0102121
`
`a
`
`should be minimized.
`
`In the case of the above-mentioned
`
`gold-195m isotope having a half-life of approximately 30
`seconds, it is very much desired,
`if not necessary,
`to
`administer said isotope directly from the generator to the
`patient.
`In a clinic in which radioactive isotopes for
`diagnostic purposes are used,
`the apparatus necessary for
`
`detection, for example, a gamma camera with special colli-
`mator and a computer,
`is usually fixedly arranged. For a
`ra@iodiagnostic examination the patient is then brought
`(wheeled)
`to the detection apparatus.
`
`10
`
`it is therefore obvious to give the very short—
`living material to be used for the examination,
`in parti-
`eular a generator for producing a very short-living iso-
`tope, a fixed place close to the detection apparatus. It
`is feasible that high requirements as regards the shiel-
`ding from radioactive radiation have to be imposed upon
`such a device beside the patient to be examined ("bed-side
`arrangement"). In fact, not only the hospital personnel
`familiar with handling radioactive material will have to
`be present near the radiation source for a longer period
`of time, but also other personnel accompanying the patient
`will have to be shielded from unnecessary radioactive ra-
`
`diation. Moreover it is of utmost
`
`importance for the exa-
`
`mination that the source of radiation should be shielded
`
`carefully from the gamma camera which is very disturbance-
`
`-sensitive to background radiation.
`
`A fixed arrangement as suggested above which
`
`would satisfy these requirements, however, has important
`
`practical disadvantages, namely:
`{1} it is not possible to move the device around the
`patient's bed. This is a disadvantage because in exa-
`minations with very short-living radioactive isotopes,
`the organ,
`for example,
`the heart, has to be inspected
`usually in various directions by means of the gamma
`camera, 50 as to gain optimum insight in the function
`of the organ. A fixed bed-side arrangement of the ra-
`dioactive material to be administered considerably
`
`20
`
`25
`
`30
`
`-—eee
`
`| 1559 of 1754
`1559 of 1754
`
`

`

`.
`
`0102121
`
`—4-
`
`restricts the possibilities of moving the bed with the
`patient with respect to the gamma camera. This disad-
`vantage is the larger since,
`for reasons which will
`
`be stated hereinafter,
`
`the connection between the
`
`source of the radicactive material and the patient
`
`should be as short as possiblic.
`(2) Assembling of the device must take place for the
`greater part under aseptic conditions because the
`
`radioactive material must be introduced into the
`
`patient's body directly and cannot be previously sub-
`
`jected to a separate sterilization.
`in par-
`Because the device with radioactive material,
`ticular the radio isotope generator, will be used for
`a longer period of time, such an assembling shouldbe
`
`earried out under so-called laminar flow conditions,
`
`and therefore requires provisions which are particu-
`larly difficuit to realize in an examination room.
`(3) Another important disadvantage relates to the working
`with radioactive material upon assembling the device.
`
`As a matter of fact,
`
`the shielding from radioactive
`
`radiation is not yet optimum during the assembly,
`
`so
`
`that such an assembly,
`
`in which large quantities of
`
`not yet optimally shielded activity are handled,
`
`should therefore take place in a so-called hot-lab of
`
`a nuclear medical department of a clinic and not in an
`
`examination room for patients Where in addition dis-
`
`turbance-sensitive detection apparatus is arranged.-
`
`It is the object of the present invention to pro-
`vide a shielding device for a reservoir comprising radio-—
`
`in particular a column for a radioisotope
`active material,
`generator, which does not exhibit the above-mentioned dis-
`advantages.
`the shielding device according
`For that purpese,
`to the invention is provided with means with which the
`device can be moved forward. The complete device compri-
`Sing radioactive material can now be assembled in suitable
`
`rooms intended for this purpose and can then be wheeled to
`
`10
`
`6
`
`20
`
`25
`
`30
`
`35
`
`1560 of 1754
`1560 of 1754
`
`

`

`0102121
`
`-5-
`
`the examination room beside the patient's bed. Because the
`shielding device can be freely shifted,
`the device can be
`moved at will around the patient during the examination.
`
`Such a movable shielding device for a column for a radio-
`
`isotope generator is moreover more flexible because the
`device can be used, if desired, for any generator, for
`example, a rubidium-krypton-8lm, a strontium-rubidium &2
`or a mercury~gold 195m generator.
`It is of course necessary that the shielding de-
`
`vice should also satisfy ali conventional safety require-
`
`ments in addition to the above-mentioned radiological sa-
`fety requirements. This involves,
`for example,
`that the
`device should be sufficiently stable and be protécted as
`weil as possibile from calamities,
`for example, a fire; in
`
`the latter case, of course. it should be prevented that
`the radioactive radiation can pass the-shielding device
`and enter the examination room.
`
`Preferably the device in addition comprises pro-
`
`visions for the safe handling of radioactive material,
`such as a receptacle for waste fluid, a work-top, etc.
`These provisions enable the user to carry out various ma-—
`nipulations with radioactive materials at different places
`withont risky manually displacing these materials, be-
`cause, as a matter of fact,
`the device can be moved for-
`
`ward.
`
`,
`
`On its lower side the shielding device preferably
`
`comprises at least three, preferably five, casters to be
`able to easily turn and manoeuvre the heavy device in the
`restricted space around a patient. As a result of the lead
`cover, a shielding device according to the invention ap-
`
`proaches a weight of approximately 360 kg.
`Furthermore it is desired to provide the device
`
`it)
`
`16
`
`20
`
`25
`
`with a grip at a height which is suitable for hand-move-
`ment. For this purpose, a grip consisting of a circumfe~
`
`a5
`
`rential tubular or rod-shaped member connected to the out—
`side of the lead cover has proved particularly suitable.
`When such a grip having no projections is used, it is
`
`1561 of 1754
`1561 of 1754
`
`

`

`0102121
`
`6
`
`avoided that components of the device or connections can
`be drawn along or loose during movement of the shielding
`
`device,
`
`When using the device it is often necessary to
`
`temporarily store radioactive waste material. For example,
`when a gold-195m generator is used,
`the generator column
`must first be rinsed several times with eluent before an
`
`eluate is obtained having a composition which is suffi-
`
`ciently constant for administration to a patient. It is
`
`w
`
`therefore advantageous that the device moreover comprises
`
`a separate lead-shielded space for a receptacle for radio-
`-active waste material.
`
`Because the radioactive liquid has to be introdu-
`
`15
`
`the means for doing
`ced directly into the patient's body,
`this are preferably connected on or to the shielding -de—
`
`vice.
`
`20
`
`25
`
`In a suitable embodiment
`
`the shielding device
`
`according to the invention comprises a base in which the
`means to move the device are present, a central part of
`reduced outside diameter in which the lead cover for the
`
`reservoir containing radioactive material is present, and
`a top part which comprises;
`the lead closure for the ac-
`cess in the cover,
`the grip,
`the access to the shielded
`space for the waste reservoir and the means to introduce a
`radioactive liquid into a patient's body.
`As a resuit of the large diameter of grip and
`base as compared with that of the reservoir shielded by
`
`means of a lead cover,
`
`the distance between the radiation
`
`30
`
`source and the operating personnel is increased, for
`
`example, by a factor of approximately 2. As a result of
`this the radiation received is still further reduced, for
`
`example, by a factor of approximately 4 as compared with
`
`the radiation at the outer surface of the shielded reser-
`
`35
`
`voir.
`
`Lead is vulnerable because is is a soft metal.
`Moreover, it has a low melting=point, 327°C, so that in
`the case of a fire, it will melt and drip away,
`thus allo-
`
`1562 of 1754
`1562 of 1754
`
`

`

`
`
`0102121
`
`-~7J=
`
`wing radioactive radiation to be released from the cover.
`Therefore,
`the lead cover for the reservoir consists pre-
`
`ferably and in agreement with the requirements which are
`
`imposed upon the storage of radioactive material in
`various countries, of a lead vessel which is open at its
`top and which is enclosed between sheet material of iron
`
`or steel, protected on the outside against corrosion, or
`of stainless steel, while the open top end accessible for
`
`the reservoir can be closed by a lead lid provided with
`the same sheet material on the outside, an aperture for a
`connection between the reservoir and the means for.
`introducing a radioactive liquid into a patient's body
`being present
`in the 1id or between the vessel and the
`
`lid. The sheet material which can withstand high
`-
`temperatures ensures sufficient safety for the ambience in-
`the case of a calamity, for example, a fire,
`seo that the
`lead shielding remains contained and no undesired
`radioactive radiation can get out of the shielding systen.
`
`10
`
`15
`
`20
`
`It cannot always be avoided that a little radio-
`active liqdid is spilled when installing or using the
`
`source of the radioactive material. Then it is difficuit
`
`25
`
`30
`
`35
`
`to thoroughly clean the vessel which forms part of the
`heavy shielding device. Therefore, a stainless steel ves-—
`
`sel is preferably present between the substantially lead
`
`vessel and the reservoir, which stainless steel vessel
`
`comprises on its open top a radially outwardly projecting
`
`flange to which the 1id can be sealingly connected.
`The shielding device in accordance with the in-
`
`vention serves in particular for shielding a radio isotope
`
`generator. The provisions necessary upon eluting a genera-
`
`tor column are preferably connected on or to the above-
`
`-mentioned top part of the device, namely a reservoir for
`the eluent for the generator column which communicates
`with the column; means for pumping or injecting the eluent
`out of the eluent reservoir into the column; means for
`
`bringing the resulting eluate out of the column into a |
`patient's body; means for adding a rinsing of formulating
`
`1563 of 1754
`1563 of 1754
`
`

`

`0102121
`
`a
`
`liquid to the eluate; and a tube which is connected on one
`
`side to the means for adding the rinsing or formulating
`Liquid and which on its other side has a member which can
`
`be connected to an auxiliary means to admit liquids to the
`blood vessels or body cavities of a patient.
`
`in order to be able to handle all operating mem—
`bers easily, rapidiy and safely, a connection and opera-
`ting block or tray is connected to the top part,
`in which
`
`block are accommodated injection means for the eluent and
`
`the eluate, vaives to prevent undesired directions of flow
`
`Of Liquids, cocks to enable or block the passage of li-
`quids, and connection provisions for the means provided in
`the block both mutually and to the tubes which are
`
`the column and the auxiliary
`connected to the reservoirs,
`means to be used for the administration to a patient.
`Preferably the operating block or tray is attached on top
`of the lid of the lead vessel and the lid is provided with
`
`a bore to let pass connecting tubes from the generator to
`the auxiliary means for injection and from the auxiliary
`means to the waste fluid receptacle thereby shielding the
`environment as far as possible from radiation emanating
`from these tubes when radioactive liquid passes through
`them. The above embodiment has the advantage that an
`
`optimum safety can be reached inspite of the excess
`
`pressure at which generally the radioactive liquid is
`
`administered to a patient. Moreover,
`
`the path which the
`
`eluate has to cover, hence the distance between the
`
`generator and the patient, can be kept as short as
`possible. This latter is of importance in particular
`because, when very short-living radio-isotopes are used,
`high requirements are generally imposed upon the volume to
`
`be administered to the patient and in which the
`
`radioactive material is present. As described in the
`
`above-mentioned Netherlands Patent Application 8201591,
`
`.
`
`repeated administrations within a short period of time are
`
`necessary for various applications.
`
`In order to enable
`
`such examinations,
`
`the volume in which the reactivity is
`
`19
`
`15
`
`20
`
`25
`
`30
`
`35
`
`1564 of 1754
`1564 of 1754
`
`

`

`0102121
`
`-5.
`
`present must be as small as possible.
`
`The invention will now be described in greater
`
`detail with reference to an embodiment which is shown in
`the accompanying drawings.
`Figure 1 is a side-view of a shielding device according to
`the invention; figure 2 shows the same shielding device
`from top. Figure 1 is for the greater part a longitudinal
`
`we
`
`sectional view of the shielding device taken on the line
`
`I-I of fig. 2, viewed in the direction of the arrows, Fi-
`gure 3 is a longitudinal sectional view of a part of the
`device taken on the Line IEI-III of fig. 2,
`The operation of the device will be described in detail
`with reference to figure 4, Figure 4 shows an exploded
`view of a part of the device.
`,
`The base 21 of the screening device shown in Fi-
`
`gure 1 comprises a base plate 23 which is hooded with a
`
`stove-enamelled sheet iron cap 22 below which five casters
`24 are connected so as to be rotatable.
`
`20
`
`The central part 25 is mounted on said base plate
`
`and comprises a icad vessel 26 which is enclosed between
`stove-enamelled sheet iron 27. A second vessel 29 which is
`
`manufactured from stainless steel and comprises a radially
`
`outwardly projecting flange 28 is provided in the vessel.
`
`25
`
`The generator 31 is placed in vessel 29. Between the bot-—
`toms of the vessels 27 and 29 a space 30 remains in which
`
`heating elements, for example a heating plate, can be ac-
`
`commodated. As described in the above-mentioned Nether-
`
`lands Patent Application 8202407 it may be useful when
`
`30
`
`35
`
`certain radio isotope generators are used,
`for example, a
`gold-195m generator,
`to heat
`the generator column during
`the elution. If desired, a bore may be recessed in vessel
`26 for leading through a supply for the heating means.
`As shown in figures 1 and 2 a grip 33 in the form
`
`of a circumferential tube which is connected to the vessel
`
`by means of three spoke-shaped elements 34 is provided
`
`around the top part of the device. The vessel 26 can be
`
`closed on its top side by means of a lead lid 36 mounted
`
`1565 of 1754
`1565 of 1754
`
`

`

`0102121
`
`-10=-
`
`in stove-enamelled sheet iron 35 and connected to the ves=
`
`sel so as to be pivotable at 37, For compensation of the
`
`weight of the lid, a spring mechanism 38 is provided. The
`1idG can be clamped sealingly on the vessel (flange 28) by
`means of a clamping lock 39 provided with a handle. A bore
`
`32 is present in lid 36 for leading through two connection
`
`tubes,
`
`the outlets of which are framed in a suitable mount
`
`45, comprising a steel tube encased in lead, erected on
`
`10
`
`the lid of the lead vessel and forming a base for an ope-
`rating block or tray. Between the circumferential grip and
`the upper edge of the lead vessel, a circumferential
`stainless steel top 40 having upright edges is present on
`which auxiliary means necessary for using the device can
`
`nw
`
`be placed.
`
`A small lead vessel 41, also mounted in stove-
`
`for a receptacle 12a for waste ma-
`iron,
`-enamelled sheet
`terial is present in an aperture of the top 40, which ves-
`sel is connected to the large vessel 27 and can be closed
`
`20
`
`by means of a lead lid 43 provided with a grip 44.
`On-top of mount 45 is connected an operating
`
`biock or tray 46 in or on which two syringes can be acco-
`
`modated, as well as other auxiliary means needed during
`
`operation of the device.
`
`25
`
`Figure 3 shows a waste overflow bottle 12b placed
`on top 40. The inlet of the overflow bottle is connected
`
`30
`
`35
`
`to the outlet tube lib of receptacle 12a.
`As shown in Figure 1,
`two reservoirs 1 and 2 for
`
`eluent and rinsing or formulating liquid, respectively,
`
`are clamped in a stand 16 mounted on the edge of vessel 27.
`As shown in Figure 4,
`two syringes 5 and 9 provi-
`ded on their front sides with connection means in the form
`
`of Luer cones are connected to three-way cocks,
`
`the former
`
`directly to a three-way cock 4a and the latter to a three-
`~way cock 4b via two valves 8a and 8b.
`The use of the device shown will be explained
`
`with reference to figure 4. All connections between the
`
`various components, £or the greater part tube connections
`
`1566 of 1754
`1566 of 1754
`
`

`

`0102121
`
`-ll-
`
`and Luer connections, are produced under laminar flow con-
`ditions.
`
`During operation of the device the tube connec-
`tions are provided between eluent reservoir 1 and an out-
`let of three-way cock 4a,
`the inlet aperture of the gene-
`rator column 13 and the other outiet of three-way cock 4a,
`the reservoir with rinsing or formulating liquid 2 and
`
`the drain aperture of the generator column 15
`valve 8a,
`and valve 8b,
`the receptacle for waste fluid 12a and an
`outlet of three-way cock 4b and the auxiliary means to be
`used for administration to a patient and the other outlet
`
`.
`of three-way cock 4b.
`When the device is used, first three-way cock 4b
`is opened to communicate the eluate duct 7 through cock
`10b and valve 8b with the waste fluid receptacle 12a.
`Overflow bottle 12b is connecte@ to receptacle 12a through
`a tube 11b and serves as an extra safety. By means of
`three-way cock 4a, syringe 5 is communicated with eluent
`reservoir 1, after which the syringe is filled with 2 ml
`
`of eluent.-Eluent reservoir 1 and rinsing agent reservoir
`
`2, clamped in stand 16, are provided with dropping cham-
`bers 3a and 3b. After opening the cock 10a, syringe 9 is
`filled with a saline solution from reservoir 2 (through
`valve 8a):
`the tube is then closed by clamping by means of
`clamb 17. After having turned three-way cock 4a,
`the con-
`tents of syringe 5 are injected through tube 6 into the
`
`generator column 14 at 13; after-rinsing is carried out
`with 2 ml of saline solution from syringe 9. All the wash
`liquid (eluate) rinsed through the column and leaving the
`
`generator column at 15, as well as the rinsing liquid is
`collected through tubes 7 and lla in the waste receptacle
`
`i2a.
`
`After having repeated this operation several
`
`the generator is ready for connection to a patient.
`times,
`For that purpose, a sterile tube, connected to three-way
`eock 4b,
`is filled with a saline solution from syringe 93
`after opening said valve, and is then connected to an
`
`ath)
`
`b
`
`20
`
`25
`
`36
`
`35
`
`1567 of 1754
`1567 of 1754
`
`

`

`0102121
`
`-12-
`
`auxiliary means to administer the radioactive liguid to a
`patient, for example, a needle or a catheter. After having
`placed the patient in a suitable position below a gamma
`camera,
`the generator is eluted with 2 ml ef eluent by
`means of syringe 5,
`the eluate being injected directly
`into the patient. All remaining tudioactivity is then re-
`moved from the device by rinsing with 10 ml of saline sc-
`
`lution from reservoir 2 by means of syringe 9.
`The examination may be repeated any desirable
`
`1B
`
`number of times.
`
`20
`
`25
`
`30
`
`35
`
`1568 of 1754
`1568 of 1754
`
`

`

`0102121
`
`-13-
`
`CLAIMS :
`
`1. A shielding device for a reservoir comprising
`
`a radioactive material and having an inlet and an outlet
`
`in particular a column for a radio-isotope gene-
`aperture,
`rator, comprising a lead cover for the reservoir in which
`a closablie access for the reservoir is recessed, characte-
`
`rized in that the shielding device is provided with means
`with which the device can be moved forward.
`
`2. A G@evice as claimed in Claim 1, characterized
`
`in that the device comprises in addition provisions for
`the safe handling of radioactive material.
`:
`3. A device as claimed in Claim 1 or 2, characte-
`
`rized in that the device comprises on its lower side at
`
`least three, preferably five, casters.
`4, A deyice as claimed in any of the preceding
`
`Claims, characterized in that the device comprises a grip,
`preferably consisting of a circumferential tubular or rod-
`-shaped member connected to the outside of the lead cover.
`5. A device as claimed in any of the preceding
`Claims, chatacterized in that the device comprises in ad-
`
`dition a separate lead-shielded space for a reservoir for
`
`radioactive waste material.
`
`6. A device as claimed in any of the preceding
`Claims, characterized in that the device is provided with
`means for introducing a radioactive liquid into a
`patient's body, while the environment is shielded as far
`as possible from radiation emanating from these means when
`radioactive liquid passes through then.
`7. A device as claimed in Claim 6, characterized ©
`in that the device comprises a base in which the .means to
`
`move the device are present, a central part of reduced
`
`outside diameter in which the lead cover for the reservoir
`
`containing the radioactive material is present, and a top
`part which comprises:
`the lead closure for the access in
`the cover,
`the grip,
`the access to the shielded space for
`the waste reservoir and the means to introduce a radioac-—
`
`tive Liquid into a patient's bedy.
`
`20
`
`25
`
`30
`
`35
`
`1569 of 1754
`1569 of 1754
`
`

`

`0102121
`
`-14-
`
`B. A device as claimed in Claim 7, characterized
`in that the lead cover for the reservoir consists of a
`
`lead vessel which is open at its top and which is enclosed
`between sheet material of iron or steel treated externally
`against corrosion, or of stainless steel, while the open
`tep end accessible for the reservoir can be closed by
`means of a lead lid provided on its outside with the same
`sheet material, an aperture for a connection between the
`
`reservoir and the means for introducing a radioactive
`liguid into a patient's body being present in the lid or
`between the vessel and the lid.
`
`9. A device as claimed in Claim 8, characterized
`
`in that a vessel of stainless steel which at its open top
`
`side comprises a radially outwardly projecting flange to
`
`is present be-
`which the lid can be sealingly connected,
`tween the substantially lead vessel and the reservoir.
`10. A shielding device as claimed in any of the
`Claims 7-9 for a radio-isotope generator, characterized in
`that there are additionally connected on or to the top
`part: a reServoir for an eluent for the generator column
`
`which communicates with the column; means for pumping or
`injecting the eluent out of the eluent reservoir into the
`
`column; means to bring the resulting eluate out of the
`
`column into a patient's body; means to add a rinsing or
`formulating liquid to the eluate; and a tube which is con-
`nected on one side to the means for adding the rinsing or
`formulating liquid and which comprises on the other side a
`member which can be connected to an auxiliary means to
`
`admit liquid to blood vessels or body cavities of a
`
`patient.
`
`ll. A device as claimed in Claim 10, characteri-
`
`zed in that a connection and operating block or tray is
`connected to the top part,
`in which block are accomodated
`
`injection means for the eluent and the eluate, valves to
`
`prevent undesired directions of flow of liquids, cocks to
`
`enable or block the passage of liquids, and connection
`
`means for the means accomodated in the block both mutually
`
`bt)
`
`20
`
`25
`
`30
`
`35
`
`1570 of 1754
`1570 of 1754
`
`

`

`0102121
`
`-15-
`
`1
`
`and to the tubes which are connected to the reservoirs,
`
`the column and the auxiliary means to be used for adminis-~
`
`tering to a patient.
`
`10
`
`8
`
`2a
`
`25
`
`39
`
`36
`
`1571 of 1754
`1571 of 1754
`
`

`

`0102121
`
`40
`
`38
`
`MyMy |G)
`A,
`7A
`,
`33
`
`FIG.3
`
`43 44f
`
`1572 of 1754
`1572 of 1754
`
`1-IE-CiL O11
`
`FIG.1
`
`1/2
`
`
`SS
`36 3522 A
`1. 37
`VA*,
`Jee|
`
`Xog
`
`— TF
`
`
`
`MN,Sa~ i\N
`
`fe!
`
`

`

`* -
`.
`*
`
`0102121
`
`2/2
`
`femmennt
`
`FIG. 4
`
`1573 of 1754
`1573 of 1754
`
`2-TECIL 0111
`
`

`

`
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`9») eePatent
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`EUROPEANSEARCHREPORT
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`EP
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`0102121
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`83 20 1201
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`DOCUMENTS CONSIDERED TO BE RELEVANT
`Citation of documentwith indication, where appropriate,
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`Retevant
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`
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`GLASSIFICATION OF THE
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`G21G 1/04
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`{C.E.A.)
` GB-A~1 234 020
`1,2,7
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`* Claim 1;
`figure 1;
`page 2,
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`lines
`83-90; page 3,
`lines 68-76
`*
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`GB-A-Z 033 288
`(BYK
`MALLINCKRODT)
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`* Claim 1;
`figure
`1;
`page 3,
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`lines 29-40 *
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`US-A-3 710 118
`(R.L. HOLGATE)
`* Claims 1,2 *
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`—
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`Applicationnumber
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`|degmwoanneoe||degmwoanneoe|GH.3)
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`G 21F
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`The|———_Thaprasntsenchepothasbeeniawnuptoratcning||———_Thaprasntsenchepothasbeeniawnuptoratcning|Teporthasbeendrawnupforailclaims
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`Dateqen lationof thesearch
`Peeoeane
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`CATEGORY OF CITED DOCUMENTS
`T : theory or principle underlying the invention
`E : earlier
`patent document, but published on, or
`after the filing date
`D : documentcited inthe application
`L : document cited for other reasons
`_ievernntsannttinenctnenetinnnttttinge cineegtmambe sehrenmittneunentegeteipiseeteeeitce
`& : member of tha same patent family, corresponding
`document
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` EPOForm1603,03,82
`TO><x
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`+ particularly relevantIf taken alone
`+ particularly relavant if combined with another
`document of the same category
`> technological background
`: non-written disclasure
`: intermediate document
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`1574 of 1754
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`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`8 February 2007 (08.02.2007)
`
` U0 TOMeAA
`
`(10) International Publication Number
`WO 2007/016170 Al
`
`(51) International Patent Classification:
`AGIN 5/60 (2006.01)
`G21G 4/08 (2006.01)
`G21F 5/075 (2006.01)
`
`(21) International Application Number:
`PCT/US2006/029055
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`(22) International Filing Date:
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`26 July 2006 (26.07.2006)
`
`(25) Filing Language:
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`(26) Publication Language:
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`English
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`English
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`(30) Priority Data:
`60/702,927
`
`27 July 2005 (27.07.2005)
`
`US
`
`(81)
`
`(74)
`
`(72) Inventor; and
`FAGO, Frank
`(fer US only):
`(75) Inventor/Applicant
`[US/US]; 4508 Estate Court, Mason, Ohio 45040 (US).
`Agents: SEURER, Jerad, G.et al.; Mallinckrodt Inc., 675
`Medonnell Boulevard, P.O. Box 5840, St. Louis, Missouri
`63134 (US).
`Designated States (unless othenvise indicated, for every
`kind af national pratection available}: ATL, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`Co, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FL
`GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP,
`KE, KG, KM, EN, KP, KR, KZ, LA, LC, LK, LR, LS, LT,
`LU, LV, LY, MA, MD, MG, MEK, MN, MW, MX, M7, NA,
`NG, NI, NO, N%, OM, PG, PH, PL, PT, RO, RS, RU, SC,
`SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ,
`UA, UG, US, UZ, VC, VN, ZA, 7M, ZW.
`
`except US):
`(for ail designated States
`(71) Applicant
`MALLINCKRODT INC.
`[US/US], 675 McDonnell
`Boulevard, P.O. Box 5840, St. Louis, Missouri 63134
`(US).
`
`(34)
`
`Designated States (unless otherwise indicared, for every
`kind of regional protection available}; ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`2), Eurasian (AM, AZ, BY, KG, K4, MD, RU, 'TJ, TM),
`
`(Continued on next page}
`
`(54) Title: SYSTEM AND METHOD OF IDENTIFYING ELUANT AMOUNTS SUPPLIED TO A RADIOISOTOPE GENER-
`
`(57) Abstract: The invention, is directed to a system including a
`shielded container (16) , a radioisotope generator disposed within
`the shielded container, and an elution supply mechanism. The elu-
`tion supply mechanism may include an eluant supply container (4)
`at least partially external to the shielded container (16) , a conduit
`(10) extending between an inlet (20) of the radioisotope generator
`and an outlet (6, 8) of the eluant supply container, and an eluant vi-
`sualization portal.
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`ATOR
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`
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`Wo2007/016170A1IMITIIITIMIIININETANTTNMADITMMAT
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`WO 2007/016170 AX
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`—_[MINIIUUNIUININITIG TOMA CTENG UTRANT
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`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, — before the expiration of the time limit for amending the
`PR, GB, GR, HU, TE, IS, TT, LT, LU, LV, MC, NL, PL, PT,
`claims and to be republished in the event of receipt of
`RO, SE, SI, SK, TR), OAPI (BE, BJ, CK CG, CI, CM, GA,
`amendments
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`— with international search report
`
`For two-letter codes and ether abbreviatians, refer to the "“Guid-
`ance Nates an Codes and Abbreviations" appearing at the begin-
`ning of each regular issue of the PCT Gazette.
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`1576 of 1754
`1576 of 1754
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`WO 2007/016170
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`PCT/US2006/029055
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`SYSTEM AND METHOD OFIDENTIFYING ELUANT AMOUNTS
`SUPPLIED TO A RADIOISOTOPE GENERATOR
`
`FIELD OF THE INVENTION
`
`The invention relates generally to the field of nuclear medicine. Specifically, the
`[0001]
`invention relates to a system and method of identifying an amount or flow of eluant in an
`elution system configured to enable extraction of a radioactive material from a radioisotope
`
`generator for use in the practice of nuclear medicine.
`
`BACKGROUND
`
`[0002]=This section is intended to introduce the reader to various aspects of art that may
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`be related to various aspects of the present invention, which are described and/or claimed
`
`below. This discussion is believed to be helpful in providing the reader with background
`
`information to facilitate a better understanding of the various aspects of the present invention.
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`Accordingly, it should be understood that these statements are to be readin this light, and not
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`as admissions ofpriorart.
`
`[0003]
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`Nuclear medicine is a branch of health science that utilizes radioactive material for
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`diagnostic and therapeutic purposes by injecting a patient with a small dose of the radioactive
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`material, which concentrates in certain organs or biological regions of the patient. Radioactive
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`materials typically used for nuclear medicine include Technetium-99m,
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`[Indium-113m, and
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`Sirontium-87m among others. Some radioactive materials naturally concentrate toward a
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`particular tissue; for example, iodine concentrates toward the thyroid. However, radioactive
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`materials are often combined with a tagging or organ-seeking agent, which targets the
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`radioactive material for the desired organ or biologic region of the patient. These radioactive
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`materials alone or
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`in
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`combination with a tagging agent are typically defined as
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`radiopharmaceuticals in the field of nuclear medicine. At relatively lower doses of the
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`radiopharmaceutical, a radiation imaging system (€.g.,
`
`a gamma camera) can provide an
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`image of the organ or biological region that collects the radiopharmaceutical.
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`lrregularities in
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`the image are often indicative of a pathologic condition, such as cancer. Higher doses of the
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`radiopharmaceutical may be used to deliver a therapeutic dose of radiation directly to the
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`pathologic tissue, such as cancercells.
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`<A variety of elution systems are used to generate radiopharmaceuticals.
`[coo04]
`Unfortunately, radioactive shielding containers of these systems tend to block visualization of
`the state and progress of the elution process. For example, the amount of available eluant
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`WO 2007/016170
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`PCT/US2006/029055
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`and/or the amount of extracted eluate are generally unknown without opening one or more of
`the radioactive shielding containers. Rather, the pharmacist typically has to wait an estimated
`
`amount of time to ensure the process is complete, which results in wasted time or premature
`termination of the process.
`{f a specific amount of eluate is desired, then the time estimation
`may tend to result in too muchortoolittle of the eluate,
`
`SUMMARY
`
`[0005]
`
`The present
`
`invention,
`
`in certain embodiments,
`
`is directed to identifying or
`
`monitoring a volume, mass, weight, displacement or flow of a supply element (e.g., eluant)
`
`and/or an output eluate associated with eluting a radioisotope from a generator product in the
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`field of nuclear medicine. Specifically, in some embodiments, visual access may be provided
`
`into an eluant supply containerto facilitate performanceof elution procedures. For example, a
`
`visual portal into an eluant supply container during an elution can provide data for measuring
`
`and calculating metrics relating to completion of full or partial elutions and data relating to
`
`when a generator is available for milking. Other embodiments may measure an amount or
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`flow of eluant and/or eluate, such that a user can directly view the measurement(e.g., scale or
`
`flow meter) or indirectly view the measurement on a remote display screen or computer.
`
`[0006]
`
`Certain aspects commensurate in scope with the originally claimed invention are
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`set forth below.
`
`It should be understood that these aspects are presented merely to provide
`
`the reader with a brief summary of certain forms the invention might take and that these
`
`aspects are not intended to limit the scope of the invention.
`
`Indeed, the invention may
`
`encompass 4 variety of aspects that may not be set forth below.
`
`{0007]
`
`In accordance with a first aspect of the present invention, there is provided a
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`system having a shielded container, a radioisotope generat