Abstract:
An over-the-wire catheter includes a guide wire lumen that is defined by a distal bracket and a proximal bracket. Both brackets are formed as part of the catheter, and the lumen is dimensioned for receiving a guide wire therethrough. Between the distal bracket and the proximal bracket is a lateral aperture that extends along the length of the catheter and provides for selective access to the guide wire during the use and operation of the catheter.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention pertains generally to catheters that are advanced into the vasculature of a patient to perform a medical/surgical procedure. More particularly, the present invention pertains to systems and methods for guiding a catheter through the vasculature of a patient over a guide wire. The present invention is particularly, but not exclusively, useful as an over-the-wire catheter that is modified to provide an open access for manipulation of its guide wire at a location proximate the distal end of the catheter. 
       BACKGROUND OF THE INVENTION 
       [0002]    Interventional surgical procedures typically require that a catheter be somehow advanced through the vasculature of a patient to a predetermined site. Catheters, however, are typically designed for a particular purpose that is to be accomplished after the catheter has been positioned in the vasculature. Therefore, as a practical matter, a particular catheter may not necessarily have the structural wherewithal to effectively navigate the vasculature on its own. Consequently, the advancement of a catheter into the vasculature is often accomplished with assistance from other means, such as a pre-positioned guide wire. As can be easily appreciated, the pre-positioning of the guide wire, and the subsequent advancement of the catheter along the guide wire, must be done with the utmost care and precision. 
         [0003]    Presently there are two well-known methods for advancing a catheter along a guide wire. These methods are generally known as: 1) the over-the-wire method; and 2) the monorail method. For the first, i.e. the over-the-wire method, the catheter is formed with a guide wire lumen that extends the entire length of the catheter. Thus, the entire catheter follows the wire during its advancement into the vasculature. A significant advantage for this method is that the “pushability” of the catheter is substantially enhanced. On the other hand, for the monorail method, only a portion of the catheter is formed with a guide wire lumen. Accordingly, part of the catheter can remain free of the catheter to enhance the individual manipulability of the catheter. 
         [0004]    Depending on the particular medical/surgical procedure that is being performed, both methods of guide wire use have their advantages. It can happen for some specific procedures, however, that the ability to select between an over-the-wire method and a monorail method may be advantageous. For instance, procedures such as a device exchange or the crossing of a bifurcation lesion could easily give rise to the need for such a selection. Moreover, for some procedures it may be desirable to actually change from one method of guide wire use to the other during the procedure. 
         [0005]    In light of the above it is an object of the present invention to provide a catheter system that can be selectively used either as an over-the-wire type catheter or as a monorail type catheter. Another object of the present invention is to provide a catheter system that allows the operator (i.e. physician) direct access both to the catheter and to the guide wire at selected locations along the length of the catheter. Still another object of the present invention is to provide a catheter system that is relatively simple to manufacture, is easy to use and is cost effective. 
       SUMMARY OF THE INVENTION 
       [0006]    A catheter system in accordance with the present invention includes a catheter that is specifically designed to facilitate the advancement of the catheter over a guide wire and into the vasculature of a patient. To do this, the present invention provides a catheter that permits changes in the structural interaction of the catheter with the guide wire. Specifically, the catheter of the present invention allows the operator to selectively change between an over-the-wire and a monorail method of guide wire usage. More generally, the catheter system of the present invention permits an over-the-wire type operation, a monorail type operation, or a hybrid combination of the two. It also allows the operator access to the guide wire, at selected locations along the length of the catheter. 
         [0007]    Structurally, the catheter of the present invention has a proximal end and a distal end with a main lumen that extends along the length of the catheter between the two ends. Also, the catheter has a distal bracket and a proximal bracket. Specifically, the distal bracket is formed on the catheter to extend from the distal end of the catheter in a proximal direction. It surrounds and defines a distal guide wire lumen. Similarly, the proximal bracket is formed on the catheter to extend from the proximal end of the catheter in a distal direction. It surrounds and defines a proximal guide wire lumen. A consequence of this is that a lateral access is established between the distal bracket and the proximal bracket. In order to help stabilize a guide wire in the lateral access, the surface of the catheter between the distal bracket and the proximal bracket can be formed with a groove that is dimensioned to receive the guide wire therein. 
         [0008]    As envisioned for the present invention, an inflatable angioplasty balloon can be mounted on the distal end of the catheter in fluid communication with the main lumen. Also, a Y-site can be attached to the proximal end of the catheter. If used, one branch of the Y-site is placed in fluid communication with the main lumen. Thus, the Y-site establishes a main port that can be used for an inflation/deflation of the balloon. The other branch of the Y-site can then be used for the guide wire. Specifically, this other branch of the Y-site establishes a proximal end port that connects with the proximal guide wire lumen of the proximal bracket. At the distal end of the catheter, the distal bracket provides a distal end port that allows the guide wire to be introduced into the guide wire lumen of the distal bracket. As indicated above, the proximal and distal guide wire lumens can act in concert with each other to establish a comprehensive guide wire lumen for the catheter. 
         [0009]    In an alternate embodiment of the present invention, the catheter can be formed with a central bracket that is located between the distal bracket and the proximal bracket. For this embodiment, the central bracket will effectively divide the lateral access into a proximal lateral access and a distal lateral access. Structurally and functionally, the central bracket is essentially the same as either the proximal bracket or the distal bracket. 
         [0010]    In its operation, the present invention envisions that a guide wire will be pre-positioned in the vasculature of a patient. The extracorporeal end of the guide wire can then be inserted into the distal end port of the catheter and received into the distal guide wire lumen. Additional advancement of the catheter over the guide wire will then bring the exposed extracorporeal end of the guide wire past the lateral access and into the vicinity of the proximal bracket. At this point, the guide wire can be selectively inserted into the proximal guide wire lumen of the proximal bracket. If so, the guide wire will exit the proximal bracket through the proximal end port and the catheter can thereafter be used as an over-the-wire catheter. Otherwise, when the guide wire is not passed through the proximal bracket, the guide wire is restrained by only the distal bracket and can stay free from the catheter at the lateral access. In this case, the catheter can be used in a monorail methodology. It will be appreciated that the catheter&#39;s method of guide wire usage can be changed at any time during a procedure, either by selectively inserting the guide wire through the proximal bracket (over-the-wire), or not inserting the guide wire through the proximal bracket (monorail). 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0012]      FIG. 1  is a perspective view of a catheter system in its intended operational environment; 
           [0013]      FIG. 2A  is a perspective view of a preferred embodiment of a catheter of the present invention; 
           [0014]      FIG. 2B  is a view of the catheter shown in  FIG. 2A  when engaged with a guide wire for an over-the-wire operation; 
           [0015]      FIG. 2C  is a view of the catheter shown in  FIG. 2A  when engaged with a guide wire for a monorail operation; 
           [0016]      FIG. 3  is a cross section view of the catheter system of the present invention as seen along the line  3 - 3  in  FIG. 2B ; 
           [0017]      FIG. 4A  is a cross section view of the catheter system of the present invention as seen along the line  4 - 4  in  FIG. 2B ; 
           [0018]      FIG. 4B  is a cross section view of the catheter system of the present invention as seen along the line  4 - 4  in  FIG. 2C ; and 
           [0019]      FIG. 5  is a perspective view of an alternate embodiment of a catheter of the present invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0020]    Referring initially to  FIG. 1  a catheter in accordance with the present invention is shown and designated  10 . As shown, the catheter  10  has been advanced along a path  12  through the vasculature of a patient  14  over a guide wire  16 . The actual structure for the catheter  10  will be best seen in  FIG. 2A . 
         [0021]    In  FIG. 2A  it will be seen that the catheter  10  has a proximal end  18  and a distal end  20 . A Y-site  22 , of a type well known in the pertinent art, is attached to the proximal end  18  of the catheter  10  to establish a main port  24  and a proximal end port  26 .  FIG. 2A  also shows that a distal bracket  28  is formed on the catheter  10 , and that the distal bracket  28  extends in a proximal direction from the distal end  20  of the catheter  10 . Similarly,  FIG. 2A  shows a proximal bracket  30  that is formed on the catheter  10 , and that the proximal bracket  30  extends in a distal direction from the proximal end  18  of the catheter  10 . It is also seen in  FIG. 2A  that, together, the distal bracket  28  and the proximal bracket  30  establish a lateral aperture  32  that extends along the length of the catheter  10 , between the brackets  28  and  30 . 
         [0022]      FIG. 2B  shows the catheter  10  engaged with the guide wire  16  for an over-the-wire method of operation. Specifically, in this over-the-wire configuration, it will be seen that the guide wire  16  extends along the entire length of the catheter  10 , between the proximal end port  26  and a distal end port  34 , and beyond the ports  26  and  34 . Further, in the over-the-wire configuration, the guide wire  16  remains next to the catheter  10 . The guide wire  16 , however, is still accessible in the region of the lateral aperture  32 . For a different methodology, as shown in  FIG. 2C , the guide wire  16  is restrained by only the distal bracket  28 . In this monorail configuration ( FIG. 2C ), the guide wire  16  still interacts with the catheter  10 , and it can still be effectively used to advance the catheter  10 , but it can also be manipulated separately from the catheter  10 . 
         [0023]      FIG. 3  shows that the distal bracket  28  is formed with both a main lumen  36  and a guide wire lumen  38 . As will be appreciated by the skilled artisan, the proximal bracket  30  has a substantially same structure as the distal bracket  28 . Specifically, the main lumen  36 , which extends the entire length of catheter  10 , is also present in the proximal bracket  30 . Additionally, the proximal bracket  30  is formed with a portion of the guide wire lumen  38 . 
         [0024]    In detail, for the over-the-wire configuration of catheter  10  (see  FIG. 2B ) the guide wire  16  passes through the guide wire lumen  38  of the distal bracket  28  (see  FIG. 3 ). Likewise, the guide wire  16  passes through the guide wire lumen  38  that is formed into the proximal bracket  30 . Between the two brackets  28  and  30  the guide wire  16  is juxtaposed with the catheter  10  for the over-the-wire configuration. This places it in the lateral aperture  32  as shown in  FIG. 2B  and  FIG. 4A . As will be best appreciated with reference to  FIG. 4A , in order to help stabilize the guide wire  16  in the over-the-wire configuration, the catheter  10  can be formed with a groove  40 . Specifically, if used, this groove  40  will extend along the side of the catheter  10  between the distal bracket  28  and the proximal bracket  30 . 
         [0025]    In the monorail configuration for catheter  10  (see  FIG. 2C ), the guide wire  16  is held on the catheter  10  by only the distal bracket  28 . For this configuration, in the region of the lateral aperture  32 , the guide wire  16  can be separated from the catheter  10  for individual manipulation (see  FIG. 4B ). Accordingly, in the monorail configuration, the guide wire  16  does not pass through the proximal bracket  30 . 
         [0026]    An alternate embodiment for the present invention is shown as the catheter  10 ′ in  FIG. 5 . For this embodiment, the catheter  10 ′ includes a central bracket  42 . In all of its important respects, the central bracket  42  is similar to the distal bracket  28  and the proximal bracket  30  disclosed above. Specifically, the central bracket  42  is also formed with a guide wire lumen  38  and a main lumen  36 . The central bracket  42  does, however, divide what would otherwise be the lateral aperture  32  into a distal lateral aperture  44  and a proximal lateral aperture  46 . 
         [0027]    For purposes of this disclosure, the catheter  10  is shown to be a so-called “balloon catheter.” Specifically, in  FIG. 2A  it is shown that an inflatable balloon  48  is attached to the distal end  20  of the catheter  10 . More specifically, the balloon  48  is attached in fluid communication with the main lumen  36 . Thus, an inflation/deflation device (not shown) can be attached to the main port  24  of the Y-site  22 , and used to inflate/deflate the balloon  48 . Such an operation is only exemplary and, as envisioned for the present invention, the catheter  10  can be any of several types of catheters well known in the pertinent art for performing medical/surgical procedures in the vasculature of a patient  14 . Importantly, any such procedure is separate and distinct from the functional interaction of the catheter  10  with a guide wire  16 . 
         [0028]    As envisioned for the present invention, the interaction of the catheter  10  with a guide wire  16  will most often happen after the guide wire  16  has been pre-positioned in the vasculature of the patient  14 . To begin, the extracorporeal end of guide wire  16  will first be inserted through the distal end port  34  of the distal bracket  28 . As the guide wire  16  then exits from the distal bracket  28 , the operator has a choice. One choice is to do no more, and use the catheter  10  in a monorail configuration. The other choice is to insert the guide wire  16  into the guide wire lumen  38  of the proximal bracket  30  until it extends from the proximal end port  26  at the Y-site  22 . The operator can then use the catheter  10  in its over-the-wire configuration. As will be appreciated by the skilled artisan, the configurations are selectively interchangeable at any time. 
         [0029]    While the particular Over-The-Wire Catheter With Lateral Access as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.