely allow efficient perfusion.

When the guidewire 113a (in phantom) extends from the distal end 105 of the inner catheter shaft 100, blood flowing through the vessel 133 will not be able to pass. However, when the guidewire 113a (in phantom) is withdrawn proximally out through the guidewire lumen of the inner catheter 100, the side port 141 in the inner catheter 100 will be opened. Accordingly, blood can then flow through the side port 140 in the receptacle 114 and through the distal end of the lumen 120 of the receptacle 114, past the stenosis 132, and through the side port 141 in the inner catheter 100, and out its distal end 105. In this manner, perfusion can be performed; allowing blood to flow through the vessel while the stenosis is isolated.

In any of the embodiments of Figure 23, it will be appreciated that the system can also be constructed for dedicated drug delivery. Where the system is constructed for dedicated drug delivery, it is possible to use shorter balloons and the balloons can also be either elastic or inelastic. Similarly, any of the above-described embodiments can be used in drug delivery. For example, receptacles having a stent mounted thereon, or a laser, ultrasound imaging, or other tip can be used with an inner catheter for drug delivery.

In connection with the foregoing discussion, it will now be readily appreciated to those of ordinary skill in the art of angioplasty that the system contemplated in accordance with the invention represents a novel platform from which to perform intravascular procedures. In addition to the procedures hereinabove identified, the system is useful for sensor/balloon systems, balloon/perfusion systems, and atherectomy (both directional and rotational) /balloon systems. Moreover, it will be appreciated that the applications of the catheter systems of the present invention can extend from angioplasty, atherectomy, radiology, peripheral vascular angioplasty, pediatric interventional applications, and non-vascular interventional applications, such as in urology, gastroenterology, obstetrics and gynecology, etc. The catheters can be over-the-wire, fixed-wire, or otherwise. Such catheters can include balloons, transducers, lasers, fiber optics, rotational and/or directional atherectomy devices, or any combination thereof. Furthermore, it will be appreciated that numerous modifications and variations of the preferred embodiments are possible, while remaining within the scope of the intended invention. Accordingly, the claims that follow are not to be limited to any particular disclosed embodiment, but instead should be entitled to their full literal scope, together with reasonable equivalents.

Claims

WHAT IS CLAIMED IS;

1. A sliding receptacle catheter system for performing an intravascular diagnostic or therapeutic procedure, comprising: a receptacle comprising an elongate tubular shaft of a substantially constant diameter and having a receptacle lumen extending longitudinally therethrough from a proximal end to a distal end and having a first diagnostic or therapeutic means mounted on the distal end of the receptacle; and an inner catheter extending through the receptacle lumen, having a proximal end and a distal end, the catheter and the receptacle each adapted to slide longitudinally with respect to each other, the inner catheter having a second diagnostic or therapeutic means mounted on the distal end of the inner catheter.

2. The system of Claim 1, wherein the first means comprises an angioplasty balloon and the receptacle additionally comprises a balloon inflation lumen in operative communication with the balloon for inflating and deflating the balloon.

3. The system of Claim 1, wherein the second means comprises an angioplasty balloon and the inner catheter additionally comprises a balloon inflation lumen in operative communication with the balloon for inflating and deflating the balloon.

4. The system of Claim 1, wherein the first and second means comprise respective first and second angioplasty balloons and each of the receptacle and the inner catheter additionally comprise respective first and second balloon inflation lumens in operative communication with the respective first and second balloons for inflating and deflating the balloon.

5. The system of Claim 1, wherein the receptacle is positioned within and extends longitudinally through a guiding catheter.

6. The system of Claim 1, additionally comprising a guidewire extending through the receptacle but outside of the inner catheter.

7. The system of Claim 1, wherein one of the first or second means is an inflatable angioplasty balloon and the other of the first or second means is a stent placement balloon with an implantable vascular stent concentrically mounted thereover.

8. The system of Claim 1, wherein one of the first or second means is an ultrasound transducer and the other is a balloon.

9. The system of Claim 8, wherein said first means is said ultrasound transducer, said transducer being annular.

10. The system of Claim 8, wherein said second means is an ultrasound transducer.

11. The system of Claim 1, wherein one of said first and second means is adapted to emit therapeutic laser radiation and the other is a balloon.

12. The system of Claim 1, wherein both said first and said second means comprise a balloon.

13. The system of Claim 12, wherein one or both of said balloons is a relatively inelastic angioplasty balloon having a substantially fixed predetermined working diameter.

14. The system of Claim 13, wherein the first balloon and the second balloon are both angioplasty balloons, each having a different predetermined working diameter.

15. The system of Claim 12, wherein one or both of said balloons is elastic.

16. A method for stent placement, comprising: positioning the system of Claim 7 such that the angioplasty balloon is within a stenosis in a vessel; inflating and deflating the angioplasty balloon to dilate the stenosis; inserting the stent into the dilated stenosis and inflating and deflating its associated balloon to expand the stent and position the stent in the dilated stenosis.

17. The method of Claim 16, wherein the stent is positioned on the receptacle.

18. The method of Claim 16, wherein the stent is positioned on the catheter.

19. A method for isolating a region of interest in a vessel, comprising: positioning the system of Claim 12 in a region of interest in a vessel with a vessel wall, such that the first balloon is on a first side of the region of interest and the second balloon is on a second side of the region of interest; and inflating the first and second balloons to contact the vessel wall on the first and second side of the region of interest to isolate the region of interest.

20. The method of Claim 19, wherein the region of interest is a stenosis.

21. The method of Claim 20, further comprising infusing a drug selected from the group consisting of a clot inhibiting or reducing drug and a drug that inhibits restenosis through the receptacle to the stenosis.

22. A method for performing an intravascular diagnostic or therapeutic procedure, comprising: providing the system of Claim 1; positioning the system at a location in a vessel that is in need of diagnosis or therapy, with one of the first or the second diagnostic or therapeutic means in proximity to the location; actuating the one of the first or second diagnostic or therapeutic means; moving the system so that the other of the first or second diagnostic or therapeutic means is in proximity to the location; and actuating the other of the first or second diagnostic or therapeutic means.