Treatment of Coronary Stenosis

Abstract

The invention describes includes a device and method for dilating a coronary arterial stenosis and for creating a transection in the myocardium. The transection creates a new artery composed partially of the old artery and partially of the normal healing tissue and myocardium. Several dilating means are described, as well as several cutting means and alignment means by which the cutting means may be located and properly oriented. In operation, the dilating means, cutting means and alignment means are advanced in the distal end of a catheter, which may be guided into position by a guidewire.

Description

TECHNICAL FIELD

The present invention relates generally to coronary artery surgery and is directed particularly to an improved method and means for the surgical treatment of stenotic or occluded major coronary vessels while the heart is beating and without the use of the heart-lung machine.

BACKGROUND INFORMATION

In recent years occlusive coronary artery disease has been surgically treated with the use of various artery by-pass techniques involving cardiopulmonary by-pass. Although these techniques have been highly successful and can be performed with minimal risk, the unusual surgical skill required, and the complexity of the procedure, limits the operation to a small percentage of those patients who could otherwise be benefited.

In attempts to surgically treat the vast number of coronary artery disease patients to whom the usual open-heart coronary artery by-pass operation was not available or otherwise not indicated, various surgical techniques have heretofore been devised to effect myo-cardial revascularization and neo-vascularization. These procedures can be performed on the beating heart without cardiopulmonary by-pass, thereby greatly simplifying the procedure with an attendant lessening of the risk. These new techniques, moreover, have been greatly advanced by the comparatively recent development of cine-coronary arteriography.

Most promising of the new surgical techniques has been the direct approach to increase the diameter of the coronary arteries narrowed or obstructed by the disease. One technique involves longitudinal incision of the myo-cardial side of the coronary artery at the site of the stenosis or occlusion, with the insertion of a scalpel through a small incision made in the wall of the coronary artery distal to the occlusion. This procedure effects an immediate increase in the size of the lumen for restored blood flow, but in the calcific rigid artery the lumen may remain small. Upon healing, the inside myo-cardial tissue assumes an intima-like surface defining, with the contiguous decompressed arterial zone, a new lumen having an approximately normal diameter. In another of the new surgical techniques, known as percutaneous translumenal coronary angioplasty, an inflatable balloon carried at the end of a catheter or the like is passed through the affected artery to the site of the stenosis as observed in cine-coronary arteriography, and then inflated to compact the stenonic plaque and thereby increase the lumen size by dilation. A distinct advantage of this technique is that the catheter can be inserted through a peripheral artery, thereby obviating surgical opening of the chest wall to expose the heart. This technique, however, has limited application because of major problems in its use in the treatment of stenoses associated with coronary artery rigidity, obstruction, and with single severe and multiple stenoses.

Over the years, the blockage of human arteries has become a leading medical concern. This is so because a variety of serious medical complications may result from arterial blockages that reduce blood flow through an affected artery. More specifically, an arterial blockage may result in damage to the tissue that relies on the artery for its blood supply. For example, if a blockage occurs in an artery leading to the brain, a stroke may result. Similarly, if a blockage occurs in an artery which supplies blood to the heart, a heart attack may result.

Typically, arterial blockages are caused by the build-up of atherosclerotic plaque on the inside wall of the artery. These blockages, which are commonly called stenoses, may result in a partial, or even complete, blockage of the artery. As a result of the dangers associated with these arterial blockages, a variety of procedures have been developed to treat them. An angioplasty procedure is, perhaps, the most commonly used procedure for such treatment. An angioplasty procedure involves the use of an inflatable angioplasty balloon to dilate the blocked artery. A typical inflatable angioplasty device, for example, is disclosed in U.S. Pat. No. 4,896,669 which issued to Bhate et al. The Bhate et al. angioplasty device includes an inflatable angioplasty balloon which is insertable into a peripheral artery of a patient for positioning across a stenosis. Once positioned, the angioplasty balloon is then inflated to dilate the stenosis within the artery thereby improving the blood flow through the artery.

While angioplasty balloons have been widely accepted for the treatment of stenoses, recent studies have indicated that the efficacy of the dilation of a stenosis is enhanced by first, or simultaneously, incising the material that is creating the stenosis. Not surprisingly then, angioplasty balloons have been equipped with cutting edges, or atherotomes. These cutting edges are intended to incise the stenosis during the angioplasty procedure to facilitate dilation of the stenosis.

An example of an angioplasty balloon equipped with cutting edges is disclosed in U.S. Pat. No. 5,196,024 which issued to Barath for invention entitled “BALLOON CATHETER WITH CUTTING EDGE.” The Barath device includes an inflatable angioplasty balloon with a number of atherotomes mounted longitudinally on its surface. During the inflation of the Barath balloon, the atherotomes induce a series of longitudinal cuts into the stenotic material as the balloon expands to dilate the stenosis. As a result of such longitudinal cuts, the stenosis is more easily dilated, and the likelihood of damaging the artery during dilation is significantly reduced.

In general, the use of angioplasty has been found to be an effective means for reducing arterial blockage associated with the buildup of atherosclerotic plaque. In some cases, however, it has been found that the atherosclerotic plaque which forms a particular stenotic segment may be too rigid to be effectively dilated. In such cases, traditional angioplasty techniques have been found to be largely ineffective and, in some cases, even harmful. As a result, a number of differing techniques have been developed for the treatment of hardened, or rigid stenotic segments.

One such technique, which is specifically targeted at the coronary arteries, is transection. Transection, as applied to the coronary arteries, involves the creation of an elongated incision within the artery where the targeted stenosis is located. More specifically, a longitudinally oriented incision is created which spans the targeted stenosis and is positioned along the wall of the artery which is closest to the cardiac muscle. Creation of the incision causes the formation of a new arterial segment, with the new segment being composed partially of the previously occluded artery, and partially of the heart muscle, or myocardium. The new arterial segment is created from the natural healing process that to create a coronary-myocardial artery. Effectively then, transection overcomes the occluding effect of atherosclerotic plaque by allowing the occluded artery to expand into the heart muscle or myocardium. A description of this procedure is provided in “Coronary Artery Incision and Dilation” Archives of Surgery, December 1980, Volume 115, Pages 1478-1480, by Banning Gray Lary, M.D.

For the transection procedure to succeed, it is important that the incision be made on the portion of the coronary artery which directly faces the heart muscle. This is so because the transection procedure involves cutting through the arterial wall, a procedure which would ordinarily result in an uncontrolled blood loss and, perhaps, the death of the patient. However, if the transection is made on the portion of the artery against the heart, the epicardial tissues which cover the heart and the coronary arteries prevent the loss of blood, allowing the new artery to form.

Unfortunately, in the context of a transection procedure, currently available angioplasty balloons have a particular disadvantage. More specifically, practice has shown that it is generally difficult to direct the atherotomes of a traditional angioplasty balloon with the accuracy required for a successful transection. Instead, when a traditional angioplasty balloon is employed, there is an ever present danger that the transection will be created in a part of the arterial wall that is not adjacent to the heart. Specifically, there is a present inability to precisely control the position an angioplasty balloon and cutting edge in both a longitudinal and a rotational direction.

Another disadvantage associated with the use of traditional angioplasty balloons for the creation of coronary transections involves the depth of the created incision. More specifically, practice has demonstrated that effective transection requires that the created incision be deep enough to allow the new artery to form.

Another problem associated with traditional balloon angioplasty is that when inflated, perfusion is interrupted. This limits the time during which the incision may be made.

BRIEF SUMMARY

The present invention describes a device and a means for dilating a coronary stenosis, aligning a cutting means, and incising the coronary stenosis proximate the heart. They can be placed within a catheter for placement at the stenosis. Embodiments of the dilating means include a traditional angioplasty balloon, an expanding bands or “chef's hat” technique, and expanding sides of a containing catheter technique. Cutting means embodiments include a spiral knife, a scissors jack operated blade, an RF cutting wire means and a sliding retractable blade.

Alignment means embodiments include magnetic field emitters and sensors. One embodiment includes a magnet placed on the distal end of the catheter and a external magnetic sensor capable of detecting the orientation of the magnet. Alternatively, a magnetic sensor may be placed at the distal end of the catheter and a magnetic field applied externally.

Other embodiments of the alignment means include a photo-detector placed on the distal end of the catheter and an external light source. Yet another embodiment includes a sensor to detect the electrical signals of the heart, at the distal end of the catheter so as to give maximal signal when closest to the heart, and in relationship to the cutting means to enable positioning.

Yet another embodiment of a positioning means uses a transmitter and receiver. Either may be placed on the catheter and the other externally. Yet another embodiment uses an x-ray opaque device placed at the distal end of the catheter the sensing of which by an external x-ray emitter support allows positioning.

The present invention relates generally to endovascular devices that are used to increase the lumen of a restricted vessel of the body. Moreover it pertains specifically to cutting and dilating catheters used to incise a coronary artery through its vessel wall and further into the myocardium to allow for the dilation and opening of that restricted area.

Moreover it pertains specifically to endovascular devices that can be positioned to cut in a known direction and known orientation. It pertains to an apparatus that will allow the incision of the stenosis and dilation of the vessel from the periphery, i.e. the leg or neck away from the stenotic section.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will be better understood by reading the following detailed description, taken together with the drawings wherein:

FIGS. 1A and 1B show respectively a transected coronary artery before and after treatment.

FIGS. 2A and 2B show an expanding band means of dilation, before and after expansion, respectively.

FIGS. 3A and 3B show one type of cutting means, a slidable retractable cutter.

FIGS. 4A, 4B, 4C and 4D show successive views of a sliding retractable cutting means.

FIGS. 5A, 5 B and 5C are views of a scissors jack cutting means.

FIG. 6 is a view of a cutaway end view of a scissors jack cutting means combined with scissors jack dilation means in the closed position. FIG. 6B is a side view of the same.

FIG. 7 is a view of a cutaway end view of a scissors jack cutting means combined with scissors jack dilation means in the open position.

FIGS. 8A and 8B are views of a spiral cutting means in the closed and open positions respectively.

FIG. 8C is end view of a cross section of a spiral cutting means.

FIGS. 9A, 9B, 9C and 9D are views of an RF wire cutting means being deployed and retracted, in sequence.

FIG. 10 is a schematic diagram showing arrangement of a variety of positioning means.

Like reference numbers and designations in the various drawings indicate like elements.

DETAILED DESCRIPTION

In view of the limitations now present in the prior art, the present invention provides new and useful features and mechanisms for the incision of the coronary artery and myocardium. The present invention utilizes an alignment means to properly position a cutting means, a cutting means to perform cutting of the coronary artery and myocardium, a dilating means to expand the vessel and a perfusing means to supply blood to the distal portion of the vessel.

The alignment means, cutting means, and perfusing means are contained in an endovascular catheter(s). Preferably, the catheter is formed with a guidewire lumen which extends the=rough the length of the catheter and through which a guidewire may be run. The guidewire may be chosen from a variety of medical guidewire types well known in the art.

When properly placed into position from the periphery, these embodiments, in coordination with one another, are used to reconfigure the blood vessel to a desired new geometry. Once the reconfiguration is completed the catheter is then retracted and the entry wound sealed.

Referring to FIG. 1A, an occluded coronary artery is shown. The artery 16 is beneath the pericardium 14. The artery 16 sits atop the epicardium 12 and the myocardium 10. As can be seen, the lumen 20 is occluded by a stenosis 18.

Referring to FIG. 1B, the same artery 16 is shown after coronary artery incision and dilation. The stenosis 24 has been expanded, leaving a larger lumen 20. The myocardium 12 has been incised 23.

Dilation may be performed by a traditional angioplasty balloon, with the attendant stoppage of perfusion noted. In such case, the balloon may be inflated by means well known in the art. An improvement (called herein the “expanding bands” technique) on the angioplasty balloon is the collapsible mechanical method shown in FIGS. 2A and 2B. As shown in FIG. 2A, a catheter 28 may be guided to the coronary artery (not shown) by a guide wire 32. Such a guide wire 32 is of the type generally used for angioplasty procedures and is inserted through a guide wire lumen (not shown) formed in the catheter 28. The catheter 28 is shown foreshortened, but may be of any suitable length, able to conveniently reach from the point of insertion to the stenosis to be treated. A portion of the outer circumference of the distal end 30 of the catheter 28 is made from a stiff flexible material, being an expander 36. A compressor or 38 is attached by a cable or wire (not shown) to a controller 34, proximal end 26 of the catheter 28 which, when pulled, causes the compressor 38 to move toward the proximal end of the catheter 28. FIG. 2B shows a controller 34 moving in the direction shown 36 from the proximal end of the catheter 28, and likewise the compressor 38 moving in the direction shown 34, causing the expanders 36 move outward away from the central axis of the catheter 28.

One or more expanders 30 can beneficially be utilized. They need not surround the circumference of the catheter 28, but rather can be utilized in conjunction with co-located cutting means. An advantage of the chef's hat technique is that perfusion can continue in the interstices between the expanders when expanded.

For example, FIG. 3A shows an example of a “sliding retractable blade” cutting means 38. The cutting means comprises a blade of 40 controllable by a control wire 42 running through the catheter 28 to the proximal end 26. In FIG. 3A, the blade 40 is shown retracted and attached to a controller 34. When operated by the controller 34, as shown in FIG. 3B blade 42 has extended to a depth 42 and has moved an incision length 44.

The operation of the sliding retractable knife means may be seen more clearly in FIGS. 4A through 4D which show a cutaway view of a portion of the catheter 28 containing the sliding retractable blade 40. In FIG. 4A, the blade 40 is shown fully retracted. An upper control slot 46 and a lower control slot 48 are shown on one side. In operation, there would be one upper and one lower control slot on each side of the catheter 28. The blade 40 has an upper control pin 50 fitted into the upper control slot 46, and likewise a lower control pin 52 fitted into the lower control slot 48.

As the blade 40 is pulled toward the proximal end of the catheter 28 upper control pin 50 forces the blade 42 rotate counterclockwise 54. As seen in FIG. 4C, when upper control pin 50 has reached the highest point in upper control slot 46, the blade 40 has fully extended. In FIG. 4D, the blade 40 is again fully retracted, forced by control pin 52 rotate clockwise 56.

As will be seen below, the cutting means, such as the sliding retractable blade, can beneficially be held in place during operation by the dilation means. In some implementations, the dilation means and cutting means may be co-located in the same longitudinal section of the catheter 28. Use of co-located cutting and dilation means, especially in instances where the dilation means allow continuing perfusion during the procedure, permits more positive control of the cutting means with respect to length and depth of cut.

FIG. 5A shows a cutaway view of a “scissors jack” type cutting means. In this embodiment of the scissors jack, a stationary member 58 is held in position with the aid of braces 59 and 61 attached by swivel (not shown) to nuts 62 and 64, respectively and similarly attached to stationary member 58. A blade 60 is attached by swivels (not shown) to adjustable braces 67 and 68 which in turn are attached by swivels (not shown) to nuts 62 and 64. Adjustable braces 67 and 68 are constructed and attached so as to inhibit motion side to side (that is, in and out of the page in FIG. 5A.) As shown in FIG. 5B, screw rod 63 has been turned by controller 34, causing nuts 62 and 64 move away from one another, causing the blade 60 to extend from the side of the catheter 28. This may be accomplished by having the distal end of the screw rod 63 oppositely threaded from the inner portion of the screw rod 65, and likewise nuts 64 and 62 oppositely threaded. When nuts 62 and 64 are moved away from one another, it forces the blade 60 down by means of adjustable braces 67 and 68. Other implementations of a scissors jack to perform the same function and well-known in the art could be used beneficially.

FIGS. 5A and 5B show one embodiment of a dilating means used in conjunction with a scissors jack cutting means. It is not implied that this is the only dilating means described which may beneficially be used with the scissors jack cutting means. a balloon type dilation means 31 both in the unexpanded view in FIG. 5A and the expanded view in FIG. 5B. The balloon may cover all or a portion of the circumference of the catheter 28 except that portion wherein the cutting means extends beyond the circumference of the catheter 28 when co-located with the cutting means. The dilating means may be, as shown, co-located with the cutting means or placed elsewhere over the length of the catheter 28 and used sequentially with the cutting means by first dilating the stenosis and then performing the incision. It is beneficial, however, to co-locate the dilation means with the cutting means as it serves to hold the cutting means in position over the myocardium to be incised.

FIG. 5C shows another embodiment of the scissors jack means wherein the side portions brace 58 is movable. Either through a slot in the side of the catheter (not shown) or by replacing a portion of the side of the catheter with the member 58, member 58 can hold the catheter in position against the wall of the artery (not shown).

A cutaway view of transecting the catheter at the cutting means is shown in FIG. 6. The blade 60 is shown in retracted position. Pushing members 69, 70 and 71 comprise elements which are capable of protruding through the side of the catheter 28. When retracted, they can form portions of the side of catheter 28. FIG. 6B shows a portion of a catheter 28 with an extendable pushing member in the closed position.

Referring again to FIG. 6, an expanding side dilation means is shown with a scissors jack cutting means. Pushing member 69 is supported and extendable by adjustable brace 73, and pushing members 70 and 71 are supported and extendable by adjustable braces 72 and 74 respectively. The knife 60 is supported and extendable by adjustable brace 68. FIG. 7 is the same view, but with pushing members 69, 70 and 71 shown in the extended position, with extendable braces 72, 73 and 74 fully extended. Likewise the knife 60 is shown extended, with extendable brace 68 fully extended. While shown with 3 pushing members, more or fewer pushing members may be used, and may be co-located with the cutting means or separate and used sequentially. When extended, pushing members 60, 70 and 71 dilate the stenosis. This method of dilation supports simultaneous perfusion during dilation, which can continue during incision.

Referring to FIG. 8A, a cutaway view of a spiral knife cutting means is shown. A blade (not shown) is attached to a flexible but stiff membrane 75, which is wound around a control rod (not shown) attached to a controller 34 at the proximal end of the catheter 28. A guide 78 is provided to guide the blade and the stiff membrane 75 when in use. The material from which the stiff membrane 75 is made may be such as to have memory which causes it to straighten when not on around the control rod. FIG. 8B shows the same spiral knife cutting means with the blade 76 extended. Controller 34 has been rotated in the direction 35. FIG. 8C is a transected view perpendicular to the longitudinal axis of catheter 28. The spiral of the flexible membrane 75 is wrapped around the hollow control rod 33, through which guide wire 32 runs. Just as easily, guide wire 32 could run outside and parallel to control rod 33.

An RF cutting wire means is shown in FIGS. 9A, 9B, 9C and 9D, shown in sequential steps of operation. An RF cutting wire is well known in the art, being basically a wire carrying an radio frequency signal the emission of which from the end region of the wire cuts the tissue. An RF cutting wire 86 is contained within a guide 92, being a hollow tube. The end of the RF cutting wire 86 is shown retracted above in a cutaway view of a portion of the catheter 28. A slot (not shown) within which they RF cutting wire 86 can extend and travel permits the RF cutting wire 86 when extended to protrude beyond the outer perimeter of the catheter 28. A spacer 88 is placed between the proximal end of the guide 92 and a stop 90 attached to the proximal end of the RF cutting wire 84. With the spacer 88 in place, the stop 90 pressing against the spacer 88 effectively prevents the RF cutting wire 86 from protruding beyond the outer perimeter of the catheter 28.

FIG. 9B shows the same RF cutting wire cutting means with the spacer 88 removed. The stop 90 has been moved proximate the proximal end of the guide tube 92, thus allowing the stop 90 and RF cutting wire to move toward the distal and of the catheter the distance of the spacer 88, plus enable in the RF cutting wire 86 to extend beyond the outer perimeter of the catheter 28.

Referring to FIG. 9C, the guide 82 has been shifted away from the proximal end of the catheter 28 the distance of the desired cut. In FIG. 9D, the spacer 88 is then reinserted, thus moving the proximal end of the RF wire 84 and stop 90 a sufficient distance from the proximal end of the guide 92 to cause the RF wire 86 to withdraw inside the perimeter of the catheter 28. A slot (not shown) in the bottom of the catheter exists to permit the RF wire to extend beyond the perimeter of the catheter 28 for purposes of performing the cut. The depth of the cut can be set by the size of the spacer 88.

A robotic movement and rotation device may be utilized to control the motion of the catheter 28 or RF cutting wire 86 or both. The stop, 90 can be in the form of an adjustable stop, allowing a variable depth of cut, and too, can be controlled robotically. Previously recorded data from and intravascular ultrasound or other sensing means which contours the interior of the artery may be used to control the robotic movement and rotation device to cut a curve in the artery and myocardium, thus not limiting the cut to a straight line or a fixed depth.

Alignment of the cutting means is important. In order to create the new desired vessel geometry, the cutting means may need to cut through the vessel wall and in the case of a coronary artery, into the supporting myocardium. Therefore, it is important to position the cutting means so it cuts into the myocardium and not into the pericardium, or said another way, into the heart instead of away from the heart. Alignment can be accomplished by several means. As described by Lary in U.S. Pat. No. 5,713,913 “Device and method for transecting the coronary artery,” a radiographic means could be used. However due to the resolution of the x-ray systems and the fact that the heart is beating there may be difficulty in assessing the proper alignment of the cutting means as described by Lary. More effective means for positioning the cutting means in the orientation that would cut into the heart is desirable.

The present invention embodies several means to address this issue. FIG. 10 shows a schematic diagram of the overall concept embodied in each of the suggested means. A stylized chest 100 with a heart 102 therein contained has a coronary artery 104 superposed about the heart 102. A catheter 106 has been inserted in the artery 104. The internal part 108 of the positioning means is shown in the on the surface of the catheter 106 farthest from the heart 102. The external part 110 of the positioning means is shown above the chest 100. The internal part 108 of the positioning means may be placed at different orientations with respect to the heart 102 and catheter 106, such as on the part of the catheter closest to the heart 102, depending upon the positioning means utilized. In cases where the alignment means involves an internal sensor, the sensor signal may be conveyed externally by means of one or more wires running to and extending from the proximal end of the catheter.

For example, one could use an x-ray sensor on the catheter and an x-ray blocker in known orientation and position with respect to the cutting means such that the sensor would indicate the optimal position of the catheter to cut into the heart based upon the position of the x-ray emitter commonly used in the catheter lab to perform cine.

Another means of alignment is to position a magnet on the catheter with one pole pointed in the proper orientation and the other end treated to optimize the field in conjunction with a magnetic sensor located outside the chest will allow proper positioning of the catheter and attached cutting means. Alternatively, the magnetic field can be applied from outside the body, and a sensor such as a Hall effect switch or fluxgate chip which is attached to one or more wires running the length of the catheter from the distal to the proximal end. Shielding of the internal sensor may be used to inhibit triggering when the catheter is not in the optimal position.

Another means of alignment is to position an antenna on the catheter with one side collecting an emitted signal from outside the chest and the other treated in such a means as to indicate which side is facing the outside of the body, or away from the heart. Again, shielding may be used to inhibit signal reception when the catheter is not in optimal position,

Another means of alignment is to position a transmitter on the catheter with one side emitting a signal and the other treated so as to block the signal, thus indicating to an external sensor which side is facing toward the outside of the body and therefore knowing that the cutting means is facing the heart.

Another means of alignment is to provide a light sensor on the catheter which can sense a light source that passes through the body from outside the body and therefore indicate the relationship between the sensor and emitter. Knowing the relationship between the sensor and the cutting means enables positioning the cutting means. If the sensor is placed on the catheter away opposite the cutting means, a peak signal indicates the cutting means is placed toward the heart. The sensor can be shielding to inhibit light reception an all but the optimal position of the catheter, that is, when the cutting means is proximate the heart.

Another means comprises utilizing the natural electrical signals from the heart muscles contracting as the alignment method. It is well published that the heart muscles emit electrical signals on a regular basis and these signals are currently used to map the heart for ischemic sections, those with little or no signal. The present invention can utilize a directional receiver such that when the receiver was positioned to receive the maximum signal it would be facing normal to the heart and into the heart, enabling positioning the cutting means by knowing the positional relationship between the sensor and the cutting means.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features and advantages of the invention will become apparent from the description, the drawings, and the claims.

The invention has been described in terms of particular embodiments. Other embodiments are within the scope of the following claims. For example, the steps of the invention can be performed in a different order and still achieve desirable results. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.

Claims

1. A device for dilating a coronary stenosis and transecting a coronary artery comprising: means for dilating a coronary stenosis in a coronary artery;means for transecting said coronary artery;means for alignment of said the cutting means with respect to the heart.

2. The device in claim 1 wherein said cutting means is a scissors jack cutting means.

3. The device in claim 1 wherein said cutting means is a sliding retractable knife cutting means.

4. The device in claim 1 wherein said cutting means comprises a spiral knife cutting means.

5. The device in claim 1 further comprising a catheter having a distal end and a proximate end, in which said dilating means, said cutting means and said alignment means are located in said distal end.

6. The device in claim 5 in which the said dilation means and said cutting means are co-located within said catheter.

7. The device in claim 1 in which the said dilation means comprises an expanding band mechanism.

8. The device in claim 1 where in the said dilation means comprises an expanding sides mechanism.

9. The device in claim 5 wherein said catheter is further comprised of a guidewire lumen.

10. The device in claim 5 wherein the said alignment means comprises a magnetic field sensing device and a magnetic field generating means.

11. The device in claim 5 wherein the said alignment means comprises an x-ray sensor and an x-ray blocker proximate said cutting means and in fixed orientation to said cutting means.

12. The device in claim 5 wherein the said alignment means comprises an external signal source, and an antenna and a signal blocker located proximate said cutting means in fixed and known orientation with respect to said cutting means such that when the said cutting means is properly oriented said signal is receivable by said antenna and when said cutting means is mis-oriented said signal is blocked.

13. The device in claim 1 wherein said alignment means comprises an external receiver, further comprising a transmitter capable of emitting a signal and located on said catheter in known orientation and position with respect to said cutting means and proximate said cutting means, wherein said catheter is treated with signal blocking means such that a signal transmitted by said transmitter is only receivable by said receiver if the cutting means is in proper position.

14. The device in claim 5 in which said alignment means comprises a light receiver located proximate and in known position and orientation to said cutting means, further comprising an external light source such when said light source is directed at said light receiver, a maximum signal is generated by said receiver when the said cutting means is in proper position.

15. The device in claim 5 in which said alignment means comprises a sensor capable of detecting electrical signals produced by the heart, wherein said sensor is placed in known position and orientation to said cutting means such that a maximum signal is received by said sensor when said cutting means is in proper position; further comprising an external receiver means for receiving the signal from said sensor

16. The device in claim 1 wherein the cutting means comprises an RF cutting wire means.

17. A method for dilating a coronary stenosis and transecting a coronary artery comprising: providing means for dilating a coronary stenosis in a coronary artery;providing means for transecting said coronary artery;providing means for alignment of said the cutting means with respect to the heart;positioning said dilating means at a coronary stenosis and using said means to dilate the stenosis;using said alignment means to position said cutting means, and using said cutting means to incise the stenois.

18. The method in claim 17 further providing a catheter having a distal end and a proximate end, and placing said dilating means, said cutting means and said alignment means in said distal end.

19. The method in claim 19 further co-locating said dilating means and said cutting means within said catheter.

20. The method in claim 19 wherein the said alignment means comprises an external signal source, further providing antenna and a signal blocker; locating the said antenna and said blocker proximate said cutting means in fixed and known orientation with respect to said cutting means such that when the said cutting means is properly oriented said signal is receivable by said antenna and when said cutting means is mis-oriented said signal is blocked.

21. The method in claim 18 wherein said alignment means comprises an external receiver, further comprising a transmitter capable of emitting a signal; locating said transmitter on said catheter in known orientation and position with respect to said cutting means and proximate said cutting means; and treating said catheter with signal blocking means such that a signal transmitted by said transmitter is maximum when the cutting means is in proper position.