U.S. patent number 3,655,981 [Application Number 04/779,793] was granted by the patent office on 1972-04-11 for closed system generation and containerization of radioisotopes for eluting a daughter radioisotope from a parent radioisotope.
This patent grant is currently assigned to Mallinckrodt Chemical Works. Invention is credited to James R. Montgomery, Lloyd G. Struttman.
United States Patent |
3,655,981 |
Montgomery , et al. |
April 11, 1972 |
CLOSED SYSTEM GENERATION AND CONTAINERIZATION OF RADIOISOTOPES FOR
ELUTING A DAUGHTER RADIOISOTOPE FROM A PARENT RADIOISOTOPE
Abstract
Apparatus for eluting a sterile daughter radioisotope from a
parent radioisotope and containerizing the resultant eluate in an
evacuated container having a rubber stopper, providing for delivery
of a sterile pyrogen-free eluant from a sealed supply through a
sterile charge of the parent radioisotope sealed in a shielded
generator and thence to a tubular needle adapted to be pierced
through the stopper of the evacuated container for suctioning the
eluant from the sealed eluant supply into the generator and for
suctioning the resultant eluate into the container. The needle is
applied to a fitting on a plunger adapted to be pushed down to
pierce the needle through the stopper. Eluate is delivered from the
generator to the fitting for flow through the needle via an eluate
conduit having a flexible tubing portion permitting movement of the
plunger and the fitting, with an arrangement whereby the plunger,
when retracted, pinches the flexible tubing portion closed, the
flexible tubing portion being automatically released when the
plunger is driven downward to open the flexible tubing portion for
flow therethrough of the eluate under suction induced by the
piercing of the needle through the stopper into the evacuated
container.
Inventors: |
Montgomery; James R.
(Maplewood, MO), Struttman; Lloyd G. (St. Louis, MO) |
Assignee: |
Mallinckrodt Chemical Works
(St. Louis, MO)
|
Family
ID: |
25117589 |
Appl.
No.: |
04/779,793 |
Filed: |
November 29, 1968 |
Current U.S.
Class: |
250/432PD;
376/186; 604/407; 600/5; 604/201; 976/DIG.350 |
Current CPC
Class: |
G21F
5/015 (20130101); G21G 1/0005 (20130101) |
Current International
Class: |
G21F
5/015 (20060101); G21F 5/00 (20060101); G21h
005/00 () |
Field of
Search: |
;250/16T
;128/1.1,220,276 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Lawrence; James W.
Assistant Examiner: Frome; Morton J.
Claims
What is claimed is:
1. Apparatus for eluting a daughter radioisotope from a parent
radioisotope and for containerizing the resultant eluate in a
container having a closure adapted to be pierced by a needle, said
apparatus comprising:
a generator containing a supply of the parent radioisotope,
a shield enclosing the generator for shielding the user against
radioactive emission from the generator,
means for holding a supply of eluant adjacent the shield and
generator,
an eluant conduit extending from the eluant supply means through
the shield and into the generator,
a tubular fitting adapted for attachment thereto at one end of a
tubular needle for piercing said closure,
means adjacent the shield and generator mounting said tubular
fitting for movement away from a retracted position in the
direction of length of the needle to cause the needle to pierce
said closure,
an eluate conduit extending from said generator through the shield
and having a flexible tubing portion connected to the other end of
said tubular fitting permitting movement of said fitting,
said eluant conduit, generator, eluate conduit and fitting
constituting a closed passage from the eluant supply means to said
needle,
and means associated with said fitting for effecting closure of
said eluate conduit when said fitting is in its said retracted
position and opening of said eluate conduit when said fitting is
moved to cause the needle to pierce the closure of said container
for flow of eluant from the eluant supply means through the eluant
conduit into the generator for eluting the daughter radioisotope
from the parent radioisotope in the generator and flow of the
resultant eluate from the generator through the eluate conduit,
fitting and needle into the container.
2. Apparatus as set forth in claim 1 wherein the means for
effecting closure of the eluate conduit comprises a member movable
with the fitting for pinching closed the flexible tubing portion of
the eluate conduit when the fitting is in its retracted
position.
3. Apparatus as set forth in claim 2 having spring means for
biasing the fitting toward its retracted position.
4. Apparatus as set forth in claim 1 wherein the mounting means for
the fitting comprises a plunger and means guiding the plunger for
vertical sliding movement downward from a raised retracted position
toward a container positioned therebelow with its piercable closure
at the top, the fitting being adapted for attachment thereto of the
needle with the needle extending downward, the means for effecting
closure of said eluate conduit comprising a jaw member on the
plunger and a fixed jaw member thereabove, the flexible tubing
portion of the eluate conduit extending between said jaw members
and being pinched closed between said jaw members when the plunger
is in its raised retracted position.
5. Apparatus as set forth in claim 4 having spring means biasing
the plunger upward toward its raised retracted position.
6. Apparatus as set forth in claim 5 wherein the plunger is
tubular, the fitting extending through the lower end of the plunger
and adapted for attachment to its lower end of the needle, the
flexible tubing portion of the eluate conduit extending through a
lateral opening in the plunger spaced from the lower end of the
plunger and down through the plunger to a connection with the upper
end of the fitting, the jaw member on the plunger being adapted to
pinch closed said flexible tubing portion where it extends into
said opening.
7. Apparatus as set forth in claim 1 wherein the generator
comprises an elongate closed vessel adapted for vertical
disposition and having a convergent closed lower end, and means
therein spaced from its lower end for maintaining the supply of the
parent radioisotope spaced from its lower end, the eluant conduit
being in communication with the upper end of the vessel and the
eluate conduit being in communication with the lower end of the
vessel.
8. Apparatus as set forth in claim 7 wherein the vessel comprises a
tube having a hemispherical lower end and a stopper in it supper
end, the means for maintaining the parent radioisotope spaced from
its lower end comprising a filter mounted in the tube above its
lower end, the parent radioisotope being confined between the
filter and the stopper, the eluate conduit extending down through
the stopper and terminating immediately below the stopper, the
eluate conduit extending down through the stopper and the filter to
the lower end of the tube.
9. Apparatus as set forth in claim 1 further comprising a case
receiving the shield with the generator therein and also receiving
the eluant supply means, said case being formed with a recess
opening inward from the side of the case adapted to receive the
container with its piercable closure at the top of the container
and having a portion overhanging the recess, said fitting being
carried at the lower end of a plunger vertically slidable in said
overhanging portion of the case.
10. Apparatus as set forth in claim 9 wherein the means for
effecting closure of the eluate conduit comprises a jaw member on
the plunger adapted to pinch closed the flexible tubing portion of
the eluate conduit against a portion of the case when the plunger
is in a raised retracted position.
11. Apparatus as set forth in claim 10 having spring means for
biasing the plunger upward to its retracted position.
12. Apparatus as set forth in claim 11 wherein the case comprises a
bottom section and a cover, the bottom section having a bottom
wall, means extending upward from the bottom defining a chamber for
the shield, a peripheral wall extending upward from the bottom wall
having a gap therein, a panel inset in the case at the gap defining
said recess, and a head at the top of the recess, said plunger
being vertically slidable in openings in the cover and said head
and extending above the cover.
13. Apparatus as set forth in claim 12 wherein the plunger is
tubular, the fitting extending through the lower end of the plunger
and adapted for attachment to its lower end of the needle, the
flexible tubing portion of the eluate conduit extending within the
case through a lateral opening in the plunger spaced from the lower
end of the plunger and down through the plunger to a connection
with the upper end of the fitting, said portion of the case being
instituted by a jaw member on the inside of the cover at the said
opening in the cover, the jaw member on the plunger being adapted
to pinch closed said flexible tubing portion where it extends into
said opening against said jaw member on the inside of the
cover.
14. Apparatus as set forth in claim 13 wherein said spring means
comprises a coil compression spring surrounding the plunger
reacting from said head against the jaw member on the plunger.
15. Apparatus as set forth in claim 12 wherein the cover is formed
with at least one compartment for holding a supply of
containers.
16. Apparatus as set forth in claim 1 for containerizing the eluate
in an evacuated container having a closure adapted to be pierced by
a needle, wherein the means for holding the supply of eluant holds
it under atmospheric pressure and wherein, when the needle pierces
said closure, the eluant is suctioned from the eluant supply means
into the generator for eluting the daughter radioisotope from the
parent radioisotope in the generator and the resultant eluate is
suctioned from the generator through the eluate conduit, fitting
and needle into the evacuated container.
17. Apparatus as set forth in claim 16 wherein the means for
holding the supply of eluant under atmospheric pressure comprises a
sealed plastic bag.
18. Apparatus as set forth in claim 16 wherein the means for
effecting closure of the eluate conduit comprises a member movable
with the fitting for pinching closed the flexible tubing portion of
the eluate conduit when the fitting is in its retracted
position.
19. Apparatus as set forth in claim 18 having spring means for
biasing the fitting toward its retracted position.
20. Apparatus as set forth in claim 16 wherein the mounting means
for the fitting comprises a plunger and means guiding the plunger
for vertical sliding movement downward from a raised retracted
position toward an evacuated container positioned therebelow with
its piercable closure at the top, the fitting being adapted for
attachment thereto of the needle with the needle extending
downward, the means for effecting closure of said eluate conduit
comprising a jaw member on the plunger and a fixed jaw member
thereabove, the flexible tubing portion of the eluate conduit
extending between said jaw members and being pinched closed between
said jaw members when the plunger is in its raised retracted
position.
21. Apparatus as set forth in claim 20 having spring means biasing
the plunger upward toward its raised retracted position.
22. Apparatus as set forth in claim 21 wherein the plunger is
tubular, the fitting extending through the lower end of the plunger
and adapted for attachment to its lower end of the needle, the
flexible tubing portion of the eluate conduit extending through a
lateral opening in the plunger spaced from the lower end of the
plunger and down through the plunger to a connection with the upper
end of the fitting, the jaw member on the plunger being adapted to
pinch closed said flexible tubing portion where it extends into
said opening.
23. Apparatus as set forth in claim 16 wherein the generator
comprises an elongate closed vessel adapted for vertical
disposition and having a convergent closed lower end, and means
therein spaced from its lower end for maintaining the supply of the
parent radioisotope spaced from its lower end, the eluant conduit
being in communication with the upper end of the vessel and the
eluate conduit being in communication with the lower end of the
vessel.
24. Apparatus as set forth in claim 23 wherein the vessel comprises
a tube having a hemispherical lower end a stopper in its upper end,
the means for maintaining the parent radioisotope spaced from its
lower end comprising a filter mounted in the tube above its lower
end, the parent radioisotope being confined between the filter and
the stopper, the eluant conduit extending down through the stopper
and terminating immediately below the stopper, the eluate conduit
extending down through the stopper and the filter to the lower end
of the tube.
25. Apparatus as set forth in claim 16 further comprising a case
having a chamber receiving the shield with the generator therein, a
compartment adjacent said chamber receiving the eluant supply
means, said case being formed with a recess opening inward from the
side of the case adapted to receive the evacuated container with
its piercable closure at the top of the container and having a
portion overhanging the recess, said fitting being carried at the
lower end of a plunger vertically slidable in said overhanging
portion of the case.
26. Apparatus as set forth in claim 25 wherein the means for
effecting closure of the eluate conduit comprises a jaw member on
the plunger adapted to pinch closed the flexible tubing portion of
the eluate conduit against a portion of the case when the plunger
is in a raised retracted position.
27. Apparatus as set forth in claim 26 having spring means for
biasing the plunger upward to its retracted position.
28. Apparatus as set forth in claim 27 wherein the case comprises a
bottom section and a cover, the bottom section having a bottom
wall, means extending upward from the bottom defining said chamber
for the shield, a peripheral wall extending upward from the bottom
wall having a gap therein and a panel inset in the case at the gap
defining said recess, and a head at the top of the recess, said
plunger being vertically slidable in openings in the cover and said
head and extending above the cover.
29. Apparatus as set forth in claim 28 wherein the plunger is
tubular, the fitting extending through the lower end of the plunger
and adapted for attachment to its lower end of the needle, the
flexible tubing portion of the eluate conduit extending within the
case through a lateral opening in the plunger spaced from the lower
end of the plunger and down through the plunger to a connection
with the upper end of the fitting, said portion of the case being
instituted by a jaw member on the inside of the cover at the said
opening in the cover, the jaw member on the plunger being adapted
to pinch closed said flexible tubing portion where it extends into
said opening against said jaw member on the inside of the
cover.
30. Apparatus as set forth in claim 29 wherein said spring means
comprises a coil compression spring surrounding the plunger
reacting from said head against the jaw member on the plunger.
31. Apparatus as set forth in claim 28 wherein the cover is formed
with at least one compartment for holding a supply of evacuated
containers.
Description
BACKGROUND OF THE INVENTION
This invention relates to the generation and containerization of
radioactive isotope solutions, and more particularly to apparatus
for the generation and containerization under sterile conditions of
such solutions obtained as the eluate in a closed system
radioisotope generator.
The invention is particularly concerned with the preparation and
packaging, in a sterile closed system, of a solution of a daughter
radioisotope, such as technetium-99m, generated from a parent
radioisotope, such as molybdenum-99. Conventionally, the
preparation of a daughter radioisotope from a parent radioisotope
has been carried out using a generator containing the parent
radioisotope and an anion exchange medium or other medium, such as
alumina, having a high adsorptive capacity for the parent
radioisotope but a low adsorptive capacity for the daughter
radioisotope. The desired daughter radioisotope is eluted by
washing with a suitable solvent or eluant such as a sterile,
pyrogen-free isotonic saline solution. The resulting eluate
containing the daughter radioisotope in the form of a dissolved
salt is useful as a diagnostic agent, for example, and is adapted
for intravenous administration.
The generator containing the parent radioisotope adsorption medium
for eluting the daughter radioisotope is frequently referred to in
the art as a "cow", and the elution of the daughter radioisotope
therefrom is generally referred to in the art as "milking the
cow."
Some widely used daughter radioisotopes used in medical diagnosis
have relatively short half-lives, e.g., 6 hours, and it is
important therefore that they be generated or prepared shortly
before usage in the hospital, clinic or other place of use. Thus,
there is need, for example, for apparatus enabling generation and
containerization under sterile conditions once a day in a hospital
or clinic of the eluate, also under conditions wherein the user of
the apparatus is afforded maximum protection against radioactive
emission from the generator. Prior apparatus for the purpose, such
as disclosed in U.S. Pat. Nos. 2,942,943 and 3,369,121 and in the
copending coassigned U.S. patent application of Donald J. Shumate,
Ser. No. 658,872, filed Aug. 7, 1967, titled Closed System
Generation and Containerization of Radioisotopes, issued as U.S.
Pat. No. 3,535,085, Oct. 20, 1970, has not been wholly
satisfactory, primarily on account of the necessity for carrying
out a number of hand operations while the shield for the generator
is open, thus exposing the hands and possibly other parts of the
operator to radiation. Since the decay characteristics of most of
the parent-daughter radioisotope combinations presently in
large-scale use require that the generator (the "cow") be "milked"
daily, the use of the above prior devices undesirably involves
daily exposure of the operator to radioactivity during the
"milking" operation.
SUMMARY OF THE INVENTION
Accordingly, among the several objects of this invention may be
noted the provision of an improved closed system radioisotope
generation and containerization apparatus, for the generation and
containerization of a sterile solution of a daughter radioisotope,
which satisfies radiation safety requirements; the provision of
such an apparatus which minimizes operator handling and exposure;
and the provision of such an apparatus which is easy and economical
to use.
In general, apparatus of this invention is adapted for eluting a
daughter radioisotope from a parent radioisotope and for
containerizing the resultant eluate in an evacuated container
having a closure adapted to be pierced by a needle. It comprises a
generator containing a supply of the parent radioisotope, a shield
enclosing the generator for shielding the user against radioactive
emission from the generator, means for holding a supply of eluant
adjacent the shield and generator, and an eluant conduit extending
from the eluant supply means through the shield and into the
generator. A tubular fitting adapted for attachment thereto at one
end of a tubular needle for piercing said closure is mounted
adjacent the shield and generator for movement away from a
retracted position in the direction of length of the needle to
cause the needle to pierce said closure. An eluate conduit extends
from the generator through the shield and has a flexible tubing
portion connected to the other end of the tubular fitting
permitting movement of said fitting. The eluant conduit, generator,
eluate conduit and fitting constitute a closed passage from the
eluant supply to the needle. Associated with said fitting is means
for effecting closure of said eluate conduit when said fitting is
in its said retracted position and opening of said eluate conduit
when said fitting is moved to cause the needle to pierce the
closure of said evacuated container for flow of eluant from the
eluant supply means through the eluant conduit into the generator
for eluting the daughter radioisotope from the parent radioisotope
in the generator and flow of the resultant eluate from the
generator through the eluate conduit, fitting and needle into the
evacuated container. Other objects and features will be in part
apparent and in part pointed out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective of an apparatus made in accordance with
this invention, a plastic case of the apparatus being illustrated
as transparent for viewing interior detail;
FIG. 2 is a plan of the FIG. 1 apparatus;
FIG. 3 is a view in elevation of the apparatus, showing a container
in position for receiving the eluate eluted from a generator in the
case;
FIG. 4 is a vertical section on line 4--4 of FIG. 2;
FIG. 5 is a vertical section on line 5--5 of FIG. 2;
FIG. 6 is a horizontal section on line 6--6 of FIG. 3;
FIG. 7 is an enlarged fragment of FIG. 4 showing a plunger and
tubular needle of the apparatus driven downward with the needle
pierced through the stopper of the container; and
FIG. 8 is an enlarged vertical section of a generator or "cow" of
the apparatus.
Corresponding reference characters indicate corresponding parts
throughout the several views of the drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to the drawings, apparatus made in accordance with this
invention is shown essentially to comprise a generator or "cow" 1
containing a sterile pyrogen-free supply 3 of a parent
radioisotope. The generator is enclosed in a shield 5 for shielding
the user of the apparatus against radioactive emission from the
generator. At 7 is indicated means for holding a sterile
pyrogen-free supply of an eluant with the eluant under atmospheric
pressure. An eluant conduit 9 extends from means 7 through the
shield and into the generator.
At 11 is indicated a tubular fitting adapted for attachment thereto
at one end (its lower end) of a tubular needle 13, which may be a
conventional hypodermic needle. The apparatus, as will appear,
provides for the sealed sterile containerization of a sterile
pyrogen-free eluate eluted from the parent radioisotope in a sealed
sterile evacuated container or vial 15, shown as comprising a glass
bottle having a neck 17 sealed at its upper end by a closure 19
adapted to be pierced by the needle 13. Closure 19 may be a
conventional rubber stopper, and is shown as having an aluminum
foil cover 21. This cover has a removable circular central section,
shown removed in FIGS. 1 and 7 leaving an opening 23 in the
cover.
Means generally designated 25 is provided for mounting the tubular
fitting 11 (and needle 13) for movement away from the retracted
position of FIG. 3 in the direction of length of the needle to
cause the needle to pierce the closure or stopper 19. An eluate
conduit 27 extends from the generator through the shield and has a
flexible tubing portion 29 connected to the other end (the upper
end) of the tubular fitting 11 permitting the stated movement of
the fitting. At 31 is indicated means associated with the fitting
11 for effecting closure of the eluate conduit when the fitting is
in its retracted position and opening of the eluate conduit when
the fitting is moved downward to cause the needle 13 to pierce the
stopper 19 of the evacuated container 15, with resultant suctioning
of eluant from the eluant supply means 7 into the generator 1 for
eluting a daughter radioisotope from the parent radioisotope in the
generator and suctioning of the resultant eluate from the generator
through the eluate conduit 27, fitting 11 and needle 13 into the
evacuated container 15.
The generator 1, as shown, comprises an elongate cylindric vessel
33 constituted by a glass tube resembling a test tube having a
convergent closed lower end 35 of hemispherical form and a neck 37
at its upper end. A pierceable closure constituted by a rubber
stopper 39 is plugged in the neck to seal the vessel. This has an
aluminum foil cover 41 from which a circular central section has
been removed. A fritted glass filter 43 is mounted in the vessel
just above its hemispherical lower end. The vessel 33 is necked
down as indicated at 45, and the filter is lodged in the
necked-down portion and bonded therein. The space below the filter
constitutes an eluate chamber 49, and the filter serves as means
for maintaining the supply 3 of the parent radioisotope spaced from
the lower end of the vessel, so that chamber 49 is maintained free
of the supply 3.
The filter 43 has a center hole 51. The eluate conduit 27 comprises
a length of relatively small diameter metal tubing 53 (e.g.,
stainless steel tubing) bent to have a vertical leg 55 and a
horizontal arm 57. The lower end of the vertical leg 55 is beveled
as indicated at 59. The vertical leg 55 extends down through the
stopper 39, its beveled lower end 59 permitting it to be pierced
through the stopper, and reaches down through the center hole 51 in
the filter 43 substantially to the bottom of the hemispherical
lower end 35 of the vessel 33. The hole 51 may be of substantially
larger diameter than the leg, and the latter may be sealed in the
hole by a suitable sealant, such as silicone rubber as indicated at
61.
The supply or charge 3 of the parent radioisotope is packed in the
vessel above the filter and surrounds the vertical leg 55 of the
tubing 53, which leg extends down generally centrally of the
vessel. The charge 3 comprises the parent radioisotope adsorbed on
an anion exchange medium, alumina or other suitable medium, in
granular form, and having under suitable conditions, a high
adsorption capacity or affinity for the parent radioisotope but a
low adsorption capacity for the daughter radioisotope. For
generation of technetium-99m, for example, the charge 3 in the
vessel may comprise molybdenum-99, in the form of ammonium
molybdate, as the parent radioisotope, adsorbed on alumina, the
latter constituting a medium having a high adsorption capacity for
ammonium molybdate Mo-99 but a low adsorption capacity for the
daughter technetium-99m compound in the presence of certain known
eluting solutions.
The eluant conduit 9 comprises a length of relatively small
diameter metal tubing 63 (e.g., stainless steel tubing) like tubing
53, bent to have a relatively short vertical leg 65 and a
horizontal arm 67. The lower end of the vertical leg is beveled as
indicated at 69. The vertical leg 65 extends down through the
stopper 39, its beveled lower end 69 permitting it to be pierced
through the stopper, and terminates just below the stopper. The
charge 3 substantially fills the vessel from filter 43 up to the
stopper, and leg 65 may reach down just into the top of the charge.
The eluant conduit 9 further comprises a length of flexible tubing
71 interconnecting the eluant supply means 7 and a fitting 73 on
the end of the arm 67 of tubing 63. As herein shown, the eluant
supply means 7 comprises a plastic bag or transfer pack containing
the eluant, this bag being subject to being squeezed by atmospheric
pressure, the bag having an outlet 75 from which flexible tubing 71
extends to the fitting 73 on the end of arm 67. The eluant may be,
for example, a sterile pyrogen-free saline solution which in the
case of elution of technetium-99m as the daughter radioisotope from
molybdenum-99, results in the daughter radioisotope being present
in the eluate as sodium pertechnetate.
As herein illustrated, the shield 5 for the generator comprises a
relatively thick-walled receptacle, which may be made of lead or
other suitable shielding material, formed to provide a cylindric
chamber 77 extending down from the top of the receptacle, and
formed with supporting legs 79. Chamber 77 has a diameter somewhat
greater than that of the generator 1 and a length (height) somewhat
greater than that of the generator. The receptacle is formed with
two diametrically opposite slots 81 extending down from its upper
end, and is closed, after insertion of the generator therein, by a
closure constituted by a plug 83 made of lead or other suitable
shielding material inserted in the upper end of the chamber. The
generator is inserted in the chamber with arms 57 and 67 of the
metal tubing portions 53 and 63 of the eluant and eluate conduits 9
and 27 extending laterally outward through the slots 81 at the
lower ends of these slots (the generator, in effect, being hung in
the chamber by engagement of arms 57 and 67 with the lower ends of
the slots). The plug has two ears 85 extending outward therefrom
diametrically opposite one another fitting in the slots and bearing
on the arms. The plug may be removably secured to the receptacle
(after insertion of the generator) as by adhesive tape (not shown)
or in any other suitable manner.
The shield 5 with the generator 1 sealed therein and the plastic
bag 7 containing the eluant are supplied in a case generally
designated 87. This case, which may be made of either transparent
or opaque plastic or any other suitable material, comprises a
bottom section 89 and a cover 91. The bottom section 89 has a
circular flat bottom plate 93, an internal cylindric wall 95
extending up from bottom 93 and concentric therewith, and an
external peripheral wall 97 extending up from the margin of bottom
93. Wall 97 is part cylindric, having a gap 99 therein spanning
somewhat less than 90.degree. of arc. Radial partitions 101 and 103
extend from the internal wall 95 to the peripheral wall 97, the
outer ends of these partitions (which lie in planes at right angles
to one another) being joined to the peripheral wall 97 on opposite
sides of the gap 99. Partitions 105 and 107 extend from the
internal wall 95 to the peripheral wall 97 diametrically opposite
partitions 101 and 103. A curved panel 109, convexly curved as
viewed from outside the case, extends between the vertical margins
of the peripheral wall 97 on opposite sides of the gap 99 in wall
97 and butts against the internal wall 95. This curved panel
defines a recess 111 opening inward from the respective side of the
case, bottomed by portion 93a of the bottom plate.
The walls 95 and 97 and partitions 101, 103, 105, and 107 are of
equal height, somewhat less than the height of the shield 5. The
curved panel 109 has an upward extension 113 of reduced width
extending up above the level of the top of walls 95 and 97 and the
partitions. The top of the recess 111 is closed by a horizontal
head plate 115 at the top of extension 113, this plate 115 having
an inner edge curved in correspondence with the curvature of the
panel, and an outer edge 117 curved on an arc centered in the
vertical central axis of the case bottom section 89 of radius
corresponding to the radius of the inside of the peripheral wall
97. Plate 115 has a centrally located vertical opening 119 and an
annular boss 121 extending upward around this opening.
The internal wall 95 has an internal diameter somewhat larger than
the cross section of shield 5 and defines a chamber 123 located
centrally of the case bottom section 89 receiving the shield. The
feet of the latter are confined within a centering ring 125
projecting up from bottom 93 of section 89 within the wall 95.
Partitions 105 and 107 in conjunction with walls 95 and 97 define a
compartment 127 receiving the plastic eluant bag 7.
The cover 91 comprises a cylindric external peripheral wall 129
having the same diameter as wall 97, and a cylindric internal wall
131 having the same diameter as wall 95. Radial partitions 133,
135, 137, and 139 (corresponding to partitions 101, 103, 105, and
107) extend between these walls. The upper rims of walls 129 and
131 are at the same level, but wall 129 extends down somewhat
farther than wall 131. Wall 129 has a relatively wide shallow notch
141 in its lower margin, the width of this notch corresponding to
the width of gap 99. Extending around the inside of wall 129 at the
lower end thereof from adjacent one side of the notch to the other
is a rim 143 which projects down below the lower edge of wall 129
and which has a telescopic sliding fit within wall 97 of the case
bottom section 89. The downwardly projecting portion of this rim
has notches 145 receiving the partitions 103, 105, 107, and 109.
Wall 131 defines a chamber 146 for the upper end of shield 5, and
has notches 147 at its lower end for passage of arms 57 and 67.
Chamber 146 is closed at the top by a circular top plate 149 spaced
somewhat below the upper end of wall 131 to provide a circular
compartment 151 for holding a supply of needles 13. A plate 153
closes the top of the space bounded by partitions 133 and 135 and
walls 129 and 131, and a plate 155 closes the top of the space
bounded by partitions 137 and 139 and walls 129 and 131, defining
oppositely located downwardly opening chambers 157 and 159. Plates
161 close the bottom of the space bounded by partitions 133 and 139
and the bottom of the space bounded by partitions 135 and 137 and
walls 129 and 131, defining two oppositely located upwardly opening
compartments 163 for holding a supply of evacuated bottles 15.
The means 25 for mounting the tubular fitting 11 includes a tubular
plunger 165 mounted for vertical sliding movement in the opening
119 in the plate 115 and in an aligned opening 167 in the plate 153
of the cover, these plates constituting a portion of the case 87
overhanging the recess 111. An annular boss 169 extends down from
plate 153 around the opening 167, and has an annular groove 171 of
inverted V-section in its lower end. The plunger has a plug 173 in
its lower end, the fitting 11 being received in an axial opening
175 in the plug. The fitting extends down from the plug for
attachment of the needle 13 to the lower end of the fitting with
the needle extending downward from the lower end of the fitting by
applying a ferrule 177 on the upper end of the needle to the lower
end of the fitting. The plunger has a lateral opening 179 (see FIG.
7) spaced from its lower end located between the plates 115 and
153. The flexible tubing portion 29 of the eluate conduit 27
extends through this opening and down through the plunger to a
connection at 181 with the upper end of fitting 11. The plunger has
an annular collar 183 thereon immediately below the opening 179
formed with an upwardly extending annular rib 185 of inverted
V-section matching the V-section groove 171 in boss 169. A coil
compression spring 187 surrounding the plunger reacts from the boss
121 against the collar 183 to bias the plunger upward toward its
raised retracted position in which it is illustrated in FIG. 4. A
knob 189 is provided at the upper end of the plunger. Axially
extending keys 191 on the plunger slide in keyways 193 at opposite
sides of opening 167 to prevent rotation of the plunger about its
vertical axis.
The collar 183 on the plunger 165 constitutes a movable jaw member
which functions in conjunction with boss 169 as a fixed jaw member
to pinch closed the flexible tubing portion 29 of the eluate
conduit where it extends into the opening 179 when the plunger is
biased upward to its raised retracted position by the spring 187
(see FIGS. 1, 3, and 4). The latter exerts sufficient upward force
on the plunger for this purpose. When the plunger is driven
downward against the return bias of spring 187, the pinch on the
tubing portion 29 is released and the eluate conduit is thus opened
for flow of eluate.
The generator 1, containing the sterile pyrogen-free supply 3 of
the parent radioisotope, and itself being made sterile and
pyrogen-free (as by heating) is placed in chamber 77 in the lead
shield 5, and the latter is closed by the plug 83. The shield 5 and
the plastic bag 7 containing the supply of sterile pyrogen-free
eluant are placed in the bottom section 89 of the case 87, tubing
71 is connected to fitting 73, and tubing 29, extending from
fitting 11 out of the plunger 165 through opening 179, is connected
to a fitting 195 on the end of arm 57. The metal tubing and
flexible tubing portions of the eluant and eluate conduits and
fitting 11 are all in sterile and pyrogen-free condition, and it
will be understood that the needles 13 are supplied in sterile
pyrogen-free condition. The cover 91 of the case 87 is applied to
the bottom section 89, and secured thereto in any suitable manner,
as by adhesive tape, or by use of a solvent for the plastic of the
case and cover to cause them to become bonded together. The
containers or vials 15, as initially supplied, are sterile and
pyrogen-free and evacuated of air. They may have graduations marked
thereon for indicating volume of eluate drawn thereinto.
In the use of the apparatus, an evacuated container or vial 15,
held in a lead cup 197, is placed in the recess 111 of the case 87
with the stopper 19 of the vial in line with the needle 13 on the
lower end of the fitting 11. The plunger 165 is then manually
pushed downward against the upward return bias of spring 187 to
cause the needle 13 to pierce through the stopper 19 of the vial
(see FIG. 7) and simultaneously to effect release of the flexible
tubing portion 29 of the eluate conduit 27 by the jaw member 183 so
as to open the eluate conduit. This results in suctioning of the
eluant from the eluant supply bag 7 (which is under atmospheric
pressure) through the eluant conduit 9 into the generator 1 for
eluting the daughter radioisotope from the parent radioisotope in
the generator. The resultant eluate passes down through the filter
43 into the eluate chamber 49 at the lower end of the generator,
and is suctioned upward through leg 55 of metal tubing 53 and
thence through flexible tubing portion 29 of the eluate conduit 27,
and fitting 11 and needle 13 into the evacuated vial 15. The
plunger 165 is held down until the desired amount of eluate has
been suctioned into the vial, and then released to be returned to
its raised retracted position by the spring 187, resulting in
pinching of the flexible tubing portion 29 of the eluate conduit 27
to cut off further flow as might otherwise occur due to siphoning
action. The filled vial is then taken away for ultimate use, and
the apparatus is ready for the next "milking" operation.
It will be observed that the "milking" operation is carried out
without opening of the shield 5, hence does not involve any
exposure of the operator to radiation from the generator 1. The
latter at all times remains essentially sealed within the shield,
which is made of lead or other suitable material for shielding
against radioactive emission from the generator. After the first
"milking" operation, there will be some eluant in the eluant
conduit 27 from the shield to where the flexible tubing portion 29
of the eluant conduit is pinched between jaw members 183 and 169,
but radiation from this amount of eluant is minor.
While, as above described, the elution is by use of an evacuated
container 15 and suctioning of the eluant into the generator and
the eluate out of the generator (i.e., a vacuum system), the
principles of the invention are also applicable to a pressure
system, as distinguished from a vacuum system, using a nonevacuated
container or vial, and in which the eluant supply would be under
pressure above atmospheric pressure or adapted for flow by gravity
through the generator into the vial, and a vent would be provided
in the stopper of the vial.
In view of the above, it will be seen that the several objects of
the invention are achieved and other advantageous results
attained.
As various changes could be made in the above constructions without
departing from the scope of the invention, it is intended that all
matter contained in the above description or shown in the
accompanying drawings shall be interpreted as illustrative and not
in a limiting sense.
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