SHIELDING DEVICE USEFUL FOR MANIPULATING A RADIOACTIVE SOLUTION

• US 20170348485A1
• Filed: 06/02/2017
• Published: 12/07/2017
• Est. Priority Date: 06/03/2016
• Status: Active Grant

• Current Assignee: Simplivia Healthcare LTD.
• Original Assignee: Teva Medical Ltd (Teva Pharmaceutical Industries Limited)
• Inventors: LE MAITRE, Julien, LEMER, Pierre-Marie
• Granted Patent: US 10,639,420 B2
• Time in Patent Office: Days
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/1785 comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: G21F 5/015 for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
• CPC Class Codes: G21F 5/018 Syringe shields or holders syringe shielding for applying radioactive material to the body A61M5/1785

Abstract

The present disclosure relates to a device (1) for sampling and/or injection of a radioactive solution (S) in a vial (2), wherein the vial (2) comprises an opening closed by a puncturable closure member (3).

• The device (1) comprises a container (7) adapted to receive said vial (2) and a vial adaptor (4), said vial adaptor (4) having a longitudinal axis (L1), provided at a first end (41) with a hollow spike (42) adapted to pierce said puncturable closure member (3) when the vial adaptor (4) is mounted on the vial (2), and at a second end (43) with connection means (5) adapted for its removable connection to a syringe (6),
• the container (7) comprising:
  • a container body (71) adapted to receive said vial (2), the container body (71) having an opening (711), and
  • a vial adaptor support structure (72) configured for being mounted onto the opening (711) of the container body (71), and comprising retention means configured for enabling releasable retention of said vial adaptor (4) within said vial adaptor support structure (72), and
  • wherein the vial adaptor support structure (72) and the container body (71) are made at least partially of a radioprotective material for providing protection against ionizing radiation.

Claims

1. A device useful for sampling and/or injection of a radioactive solution in a vial, wherein the vial has an opening closed by a puncturable closure member, the device comprising:

a container adapted to receive said vial and a vial adaptor, said vial adaptor having a longitudinal axis, provided at a first end with a hollow spike adapted to pierce said puncturable closure member when the vial adaptor is mounted on the vial and at a second end with connection means adapted for its removable connection to a syringe adaptor,

the container comprising;

a container body adapted to receive said vial, the container body having an opening, and

a vial adaptor support structure configured for being mounted onto the opening of the container body, and comprising retention means configured for enabling releasable retention of said vial adaptor within said vial adaptor support structure, and

wherein the vial adaptor support structure and the container body are made at least partially of a radioprotective material for providing protection against ionizing radiation;

wherein the vial adaptor support structure further comprises transfer means for imparting to said vial adaptor a degree of freedom in longitudinal translation along its longitudinal axis.

2. The device according to claim 1, characterized in that the vial adaptor support structure is generally tubular with a longitudinal axis and comprises:

a tubular sleeve having a first end provided with attachment means configured for enabling mounting of the vial adaptor support structure onto the opening of the container body,

a support ring, received in said tubular sleeve, coaxial with the tubular sleeve, and defining an internal space for the reception of said vial adaptor,

wherein the transfer means are further configured for imparting to said support ring a degree of freedom in longitudinal translation along said longitudinal axis with respect to said tubular sleeve, and

the retention means are further configured for enabling connection of said vial adaptor with said support ring.

3. The device according to claim 2, characterized in that the vial adaptor support structure comprises a jacket for operating said support ring according to said degree of freedom in translation, said jacket at least partially surrounding said tubular sleeve and including fastening means configured to fasten said jacket with said support ring.

4. The device according to claim 3, characterized in that said fastening means are in the form of at least two assembly lugs connecting said jacket and said support ring and which pass through oblong holes in said tubular sleeve.

5. The device according to any one of claims 4, characterized in that said retention means comprise a radial bearing pin secured with said jacket and/or said support ring, wherein said bearing pin has an outer end accessible on an outer periphery of said jacket, provided with an operating member, and an inner end forming a bearing head,

and wherein said bearing pin is movable radially between:

an active position in which said bearing head extends into said internal space of said support ring and is adapted to abut against said vial adaptor in order to assemble said vial adaptor with said support ring and/or said jacket, and

an inactive position in which said bearing head does not abut against said vial adaptor.

6. The device according to claim 5, characterized in that said bearing pin is also one of said assembly lugs.

7. The device according to claim 2, characterized in that the device further includes indexing means to at least one position, of the assembly comprising the vial adaptor, the support ring and the jacket, relative to said tubular sleeve.

8. The device according to claim 7, characterized in that said indexing means comprise at least one retractable ball lock mounted on one of the tubular sleeve or the jacket cooperating with a recess provided on the other of the tubular sleeve or the jacket.

9. The device according to claim 2, characterized in that said support ring comprises first positioning means configured for blocking said vial adaptor in a direction along its longitudinal axis, and second positioning means adapted to prevent rotation of said vial adaptor about said longitudinal axis.

10. The device according to claim 1, further comprising:

a syringe comprising a syringe body, a piston and a syringe adaptor configured for connection to said vial adaptor, and

a protection device shaped as a shield made of radioprotective material providing protection against ionizing radiation, wherein said protection device covers at least partially said syringe body and said syringe adaptor.

11. A protection device for a syringe having a syringe body extending along a longitudinal axis and comprising, at a first end an end tip including an orifice for the passage of liquid and, at a second end, an opening for the passage of a piston provided with a maneuver head,

wherein the protection device is adapted to at least partially cover said syringe body and is made at least in part of a radioprotective material providing protection against ionizing radiation,

and wherein the protection device is in the form of a clamp comprising two half-jaws joined together by a hinge, which clamp includes operating means configured so that said half-jaws are moveable between:

a closed operative position, in which said half-jaws are assembled to form a cylinder to at least partially cover said syringe body, and

an open inactive position, adapted for the introduction and extraction of said syringe body into said half-jaws.

12. The protective device for a syringe according to claim 11, wherein said hinge is provided with biasing means tending to maintain said closed operative position.

13. The protection device for a syringe according to claim 11, characterized in that each half-jaw comprises a half-shell made of a radioprotective material providing protection against ionizing radiation, wherein said half-shell have a semi-cylindrical cross section, which is assembled with a base of plastics material,

wherein a longitudinal edge of each of said bases forms part of said hinge in association with said biasing means,

said bases of the two half-jaws (being configured such that projections project on the other side of said hinge, said projections forming actuating arms for the operations of opening and closing of the clamp.

14. The protection device for a syringe according to claim 13, wherein each half-shell, made of a radioprotective material providing protection against ionizing radiation, is assembled with its base by means of screws assembly.

15. The protection device for a syringe according to claim 12, wherein said end tip of said syringe comprises a syringe adaptor and in that said half-shells each comprises a protrusion adapted to cover at least in part said syringe adaptor.

16. The protection device for a syringe according to claim 11, wherein at least one of the two half-jaws include a transparent window to allow visual access to the contents of the syringe body.

17. The protection device for a syringe according to claim 16, wherein the two half-jaws each include a transparent window, said transparent windows facing each other when the half-jaws are in the closed operative position.

18. The protection device for a syringe according to claim 16, wherein the transparent window is made of a material providing protection against ionizing radiation.