System for safe preparation and injection of radioisotopes

Abstract

A system for radioisotope safe preparation and injection of H215O for use in positron emission tomography (PET). The invention also relates to a safety valve for controlling the flow of H215O used in PET, to the use of said safety valve, and to a method for preparing and injecting H215O.

Description

[0001] This application is a divisional application of an application filed on June 20, 2016, with application number 202111201632.0, and invention name “System for safe preparation and injection of radioactive isotopes”. Technical Field

[0002] In a first aspect, the present invention relates to a conditioning device for a system for preparing and injecting H used in positron emission tomography (PET). 2 15 O. The present invention also relates in a second aspect to a method for preparing and injecting H 2 15 In a third aspect, a method for controlling H used in PET 2 15 A safety valve for reducing the flow rate of H2O2, a fourth aspect relates to the use of the safety valve, and a fifth aspect relates to a method for preparing and injecting H2O2 2 15 O's method. Background Art

[0003] Radioactive isotopes (also called radionuclides) have several applications in medical treatment, imaging, and research. PET allows for the imaging and measurement of physiological processes within the human body through the emission of positrons from radioactive isotopes.

[0004] for example 18 F. 11 C. 15 O. 14 O. 82 Rb, and 13 Radioisotopes such as N are typically used to label radiopharmaceuticals used in PET. The half-lives associated with these radioisotopes are very short, typically on the order of a few minutes (except for 18 F has a half-life of almost two hours). Oxygen-15( 15 O) has a half-life of 122.24 seconds and is one of the most suitable radioisotopes for quantifying regional cerebral blood flow (rCBF) and quantifying regional myocardial blood flow (rMBF) in PET.

[0005] Most systems for producing radioactive water include a cyclotron that produces the target gas. The target gas from the cyclotron is transferred to a HotCell in a qualified laboratory environment where it is heated to approximately 800 °C and combined with H 2 The target gas is then transferred from 15 OO 2 Converted to H 2 15O. Then the resulting H 2 15 O is typically bubbled into a saline solution in a reservoir, thereby trapping H in the solution. 2 15 O. Then H 2 15 The O solution is manually transferred from the reservoir into a draw chamber or the like, and the desired dose for the patient is then typically manually drawn into a syringe, which is then manually transported to the PET scanning room.

[0006] because 15 O has a short half-life, so it can only be used in systems that produce the radioisotope and inject it directly into the patient. 15 O. Therefore, due to safety aspects regarding patients directly connected to the system, it is only used to a limited extent, for example for research purposes or under special exemption conditions. 15 O.

[0007] A key aspect of safety considerations in systems that generate radioisotopes and inject them into patients is the circulation of compressed gas. A cyclotron is connected at one end of such a system and delivers compressed radioactive gas, which is pressurized to 10 atm or higher. The patient is typically connected at the other end of the system via a peripheral intravenous catheter, establishing a direct connection between the patient and the compressed radioactive gas.

[0008] The standard safety feature is typically that gas passes on one side of the semipermeable membrane and saline passes on the other side. A sterile filter made of a material similar to the first semipermeable membrane will be positioned immediately in front of the patient. This sterile filter will perform a gas lock in the event that any gas passes through the first membrane, but if the gas waste pipe that directs the gas to leave is blocked, the pressure may rise to a higher pressure than the membrane can handle, which may allow the gas to pass through the filter and enter the patient. The result may be an infusion of radioactive gas from hundreds of ml / minutes up to 1 to 2 1 / minute into the patient, which may cause fatal venous air embolism.

[0009] In known valves for such systems, the valve may be configured with a discharge opening, wherein in order to release excess fluid from the system, the valve must be turned to a configuration where a flow path is established through the valve between the inflowing fluid and the discharge opening. This requires the valve to be turned manually or automatically to said configuration, and therefore the valve will not function as a safety valve if a fault occurs in the system.

[0010] Further, a fundamental problem faced by such systems operating on compressed gas is the need for fail-safe features to ensure that the compressed gas cannot enter other parts of the system thereby potentially affecting or damaging them.

[0011] In order to minimize the risk level to the patient, the manual transfer of the radioisotope from the reservoir to the patient by syringe is performed by medical personnel. In this way, the patient is not directly or indirectly connected to the cyclotron, thereby reducing the risk of accidental infusion of radioactive gases.

[0012] Manual manipulation of radioisotopes is safe for patients, but is not feasible for routine patient examinations due to repeated radiation exposure to medical personnel, who are exposed to unwanted and dangerous radiation each time an aspiration and injection is performed.

[0013] Typically, under this manual protocol, double the amount of the desired radioactivity is measured in a dose calibrator and aspirated. A timer is started, and when the radioactivity decreases due to decay of the relevant radioisotope and reaches the desired level, the aspirated amount is transferred to the patient. Due to the short half-life of the radioisotope, the timing of aspiration and injection must be very precise to determine the actual amount of radioactivity transferred to the patient.

[0014] Therefore, it is necessary to be able to generate and inject a specific amount of H with high accuracy and negligible risk to both patients and medical personnel. 2 15 O's system has requirements. Summary of the invention

[0015] Against this background, the object of the present invention is to provide a method for preparing H 2 15 O and inject it into a salt solution with enhanced safety features, a regulating device, a system, a safety valve, and a method.

[0016] For a third aspect of the present invention, this object is to provide a method for controlling H used in positron emission tomography. 2 15O flow safety valve, the valve comprising: a valve element, the valve element having a flow channel extending through the valve element; a valve housing having at least three valve openings, each valve opening allowing fluid to flow into or out of the valve; and at least two overflow recesses, each overflow recess having at least one outlet opening, wherein the valve element and the valve housing can be connected to form an assembled valve, the valve element and the valve housing are in contact with each other in a contact area, wherein the assembled valve can be arranged into at least two different opening configurations, one of the opening configurations defining a flow path through the flow channel and a group of the valve openings, and another of the opening configurations defining a flow path through the flow channel and another group of different valve openings, and wherein in each of the at least two opening configurations In the open configuration: each overflow recess is arranged between the valve element and the valve housing; at least two of the valve openings are connected through the flow channel; at least one of the valve openings is not connected to the flow channel; the contact area forms a fluid stopper, which is used to prevent fluid from flowing into the at least one valve opening that is not connected to the flow channel; the overflow recesses are not in fluid communication with the flow channel; each overflow recess is positioned to establish an interruption in the contact area, so that the overflow recesses establish a safe release port for discharging the overflow fluid, and in the event of overpressure, the overflow fluid passes through the fluid stopper through the corresponding outlet opening, so that in the at least two open configurations, the overflow fluid is prevented from entering the at least one valve opening that is not connected to the flow channel.

[0017] By providing a valve comprising the at least two overflow recesses, when the assembled valve is arranged into the at least two different open configurations, the overflow recesses ensure that no fluid will travel from the at least two valve openings connected by the flow channel to the at least one valve opening not connected to the flow channel, as the fluid will pass through the overflow recesses and be discharged away from the valve.

[0018] The assembled valve can be arranged in a closed configuration in which the flow channel is not connected to any of the valve openings, so that no flow path is established through the flow channel and the valve openings. In this closed configuration, the fluid present in the valve openings may also be overpressured. If the fluid passes through the fluid stop, the overflow recesses allow the overflow fluid to be discharged through the corresponding outlet openings.

[0019] Since the pressure in these overflow recesses is less than the pressure integrity of the adjacent valve opening, the pressure differential ensures that overflow fluid will be discharged from the valve.

[0020] The valve thus acts as a safety valve preventing undesired pressurized fluid from entering the one or more valve openings when such entry is not intended.

[0021] In the context of the present application, it is understood that the pressurized fluid may also be a fluid at atmospheric pressure (approximately 1.01325 bar). When the system operates under normal conditions, preferably the fluid is at approximately 1 to 3 bar, preferably 1.5 to 2.5 bar, more preferably approximately 2 bar.

[0022] It should also be understood that "unexpected" fluid refers to, but is not limited to, the following two types of fluids: fluids that are not expected to flow from one opening of the valve to another opening when the valve is in a closed configuration, regardless of the pressure of the fluid; and fluids that are pressurized to an unexpectedly higher pressure than expected due to, for example, a system failure before the valve. Vice versa, the term "desired" fluid refers to a fluid that is expected to pass through a valve in an open configuration under normal operating conditions.

[0023] Under such normal operating conditions of the system, and when the valve is arranged in an open configuration with the flow passage connected to the valve opening, the amount of fluid passing through the valve is in the range of approximately 500 ml / min to 1000 ml / min.

[0024] When the desired fluid passes through the flow channel and the valve openings, the fluid may be at about atmospheric pressure. When the fluid passes through the flow channel and the valve openings normally, there is no significant pressure drop.

[0025] When the valve is arranged to prepare H 2 15 O and injecting it into a system of saline solution, the valve will act as a safety valve and will therefore prevent undesirable pressurized fluid from reaching a patient fluidly connected to the system and causing harm to the patient.

[0026] The safety valve will ensure that in the event of a malfunction in the function of the system before the valve occurs (e.g. a malfunction causing unexpected high pressure fluid to reach the valve openings and the flow passage of the valve is not connected to any valve opening), the fluid will be discharged from the valve through these overflow recesses and will not enter the other valve openings.

[0027] The same applies when the valve is in the open position and a patient is connected to a connecting element of the valve, wherein the valve opening of the connecting element is not in fluid connection with the flow path. Here, fluid will flow between the valve openings and the flow path, and if a malfunction occurs and undesired pressurized fluid enters the valve openings and the flow path, overflow fluid that will enter the contact area between the valve element and the valve housing will drain through the recesses that are located between the valve opening of the connecting element connected to the patient and the valve opening connected to the flow path.

[0028] Therefore, regardless of the configuration of the valve, the recesses will act as a safety measure and eliminate the need to switch between multiple configurations, thereby improving the safety of patients connected to the system.

[0029] Thus in embodiments, the assembled valve may be arranged in a third, different closed configuration in which the flow channel is not connected to any of the valve openings such that no flow path through the flow channel and valve openings is established.

[0030] The contact area between the valve element and the valve housing is understood to be the area where the surface of the valve element is directly adjacent to the surface of the valve housing. The fluid stop in the contact area ensures functional tightness between the valve housing and the valve element.

[0031] In the context of the present application, the term "connected" may also be understood as fluidly connected and / or in fluid communication.

[0032] In the context of this application, the term "fluid" includes both gases and liquids.

[0033] The at least three valve openings may have any shape that permits fluid to flow from one side of the opening to the other side. The valve openings are preferably circular.

[0034] The valve housing and / or the valve element may be of any desired shape, such as cylindrical, circular, rectangular, or spherical.

[0035] The size of the valve element may vary depending on the size of the valve housing.

[0036] The safety valve may be formed of a material selected from the group consisting of: an inert material, a polymer material, a metal and a metal alloy, and a ceramic; or a combination of these materials. In principle, any material that is compatible with the fluid, has sufficient strength and material properties to provide a tight fluid barrier, and can withstand sterilization may be used.

[0037] Depending on the material of the safety valve, the valve can be produced by a variety of methods (eg, injection molding, lathing, milling, casting, and / or 3D printing).

[0038] The valve element and the valve housing may be made of different material compositions. By constructing the valve element and the valve housing with different material compositions, a tighter fit may be achieved. The valve element may be formed of a material having a lower material strength than the material of the valve housing to achieve selective rupture of the valve element rather than the valve housing during an accidental pressure rise.

[0039] In an embodiment, the valve housing further comprises a connecting element having a first end and a second end and an inner fluid space, the connecting element being connected to the valve housing at the second end such that the fluid space is in fluid contact with one of the at least three valve openings.

[0040] By providing a connection element, it is easy to connect the safety valve directly to different medical systems in which valves are used to prevent pressurized fluid from entering, for example, a patient's vein or artery, and it is therefore desirable to enhance the safety of the system to ensure that no overflow fluid will travel to an unintended valve opening. Such a medical system may be a device for preparing and injecting H 2 15 O system, wherein the safety valve will ensure that overflow fluid will not be diverted to the patient line and avoid accidental infusion of fluid into the patient's circulatory system causing a potentially life-threatening situation.

[0041] In an embodiment, the connection element is cylindrical.The at least three connection elements may extend radially from the housing.The at least three connection elements may have substantially equal lengths.

[0042] In an embodiment, the valve housing comprises three connecting elements.

[0043] In an embodiment, the at least two overflow recesses are arranged in the valve housing.

[0044] In an embodiment, the at least two overflow recesses are arranged in the valve element.

[0045] The overflow recesses may have any shape, such as curved or twisted. The overflow recesses are preferably linear.

[0046] By providing the at least two overflow recesses in the valve housing and / or the valve element, an easily assembled valve is provided with a minimum number of components, thereby making the valve cost-effective and easy to produce and assemble.

[0047] In an embodiment, the valve element further comprises a first end and a second end defining a first longitudinal axis, and the valve housing further comprises: a housing comprising a first end and a second end and a second longitudinal axis extending between the first end and the second end, the second longitudinal axis being coaxial with the first longitudinal axis; an internal spacing for receiving the valve element, the internal spacing being closed by the housing; and the at least three valve openings arranged in the housing, each opening allowing fluid to flow into or out of the internal spacing, wherein the at least two overflow recesses extend axially between the first end and the second end of the housing, wherein the valve element is axially movable along the second longitudinal axis so that a portion of the valve element can be inserted into the internal spacing of the valve housing to form an assembled configuration, and the valve element is rotatable within the internal spacing around the second longitudinal axis so that the valve element and the valve housing can be changed between the at least two different open configurations, wherein each overflow recess is arranged between the valve element and the housing when the valve element is arranged within the internal spacing in the two different open configurations.

[0048] By providing the safety valve with a valve element that can be inserted into the valve housing, the valve element can be fixed inside the valve housing so as to prevent the valve element from moving in a radial direction relative to the first longitudinal direction, thereby establishing a very high functional tightness in the contact area and thus establishing a better fluid barrier to prevent any excess fluid from passing through the contact area.

[0049] When a portion of the valve element is inserted into the interior space, the valve housing may be rotatable about the valve element about the first longitudinal axis 124 of the valve element.

[0050] The rotation of the valve element and / or valve housing may be automatic and / or manual.

[0051] In an embodiment, the valve housing comprises three valve openings.

[0052] In an embodiment, the safety valve comprises three overflow recesses.

[0053] In embodiments, the valve element comprises a flow passage.

[0054] In an embodiment, the number of valve openings is equal to the number of overflow recesses.

[0055] In some embodiments, the valve housing comprises six valve openings and / or six overflow recesses. The six valve openings and / or the six overflow recesses are preferably evenly distributed along the circumference of the valve housing and / or the valve element.

[0056] In an embodiment, the at least three valve openings are equidistantly distributed in the housing. The angle between each of the valve openings relative to adjacent valve openings is preferably 120 degrees.

[0057] In an embodiment, the flow channel comprises a first flow channel and a second flow channel, wherein the first flow channel and the second flow channel extend at an angle relative to each other. The angle is preferably 120 degrees.

[0058] By setting these valve openings at approximately equal angles to the first flow channel and the second flow channel, when the valve element is arranged inside the internal spacing, the first flow channel and the second flow channel passing through the valve element will coincide with two valve openings of the at least three valve openings of the valve housing, so that two valve openings of the at least three valve openings can be connected through the flow channel.

[0059] In an embodiment, the at least two overflow recesses are arranged in the housing.

[0060] In an embodiment, the at least two overflow recesses extend between the first end and the second end of the housing and open into the first end and the second end.

[0061] In an embodiment, the at least two overflow recesses extend between and open into the first end and / or the second end of the housing.

[0062] The overflow recesses can extend radially in the housing, having a depth up to the thickness of the housing.

[0063] In an embodiment, the at least two overflow recesses are arranged in the valve element.

[0064] In an embodiment, the at least two overflow recesses extend between the first end and / or the second end of the valve element and open into the first end and / or the second end.

[0065] By providing overflow recesses extending the entire length of the housing or valve element, the overflow recesses ensure that any fluid travelling along the fluid stop between the valve element and the valve housing will be expelled from the valve through the overflow recesses.

[0066] In an embodiment, the connecting element extends into the inner spacing.

[0067] In some embodiments, the overflow recesses may comprise a material having different material properties than the housing material. This is advantageous when the valve is used in systems dealing with high pressures and / or constructed of high strength materials such as metals or metal alloys or ceramics.

[0068] In an embodiment, the housing is cylindrical.

[0069] In an embodiment, the valve element is cylindrical.

[0070] By providing the housing and / or the valve element with a cylindrical shape, a good balance between the amount of material used and the strength and rigidity of the entire valve is ensured.

[0071] In an embodiment, the flow channel and the at least three valve openings are arranged in and extend along a same plane in at least two configurations of the assembled valve.

[0072] Thus, the safety valve can be arranged without requiring much space, since both the inlet and the outlet are arranged in the same plane, rather than having the inlet perpendicular to the flow channel / valve opening.

[0073] In an embodiment, when the valve is in the assembled configuration, the plane is substantially perpendicular to the first axis and the second axis.

[0074] It is to be understood that a plane is a flat, two-dimensional surface that extends to infinity, and that the flow channel and the valve opening are located on the same plane and extend in different directions on the same plane.

[0075] In an embodiment, the overflow fluid is at approximately 1 to 10 bar, preferably approximately 1 to 5 bar, and more preferably approximately 1 to 3 bar.

[0076] In an embodiment, the valve openings are distributed equidistantly around the circumference of the housing, the valve openings are preferably distributed at an angle of substantially 120 degrees.

[0077] The inner circumference of the housing may be substantially equal to the outer circumference of the valve element.

[0078] The valve element includes a first end and a second end defining a first longitudinal axis. The valve housing includes a first end, a second end, and a second longitudinal axis extending between the first end and the second end. When the valve is in an assembled configuration, the second longitudinal axis is coaxial with the first longitudinal axis of the valve element.

[0079] In an embodiment, the valve element comprises a handle for rotating the valve element inside the valve housing.

[0080] When assembling the safety valve, the valve element can be rotated inside the valve housing, the rotation being about the second longitudinal axis.

[0081] When a portion of the valve element is inserted into the internal spacing, the handle may protrude from the valve element to the exterior of the housing.The handle preferably extends radially from the valve element.

[0082] In an embodiment, the handle comprises a first protrusion, a second protrusion, and a third protrusion extending radially from the valve element. The first protrusion and the second protrusion are preferably arranged in the circumference of the valve element at an angle of 90 degrees relative to each other. The second protrusion and the third protrusion are preferably arranged in the circumference of the valve element at an angle of 90 degrees relative to each other.

[0083] The handle may be a recess recessed into the valve element. The recess may be configured to have a square, triangle, circle, oval, rectangle, star, or any combination thereof.

[0084] In an embodiment, the valve housing further comprises a sterile filter element, the filter being arranged such that any overflow fluid discharged from the overflow recesses passes through the filter element.The filter element may be arranged at the first end and / or the second end of the housing.

[0085] In further embodiments, the filter covers the entire at least one outlet opening of each of the at least two overflow recesses.

[0086] In a further embodiment, the at least two overflow recesses are arranged in the housing and extend between the first end and the second end of the housing. The at least one outlet opening is arranged in the second end of the housing so that the overflow recesses lead into the second end of the housing, wherein the filter element is arranged inside the internal spacing at the second end of the housing. Thus the discharged fluid leaves the safety valve only at the second end of the housing, and thus all the discharged fluid passes through the sterile filter and is then discharged from the safety valve.

[0087] The filter further prevents any contaminated air from the environment surrounding the valve from entering the safety valve.

[0088] The filter element may have any suitable shape. The filter element may have the same shape as the internal spacing and is preferably circular.

[0089] The filter element may be formed of a material selected from the group consisting of: a porous polymer membrane, sintered particles or fibers made of a polymer, a metal or a ceramic; or a combination of such materials.

[0090] The filter element may have a pore size of 0.10 um to 100 um, preferably 0.2 um to 0.45 um.

[0091] The filter element may be a HEPA filter.

[0092] In a fourth aspect, the present invention relates to a safety valve according to the third aspect described above in a method for preparing H 215 O and inject it into the system of saline solution.

[0093] The system may be a system according to the second aspect as described below.

[0094] By providing a safety valve in such a system, if a system malfunction occurs, ie a malfunction that could result in undesirably high levels of fluid in the tubing connected to the patient, the safety valve will protect the patient from being harmed by the unwanted fluid.

[0095] In a second aspect, the present invention relates to a method for preparing and implanting H for use in positron emission tomography (PET). 2 15 O system, the system comprising: for producing H 2 15 O salt solution production device; for establishing a first bolus injection device for injection, the first bolus injection comprising the H 2 15 O salt solution and having a predefined volume and radioactivity concentration (mBq / m1), the bolus device comprising a valve; and a regulating device for regulating the injection curve of the first bolus amount.

[0096] As used herein, the term "oxygen-15 labeled water" is intended to encompass H 2 15 O, such as 015-H2O, O15-H 2 O, H 2 [ 15 O], H 2 O[ 15 O], and 15 OH 2 O.

[0097] By providing a method for preparing and injecting H 2 15 O's system, which can be arranged in close proximity to a PET-scanner, eliminates the need for manual manipulation of the radioisotope, thereby improving the safety of patients and medical staff.

[0098] Furthermore, since the system operates continuously, dose infusion can be performed precisely at the moment of interest. This enables time-critical studies such as brain activation studies and cardiac stress studies. The system supports a variety of different study protocols by offering different infusion bolus volumes.

[0099] According to the second aspect of the invention, the amount of radioactivity produced can be accurately determined (because H 2 15In some embodiments, the radioactivity is prepared in a predefined bolus volume and the injection curve is defined and adjusted, i.e., the injection rate in relation to time, which defines the amount of radioactivity injected during the injection phase. In some embodiments, the injection rate is constant throughout the injection phase. In this way, the radioactivity and the bolus volume are well defined.

[0100] In some embodiments, the injection rate varies throughout the injection phase.

[0101] As used herein, the term "bolus" refers to a specific volumetric amount.

[0102] As used herein, the term "injection curve" refers to a graph on an XY diagram, wherein the Y-axis represents the concentration of radioactivity [Bq / s] as a function of time, and the X-axis represents time [s].

[0103] In an embodiment, the system according to the second aspect comprises a processing unit.

[0104] Here and hereinafter, the term 'processing unit' is intended to include any circuit and / or device adapted to perform the functions described herein. Specifically, the above term includes a general or special programmable microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a programmable logic array (PLA), a field programmable gate array (FPGA), a dedicated electronic circuit, etc., or a combination thereof.

[0105] The processing unit can be connected to the production device and / or the bolus device and / or the regulating device and / or the entire system according to the second aspect and / or specific parts thereof.

[0106] In an embodiment, the valve is a safety valve according to the third aspect of the invention.

[0107] The system can be connected to a patient so that a bolus can be injected directly from the system into the patient. The bolus can be administered intravenously, intramuscularly, intrathecally, or subcutaneously.

[0108] Parts of the system may be arranged within or behind the radiation protection shield.

[0109] In an embodiment, the present invention relates to a production device for a system according to the second aspect, the production device comprising: 15 O and H 2 The gas mixture is converted into H 2 15 O conversion element; a valve control element for adjusting the flow rate of the gas mixture; a valve control element for converting H 2 15 O is combined with brine from the first brine feeder to produce H2 15 O salt solution merging device; for measuring the H 2 15 O saline solution, wherein the valve control element is regulated by the first radiation detector.

[0110] According to this embodiment, the 15 O and H 2 The gas mixture is fed to the production unit at a constant flow rate and pressure. The valve control element provided can adjust the gas converted into H 2 15 O gas mixture, and thereby adjust the H 2 15 H in O salt solution 2 15 The concentration of O.

[0111] The gas mixture may include a compressed or pressurized gas mixture.

[0112] The gas mixture is preferably converted into H in vapor form. 2 15 O.

[0113] The radiation detector may include a control element for comparing the measured radiation amount with a predefined radiation interval, said interval depending on the desired H in the salt solution. 2 15 O. This range can be determined based on the desired H 2 15 The amount of O is manually and / or automatically input, the desired amount may vary from patient to patient. The control component may be controlled by a processing unit.

[0114] In an embodiment, the conversion element comprises converting the gas mixture into H at an elevated temperature. 2 15 O's furnace.

[0115] The elevated temperature may be between 200°C and 1000°C, preferably approximately 800°C for non-catalyzed reactions, and approximately 300°C for Pd-catalyzed reactions.

[0116] In an embodiment, the valve control element comprises at least one valve for directing the flow of the gas mixture through the conversion element (thereby converting the gas mixture into H 2 15 O), or when it is not desired to produce any more H 2 15 O, the gas mixture flow bypasses the conversion element (so that the gas mixture will not be converted into H 215 O).

[0117] In further embodiments, the at least one valve is a two-way valve.

[0118] In further embodiments, the at least one valve is a safety valve according to the third aspect of the invention.

[0119] In further embodiments, the valve control element further comprises a third gas waste device.The at least one valve directs the gas mixture to the furnace, or bypasses the furnace and the gas is directed to the third gas waste device.

[0120] The third gas waste device may be a slow seepage gas waste device. Alternatively, the third gas waste device may be an external exhaust conduit dedicated to exhausting the gas mixture.

[0121] In an embodiment, the merging device comprises: for receiving H 2 15 O and a reservoir for the first saline solution; a second gas waste device for exhausting any excess gas from the reservoir; a third pump connected at one end to the reservoir and at another end to a decay line connected to a liquid waste device, wherein the third pump pumps excess liquid waste from the reservoir, through the decay line and into the liquid waste device.

[0122] By providing a combined unit that is not pressurized / operates at normal pressure, an additional safety feature is provided to ensure that no gas is dissolved in the radioactive water.

[0123] It should be noted that in the context of the present specification, the term "reservoir" is not limited to a specific reservoir, but may also be other containers with a predefined volume, such as a tank, a basin, a storage / storage element, a vessel, or a receptacle.

[0124] It should be noted that in the context of this specification, the term "slow seepage gas waste unit" refers to a system that allows the transfer of a gas containing a small amount of radioactive isotopes (such as 15 The excess gas of the radiation shield is delayed for an appropriate number of half-lives (preferably at least five half-lives) and then exhausted to the open space so that the residual radioactivity is reduced to an acceptable level. The slow seepage gas waste device will typically be located behind the radiation shield.

[0125] The second gas waste device may be a slow seepage gas waste device. Alternatively, the second gas waste device may be an external exhaust pipeline dedicated to exhausting excess radioactive gas. 15 O has a short half-life and the volume of gas involved is small, so when the gas is expelled, the radioactivity is almost zero.

[0126] Include 15 O and H 2 The gas mixture fed to the conversion element may contain small amounts of nitrogen oxides (NOx), which are reduced to ammonia (NH 3 ). Therefore, if there is ammonia accumulation, the H in the reservoir 2 15 The pH of the O salt solution will increase.

[0127] In an embodiment, the merging device further comprises: a first pump connected to the first saline feeder to provide the saline solution to the reservoir; and a pH measuring device connected to the recession line, wherein the first pump is regulated by the pH measuring device.

[0128] The amount of the first saline solution from the first saline feeder may be an adjustable amount.The amount of the first saline solution may be adjusted manually and / or automatically by a processing unit.

[0129] The first saline solution may be continuously pumped into the reservoir.

[0130] By providing a pH measuring device that can detect H 2 15 O salt solution changes in pH. If H 2 15 These changes may occur if large amounts of ammonia are present in the O salt solution.

[0131] To ensure that ammonia does not accumulate in the reservoir, the inflow of salt solution and the H 2 15 O salt solution outflow, so that ammonia is flushed out of the reservoir.

[0132] The ammonia content in the reservoir should be below 15 ppm, preferably below 10 ppm.The pH level in the reservoir should be from 4 to 10, preferably from 5 to 9, more preferably from 5.5 to 8.5.

[0133] Providing a relatively long decay line allows radioactive H 2 15 O reaches the waste bottle after decaying. Before reaching the waste bottle, the radioactive H 2 15 O will preferably be delayed by at least five half-lives.

[0134] The waste bottle may be placed outside of a radiation shield arranged around the system.A radiation detector may also be arranged adjacent to the decay line or waste bottle.

[0135] The pumping speed of P3 is greater than or equal to the pumping speed of P1 to ensure that H 215 The reservoir of the O salt solution does not overflow.

[0136] Any excess gas present in the reservoir is exhausted through a second gas waste device. The second gas waste device may be a slow permeation gas waste device.

[0137] In an embodiment, the present invention relates to a bolus device for use in a system according to the second aspect, wherein the bolus device comprises: 2 15 A reservoir for a H2O salt solution; a delivery tube for allowing the H 2 15 O salt solution circulates from the reservoir through the loop element and the regulating device and returns to the reservoir; a second pump for regulating the flow, wherein the regulating device includes a valve, the regulating device having a first configuration and a second configuration, wherein the second configuration of the regulating device establishes a first bolus amount of the H 2 15 O saline solution, the first bolus having a predefined volume and radioactivity concentration.

[0138] By providing a continuously circulating, readily available H 2 15 O saline solution, the system is ready at any point in time to create a first bolus for infusion into the patient, thus avoiding unnecessary waiting times.

[0139] The reservoir may include H produced according to an embodiment of the present invention. 2 15 O salt solution.

[0140] Furthermore, due to H 2 15 The H2O2 salt solution is continuously circulated in the delivery pipe from and to the reservoir at a high speed by a second pump, and the newly formed H 2 15 O is continuously mixed with the brine, so the available H 2 15 The O salt solution will maintain a roughly constant radioactivity concentration.

[0141] The speed of the second pump is preferably from 0.1 ml / min to 100 ml / min.

[0142] In an embodiment, the bolus device comprises a processing unit.

[0143] The regulating means may be controlled manually and / or automatically by the processing unit.

[0144] In an embodiment, the regulating means comprises at least two valves.

[0145] In an embodiment, the regulating means comprises a safety valve according to the third aspect of the invention.

[0146] In an embodiment, the at least two valves are arranged on either side of the loop element.One of the two valves may be connected to a patient line.

[0147] By using the safety valve according to the third aspect of the invention, no overflow liquid will enter the patient line, thereby ensuring a safer system.

[0148] In an embodiment, the loop element has an adjustable volume. The volume of the loop element can be adjusted manually and / or automatically by the processing unit. The volume of the loop element can also be adjusted by changing a part or parts of the loop element so that a different part or parts of the loop element are given a volume so that the loop element has another volume.

[0149] Thus, different bolus volumes and radioactivity concentrations may be readily provided for different patients and / or measurements, thereby eliminating the need for manual aspiration of the bolus by medical personnel.

[0150] In an embodiment, a first radiation detector is arranged adjacent to the loop element, the first radiation detector comprising a first detector unit and a second detector unit, wherein the first detector unit and the second detector unit measure the H present in the loop element. 2 15 O salt solution with a first radioactivity value and a second radioactivity value.

[0151] The first detector unit and the second detector unit are preferably arranged at different positions adjacent to the loop element, so that the detectors measure the H at different positions in the loop element. 2 15 O salt solution. The first radiation detector can be individually shielded to produce accurate radiation measurements.

[0152] In a first aspect, the invention relates to a regulating device for a system according to the second aspect, the regulating device comprising: a second saline feeder; a loop element comprising a first bolus amount of said H 2 15O saline solution; an injection device for collecting a predefined second bolus amount of saline from the second saline feeder and injecting the second bolus amount into the loop element at a predefined speed so that the second bolus amount pushes the first bolus amount into the patient line; a second radiation detector adjacent to the patient line, the radiation detector measuring an injection curve of the first bolus amount, wherein the injection speed and volume of the second bolus amount adjust the injection curve of the first bolus amount.

[0153] By providing the infusion device, the infusion curve for the first bolus amount infused into the patient line can be adjusted depending on individual requirements for different measurements.

[0154] In an embodiment, the regulating device according to the first aspect comprises a processing unit.

[0155] The predefined injection speed may be changed during the injection process. The speed preferably decreases during the injection process. The change in speed may be controlled manually or by the processing unit.

[0156] The predefined second bolus amount of saline may have a variable volume depending on different patients and measurements. The predefined second bolus amount may be collected manually and / or automatically by the infusion device. The automatic collection may be controlled by the processing unit.

[0157] In an embodiment, the injection device comprises a fourth valve. The fourth valve may be a safety valve according to the third aspect of the present invention.

[0158] The second saline feed may be connected to the fourth valve.

[0159] In an embodiment, the injection device comprises a collecting element. The collecting element may be connected to the fourth valve. The collecting element may be a medical syringe.

[0160] The second detector measures the radioactivity value of a specific portion of the patient line. This portion has a known length, size, and volume. Since the volume of this portion of the patient line is constant, the radioactivity is measured at short time intervals (1 to 10 measurements per second), and the injection rate is known, a curve (herein referred to as the injection curve) can be obtained in an XY coordinate system, which shows the amount of injection activity as a function of time.

[0161] The second radiation detector measures an infusion profile of the first bolus immediately before the first bolus is injected into the patient.

[0162] In a fifth aspect, the present invention relates to a method for preparing H for use in positron emission tomography. 2 15O method, the method comprising the steps of: at an elevated temperature 15 O and H 2 The gas mixture is converted into H 2 15 O; providing a valve control element to adjust the flow rate of the gas mixture; H 2 15 O is combined with brine from the first brine feeder to produce H 2 15 O salt solution; providing a first radiation detector to measure the H 2 15 O radioactivity in the salt solution; regulating the flow rate of the gas mixture through the first radiation detector; providing a reservoir to receive the H 2 15 O salt solution; providing a second gas waste device for exhausting any excess gas from the reservoir; providing a third pump connected at one end to the reservoir and at the other end to a decay line, the decay line being connected to a liquid waste device; using the third pump to pump any excess liquid waste from the reservoir through the decay line and into the liquid waste device; providing a delivery pipe and a second pump to allow the H 2 15 O salt solution circulates from the reservoir through the loop element and returns to the reservoir; providing a regulating device; establishing a first bolus amount of the H 2 15 O saline solution, the first bolus having a predefined volume and radioactivity concentration; providing a second saline feeder; collecting a predefined second bolus of saline from the second saline feeder; injecting the second bolus into the loop element at a predefined rate so that the second bolus pushes the first bolus into the patient line; measuring an injection curve value of the first bolus with a second radiation detector adjacent to the patient line, thereby adjusting the injection curve of the first bolus by the injection rate and volume of the second bolus.

[0163] In an embodiment of the fifth aspect, the regulating device comprises a safety valve according to the third aspect of the invention.

[0164] The generation of systems for preparing and injecting radioisotopes into patients presents a number of challenges. Safety requirements for such systems that may be connected to patients are extremely high to ensure the safety of the patient and medical staff. By providing a system according to the second aspect, different parts of the system help ensure a higher safety standard than was previously possible.

[0165] The safety valve according to the third aspect is particularly useful in the system according to the second aspect, as it will prevent overflow fluid from moving forward in the system and eventually entering the patient. Excess gas in particular is a very high risk factor, which can be easily eliminated by implementing the safety valve according to the third aspect.

[0166] Different aspects of the present invention may be implemented in different ways, each of which produces one or more benefits and advantages described in combination with at least one of the aspects described above, and each has one or more preferred embodiments, including embodiments described in combination with at least one aspect disclosed above and / or in the dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0167] The above and / or additional objects, features, and advantages of the present invention will be further described by the following illustrative and non-limiting detailed description of embodiments of the present invention with reference to the accompanying drawings, in which:

[0168] Figure 1 A method for preparing and implanting H for use in positron emission tomography according to a second aspect of the present invention is shown. 2 15 Schematic diagram of the system of O.

[0169] Figure 2 is a flow chart illustrating the interaction between the bolus device and the infusion device.

[0170] Figure 3A and Figure 3B An embodiment and a first aspect according to the invention are shown.

[0171] Figure 4A and Figure 4B Different injection profiles for the first bolus are shown.

[0172] Figure 5 A perspective view showing an embodiment of a safety valve according to a second aspect of the present invention.

[0173] Figure 6 Shows Figure 5 A perspective view of the safety valve is shown in the assembled configuration.

[0174] Fig. 7A , Figure 7B ,and Figure 7C Cross-sectional views of the assembled safety valve are shown in a first assembled configuration, a second assembled configuration, and a third assembled configuration.

[0175] Figure 8 A perspective view of an embodiment of a valve according to a third aspect of the invention is shown.

[0176] Fig. 9 Shows Figure 8 A cross-sectional view of the safety valve is shown in the assembled position. DETAILED DESCRIPTION

[0177] In the following description, reference is made to the accompanying drawings which show, by way of illustration, how the invention may be practiced. It should be noted that for illustration purposes, in particular the dimensions of the distances between the various elements shown are not real.

[0178] It should be understood that the terms "safety valve" and "valve" are both used in the context of the present invention to describe the safety valve according to the third aspect of the present invention.

[0179] Figure 1 A method for preparing a sterile injectable form of H 200 for performing a PET scan embodying the present invention is shown. 2 15 Schematic diagram of System 1 of O.

[0180] The system 1 comprises a processing unit for controlling the various parts of the system. If desired, the processing unit can be manually overwritten.

[0181] Here and hereinafter, the term 'processing unit' is intended to include any circuit and / or device adapted to perform the functions described herein. Specifically, the above term includes a general or special programmable microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a programmable logic array (PLA), a field programmable gate array (FPGA), a dedicated electronic circuit, etc., or a combination thereof.

[0182] Radioactivity is typically generated in a cyclotron in the cyclotron arch 500 by irradiating a flowing gas target of nitrogen and oxygen. 15 O gas. Released from the cyclotron target chamber 501 15 The amount of O gas is controlled by a mass flow controller (MFC) (not shown) located in connection with the target chamber 501. The MFC is preset to control the gas within a specific flow rate range.

[0183] The MFC is equipped with a closed loop control system which takes an input signal from the system operator or a processing unit, compares the input signal with the value from the mass flow sensor, and adjusts the proportional valve accordingly to achieve the desired flow rate.

[0184] Then 15 The O gas passes through the NOx trap 502, where most of the nitrogen oxides formed by the reaction between nitrogen and oxygen in the target chamber 501, such as NO, N 2 O and / or NO 2It is desirable to remove the nitrogen oxides at this point, since they may subsequently be converted to unwanted ammonia (NH 3 ).

[0185] The gas is then mixed with hydrogen (H 2 ) to form H 2 and 15 O gas mixture 221. With 15 O gas mixed with H 2 The amount of gas is controlled by another MFC (not shown) located after the hydrogen tank 503.

[0186] The gas mixture 221 is then directed through a tube 504 extending from the cyclotron arch bank 500 and into a PET scanning room 505, in which a PET scanner (not shown), a patient 521, and the invention according to the second aspect are arranged. To avoid high pressures that could lead to unstable flow rates, the tube 504 is equipped with a pressure relief valve (not shown).

[0187] The gas mixture 221 then passes through a first sterile filter 506 to remove any unwanted particulate and microbial impurities, thereby ensuring that the system remains sterile.

[0188] After the first sterile filter 506, a pressure sensor 507 and a pressure relief valve 508 are connected to the gas delivery tube 504. The pressure sensor 507 continuously measures the pressure in the tube 504. If the pressure exceeds a predetermined safety level, the valve 508 directs the gas mixture 221 to the first gas waste device 509.

[0189] The gas mixture 221 is then directed to the pipe node 510. The valve control element 250 controls the manner in which the gas mixture 221 is directed from the pipe node 510. The valve control element 250 includes a second valve 251 and a third valve 252.

[0190] When the second valve 251 is open, the gas 221 is directed through the conversion element 220. The conversion element 220 is a furnace 220 in which the gas mixture 221 is converted into H 2 15 If the second valve 251 is closed and the third valve 252 is open, the gas mixture 221 will bypass the furnace 220 and the gas mixture 221 will not be converted into H 2 15 O. This is when it is not expected to produce any more H 2 15 It is realized at O.

[0191] The gas mixture 221 from the third valve 252 and / or the H from the second valve 2512 15 O is then directed into the reservoir 281. A first pump 292 connected to the first saline feeder 290 continuously pumps the first saline stream 291 into the reservoir 281. Thus, H 2 15 O and brine are combined in reservoir 281 to form H 2 15 O salt solution.

[0192] The first radiation detector 240 is positioned elsewhere in the system. The first radiation detector 240 measures the H 2 15 The signal from the first radiation detector 240 is used as an input in a closed loop regulation algorithm, such as PID or fuzzy logic executed on a processing unit. The output from the processing unit regulates the valve control element 250 and thus determines how much H is produced. 2 15 O.

[0193] The second gas waste device 282 is connected to the reservoir 281. The second gas waste device 282 exhausts the gas from the reservoir 281, thereby ensuring that no gas is dissolved in the H 2 15 O salt solution.

[0194] The third pump 283 is connected to the reservoir 281 at one end and to the decay line 284 at the other end. The decay line 284 is further connected to the liquid waste device 285. The third pump 283 continuously pumps excess liquid waste from the reservoir 281 through the decay line 284 and into the liquid waste device 285.

[0195] The reservoir 281 is also connected to the delivery tube 301 so that H from the reservoir 281 2 15 O salt solution circulates and returns to the reservoir 281. 2 15 The O salt solution is pumped from the reservoir 281 into the delivery pipe 301 , and into the regulating device 340 and the loop element 320 by the second pump 302 .

[0196] The regulating device 320 includes a fifth valve 422 and a sixth valve 423. These valves 422 and 423 are as follows. Figure 5 7 . Valves 422 , 423 are arranged on each side of the loop element 320 . A fifth valve 424 is further connected to the infusion device 420 , and a sixth valve 425 is further connected to the patient line 520 .

[0197] The fifth valve 424 is arranged in a first configuration of at least two different configurations such that H2 15 The H salt solution flow passes through the fifth valve 424 and is directed into the loop, and the injection device 420 is isolated from the rest of the system. If the fifth valve 424 is arranged in the second configuration, then H 2 15 The O salt solution will not be able to pass through the fifth valve 424 , which disconnects the connection between the loop 320 and the injection device 420 .

[0198] The sixth valve 425 is arranged in a first configuration of at least two different configurations such that H 2 15 The H salt solution passes through the sixth valve 425 and is further directed into the delivery pipe 301 and returned to the reservoir 281. If the sixth valve 425 is arranged in the second configuration, the H 2 15 O saline solution will be directed to the patient line 520, and the H 2 15 The portion of the O salt solution that is transported back to the reservoir 281 is isolated from the sixth valve 425 .

[0199] The first radiation detector 240 is arranged adjacent to the loop element 320. The first radiation detector 240 includes a first detector unit and a second detector unit (not shown), wherein the first detector unit and the second detector unit measure the H present in the loop element 320. 2 15 O salt solution with a first radioactivity value and a second radioactivity value.

[0200] If the first activity value and the second activity value differ from a user preset threshold level by more than 20%, preferably 15%, more preferably 10%, the processing unit will prevent the injection from occurring.

[0201] When the fifth valve 422 and the sixth valve 423 are arranged in the second configuration, the fifth valve 424, the sixth valve 425, and the loop element 320 establish the H of the first bolus amount. 2 15 O saline solution. The first bolus has a predefined volume and radioactivity concentration.

[0202] The injection device 420 includes a fourth valve 422 and a collecting element 423. The collecting element 420 is a medical syringe 420. The fourth valve 422 is Figures 5 to 8 The medical syringe 420 can be controlled manually, and / or automatically by the processing unit. The second saline feeder 401 is connected to a fourth valve 423.

[0203] The fourth valve 423 is arranged in a first configuration of at least two different configurations so that the connection between the medical syringe 422 and the fifth valve 424 is disconnected. If the fourth valve 423 is arranged in a second configuration, the connection between the medical syringe 422 and the second saline feeder 401 will be disconnected.

[0204] When the fourth valve 423 is in the second configuration, the medical syringe 422 may collect a predefined second bolus amount of saline from the second saline feeder 401 .

[0205] The patient line 520 connected to the sixth valve 425 is also connected to a bubble detector 522 , a check valve 523 , a second sterile filter 524 , and a patient 521 .

[0206] The bubble detector 522 detects whether there are any unwanted bubbles in the first bolus amount and / or the second bolus amount. In the unwanted event that bubbles are detected, the processing unit connected to the bubble detector 522 stops the infusion to the patient.

[0207] The check valve 523 is a one-way valve. The valve 523 ensures that the first bolus amount and / or the second bolus amount that have passed through the valve 523 cannot pass back into the system. Likewise, any fluid from the patient 521 cannot cross the check valve 523 and pass back into the system.

[0208] The second sterile filter 524 removes any unwanted particulate and microbial impurities that may remain, thereby ensuring that the first bolus amount and / or the second bolus amount are sterile before entering the patient 521.

[0209] A second radiation detector 440 arranged adjacent to the patient line measures the infusion profile of the first bolus amount.

[0210] Patient 521 may be placed in a scanner, such as a positron emission tomography (PET) scanner (not shown), where the distribution of the radioisotope within patient 521 may be monitored before, during, and after injection of the first bolus amount.

[0211] Figure 2 The present invention is a demonstration of the interaction of a bolus device with an infusion device to provide an infusible H having a predefined volume and radioactivity concentration. 2 15 Flow chart of O salt solution.

[0212] In section A, a second pump 302 connected to the delivery pipe 301 regulates H 2 15 O salt solution flow rate so that the H 2 15O salt solution is continuously pumped from reservoir 281 through delivery tube 301, loop element 320, and regulating device 340, thereby providing readily available H in loop element 320 at any given time. 2 15 O salt solution.

[0213] The regulating device 340 comprises a fifth valve 424 and a sixth valve 425 arranged on respective sides of the loop element 320 in a first configuration.

[0214] The first radiation detector 240 is arranged adjacent to the loop element 320. The first radiation detector 240 includes a first detector unit and a second detector unit, which measure the H present in the loop element 320. 2 15 O salt solution with a first radioactivity value and a second radioactivity value.

[0215] When the activity in loop element 320 reaches a desired level, which level may vary between different measurements and between different patients, section B begins automatically or manually.

[0216] In part B, the fifth valve 424 and the sixth valve 425 are changed from the first configuration to the second configuration so that the loop element 320 is not connected to the delivery pipe 301 and the system generates H. 2 15 O saline solution. In addition, patient 521 is also isolated from the rest of the system.

[0217] The fifth valve 424 and the sixth valve 425 can change configuration simultaneously or individually. The second configuration of the fifth valve 424 and the sixth valve 425 establishes the H of the first bolus amount. 2 15 O salt solution, the first bolus amount is the H present in the loop element 320 2 15 O saline solution. The first bolus thus has a predefined volume and activity concentration, which is measured by the first detector unit and the second detector unit.

[0218] The loop element 320 has an adjustable volume that can be varied from patient to patient and from measurement to measurement.

[0219] In the second configuration, the sixth valve 425 is connected to the patient line 520 , and the fifth valve 424 is connected to the fourth valve 422 .

[0220] In part C, the fourth valve 422 is connected to the second saline feed 401 and the collecting element 423. When the fourth valve 422 is in the first configuration, the connection between the collecting element 423 and the fifth valve 424 is disconnected.

[0221] The fourth valve 422 is switched to the second configuration, and the connection between the collecting element 423 and the second saline feeder 401 is disconnected.

[0222] In part D, the collecting element 423 draws the desired amount of saline from the second saline feed 401, thus creating a second bolus of saline. The second bolus of saline is preferably 5 ml to 150 ml, more preferably 10 ml to 100 ml.

[0223] In part E, the fourth valve 422 is switched to the first configuration, thereby establishing a connection between the collection element 423 comprising the second bolus amount of saline and the fifth valve 424 .

[0224] In section F, fourth valve 422 , fifth valve 424 , and sixth valve 425 are arranged in the first configuration. Collection element 423 injects a second bolus of saline into loop element 320 .

[0225] In section G, the velocity of the second bolus will be present at the H of the first bolus in loop element 320. 2 15 O saline solution and the second bolus itself are pushed into patient line 520 and ultimately into patient 521. The injection rate and amount of saline adjusts the injection profile of the second bolus into patient 521.

[0226] A second radiation detector 440 adjacent to the patient line 520 measures an infusion profile of the first bolus amount.

[0227] In the above Figure 2 All parts from A to G in the description of can be started and executed manually and / or automatically by the processing unit. The start of a part also depends on the termination of another part.

[0228] Figure 2 An arrangement of the various parts is shown as an example. Parts C and D (where the second bolus of saline is established) can also be placed in part B (where the first bolus of saline is established). 2 15 O salt solution) before.

[0229] Figure 3A and Figure 3B A further embodiment according to the first aspect of the invention is presented.

[0230] The storage 281 includes H 215 O salt solution. The second pump 302 pumps H 2 15 O salt solution is continuously pumped from reservoir 281 into delivery tube 301 , through regulating device 340 and loop element 320 , and back into reservoir 281 .

[0231] The regulating device 340 comprises a plurality of safety valves according to the third aspect of the present invention. Figure 3A and Figure 3B In FIG. 1 , the plurality of valves are represented as 7 valves.

[0232] exist Figure 3A In the embodiment, the adjustment device 340 is in a first configuration, in which H 2 15 O saline solution is pumped through loop element 320. Infusion device 420 is also in the first configuration in which a second bolus of saline is established.

[0233] exist Figure 3B , the regulating device 340 is in a second configuration in which a second bolus amount is established and the connection from the loop element 320 to the patient line 520 is disconnected. The injection device 420 is also in a second configuration in which a second bolus amount of saline can be injected into the loop element 320, and the first bolus amount and the second bolus amount can enter the patient line 520.

[0234] Figure 4A A and B show different injection profiles of the first bolus.

[0235] When adjusting the infusion profile of the first bolus (also referred to as bolus modulation), there are two external parameters that can be used to influence the infusion profile, namely the infusion rate and the bolus volume.

[0236] According to the present invention, the volume of the first bolus is determined by the volume of loop element 320. The volume of loop element 320 may vary depending on the bolus volume desired for a particular patient or measurement.

[0237] According to the present invention, the injection rate is determined by the injection device 420. The injection rate may vary depending on the rate desired for a particular patient or measurement.

[0238] These parameters can be changed both manually and automatically.

[0239] Further, the radioactivity is measured by a second radiation detector (not shown). Accurate measurements can only be made in a specific measurement window where the radioactivity level is within a certain range. This range, and therefore the measurement window, may vary with the different types of measurements performed.

[0240] Most commonly, the injection is performed at a uniform injection rate, resulting in Figure 4A The injection curve is shown.

[0241] The uniform injection rate results in an injection curve with a steep peak. The steep peak limits the time period during which the activity level is within the measurement window and thus limits the period during which the second radiation detector can measure activity according to the first injection curve.

[0242] On the contrary, if the injection is started at a slightly higher injection rate (which is then reduced during the injection process), then Figure 4B The injection profile shown is more evenly distributed in the region of interest, thereby providing an injection profile where the activity level persists for a longer period of time within the measurement window than an injection profile injected at a uniform rate as shown in FIG. 4a.

[0243] As the activity levels persist for a longer period of time within the desired measurement window, for example, it is possible to have a longer time period over which the PET scanner can accumulate data.

[0244] Further, the ability to modulate the injection curve is very useful during examinations related to cardiac studies, where the injection bolus should be neither too steep nor too wide relative to the patient's pulse. A too steep curve will result in too few data points available in the available window. A too wide curve will result in the inability to determine parameters necessary for cardiac studies, such as different centroid times.

[0245] exist Figure 5 , the valve 100 is shown before being assembled into the assembled valve 100. The valve comprises a valve element 120, a valve housing 150 and three overflow recesses 180A, B, C.

[0246] The valve element 120 includes a first end 122 and a second end 123. The first end 122 and the second end 123 define a first longitudinal axis 124. The valve element 120 is cylindrical. A flow passage 121 extends through the valve element 120 substantially perpendicular to the first longitudinal axis 124.

[0247] The valve housing 150 is cylindrical and includes a cylindrical housing 156. The housing 156 includes a first end 157, a second end 158, and a second longitudinal axis 159 extending between the first end and the second end. When the valve is in an assembled configuration, the second longitudinal axis 159 is coaxial with the first longitudinal axis 124 of the valve element 120.

[0248] The valve housing 150 also includes an internal space 165 enclosed by the housing 156, and includes first, second, and third valve openings 151A, B, C. Each valve opening 151A, B, C allows fluid to flow into or out of the housing 156. The valve openings 151A, B, C are equidistantly distributed at an angle of approximately 120 degrees from each other along the circumferential direction 160 of the housing.

[0249] The valve element 120 is axially movable along the second longitudinal axis 159 such that the second end and a portion of the valve element 120 may be inserted into the interior space 165 of the valve housing 150 to form the assembled valve 100 .

[0250] The valve element 120 includes a handle for rotating the valve element 120 inside the valve housing 150 at the first end. The handle includes a first protrusion, a second protrusion, and a third protrusion 125A, B, C arranged in the outer circumference 126 of the valve element 120, and these protrusions 125A, B, C extend radially from the valve element 120. The first protrusion and the second protrusion 125A, B are arranged to be at a 90 degree angle relative to each other. The second protrusion and the third protrusion 125B, C are arranged to be at a 90 degree angle relative to each other. The first protrusion and the third protrusion 125A, C are arranged to be at a 180 degree angle relative to each other. These protrusions 125A, B, C have a rectangular shape.

[0251] The valve housing 150 comprises a first hollow connecting element, a second hollow connecting element, and a third hollow connecting element 152A, B, C. The connecting elements 152A, B, C each have: a first end 153A, B, C; a second end 154A, B, C; and an internal fluid space 155A, B, C. The connecting elements 152A, B, C are connected to the valve housing 150 at the second end 154A, B, C, so that the fluid space 155A, B, C is in fluid contact with the three valve openings 151A, B, C.

[0252] Three linear overflow recesses 180A, B, C are arranged in the valve housing 150, more precisely, these overflow recesses 180A, B, C are arranged in the housing 156. Each overflow recess 180A, B, C extends axially between the first end 157 and the second end 158 of the housing 156. Each overflow recess 180A, B, C has a first outlet opening and a second outlet opening 181A, B. The overflow recesses 180A, B, C are equidistantly distributed at an angle of approximately 120 degrees to each other along the circumferential direction 160 of the housing.

[0253] Figure 6 A perspective view of the assembled valve 100 is shown.

[0254] The valve element 120 is arranged inside the inner spacing 165. The valve element 120 is rotatable about the second longitudinal axis 159 within the inner spacing 165 so that the valve element 120 and the valve housing 150 can be changed between at least three different open configurations 100A, B, C, namely Fig. 7A , Figure 7B ,and Figure 7C Shown are a first open configuration, a second open configuration, and a third open configuration.

[0255] The valve housing 150 includes a circular bottom plate 162. The bottom plate 162 is connected to the second end 158 of the housing 156, extending across the entire second end 158, such that the bottom plate 162 closes the internal space 165 at the second end 158.

[0256] The three outlet openings 181B of the overflow recesses 180A, B, C are arranged in the bottom plate 162 so that excess fluid can be discharged through the overflow recesses 180A, B, C through the bottom plate 162 .

[0257] Fig. 7A , Figure 7B and Figure 7C Cross-sectional views of the assembled valve are shown in a first assembled configuration, a second assembled configuration, and a third assembled configuration.

[0258] exist Fig. 7A -C, the first connecting element, the second connecting element, and the third connecting element 152A, B, C are connected to the first valve opening, the second valve opening, and the third valve opening 151A, B, C.

[0259] The valve element 120 and the valve housing are in contact with each other in three contact areas 101A, B, C. More specifically, the outer circumference 126 of the valve element 120 is adjacent to the inner circumference 161 of the outer shell 156 of the valve housing 156 in these three contact areas 101A, B, C. Each of these contact areas 101A, B, C forms a fluid stop 103.

[0260] Each overflow recess 180A, B, C is arranged between the valve element 120 and the valve housing 150. These overflow recesses 180A, B, C are not in fluid communication with the flow channel 121.

[0261] The first overflow recess 180A is positioned to create an interruption of the first contact area 101 A. The second overflow recess 180B is positioned to create an interruption of the second contact area 101 B. The third overflow recess 180C is positioned to create an interruption of the third contact area 101C.

[0262] Each overflow recess 180A, B, C establishes an interruption of the contact area 101A, B, C, so that each overflow recess 180A, B, C establishes a safe release port for discharging overflow fluid, which passes through the fluid stopper 103 through the corresponding outlet opening 181A, B (not shown) in the event of overpressure.

[0263] exist Fig. 7A , the assembled valve 100 is shown in a first assembled open configuration. The first and second valve openings 151A, B are connected via the flow channel 121 . The third valve opening 151C is not connected to the flow channel 121 .

[0264] The first assembled open configuration 100A has a flow path 102 through the first and second connecting elements 152A,B, the flow passage 121 , and the first and second valve openings 151A,B.

[0265] The second and third contact areas 101B, C each form a fluid stopper 103 that prevents fluid from flowing into the third valve opening 151C that is not connected to the flow channel 121. If any fluid passes through the fluid stopper 103 in the second contact area 101B, the fluid will be discharged through the second overflow recess 180B. If any fluid passes through the fluid stopper 103 in the third contact area 101C, the fluid will be discharged through the third overflow recess 180C.

[0266] exist Figure 7B , the assembled valve 100 is shown in a second assembled open configuration. The second and third valve openings 151B, C are connected via the flow channel 121. The first valve opening 151A is not connected to the flow channel 121.

[0267] The second assembled open configuration 100B has a flow path 102 through the second and third connecting elements 152B,C, the flow passage 121 , and the second and third valve openings 151B,C.

[0268] The first and third contact areas 101A, B each form a fluid stopper 103 that prevents fluid from flowing into the first valve opening 151A that is not connected to the flow channel 121. If any fluid passes through the first stopper 103 in the first contact area 101C, the fluid will be discharged through the first overflow recess 180C. If any fluid passes through the fluid stopper 103 in the second contact area 101B, the fluid will be discharged through the second overflow recess 180B.

[0269] exist Figure 7C, the assembled valve 100 is shown in a third assembled open configuration. The first and third valve openings 151A, C are connected via the flow channel 121 . The second valve opening 151B is not connected to the flow channel 121 .

[0270] The third assembled open configuration 100C has a flow path 102 through the first and third connecting elements 152A,C, the flow passage 121 , and the first and third valve openings 151A,C.

[0271] The first and second contact areas 101A, B each form a fluid stopper 103 that prevents fluid from flowing into the first valve opening 151A that is not connected to the flow channel 121. If any fluid passes through the first stopper 103 in the first contact area 101C, the fluid will be discharged through the first overflow recess 180C. If any fluid passes through the fluid stopper 103 in the second contact area 101B, the fluid will be discharged through the second overflow recess 180B.

[0272] exist Fig. 7A and Figure 7C , a plane P is shown. The valve openings 151A, B, C and the flow path 121 are arranged in the same plane P and extend along said plane P.

[0273] When the valve is in the assembled configuration, the plane P is substantially perpendicular to the first axis 124 and the second axis 159 ( Figure 5 shown).

[0274] exist Figure 8 and Fig. 9 , an embodiment of a safety valve according to the third aspect of the present invention is shown in an unassembled position and an assembled position, respectively. This embodiment corresponds to Figure 5 7, the difference being that:

[0275] The valve element 120 has three flow passages 121A, B, C, each of which extends through the valve element 120 .

[0276] The valve housing 150 has six valve openings 151A, B, C, D, E, F. Each valve opening 151A, B, C, D, E, F allows fluid to flow into or out of the housing 156. The valve openings 151A, B, C, D, E, F are equidistantly distributed at an angle of approximately 60 degrees to each other along the circumferential direction 160 of the housing. The valve housing 150 has six hollow connecting elements 152A, B, C, D, E, F.

[0277] The valve comprises six overflow recesses 180A, B, C, D, E, F. The overflow recesses are equidistantly distributed at an angle of approximately 60 degrees to one another along the circumferential direction 160 of the housing.

[0278] The assembled valve 100 can be changed between six different opening configurations 100A, B, C, wherein: in one opening configuration, three flow paths 102A, B, C are defined through three flow channels 121A, B, C and three groups of valve openings; and in another configuration in the opening configuration, three different flow paths 102D, E, F are defined through the three flow channels 121A, B, C and three different groups of valve openings; and in a third configuration in the opening configuration, three different flow paths 102G, H, I are defined through the flow channels 121A, B, C and three different groups of valve openings.

[0279] The following items are embodiments of the present invention:

[0280] 1. A method for controlling H used in positron emission tomography 2 15 A valve 100 for controlling a flow rate of O, the valve 100 comprising:

[0281] a valve element 120 having a flow passage 121 extending through the valve element 120,

[0282] a valve housing 150 having at least three valve openings 151A, B, C, each valve opening 151A, B, C allowing fluid to flow into or out of the valve 100, and

[0283] at least two overflow recesses, each overflow recess having at least one outlet opening,

[0284] Wherein the valve element 120 and the valve housing 150 can be connected to form the assembled valve 100, the valve element 120 and the valve housing 150 are in contact with each other in a contact area,

[0285] wherein the assembled valve 100 can be arranged into at least two different configurations, one of the configurations defining a flow path through the flow channel 121 and a set of the valve openings, and another of the configurations defining a flow path through the flow channel 121 and another different set of the valve openings, and

[0286] Wherein in each of the at least two configurations:

[0287] - each overflow recess is arranged between the valve element 120 and the valve housing 150,

[0288] at least two of the valve openings are connected via the flow channel 121 ,

[0289] at least one of the valve openings is not connected to the flow channel 121 ,

[0290] the contact area forms a fluid stop for preventing the fluid from flowing into the at least one valve opening which is not connected to the flow channel 121,

[0291] - the overflow recesses are not in fluid communication with the flow channel 121,

[0292] -Each overflow recess is positioned to establish an interruption in the contact area so that these overflow recesses establish a safe release port for discharging the overflow fluid, which in the event of overpressure passes through the fluid block via the corresponding outlet opening, thereby preventing the overflow fluid from entering the at least one valve opening that is not connected to the flow channel 121 in the at least two configurations.

[0293] 2. A valve 100 according to item 1, wherein the valve housing 150 further comprises a connecting element having a first end and a second end and an internal fluid space, the connecting element being connected to the valve housing 150 at the second end so that the fluid space is in fluid contact with one of the at least three valve openings 151A, B, C.

[0294] 3. The valve 100 according to item 1 or 2, wherein the at least two overflow recesses are arranged in the valve housing 150 and / or in the valve element 120.

[0295] 4. The valve 100 according to any one of the preceding items, wherein

[0296] The valve element 120 also includes a first end and a second end defining a first longitudinal axis, and

[0297] The valve housing 150 also includes:

[0298] - a housing comprising a first end and a second end and a second longitudinal axis extending between the first end and the second end, the second longitudinal axis being coaxial with the first longitudinal axis,

[0299] an internal space for receiving the valve element 120, said internal space being closed by the housing, and

[0300] - the at least three valve openings 151A, B, C arranged in the housing, each opening allowing fluid to flow into or out of the inner space,

[0301] wherein the at least two overflow recesses extend axially between the first end and the second end of the housing,

[0302] wherein the valve element 120 is axially movable along the second longitudinal axis so that a portion of the valve element 120 can be inserted into the internal spacing of the valve housing 150 to form an assembled configuration, and the valve element 120 is rotatable within the internal spacing about the second longitudinal axis so that the valve element 120 and the valve housing 150 can be changed between the at least two different configurations,

[0303] When the valve element 120 is arranged inside the inner distance and in the two different configurations, each overflow recess is arranged between the valve element 120 and the housing.

[0304] 5. The valve 100 according to any of the preceding items, wherein the valve housing 150 comprises three valve openings 151A, B, C, and / or the valve comprises three overflow recesses, and / or the valve element 120 comprises a flow channel 121 .

[0305] 6. A valve 100 according to any one of the preceding items, wherein the at least two overflow recesses are arranged in the housing, and / or the at least two overflow recesses extend between the first end and the second end of the housing and open into the first end and / or the second end, and / or the at least two overflow recesses extend between the first end and the second end of the valve element 120 and open into the first end and / or the second end.

[0306] 7. A valve 100 according to any one of the preceding items, wherein the housing is cylindrical, and / or the valve element 120 is cylindrical, and / or the valve openings are equidistantly distributed around the circumference of the housing, and the valve openings are preferably distributed at an angle of approximately 120 degrees to each other in the circumferential direction.

[0307] 8. A method for preparing and injecting H for use in positron emission tomography 2 15 O system, the system comprising:

[0308] -For the production of H 2 15 O salt solution production plant,

[0309] - a bolus amount means for establishing a first bolus amount for injection, said first bolus amount comprising said H 2 15 O salt solution and having a predefined volume and radioactivity concentration, the bolus device comprises a valve 100, and

[0310] - Adjustment means for adjusting the injection curve of the first bolus amount.

[0311] 9. A production device for the system according to item 8, the production device comprising:

[0312] - At elevated temperatures will contain 15 O and H 2 The gas mixture 221 is converted into H 2 15 O transformation element,

[0313] - a valve control element 250 for regulating the flow of the gas mixture 221,

[0314] - Used to convert H 2 15 O is combined with brine from the first brine feeder to produce H 2 15 O salt solution merging device,

[0315] - used to measure the H 2 15 O first radiation detector 240 for radioactivity in saline solution,

[0316] The valve control element 250 is regulated by the first radiation detector 240 .

[0317] 10. The production device according to item 9, wherein the merging device comprises:

[0318] - For receiving H 2 15 O and a reservoir 281 of the first saline solution,

[0319] - a second gas waste device for discharging any excess gas from said reservoir 281,

[0320] a third pump connected at one end to the reservoir 281 and at the other end to a decay line connected to a liquid waste device,

[0321] wherein the third pump pumps excess liquid waste from the reservoir 281 through the decay line and into the liquid waste device,

[0322] And / or the merging device further comprises:

[0323] a first pump connected to the first saline feeder to provide the reservoir 281 with the saline solution, and

[0324] - a pH measuring device connected to the decay line,

[0325] Wherein the first pump is regulated by the pH measuring device.

[0326] 11. A bolus device for use in a system according to item 8, wherein the bolus device comprises:

[0327] -Contains H 2 15 O salt solution reservoir 281,

[0328] - A delivery pipe 301, which is used to make the H 2 15 O salt solution circulates from the reservoir 281 through the loop element 320 and the regulating device 340 and returns to the reservoir 281,

[0329] - a second pump 302 for regulating said flow rate,

[0330] The regulating device 340 includes a valve, and the regulating device 340 has a first configuration and a second configuration, wherein the second configuration of the regulating device 340 establishes the H of the first bolus amount. 2 15 O saline solution, the first bolus having a predefined volume and radioactivity concentration.

[0331] 12. The bolus device according to item 11, wherein the valve is a valve according to any one of items 1 to 5, and / or

[0332] The loop element 320 has an adjustable volume, and / or

[0333] The first radiation detector 240 is arranged adjacent to the loop element 320, and the first radiation detector 240 includes a first detector unit and a second detector unit, wherein the first detector unit and the second detector unit measure the H present in the loop element 320. 2 15 O salt solution with a first radioactivity value and a second radioactivity value.

[0334] 13. A regulating device for the system according to item 8, the regulating device comprising:

[0335] - a second brine feeder 401,

[0336] - a loop element 320, which includes the H of the first bolus amount 2 15 O salt solution,

[0337] an injection device 420 for collecting a predefined second bolus amount of saline from the second saline feeder 401 and injecting the second bolus amount into the loop element 320 at a predefined rate so that the second bolus amount pushes the first bolus amount into the patient line 520,

[0338] a second radiation detector 440 adjacent to the patient line 520, said radiation detector measuring an infusion profile of said first bolus amount,

[0339] The injection speed and volume of the second bolus adjust the injection curve of the first bolus.

[0340] 14. A method for preparing H for use in positron emission tomography 2 15 O method, the method comprising the following steps:

[0341] - At elevated temperatures will contain 15 O and H 2 The gas mixture 221 is converted into H 2 15 Oh,

[0342] - providing a valve control element 250 to adjust the flow rate of the gas mixture 221,

[0343] -H 2 15 O is combined with brine from the first brine feeder to produce H 2 15 O salt solution,

[0344] - A first radiation detector 240 is provided to measure the H 2 15 O radioactivity in saline solution,

[0345] - regulating the flow rate of the gas mixture 221 by means of the first radiation detector 240,

[0346] - A storage 281 is provided to receive the H 2 15 O salt solution,

[0347] - providing a second gas waste means for discharging any excess gas from said reservoir 281,

[0348] - providing a third pump connected at one end to the reservoir 281 and at the other end to a decay line connected to a liquid waste device,

[0349] - pumping any excess liquid waste from the reservoir 281 through the decay line and into the liquid waste device with the third pump,

[0350] - Provide a delivery pipe 301 and a second pump 302 to allow the H 2 15 O salt solution circulates from the reservoir 281 through the loop element 320 and returns to the reservoir 281,

[0351] - providing a regulating device 340,

[0352] - Establishing the first bolus amount of H in the loop element 320 2 15 O saline solution, the first bolus having a predefined volume and radioactivity concentration,

[0353] - providing a second brine feeder 401,

[0354] - collecting a predefined second bolus amount of saline from said second saline feeder 401,

[0355] - injecting the second bolus amount into the loop element 320 at a predefined rate so that the second bolus amount pushes the first bolus amount into the patient line 520,

[0356] - measuring the infusion profile of the first bolus amount with a second radiation detector 440 adjacent to the patient line 520,

[0357] - adjusting the injection profile of the first bolus with the injection rate and volume of the second bolus.

[0358] 15. The system according to item 8, wherein

[0359] The valve is according to any one of items 1 to 7, and / or

[0360] The production plant is according to item 9 or 10, and / or

[0361] The bolus device is according to item 11 or 12, and / or

[0362] The regulating device is according to item 13, and / or

[0363] The valve is according to any one of items 1 to 7, and the production device is according to item 9 or 10, and / or

[0364] The valve is according to any one of items 1 to 7 and the bolus device is according to item 11 or 12, and / or

[0365] The valve is according to any one of items 1 to 7 and the regulating device is according to item 13, and / or

[0366] The production device is according to item 9 or 10 and the bolus device is according to item 11 or 12, and / or

[0367] The production device is according to item 9 or 10, and the regulating device is according to item 13, and / or

[0368] The bolus device is according to item 11 or 12 and the regulating device is according to item 13, and / or

[0369] The valve is according to any one of items 1 to 7, and the production device is according to item 9 or 10, and the bolus device is according to item 11 or 12, and / or

[0370] The valve is according to any one of items 1 to 7, the production device is according to item 9 or 10, and the regulating device is according to item 13, and / or

[0371] The valve is according to any one of items 1 to 7, and the bolus device is according to item 11 or 12, and the regulating device is according to item 13, and / or

[0372] The production device is according to item 9 or 10, and the bolus device is according to item 11 or 12, and the regulating device is according to item 13, and / or

[0373] The valve is according to any one of items 1 to 7, and the production device is according to item 9 or 10, and the bolus device is according to item 11 or 12, and the regulating device is according to item 13.

Claims

1. A method for controlling H2 used in positron emission tomography 15 A safety valve with a flow rate of O, the valve comprising: a valve element having a flow passage extending through the valve element, a valve housing extending between a first end and a second end and having at least three valve openings, each valve opening allowing fluid to flow into or out of the valve, and at least two overflow recesses, each overflow recess extending to a first end and a second end of the valve housing, each overflow recess comprising an outlet opening at both the first end and the second end of the valve housing, wherein the valve element and the valve housing are connectable to form an assembled valve, the valve element and the valve housing being in contact with each other in a contact region, wherein the assembled valve is arrangable into at least two different open configurations, one of the open configurations defining a first flow path through the flow channel and a set of valve openings, and another of the open configurations defining a second flow path through the flow channel and another different set of valve openings, and wherein in each of the at least two open configurations: - each overflow recess is arranged between the valve element and the valve housing, at least two of the valve openings are connected via the flow channel, at least one of the valve openings is not connected to the flow channel, the contact area forms a fluid stop for preventing fluid from flowing into the at least one valve opening which is not connected to the flow channel, - the overflow recesses are not in fluid communication with the flow channel, - Each overflow recess is positioned to establish an interruption in the contact area so that these overflow recesses establish a safe release port for discharging overflow fluid, which in the event of overpressure passes through the fluid stopper via the corresponding outlet opening, so that in the at least two open configurations, the overflow fluid is prevented from entering the at least one valve opening that is not connected to the flow channel.

2. A safety valve according to claim 1, wherein the assembled valve can be arranged into a third different closed configuration, in which the flow channel is not connected to any of the valve openings, so that no flow path is established through the flow channel and the valve opening.

3. The safety valve according to claim 1, wherein the valve housing further comprises a connecting element having a first end and a second end and an internal fluid space, the connecting element being connected to the valve housing at the second end so that the fluid space is in fluid contact with one of the at least three valve openings.

4. The safety valve according to claim 1, wherein the at least two overflow recesses are arranged in the valve housing.

5. The safety valve according to claim 1, wherein The valve element also includes a first end and a second end defining a first longitudinal axis, and The valve housing also includes: - a housing comprising a first end and a second end and a second longitudinal axis extending between the first end and the second end, the second longitudinal axis being coaxial with the first longitudinal axis, - an internal space for receiving the valve element, said internal space being closed by the housing, and - the at least three valve openings arranged in the housing, each opening allowing fluid to flow into or out of the inner space, wherein the at least two overflow recesses extend axially between the first end and the second end of the housing, wherein the valve element is axially movable along the second longitudinal axis so that a portion of the valve element can be inserted into the inner spacing of the valve housing to form an assembled configuration, and the valve element is rotatable about the second longitudinal axis within the inner spacing so that the valve element and the valve housing can be changed between the at least two different configurations, When the valve element is arranged within the inner spacing in the two different configurations, each overflow recess is arranged between the valve element and the housing.

6. The safety valve according to claim 5, wherein the at least two overflow recesses are arranged in the housing and / or the at least two overflow recesses extend between the first end and the second end of the housing and open into the first end and / or the second end.

7. The safety valve according to claim 5, wherein in the at least two configurations of the assembled valve, the flow channel and the at least three valve openings are arranged in a same plane and extend in the same plane.

8. The safety valve of claim 7, wherein the same plane is substantially perpendicular to the first axis and the second axis when the valve is in the assembled configuration.

9. The safety valve of claim 1, wherein the relief fluid is at approximately 1 to 10 bar.

10. The safety valve according to claim 5, wherein the housing is cylindrical.

11. The safety valve according to claim 1, wherein the valve element is cylindrical.

12. The safety valve according to claim 5, wherein the valve openings are equidistantly distributed around the circumference of the housing, and the valve openings are distributed at an angle of approximately 120 degrees to each other in the circumferential direction.

13. The safety valve according to claim 1, wherein the valve housing comprises three valve openings.

14. The safety valve according to claim 1, wherein the valve housing comprises three overflow recesses.

15. The safety valve of claim 1, wherein the valve element includes a flow passage.

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