Abstract:
An infusion flow guidewire and a system including an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a nitinol hypotube, a flexible tip having a closed distal end, a coil, a core wire and at least one distally located rearwardly directed jet orifice for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided in the system for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
       [0001]    This patent application is related to patent application Ser. No. 11/702,990 filed Feb. 6, 2007, entitled “Miniature Flexible Thrombectomy Catheter,” which is pending; to patent application Ser. No. 11/702,995 filed Feb. 6, 2007, also entitled “Miniature Flexible Thrombectomy Catheter,” which is pending; to patent application Ser. No. 11/237,558 filed Sep. 28, 2005, entitled “Thrombectomy Catheter Deployment System,” which is pending; and to patent application Ser. No. 11/581,613 filed Oct. 16, 2006, entitled “Occlusive Guidewire System Having an Ergonomic Handheld Control Mechanism Prepackaged in a Pressurized Gaseous Environment and a Compatible Prepackaged Torqueable Kink-Resistant Guidewire with Distal Occlusive Balloon,” which is pending. 
         [0002]    This application claims priority from the earlier filed U.S. Provisional Application No. 60/934,281 filed Jun. 12, 2007, entitled “Floppy Flow Wire”, and is hereby incorporated into this application by reference as if fully set forth herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The field of the present invention relates to mechanical thrombectomy and catheter directed thrombolysis and for use in neurologic arteries where vessels are characterized by difficulty to deliver ablation devices thereinto due to the small size of the vessel and the tortuousity of the vessels. High efficacy of any thrombus or clot removing device is highly desirable when dealing with the removal of organized and difficult to remove materials which have been expelled from the left atrium or aorta. Furthermore, a guidewire-type catheter that is highly deliverable, such as by the use of a 0.014 inch guidewire such as provided by the present invention, can be utilized in the distal arteries of the coronary or peripheral arteries especially when such a catheter must be delivered through diseased vessel segments since it has a small crossing profile and is structurally suited for such a task. 
         [0005]    2. Description of the Prior Art 
         [0006]    Prior art devices such as thrombectomy catheters and closely related devices have been previously developed and designed to access and treat sites along the neurological anatomy. Such devices included catheters which were delivered within the vasculature in two parts. First, a microcatheter which is essentially a tube functioning as the effluent lumen of the thrombectomy catheter would be delivered to the treatment site over a guidewire. Then, a nitinol jet body with a guidewire tip on it was delivered inside the microcatheter to the treatment site. The jet body is the part of the thrombectomy catheter that delivers saline to the distal end of the catheter. The jet body has small jet orifices that are partly responsible for the high back pressures developed by the catheter. The jet orifices are positioned to direct high speed fluid jet streams within the catheter body. In previous neurological thrombectomy catheters, the jet body was designed to include a short skirt. When the jet body was activated by pumped saline, recovered pressures within the catheter assembly would expand the skirt such that the two parts became a unified single catheter assembly. The sequential exchange of devices meant that no guidewire was in place once the jet body was delivered. Hence, there was ample lumen for suitable exhaust flow and the catheter size could be kept smaller due to the absence of a guidewire. Generally, this two-part configuration for delivery to access and treat the site was difficult to accomplish. Some microcatheters would actually stretch while the jet body was advanced through the lumen, hence the jet body was never exposed to enable its activation. On occasions, the microcatheter would ovalize or otherwise distort in a tortuous anatomy, thus making it difficult to deliver the jet body through such a misshaped lumen. Furthermore, interventionalists are never comfortable giving up their wire position and removing the guidewire in exchange for a jet body was regarded as a bit awkward and non-intuitive. Previous versions of neurologic thrombectomy catheters were often underpowered for the tough thrombus that was found in embolic stroke patients (organized thrombus from the left atrium). With any given AngioJet® style catheter design, there is a tradeoff between the thrombectomy power of the catheter and the vessel safety of that catheter design. The essence of the problem is that neurological arteries are highly fragile since they have very thin and unsupported vessel walls and the clot material adhering thereto is tough and organized. 
         [0007]    Currently produced 3Fr catheters are designed to be more easily deliverable to small distal vessels and they are envisioned to be an improvement over first generation products. The 3Fr catheters have a transitioned sized hypotube assembly which is intended to achieve a level of deliverability far superior to the currently available 4Fr catheters and, due to their smaller profile, will greatly enhance their deliverability. Nevertheless, the 3Fr catheter will not achieve the level of deliverability of a 0.014 inch infusion flow guidewire as discussed in the present invention. The crossing profile of 1.07Fr of the 0.014 inch infusion flow guidewire versus the 3Fr catheter is of substantial benefit. Furthermore, a catheter that rides over a guidewire will interact with the guidewire creating a drag which will diminish the ultimate deliverability of the catheter device, whereas a 0.014 inch infusion flow guidewire of the present invention does not have this problem. 
       SUMMARY OF THE INVENTION 
       [0008]    The general purpose of the present invention is to provide a highly deliverable infusion flow guidewire having a substantial thrombectomy/fibrinolytic infusion effectiveness. 
         [0009]    According to one or more illustrations of the present invention, there is provided an infusion flow guidewire system that is preferably used with an external pressurized fluid supply, such as an AngioJet® pump set or other suitable device. The infusion flow guidewire system is comprised of major structures including: an infusion flow guidewire; a delivery sheath having a proximally located torque handle; and a torque device which can be removably attached to the proximal end of the infusion flow guidewire to facilitate the connection of the proximal end of the infusion flow guidewire to the distal end of an external pressurized fluid supply. 
         [0010]    The infusion flow guidewire is comprised of components which transitionally provide for increasing flexibility along the length of the infusion flow guidewire where the most flexible region of the guidewire is at the distal end thereof. A major portion of the infusion flow guidewire is a hypotube of flexible nitinol material which is drawn down to a reduced diameter section near the distal end thereof providing one portion thereof with increased flexibility. The drawn-down distal end of the flexible hypotube, herein referred to as the drawn hypotube section, extends through a reinforcement collar and is secured therein by laser welds, soldering, welding or other suitable method, and distally extends further a short distance to terminate and secure within the proximal end of an even more flexible coil of platinum. The proximal round end of a flexible gold-plated core wire is located and secured within the distal end of the drawn hypotube section of the flexible hypotube. It is in coaxial alignment with the distal end of the drawn hypotube section of the flexible hypotube and with the proximal portion of the flexible coil of platinum. It is mutually secured by laser swages, soldering, welding or other suitable method. The proximal round section of the flexible gold-plated core wire extends partially in a distal direction along and within the flexible coil of platinum preferably tapering along a distal direction to continually reduce the cross section. The round tapered shape of the flexible gold-plated core wire transitions into an even more flexible flat shape to extend along the distal region of the flexible coil of platinum. A flexible tip having shapeable attributes is comprised of a distal tip weld and portions of both the flexible coil and the core wire distal to the flexible coil. One or more rearwardly directed jet orifices extend through the reinforcement collar and through the drawn hypotube section for rearwardly directed jet flow therefrom. 
         [0011]    A coupling assembly is provided for rapid connection of the proximal end of the infusion flow guidewire to a high pressure supply device, such as the AngioJet® pump set or other suitable device. The delivery sheath, including a proximally located torque handle, is provided for fixing the position of the delivery sheath with respect to the infusion flow guidewire or for combined unitary maneuvering thereof, as required. 
       SIGNIFICANT ASPECTS AND FEATURES OF THE PRESENT INVENTION 
       [0012]    One significant aspect and feature of the infusion flow guidewire system, the present invention, is the use of an infusion flow guidewire with a delivery sheath. 
         [0013]    One significant aspect and feature of the infusion flow guidewire is the use of high velocity fluid jet streams for drug infusion. 
         [0014]    One significant aspect and feature of the infusion flow guidewire is the use of high velocity fluid jet streams for tissue maceration. 
         [0015]    One significant aspect and feature of the infusion flow guidewire is the use of high velocity fluid jet streams for moving debris in a preferred direction. 
         [0016]    Yet another significant aspect and feature of the infusion flow guidewire is the use of nitinol tubing for the body of the infusion flow guidewire for the purpose of kink resistance. 
         [0017]    Another significant aspect and feature of the present invention is the use of a laser swaging technique for attaching a gold-plated flexible stainless steel guidewire tip core wire to a nitinol hypotube. 
         [0018]    Still another significant aspect and feature of the present invention is the use of a nitinol hypotube for the body of the infusion flow guidewire for the purpose of maximizing flow rate, i.e., minimizing flow resistance by maximizing ID. 
         [0019]    Yet another significant aspect and feature of the present invention is the use of a nitinol hypotube for the body of the infusion flow guidewire for the purpose of minimizing complex joints between dissimilar metals. 
         [0020]    A further significant aspect and feature of the present invention is a delivery sheath for support in delivering the infusion flow guidewire and to aid in giving the guidewire a 1:1 torque ratio which is preferred for guidewires. 
         [0021]    A still further significant aspect and feature of the present invention is a flow guidewire performing substantially as a 0.014 inch outer diameter guidewire. 
         [0022]    A still further significant aspect and feature of the present invention is the use and design of an easily detachable coupling assembly connecting an infusion flow guidewire to a high pressure supply line and a high pressure supply. 
         [0023]    A still further significant aspect and feature of the present invention is the use of a coupling assembly using collet and O-ring assemblies to grasp or provide a seal about the proximal end of an infusion flow guidewire. 
         [0024]    A still further significant aspect and feature of the present invention is the use of a coupling assembly to removably secure to and rotationally and/or longitudinally maneuver an infusion flow guidewire. 
         [0025]    A still further significant aspect and feature of the present invention is the use of a torque handle using a collet to grasp an infusion flow guidewire. 
         [0026]    A still further significant aspect and feature of the present invention is the use of the components of a torque handle to secure to and rotationally and/or longitudinally maneuver a hypotube and/or a delivery sheath either unitarily or singly. 
         [0027]    A still further significant aspect and feature of the present invention is a 0.014 inch infusion flow guidewire driven by a pressure exceeding 0.10 kpsi with a delivered flow rate in excess of 3 cc/min. 
         [0028]    A still further significant aspect and feature of the present invention is a fluid jet stream velocity for a 0.014 inch infusion flow guidewire between 0.1 and 100 m/s. 
         [0029]    A still further significant aspect and feature of the present invention is a fluid jet stream velocity for a 0.014 inch infusion flow guidewire greater than 100 m/s. 
         [0030]    A still further significant aspect and feature of the present invention is the use of fluid jet streams emanating from the infusion flow guidewire in any direction (i.e., 360 degrees from the axis of the wire), such as distally, proximally, perpendicularly or combined and diverse direction. 
         [0031]    A still further significant aspect and feature of the present invention is use of one or more fluid jet streams. 
         [0032]    A still further significant aspect and feature of the present invention is use of round jet orifices with diameters greater than 0.001 inch and less than the diameter of the wire, although the jet orifices could be noncircular or elongated in shape or in other geometrically configured shapes. 
         [0033]    A still further significant aspect and feature of the present invention is that this high pressure high velocity jet technology could also be used for larger guidewires with a 0.018 inch diameter or a 0.035 inch diameter, or guidewires with less than 0.045 inch diameter. 
         [0034]    A still further significant aspect and feature of the present invention is the use of a stainless steel guidewire extension with an irregularly shaped distal end or with a conical shaped distal end which is accommodated by the inner diameter of the hypotube to increase the length of an infusion flow guidewire rapid exchange wire to function as an exchange length wire for over-the-wire device use. 
         [0035]    A still further significant aspect and feature of the present invention is the use of the infusion flow guidewire with the Thrombectomy Catheter Deployment System disclosed in patent application Ser. No. 11/237,558 (The AngioJet® Ultra Console) by the inventors. 
         [0036]    Yet a further significant aspect and feature of the present invention is to use the present invention in combination with other devices, such as a regular AngioJet® catheter, simple syringe suction catheters, roller pump facilitated suction or in an exhaust-pressure-operated balloon catheter system (Proxy Cat) disclosed in patent application Ser. No. 11/294,006 by the inventors or with other devices. 
         [0037]    Having thus briefly described embodiments of the present invention and having mentioned some significant aspects and features of the present invention, it is the principal object of the present invention to provide an infusion flow guidewire system. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0038]    Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein: 
           [0039]      FIG. 1  is an isometric view of the infusion flow guidewire system where the major components of the system are shown separated, the present invention; 
           [0040]      FIG. 2  is an isometric view of the infusion flow guidewire system in the engaged form; 
           [0041]      FIG. 3  is an assembled view of the drawn hypotube section and the flexible tip components of the guidewire system; 
           [0042]      FIG. 4  is an exploded view of the components of  FIG. 3 ; 
           [0043]      FIG. 5  shows views along section lines  5 A- 5 A,  5 B- 5 B,  5 C- 5 C, and  5 D- 5 D of  FIG. 3 ; 
           [0044]      FIG. 6  is an exploded isometric view of a torque handle; 
           [0045]      FIG. 7  is an exploded vertical cross section view of the components of  FIG. 6 ; 
           [0046]      FIG. 8  is a view of the components shown in cross section in  FIG. 7  arranged as an assembly; 
           [0047]      FIG. 9  is an exploded isometric view of a coupling assembly; 
           [0048]      FIG. 10  is an exploded vertical cross section view of the components of  FIG. 9 ; 
           [0049]      FIG. 11  is a view of the components shown in cross section in  FIG. 10  arranged as an assembly; 
           [0050]      FIG. 12  illustrates an extension wire for use with the preferred nitinol wire infusion flow guidewire; 
           [0051]      FIG. 12   a  is an isometric view of an alternate distal end shape for the extension wire of  FIG. 12 ; 
           [0052]      FIG. 13  shows the location of the jet orifices in close proximity to and proximal to the thrombus; 
           [0053]      FIG. 14  shows the location of the jet orifices in close proximity to and distal to the thrombus; and, 
           [0054]      FIG. 15  shows the location of the jet orifices aligned within the thrombus. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0055]      FIG. 1  is an isometric view of the infusion flow guidewire system  10  wherein the major components are shown separated.  FIG. 2  is an isometric view of the components of the infusion flow guidewire system  10  in the engaged form. Each figure illustrates readily visible components including: a flexible infusion flow guidewire  12  having a coupling assembly  14  removably attached at the proximal end thereof and a flexible delivery sheath  16  (also known as a guide catheter) of braided polyimide preferably having an outside diameter of 0.035 inch and an inner diameter of 0.017 inch. A proximally located torque handle  18  is shown attached to the proximal end of the delivery sheath  16 . Special attention is paid to the connecting structure in the form of a high pressure supply line  20  which enables connection between an AngioJet® pump set (or another suitable device) and the infusion flow guidewire  12  where the high pressure supply line  20  does not exceed an infusion flow guidewire  12  having an outer diameter of 0.014 inch in order to enable the exchange of 0.014 inch compatible devices and does not impinge the inner diameter of 0.010 inch at the proximal end infusion flow guidewire  12  in order to provide for a suitable flow therethrough. For reference, the section of high pressure supply line  20  to which the invention can be attached is also shown in alignment with the proximal end of the coupling assembly  14 . 
         [0056]    The infusion flow guidewire  12  includes a hypotube  22  (a high pressure tube), preferably of flexible nitinol, at least one proximally directed jet orifice  32 ,  34  ( FIG. 5 ), and a flexible tip  24 , and other components described later in detail. Preferably, the greater portion of the hypotube  22  has an outer diameter of 0.014 inch and in inner diameter of 0.010 inch The hypotube  22  also includes a distally located drawn hypotube section  22   a  of reduced diameter for increased flexibility of the distal portion of the infusion flow guidewire  12 . The multiple component shapeable and flexible tip  24 , also shown in  FIG. 3 , which is located distally on the drawn hypotube section  22   a , provides a flexibility greater than that of the drawn hypotube section  22   a.    
         [0057]    With reference to  FIGS. 3 ,  4  and  5 , each figure shows different views in increasing detail exemplifying the generally overlapping and coaxial relationship of components of the flexible tip  24  to each other and to the drawn hypotube section  22   a . The overlapping relationships and structure of such components are now described where  FIG. 3  is an assembled view,  FIG. 4  is an exploded view of the components of  FIG. 3 , and where  FIG. 5  shows views along section lines  5 A- 5 A,  5 B- 5 B,  5 C- 5 C,  5 D- 5 D and  5 E- 5 E of  FIG. 3 . 
         [0058]    The complete length of a nitinol reinforcement collar  26  in the form of a tube (0.014 inch OD by 0.010 inch ID for purpose of example and illustration) is aligned over and about a distal region of the drawn hypotube section  22   a  at the distal end of the hypotube  22  and is secured thereto by laser welds  28  and  30  as shown in  FIG. 5 . As shown in section line  5   b - 5   b  of  FIG. 5 , a unitary rearwardly directed jet orifice  32  is provided by a hole  32   a  in the reinforcement collar  26  in close alignment with a hole  32   b  in the distal region of the drawn hypotube section  22   a  and, correspondingly, another unitary rearwardly directed jet orifice  34  is provided by a hole  34   a  in the reinforcement collar  26  in close alignment with a hole  34   b  in the distal region of the drawn hypotube section  22   a . The reinforcement collar  26  provides a structural support along and about the drawn hypotube section  22   a  in the region of the jet orifices  32  and  34 . The rearwardly directed jet orifices  32  and  34  are used to direct high pressure fluid jet streams proximally, as later described in detail. One or more such rearwardly directed jet orifices, such as jet orifices  32  and  34 , may be formed by electrical discharge machining or by other suitable processes. Although symmetric rearwardly directed orifices  32  and  34  are shown, other symmetric or asymmetric jet orifice configurations can be used including one or more orifices which can be rearwardly, forwardly, perpendicularly directed in one or more directions or combinations of directions. 
         [0059]    At the distal region of the infusion flow guidewire  12 , the proximal end of a flexible coil  36  (preferably of, but not limited to, platinum) is aligned over and about the distal end of the drawn hypotube section  22   a  and can be soldered, welded or otherwise suitably secured thereto. The proximal terminus of the flexible coil  36  is aligned with the distal terminus end of the reinforcement collar  26  and can be soldered, welded, or otherwise suitably secured thereto. 
         [0060]    A flexible core wire  38  of gold-plated steel consists of a core wire round section  38   a  with a contiguous core wire flat section  38   b  of the same material. The core wire  38  is attached to the distal end of the drawn hypotube section  22   a  and extends distally therefrom and is in coaxial alignment with the flexible coil  36  along the inner length thereof. More specifically, the proximal end of the core wire round section  38   a  is aligned within the lumen  40  of the drawn hypotube section  22   a . At the distal end of the drawn hypotube section  22   a , the core wire round section  38   a  is in direct coaxial alignment within the inner and distal portion of the drawn hypotube section  22   a  and in indirect coaxial alignment with the proximal portion of the flexible coil  36 . The proximal end of the gold-plated core wire round section  38   a  is secured to the inner wall of the drawn hypotube section  22   a  by laser swages  43   a ,  43   b  and  43   c  by the process referred to in related patent application No. 11/702,990 filed Feb. 6, 2007, entitled “Miniature Flexible Thrombectomy Catheter,” and to patent application Ser. No. 11/702,995 filed Feb. 6, 2007, also entitled “Miniature Flexible Thrombectomy Catheter,” describing the process and use of laser swaging of gold-plated components to nitinol components. Such laser swaging of components, as described therein, provides for superior attachment and connection of the proximal end of the gold-plated core wire round section  38   a  to the drawn hypotube section  22   a  without degrading or weakening the swaged components. Preferably, the diameter of the core wire round section  38   a  is reduced in a distal direction transitioning to the flattened profile of the core wire flat section  38   b . The core wire flat section  38   b  extends along the inner and distal portion of the flexible coil  36 , thus providing an increased flexibility along the length of the flexible core wire  38 . The distal terminus of the core wire flat section  38   b  is secured to the distal terminus of the flexible coil  36 , such as by a weld  41 . 
         [0061]    With reference to  FIGS. 6 ,  7  and  8 , each figure shows the relationships of components of the torque handle  18  to each other, to the hypotube section  22  and to the delivery sheath  16 . The relationships and the structure of such components are now described where  FIG. 6  is an exploded isometric view of the torque handle,  FIG. 7  is an exploded vertical cross section view of the components of  FIG. 6 , and  FIG. 8  is a view of the components shown in cross section in  FIG. 7  arranged as an assembly. 
         [0062]    The torque handle  18  includes a torque body  42 , a collet  44 , a collet nut  46 , and a strain relief  48  having a passage  49 , the assembly of which provides for the coaxial accommodation of the delivery sheath  16  and the hypotube  22 . The torque body  42  is generally cylindrical in shape and includes a centrally located bore  50 , proximally located external threads  52 , and a proximally located annular tapered actuating surface  54  located between the proximal end of the bore  50  and the proximal end of the threads  52 . The centrally located bore  50  accommodates portions of one or more components including the hypotube  22 , the delivery sheath  16 , and one end of the strain relief  48  in coaxial fashion. An annular positioning ring  56  is also located about the exterior of the torque body  42 . 
         [0063]    The collet  44 , as generally known in the art, includes at least a plurality of like spaced slots  58  extending longitudinally along a portion of such a collet  44  defining, in part, a plurality of like spaced flexible jaws  60 , each having a distally located tapered and arcuate surface  62  for collective simultaneous forced interaction with the annular tapered actuating surface  54  of the torque body  42 . Each of the like spaced flexible jaws  60  of the collet  44  has a proximally located tapered and arcuate surface  64  for collective simultaneous forced interaction with features of the collet nut  46 , such features being later described in detail. Each of the like spaced flexible jaws  60  includes a centrally located tapered arcuate surface  66 , preferably an inward taper, to accommodate the loading of the hypotube  22  from a proximal location. The tapered arcuate surfaces  66  of the collet  44  adjoin a passageway  68  located between the innermost portions of the flexible jaws  60  and which passageway  68  adjoins a larger bore  70 . The passageway  68  accommodates the hypotube  22  in coaxial fashion and the bore  70  accommodates the hypotube  22  and the proximal end of the delivery sheath  16  in coaxial fashion. The proximal end of the delivery sheath  16  secures centrally within the bore  70  in alignment with the passageway  68 , such as by adhesive  71  or other suitable method. The strain relief  48  secures in the bore  50  of the torque body  42 . 
         [0064]    The collet nut  46  includes a centrally located bore  72  aligned with internal threads  74  which accommodate the external threads  52  and the adjacent unthreaded proximal end of the torque body  42 , respectively. An internal annular tapered surface  76  extends in a proximal direction from the internal threads  74 . A passageway  78  adjoins the annular tapered surface  76 . An outwardly opening annular tapered passageway  80  adjoins the passageway  78 . The tapered wall of the annular tapered passageway  80  accommodates the insertion of the hypotube  22 . In order to frictionally engage the hypotube  22 , the wall of the annular tapered surface  76  maintains a forced intimate contact with the tapered and arcuate surfaces  64  of the collet  44  in order to flex and force the collet jaws  60  against the hypotube  22  in the passageway  68  in frictional engagement when the collet nut  46  and the torque body  42 . Either the collet nut  46  or the torque body  42  is rotated with respect to each other to draw the torque body  42  and the collet nut  46  together about the collet  44 . Thus, the torque handle  18  is engaged in frictional engagement with and about the hypotube  22  in order that a unitary longitudinal and/or torque movement of the infusion flow guidewire  12  and the delivery sheath  16  can be accomplished within the vasculature. 
         [0065]    Independent movement of the infusion flow guidewire  12  or of the delivery sheath  16  with respect to each other or within the vasculature can be accomplished by loosening the collet nut  46  in order to release the frictional engagement of the torque handle  18  with the hypotube  22 . Longitudinal and/or torque movement of the delivery sheath  16  can be accomplished by grasping and actuating the torque body  42 . Longitudinal and/or torque movement of the infusion flow guidewire  12  can be accomplished without interference with the torque handle  18  by grasping and actuating the torque coupling assembly  14  which can be in frictional engagement with the proximal end of the hypotube  22 , as later described in detail. 
         [0066]    With reference to  FIGS. 9 ,  10  and  11 , each figure shows different relationships of components of the coupling assembly  14  to each other, to the high pressure supply line  20  and to the hypotube section  22 . Such relationships and the structure of the components are now described where  FIG. 9  is an exploded isometric view of the torque coupling assembly  14 ,  FIG. 10  is an exploded vertical cross section view of the components shown in  FIG. 9 , and  FIG. 11  is a view of the components shown in cross section in  FIG. 10  arranged as an assembly. 
         [0067]    The coupling assembly  14 , which is removably attached to the hypotube  22  of the infusion flow guidewire  12 , is provided for rapid connection of the proximal end of the hypotube  22  of the infusion flow guidewire  12  to a high pressure supply device, such as the AngioJet® pump set or other suitable device. The AngioJet® pump set is described in detail in patent application Ser. No. 11/237,558 filed Sep. 28, 2005, entitled “Thrombectomy Catheter Deployment System”. In particular, the coupling assembly  14  provides for communication and connection between the proximal end of the hypotube  22  to the distal end of the high pressure supply line  20  which is connected to a high pressure supply device. The coupling assembly  14  includes a proximal knob  82  which generally is stationary with reference to an opposing distal knob  84 . The distal knob  84  is rotatable with reference to the proximal knob  82 . The proximal knob  82  is indirectly connected to the distal end of the high pressure supply line  20 , as later described in detail. The distal knob  84  is used for removable attachment of the proximal end of the hypotube  22  to provide communication of the hypotube  22  with the proximal end of the high pressure supply line  20 , the latter being secured indirectly to the proximal knob  82 . 
         [0068]    A plurality of components, which components are substantially stationary, is connected to and associated with the generally stationary proximal knob  82  and include a threaded insert  85 , set screws  86 , a threaded body  88 , an O-ring  90 , and a compression fixture  92 . The stationary proximal knob  82  includes a longitudinally oriented central bore  94  and opposed body holes  96  and  98  aligned perpendicular to and intersecting the bore  94  for accessing of the set screws  86 . The threaded insert  85  is aligned in and is suitably secured within the central bore  94  of the proximal knob  82 , such as by, but not limited to, the use of adhesives or frictional engagement. The threaded insert  85  includes internal threads  100  and threaded holes  102  and  104  aligned perpendicular to and intersecting the internal threads  100  in order to facilitate threaded engagement of the set screws  86  with the proximal end of the threaded body  88  to ensure secure fastening of the threaded body  88  within the internal threads  100  of the threaded insert  85 . The threaded body  88  includes external threads  106  with the proximal portion of the threads  106  threadingly engaging the threads  100  of the threaded insert  85 . The threaded body  88  also includes a partial bore  108  having an internal annular end surface  109 , a centrally located proximally extending tubular flange  110 , and a passageway  112  ( FIG. 10 ), being part of the tubular flange  110  extending through the tubular flange  110  and connecting to the bore  108 . The distal end of the high pressure supply line  20  is suitably secured to the tubular flange  110  within the proximal portion of the passageway  112  of the tubular flange  110 , as shown in  FIG. 11 . The compression fixture  92  has a generally cylindrical shape and includes a passageway  114  extending along the longitudinal axis thereof. The compression fixture  92  terminates proximally at an annular recess  116  and distally at an annular tapered actuating surface  118 . The annular recess  116  of the compression fixture  92  accommodates the O-ring  90 . The compression fixture  92  aligns closely within the bore  108  of the threaded body  88  and is longitudinally positionable therewithin. 
         [0069]    A plurality of components, which can be unitarily actuated in rotary fashion, is connected to and associated with the distal knob  84  including a threaded insert  120  and a tubular collet  122 . The distal knob  84  includes a bore  124  terminating at an annular end surface  126  and a passageway  128  having a taper  129  extending from the annular end surface  126  through the distal wall of the distal knob  84  for accommodation of the hypotube  22 . The threaded insert  120  includes a partial bore  130  terminating at one end by an annular end surface  132  and at the other end by adjacent threads  134 . The threads  134  progressively engage the distal portion of the external threads  106  of the threaded body  88 . A passageway  136  extends from the bore  130  through a distal wall  138  of the threaded insert  120 . The tubular collet  122  includes a plurality of like spaced flexible jaws  140  each having a tapered and arcuate surface  142  surrounding a centrally located multiple radius passageway  144 . The threaded insert  120  is suitably secured within the bore  124  of the distal knob  84 , such as, but not limited to, by the use of adhesives or frictional engagement. The tubular collet  122  aligns to the annular end surface  132  of the threaded insert  120 , whereby the passageway  144  of the tubular collet  122  and the passageway  136  of the threaded insert  120  are in coaxial alignment. 
         [0070]    The coupling assembly  14 , which is removably attached to the hypotube  22  of the infusion flow guidewire  12  and which is provided for rapid connection to the proximal end of the hypotube  22  of the infusion flow guidewire  12 , uses previously described structure to effect suitable connection and coupling thereof and therewith. More specifically, the components of the coupling assembly  14  are assembled, as shown in  FIG. 11 , where the hypotube  22  is positioned, sealed and secured within the coupling assembly  14 . The hypotube  22  is shown in coaxial direct alignment within the passageway  128  and taper  129  of the distal knob  84 , the passageway  136  of the threaded insert  120 , the passageway  144  of the tubular collet  122 , the annular tapered actuating surface  118  of the compression fixture  92 , the passageway  114  of the compression fixture  92 , the center of the O-ring  90 , and finally, within and in communication with the passageway  112  of the threaded body  88  resulting in a suitable communication with the high pressure supply line  20 . As the distal knob  84  is rotated and advanced proximally along the threads  106  of the threaded body  88 , the tube collet  122  is forcefully positioned against the annular tapered actuating surface  118  of the compression fixture  92 , thereby urging and advancing the compression fixture  92  proximally. During such urging and advancement, sealing and securing of the hypotube  22  within the coupling assembly  14  are accomplished. Sealing is provided by the resultant advancement of the compression fixture  92  to cause the O-ring  90 , which is located in the annular recess  116  of the compression fixture  92 , to bear against the annular end surface  109  of the threaded body  88  to deform the O-ring  90  thereby effecting a seal about the hypotube  22 , as well as perfecting a seal with the passageway  112  of the threaded body  88 . A seal is also perfected between the bore  108  of the threaded body  88  and the passageway  112  of the threaded body  88 . Securing of the hypotube  22  within the coupling assembly  14  is provided by the interaction of the advancing tapered and arcuate surfaces  142  of the tubular collet jaws  140  with the annular tapered actuating surface  118  of the compression fixture  92 , whereby the collet jaws  140  are forcibly urged inwardly about the longitudinal axis of the tubular collet  122  to frictionally engage the hypotube  22 . The engagement of the O-ring  90  about the hypotube  22  also provides for additional securement by frictional engagement. 
         [0071]      FIG. 12  illustrates a stainless steel extension wire  139  for use with the preferred all nitinol wire infusion flow guidewire  12 , including a constant size body  141  and an irregular shaped distal end  143 . The irregular shaped distal end  143  can be inserted into the inner diameter of the nitinol infusion flow guidewire  12  to be engaged therein in light frictional engagement to easily and quickly convert a rapid exchange length wire into an exchange length wire (for over-the-wire devices). As shown in  FIG. 12   a , another shape could be substituted for the irregular shaped distal end  143  including a tapered section  145  and a constant size extension  147  which can frictionally engage the inner diameter of the infusion flow guidewire  12 . 
         [0072]    Alternatively, other configurations of the present invention can be advantageous. First, an infusion flow guidewire can be fashioned where a proximal section of the nitinol hypotube  22  is replaced by a proximally located section of stainless steel hypotube joined to a shortened length of the nitinol tube, such as is used for the hypotube  22 , instead of the full length nitinol hypotube  22 . The drawn hypotube section  22   a  and components located distally thereto remain unchanged. In this construction, the proximal section of stainless steel structure provides a more pushable and torqueable proximal infusion flow guidewire end, thereby eliminating the need for and the use of the delivery sheath  16 , as previously described. This approach requires a connection between the stainless steel hypotube section and the reduced length nitinol hypotube section, such as those seen in the 0.014 inch guard dog device (application Ser. No. 11/581,613) or 3Fr swage proximal swage joint (application Ser. Nos. 11/702,990 and 11/702,995). The proximal end of the nitinol section could be drawn down and inserted in the distal inner diameter of the stainless steel section and then swaging the stainless steel section over the drawn nitinol. Another configuration could be accomplished by drawing the distal end of the stainless steel, gold plating it, and then laser swaging the proximal end of the nitinol onto the distal stainless steel section. Such designs are more economically feasible due to the reduction in the use of nitinol. 
         [0073]    A second alternative construction involves the jet orifices. The greatest difficulty is achieving a high velocity and significant flow rate for the jet orifices. However, if one were to produce a series of orifices, 8-10 orifices for example, along the distal end of the infusion flow guidewire  12 , preferably on the collar  26 , one could produce a weeping style infusion catheter similar to the Prostream guidewire. The orifices could be proximally, distally or perpendicularly directed in multiple combinations or arrangement thereof. In this case, the device would still have the advantage of a 0.014 inch profile versus the 0.035 inch profile for the Prostream, but would be incapable of conducting power pulse as previously described. 
         [0074]    Thirdly, the connection for the pump to the infusion flow guidewire could be of an alternative arrangement. Rather than using a screw mechanism to squeeze the O-rings about the flow wire, one could use a hinged handle on a cam to advance a pusher plate to squeeze the O-rings. 
       Mode of Operation 
       [0075]    This invention describes a 0.014 inch infusion flow guidewire system which can infuse fibrinolytics and which can also macerate and propel fluid or debris in a proximal direction. The guidewire system can be operated with devices using an AngioJet® system in various forms of implementation for treatment of thrombus in small vessels, such as in distal peripheral vessels, e.g., foot or other neurovascular sites. Delivery of the infusion flow guidewire  12 , preferably of 0.014 inch diameter, is facilitated by inserting the delivery sheath  16  into and along the vasculature to position the distal end of the delivery sheath  16  at a location in close proximity to a thrombus site. Such positioning is facilitated by grasping the torque handle  18  and urging the delivery sheath  16  distally. Then, the flexible tip  24  of the infusion flow guidewire  12  can be inserted into and engage the proximal end of the torque handle  18 , and thence, gain entry into the delivery sheath  16 , whereby the hypotube  22  and the flexible tip  24  can be positioned distally therein by the use of the attached coupling assembly  14 . In the alternative, the infusion flow guidewire  12  can be prepackaged in the delivery sheath  16  for unitary delivery. When delivery is accomplished, fibrinolytics can be introduced or maceration of thrombus can take place in conjunction with an AngioJet® system, such as disclosed in patent application Ser. No. 11/237,558 filed Sep. 28, 2005, entitled “Thrombectomy Catheter Deployment System,” or with other AngioJet® systems. As previously described, the torque handle  18  can be tightened over and about the hypotube  22  and unitary longitudinal and rotary positioning of the infusion flow guidewire  12  including the hypotube  22  can be accomplished. The clamping action of the torque handle  18  can be terminated by loosening the collet nut  46 , whereby the infusion flow guidewire  12  can be longitudinally and rotatingly positioned independently of the delivery sheath  16  by use of the attached coupling assembly  14  to achieve the desired position. When the infusion flow guidewire  12  is in the desired position, the coupling assembly  14  can be rotationally actuated to release the proximal end of hypotube  22  at the proximal end of the infusion flow guidewire  12  to allow separation of the hypotube  22  and the coupling assembly  14 , thereby allowing access over and about the infusion flow guidewire  12  by other devices, as necessary. 
         [0076]      FIGS. 13 ,  14  and  15  show various locations of the jet orifices  32  and  34  with respect to the thrombus  148  located in a vessel  150 , such locations being used for various operating modes.  FIG. 13  shows the location of the jet orifices  32  and  34  in close proximity to and proximal to the thrombus  148 ,  FIG. 14  shows the location of the jet orifices  32  and  34  in close proximity to and distal to the thrombus  148 , and  FIG. 15  shows the location of the jet orifices  32  and  34  aligned within the thrombus  148 . 
         [0077]    Preferably, the invention is used with and is connected to an AngioJet® system. The invention may be used either to inject fibrinolytics, to macerate and propel fluid or debris in a proximal direction, or to accomplish all or other such functions. A hypothetical procedure, such as for use in the foot, for example, may be to advance the infusion flow guidewire to this very distal anatomy, farther than currently possible with available thrombectomy catheters. As shown in  FIG. 13 , fibrinolytics  146  can be delivered at a nominal rate, such as by use of an AngioJet® system, in close proximity to the proximal portion of a buildup of thrombus  148  located in the vessel  150  for the treatment and softening of the thrombus prior to thrombus removal. 
         [0078]    As shown in  FIG. 14 , the jet orifices  32  and  34  can be positioned in close proximity and distal to the thrombus  148  where an AngioJet® system can deliver fibrinolytic at a nominal rate or in the power pulse mode, the latter mode of which proximally directs and infuses a fibrinolytic to the thrombus  152  of the thrombosed vessel segment in a direction as shown by arrows  152 . This will ensure that the fibrinolytic is driven into the organized thrombus debris for effective loosening of the thrombus  148 . Following a period of time, the physician would operate the same infusion flow guidewire  12  to macerate the organized debris by high pressure jet streams emanating proximally from the jet orifices  32  and  34  in a direction shown by arrows  152  The net effect of the procedure is that any thrombus  148  that would have been removed by a long duration drip is removed in the catheterization laboratory with the power pulse technique. This avoids the need to keep patients on a long term drip of fibrinolytics which is undesirable from a bleeding complication perspective. The flow rate and the jet orifice  32  and  34  arrangement of the infusion flow guidewire  12  result in a power direct infusion of fluid sufficient to disrupt and macerate the thrombus or push debris in the direction of the jet flow subsequent to breaking through the thrombus  148 . Preferably, the infusion flow guidewire  12  is actuated in a to and fro motion, as well as a rotary motion. 
         [0079]    As shown in  FIG. 15 , the jet orifices  32  and  34  are positioned in the midst of the thrombus  148 . Again, an AngioJet® system can be used to deliver fibrinolytics under nominal pressure or under power pulse pressures. Such a location of the jet orifices  32  and  34  can be advantageous in treatment at the center of the thrombus  148  from the inside to the outside thereof. After a suitable length of time, high pressure jet streams emanating from the jet orifices  32  and  34  in a direction as shown by arrows  152  macerate the thrombus  148 . Preferably, the infusion flow guidewire  12  is actuated in a to and fro motion, as well as a rotary motion. 
         [0080]    An aspiration catheter or an AngioJet® catheter, such as one with a proximal balloon, could be delivered over the infusion flow guidewire  12  and connected an AngioJet® system roller pump. Thus, the infusion flow guidewire system  10  could conduct thrombus maceration coupled with aspiration. Although the infusion flow guidewire system  10  may not be truly isovolumetric, there would be some aspiration of the material. Furthermore, the high velocity fluid jet stream from the infusion flow guidewire  12  is generally effective in macerating debris. Finally, once the debris is removed, there may need for other treatments. For example, a stent could be delivered over the same wire following the thrombectomy/lysis procedure. Other techniques for use of the infusion flow guidewire  12  would be to first treat the thrombus segment with the “Power Pulse” technique. Following this procedure, a pressurized bag of saline/lytic could be attached to the infusion flow guidewire  12  and the patient moved out of the catheterization laboratory. 
         [0081]    Alternatively, the physician may elect to only conduct a drip type procedure with the infusion flow guidewire  12  or a nominal pressure slow infusion could be accomplished with an AngioJet® system. There are many potential treatment modalities. The AngioJet® system along with its capability of delivering fluid at pressures up to 20 kpsi, can enable the 0.014 inch infusion flow guidewire  12  to deliver a powerful stream of fluid sufficient to the treatment site, if required. 
         [0082]    The entire infusion flow guidewire  12  is fashioned of nitinol to eliminate any flow restrictions between nitinol tubing and previously used stainless steel tube components and associated joint restrictions, as well as wall thickness strength constraints. The use of nitinol tubing also makes the infusion flow guidewire  12  kink resistant. The goal of the infusion flow guidewire system  10  is to enable delivery of as much a flow rate as possible to the jet orifices  32  and  34 . The resulting flow rate, divided by the jet hole area, will yield the jet velocity. Vessel safety tests have shown that jet velocity higher than the AngioJet® catheter side exhaust holes (15 m/s) are safe, but that the velocities must be less than the AngioJet® internal jets (150 m/s). However, there may be occasions where destructive velocities in excess of 150 m/s may be required in treatment of calcific plaque, tissue destruction or disruption. Hence, the jet hole diameter and the entire flow resistance of the device is engineered to yield jet velocities in the range of 15 to 100 m/s. Aside from connections between stainless steel and nitinol, there may be other major restrictions that require attention. First, the infusion flow guidewire  12  should preferably be a rapid exchange length of 190 cm in order to achieve the least resistance as possible. Secondly, the ID of the nitinol infusion flow guidewire  12  should be as large as practical preferably 0.010 inch diameter dimension. Third, the drawn hypotube section  22   a  at the distal end of the infusion flow guidewire  12  is designed as short as possible in order to achieve an acceptably deliverable infusion flow guidewire. Importantly, an infusion flow guidewire  12  device of 0.014 inch can deliver a significant flow rate (&gt;5 cc/min) to the jet orifices  32  and  34  using a typical AngioJet® pressure range of 0.25 kpsi to 12 kpsi. 
         [0083]    Various modifications can be made to the present invention without departing from the apparent scope thereof.