Angioplasty Method and Means for Performing Angioplasty

Cardiac catheterization and angioplasty are common medical procedures. The coronary arteries are vessels which supply the heart muscle with blood and are located on the outside surface of the heart. In order to visually examine the coronary arteries, a contrast agent has to be injected into the vessels before x-ray pictures can be taken of them. This is accomplished through a procedure called cardiac catheterization. This contrast agent is delivered through a catheter, which is a small hollow tube. This catheter is advanced to the heart under x-ray guidance, usually being inserted at the level of the groin into the femoral artery. This is accomplished through a needle which is first advanced into the femoral artery and subsequently the catheter is passed through the needle into the blood vessel or femoral artery. The femoral artery in turn is a tributary of the great vessel originating in the heart and therefore the catheter can be passed in a retrograde fashion under x-ray guidance very easily back to the origin of the coronary arteries.

Once the catheter is positioned at the origin of the coronary arteries, a dye syringe is placed on the end of the catheter remaining outside the patient and injections are performed with simultaneous x-ray pictures being taken.

An angioplasty procedure is similar in technique but more invasive, by the fact that a smaller catheter with a deflated balloon on its tip is advanced through the catheter which is positioned at the origin of the coronary artery and advanced down into the coronary artery to the site of where the vessel is narrowed. The balloon dilatation catheter is not advanced down the coronary artery by itself, however, first, a very small guide wire is advanced down the coronary artery, across the narrowed segment and then advanced further down into the coronary artery, beyond the narrowed segment. The balloon dilatation catheter is then advanced over the guide wire to the site of the narrowing. The guide wire allows the balloon dilatation catheter to track over it, thereby facilitating advancement of the balloon dilatation catheter down the vessel and thus preventing damage to the vessel wall. Once the balloon is positioned at the site of the narrowing in the vessel, the balloon is inflated by means of a hand held balloon inflation device. The balloon is inflated for generally two to three minutes and then deflated and withdrawn. This compresses the fatty-like material which is responsible for narrowing the coronary artery and opens the vessel, allowing for proper blood flow to the heart muscle.

At times it is difficult to advance the balloon dilatation catheter to the site of the narrowing, as these vessels are not always straight and often times bends in the vessel have to be negotiated before reaching the point of narrowing. Frequently, the balloon dilatation catheter cannot be easily advanced and the guiding catheter which is housing the balloon dilatation catheter and the guide wire, comes loose from its position at the origin of the coronary artery and does not provide enough structural support or backup to allow advancement of the balloon dilatation catheter to the narrowed site.

The purpose of my invention is to secure the guiding catheter to its position in the origin of the coronary artery, (coronary ostium), so that the balloon dilatation catheter can be housed therein and advanced forwardly into the coronary artery without losing structural support or backup from the guiding catheter. When the guiding catheter remains in a fixed position, it facilitates immensely the ability to advance the balloon dilatation catheter. At times angioplasties are unsuccessful purely on the basis of not being able to find a guiding catheter which will allow enough structural support to advance the balloon dilatation catheter properly.

It is therefore a principal object of this invention to provide a method and means to secure or anchor the guiding catheter in the origin of the coronary artery so that the balloon dilatation catheter can be easily advanced therefrom into the coronary artery without losing its structural support from the guiding catheter.

This invention comprises an angioplasty procedure wherein the balloon dilatation catheter is movably positioned within an anchoring catheter which in turn is located within a guiding catheter. Internal balloons in the anchoring catheter can be inflated to secure it to the balloon dilatation catheter. External balloons on the anchoring catheter can be inflated to anchor it to the inside of the guiding catheter. The external fixation balloons can be selectively inflated and deflated from the internal fixation balloons. Other external balloons on the distal end and outer surface can be inflated to secure the anchoring catheter within the blood vessel beyond the distal end of the guiding catheter. Perforations appear in the anchoring catheter to permit blood to flow inside and outside thereof.

The method of this invention inserts a conventional guiding catheter into the origin of the coronary artery, (coronary ostium). The conventional guide wire, conventional balloon dilatation catheter, and anchoring catheter are then inserted through the guiding catheter with the anchoring catheter and balloon dilatation catheter being secured together by the internal fixation balloons on the anchoring catheter. As the balloon dilatation catheter and anchoring catheter are advanced over the guide wire and into the coronary artery, the internal fixation balloons are deflated and the spaced external fixation balloons are inflated, thus securing the anchoring catheter to both the guiding catheter and the interior of the proximal portion of the coronary artery. This therefore serves to secure the guiding catheter to the origin of the coronary artery. The balloon dilatation catheter is then extended from the anchoring catheter tracking over the guide wire to perform the conventional function with respect to the narrowed section of the blood vessel.

FIG. 1 is a schematic view of a human heart with the apparatus of this invention inserted into a coronary artery;

FIG. 2 is an enlarged scale schematic view of the segment A in FIG. 1;

FIG. 3 is a large scale sectional-perspective view of the forward or distal ends of the balloon dilatation, anchoring and guiding catheters;

FIG. 4 is a typical cross-sectional view at an enlarged scale taken on line 4--4 of FIG. 3,

FIG. 5 is an enlarged scale sectional view of FIG. 2;

FIG. 6 is an end elevational view of an inflation valve for the internal and external balloons of the anchoring catheter;

FIG. 7 is a schematic sectional view through the valve of FIG. 6 when the internal balloons are inflated; and

FIG. 8 is a schematic sectional view through the valve of FIG. 6 when the external balloon of the anchoring catheter are inflated.

FIG. 1 shows a schematic view of a heart muscle 10 connected to the primary blood supply vessel 12 (aorta). A coronary artery 14 is also depicted in FIG. 1. The numeral 14A in FIG. 1 and FIG. 5 shows the plaque or obstruction in the coronary artery 14.

With reference to FIG. 5, the numeral 16 reveals a conventional guide wire 16 over which a balloon dilatation catheter 18 is slidably mounted. Catheter 18 has an inflatable balloon 18A on the distal end thereof. Catheter 18 has its internal diameter divided by membrane 20A to create a balloon inflation passageway 20 and a guide wire passageway 20B (FIG. 4).

Balloon dilatation catheter 18 is slidably mounted within the hollow interior of anchoring catheter 22. The outer wall 24 of anchoring catheter 22 has two hollow elongated internal balloon inflation passageways 26, each of which has a better artistic definition port 28. Two pairs of flexible internal balloons 30 extend inwardly within the hollow interior of the anchoring catheter 22 and extend over ports 28.

Similarly, the outer wall 24 of anchor catheter 22 has two external balloon passageways 32 (FIG. 4) each of which have external ports 34 in (FIG. 4). A first concentric external balloon 36 extends outwardly from wall 24 over a first pair of ports 34, and a second concentric balloon 38 extends over a second pair of ports 34. As also seen in FIG. 4, a plurality of blood perfusion ports 40 extend through wall 24 of anchoring catheter 22 on opposite sides of balloons 36 and 38.

The numeral 41 (FIG. 5) designates a guiding catheter whose function will be described hereafter.

FIG. 6 shows an end elevation of a balloon inflation valve 42 which has a body 44 depicted in FIG. 7. A horizontal bore 46 extends into body 44 and rotatably supports spool 48 which has an elongated 90 degree notch 50 which is in communication with a contrast agent inlet 52 which is also in communication with bore

Horizontal bores 26A and 32A also extend into body 44 and are adapted to be connected (not shown)) with internal balloon inflation passageways 26 and external balloon inflation passageways 32, respectively.

A conventional knob 60 (FIG. 6) is mounted on the outer end of spool 48 (FIG. 7) and has a guide tab 60A thereon which is adapted to engage stop element 62 or 62A which are embossed on the outer face of body 44 as shown in FIG. 6. When tab 60A engages stop element 62, the spool 48 is in the position of FIG. 7 to introduce contrast agent through passageway 52, bore 46, and passageway 26B to introduce air under pressure into bore 26A whereupon the internal balloon inflation passageways 26 will receive a source of contract agent to inflate the flexible internal balloons 30 of anchoring catheter 22. When the spool 48 is changed from the position of FIG. 7, as just described, to the position of FIG. 8, contrast agent is introduced in a similar manner but through passageway 32A to cause the two external balloons 36 (depicted in FIG. 3) and 38 to inflate in like manner. It should be noted that when the valve spool 46 is moved from the position of FIG. 7 to FIG. 8, or vice versa, only one of the passageways 26A or 32A will have contrast agent, while contrast agent will be denied to the other of such passageways. The spool will allow only the internal balloons or the external balloons to inflate, but not both at the same time. Thus, the valve 42 will guarantee that the internal and external balloons of the anchoring catheter 22 will not both be inflated simultaneously. This prevents any injury to the patient by preventing any shearing force which could be created if both sets of balloons were inflated simultaneously and an attempt to advance the balloon dilatation catheter was made resulting in dragging the anchoring catheter and externally inflated balloons along with it.

In operation, the guiding catheter 41 is inserted into the groin of the patient in the manner described above and positioned at the origin of the coronary artery 14. The balloon dilatation catheter 18 is inserted over guide wire 16, and both the guide wire 16 and balloon dilatation catheter 18 are then inserted within anchoring catheter 22. The assembled guide wire 16, balloon dilatation catheter 18 and anchoring catheter 22 are moved as a unit into guiding catheter 41 after the internal fixation balloons 30 of the anchoring catheter have been inflated in the manner described. At this point in time, the external balloons 36 and 38 of anchoring catheter 22 are still deflated. The above described assembled components are extended through the guiding catheter until the guide wire 16 and the distal end of the anchoring catheter 22 extend distally beyond the distal end of the guiding catheter. At that point in time, the internal balloons 30 are deflated in the manner described by valve 42 and the external balloons 36 and 38 are inflated. The external balloon 38 engages the inner wall of coronary artery 14, while the external balloon 36 engages the interior of the guiding catheter 41. This secures the guiding catheter 41 to the coronary artery 14.

With deflation of the internal fixation balloons, the balloon dilatation catheter 18 is now movable independent of the anchoring catheter and is thereupon moved to the position shown in FIGS. 1, 2 and 5 so that the balloon 18A is adjacent the plaque 14A. This can be easily accomplished by the reason of the fact that the anchoring catheter is secured both to the internal wall of the blood vessel and to the internal surface of the guiding catheter 41, anchoring the guiding catheter to the coronary ostium, thus providing backup support for advancement of the balloon dilatation catheter over the guide wife. The balloon 18A is then inflated in the conventional manner to treat the plaque 14A. After this has been done, the external balloons 36 and 38 are deflated, and the respective catheters can be removed in the conventional fashion.

The perfusion ports 40 allow for blood to flow through the anchoring catheter and down the coronary artery while the balloons are inflated. This is very critical so as to continue to support the heart muscle 10 with oxygen while the balloons are inflated and anchoring the guiding catheter to the coronary artery.

It is therefore seen that this invention will accomplish at least all of its stated objectives.