Abstract:
A catheter and stent delivery system for alleviating a blockage within a vessel of a patient, allowing for the precise placement of a non-sliding balloon catheter assembly in a single step. The catheter assembly comprises a guide wire, a balloon wrapped around the distal end of the guide wire, and an inflation lumen running the length of the-guide wire, temporarily attached to said guide wire in a non-sliding means, and embodying an adapter to accommodate an inflation syringe, the inflation lumen and the guide wire. A stent can be utilized around the inflation balloon to further alleviate the stenosis.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to the field of angioplasty. In particular, the present invention relates to a balloon catheter and guide wire that can be inserted into a patient in a single step, and furthermore, allow the exchange of the balloon catheter without removing the guide wire.  
         BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates to a catheter for use in angioplasty procedures. Over the last two decades, the medical procedure known as angioplasty has become widely accepted as a safe and effective method for treating various types of vascular stenoses. For example, angioplasty is widely used for opening stenosis throughout the vascular system and particularly for opening stenosis in coronary artery disease. At present, the most common form of angioplasty is called percutaneous transluminal angioplasty. This procedure utilizes an elongated, more or less, flexible dilation catheter with an inflatable balloon at its distal end. Using a fluoroscope and radio opaque dye for visualization a physician may steer the distal end of the balloon catheter into position through a guide catheter and across the stenosis. Once so positioned, the dilation balloon is inflated for a brief duration to open the artery and establish adequate blood flow.  
           [0003]    Typically, inflation of the balloon is accomplished by supplying a pressurized fluid through an inflation lumen in the catheter. The lumen is connected to an apparatus which includes a source of pressurized inflation fluid and is located outside the patient&#39;s body. Conversely, applying a negative pressure until the inflation lumen collapses the balloon to its minimal dimension allows for removal of the balloon catheter from within the target blood vessel. Such an application of negative pressure to the balloon catheter is also used to ensure that the balloon has its minimal dimension during the insertion of the balloon to the treatment site.  
           [0004]    In the past, a number of balloon catheter designs have been developed which contribute to the safety and acceptability of the PTCA or similar medical procedures. The most common design is known as “over the wire balloon catheter”. Conventional dual lumen devices typically utilize a relatively large lumen for the passage of the guide wire and a second parallel lumen is provided for inflation and deflation of the balloon. Typically, a steerable guide wire is positioned within the larger lumen and the entire assembly is maneuvered into an initial position within the previously positioned guide catheter of large enough size to pass the balloon catheter therethrough. From here the guide wire can be rotated axially, extended or retracted into position across the lesion. The balloon dilation catheter is subsequently advanced along the guide wire in a sliding manner to position its deflated balloon across the lesion. Inflation of the balloon then effects the dilation of the stenosis. After the deflation, the deflated balloon is withdrawn in a sliding manner back in the guide catheter.  
           [0005]    Though successful at opening stenotic lesions, this dual lumen catheter is relatively bulky and somewhat stiff as well. The technology has progressed to a point where these catheters can be used in a majority of the procedures, but the larger lumen still restricts the use of a smaller size guide catheter. These over the wire balloon catheters are difficult to use and require additional assistance or an implanting physician to control the guide wire during the positioning of the assembly because the movement of the catheter and guide wire are independent of each other. This complex coordinated activity requires both experience and skill and may result in slower insertion procedures than desired. This becomes especially important when angioplasty or stent placement are performed using distal emboli protection.  
           [0006]    An alternative over the wire catheter assembly utilizes a non-removable guide wire that allows for longitudinal and axial movement. However, this design has a significant drawback because the entire guide wire catheter assembly must be removed to accomplish the replacement or exchange of the balloon. In some cases of PTCA, it is necessary to replace the balloon with one of a different diameter or configuration following initial dilatation. Additionally, cases of acute reclosure have been noted where the lesion re-closes following dilatation and removal of the balloon catheter. This alternative over the wire system adds to the difficulty of the subsequent procedures by requiring that the placement of the catheter renegotiate the entire vascular pathway without the advantage of the retained guide wire position. That is, when the catheter is pulled out to allow the catheter exchange, the path to the treatment site is at least partially lost because the guide wire comes out with the catheter assembly.  
           [0007]    Another version of conventional balloon catheter is known as “monorail variance” of the standard balloon on the wire system and has been developed so that only a distal part of the balloon catheter tracks over the guide wire. These monorail catheter systems utilize a conventional balloon inflation lumen and a relatively short guiding or through-lumen for the guide wire at the distal end of the catheter. Use of this catheter involves insertion of the guide wire across the stenosis first and then advancing the monorail catheter to the stenosis site in a sliding manner. After deflation, the monorail catheter is withdrawn in the guide catheter in a sliding manner.  
           [0008]    The principle benefits of monorail variant balloon catheters is the reduction of frictional drag over the length of the guide wire, which is external of the catheter over much of the length of the catheter, and ease of the balloon exchange. The monorail catheter provides for the ability to re-cross an acutely closed vessel or to exchange the balloon without removing or extending the guide wire. However, a disadvantage of this design is increased difficulty in steering the guide wire because the guide wire is not supported by the balloon catheter itself. Additionally, monorail catheters are at least of dual lumen configuration at the distal end. This design produces a larger profile for the catheter and a larger shaft size.  
           [0009]    Another conventional balloon dilatation catheter design is the fixed wire or integrated “balloon on a wire dilatation catheter”. This single lumen design utilizes a guide wire having a relatively small diameter positioned within an inflation lumen and is permanently fixed to the distal end of the dilation catheter. This design produces a low profile assembly which is able to cross severely narrow lesions and to navigate tortuous vascular pathways. Additionally, the fixed guide wire is bonded to the distal end of the balloon and improves the steerability and pushability of these designs. This aspect of the fixed wire catheter also enhances their maneuverability.  
           [0010]    The thin shaft design of the guide wire of this catheter also improves visualization and enables all but the tightest critical lesions to be crossed. However, although able to provide relatively quick and simple balloon placement as well as providing access to the lesions otherwise unsuitable for PTCA, balloon on a wire systems sacrifice both ability to maintain the guide wire position across the lesion when exchanging balloons and also the safety advantage of being able to re-cross an acutely closed vessel without repositioning the entire assembly.  
           [0011]    In view of the deficiencies of the conventional technology, it is an object of the present invention to provide a “balloon on a wire” dilatation catheter which incorporates all the benefits of the smallest diameter “fixed wire” system and in addition, it allows for the complete removal of the balloon while maintaining the wire position. When used as a stent delivery system for primary stenting, this device will provide an extremely low profile throughout its entire length and will be extremely flexible. A distal protection device can be easily added to this system as well, which will make the entire process an easy, single step.  
         SUMMARY OF THE INVENTION  
         [0012]    In light of the aforementioned prior art designs, it is an object of the present invention to provide a catheter and stent delivery system with extremely low profile throughout the entire length of the catheter for the treatment of a stenosis within the arteries of a patient.  
           [0013]    It is a further object of the present invention to provide a catheter and stent delivery system with a low profile throughout the entire length of the catheter having improved flexibility especially in the balloon segment.  
           [0014]    Another object of the present invention is to provide a balloon and inflation lumen which are wrapped securely around the guide wire during insertion into the patient through temporary mechanical or chemical bonds, preventing any sliding movement between the guide wire and the balloon and inflation lumen. Upon inflation, the bonds disrupt releasing the guide wire from the inflation lumen and balloon.  
           [0015]    Another object of the present invention is to provide a catheter wherein the inflation lumen and balloon are wrapped around the guide wire during insertion into the patient allowing for easy removal of the balloon and the inflation lumen from the patient after deflation, retaining the guide wire in position within the patient.  
           [0016]    It is a further object of the present invention to provide for a catheter that comprises a guide wire and multiple inflation lumens and balloons of varying size that are inserted into the patient simultaneously allowing for a two-step angioplasty procedure without disturbing the guide wire position between steps.  
           [0017]    Another object of the present invention is to provide a catheter that embodies optional expandable, cone-shaped gold markers attached to both the distal and proximal ends of the catheter balloon for ease of insertion of the catheter, and for monitoring the position of the balloon during insertion into the patient through fluoroscopy.  
           [0018]    It is another object of the present invention to provide for a catheter and stent delivery system in which a stent is inserted within the stenosis of a patient, and subsequently allowing the removal of the balloon catheter and inflation lumen while maintaining the position of the guide wire within the patient.  
           [0019]    It is a further object of the present invention to provide a balloon catheter and stent delivery system wherein the guide wire, inflation lumen and balloon are inserted into the patient simultaneously and positioned across the stenosis in one step without sliding movement between the guide wire and inflation lumen or balloon.  
           [0020]    It is a final object of the present invention to provide a balloon catheter and stent delivery system which may be manufactured at a low cost and reduces the time required to accomplish the task of primary stenting.  
           [0021]    The foregoing objects and others are accomplished in the preferred embodiment of the invention by a catheter and stent delivery system for use in an angioplasty procedure on a patient comprising three elements. The first element is a guide wire of which many different sizes and forms are available. The present invention is intended to cover many currently available guide wires as well as the ones that will be available in the future. The second element is an inflatable balloon having a proximal end and a distal end. The distal end is closed, preventing communication of the interior volume with the exterior environment. The proximal end of the inflatable balloon is connected to an inflation lumen. The elongated inflation lumen has a proximal end and a distal end. The distal end of the inflation lumen is connected to the proximal end of the balloon and the proximal end of the inflation lumen is connected to a special adapter that can be connected to an inflation device such as a syringe. The Inflation lumen and the balloon are at least partially wrapped around the guide wire in a manner which prohibits any sliding movement of the guide wire. The balloon is at least partially wrapped around the guide wire near the distal end of the guide wire and may further embody a stent wrapped around the balloon. This system of having the guide wire wrapped with the inflation lumen and the balloon provides for an extremely low profile for the entire length of the catheter system. The inflation lumen and balloon may be held in place temporarily by either mechanical means or some adhesive as needed. These temporary bonds subsequently disrupt for separation of the balloon and inflation lumen from the guide wire for removal there from. The balloon may be secured around the guide wire at a predetermined location from the distal tip of the guide wire so as to allow a balloon catheter system with short, medium or long protruding wire tips, depending on the user&#39;s preference. The guide wire can be of varying stiffness and various transition segments so as to provide smooth torqueing and advancement of the entire system into the appropriate position.  
           [0022]    The third element of the system is a detachable clip device designed to specifically accommodate the inflation lumen and guide wire which become physically separate towards the proximal end of the system. This clip device holds the inflation lumen and guide wire together outside of the guiding catheter during maneuvering and advancement of the system into the appropriate position. Once the inflation of the balloon is carried out, the clip can be removed so that the wire can be left in place and the inflation lumen which is permanently connected to the clip, can be removed completely along with the balloon once the inflation is completed.  
           [0023]    Two semicircular cone-shaped gold markers, may be implemented in the system as a means for providing a visual indicator for monitoring outside the patient and which are permanently attached to the distal and proximal ends of the balloons, allowing for easier insertion and maneuverability of the catheter device during insertion and removal, and further allow enhanced positioning of the balloon and stent by monitoring through fluoroscopy outside the patient.  
           [0024]    Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0025]    The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:  
         [0026]    [0026]FIG. 1 is a cross-sectional view of the pre-inflated balloon catheter in position across a partial stenosis;  
         [0027]    [0027]FIG. 2 is a cross-sectional view of the inflated balloon catheter alleviating the stenosis;  
         [0028]    [0028]FIG. 3 is a cross-sectional view of the deflated balloon catheter after treating the stenosis, prior to withdrawal of the balloon and inflation lumen;  
         [0029]    [0029]FIG. 4 is a cross sectional view of the remaining guide wire of the balloon catheter, after the balloon and inflation lumen are removed;  
         [0030]    [0030]FIG. 5 is a partial side view of the balloon catheter showing the balloon and the inflation lumen wrapped around the guide wire;  
         [0031]    [0031]FIG. 6 is a cross sectional view of FIG. 5 taken along line  6  showing the balloon wrapped around the outside of the guide wire in its pre-inflated stage;  
         [0032]    [0032]FIG. 7 is a cross-sectional view of FIG. 5, taken along line  7  showing the inflation lumen partially encircling the guide wire;  
         [0033]    [0033]FIG. 8 is a partial side view of the balloon catheter wherein the inflated balloon is disposed along side of the guide wire;  
         [0034]    [0034]FIG. 9 is a cross-sectional view of FIG. 8, taken along line  9  showing the inflated balloon adjacent to the guide wire;  
         [0035]    [0035]FIG. 10 is a cross-sectional view of FIG. 8, taken along line  10 , showing the inflation lumen adjacent to the guide wire;  
         [0036]    [0036]FIG. 11 is a partial side view of the deflated balloon catheter after treating a stenosis, prior to removal;  
         [0037]    [0037]FIG. 12 is a cross-sectional view of FIG. 11, taken along line  12 , showing the deflated balloon adjacent to the guide wire after treating the stenosis;  
         [0038]    [0038]FIG. 13 is a cross-sectional view of FIG. 11, taken along line  13  showing the deflated inflation lumen adjacent to the guide wire;  
         [0039]    [0039]FIG. 14 is a sectional side view of the torquer for manipulating the inflation lumen and the guide wire of the balloon catheter outside the patient;  
         [0040]    [0040]FIG. 15 is a cross sectional view of the torquer, guide wire and inflation lumen;  
         [0041]    [0041]FIG. 16 is a side view of the balloon wrapped around the guide wire, prior to inflation, with gold markers attached to the proximal and distal ends of the balloon;  
         [0042]    [0042]FIG. 17 is a cross-sectional view of FIG. 16, taken along line  16  showing the guide wire, the balloon wrapped around the guide wire, and the gold markers;  
         [0043]    [0043]FIG. 18 is a cross-sectional view of one embodiment of the inflation lumen fully encircling the guide wire;  
         [0044]    [0044]FIG. 19 is a cross-sectional view of an alternate embodiment of the inflation lumen partially encircling the guide wire;  
         [0045]    [0045]FIG. 20 is a cross-sectional view of an alternative embodiment of the inflation lumen having a semi-rigid outer-shell with some elasticity and an inner-shell of pliable thin material, allowing the inflation lumen to wrap tightly around the guide wire;  
         [0046]    [0046]FIG. 21 is a side view of a balloon catheter embodying two separate balloons with gold markers on a single guide wire, the latter of which embodies a stent wrapped around the balloon;  
         [0047]    [0047]FIG. 22 is a cross-sectional view of FIG. 21, taken along line  22  showing the guide wire, the un-inflated balloon, a stent, and the inflation lumen of a second balloon;  
         [0048]    [0048]FIG. 23 is a cross sectional view of the guide wire having a first and second inflation lumen partially wrapped around it for the inflation of a distal and a proximal balloon respectively;  
         [0049]    [0049]FIG. 24 is a side view of a balloon catheter embodying a distal protection balloon on the guide wire;  
         [0050]    [0050]FIG. 25 is a fragmentary side view of the guide wire and the encircling inflation lumen;  
         [0051]    [0051]FIG. 26 is a fragmentary side view of the balloon catheter at the location of the balloon having a stent in place around the pre-inflated balloon; and  
         [0052]    [0052]FIG. 27 is a plan side view of an alternative embodiment to the balloon having an offset attachment of the inflation lumen. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0053]    The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.  
         [0054]    Referring now to FIGS. 1 through 4, the balloon catheter with or without a stent delivery system of the present invention is shown positioned within an arterial vessel such as a coronary vessel over a partial stenosis. Referring now specifically to FIG. 1, the balloon catheter  10  is shown within an arterial vessel  12  having a stenosis  14  comprising a guide wire  20 , an inflation lumen  30  and a balloon  40  attached to the inflation lumen  30  and wrapped around the guide wire  20 , prior to inflation from an external source. FIG. 2 depicts the balloon catheter  10  in its inflated state, wherein the balloon  40  is inflated by way of the inflation lumen  30  from an external source. Once inflated, the balloon  40  becomes unwrapped from the guide wire  20  and exerts a force against the arterial walls and compresses the stenosis, alleviating the blockage. In the event that a stent was pre-mounted to the balloon  40 , it would be deployed upon inflation of the balloon  40 .  
         [0055]    [0055]FIG. 3 shows the balloon catheter  10  subsequent to the deflation of balloon  40  following the alleviation of the stenosis  14  in an arterial vessel  12 . Once deflated, the balloon  40  and inflation lumen  30  are no longer wrapped around the guide wire  20  and are positioned adjacent to the guide wire  20 . This allows the subsequent removal of the inflation lumen  30  and balloon  40  while maintaining the guide wire  20  in position within the arterial vessel  12  as depicted in FIG. 4. By maintaining the guide wire  20  within the arterial vessel  12 , it allows an optional secondary balloon and inflation lumen to be inserted along the guide wire  20  for further alleviation of the stenosis.  
         [0056]    Referring now to FIGS. 5 and 8, the catheter  10  is shown having a guide wire  20  with a balloon  40  and an inflation lumen  30 . FIG. 5 specifically depicts balloon  40  as being tightly wrapped around guide wire  20 , exemplifying the pre-inflated state. The guide wire  20  has a bent, distal end  23  to allow the steering of the catheter  10  in tortuous locations or in a side branch of a vessel by the user. FIG. 8, shows the distal end of the balloon catheter  10  wherein the balloon  40  is inflated, causing it to become unwrapped from the guide wire  20  and repositioned adjacent to the guide wire  20 . Furthermore, when the balloon  40  becomes unwrapped, the corresponding inflation lumen  30  separates from the guide wire  20  and also becomes repositioned adjacent to the guide wire  20 . Upon deflation, the inflation lumen  30  and balloon  40  are allowed to be withdrawn from the arterial vessel  12  while maintaining the guide wire  20  within, providing for the insertion of a second balloon  40  and inflation lumen  30  along the guide wire  20 .  
         [0057]    Referring now to FIGS. 6, 7,  9 , and  10 , cross sectional views of the balloon catheter  10  are shown at various locations and states depicting the guide wire  20 , the inflation lumen  30  and balloon  40 . Specifically, FIG. 6 shows a cross-sectional view of FIG. 5 taken along line  6  showing the guide wire  20 , and the pre-inflated balloon  40  wrapped around the guide wire  20 . FIG. 7 illustrates a cross sectional view of FIG. 5 taken along line  7  showing the guide wire  20  and the pre-inflated inflation lumen  30  partially wrapped around the guide wire  20 . FIG. 9 shows a cross sectional view of FIG. 8 taken along line  9  showing the guide wire  20  and the inflated balloon  40  unwrapped and oriented adjacent to the guide wire  20 , while FIG. 10 depicts a cross sectional view of FIG. 8 taken along line  10  showing the guide wire  20  and the inflated and separated inflation lumen  30 .  
         [0058]    [0058]FIG. 11 shows the distal end of the balloon catheter  10  of the present invention in the post deflation state. Once the stenosis has been alleviated, balloon  40  is deflated, leaving the inflation lumen  30  and balloon  40  deflated adjacent to the guide wire  20 . FIG. 12 is a cross-sectional view of FIG. 11 taken along line  12  depicting the deflated balloon  40  along side the guide wire  20 , while FIG. 13 is a cross sectional view of FIG. 11 taken along the line  13  showing the deflated inflation lumen  30  and the guide wire  20 .  
         [0059]    [0059]FIGS. 14 and 15 show a torquer  50  that holds the guide wire  20  in place, allowing the manipulation of the catheter in an axial and rotational manner within the arterial vessels. It provides for an aperture  52  for attachment to an inflation syringe. The aperture  52  is in direct communication with the inflation lumen  30 . After balloon  40  is deflated, torquer  50  may be opened up, releasing the guide wire  20 , providing for the removal of balloon  40  and inflation lumen  30 .  
         [0060]    Referring now to FIG. 16, a close-up view of the uninflated balloon  40  wrapped around the guide wire  20  of the present invention is illustrated. In this preferred embodiment, a pair of optional gold markers  44  are attached to both the distal and proximal ends of the uninflated balloon  40 . Each gold marker is comprised of two pieces having a generally frustoconical shape. The markers  44  are attached to both ends of the wrapped balloon  40  in opposing orientations to provide for easy maneuverability of the balloon catheter  10  through the arterial vessels  12  of the patient. The markers  44  further provide for a means of tracking the movement of the balloon catheter  10  through the arterial vessels  12  while inserting, removing, and positioning the balloon catheter  10  within the patient by means of monitoring through fluoroscopy.  
         [0061]    These markers  44  are further depicted in the cross-sectional view of FIG. 17 which is taken from line  17  of FIG. 16. Illustrated is the balloon  40  prior to inflation wrapped around the guide wire  20  with the two-piece gold marker  44  attached to the balloon. When the balloon catheter  10  is positioned correctly in the arterial vessel  12  across a stenosis, the balloon  40  is inflated by way of the inflation lumen  30 , and as it expands and separates away from the guide wire  20 , the two halves that make up each gold marker  44  separate apart but maintain their attachment to the distal and proximal ends of balloon  40 . When balloon  40  is subsequently deflated after alleviation of the stenosis  14 , the gold markers  44  maintain their attachment to balloon  40  for withdrawal therewith along with the inflation lumen  30  while maintaining the guide wire  20  within the vessel  12 .  
         [0062]    [0062]FIGS. 18 through 20 illustrate cross-sectional views of alternative embodiments to the inflation lumen  30 , as shown wrapped around the guide wire  20  in the pre-inflated stage. Specifically, FIG. 18 shows the preferred embodiment wherein the inflation lumen  30  wraps completely around the guide wire  20 . During inflation, inflation lumen  30  separates from the guide wire  20  for subsequent removal from the arterial vessel, leaving the guide wire  20  in position. FIG. 19 depicts a cross sectional view of the inflation lumen  30  in the pre-inflated state, similar to that of FIG. 18, but the inflation lumen  30  only wraps partially around the guide wire  20 . During inflation, this embodiment may provide for easier separation of the inflation lumen  30  from the guide wire  20 . Finally, FIG. 20 is a cross-sectional view of a third embodiment of the inflation lumen  30 , comprising a semi-rigid outer shell  32 , that provides for a predetermined amount of elasticity and an inner surface  34  of a pliable thin material. This may allow the guide wire  20  to be contained within the folded inflation lumen  30  easily while still providing for a simple means of separation when inflation is so desired. In addition, this will provide for additional stiffness resulting in greater pushability.  
         [0063]    Referring now to FIG. 21, the distal end of the balloon catheter  10  of the present invention is shown having a first balloon element  60  and a second balloon element  70 . Both the first balloon element  60  and the second balloon element  70  are located inline on the guide wire  20 . The first balloon element  60  comprises a first balloon  62  of a predetermined size, wrapped around the guide wire  20 . Attached to the balloon  62  are a first set of gold markers  64  and a second set of gold markers  66  attached to the distal end  63  and the proximal end  65  of the first balloon  62 . The first balloon  62  has a corresponding inflation lumen  68  which wraps around guide wire  20  and travels proximally down guide wire  20  towards the proximal end of balloon catheter  10 .  
         [0064]    A predetermined distance proximal the first balloon element  60  on the guide wire  20 , is a second balloon element  70 . Similar to the first balloon element  60 , the second balloon element  70  comprises a balloon  72  wrapped around guide wire  20  and having a corresponding first and second set of gold markers  74  and  76  respectively, attached to the proximal end  75 , and distal end  77  of the balloon  72 , respectively. The second balloon  72  will have a generally larger inflated diameter than the first balloon  62 , providing for further alleviation of the stenosis  14 . A stent  78  may be embodied around the pre-inflated second balloon  72  which will expand as the balloon  72  is inflated. As the balloon  72  is deflated, the stent  78  will maintain its expanded state, pressing against the alleviated stenosis, while the deflated balloon  72  and corresponding secondary inflation lumen  73  may be withdrawn from the arterial vessel  12  while maintaining the guide wire  20  in position within the arterial vessel  12 . The inflation lumen  68  of the first balloon element  60  travels along the outside of the second balloon element  70  adjacent to the gold markers  74  and  76 , the stent  78 , and the balloon  72 . The second inflation lumen  73  corresponding to balloon  72  also runs proximally down guide wire  20 .  
         [0065]    When inserting this dual type of balloon catheter, the treating physician guides the balloon catheter  10  through the arterial vessels  12  to the location of the stenosis  14 , wherein when he positions the first balloon element  60  over the stenosis  14  and proceeds to inflate the first inflation lumen  68  and subsequently, the first balloon  62  as well. Once the stenosis  14  has been treated, the physician deflates the first balloon element  60  and removes balloon  62  and corresponding inflation lumen  68 . The physician then proceeds to guide the balloon catheter  10  further into the arterial vessels until the second balloon element  70  is positioned over the same stenosis  14 . The second balloon  72 , generally of a larger diameter, can allow further alleviation of the stenosis  14  by expanding further radially and henceforth, exerting greater pressure against the stenosis  14 . This second balloon element  70  may embody a stent  78  which may be inserted within the stenosis  14  to further enhance the alleviation. After deflation, the second inflation lumen  73  and attached second balloon  72  with attached gold markers  74  and  76  may be withdrawn from the patient&#39;s arterial vessel  12 , maintaining guide wire  20  in position for future catheter utilization or subsequent removal.  
         [0066]    [0066]FIG. 22 illustrates a cross-sectional view of FIG. 21, taken at line  22  showing the second balloon element  70 . The first inflation lumen  68  for inflating the first balloon element  60  is partially wrapped around the outside stent  78  of the second balloon element  70 . The second balloon  72  in its pre-inflated stage is depicted wrapped around the guide wire  20  underneath the stent. FIG. 23 shows a cross sectional view of FIG. 21, along line  23 , depicting the guide wire  20  with both inflation lumens  68  and  30  respectively wrapped around the guide wire  20 , corresponding to their respective distal and proximal balloons.  
         [0067]    [0067]FIG. 24, shows a partial side view of the balloon catheter  10  at the location of the balloon  40 , in its pre-inflated position wrapped around the guide wire  20 , embodying a pair of gold markers  44  attached to the distal and proximal ends of the balloon  40 . A distal protection balloon  43  is shown attached to the guide wire  20 , distal to the balloon  40  and proximal to the distal end of the guide wire. The protection balloon  43  prevents the distal embolization atherosclerotic or thrombotic material. Different types of distal protection devices may be incorporated in place of the balloon.  
         [0068]    [0068]FIGS. 25 and 26 show a broken side view of the balloon catheter  10  of the present invention. FIG. 25 shows a partial cutaway view of the inflation lumen  30  wrapped around the guide wire which makes up the majority of the length of the balloon catheter  10 . FIG. 26 depicts a partial cutaway of the balloon catheter  10  at the location of the balloon  40  wherein the balloon  40  is wrapped around the guide wire  20  in its pre-inflated position and embodies a stent  50  around the balloon  40 . The inflation lumen  30  is partially wrapped around the guide wire  20 , also illustrating the pre-inflated position. Upon inflation by an external force, the inflation lumen  30  and the balloon  40  will expand radially, unwrapping from the guide wire  20  and forcing the stent  50  outward radially, alleviating the stenosis  14  within the arterial vessel  12  of the patient. Once the balloon  40  and attached inflation lumen  30  are allowed to deflate, the stent  50  remains in its radially expanded position with the arterial vessel and the inflation lumen  30  and balloon  40 , which are now unassociated with the guide wire  20 , and may be withdrawn from the patient while maintaining the guide wire  20  in position.  
         [0069]    The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.