Abstract:
An exhaust-pressure-operated balloon catheter system which is a cross stream thrombectomy catheter, such as, but not limited to, an Angiojet® catheter with a flexible and expandable balloon, wherein the balloon is formed from and is continuous with the catheter tube which, in part, forms the cross stream thrombectomy catheter, wherein the balloon is deployable and expandable about the distal region of the cross stream thrombectomy catheter to act as an occluder device, and wherein the balloon is located proximal to the fluid jet emanator and inflow and outflow orifices upstream of ablative cross stream flows. The balloon is expandably deployed by the exhaust or back pressure created by the operation of the cross stream flows as generated by the fluid jets of the operating exhaust-pressure-operated balloon catheter system.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
       [0001]    This patent application is related to application Ser. No. 10/455,096 entitled “Thrombectomy Catheter Device Having a Self-Sealing Hemostasic Valve” filed on Jun. 05, 2003, which is pending. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a thrombectomy catheter, and more particularly, relates to an exhaust-pressure-operated balloon catheter system which is a cross stream thrombectomy catheter, such as, but not limited to, an Angiojet® catheter with a flexible and expandable balloon, wherein the balloon is deployable and expandable about the distal region of the cross stream thrombectomy catheter and wherein the balloon is located proximal to the fluid jet emanator and inflow and outflow orifices upstream of ablative cross stream flows. The balloon is expandably deployed by the exhaust or back pressure created by the operation of the cross stream flows as generated by the fluid jets of the operating exhaust-pressure-operated balloon catheter system. 
         [0004]    2. Description of the Prior Art 
         [0005]    Prior art thrombectomy catheter systems incorporated a manifold and a catheter having a plurality of inflow and outflow orifices involved with ablation jet flow in cooperation with an inflatable occludive balloon. The occlusive balloons, for the most, required elaborate schemes for attachment to the catheter tube which acted as an exhaust tube to carry away particulate and other fluids present in the ablation processes. Often, the balloon would be aligned over and about the catheter/exhaust tube and then secured thereto by adhesive, electronic bonding, or the like. A separate inflation lumen including inflation orifices was often required for communication with and for inflation of the occlusive balloon; or complex schemes requiring the use of moveable components were relied on to expand the occlusive balloon during the thrombectomy procedure. Other expansion methods were used as well. 
       SUMMARY OF THE INVENTION 
       [0006]    The general purpose of the present invention is to provide an exhaust-pressure-operated balloon catheter system to elegantly stop blood flow in a vessel. Flow cessation optimizes the effectivity of Angiojet® style thrombectomy catheter devices and procedures involving drug infusion, embolization containment, thrombectomy and other procedures, and reduces hemolysis since the amount of blood available to lyse is minimized. This invention utilizes a proximally located balloon with an Angiojet® thrombectomy catheter device involving cross stream ablation flows, and, more specifically, utilizes an inflatable balloon formed out of the catheter tube (exhaust tube) of an Angiojet® thrombectomy catheter device which is proximally located with respect to cross stream flows and deployed using the back pressure created by the operation of the cross stream flows generated by the fluid jets of the thrombectomy catheter. Although balloons attached to catheters proximal or distal to the inflow and outflow orifices have been suggested in the past, the present invention goes one step further by creating a balloon incorporating the structure of a catheter tube (exhaust tube) of Pebax, polyurethane or other suitable material while using the exhaust pressure of the fluid jets to fill and sustain expansion of the balloon for purposes of proximal protection or occlusion, and in some cases when used in antigrade flow, distal protection. This arrangement minimizes overall general profile, minimizes the number of components and design complexity, minimizes manufacturing cost, and provides an exhaust-pressure-operated balloon catheter system which is very easy to use since the balloon is deployed automatically when the exhaust-pressure-operated balloon catheter system is activated. 
         [0007]    Since Angiojet® style thrombectomy catheters remove debris more effectively in stagnant flow, as well as being more effective in other procedures having a stagnant flow, the present invention is useful in several applications. The invention could be used in cooperation with a filter to more effectively remove debris from within and around the filter. The invention could be used to increase the amount of debris/thrombus removed from a particular vessel length. With this in mind, the invention could also minimize any distal or proximal embolization. The invention could be used to deliver drugs more effectively to a stagnant field. The balloon could also be used for centering or positioning a catheter in a vessel. Finally, the invention could be used to break up clots as it is moved through a blocked vessel (modified embolectomy). 
         [0008]    According to one or more embodiments of the present invention, there is provided an exhaust-pressure-operated balloon catheter system including a manifold and closely associated components, including a hemostatic nut assembly, a self-sealing hemostatic valve, a threaded high pressure connection port, a catheter tube (sometimes referred to as an exhaust tube) connectingly extending from the manifold through a strain relief, a catheter tube tapered tip having a plurality of outflow orifices and inflow orifices in close proximity thereto extending through the sidewalls of the catheter tube, a high pressure tube connectively extending from the threaded high pressure connection port through the manifold and through the catheter tube to a fluid jet emanator located distal to the plurality of outflow orifices and inflow orifices, a first set of support rings spaced along and secured to a distal portion of the high pressure tube, a support ring and the previously mentioned fluid jet emanator spaced along and secured to a distal portion of the high pressure tube, a thin wall section of the catheter tube (herein referred to as the balloon) aligned between the full thickness catheter portions, wherein the full thickness catheter portions align over and about, as well as extending in opposite directions from, the first set of spaced support rings, radiopaque marker bands secured over and about the catheter tube in alignment with the underlying first set of support rings, and a portion of the catheter tube which is in close proximity to the plurality of outflow orifices and inflow orifices, wherein such a portion of the catheter tube aligns over and about the spaced support ring and the previously mentioned fluid jet emanator and is secured thereabout and thereto by radiopaque marker bands. 
         [0009]    One significant aspect and feature of the exhaust-pressure-operated balloon catheter system, the present invention, is the use of a proximally located balloon (herein called the proximal balloon) on an Angiojet® style thrombectomy catheter, wherein the balloon is of decreased wall thickness and is created from the catheter tube (exhaust tube) itself. 
         [0010]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter which is deployed by the back pressure created by operating the exhaust-pressure-operated balloon catheter system. 
         [0011]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter which is fixed and positioned between two marker bands with underlying support rings or by other suitable means. 
         [0012]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter used for the purpose of cessation of fluid flow in a blood vessel or other body conduit. 
         [0013]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter used for the purpose of cessation of fluid flow in a blood vessel or other body conduit to maximize the effect of the thrombectomy catheter in terms of debris or tissue removal. 
         [0014]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter used for the purpose of cessation of fluid flow in a blood vessel or other body conduit to maximize the effect of the thrombectomy catheter in terms of debris or tissue removal from a distal protection filter wire or a balloon. 
         [0015]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter used for the purpose of centering a catheter tube. 
         [0016]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is a proximal balloon on an Angiojet® thrombectomy catheter used for the purpose of modified embolectomy. 
         [0017]    Another significant aspect and feature of the exhaust-pressure-operated balloon catheter system is for the purpose of drug delivery to a blood vessel or other body conduit. 
         [0018]    Having thus briefly described an embodiment 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 exhaust-pressure-operated balloon catheter system. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    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: 
           [0020]      FIG. 1  is a plan view showing the visible components of an exhaust-pressure-operated balloon catheter system, the present invention, illustrating major features, components or assemblies of the invention; 
           [0021]      FIG. 2  is a segmented exploded isometric view of the exhaust-pressure-operated balloon catheter system; 
           [0022]      FIG. 3  illustrates the alignment of  FIGS. 4   a,    4   b  and  4   c;    
           [0023]      FIGS. 4   a,    4   b  and  4   c  together illustrate a cross sectional view in different scales of the components of the exhaust-pressure-operated balloon catheter system along the lines  4   a - 4   a,    4   b - 4   b,  and  4   c - 4   c  of  FIG. 1 ; 
           [0024]      FIG. 5  illustrates the invention connected to ancillary devices; and, 
           [0025]      FIG. 6  illustrates the exhaust-pressure-operated balloon catheter system in the performance of the method of use of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0026]      FIG. 1  is a plan view showing the visible components of an exhaust-pressure-operated balloon catheter system  10 , the present invention, illustrating major features, components or assemblies of the invention. Such major features, components or assemblies of the invention include a one-piece manifold  12  having a catheter tube  14  extending therefrom and attached thereto, including details as now described. A flexible, expandable and inflatable balloon, herein referred to as the balloon  16 , is shown in the deflated position being an integral part of the catheter tube  14 , the latter of which can be referred to as an exhaust tube. The balloon  16  is located near the distal end of the catheter tube  14  just proximal to a plurality of inflow orifices  18   a - 18   n  and a plurality of outflow orifices  20   a - 20   n  located along and about the distal end of the catheter tube  14 . The expanded profile of the balloon  16  is shown in dashed lines as an expanded balloon  16   a.  The visible portion of the one-piece manifold  12  includes a central tubular body  24 , a high pressure branch  26  including an integral threaded connector port  28  ( FIG. 2 ) extending angularly from the central tubular body  24 , an exhaust branch  30  including an integral threaded connector port  32  extending angularly from the high pressure connection branch  26 , and a cavity body  34  extending proximally from the central tubular body  24 . The catheter tube  14  has a lumen  40  ( FIG. 2 ) and the proximal end of the catheter tube  14  extends through and seals against the interior of a strain relief  36  and through a concentrically located connector  38  such that the lumen  40  communicates with the interior of the manifold  12 . The catheter tube  14  extends distally to include a tapered tip  42  whereat the lumen  40  decreases in diameter (see  FIG. 4   c ) and wherein all parts are flexible. Opposed radiopaque marker bands  46  and  48  are shown located around and about the catheter tube  14  at both sides of the balloon  16 , and opposed radiopaque marker bands  50  and  52  are shown located around and about the catheter tube  14  at both sides of the plurality of inflow orifices  18   a - 18   n  and the plurality of outflow orifices  20   a - 20   n.  A hemostatic nut assembly  54  aligns to and snappingly and threadingly engages features of the cavity body  34 . A threaded high pressure connection port  56  suitably secures to the inner portion of the integral threaded connector port  28  of the high pressure connection branch  26  in cooperation with a connector  58 . 
         [0027]      FIG. 2  is a segmented exploded isometric view of the exhaust-pressure-operated balloon catheter system  10 , the present invention, and  FIGS. 4   a,    4   b  and  4   c,  the alignment of which is shown in  FIG. 3 , together illustrate a cross sectional view in different scales of the components of the exhaust-pressure-operated balloon catheter system  10  excluding the full length of the catheter tube  14 , but including a guidewire  60  ( FIG. 4   a ) such as is incorporated in the use of the invention.  FIGS. 4   b  and  4   c  are illustrated in a scale slightly larger than that of  FIG. 4   a  for purposes of clarity. The catheter tube  14 , which also serves and functions as an exhaust tube, and a high pressure tube  62  are foreshortened and shown as partial lengths for the purpose of clarity. 
         [0028]    With reference to  FIG. 2  and  FIGS. 4   a,    4   b  and  4   c  together, the instant invention is further described. The manifold  12  includes connected and communicating passageways and cavities including a high pressure branch passageway  64  within the high pressure branch  26  and integral threaded connector port  28 , an exhaust branch passageway  66  within the exhaust branch  30  and integral threaded connector port  32  intersecting and in communication with the high pressure branch passageway  64 , and a tapered central passageway  68  extending from and through a distally directed threaded connection port  70  integral to the central tubular body  24  and through the central tubular body  24  to and communicating with a cavity  72 , which preferably is cylindrical, located central to the cavity body  34 . Internal threads  74  ( FIG. 4   a ) are located about the interior of the cavity body  34  and near the proximal region of the manifold  12  for accommodation of the threaded end of the hemostatic nut assembly  54 . 
         [0029]    Beneficial to the instant invention is the use of a self-sealing hemostatic valve  76 , the shape and functions of which are described in detail in pending application Ser. No. 10/455,096 entitled “Thrombectomy Catheter Device Having a Self-Sealing Hemostasic Valve” filed on Jun. 05, 2003. The self-sealing hemostatic valve  76  is aligned, captured and housed in the distal portion of the cavity  72  at the proximal region of the manifold  12 . The cavity  72  is tubular in shape including a tubular cavity wall  78 , the threads  74 , and an intersecting planar surface  80  which is annular and circular. An orifice  82  located central to the planar surface  80  is common to the cavity  72  and the tapered central passageway  68 . The hemostatic nut assembly  54  includes a passageway  86  extending through the general body and through a cylindrical boss  84  having external threads  88 . An integral actuator knob  90  is also part of the hemostatic nut assembly  54 . The proximal end of the manifold  12  utilizes the internal threads  74  for attachment of the hemostatic nut assembly  54  to the manifold  12  where the external threads  88  of the hemostatic nut assembly  54  rotatingly engage the internal threads  74  of the manifold  12  to cause the cylindrical boss  84  to bear against the self-sealing hemostatic valve  76 , thereby causing the self-sealing hemostatic valve  76  to seal against the guidewire  60  and to seal the proximal portion of the tapered central passageway  68  where such sealing is effective during static or actuated states of the invention. Also included in the hemostatic nut assembly  54  is an annular lip  92 , best shown in  FIG. 2 , which can be utilized for snap engagement with dimples  94  ( FIG. 2 ) protruding inwardly from the tubular cavity wall  78  of the cavity body  34 . 
         [0030]    Also shown is a ferrule  96  which aligns within the passageway  98  of the threaded high pressure connection port  56  the combination of which aligns within a portion of the high pressure branch passageway  64  at the threaded connector port  28 . The proximal end of the high pressure tube  62  is utilized to receive high pressure ablation liquids and suitably secures in a center passage of the ferrule  96  to communicate with the passageway  98  of the threaded high pressure connection port  56 . The high pressure tube  62  also extends through the high pressure branch passageway  64 , through part of the tapered central passageway  68 , through coaxially aligned components including lumen  40  in the catheter tube  14 , the connector  38  and the strain relief  36 , thence through the balance of the length of the lumen  40  in the catheter tube  14  to attach to other components as now described. The high pressure tube  62  extends through support rings  100 ,  102  and  104  and to the tip  42  where termination of the high pressure tube  62  is provided in the form of a fluid jet emanator  106 , described in other applications and patents assigned to the assignee. The high pressure tube  62  also extends through the radiopaque marker bands  46 ,  48  and  50  and to the fluid jet emanator  106  and the radiopaque marker band  52 . The high pressure tube  62  preferably is attached to the support rings  100 ,  102  and  104  and the fluid jet emanator  106 , such as by welding or other suitable means, where the support rings  100 ,  102  and  104  and the fluid jet emanator  106  function as co-located supports for the catheter tube  14  in the region beneath the radiopaque marker bands  46 ,  48 ,  50  and  52 . In  FIG. 2 , the radiopaque marker bands  46 ,  48 ,  50  and  52  are shown displaced distally a short distance from the support rings  100 ,  102  and  104  and the fluid jet emanator  106  for the purpose of clarity and are shown in frictional engagement in their actual position along and about the distal portion of the catheter tube  14  in  FIGS. 4   b  and  4   c.    
         [0031]    The relationships of the radiopaque marker bands  46 ,  48 ,  50  and  52  and of the support rings  100 ,  102  and  104  and the fluid jet emanator  106  to each other and to the catheter tube  14  are shown best in  FIGS. 4   b  and  4   c.  In  FIG. 4   b,  the balloon  16  is shown contiguous with the catheter tube  14 , wherein the balloon  16  is of a reduced wall thickness when compared to the general wall thickness of the catheter tube  14 . The wall thickness of the balloon  16  is of suitable thickness to allow inflation of the balloon  16  to expand to meet and seal against the wall of the vasculature in which a thrombectomy procedure, drug delivery procedure or other procedure can take place. The radiopaque marker bands  46  and  48  and the support rings  100  and  102  are shown forcibly contacting the full wall thickness of the catheter tube  14  adjacent to the balloon  16 , thereby allowing the full length of the thinner wall of the balloon  16  to be utilized for expansion. Alternatively, a suitable portion of the balloon  16  could also be engaged between the radiopaque marker bands  46  and  48  and the support rings  100  and  102 . Expansion of the balloon  16  is shown in dashed lines by the expanded balloon  16   a.    
         [0032]      FIG. 4   c  shows the positioning of the radiopaque marker bands  50  and  52  around and about the distal portion of the catheter tube  14 . The distally located radiopaque marker band  52  is forcibly applied over and about the distal portion of the catheter tube  14  to cause frictional annular engagement of a portion of the catheter tube  14  with all or part of an annular groove  108  of the fluid jet emanator  106 . Such frictional engagement is sufficient to place the outer radius surface of the radiopaque marker band  52  (also  46 ,  48  and  50 ) in a position lesser than the general and greater outer radial surface of the catheter tube  14 , thereby providing, in part, catheter tube  14  having no elements protruding beyond the general outer radial surface thereof for unimpeded and smooth distal or proximal transition of the catheter tube  14  within a vein, artery or the like. A passage  109  is shown central to the fluid jet emanator  106  to accommodate passage of a guidewire. 
         [0033]    Structure is provided to nurture and aid introduction of and passage of the distal portion of the catheter tube  14  through blood vessels, arteries and the like to the sites of thrombotic deposits or lesions. The tapered tip  42 , as opposed to a rounded and non-tapered tip, can part and more easily penetrate thrombotic deposits or lesions during insertional travel in a distal direction instead of advancing or pushing such thrombotic deposits or lesions distally. The decreasing diameter in a distal direction of the tapered tip  42  also allows for increasing flexibility to negotiate and pass through tortuous paths. 
         [0034]    The exhaust tube support rings  100  and  102  in use with the radiopaque marker bands  46  and  48  in the regions surrounding the opposed ends of the balloon  16  are examples of structures offering support or reinforcement along the catheter tube  14  in the regions surrounding the ends of the balloon  16 . The exhaust tube support ring  104  and fluid jet emanator  106 , in use with the radiopaque marker bands  50  and  52 , are other examples of structures offering support or reinforcement along the catheter tube  14 . Such support allows the use of thinner wall dimension for the catheter tube  14  to allow for a larger and more effective and efficiently sized lumen  40 , as well as contributing to a reduced size outer diameter. Such support also contributes to supportively maintaining the diameter and overall shape of the catheter tube  14  when the catheter tube  14  is pushed or advanced along a vein or vessel, as well as aiding torsional support. 
       Mode of Operation 
       [0035]    Generally, a normal guidewire is deployed in a vessel requiring treatment, or in the alternative, a filter guidewire or balloon occlusion guidewire could be used. After other necessary interventional procedures, the exhaust-pressure-operated balloon catheter system  10  is advanced over the guidewire for debris/thrombus removal, drug infusion or other procedures and maneuvered into the appropriate position for treatment. A guide catheter or sheath can be incorporated as necessary to offer assistance in placing the catheter tube  14  of the exhaust-pressure-operated balloon catheter system  10  within the desired location of the vasculature. The exhaust-pressure-operated balloon catheter system  10  is activated, wherein the balloon  16  is automatically and expandingly deployed forming an expanded balloon  16   a  and debris or drugs are removed or infused. The balloon  16  can be alternately pressurized and depressurized, wherein the exhaust-pressure-operated balloon catheter system  10  may be moved proximally or distally during the procedure to maximize the effect of the system. When the procedure is complete, the balloon  16  generally is deflated sufficiently under normal arterial pressure to be removed safely, or deflation can be aided with a manual syringe attached to an effluent line, or deflation could be aided via use of a roller pump. Further interventions can be executed as normal over the remaining wire or wire device. 
         [0036]    More specifically,  FIGS. 5 and 6  illustrate the mode of operation where  FIG. 5  illustrates the invention connected to ancillary devices, and where  FIG. 6  illustrates the distal portion of the exhaust-pressure-operated balloon catheter system  10  in the performance of the method of use of the present invention. The mode of operation is best understood by referring to  FIGS. 5 and 6  along with previously described figures. 
         [0037]    The exhaust-pressure-operated balloon catheter system  10  is shown engaged over and about a guidewire  60 , wherein the guidewire  60  (previously engaged into a vein or artery) first slidably engages the lumen  40  of the guidewire tube  14  at the tapered tip  42  followed by slidable engagement of the passage  109  of the fluid jet emanator  106 , slidable engagement of the tapered central passageway  68 , and slidable and sealed engagement with the hemostatic valve  76  to exit from the hemostatic nut assembly  54 . A high pressure fluid source  110  and a high pressure fluid pump  112  connect to the manifold  12  via the threaded high pressure connection port  56  and a connector  113 . An exhaust regulator  114 , such as a roller pump or other suitable device, and a collection chamber  116  connect to the threaded connector port  32  of the exhaust branch  30  by a connector  117 , as shown. 
         [0038]      FIG. 6  illustrates the exhaust-pressure-operated balloon catheter system  10  in the performance of the method of use of the present invention, with particular attention to the distal portion of the exhaust tube  14  including the flexible tapered tip  42  positioned in a blood vessel  118 , artery or the like at the site of a thrombotic deposit or lesion  120  where the blood vessel  118  and the main thrombotic deposit or lesion  120  are shown in cross section. Multiple jet streams of high velocity jet flow  122  of saline (or other suitable fluid) are emitted in a proximal direction from the fluid jet emanator  106  to impinge upon and carry away thrombotic deposits or lesions  120  which have been reduced to particulate form. Alternatively, other fluid jet emanators of different structures can be incorporated within the distal portion of the catheter tube  14  as an alternative to the jet emanator  106  illustrated in this figure to emanate or emit one or more high velocity jet flow(s)  122  proximally along or near the longitudinal axis of the catheter tube  14  to accomplish the same purpose as that described for the fluid jet emanator  106 . The high velocity jet flow(s)  122  of saline pass outwardly through the outflow orifice(s)  20   a - 20   n  in a radial direction creating cross stream jet(s)  124  directed outwardly toward the wall of the blood vessel  118  and are influenced by the low pressure at the inflow orifice(s)  18   a - 18   n  to cause the cross stream jet(s)  124  to flow distally and circumferentially to impinge on, provide drag forces on, and break up thrombotic deposits or lesions  120  and to, by entrainment, urge and carry along the particles of thrombotic deposits or lesions  120  through the inflow orifice(s)  18   a - 18   n,  a relatively low pressure region, into the high velocity jet flows  122  where the thrombus  120  is further macerated into microscopic particles, and thence into the catheter tube lumen  40  to pass through the expanded balloon  16   a,  and thence further through the lumen  40  for subsequent exhausting. The exhaust outflow is driven by internal pressure which is created by the high velocity jet flow(s)  122  and the fluid entrained through the inflow orifice(s)  18   a - 18   n  to cause pressurization of the lumen  40  and the balloon  16  and is utilized to several advantages. One advantage of which is that in a no flow situation when distal flow of blood is stopped by inflation of the intervening inflated and expanded balloon  16   a,  the particles of thrombotic deposits or lesions  120  are substantially trapped and can be more effectively circulated, recirculated and rediluted until all that remains is saline and minute particles of thrombotic deposits or lesions  120  which are subsequently removed in a proximal direction through the lumen  40  of the catheter tube  14  by promoting flow through the exhaust regulator  114 . Another advantage is the utilization of the exhaust outflow and internal pressure which is created by the high velocity jet flow(s)  122  in combination with the restriction of the outflow, such as influenced by the exhaust regulator  114 , to cause automatic expansion of the balloon  16  which forcibly impinges and seals against the inner walls of the blood vessel  118 . The reduced thickness of the material comprising the balloon  16  allows the balloon  16  to expand sufficiently to become an expanded balloon  16   a  restricted by impingement with the wall of the blood vessel  118 . Inflation pressure and flows can be influenced by controlling of input pressure fluid at the high pressure fluid pump  112  and by controlling of the exhaust rate at the exhaust regulator  114 . The present invention discloses an exhaust-pressure-operated balloon catheter system  10  utilizing the concept of a continuously formed inflatable and expandable balloon being continuously formed of the same material as the catheter (exhaust tube) and automatically inflated by internal pressurization as caused by high velocity jet flows, cross stream jets, and the like. Such a concept can also be applied to other thrombectomy catheters and systems, such as, but not limited to, all AngioJet® catheters including rapid exchange catheters, over-the-wire catheters, and catheters which are pressurized by a fluid flow source. 
         [0039]    Various modifications can be made to the present invention without departing from the apparent scope thereof. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 EXHAUST-PRESSURE-OPERATED BALLOON CATHETER SYSTEM 
               
               
                 PARTS LIST 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                  10 
                 exhaust-pressure-operated balloon catheter system 
               
               
                   
                  12 
                 manifold 
               
               
                   
                  14 
                 catheter tube 
               
               
                   
                  16 
                 balloon 
               
               
                   
                  16a 
                 expanded balloon 
               
               
                   
                  18a-n 
                 inflow orifices 
               
               
                   
                  20a-n 
                 outflow orifices 
               
               
                   
                  24 
                 central tubular body 
               
               
                   
                  26 
                 high pressure branch 
               
               
                   
                  28 
                 threaded connector port 
               
               
                   
                  30 
                 exhaust branch 
               
               
                   
                  32 
                 threaded connector port 
               
               
                   
                  34 
                 cavity body 
               
               
                   
                  36 
                 strain relief 
               
               
                   
                  38 
                 connector 
               
               
                   
                  40 
                 lumen 
               
               
                   
                  42 
                 tapered tip 
               
               
                   
                  46 
                 radiopaque marker band 
               
               
                   
                  48 
                 radiopaque marker band 
               
               
                   
                  50 
                 radiopaque marker band 
               
               
                   
                  52 
                 radiopaque marker band 
               
               
                   
                  54 
                 hemostatic nut assembly 
               
               
                   
                  56 
                 threaded high pressure connection port 
               
               
                   
                  58 
                 connector 
               
               
                   
                  60 
                 guidewire 
               
               
                   
                  62 
                 high pressure tube 
               
               
                   
                  64 
                 high pressure branch passageway 
               
               
                   
                  66 
                 exhaust branch passageway 
               
               
                   
                  68 
                 tapered central passageway 
               
               
                   
                  70 
                 threaded connection port 
               
               
                   
                  72 
                 cavity 
               
               
                   
                  74 
                 internal threads 
               
               
                   
                  76 
                 self-sealing hemostatic valve 
               
               
                   
                  78 
                 tubular cavity wall 
               
               
                   
                  80 
                 planar surface 
               
               
                   
                  82 
                 orifice 
               
               
                   
                  84 
                 boss 
               
               
                   
                  86 
                 passageway 
               
               
                   
                  88 
                 external threads 
               
               
                   
                  90 
                 actuator knob 
               
               
                   
                  92 
                 annular lip 
               
               
                   
                  94 
                 dimple 
               
               
                   
                  96 
                 ferrule 
               
               
                   
                  98 
                 passageway 
               
               
                   
                 100 
                 support ring 
               
               
                   
                 102 
                 support ring 
               
               
                   
                 104 
                 support ring 
               
               
                   
                 106 
                 fluid jet emanator 
               
               
                   
                 108 
                 annular groove 
               
               
                   
                 109 
                 passage 
               
               
                   
                 110 
                 high pressure fluid source 
               
               
                   
                 112 
                 high pressure fluid pump 
               
               
                   
                 113 
                 connector 
               
               
                   
                 114 
                 exhaust regulator 
               
               
                   
                 116 
                 collection chamber 
               
               
                   
                 117 
                 connector 
               
               
                   
                 118 
                 blood vessel 
               
               
                   
                 120 
                 thrombotic deposit or lesion 
               
               
                   
                 122 
                 high velocity jet flow 
               
               
                   
                 124 
                 cross stream jets