Abstract:
A single operator exchange fluid jet thrombectomy method employing a single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. The outer catheter assembly is common to any mode of usage and includes a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a jet emanator and a flow director are passed and advanced. In the method, thrombus is dislodged, entrained, and broken into pieces by fluid jets and evacuated through the lumen of the guide catheter.

Description:
CROSS REFERENCES TO CO-PENDING APPLICATIONS 
     This patent application is a continuation-in-part of Ser. No. 09/356,783, entitled “Rheolytic Thrombectomy Catheter and Method of Using Same”, filed on Jul. 16, 1999, pending, which is a divisional of Ser. No. 09/019,728, entitled “Rheolytic Thrombectomy Catheter and Method of Using Same”, filed on Feb. 06, 1998, U.S. Pat. No. 5,989,210. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a method of treating matter in a body vessel or cavity, especially to removing undesired obstructing material, such as thrombus, from a body vessel or cavity having an obstruction, by employing an interchangeable and separable catheter system for alternatively incorporating the principles of a rheolytic thrombectomy catheter or the principles of a crossflow thrombectomy catheter, or of the simultaneous use of the principles of both the rheolytic thrombectomy catheter and the crossflow thrombectomy catheter. 
     More particularly, the present invention relates to a method of treatment of the human body by means of an elongated device which may be a single catheter assembly or a multiple component catheter assembly and which is suitable for use through percutaneous or other access, for endoscopic procedures, or for intraoperative use in either open or limited access surgical procedures. Still more particularly, the present invention relates to a method of treatment of the human body involving use of an elongated device in the form of a rheolytic thrombectomy catheter or, alternately, in the form of a fluid jet thrombectomy catheter, the latter hereinafter termed crossflow thrombectomy catheter, and having a commonly used outer catheter assembly, each device being incorporated for fragmentation and removal of thrombus or other unwanted material from blood vessels or body cavities, and each device using high velocity saline (or other suitable fluid) jets to macerate the thrombus or other unwanted material. The elongated device bears certain similarities to a known waterjet thrombectomy catheter and can be used as such, but differs therefrom in several material respects, a major distinction being in the provision of interchangeable alternate means which produce inwardly directed jets with or without crossflow jets. The crossflow jets create a recirculation flow pattern optimized for clearing a large cross section of mural thrombus or other similar material, the name crossflow thrombectomy catheter deriving from this major distinction. Further, the method of the present invention also involves a system constituted either by the combination of the elongated device with both pressurized fluid source means and exhaust regulation means or by the combination of the elongated device with only pressurized fluid source means. 
     2. Description of the Prior Art 
     Procedures and devices have been developed for ease in removing tissue and various deposits. Several such devices employ a jet of saline as the working tool to help break up the tissue deposit and further provide a suction means to remove the deposit. U.S. Pat. No. 5,135,482 to Neracher describes a hydrodynamic device for removal of organic deposit from a human vessel. A supply of saline is delivered by a high pressure duct to the distal end of a catheter. The saline exits the duct as a jet that is directed generally forward and directly toward the tissue to be broken up. The duct is contained within and can move axially with respect to a hose that is positioned around the duct. A vacuum suction is applied to the hose to remove the debris that is created from the broken-up tissue. This device is not intended to pass through tortuous pathways found in the fragile vessels of the body, and any attempt to employ the device for such purpose would be far too traumatic to the patient. 
     Another drainage catheter, described by Griep in U.S. Pat. No. 5,320,599, has a discharge channel and a pressure channel. The channels are formed into a single catheter tube such that the two tubes are fixed with respect to each other. 
     Waterjet thrombectomy catheters have been described in which a distal-to-proximal-directed waterjet(s) flow(s) past a window, orifice or gap at the distal end of the catheter, re-entering the catheter and pushing flow through an evacuation lumen. When placed in a vessel containing thrombus and activated, the high velocity jet(s) will entrain surrounding fluid and thrombus into the window, orifice or gap region, where the high shear forces of the jet(s) will macerate the thrombus. The macerated particles will be removed from the body by the pressure generated on the distal end of the evacuation lumen by the impingement of the high velocity waterjet(s). 
     A limitation of these waterjet thrombectomy catheters has been the inability to remove organized, wall-adherent thrombus from large vessels. In accordance with the method of the present invention, the single operator exchange fluid jet thrombectomy device described and utilized in the method overcomes this limitation by optimizing the recirculation pattern at the tip of the device to increase the drag force exerted on the mural thrombus to break it free from the vessel wall and allow it to be removed by the device. 
     Methods practiced with prior art devices often required the use of more than one operator where one operator must stabilize the guidewire while the second operator introduces the catheter over the guidewire into the anatomy. 
     The method of the present invention overcomes the disadvantages of the procedures using current devices by relying on an interchangeable catheter system utilizing either the rheolytic thrombectomy catheter or the crossflow thrombectomy catheter, each of which can be operated by one practitioner, and which offers multiple advantages over previous rheolytic thrombectomy catheter designs. More specifically, the method of the present invention is effectual for removal of unwanted deposits in the body, such as, but not limited to, deposits in bile ducts, the brain or other hematomas, and brain ventricles, for example. 
     SUMMARY OF THE INVENTION 
     The present invention, a single operator exchange fluid jet thrombectomy method, relies on use of a single operator exchange fluid jet thrombectomy device, which is a surgical device for removal of material such as thrombus from a vessel or other body cavity. As shown in one or more embodiments, the single operator exchange fluid jet thrombectomy device can function as a rheolytic thrombectomy catheter for removing tissue from a vessel or other body cavity and includes an outer catheter assembly common to any mode of operation, the commonly used outer catheter assembly of which is comprised of a manifold and a first tube or guide catheter having a lumen with an open distal end, the lumen being of a diameter sufficient to allow passage of an inner catheter assembly. One such inner catheter assembly as incorporated in use with the single operator exchange fluid jet thrombectomy device is comprised of a high pressure second tube having a high pressure lumen and a geometrically configured distally located jet emanator having one or more rearwardly directed orifices for directing one or more jets of saline toward the distal end of a flow director, a proximally located transitional stop fixed to the second tube adjacent to the second tube proximal end, and an exhaust tube. The inner catheter assembly is movable axially within the outer catheter assembly such that the proximally located transitional stop engages the proximally located stationary stop to hold the jet emanator in a desired relationship with respect to the distal end of the outer catheter assembly. 
     The single operator exchange fluid jet thrombectomy device provides a catheter combination for use as a rheolytic thrombectomy catheter including the first tube or guide catheter, being a part of a common use outer assembly, the first tube or guide catheter having a proximal end, a manifold attached thereto, an open distal end, and a lumen extending between the proximal end and the open distal end; the second tube, being a part of an inner catheter assembly, the second tube being separable from the first tube or guide catheter and being insertable within the lumen of the first tube or guide catheter, the second tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; a flow director having an inner body and an exhaust tube which may or may not be expandable, each being located near but not at the second tube distal end, a pressure operated sealable or closely fit annulus between the outer surface of the exhaust tube and the interior annular surface of the first tube or guide catheter, a jet emanator integrally formed at the distal end of the second tube or attached thereto by a bonding operation into which at least one jet orifice is machined or otherwise formed on the proximal side thereof to create a jet emanator for directing fluid proximally for thrombus ablation and subsequently through a lumen in the flow director and the lumen of the first tube or guide catheter, being also a part of the inner catheter assembly, the jet emanator and flow director, including the inner body thereof, being capable of passage through the lumen of the first tube or guide catheter and over a guidewire, and being characterized by the ability to provide a localized region of low pressure associated with a liquid flow directed generally proximally and into the inner body, into an exhaust tube, and into the lumen of the first tube or guide catheter through the distal end of the first tube or guide catheter. A variable displacement distance means for indexing an appropriate positional and variable relationship of the jet emanator to the distal end of the first tube or guide catheter is provided. A stop means is provided for limiting movement of the second tube and preferably includes a proximally located hemostasis nut/stop at the proximal end of a manifold of the outer catheter assembly and a proximally located filter housing/high pressure connection/stop assembly projecting outwardly from the proximal end of the second tube. When the second tube is advanced within the first tube or guide catheter, fluoro-imaging can be incorporated to provide adequate spacing and relationship between the jet emanator and the distal end of the first tube or guide catheter. This relationship is also referred to as variable displacement distance. Lateral positioning of the second tube within the first tube or guide catheter is readily accomplished during the first stage (insertion) in an unpressurized operational mode where the sealable or closely fit annulus is suitably sized to allow easy unrestricted passage of the second tube within and through the first tube or guide catheter. A representative exhaust tube is shown in many embodiments with additional reference to the following exhaust tube types including, but not limited to, an exhaust tube which can be compliant expandable where the diameter of the exhaust tube depends on applied pressure and subsequent restriction by the guide catheter, a non-compliant expandable exhaust tube where the diameter of the exhaust tube is dependent on the designed diameter or the exhaust tube can be not expandable, but closely fit to the first tube or guide catheter. During the operational pressurized mode, jetted saline causes an expandable exhaust tube to expand, thus partially or fully closing, restricting, modifying or eliminating the open annulus to pressure seal the first tube or guide catheter to the second tube, but still allowing movement relative to each other. In the alternative, a closely fit annulus incorporating a non-expandable exhaust tube offers partial but effective restrictive closing to substantially pressure seal or close the first tube or guide catheter to the second tube. 
     The above embodiment is utilized in a method of removing thrombus from an obstructed body vessel. The method includes the steps of: 
     a. providing a guidewire and an outer catheter assembly including a manifold, a first tube or guide catheter having an interior annular surface, a distal end, and an externally located stationary hemostasis nut/stop positioned at the manifold proximal end; 
     b. advancing the first tube or guide catheter proximal to a vascular site containing thrombus; 
     c. advancing the guidewire through the first tube or guide catheter and past the vascular site containing thrombus; 
     d. providing an inner catheter assembly including a second tube carrying a jet emanator at its distal end, a flow director including an expandable or non-expandable exhaust tube proximal of the jet emanator, and a transitional filter housing/high pressure connection/stop assembly at its proximal end; 
     e. advancing the inner catheter assembly to a desired position within the first tube or guide catheter, so that a gap or space proximal to the jet emanator extends past the distal end of the first tube or guide catheter, while the proximal end of the flow director remains proximal to the distal end of the first tube or guide catheter; 
     f. providing a high pressure saline supply to the second tube so as to cause at least one jet of saline to emanate from the jet emanator and to entrain thrombus into the gap or space where the thrombus is macerated and then pushed through the flow director and into the first tube or guide catheter for removal from the body; and, 
     g. providing impingement of at least one jet on the interior annular surface of an exhaust tube to create sufficient stagnation pressure to expand the exhaust tube against the interior annular surface of the first tube or guide catheter or utilize a closely fit annulus and force evacuation of debris through the flow director and the first tube or guide catheter out of the body with no need for additional suction. 
     In the method, the inner catheter assembly can be moved axially relative to both the first tube or guide catheter and guidewire to facilitate distal and proximal movement of the inner catheter assembly to remove thrombus distributed axially throughout the vasculature. 
     An alternate embodiment useful in the method includes a crossflow/flow director inserted into the common outer catheter assembly to function substantially as described above, but to include the features and functions of a crossflow thrombectomy catheter. 
     One significant aspect and feature of the method of the present invention is the use of a single operator exchange fluid jet thrombectomy device operable by one practitioner. 
     Another significant aspect and feature of the method of the present invention is the use of a single operator exchange fluid jet thrombectomy device having an outer catheter assembly which can accommodate various inner catheter assemblies configured to function either as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. 
     Another significant aspect and feature of the method of the present invention is the provision of a transitional filter housing/high pressure connection/stop assembly on the proximal end of the second tube which impinges a hemostasis nut/stop on the manifold to position the jet emanator at a defined distance beyond the distal end of the guide catheter. 
     Other significant aspects and features of the method of the present invention are the provisions of a transitional filter housing/high pressure connection/stop assembly proximally located at the end of the inner catheter assembly and a stationary hemostasis nut/stop proximally located on the outer catheter assembly which engage to prevent the inner catheter assembly from being excessively advanced, so that the exhaust tube proximal end does not become disengaged from the distal end of the first tube or guide catheter. 
     A further significant aspect and feature as found in additional embodiment groups employed in the method of the present invention is an annulus which is open for lateral movement of the inner catheter assembly within the outer catheter assembly during the initial unpressurized mode (insertion) and which can be modulated to a partially or fully closed position and sealed by jetted saline during the ablation process to provide maximum proximally directed saline flow with minimum or no leakage between the outer and inner catheter assemblies when thrombotic tissue is broken up and carried proximally. 
     Another significant aspect and feature of the method of the present invention is the provision of a flow director which can use either a compliant expandable, a non-compliant expandable, a non-expandable, non-compliant close fit, or a combination compliant/non-compliant exhaust tube. 
     Yet another significant aspect and feature of the method of the present invention is the ability to incorporate various emanator shapes, styles and designs. 
     Another significant aspect and feature of the method of the present invention is the ability to reduce cost aspect since effluent outflow or exhaust can be collected using a standard Y-connector. 
     Having thus described embodiments and significant aspects and features pertaining to the method of the present invention, it is the principal object of the present invention to provide a single operator exchange fluid jet thrombectomy method to remove undesired obstructing material such as thrombus from a body vessel or other body cavity. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     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: 
     FIG. 1 is a simplified block diagram view of a single operator exchange fluid jet thrombectomy device useful in the method of the present invention. 
     FIG. 2 illustrates a side view of a single operator exchange fluid jet thrombectomy device; 
     FIG. 3 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device; 
     FIG. 4 illustrates an isometric view of the distal end of the first tube or guide catheter with a portion of the inner catheter assembly protruding therefrom; 
     FIG. 5 illustrates an exploded view of the components of FIG. 4; 
     FIG. 6 illustrates an isometric view of one jet emanator means, a toroidal loop. 
     FIG. 7 illustrates a cross section view of the distal end of the first tube or guide catheter and the flow director in the unpressurized mode, along the line  7 — 7  of FIG. 2; 
     FIG. 8 illustrates a cross section view of the elements of FIG. 7 in the pressurized mode; 
     FIG. 9 illustrates a cross section view of the elements of FIG. 7 in the partially pressurized mode; 
     FIG. 10 illustrates a cross section view of the junction of the inner body and the expandable exhaust tube along line  10 — 10  of FIG. 7; 
     FIG. 11 illustrates a cross section view at the distal end of the first tube or guide catheter along line  11 — 11  of FIG. 7 in the unpressurized mode; 
     FIG. 12 illustrates a cross section view at the distal end of the first tube or guide catheter along line  12 — 12  of FIG. 8 in the pressurized mode; 
     FIG. 13 illustrates a cross section view at the distal end of the first tube or guide catheter along line  13 — 13  of FIG. 9 in the partially pressurized mode; 
     FIG. 14, a first alternative embodiment, illustrates a cross section view of the elements of FIG. 7 featuring an optional non-compliant expandable exhaust tube; 
     FIG. 15 illustrates the non-compliant expandable exhaust tube of FIG. 14 in the inflated mode to close a previously open annulus; 
     FIG. 16, a second alternative embodiment, illustrates a cross section view of the elements of FIG. 7 featuring an optional non-expandable, non-compliant fit tube; 
     FIG. 17, a third alternative embodiment, illustrates a cross section view of the elements of FIG. 7 featuring a compliant/non-compliant exhaust tube where one segment is more flexible than an adjacent segment; 
     FIG. 18 illustrates a cross section view and in partial cutaway of the distal end of the single operator exchange fluid jet thrombectomy device in operation in a blood vessel; 
     FIG. 19, a fourth alternative embodiment, illustrates a side view of a single operator exchange fluid jet thrombectomy device incorporating an inner catheter assembly having a crossflow capability; 
     FIG. 20 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device of FIG. 19; 
     FIG. 21 illustrates an isometric view of the distal end of the first tube or guide catheter with a portion of the inner catheter assembly of FIG. 20 protruding therefrom; 
     FIG. 22 illustrates an exploded view of the components of FIG. 21; 
     FIG. 23, a fifth alternative embodiment, illustrates a view of the elements of FIG. 6 including one or more outflow orifices; 
     FIG. 24 illustrates a cross section view of the distal end of the first tube or guide catheter and the crossflow/flow director in the unpressurized mode, along line  24 — 24  of FIG. 19; 
     FIG. 25 illustrates a cross section view of the elements of FIG. 24 in the pressurized mode; 
     FIG. 26, a sixth alternative embodiment, illustrates a cross section view of the elements of FIG. 24 featuring a non-compliant expandable exhaust tube; 
     FIG. 27 illustrates the non-compliant expandable exhaust tube of FIG. 26 in the inflated mode to close the previously open annulus; 
     FIG. 28, a seventh alternative embodiment, illustrates a cross section view of the elements of FIG. 24 featuring an optional non-expandable, non-compliant close fit exhaust tube; 
     FIG. 29, an eighth alternative embodiment, illustrates a cross section view of the elements of FIG. 24 featuring an optional compliant/non-compliant exhaust tube; 
     FIG. 30 illustrates a view in cross section and in partial cutaway of the mode of operation of the single operator exchange fluid jet thrombectomy device utilizing the inner catheter assembly of FIG. 24; 
     FIG. 31, a ninth alternative embodiment, illustrates an exploded view of a jet emanator in the form of a jet cap; 
     FIG. 32 illustrates an assembled view of the elements of FIG. 31; 
     FIG. 33 illustrates a cross section view of the jet cap along line  33 — 33  of FIG. 32; 
     FIG. 34, a tenth alternative embodiment, illustrates an isometric view of a jet cap having formed passages; 
     FIG. 35 illustrates a side view of the formed passage jet cap in use as an emanator; 
     FIG. 36 illustrates a proximal view of the formed passage jet cap; 
     FIG. 37, an eleventh alternative embodiment, illustrates a cross section view of an inner body along line  37 — 37  of FIG. 38; 
     FIG. 38 illustrates an end view of the inner body along line  38 — 38  of FIG. 37; 
     FIG. 39, a twelfth alternative embodiment, illustrates a cross section view of an inner body along line  39 — 39  of FIG.  40 ;, 
     FIG. 40 illustrates an end view of the inner body along line  40 — 40  of FIG. 39; 
     FIG. 41, a thirteenth alternative embodiment, illustrates a cross section view of a first tube or guide catheter having a distally located inflatable balloon; 
     FIG. 42 illustrates the first tube or guide catheter of FIG. 41 in use in a blood vessel; 
     FIG. 43, a fourteenth alternative embodiment, illustrates a cross section view of a first tube or guide catheter having a distally located inflatable balloon and another inflatable balloon located proximal to the distally located inflatable balloon; 
     FIG. 44 illustrates the first tube or guide catheter of FIG. 43 in use in a blood vessel; 
     FIG. 45, a fifteenth alternative embodiment, illustrates a side view of a single operator exchange fluid jet thrombectomy device; 
     FIG. 46 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device of FIG. 45; 
     FIG. 47 illustrates a cross section view along line  47 — 47  of FIG. 45 of the single operator exchange fluid jet thrombectomy device; 
     FIG. 48 illustrates the elements of FIG. 45 having a second tube of a predetermined length to limit the distance a jet emanator can travel beyond the distal end of the first tube or guide catheter; 
     FIG. 49 illustrates the use of a centering ring with the elements of FIGS. 45,  46 ,  47  and  48 ; 
     FIG. 50 illustrates a semi-exploded side view of the elements of FIG. 49; and, 
     FIG. 51 illustrates a cross section view of the single operator exchange fluid jet thrombectomy device along line  51 — 51  of FIG.  49 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 illustrates in block diagram form a single operator exchange fluid jet thrombectomy device  10  for use in the method of the present invention showing the interrelation of the various functional means thereof for use in removing thrombus or other unwanted material from a body vessel or cavity. 
     The major components of the system include an elongated device in the form of a single operator exchange fluid jet thrombectomy device, a pressurized fluid source means, and, optionally, an exhaust regulation means connected to a collection system (not shown). 
     The elongated device includes first and second tubular means each having a proximal end and a distal end. The second tubular means is in the form of a high pressure tubular means having pressurized fluid connection means providing a fluid connection permanently or detachably coupled to its proximal end and jet emanator means at its distal end, the pressurized fluid connection means being connectible to the pressurized fluid source means. The first tubular means is in the form of either an exhaust tubular means, as shown, or other tubular means (not shown in FIG. 1 but described in detail in relation to FIGS. 2 and 3) which serves as an alternative to an exhaust tubular means in those instances when exhausting is not necessary or desired. When in the form of an exhaust tubular means, the first tubular means is usually associated with exhaust regulation means, although an exhaust regulation means is not essential. Whether in the form of an exhaust tubular means or other tubular means, the first tubular means includes outflow means and inflow means which in concert with high velocity jet(s) produced by the jet emanator means create rheolytic fluid flow or create optional crossflow jet(s) that establish a flow recirculation pattern, depending on the style of second tubular means. 
     The optional outflow means (crossflow) consists of one or more outflow orifices through which saline, blood or other fluid or a mixture thereof with macerated thrombus or other unwanted material debris flows from a region of higher pressure within the exhaust tubular means or other tubular means to outside the exhaust tubular means or other tubular means. The one or more outflow orifices are typically somewhat downstream from the high velocity region of the high velocity jet(s) where the velocities are lower and the mass flow rate is greater due to entrained fluid; and flow of fluid with or without macerated debris typically flows through the one or more outflow orifices with a component in the radial direction, creating crossflow jet(s). The outflow orifices may be round, elliptical, conical, slits, gaps between components, or other shapes or designs. 
     The optional inflow means (crossflow) consists of one or more inflow orifices through which the high velocity jet(s) draw in by fluid entrainment blood or other fluid from a body vessel or cavity, including thrombus or other unwanted material which may be present in the blood or other fluid. The one or more inflow orifices are typically near the high velocity region of the high velocity jet(s) where entrainment forces are great. The inflow orifices may be round, elliptical, conical, slits, gaps between components, or other shapes or designs. 
     The high pressure tubular means comprises an elongated structure having at least one passage or lumen along the length thereof suitable for passage of high pressure fluid. The elongated structure can be tubing with a circular or non-circular cross section and can be made of high strength polymeric material such as polyimide, metallic material such as stainless steel or titanium, or composite material such as fiber-reinforced material or a layered structure composed of layers of different materials. 
     The exhaust tubular means comprises an elongated structure having at least one passage or lumen along the length thereof suitable for passage of fluid and thrombus or other unwanted material debris. The elongated structure can be tubing with a circular or non-circular cross section and can be made of polymeric material such a polyethylene, polyester, polyurethane, or polyether block amide; high strength polymeric material such as polyimide; metallic material such as stainless steel or titanium; or composite material such as fiber-reinforced polymeric material or a layered structure composed of layers of different materials. Further, the elongated structure may have an attached structure near its distal end such as a chamber or manifold to accommodate the inflow means and optional outflow means. 
     The other tubular means comprises an elongated structure having at least one passage or lumen along the length thereof suitable for passage of fluid. The elongated structure can be tubing with a circular or non-circular cross section or may resemble a shorter chamber such as a manifold, molded or constructed of multiple components. Suitable materials for the other tubular means are polymeric material such as polyethylene, polyester, or polyurethane; high strength polymeric material such as polyimide; metallic material such as stainless steel or titanium; or composite material such as fiber-reinforced polymeric material or a layered structure composed of layers of different materials. 
     If desired, isolation means (not shown) can be provided as part of the elongated device to isolate the region of the body vessel or cavity being treated, although this is not always required. Isolation means can include balloons, filters, baskets, membranes, blood pressure modification, fluid flow control, or other occlusion devices such as are known in the art. Isolation means can limit passage of debris in the blood vessel, limit the flow of blood in the area of the elongated device, or confine the recirculation area. Also if desired, additional tubular means can be provided for communication between the proximal end and the distal end of the elongated device, such as for passage of fluid or other material or for passage of devices such as guidewires, catheters, or imaging tools, or for actuation of isolation means, for inflation of a balloon, or for passage of medication or body fluids. The additional tubular means (not shown) comprises an elongated structure having at least one passage or lumen along the length thereof; for example, the elongated device can include a multiple-lumen tube, in which one lumen functions as the high pressure tubular means, a second lumen functions as the exhaust tubular means, and one or more additional lumens function as the additional tubular means which communicates between the proximal and distal ends of the elongated device. 
     The pressurized fluid source means includes fluid such as saline and one or more pumps or pressure intensifiers or pressurized fluid containers for delivering the fluid under pressure to the high pressure tubular means through the pressurized fluid connection means coupled to the proximal end thereof. The fluid can be provided at a single pressure or at multiple pressures, at variable or adjustable pressure, and at a steady flow or unsteady flow such as pulsatile flow. 
     The exhaust regulation means, when present, comprises structural components which increase, decrease, limit, or adjust the rate of flow of fluid and thrombus or other unwanted material debris along the exhaust tubular means and can be one or more pumps such as roller pumps or peristaltic pumps, clamps, restrictors, or other devices to influence the fluid flow rate. The exhaust regulation means can regulate exhaust at a predetermined or user-adjustable flow rate which can be correlated with or independent of the rate of flow of the pressurized fluid flowing along the high pressure tubular means. Further, the exhaust regulation means can have pressure measurement or flow rate measurement capabilities. The exhaust regulation means is connected to a suitable collection system (not shown). 
     The system is placed in operation by first inserting the first tubular means into a body vessel or cavity and advancing it to a site of thrombus or other unwanted material in the body vessel or cavity followed by insertion of a guidewire which is inserted to or past the site of the thrombus or other unwanted material. Subsequently, the second tubular means is advanced along the guidewire and is accommodated by the first tubular means. Then the proximal end of the second tubular means is connected to the pressurized fluid source means which provides pressurized saline (or other biologically compatible fluid) to the proximal end of the high pressure tubular means via the pressurized fluid connection means. At the distal end of the high pressure tubular means, pressurized saline (or other fluid) passes into the jet emanator means which produces high velocity saline (or other fluid) jet(s). The high velocity saline (or other fluid) jet(s) entrain blood or other fluid from the body vessel or cavity and draw it into the distal portion of the elongated device through the inflow means, carrying thrombus or other unwanted material from the body vessel or cavity along with the blood or other fluid. The high velocity saline (or other fluid) jet(s) together with the entrained blood or other fluid create a region of elevated pressure in the elongated device; this region of elevated pressure communicates with or is a part of the distal portion of the exhaust tubular means. Optionally, the elevated pressure in the elevated pressure region drives fluid flow through the outflow means, creating crossflow jet(s) which have a radial component and may have circumferential and/or axial component(s) as well. The fluid in the elevated pressure region includes saline (or other fluid) from the high velocity jet(s) as well as the entrained blood or other fluid from the body vessel or cavity. The crossflow jet(s) impart normal and drag forces on thrombus or other unwanted material in the body vessel or cavity and greatly improve the effectiveness of the device in removing and breaking apart thrombus or other unwanted material which may be adhered to the body vessel or cavity, and form a recirculation pattern which further aids in drawing thrombus or other unwanted material towards the inflow means. The combination of outflow means, crossflow jet(s), recirculation pattern, inflow means, and high velocity jet(s) synergistically acts to provide for enhanced breakup and removal of thrombus or other unwanted material. The elevated pressure in the elevated pressure region can also aid in the transport of fluid and thrombus or other unwanted material debris through the exhaust tubular means. If desired, the rate of flow of fluid and thrombus or other unwanted material can be regulated by providing exhaust regulation means, although this is not always required. 
     FIG. 2 illustrates a side view of a single operator exchange fluid jet thrombectomy device  10  useful for the removal of thrombus, and FIG. 3 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device  10 . The single operator exchange fluid jet thrombectomy device  10  includes two major assemblies: namely, an outer catheter assembly  12 , which is a core assembly, and an inner catheter assembly  14  configured to function as a rheolytic thrombectomy catheter, which can be exchanged with other styles or designs of inner catheter assemblies, as desired, such as shown in FIGS. 19 and 20, to fit substantially within the outer catheter assembly  12 . The outer catheter assembly  12  is preferably a standard guide catheter, but may also be a catheter specifically designed for this application. The outer catheter assembly  12  design should have proper torque, stiffness, and shape to place the device in the thrombus containing blood vessel. The inner catheter assembly  14 , when in use, aligns substantially concentrically to and mostly within the outer catheter assembly  12  and extends beyond both ends of the outer catheter assembly  12 . A guidewire  16  including a flexible tip  18  at one end and a proximal end  17  opposing the flexible tip  18  is shown in substantially concentric alignment to both the outer catheter assembly  12  and the inner catheter assembly  14 . Externally visible components, or portions of components, of the outer catheter assembly  12  and of the inner catheter assembly  14  of the single operator exchange fluid jet thrombectomy device  10 , as illustrated in FIGS. 2 and 3, also include a manifold  20 , also known as a Y-adapter, a hemostasis nut/stop  22  secured in the proximal end  24  of the manifold  20 , a Luer connection  26  located at the proximal end  28  of an angled manifold branch  30  extending from the manifold  20 , and a first tube or guide catheter  32 , having a Luer connection  35  at a proximal end  33 , secured to distal end  34  of the manifold  20  by Luer fitting  36 . Opposing manipulating tabs  38  and  40  are also provided near the proximal end  33  of the first tube or guide catheter  32 . The externally visible components of the inner assembly  14 , illustrated in FIG. 2, also include a high pressure second tube  42 , a transitional filter housing/high pressure connection/stop assembly  44  concentrically aligned to and secured over and about the proximal end  46  of the second tube  42 , a flow director  48   a  comprised substantially of an exhaust tube in general and generally referred to as exhaust tube  72 , which is further and specifically referred to and specified as either a compliant expandable exhaust tube  72   a , a non-compliant expandable exhaust tube  72   b , or a non-expandable, non-compliant close fit exhaust tube  72   c  aligned over and about the distal end  50  (FIG. 4) of the second tube  42 , an optional jet cap  54  having a central passage  55  (FIG. 4) aligned to and secured over and about a jet emanator  52  which could be and which is shown as a toroidal loop  52   a  having a passage  53  (FIG. 5) at the distal end  50  of the second tube  42 , a radio-opaque marker  56  aligned over and about a distal end  60  of the first tube or guide catheter  32  and a radio-opaque marker  58  located at the distal end  57  of the exhaust tube  72 , which could be and which is shown as a compliant expandable exhaust tube  72   a , to mark the substantially co-located distal end  50  of the second tube  42  and distal end  62  of the inner catheter assembly  14  including the jet emanator  52  and optional jet cap  54 . An optional radio-opaque marker  59  can also be located and attached to or be integral to the proximal end  63  of the exhaust tube  72  and included, along with radio-opaque marker  58 , as an optional integral part of the flow director  48   a . An inner body  66 , part of the flow director  48   a , frictionally engages the distal end  57  of the exhaust tube  72  of the flow director  48   a , as later described in detail. The high pressure second tube  42  can be drawn and tapered in incremental steps to provide degrees of flexibility along its length. For purposes of example and illustration, the second tube  42  can include an initial and proximal outer diameter of 0.018 inch or smaller, and can include a plurality of incrementally stepped down portions each of lesser outer diameter, where the last portion is stepped down to an outer diameter of 0.008 inch at the distal end  50  (FIG.  4 ). The second tube  42  becomes increasingly more flexible from the proximal end  46  towards the distal end  50  due to the incremental diameter decrease along its length. Increasing flexibility along the length of the second tube  42  allows for easier flexed penetration into tortuous vascular paths. Although the second tube  42  is stepped down in increments, the second tube  42  can also be fashioned of a constantly decreasing outer diameter to provide increasing flexibility along its length and shall not be construed to be limiting to the scope of the invention. 
     FIG. 4 illustrates an isometric view of the distal end  60  of the first tube or guide catheter  32  with a portion of the inner catheter assembly  14  protruding therefrom, and FIG. 5 illustrates an exploded view of the components of FIG.  4 . Illustrated in particular is the relationship of the components aligned in the distal end  60  of the first tube or guide catheter  32  during use of the invention, where an exhaust tube  72  in the form of a compliant expandable exhaust tube  72   a  is utilized. Guidewire  16  is not shown for purposes of brevity and clarity. The second tube  42  extends proximally through the flow director  48   a , and collectively the second tube  42  and the flow director  48   a  extend proximally through the first tube or guide catheter  32 . As illustrated in the unpressurized mode in FIG.  4  and as also illustrated in the unpressurized mode in FIG. 7, it is noted that an annulus  68  is formed between the interior annular surface  64  of the first tube or guide catheter  32  and an outer annular surface  70   a  of an exhaust tube  72 . During normal pressurized operation, an exhaust tube  72 , in this case a compliant expandable exhaust tube  72   a , expands to cause the outer annular surface  70   a  of an exhaust tube  72  to expand and impinge the interior annular surface  64  of the first tube or guide catheter  32 , thereby closing the annulus  68 , as later described in detail. The inner body  66  includes a reduced radius neck  74  interrupted by an annular barb  76  both of which are accommodated by the interior annular surface  78  at the distal end  57  of exhaust tube  72 . The reduced radius neck  74  also includes a slotted cutout  80  (FIG. 10) for mounting, such as by welds  81  and  83  or other suitable means, of the distal end  50  of the second tube  42 . Also included, and as shown in FIGS. 5 and 7, in the interior of the inner body  66  is a passage  82  having a ramped annular surface  84 . A space  88  is located between the inner body  66  and the jet emanator  52  where the thrombus is macerated and then pushed through the flow director  48   a  and into the first tube or guide catheter  32  for removal from the body. 
     During performance of the method of the invention the outer catheter assembly  12  is advanced along a vein or other blood vessel or passage to a vascular site containing thrombus followed by the passage of the guidewire  16  through and beyond the distal end  60  of the first tube or guide catheter  32  and thence followed by advancement of the inner catheter assembly  14  along the guidewire  16  and along the interior of the outer catheter assembly  12 . As the second tube  42  is positioned, during pressurized or unpressurized operation, the flow director  48   a , the jet emanator  52 , the optional jet cap  54 , along with the second tube  42 , move and position as a unit to a desired position along a variable displacement distance  86  which is the distance from the distal end  60  of the first tube or guide catheter  32  to and including the optional jet cap  54 . The variable displacement distance  86  can range from a minimum distance where the jet emanator  52 , or the optional jet cap  54 , at the distal end  50  of the second tube  42  is positioned just inside the distal end  60  of the first tube or guide catheter  32 , where no thrombus ablation occurs, to a maximum distance where the jet emanator  52 , or the optional jet cap  54 , has advanced to a position well beyond the distal end  60  of the first tube or guide catheter  32 , thus positioning the proximal end  63  of an exhaust tube  72  along a region proximal to the distal end  60  of the first tube or guide catheter  32 , whereby a major portion of the exhaust tube  72 , the entire inner body  66 , the jet emanator  52 , and the optional jet cap  54  are distally located with reference to the distal end  60  of the first tube or guide catheter  32 . At or near this extended position, further distal movement is prevented by impingement of the transitional filter housing/high pressure connection/stop assembly  44  with the hemostasis nut/stop  22 , which are shown in FIG.  2 . 
     FIG. 6 illustrates an isometric view of one jet emanator  52  means, being a toroidal loop  52   a , which may be utilized at the distal end  50  of the second tube  42  to direct high velocity jet streams proximally along or near the longitudinal axis of the second tube  42  and an exhaust tube  72 . Any jet emanator means such as the ones shown herein or the ones shown in related patent application Ser. No. 09/417,395 by the inventors which comprise a distal tubular structure of a high pressure tubular means, such as the second tube  42 , through which pressurized fluid flows creating high velocity fluid jets which emanate from one or more orifices in the distal tubular structure, can be used. The distal tubular structure can be of straight, curved, L-shaped, J-shaped, U-shaped, helical, toroidal or semi-toroidal shape, or can be a chamber such as a manifold, and may be formed of a single component, such as a metal hypo-tube, or of multiple components, such as multiple hypo-tubes, welded manifold components, or molded manifold components. The distal tubular structure forming the jet emanator means may be formed as a unitary part of the high pressure tubular means such as by forming a metal hypo-tube into a toroidal shape, or one of the other shapes mentioned above, with a single orifice or multiple orifices produced by drilling or cutting. The orifices can be round, slits, or other shapes so that fluid flowing therethrough forms one or more discrete high velocity fluid jets or merges into combination jets. Alternatively, the distal tubular structure forming the jet emanator means may be a separate structure having any one of the aforementioned shapes and orifice constructions which is attached to the distal end of the high pressure tubular means. In either event, the distal tubular structure forming the jet emanator means is in fluid communication with the high pressure tubular means. In any circumstance, highly pressurized fluid(s) first passes through a lumen of the high pressure tubular means enroute to the variously shaped and configured distally located jet emanator means. 
     As previously mentioned, FIG. 6 illustrates an isometric view of the jet emanator  52  in the form of a toroidal loop  52   a  which is located at the distal end  50  of the second tube  42 , the jet emanator  52  being sometimes referred to as a jet body. Illustrated in particular are a plurality of proximally directed jet orifices  90   a - 90   n  located on the proximal surface of the toroidal loop  52   a  which direct high velocity jet streams proximally, as shown by dashed lines, along or near the longitudinal axis of the second tube  42  and the exhaust tube  72  which, of course, can be one of several styles described. The toroidal loop  52   a  includes a circular passage  53  along the inner circumference to provide for, to accommodate alignment of, and to permit passage along a guidewire, such as the guidewire  16  shown partially in FIG.  18 . Multiple jet orifices  90   a - 90   n  located at points along the toroidal loop  52   a  can advantageously direct high velocity jet streams on multiple sides of the guidewire  16  when it is positioned in the passage  53  to avoid having guidewire  16  block or hamper the macerating effect of the jet streams on thrombotic matter. 
     FIGS. 7,  8  and  9  substantially illustrate the mutual accommodation and the alignment of the distal portions of the outer catheter assembly  12  and inner catheter assembly  14 , where exhaust tube  72  is in the form of a compliant expandable exhaust tube  72   a.    
     FIG. 7 illustrates a cross section view of the distal end  60  of the first tube or guide catheter  32  and the flow director  48   a  in the unpressurized mode, including the second tube  42  and the flow director  48   a  in extended concentric alignment with the first tube or guide catheter  32  and associated components, along line  7 — 7  of FIG.  2 . Illustrated in particular is the relationship of the interior annular surface  64  of the first tube or guide catheter  32  and the outer annular surface  70   a  of an exhaust tube  72 , in the form of a compliant expandable exhaust tube  72   a , which form the annulus  68  which is elongated. Typically, the compliant expandable exhaust tube  72   a  can be fashioned of, but not limited to, materials such as urethane or silicone, for example. A horizontally aligned slotted cutout  80  (FIG. 10) in the upper region of the inner body  66  accommodates the distal end  50  of the second tube  42  which suitably secures and seals therein. Also illustrated is the optional jet cap  54  which secures at the distal end  50  of the second tube  42  over and about the jet emanator  52 . The optional jet cap  54  includes passage  55  which intersects a proximally facing annular capturing cavity  92  which accommodatingly accepts and fits and secures to the toroidal loop  52   a , a jet emanator  52 . Jet orifices  90   a - 90   n  located on toroidal loop  52   a  at the distal end  50  of the second tube  42  are directed rearwardly and slightly towards the longitudinal axis of the exhaust tube  72  and of the inner body  66 . The predetermined and suitable space  88  is located between the proximal region of a jet emanator  52 , and, in general, the distal end  57  of the exhaust tube  72 , and, more specifically, the distal end of the ramped annular surface  84  of the inner body  66 . The maximum distal position of the space  88  with relation to the distal end  50  of the second tube  42  can be determined, if so constructed using a suitable length second tube  42 , by the relationship of the distal end of the transitional filter housing/high pressure connection/stop assembly  44  (FIG. 2) and the hemostasis nut/stop  22  which contact each other to limit the distal movement of the second tube  42 . The location of space  88  can also be determined by observation of the relationship of one or more of the following components, including the radio-opaque marker  56  at the distal end  60  of the first tube or guide catheter  32 , the radio-opaque marker  59 , the radio-opaque marker  58 , the inner body  66 , the jet cap  54 , or of other components by known observation methods. The second tube  42  can be fashioned of material such as, but not limited to, stainless steel or nickel titanium alloys. 
     FIG. 8 illustrates a cross section view of the elements of FIG. 7, including the second tube  42  and the flow director  48   a  in extended concentric alignment with the first tube or guide catheter  32  and associated components in the pressurized mode. Subsequent to proper positioning of the appropriate component of the invention in a vessel or other body member in the unpressurized mode, saline  94 , under high pressure, is injected through the inner catheter assembly  14  through a high pressure lumen  93  of the second tube  42  and delivered to the distal end  50  to emanate as saline jet flow  96  from the jet orifices  90   a - 90   n  of the toroidal loop  52   a . The pressurized saline jet flow  96  is directed partially into the ramped annular surface  84  and the passage  82  of the inner body  66  and partially into the lumen  98  of the exhaust tube  72  to pressurize the exhaust tube  72  causing the exhaust tube  72  in the form of a compliant expandable exhaust tube  72   a  to expand and force the outer annular surface  70  of the exhaust tube  72  to seal against the interior annular surface  64  of the first tube or guide catheter  32 . The saline jet flow  96  also flows to entrain thrombotic tissue adjacent to or lying within the space  88  to break up and erode the thrombotic tissue. Positive pressurized flow of the pressurized saline and the entrained particles of thrombotic tissue is prevented from back flowing out of the previously open annulus  68  which has been subsequently closed by the seal between the inner catheter assembly  14  within the outer catheter assembly  12  and is allowed to travel under full pressurized force along the lumen  98  of the exhaust tube  72  and along a lumen  100  central to the first tube or guide catheter  32  and thence through a catheter lumen interior to the manifold  20  and outwardly through the angled manifold branch  30 . The ability to insert and maneuver the inner catheter assembly  14  within the outer catheter assembly  12  freely and unhampered and then to subsequently effect a seal between the inner catheter assembly  14  and the outer catheter assembly  12  while maintaining maneuverability contributes to the novelty, efficiency, and usefulness of the method of the invention. 
     FIG. 9 illustrates a cross section view of the elements of FIG. 7, including the second tube  42  and the flow director  48   a  in extended concentric alignment with the first tube or guide catheter  32  and associated components in a partially pressurized mode or when the expandable exhaust tube is deliberately undersized to prevent a complete seal from being made. This figure illustrates the partially pressurized mode where it is desirable to have the annulus  68  reduced in size from that shown in FIG.  7 . Such reduction allows more freedom of longitudinal and rotational movement and maneuverability between the inner catheter assembly  14  and the outer catheter assembly  12  while still maintaining a suitable seal. Freedom of rotational movement is desirable to permit greater flexibility with respect to full and effective radial positioning of the space  88 . Sufficient saline pressure may still be maintained and any pressure loss through the reduced size annulus  68  is negligible. 
     FIG. 10 illustrates a cross section view of the junction of the inner body  66  and the exhaust tube  72  along line  10 — 10  of FIG.  7 . Illustrated in particular is the mounting and the securing of the second tube  42  to opposing sides of the slotted cutout  80  in the reduced radius neck  74  and/or ramped annular surface  84  of the inner body  66  by welds  81  and  83 . Positioning and securing of the second tube  42  in the upper region of the inner body  66  ensures alignment of the optional jet cap  54  and a jet emanator  52  with the inner body  66 . 
     FIG. 11 illustrates a cross section view at the distal end  60  of the first tube or guide catheter  32  along line  11 — 11  of FIG. 7 in the unpressurized mode. Illustrated in particular is the annulus  68  between the interior annular surface  64  and the outer annular surface  70 . Annulus  68  allows for ready and adequate passage of the flow director  48   a  through the first tube or guide catheter  32  subsequent to positioning of the outer catheter assembly  12  (FIG.  3 ). 
     FIG. 12 illustrates a cross section view at the distal end  60  of the first tube or guide catheter  32  along line  12 — 12  of FIG. 8 in the pressurized mode. Illustrated in particular is the closing or elimination of the annulus  68  (FIG. 7) between the interior annular surface  64  and the outer annular surface  70   a . Closing of the annulus  68  allows for sealing of the flow director  48   a  against the interior annular surface  64  to maintain full pressurization. 
     FIG. 13 illustrates a cross section view at the distal end  60  of the first tube or guide catheter  32  along line  13 — 13  of FIG. 9 in the partially pressurized mode or non-sealing design. Illustrated in particular is the reduction in size of the annulus  68  (FIG. 7) between the interior annular surface  64  and the outer annular surface  70   a.    
     FIG. 14, a first alternative embodiment, illustrates a cross section view of the elements such as described in FIG. 7, including the second tube  42  and an optional flow director  48   b  in loose and non-regular alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as previous embodiments, but differs from the previous embodiments in that an optional flow director  48   b  is provided which includes the components of the flow director  48   a  with the exception of an exhaust tube  72  in the form of an optional non-compliant expandable exhaust tube  72 b. The non-compliant expandable exhaust tube  72   b  can be fashioned of material, such as, but not limited to, flexible polyethylene or polyethylene terephthalate, for example, and can be expanded from an irregular or baggy appearing tubular structure to a regular appearing shaped structure, such as shown in FIG.  15 . 
     FIG. 15 illustrates a cross section view of the elements of FIG. 14 in the pressurized mode where the exhaust tube  72  in the form of a non-compliant expandable exhaust tube  72   b  is pressurized by high pressure saline  94  emanating as saline jet flow  96  from a jet emanator  52 , depicted more specifically as a toroidal loop  52   a , thereby causing the non-compliant expandable exhaust tube  72   b  to expandingly assume a regular shape and structure which forces the outer surface  70   b  (now annular) to closingly seal against the interior annular surface  64  of the first tube or guide catheter  32  to close the previously open annulus  68 . 
     FIG. 16, a second alternative embodiment, illustrates a cross section view of the elements such as depicted in FIG. 7, including the second tube  42  and an optional flow director  48   c  in extended concentric alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as previous embodiments, but differs from the previous embodiments in that an optional flow director  48   c  is provided which includes the components of the flow director  48   a  with the exception of an exhaust tube  72  in the form of an optional non-expandable, non-compliant close fit exhaust tube  72   c . The non-expandable, non-compliant close fit exhaust tube  72   c  can be fashioned of material, such as, but not limited to, PEBAX or nylon copolymer, for example, and is of a regular shaped structure, such as, but not limited to, a tube. This figure illustrates the pressurized mode where it is desirable to have the annulus  68  not entirely closed. Such an arrangement allows more freedom of longitudinal and rotational movement and maneuverability between the inner catheter assembly  14  and the outer catheter assembly  12  while still maintaining a suitable seal. Freedom of rotational and longitudinal movement is desirable to permit greater flexibility with respect to full and effective positioning of the space  88 . Sufficient saline pressure may still be maintained and any pressure loss through the reduced size annulus  68  is negligible. 
     FIG. 17, a third alternative embodiment, illustrates a cross section view of the elements of FIG. 7, including the second tube  42  and an optional flow director  48   d  in extended concentric alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as previous embodiments, but differs from the previous embodiments in that an optional flow director  48   d  is provided which includes the components of the flow director  48   a  of FIG. 7 with the exception of an exhaust tube  72  in the form of an optional compliant/non-compliant exhaust tube  72   d  having continuous segments of different durometer characteristics whereby one segment is of different flexibility than an adjacent segment. Segment  102   a  is of a durometer reading consistent with the compliant expandable exhaust tube  72   a , previously described, which allows expansion of the segment  102   a , such as previously described. Segment  102   b , however, is of a durometer reading which is consistent with the non-compliant expandable exhaust tube  72   b  such that expansion of the segment  102   b  is prevented or limited by its own structure to maintain a constant or near constant diameter. Alternatively, the segments  102   a  and  102   b  could be of separate construction and joined such as by gluing, ultrasonic welding, fusing, or any suitable method to provide the compliant/non-compliant exhaust tube  72   d.    
     MODE OF OPERATION 
     FIG. 18 illustrates a cross section view in partial cutaway of the distal end of the single operator exchange fluid jet thrombectomy device  10  in operation in a blood vessel  104 . FIG. 18, with reference to elements previously described in relation to FIGS. 1-13, best illustrates the mode of operation of the single operator exchange fluid jet thrombectomy device  10  in the performance of the method of the present invention, with particular attention to the distal end  60  of the first tube or guide catheter  32 , the flow director  48   a , the second tube  42 , the jet emanator  52  and the optional jet cap  54  and guidewire  16  positioned in a blood vessel  104 , artery or the like at the site of a thrombotic deposit or lesion  106 . 
     The first tube or guide catheter  32 , which is flexible and which serves as a flexible evacuation tube, is first advanced to reach a location proximal of the thrombotic deposit or lesion  106 . With the distal end  60  of the first tube or guide catheter  32  positioned near the thrombotic deposit or lesion  106 , the flexible tip  18  of the guidewire  16  is then introduced into the first tube or guide catheter  32  via the manifold  20  and thence the guidewire  16  is advanced through and past the distal end  60  of the first tube or guide catheter  32  and then along a blood vessel  104  or vein in the patient&#39;s body. The guidewire  16  is advanced through the vasculature to and beyond the site of the thrombotic deposit or lesion  106 . For a distal coronary vessel or a vessel of the brain, typically the guidewire has a diameter which can range from 0.010-0.018 inch. This procedure can also be applied to larger vessels which require larger diameter guidewires up to 0.038 inch. Once the guidewire  16  has been advanced along the blood vessel  104  and has reached or has been advanced through the thrombotic deposit or lesion  106 , the inner catheter assembly  14  can be brought into engagement with the catheter assembly  12 . Such engagement is initiated by accommodation of the guidewire  16  by the passage  53  of the jet emanator  52  and the passage  55  of the optional jet cap  54 , if incorporated. The inner catheter assembly  14  is then advanced distally whereby the proximal end  17  of the guidewire  16  enters the space  88  and the components of the flow director  48   a  to subsequently extend proximally from the flow director  48   a . Further advancement of the inner catheter assembly  14  along the guidewire  16  brings the jet emanator  52  and optional jet cap  54  and the flow director  48   a  of the inner catheter assembly  14  and the second tube  42  into aligned accommodation initially by the manifold  20  and then by the first tube or guide catheter  32 . The jet emanator  52 , the optional jet cap  54 , the flow director  48   a , which can have a lubricous coating to aid in deployment through the lumen  100  of the first tube or guide catheter  32 , and the second tube  42  are then advanced within the lumen  100  of the first tube or guide catheter  32  to a position along the variable displacement distance  86  where the distal end  57  of the exhaust tube  72 , in this case in the form of a compliant expandable exhaust tube  72   a , and including the inner body  66  are positioned as desired beyond the distal end  60  of the first tube or guide catheter  32 , whereby the exhaust tube  72  is aligned to the distal end  60  of the first tube or guide catheter  32 . The passage  82  of the inner body  66 , the lumen  98  of the exhaust tube  72 , and the lumen  100  of the first tube or guide catheter  32  serve as an evacuation tube. The single operator exchange fluid jet thrombectomy device  10  can then be activated by providing high pressure liquid, preferably saline, to the proximal end  33  of the first tube or guide catheter  32  via the manifold  20 . 
     High pressure saline  94 , or other liquid, from the manifold  20  is provided and flows through the high pressure lumen  93  of the second tube  42  to enter orifices  90   a - 90   n  of the jet emanator  52 . The high pressure saline exits the jet emanator  52  as high velocity saline jet flow  96  directed toward the open ramped annular surface  84  and enters into the passage  82  of the inner body  66  at the distal end  57  of the exhaust tube  72 . The high pressure saline jet flow operates to close the annulus  68  to ensure positive flow without leak-back through an annulus such as annulus  68 , as previously described, and to dislodge tissue from the thrombotic deposit or lesion  106  and entrain the tissue into the saline jet flow  96  where it is broken up into smaller fragments and carried proximally. 
     Impingement of the saline jet flow  96  into the flow director  48   a  and the first tube or guide catheter  32  creates a stagnation pressure within the lumen  98  of the exhaust tube  72  and the lumen  100  of the first tube or guide catheter  32  (evacuation lumen) that drives the debris particles of thrombotic deposit or lesion  106  toward the proximal end  33  of the first tube or guide catheter  32 . 
     Subsequent to initial activation, the inner catheter assembly  14  can be advanced over the guidewire  16  through tortuous turns to reach the thrombotic deposits or lesions  106  beyond the region of initial ablative action for further ablative action. 
     A positive displacement piston pump (not illustrated) can be used to provide liquid, preferably saline, under pressure to the proximal end of the second tube  42 . A pressure ranging from 50-50,000 psi will provide the energy to create a useful high velocity saline jet flow  96  as the saline exits the jet orifices  90   a - 90   n  located at the proximal surface of the jet emanator  52 . The flow rate of saline can be controlled by adjusting the pumping rate of the positive displacement piston pump. The proximal end  33  of the first tube or guide catheter  32  interfaces with a metering device through the Luer connection  26  at the manifold branch  30 , for example, a roller pump, prior to discharge of the evacuated thrombotic debris into a collection bag for disposal. The rate of evacuation can be controlled by adjusting the rate of the roller pump. The rate of saline inflow can be balanced with the rate of removal of thrombotic debris by simultaneous adjustment of the piston pump and the roller pump. The rate of saline inflow can be less than, equal to, or greater than the rate of removal of thrombotic debris. The rate of thrombus removal can be set to slightly exceed the rate of saline inflow to reduce the likelihood for distal embolization of thrombotic tissue. 
     Because numerous modifications may be made to the method without departing from the spirit thereof, the scope of the method is not to be limited to the embodiments illustrated and described that are involved in the method. Rather, the scope of the method is to be determined by the appended claims and their equivalents. 
     FIG. 19, a fourth alternative embodiment, illustrates a side view of a single operator exchange fluid jet thrombectomy device  110  useful for the removal of thrombus, and FIG. 20 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device  110 . The single operator exchange fluid jet thrombectomy device  110  includes two major assemblies: namely, an outer catheter assembly  12 , as previously described in detail and which is a core assembly, and an inner catheter assembly  114  configured to function as a crossflow thrombectomy catheter, which has been substituted or exchanged for the previously described inner catheter assembly  14  and which is shown as an example of inner catheter assemblies which can be exchanged with other styles or designs of inner catheter assemblies as desired to fit substantially within and to be incorporated with the outer catheter assembly  12 . The inner catheter assembly  114 , when in use, aligns substantially concentrically to and mostly within the outer catheter assembly  12  and extends beyond both ends of the outer catheter assembly  12 . Guidewire  16  including a flexible tip  18  at one end and a proximal end  17  opposing the flexible tip  18  is shown in substantially concentric alignment to both the outer catheter assembly  12  and the inner catheter assembly  114 . Externally visible components, or portions of components, of the outer catheter assembly  12  correspond to the previous descriptions. Much of the structure of the previously described inner catheter assembly  14  is incorporated and utilized in the inner catheter assembly  114 . Externally visible components or portions of components of the inner catheter assembly  114  of the single operator exchange fluid jet thrombectomy device  110  include the high pressure second tube  42 , the transitional filter housing/high pressure connection/stop assembly  44  concentrically aligned to and secured over and about the proximal end  46  of the second tube  42 , a crossflow/flow director  116   a  having a lumen  154  (FIG. 24) and comprised substantially of an exhaust tube  122  in the form of a compliant expandable exhaust tube  122   a  aligned over and about the distal end  50  (FIG. 4) of the high pressure second tube  42 , a flexible tapered tip  117  having a passage  119  (FIG. 21) and being contiguous with and extending distally from the exhaust tube  122  of the crossflow/flow director  116   a , the end of the flexible tapered tip  117  at the passage  119  being the distal end  124  of the inner catheter assembly  114 , a jet emanator  52  having a passage  53  (FIG. 22) at the distal end  50  of the second tube  42 , and a radio-opaque marker  118  located along and at the distal end  120  of the crossflow/flow director  116   a  and aligned adjacent to and in close proximity to the jet emanator  52  to mark the substantially co-located distal end  50  of the second tube  42  and distal end  120  of the crossflow/flow director  116   a . An optional radio-opaque marker  126  can also be located and attached to or be integral to the proximal end  128  of the crossflow/flow director  116   a  and included, along with radio-opaque marker  118 , as an optional integral part of the crossflow/flow director  116   a . An inner body  130  of either metal or plastic (FIG.  22 ), part of the crossflow/flow director  116   a , frictionally engages the distal end  120  of the crossflow/flow director  116   a  interior of the exhaust tube  122  of the crossflow/flow director  116   a , as shown in FIG.  24 . Also featured on the exhaust tube  122  of the crossflow/flow director  116   a  are one or more outflow orifices  134  and one or more inflow orifices  136  for creating a crossflow so that the inner catheter assembly will function as a crossflow thrombectomy catheter. An optional radio-opaque marker  127  can be included on the exhaust tube  122  of the crossflow/flow director  116   a  between one or more outflow orifices  134  and one or more inflow orifices  136 . 
     FIG. 21 illustrates an isometric view of the distal end  60  of the first tube or guide catheter  32  with a portion of the inner catheter assembly  114  protruding therefrom, and FIG. 22 illustrates an exploded view of the components of FIG.  21 . Illustrated in particular is the relationship of the components aligned in the distal end  60  of the first tube or guide catheter  32  during use of the invention. Guidewire  16  is not shown for purposes of brevity and clarity. The second tube  42  extends proximally through the crossflow/flow director  116   a , and collectively the second tube  42  and the crossflow/flow director  116   a  extend proximally through the first tube or guide catheter  32 . As illustrated in the unpressurized mode and as also illustrated in FIG. 24, it is noted that an annulus  138  is formed between the interior annular surface  64  of the first tube or guide catheter  32  and an outer annular surface  140  of the exhaust tube  122 , which is in the form of a compliant expandable exhaust tube  122   a . The inner body  130  includes a reduced radius neck  142  extending proximally from a larger radius shoulder  144  and also includes a passage  146  for accommodation of the guidewire  16 . The jet emanator  52 , in the form of a toroidal loop  52   a , aligns to and secures, such as by welding, gluing or other suitable means, to the proximal region of the inner body  130 , as shown in FIG.  24 . Swaging of the radio-opaque marker  118  over the exhaust tube  122  and inner body  130  secures the assembly in order to keep the distance from the jet emanator  52  and inflow orifices  136  constant for optimal thrombectomy function. During normal pressurized operation, the exhaust tube  122  expands to cause the outer annular surface  140  of the exhaust tube  122  to expand and impinge the interior annular surface  64  of the first tube or guide catheter  32 , thereby closing and eliminating the annulus  138 , much the same as previously described for use of the inner catheter assembly  14  with the outer catheter assembly  12  and as later shown in FIG.  25 . Also, pressurized saline flow passes from the outflow orifice(s)  134  to dislodge thrombotic materials which are returned to the interior of lumen  154  of the crossflow/flow director  116   a  through the inflow orifice(s)  136  where the thrombus is macerated and then pushed through the crossflow/flow director  116   a  and into the first tube or guide catheter  32  for removal from the body. 
     During performance of the method of the invention the outer catheter assembly  12  is advanced along a vein or other blood vessel or passage proximal to a vascular site containing thrombus followed by the passage of the guidewire  16  through and beyond the distal end  60  of the first tube or guide catheter  32  and thence followed by advancement of the inner catheter assembly  114  along the guidewire  16  and along the interior of the outer catheter assembly  12 . As the second tube  42  is positioned, during pressurized or unpressurized operation, the crossflow/flow director  116   a , the jet emanator  52 , along with the second tube  42 , move and position as a unit to a desired position along a variable displacement distance  148  which is the distance from the distal end  60  of the first tube or guide catheter  32  to and including the distal end  120  of the crossflow/flow director  116   a . The variable displacement distance  148  can range from a minimum distance where the jet emanator  52  at the distal end  50  of the second tube  42  (distal end  120  of the crossflow/flow director  116   a ) is positioned just inside the distal end  60  of the first tube or guide catheter  32 , where no thrombus ablation occurs, to a maximum distance where the jet emanator  52  has advanced to a position well beyond the distal end  60  of the first tube or guide catheter  32 , thus positioning the proximal end  128  of the crossflow/flow director  116   a  along a region proximal to the distal end  60  of the first tube or guide catheter  32 , whereby a major portion of the exhaust tube  122 , the entire inner body  130 , and the jet emanator  52  are distally located with reference to the distal end  60  of the first tube or guide catheter  32 . Incremental advancement distally of the crossflow/flow director  116   a  distally reveals the inflow orifice(s)  136  and the outflow orifice(s)  134  sequentially. In some cases, it would be advantageous to operate with the outflow orifices  134  blocked when treating a soft unstable thrombus to remove easily embolized material, and then operate with the outflow orifices  134  exposed to remove the more strongly adherent thrombus or other tissue. At or near this extended position, further distal movement is prevented by impingement of the transitional filter housing/high pressure connection/stop assembly  44  with the hemostasis nut/stop  22 , which are shown in FIG.  19 . 
     FIG. 23, a fifth alternative embodiment, illustrates a view of the elements of FIG. 6 including one or more optional outflow orifice(s)  170  for incorporation of saline crossflow with the inner catheter assembly  14  of the single operator exchange fluid jet thrombectomy device shown in FIG.  2 . High pressure saline jet flow  96  emanating from the jet emanator  52  initially enters passage  82 , flows through passage  82  into the exhaust tube  72  to outflow orifice(s)  170 , exits radially to form a crossflow jet  172  to impinge and entrain thrombotic deposits or lesions, and thence is directed distally and drawn again through passage  82  of the inner body  66 , which functions as an inflow orifice, where the thrombotic deposits or lesions are macerated by the high pressure saline jet flow  96  to be further entrained by the high pressure saline jet flow  96  for travel along the lumen  98  of the exhaust tube  72 . Thus, maceration including the attributes of saline crossflow jets, such as crossflow jet  172 , and the attributes of maceration occurring at the space  88  are combined. 
     FIGS. 24 and 25 substantially illustrate the mutual accommodation and the alignment of the distal portions of the outer catheter assembly  12  and inner catheter assembly  114 . 
     FIG. 24 illustrates a cross section view of the distal end  60  of the first tube or guide catheter  32  and the crossflow/flow director  116   a  in the unpressurized mode, including the second tube  42  and the crossflow/flow director  116   a  in extended concentric alignment with the first tube or guide catheter  32  and associated components, along line  24 — 24  of FIG.  19 . Illustrated in particular is the relationship of the interior annular surface  64  of the first tube or guide catheter  32  and the outer annular surface  140  of the exhaust tube  122 , in the form of a compliant expandable exhaust tube  122   a , which form the annulus  138  which is elongated. Jet orifices  90   a - 90   n  (FIG. 6) located at jet emanator  52  at the distal end  50  of the second tube  42  are directed rearwardly and slightly towards the longitudinal axis of the exhaust tube  122 . 
     The maximum distal position of the distal end  50  of the second tube  42  with respect to the distal end  60  of the first tube or guide catheter  32  can be determined by using a suitable length second tube  42 . The distal end of the transitional filter housing/high pressure connection/stop assembly  44  (FIG. 19) and the hemostasis nut/stop  22  (FIG. 19) can contact each other to limit the distal movement of the second tube  42  and the attached crossflow/flow director  116   a . The location of the crossflow/flow director  116   a  and its position with respect to the distal end  60  of the first tube or guide catheter  32  can also be determined by observation of the relationship of one or more of the following components, including the radio-opaque marker  56  at the distal end  60  of the first tube or guide catheter  232 , the radio-opaque markers  126  and  127 , the radio-opaque marker  118 , the inner body  130 , the flexible tapered tip  117 , or of other components by known observation methods. 
     FIG. 25 illustrates a cross section view of the elements of FIG. 24, including the second tube  42  and the crossflow/flow director  116   a  in extended concentric alignment with the first tube or guide catheter  32  and associated components, in the pressurized mode. Subsequent to proper positioning of the appropriate component involved in the method in a vessel or other body member in the unpressurized mode, saline  150 , under high pressure, is injected through the inner catheter assembly  114  through the high pressure lumen  93  of the second tube  42  and delivered to the distal end  50  to emanate as saline jet flow  152  from the jet orifices  90   a - 90   n  of the jet emanator  52 . The pressurized saline jet flow  152  is directed proximally into the lumen  154  of the crossflow/flow director  116   a  where it (1) operates to pressurize the exhaust tube  122  causing the exhaust tube  122 , in the form of a compliant expandable exhaust tube  122   a , to expand and force the outer annular surface  140  of the exhaust tube  122  to closingly seal against the interior annular surface  64  of the first tube or guide catheter  32 , (2) exits one or more outflow orifices  134  to break up and erode the thrombotic tissue, and (3) entrains loosened thrombotic tissue adjacent to and about the exposed portion of the crossflow/flow director  116   a  and to return the loosened thrombotic material through one or more inflow orifices  136 . Positive pressurized flow of the pressurized saline prevents saline from back flowing out of the previously open annulus  138  which has been pressurized to the closed position by creation of a seal between the inner catheter assembly  114  within the outer catheter assembly  12  and allows the saline to travel while carrying the entrained particles of thrombotic tissue under full pressurized force along the lumen  154  of the crossflow/flow director  116   a  and along a lumen  100  central to the first tube or guide catheter  32  and thence through a catheter lumen interior to the manifold  20  and outwardly through the angled manifold branch  30  where its flow may or may not be regulated. The ability to insert and maneuver the inner catheter assembly  114  within the outer catheter assembly  12  freely and unhampered and then to subsequently effect a seal between the inner catheter assembly  114  and the outer catheter assembly  12  while maintaining maneuverability contributes to the novelty, efficiency, and usefulness of the method of the invention. 
     FIG. 26, a sixth alternative embodiment, illustrates a cross section view of the elements of FIG. 24, including the second tube  42  and an optional crossflow/flow director  116   b  in loose and non-regular alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as a previous embodiment(s), but differs from the previous embodiments in that an optional crossflow/flow director  116   b  is provided which includes the components of the crossflow/flow director  116   a  with the exception of an exhaust tube  122  in the form of a non-compliant expandable exhaust tube  122   b . The non-compliant expandable exhaust tube  122   b  can be fashioned of material, such as, but not limited to, flexible polyethylene or polyethylene terephthalate, for example, and can be expanded from an irregular or baggy appearing tubular structure to a regular appearing shaped structure, such as shown in FIG.  27 . 
     FIG. 27 illustrates a cross section view of the elements of FIG. 26 in the pressurized mode where the exhaust tube  122  in the form of a non-compliant expandable exhaust tube  122   b  is pressurized by high pressure saline  150  emanating as saline jet flow  152  from a jet emanator  52 , depicted specifically as a toroidal loop  52   a , thereby causing the non-compliant expandable exhaust tube  122   b  to expandingly assume a regular shape and structure which forces the outer surface  140  (now annular) to closingly seal against the interior annular surface  64  of the first tube or guide catheter  32  to close the previously open annulus  138 . 
     FIG. 28, a seventh alternative embodiment, illustrates a cross section view of the elements of FIG. 24, including the second tube  42  and an optional flow director  116   c  in extended concentric alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as previous embodiments, but differs from the previous embodiments in that an optional flow director  116   c  is provided which includes the components of the flow director  116   a  with the exception of an exhaust tube  122  in the form of an optional non-expandable, non-compliant close fit exhaust tube  122   c . The non-expandable, non-compliant close fit exhaust tube  122   c  can be fashioned of material, such as, but not limited to, PEBAX or nylon copolymer, for example, and is of a regular shaped structure, such as, but not limited to, a tube. This figure illustrates the pressurized mode where it is desirable to have the annulus  138  not entirely closed. Such an arrangement allows more freedom of longitudinal and rotational movement and maneuverability between the inner catheter assembly  114  and the outer catheter assembly  12  while still maintaining a suitable seal. Freedom of rotational movement is desirable to permit greater flexibility with respect to full and effective radial positioning of the inner catheter assembly  114 . Sufficient saline pressure may still be maintained and any pressure loss through the reduced size annulus  138  is negligible. 
     FIG. 29, an eighth alternative embodiment, illustrates a cross section view of the elements of FIG. 24, including the second tube  42  and an optional flow director  116 d in extended concentric alignment with the first tube or guide catheter  32  and associated components. This embodiment operates much the same as previous embodiments, but differs from the previous embodiments in that an optional flow director  116   d  is provided which includes the components of the flow director  116   a  of FIG. 24 with the exception of an exhaust tube  122  in the form of an optional compliant/non-compliant exhaust tube  122   d  having continuous segments of different durometer characteristics whereby one segment is more flexible than an adjacent segment. Segment  214   a  is of a durometer reading consistent with the compliant expandable exhaust tube  122   a  previously described which allows expansion of the segment  214   a , such as previously described. Segment  214   b , however, is of a durometer reading which is consistent with the non-compliant expandable exhaust tube  122   b  such that expansion of the segment  214   b  is prevented or limited by its own structure to maintain a constant or near constant diameter. Alternatively, the segments  214   a  and  214   b  could be of separate construction and joined such as by gluing, ultrasonic welding, fusing, or any suitable method to provide complaint/non-compliant the exhaust tube  122   d.    
     MODE OF OPERATION 
     FIG. 30 illustrates a cross section view in partial cutaway of the mode of operation of the single operator exchange fluid jet thrombectomy device  110  in the performance of the method of the present invention, with particular attention to the distal end  120  of the crossflow/flow director  116   a  and the flexible tapered tip  117  positioned in a blood vessel  156 , artery or the like at the site of a thrombotic deposit or lesion  158 . High velocity jet flow  152  of saline (or other suitable fluid) is shown being emitted in a proximal direction from the jet emanator  52  to sealingly expand the exhaust tube  122  of the crossflow/flow director  116   a  and to impinge upon and carry away thrombotic deposits or lesions  158 . Other jet emanators can be incorporated at the distal end  50  of the second tube  42  as an alternative to the jet emanator  52  illustrated in this figure to emanate or emit one or more high velocity jet flow(s)  152  distally along or near the longitudinal axis of the second tube  42  and the exhaust tube  122  to accomplish the same purpose as that described for the jet emanator  52 . The high velocity jet flow(s)  152  of saline pass outwardly through the outflow orifice(s)  134  in a radial direction creating crossflow jet(s)  160  (lower velocity jet(s)) directed outwardly toward the wall of the blood vessel  156  and are influenced by the low pressure at the inflow orifice(s)  136  to cause the crossflow jet(s)  160  to flow circumferentially and distally to impinge on, provide drag forces on, and break up thrombotic deposits or lesions  158  and to, by entrainment, urge and carry along the particles of thrombotic deposits or lesions  158  through the inflow orifice(s)  136 , a relatively low pressure region, into the high velocity jet flows  152  where the thrombus is further macerated into microscopic particles, and into the exhaust lumen  154  (FIG.  24 ). The entrainment through the inflow orifice(s)  136  is based on entrainment by the high velocity jet flow(s)  152 . The outflow is driven by internal pressure which is created by the high velocity jet flow(s)  152  and the fluid entrained through the inflow orifice(s)  136 . Enhanced clot removal is attainable because of the recirculation pattern established between inflow and outflow orifices  136  and  134 , which creates a flow field that maximizes drag force on wall-adhered thrombus. Since the entrained thrombus is macerated into microscopic particles, those particles that exit the outflow orifices  134  are not of sufficient size to significantly block the distal circulation, and will be re-entrained into the inflow orifices  136  at a high rate. 
     FIGS. 31 and 32, a ninth alternative embodiment, illustrate an exploded view and an assembled view of a jet emanator in the form of a jet cap  220 , which can be utilized in the inner catheter assembly  114  of the single operator fluid jet exchange thrombectomy device  110 . The jet cap  220  is substantially a combination of an emanator and an inner body and the jet cap  220  can be utilized in lieu of the jet emanator  52 , more specifically designated as a toroidal loop  52   a , and the inner body  130 . One portion of the jet cap  220  includes a main cylindrical-like body  222  having opposing annular rings  224  and  226  extending from the ends thereof, a guidewire lumen  228  extending through the main body  222 , an annular extension  230  extending outwardly from one end of the main body  222  and having an annular surface  232  which lies in the same plane as an annular surface  234  of the annular ring  224 , an annulus  236  between one end of the main body  222 , the annular ring  224  and the annular extension  230 , and an annular extension  238  extending outwardly from and beyond the annular surface  232  of the annular extension  230 . Another portion of the jet cap  220  includes a round plate  240  including a central hole  242 , a receptor hole  224  for accommodation of a second tube  42  and a plurality of jet orifices  246   a - 246   n  aligned concentric to the central hole  242 . 
     FIG. 33 illustrates a cross section view of the jet cap  220  along line  33 — 33  of FIG. 32, where all numerals correspond to those elements previously described. The central hole  242  of the round plate  240  utilizes the annular extension  238  to align the round plate  240  to the annular surface  232  and the annular surface  234  of the annular ring  224  and is suitably secured thereto. Such close alignment seals to the annulus  236  which forms a circular chamber for the distribution of high pressure saline through the sealed annulus  236 . Annular rings  224  and  226  can engage and are fixed in the interior annular surface  64  of an exhaust tube  122 . High pressure saline is delivered to the second tube  42 , which suitably secures in the receptor hole  244  located on the round plate  240  and as such is distributed through the sealed annulus  236  to emanate high pressure saline jet flow through the rearwardly directed jet orifices  246   a - 246   n.    
     FIG. 34, a tenth alternative embodiment, illustrates an isometric jet emanator in the form of a jet cap  250  having formed passages contained therein. The formed passage jet cap  250  has a one-piece body  252  which includes a rounded taper  254  tapering downwardly in the distal direction. A guidewire lumen  256  extends longitudinally through the body  252  extending between a, proximal surface  258  and a distal surface  259 . A U-shaped passageway  260 , for the conveyance of high pressure saline, is located interior to the body  252  and terminates at one end as a jet orifice  262  at the proximal surface  258  and at a receptor hole  264  for the accommodation of a second tube  42  at the proximal surface  258 . In the illustration, a second tube  42  is shown for delivery of high pressure saline to the passageway  260 . 
     FIG. 35 illustrates a side view of the formed passage jet cap  250  in use as an emanator, such as in use with a flow director  48   a  of a single operator fluid jet exchange thrombectomy device. The formed passage jet cap  250  can also be incorporated (not illustrated) with additional proximally located structure having inflow and outflow orifices, such as inflow orifice(s)  136  and outflow orifice(s)  134  shown previously, to function with a crossflow/flow director for configuration and use as a single operator jet exchange thrombectomy device having crossflow capabilities. 
     FIG. 36 illustrates a proximal end view of the formed passage jet cap  250 . 
     FIG. 37, an eleventh alternative embodiment, illustrates a cross section view of an inner body  180  along line  37 — 37  of FIG. 38, and FIG. 38 illustrates an end view of the inner body  180  along line  38 — 38  of FIG. 37, which can be substituted at one end of the inner catheter assembly  14 . More specifically, the inner body  180  can be substituted for the flow director  48   a  at the distal end  50  of the second tube  42 . The inner body  180 , which is cylindrically shaped, can be of plastic or other suitable material and includes a bore  181  for fixed accommodation of the second tube  42  extending longitudinally through the inner body  180  as well as a guidewire passage  183  extending longitudinally through the inner body  180 . The inner body  180  also includes a longitudinally aligned exhaust lumen  182  extending through the inner body  180  to communicate with the lumen  100  of the first tube or guide catheter  32 . A jet emanator  184 , which is curved, extends from the distal end  50  of the second tube  42  and is directed to align and to introduce a high pressure saline jet  186  with the exhaust lumen  182 . The high pressure saline jet  186  transits a space  188  between the curved jet emanator  184  and the distal end  190  of inner body  180  to contact and break away thrombotic material or lesions which are subsequently entrained therein to be evacuated via the exhaust lumen  182  and lumen  100  of the first tube or guide catheter  32  of the outer catheter assembly  12 . 
     FIG. 39, a twelfth alternative embodiment, illustrates a cross section view of an inner body  200  along line  39 — 39  of FIG. 40, and FIG. 40 illustrates an end view of the inner body  200  along line  40 — 40  of FIG. 39, which can be substituted at one end of the inner catheter assembly  14 . More specifically, the inner body  200  can be substituted for the flow director  48   a  at the distal end  50  of the second tube  42 . The inner body  200 , which is cylindrically shaped, can be of plastic or other suitable material and includes a bore  202  for fixed accommodation of the second tube  42  extending longitudinally through the inner body  200 , as well as a large multipurpose lumen  204  extending longitudinally through the inner body  200 . The multipurpose lumen  204  serves as an exhaust lumen and as a passage for accommodation of a guidewire. The multipurpose lumen  204  communicates with the lumen  100  of the first tube or guide catheter  32 . A jet emanator  206 , which is curved, and which is offset from the multipurpose lumen  204 , extends from the distal end  50  of the second tube  42  and is directed to align and to introduce a high pressure saline jet  208  with the multipurpose lumen  204 . The high pressure saline jet  208  transits a space  210  between the curved jet emanator  206  and the distal end  212  of inner body  200  to contact and break away thrombotic material or lesions which are subsequently entrained therein to be evacuated via the multi-purpose lumen  204  and lumen  100  of the first tube or guide catheter  32  of the outer catheter assembly  12 . 
     FIG. 41, a thirteenth alternative embodiment, illustrates a side view of a manifold  285  and a view in partial cross section of a first tube or guide catheter  270  which can be incorporated substantially in lieu of and resembling for the most a first tube or guide catheter  32 , previously illustrated, including a distal end  272  which is tapered, a passage  273  for a guidewire, a proximal end  274 , a Luer connection  276 , manipulating tabs  278  and  280 , a manifold branch  281  extending from the first tube or guide catheter  270  and a Luer connector  283  at the end of the manifold branch  281 , and other members as now described. The first tube or guide catheter  270  includes an inflatable balloon  282 , shown in the inflated mode, which is suitably secured to and which is located about one end of and near the distal end  272  of the tubular structure. A lumen  284  for effluent evacuation extends along the interior of the first tube or guide catheter  270 . An inflation lumen  286  partially utilizing the interior wall  288  extends partially along the length of the lumen  284  and connects with the manifold branch  281  and Luer connector  283  to communicate with and for inflation of the balloon  282 . Manifold  285 , similar to manifold  20  of FIG. 2, is provided including a hemostasis nut/stop  287  secured in the proximal end  289  of the manifold  285 , a Luer connection  291  located at the proximal end  293  of an angled manifold branch  295  extending from the manifold  285  and a Luer fitting  297  at the distal end  299  of the manifold  285 . 
     FIG. 42 illustrates the first tube or guide catheter  270  in use in a blood vessel  275 . The inflatable balloon  282  which inflates to contact and seal against the blood vessel  275  provides for a region of proximal occlusion  292  with respect to the location of the inflated balloon  282 , that region extending proximally from the inflated balloon  282  between the first tube or guide catheter  270  and the blood vessel  275 . Such a region of proximal occlusion  292  prevents thrombotic deposits or lesions from traveling proximally along and about the exterior of the first tube or guide catheter  270  and the interior of the blood vessel  275  and ensures removal of the thrombotic deposits or lesions along and through the lumen  284 . Cessation of flow also minimizes the possibility of distal embolization of thrombotic debris. Inflation of the balloon  282  provides for centering of the first tube or guide catheter  270  and a suitable jet emanator within the blood vessel  275  to provide for centrally located and evenly applied saline emanation which can also preclude having the jetted saline emitted dangerously close to the wall of the blood vessel  275 . Such centering allows for more powerful suction without damage to the blood vessel wall. 
     FIG. 43, a fourteenth alternative embodiment, includes the components and members described in FIG. 41, including an additional inflatable balloon  294  located proximal to the inflatable balloon  282  to provide a first tube or guide catheter  296  which can be incorporated substantially in lieu of and resembling for the most a first tube or guide catheter  32 , previously illustrated, including a distal end  272  which is tapered, a passage  273  for a guidewire, a proximal end  274 , a Luer connection  276 , manipulating tabs  278  and  280 , a manifold branch  281  extending from the first tube or guide catheter  270  and a Luer connector  283  at the end of the manifold branch  281 , and other members as now described. The first tube or guide catheter  296  includes inflatable balloons  282  and  294  shown in the inflated mode, which are suitably secured to and one of which, inflatable balloon  282 , is located about one end of and near the distal end  272  of the tubular structure and the other inflatable balloon  294  is located proximally and opposingly with respect to the inflatable balloon  282  on the tubular structure. A lumen  284  for effluent evacuation extends along the interior of the first tube or guide catheter  296 . An inflation lumen  286   a  partially utilizing the interior wall  288  extends the length of the lumen  284  and connects with the manifold branch  281  and the Luer connector  283  to communicate with and for inflation of the balloons  282  and  294 . A plurality of inflow orifices  298   a - 298   n  are included in the tubular structure to provide for suction of thrombus or other effluent through a flow director  300 , shown representatively in dashed lines in FIG.  44 . 
     FIG. 44 illustrates the first tube or guide catheter  296  in use in a blood vessel  275 . The inflatable balloons  282  and  294  which are inflated to contact and seal against the blood vessel  275  provide for a sealed region  302  extending proximally from the inflated balloon  282  and distally from the inflated balloon  294 , between the first tube or guide catheter  296  and the blood vessel  275 . Such a sealed region  302  of occlusion contains thrombotic deposits or lesions about the exterior of the first tube or guide catheter  296  and between the inflatable balloon  282  and  294  and ensures removal of the thrombotic deposits or lesions through the flow director  300 , the position of which can be varied longitudinally. Such an arrangement is also helpful in preventing proximal and distal embolizations. Inflation of the inflatable balloons  282  and  294  provides for centering of the first tube or guide catheter  296  within the blood vessel  275  to provide for centrally located and evenly applied saline emanation which can also preclude having the jetted saline emitted dangerously close to the wall of the blood vessel  275 . Such centering allows for more powerful suction without damage to the wall of the blood vessel  275 . 
     FIG. 45, a fifteenth alternative embodiment, illustrates a side view of a single operator exchange fluid jet thrombectomy device  310  which can be incorporated for the removal of thrombus, and FIG. 46 illustrates a semi-exploded side view of the single operator exchange fluid jet thrombectomy device  310 . The single operator exchange fluid jet thrombectomy device  310  includes two major assemblies: namely, an outer catheter assembly  12 , as previously described in detail and which is a core assembly, and an inner catheter assembly  314  configured to function as a thrombectomy catheter, which has been substituted or exchanged for the previously described inner catheter assembly  14  and which is shown as an example of inner catheter assemblies which can be exchanged with other styles or designs of inner catheter assemblies as desired to fit substantially within and to be incorporated with the outer catheter assembly  12 . The inner catheter assembly  314 , when in use, aligns mostly within the outer catheter assembly  12  and extends beyond both ends of the outer catheter assembly  12 , although the amount extending beyond both ends is not necessarily illustrated proportionally. Both the outer catheter assembly  12  and the inner catheter assembly  314  align over and about the guidewire  16  which includes a flexible tip  18  at one end and a proximal end  17  opposing the flexible tip  18 . Externally visible components, or portions of components, of the outer catheter assembly  12  correspond to the previous descriptions. Much of the structure of the previously described inner catheter assembly  14  is incorporated and utilized in the inner catheter assembly  314 . Externally visible components or portions of components of the inner catheter assembly  314  of the single operator exchange fluid jet thrombectomy device  310  include the high pressure second tube  42 , the transitional filter housing/high pressure connection/stop assembly  44  concentrically aligned to and secured over and about the proximal end  46  of the second tube  42 , and a jet emanator  52  consisting of a toroidal loop  52   a  having a passage  53  (FIG. 22) at the distal end  50  of the second tube  42 . Optionally, a jet cap, such as jet cap  54  of FIG. 2, can be included over and about the jet emanator  52  consisting of a toroidal loop  52   a . The inner catheter assembly  314  is  10  deployed within the outer catheter assembly  12  and is positioned to place the jet emanator  52  distal to the distal end  60  of the first tube or guide catheter  32  by a distance of 0.005 inch to 0.500 inch depending on the type of anatomy and material to be removed. 
     FIG. 47 illustrates a cross sectional view along line  47 — 47  of FIG. 45 of the single operator exchange fluid jet thrombectomy device  310  looking distally. The alignment of the jet emanator  52 , in this case, a toroidal loop  52   a , is such that saline jet flow  96  emanating from at least one of the jet orifices  90   a - 90   n  will impinge the lumen  100  of the first tube or guide catheter  32  to provide stagnation pressure for effluent evacuation. Other streams of saline jet flow  96  emanating from the jet orifices  90   a - 90   n  may not impinge the lumen  100 , as the device can be tailored and configured for particular anatomy and material to be removed to prevent undesirable damage from these jets. The saline jet flow emanating from the jet orifices  90   a - 90   n  creates suction and maceration forces at the distal end  60  of the first tube or guide catheter  32  for removal of undesirable material. 
     FIG. 48 illustrates the elements of FIG. 45 where the length of the second tube  42  is of a predetermined length, whereby the transitional filter housing/high pressure connection/stop assembly  44  impinges the hemostasis nut/stop  22  to limit the distance the jet emanator  52 , in this case a toroidal loop  52   a , can extend distally beyond the distal end  60  of the first tube or guide catheter  32  to prevent emanation of saline jet flow from one or more of the jet orifices  90   a - 90   n  from not impinging the lumen  100  of the first tube or guide catheter  32  in order to provide a maximum safe gap  316 , the distance between the jet emanator  52  and distal end  60  of the first tube or guide catheter  32 , in order to avoid undesirable damage to a vessel wall. 
     FIG. 49 illustrates a side view, and FIG. 50 illustrates a semi-exploded side view, of the elements and features of FIGS. 45,  46 ,  47  and  48  additionally including a centering ring  318  secured to the second tube  42  slightly proximal to the jet emanator  52 . The centering ring  318  is placed such that it remains housed within the first tube or guide catheter  32  to ensure coaxial positioning of the centering ring  318  within the first tube or guide catheter  32 . Such coaxial positioning ensures impingement of the saline jet flow emanating from the jet orifices  90   a - 90   n  with the lumen  100  of the first tube or guide catheter  32  and as such avoids having saline jet flow which does not impinge the lumen  100  of the first tube or guide catheter  32 . 
     FIG. 51 illustrates a cross section view of the single operator exchange fluid jet thrombectomy device  310  along line  51 — 51  of FIG. 49, wherein the centering ring  318  is utilized. The centering ring  318  is sized to allow longitudinal movement within and along the lumen  100  of the first tube or guide catheter  32 . A centering ring surround  320  extends inwardly from the centering ring  318  to surround and firmly attach to the second tube  42 . Such firm attachment maintains the aligned relationship of the jet emanator  52 , in this case a toroidal loop  52   a , with the second tube  42 . The aligned relationship, of course, is maintained as the second tube  42  is advanced to position the jet emanator  52  the desired distance beyond the distal end  60  of the first tube or guide catheter  32  to ensure alignment of all of the jet orifices  90   a - 90   n  with the lumen  100  at the distal end  60 . 
     Various modifications can be made to the present invention without departing from the apparent scope hereof. 
     
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 PARTS LIST 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                  10 
                 single operator exchange fluid jet 
               
               
                   
                   
                 thrombectomy device 
               
               
                   
                  12 
                 outer catheter assembly 
               
               
                   
                  14 
                 inner catheter assembly 
               
               
                   
                  16 
                 guidewire 
               
               
                   
                  17 
                 proximal end (of guidewire) 
               
               
                   
                  18 
                 flexible tip 
               
               
                   
                  20 
                 manifold 
               
               
                   
                  22 
                 hemostasis nut/stop 
               
               
                   
                  24 
                 proximal end (of manifold) 
               
               
                   
                  26 
                 Luer connection 
               
               
                   
                  28 
                 proximal end (of manifold branch) 
               
               
                   
                  30 
                 manifold branch 
               
               
                   
                  32 
                 first tube or guide catheter 
               
               
                   
                  33 
                 proximal end (of first tube or guide catheter) 
               
               
                   
                  34 
                 distal end (of manifold) 
               
               
                   
                  35 
                 Luer connection 
               
               
                   
                  36 
                 Luer fitting 
               
               
                   
                  38 
                 manipulating tab 
               
               
                   
                  40 
                 manipulating tab 
               
               
                   
                  42 
                 second tube 
               
               
                   
                  44 
                 transitional filter housing/high pressure 
               
               
                   
                   
                 connection/stop assembly 
               
               
                   
                  46 
                 proximal end (of second tube) 
               
               
                   
                  48a-d 
                 optional flow directors 
               
               
                   
                  50 
                 distal end (of second tube) 
               
               
                   
                  52 
                 jet emanator 
               
               
                   
                  52a 
                 toroidal loop 
               
               
                   
                  53 
                 passage 
               
               
                   
                  54 
                 jet cap 
               
               
                   
                  55 
                 passage 
               
               
                   
                  56 
                 radio-opaque marker (at distal end 
               
               
                   
                   
                 of first tube or guide catheter) 
               
               
                   
                  57 
                 distal end (of expandable exhaust tube) 
               
               
                   
                  58 
                 radio-opaque marker (at distal 
               
               
                   
                   
                 end of expandable exhaust tube) 
               
               
                   
                  59 
                 radio-opaque marker (at proximal 
               
               
                   
                   
                 end of expandable exhaust tube) 
               
               
                   
                  60 
                 distal end (of first tube or guide catheter) 
               
               
                   
                  62 
                 distal end (of inner catheter assembly) 
               
               
                   
                  63 
                 proximal end (of expandable exhaust tube) 
               
               
                   
                  64 
                 interior annular surface 
               
               
                   
                  66 
                 inner body 
               
               
                   
                  68 
                 annulus 
               
               
                   
                  70a 
                 outer annular surface 
               
               
                   
                  70b 
                 outer surface 
               
               
                   
                  72 
                 exhaust tube 
               
               
                   
                  72a 
                 compliant expandable exhaust tube 
               
               
                   
                  72b 
                 non-compliant expandable exhaust tube 
               
               
                   
                  72c 
                 non-expandable, non-compliant close 
               
               
                   
                   
                 fit exhaust tube 
               
               
                   
                  72d 
                 compliant/non-compliant exhaust tube 
               
               
                   
                  74 
                 reduced radius neck 
               
               
                   
                  76 
                 annular barb 
               
               
                   
                  78 
                 interior annular surface 
               
               
                   
                  80 
                 slotted cutout 
               
               
                   
                  81 
                 weld 
               
               
                   
                  82 
                 passage 
               
               
                   
                  83 
                 weld 
               
               
                   
                  84 
                 ramped annular surface 
               
               
                   
                  86 
                 variable displacement distance 
               
               
                   
                  88 
                 space 
               
               
                   
                  90a-n 
                 jet orifices 
               
               
                   
                  92 
                 capturing cavity 
               
               
                   
                  93 
                 high pressure lumen 
               
               
                   
                  94 
                 saline 
               
               
                   
                  96 
                 saline jet flow 
               
               
                   
                  98 
                 lumen (of expandable exhaust tube) 
               
               
                   
                 100 
                 lumen (of first tube or guide catheter) 
               
               
                   
                 102a-b 
                 segments 
               
               
                   
                 104 
                 blood vessel 
               
               
                   
                 106 
                 thrombotic deposit or lesion 
               
               
                   
                 110 
                 single operator exchange fluid 
               
               
                   
                   
                 jet thrombectomy device 
               
               
                   
                 114 
                 inner catheter assembly 
               
               
                   
                 116a-d 
                 crossflow/flow directors 
               
               
                   
                 117 
                 flexible tapered tip 
               
               
                   
                 118 
                 radio-opaque marker (at distal 
               
               
                   
                   
                 end of crossflow/flow director) 
               
               
                   
                 119 
                 passage 
               
               
                   
                 120 
                 distal end (of crossflow/flow director) 
               
               
                   
                 122 
                 exhaust tube 
               
               
                   
                 122a 
                 compliant expandable exhaust tube 
               
               
                   
                 122b 
                 non-compliant expandable exhaust tube 
               
               
                   
                 122c 
                 non-expandable, non-compliant 
               
               
                   
                   
                 close fit exhaust tube 
               
               
                   
                 122d 
                 compliant/non-compliant exhaust tube 
               
               
                   
                 124 
                 distal end (of inner catheter assembly) 
               
               
                   
                 126 
                 radio-opaque marker (at proximal 
               
               
                   
                   
                 end of crossflow/flow director) 
               
               
                   
                 127 
                 radio-opaque marker 
               
               
                   
                 128 
                 proximal end (of crossflow/flow director) 
               
               
                   
                 130 
                 inner body 
               
               
                   
                 134 
                 outflow orifice 
               
               
                   
                 136 
                 inflow orifice 
               
               
                   
                 138 
                 annulus 
               
               
                   
                 140 
                 outer annular surface 
               
               
                   
                 142 
                 reduced radius neck 
               
               
                   
                 144 
                 shoulder 
               
               
                   
                 146 
                 passage 
               
               
                   
                 148 
                 variable displacement distance 
               
               
                   
                 150 
                 saline 
               
               
                   
                 152 
                 saline jet flow 
               
               
                   
                 154 
                 lumen (of crossflow/flow director) 
               
               
                   
                 156 
                 blood vessel 
               
               
                   
                 158 
                 thrombotic deposit or lesion 
               
               
                   
                 160 
                 crossflow jet(s) 
               
               
                   
                 170 
                 outflow orifice(s) 
               
               
                   
                 172 
                 crossflow jet 
               
               
                   
                 180 
                 inner body 
               
               
                   
                 181 
                 bore 
               
               
                   
                 182 
                 exhaust lumen 
               
               
                   
                 183 
                 guidewire passage 
               
               
                   
                 184 
                 curved jet emanator 
               
               
                   
                 186 
                 saline jet 
               
               
                   
                 188 
                 space 
               
               
                   
                 190 
                 distal end (of inner body 180) 
               
               
                   
                 200 
                 inner body 
               
               
                   
                 202 
                 bore 
               
               
                   
                 204 
                 multi-purpose lumen 
               
               
                   
                 206 
                 curved jet emanator 
               
               
                   
                 208 
                 saline jet 
               
               
                   
                 210 
                 space 
               
               
                   
                 212 
                 distal end (of inner body 200) 
               
               
                   
                 214a-b 
                 segments 
               
               
                   
                 220 
                 jet cap 
               
               
                   
                 222 
                 main body 
               
               
                   
                 224 
                 annular ring 
               
               
                   
                 226 
                 annular ring 
               
               
                   
                 228 
                 guidewire lumen 
               
               
                   
                 230 
                 annular extension 
               
               
                   
                 232 
                 annular surface 
               
               
                   
                 234 
                 annular surface 
               
               
                   
                 236 
                 annulus 
               
               
                   
                 238 
                 annular extension 
               
               
                   
                 240 
                 round plate 
               
               
                   
                 242 
                 central hole 
               
               
                   
                 244 
                 receptor hole 
               
               
                   
                 246a-n 
                 jet orifices 
               
               
                   
                 250 
                 formed passage jet cap 
               
               
                   
                 252 
                 body 
               
               
                   
                 254 
                 rounded taper 
               
               
                   
                 256 
                 guidewire lumen 
               
               
                   
                 258 
                 proximal surface 
               
               
                   
                 259 
                 distal surface 
               
               
                   
                 260 
                 passageway 
               
               
                   
                 262 
                 jet orifice 
               
               
                   
                 264 
                 receptor hole 
               
               
                   
                 270 
                 first tube or guide catheter 
               
               
                   
                 272 
                 distal end 
               
               
                   
                 273 
                 passage 
               
               
                   
                 274 
                 proximal end 
               
               
                   
                 275 
                 blood vessel 
               
               
                   
                 276 
                 Luer connection 
               
               
                   
                 278 
                 manipulating tab 
               
               
                   
                 280 
                 manipulating tab 
               
               
                   
                 281 
                 manifold branch 
               
               
                   
                 282 
                 inflatable balloon 
               
               
                   
                 283 
                 Luer connector 
               
               
                   
                 284 
                 lumen 
               
               
                   
                 285 
                 manifold 
               
               
                   
                 286 
                 inflation lumen 
               
               
                   
                 286a 
                 inflation lumen 
               
               
                   
                 287 
                 hemostasis nut/stop 
               
               
                   
                 288 
                 interior wall 
               
               
                   
                 289 
                 proximal end 
               
               
                   
                 291 
                 Luer connection 
               
               
                   
                 292 
                 region of proximal occlusion 
               
               
                   
                 293 
                 proximal end 
               
               
                   
                 294 
                 inflatable balloon 
               
               
                   
                 295 
                 manifold branch 
               
               
                   
                 296 
                 first tube or guide catheter 
               
               
                   
                 297 
                 Luer fitting 
               
               
                   
                 298a-n 
                 inflow orifices 
               
               
                   
                 299 
                 distal end 
               
               
                   
                 300 
                 flow director 
               
               
                   
                 302 
                 sealed region 
               
               
                   
                 310 
                 single operator fluid jet 
               
               
                   
                   
                 thrombectomy device 
               
               
                   
                 314 
                 inner catheter assembly 
               
               
                   
                 316 
                 maximum safe gap 
               
               
                   
                 318 
                 centering ring 
               
               
                   
                 320 
                 centering ring surround