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WO2009039074A1 - Soupape de générateur de radio-isotopes - Google Patents

Soupape de générateur de radio-isotopes Download PDF

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Publication number
WO2009039074A1
WO2009039074A1 PCT/US2008/076487 US2008076487W WO2009039074A1 WO 2009039074 A1 WO2009039074 A1 WO 2009039074A1 US 2008076487 W US2008076487 W US 2008076487W WO 2009039074 A1 WO2009039074 A1 WO 2009039074A1
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WO
WIPO (PCT)
Prior art keywords
needle
generator
aperture
sealing member
radioisotope
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2008/076487
Other languages
English (en)
Inventor
Duane L. Horton
Kevin R. Martz
David W. Pipes
Andrew D. Speth
William A. Hagen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mallinckrodt Inc
Original Assignee
Mallinckrodt Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mallinckrodt Inc filed Critical Mallinckrodt Inc
Publication of WO2009039074A1 publication Critical patent/WO2009039074A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G4/00—Radioactive sources

Definitions

  • the invention relates generally to radioisotope generators and, more specifically, to radioisotope- generator valves.
  • radioactive material In the field of nuclear medicine, health-care professionals often diagnose and treat patients with radioactive material. Typically, the health-care professional injects a patient with a small dose of the radioactive material, which once in the patient's body, concentrates in certain organs or regions. Some radioactive materials naturally concentrate in a particular tissue: for example, iodine concentrates in the thyroid. Examples of radioactive material used for nuclear medicine include technetium-99m, indium-111 , and strontium-89. Frequentiy, the radioactive material is combined with a tagging or organ-seeking agent, which targets the radioactive material for the desired organ or biologic region of the patient.
  • radiopharmaceuticals These radioactive materials, alone or in combination with a tagging agent, are typically referred to as radiopharmaceuticals.
  • a radiation imaging system e.g., a gamma camera
  • Irregularities in the image often indicate a pathology, such as cancer.
  • Higher doses of the radiopharmaceutical may treat pathologic tissue, such as cancer ceils.
  • radiopharmaceuticals decay rapidly, so manufacturing and using them is a time-sensitive process.
  • the radiopharmaceuticai is drawn from a radioisotope generator by eluting, or separating, the radiopharmaceuticai from a more-stable radioactive material that decays into the desired radiopharmaceutical, e.g., molybdenum-99, as it decays, produces technetlum-99m.
  • the desired radioactive material is carried from the generator by a solvent, referred to as an eluant, and the radioisotope generator outputs a radioactive solution, referred to as an eluate, which is typically received in a viai connected to the output of the radioisotope generator.
  • a solvent referred to as an eluant
  • the radioisotope generator outputs a radioactive solution, referred to as an eluate, which is typically received in a viai connected to the output of the radioisotope generator.
  • the generator includes a radioisotope generator having an aperture, a resilient member (such as a spring) connected to the radioisotope generator, and a sealing member (such as a rubber body) connected, either directly or indirectly, to the radioisotope generator via the resilient member.
  • the sealing member obstructs, e.g., seals, the aperture depending on whether the resilient member is biased.
  • a method for generating a radioisotope includes automatically closing a fluid port (e.g., an aperture of a needle) of a radioisotope generator in response to removal of a vial, such as an eluate receptacle or an eluant source container.
  • a fluid port e.g., an aperture of a needle
  • a radioisotope- elution system that includes a generator, radiation shielding disposed at least partially about the generator, a fluid port fluidly coupled to the generator, and a valve configured to obstruct the outlet based on whether a container is connected to the generator,
  • a valve for an elution system includes a needle having an aperture, a sealing member, and a resilient member connected to the needle and the sealing member.
  • the resilient member obstructs the aperture with the sealing member depending on whether a container is connected to the needle.
  • FIG. 1 is an elevation view of a radioisotope-elution system
  • FIG.2 is a cross-section of the radioisotope-elution system of FIG. 1;
  • FIGS. 3 and 4 are exploded views of the radtoisotope-elution system of FIG. 1 from different perspectives;
  • FIG. 5 is a top-perspective view of the radioisotope-elution system of FIG. 1 ;
  • FIG.6 is a perspective view of a valve
  • FIGS.7 and 8 are cross-sections of the valve of FIG.6 closed and open, respectively;
  • FIG.9 is a perspective view of another valve
  • FIG. 10 is a perspective view of a plunger of the valve of FiG.9;
  • FIG. 11 is a perspective view of an upper body of the valve of FIG. 9;
  • FiGS. 12 and 13 are cross-sections of the valve of FIG.9 dosed and open, respectively;
  • FIG. 14 is a perspective view of a third valve
  • FIGS. 15 and 16 are cross-sections of the valve of FIG.14 closed and open, respectively;
  • FIG. 17 is a flow chart of a nuclear medicine process
  • FIG. 18 is a diagram of a system for loading a syringe with a radioisotope
  • FIG. 19 is a diagram of a nuclear-imaging system.
  • the articles “a,” “an,” “the,” “said,” and the like mean that there are one or more of the elements.
  • the terms “comprising,” “including,” “having,” and the like are inclusive and mean that there may be additional elements other than the listed elements.
  • the use of “top,” “bottom,” “above,” “below,” and variations of these terms does not require any particular orientation of the components relative to some extrinsic reference, e.g., gravity.
  • the term “coupled” refers to the condition of being directly or indirectly connected or in contact.
  • the phrase “in fluid communication” or “fluidly coupled” indicates that fluid or fluid pressure may be transmitted from one object to another.
  • the phrases “in thermal communication” and “thermally coupled” indicate that heat may be transferred from one object to another.
  • the word “exemplary” means “an example” and not necessarily a preferred embodiment.
  • FIG. 1 is an elevation view of an exemplary elution system 10, which includes an auxiliary shield 12 and a shielded elution assembly 14.
  • the illustrated elution system of 10 also has a valve 15, several examples of which are described below, that tends to mitigate some of the problems with conventional elution systems.
  • the valve 15 closes (automatically or manually) an output of the elution system 10 in response to a vial being removed from the output. Consequently, in some embodiments, the elution system 10 is believed to be less likely to leak eluate after an elution. Examples of the valve 15 are described further below, after describing other components of the elution system 10.
  • the illustrated etution system 10 has an auxiliary shield 12, which in this embodiment, includes a base 16, a lid 18, and a plurality of generally step-shaped, tiered modular rings 20 disposed one over the other between the base 16 and the lid 18 (see FIG. 2).
  • Substantially all or part of the illustrated auxiliary shield 12 may be made of, or include, one or more radiation-shielding materials, such as lead, tungsten, depleted uranium, or tungsten-impregnated plastic.
  • One or more of the components of the auxiliary shield 12 may be lined with, powder coated on, and/or embedded in other materials, such as a polymer.
  • At least a portion (e.g., a majority, or a substantial entirety) of the lid 18 of the assembly 12 may be over-molded with polycarbonate resin (or other polymer). Embedding or over molding the shielding materials may enhance durability and/or facilitate formation of components with smaller dimensional tolerances than components made entirely out of shielding materials.
  • the modular aspect of the rings 20 may tend to enhance adjustment of the height of the auxiliary shield 12, and the step-shaped configuration may tend to contain some radiation that might otherwise escape through an interface between the rings 20. While FIGS. 1 and 2 depict one example of an auxiliary shield 12, it should be noted that, as with the other examples described herein, other types or configurations may be employed.
  • FIG.2 is a cross-section, elevation view that illustrates additional features of the elution system 10, including a radioisotope generator 22 (hereinafter, generator), an eluant source 24, and an eluate receptacle 26 disposed within the auxiliary shield 12.
  • a radioisotope generator 22 hereinafter, generator
  • eluant source refers to a container (e.g., a vial or a conduit) that has or had an elution source fluid (e.g., oxidant-free, physiologic saline) disposed therein.
  • an "eluate receptacle” refers to a container that receives the eluate.
  • the eluant source 24 is coupled to the generator 22 via one or more inlet needles 28 (e.g., a pair of hollow needles, one of which vents, and one of which is in direct fluid communication with the generator 22), while the eluate receptacle 26 is coupled to the generator 22 via one or more outlet needles 30 (e.g., a single-hollow needle).
  • the eluant source 24 and eluate receptacle 26 may be said to be in fluid communication with the generator 22 (e.g., associated in a manner that enables fluid to flow from the eluant source 24 to eluate receptacle 26, through the generator 22).
  • the eluate receptacle 26 is disposed inside an elution shield 32 of the shielded elution assembly 14.
  • the elution shield 32 may be made of lead, tungsten, tungsten impregnated plastic and/or another suitable radiation-shielding material.
  • the illustrated generator 22 includes an elution column configured to separate and output a desired radioisotope.
  • Certain medically-useful radioisotopes have relatively short half-lives (e.g., technetium-99m (99mTc) has a half-life of approximately 6 hours).
  • the elution column may include a more-stable radioisotope that decays into the desired radioisotope (e.g., molybdenum-99 (99Mo) has a half-life of approximately 66 hours and decays into 99mTc).
  • the generator 22 may also include shielding configured to diminish radiation, and tubing to conduct fluids into and out of the elution column.
  • an eluant inside the eiuant source 24 is circulated through the inlet needle 28, through the generator 22 (including the elution column), and out through the outlet needle 30, into the eluate receptacle 26.
  • This circulation of the eluant washes out (e.g., extracts) a radioactive material, such as a radioisotope, from the generator 22.
  • a radioactive material such as a radioisotope
  • the generator 22 includes an internal radiation shield (e.g., lead shell) that encloses a radioactive parent, such as molybdenum-99, affixed or otherwise coupled to the surface of beads of alumina or a resin exchange column.
  • the parent molybdenum-99 decays, with a half-life of about 66 hours, into metastable technetium-99m.
  • the daughter radioisotope, e.g., technetium-99m is generally held less tightly than the parent radioisotope, e.g., molybdenum-99, within the generator 22. Accordingly, the daughter radioisotope, e.g., technetium-99m, can be extracted with a suitable eluant, such as an oxidant-free, physiologic saline solution.
  • the elution assembly 14 can be removed from the radtotsotope-elution system 10. As discussed in further detail below, the extracted daughter radioisotope can then, if desired, be combined with a tagging agent to diagnose or treat a patient (e.g., in a nuclear-medicine facility).
  • a desired amount e.g., desired number of doses
  • the extracted daughter radioisotope can then, if desired, be combined with a tagging agent to diagnose or treat a patient (e.g., in a nuclear-medicine facility).
  • the illustrated elution system 10 is configured to perform two types of elutions: a dry elution and a wet elution, examples of both of which are described below.
  • a dry elution prior to the elution, the eluant receptacle 26 is substantially evacuated, and the eluant source 24 is filled with a volume of saline that generally corresponds to the desired volume of radioisotope solution.
  • the vacuum in the eluant receptacle 26 draws eluant from the eluant source 24, through the generator 22, and into the eluant receptacle 26.
  • a remaining vacuum in the eluant receptacle 26 draws air, or other non-eluant fluid, through the generator 22, thereby removing eluant that might otherwise remain in the generator 22.
  • Air or other appropriate fluids may flow into the eluant source 24 through the inlet vent needle 28 and into the generator 22 through the other inlet needle 28,
  • the volume and pressure of the eluant receptacle 26 may be selected such that substantially all of the eiuant is drawn out of the generator 22 by the end of an elution. In contrast, a wet elution potentially leaves eluant in the generator 22.
  • the eluant source 24 is generally larger than the eluant receptacle 26, so an eluant source 24 may supply multiple elutions that refill the eluant receptacle 26 multiple times. Because the eluant source 24 and the generator 22 are not necessarily evacuated by the eluant receptacle 26, after a wet elution, residual eluant may remain in the generator 22.
  • the elution system 10 may include the valve 15.
  • the position of the valve 15, in the presently described embodiment, is clearly illustrated in FlG.5, which is a top-perspective view of the elution system 10.
  • the valve 15 may be configured to automatically or manually seal a passage in fluid communication with the outlet of the elution system 10, e.g., the outlet needle 30.
  • the valve 15 is configured to automatically seal the passage in response to the removal of the eluate receptacle 26 and automatically unseal the passage in response to the presence of the eluate receptacle 26.
  • embodiments of the valve 15 are described by way of three examples.
  • FIG.6 depicts a valve 34 that exemplifies the valve 15 illustrated in the previous figures, in this embodiment, the valve 34 includes the outlet needle 30, a body 36, an upstream passage 38, a needle spacer 40, a sealing member 42, a sealing-member support 44, and an alignment rail 46. Interior components are described below in reference to FIGS.7 and 8, which illustrate cross-sections of the valve 34 in the open and closed positions.
  • the illustrated body 36 defines a generally circular, right-cylindrical volume that is generally concentric about the outlet needle 30.
  • the body 36 may be injection molded or otherwise formed from plastic or other appropriate materials.
  • the upstream passage 38 extends from, and is in fluid communication with, the needle 30 and may include an offsetting portion 45 that aligns with other components of the generator 22.
  • the needle spacer 40 in this embodiment, extends from a base 49 of the body 36 in a direction that is generally perpendicular to the outlet needle 30.
  • the needle spacer 40 may be made of plastic, and may include an aperture or channel 47 near its distal end to hold the inlet needles 28 in generally fixed relation to the outlet needle 30, e.g., generally parallel and at a generally fixed distance.
  • the seating member 42 is held by the seaiing-member support 44, e.g., by an interference fit or an adhesive, and is generally concentric about the outlet needle 30.
  • the sealing member 42 may be made of or include a resilient material, such as an elastomer, e.g., rubber.
  • the sealing member 42 defines a generally circular, right-cylindrical volume and includes an aperture 48 in which the outlet needle 30 is slideably disposed. For example, by applying an appropriate amount of force to the sealing member 42 in a direction generally parallel to the outlet needle 30, the sealing member 42 may be slid along the outlet needle 30, as described below.
  • the seating member 42 may be described as having a single degree of freedom relative to the outlet needle 30.
  • the aperture 48 in an unbiased state, may be smaller than an outer diameter of the outlet needle 30, so that the sealing member 42 deforms around the outlet needle 30 and biases the outlet needle 30 in a direction generally perpendicular to the length of the outlet needle 30, e.g., concentrically.
  • the sealing-member support 44 is slideably disposed in the body 36 and is affixed to the sealing member 42, so that like the sealing member 42, it has a single degree of freedom relative to both the outlet needle 30 and the body 36.
  • the presently described sealing-member support 44 is generally concentric about the outlet needle 30 and is generally rotationally symmetric.
  • the sealing-member support 44 includes a circular, right-cylindrical receptacle 50 in which the sealing member 42 is partially or entirely disposed.
  • the alignment rail 46 may be affixed to the body 36, e.g., it may be integrally formed as a single part with the body 36, or it may be adhered or interlocked with the body 36. tn the illustrated embodiment, the alignment rail 46 has a generally uniform cross-section in the direction of the outlet needle 30 and is positioned on the body 36 adjacent the needle spacer 40.
  • FIG. 7 illustrates a cross-section of the valve 34 in the closed position.
  • the illustrated valve 34 includes the following features: a needle aperture 52; a sealing- member restraint 54; an interior 56; a resilient member 58; an upper, resiiient-member mount 60; a lower, resilient- member mount 62; and a needle passage 64.
  • the needle aperture 52 is a hole in the side of the needle 30 and is positioned on the needle 30 such that when the valve 34 is in the closed position, the sealing member 42 covers the needle aperture 52. Consequently, in some embodiments, the sealing member 42 may tend to prevent fluid, e.g. liquid, from exiting the needle 30 via the needle aperture 52.
  • the illustrated needle aperture 52 is offset from the end of the needle 30 and is not at the end of the needle 30. In some embodiments there needle 30 includes more than one needle apertures 52 disposed at substantially the same offset or different offsets along the needle 30. In some embodiments, these needle apertures 52 may be the same or different sizes.
  • the illustrated sealing-member restraint 54 is a ring-shaped ledge that extends radially inward from the body 36 and constrains the movement of the sealing member 42 and sealing-member support 44. To this end, the sealing-member restraint 54 may overlap and contact the sealing-member support 44 when the valve 34 is in the closed position. In some embodiments, when closed, the sealing-member support 44 is biased against the sealing-member restraint 54 by the resilient member 44.
  • the illustrated resilient member 58 is a helical-compression spring disposed in the interior 56 of the body 36. In this embodiment, the resilient member 58 applies a force to the sealing-member support 44 in the direction of the outlet needle 30 toward the needle aperture 52.
  • the illustrated resilient member 58 is affixed to the upper, resilient-member mount 60 and the lower, resilient-member mount 62 by an interference fit.
  • Other embodiments may include other types of resilient members, such as a cantilevered beam, a wave spring, or an elastomer member, or other types of devices configured to move the sealing member 42, such as a piston in a cylinder (e.g., a pneumatic device), opposing magnets, electromagnets, a motor (e.g., a linear motor), a shape- memory alloy, a thermally-expanding member, or a petzo-electric device.
  • a piston in a cylinder e.g., a pneumatic device
  • opposing magnets e.g., a linear motor
  • a shape- memory alloy e.g., a thermally-expanding member
  • a petzo-electric device e.g., a petzo-electric device.
  • the needle passage 64 of the presently described embodiment extends from the interior 56, through the base 49, to the exterior of the body 36.
  • This needle passage 64 includes a bend to accommodate the offset portion 45 of the upstream passage 38.
  • FIG.7 depicts the valve 34 in the closed position
  • FIG.8 depicts the valve 34 in the open position.
  • the eluate receptacle 26 is positioned proximate to, e.g., in contact with, the valve 34 and is pushed against the sealing-member support 44, as indicated by arrow 70 in FlG. 8.
  • the eluate receptacle 26 is a vial including a stopper 66 made of a resilient material, such as rubber, that seals an interior 68, which may be at a sub-atmospheric pressure, e.g., a vacuum or a pressure approaching a vacuum.
  • the eluate receptacle 26 is moved in direction 70 generally parallel to the outlet needle 30, until a distal end 72 displaces the sealing member 42 and sealing-member support 44 a distance 74.
  • a downward force from the eluate receptacle 26 further biases, e.g., compresses, the resilient member 58, and the sealing member 42 and sealing-member support 44 translate, e.g., move along a substantially linear path with or without rotating.
  • the sealing-member support 44 moves, the sealing member 42 slides over the needle 30, and the perimeter of the sealing-member support 44 is guided by, e.g., slides against, the interior 56 of the body 36.
  • the needle 30 pierces the stopper 66, and the stopper 66 translates past the needle aperture 52, thereby placing the interior 68 of the eluate receptacle 26 in fluid communication with the upstream passage 38 and the generator 22.
  • the vacuum (or relative pressure difference, e.g., the eluant source 24 may be pressurized) may drive eluate through the generator 22 and into the eluate receptacle 26.
  • the eluate receptacle 26 is removed by reversing the process described above. As the eluate receptacle 26 translates in a direction opposite the arrow 70, the resilient member 58 relaxes, driving the sealing member 42 and sealing member support 44 back along the outlet needle 30 until the sealing member support 44 contacts the sealing-member restraint 54. At this point, the sealing member 42 covers the needle aperture 52, thereby closing the valve 34. Thus, the illustrated valve 34 automatically closes in response to removal of the eluate receptacle 26, which is believed to reduce the likelihood of residual eluate leaking from the generator 22.
  • the illustrated vaive 34 obstructs, e.g., seals, the outlet of the elution system 10 near the needle aperture 52, e.g., at the needle aperture. This is believed to reduce the volume of eluate upstream from the obstruction.
  • Embodiments may obstruct or seal the outlet of the elution system within the needle 30, within the upstream passage 38, e.g., adjacent the needle 30, or between the needle 30 and the generator 22.
  • FIG. 9 illustrates another example of a valve 76, which in this embodiment, includes the outlet needle 30 and upstream passage 38, along with a plunger 78, an upper body 79, and a lower body 80.
  • the upstream passage 38 is generally aligned with, and parallel to, both the outlet needle 30 and a central axis 81, but in other embodiments, the upstream passage 38 may have a bend similar to the offsetting portion 45 in FIGS.6-8.
  • the valve 76 may respond to the approach of an eluate receptacle 26 by opening the valve 76.
  • the eluate receptacle 26 may displace the plunger 78, which opens the vaive 76, and as the eluate receptacle 26 is removed, the plunger 78 may return to its original position and internal components described below may close the valve 76.
  • the plunger 78 is illustrated in greater detail in FIG, 10. !n this embodiment, the plunger 78 includes a contact plate 82, an extension 84, a needle passage 86, and legs 88, 90, and 92.
  • the contact plate 82, the extension 84, the needle passage 86, and each of the legs 88, 90, and 92 in this embodiment, each define a generally circular, right-cylindrical volume.
  • the illustrated plunger 78 includes three legs 88, 90, and 92 that are generally equally distributed about the central axis 81 and extended generally parallel to the central axis 81. Other embodiments may include more or fewer legs or legs of a different shape.
  • the plunger 78 may be made of a single body of plastic or other appropriate materials.
  • the upper body 79 includes a recess 94, a needle passage 96, and leg apertures 98, 100, and 102.
  • Each of these features may define a generally circular, right-cylindrical volume that extends generally parallel to the central axis 81 .
  • the recess 94 and needle passage 96 are generally concentric about the central axis 81, and the leg apertures 98, 100, and 102 are complementary to the legs 88, 90, and 92 of the plunger 78.
  • the leg apertures 98, 100, and 102 are sized to form a sliding seal with the legs 88, 90, and 92 so that the plunger 78 can translate along the central axis 81 while the leg apertures 98, 100, and 102 tend to prevent fluid from flowing past the legs 88, 90, and 92.
  • the recess 94 is substantially smaller than the contact plate 82, but in other embodiments, the contact plate 82 may be smaller or about the same size as the recess 94.
  • FlG. 12 illustrates a cross-section of the valve 76 in the dosed position.
  • the illustrated valve 76 includes an upper-static seal 104, a movable seal 106, a leg-contact plate 108, a resilient member 110, and a lower-static seal 112 disposed in an interior 114.
  • the upper-static seal 104 and lower-static seal 112 may have a generally tubular shape with a central passage that is in fluid communication with the outlet needle 30 and the upstream passage 38, respectively.
  • the movable seal 106 is affixed to the leg-contact plate 108, and the leg-contact plate 108 and movable seal 106 are, in the presently described closed position, biased against the upper-static seal 104 by the resilient member 110.
  • the illustrated leg-contact plate 108 contacts the distal ends of the legs 88, 90, and 92 and may include recesses for receiving the legs 88, 90, and 92.
  • both the outlet needle 30 and the upstream passage 38 include a flared portion 116 and 118 in sealing contact with the upper-static seal 104 and the lower-static seal 112, respectively.
  • the upper-static seal 104, the movable seal 106, and the lower-static seal 112 may be made from an elastomer, such as rubber, and the resilient member 110 may be a helical, compression spring or other device configured to drive movement, such as those described above.
  • the outlet needle 30 includes a needle aperture 52 at its tip.
  • FIG. 13 illustrates the valve 76 in the open position.
  • the eluate receptacle 26 is moved in the direction 70, which is generally parallel to the centra! axis 81 , and its distal end 72 pushes the contact plate 82 downward.
  • the plunger 78 translates, the dimension 120 is reduced, and the legs 88, 90, and 92 slide through the leg apertures 98, 100, and 102 and push against the leg-contact plate 108.
  • the leg-contact plate 108 moves in response to the force from the legs 88, 90, and 92, it carries the movable seal 106 away from the upper-static seal 104 and biases, or further biases, the resilient member 110.
  • the movement of the movable seal 106 creates a gap between the moveable seal 106 and the upper-static seal 104 through which eluate may flow, as illustrated by flow path 122.
  • the eluate flows out of the upstream passage 38, into the interior 114, around the sides of the leg-contact plate 108, around the legs 88, 90, and 92, through the gap between the movable sea! 106 and the upper-static seal 104, through the outlet needle 30, and into the interior 68 the eluate receptacle 26.
  • the valve 76 may respond by closing.
  • the resilient member 110 may relax and drive the leg-contact plate 108 upward, or toward the upper-static seal 104, which may close the gap between the movable seal 106 and the upper-static seal 104.
  • the movement of the leg-contact plate 108 may also drive the plunger 78 upward via the legs 88, 90, and 92.
  • the legs 88, 90, and 92 slide through the leg apertures 98, 100, and 102, the interior 114 may remained substantially sealed.
  • the resilient member 110 may drive the valve 76 back to the closed state illustrated by FlG. 12.
  • FIG. 14 illustrates a third example of a valve 124.
  • the illustrated valve 124 inciudes an upper body 126, a lower body 128, and a sealing member 130.
  • the upper body 126 defines a generally circular, right- cylindrical volume that is concentric about a central axis 132.
  • the upper body 132 is slideably connected, e.g., connected in a manner that allows for a single degree of freedom, to the lower body 128, which includes a needle spacer 40 and a guide 134 into which the upper body 126 slides, as described below.
  • the illustrated sealing member 30 is disposed in the upper body 130 opposite the lower body 128 and may be made out of or include a resilient material, such as, an elastomer, e.g., rubber.
  • FIG. 15 illustrates a cross-section of the valve 124 in the closed position.
  • the upper body 126 includes an aperture 136, a contact ring 137, and a sheath 138.
  • the illustrated aperture 136 envelopes part of sealing member 130 and substantially all of a distal portion of the outlet needle 30, at least when the valve 124 is closed.
  • the contact ring 137 in this embodiment, is a ledge that extends radially inward from the sides of the upper body 126 and defines a passage that is smaller than or roughly the same size as the aperture 136.
  • the illustrated sheath 138 is a thinner portion of the upper body 126 that is at a distal end of the upper body 126 opposite the sealing member 130,
  • the presently described sealing member 130 includes an aperture 139 that is generally concentric to the central axis 132 and is generally aligned with the outlet needle 30.
  • the aperture 139 may have a generally uniform diameter along its length or it may vary in diameter, e.g., a distal portion may be narrower than the portion closer to the tip of the outlet needle 30.
  • the illustrated sealing member 130 covers the needle aperture 52 at the tip of the outlet needle 30 and, in some embodiments, concentrically biases the tip of the outlet needle 30.
  • the guide 134 includes a recess 140 through which the upper body 126 slides and a needle support 142.
  • a resilient member 144 inside both the sheath 138 and the recess 140 is a resilient member 144, which in this embodiment is a helical, compression spring, but in other embodiments may include one or more devices configured to generate movement, as described above.
  • the needle support 142 may define a generally circular, right-cylindrical volume that is concentric to the central axis 132, and it may be disposed between the resilient member 144 and side walls 145 of the guide 134.
  • the needle support 142 may be complementary to contact ring 137 and, in some embodiments, may form a sliding seal with the contact ring 137.
  • the bottom of the resilient member 144 may be biased between, or rest against, the contact ring 137 and a base 147 of the guide 134 that extends between the side walls 145 and the needle support 142.
  • FIG. 16 illustrates the valve 124 in the open position.
  • the valve 124 is opened by the approach of the eluate receptacle 26.
  • the stopper 66 pushes the upper body 126 into the guide 134, and as fie upper body 126 and the sealing member 130 retreat in response, the contact ring 137 of the upper body 126 biases, e.g. compresses, or further biases resilient member 144.
  • the sealing member 130 slides over the outlet needle 30, and the outlet needle 30 is exposed and pierces the stopper 66 of the eluate receptacle 26.
  • the illustrated valve 124 automatically closes as the eluate receptacle 26 is withdrawn. Without the stopper 66 pressing against the sealing member 130, the resilient member 144 relaxes and drives the upper body 126 out of the recess 140. When the upper body 126 reaches the position illustrated by FIG. 15, the sealing member 130 may cover the needle aperture 52, thereby substantially or completely sealing the outlet needle 30. Thus, when the eluate receptacle 26 is removed, the sealing member 130 may tend to prevent eluate from leaking through the outlet needle 30.
  • valve 15 sea! a passage to the eluate receptacle 26
  • other embodiments may include a valve 15 to seal passages to other containers.
  • the valve 15 may seal a passage to the eluant source 24.
  • two valves 15 may seal two passages, one to the eluate receptacle 26 and one to the eluant source 24.
  • FIG. 17 is a flowchart illustrating an exemplary nuclear medicine process that uses the radioactive isotope produced by the previously discussed radioisotope-elution systems 10.
  • the process 162 begins by providing a radioactive isotope for nuclear medicine at block 164.
  • block 164 may include eluting technetium-99m from the generator 22 illustrated and described in detail above.
  • the process 162 proceeds by providing a tagging agent (e.g., an epitope or other appropriate biological directing moiety) adapted to target the radioisotope for a specific portion, e.g., an organ, of a patient.
  • a tagging agent e.g., an epitope or other appropriate biological directing moiety
  • the process 162 then proceeds by combining the radioactive isotope with the tagging agent to provide a radiopharmaceutical for nuclear medicine.
  • the radioactive isotope may have natural tendencies to concentrate toward a particular organ or tissue and, thus, the radioactive isotope may be characterized as a radiopharmaceutical without adding any supplemental tagging agent.
  • the process 162 then may proceed by extracting one or more doses of the radiopharmaceutical into a syringe or another container, such as a container suitable for administering the radiopharmaceutical to a patient in a nuclear medicine facility or hospital.
  • the process 162 proceeds by injecting or generally administering a dose of the radiopharmaceutical into a patient. After a pre-selected time, the process 162 proceeds by detecting/imaging the radiopharmaceutical tagged to the patient's organ or tissue (block 174).
  • block 174 may include using a gamma camera or other radiographic imaging device to detect the radiopharmaceutical disposed on or in or bound to tissue of a brain, a heart, a liver, a tumor, a cancerous tissue, or various other organs or diseased tissue.
  • FIG. 18 is a block diagram of an exemplary system 176 for providing a syringe having a radiopharmaceutical disposed therein for use in a nuclear medicine application.
  • the system 176 includes the radioisotope-elution system 10.
  • the system 176 also includes a radiopharmaceutical production system 178, which functions to combine a radioisotope 180 (e.g., technetium-99m solution acquired through use of the radioisotope-elution system 10) with a tagging agent 182.
  • this radiopharmaceutical production system 178 may refer to or include what are known in the art as "kits" (e.g., Technescan® kit for preparation of a diagnostic radiopharmaceutical).
  • the tagging agent may include a variety of substances that are attracted to or targeted for a particular portion (e.g., organ, tissue, tumor, cancer, etc.) of the patient.
  • the radiopharmaceutical production system 178 produces or may be utilized to produce a radiopharmaceutical including the radioisotope 180 and the tagging agent 182, as indicated by block 184.
  • the illustrated system 176 may also include a radiopharmaceutical dispensing system 186, which facilitates extraction of the radiopharmaceutical into a vial or syringe 188.
  • the various components and functions of the system 176 are disposed within a radiopharmacy, which prepares the syringe 188 of the radiopharmaceutical for use in a nuclear medicine application.
  • the syringe 188 may be prepared and delivered to a medical facility for use in diagnosis or treatment of a patient.
  • FiG. 19 is a block diagram of an exemplary nuclear medicine imaging system 190 utilizing the syringe 188 of radiopharmaceutical provided using the system 176 of FIG. 18.
  • the nuclear medicine imagining system 190 includes a radiation detector 192 having a scintillator 194 and a photo detector 196.
  • the scintillator 194 emits light that is sensed and converted to electronic signals by the photo detector 196.
  • the imaging system 190 also can include a collimator to coilimate the radiation 198 directed toward the radiation detector 192.
  • the illustrated imaging system 190 also includes detector acquisition circuitry 202 and image processing circuitry 204.
  • the detector acquisition circuitry 202 generally controls the acquisition of electronic signals from the radiation detector 192.
  • the image processing circuitry 204 may be employed to process the electronic signals, execute examination protocols, and so forth.
  • the illustrated imaging system 190 also includes a user interface 206 to facilitate user interaction with the image processing circuitry 204 and other components of the imaging system 190. As a result, the imaging system 190 produces an image 208 of the tagged organ within the patient 200. Again, the foregoing procedures and resulting image 208 directly benefit from the radiopharmaceutical produced by the elution system 10 having one or more of the valves described above.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne des systèmes, des procédés et des dispositifs comprenant un générateur de séparation de radio-isotopes. Dans certains modes de réalisation, le générateur comprend un générateur de radio-isotopes présentant une ouverture, un élément résilient relié au générateur de radio-isotopes, et un élément de fermeture étanche relié au générateur de radio-isotopes par l'élément résilient. L'élément de fermeture étanche peut être configuré pour obstruer l'ouverture selon que l'élément résilient est sollicité ou non.
PCT/US2008/076487 2007-09-19 2008-09-16 Soupape de générateur de radio-isotopes Ceased WO2009039074A1 (fr)

Applications Claiming Priority (2)

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US97350107P 2007-09-19 2007-09-19
US60/973,501 2007-09-19

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WO2009039074A1 true WO2009039074A1 (fr) 2009-03-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITPD20100186A1 (it) * 2010-06-11 2011-12-12 Attilio Cecchin Apparecchio per eluizione e procedimento di eluizione

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4387303A (en) * 1979-03-26 1983-06-07 Byk-Mallinckrodt Cil B.V. Radioisotope generator
US4833329A (en) * 1987-11-20 1989-05-23 Mallinckrodt, Inc. System for generating and containerizing radioisotopes
WO2007016170A1 (fr) * 2005-07-27 2007-02-08 Mallinckrodt Inc. Système et procédé d'identification des quantités d'éluant fournies à un générateur de radio-isotopes

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4387303A (en) * 1979-03-26 1983-06-07 Byk-Mallinckrodt Cil B.V. Radioisotope generator
US4833329A (en) * 1987-11-20 1989-05-23 Mallinckrodt, Inc. System for generating and containerizing radioisotopes
WO2007016170A1 (fr) * 2005-07-27 2007-02-08 Mallinckrodt Inc. Système et procédé d'identification des quantités d'éluant fournies à un générateur de radio-isotopes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITPD20100186A1 (it) * 2010-06-11 2011-12-12 Attilio Cecchin Apparecchio per eluizione e procedimento di eluizione

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