EP0390916A4

EP0390916A4 - Device for the oral administration of a radioactive liquid

Info

Publication number: EP0390916A4
Application number: EP19900901098
Authority: EP
Inventors: Harm Martinus Benjamins
Original assignee: Mallinckrodt Inc
Current assignee: Mallinckrodt Inc
Priority date: 1988-09-14
Filing date: 1989-08-25
Publication date: 1991-03-13
Also published as: JPH03501351A; AU4832590A; WO1990003200A2; EP0390916A1; WO1990003200A3

Abstract

The invention relates to a device for the oral administration of a radioactive liquid, comprising: a reservoir for the radioactive liquid to be enclosed within a shielding sleeve, a separate holder for rinsing liquid to be accommodated outside the sleeve, a connection tube to communicate the interior of the holder for rinsing liquid with the interior of the reservoir, and a suction tube which has such a length that one end can be provided in the interior of the reservoir and the other end, namely the suction end, can reach the patient's mouth, in which: the reservoir is sealed by means of a pierceable rubber stopper, the ends of the connection tube and of the suction tube, which permit communication with the interior of the reservoir, comprise hollow needles, and the connection tube comprises a one-way valve to prevent radioactive liquid from flowing from the reservoir into the holder for rinsing liquid.

Description

Device for the oral administration of a radioactive liquid.

The invention relates to a device for the oral adminis ration of a radioactive liquid.

For medical considerations it may be desired to give a patient such a liquid to drink. A well-known example of such a radioactive substance for oral administration is radioactive iodine, in particular iodine-131. This radio¬ active iodine is given a patient to drink, for example, in the form of sodium iodide dissolved in water, either as a diagnostic, namely to provide information about the activity of the thyroid gland, or as a therapeutic, namely to control thyroid gland tumours. It will be obvious that such an adminis ration often is not very comfortable for the patient and moreover is not safe both for him/herself and for his/her environment. In fact, the possibility of spilling the solution given to drink is great. The invention relates more in particular to a device for the oral adminis ration of a radioactive liquid, comprising

- a reservoir for the radioactive liquid to be enclosed within a shielding sleeve, - a separate holder for rinsing liquid to be accommodated outside the sleeve,

- a connection tube to communicate the interior of the holder for rinsing liquid with the interior of the reservoir , and - a suction tube which has such a length that one end can be provided in the interior of the reservoir and the other end, namely the suction end, can reach the patient's mouth.

Because lead provides a good shielding from radio- active radiation, the shielding sleeve is usually manufac¬ tured from lead. Such a device is known from the recently published United States Patent Specification 4,715,359. The object of the device described therein is to be able to administer a radioactive iodine-containing liquid safer for the patient and his/her environment. For that purpose the reservoir for the radioactive liquid can be closed by means of a screw cap to replace the conventional closure. This screw cap is perforated to enable the ends of connection tube and suction tube to reach the interior of the reservoir, the construction permitting fixation of said tubes in the perforations in the screw cap in such a manner that the end of the suction tube extends deeper in the reservoir than that of the connection tube. As a result of this return of the radioactive liquid through the connection tube into the holder for rinsing liquid can be prevented.

The major disadvantage of the known device is that the conventional reservoir closure must first be removed before the screw cap with the set of tubes fixed therein can be provided. As a result of this, the person who makes the device ready for use in this manner is exposed to radioac¬ tive radiation for a considerable period of time. Moreover, radioactive liquid may be spilled during the said manipula¬ tions, which may also constitute a danger for the environ¬ ment. Another particular aspect is that, when using iodine- 131-containing liquids, contamination of the environment may take place as a result of the great volatility of this substance. Moreover, it is a difficult operation to provide a screw cap equipped with two tubes on a reservoir which is filled with radioactive liquid, which involves the danger that the tubes can move in the screw cap so that the hermetic seal may be lost and the return safety can be endangered.

It is the object of the present invention to provide a device for the oral administration of a radioactive liquid which does not exhibit the above-mentioned disadvantages. For that purpose, the device according to the invention which, as indicated hereinbefore, comprises a reservoir for radioactive liquid to be enclosed within a shielding sleeve, a holder for rinsing liquid, a connection tube and a suction tube, is characterized in that

- the reservoir is sealed by means of a pierceable rubber stopper ,

- the ends of the connection tube and of the suction tube, which permit communication with the interior of the reservoir, comprise hollow needles, and

- the connection tube comprises a one-way valve to prevent radioactive liquid from flowing from the reservoir into the holder for rinsing liquid. For using the device according to the invention it is not necessary to remove the rubber sealing stopper with which such a reservoir is usually sealed hermetically and which is usually kept in its place by means of a flanged capsule. The rubber stopper can be pierced by means of the needles, in which the desired communications with the interior of the reservoir can be produced to make the device ready for use. In order to prevent return of the radioactive liquid, from the reservoir into the shielded holder for rinsing liquid, a one-way valve is provided in the connection tube. In contrast with the return safety in the known device, this is a more convenient and absolutely safe facility.

The device according to the invention preferably also comprises a tube sealing means, for example, a tube clip or some other means suitable for this purpose, to enable sealing of the suction tube between the hollow needle and the suction end. In this manner the device made ready for use can always remain sealed hermetically up to the instant the patient will use it so that no radioactive substance can be released. For using the device the patient can simply open or remove the tube sealing means, after which he/she can take the radioactive liquid by sucking; in doing this the reservoir will be rinsed with rinsing liquid from the holder.

In a further preferred embodiment the device according to the invention is constructed so that the shielding sleeve comprises two portions, namely (1) a sleeve-like portion which is open at its upper end and which at its lower end is accessible for the ends of the needles of connection and suction tubes, and (2) a lid having an upright circumferential edge or a thickened central portion, as a result of which the lid is movable telescopically over a given distance with respect to the open upper end of the sleeve-like portion; and that the sleeve-like portion is proportioned so that the reservoir with radioactive liquid can be accommodated therein in the upside-down position in such a manner that, prior to use of the device, the rubber sealing stopper bears on the ends of the above-mentioned needles present in said portion, the bottom of the reservoir projecting above the open upper end of the sleeve-like portion and the lid not adjoining the said open upper end but bearing on the bottom of the reservoir so that, when the device is made ready for use, pressure can be exerted on the lid of the shielding sleeve as a result of which the said lid can move over the above-mentioned distance, the reservoir being pushed down and the rubber stopper being pierced by the needles of connection tube and suction tube to produce the desired communications. The advantage of this preferred embodiment is the particularly simply and safe manner in which the device can be made ready for use. As a matter of fact, by simply exerting pressure on the lid, i.e. pushing it down over a certain distance with respect to the sleeve-like portion, the rubber stopper is pierced by the needles, the desired communications being produced. So during making the device ready for use the reservoir with radioactive liquid remains safely enclosed by the shielding sleeve. After using the device for administering a dose of radioactive liquid, the emptied reservoir can simply be taken out of the reservoir by removing the lid from the sleeve-like portion of the shielding sleeve. For the easy removal also of the tube set equipped with the needles from the above-mentioned preferred embodiment according to the invention it is advantageous to construct the said device so that at least one vertical groove is recessed in the wall of the sleeve-like portion of the shielding sleeve which groove is present in the proximity of the bottom of the said portion or extends downwards into the said bottom and which groove is proportioned so that the ends of the needles of connection tube and suction tube can be admitted therethrough to the sleeve-like portion. After removing the reservoir and the tube set, a "fresh" reservoir, i.e. a hermetically sealed reservoir filled with radioactive liquid, may be introduced into the shielding sleeve in the same manner and a new tube set may be provided. The device then is in a position again to be made ready for use in the above-described manner and then to be used by a patient for taking a dose of radioactive liquid. In another likewise very favourable embodiment the device according to the invention is constructed so that the needles of connection tube and suction tube are connected parallel to each other in a needle holder which, after providing the needle ends inside the sleeve-like portion of the shielding sleeve, engages the lower end of the said portion and thus fixes the needles in the upright position with respect to the said sleeve-like portion. After using the device for administering a dose of radioactive liquid, the emptied reservoir in this latter preferred embodiment can easily be removed together with the tube set connected thereto by means of the needles. In doing this it is not necessary to detach the tube set from the empty reservoir, so that the safety of the device is further improved.

The invention finally relates to a tube set for the above device according to the invention comprising a connection tube which is provided with a one-way valve and at one end with a hollow needle, and a suction tube which is optionally provided with a tube sealing means and which at one end also comprises a hollow needle and at the other end is optionally provided with a suction mouthpiece. If desired, the needles may be connected parallel to each other in a needle holder. This tube set is preferably disposable and is then replaced by a fresh tube set for each adminis ration. The needles of said tube set are manufactured from a metal or a suitable non-deformable synthetic resin, preferably from stainless steel. The tubes are of a suitable flexible material, preferably a rubber or a synthetic material, for example, a silicone rubber. The suction end of the suction tube may comprise a suitable mouthpiece preferably manufactured from a synthetic material .

The invention will now be described in greater detail, by way of example, with reference to preferred embodiments which are shown in the drawings which are longitudinal sectional views of devices according to the invention.

Iri Figure 1, the lid 2 of the lead shielding sleeve 1 comprises an upright circumferential edge 3 which can move telescopically over a distance "a" over the externally narrowed upper end 4 of the sleeve-like portion 5 of the sleeve. A reservoir 7 for radioactive liquid is provided upside down in the shielding sleeve and bears with a pierceable rubber stopper 8 which is held in its place by a flanged capsule 9, on two needle ends. The hollow needles 10 and 11 communicate, through connection tube 12 and suction tube 13, with a cup-shaped holder 14 for rinsing liquid and a suction mouthpiece 15, respectively. A one-way valve 16 which passes liquid only in the direction of the reservoir 7 is incorporated in the connection tube 12. Suction tube 13 is provided with a tube clip 17. The device is placed on a suitable mount 18. The sleeve-like portion 5 comprises vertical grooves (not shown in the drawing) which extend downwards into the bottom and open into an aperture 6 through which the needles can be inserted within this sleeve-like portion into the position shown in the drawing.

After placing the cup-shaped holder with rinsing liquid and providing the tube set in the correct position, the reservoir containing radioactive liquid is placed inside the lead shielding sleeve so that the pierceable rubber stopper bears on the needle ends. By exerting a downward pressure on the lid, said lid is lowered over a distance "a", the sharp needle ends piercing the rubber stopper of the reservoir. The device is now ready for use. When using the device, the patient detaches the tube clip 17, takes mouthpiece 15 into his/her mouth and sucks the radioactive liquid. As a result of the vacuum formed in the reservoir during sucking, rinsing liquid is drawn from the cup-shaped holder into the reservoir. This rinsing liquid ensures that all the radioactive material from the reservoir reaches the patient's mouth and can thus be swallowed; this promotes the accuracy of the determination. The embodiment shown in Figure 2 also comprises a reservoir 20 enclosed within a shielding sleeve 19. The device shown in this Figure has already been made ready for use, the hollow needles 21 and 22 of a tube set having pierced the rubber stopper 32 of the reservoir. The set further comprises a, schematically shown, suction tube 23 with one-way valve 24, also schematically shown, suction tube 25 with tube clip 26, and a needle holder 27 in which the needles are connected. The holder with rinsing liquid is referenced 28 and reference numeral 29 denotes the mount on which the device is placed. The lead shielding sleeve again consists of two portions, namely a sleeve-like portion 30 having an open lower end through which the ends of the needles can be admitted to the shielding sleeve, and a lid 31 which, during making the device ready for use, has pushed the reservoir downwards over such a distance that the stopper 32 of the reservoir has been pierced by the needles. The synthetic material holder 27 in which the needles are secured and which engages the open lower end of the sleeve-like portion of the shielding sleeve ensures that the needles are fixed in the upright position with respect to said sleeve-like portion and hence also with respect to the reservoir placed in the shielding sleeve. A holder of a synthetic material may be connected around the reservoir in a clamping manner, for example, as described in Netherlands Patent Application 7805066. In order to protect the user of the device and his/her environment even better from radioactive radiation, a lead container 31 is further provided inside the mount. After use of the device the tube set including the reservoir which is then empty can simply be taken out of the device and be replaced by a fresh tube set and a reservoir filled with radioactive liquid.

Claims

1. A device for the oral administration of a radioactive liquid, comprising:

a reservoir for holding the radioactive liquid, being sealed by a pierceable rubber stopper and being adapted to be enclosed in a shielding sleeve;

a holder for holding rinsing liquid provided separately from the shielding sleeve;

a connection tube having a first end provided with a hollow needle for communicating with the interior of the reservoir, and a second end for communicating with the interior of the holder, the connection tube including a one-way valve which permits flow of the rinsing liquid from the holder to the reservoir and prevents flow of the radioactive liquid from the reservoir to the holder; and

a suction tube having a first end provided with a hollow needle for communicating with the interior of the reservoir, and a second end for allowing the oral administration of the radioactive liquid to a patient.

2. A device according to claim 1, further including sealing means located between the first end and the second end of the suction tube, for sealing the suction tube.

3. A device according to claim 1, further including a shielding sleeve enclosing the reservoir, the shielding sleeve comprising:

a sleeve-like portion having an open upper end, and having a lower end adapted for receiving the connection tube needle and the suction tube needle; and

a lid portion which cooperates in a telescopic manner with the sleeve-like portion and is adapted to move over a predetermined distance with respect to the open upper end of the sleeve-like portion;

wherein the sleeve-like portion is proportioned to accommodate the reservoir, having radioactive liquid therein, so that the rubber stopper of the reservoir bears on the ends of the connection tube needle and the suction tube needle which are positioned within the lower end of the sleeve-like portion;

wherein prior to use of the device, the reservoir projects above the open upper end of the sleeve-like portion and the lid portion bears upon the projecting part of the reservoir; and

wherein to make the device ready for use, pressure is exerted on the lid portion to move the lid portion the predetermined distance and thereby push the reservoir down and pierce the rubber stopper with the connection tube needle and the suction tube needle to accomplish communication with the interior of the reservoir.

4. A device according to claim 3, wherein the sleeve-like portion of the shielding sleeve includes at least one groove extending from the lower end of the sleeve-like portion, the at least one groove being proportioned to allow the connection tube needle and the suction tube needle to be admitted into the interior of the sleeve-like portion.

5. A device according to claim 3, further including a needle holder which engages the lower end of the sleeve-like portion of the shielding sleeve, and which holds the connection tube needle and the suction tube needle parallel to each other and fixed in an upright position with respect to the sleeve-like portion.

6. A device'according to claim 1, further including a suction mouthpiece attached to the second end of the suction tube.

7. A device according to claim 3, further including sealing means located between the first end and the second end of the suction tube, for sealing the suction tube; and a suction mouthpiece attached to the second end of the suction tube.

8. A device according to claim 4, further including sealing means located between the first end and the second end of the suction tube, for sealing the suction tube; and a suction mouthpiece attached to the second end of the suction tube.

9. A device according to claim 5, further including sealing means located between the first end and the second end of the suction tube, for sealing the suction tube; and a suction mouthpiece attached to the second end of the suction tube.