Abstract:
Methods of conducting thrombectomy procedures and deploying a thrombectomy catheter are disclosed. A thrombectomy procedure is conducted with a thrombectomy catheter deployment system. A drive unit configured to operate an infusion pump is provided. The drive unit is operable according to one or more operating modes. A preconnected and consolidated pump and catheter assembly configured for loading in the drive unit is also provided. The assembly is separate from the drive unit prior to loading. The infusion pump and a catheter of the assembly are in communication prior to loading. The assembly provides one or more digital instructions to the drive unit. The drive unit is operable according to the one or more operating modes referenced by the one or more digital instructions. The assembly is loaded into the drive unit, and the drive unit is engaged to the infusion pump for operation of the infusion pump.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     This application is a division of U.S. patent application Ser. No. 11/237,558, filed Sep. 28, 2005 now U.S. Pat. No. 7,935,077, entitled “Thrombectomy Catheter Deployment System”, which is hereby incorporated into this application by reference as if fully set forth herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     In the human body blockages in blood vessels, arteries and the like often oppose the free flow of blood therein, one such blockage of which is thrombus. Thrombus is coagulated blood that is developed invivo. Thrombus blocks blood flow to living tissue leading to ischemia and eventually tissue death. Depending on the end organ and the amount of blocked blood flow, the effects of thrombus can range from unnoticeable to patient death. Thrombus residing in a variety of native vessels and grafts can be treated. The occurrence and presence of thrombus occurs in several ways. First, it occurs in coronary procedures where thrombus is associated with myocardial infarction or heart attack. Thrombus is also common in older saphenous vein bypass grafts. Second, peripheral artery interventional procedures can encounter thrombus as well. The use of synthetic grafts and stents for the treatment of peripheral arterial disease can produce thrombus as a result of blood material interactions. Furthermore, thrombus can be formed resulting from the progression of the peripheral artery disease itself. As the artery becomes blocked with atherosclerotic material, thrombus can result as blood passes through the restricted diseased vessel. Venous thrombus can result from either vessel injury or hypercoagulable blood chemistry. Finally, interventional procedures themselves can create thrombus. Access to the patient&#39;s arterial vascular system is commonly accomplished via a femoral artery puncture. At the end of the procedure, the puncture site must be closed by either applying pressure until a natural thrombotic plug forms or using an arterial closure product which typically uses some sort of collagen plug or suture. In either case, thrombus can form at the puncture site and move down the femoral artery. Furthermore, during the interventional procedure itself, foreign materials such as catheters and guidewires are introduced into the patient&#39;s blood stream. The patient needs anticoagulants, typically heparin, to prevent the occurrence of thrombus. On occasion, inattention to activated clotting times can result in the occurrence of thrombus during the procedure. Third, other parts that have been treated by thrombectomy catheters include arterial-venous access grafts for hemodialysis patients. Thrombectomy catheters have proven effective in opening these grafts that occasionally become blocked with thrombus. Thrombectomy catheters have also been used in the venous system for deep vein thrombosis and occasionally in neurological venous applications. Finally, thrombectomy catheters have been clinically investigated in neurological arterial applications as well. In general, thrombectomy catheters have a potential application wherever thrombus forms in native arteries, veins and grafts. Having developed such thrombectomy catheters, there exists a need for a deployment system to allow simple and rapid use of a thrombectomy catheter and the devices supporting use of the thrombectomy catheter. 
     2. Description of the Prior Art 
     Comparison of Prior Art Devices to the Present Invention 
     Current thrombectomy catheter utilization devices consist of a drive unit, disposable components including a variety of sterile thrombectomy catheters, a transportable sterile pump, bubble detectors, a saline supply tube/bag spike assembly, a nonsterile waste or effluent collection bag, and other associated components. Often, the use of such devices is overall cumbersome involving a large number of setup steps required for preparation and use. The current setup steps are roughly as follows (assuming the drive unit is on):
         (1) open sterile package for the pump set;   (2) do a sterile exchange to hand off the catheter connection end of the pump supply line to the sterile technician;   (3) preclamp a Roberts clamp for the saline supply tube line;   (4) load the pump into the capture block while simultaneously loading the pump piston head into a reciprocating ram;   (5) spike a heparinized bag of saline;   (6) install the saline supply tube into an inlet bubble detector;   (7) unclamp the bag spike Roberts clamp to enable the pump to become primed;   (8) open the effluent collection bag packaging and remove the effluent collection bag;   (9) attach the effluent return tube to the proximal end of the pump supply line effluent connection;   (10) hang the effluent collection bag on the side of the drive unit;   (11) install the effluent waste tube through the roller pump;   (12) close the roller pump cover;   (13) push the effluent waste tube into the outlet bubble detector just proximal to the roller pump;   (14) select the catheter mode on the drive unit;   (15) open the catheter sterile packaging;   (16) do a sterile exchange to hand off the entire catheter to the sterile technician;   (17) connect the high pressure connection from the pump supply line to the catheter;   (18) connect the effluent Luer connection from the supply line to the catheter; and,   (19) submerge the catheter tip in a bowl of sterile saline and operate a drive unit foot switch to prime the catheter.       

     Compare this to the thrombectomy catheter deployment system, the present invention, having a plurality of preconnected components where the setup consists of:
         (1) opening sterile package for the pump and catheter assembly;   (2) doing a sterile exchange to hand off the catheter to the sterile technician;   (3) loading the pump/catheter assembly into a capture block in the drive unit (this will automatically position the attached effluent collection bag in a supported position to the front of the drive unit);   (4) spiking a heparinized bag of saline; and,   (5) submerging the catheter tip in a bowl of sterile saline and operating the drive unit to prime the catheter.       

     Other differences concern the drive unit itself. Current drive units are electrically operated analog devices with a very small number of available modes. The drive unit of the thrombectomy catheter deployment system uses digital technology to enable thousands of modes. The analog technology in current drive units require calibration of several pot style resistors to modify an existing mode to produce a new mode profile. This would be conducted in the field by a service technician. The thrombectomy catheter deployment system inputs the mode information automatically via a barcode or radio frequency identification technology so no hardware or software changes are required by any field service staff when new modes are added or deleted from the thrombectomy catheter deployment system operation portfolio. 
     Current generation drive units have sequentiality built into the setup steps. The drive unit must turn on and go through self-test prior to placing the pump into the capture block. The pump must be loaded prior to spiking the saline supply bag, etc. Compare this to the instant invention where the disposable pump/catheter assembly can be loaded prior to turning on the drive unit. Furthermore, the saline supply bag can be spiked prior to or after loading the pump. The only step that requires sequentiality is priming the catheter (the saline supply bag must be spiked and the pump must be in the drive unit in order to operate the catheter so that the catheter can be primed). Current thrombectomy utilization devices have alarm conditions that hinder the setup procedure including detection of air from the saline supply tube/bag spike assembly. For example, forgetting to preclamp the Roberts clamp on the drive often results in air being introduced into the pump and trips an alarm. The thrombectomy catheter deployment system, the present invention, uses a saline supply tube/bag spike assembly and a drive unit which prevent air introduction into the pump and includes a mechanism in the drive unit to correct itself by a repeated pump prime action to remove air from the pump; i.e., the drive unit burps the pump if air is in the pump. 
     Current thrombectomy catheter utilization devices involve substantially a two-handed installation maneuver where a pump body is aligned within a capture block in the drive unit while a piston head of the pump is simultaneously loaded into a receptor in a reciprocating linear actuator. Each manual maneuver requires devoted attention and coordination by the operator. Contrast this to the thrombectomy catheter deployment system, the present invention, where a preconnected pump/catheter assembly is simply placed in a capture block whereupon, by command, the capture block and the preconnected pump/catheter assembly is positioned to cause automatic engagement of the pump piston head with a reciprocating linear actuator without any extraordinary effort by the operator. 
     Combining the thrombectomy catheter and pump enables positioning of the high pressure saline supply tube inside the effluent return tube in coaxial fashion, thereby reducing parts and bulk, making it easier to handle and package. The high pressure saline supply tube is a metal hypotube that delivers saline from the output of the pump to the thrombectomy catheter. The high pressure saline supply tube extends through a connection manifold assembly and through the lumen of the effluent return tube. The effluent return tube delivers macerated thrombus/blood back to an effluent collection bag via the connection manifold assembly and an effluent waste tube. The connection manifold assembly includes a plastic connector on a proximal port. The connection manifold assembly serves as a junction between the effluent return tube and the effluent waste tube. 
     Current manifolds of the thrombectomy catheter utilization devices include four ports: a hemostatic valve for a guidewire, a port for the catheter tube, a port for the supply tube/catheter hypotube, and a port for effluent. The connection manifold assembly of the thrombectomy catheter deployment system, the present invention, only requires three ports: a proximal port for the hemostatic valve, a distal port for the effluent waste tube, and a distal port for the coaxially aligned high pressure saline supply tube/effluent return tube. Since the high pressure saline supply tube is inside the effluent return tube, there is only one port on the connection manifold assembly needed instead of the two on a current art manifold. Furthermore, removing a port removes the ability of the physician to inject contrast through the catheter. This is a safety concern, since contrast injection through the catheter has been associated with unintended air introduction into the patient. Also, combining the pump and catheter as an assembly minimizes the ports on the connection manifold assembly and prevents unauthorized fluid introduction. 
     Occasionally, a pump with a sticky inlet check ball will lead to priming difficulties. Often, current pumps have valves utilizing a stainless steel ball in communication with a high tolerance peened metal surface of a ball seat to serve as an inlet check valve. The ball seat in each pump is peened with a ball to create an ideal sealing surface. Peening of the ball seat is critical. If the surface is overpeened by using excessive force with an excessively small ball for peening, the ball can become stuck in the ball seat. If the surface is not sufficiently peened, such as by an excessively large ball with insufficient force, the check ball will not seal properly and flow will go out past the check ball rather than out the pump outlet to the thrombectomy catheter. The design of an insert molded pump in the thrombectomy catheter deployment system is intended to prevent the incidence of something called sticky check balls. The insert molded pump of the present invention has a much larger stainless steel ball (0.172 inch versus 0.078 inch diameter for example and illustration), and the ball seals against a molded plastic seat to prevent the occurrence of sticky check balls. The use of an insert molded pump also provides for more economy and size and tolerance predictability. 
     SUMMARY OF THE INVENTION 
     The general purpose of the present invention is to provide a thrombectomy catheter deployment system. 
     Current thrombectomy catheter utilization devices include a nondisposable drive unit which accommodates disposable components such as a catheter, a pump, a waste bag, bubble traps, a bag spike, and other closely associated components which are loaded into or closely associated with the drive unit support structures which are used to operate a thrombectomy catheter where the use of such is characterized by customers as a relatively difficult to use system. The discovery of thrombus during an interventional procedure is often an unexpected and emergency situation. The ability to set up the thrombectomy catheter utilization devices as rapidly as other common interventional tools would be highly beneficial. For example, balloon catheters take only seconds to prime. Although a well trained individual can set up a thrombectomy catheter utilization device in less than a minute, current thrombectomy catheter utilization devices have limited tolerance for nonsequential setup steps. Any miscue by the user can easily extend the setup time beyond one minute, and in some cases the setup time can exceed 30 minutes, especially for untrained personnel. In an effort to dramatically improve the ease of use and rapid deployment for a thrombectomy catheter utilization device, the thrombectomy catheter deployment system, the present invention, removes many setup steps and alarms, such as found in prior art thrombectomy catheter utilization devices. Fundamental to the thrombectomy catheter deployment system is the combination of a pump and a thrombectomy catheter, as well as other closely associated components broadly known as a disposable pump/catheter assembly. This combination in itself removes multiple assembly steps for the disposable pump/catheter assembly. Most importantly, the disposable pump/catheter assembly is incorporated into use with a nondisposable onboard roller pump to ensure that isovolumetric flow is achieved. Isovolumetric flow means that the flow rate of the effluent flow (blood, saline, and macerated thrombus) equals the flow rate of saline infused into the patient. The combination of the pump and catheter enables each disposable assembly to be tested to ensure that the fluid restrictions are appropriate to achieve this balanced flow. Typically, thrombectomy catheters remove more flow from the patient than the infused flow rate. Consequently, the roller pump is utilized to function as a fluid restrictor. 
     Other detractions to the quick and simple utilization of the thrombectomy catheter utilization devices include realization and observation of operating parameters requiring operator intervention or input of such information being referred to as operating mode which conveys particulars concerning pump stroke length, downstroke speed, acceleration time, deceleration time, upstroke speed, and total cycle time. Operating mode is the position versus time curve for the pump ram. It is clearly important information for operating a thrombectomy catheter utilization device, but many users have no idea what mode information means. The idea of an operating mode is foreign to the user. Therefore, barcode information regarding the pump and the catheter are displayed on the pump and automatically detected by the drive unit of the thrombectomy catheter deployment system without user intervention. Such collective information regarding the pump and catheter combination is included on the barcode for operation of the particular pump and particular catheter combination as determined during the manufacturing process. Thereby, calibration between the pump/catheter assembly with the control circuitry of the drive unit is automatic, requiring no operator action. The use of a barcode enables essentially unlimited numbers of modes to be conveyed to the drive unit since the aforementioned mode particulars will all be part of the barcode information. Thus, no field upgrade is needed for either hardware or software when a new mode is developed for a new catheter. Without the combination of the pump/catheter assembly, operation would be extremely difficult. 
     The mode information directs the drive unit to operate the pump at a flow rate appropriate to the attached catheter. The catheter is the primary fluid restrictor. Therefore, the catheter design is what determines which mode is appropriate. The mode is the flow rate versus time curve. For example, one could have a 0.5 sec. downstroke and a 0.5 sec. upstroke. Alternatively, one could have a 0.3 sec. downstroke and a 0.7 sec. upstroke. Both would give 60 strokes per minute, but are different modes. By combining the pump and catheter, the barcode information on the pump applies to the integral catheter. 
     The barcode is also an important feature for preventing unauthorized competitive products to be used on proprietary drive units of the instant invention. The safety of the thrombectomy catheter deployment system considers all aspects of the system including the disposable pump, disposable catheter, saline supply tube/bag spike assembly, effluent collection bag, and drive unit. The ability to use the barcode information to prevent unauthorized products from being used on the thrombectomy catheter deployment system is fundamental for ensuring safety and preventing the thrombectomy catheter deployment system drive unit from being damaged. 
     The general purpose of the present invention is a thrombectomy catheter deployment system. The thrombectomy catheter deployment system is designed to include structure to successfully deploy and support the use of an included thrombectomy catheter, wherein multiple, high velocity saline jets at the distal end of a catheter remove unorganized/(relatively fresh) thrombus from arteries and vascular grafts or percutaneously lyse and remove unorganized (relatively fresh) thrombus from arteries and vascular grafts. One of the main and central components of the thrombectomy catheter deployment system includes a broadly encompassing pump/catheter assembly which is disposable and of single use, having, in part, a thrombectomy catheter and connected pulsatile pump, various tubing, and an effluent collection bag. Another main and central component of the thrombectomy catheter deployment system is a drive unit which is nondisposable and which accommodates the pump/catheter assembly about or within the drive unit enclosure. The drive unit includes a carriage assembly and a reciprocating linear actuator, each for the accommodation of the pump/catheter assembly. The drive unit also includes an operator interface and other components essential for operation of the instant invention. The carriage assembly readily and simply accommodates the pump/catheter assembly, which is disposable, and positions the pump piston head of the pump for automatic connection to the reciprocating linear actuator. The reciprocating linear actuator drives the pump to pressurize saline and supply high pressure saline to the thrombectomy catheter. Jet streams are created at the distal tip of the catheter tube by high pressure saline being introduced through small orifices. The saline is sprayed out through the jet orifices indirectly into the vascular segment being treated. The high velocity saline jets are proximally directed and create a localized vacuum at the catheter tip that results in the entrainment, dissociation, and ultimate evacuation of blood, saline, and thrombus into an external effluent collection bag. The macerated thrombus is pushed through the evacuation lumen of the effluent return tube due to the dynamic pressure generated by proximally directed jets. Secondary flow patterns of fluid (blood, saline) created by the jets provide a disruption of the thrombus and assist in the delivery of thrombus fragments into the pathway of the proximally directed saline jets for further ablation and removal. The secondary flow provides sufficient mixing in the vessel to allow thrombus ablation and removal in a vessel that is larger in diameter than the catheter shaft. 
     The thrombectomy catheter deployment system uses isovolumetric flow where the effluent flow rate being evacuated from the vessel is the same as the infused flow rate of saline delivered to the thrombectomy catheter. In general, the effluent flow rate without a roller pump is larger than the infused flow rate. The thrombectomy catheter deployment system uses a roller pump on the effluent waste tube to apply a restriction to ensure that the effluent flow rate is the same as the infused flow rate. Also, the roller pump prevents blood flow through the thrombectomy catheter to the effluent collection bag during periods when the catheter tube is in the patient but the catheter tube is not being activated. The thrombectomy catheter deployment system uses an automatically engaging structure to engage the effluent waste tube with the roller pump. No extra user intervention is required to install the effluent waste tube into the roller pump engaging structure. The benefit of this approach for flow control is the elimination of user interaction to install the effluent waste tube in the roller pump assembly. 
     The drive unit contains a positionable carriage assembly and a specially designed reciprocating linear actuator that engages the pump piston head without user intervention. A capture block is included in a positionable carriage assembly. When the carriage assembly is extended to the open position, the pump/catheter assembly is manually placed into the capture block followed by closing of the carriage assembly. The reciprocating linear actuator contains spring pawls located in a pump connector, a capture mechanism, that enables the reciprocating linear actuator to vertically engage the pump piston head as the reciprocating linear actuator is lowered onto the pump piston head. The reciprocating linear actuator is the moving part of the drive unit that reciprocatingly moves the piston of the pump up and down to provide high pressure saline for use in the thrombectomy catheter. At the end of the procedure, sliding disengagement of the pump piston head from the pump connector of the reciprocating linear actuator occurs in a horizontal direction when the carriage assembly and capture block position the pump forward from the pump connector. 
     The thrombectomy catheter deployment system employs an insert molded pump. Insert molding the pump enables the pump to be made economically, while still maintaining adequate integrity. Molding the plastic and glass-filled nylon about a stainless steel insert enables the high tolerance fits to be created by the molding process rather than have high tolerance fits machined into the stainless steel parts. Insert molding the pump also reduces the weight of the pump, making the packaging easier, as generally packaging robustness needs to increase with increased weight of the packaged item. Finally, insert molding enables the elimination of several of the components, thus further reducing cost and complexity. 
     The thrombectomy catheter deployment system contains a barcode reader for automatic mode selection and for pertinent data regarding the individual catheter tube and individual pump and associated operating parameters. The need for service to upgrade the software on the drive unit for new catheter modes is eliminated as the information can be contained on the barcode. Also eliminated is the need for the customer to input the mode information. The barcode information is protected by a data protection scheme, computer redundancy check (CRC), that ensures that the mode information is input into the drive unit in a reliable fashion. Furthermore, a special alphanumeric sequence, or encryption technique, can be built into the barcode information to ensure that only authorized proprietary catheters and pumps are used in the thrombectomy catheter deployment system. Note that the barcode and the barcode reader may, in fact, be a radio-frequency transponder and reader or other equivalent digital tagging technology. 
     A bag spike and associated components are included which minimize bubble formation for use with a bubble trap. The bag spike is designed to prevent a continuous stream of bubbles from entering the pump. The bag spike uses a high flow spike, as well as larger inside diameter tubing, to reduce the fluid restriction between the bag and the pump. Furthermore, the bubble trap is positioned at the pump inlet. The bubble trap is designed with interior walls to enhance debubbling of the saline prior to the pump inlet. Therefore, if the bag spike or saline supply tube is perforated, any bubbles that enter the tube will be removed by the bubble trap. If the bubble trap itself were to develop a perforation, the saline would leak out rather than suck air into the trap since it is attached directly at the pump inlet and has sufficiently low fluid restriction. 
     According to one or more embodiments of the present invention, there is provided a thrombectomy catheter deployment system including a drive unit and a pump/catheter assembly. The drive unit includes necessary components providing for transporting of the drive unit, including wheels, a brake, and a handle, and also contains support devices for operation of the invention. Centrally located automatically opening doors accommodate movement of a carriage assembly inwardly and outwardly to and from the interior of the drive unit. The carriage assembly accommodates a manually-placed pump/catheter assembly which is transported into or out of the interior of the drive unit for automatic engagement with a reciprocating linear actuator. A user interface is incorporated at the upper region of the drive unit. The pump/catheter assembly includes a plurality of preconnected components including, but not limited to, a pump, a thrombectomy catheter, a bubble trap, a connection manifold assembly at the bubble trap, an effluent waste tube, an effluent collection bag, a saline supply tube, a bag spike, and a coaxial high pressure saline supply tube and effluent return tube connected to the thrombectomy catheter. 
     One significant aspect and feature of the present invention is a thrombectomy catheter deployment system which greatly simplifies setup procedures for deployment and operation of a thrombectomy catheter. 
     Another significant aspect and feature of the present invention is a thrombectomy catheter deployment system incorporating a drive unit and a pump/catheter assembly. 
     Another significant aspect and feature of the present invention is the use of a pump/catheter assembly which is disposable and which is one use. 
     Still another significant aspect and feature of the present invention is a thrombectomy catheter deployment system having a carriage assembly in a drive unit which accommodates a pump/catheter assembly. 
     Yet another significant aspect and feature of the present invention is the utilization of a pump/catheter assembly where the pump/catheter assembly has preconnected components including a pump, a thrombectomy catheter, a bubble trap, a connection manifold assembly at the bubble trap, an effluent waste tube, an effluent collection bag, a saline supply tube, a bag spike, and a coaxial high pressure saline supply tube and effluent return tube connected to the thrombectomy catheter. 
     Yet another significant aspect and feature of the present invention is the direct connection of a bubble trap to the pump of the pump/catheter assembly to effectively debubble saline solution. 
     A further significant aspect and feature of the present invention is the use of a pump/catheter assembly wherein the pump of the pump/catheter assembly is positioned by a carriage assembly for automatic capture or release of a pump piston head by a pump connector of a reciprocating linear actuator. 
     A further significant aspect and feature of the present invention is the outward positioning of a carriage assembly to cause release of a pump piston head from the pump connector. 
     A further significant aspect and feature of the present invention is the use of a pump/catheter assembly wherein the effluent waste tube of the pump/catheter assembly is automatically engaged or disengaged by a roller pump. 
     A further significant aspect and feature of the present invention is the use of a roller pump in engagement with an effluent waste tube to achieve isovolumetric flow control. 
     A still further significant aspect and feature of the present invention is the use of an insert molded pump incorporating close tolerance molded components including a molded check ball seat. 
     A further significant aspect and feature of the present invention is the incorporation of a barcode reader in a drive unit to read a barcode on a pump/catheter assembly. 
     A still further significant aspect and feature of the present invention is the use of barcode information to access data regarding the individual pump and the individual thrombectomy catheter of a pump/catheter assembly. 
     A still further significant aspect and feature of the present invention is the use of barcode information to reprogram the operation of the drive unit. 
     A still further significant aspect and feature of the present invention is the use of barcode information to hinder the use of unauthorized pump/catheter assemblies. 
     A further significant aspect and feature of the present invention is the use of a saline supply tube/bag spike assembly with large tubing incorporated for bubble-free transfer of saline. 
     Having thus briefly described the present invention and mentioned some significant aspects and features thereof, it is the principal object of the present invention to provide a thrombectomy catheter deployment system. 
    
    
     
       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 view of a thrombectomy catheter deployment system, the present invention; 
         FIG. 2  is a view of the thrombectomy catheter deployment system where external panels of the drive unit have been removed to reveal components residing in the drive unit; 
         FIG. 3  is a rear view of the drive unit; 
         FIG. 4  is a rear view of the drive unit where panels have been removed to reveal components residing in the drive unit; 
         FIG. 5  is an exterior view of the pump, the bubble trap, the connection manifold assembly, and a fixture of the pump/catheter assembly; 
         FIG. 6  is a semi-exploded side view of the elements of  FIG. 5  illustrating the relationship of the pump, the bubble trap, the connection manifold assembly, and the fixture; 
         FIG. 7  is a cross section view of the majority of the elements of  FIGS. 5 and 6  showing the complete mating of the pump, the bubble trap, and the connection manifold assembly; 
         FIG. 8  is a view showing components which locate centrally in the instant invention and which are of major significance to the operation of the instant invention, including a carriage assembly, a pump aligned within and capturing components of the carriage assembly, and a linear actuator assembly in alignment to specific regions of the carriage assembly and to the pump; 
         FIG. 9  illustrates the alignment of  FIGS. 10   a  and  10   b  with respect to each other; 
         FIGS. 10   a  and  10   b  combine to show an exploded isometric view of the components comprising the carriage assembly, and  FIG. 10   c  references the relationship of a pivotable top mounting plate to a configured bracket and a load cell; 
         FIG. 11  is a right side top view of the carriage assembly; 
         FIG. 12  is a right side bottom view of the carriage assembly; 
         FIG. 13  is a left side top view of the carriage assembly; 
         FIG. 14  is a left side bottom view of the carriage assembly; 
         FIG. 15  is a top view of the carriage assembly where the cover and the carriage plate have been removed; 
         FIG. 16  is a bottom view of the carriage assembly where the bottom mounting plate and the configured bracket have been removed; 
         FIG. 17  is an isometric view of the front and one side of the carriage assembly without the cover where the pump is secured thereto; 
         FIG. 18  is an isometric view of the rear and one side of the carriage assembly without the cover where the pump is secured thereto; 
         FIG. 19  is an isometric view of the linear actuator assembly and an exploded view of a pump connector; 
         FIG. 20  is a cross section view of the pump connector and a front view of the pump piston head and piston in alignment below the pump connector; 
         FIG. 21  is a cross section view of the pump connector and a front view of the pump piston head and piston where the pump piston head firmly engages the pump connector; 
         FIG. 22  is a cross section side view of the pump connector and a side view of the pump piston head and piston where the pump piston head firmly engages the pump connector by action of spring pawls; 
         FIG. 23  is a cross section side view of the pump connector and a side view of the pump piston head and piston where the pump piston head has been disengaged from the pump connector; 
         FIG. 24  is an isometric view of the pump piston head showing the relationship of the arcuate ribs to the spaces and of the protuberances to the central body; 
         FIG. 25  is an isometric view of the pump prior to insertion into and accommodation by the capture block of the carriage assembly; and, 
         FIG. 26  is a barcode flow chart. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1  is a view of a thrombectomy catheter deployment system  10 , the present invention. Directly visible in the illustration are a drive unit  12  and a pump/catheter assembly  14  comprising the thrombectomy catheter deployment system  10 . Shown on the drive unit  12  are a plurality of removable panels  16   a - 16   n  about and along the drive unit  12  enclosing structure exposed to view in  FIG. 2 . Centrally located in the drive unit  12  and aligned to the lower region of the panel  16   g  are automatically opening doors  18  and  20  which open to expose the interior of the drive unit  12  and the rear portion of a carriage assembly  22  also shown in  FIG. 2 . The front portion of the carriage assembly  22 , which accommodates the pump/catheter assembly  14 , is shown extending from the interior of the drive unit  12  beneath the closed doors  18  and  20 . The carriage assembly  22  is rearwardly and forwardly positionable to the closed and open positions, respectively. A removable drip tray  24  is shown in oblique orientation located on the front of the drive unit  12  extending from below the carriage assembly  22  toward the panel  16   a . The drip tray  24  and a receptacle  26 , which is removable, located above panel  16   a , collectively support and accommodate an effluent collection bag, such as effluent collection bag  28  of the pump/catheter assembly  14 . A carriage assembly activation switch  30  located on panel  16   g  facilitates positioning of the carriage assembly  22  inwardly or outwardly. A user interface  32  including memory capabilities is located at the upper region of the drive unit  12  between the upper regions of the upper side panels  16   e  and  16   f  ( FIG. 3 ). Saline bag hooks  34  and  36  extend through the panels  16   e  and  16   f  to secure to mounting pads  38  and  40 , shown in  FIGS. 4 and 2 , respectively. A continuous handle  42  formed of tubing with appropriate mounting extensions secures through the panels  16   f ,  16   c ,  16   e  and  16   b  to secure to mounting pads  44 ,  46 ,  48  and  50  shown in  FIGS. 4 and 2 , respectively. A plurality of wheels  52   a - 52   n  and brake pedals  54  and  55  ( FIG. 3 ) for wheel lockage are located at the lower region of the drive unit  12 . The pump/catheter assembly  14  is shown apart from the drive unit  12  and includes a pump  56  and a thrombectomy catheter  58 . Other components included in the pump/catheter assembly  14  are a bubble trap  60  attached directly to the pump  56 , a connection manifold assembly  62  connected directly to the bubble trap  60 , an effluent return tube  66  connected between the connection manifold assembly  62  and the thrombectomy catheter  58 , a coaxially arranged high pressure saline supply tube  64  aligned inside the effluent return tube  66  attached between the output of the pump  56  and the thrombectomy catheter  58 , a transition fixture  69  between the distal end of the effluent return tube  66  and the proximal end of the thrombectomy catheter  58 , an effluent waste tube  68  connecting the effluent collection bag  28  to the connection manifold assembly  62 , and a large diameter saline supply tube  70  having a bag spike  71  connecting a saline supply bag  72  to the connection manifold assembly  62  which communicates with the interior of the bubble trap  60 . Other interconnections and features of the components of the pump/catheter assembly  14  are described later in detail. 
       FIG. 2  is a view of the thrombectomy catheter deployment system  10  where the panels  16   a - 16   n  have been removed to reveal other components residing in the drive unit  12 . The carriage assembly  22  and a splash guard  74 , which serves as a mounting structure for the doors  18  and  20 , are shown removed and distanced from the general structure of the drive unit  12 . The splash guard  74  supports the doors  18  and  20 , and with the doors  18  and  20  encompasses the majority of the area about the carriage assembly  22  to assist the drip tray  24  in containing any leaking fluids in and about the carriage assembly  22  and any associated enclosed or related portions of the pump/catheter assembly  14  by channeling any stray fluids into the removable receptacle  26 . A plurality of configured support structures  76   a - 76   d  resembling heat sink structure extend vertically from a base  78  which serves as a mount for the wheels  52   a - 52   n  and associated structure. Vertically aligned panels  80  and  82  are attached to the upper regions of the support structures  76   d  and  76   a  for support of the user interface  32  and for serving as a mount for the mounting pads  38  ( FIG. 4) and 40 . A vertically oriented reciprocating linear actuator  84  is partially shown behind the user interface  32  mounted in support structure extending between the upper portions of the support structures  76   a  and  76   d  in the upper region of the drive unit  12  in vertical alignment with the carriage assembly  22  for subsequent automatic engagement of the pump  56  of the pump/catheter assembly  14 , as later described in detail. Also attached to the inner surface of the support structure  76   d  is a barcode reader assembly  86  including a mirror  87  mounted at an angle which reads a barcode included on the pump  56  subsequent to insertion of the pump/catheter assembly  14 . Also shown located suitably mounted in the lower regions of the drive unit  12  are an isolation transformer  88 , a power supply  90  for electrical current stabilization, and a linear actuator controller  92 . 
       FIG. 3  is a rear view of the drive unit  12  showing a rear access panel  94 , a foot switch  95 , a foot switch holder  96 , and a hanger  98  for accommodation of an electrical supply cord  100  and a foot switch cord  102 . The foot switch  95  is incorporated to be controlled by the physician operator in order to pressurize the thrombectomy catheter  58 . 
       FIG. 4  is a rear view of the drive unit  12  where the panels  16   a - 16   n  have been removed to reveal other components residing in the drive unit  12 . The splash guard  74  is shown removed and distanced from the general structure of the drive unit  12 . An aperture  75  is included in the splash guard  74  for use with the mirror  87  of the barcode reader assembly  86 . The rear access panel  94  is shown removed from the drive unit  12  to reveal the rear connection chassis  104  having a foot switch cord receptacle, a ground plug, a power cord receptacle, and an electrical breaker. A panel  108  is also shown removed from the rear of the drive unit  12 . A fan cavity  106  (fan not shown) is located in the base  78  to provide ducted air flow along the interior of the drive unit  12  to cool the reciprocating linear actuator  84  and other components therein. Another internal fan (not shown) is located within the interior of the drive unit  12  to assist with cooling air flow. 
       FIG. 5  is an exterior view of several components of the pump/catheter assembly  14  generally including the pump  56 , the bubble trap  60 , the connection manifold assembly  62 , and a fixture  140 . The pump  56 , of generally cylindrical configuration, centers about a tubular body  112  of stainless steel or other suitable material. Components, preferably of impact modified 14% glass nylon, such as ZYTEL® or other suitable plastic, are located about the lower region of the tubular body  112  and include a one-piece base  109  having an upper portion  110  and a continuously formed geometrically configured lower portion  111  both preferably molded continuously about the lower region of the tubular body  112  ( FIG. 7 ). An annular surface  117  is included at the top of the upper portion  110  of the base  109  for intimate contact with capture tabs of the carriage assembly  22  to contain the pump  56  within the carriage assembly  22 , as later described in detail. A top body  114 , preferably of impact modified 14% glass nylon, such as ZYTEL® or other suitable plastic, is preferably molded continuously about the upper region of the stainless steel tubular body  112 . The one-piece base  109  and the top body  114  and a connecting panel  115  are continuously molded or otherwise suitably constructed to encompass the greater part of the tubular body  112 . A data plate  113  is also included on the top body  114  for the inclusion of barcode or other informational displays to determine operational parameters of the invention. The pump  56  also includes a hemispherically-shaped pump piston head  116  having configured geometry and a flexible boot  118  connected to and extending between the top body  114  and the pump piston head  116 . The geometrically configured lower portion  111  of the base  109  serves as a mount for and is in direct communication with one end of the bubble trap  60 , as best viewed in  FIGS. 6 and 7 . The connection manifold assembly  62  secures directly to the other end of the bubble trap  60  and includes a bracket  120  to which is attached a vertically oriented tubular manifold  148  having a plurality of ports attached therethrough including a saline inlet port  122 , an effluent outlet port  124 , a Luer style effluent return port  126 , and an auxiliary port  128  and cap  130 . Also shown are connectors  132  and  134  connectingly extending between the connection manifold assembly  62  and the upper portion  110  of the base  109 . The bubble trap  60  includes mating halves  60   a  and  60   b  of which mating half  60   a  is shown. A hydrophobic filter  136  is included at the upper forward region of the bubble trap half  60   a . Another hydrophobic filter  138  on the bubble trap half  60   b  ( FIG. 7 ) opposes the hydrophobic filter  136  on the bubble trap half  60   a . The fixture  140 , and components associated therewith, assists in support and connection of the effluent return tube  66  to the effluent return port  126  by a connector  142  combined continuously with a connection tube  144 , and also assists in support, passage and connection of the saline tube  70  with the saline inlet port  122 . The fixture  140  includes outwardly extending vertically aligned and opposed tabs  141   a  and  141   b  which prevent the fixture  140  and associated effluent return tube  66  containing the high pressure saline supply tube  64  and the saline supply tube  70  from contacting a roller pump  240  located in the carriage assembly  22 , as shown and later discussed in detail. 
       FIG. 6  is a semi-exploded side view of the elements of  FIG. 5  illustrating the relationship of the pump  56 , the bubble trap  60 , the connection manifold assembly  62 , and the fixture  140 . Also shown is the vertically oriented tubular manifold  148  secured to the bracket  120 . The effluent outlet port  124  connects to and communicates with the lower interior of the tubular manifold  148 . The effluent return port  126  connects to and communicates with the upper interior of the tubular manifold  148 . Also connecting to the tubular manifold  148  is a horizontally aligned passage port  150  and closely associated connector  132 , each opposing the effluent return port  126 . The passage port  150  accommodates the high pressure saline supply tube  64  which extends distally through the lumen  151  ( FIG. 7 ) of the passage port  150 , the connector  132 , the upper region of the tubular manifold  148 , the effluent return port  126 , the connector  142 , the connection tube  144 , and into and through the effluent return tube  66  in coaxial fashion to connect to the thrombectomy catheter  58  ( FIG. 1 ). The proximal end of the high pressure saline supply tube  64  includes a high pressure fitting  152  welded near the distal end of the metal high pressure saline supply tube  64  to facilitate connection of the high pressure saline supply tube  64  for communication with the interior of the pump  56 . The proximal end of the high pressure saline supply tube  64 , which is the inlet to the high pressure saline supply tube  64 , includes a plurality of very small holes (not shown) comprising a filter at the proximal end thereof. The connector  134  has internal and external threads and is aligned over and about the high pressure saline supply tube  64  distal to the high pressure fitting  152  and threadingly engages a threaded connection port  154  extending horizontally from the upper portion  110  of the base  109  of the pump  56 . The connector  134  is rotated to intimately engage the high pressure fitting  152  to urge the high pressure fitting  152  into engagement with corresponding mating structure located internally in the pump  56 . Connector  132  is utilized to engage the externally threaded end of the connector  134  to secure the connector  134 , and thus the pump  56 , to the connection manifold assembly  62  and to provide for fixation of the bubble trap  60  to the pump  56 . In addition, direct connection and communication between the pump  56  and the bubble trap  60  is provided by a horizontally oriented pump saline inlet port  156  which engages a corresponding geometry receptor port  158  and seal  159  interior to one end of the bubble trap  60 . The saline inlet port  122  located on the bracket  120  extends behind the tubular manifold  148  to communicate with the interior of the bubble trap  60  for saline debubbling, whereby unpressurized saline is made available for use by the pump  56 . 
       FIG. 7  is a cross section view of the majority of the elements of  FIGS. 5 and 6  showing the complete mating of the pump  56 , the bubble trap  60 , and the connection manifold assembly  62 . Also revealed are one or more transverse obliquely mounted baffles  160  in an interior cavity  162  of the bubble trap half  60   b  which assist in the direction of, the breakup of, and the dispersion of any ingested bubbles through the saline inlet port  122 . An arcuate baffle  164  is located in horizontal alignment with the saline inlet port  122  in order to direct any ingested bubbles upwardly toward the hydrophobic filters  136  and  138 . Clearance space is also provided above the baffles  160  and the arcuate baffle  164  allowing upward migration of bubbles along the upwardly sloping top walls of the bubble trap halves  60   a  and  60   b  toward the hydrophobic filters  136  and  138  for venting of bubble air overboard. 
     The pump  56  is an insert molded pump having a tubular body  112  of stainless steel encased in glass-filled impact modified nylon, such as ZYTEL® or other suitable material, to provide structural integrity for the pump  56 . Glass-filled impact modified nylon is continuously molded on both the inside and outside of the tubular body  112  to provide high tolerance features making the pump  56  much more economical to produce and more reproducible. Glass-filled impact modified nylon is incorporated for use in the upper portion  110  and the geometrically configured lower portion  111  of the base  109 , and in the top body  114 , and is molded continuously about the tubular body  112 . Also, it is incorporated into use as a centrally located cylinder  170  molded to the cylindrical-like inner wall  171  of the tubular body  112 . A check ball seat  172  located in the lower region of the cylinder  170  is part of the continuously molded glass-filled impact modified nylon and accommodates a large stainless steel inlet check ball  174 . The check ball seat  172  is molded to best accommodate the inlet check ball  174  for proper sealing during the pressurization stroke of a pump piston  180 . The check ball seat  172  is supported underneath by the lower portion of the tubular body  112 . This arrangement provides dissimilar materials for the sealing arrangement. The mutual contacting of the stainless steel inlet check ball  174  and the molded glass-filled impact modified nylon of the check ball seat  172  gives sufficient compliance to ensure a reliable seal. A passage  176  extends from the check ball seat  172  and through the pump saline inlet port  156 . Mating structure conforming to the shape of the high pressure fitting  152  in the form of a configured receptor  178  is located in the molded glass-filled impact modified nylon of the upper portion  110  of the base  109  intersecting the interior of the cylinder  170  just above the check ball seat  172 . The piston  180  engages the interior of the cylinder  170  to interact therein to provide for intake of saline during upstroke movement and for pressurization of saline during downstroke movement in concert with the positioning of the inlet check ball  174 . Provision for sealing the piston  180  with the cylinder  170  is also provided. A stainless steel threaded insert  182  with a centrally located body hole  184  engages an internal thread at the upper end of the tubular body  112  to forcibly retain a cylindrically-shaped open end high pressure seal  186  of UHMWPE (ultra high molecular weight polyethylene) or HDPE (high density polyethylene) against the upper region of the cylinder  170  where the high pressure seal  186  seals against the piston  180 . A silicone O-ring  188  is located between the bottom of the high pressure seal  186  and the top of the cylinder  170 . The flexible boot  118  extends between and attaches between an annular boot mounting groove  190  at the top of the top body  114  and an annular boot mounting groove  192  at the lower region of the pump piston head  116 . 
       FIG. 8  is a view showing components which locate centrally in the instant invention and which are of major significance to the operation of the instant invention. Shown are the carriage assembly  22 , the pump  56  aligned within and capturing components of the carriage assembly  22 , and a linear actuator assembly  200  in alignment to specific regions of the carriage assembly  22  and to the pump  56 . A cover  202 , having a configured shape and multiple features, aligns over and about the mechanism structure incorporated to operate the carriage assembly  22 . Features of the cover  202  are also included to prevent contact of the effluent return tube  66  and contained high pressure saline supply tube  64  and the saline supply tube  70 , which are captively held by the fixture  140 , with a roller pump  240 . 
     Opposed cams  208  and  210  extend upwardly from the top surface of the cover  202  to open the normally closed doors  18  and  20  which are pivotally operated about living hinges at the forward region of the splash guard  74 . Also extending upwardly from the top surface and near the front of the cover  202  are opposed tube guides  212  and  214 , generally being rectangular and box-like in shape, but including opposed angled surfaces  216  and  218  which direct the effluent return tube  66  for engagement with a roller pump and other associated structure underlying the opposed tube guides  212  and  214  during loading. The tube guides  212  and  214  also function as covers for components of the roller pump  240  which are located directly beneath. The opposed angled surfaces  216  and  218  can also contact the tabs  141   a  and  141   b  of the fixture  140  to prevent entry of the associated effluent return tube  66  containing the high pressure saline supply tube  64  and the saline supply tube  70  from contacting the roller pump  240  located in the carriage assembly  22 . The opposed angled surfaces  216  and  218  are also shown in  FIG. 10   a  and  FIG. 25 . A channel  220  is also included at the front of the cover  202  for accommodation of the effluent waste tube  68 . A two-piece capture block  222  having configured geometry is comprised of a capture block top  222   a  and a capture block bottom  222   b , the bottom portion of the latter being aligned to the upper surface of the cover  202  and secured to other underlying structure, as described later in detail. The capture block  222  provides and coordinates alignment of the upper portion  110  and the geometrically configured lower portion  111  of the base  109  of the pump  56  to the carriage assembly  22 . Other components assist to secure the pump  56  in the capture block  222 , as described later in detail. A horizontally oriented bottom mounting plate  224 , a part of the carriage assembly  22 , secures between the support structures  76   a  and  76   d . Also mounted between the support structures  76   a  and  76   d , but at a higher level, is the mounting plate  226  associated with the linear actuator assembly  200 . The reciprocating linear actuator  84  secures to the mounting plate  226  and includes an actuator shaft  228  freely extending through the mounting plate  226  and a cylindrically-shaped pump connector  230  secured to the bottom of the actuator shaft  228 . Downward actuation of the actuator shaft  228  causes automatic and secure overhead snap engagement of the pump connector  230  with the pump piston head  116  of the pump  56  for subsequent reciprocating operation of the pump  56 . Disengagement of the pump connector  230  from the piston pump head  116  is automatic when the carriage assembly  22  is operated to the extended open position where the pump piston head  116  exits the pump connector  230  through a side opening  231 . The pump connector  230  is described later in detail. A stroke limit shaft  232 , a stroke limit shaft mount  234 , and a stop fixture  236  on the upper portion of the stroke limit shaft  232  are also shown. 
       FIG. 9  illustrates the alignment of  FIGS. 10   a  and  10   b  with respect to each other. 
       FIGS. 10   a  and  10   b  combine to show an exploded isometric view of the components comprising the carriage assembly  22 .  FIG. 10   c  is an exploded rear view referencing pivotal mounting of a top mounting plate  244  to a configured bracket  242  and a load cell  258  secured therebetween. 
       FIG. 11  is a right side top view of the carriage assembly  22 ,  FIG. 12  is a right side bottom view of the carriage assembly  22 ,  FIG. 13  is a left side top view of the carriage assembly  22 , and  FIG. 14  is a left side bottom view of the carriage assembly  22 . For purposes of brevity and clarity, the cover  202 , the carriage plate  238 , and the front truck  300  are not shown in  FIGS. 11 ,  12 ,  13  and  14 . 
     With reference to  FIGS. 10   a ,  10   b ,  10   c ,  11 ,  12 ,  13  and  14 , the carriage assembly  22  is now described. The carriage assembly  22  includes components which are stationary and components which are movably actuated with respect to the stationary components to a closed or open position during operation of the carriage assembly  22 . The interaction of the stationary components with the movably actuated components to the closed position provides for capturing and transporting the pump  56  for automatic coupling to and actuation by the linear actuator assembly  200 , as well as simultaneously accomplishing interfacing of the effluent waste tube  68  with the roller pump  240  and, when the procedure is finished, provides simultaneous interaction in the reverse order to the open position to provide automatical decoupling of the pump  56  from the linear actuator assembly  200  and for disengagement of the effluent waste tube  68  from the roller pump  240 . 
     Some substantial mounting structure components which are generally stationary and connected include the bottom mounting plate  224 , the configured bracket  242  which suitably and adjustably secures to the top of the bottom mounting plate  224 . Other structure generally being stationary suitably aligns and secures to the above mentioned substantial mounting structure components including a mounting flange  246  secured to the side of a vertically oriented pivot flange  247  at the front of the configured bracket  242  to accommodate a roller pump motor  248  and a gear drive  250  which is coupled to a roller pump motor  248 . A pivotable top mounting plate  244 , a substantial mounting structure, secures in pivotal fashion to the vertically oriented pivot flange  247  which extends vertically from the forward region of the configured bracket  242 . A pinion shaft  252 , which is slotted, slidingly engages the gear drive  250 . The near end of the pinion shaft  252  is machined to include mounting of a pinion gear  253  ( FIG. 14 ) and is rotatingly captured in a pinion shaft end bracket  254 . A pinion shaft support  251  aligns over and about the pinion shaft  252  and secures to the rear of the gear drive  250 . The pinion shaft end bracket  254  secures to the underside of the positionable carriage plate  238  with a plurality of screws  255  ( FIG. 11 ) and maintains contact of the pinion gear  253  at the near end of the pinion shaft  252  with a roller pump drive gear  256  extending perpendicularly from the roller pump  240 . As the carriage plate  238  and attached components are movably actuated by the action of a carriage motor  257 , as later described in detail, the attached pinion shaft end bracket  254  slidingly repositions the connected pinion shaft  252  within the gear drive  250 . Rotational force can be delivered by the pinion shaft  252  to the movably actuated roller pump  240  regardless of the horizontal position of the roller pump  240  with respect to roller pump motor  248 . An aperture  264  is included extending through the top mounting plate  244  to pivotally accommodate the upper portion of the pivot flange  247  extending vertically from the configured bracket  242 . Opposed pivot bushings  265  align in a horizontally aligned bore  267  at the upper portion of the pivot flange  247 . The bore  267  and the included pivot bushings  265  align within the aperture  264  and with horizontally aligned and opposed holes  270  and  271  adjacent to the aperture  204  and are pivotally secured therein by a pin  273  extending coaxially through the pivot bushings  265 , the bore  267 , and the holes  270  and  271  thereby pivotally securing the upper end of the pivot flange  247  within the aperture  264 . Thus, a portion of the top mounting plate  244  is supported in pivotal fashion and the top mounting plate  244  and components secured directly thereto can pivot a short distance thereabout. Such pivotal action is useful in sensing the force applied to the pump  56  by the reciprocating linear actuator  84 . Additional attachment by use of the load cell  258  of the top mounting plate  244  to the bottom mounting plate  224  is provided by a screw  262  extending through a recessed hole  260  in the top mounting plate  244 , and into the top of the load cell  258 , and by another screw  261  extending through a hole  275  in the bottom of the configured bracket  242  into the bottom of the load cell  258 . Downward force delivered to the pump  56  by the reciprocating linear actuator  84  is sensed by force transmitted through the capture block  222 , the slides  300  and  302 , the linear guide  296 , and the top mounting plate  244  to apply varied forces to the load cell  258 . 
     A horizontally aligned adjustable stop  259  is included in threaded engagement with the rear edge of the top mounting plate  244  to impinge an internally mounted pressure sensor (not shown) to facilitate alignment of the capture block  222  with the linear actuator assembly  200 , more specifically, with the pump connector  230  and to signal closure of the carriage plate  238 . A carriage motor mounting plate  266  secures to one edge of the top mounting plate  244  and includes an aperture  268 . The carriage motor  257 , which includes a gear  272 , suitably secures to the underside of the carriage motor mounting plate  266 , with the gear  272  aligning to and extending through and above the aperture  268  to engage a plurality of teeth  274  of a linear guide  276  which is secured to the underside of the carriage plate  238  by a plurality of screws  277  ( FIG. 11 ). Such a relationship provides for power to movably actuate the carriage plate  238  and associated components, as later described in detail. A cam post  278  extends perpendicularly from the carriage motor mounting plate  266  for interaction with components closely associated with the roller pump  240 , as later described in detail, including a cam assembly  320 . The top mounting plate  244  includes a rearwardly located wide portion  263  for suitable mounting of a capture clip mounting bracket  280 . The capture clip mounting bracket  280  includes opposed and spaced horizontally oriented feet  282  and  284  which mate to the rearwardly located wide portion  263  of the top mounting plate  244 . A top plate  286  of the capture clip mounting bracket  280  accommodates a horizontally oriented capture clip  288  which suitably secures thereto, as by fasteners  289 . The capture clip  288  includes opposed beveled end capture tabs  290  and  292  spaced by a slot  294 . The capture clip  288  is instrumental in automatic securing of the pump  56  to the carriage assembly  22 . A linear guide  296  having a “T” cross section suitably secures to the upper surface of the top mounting plate  244 . A stop block  298  secures to the near end of the linear guide  296 . 
     Movably actuated components of the carriage assembly  22  include the carriage plate  238  and other attached components, as now described. Direct positionable coupling of the carriage plate  238  to the linear guide  296  is provided by a front truck  300  and a similarly constructed rear truck  302  which suitably mount to the underside of the carriage plate  238  and which slidingly engage the linear guide  296 . One end of the carriage plate  238  includes features for mounting of other components, such features including a circular opening  304  for accommodation of structure of the roller pump  240 , and a cam assembly cavity  305 . The roller pump  240  aligns to and suitably secures to the upper side of the carriage plate  238  with the roller pump drive gear  256  aligning to and extending through the opening  304 . The roller pump  240  includes a base  306  secured to the carriage plate  238  by a plurality of screws  307  ( FIG. 11 ), a roller cover  308  mounted to the base  306  which houses a roller assembly  309  ( FIG. 13 ), a positionable outside race or platen  310  having an interior arcuate surface  312  and being positionable across and along the base  306 , a front guide  314  and a mirror image-like rear guide  315  ( FIG. 13 ), and opposed front and rear receptor slots  316  and  318  in the front guide  314  and the rear guide  315 , respectively, adjacent to the arcuate surface  312 . A cam assembly  320  having a slotted tab  322  extending horizontally therefrom secures to the upper region of the carriage plate  238  utilizing the cam assembly cavity  305  and a cam assembly mount  324 . The cam assembly  320  is located just below and in close communication with the positionable outside race or platen  310  of the roller pump  240 , whereby the position of the positionable outside race or platen  310  is influenced by the slotted cam  322 . The slotted cam  322  can engage the cam post  278  extending from the carriage motor mounting plate  266  to facilitate positioning of the positionable outside race or platen  310  toward or away from the pump roller assembly  309  under the roller cover  308  in cooperation with a rotating cam post assembly  326  located between the cam assembly  320  and the outside race or platen  310  to automatically engage or disengage the effluent waste tube  68 . A position encoder (not shown) is located on the underside of the roller pump  240  in close alignment with and above the roller pump gear  256  to verify the rotational speed of the roller pump  240 . 
     The two-piece capture block  222  having configured geometry is comprised of a capture block top  222   a  and a capture block bottom  222   b . A vertically aligned arcuate surface  328  is located in the capture block top  222   a  intersecting opposed partially formed rectangular-shaped slots  330  and  332  located on the underside of the capture block top  222   a . The capture block bottom  222   b  includes a vertically aligned arcuate surface  334 . The top of the capture block bottom  222   b  engages the bottom of the capture block top  222   a  to complete the formation of the rectangular-shaped slots  330  and  332  which extend horizontally from the front to the back of the assembled capture block  222  and to aligningly combine the arcuate surface  328  of the capture block top  222   a  with the arcuate surface  334  of the capture block bottom  222   b  to form a continuous receptor slot  335  ( FIG. 11 ) which is utilized to accommodate loading of the pump  56 . The capture tabs  290  and  292  of the capture clip  288  extend fully through the slots  330  and  332  when the carriage assembly  22  is movably actuated to the closed position to engage the geometry of and capture the pump  56  when located within the receptor slot  335  formed by the arcuate surfaces  328  and  334  of the capture block  222 . The capture block bottom  222   b  includes a left and right skirted base  336  and  338 , respectively, which engage apertures  340  and  342  at the rear top portion of the cover  202 . The bottoms of the left skirted base  336  and the right skirted base  338  extend through the apertures  340  and  342  to rest and secure against a spacer plate  344  which, in turn, aligns to the top surface of the carriage plate  238 . Vertically oriented alignment pins  346  and  348  secure in the carriage plate  238  and extend upwardly through holes in the spacer plate  344  into holes (not shown) in the bottoms of the left skirted base  336  and the right skirted base  338 . Fastener screws  350  and  352  extend through vertically aligned holes in the capture block top  222   a , the capture block bottom  222   b , holes in the spacer plate  344 , and into threaded holes in the carriage plate  238  to secure the capture block  222  to the carriage plate  238 . A bottom cover  203  mates to the underside of the cover  202 . 
       FIG. 15  is a top view of the carriage assembly  22  where the cover  202  and the carriage plate  238  have been removed for the purposes of brevity and clarity. The pump  56  is shown capturingly engaged within the capture block  222 . The positionable tube clamp  310  of the roller pump  240  is shown actuated to the closed position as a result of interaction of the slotted tab  322  of the cam assembly  320  with the cam post  278  during inward positioning of the carriage plate  238  to the closed position in order to automatically capture the effluent waste tube  68  ( FIG. 8 ) between the arcuate surface  312  of the positionable tube clamp  310  and the roller assembly  309  located beneath roller cover  308 . Outward positioning of the carriage plate  238  to the open position releases the effluent waste tube  68  from influence of the roller pump  240 . 
       FIG. 16  is a bottom view of the carriage assembly  22  where the bottom mounting plate  224  and the configured bracket  242  have been removed for the purposes of brevity and clarity. Shown in particular is the relationship of the pinion shaft  252  and pinion gear  253  to the roller pump drive gear  256 . 
       FIG. 17  is an isometric view of the front and one side of the carriage assembly  22  without the cover  202  where the pump  56  is secured thereto. The positionable tube clamp  310  normally would be actuated along the base  306  to the closed position to capture an effluent waste tube  68 , but is shown left open to reveal the roller assembly  309  of the roller pump  240 . 
       FIG. 18  is an isometric view of the rear and one side of the carriage assembly  22  without the cover  202  where the pump  56  is secured thereto. Shown in particular is the relationship of the linear guide  276  connected to the underside of the carriage plate  238 , wherein such a relationship is instrumental in the transfer of force from the carriage motor  257  and gear  272  to the carriage plate  238  which is operated along the linear guide  296 . 
       FIG. 19  is an isometric view of the linear actuator assembly  200  including an exploded view of the pump connector  230  which attaches to the lower region thereof. In addition to the previously shown actuator shaft  228  freely extending through the mounting plate  226 , the stroke limit shaft  232 , the stroke limit shaft mount  234 , and the stop fixture  236  on the upper portion of the stroke limit shaft mount  234 , a connector plate  354  is shown connecting the lower part of the stroke limit shaft  232  to the lower region of the actuator shaft  228  at a reduced diameter portion  228   a  of the actuator shaft  228 . The reduced diameter portion  228   a  of the actuator shaft  228  has a hole  229  therethrough for receipt of a securing device used to couple the actuator shaft  228  to the pump connector  230 , as explained fully with reference to  FIG. 20 . 
       FIG. 20  is a cross section view of the pump connector  230  and a front view of the pump piston head  116  and piston  180  in alignment below the pump connector  230 . With reference to  FIGS. 19 and 20 , the pump connector  230  is now described. The pump connector  230  includes a cylindrically-shaped body  356 , a base  358  conforming to the shape of the body  356  for mating thereto, a configured spring plate  360  which is suitably secured between the upper part of the base  358  and the lower portion of the body  356 , alignment pins  362 , an anti-rotation pin  364 , and fastening devices. The body  356  has a centrally located receptor cavity  366  which is a bore terminating as a dome shape. The upper portion of the side opening  231  is in the form of a slot having an arcuate top aligning perpendicular to and intersecting the receptor cavity  366 . The base  358  is arcuate in shape and includes a bore  368  which is beveled for guidance of the pump piston head  116  into the receptor cavity  366  and also includes a slot which forms the lower region of the side opening  231 . The spring plate  360  is arcuate in shape to conform to the arcuate shape of the base  368  and the lower portion of the body  356  and includes spring pawls  370   a - 370   n  extending at an angle upwardly therefrom. The body  356  includes a bore  367  in the center of its top for receiving the reduced diameter portion  228   a  of the actuator shaft  228 . An interrupted hole  365  intersects the bore  367  for alignment with the hole  229  in the reduced diameter portion  228   a  of the actuator shaft  228  to receive a pin (not shown) or some other type fastening device for affixing the actuator shaft  228  to the body  356 . 
     The pump piston head  116 , which includes material-saving relief structure and is best shown in  FIG. 24 , includes a top portion which is generally hemispherical in shape to conform with the dome shape of the receptor cavity  366 . The generally hemispherical top portion is formed by a plurality of radially aligned arcuate ribs  372   a - 372   n  emanating from the top of the pump piston head  116  to meet with the topmost disk-like protuberance  374   a  of a plurality of horizontally aligned spaced protuberances  374   a - 374   c  extending outwardly from above a cylindrically-shaped central body  375  of the pump piston head  116 . A plurality of spaces  376   a - 376   n  are interspersed between the arcuate ribs  372   a - 372   n . The structure of the arcuate ribs  372   a - 372   n , the spaces  376   a - 376   n , and the upper portion of the protuberance  374   a  is incorporated to prevent rotation of the pump piston head  116  and piston  180  about the vertical axis thereof as is explained with reference to  FIG. 22 . Protuberance  374   b  extends outwardly to exceed the profile presented by the underlying protuberance  374   c  and is utilized in captured intimate contact in cooperation with the spring pawls  370   a - 370   n , as shown in  FIGS. 21 and 22 . 
       FIG. 21  is a cross section view of the pump connector  230  and a front view of the pump piston head  116  and piston  180  where the pump piston head  116  is firmly engaged by the pump connector  230 . Downward actuation of the actuator shaft  228  causes automatic and secure overhead snap engagement of the pump connector  230  with the pump piston head  116  of the pump  56  for subsequent reciprocating operation of the pump  56  by action of the linear actuator assembly  200 . During such engagement, portions of the outwardly facing surface of the protuberance  374   a  first engage the plurality of spring pawls  370   a - 370   n  followed by subsequent disengagement therefrom followed by a second engagement of the plurality of spring pawls  370   a - 370   n  by portions of the outwardly facing surface of the protuberance  374   b  followed by disengagement therefrom followed finally by engagement of the plurality of spring pawls  370   a - 370   n  with and against portions of the downwardly facing surface of the protuberance  374   b  in close proximity to the upper region of the central body  375  at which time the arcuate ribs  372   a - 372   n  firmly engage and are held against the dome-like upper structure of the receptor cavity  366 . 
       FIG. 22  is a cross section side view of the pump connector  230  and a side view of the pump piston head  116  and piston  180  where the pump piston head  116  is firmly engaged by the pump connector  230  by action of the spring pawls  370   a - 370   n . Shown in particular is the engagement of a projection  364   a  extending from the anti-rotation pin  364  located in the body  356  of the pump connector  230  with one of the spaces  376   a - 376   n . Such engagement also places the projection  364   a  between a consecutive pair of the arcuate ribs  372   a - 372   n , which are thin in shape to divert the rounded end of the projection  364   a  into one of the spaces  376   a - 376   n . Such an intrusive arrangement serves to prevent rotation of the pump piston head  116  and attached piston  180  about the vertical axis thereof. 
       FIG. 23  is a cross section side view of the pump connector  230  and a side view of the pump piston head  116  and piston  180  where the pump piston head  116  has been disengaged from the pump connector  230 . Disengagement of the pump connector  230  from the pump piston head  116  is automatic when the carriage assembly  22  is operated outwardly to the extended open position to cause the pump piston head  116  to exit the pump connector  230  through the side opening  231  in a horizontal motion. The operation of the carriage assembly  22  to the extended open position causes the spring pawls  370   a - 370   n  to slidingly disengage the underside of the protuberance  374   b.    
       FIG. 24  is an isometric view of the pump piston head  116  showing the relationship of the arcuate ribs  372   a - 372   n  to the spaces  376   a - 376   n  and of the protuberances  374   a - 374   c  to the central body  375 . 
       FIG. 25  is an isometric view of the pump  56  prior to insertion into and accommodation by the capture block  222  of the carriage assembly  22 . 
       FIG. 26  is a barcode flow chart. 
     MODE OF OPERATION 
     Operation of the thrombectomy catheter deployment system  10  utilizes the user interface  32  for controlling the functional operation thereof in conjunction with other components. The thrombectomy catheter deployment system  10  is initiated by opening a sterile package containing the disposable pump/catheter assembly  14  for loading into the drive unit  12 . At a suitable time, the carriage assembly  22  is movably actuated to the open position, such as shown in  FIG. 25 , for acceptance of various components of the pump/catheter assembly  14 . The pump  56  aligns to the receptor slot  335  of the capture block  222  and the effluent return tube  66  with the contained high pressure saline supply tube  64  and the effluent waste tube  68  align over and between the tube guides  212  and  214  overlying the roller pump  240 . The base  109  of the pump  56  is then urged into engagement with the receptor slot  335  of the capture block  222 , such as shown in  FIG. 8 , and at the same time the effluent waste tube  68  is urged along the angled surfaces  216  and  218  of the tube guides  212  and  214  into the front receptor slot  316  and the rear receptor slot  318  of the open roller pump  240 . The effluent return tube  66  with the included high pressure saline supply tube  64  and the saline supply tube  70  are denied entry to the underlying open roller pump  240  by interference of the fixture  140  with the angled surfaces  216  and  218  of the tube guides  212  and  214 . During such positioning, the effluent collection bag  28  is automatically and supportively placed in the combined drip tray  24  and receptacle  26 . The saline supply bag  72  containing heparinized saline can be spiked prior to or subsequent to loading the pump  56  and suitably positioned, such as on the saline bag hook  34  or  36 . The carriage motor  257  is then energized by depressing the carriage assembly activation switch  30  to movably actuate the carriage plate  238  and the cover  202  to the closed position, whereby further capturing of the effluent waste tube  68  and of the pump  56  occur. During such movably actuated capturings, the positionable tube clamp  310  is advanced to automatically and forcibly engage the effluent waste tube  68  for use in the roller pump  240 , and the pump  56  is automatically captured in the receptor slot  335  of the capture block  222 . Capture of the pump  56  in the receptor slot  335  of the capture block  222  occurs during inwardly directed advancement of the carriage plate  238  when the slots  330  and  332  of the capture block  222  engage the capture tabs  290  and  292  of the capture clip  288  at which time simultaneous engagement of the annular surface  117  of the pump  56  by the capture tabs  290  and  292  occurs. Capturing of the pump  56  provides for secure and stable mounting and support of the pump  56  and the components directly associated with the pump  56 , such as, but not limited to, the bubble trap  60 , the connection manifold assembly  62  and proximal ends of the effluent waste  68 , the saline supply tube  70 , the effluent return tube  66 , and other associated structure. When the carriage plate  238  is movably actuated to the fully advanced closed position, the barcode reader assembly  86  senses individualized data regarding each particular and individual pump  56  located on the data plate  113  of any pump  56  which is utilized to facilitate tailored operation of the reciprocating linear actuator  84  and/or other components essential to best and proper operation of each particular and individual pump  56 . When the carriage plate  238  is movably actuated to the fully advanced closed position, the reciprocating linear actuator  84  is energized as required to cause the pump connector to descend downwardly in vertically directed motion to engage and capture the pump piston head  116 , as described with reference to  FIGS. 21 and 22 . At an appropriate time, the tip of the thrombectomy catheter  58  is placed in a bowl of sterile saline and the pump  56  is operated by action of the reciprocating linear actuator  84  to prime the thrombectomy catheter  58 . Medical personnel insert the thrombectomy catheter  58  into the patient at a convenient time, and operation of the thrombectomy catheter deployment system  10  incorporating the user interface  32  and the foot switch  95  can begin, as desired. The reciprocating linear actuator  84  is actuated according to the operating parameters as sensed by the barcode reader assembly  86  to influence proper saline pressures, pump speed, flow rates, and the like to operate the pump  56  to deliver pressurized saline to the thrombectomy catheter  58  via the high pressure saline supply tube  64  residing in the effluent return tube  66 . Supply saline is routed through the bubble trap  60  and highly pressurized by the pump  56 , as previously described, and through the high pressure saline supply tube  64  to the thrombectomy catheter  58  for use in a thrombectomy or other related procedure. Effluent is returned through the effluent return tube  66  to the connection manifold assembly  62  for collection in the effluent collection bag  28  through the roller pump controlled effluent waste tube  68 . When the thrombectomy procedure is complete, the carriage plate  238  is movably actuated outwardly to the open position for manual removal of the components of the pump/catheter assembly  14 . During movable actuation outwardly to the open position, the positionable tube clamp  310  is repositioned to cause release of the effluent waste tube  68  from the roller pump  240 , and the pump piston head  116  is slidingly disengaged from the pump connector  230  in a horizontal direction through the side opening  231 , as described with reference to  FIG. 23 . 
     Various modifications can be made to the present invention without departing from the apparent scope thereof.