Abstract:
An attachment tool to facilitate the attachment of one or more catheters or similar elongated instruments to a guide-wire or other elongated guide member, without requiring access to either end of said wire or member. The tool provides repeatable and reliable alignment of components to be attached, while being operated with a single hand. The catheter systems can be used for revascularization or treatment of arteries and lumens within the body, and the associated delivery of therapies therein and can include side attachable and over-the-wire components and/or low profile combination catheters to allow for flush and extraction of debris in small or tortuous anatomic pathways.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application is a divisional application of U.S. application Ser. No. 10/477,475 filed on May 27, 2004 entitled Tool for Facilitating the Connecting of a Catheter or Other Tubular Member onto a Guide-Wire Without Access to the Ends of the Guide Wire, which in turn is a national phase application of PCT/US02/16251 filed on May 21, 2002, entitled Tool for Facilitating the Connecting of a Catheter or Other Tubular Member onto a Guide-Wire Without Access to the Ends of the Guide Wire, which takes its priority from U.S. application Ser. No. 09/861,728 (now U.S. Pat. No. 6,517,518 issued on Feb. 11, 2003), filed on May 21, 2001, which is a continuation-in-part application of U.S. patent application Ser. No. 09/523,077 (now U.S. Pat. No. 6,569,151 issued on May 27, 2003), filed on Mar. 10, 2000, entitled Device for Connecting a Catheter or Other Tubular Member onto a Guide-Wire Without Access to the Ends of the Guide-Wire, all of which are assigned to the same assignee as this invention and all of whose entire disclosures are fully incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates generally to medical devices and more particularly to devices for use with catheters or other tubular devices that are arranged to be located at some intra-lumenal, e.g., intra-vascular, position within the body of a being by a conventional guide-wire or other guide member.  
       BACKGROUND OF THE INVENTION  
       [0003]     Heretofore the mounting of a tubular instrument, e.g., a catheter, on a guide-wire has typically required access to either the distal or the proximal end of the guide-wire. Where the guide-wire is already in place, access has been achieved by mounting the instrument on the proximal end of the guide-wire and then sliding it into place over or along the guide-wire. For example, the so-called “over-the-wire” catheter (such as a balloon angioplasty catheter) has a central or other longitudinal extending passageway therethrough arranged to receive the guide-wire. In particular, the passageway of such a catheter is introduced on the proximal end of the guide-wire and then the catheter is slid down the guide-wire to the desired location. The advantage of this type of instrument and guidance system is that it can have a relatively small cross-sectional area or “crossing-diameter,” a feature of some importance in applications wherein the lumen being traversed is small, e.g., an artery occluded by atherosclerotic deposits. The so-called “mono-rail” catheter doesn&#39;t make use of a central passageway for receipt of the guide-wire, but instead makes use of some externally located connector located on the distal end of the catheter and arranged to receive the guide-wire through it. The mono-rail catheter is also arranged to be introduced on the proximal end of the guide-wire, but outside the guide-wire so that the guide-wire passes through the connector on the distal end of the catheter, with the catheter itself being located beside the guide-wire so that it can be slid along the guide-wire to the desired location.  
         [0004]     As will be appreciated by those skilled in the art, if the proximal end of the guide-wire has some structure permanently or transiently mounted or secured on it, e.g., a twist or torque handle (for rotating the guide-wire to a desired angular orientation), a valve (to enable some fluid to be introduced through the guide-wire, such as to inflate a balloon on the distal end of the guide-wire), another catheter, etc., that is of a relatively large diameter or cross-sectional area, such a proximally mounted structure would necessarily impede the mounting of the instrument over the guide-wire once the guide-wire is in place within the being&#39;s body.  
         [0005]     In U.S. Pat. No. 6,022,336 (Zadno-Azizi, et al.) there is disclosed a catheter system for revascularizing an occluded vessel and for containing any emboli produced during the use of the system. As best seen in  FIGS. 7 and 10 A of that patent the instrument makes use of plural catheters for providing at least one pair of paths for irrigation and aspiration fluid flow. One of the catheters, designated as an “intermediate” catheter includes an externally mounted lumen structure for receipt of an inner catheter therethrough. This lumen structure may include a longitudinally extending slit or weakened area along the entire length of the lumen structure to facilitate faster and easier insertion and removal of the inner catheter through the side wall of the lumen structure. By inserting and removing the inner catheter through the slit in the side wall of the lumen structure, the need to remove adapters and attachments from the proximal end prior to slidably advancing or removing the intermediate catheter over the inner catheter is eliminated. Thus, this lumen structure which is mounted at the distal end of the intermediate catheter for accommodating the inner catheter enables the intermediate catheter to be guided along the inner catheter in a manner like the heretofore discussed mono-rail catheters are slid along a guide-wire. However, unlike the prior art devices for mounting an instrument on a guide-wire in a mono-rail like arrangement, the device of Zadno-Azizi, et al. patent does not require access to the proximal end of the intermediate catheter or guide-wire. Instead the device of the Zadno-Azizi, et al. patent enables the inner catheter to be inserted laterally into a longitudinally extending access slit in the lumen structure at an intermediate location along the inner catheter. By inserting and removing the inner catheter through the slit in the side wall of the lumen structure on the distal end of the intermediate catheter, the need to remove adapters and attachments from the proximal end of the intermediate catheter prior to slidably advancing or removing that catheter over the inner catheter is eliminated.  
         [0006]     While the instrument of the Zadno-Azizi, et al. patent appears generally suitable for its intended purposes, it appears to leave something to be desired from various standpoints. For example, since the lumen structure with the access slit is located externally to the intermediate catheter it will necessarily add its diameter to the diameter of the intermediate catheter, thereby limiting its usefulness to relatively large crossing diameter lumens. Also, the manner in which the intermediate catheter is attached or mounted onto the inner catheter or guide-wire may be somewhat difficult to achieve, and the additional structure, e.g., the slit bearing lumen structure, on the distal end could cause the distal end to get snagged on stents placed in the vessel. Further still, since the slit through which the inner catheter or guide-wire is inserted is linear and extends longitudinally, the inner catheter or guide-wire may come out of the lumen during the traversal of difficult anatomical orientations, e.g., tortuous vascular paths.  
       SUMMARY OF THE INVENTION  
       [0007]     In accordance with one aspect of the invention, an attachment tool and method of use are provided for facilitating the attachment of a catheter or elongated instrument having a connector thereon to a guide-wire or other elongated guide member. The tool comprises surfaces arranged to cause the catheter to contact the guide-wire or other elongated guide member upon the application of a force, e.g., a twisting force, a longitudinal force, a lateral force, etc., to the tool or to the catheter or elongated instrument, whereupon the catheter or elongated instrument is attached to the guide-wire or other elongated guide member.  
         [0008]     In accordance with another aspect of the invention, a tubular instrument system is provided. The system is arranged to be used with a guide-wire or other elongated guide member. The guide-wire or other guide member has a distal end portion arranged to be extended to some interior position within a lumen in the body of a living being, and also has a proximal end portion arranged to be located outside the body of a living being, and also has a proximal end portion arranged to be located outside the body of a living being. The system comprises at least a first and second tubular component. The first tubular component has an end portion having a connector arranged to be connected to the guide-wire or other guide member so that the first tubular component can be guided to a desired position within the body of the being.  
         [0009]     In accordance with another aspect of the invention the connector establishes a path into which a portion of the guide-wire or other guide member can be inserted from a lateral direction by a twisting action without requiring access to either end of the guide-wire or other guide member.  
         [0010]     In accordance with another aspect of the invention, the second tubular component comprises a second end portion including a connection arranged to be readily connected to the guide-wire or other guide member so that the second tubular component can be guided to a desired position within the body of the being along the guide-wire or other guide member.  
         [0011]     In accordance with another aspect of the invention the second connector establishes a path into which a portion of the guide-wire or other guide member can be inserted from a lateral direction by a twisting action without requiring access to either end of the guide-wire or other guide member.  
         [0012]     In accordance with another aspect of the invention the first tubular component is arranged to have a fluid injected through it at a first flow rate, and in certain of these embodiments, the second tubular component is arranged to evacuate fluids and debris therethrough at a second flow rate. The second flow rate may be higher or the same as the first flow rate. The fluids may contain drugs or other therapy agents, and the extracted fluid may also contain debris created or dislodged by the procedure.  
         [0013]     In accordance with another aspect of the invention the second tubular component is arranged to be used in an over-the-guide-wire insertion procedure.  
         [0014]     In accordance with another aspect of the invention a combination catheter embodiment is provided including first and second tubular components. The second tubular component is attached adjacent to the first tubular component and has a path or opening at an end portion into which at least a portion of the fluid and debris may enter. The fluid and debris is removed through a channel or passageway in the second tubular component.  
         [0015]     In accordance with another aspect of the invention, the first tubular component of the combination catheter includes a connector, like those described above, for attachment to the guide-wire or other guide member. Alternate embodiments may use the traditional over-the-wire approaches to insertion and navigation. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0016]      FIG. 1  is an isometric view of the distal end of one embodiment of a catheter constructed in accordance with this invention and shown after it has been mounted on a conventional guide-wire by a helical connector forming a portion of the distal end of the catheter;  
         [0017]      FIG. 2  is a longitudinal sectional view of the distal end of the embodiment of the catheter shown in  FIG. 1 ;  
         [0018]      FIG. 3  is an isometric view of the distal end of another embodiment of a catheter, e.g., a beveled distal end catheter, constructed in accordance with this invention and shown after it has been mounted on a conventional guide-wire by a “helical-cut” connector forming a portion of the distal end of the catheter;  
         [0019]      FIG. 4  is a longitudinal sectional view of the distal end of the embodiment of the catheter shown in  FIG. 3 ;  
         [0020]      FIG. 5  is an isometric view of the distal end of still another embodiment of a catheter constructed in accordance with this invention and shown after it has been mounted on a conventional guide-wire by a “pigtail” connector forming a portion of the distal end of the catheter;  
         [0021]      FIG. 6  is a longitudinal sectional view of the distal end of the embodiment of the catheter shown in  FIG. 5 ;  
         [0022]      FIG. 7  is a reduced top plan view of the embodiment of the catheter shown in  FIG. 1 ;  
         [0023]      FIG. 8  is an enlarged top plan view of the portion of the embodiment of the catheter shown within the area bounded by the circular broken line in  FIG. 7 ;  
         [0024]      FIG. 9  is an isometric view of the distal end of the embodiment of the catheter shown in  FIG. 1  during an initial step in the mounting of the catheter on the guide-wire;  
         [0025]      FIG. 10  is an isometric view similar to  FIG. 9  but showing the distal end of the embodiment of the catheter of  FIG. 1  during an intermediate step in the mounting of the catheter on the guide-wire;  
         [0026]      FIG. 11  is an isometric view similar to  FIGS. 9 and 10  but showing the distal end of the embodiment of the catheter of  FIG. 1  at a still later step in the mounting of the catheter on the guide-wire.  
         [0027]      FIG. 12  is an isometric view of the distal end of another embodiment of a catheter constructed in accordance with this invention;  
         [0028]      FIG. 13  is an isometric view similar to  FIG. 12  but showing the distal end of the embodiment of the catheter of  FIG. 12  during an initial step in the mounting of the catheter on a guide-wire; and  
         [0029]      FIG. 14  is an isometric view similar to  FIGS. 12 and 13  but showing the distal end of the embodiment of the catheter of  FIG. 12  after the catheter has been mounted on the catheter on the guide-wire.  
         [0030]      FIG. 15  is an isometric view of the open clamshell attachment tool showing the internal bore and features used to direct the guide-wire into the internal bore prior to the closing of the clamshell.  
         [0031]      FIG. 16  is an isometric view of the catheter attached to the guide-wire inside the funnel of the closed attachment tool.  
         [0032]      FIG. 17  is an isometric view of a system including a guide-wire having a plurality of catheters connected thereon, with each catheter having a distal tip connector connected to the guide-wire by the attachment tool of  FIG. 15 .  
         [0033]      FIG. 17A  is a cross-sectional view of an embodiment of the catheter system shown in  FIG. 17 , at section A-A.  
         [0034]      FIG. 18  is an isometric view of a system including a guide-wire having a plurality of  5  catheters connected thereon, with a first catheter having a distal tip connector connected to the guide-wire by use of the attachment tool of  FIG. 15  and a second catheter loaded onto the guide-wire in a traditional manner from the end of the guide-wire.  
         [0035]      FIG. 18A  is a cross-sectional view of an embodiment of the catheter system shown in  FIG. 18 , at section line A-A.  
         [0036]      FIG. 19  is an isometric view of a system including a guide-wire having a plurality of catheters connected thereon, with each catheter having a distal tip connector like that of  FIG. 17 , but with the guide-wire including a debris blocking balloon.  
         [0037]      FIG. 19A  is a cross-sectional view of the embodiment of the catheter system shown in  FIG. 19 , at section line A-A.  
         [0038]      FIG. 20  is an isometric view of a single combination catheter having a plurality of passageways and a distal tip connector, like that of  FIG. 17 , but with the guide-wire including debris blocking balloon.  
         [0039]      FIG. 20A  is a cross-sectional view of the embodiments of the catheter system shown in  FIGS. 20 and 21 , at section line A-A of  FIG. 20 .  
         [0040]      FIG. 20B  is a cross-sectional view of the embodiments of the catheter system shown in  FIGS. 20 and 21 , at section line B-B of  FIG. 20 .  
         [0041]      FIG. 21  is an isometric view of a combination catheter, similar to that shown in  FIG. 20 , but additionally comprises a flow blocking wall and a pair of high-pressure flow ports.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0042]     Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown at  20  in  FIG. 1  the distal end of a tubular instrument, such as an infusate catheter for use in a intravascular revascularization system, and having a connector  22  constructed in accordance with one embodiment of this invention for quickly and easily securing the catheter  20  onto a conventional guide-wire  24  without requiring access to either end of the guide-wire.  
         [0043]     Before discussing the details of the connector  22 , it should be pointed out that the subject invention can be used with any type of tubular instrument, be it a catheter or otherwise, that is arranged to be extended along a guide-wire or other elongated guide member into the body of a living being to a desired location and without requiring access to either end of the guide-wire or other elongated guide member. In the embodiments shown herein the guide-wire  24  is shown as being a tubular member, but can, if desired be a solid wire.  
         [0044]     The infusate catheter whose distal end is shown in  FIG. 1  is shown fully in the plan view of  FIG. 7  and is merely exemplary of any type of catheter or tubular instrument for which the subject invention has application and utility (e.g., an angiographic or other diagnostic catheter, a drug or therapy delivery catheter, a prosthesis delivery catheter, a revascularization catheter, a ultrasound or vascular filter wire). As best seen in  FIG. 7  the catheter  20  basically comprises an elongated tubular body  20 A terminating at a distal end  20 B at which the connector  22  of the subject invention is located. The opposite or proximal end of the catheter  22  is in the form of an enlarged hub or connector  20 C for connection to the associated components of the revascularization system (not shown). A central passageway  20 D extends through the catheter and terminates at an open free end  20 E ( FIGS. 7 and 1 ). In the exemplary embodiment of catheter  20 , the passageway  20 D is arranged to carry an infusate liquid therethrough for ejection via opening  20 E into the portion of the vessel being revascularized or diagnosed.  
         [0045]     Turning now to  FIG. 1  the details of the connector  22  will now be considered. As can be seen the connector is in the form of a helical channel  28  cut into the wall  30  of the catheter at the distal end portion  20 B so that it is in communication with the interior passageway  20 D of the catheter along the entire length of the channel. The channel  28  may be of fixed or variable pitch and includes a widened or flared mouth  32  where it meets or merges with the open free end  20 D of the catheter. It is through this mouth that the guide-wire, catheter or other elongated guide member is inserted into the channel. The opposing sides of said mouth  32  may be radially offset or displaced (not shown), relative to each other, to facilitate the entry of said guide-wire  24  into said channel  28 . The proximal end of the channel  28  terminates in an elongated slot or exit window  34  that is also in communication with the interior passageway  20 D. It is through the window  34  that the guide-wire exits the channel. Thus, the channel forms a path into which the guide-wire can be inserted to slidingly connect the catheter to the guide-wire. As will be discussed in detail to follow, the path is constructed so that the entry of the guide-wire into and through it can be facilitated easily, quickly and reliably with only a slight twisting action. It should be understood that the connector segment of catheter  20  can be a stand-alone device which may be positioned or otherwise attached to a portion (e.g. the distal tip) of any catheter or elongated member. For example, the sleeve-like tubular connector system can be provided in a number of diameters and lengths and can be slid onto the end of a variety of compatible catheters or elongate members and then secured in place (e.g. crimped).  
         [0046]     In accordance with one preferred aspect of this invention the material making up the connector portion of catheter  20  is preferably resilient so that the guide-wire  24  can be extended into the mouth  32  of the channel and then into contiguous portion of the channel  28 , whereupon the channel flexes open somewhat to enable the guide-wire to pass therethrough to exit from the window  34 . As the guide-wire moves proximally along the channel to the window  34 , portions for the channel distally of the guide wire flexes back to the initial position, whereupon when the guide-wire is within the window, the channel will have assumed its unflexed or normally closed condition. It should, however, be pointed out at this juncture that the catheter or the material forming slot need not be resilient, so long as the slot can accommodate the guide-wire therein to enable it to slide with respect thereto, as will be described later.  
         [0047]     In order to facilitate the exit of the guide-wire  24  from the channel  28  at the window  34  and to ensure that the guide-wire extends closely parallel to the outer surface of the catheter from its exit point proximally, an elongate recess or depression  36  is formed in the wall  30  of the catheter  20  immediately proximally of the window  34 . The recess  36  extends along an axis parallel to the longitudinal axis of the catheter and, as best seen in  FIG. 2 , inclines upward from its lowest point where it merges with the proximal end of the window  34  to the point where it terminates at the outer circular surface of the catheter proximally of the window.  
         [0048]     In the exemplary embodiment shown the outer diameter of the catheter is approximately 0.05 inch. The spiral channel  20  forms at least one complete revolution about the periphery of the catheter so that the entry mouth  32  is axially aligned with the exit window  34 . The width of the entrance mouth is approximately 0.025 inch. The width of the exit window is greater than the width of the channel  28 , e.g., 0.02 inch versus 0 to 0.015 inch. The length of the channel  28  measured longitudinally from the open end  20 E of the catheter to the proximal end of the window  34  (i.e., the lowest point of the recess  36 ) is approximately 0.25 inch. It should be understood that in some instances it may be desirable that the open end  20 E of the connector portion of the catheter be beveled or tapered to provide a good fit and smooth transition when the catheter is advanced along to the guide-wire through tissue or the vasculature of the living being.  
         [0049]     In order to enable the user of the catheter to orient it in the desired rotational attitude for mounting onto the guide-wire, a process to be discussed in detail later, an indicator marker or indicia, such as an arrow  38 , is provided on the catheter aligned with the flared mouth  32  so that the user of the catheter can readily determine the location of the channel&#39;s mouth  32  by viewing the indicator arrow  38 .  
         [0050]     The mounting of the catheter  20  on the guide-wire  24  will now be discussed with reference to  FIGS. 9-11 . It is assumed that the guide-wire is already in place so that its distal end (not shown) is located at some internal situs within the body of the being, while its proximal end is located outside the body of the being, with some intermediate portion, designated by the reference number  24 A herein, also being located outside the body of the being distally of the proximal end of the guide-wire. It is at this intermediate position that the catheter  20  is mounted on the guide-wire using the connector  22 . It should be pointed out at this juncture that while the portion  24 A of the guide-wire is preferably outside the body of the being, such an arrangement is not required. In this regard in some medical applications the guide wire portion  24 A where the catheter is to be connected may be located internally of the being and access provided to it via a natural body orifice or opening or through some surgically formed opening.  
         [0051]     In any case, as best seen in  FIG. 9  the catheter  20  is oriented or twisted so that the entry mouth  32  at the distal end of the channel is aligned with the portion  24 A of the guide-wire  24 . The arrow indicia  38  facilitates the correct orientation alignment procedure. Once aligned the distal end of the catheter  20  is moved in a lateral direction (e.g., from the side of the guide-wire) toward it (or the guide-wire is moved toward the catheter) so that the guide-wire portion  24 A enters into the mouth of the channel  116 . Then the catheter is twisted or rotated in the direction shown by arrow  40  to cause the guide-wire portion  24 A to enter into the contiguous portion of the channel  28 , whereupon the channel flexes open, as described earlier. Continued twisting of the catheter in the direction of arrow  40  causes the guide-wire to move further down the channel as shown in  FIG. 11 . Continued twisting of the catheter with respect to the guide-wire in the direction of arrow  40  eventually brings the guide-wire portion  24 A into the exit window  32 , as shown in  FIGS. 1 and 2 , whereupon the guide-wire portion  24  exits the window and is guided upward by the inclined recess  36  until it is generally parallel to the outer surface of the catheter  20  (as best seen in  FIG. 1 ). Once this has been accomplished, the catheter can be slid or moved in the distal direction along the guide-wire to bring the open distal end  20 E of the catheter to the desired position within the being&#39;s body, e.g., at a situs of the atherosclerotic deposit to be removed.  
         [0052]     In  FIGS. 3 and 4  there is shown an alternative embodiment of a catheter  20  constructed in accordance with this invention. The catheter  20  is in all material respects identical to the catheter  20 , except for the shape of its distal end. Thus, in the interest of brevity the details of the construction and the operation of the catheter  20  will not be reiterated and the same reference numbers will be given to the common components. As can be seen in  FIGS. 3 and 4  the distal end of the catheter  20  includes a beveled end  20 E. The entry mouth to the channel  28  is located on the most proximal portion of the beveled end  20 E for initial receipt of the guide-wire portion  24 A therein.  
         [0053]     In  FIGS. 5 and 6  there is shown another embodiment of a catheter  100  constructed in accordance with this invention. The catheter  100  also includes a connector  102  (to be described in detail hereinafter) for facilitating the mounting of the catheter on a portion  24 A of the guide-wire from a lateral or side direction and without requiring access to either end of the guide-wire. However, unlike the embodiments of  FIGS. 1-4 , the connector  102  of the catheter  100  is located externally to the outer surface of the distal end of the catheter  100  to form the path or channel for the guide-wire therebetween.  
         [0054]     The connector  102  basically comprises a helical wire having plural consecutive helices  104  and terminating at one end in a distal end portion  106  and at the opposite or proximal end portion  108 . The distal end portion  108  is linear and is centrally disposed within the helices  104  (See  FIG. 6 ). The distal end portion is arranged to be fixedly secured in a central bore  110  in the distal end of the catheter  100 . As can be seen the distal end of the catheter is closed, e.g., it includes a dome-shaped end wall  112  into which the bore  110  extends. Since the end of the catheter  100  is closed, if it is to be used as an influsating device it includes plural outlet ports or openings  116  extending through the sidewall  30  of the distal end portion and in communication with the central passageway  118  of the catheter. The helices  104  extend backward from the distal end portion  106  of the connector  102  and about the periphery of the outer surface of the catheter  100  to form an annular space or channel  120  therebetween. The thickness of the channel is just slightly greater than the outside diameter of the guide-wire (for reasons to be explained later). The proximal end portion  108  terminates in a somewhat bulbous free end  122  which is also spaced from the outer surface of the catheter and which forms the entry mouth for the channel  120 . The connector  102  may be formed of any suitable biocompatible material, e.g., stainless steel, plastic, etc.  
         [0055]     The mounting of the catheter  100  on the guide-wire portion  24 A is accomplished by orienting or aligning the catheter  100  so that the guide-wire portion can be inserted into the entry mouth, i.e., the space between the bulbous distal free end  122  of the connector  102  and the outer surface of the catheter  100 . Once aligned the distal end of the catheter  100  is moved in a lateral direction (e.g., from the side of the guide-wire) toward it (or the guide-wire is moved toward the catheter) so that the guide-wire portion  24 A enters into the mouth of the channel  120 . Then the catheter  100  is twisted or rotated in the direction shown by arrow  40  to cause the guide-wire portion  24 A to enter into the contiguous portion of the channel  120 , i.e., the helical portion defined by the helix closest to the free end  122 . Continued twisting of the catheter in the direction of arrow  40  causes the guide-wire to move further down the channel, guided by the helices  104  until it exits from the channel at the distal most helix  104 . At this time the guide-wire will be within the confines of the channel and disposed parallel to and very closely adjacent to the outer surface of the catheter. Once this has been accomplished, the catheter  100  can be slid or moved in the distal direction along the guide-wire  24  to bring the distal end of the catheter to the desired position within the being&#39;s body, e.g., at a situs of the atherosclerotic deposit to be removed.  
         [0056]     In accordance with one preferred aspect of this invention the diameter of the wire making up the connector  102  is quite small, e.g., 0.010 inch, and the thickness of spacing between the inner surfaces of the connector&#39;s helices  102  and the outer surface of the catheter  100  (i.e., the thickness of the annular channel  120 ) is just slightly larger than the outside diameter of the catheter. Thus, the catheter  100  with the connector  102  thereon will still exhibit a small crossing diameter (albeit somewhat greater than a comparable diametrically sized catheter making use of the connectors like shown in  FIGS. 1-4 ).  
         [0057]     In  FIGS. 12-14  there is shown yet another alternative embodiment of a catheter  200  constructed in accordance with this invention. The catheter  200  is similar to the catheter  20  in that it is a hollow tubular member having a central passageway  20 D terminating at an open distal end  20 E, yet is also similar to the catheter  100  in that catheter  200  includes an externally located connector  202 . The connector  202  is like the other connectors described heretofore arranged to enable a guide wire  24  or other elongated guide member to be readily connected to the catheter by inserting it into a path (to be described hereinafter) by a twisting action, whereupon the catheter or other instrument can be slid along the guide-wire or other elongated guide member, yet is resistant to accidental disconnection.  
         [0058]     As can be seen the connector  202  basically comprises a sleeve  204  formed of any biocompatible material, like those described heretofore, and having a pair of fingers  206  and  206  projecting outward therefrom. The sleeve  204  includes a circular central passageway whose inside diameter is approximately the same as the outside diameter of the distal end portion of the catheter  200  to accommodate that portion of the catheter extending therethrough. The sleeve is secured in place by any suitable means, e.g., an adhesive, by friction fit, etc. Moreover, the sleeve may be integrally formed on the distal end portion of the catheter. In fact, as will be appreciated from the discussion to follow, the use of a sleeve may be eliminated if the connector is formed integrally with the catheter. In such an arrangement, all that is required is that distal end of the catheter include the fingers  206  and  208  to form the guide-wire receiving path.  
         [0059]     Each of the fingers  206  and  208  projects outward from the longitudinal axis of the connector and the longitudinal axis of the distal end of the catheter  200 . Each of the fingers includes an overhanging, e.g., arcuate, free end  210 . The free end of the respective fingers are directed in opposed directions to each other, i.e., they are directed so that they face each other but are offset from each other in the longitudinal direction. In particular, the free end  210  of the finger  206  is directed from one side of the catheter  200  towards the free end  210  of the finger  208  on the other side of the catheter. The fingers  206  and  208  may extend tangentially, radially or at some other orientation away from the central longitudinal axis of the catheter  200  so that the free end  210  of the finger  206  and the free end  210  of the finger  208  each form a respective portion of a channel or path  212  between them and the portion of the sleeve from which they project (or from the portion of the catheter from which they project if no sleeve is utilized, e.g., the fingers are formed integrally with the catheter  200 .  
         [0060]     In the preferred embodiment shown herein the path  212  is of a generally circular cross-section and extends linearly along the longitudinal axis of the catheter immediately adjacent the outer surface of the sleeve  204 . It is in this channel or path  214  that the guide-wire portion  24 A of the guide-wire  24  is arranged to be inserted to slidingly mount the catheter on the guide-wire. In accordance with a preferred embodiment of this invention the free ends  210  of the fingers  206  and  208  extend around the periphery of the guide-wire so that the fingers and contiguous portion of the sleeve each engage or encircle more than  180  degrees of the periphery of the guide-wire when the guide-wire is within the path or channel to prevent the guide-wire from accidentally coming out of the path or channel. The entry point or entrance to the path or channel  212  is provided by the space or gap  214  between the fingers  206  and  208 .  
         [0061]     In order to minimize the crossing-diameter of the catheter  200 , the fingers  206  and  208  of the connector are preferably dimensioned to keep their height or projection from the central longitudinal axis of the catheter  200  as short as possible, while still enabling the guide-wire portion  24 A to be held securely in the path  212  for sliding movement resistant to accidental disconnection. Thus, in the preferred embodiment shown in the cross-sectional area of the channel  212  is just slightly larger than the outside diameter of the guide-wire  24 A and the fingers are very thin.  
         [0062]     The connection of the catheter  200  to the guide-wire portion  24 A will now be described with reference to  FIGS. 13 and 14 . As before, it is assumed that the guide-wire  24  is already in place so that its distal end (not shown) is located at some internal situs within the body of the being, while its proximal end is located outside the body of the being, with the intermediate portion  24 A of the guide wire also being located outside the body of the being distally of the proximal end of the guide-wire. As pointed out earlier while the portion  24 A of the guide-wire is preferably outside the body of the being, such an arrangement is not required. In this regard in some medical applications the guide wire portion  24 A where the catheter is to be connected may be located internally of the being and access provided to it via a natural body orifice or opening or through some surgically formed opening.  
         [0063]     In any case, as best seen in  FIG. 13  the catheter  202  is oriented so that the entry mouth or gap  214  of the path  212  at the distal end of the channel is aligned with the portion  24 A of the guide-wire  24 , e.g., the longitudinal axis of the guide-wire portion  24 A is perpendicular to the longitudinal axis of the catheter  200  and is between the fingers forming the gap. Once so aligned the distal end of the catheter  20  is twisted about an axis perpendicular to the longitudinal axis of the catheter to bring the more distally located portion of the guide-wire portion  24 A into the path  212  under the finger  206 , while at the same time bringing the more proximally located portion of the guide-wire portion  24 A into the path  212  under the finger  208  as shown in  FIG. 14 . This action completes the sliding securement of the catheter on the guide-wire  24 . Therefore, once the sliding securement has been accomplished, the catheter  200  can be slid or moved in the distal direction along the guide-wire  24  to bring the open distal end  20 E of the catheter to the desired position within the being&#39;s body, e.g., at a situs of the atherosclerotic deposit to be removed.  
         [0064]     It should be pointed out at this juncture that while the foregoing discussion has described the twisting of the catheter or other tubular instrument with respect to the guide-wire or other elongated guide member to releasably secure the two together, that methodology is not the only method for achieving their releasably securement. Thus, as will be appreciated by those skilled in the art, the guide-wire or other elongated guide member can be twisted with respect to the catheter or other tubular instrument to cause the guide-wire or other tubular instrument to be introduced into the path for holding the two together.  
         [0065]     It should also be pointed out that while the foregoing discussion has described catheters or other tubular instruments with the various types of connectors forming a portion thereof, it should be clear that connectors, per se, may be constructed in accordance with this invention for mounting, e.g., retrofitting, to existing catheters or other tubular instruments. Thus, the subject invention not only contemplates catheters or other elongated tubular instruments including connectors for connecting the catheters or other tubular instruments to guide-wires or other elongated guide member, but also contemplates connectors, per se, for use with conventional catheters to achieve those ends.  
         [0066]     In a preferred embodiment an attachment tool  300  comprises a hinged clamshell construction, that when closed provides for an interior longitudinal bore  301  for the guide-wire (or other elongated guide member) that expands into a conical funnel portion  302  at the leading end (proximal end)  310  of the tool. The tool further comprises two halves, a first half  303  on which is located on a pair of raised v-shape protrusions  304  through which the guide-wire  24  is placed into the bore  301 . The raised protrusions  304  are arranged co-linear with a bore  301 , and on either side of same, to allow for easy placement of said guide-wire, and also engage the second half of the tool  305  in a mating depressed portion  306 . The engagement of the protrusion of the first half and the depression of the second half, during closing of the tool  300  by rotating  330  one half of tool, serve to align the closed tool, thereby creating a smooth funnel opening  302 , or catheter entry port. Living hinges  307  allow for one-handed closure of the tool around the guide-wire  24  (not shown), a small indentation  308  provides for a tab to open the closed tool to remove it from the attached catheter-guide-wire apparatus. The bore  301  extends the full length of the first half  303 , and can be utilized for guide-wire alignment at the distal end  309  opposite the funnel opening  302 .  
         [0067]     The tool  300  is intended to be closed over the guide-wire  24 , as is shown in  FIG. 16 , whereby the guide-wire shall then reside within the bore  301  inside the closed tool. The catheter  20  containing the distal tip connector  28  (e.g., one of the various embodiments previously described) is then advanced into the open funnel portion of the tool  302 , and the catheter is simultaneously advanced  311  and twisted  40  to effect attachment of the connector  310  to the guide-wire (as previously described). The conical funnel  302  serves to press the catheter against the guide-wire, facilitating the entry of the guide-wire into the mouth  32  provided at the entry of the helical channel  28 .  
         [0068]     In yet another embodiment, said attachment tool  300  causes alignment of said guide-wire  24  and said catheter  20 , as shown in  FIG. 16 ; however, the tool of this embodiment further utilizes a detent to facilitate engagement of said guide-wire  24  with said channel  28 , wherein said detent comprises a mouth  32  (as shown in  FIG. 1 ) or an offset (not shown), as previously described herein.  
         [0069]     Once the catheter is fully attached, the tool is then opened with tab  308  to release the guide-wire, and the catheter can be advanced or retracted freely and securely along the wire. This exemplary tool embodiment is designed to be functional and easy-to-use with one hand, but other embodiments causing contact and engagement of the catheter and wire are anticipated and within the concept of the present invention.  
         [0070]     The attachment tool  300  may be sized to allow its insertion into a natural body orifice, or other surgical created entry site, wherein said tool may attach a plurality of catheters while said tool is located entirely inside of the body. It is within the concept of this invention to operate the attachment tool with hands, fingers, or other instruments, thereby enabling the attachment of catheters to a guide-wire at various remote areas within the body.  
         [0071]     The longitudinal bore  301  arranged therebetween the proximal and distal ends of said tool  300  allows communication through the tool. This communication allows catheters or other instruments comprising functional members (not shown) located distal to the distal tip connector, and attached thereto, to be arranged in the bore  301  such that said member extends through the distal end  309  of said tool  300 . As a non-limiting example, said functional member may comprise a steering tip (for steering the functional member, and catheter, independently of guide wire  24 ), an angioplasty balloon (with or without a steering tip, which may be used to occlude an arterial branch), or a catheter for the delivery of a therapy or diagnostic equipment (e.g., a drug, biologically active agent, radioactive source, ultrasonic source, or other prosthesis).  
         [0072]     Since the distal tip connector, as previously described, does not need access to the ends of the guide-wire, a plurality of catheters may be attached to the guide-wire while the guide-wire is in-place (i.e., extending into the body, to the site of the procedures) without requiring access to the end of the guide-wire. A preferred embodiment of the attachment tool, of the present invention, facilitates this attachment.  
         [0073]     As an example,  FIG. 17  shows a system  450  composed of a pair of catheters  400  and  410 , each including a channel-type of distal tip connector. In particular, catheter  400  includes distal tip connector  28 , while the catheter  410  includes a distal tip connector  29 . The connector  29  is identical to connector  28  described heretofore and shown in more detail in  FIG. 1 . The catheters  400  and  410  may each additionally include a radio-opaque marker  401  to facilitate the precise placement of the catheter during any intravascular procedure utilizing the catheter. The catheter  410  is attached to the guidewire  24  in a similar manner to catheter  400  but located proximally to the distal end of the catheter  400 . The attachment tool  300  (shown clearly in  FIGS. 15-16 ) effects the placement of the catheters  400  and  410  of the multiple catheter system  450 . It should be appreciated by those skilled in the art that the system  450  may include more than the two catheters shown, with the number of catheters actually being placed on the guide-wire limited only by the crossing diameter of the artery or other blood vessel into which they are placed.  
         [0074]     The benefits of the attachment tool  300  and the multiple catheter system constructed in accordance with this invention can be readily appreciated by reference to  FIGS. 17, 17A ,  18  and  18 A. In particular, the cross-sectional view of  FIG. 17A  shows the non-concentric arrangement of the catheters  400  and  410  and guidewire  24  of the system  450  in a blood vessel. As previously described, the flow or access through each of the catheters of the system is not impeded by the guide-wire since neither catheter  400  nor catheter  410  needs to house other catheters or the guide-wire extending fully therethrough, i.e., only the distal end portion of each catheter houses a portion of the guide-wire. The guidewire  24  is effectively located external to each catheter, except for the portion at the respective connectors  28  and  29 , that is, the portion contiguous with the distal ends  418  and  419 , respectively. Thus, it can be seen that the flow path, i.e., the interior passageway  404 , through the first catheter remains largely unrestricted by the guidewire. In a similar manner, the flow path or passageway  415  through the catheter  410  also remains unrestricted by the guidewire.  
         [0075]     As will be appreciated by those skilled in the art, the free flow of fluid through the catheters of the system  450  allows or improves the ability to perfuse diagnostic or therapeutic fluids and drugs via the interior of its catheters. Additionally, higher pressures and/or flow rates can be accommodated by the system  450  to facilitate the removal of fluids and/or debris from within the blood vessel.  
         [0076]     In  FIG. 18  there is shown a system  460  including a pair of catheters  400  and  420  on a single guidewire  24 . The catheter  400  is constructed like that of  FIG. 17 . The catheter  420  is conventional type and is attached to the guidewire  24  proximally of the catheter  400 . In particular, the catheter  400  is attached to the guidewire  24  via a distal tip connector  28  like that described above. The second catheter  420 , being of a more conventional design, is threaded over the guidewire  24  using the traditional concentric loading configuration or method.  
         [0077]     The concentric loading method restricts the flow of fluid through the hollow interior  424  of the catheter  420  since the guidewire extends through the catheter. Thus, as can be seen in  FIG. 18A , the catheter  420  which is loaded over the guidewire  420  in the traditional manner will have a reduced flow path  424  therethrough compared to the flow path of  404  through the catheter  400 .  
         [0078]     In  FIG. 18  the system  460  is shown during the procedure of revascularizing an artery having an atherosclerotic plaque deposit  402  therein. The system shown in  FIG. 18  includes a distal balloon  406  on the distal end of the guidewire  24  to provide protection from debris  403  produced during the revascularization procedure flowing distally from the situs of the procedure, which action could cause stroke, heart attack, an adverse pulmonary event or some other adverse effect. The revascularization procedure in the artery may be accomplished by using an infusate fluid which flows down the interior passageway  404  of the catheter  400  and out its open distal end. This flow of infusion liquid out of the catheter  400  to engage the plaque deposit  402  is shown by the arrows  412  in  FIG. 18 . In carrying out the revascularization procedure infusion fluid may pick up debris  403  liberated from the plaque deposit  402 . The fluid flow  412  emanating from the distal opening of the catheter  400  for carrying the debris may be complemented by an additional fluid flow path  34  emanating from the proximal end or window  34  of the distal tip connector  28 . In any case, the debris  403  produced during the revascularization is carried via a debris removal flow stream  422  into the open distal end of the passageway  424  in the catheter  420  and from there through the catheter for extraction outside the body of the being.  
         [0079]     It should be pointed out at this juncture that the embodiment of the system shown in  FIG. 18  is merely exemplary of the benefits of utilizing a multiple catheter system on a single guide-wire. It should be recognized that the system of  FIG. 18  may not be as efficient as a system employing multiple non-concentric catheters,  10  such as the system  450  shown in  FIG. 17  used with a debris blocking balloon  406 . Notwithstanding that fact, the system of  FIG. 18  still has considerable utility. However, it is preferable when utilizing a multiple catheter system to utilize catheters constructed like the catheters  400  and  410  of  FIG. 17 , whose deployment is facilitated by the use of the attachment tool  300  of the present invention. In such an arrangement, best seen in  FIG. 19 , the system  480  includes debris blocking member or balloon  406  shown attached to the distal end of the guidewire  24 . The catheters  400  and  410  are connected to the guide-wire in the manner as described above and operated in the manner described with respect to  FIG. 18 . The balloon  406  serves to block the distal flow of debris and to facilitate its safe removal.  
         [0080]     In yet another embodiment of this invention, there is shown in  FIG. 20 a  catheter system  500  including a guide-wire  24  and a combination catheter  501 . That catheter includes a pair of longitudinal passageways extending through the interior of the catheter. The system shown in  FIG. 20  is arranged to present a decreased or minimized cross-sectional area. To that end, the catheter  501  includes a distal end portion having a connector  28  like that shown and described above for attaching the catheter  501  to the guidewire  24 . The guidewire  24  has a distally located debris blocking balloon  406 . Unlike the catheters  20  and  400  the balance of catheter  501 , i.e., the portion from near the distal end to the proximal end (not shown) is of an enlarged outside diameter and is split longitudinally to form  30  a pair of side-by-side passageways which will be described later. An outlet port or hole  522  is located extending through the outer wall of the catheter  501  at the point at which the smaller diameter distal end portion merges with the larger diameter portion. The outlet  522  communicates with a longitudinally extending passageway  520  extending from that opening to the proximal end of the catheter. The passageway  520  is formed by a longitudinally extending wall  523  (see  FIG. 20B ). The wall  523  extends from the portion at which the outlet  522  is located to the proximal end of the catheter.  501 . The distal end of the catheter  501  includes a circularly shaped passageway  20 D extending from that end proximally. The passageway  20 D merges into a semi-circular shaped passageway  20 D in the portion of the catheter immediately proximally of the outlet  522 . Thus, as shown in  FIG. 20B , the portion of the passageway  20 D located in the proximal portion of the catheter  501  is of semi-circular shape and is in fluid communication with the circular shaped passageway  20 D at the distal end of the catheter  501 . The communicating passageways  20 D serve to provide a path for introduction of an infusate liquid through the catheter and out of its open distal end. This fluid flowing out of the catheter is shown by the arrows  512 . This flow may be used to revascularize the vessel and to carry debris  403  produced by the revascularization procedure to the outlet  522 . Thus, the debris can flow into that outlet and through the passageway  520  for removal from the body of the being. The first passageway or channel  20 D can be used for carrying drugs or other therapeutic agents along with the infusate fluid into the blood vessel.  
         [0081]     In  FIG. 21  there is shown a further embodiment of the system of this  20  invention. The embodiment shown in  FIG. 21  comprises a catheter  514  which is similar to the catheter  501  except that it includes a fluid stopping wall  560  located just slightly proximally of the connector  28 . A pair of outlet ports  562  are located in the catheter immediately proximally of the fluid stopping wall  560 . The outlets  562  are in fluid communication with the infusion fluid passageway  20 D (see  FIG. 20B ). Thus, an infusion fluid flowing down the passageway  20 D is blocked from gaining egress out the distal end of the catheter  501 , but instead passes through the outlet ports  562  in the form of plural high pressure flows  561 . The high pressure flows  561  can be very effective for removing the plaque  402  from the interior of the artery wall. The debris  403  produced by the plaque removal can then flow into the outlet  522  and down its communicating passageway  520  for removal from the body of the being in the same manner as described above.  
         [0082]     Thus, it should be appreciated that the high pressure combination catheter  514  of  FIG. 21  is particularly useful for, among other things, dislodging debris from the artery or lumen wall or assisting the penetration of the fluid, which may carry a therapeutic agent or drug, into or through the arterial wall or tissue.  
         [0083]     It should be pointed out at this juncture that the foregoing multicatheter and combination catheter embodiments described above may utilize an infusate fluid introduced through the first catheter component at a first flow rate and the infusate and debris together with some blood or bodily fluid may be removed at a second flow rate that may be similar to or greater than the first flow rate. A greater second flow rate may cause the removal of some upstream blood or fluid via the path  534  (see  FIGS. 20 and 21 ) to ensure that no debris  403  passes the outlet  522 .  
         [0084]     Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.