Abstract:
A pressure sleeve assembly and a method of its use in a fluid injection system are disclosed. The pressure sleeve assembly includes a longitudinal base member, an endplate associated with the longitudinal base member, a fixed or freely removable door, a cylinder and a pivotal arm coupling the cylinder to the longitudinal base member. The pressure sleeve assembly includes properties that increase the ease of use and maintenance of the assembly so as to reduce the effort required by the user and increase the biosafety aspect of the assembly. In addition, the pressure sleeve assembly includes properties that reduce the amount of effort required by the physician prior to and during use of the system as well as properties that increase its range of applications.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates generally to fluid injection systems. The present invention particularly relates to a pressure sleeve for housing a syringe usable for injection of fluids in medical procedures such as angiography, magnetic resonance imaging (MRI), computer tomography (CT) and radiology. In addition, the invention relates to a pressure sleeve assembly that allows for front and/or rear loading and removal of a syringe.  
         BACKGROUND OF THE INVENTION  
         [0002]    Fluid injection systems are used in numerous medical procedures that require injection of fluid into a patient. One non-limiting example of such a procedure is the treatment of coronary artery disease where an artery feeding into the heart has become obstructed or narrowed. In such conditions, an angioplasty, or stent placement, is often a prescribed treatment and in preparing for such procedures, an angiogram is performed.  
           [0003]    In such procedures, a large volume of a radio-opaque “dye” or contrast media is injected into the vasculature of the patient to the site of obstruction. X-ray videos are then taken of the coronary arteries using the contrast media, thus providing an image of the location and severity of the blockage in the diseased vessel.  
           [0004]    Due to the pressure and large volume of fluid being injected into a patient during cardiological procedure and many other types of procedures (e.g. MRI, CT, etc.), specialized injection systems have been developed which enclose and retain the injecting syringes during use. These systems typically use a disposable syringe since non-disposable syringes can oftentimes be impractical and prohibitive from a cost and process standpoint. Such systems restrict and prevent bursting or leakages of the pressurized fluid during use of the injecting syringe. Due to the safety and reliability requirements of systems containing such pressurized fluids, various pressure sleeve systems have been developed for medical use. Examples of these systems can be found in U.S. Pat. No. 5,899,885 and U.S. Pat. No. 5,779,675.  
           [0005]    In each of the above-referenced patents, there is disclosed a fluid injection system that utilizes a specialized pressure sleeve designed to accommodate the biosafety requirements for each injection system. These pressure sleeve designs are also intended to simplify the operation of the injector by enabling the user to introduce the syringe into the injection system from the front of the system. Such designs are typically referred to as “front-loading” injection systems.  
           [0006]    Although the front-loading systems disclosed in the above-referenced patents (and other similar devices not specifically described) offer improvements over the earlier pressure sleeve designs, such systems are not always optimal. For example, one disadvantage of a front-loading pressure sleeve design as shown is that a user can accidentally attempt to remove the syringe from the system when the syringe plunger is still engaged (at the rear end of the plunger) to the actuator ram of the injection system. If the syringe is successfully removed with the plunger still attached to the actuator, any remaining injection fluid will flood the pressure sleeve assembly and likely seep onto the actuator and eventually into the injector housing. Although not creating a biohazard, this undesirable result may somewhat reduce long term performance and thus, requires disassembly of the sleeve in order to thoroughly clean the system.  
           [0007]    Another example of a disadvantage of the front-loading system such as discussed above is the difficulty in removing the syringe and/or pressure sleeve from the system if there has been any leakage or inadvertent spilling of injection media into the pressure sleeve. This difficulty results from the injection media solidifying or accumulating on the pressure sleeve surfaces and thereby inhibiting smooth movement of the syringe into or out of the pressure sleeve, as well as movement of the pressure sleeve out of the injector. Oftentimes, the only way to remove the syringe and/or pressure sleeve under such conditions is to pry the device out by hand or with some sort of makeshift tool.  
           [0008]    In view of the above, it is apparent that although improvements in pressure vessel sleeves have been made, there is a continuing need to provide better pressure sleeve systems that are reliable and less likely to result in fluid contamination of the pressure sleeve assembly. There is also a need to provide an injection device having a pressure sleeve system that is simpler to use and easier to maintain. Such improved fluid injection systems include properties that reduce the amount of effort required prior to and during use of the system as well as properties that increase the device&#39;s range of applications.  
         OBJECTS AND SUMMARY OF THE INVENTION  
         [0009]    In view of the foregoing, it is an object of the present invention to provide a pressure sleeve assembly that addresses the limitations and disadvantages associated with prior devices, yet meets the needs of the users.  
           [0010]    A further object of the invention is to provide a pressure sleeve assembly that is efficient, requires minimal effort by the user, is easy to assemble, disassemble and maintain.  
           [0011]    Still another object of the invention is to provide a pressure sleeve assembly that is freely accessible. Such an assembly allows for changing syringe configurations for use in different applications.  
           [0012]    A further object of the invention is to provide a pressure sleeve assembly having a pivotable pressure sleeve. This configuration allows for a fully exposed sleeve, which increases its accessibility and ease of cleaning. A pivotable pressure sleeve can have a permanently mounted door, thereby creating a “chamber” area for the syringe. Alternatively, the pressure sleeve can be stationary and have a removable door.  
           [0013]    A further object of the invention is to provide an axial force management system such that a forward plate of the injector is rigidly mounted to the support and can withstand the primarily axial forces being exerted against a syringe mounted in a pressure sleeve.  
           [0014]    A further object of the invention is to provide a pressure sleeve assembly configured so as to have a pressure transducer or sensor coupled to or located within or on the front plate thereby providing a direct and more accurate measurement of fluid pressure within the syringe.  
           [0015]    An additional object of the invention is to provide an injection system for delivery of contrast media or other fluids. The system can include a power supply, an injector head, a console and a pressure sleeve assembly, where the pressure sleeve assembly can have a longitudinal base member having a receptacle area, a cylinder having a first opening and a second opening, a pivotal arm movable between a first position and a second position, coupling the cylinder to the longitudinal base member, where the cylinder is exposed when in the open position and resides within the receptacle area of the longitudinal base member when in the closed position, and a door positioned at the first opening of the cylinder in the closed position, where the door is fixed to the longitudinal base member.  
           [0016]    These and other objects not specifically enumerated herein are believed to be addressed by the present invention, which contemplates a pressure sleeve assembly and its use with a fluid injection system for delivery of fluids during numerous types of medical procedures. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    [0017]FIG. 1 is a perspective view of one preferred embodiment of an injection device in accordance with the present invention;  
         [0018]    [0018]FIG. 2 is a first perspective view of a preferred embodiment of a pressure sleeve assembly in an open position in accordance with the present invention;  
         [0019]    [0019]FIG. 3 is a second perspective view of a preferred embodiment of a pressure sleeve assembly in an open position in accordance with the present invention;  
         [0020]    [0020]FIG. 4 is a third perspective view of a preferred embodiment of a pressure sleeve assembly in an open position in accordance with the present invention;  
         [0021]    [0021]FIG. 5 is a first perspective view of a preferred embodiment of a pressure sleeve assembly in a closed position in accordance with the present invention;  
         [0022]    [0022]FIG. 6 is a second perspective view of a preferred embodiment of a pressure sleeve assembly in a closed position in accordance with the present invention;  
         [0023]    [0023]FIG. 7 is a third perspective view of a preferred embodiment of a pressure sleeve assembly in a closed position in accordance with the present invention;  
         [0024]    [0024]FIG. 8 a perspective view of a preferred embodiment of a pressure sleeve assembly in accordance with the present invention having a removable door.  
         [0025]    [0025]FIG. 9 is a second perspective view of the preferred embodiment of a pressure sleeve assembly in accordance with the present invention;  
         [0026]    [0026]FIG. 10 is a perspective view of a preferred embodiment of a pressure sleeve assembly in accordance with the present invention which includes a pressure sleeve locking device; and,  
         [0027]    [0027]FIG. 11 is a perspective view of a preferred embodiment of a pressure sleeve assembly in accordance with the present invention, which includes a device for sensing closure of the assembly.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0028]    FIGS.  1 - 9  show various embodiments of a pressure sleeve assembly usable in a fluid injector system such as described in co-pending U.S. application Ser. No. 08/488,443 filed Jan. 20, 2000, U.S. application Ser. No. 08/966,088 filed Nov. 7, 1997, U.S. application Ser. No. 08/957,228 filed Oct. 24, 1997 and U.S. application Ser. No. 08/957,801 filed Oct. 24, 1997, as well as U.S. Pat. Nos. 5,800,397, 5,988,587 and 5,573,515, the disclosures of which are hereby incorporated by reference in their entirety. Referring particularly to FIG. 1, an injector system includes an injector head  220  upon which a display screen  210  is mounted. A power supply (not shown) is connected to the injector head  220 . At one end of the injector head is located the structure that holds a syringe during an injection. This structure includes a pressure sleeve assembly.  
         [0029]    Generally, a pressure sleeve assembly can be used for delivery of fluid, such as contrast media, to a patient during a medical procedure. Typically a pressure sleeve assembly is used to house and provide support for a syringe through which fluid is injected into a catheter line feeding into a patient. When a fluid-filled syringe is contained within the pressure sleeve assembly, the forward motion of an actuator (coupled to the rear end of a plunger or wiper of the syringe) drives the fluid forward from the syringe into a catheter attached to the syringe. Due to the pressure forces generated within a syringe during fluid delivery, a pressure sleeve assembly is desirable for containment and support of the syringe. Any of the pressure sleeve assemblies described herein may be used in a fluid delivery system for housing a syringe component.  
         [0030]    FIGS.  2 - 7  show a first embodiment of a pressure sleeve assembly  10 , which includes a longitudinal base member  20  having a receptacle area  30 , a cylinder  40  for housing a syringe, a pivotal arm structure  50 , a faceplate  62  that is connected with the longitudinal base member  20 , and a stationary forward plate  60 . The cylinder  40  is mounted on the pivotal, or “hinged,” arm structure  50 , which, in turn, is movable between a closed position (FIGS.  5 - 7 ) where the cylinder  40  is disposed in the receptacle area  30  and an open position (FIGS.  1 - 3 ), where the cylinder  40  is disposed away from the receptacle area  30 .  
         [0031]    The cylinder  40  includes a first opening  44  which is covered by the forward plate  60  when in the closed position, and a second opening  46  which is covered by the endplate  62  when in the closed position. The endplate  62  is attached to the end of the longitudinal base member  20  generally along two of the endplate&#39;s four sides.  
         [0032]    As described above (and with reference to the referenced patents and application), a pressure sleeve assembly  10  typically receives a syringe  25  that contains or holds the fluid that is or will be injected into a patient. With reference to FIGS.  2 - 3 , the syringe  25  is placed within the cylinder  40  of the assembly  10  and the fluid is moved by an actuator (not shown) that pushes a wiper or syringe plunger of the syringes forward to dispense fluid or backward to fill the syringe  25 . Therefore, the endplate  62  of the pressure sleeve assembly  10  has an opening  66  through which the actuator extends and contacts the rear surface of a wiper or plunger of the syringe. The fluid within the syringe is pushed forward by movement of the actuator against the wiper of the syringe. Therefore, the opening  66  of the endplate  62  will be axially aligned with the second opening  46  of the cylinder  40  when the pivotal, or “hinged,” arm structure  50  is in the closed position so as to allow free extension and retraction of the actuator into the cylinder  40 . The endplate  62  can also include structures or holes  76 , which allow for its connection or attachment to other elements or structural supports in the fluid injection system.  
         [0033]    Perspective views of the pressure sleeve assembly  10  with the arm structure  50  in a closed position (during fluid injection) are shown in FIGS.  5 - 7 .  
         [0034]    Referring to FIG. 3, when the arm structure  50  is in the open position, a syringe  25  is generally loaded into the first opening  44 , but, with certain designs, the syringe  25  can be loaded through the second opening  46 . In this embodiment of the present invention (also referred to herein as the “rotatable cylinder” embodiment), the cylinder  40  of the pressure sleeve assembly  10  is coupled to the longitudinal base member  20  by an arm structure  50  that includes a pair of supports  52 . One support  52  is attached at a location on the longitudinal base member  20  near the first opening  44  of the cylinder  40 . The second support  52  is attached to a location on the longitudinal base member  20  near the second opening  46  of the cylinder. The support  52  located near the first opening  44  includes a grasping surface  53  that serves as a surface for the user to pull and push the cylinder  40  into and out of the receptacle area  30 , respectively.  
         [0035]    Use of a pivotal, or “hinged,” arm structure  50  allows for exposure of the cylinder  40  by a rotational/pivotal movement and, thus, allows axial insertion of the syringe into the pressure sleeve and “radial” loading of a syringe into the closed portion of the receptacle area  30 . Any type of fastener, hinge or attachment mechanism that allows for radial or rotational movement of the pivotal arm structure  50  can be used to connect the pivotal arm  50  to the longitudinal base member  20 . In the embodiment shown, an elongated hinge structure  11  is utilized. The longitudinal base member  20  provides the primary structural support platform for the cylinder  40 , the endplate  62  and forward plate  60 . The endplate  62 , forward plate  60  and cylinder  40 , together create a chamber within which a syringe can be retained during fluid injection. After the syringe is inserted into the cylinder  40 , when the arm structure  50  is in the open position, the cylinder  40  can be pushed or rotated into the receptacle area  30  place into the closed position, thus placing the syringe into a position for performing a fluid injection.  
         [0036]    The rotatable pressure sleeve assembly  10  having the pivotal arm structure  50  discussed above allows for a cylinder  40  that can remain attached to the pressure sleeve assembly  10 , but can still be fully exposed. This advantage aids in the removal and cleaning of the syringe and the cylinder  40 , since the motion and effort required for pulling or “extracting” out a syringe and/or cylinder  40  is simpler than that requiring sliding or “prying” out a non-rotating cylinder. Therefore, a rotatable pressure sleeve assembly  10  having fully exposable cylinder  40  provides easy access to component parts for cleaning or other manipulation.  
         [0037]    An additional feature of a rotatable pressure sleeve assembly  10  that is advantageous is that in order to remove the syringe contained within the cylinder  40 , the user must pivot the arm structure  50  (and thus the cylinder  40 ) away from the longitudinal base member  20 . Before this pivotal movement can take place, the user must first ensure that the wiper or plunger of the syringe is disengaged from the actuator. As a result, with the rotatable pressure sleeve assembly  10 , the user cannot accidentally remove the syringe with the wiper/plunger still connected to the actuator. This result reduces the chances of flooding the cylinder with fluid, thereby further increasing the reliability aspect of this invention.  
         [0038]    The rotational movement of the rotatable pressure sleeve  10  is similar to that of the bullet chamber in a revolver firearm. That is, the cylinder  40  or “barrel” of the assembly can be unlocked, and rotated (via the arm structure  50 ) out of the closed position to expose the “full chamber” of the cylinder  40  (FIG. 2). Once the “barrel” is exposed or open (FIG. 3), the syringe is slid into the first opening  44  of the cylinder  40  (FIG. 4) and the cylinder  40  containing the syringe is rotated back into its initial, closed position (FIGS.  5 - 7 ). To lock the cylinder  40  and arm structure  50  in the closed position, the cylinder  40  can preferably include thermoplastic polymers such as polycarbonate, amorphous nylon, PET, acrylic or any other suitable clear plastic.  
         [0039]    Referring to FIGS. 10 and 11, there is disclosed a number of ways of sensing and locking the pressure cylinder  40  into place. For example, referring to FIG. 10, an axially movable pin  502  may be disposed in the backplate  62  for engagement with a pin receptacle  506  in the cylinder  40 . Furthermore, the pin could be actuated by a solenoid or other control mechanism  504 . In use, once it is determined that the pressure cylinder  40  is in the closed position, the solenoid  504  could be actuated such that the pin extends forward and is received in the receptacle  506  of the cylinder  40 . The cylinder  40  then remains locked in the closed position until reverse actuation of the pin  502  occurs. Control of the pin actuation can be done automatically through the injection machine control system or manually by the user.  
         [0040]    Referring to FIG. 11, a sensor mechanism is disclosed including a permanent magnet  602  mounted in near the grasping surface  53  of the arm structure  50  and a hall effect sensor  604  mounted in the backplate  62 . When the cylinder  40  has been rotated into the closed position, the permanent magnet  602  is located near enough to the hall effect sensor  604  to trigger a signal that indicates to the user that the cylinder has been moved into the closed position. The hall effect sensor  604  is typically in communication with the injector control system such that triggering of the sensor will serve as a safety to dictate when performance of an injection may be safely performed.  
         [0041]    Referring to FIGS.  2 - 4 , another aspect of the rotatable pressure sleeve  10  in accordance with the present invention is a slot  21  located in the cylinder  40  for receiving the stem  23  of the fluid fill port of the syringe  25 . The slot  21  is located at a location on the cylinder  40  so that the stem  23  is protruding substantially vertically upwardly from the cylinder  40  when the cylinder  40  has been rotated into the closed position. The slot  21  also serves a “keying” function insofar as a cylinder  40  loaded with a syringe cannot be rotated into the closed position unless the stem  23  of the syringe  25  has been “keyed” into place into the slot  21 . If the stem  23  is not “keyed” into place into the slot  21 , a portion of the syringe  25  will remain protruding from the cylinder  40  and thus prevent rotation of the cylinder  40  into the closed position.  
         [0042]    In another aspect of the invention, the front plate  60  includes a curved slot  68 , which receives, and guides a fluid exit port  27  of the syringe  25  as the cylinder  40  is rotated into the closed position. As with the slot  21  for receiving the stem  23  of the syringe  25 , the curved slot  68  also serves to ensure that the syringe  25  has been properly inserted/loaded into the cylinder  40 . If not properly “keyed” into the curved slot  68  the cylinder  40  cannot be properly rotated into the closed position. Furthermore, as with the slot  21 , the curved slot  68  ensures that the syringe  25  is properly inserted for engagement with the actuator once the cylinder  40  has been rotated into the closed position.  
         [0043]    In addition to the two “keying” features discussed above, the present invention contemplates an indexing feature for further controlling the placement of the syringe  25  into the pressure sleeve  10 . The indexing feature includes an indentation or slot  102  located at one end of the syringe  25 . This slot mates with a corresponding protrusion (not shown) located on the internal surface of the cylinder  40 . In order for the syringe to be inserted properly into the cylinder  40 , the slot  102  must be aligned correctly with the mating protrusion so that the two structures mate and thus allow full insertion of the syringe  25  into the cylinder  40 . In this connection, the reader is referred to similar types of indexing features as set forth in co-pending U.S. application Ser. No. 09/542422, entitled Fluid Management and Component Detection System, filed Apr. 21, 2000, and the disclosure of which is hereby incorporated by reference in its entirety.  
         [0044]    One notable advantage of the rotatable pressure sleeve  10  of the present invention is that a sensing device  230  (FIG. 2) may be placed in or on the stationary forward plate  60  to engage with the front surface of the syringe  25 . Specifically, the forward plate  60  can be designed to include a load cell  230  or other sensor which, through the controller of the device, will allow for a direct measurement of the force or pressure (force/unit area) being exerted by the actuator on the syringe. In this connection, the load cell  230  can be used to detect the syringe “dry” (no fluid present) friction at several speeds which allows for the computation and characterization of the inherent frictional losses within the syringe at various positions and velocities of the wiper. Such information can be stored and used for a more accurate determination of the actual pressure being exerted during injection of fluid. Another potential use of the sensor  230  is as a detector of the presence of the syringe  25  in the receptacle area  30 . For example, if the pressure sleeve  40  has been rotated into the closed position but there has been no syringe  25  placed into the pressure sleeve  40 , then there is no structure from which the actuator could exert pressure on the sensor  230 . The absence of such pressure as sensed by the sensor  230  could be used to indicate that there is no syringe present in the sleeve  40 . Examples of load cells usable in this manner are products made by Entran.  
         [0045]    FIGS.  8 - 9  show an alternative embodiment of a pressure sleeve assembly  10  in accordance with the present invention wherein the door  80  of the assembly  10  is removable from the longitudinal base member  20 . A removable door  80  can be included in a pressure sleeve assembly having a cylinder  40  that is coupled to the longitudinal base member  20  by a pivotal arm  50  as in FIGS.  2 - 7 . Alternatively, as shown in FIG. 9, a removable door  80  can be included in a pressure sleeve assembly  10  having a cylinder  40  which is manually insertable and removable from the receptacle area  30 .  
         [0046]    In a preferred embodiment, the removable door  80  can include a hole  84  along an upper corner of the door  80  which serves as a “finger holster”  84  through which the user can insert a finger to grasp and remove the door. Additionally, the base of the removable door  80  can include a groove  26  which engages into corresponding structure located within a slot  22  in the longitudinal base member  20  so as to secure the removable door  80  when it is moved into place. The removable door  80  can also include an index pin  83  which also engages with a corresponding receptacle or structure  24  in the slot  22  of the longitudinal base member  20  to further secure the removable door  80  into place. The longitudinal base member  20  can also include a guide slot  26  located along an upper edge of bar number  20  in alignment with the slot  22  of the longitudinal base member  20 . The guide track  26  guides the removable door  80  into place as the door  80  is moved down into place and serves as additional support for the removable door  80  when in place.  
         [0047]    An advantage of a pressure sleeve assembly  10  having a removable door  80  is improved accessibility to component parts of the assembly  10 , such as the cylinder  40  and syringe  25 . A removable door  80  also improve maintenance and more reliable repeated use of the assembly by allowing for complete cleaning of the door  80  and the area of the longitudinal member  20  surrounding its site of insertion  22 . This advantage reduces the possibility of contrast media or other fluid from accumulating and crystallizing and causing the door to be stuck into place. A removable door  80  also allows use of the pressure sleeve assembly with syringes having a variety of configurations. For example, the slot  88  of the removable door  80  can be located at different sites on the door so as to accommodate varying neck region configurations of different syringe types.  
         [0048]    When a syringe  25  has been placed into the receptacle area  30 , the endplate  62  covers the second opening  46  of the cylinder  40  and the removable door  80  covers the first opening  44  of the cylinder  40 . To open the assembly  10 , the removable door  80  is lifted upward and out of the slot  22  (FIG. 8). Removal and insertion of the cylinder  40  can be achieved by either placing the cylinder  40  directly into the receptacle area  30  or by sliding the cylinder  40  into the receptacle area  30  from the front area of the longitudinal base member  70 . In this fashion, the removable door  80  serves as a “hardware lock” to the pressure sleeve assembly  10  by holding the cylinder  40  in place.  
         [0049]    In this embodiment, the cylinder  40  may be retained in place by the frictional contact and engagement of certain surfaces in the receptacle area  30  contacting the outer surfaces of the pressure sleeve  40 . In one embodiment, the certain surfaces could be the rail structures extending longitudinally along the receptacle area of the pressure sleeve assembly  10 . In such an embodiment, the structure defining the receptacle area generally leaves an approximately 180 degree opening for receiving the sleeve  40 .  
         [0050]    In one particular embodiment, the structure forming the receptacle area  30  may include a electrical luminescent (“EL”) strip or backlight foam structure layered on the surfaces defining the receptacle area  30 . In such an embodiment, the rail structures in association with the EL layer form a complaint surface that snugly receives and retains the pressure sleeve  40 .  
         [0051]    As described above, a pressure sleeve assembly  10  can be used for a variety of medical treatments where injection of a fluid is desired in a medical procedure. Depending upon the particular medical procedure, the pressure sleeve assembly  10  can be used to deliver a variety of fluids. For example, in certain angiographic applications, the assembly can be used to deliver contrast media via a catheter to a patient suffering from a problematic cardiovascular or other vascular condition. In such a procedure, the contrast media will preferably have a viscosity between 2 and 30 centipoise (for all functions at the temperatures used). The contrast media can be injected by the syringe  25  contained within the cylinder  40  of the pressure sleeve assembly  10  through angiography catheters rated for a maximum 1200 psi pressure with flow rate of about 40 ml/sec.  
         [0052]    The manner of loading the syringe  25  into the pressure sleeve assembly  10  varies somewhat according to several embodiments of the invention.  
         [0053]    In the embodiment of a rotatable cylinder assembly  10 , the cylinder is rotated into the open position. The syringe  25  is then loaded into the cylinder  40  (either front-loaded, or if suitable, rear-loaded) and the cylinder  40  rotated back into the closed position. Alternatively, if the pressure sleeve assembly  10  includes a removable door  80  with non-rotatable cylinder, the door  80  is slid out of position to expose the first opening  44  of the cylinder  40 . The syringe is then front-loaded into the cylinder  40  and the door  80  replaced back into position covering the first opening  44  of the cylinder  40 . As discussed above, various embodiments of the pressure sleeve assembly  10  offer particular advantages relating to the simplification of the loading and cleaning of the device.  
         [0054]    The present invention also contemplates a method of assembly or fabricating a pressure sleeve assembly  10 . Various materials can be used for constructing a pressure sleeve assembly  10 , so long as the material used for the cylinder  40  is sufficiently rigid and durable so as to withstand the level of pressure or force exerted by the fluid contained within the cylinder  40 . This level of pressure or force may vary depending upon the particular procedure being performed and the use or type of fluid being used. Preferably, materials used to fabricate the pressure sleeve assembly will be of a non-rusting or non-corrosive, rigid type of material such as stainless steel, aluminum or plastic. Additionally, the configuration and size of the pressure sleeve assembly  10 , particularly of the cylinder  40 , can be adapted to be compatible with a variety of injection systems as well as to hold a variety of syringe sizes and shapes.  
         [0055]    Due to high-pressure forces created within the syringe  25  during fluid injection, substantial structural support is needed to contain the syringe  25  and its fluid contents. Therefore, the cylinder  40  which houses the syringe  25 , is preferably manufactured from a material of suitable strength or thickness to withstand about 1 to 2000 psi, or preferably of about 200 to 1200 psi. It is also preferable that the cylinder  40  be made of a generally clear material so that the user can visually check the syringe  25  and its fluid contents during a procedure.  
         [0056]    Method For Use of a Pressure Sleeve Assembly with a Fluid Injection System  
         [0057]    The present invention also contemplates a method of using a pressure sleeve assembly  10  in a fluid injection system for delivery of fluid to patient. The method includes providing a pressure sleeve assembly as described above and shown in FIG. 1. Referring to FIG. 1, the system  100  includes a power supply (not shown), a control panel  210  and an injector head  220  having a pressure sleeve assembly  10 . The power supply connects to the injector head  220 , providing power to the fluid injection system and electrical safety separation of the fluid injection system  100  from a main power source. As disclosed in the pending applications discussed above (and incorporated by reference), the injector head  220  houses electrical controls and sensors for the fluid injection system  100 . The injector head can be designed so as to be free standing or mountable on for example, a patient&#39;s bed rail, pedestal cart, or other supportive structure. The control panel  210  is connected to the injector head  220  and can be connected by cable or may be connected by wireless connection such as radio frequency, infrared optic, or ultrasonic link. The control panel  210  can include a display screen  212 , visible and audible indicators, as well as control switches or buttons to provide operator controls and prompts. The control panel  210  functions as the user interface providing operation prompts, status information, and alerts prior to and during use of the fluid injection system.  
         [0058]    The pressure sleeve assembly  10  is coupled to the injector head  220 . The pressure sleeve assembly  10  can also include additional components to facilitate its use with a fluid injection system such as, for example, lighting  410  to facilitate manual bubble detection within a fluid line, a cradle  420  for holding or hanging a fluid source. The pressure sleeve assembly  10  can also include additional sensors or components for detecting the status of various components, such as the presence of air in the fluid line or the level of fluid or contrast media in the bottle.  
         [0059]    Also included, if desired, for use with the fluid injection system are accessory items such as disposable angiographic kits. Included in such kits are single use items such as syringe, valves, tubing, high-pressure tube extension, stopcocks, patient manifold, cables, pressure transducer, and/or other components, which aid or provide interface between the system, the patient and the operator. Such items are available in the art and described, for example, in the publication entitled ACIST™ System Operator&#39;s Guide (supra).  
         [0060]    In a preferred embodiment, a pressure sleeve assembly  10  is intended for use with an angiographic system that supplies radio-opaque contrast media to a catheter at a user-determined variable flow rate which can be instantaneously and continuously varied. Such a system is described, for example in ACIST™ System Operator&#39;s Guide (Copyright 1999 for ACIST™ Model CL100H Injection System; ACIST Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, Minn. 55344). Alternatively, a pressure sleeve assembly as disclosed herein, can also be used with a variety of Angiographic or other Fluid Injector Systems described in co-pending U.S. application Ser. No. 08/488,443 filed Jan. 20, 2000, U.S. application Ser. No. 08/966,088 filed Nov. 7, 1997, U.S. application Ser. No. 08/957,228 filed Oct. 24, 1997 and U.S. application Ser. No. 08/957,801 filed Oct. 24, 1997, as well as U.S. Pat. Nos. 5,800,397, 5,988,587 and 5,573,515, the disclosures of which are hereby incorporated by reference in their entirety  
         [0061]    The present invention provides efficient and reliable delivery of fluid in a medical procedure. The features of the invention, as described herein, provide a fluid injection assembly and system that is less cumbersome to use, easier to maintain and more versatile for the user.  
         [0062]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.  
         [0063]    All publications and patent applications in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.