CN101184518A - Radiopharmaceutical tanks and portable power injectors - Google Patents

Abstract

Certain embodiments of the invention relate to a radiopharmaceutical system having a shielded cordless injector and various radiopharmaceutical pig and syringe structures that permit the syringe to remain in the pig during transportation and use of the syringe. In some embodiments, the shielded cordless injector may include an injector, a radiation shield disposed at least partially about the injector, a drive coupled to the injector, and an energy storage device coupled to the drive. The pig may have a computer with a display screen that displays a radioactivity level of a radiopharmaceutical and/or a desired (e.g., correct) unit dose volume of a radiopharmaceutical to be administered to a patient.

Description

Radiopharmaceutical tanks and portable power injectors

This application relates to and claims U.S. Provisional Patent Application, Serial No. 60/681,330, filed May 16, 2005, entitled RADIOPHARMACEUTICAL PIG; and Serial No. 60/681,254, filed May 16, 2005, U.S. Provisional Patent Application entitled RADIOPHARMACEUTICALSYRINGE AND PIG COMBINATION; filed May 16, 2005, Serial No. 60/681,253, priority of U.S. Provisional Patent Application entitled RADIOPHARMACEUTICALFILLING AND DELIVERY SYSTEM.

technical field

The present invention relates generally to a powered medical fluid injector and, more particularly, to a power injector and/or energy storage device having properties such as radiation shielding.

Background technique

The purpose of this section is to introduce the reader to various techniques that may be related to various aspects of the invention that are described and/or claimed below. It is believed that this introduction helps to provide the reader with background information to facilitate a better understanding of the various aspects of the invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

Providers of therapeutic technologists often have problems filling syringes with radiopharmaceuticals on site. Proper use of radiation shielding by technicians during the syringe aspiration and calibration process presents its own set of challenges. Radiation needle shields tend to be heavy and cumbersome for the technician to use and can hinder viewing during the drawing of the radiopharmaceutical into the syringe. Under certain conditions, the use of syringe radiation shielding can hinder the handling of radiopharmaceuticals and increase the time taken for the aspiration and dose calibration process.

Power injectors are commonly used in medical devices that inject fluids into patients. For example, power injectors are utilized to inject drugs into patients during certain medical and diagnostic procedures. Similarly, a power injector can inject contrast or marker reagents into a patient. Typically, a power injector includes a needle and an electric motor that drives the needle. Generally, electric motors draw power through power lines. Unfortunately, the power cord can obstruct the movement of the power injector, thereby potentially making the power injector even more inconvenient to use.

Contents of the invention

Certain aspects of the invention commensurate in scope with the claims of the invention are presented below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the invention might take and that these aspects are not intended to limit the scope of the invention. Indeed, the invention may include various aspects not described below.

A first aspect of the invention relates to a radiopharmaceutical canister that facilitates withdrawal of a desired (eg, correct) unit dose volume of radiopharmaceutical from a container. The radiopharmaceutical canister electronically displays the real-time radioactivity level of the radiopharmaceutical contained in the container in the canister. Thus, if several containers of the same radiopharmaceutical exist, the clinician can quickly determine which container is the oldest and should be used first by simply looking at the display on the canister.

Certain radiopharmaceutical canisters of the present invention allow the correct unit dose volume to be determined simply by the clinician, thereby reducing the need for the clinician to consult charts, spreadsheets, and use computer programs. Certain radiopharmaceutical canisters of the present invention electronically calculate and display the correct unit dose volume in response to the desired prescription dose entered by the clinician. A particular feature of the present invention is that it may be particularly helpful in manually withdrawing the radiopharmaceutical from the container into the syringe.

A second aspect of the invention may provide a radiopharmaceutical syringe and canister combination that potentially reduces a person's exposure to radiation from the radiopharmaceutical (eg, during injection of the radiopharmaceutical into a patient). The radiopharmaceutical syringe and canister combination of the present aspect can potentially protect a person from radiation during one or both of electric and manual injection of radiopharmaceuticals. Thus, at least some radiopharmaceutical syringe and canister combinations of the present aspects may be particularly beneficial in providing radiation protection during the slower and longer procedure of injecting a radiopharmaceutical.

In a third aspect, the invention is directed to a device for immobilizing and injecting radiopharmaceuticals. The device includes a can, a lid, and a syringe. The canister has a body that includes one or more suitable radiation shielding materials (eg, lead, tungsten, tungsten-containing plastic, etc.). This body of the canister generally has a socket defined therein to accommodate at least a portion of the syringe. Additionally, the body typically includes an outlet opening defined at one end thereof. The cover of the device is designed to be releasably attached to the main body so that the user can cover or uncover the outlet opening on one end of the main body as desired. The device is designed to support the needle tube within the body. As a result, the needle remains within the body of the device (from the syringe) during injection of the radiopharmaceutical into the patient.

For a fourth aspect, the present invention may provide a multi-dose radiopharmaceutical filling and delivery system that allows the needle cannula to be efficiently filled on-site by the handler (eg, at sufficiently little cost and/or sufficiently little risk of radiation exposure). In a way, the filling and delivery system of the present invention tends to reduce the risk of radiation exposure in either or both of filling the needle and injecting the radiopharmaceutical into the patient. To some extent, the filling and delivery system of the present invention can reduce the risk of radiation exposure during either or both electric and manual injection of radiopharmaceuticals. Accordingly, certain embodiments of the filling and delivery system of the present invention may be particularly beneficial in providing radiation protection during the slower and longer procedure of injecting a radiopharmaceutical.

In a fifth aspect, the invention is directed to a device for filling a syringe from a vial containing a radiopharmaceutical. The apparatus generally includes a base, a cap, and a radiation shielding container adapted to substantially enclose a vial containing the radiopharmaceutical except for an open area in the base. The device also includes a filling and injection device comprising a body and a mounting structure. The body of the filling and injecting device typically includes a side wall and an opening extending through the side wall. The mounting structure of the filling and injecting device is generally adapted to support a syringe, the needle of which is located in the opening of the body. The container and filling and injecting device are generally designed such that the side walls of the body can accommodate the container so that the opening in the base can be positioned next to the opening in the body. This arrangement enables the radiopharmaceutical in the vial to be in fluid communication with the syringe needle. Viewed at least in one aspect, this aspect of the invention features a power injector and shielding system for a radiopharmaceutical that facilitates accurate filling and reduces radiation exposure during the filling and injection process.

For a sixth aspect, the invention relates to an apparatus for transferring radiopharmaceuticals from a vial having a septum facilitating sealing of the radiopharmaceutical therein to a syringe. This equipment includes filling and injection devices and containers. The container is usually designed to hold the vial in an orientation such that the opening of the container is adjacent the septum of the vial. The radiation shielding of the container is usually designed to be positioned substantially around the vial containing the radiopharmaceutical except for the septum region. The filling and injecting device of the device comprises a body and a mounting structure adapted to support a syringe, the needle of which is located in the opening of the body. The body of the filling and injecting device is designed to receive (or accommodate) at least a portion of the container in such a way that the opening in the body of the device abuts the opening of the container. Additionally, the container and device are preferably arranged such that the needle of the syringe pierces the septum, thereby placing the radiopharmaceutical in the vial in fluid communication with the syringe.

In a seventh aspect, the invention is directed to a device for filling a syringe from a vial containing a radiopharmaceutical. The apparatus includes a container adapted to hold a vial containing a radiopharmaceutical and which includes radiation shielding. In addition, the device comprises a filling and injecting device comprising a mounting structure adapted to support a cannula, the needle of which is located in the opening of the body of the device. The device body is designed to be disposed about at least a portion of the vial and is generally adapted to bring the radiopharmaceutical in the vial into fluid communication with the needle of the cannula. The electromechanical device of the apparatus may be adapted to bias (eg, advance and/or retract) the plunger of the needle to fill the needle with the radiopharmaceutical in the vial.

An eighth aspect of the invention is directed to a method of filling a syringe from a vial having a septum sealing the radiopharmaceutical in the vial. In this method, a radiation shielded container is provided that encloses a major portion of the vial. The container can at least substantially secure the vial such that the vial's septum is adjacent the container opening. The needle can be positioned in the filling and injecting device such that the needle of the needle is located in the opening of the filling and injecting device. The container may be positioned above the filling and injecting device such that the vial septum is positioned above the opening of the filling and injecting device. At least one of the container and the filling and injecting device is movable relative to each other such that the needle of the needle pierces the septum of the vial thereby placing the radiopharmaceutical in the vial in fluid communication with the needle.

A ninth aspect of the present invention is directed to a shielded, cordless syringe assembly comprising a syringe, a radiation shield disposed at least partially around the syringe, a driver coupled to a needle, and an energy storage device coupled to the driver.

A tenth aspect of the present invention is directed to a power injector system having a needle, a needle driver coupled to the needle, and a capacitor coupled to the needle driver.

An eleventh aspect of the present invention is directed to a method wherein electrical energy is stored in the cordless injector and the environment is shielded from the radiopharmaceutical in the cordless injector. In addition, the flow of radioactive material is driven by electrical energy.

There are various refinements of the features set forth above in relation to the various aspects of the invention. Other features may also be incorporated into these various aspects. These refinements and additional features may exist independently or in any combination. For example, various features described below in relation to one or more of the illustrated embodiments may be incorporated into any one of the above-described aspects of the invention alone or in any combination. In addition, the above brief summary is only intended to familiarize the reader with certain aspects and contents of the present invention, and not to limit the subject matter of the claims.

Description of drawings

These and other features, aspects and advantages of the present invention will be better understood when read in the following detailed description when read with reference to the accompanying drawings, in which like reference numerals refer to like parts throughout:

Figure 1 is a schematic diagram showing one embodiment of an improved tank for containing a radiopharmaceutical container during the life of the improved tank;

Figure 2 is a perspective view of the improved tank shown in Figure 1;

Fig. 3 is a schematic block diagram of the circuit adopted in the improved tank shown in Fig. 1;

Figure 4 is a schematic diagram showing another embodiment of a modified tank and control, dose aligner for use in a container containing a radiopharmaceutical;

Fig. 4A is a schematic diagram of the end view of the improved tank shown in Fig. 4;

Figure 5 is a schematic diagram showing the combination of a needle tube and a tank;

6A to 6C are perspective views of one embodiment of a syringe and canister combination;

Figure 7A is a schematic cross-sectional view of another syringe and canister combination;

Figure 7B is a perspective view of the syringe and canister combination of Figure 6A;

Figure 7C is a schematic cross-sectional view of yet another needle tube and tank combination;

Figure 8 is a schematic diagram illustrating an exemplary embodiment of a multi-dose radiopharmaceutical filling and delivery system;

9 is a cross-sectional view of a vial and vial container mounted on a filling and injection device for use with the multidose radiopharmaceutical filling and delivery system of FIG. 8;

Figure 10 is a front elevational view of a filling and injection device for use with the multi-dose radiopharmaceutical filling and delivery system of Figure 8;

11 is a perspective view of a vial container mounted on a filling and injection device for use with the multidose radiopharmaceutical filling and delivery system of FIG. 8;

12 is a schematic block diagram of a control system of a filling and injection device for use with the multi-dose radiopharmaceutical filling and delivery system of FIG. 8;

Figure 13 is a schematic block diagram of an exemplary embodiment of a cordless filling and injecting device;

Figure 14 is a schematic block diagram of an exemplary embodiment of a battery powered filling and injection device;

Figure 15 is a schematic block diagram of an exemplary embodiment of a capacitively powered filling and injection device;

Figure 16 is an illustration of an exemplary embodiment of a cordless fill and inject device and base;

Figure 17 is an illustration of an exemplary embodiment of a cordless filling and injecting device with a dual needle;

Figure 18 is an illustration of an exemplary embodiment of a cordless filling and injecting device with an exemplary syringe;

Figure 19 is a flowchart illustrating an exemplary embodiment of a nuclear medicine procedure using one or more of the embodiments shown in Figures 1-18;

Figure 20 is a block diagram illustrating an exemplary embodiment of a radiopharmaceutical production system using one or more of the embodiments shown in Figures 1-18; and

Figure 21 is a block diagram illustrating an exemplary embodiment of a nuclear imaging system using one or more of the embodiments shown in Figures 1-18.

Detailed ways

One or more specific embodiments of the present invention will be described below. In order to provide a concise description of these embodiments, not all components used in actual applications will be described in the specification. It will be appreciated that in the development of any such practical application, as in any engineering and design project, various application-specific decisions must be made in order to achieve the developer's specific goals, such as subject to system-related and business-related constraints, and This can vary from one application to another. Furthermore, it should be understood that such a development effort would be complex and time consuming, but would be a routine undertaking of design, tooling, and fabrication for those skilled in the art, having the aid of this disclosure.

A typical life cycle of a radiopharmaceutical container and associated tank is shown in FIG. 1 as radiopharmaceutical life system 18 . Referring to FIG. 1, container 20 may be filled and packaged at supply facility 24, which may be remote or near facility 42 in which the radiopharmaceutical is to be used. Within supply plant 24 , container 20 may be filled with radiopharmaceutical at filling station 28 . A quality control check of the radiopharmaceutical may be performed at a quality control station 31 ; thereafter, the container 20 may be placed in a tank 33 . The medicated canisters 33 may then be packaged at the packaging station 36 individually or as a batch in suitable shipping cases and the shipping cases 34 may be temporarily lined up and stored at the shipping/receiving department 38 .

Orders for radiopharmaceutical containers 20 may be received from various sources, such as purchasing office 25 of medical facility 42, or physician's office 27 as part of facility 42 or independently thereof. Additionally, an order may or may not be associated with a particular patient. Based on the order, the shipping case 34 may enter a distribution channel 40 through which it may be delivered to a facility 42, such as a hospital or other medical facility. In the example of FIG. 1 , facility 42 is a hospital having a shipping/receiving area 44 for receiving shipping cases 34 containing canisters 33 filled with radiopharmaceutical containers 20 . Typically (but not always), totes 34 are stored within a hospital 42 in a nuclear medicine department 29 , which typically includes a radiopharmaceutical room 48 and/or a procedure room 26 . The container 20 can be removed from the canister 33 as desired; during a dose calibration procedure 49 , the radiopharmaceutical can be withdrawn from the container 20 into the needle 69 ready for injection into the patient 52 .

Withdrawing the correct unit dose volume of the radiopharmaceutical into the needle 69 generally requires knowledge of the radiopharmaceutical's planned radioactivity level at the time of disposal. To make this determination, it is often helpful to know information such as the level of radioactivity when the syringe was filled, the time and date of filling, the time and date of planned disposal, and the rate of radioactive decay of the radiopharmaceutical. Using the planned radioactivity level at the time of disposal and the prescribed dose of the radiopharmaceutical, the correct unit dose volume can be determined. Thus, as previously stated, determination of the correct unit dose volume is difficult and time consuming for a clinician given the tools currently available.

In the depicted embodiment, the filling station 28 , quality control check station 31 , container handling and cleaning of the tanks are done at the supply plant 24 remote from the hospital 42 . In alternative embodiments, one or more of these procedures may be performed in a radiopharmaceutical room or other location inside or outside the hospital.

Figure 2 shows a radiopharmaceutical canister 33 that can be used by a clinician to easily determine the correct unit dose of radiopharmaceutical. The canister 33 for securing a container containing radiopharmaceuticals has a body 101 and a lid 103 secured to the body in a known manner (for example, a bayonet type connection). The body 101 and lid 103 can take on any suitable can design, shape and configuration and are not limited to what is shown. In other words, the principles of the present invention can be applied to any radiopharmaceutical canister that includes one or more radiation shielding materials and is used to secure well-known syringes or vials.

The lid 103 includes a tank computer 278 having a display screen 107 mounted on the upper surface 105 of the lid, an upper switch 109 , and a lower switch 111 . Referring to FIG. 3 , the display screen 107 , the upper switch 109 , and the lower switch 111 of the tank computer 278 are electrically connected to the digital processor 113 , which is mounted on the substrate 115 together with the switches 109 , 111 and the display screen 107 . Substrate 115 is bonded to an inner surface of the lid opposite surface 105 (not shown) by fasteners, adhesive, or other known means. Various other embodiments of canister 33 may include any of a variety of other suitable locations and arrangements for display screen 107 , upper switch 109 , lower switch 111 , and/or digital processor 113 .

Referring to FIG. 1, within supply plant 24, as part of preparation of a radiopharmaceutical prescription, tank computer processor 113 can be programmed with data, for example, radiopharmaceutical identification and decay rate, radiopharmaceutical measured activity level, time of measurement and date, patient name, planned treatment time and date, prescribed dose of radiopharmaceutical, etc. Data may be stored in memory 114 and input into digital processor 113 via communication link 117, which may be a wired or wireless link. Additionally, data may be manually or automatically entered into tank computer processor 113 one or more times (eg, during radiopharmaceutical prescription preparation).

Knowing the level of activity at the time of filling and the rate of radioactive decay, the tank computer processor 113 is designed to automatically update (eg, substantially in real time) the level of activity of the radiopharmaceutical within the tank 33 . In some embodiments of the canister 33, the current radioactive level of the radiopharmaceutical inside may be displayed on the first digital display 119 within the display screen 107 in suitable units (eg, mCi/mL) representing the current radioactive level . Thus, during storage or transport of tank 33, tank computer processor 113 is able to continuously change the value represented by display 119 to reflect the level of radiopharmaceutical activity in container 20 in substantially real time. The canister computer processor 113 of some embodiments may also display (in a second digital display 121 within the display screen 107) a numerical value representing the stored radiopharmaceutical prescription dose. Knowing the real-time radioactivity level and prescribed dose, the digital processor 113 of these embodiments can display (in the third digital display 123 within the display screen 107) a value representing the correct unit dose volume of the radiopharmaceutical (e.g., by the clinician drawn into a syringe or ejected from a syringe already prefilled in a canister).

Just prior to injecting the radiopharmaceutical into the patient 52, the clinician may view the second digital display 121 representing an earlier programmed prescribed dose of the radiopharmaceutical. If the prescribed dose matches the clinician's desired prescribed dose, the clinician can simply read the third digital display 123 to determine the correct unit dose volume of the radiopharmaceutical. If the prescribed dose has been changed due to prescription requirements, the clinician can operate the upper switch 109 and/or the lower switch 111 to change the value of the second digital display 121 to match the new prescribed dose.

It may also be desirable to alter the prescribed dosage because the time and date of treatment have changed from what was planned when the prescription was issued. In this case, the prescribed dose (eg, injection volume) of the radiopharmaceutical can be calculated just prior to treatment based on the radiopharmaceutical's radioactivity level at that time. In the radiopharmaceutical room 48 of the hospital 42, new values for radiopharmaceutical activity levels and decay rates and/or prescribed doses may be entered into tank computer processor 113.

After use, the container 20 can be placed in the tank 33 again and returned to the supply plant 24 . At the reprocessing station 51, the radiopharmaceutical container 20 can be disposed of and the canister 33 can be cleaned for reuse (eg, in a known manner).

Referring to Figure 4, there is shown a canister comprising a microprocessor with some type of input/output means. Tank 33a is designed to hold, store and/or transport vials containing radiopharmaceuticals; tank 33b is designed to hold, store and/or transport syringes containing radiopharmaceuticals. Canisters 33a and 33b have respective bodies 101a and 101b and respective caps 103a and 103b, which are detachable from respective bodies 101a and 101b in known manner for loading and unloading radiopharmaceutical vials or syringes.

Tanks 33a, 33b have corresponding tank computers 278a, 278b with corresponding input/output ("I/O") devices 280a, 280b, eg, corresponding input switches 282a, 282b and corresponding output displays 284a, 284b. Input switches 282a, 282b and output displays 284a, 284b can be connected to the tank computer processor in a circuit similar to that shown in FIG. 3 . Tank computers 278a, 278b may be used to provide functionality substantially similar to that described with reference to tank computer 278 of FIGS. 2 and 3 . 4A, each tank 33a, 33b has a corresponding electrical connector 288 on a corresponding bottom surface 286a, 286b, which is mechanically connected to an electrical connector 289 mounted on an upper surface 290 of a base unit 291, and providing electrical communication therewith. The electrical connector 289 is electrically connected to a computer in the control unit 292 via a wired connection 293 such as a cable. Thus, when one of the tanks 33a, 33b is mounted on the base unit 291, thereby being mechanically connected to the electrical connectors 288, 289, the corresponding tank computer 278a, 278b is electrically connected to the base unit 291 via lead wires computer.

The control unit 292 has various input devices 294, such as input keys and/or switches, and output devices 295, such as a display screen. The control unit 292 is electrically connected to the dose calibrator 296 . Dose calibrator 296 has a radiation sensor (not shown) that allows control unit 292 to monitor the radiopharmaceutical level of activity in the dose calibrator in known manner.

The dose calibrator 296, control unit 292 and base unit 291 are typically located in the radiopharmaceutical room and are used when a radiopharmaceutical prescription is placed in a vial or syringe. The prescribed dose is filled into the vial or syringe using the control unit 292 and dose calibrator 296 . Typically, for application to vials, syringes and/or canisters 33a, 33b, a label is prepared indicating one or more of the following data: radiopharmaceutical, isotope type, activity level at the time of placement in the vial or syringe, Predicted dose, patient name, etc. While also valuable data, the exact usage time cannot be known when preparing the label.

However, in the embodiment of Figures 3 and 4, dose calibrator 296, control unit 292, base unit 291, tank processor 113 and input and output devices 284a, 284b, 286a, 286b form a system that can The radiopharmaceutical, technician or caregiver provides greater or more precise information related to the dose of the radiopharmaceutical. In this example, the control unit 292 may send information to the canister computer processor 113 disposed in the vial 33a or syringe 33b related to the radiopharmaceutical, isotope type, radioactive activity level at the time of placement in the vial or syringe, patient name, etc. The data. Additionally, the canister computer processor 113 may calculate and provide the prescription time stored in the vial 33a or syringe 33b to the corresponding output device 284a, 284b. Other data can also be determined and displayed, eg, current real-time activity levels, current recommended dosage, etc. The input devices 282a, 282b can be used to retrieve stored data and enter new data, and the display screen 107 can be used to display the data for the clinician. For example, by holding the switches 109, 111 while in the depressed state for a period of time, the canister computer processor 113 can be programmed to provide an output to the display screen 107 indicative of the identification of the radiopharmaceutical within the container. In other applications, the switches 109, 111 may be used to provide different display options in a known manner. For example, the display screen 107 can be programmed to turn off after a period of time to conserve energy, and the display screen 107 can be activated by holding one of the switches 109, 111 depressed for a period of time. Other switches may be added to provide other display options, for example, a reset switch 125 may be used to reset the operation of the digital processor 113 .

Utilizing the various embodiments presented herein, the person handling the canister 33a, 33b obtains up-to-date information about the radiopharmaceutical, as well as its age and activity level, without opening the canister and physically touching the vial or canister. Thus, the potential exposure of the handler to the radiopharmaceutical is reduced. Additionally, an inventory of the various radiopharmaceuticals is often maintained, and the output devices 284a, 284b allow the handler to easily determine the earliest canister 33a, 33b that is usually selected for use.

In the embodiment of FIG. 4 , the tanks 33 a, 33 b are electrically connected to the base unit 291 through electrical connectors 288 , 289 . In a first alternative embodiment, the base unit 291 and the electrical connector 289 may be functionally integrated into the control unit 292 . For example, electrical connector 289 may be mechanically mounted on, and/or integrated into, control unit 292 . Thus, the leads 293 would be within the control unit 292, or could be eliminated if the connector 289 were mounted directly on a printed circuit board or other substrate within the control unit 292. In other embodiments, the electrical connector 288 may be mounted on the end surface of the can lid 103a, 103b. In yet another embodiment, one of the I/O devices 286a, 286b and the connector 288 may be mounted together on the corresponding tank end face 286a, 286b or on the end face of the corresponding lid 103a, 103b. In yet another embodiment, a wireless connection may be used, for example, by using a radio frequency identification device ("RF-ID"). RF-ID systems carry data in what is commonly referred to as a tag transponder, which is retrieved by a machine-readable device. Thereby, an RF-ID tag or transponder, with a chip such as a programmable processor, associated memory and at least one communication antenna, can be connected to the tanks 33a, 33b. The data within the RF-ID chip and associated memory can provide various forms of information related to radiopharmaceuticals and associated vials or syringes and tanks.

RF-ID systems also require means for reading data from and, in some applications, writing data to the tags, and means for communicating the data with a computer or information management system. Thus, data is read from or written to, if applicable, the RF-ID tag by the machine-readable device at the appropriate time and place to meet specific application needs. Such a machine readable device may be associated with the base unit 291, or may be associated with the control unit 292, in which embodiment the base unit 291 is removable. Thus, the RF-ID system has the flexibility to allow data to be written to and read from the tag at different times and at different locations.

A typical life cycle of a radiopharmaceutical syringe and canister combination 130 is shown in FIG. 5 . The radiopharmaceutical syringe and canister combination 130 includes a cannula 132 at least substantially surrounded by a canister 134 . The radiopharmaceutical may be drawn into the syringe 132 and packaged at the supply facility 24, which may be remote or near the setting 42 where the radiopharmaceutical is to be used. Within supply plant 24 , needle 132 may be filled with radiopharmaceutical at extraction station 28 . Canister 134 may or may not be placed around needle 132 during this filling. Quality control testing of radiopharmaceuticals may be performed at the quality control station 31 . Thereafter, an outlet end cap or cap 140 and a brim end cap 152 can be affixed to the syringe and canister combination 130 to provide a product that can be effectively characterized as completely capping the cannula and canister combination 131, as shown in FIG. 6A, which can Provides radiation shielding for radiopharmaceuticals in the syringe. The capped syringe and canister combination 131 may then be packaged at the packaging station 36 individually or as a batch in suitable shipping boxes 34 which may be temporarily lined up or stored at the shipping/receiving department 38 . In a manner similar to that described with reference to FIG. 1 , upon order, the shipping boxes 34 may enter a distribution channel 40 through which they may be transported to a facility 42 and subsequently provided to the nuclear medicine department 29, which may include a radiopharmaceutical room 48 and/or a disposal Room 26.

Referring to FIG. 6B , a radiopharmaceutical syringe and canister combination 130 is comprised of a cannula 132 and a canister 134 . Canister body 136 mounts over all or a substantial portion of syringe barrel or body 138 and may be constructed entirely or in part of lead, tungsten and/or any other material that protects a person from exposure to radiation from the radiopharmaceutical in syringe 132 . Canister body 136 and syringe body 138 may be manufactured as a single integral piece or as separate pieces. Canister body 136 may be permanently affixed to syringe body 138 with an adhesive, a mechanical connection, or may simply slide over syringe body 138 with an interference fit. Other ways of providing a tank around the injection body may also be suitably used.

Referring to FIG. 6B , canister outlet end cap 140 may be used to cover connector 144 over needle outlet end 142 . Connector 144 may be sized and shaped to accommodate tubing. Canister outlet end cap 140 may be mounted to and/or contact outlet end 142 of syringe body 138 via an interference fit, threaded connection, fastener, or other known manner that provides connection 153 ( FIG. 6A ) in which radiation leakage is inhibited or substantially eliminated. Or one or both of one end 145 of the tank main body 136. Canister outlet end cap 140 may be formed in whole or in part of lead, tungsten, and/or any other material that protects a person from exposure to radiation from the radiopharmaceutical in needle barrel 132 .

The needle cannula 132 includes a plunger 146 that extends into the needle cannula body 138 and is connected to the plunger 148 . Plunger 146 has an outer end 147 ( FIG. 6C ) which may be sized and shaped to any desired shape to connect with a translating drive shaft (not shown) within syringe 158 so that the needle drive rod can push plunger 146 . Plunger 148 may be formed in whole or in part of lead, tungsten, and/or any other material that shields a person from exposure to radiation from the radiopharmaceutical in needle barrel 132 . In the exemplary embodiment of FIG. 6B , the plunger 148 has a radiation shield 150 . Thus, the radiation shield 150 on the canister body 136 and plunger 148 provides some radiation protection in the vicinity of the plunger rod 146 .

The canister 134 has a brim end cap 152 that is removably attached to the opposite end of the needle cannula body 138 via an interference fit, threaded connection, fastener, or other known means that provides a connection 159 (FIG. 2A) therebetween that inhibits or substantially eliminates radiation leakage. end 155, or the opposite end 157 of the tank body 136. Canister rim end cap 152 may be formed in whole or in part of lead, tungsten, and/or any other material that protects a person from exposure to radiation from the radiopharmaceutical in needle barrel 132 .

A fully capped canister and syringe combination 131 (FIG. 6A) can be used to inject radiopharmaceuticals manually or with a power injector. For manual injection as shown in FIG. 6B , canister end caps 140 and 152 can be removed to provide a fully uncapped canister and syringe combination 135 . A tube (or other suitable delivery conduit) may be connected to connector 144 . The clinician can then depress the plunger 146 to inject the radiopharmaceutical. For use with a power injector, only the end cap 140 may be removed; and, as shown in FIG. 6C , the brim end cap 152 may remain attached to provide a partially covered syringe and canister combination 133 . Brimmed end cap 152 may be designed to allow syringe and canister combination 130 to be installed in power injector 158 . A typical power injector that may be suitable for use with a partially capped syringe and canister 133 is shown and described in U.S. Patent Application Publication No. US 2004/0024361 Al, entitled "Injector" and assigned to the assignee of the present invention. The entirety of U.S. Patent Application Publication No. US 2004/0024361 Al is hereby incorporated by reference.

The presence of radiation shielding provided by canister body 136, plunger layer 150 (if used), and rimmed end cap (if used) can at least substantially inhibit human radiopharmaceutical administration when used manually or with a power injector. Exposure to radiation. After the radiopharmaceutical has been ejected from the syringe 132, the end caps 140 and 152 can be connected as shown in FIG. At the reprocessing station 51, the needle cannula can be disposed of and the canister 134 and end caps 140, 152 can be cleaned for reuse.

Referring to FIG. 7A , another embodiment of a syringe-tank assembly 130a includes a syringe 160 mounted within a canister 162 . Tank 162 has an outer cover 164 and inner liner 166 of lead, tungsten, and/or other radiation shielding material. In this embodiment, the syringe is a two-stage syringe having first and second plungers 163, 165, respectively. The needle cannula 160 has a first lumen 167 with a first outlet end 184 and a second lumen 169 with a second outlet end 186 . Tip 188 is removably mounted over outlet ends 184 , 186 . The first lumen 167 can be filled with a radiopharmaceutical and the second lumen 169 can be filled with saline solution and/or other suitable biocompatible fluids (eg, heparin solution, sterile water, dextrose solution, etc.). The cannula 160 can be secured in the canister 162 by suitable means (eg, by a retractable clip 170 that is biased towards the outer surface of the cannula 160). The clip can be released by actuating a release button 172 mounted on an outer surface 174 of the tank 162 .

The first plunger 163 is shaped as a ring and contacts the cylindrical side wall of the first cavity 167 formed on the outside, and the second plunger 165 is shaped to fit and contact the cylindrical side wall of the second cavity 169 formed on the inside. . The plungers 163, 165 may be made in whole or in part of lead, tungsten and/or other radiation shielding materials. In the exemplary embodiment of FIG. 7A, plunger 163 is made entirely of radiation shielding material, while plunger 165 has an outer guide layer 171 of radiation shielding material. Additionally, in the exemplary embodiment of FIG. 7A , the canister 162 can be sized and shaped to correspond to a standard size (eg, 125 ml syringe) cannula and can have a rim 182 that allows the cannula and cannula combination 130a to fit in a syringe. Examples of manual and powered injectors suitable for handling dual-chamber or two-stage syringes 160 are in U.S. Provisional Application No. 60/695,467, entitled "DualChamber Syringe," filed June 30, 2005 and assigned to the assignee of the present application shown and described in. US Provisional Application 60/695,467 is hereby incorporated by reference in its entirety.

End cap 176 may be mounted on tank end surface 178 over tank outlet opening 180 . Cover 176 may be made of lead, tungsten, and/or other materials that provide shielding from radiation from the radiopharmaceutical. Cover 176 may be designed to slide or fit over surface 178 to selectively open and cover opening 180 . Alternatively, cover 176 may be pivotally mounted on surface 178 to allow a user to selectively open and cover opening 180 as desired. Alternatively, the cover 176 may be secured to the end face 178 by removable fasteners, thereby allowing the user to cover or uncover the opening 180 as desired. Incidentally, other ways of providing covering or opening can be constituted by various possible combinations of the above.

Canister 162 may have a printed label 173 as shown in FIG. 7B . Additionally, canister 162 may have a radio frequency identification device ("RF-ID") 175, which may be part of tag 173 or separate therefrom. Data related to the radiopharmaceutical, syringe 160 and canister 162 can be read from and/or written to the RF-ID at each stage of the corresponding life cycle of these components. Additionally, canister 162 may have a user interface 177 including a display screen 179 mounted on exterior surface 174 and/or an input device 181 such as a switch. Display 179 and/or switch 181 may be connected to a digital processor (not shown) with memory, which may be used to store data related to the radiopharmaceutical, its radioactivity level, and the like.

The continued presence of radiation shielding provided by canister 162 and plunger layer 171 (if used) during injection of a radiopharmaceutical into a patient may at least substantially inhibit radiation exposure to persons handling needle and canister combination 130a and performing radiopharmaceutical administration.

In an alternative embodiment shown in FIG. 7C , needle 160 may be secured within canister 162 by an annular (or other suitable design) protrusion 168 that provides an interference fit of needle 160 within canister 162 . In another embodiment, depending on the radiation level of the radiopharmaceutical, the radiation shielding protection of the plunger may be eliminated. Additionally, depending on the radiation level of the radiopharmaceutical, the brim end cap 152 may be made of a material that does not provide radiation protection shielding.

Various components of a typical multi-dose radiopharmaceutical filling and delivery system 200 are shown in FIG. 8 . This filling and delivery system 200 may be adapted for use at the handler. The filling and delivery system 200 generally includes a shielded radiopharmaceutical container 206 and a filling and injection device 220 . Incidentally, the radiation shielding of container 206 may be any suitable shielding material (eg, lead, tungsten-containing plastic, and/or tungsten). After the syringe is placed in the filling and injecting device 220, the radiopharmaceutical container 206 may be mounted atop the filling and injecting device 220 as shown in FIG. 11, as will be described below. The filling and injecting device 220 is then operable to provide powered filling of the radiopharmaceutical syringe at the prescribed unit dose volume. The power fill process of certain embodiments is characterized as being fast, accurate, and/or exhibiting a lower risk of exposure than known systems. Thereafter, container 206 may be disengaged from device 220, and filling and injection device 220 may be operated to provide powered injection of the radiopharmaceutical to the patient. Alternatively, the needle cannula can be removed from the fill and inject device 220 and used manually to inject the radiopharmaceutical into the patient.

The handler purchases radiopharmaceuticals from the radiopharmaceutical room in multi-dose vials 202 ( FIG. 8 ), which can be removed from their shipping cans and placed in vial holders 204 of containers 206 . Vial holder 204 may be secured to container base 210 and container cap 208 may be secured above container base 210 . As shown in FIG. 9 , the threaded plug 216 can be installed in the cap 208 , whereby the cap 208 can be stably fixed to the base 216 by threading the threaded plug 216 and the internal thread on the holder 204 . The mechanical connection between cap 208 and base 210 may be any suitable interconnection, such as quick turn threads (eg, high-pitch threads, snap-type threads, etc.). Vial holder 208 and plug 216 may comprise any suitable radiation shielding material (eg, lead, tungsten plastic, and/or tungsten) capable of providing radiation shielding from radiopharmaceuticals within vial 202 .

Container 206 at least generally allows radiopharmaceutical vial 202 to be conveniently handled and shipped while providing radiation protection around vial 202 (eg, except at opening 218). Incidentally, nuclear medicine department personnel are accustomed to handling devices with radiopharmaceuticals disposed therein, which have "live" or "hot" openings, and thus, opening 218 does not represent a new handling regulation. To cover the opening 218, the container 206 may be placed in a base support or pad 212 comprising any suitable radiation shielding material. As such, the radiopharmaceutical within container 206 is adequately shielded when placed on base pad 212 . Container 206, cap 208, and/or base pad 212 may be patterned, labeled, and/or color-coded for quick visual identification of different radiopharmaceuticals or other predetermined indicia.

The filling and delivery system 200 also includes a filling and injecting device 220 shown in FIG. 10 that provides powered filling or dispensing of radiopharmaceutical from a needle 222 supported therein. Prior to installation in filling and injecting device 220 , needle cannula 222 may be inserted into needle cannula radiation shield 224 . The radiation shield 224 may have one or more internal protrusions and/or other suitable means to at least help secure the needle cannula 222 in the shield 224 so that the shield 224 and the needle cannula 222 do not separate during normal handling, but the needle cannula 222 does not separate during normal handling. Can be detached from shield 224 if desired. Radiation shielding 224 may be said to provide a first level of radiation shielding during manual handling, handling, and/or direct use of needle 222 to inject radiopharmaceuticals into a patient. Cannula radiation shield 224 may exhibit standard outer dimensions and/or shapes to facilitate securing needle 222 within filling and injecting device 220 in a proper orientation. Thus, different sized syringes can be held with matching syringe shields all having common or similar outer dimensions and/or shapes. Shielded cannula holder 224 may be made of tungsten, tungsten-containing plastic, lead, and/or any other material that provides radiation shielding from radiopharmaceuticals. Additionally, the shape and size of the shielded cannula holder 224 may vary (eg, to meet the functional, ergonomic, and/or shielding needs of different applications).

In the exemplary embodiment of FIG. 10, the fill and inject device 220 has a removable side wall 226 with a pair of U-shaped resilient clips 228 that secure the cannula shield 224 in a desired position and orientation. With shielded syringe holder 224 properly positioned in clip 228 , side wall 226 may then be repositioned against body 230 of filling and injecting device 220 . Injection needle 234 may move through slot 232 ( FIG. 8 ) in upper wall 248 of fill and inject device 220 and may be positioned in central bore 250 . Injection needle 234 preferably extends through and above upper wall 248 , also shown in FIG. 9 .

As shown in FIG. 12 , the needle cannula 222 can have a pusher 236 with a brim end 238 . The belt along end 238 may be sized and shaped to interconnect with a powered translational electromechanical drive 239 housed in filling and injecting device 220 . The electromechanical drive 239 is shown to include a plunger drive ram 241 coupled to a syringe drive 243, such as an electric motor. The operation of syringe driver 243 may be controlled by microprocessor 245 having memory 247 . Microprocessor 245 may be connected to power interface 249 , which in turn is connected to power supply 251 . The microprocessor 245 may also be connected to a user interface 254 (FIG. 8), and the user interface 254 may include, but is not limited to, a display screen 256 and/or an input device 258, such as a switch. Memory 247 may be used to store data related to the operation of filling and injection device 220, which may include, but is not limited to, programs used to control filling and/or injection operations, information related to radiopharmaceuticals, other procedural or non-procedural information, patient information, providing communications back to the pharmacy, etc. Remote control 253 can be used to help provide communications with pharmacies and manufacturers, among others. Display 256 may incorporate alphanumeric and/or graphical displays to display data including, but not limited to, fill and injection parameters, status, installed components, radiopharmaceutical information, instructions, alerts, and the like. A remote control 253 connected to a power source 251 may optionally be used in place of the user interface 254 for remotely controlling the operation of the filling and injecting device 220 .

Controls and electromechanical drives of the type shown in FIG. 12 and which may be suitable for filling and injecting device 220 are shown in U.S. Patent Application Publication No. US 2004/0024361 A1 entitled "Injector" and assigned to the assignee of the present invention And introduce, U.S. Patent Application Publication No.US2004/0024361 A1 is hereby incorporated by reference in its entirety.

As shown in FIG. 11 , container 206 may be lifted off base pad 212 and placed over upper end 235 of injection and fill device 220 . As shown in FIG. 9 , a container base 210 with a radiation shield 204 is located within a cavity 240 . The container 206 and filling and injecting device 220 may be engaged by mating the threads 240 and 242 together and then rotating them relative to each other, thereby engaging the threads 240 and 242 . Engagement of threads 240 and 242 translates container 206 relative to filling and injecting device 220 and septum 244 on the lower end of vial 202 is pierced by needle 234 extending through upper wall opening 250 . As such, needle 234 may be in fluid communication with radiopharmaceutical 252 in vial 202 . The septum 244 is located generally adjacent the upper wall 248 when the container 206 and the filling and injecting device 220 are fully secured together.

In alternative embodiments, the mechanical connection between container 206 and filling and injecting device 220 may be any quick turn thread or any other quick connect and disconnect device. In another embodiment, the mechanical connection, eg, threads 240 and 242 , can be eliminated so that the container 206 is simply placed on the upper end 235 of the filling and injecting device 220 . In variations of this embodiment, there may be an interference fit between the container 206 and the walls of the cavity 246 .

The filling and injecting device 220 preferably incorporates complete radiation shielding around its side walls and one or more end walls made of tungsten, tungsten-containing plastic, lead, and/or any other material that provides radiation protection from the radiopharmaceutical . Additionally, needle radiation shield 244 surrounding needle 222 provides another level of shielding from radiopharmaceutical radiation. Thus, during power filling of the needle 222 with a radiopharmaceutical, or during power injection of a radiopharmaceutical, the person handling the filling and injection device 220 is shielded from radiation from the radiopharmaceutical, with only the potential for radioactive leakage is through the central hole 250 . As previously stated, Department of Nuclear Medicine personnel are subject to regulations for handling this "live opening", so this should not pose a significant risk of radiation exposure.

Fill and inject device 220 may have a printed label 260 as shown in FIG. 8 . Additionally, the fill and inject device 220 may have a radio frequency identification device ("RF-ID") tag 262, which may be part of the tag 260 or separate therefrom. As shown in FIG. 12 , the microprocessor 245 may have an RF-ID interface 263 for reading data from and/or writing data to an RF-ID tag 262 . Vial 202 may have RF-ID tag 259 and/or syringe 222 may have RF-ID tag 261 . A suitable read/write device 255 , which may be connected to a computer, may be used to read or write data to one or more of the RF-ID tags 259 , 261 , 262 . Computer 257 may be located at any suitable location, and is shown at the location of a user of fill and inject device 220 (eg, a medical facility or pharmacy). Thus, data related to the radiopharmaceutical, needle 222, container 206, and/or filling and injection operations can be read from or sent to RF-ID tag 262 at virtually every work step of filling and injection device 220 (if desired). written therein, and this data can be obtained by the microprocessor 245 of the filling and injecting device 220 . Additionally, data written to or read from one or more of the RF-ID tags 259, 260, 261 may be communicated to other computers in a suitable manner (as known in the art) (e.g., via computer 257), including remote computers.

Thus, after determining that a particular radiopharmaceutical is to be used, the radiopharmaceutical is identified by one of manual (e.g., via user interface 254) and automatic (e.g., using one or more of read/write device 255 and RF-ID tags 259, 262) Either way or both, data from the vial label can be loaded into the microprocessor memory 247 and the data can be loaded into the syringe RF-ID tag 261 using the read/write device 255. This data may include, but is not limited to, the following:

- prescription data.

- identification of the radiopharmaceutical, its brand, its supplier, etc.

- the level of radioactivity per milliliter measured by the pharmacy.

- Radioactive decay rate.

- the time and date of calibration.

- Vial usage history.

- expected remaining volume.

- Validity period.

A user may operate the user interface 254 to select a portion of these data for display. Thus, prior to the filling operation, the controls of the filling and injecting device 220 can be programmed to automatically or selectively check data, including but not limited to

- Effectiveness of validity period and time.

- Recall information.

- Syringe installation and disassembly information to prevent re-use of syringes.

- Past use of the vial and whether the vial is currently suitable for use.

- the effectiveness of the filling procedure by checking the desired remaining volume of the vial.

- Calculates and displays recommended fill volume based on pharmacy measured activity level, decay rate data, calibration time and date, and prescribed dose and injection time and date.

- Product promotions from radiopharmaceutical suppliers.

- Drug packaging insert information.

Data that can be manually programmed and/or written to the RF-ID tag 262 (e.g., via the read/write device 255) using the user interface 254 for use by the microprocessor 245 to at least generally control the operation of the filling and injection device 220 can include , but not limited to, the following:

- Fill volume per fill.

- Calculation of vial remaining volume from usage history.

- the date and time of each fill.

- for each filling and activity level.

- Any other information to be entered by the user, including but not limited to the following: patient related information, device status eg service needs, usage history etc.

The fill/injection device 220 can consistently fill the syringe with the correct unit dose volume with very high accuracy in a single fill operation. This can eliminate the time-consuming and repetitive manual process of dose adjustment, and/or can reduce the risk of user exposure to radiation. As a result, wasted syringes and costly overfills can be reduced or substantially eliminated, and/or disposers can experience more efficient use of pharmacy-provided vials.

The fill and inject device 220 can monitor the back pressure created during a power injection and can pause or abort injections with abnormally high or low pressures. Low pressure would indicate an empty needle or leak, while high pressure would indicate a blockage or possible spillage.

In applications where the fill and inject device 220 is used by a pharmacy rather than a handler to fill unit dose syringes, and RF-ID tags are used on the syringes, the fill and inject device may be used for some of the vial and syringe fill information described above. Or all-to-needle RF-ID tags.

In the exemplary embodiment of FIG. 9 , needle mounting structure 228 is pivotable away from the main body of filling and injecting device 220 . In an alternative embodiment, the cannula mounting structure may be completely separate from the filling and injecting device. Additionally, in the exemplary embodiment shown and described, the cannula 222 has a needle 234 . However, the filling and injecting device 220 may be used to fill and/or dispense radiopharmaceuticals from a needle-free syringe. In this embodiment, an intermediate connector may be utilized to interface with and provide fluid communication with vial 202 . One example of a suitable intermediate connector may include a needle on one end to pierce a vial septum, and a fitting (eg, via a suitable luer fitting) on the opposite end that may connect to a needle tubing featuring a needleless nozzle. Additionally, in Figure 12, the filling and injecting device may be corded or cordless (eg, battery powered).

In the exemplary embodiment shown and described, the filling and injecting device 220 is a handheld device. However, the filling and injecting device 220 may be hand-held when power injecting the radiopharmaceutical, or may be mounted on a support. Support mounted injectors can be remotely started, stopped and/or automatically activated after manual activation via attached cable or console.

For the illustrated embodiment, the radiation shields 204, 216 for the container 206 are described as mounted in the cap 208 and the base 210, respectively. Other embodiments may include a radiation shield that may be fully or partially housed within the cap 208 and/or base 210, or may be a separate and separate component separately connected to the cap 208 and base 210, or be of other suitable configuration.

13-15 illustrate a typical cordless fill and inject device 220 . In the embodiment of FIG. 13 , the cordless fill and inject device 220 may have an energy storage device 302 , a docking station 300 , and a power controller 303 . Advantageously, energy storage device 302 may support cordless operation of certain embodiments of filling and injecting device 220, as described below. The energy storage device 302 may include a battery 304 as shown in FIG. 14 , or a capacitor 305 as shown in FIG. 15 . The battery 304 may include, for example, a lead acid battery, a lithium ion battery, a lithium ion polymer battery, a nickel cadmium battery, a nickel metal hydride battery, or an alkaline battery, among others. Capacitor 305 may include, for example, electrolytic capacitors, tantalum capacitors, supercapacitors, polyester film capacitors, polypropylene capacitors, polystyrene capacitors, metallized polyester film capacitors, epoxy capacitors, ceramic capacitors, multilayer ceramic capacitors, silver-mica capacitors, variable capacitors and/or air core capacitors. In other embodiments, energy storage device 302 may include other forms of electrical energy storage, such as an inductor; mechanical energy storage, such as a pressurized fluid chamber, a flywheel or other kinetic energy storage device, a spring, and/or some other elastic member; and/or Or chemical energy storage, eg like fuel cells. In certain embodiments suitable for use in the vicinity of magnetic resonance imaging (MRI) machines, energy storage device 302 may be substantially or completely free of iron.

Upon assembly, the hub 300 can be connected to the filling and injecting device 220 and the energy storage device 302 . The power controller 303 may be partially or fully integrated in the microprocessor 245 , or the power controller 303 may be separate from the microcontroller 245 . Power controller 303 may communicate with energy storage device 302 via power interface 245 . Power controller 303 may receive signals from energy storage device 302 related to various energy storage parameters, such as energy storage level, temperature, rate of charge, or rate of energy release. For example, embodiments employing capacitor 304 may also include protection circuitry to limit the rate at which the capacitor charges and/or discharges, thereby limiting other components from taking higher currents. In some embodiments, the protection circuit can be partially or fully integrated in the power controller 303 .

In operation, power controller 303 may monitor and control energy storage device 302 . For example, power controller 303 may monitor and/or control the rate and/or level of charging of energy storage device 302 . Similarly, in some embodiments, power controller 303 may monitor and/or control the rate and/or level of discharge of energy storage device 302 . For example, power controller 303 may determine whether energy storage device 302 is charged to a predetermined level, such as fully charged or discharged, and send a signal to display 256 and/or dock 300 to indicate that level.

In some embodiments, the power controller 303 and/or the microprocessor 245 can determine whether the energy storage device 302 has an energy level sufficient to drive the required injection or filling operation. Power controller 303 and/or microprocessor 245 may enable operation if energy storage device 302 has sufficient energy levels to drive the operation. On the other hand, if energy storage device 302 has insufficient energy levels to drive the desired work, power controller 302 and/or microprocessor 245 may send a warning signal, eg, to display 256, and/or prevent the desired work from being performed.

Memory 247 and/or memory within energy storage device 302 , power controller 303 , or other components of filling and injecting device 220 may record the life cycle of energy storage device 302 . For example, the number of times energy storage device 302 has been charged and/or discharged may be recorded and retained by memory. In some embodiments, microprocessor 245 and/or power controller 303 may send a signal to display 256 indicating the life of energy storage device 302 . For example, a failure warning signal and/or a charge/discharge cycle count may be sent to and displayed via display 256 . In some embodiments, the energy storage device 302 may include information for storing information indicative of its lifetime, such as, for example, date of manufacture, tracking number, charge/discharge cycle count, energy storage device type, manufacturer identification, expiration date, and/or memory with remaining storage capacity, etc. Additionally, in some embodiments, energy storage device 302 may include RFID circuitry for communicating with other devices.

In some embodiments, the docking station 300 can charge the energy storage device 302 . Alternatively or additionally, the energy storage device 302 may receive energy from a power source other than the docking station 300, such as from a photoelectric device connected to the injection device 220, a hand crank or other manual charging device, and/or from a refilling energy recycling device. energy of.

FIG. 16 shows a typical cordless fill and inject device 306 having an energy storage device 302 that can be connected to a docking station 300 . A typical cordless fill and inject device 306 may include the features of the previously described fill and inject devices. The present cordless fill and inject device features shielded needle assembly 308 , shield 310 , needle drive 312 , hub electrical interface 314 , and hub mechanical interface 315 . The socket electrical interface 314 may include a plurality of wires 332 , 333 , 334 , 335 . In this embodiment, the cannula assembly 308 can include a cannula 316 and a shield 318 . The illustrated cannula 316 can have a needle 320 , a barrel 322 , a plunger 324 , and a plunger rod 326 with an outer end 328 . One or more fluids 330 may be disposed within barrel 322 of needle tube 316 . For example, fluid 330 may include, for example, radiopharmaceuticals, contrast media, saline solutions, markers, or other drugs. In certain embodiments, needle 316 may be a single stage needle, a two stage needle with a different fluid in each stage, a multi-syringe needle, or a needle with more than two stages and more than two fluids.

Shields 310, 318 may include electromagnetic shields, radiation shields, thermal shields, or combinations thereof. In certain embodiments, shields 310, 318 are characterized by radiation shielding materials such as lead, depleted uranium, tungsten, tungsten-containing plastics, and the like. Alternatively or additionally, the shields 310, 318 may comprise electromagnetic shielding materials such as layers, mesh or other forms of copper, steel, conductive plastic, or other conductive materials. In particular embodiments, shields 310, 318 are substantially or completely free of iron. Shield 310 may completely enclose needle 316, needle drive 312, and/or energy storage device 302; substantially enclose one or more of components 316, 312, 310; or partially enclose one of components 316, 312, 310 or more. Similarly, shield 318 may fully, substantially, or partially surround needle cannula 316 . It should also be noted that some embodiments may not include shields 310 and/or 318, which is not to say that any of the other features described herein may also be omitted.

The needle drive 312 may include piezoelectric drives, linear motors, shape memory alloys, rack and pinion systems, worm gear and wheel assemblies, planetary gear assemblies, belt drives, gear drives, manual drives, and/or pneumatic drives. For example, in the embodiment of FIG. 18 described below, the needle drive 312 may include an electric motor and a screw drive. In some embodiments, needle drive 312 may be completely, substantially, or partially ferrous.

Dock 300 may include a complementary electrical interface 336 , a complementary mechanical interface 338 , and a power cord 340 . The complementary electrical interface 336 may include a plurality of female connectors 342 , 343 , 344 , 345 . The power cord 340 may be used to receive power from a wall outlet, and the dock 300 may include power conditioning circuits such as transformers, rectifiers, and low-pass power filters. In some embodiments, the socket may be configured to accept wall outlet AC power and output DC power via female connectors 342 , 343 , 344 , 345 . In certain embodiments, dock 300 may include an independent power source, such as a battery, or a generator. For example, the generator may include solar cells, a gas motor powered generator, a mechanical crank coupled to the generator, and the like. In addition, the connecting base 300 can be installed on a movable frame, a swing arm, a car, an imaging device, a hospital bed, a wall mount, or other suitable mounting bases.

In operation, the cordless fill and inject device 306 can be engaged with the hub 300 . Specifically, the mechanical interface 315 of the connection base can cooperate with the complementary mechanical interface 338 , and the electrical interface 314 of the connection base can cooperate with the complementary electrical interface 336 . Power may flow through power cord 340 , through female connectors 342 , 343 , 344 , 345 , into male connectors 332 , 333 , 334 , 335 . Power may flow into energy storage device 302 . In some embodiments, energy storage device 302 may be charged while filling needle 316 . For example, while charging energy storage device 302 , needle drive 312 may apply force 331 that moves plunger 324 downward within needle 322 , thereby drawing fluid into needle 322 . During filling, in situ or ex situ feedforward or feedback control can control the filling rate and/or filling volume.

After energy storage device 302 is charged or activated, cordless fill and inject device 306 can be removed from dock 300 and used to inject radiopharmaceutical 330, markers, or other substances without any power cords interfering with the process. The injection can be performed at the same location where the cordless fill and injection device 306 is filled and charged, or the cordless fill and injection device 306 can be transported in a charged and filled state for use at another location. During an injection, energy may flow from energy storage device 302 to needle drive 312 , which may apply force 331 to outer end 328 of pushrod 326 . Plunger 326 may drive plunger 324 through barrel 332 and inject fluid 330 . During injection, feedforward or feedback control is performed in situ or ex situ to control the rate and/or volume of the injection.

Figure 17 shows a typical cordless fill and inject device 348 with a dual needle. The present cordless fill and inject device 348 may include a secondary needle 350 and a secondary needle drive 352 . The secondary needle 350 can be shielded and can include a fluid 354, which can be one or more of the fluids 330 previously listed. In this embodiment, this needle tube 350 may be within the shield 310 , but in other embodiments, the secondary needle tube 350 may be partially or completely outside the shield 310 . Additionally, the dual needles 348 may be independent of each other or integrated or united into a multi-barrel needle.

In operation, needle drive 352 may apply force 354 to secondary needle 350 and drive fluid 354 out of or into secondary needle 350 . In some embodiments, needle drive 312 and secondary needle drive 352 may be partially or fully integrated into a single needle drive. Alternatively, needle drive 312 and secondary needle drive 352 may be independent needle drives. During injection and/or filling, independently, in situ and ex situ, the flow rate and/or volume of fluid 330 and/or 354 injected or filled by the cordless filling and injection device 348 can be feedforward and feedback controlled.

FIG. 18 shows a typical needle drive 312 within the cordless fill and inject device 306 . The illustrated needle drive 312 may include an electric motor 356 , a transmission 358 , and a linear drive 360 . Electric motor 356 may be a DC electric motor or an AC electric motor, such as a stepper motor. The illustrated transmission 358 may include a drive pulley 362 , a driven pulley 364 , and a belt 366 . The present linear driver 360 may have an externally threaded rod, worm, or screw 368 , a cannula 370 , an external rod 372 , and a needle hub 374 . The transmission 358 may be a reduction transmission. For example, the ratio of the diameter of the driven wheel 364 to the diameter of the driving wheel 362 may be greater than 1.5:1, 2:1, 3:1, 4:1, 5:1, 8:1, 12:1, or greater. The needle hub 374 may include a wider outer hub 376 and a stem slot 378 . In certain embodiments, some or all of these components 356, 358, 360 may be substantially or completely free of iron. Additionally, some or all of these components 356 , 358 , 360 may be partially, substantially, or fully shielded by shield 310 .

In operation, electric motor 356 may drive drive wheel 362 . As drive pulley 362 rotates, belt 366 may turn driven pulley 364 . Rotation of driven wheel 364 may drive screw 368 , which may rotate within sleeve 370 . The sleeve 370 may be threaded such that rotation of the screw 368 applies a linear force to the sleeve 370 . A linear slide mechanism prevents the sleeve 370 from rotating while allowing the sleeve 370 to translate up and down the screw 368 . As the screw 368 rotates, the outer rod 374 may push the screw 368 down through the sleeve or push the screw 368 up. Outer rod 372 is linearly movable relative to the screw and drives needle 316 through needle hub 374 .

19 is a flowchart of a typical nuclear medicine procedure employing one or more of the needles shown with reference to FIGS. 1-18. As shown, process 380 begins at block 382 by providing a radioisotope for use in nuclear medicine. For example, block 382 may include eluting technetium-99m from the radioisotope emitter. At block 384, process 380 proceeds by providing a radioisotopic labeling agent (eg, an antigen or other suitable biologically directed enzyme) suitable for targeting a particular part of the patient, such as an organ. At block 386, the process 380 then proceeds by combining the radioisotope with the marker to provide a radiopharmaceutical for nuclear medicine. In certain embodiments, the radioisotope may have a natural tendency to concentrate toward a particular organ or tissue, whereby the radioisotope may be characterized without the addition of any supplemental markers. At block 388, process 380 may proceed by withdrawing one or more doses of the radiopharmaceutical into a syringe or other container, such as a container suitable for administering the radiopharmaceutical to a patient in a nuclear medicine facility or hospital. At block 390, process 380 proceeds by injecting or typically administering a dose of radiopharmaceutical and one or more supplemental fluids into the patient. After a preselected time, process 380 proceeds by detecting/imaging the radiopharmaceutical that labels the patient's organ or tissue (block 392). For example, block 392 may involve the use of a gamma camera or other radiographic imaging device to detect radiopharmaceuticals on, in, or bordering the brain, heart, liver, tumor, cancer tissue, or various other organs or diseased tissue.

FIG. 20 is a block diagram of an exemplary system 394 for providing a syringe with a radiopharmaceutical disposed therein for use in nuclear medicine applications. For example, the needle tube may be one of the needle tubes shown and described with reference to FIGS. 1 to 18 . As shown, system 394 may include a radioisotope elution system 396 having a radioisotope generator 398 , an eluent supply vessel 400 , and an eluent output vessel or dose vessel 402 . In certain embodiments, the eluent output vessel 402 may be under vacuum such that the pressure differential between the eluent supply vessel 400 and the eluent output vessel 402 facilitates the generation of eluent (e.g., saline) by radioactive isotopes. 398 and out through the eluent conduit to the eluent output container 402 for circulation. As an eluent, such as a saline solution, is circulated through the radioactive generator 398, the circulated eluent typically washes or elutes the radioactive isotope, eg, Technetium 99m. For example, one embodiment of the radioisotope generator 398 may include a radiation shielding enclosure (eg, lead shield) that surrounds the surface of a radioactive precursor, such as molybdenum 99, absorbed to aluminum or beads of a resin exchange column. Within the radioisotope generator 398, the parent molybdenum-99 is converted to metastable technetium-99m after a half-life of 67 hours. Product isotopes, such as technetium 99m, are generally less tightly held within radioisotope generator 398 than parent radioisotopes, such as molybdenum 99. Thus, the product radioisotope, eg technetium 99m, can be extracted or washed out using a suitable eluent, such as anaerobic saline. The eluate output from the radioisotope generator 398 to the eluent output container 402 generally includes the eluate and the radioisotope eluted or eluted from the radioisotope generator 398 . After the desired amount of eluent is received in eluent generator 402, the valve can be closed and eluent circulation and output of eluent stopped. As described in more detail below, the extracted product radioisotope can then be combined with a marker as needed to facilitate diagnosis and disposition of the patient (eg, in a nuclear medicine facility).

As shown in FIG. 20 , the system 394 may also include a radiopharmaceutical production system 404 that functions to combine a radioisotope 406 (eg, a technetium 99m solution obtained through use of the radioisotope elution system 396 ) with a marker 408 . In certain embodiments, the radiopharmaceutical production system 404 may be referred to as or include what is known in the art as a "kit" (eg, a Technescan(R) kit for preparing diagnostic radiopharmaceuticals). Again, markers can include various substances that attract to or mark specific parts of a patient (eg, organs, tissues, tumors, cancer cells, etc.). As a result, radiopharmaceutical production system 404 produces or can be used to produce a radiopharmaceutical including radioisotope 406 and marker 408 , as indicated at block 410 . The illustrated system 394 may also include a radiopharmaceutical dispensing system 412 that facilitates drawing the radiopharmaceutical into a vial or syringe 414 as shown in FIGS. 1-18. In certain embodiments, the various components and functions of the system 814 may be located in a pharmacy that prepares syringes 414 for radiopharmaceuticals used in nuclear medicine applications. For example, needle tube 414 may be prepared and delivered to a medical facility for use in the diagnosis and treatment of a patient.

21 is a block diagram of an exemplary nuclear medicine imaging system 416 employing a cannula 414 of radiopharmaceuticals provided using the system 394 of FIG. 20 . As shown, the nuclear medicine imaging system 416 includes a radiation detector 418 having a scintillator 420 and a light detector 422 . In response to radiation 428 emitted from a landmark organ within patient 426, scintillator 420 emits light that can be sensed by photodetector 422 and converted into an electrical signal. Although not shown, imaging system 416 may also include a collimator that collimates radiation 424 directed toward radiation detector 418 . The illustrated imaging system 416 may also include detector acquisition circuitry 428 and image processing circuitry 430 . Detector acquisition circuitry 428 generally controls the acquisition of electrical signals from radiation detectors 418 . Image processing circuitry 430 may be used to process electrical signals, perform inspection protocols, and the like. The illustrated imaging system 416 may also include a user interface 432 to facilitate user handling of the image processing circuitry 430 and other components of the imaging system 416 . As a result, imaging system 416 generates image 434 of the marked organ within patient 426 .

When introducing elements of various embodiments of the present invention, "a", "an", "the" and "said" are intended to mean that there are one or more elements. The terms "comprising", "comprising" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, the use of "top", "bottom", "upper", "lower" and variations of these terms is for convenience, but does not require any particular orientation of the components.

While the invention is susceptible to various changes and alternative forms, specific embodiments have been shown by way of example in the drawings and described in detail herein. However, it should be understood that the invention should not be limited to the particular forms disclosed. On the contrary, the invention is to cover all changes, equivalents and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.

Claims (81)

1. A radiopharmaceutical device comprising: first computer; a first electrical connector having a wired connection to the first computer; and A radiopharmaceutical tank, including radiation shielding material and comprising: a second computer; and Mounted on the radiopharmaceutical pod and electrically connected to a second electrical connector of the second computer, wherein the first electrical connector is connectable to the second electrical connector to electrically connect the first computer of the radiopharmaceutical pod with the second computer. 2. The apparatus of claim 1, further comprising a base unit supporting the first electrical connector. 3. The apparatus of claim 1, further comprising a control unit supporting the first computer. 4. The apparatus of claim 3, wherein the control unit also supports the first electrical connector. 5. The apparatus of claim 3, further comprising a dose calibrator electrically connected to and controlled by the control unit. 6. A radiopharmaceutical device comprising: Radiopharmaceutical tanks, including radiation shielding material and comprising: First Computer; and electrically connected to the first electrical connector of the first computer; A base unit configured to mechanically support a radiopharmaceutical tank; a second computer; and a second electrical connection on the base unit and having a wireless connection to a second computer, a second electrical connector connectable to the first electrical connector to electrically connect the second computer of the radiopharmaceutical tank with the first computer . 7. The apparatus of claim 6, further comprising a control unit supporting the second computer. 8. The apparatus of claim 7, further comprising a dose calibrator electrically connected to and controlled by the control unit. 9. A radiopharmaceutical tank comprising: a body comprising at least one radioactive shielding material and having a receptacle suitable for containing a radiopharmaceutical container; a lid comprising at least one radioactive shielding material releasably connected to the body to seal the container in the can; and A computer including a memory and an input/output device is mounted on one of the main body and the cover. 10. The radiopharmaceutical pod of claim 9, further comprising a first electrical connector electrically connected to the computer and mounted on an outer surface of one of the body and the cover, wherein the first electrical connector is mounted on end face of the body. 11. The radiopharmaceutical pod of claim 9, further comprising a first electrical connector electrically connected to the computer and mounted on an outer surface of one of the body and the cover, wherein the first electrical connector is mounted on end face of the cover. 12. The radiopharmaceutical pod of claim 9, further comprising a first electrical connector electrically connected to the computer and mounted on an outer surface of one of the body and the cover, wherein the first electrical connector is mounted on The end face of the main body, and the input/output device is installed on the main body. 13. The radiopharmaceutical pod of claim 9, further comprising a base unit, a first electrical connector electrically connected to the computer and mounted on an outer surface of one of the main body and the cover, and a base unit supported by the base unit. The second electrical connector can be connected with the first electrical connector. 14. An apparatus for storing and administering radiopharmaceuticals, comprising: The needle tube includes a plunger and an outlet port; tank, including: a body for receiving the needle cannula and comprising a body providing radioactive shielding material, and an outlet opening on one end of the body for receiving the outlet end of the needle cannula, and a reservoir clip operable to contact and retain the cannula within the cannula; and A cap covering the exit opening, the cap being movable to open the exit opening and the exit end of the syringe. 15. The device of claim 14, wherein the cover includes a material that provides radiation shielding. 16. The apparatus of claim 14, wherein the plunger comprises a material that provides radiation shielding. 17. The apparatus of claim 14, wherein the cover is slidably mounted on one end of the body. 18. The apparatus of claim 14, wherein the cover is pivotally mounted on one end of the body. 19. The apparatus of claim 14, wherein the cover is mounted on one end of the body with a removable fastener. 20. The device of claim 14, wherein the cover is movably coupled to one end of the body. 21. The device of claim 14, wherein the cover comprises an end cap movably coupled to one end of the cannula. 22. The apparatus of claim 14, wherein the tank further includes a rim end extending from opposite ends of the body. 23. The apparatus of claim 22, wherein the brim end of the canister is adapted to fit into a power injector operable to dispense the radiopharmaceutical from the syringe. 24. The apparatus of claim 14, wherein the canister is adapted to fit into a hand-held power injector operable to dispense the radiopharmaceutical from the syringe. 25. An apparatus for storing and administering radiopharmaceuticals, comprising: a syringe including a plunger and an outlet port; and tank, including: A tubular body for receiving a cannula and comprising: materials that provide radiation shielding, and an outlet opening on one end of the tubular body for receiving the outlet end of the needle, A cover made of a material that provides radiation shielding and covering the exit opening, the cover being movable to open the exit opening and the exit end of the syringe; and A hand-held power injector supporting the canister is operable to move the plunger and dispense the radiopharmaceutical from the needle. 26. An apparatus for storing and administering radiopharmaceuticals, comprising: Needles include: a first cavity having a first outlet port and adapted to contain a radiopharmaceutical; a first plunger located within the first chamber; having a second outlet port for containing a liquid biocompatible with the radiopharmaceutical, and a second plunger located in the second chamber; and tank, including: A tubular body for receiving a cannula and comprising: materials that provide radiation shielding, and outlet openings near the first and second outlet ends of the needle; and A cap covering the first and second outlet ports, the cap being movable to open the outlet opening and the outlet end of the needle cannula. 27. The apparatus of claim 26, wherein the cover includes a material that provides radiation shielding. 28. The apparatus of claim 26, wherein the needle cannula is supported within the tubular body by a retractable clip. 29. The apparatus of claim 26, wherein the needle cannula is supportable within the tubular body by an interference fit with a portion of the tubular body. 30. An apparatus for filling a syringe from a vial containing a radiopharmaceutical, comprising: container, including: a base including an opening extending therethrough, cap, and Radiation shielding suitable for substantially enclosing vials containing radiopharmaceuticals other than the opening in the base; and Handheld power filling and injection devices, including: a body comprising a side wall and an opening extending through the side wall; and A mounting structure adapted to support a needle with the needle within the opening of the body, the sidewall receiving the container and positioning the opening in the base proximate the opening in the body such that the radiopharmaceutical in the vial is in fluid communication with the needle of the needle. 31. The device of claim 30, further comprising a releasable coupling operable to connect the cap to the base. 32. The apparatus of claim 30, further comprising a releasable coupling operable to connect the container to the filling and injecting device. 33. The apparatus of claim 30, further comprising a pedestal support for receiving the pedestal and including a radiation shield covering the opening in the pedestal. 34. The apparatus of claim 30, further comprising a radiation shield positionable in the mounting structure and adapted to substantially surround the needle cannula. 35. The apparatus of claim 30, wherein the body further comprises a radiation shield substantially entirely around the body except for an area of the opening in the body. 36. An apparatus for filling a cannula with a needle from a vial having a septum sealing a radiopharmaceutical therein, the apparatus comprising: container, including: a container opening adapted to hold the vial such that the container opening is adjacent the septum of the vial, and Radiation shielding suitable for completely enclosing vials containing radiopharmaceuticals except for the septum region; and Handheld power filling and injection devices, including: including the body of the opening; and A mounting structure adapted to support a cannula having a needle within an opening in a body that receives a container so that the opening in the body is positioned proximate to the opening of the container and such that the needle of the cannula pierces the septum thereby allowing the vial to The radiopharmaceutical is in fluid communication with the needle. 37. The apparatus of claim 36, wherein the container further comprises: base; and A cap that can be attached to the base. 38. The apparatus of claim 36, wherein the mounting structure is movable relative to the body. 39. The apparatus of claim 36, further comprising a support for receiving the container and including a radiation shield covering the opening of the container. 40. The apparatus of claim 36, further comprising a radiation shield positionable in the mounting structure and adapted to substantially surround the needle cannula. 41. The apparatus of claim 36, wherein the body further comprises a radiation shield extending substantially completely around the body except for an area of the opening in the body. 42. An apparatus for filling a syringe having a needle and a plunger from a vial containing a radiopharmaceutical, the apparatus comprising: Containers comprising radiation shielding and adapted to hold vials containing radiopharmaceuticals; and Handheld power filling and injection devices, including: a body including an opening extending through the sidewall; An installation structure suitable for supporting the needle tube, the needle of the needle tube is located in the opening of the main body, the body houses the container and is adapted to fluidly communicate the radiopharmaceutical in the vial with the syringe needle, and An electromechanical device adapted to operate a syringe plunger to fill a syringe with radiopharmaceutical from a vial. 43. The device of claim 42, further comprising: can operate a controller connected to the electromechanical device; and A user interface comprising an input device and a display connected to the controller for inputting and displaying data. 44. The apparatus of claim 42, further comprising an RF-ID tag mounted on the filling and injecting device and in electrical communication with the controller. 45. The apparatus of claim 42, further comprising a base support for receiving the base and including a radiation shield covering the opening in the base. 46. The apparatus of claim 45, further comprising a radiation shield positionable in the mounting structure and adapted to substantially surround the needle cannula. 47. The apparatus of claim 45, wherein the body further comprises a radiation shield extending substantially completely around the body except for an area of the opening in the body. 48. A method of filling a syringe from a vial having a septum sealing a radiopharmaceutical therein, the method comprising: providing a container having radiation shielding surrounding the vial except for the region of the septum, the container securing the vial such that the septum of the vial is positioned adjacent the opening of the container; Loading a syringe in a hand-held powered filling and injection device to position the needle of the syringe in the opening of the filling and injection device; positioning the container above the filling and injecting device so that the septum of the vial is above the opening of the filling and injecting device; and The container and filling and injecting device are moved relative to each other such that the needle of the syringe pierces the septum of the vial and puts the radiopharmaceutical in the vial in fluid communication with the syringe. 49. The method of claim 48, wherein prior to loading the needle, the method further comprises placing the needle in a radiation shield that substantially surrounds the needle except for the needle and the needle pusher. 50. The method of claim 49, wherein loading the needle further comprises: operably connecting the syringe plunger to the electromechanical driver in the filling and injecting device; and The electromechanical drive is operated to move the needle plunger and fill the needle with radiopharmaceutical from the vial. 51. The method of claim 50, further comprising: Thereafter, the container is removed from the filling and injection device; connecting the syringe needle to the tubing connected to the patient; and The electromechanical drive is operated to move the needle plunger to infuse the radiopharmaceutical from the needle into the patient. 52. The method of claim 51 , further comprising: Thereafter, the container is removed from the filling and injection device; and The needle is manually manipulated to inject the radiopharmaceutical into the patient. 53. A shielded cordless syringe assembly comprising: syringe; a radiation shield disposed at least partially around the syringe; an actuator connected to the syringe; and Energy storage device connected to the drive. 54. The assembly of claim 53, wherein the energy storage device comprises a battery. 55. The assembly of claim 54, wherein the battery comprises lithium. 56. The assembly of claim 54, wherein the battery comprises nickel. 57. The assembly of claim 53, wherein the energy storage device comprises a capacitor. 58. The assembly of claim 57, wherein the capacitor comprises a supercapacitor. 59. The assembly of claim 53 including an energy controller coupled to the energy storage device. 60. The assembly of claim 53, wherein the radiation shield comprises tungsten-containing plastic. 61. The assembly of claim 53, comprising a radiopharmaceutical disposed within a syringe. 62. The assembly of claim 53, including a connection socket. 63. The assembly of claim 62, wherein the shielded cordless syringe includes a first electrical connector, and the connector receptacle includes a second electrical connector that mates with the first electrical connector in the engaged position of the shielded cordless syringe. 64. The assembly of claim 62, wherein the socket includes an independent power source. 65. The assembly of claim 62, wherein the connection base is coupled to a moving frame, a swivel arm, a hospital bed, an imaging device, or a combination thereof. 66. A powered medical fluid injection system comprising: Needle; a needle driver coupled to the needle; and Capacitor connected to needle driver. 67. The system of claim 66, wherein the capacitor, or the needle driver, or both are substantially free of iron. 68. The system of claim 66, wherein the container comprises a supercapacitor. 69. The system of claim 66, wherein the needle drive comprises a screw drive. 70. The system of claim 66, wherein the needle driver comprises a piezoelectric drive. 71. The system of claim 66, comprising an energy director coupled to a capacitor. 72. The system of claim 66, comprising a radiation shield, or an electromagnetic shield, or a combination thereof disposed about the main portion of the needle cannula. 73. The system of claim 66, comprising a hub having electrical and mechanical connectors that mate with a portable injector unit including a syringe driver and capacitor. 74. The system of claim 73, wherein the docking station is coupled to a moving frame, a swivel arm, a hospital bed, an imaging device, or a combination thereof. 75. The system of claim 66, comprising a radiopharmaceutical, a contrast medium, a medical fluid, or a combination thereof disposed in the needle. 76. A method of operating a medical fluid needle, the method comprising: Storing electrical energy in cordless syringes; shielding the environment from radioactive material within the cordless syringe; and Electrical energy is used to drive the flow of radioactive material. 77. The method of claim 76, wherein storing electrical energy comprises charging a battery in the cordless injector via the docking station. 78. The method of claim 76, wherein storing electrical energy comprises charging a capacitor in the cordless injector. 79. The method of claim 76, wherein shielding the environment comprises shielding the environment with a shield comprising tungsten and plastic. 80. The method of claim 76, wherein driving the flow of the radiopharmaceutical includes controlling the flow rate and flow of the radioactive material. 81. The method of claim 76, comprising detecting, processing, or generating image data related to injecting radioactive material into a subject.

Images