U.S. patent application number 12/781543 was filed with the patent office on 2010-11-11 for systems, methods and apparatus for preparation, delivery and monitoring of radiopharmaceuticals.
This patent application is currently assigned to GENERAL ELECTRIC COMPANY. Invention is credited to Michael Brussermann, Paritosh Jayant Dhawale, Mark Alan Jackson, Ulrich Ketzscher, Hernan Rodrigo Lara.
Application Number | 20100286512 12/781543 |
Document ID | / |
Family ID | 41328863 |
Filed Date | 2010-11-11 |
United States Patent
Application |
20100286512 |
Kind Code |
A1 |
Dhawale; Paritosh Jayant ;
et al. |
November 11, 2010 |
SYSTEMS, METHODS AND APPARATUS FOR PREPARATION, DELIVERY AND
MONITORING OF RADIOPHARMACEUTICALS
Abstract
In one aspect, systems, methods and apparatus are provided
through which a dispensing station dispenses a large quantity of a
radiotracer to one or more positron emission tomography imaging
stations. In some aspects a quality control unit verifies the
quality of the radiotracer. In some embodiments, components of the
system are coupled by a local area network. In some aspects, each
positron emission tomography imaging station includes an injector
system, a physiological monitoring device, and a positron emission
tomography scanner. All of the devices can be controlled by a
computer system.
Inventors: |
Dhawale; Paritosh Jayant;
(Menomonee Falls, WI) ; Jackson; Mark Alan;
(Menomonee Falls, WI) ; Lara; Hernan Rodrigo;
(Milwaukee, WI) ; Brussermann; Michael; (Muenster,
DE) ; Ketzscher; Ulrich; (Muenster, DE) |
Correspondence
Address: |
DEAN D. SMALL;THE SMALL PATENT LAW GROUP LLP
225 S. MERAMEC, STE. 725T
ST. LOUIS
MO
63105
US
|
Assignee: |
GENERAL ELECTRIC COMPANY
Schenectady
NY
|
Family ID: |
41328863 |
Appl. No.: |
12/781543 |
Filed: |
May 17, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10792029 |
Mar 2, 2004 |
7734331 |
|
|
12781543 |
|
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Current U.S.
Class: |
600/431 ;
222/52 |
Current CPC
Class: |
G16H 20/40 20180101;
A61M 5/172 20130101; G16H 30/40 20180101; G21H 5/02 20130101; G16H
20/13 20180101; G21G 4/08 20130101; G21F 5/018 20130101; A61M
5/1785 20130101; G16H 40/63 20180101; A61B 6/548 20130101; G01T
1/00 20130101; G16H 20/17 20180101; A61M 5/007 20130101; A61B 6/037
20130101 |
Class at
Publication: |
600/431 ;
222/52 |
International
Class: |
A61B 6/00 20060101
A61B006/00; B67D 99/00 20100101 B67D099/00 |
Claims
1. An apparatus comprising: a local area network, operably coupled
to at least one positron emission tomography imaging system; a
dispensing station to receive a multidose vial of a radiotracer,
and to dispense portions of the radiotracer, at least one positron
emission tomography imaging system, the dispensing station being
operably coupled to the local area network; and a control system
operably coupled to the local area network, to receive status
information from, and send commands to, the at least one positron
emission tomography imaging system and the dispensing station.
2. The apparatus of claim 1, further comprising a quality control
unit, to monitor the radionucleic and chemical purity of the
radiotracer that is dispensed by the dispensing station, the
quality control unit being operably coupled to the local area
network, operably coupled to the control system and operably
coupled to the dispensing station.
3. The apparatus of claim 1, wherein the local area network is
further operably coupled to a radioisotope producer and wherein the
dispensing station receives the radioisotope from the radioisotope
producer.
4. The apparatus of claim 3, wherein the radioisotope producer
further comprises a cyclotron.
5. The apparatus of claim 3, wherein the radioisotope producer
further comprises a linear accelerator.
6. The apparatus of claim 3, wherein the radioisotope producer
further comprises a radioisotope generator.
7. The apparatus of claim 1, wherein the apparatus further
comprises being mounted on wheels.
8. A medical radiopharmaceutical administration system comprising:
a local area network, operably coupled to at least one positron
emission tomography imaging system and operably coupled to a
radioisotope producer; a chemical synthesizer operably coupled to
the radioisotope producer, to receive the radioisotope, and to
produce a radiotracer; a dispensing station to receive from the
chemical synthesizer a liquid radiotracer in quantities suitable
for multiple doses of the radiopharmaceutical, and to dispense the
radiopharmaceutical to the at least one positron emission
tomography imaging system, the dispensing station being operably
coupled to the local area network; and a control system operably
coupled to the local area network, to receive status information
from, and send commands to, the at least one positron emission
tomography imaging system and the dispensing station.
9. The medical radiopharmaceutical administration system of claim
8, further comprising a quality control unit, to monitor the
radionucleic and chemical purity of the radiopharmaceutical that is
dispensed by the dispensing station, the quality control unit being
operably coupled to the local area network, operably coupled to the
control system and operably coupled to the dispensing station.
10. The medical radiopharmaceutical administration system of claim
8, wherein the radioisotope producer further comprises a
cyclotron.
11. The medical radiopharmaceutical administration system of claim
8, wherein the radioisotope producer further comprises a linear
accelerator.
12. The medical radiopharmaceutical administration system of claim
8, wherein the radioisotope producer further comprises a
radioisotope generator.
13. A medical radiopharmaceutical administration system comprising:
a local area network, operably coupled to at least one positron
emission tomography imaging system; a dispensing station to receive
liquid fluorodeoxyglucose in quantities suitable for multiple doses
of the liquid fluorodeoxyglucose, and to dispense the
fluorodeoxyglucose to the at least one positron emission tomography
imaging system, the dispensing station being operably coupled to
the local area network; and a control system operably coupled to
the local area network, to receive status information from, and
send commands to, the at least one positron emission tomography
imaging system, the dispensing station, and the quality control
unit.
14. The medical radiopharmaceutical administration system of claim
13, wherein the local area network is further operably coupled to a
cyclotron and wherein the dispensing station receives the liquid
fluorodeoxyglucose.
15. The medical radiopharmaceutical administration system of claim
13, wherein the system further comprises being mounted on
wheels.
16. The medical radiopharmaceutical administration system of claim
13, wherein the at least one positron emission tomography imaging
system further comprises a plurality of positron emission
tomography imaging systems, and wherein each of the at least one
positron emission tomography imaging system further comprises: a
computer system having a graphical user interface operably coupled
to the local area network; an injector system to extract at least
one individual dose from the liquid fluorodeoxyglucose and to
inject the at least one individual dose into the living subject,
the injector system being operably coupled to the local area
network; and a physiologic monitoring system operably coupled to
the injector system and operably coupled to the living subject.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 10/792,029, filed Mar. 2, 2004, entitled "SYSTEMS, METHODS, AND
APPARATUS FOR PREPARATION, DELIVERY AND MONITORING OF
RADIOPHARMACEUTICALS", the entirety of which is incorporated herein
by reference.
[0002] This application is related to copending U.S. application
Ser. No. 10/792,683, filed Mar. 2, 2004 entitled "SYSTEMS, METHODS
AND APPARATUS FOR INFUSION OF RADIOPHARMACEUTICALS".
FIELD OF THE INVENTION
[0003] This invention relates generally to positron emission
tomography, and more particularly to positron emission tomography
control systems.
BACKGROUND OF THE INVENTION
[0004] The subject matter disclosed herein relates to gamma
cameras, and more particularly to methods for calculating linearity
and uniformity maps for non-pixelated gamma cameras.
[0005] In conventional positron emission tomography control
systems, an individual dose of a premeasured radiotracer is
administered to an individual patient. The individual premeasured
radiotracer is prepared by a radiotracer supplier (commonly called
a radiopharmacy). A Cyclotron is used most commonly to prepare the
radiotracer. The radiotracer is delivered to a medical facility
that administers the individual premeasured radiotracer as a
radiopharmaceutical. The individual premeasured radiotracer is
prepared by the radiotracer supplier in accordance with a
prescription from a physician. The prescription includes a
prescribed amount of radioactivity at a future time and a date of
the prescribed administration in a known volume of a liquid
suitable for injection into a living subject.
[0006] The conventional process of radiotracer production in a
cyclotron performed by a radiotracer supplier is as follows: The
radiotracer supplier irradiates a target material in the cyclotron
with a beam of protons or deuterons to produce a desired amount of
radioactivity in the target material. The extent of irradiation is
planned to fulfill the need of radioactivity at the prescribed
future time and date. The irradiated target material is a
radioisotope. Examples of cyclotron produced radioisotopes include
nitrogen-13, fluorine-18, carbon-11 and oxygen-15. Often, compounds
are bond to the radioisotope to produce radiotracers such as
fluorodeoxyglucose (FDG) which is produced using fluorine-18. Other
radiotracers include nitrogen-13 ammonia which is used in
myocardial applications, carbon-11 tracers which are commonly used
in neurologic applications: and oxygen-15 gas as well as tracers
derived from it which are commonly used in blood flow applications.
FDG is by far the most commonly used radiotracer and has a half
life of 109 minutes allowing for its distribution from a
centralized radiopharmacy to multiple imaging sites.
[0007] Typically the radiotracer supplier packages the radiotracer
in an individual dose vial such as in the case of FDG. Thereafter,
the individual dose vial is packaged in an individual lead-shielded
container. Each lead-shielded container weighs approximately 50-60
lbs. Typically, the radiotracer supplier will prepare a number of
individual dose vials for each medical facility each day. Each of
the dose vials are packaged in an individual container. As a
result, a number of 50-60 lb containers will be delivered to each
medical facility each day. Furthermore, in order to accommodate
unplanned changes in the needs of radiotracer by a medical
facility, as well as to meet other logistical needs, conventionally
two or more deliveries of individual dose vials in individual
containers will be made each day. The two or more deliveries are
typically performed in the early morning before 7 am, and in the
late morning between 10 am and 11 am, or as desired by the medical
facility. The cost and overhead of preparing individual dose vials,
packaging and transporting a number of the heavy containers twice a
day is significant.
[0008] In addition, when the radiopharmaceutical is administered to
the patient, the PET technician is exposed to radioactivity. The
PET technician connects an intravenous tube (IV) into the
radiopharmaceutical container, inserts a needle at the other end of
the IV into the patient, starts the infusion of the radioisotope
through the IV, monitors the progress of the infusion, and ends the
infusion, all the while remaining close-by the patient and the IV
containing the radiopharmaceutical. This close proximity to the
radioactivity results in numerous low levels of exposure to
radioactivity that can be harmful to the health of the PET
technician.
[0009] Quality control of the amount of radionucleic and chemical
purity of the bulk batch is typically performed under manual
direction and control by the supplier. As a result of the manual
aspects of the quality control, the standards of quality control
are subjective. Furthermore, conventional systems can be slow,
which requires that the radioisotope material must be produced at a
much stronger level of radioactivity in order to have the required
amount of radioactivity at the time of injection.
[0010] A number of radioisotopes have such short half-lives, that
the radioisotope must be produced by a cyclotron in close proximity
to the medical facility. Nitrogen-13 ammonia has a half-life of 10
minutes, and oxygen-15 has a half-life of 2.1 minutes. Due to its
short half-life, nitrogen-13 ammonia and oxygen-15 necessitate
production in close proximity to the medical facility site.
Therefore, the use of nitrogen-13 ammonia and oxygen-15 for PET is
limited to those sites that have immediate access to its
production.
[0011] More generally, conventional systems are sequential and step
wise. Major functions, such as the production of the radiotracer,
and the injection of the radiopharmaceutical, collection of
clinical data following a specific imaging protocol, are managed by
separate organizations, by different personnel, often in a somewhat
uncoordinated and disjoint manner.
[0012] For the reasons stated above, and for other reasons stated
below which will become apparent to those skilled in the art upon
reading and understanding the present specification, there is a
need in the art to reduce the number of individual dose vials and
shielded containers that radioisotope suppliers prepare and deliver
to each medical facility each day. There is also a need to reduce
the number of delivery trips that a radiotracer supplier makes to
each medical facility each day. In addition, there is a need to
reduce the exposure of people, such as PET technicians, to
radioactivity during the manual steps of administering a
radiopharmaceutical to patients. There is also a need to improve
the quality control of the administration of radiopharmaceuticals
to patients. Moreover, there is a need to reduce the disjoint
management and control of the functions of preparing and injection
radioisotopes into patients. Furthermore, there is a need to
provide a convenient method for on-site production and
administration of nitrogen-13 ammonia radiopharmaceutical for
cardiac studies.
BRIEF DESCRIPTION OF THE INVENTION
[0013] The above-mentioned shortcomings, disadvantages and problems
are addressed herein, which will be understood by reading and
studying the following specification.
[0014] In one aspect, a system includes a local area network that
is operably coupled to one or more positron emission tomography
imaging systems. The system also includes a dispensing station that
is operable to receive a multidose portion or vial of a
radiopharmaceutical. The dispensing station is operable to dispense
portions of the radiopharmaceutical to the one or more positron
emission tomography imaging system. The dispensing station is also
operably coupled to the local area network. The dispensing station
dispenses a radiopharmaceutical in the patients who are
subsequently imaged using the positron emission tomography imaging
systems. The dispensing station allows a multidose portion of the
radiopharmaceutical to be dispensed to the patients, which provides
economies of scale and a convenient way of distribution of the
radiopharmaceutical.
[0015] In another example, the system also includes a quality
control unit. The quality control unit is operable to monitor the
radiochemical and the radionucleic purity of the
radiopharmaceutical that is dispensed by the dispensing station.
The quality control unit is operably coupled to the local area
network and operably coupled to the dispensing station.
[0016] In still another example, a chemical synthesizer is operably
coupled between a radioisotope producer, (e.g. a cyclotron, a
linear accelerator or a radioisotope generator) and the dispensing
station. The synthesizer receives a radioisotope from the
radioisotope producer, bonds the radioisotope to a biological
compound, and transfers the resulting radiotracer to the dispensing
station.
[0017] In yet another example, the apparatus includes a control
system that is operably coupled to the local area network, to
receive status information from, and send commands to, any one of
the device in the system, such as the one or more positron emission
tomography imaging systems, the dispensing station, the chemical
synthesizer and the quality control unit. The control system
determines an amount of radioactivity and an amount of radioisotope
to produce and sends instructions to the radioisotope producer
accordingly.
[0018] In some examples, a positron emission tomography imaging
system includes an injector system, a physiologic monitor operably
coupled to the injector, and a positron emission tomography scanner
operably coupled to the physiologic monitor and the injector. The
injector is operable to receive multiple doses of the
radiopharmaceutical and operable to inject individual doses of the
radiopharmaceutical into a patient, initiate scanning at a
predefined time following a specific predefined clinical protocol.
The injector is also capable of injecting other pharmaceuticals as
defined in the protocol.
[0019] In addition to the aspects and advantages described in this
summary, further aspects and advantages will become apparent by
reference to the drawings and by reading the detailed description
that follows.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a diagram illustrating a system-level overview of
an embodiment;
[0021] FIG. 2 is a block diagram of an apparatus for injecting one
or more individual doses of a radiopharmaceutical from a multiple
dose of the radiopharmaceutical;
[0022] FIG. 3 is a block diagram of a dispensing station according
to an embodiment;
[0023] FIG. 4 is a block diagram of an automated injector system
for PET medications according to an embodiment;
[0024] FIG. 5 is a block diagram of a medical radiopharmaceutical
administration system according to an embodiment;
[0025] FIG. 6 is a block diagram of a medical radiopharmaceutical
administration system according to an embodiment;
[0026] FIG. 7 is a flowchart is an embodiment of a method of
operation of an embodiment of the injector system;
[0027] FIG. 8 is a flowchart of an embodiment of a method of
preparing an injector system for use by a number of patients;
[0028] FIG. 9 is a flowchart of an embodiment of method of
preparing an injector system for each individual patient;
[0029] FIG. 10 is a flowchart of an embodiment of a method of
administering an injection using injector system in FIG. 4 for each
individual patient;
[0030] FIG. 11 is a flowchart of a method performed by a control
system according to an embodiment; and
[0031] FIG. 12 is a block diagram of the hardware and operating
environment in which different embodiments can be practiced.
DETAILED DESCRIPTION OF THE INVENTION
[0032] In the following detailed description, reference is made to
the accompanying drawings that form a part hereof, and in which is
shown by way of illustration specific embodiments which may be
practiced. These embodiments are described in sufficient detail to
enable those skilled in the art to practice the embodiments, and it
is to be understood that other embodiments may be utilized and that
logical, mechanical, electrical and other changes may be made
without departing from the scope of the embodiments. The following
detailed description is, therefore, not to be taken in a limiting
sense.
[0033] The detailed description is divided into five sections. In
the first section, a system level overview is presented. In the
second section, apparatus of an embodiment are provided. In the
third section, methods of embodiments are provided. The fourth
section, the hardware and the operating environment in conjunction
with which embodiments may be practiced are described. In the fifth
section, a conclusion of the detailed description is provided.
System Level Overview
[0034] FIG. 1 is a block diagram that provides a system level
overview of a medical radiopharmaceutical administration system
100. The medical radiopharmaceutical administration system 100 is
an integrated system for production, quality control and
distribution of medical radiopharmaceuticals in positron emission
tomography (PET) imaging.
[0035] System 100 includes a cyclotron 101. The cyclotron 101
irradiates a target material with radiation, producing a
radioisotope 102. Multiple doses of the radioisotope 102 are
produced by the cyclotron 101. Other examples of devices that
produce radioisotopes include linear accelerators (LINIACs) and
radioisotope generator. Rubidium-82 is produced by a radioisotope
generator. In some embodiments, the radioisotope 102 is chemically
bonded to a biological compound in a chemical synthesizer 103,
producing a radiotracer 104.
[0036] The multidose portion of radioisotope 102 or radiotracer 104
is transferred to a dispensing station 106. In embodiments where
the radiotracer 104 or radioisotope 102 have a short half life
(e.g. carbon-11, oxygen-15 and nitrogen-13), the transfer is
performed through a line that shields radioactivity, such as a
lead-shielded line 108 as shown in FIG. 1. In embodiments where the
radiotracer 104 or radioisotope 102 has a longer half life (e.g.
flourine-18) the transfer may be performed by placing the multidose
portion of radioisotope 102 or radiotracer 104 in a reservoir and
transporting the reservoir to the dispensing station 106 and
emptying the contents of the reservoir in the dispensing station
106. Regardless of how the material is transported, the multidose
portion of radioisotope 102 or radiotracer 104 is stored in the
dispensing station 106.
[0037] In some embodiments, system 100 also includes a quality
control unit (QC) 110 that monitors the amount of radioactivity and
other measures of quality and quantity of the multidose portion of
radioisotope that is stored in the dispensing station 106. QC 110
allows the radionucleic and chemical purity, that being the quality
of the radioisotope in terms of the amount of radioactivity of
desired isotope, and chemical purity of the radiotracer, to be
verified. In some embodiments quality control monitoring, analysis
and verification is performed at particular time intervals or for
particular production batches or for one representative sample of
bulk produced radiotracer. The time intervals and batches can be
predetermined and modified by an operator. As a result, QC 110
allows the quality control functions to be performed by an
automated process which is more efficient, provides less
occupational exposure, and more reliable than conventional systems.
Thus, system 100 improves the quality control of the administration
of radiopharmaceuticals to patients. In a system that produces and
distributes nitrogen-13 ammonia, the QC 110 may still be present
but may be used only on some predefined productions.
[0038] In some embodiments, the QC 110 includes a high-performance
liquid chromatography (HPLC) device and/or a Nal detector. In some
embodiments, QC 110 also includes a filter for the multidose
portion of radioisotope that is stored in the dispensing station
106. As a result, QC 110 provides QC and filter functions that are
automated, which is more convenient and more reliable than
conventional systems.
[0039] In the embodiment shown in FIG. 1, the QC 110 samples
multidose radiotracer 104 from the dispensing station 106. In other
embodiments, the QC 110 samples multidose radiotracer 104 from a
cyclotron target in the cyclotron 101. In some additional
embodiments, the QC 110 estimates the amount of radioactivity in
the radiotracer 104 using a calculation based on the half-life of
the radiotracer 104 and the amount of time that has lapsed since
the production of the radiotracer 104.
[0040] In some embodiments, system 100 includes one or more
radiation shields 112 that surround portions of the system that are
radioactive. The radiation shielding 112 typically includes lead.
The radiation shielding 112 protects all individuals from
radiation, and in particular, the radiation shielding 112 protects
personnel that operate the cyclotron 101, dispensing station
106.
[0041] From the dispensing station 106, multidose portions of
radiotracer 104 are dispensed to one or more PET imaging systems
114 and 116. In some embodiments, the transfer or transportation of
the multidose portions of radiotracer 104 to the PET imaging
systems 114 or 116 is performed through a line, 118 or 120, such as
lead-shielded lines that shield radioactivity. In other
embodiments, the multidose portions of radiotracer 104 is
transferred or transported by placing the multidose portion of
radiotracer 104 in a reservoir and transporting the reservoir to
the PET imaging systems 114 and 116.
[0042] Each of the PET imaging systems 114 and 116 include an
injector system 122 and 124 respectively One implementation of the
injector systems 122 or 124 is discussed in more detail in FIG. 4
below. Injector systems 122 and 124 extract individual doses 126
and 128 of a radiopharmaceutical prepare, and inject or deliver,
the dose into living subjects 130 and 132, respectively. In some
embodiments, the living subjects 130 and 132 are human patients.
Thus, system 100 allows a multidose portion of radiotracer 104 to
be dispensed as individual doses 126 and 128. In comparison to
conventional systems that require irradiation and shipment of many
individual doses of radiopharmaceutical, preparation and shipment
of a multidose portion of radiotracer 104 by system 100 is more
convenient. System 100 also offers a more automated process that is
more reliable than conventional systems that require more human
operation. Furthermore, system 100 reduces unwanted radiation
exposure to the staff.
[0043] In some embodiments, a physiologic monitoring device (PM)
134 and 136 is operably coupled to the injector system 122 and 124
and to the living subjects 130 and 132, respectively. The PMs 134
and 136 monitor a number of measures of the health of the living
subject, such as blood pressure and heart activity as represented
by an electrocardiogram (EKG). The PMs 134 and 136 detect
abnormalities in the measures of the health of the living subject
and provide notice of the abnormalities to the control system as
well to clinical staff.
[0044] Each PET imaging system 114 and 116 also includes a PET
scanner 138 and 140, respectively. Each PET imaging system may have
one or more scanners.
[0045] The living subject 130 and 132 is placed inside the scanner
138 and 140 after or during injection of the radiopharmaceutical
126 and 128 to detect the radioactivity of the injected
radiopharmaceutical 126 and 128 in the living subject 130 and 132,
respectively.
[0046] A computer with a graphical user interface (GUI) 142 and 144
is located at the PET imaging system 114 and 116. A PET technician
operates the computer GUI 142 and 144 in order to control, manage
and oversee the entire PET process, including activities of the
injector system, such as dispensing and injection of the individual
dose of radiopharmaceutical 126 and 128 into the living subject 130
and 132 and scanning the living subject using appropriate clinical
protocol. One embodiment of computer 142 or 144 is computer 1202 in
FIG. 12.
[0047] In some embodiments, computer 142 or 144 receives notice
from the PMs 134 and 136 of abnormalities in the measurements of
the health of the living subject, and consequently instructs the
injector system 122 and 124 respectively to halt infusion or take
other appropriate corrective action. In still further embodiments,
computer 142 or 144 instructs the scanner 138 or 140 to initiate a
scanning operation at an appropriate time after infusion by the
injector system 122 or 124, respectively. In still further
embodiments, one injector system is controlled by its stand-alone
user interface and used to inject a prescribed amount of
radioactivity in patients who are scanned either sequentially on a
single scanner, or in parallel on multiple scanners.
[0048] Portions of the PET imagining systems 114 or 116 are known
as dosing stations. One dosing station in FIG. 1 includes injector
system 122, PM 134 and computer 142. Another dosing station in FIG.
1 includes injector system 124, PM 136 and computer 144.
[0049] In some embodiments, system 100 includes a control system
146. The control system 146 is operable to receive status
information from, and send commands to, the PET devices such as the
cyclotron 101, dispensing station 106, quality control device 110,
injector systems 122 and 124, physiologic monitors 130 and 136,
scanners 138 and 140, and computers 142 and 144. In some
embodiments, a computer program in the control system 146 is
operable to calculate amounts of multidose radiotracer 104 to be
transported to the injector system 124 based on specific site
control variables. One embodiment of computer 146 is computer 1202
in FIG. 12.
[0050] In some further embodiments, control variables include the
distance and transfer time between the scanner 138 or 140 and a
cyclotron 101 that produces nitrogen-13 ammonia. In those
embodiments, system 100 provides a convenient method for on-site
production and administration of nitrogen-13 ammonia
radiopharmaceutical for cardiac studies.
[0051] In yet further embodiments, a computer program in the
control system 146 stores production and dosing data. Thus system
100 provides for a more centralized storage of records in the
preparation, delivery, monitoring and injection of radiotracers to
patients, which reduces disjoint management and control of those
functions that conventional systems exhibit.
[0052] In yet a further embodiment, data that describes high level
descriptors of one or more living subjects to be treated by system
100 is read from a PET scanner 138 or 140, or other device. One
example of the other devices is a patient information system in the
medical facility. The data is received by the control system 146.
The high level descriptors include the prescribed dose for each
living subject and the injection time schedule for the living
subjects. In still further embodiments, the data includes the type
of radiopharmaceutical (e.g. oxygen-15), a predefined parametric
equation, and/or clinical protocol being followed in the medical
procedure.
[0053] Based on this data, the required radiotracer dose activity
is calculated and compared to the total activity available in the
multidose portion of the radiotracer 104. If there will be a
shortage, the system 100 will notify the operator. If the cyclotron
101 is managed by an outside radioisotope supplier, the supplier
will be notified via an Internet link or other electronic means.
The supplier will be notified of the additional dose activity
required and what time the additional radiotracers will be
required.
[0054] System 100 provides scalable economies of efficiency.
Economy of scale is provided by the use of more than one PET
imaging system for each dispensing station 106, quality control
unit 110 and each control system 146.
[0055] In some embodiments, control system 146 is a computer
system, such as shown in FIG. 12. In some embodiments, the control
system 146 is operably coupled to the PET devices through a local
area network (LAN) 148. Communication links of the LAN may be
implemented either through physical cabling or though a wireless
link. Communication links between the LAN 148 and the PET imaging
systems 114 and 116 and the cyclotron are implemented through LAN
interfaces that are well-known in the art. In some embodiments, the
physiologic monitoring devices 134 and 136 are also operably
coupled directly to the LAN 148. In embodiments where the cyclotron
101, the devices that are within the radiation shield 112, and/or
the scanning systems 114 and 116 are in different facilities, the
LAN communication links between these portions of the system are
wide-area networks. As an alternative to a LAN 148, the devices of
system 100 may be operably coupled through a direct communication
link.
[0056] In some embodiments, the control system 146 manages the
process of producing the radiotracer 104 and delivering the
radioisotope according to the current requirements of a PET imaging
system. The control system 146 is capable of receiving information
describing an amount of a requested individual dose 126 or 128,
sending instructions to the cyclotron 101 to produce the individual
quantity of the radioisotope, sending instructions to the
dispensing station to dispense the individual quantity of the
radioisotope to the requesting PET imaging system. In some
embodiments, the request is initiated by an operator of the
graphical user interface of a computer 142 or 144 in a PET imaging
system 114 or 116. In some embodiments, control system 146 receives
notice from the PMs 134 and 136 of abnormalities in the
measurements of the health of the living subject, and consequently
instructs the injector system 122 and 124 respectively, to halt
infusion. In yet some further embodiments, when the QC 110
indicates that quality is below acceptable minimum standards, the
control system 146 provides notice to an operator of the control
system 146 of the indications of the unacceptable quality and
instructs the systems to purge the radiotracer from the
apparatus.
[0057] In still further embodiments, control system 146 instructs
the scanner 138 or 140 to initiate a scanning operation at an
appropriate time after infusion by the injector system 122 or 124,
respectively. In yet further embodiments, scanner 138 or 140
follows a pre-defined set of acquisition strategies depending on a
radiotracer and a clinical protocol being use. In some embodiments,
the acquisition strategies includes initiation of scanning after a
predefined time following injection of the radiotracer, introducing
a pharmaceutical stress agent followed by injection of radiotracer
and imaging once again after predefined time.
[0058] Furthermore, in some embodiments portions of the system 100
are mounted inside a moveable structure with or without wheels in
order to provide a portable or relocateable medical
radiopharmaceutical administration system 100 for preparation and
injection of radiopharmaceuticals from multiple doses of the
radiopharmaceutical. In one example, the radiation shield 112 is
mounted on a structure having wheels so the portions of the system
within the radiation shield that are radioactive are more easily
moved from one location to another.
[0059] The system level overview of the operation of an embodiment
has been described in this section of the detailed description.
System 100 is an integrated system for production, quality control
distribution and imaging using PET radiopharmaceuticals. System 100
reduces the disjoint management and control of the functions of
preparing and injection radioisotopes into living subjects. System
100 provides an end-to-end control system which treats the clinical
challenges of administering radioisotopes to living subjects as a
single problem, and provides and integrated production, dispensing,
quality control, infusion, data acquisition scheme in an automated
manner. In addition, it provides an automated way of administering
sequential PET imaging protocols such as in rest-stress cardiac PET
imaging.
[0060] While the system 100 is not limited to any particular
cyclotron 101, multidose portion of radiotracer 104, dispensing
station 106, individual portion of radiopharmaceutical 126 and 128,
PET imaging systems 114 and 116, shield 112, quality control device
110, injector systems 122 and 124, physiologic monitors 134 and
136, scanners 138 and 140, and computers 142 and 144, control
system 146 and LAN 148. For sake of clarity, simplified components
have been described.
Apparatus of an Embodiment
[0061] In the previous section, a system level overview of the
operation of an embodiment was described. In this section, the
apparatus of such an embodiment are described by reference to a
series of block diagrams. Describing the apparatus enables one
skilled in the art to make and use the apparatus.
[0062] FIG. 2 is a block diagram of an apparatus 200 for injecting
one or more individual doses 126 or 128 of a radiopharmaceutical
from a multiple dose of the radiopharmaceutical. Apparatus 200
includes an extraction apparatus 202. The lower end of the
extraction apparatus 202 is placed in a multiple dose of the
radiopharmaceutical. An individual dose 126 or 128 is removed from
the multiple dose of the radiopharmaceutical by the extraction
apparatus 202 through a suction or vacuum action. The extraction of
an individual dose 126 or 128 of a radiopharmaceutical from a
multiple dose of the radiopharmaceutical reduces the number of
individual dose vials and shielded containers that radioisotope
suppliers prepare and deliver to each medical facility each day.
The extraction of an individual dose 126 or 128 also reduces the
number of delivery trips that a radiotracer supplier makes to each
medical facility each day. FIG. 2 shows one example of an
extraction apparatus 202 that is a drug delivery system.
[0063] The extraction apparatus 202 is operably coupled to an
intravenous injection apparatus 204 having an intravenous needle.
The extraction apparatus 202 is coupled through intravenous tubing
206. Tubing provides operable coupling through which liquids can be
transferred, transported and/or distributed. In some embodiments,
the tubing 206 is a lead-shielded line that reduces the exposure of
people, such as PET technicians, to radioactivity during the manual
steps of administering a radiopharmaceutical to patients. The
individual dose of the radiopharmaceutical is dispensed through the
tubing 206 and injected in a living subject through the intravenous
injection apparatus 204.
[0064] Thus, apparatus 200 allows individual doses 126 or 128 of a
radiopharmaceutical to be dispensed from a multiple dose of the
radiopharmaceutical and injected in a living subject at the same
medical facility. The apparatus 200 also provides a more convenient
means of preparing and distributing individual doses 126 or 128 of
a radiopharmaceutical than conventional systems that require
irradiation and shipment of each individual doses of
radiopharmaceutical.
[0065] FIG. 3 is a block diagram of a dose calibrator system 300
according to an embodiment. The dose calibrator system 300 allows a
multidose portion of radiopharmaceutical to be dispensed as one or
more individual doses. A multidose portion of a radiopharmaceutical
is a quality-controlled quantity of a radiotracer 104 that is
reasonably calculated to provide radioactivity for more than one
dose of radioactivity. An individual dose of a radiopharmaceutical
is a quantity of a radiopharmaceutical that is reasonably
calculated to provide radioactivity for one dose of
radioactivity.
[0066] The dose calibrator system 300 receives a reservoir 302 to
contain a multiple dose of a radiopharmaceutical in FIG. 1. The
reservoir 302 is received into a cavity of the dose calibrator
system 300. The reservoir 302 is also known as a multidose vial. A
mechanical holding apparatus 304, such as a carriage arm, holds the
reservoir 302 inside the dispensing station. In some embodiments,
the mechanical holding apparatus 304 is mounted on the inside of
the cavity of the dose calibrator system 300. The multidose vial
302 in system 300 reduces the number of vials of individual doses
that a radiotracer supplier needs to deliver to a medical facility
each day, which in turn reduces the number of delivery trips that a
radiotracer supplier needs to provide to each medical facility each
day.
[0067] The dose calibrator system 300 extracts individual doses 126
or 128 of radiopharmaceutical from the reservoir 302 through an
extraction apparatus 202. The extraction apparatus 202 is mounted
to the dose calibrator system 300, such as being mounted inside the
cavity of the dose calibrator system 300. The individual dose 126
or 128 of radiopharmaceutical is dispensed to one or more PET
imaging systems 112 and 114 in FIG. 1. Thus, the dose calibrator
system 300 allows a multidose portion of radiopharmaceutical to be
dispensed from the reservoir 302 as one or more individual doses.
Dose calibrator system 300 provides a more convenient means of
preparing and distributing individual dose 126 or 128 of
radiopharmaceutical than conventional systems that require
irradiation and shipment of many individual doses of
radiopharmaceutical.
[0068] FIG. 4 is a block diagram of an automated injector system
for PET medications 400 according to an embodiment. Injector system
400 is one embodiment of injector systems 122 and 124.
[0069] System 400 allows an individual dose of a
radiopharmaceutical 126 or 128 to be dispensed from a multidose
vial 302. The multidose vial 302 contains a multiple dose portion
of a radiotracer. The multidose vial 302 is delivered by a
radiotracer supplier to the site of the system 400 in a
lead-shielded shipping container 402. The multidose vial 302 in
system 400 reduces the number of vials of individual doses that the
radiotracer supplier needs to deliver to a medical facility each
day, which in turn reduces the number of delivery trips that the
radiotracer supplier needs to provide to each medical facility each
day.
[0070] The shipping container 402 is placed into a fixed position
under a lead-shielded dose calibrator system 404 (also known as an
ion-chamber) and the top cover 306 of the multidose vial 302 is
removed. The top cover 406 may be removed either manually or by
automated mechanical means. An example of an automated means is one
in which a pneumatic arm 304 lowers into the shipping container 402
and attaches to the multidose vial 302. The multidose vial 302 is
raised from the shipping container 402 into the dose calibrator
system 404 and a needle 408 is automatically inserted into the
multidose vial 302. An individual dose 126 or 128 is extracted from
the multiple dose of the radiopharmaceutical by the extraction
apparatus 202 through a suction or vacuum action. Thus, system 400
allows a multidose portion of radiopharmaceutical to be dispensed
as individual doses 126 or 128. System 400 provides a more
convenient means of preparing and injecting an individual dose of a
radiopharmaceutical than conventional systems that require
irradiation and shipment of many individual doses of
radiopharmaceutical. System 400 provides significant economies of
scale in the preparation and distribution of doses of
radiopharmaceuticals.
[0071] The extraction means 302 extracts an amount of
radiopharmaceutical that is reasonably calculated to provide an
individual dose of the radiopharmaceutical 126 or 128. The amount
of the individual dose 126 or 128 is calculated based on the type
of radiopharmaceutical, the radioactive half-life of the
radiopharmaceutical, a predefined parametric equation, clinical
protocol being followed, the projected time of injection into a
living subject 124 and high level descriptors of the living
subject, such as the weight, sex and physical dimensions of the
living subject.
[0072] Components of system 400 have predefined sizes and shapes
that are designed to physically integrate with each other. In one
example, the multidose vial 302 and the shielded shipping container
402 have predefined sizes and shapes that are designed to
physically integrate with each other. In another example, the
multidose vial 302 and the lead-shielded dose calibrator system 404
have predefined sizes and shapes that are designed to physically
integrate with each other. The integrated shapes allow the
components to fit together within prescribed tolerances to reduce
escape of radioactive materials and to allow automated processes
such as the multidose vial 302 being removed by a carriage arm from
the shielded shipping container 402 and being received into the
dose calibrator system 404. In some embodiments, the predefined
sizes and shapes are specified by a radiotracer supplier, and are
unique to that radiotracer supplier. Having predefined sizes and
shapes of the components provides strong incentive to a medical
facility to continue patronage of the radiotracer supplier where
the multidose vial 302 and the shielded shipping container 402 may
not have a size and shape that is physically compatible with the
dose calibrator system 404 to the extent that the dose calibrator
system 404 may not receive the multidose vial 302.
[0073] In some embodiments, the extraction means 202 is operably
coupled through intravenous tubing 206 to a device that regulates
the flow of multiple liquids, such as a solenoid driven 3-way
stopcock 410 or another type of multiport value. The stopcock 410
is also operably coupled to a reservoir of another liquid
pharmaceutical, such as an intravenous bag of sodium chloride
(NaCl) of appropriate concentration 412 commonly known as saline.
The individual dose 126 or 128 is mixed with the NaCl 412 by the
stopcock 410. The mixture is pumped from the stopcock 410 by a pump
414, such as a peristaltic pump.
[0074] In some embodiments, a second reservoir 416 in a second dose
calibrator 418 receives the mixture from the peristaltic pump 414.
In some embodiments, the reservoir 416 is a vial that has a "V"
shaped bottom and is known as a patient vial. The mixture passes
through a filter 415, such as a 0.22 micron radiotracer filter, and
is stored in the second reservoir 416. In some embodiments, an
infusion pump is operably coupled to the peristaltic pump 414 as an
alternative to the reservoir 416 in a second dose calibrator 418.
In some embodiments, the dose calibrator includes an ion chamber
that measures the amount of radioactivity of the mixture. The
measurement of the radioactivity allows the adequacy of the
radioactivity of each individual dose to be verified immediately
prior to injection, and in close proximity to the site of
injection.
[0075] The mixture is pumped toward the living subject by an
infusion system 420, such as infusion pump, through a second device
that regulates the flow of multiple liquids, such as a second
solenoid driven 3-way stopcock 422. The stopcock 422 is also
operably coupled to a reservoir of another liquid pharmaceutical,
such as an intravenous bag containing a non-radiological
pharmaceutical 424 such as pharmacological stress agent. Examples
of stress agents used in myocardial perfusion studies include
dipyridamole and adenosine. In some embodiments, a receptacle for
waste 426 is operably coupled to the intravenous tube 206 between
the device that regulates the flow of multiple liquids 422 and the
infusion pump 420.
[0076] The infusion pump 420 pumps the mixture into the living
subject 124 through an intravenous injection apparatus 204 having
an intravenous needle, thus providing an individual dose 126 or 128
of a radiopharmaceutical to a living subject 124 from a multiple
dose 104 of the radiopharmaceutical. In various embodiments, the
radiopharmaceutical is also mixed with other pharmaceuticals such
as saline 412 and/or a pharmaceutical 424, thus providing
flexibility in configurations to support a variety of medical
applications.
[0077] In some embodiments of system 400, a dose meter verifies the
quantity of the individual dose 126 or 128 of the
radiopharmaceutical. The dose meter may be operably coupled to
either the intravenous tubing 206 or intravenous tubing 428. IV
tubing is also known as patient tubing. In other embodiments,
system 400 also includes one or more additional dose calibrators
404. The additional dose calibrator(s) 404 allow the system to
inject radiopharmaceutical(s) other than the radiopharmaceutical in
dose calibrator system 404.
[0078] In order to protect living subjects from exposure to
pharmaceuticals and microorganisms of living subjects who have used
the system 400 earlier, numerous components of the system are
replaced for each use. The components that are replaced after each
use of the system are all of the disposable items situated between
the filter 415 and the living subject 124. The disposable items
include the IV tubing 428 and intravenous injection apparatus
204.
[0079] One example of the operation of system 400 is described in
detail in method 800 in FIG. 8.
[0080] FIG. 5 is a block diagram of a medical radiopharmaceutical
administration system according to an embodiment 500. The medical
radiopharmaceutical administration system 500 is an integrated
system for production, quality control and injection of individual
doses of a radiopharmaceutical in positron emission tomography
(PET) imaging.
[0081] In system 500, a cyclotron target 502 produces a
radioisotope, such as nitrogen-13 ammonia. In the nitrogen-13
ammonia embodiments, the target material that is placed in the
cyclotron target 502 may be either an ethyl alcohol mixture of
appropriate molarity in high resistivity water, methane over
pressure on water, or simply water followed by reduction of anions
using DeVarda's alloy. Furthermore, the cyclotron target 502 has a
cavity volume of between about 0.5 milliliters and less than about
10 milliliters.
[0082] A pump 503 receives the radioisotope and deposits the
radioisotope in a holding reservoir 504. The radioisotope is
circulated within the holding reservoir 504.
[0083] Later, the pump receives the radioisotope from the holding
reservoir 504. The pump also receives optionally, a rinse solution
506. The pump 503 also returns waste to reservoir 508. Waste is
additional unneeded portions of the radioisotope and/or the rinse
solution 506.
[0084] Components of the system 500 that produce the radioisotope
mixture, such as pump 503, the cyclotron target 502, the
radioisotope reservoir 504, the rinse solution 506, and the waste
reservoir 508 are all located in the same room 509 with a
cyclotron. The remainder of the components of system 500 may be
located in the same building as the cyclotron room 509, or in a
nearby building in the same medical complex.
[0085] In some embodiments, the mixture of the nitrogen-13 ammonia
or other radioisotope and the rinse solution 506 flows from the
pump 503 into a filter 415, such as a 0.22 micron radiotracer
filter.
[0086] The mixture flows into a dose calibrator system 404. The
dose calibrator system 404 extracts an individual dose 126 or 128
of the mixture. The individual dose flows into an infusion device
such as syringe pump 512 or an infusion pump. In some embodiments,
sterile water for injection from reservoir 514 and/or a stress
agent from a stress agent reservoir 516 also flows into the syringe
pump 512. The water is used as a flush for the lines 206. From the
syringe pump, the mixture of the individual dose, the water and the
stress agent flows into an intravenous injection apparatus 204
having an intravenous needle, through intravenous tubing, injection
into a living subject. Thus dose calibrator system 404 allows a
multiple dose of a radiopharmaceutical to be administered to one or
more living subjects in individual doses, optionally with a stress
agent, sterile water, and a rinse solution. The dose calibrator
system 404 reduces the number of vials of individual doses that a
radiotracer supplier needs to deliver to a medical facility each
day, which in turn reduces the number of delivery trips that a
radiotracer supplier needs to provide to each medical facility each
day.
[0087] Waste from the syringe pump 512 also flows to a waste
reservoir 518. The quality of the mixture of dose is monitored by
the quality control unit 110. Intravenous tubing 206 is used in
system 500 to transport the liquids and mixtures.
[0088] Portions or all of the system 500 may be placed on a table
520 or mounted on a support structure. Furthermore, portions of the
system 500 may also be mounted inside a moveable structure having
wheels in order to provide a portable medical radiopharmaceutical
administration system 500 for preparation and injection of
individual doses of a radiopharmaceutical from multiple doses of
the radiopharmaceutical.
[0089] System 500 provides a convenient method for on-site
production and administration of radiotracer, such as nitrogen-13
ammonia.
[0090] FIG. 6 is a block diagram of a medical radiopharmaceutical
administration system according to an embodiment 600. The medical
radiopharmaceutical administration system 600 is an integrated
system for production, quality control and injection of individual
doses of a radiopharmaceutical in positron emission tomography
(PET) imaging.
[0091] In system 600, a cyclotron target 502 produces a
radioisotope, such as nitrogen-13 ammonia. In the nitrogen-13
ammonia embodiments, the target material that is placed in the
cyclotron target 502 to produce nitrogen-13 ammonia may be either
an ethyl alcohol mixture of appropriate molarity in high
resistivity water, methane over pressure on water, or simply water
followed by reduction of anions using DeVarda's alloy. Furthermore,
the cyclotron target 502 has a cavity volume of between about 0.5
milliliters and less than about 10 milliliters.
[0092] A pump 503 receives the radioisotope and deposits the
radioisotope in a holding reservoir 504. The radioisotope is
circulated within the holding reservoir 504.
[0093] Later, the pump receives the radioisotope from the holding
reservoir 504. The pump also receives optionally, a rinse solution
506. The pump 503 also returns waste to reservoir 508. Waste is
additional unneeded portions of the radioisotope and/or the rinse
solution 506.
[0094] In some embodiments, the mixture of the radioisotope and the
rinse solution 506 flows from the pump 503 into a filter 415, such
as a 0.22 micro radiotracer filter. The quality of the mixture is
tested by quality control unit 110.
[0095] The mixture flows into a dose calibrator system 404. The
dose calibrator system 404 extracts an individual dose 126 or 128
of the mixture through extraction apparatus 202 by a suction or
vacuum action. Thus, system 600 allows a multidose portion of
radiopharmaceutical to be dispensed as individual doses 126 or 128.
System 600 provides a more convenient means of preparing and
injecting an individual dose of a radiopharmaceutical than
conventional systems that require irradiation and shipment of many
individual doses of radiopharmaceutical. System 600 provides
significant economies of scale in the preparation and distribution
of doses of radiopharmaceuticals. The multidose vial 302 in system
600 reduces the number of vials of individual doses that a
radiotracer supplier needs to deliver to a medical facility each
day, which in turn reduces the number of delivery trips that a
radiotracer supplier needs to provide to each medical facility each
day.
[0096] The extraction means 302 extracts an amount of
radiopharmaceutical that is reasonably calculated to provide an
individual dose of the radiopharmaceutical 126 or 128. The amount
of the individual dose 126 or 128 is calculated based on the
radioactive half-life of the radiopharmaceutical, the projected
time of injection into a living subject 124 and the weight of the
living subject 124.
[0097] In some embodiments, the extraction means 202 is operably
coupled through intravenous tubing 206 to a device that regulates
the flow of multiple liquids, such as a solenoid driven 3-way
stopcock 410 or another type of multiport value. The stopcock 410
is also operably coupled to a reservoir of another liquid
pharmaceutical, such as an intravenous bag of sodium chloride
(NaCl) 412 commonly known as saline. The individual dose 126 or 128
is mixed with the NaCl 412 by the stopcock 410. The mixture is
pumped from the stopcock 410 by a peristaltic pump 414.
[0098] In some embodiments, a second reservoir 416 in a second dose
calibrator 418 receives the mixture from the peristaltic pump 414.
The mixture is stored in the second reservoir 416. In some
embodiments, an infusion pump is operably coupled to the
peristaltic pump 414 as an alternative to the reservoir 416 in a
second dose calibrator 418.
[0099] The mixture is pumped toward the living subject by an
infusion pump 420, through a second device that regulates the flow
of multiple liquids, such as a second solenoid driven 3-way
stopcock 422. The stopcock 422 is also operably coupled to a
reservoir of another liquid pharmaceutical, such as an intravenous
bag containing a pharmaceutical 424. In some embodiments, a
receptacle for waste 426 is operably coupled to the intravenous
tube 206 between the device that regulates the flow of multiple
liquids 422 and the infusion pump 420.
[0100] The infusion pump 420 pumps the mixture into the living
subject 124 through an intravenous injection apparatus 204 having
an intravenous needle, thus providing an individual dose 126 or 128
of a radiopharmaceutical to a living subject 124 from a multiple
dose 104 of the radiopharmaceutical. In various embodiments, the
radiopharmaceutical is also mixed with other pharmaceuticals such
as NaCl 412 and/or a pharmaceutical 424, thus providing the
flexibility in configurations to support a variety of medical
applications.
Methods of an Embodiment
[0101] In the previous sections, a system level overview of the
operation of an embodiment was described and embodiments of
apparatus were described. In this section, the particular methods
performed by PET technologists and the control system 146 of such
an embodiment are described by reference to a series of flowcharts.
Describing the methods by reference to a flowchart enables one
skilled in the art to develop manual procedures or computer
instructions.
[0102] FIG. 7 is a flowchart is an embodiment of a method 700 of
operation of apparatus 400. Method 700 is performed by a PET
technologist. Typically, method 700 is performed once for each day
of operation of a PET scanning system.
[0103] A PET technologist prepares system 400 for use by a number
of patients in action 702, which is described in greater detail in
FIG. 8. Then system 400 is repeatedly prepared 704 for each
individual patent as described in FIG. 9 and the injection for each
patient is administered 706 as described in FIG. 10.
[0104] Thereafter, in some embodiments, a radiotracer supplier of
the radiopharmaceutical is notified of the number of doses and
total activity used for the day and the requirements for the next
day.
[0105] FIG. 8 is a flowchart of an embodiment of a method 800 of
preparing injector system 400 for use by a number of patients.
Method 800 is one embodiment of action 702 in FIG. 7.
[0106] According to method 800, the computer system 142 or 142 is
activated 802.
[0107] Method 800 also includes delivering 804 a multidose vial 302
of radioisotope to the system 400. The multidose vial 302 is raised
806 into the dose calibrator system 404.
[0108] FIG. 9 is a flowchart of an embodiment of method 900 of
preparing an injector system 400 for each individual patient.
Method 900 is one embodiment of action 704 in FIG. 7. The actions
in method 900 are directed toward installing new disposable
items.
[0109] Method 900 includes installing 902 a patient vial 416 that
is clean, sterile and pyrogens-free into dose calibrator 418.
Method 900 also includes connecting 904 an output needle to line
206 from the peristaltic pump 414. The output needle is inserted in
906 or placed at the bottom of the vial 416. Thereafter, the PET
technologist places 908 the vial 416 into dose calibrator 418.
[0110] Method 900 also includes installing 910 a new stopcock 422.
A new IV line 428 is also installed 912 through the new stopcock
422 by feeding the IV line 428 into a first input of 3-way stopcock
410. A new IV 204 is also installed 914. An IV line from a saline
bag or a bag of another pharmaceutical 412 is attached 916 to a
second input of the 3-way stopcock 410.
[0111] Thus, in method 900, a new vial 416, IV line 428, stopcock
422 and IV 204 is used for each patient.
[0112] Thereafter, system 400 is ready to begin administration of
an individual dose to a patient.
[0113] FIG. 10 is a flowchart of an embodiment of a method 1000 of
administering an injection using injector system 400 for each
individual patient. Method 1000 is an embodiment of action 706 in
FIG. 7.
[0114] Method 1000 includes extracting 1002 an individual dose of a
radiopharmaceutical from a multi dose vial 302. The
radiopharmaceutical is pumped through a 3-way stopcock 410 into a
patient vial 416 that is located in a patient dose calibrator
418.
[0115] When the required amount of radioactivity is present in the
patient vial 416, a comparison is done to verify 1004 that the
amount of radioactivity in the patient vial 416 is the same amount
of radioactivity that has been vacated from the multi dose vial
302. If so, additional saline is added 1006 via the 3-way stopcock
410 and saline bag 412 into the patient vial 416.
[0116] The patient dose is recorded by the system 142 or 144 and
the recorded dose that is recorded on the computer systems is
verified 1008 with the patient vial by the PET technologist. The
patient initial dose activity at an initial time is recorded
1010.
[0117] The patient is then injected 1012 at a prescribed rate. Note
that where the radiotracer is FDG, the injection is performed in a
separate room approximately one hour before scanning.
[0118] When the activity vial is empty, the patient 3-way stopcock
422 input is selected to saline to allow the flow to flush or purge
1014 the patient line 428 of radioactive substances. After a
prescribed time, the saline drip is complete, and the patient line
428 is removed, the stopcock 422 and the saline line are
disconnected 1016.
[0119] The saline line, patient line 428 and stopcock 422 are
placed 1018 into the patient dose calibrator 418 and the residual
activity in the patient dose calibrator 418 at this final time is
measured 1020. Both the initial dose and residual activities and
associated time marks are transmitted 1022 to the PET scanner by
the injector system 400.
[0120] Describing the following method by reference to a flowchart
enables one skilled in the art to develop computer programs,
firmware, or hardware, including such instructions to carry out the
methods on suitable computerized clients and/or servers executing
the instructions from computer-readable media. Similarly, the
methods performed by computer programs, firmware, or hardware are
also composed of computer-executable instructions.
[0121] FIG. 11 is a flowchart of a method 1100 performed by the
control system 146 according to an embodiment. The method is
directed towards managing radioisotope material in system 1100.
Method 1100 is performed by a program executing on, or performed by
firmware or hardware that is a part of, a computer, such as
computer 1202 in FIG. 12.
[0122] Method 1100 includes receiving 1102 information describing a
requested amount of radioactivity, the type of radioisotope, the
projected time of injection of the radioisotope, high level patient
descriptors, and the identification of the PET imaging system that
initiated the request. Thereafter, the method includes determining
1104 an amount of target material to be used during the irradiation
process, and an amount of radioactivity of the radioisotope to be
produced during irradiation. The determining 1104 is calculated
from the descriptive information. Thereafter, the method includes
sending 1106 instructions to a target in the cyclotron 101 to
produce the required quantity of the radioisotope. Subsequently,
the method includes sending 1108 instructions to dispensing station
106 to dispense the quantity of the radioisotope to the requesting
PET imaging system. Method 1100 reduces the disjoint management and
control of the functions of preparing and injecting radioisotopes
into living subjects by managing radioisotopes by the control
system 146. A technical effect of method 1100 is that the
preparation and injection of radioisotopes into living subjects is
managed and controlled by computer implemented processes.
[0123] In some embodiments, method 1100 is implemented as a
computer data signal embodied in a carrier wave, that represents a
sequence of instructions which, when executed by a processor, such
as processor 1204 in FIG. 12, cause the processor to perform the
respective method. In other embodiments, method 1100 is implemented
as a computer-accessible medium having executable instructions
capable of directing a processor, such as processor 1204 in FIG.
12, to perform the respective method. In varying embodiments, the
medium is a magnetic medium, an electronic medium, or an optical
medium.
[0124] Method 1100 can be embodied as computer hardware circuitry
or as a computer-readable program, or a combination of both. In
another embodiment, method 1100 is implemented in an application
service provider (ASP) system.
[0125] More specifically, in the computer-readable program
embodiment, the programs can be structured in an object-orientation
using an object-oriented language such as Java, Smalltalk or C++,
and the programs can be structured in a procedural-orientation
using a procedural language such as COBOL or C. The software
components communicate in any of a number of means that are
well-known to those skilled in the art, such as application program
interfaces (API) or interprocess communication techniques such as
remote procedure call (RPC), common object request broker
architecture (CORBA), Component Object Model (COM), Distributed
Component Object Model (DCOM), Distributed System Object Model
(DSOM) and Remote Method Invocation (RMI).
Hardware and Operating Environment
[0126] FIG. 12 is a block diagram of the hardware and operating
environment 1200 in which different embodiments can be practiced.
The description of FIG. 12 provides an overview of computer
hardware and a suitable computing environment in conjunction with
which some embodiments can be implemented. Embodiments are
described in terms of a computer executing computer-executable
instructions. However, some embodiments can be implemented entirely
in computer hardware in which the computer-executable instructions
are implemented in read-only memory. Some embodiments can also be
implemented in client/server computing environments where remote
devices that perform tasks are linked through a communications
network. Program modules can be located in both local and remote
memory storage devices in a distributed computing environment.
[0127] Computer 1202 includes a processor 1204, commercially
available from Intel, Motorola, Cyrix and others. Computer 1202 is
one embodiment of computer 142, 144 or 146 in FIG. 1.
[0128] Computer 1202 also includes random-access memory (RAM) 1206,
read-only memory (ROM) 1208, and one or more mass storage devices
1210, and a system bus 1212, that operatively couples various
system components to the processing unit 1204. The memory 1206,
1208, and mass storage devices, 1210, are types of
computer-accessible media. Mass storage devices 1210 are more
specifically types of nonvolatile computer-accessible media and can
include one or more hard disk drives, floppy disk drives, optical
disk drives, and tape cartridge drives. The processor 1204 executes
computer programs stored on the computer-accessible media.
[0129] Computer 1202 can be communicatively connected to the
Internet 1214 via a communication device 1216. Internet 1214
connectivity is well known within the art. In one embodiment, a
communication device 1216 is a modem that responds to communication
drivers to connect to the Internet via what is known in the art as
a "dial-up connection." In another embodiment, a communication
device 1216 is an Ethernet.RTM. or similar hardware network card
connected to a local-area network (LAN) that itself is connected to
the Internet via what is known in the art as a "direct connection"
(e.g., T1 line, etc.).
[0130] A user enters commands and information into the computer
1202 through input devices such as a keyboard 1218 or a pointing
device 1220. The keyboard 1218 permits entry of textual information
into computer 1202, as known within the art, and embodiments are
not limited to any particular type of keyboard. Pointing device
1220 permits the control of the screen pointer provided by a
graphical user interface (GUI) of operating systems such as
versions of Microsoft Windows.RTM.. Embodiments are not limited to
any particular pointing device 1220. Such pointing devices include
mice, touch pads, trackballs, remote controls and point sticks.
Other input devices (not shown) can include a microphone, joystick,
game pad, satellite dish, scanner, or the like.
[0131] In some embodiments, computer 1202 is operatively coupled to
a display device 1222. Display device 1222 is connected to the
system bus 1212. Display device 1222 permits the display of
information, including computer, video and other information, for
viewing by a user of the computer. Embodiments are not limited to
any particular display device 1222. Such display devices include
cathode ray tube (CRT) displays (monitors), as well as flat panel
displays such as liquid crystal displays (LCD's). In addition to a
monitor, computers typically include other peripheral input/output
devices such as printers (not shown). Speakers 1224 and 1226
provide audio output of signals. Speakers 1224 and 1226 are also
connected to the system bus 1212.
[0132] Computer 1202 also includes an operating system (not shown)
that is stored on the computer-accessible media RAM 1206, ROM 1208,
and mass storage device 1210, and is and executed by the processor
1204. Examples of operating systems include Microsoft Windows.RTM.,
Apple MacOS.RTM., Linux.RTM., UNIX.RTM.. Examples are not limited
to any particular operating system, however, and the construction
and use of such operating systems are well known within the
art.
[0133] Embodiments of computer 1202 are not limited to any type of
computer 1202. In varying embodiments, computer 1202 comprises a
PC-compatible computer, a MacOS.RTM.-compatible computer, a
Linux.RTM.-compatible computer, or a UNIX.RTM.-compatible computer.
The construction and operation of such computers are well known
within the art.
[0134] Computer 1202 can be operated using at least one operating
system to provide a graphical user interface (GUI) including a
user-controllable pointer. Computer 1202 can have at least one web
browser application program executing within at least one operating
system, to permit users of computer 1202 to access intranet or
Internet world-wide-web pages as addressed by Universal Resource
Locator (URL) addresses. Examples of browser application programs
include Netscape Navigator R' and Microsoft Internet Explorer
R'.
[0135] The computer 1202 can operate in a networked environment
using logical connections to one or more remote computers, such as
remote computer 1228. These logical connections are achieved by a
communication device coupled to, or a part of, the computer 1202.
Embodiments are not limited to a particular type of communications
device. The remote computer 1228 can be another computer, a server,
a router, a network PC, a client, a peer device or other common
network node. The logical connections depicted in FIG. 12 include a
local-area network (LAN) 1230 and a wide-area network (WAN) 1232.
Such networking environments are commonplace in offices,
enterprise-wide computer networks, intranets and the Internet.
[0136] When used in a LAN-networking environment, the computer 1202
and remote computer 1228 are connected to a local network 1230
through network interfaces or adapter 1232, which is one type of
communications device 1216. Remote computer 1228 also includes a
network device 1234. When used in a conventional WAN-networking
environment, the computer 1202 and remote computer 1228 communicate
with a WAN 1236 through modems (not shown). The modem, which can be
internal or external, is connected to the system bus 1212. In a
networked environment, program modules depicted relative to the
computer 1202, or portions thereof, can be stored in the remote
computer 1228.
[0137] Computer 1202 also includes a power supply 1238. The power
supply can be a battery. In some embodiments, computer 1202 is also
operably coupled to a storage area network device (SAN) 1240 which
is a high-speed network that connects multiple storage devices so
that the multiple storage devices may be accessed on all servers in
a LAN such as LAN 1230 or a WAN such as WAN 1236.
[0138] Embodiments of 1200 operate in a multi-processing,
multi-threaded operating environment on a computer.
CONCLUSION
[0139] A radiopharmaceutical distribution system has been
described. Although specific embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that any arrangement which is calculated to achieve the
same purpose may be substituted for the specific embodiments shown.
This application is intended to cover any adaptations or
variations. For example, one of ordinary skill in the art will
appreciate that implementations can be made in a procedural or
objected-oriented design environment or any other design
environment that provides the required relationships.
[0140] In particular, one of skill in the art will readily
appreciate that the names of the methods and apparatus are not
intended to limit embodiments. Furthermore, additional methods and
apparatus can be added to the components, functions can be
rearranged among the components, and new components to correspond
to future enhancements and physical devices used in embodiments can
be introduced without departing from the scope of embodiments. One
of skill in the art will readily recognize that embodiments are
applicable to future communication devices, different file systems,
and new data types.
[0141] The terminology used in this application is meant to include
all medical, object-oriented, database and communication
environments and alternate technologies which provide the same
functionality as described herein.
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