Lockable syringe shield

Abstract

The present invention relates to a radiation protection device (1) for a syringe containing a radioactive solution, comprising: - a cylindrical shielding body (2) made of a radioprotective material, open at each of the ends (3, 5) thereof, an upstream end (5) comprising a cylinder section having a smaller outer diameter than the cylindrical shielding body (2), the cylinder section having grooves (6) and having, at the top thereof, two arcuate projections (7) capable of conforming to the shape of the flanges (22) of the syringe; and a downstream end (3) having a conical shape capable of accommodating the tip of the syringe; - a rotary securing system (10) for securing the position of the syringe in the cylindrical shielding body (2), capable of cooperating with the upstream end (5) in order to place the rotary securing system (10) in a plurality of defined positions, including at least one position for releasing the syringe and at least one position for immobilising the syringe, via its flanges (22), in relation to the cylindrical shielding body (2).

Description

LOCKABLE SYRINGE SHIELD Object of the invention

[0001] The present invention belongs to the field of radiation protection and relates to syringe shielding. More specifically, the invention concerns a device for holding and handling a shielded syringe for filling a syringe with a radioactive solution.

[0002] The type of syringe suitable for use in the context of the invention is generally a single-use plastic syringe comprising a tube with a piston at one end and an opening at the other end to which a hollow needle or a small tube is attached. The end of the tube housing the piston is generally equipped with lateral fins that allow for easier manipulation of the piston by the operator. Examples include standard injection syringes manufactured by BD®. State of the

[0003] In the field of nuclear medicine, radiopharmaceutical preparations intended for injection into patients for imaging or the treatment of various diseases or bodily dysfunctions contain radioactive atoms that emit particles (alpha, beta) and ionizing radiation (X-rays, gamma rays). These emissions can damage the cells and DNA of exposed individuals, thus increasing the risk of cancer and other serious illnesses. Prolonged or high-dose exposure to this radiation can also lead to acute effects such as radiation burns, acute radiation sickness, and organ dysfunction.

[0004] In particular, healthcare professionals responsible for filling syringes with radiopharmaceutical preparations for patient injection are especially exposed. For their protection, it is therefore essential that these syringes, during filling, subsequent transport to the patient or dispensing site, and during the injection of the radiopharmaceutical preparation, be covered with a shielded syringe handling and retention device made from a material that prevents excessive radioactivity from escaping from the syringe into the immediate environment.

[0005] Currently available commercially, radiation protection devices of this type consist of a roughly cylindrical sheath made of a radioprotective material (lead, tungsten, etc.) designed to cover or surround the cylindrical body of the syringe. This protective sheath has an opening at its front end for the injection needle or the needle's receiving cone. It also has an opening at its rear end for inserting and removing the syringe body, as well as for actuating the syringe plunger.

[0006] US patent 11556216 describes a shielded syringe holder. The holder incorporates shielded glass, allowing the operator to read the volume level in the syringe. However, this holder is designed for vertical placement, which presents a significant risk of instability and hinders easy connection of the syringe to transfer devices (needle, check valve, etc.). Furthermore, securing the syringe in this holder requires manual manipulation of the syringe plunger. Rotating the syringe body using only the plunger (which must be raised) requires considerable force, risks breaking the plunger, and, most importantly, exposes the operator to radiation from the syringe contents through the upper opening of the shielded syringe holder.

[0007] US patent 7351227 B2 describes a two-part syringe shield that slides over one another. Once inserted into the inner part The syringe is attached to the device using pivoting latches. Handling the syringe body, for filling and emptying, is then accomplished using two protrusions located opposite each other on the inner part of the shielded device. Horizontal handling or handling along a table of a shielded screen in an injection room, for example, is therefore not easy. Furthermore, there is no locking or securing mechanism to prevent the inner part from sliding within the outer part of the device; the two parts can easily separate, which defeats the purpose. A one-piece shielded device is desired. In the same US patent 7351227 B2, another variant of this shield features a cylinder that can be closed using two half-tablets that can be manually brought together by sliding along a cradle until they encircle the syringe plunger, which can then be operated manually.In this variant, however, there is no locking mechanism for these two half-tablets. The US6589158B2 document also presents a syringe shielding device with two rotating arms that can be moved apart to allow the syringe to be inserted, and then brought back together to lock the syringe in place.

[0008] Document WO 2023 / 180445A1 describes a radiation protection device for use with a syringe for injecting a radioactive product. This radiation protection device comprises a tubular radiation protection structure with a lateral housing for a transparent radiation-shielding material. One end of the shield has a tenon structure adapted to cooperate with a complementary mortise structure in the lateral housing, and a retractable locking mechanism is adapted to cooperate with another end of the transparent radiation-shielding material to lock it in position. When placed in the device, the syringe is held in place either by a pivoting latch acting on one of the syringe's fins or by a locking pin whose tip is adapted to cooperate with the syringe body.

[0009] Document WO 20121 / 68586A1 concerns a radiation protection device intended to be fitted to a syringe used for injecting product(s) frad ioactif(s). This radiation protection device comprises a tubular radiation protection envelope which includes a tubular outer part, constituting at least part of its outer surface, made of plastic material and preferably of elastomer material with a Shore A hardness value between 30 and 80. In this device, the syringe is held in place by tightening a constrictive annular part which can be deformed by manual pressure to eliminate the friction force opposing the translation of the tubular envelope relative to the syringe body, which is thus freed.

[0010] US patent 2006 / 289807 A1 discloses a pharmaceutical container used to transport a syringe containing a liquid radiopharmaceutical from a radiopharmacy to a medical facility for administration to a patient. The pharmaceutical container includes an elongated polymer cap that is removably attached to an elongated polymer base. The elongated polymer cap includes a cap shell that completely surrounds a cap shielding element, and the elongated polymer base includes a base shell that completely surrounds a base shielding element. Preferably, the polymer used for the cap shell and the base shell is a polycarbonate resin, for example, LEXAN®. No inner lining is used, and the cap shielding element and the base shielding element, which are preferably, but not necessarily, made of lead, are completely sealed and not exposed.

[0011] US patent 2007 / 129591 A1 discloses a radiation shielding container for storing a syringe, comprising a body assembly and a cap assembly that can be attached to the body assembly such that first and second chamber parts define a chamber for storing the syringe. The body assembly includes a body shield made of radiation-shielding material, a body shell that defines a first cavity having an open end to receive the body shield and defines a first chamber part to receive a portion of the syringe, an internal wall of the body shell separating the first cavity and the first chamber part, and a body cap attached to the shell of body to cover the open end of the first cavity and retain the body shield inside the first cavity. The cap assembly includes a cap shield formed of a radiation-shielding material, a cap shell that defines a second cavity having an open end to receive the cap shield and defines a second chamber portion to receive a portion of the syringe, an internal wall of the cap shell separating the second cavity and the second chamber portion, and a cap cap attached to the cap shell to cover the open end of the second cavity and retain the cap shield inside the second cavity.

[0012] Document FR 2 989 175 A1 discloses equipment for filling a syringe with a radioactive product and directly measuring the radioactivity contained in said syringe. This equipment comprises: a container for the radioactive source product; a receiving well for an activity measurement chamber; a syringe support device positioned within a syringe protector; and means for automatically extracting the syringe from its syringe protector inside the activity measurement chamber to allow direct measurement of the radioactivity contained in said syringe, and then for automatically reinserting said syringe into said syringe protector before the support device is removed from said measurement chamber. The support is advantageously combined with means for manually operating the syringe plunger for filling / ejecting the radioactive product.

[0013] On the market, you can also obtain tungsten syringe shields, such as for example: https: / / www.vonqahlen.com / products / radiopharmaceutical-packaqinq / hotlab- furniture-and-accessories / personal-protection / tunqsten-syrinqe-shields-fpet)).

[0014] In these systems, the syringe is held in the syringe shield by means of either a locking pin or a small screw whose tip is adapted to cooperate with the syringe body, which presents a risk of leakage.

[0015] In addition to its role in radiation protection, it is important that the design of the syringe shielding device allows for secure positioning of the syringe in the shielding and easy handling of the syringe afterwards when it is inserted into the shielding, both for aspiration and expulsion movements, as well as during transport, which the present invention advantageously allows. Objectives of the invention

[0016] The present invention aims to provide a radiation protection device for a syringe containing a radioactive solution.

[0017] The device of the invention aims to allow both the proper positioning of a syringe in a syringe shield, easy securing of the position of the syringe in said shield and maximum protection of operators against radiation during the transport of the syringe or during the movements of aspiration and / or expulsion of a radioactive solution from the syringe. Main characteristic elements of the invention

[0018] The present invention relates to a syringe shielding device comprising a syringe body and a plunger, enabling the safe handling of a radioactive solution. The device includes a mostly cylindrical shielding body with an opening at each end into which the syringe can be inserted. The shielding body further includes a radiation-tight reading window. One of the open ends of the shielding body is slightly constricted to accommodate the syringe tip, which can be, for example, either a Luer-slip or Luer-lock type. The other end of the shielding body is shaped to match the fins of the syringe, ensuring that the syringe is positioned correctly and precisely within the syringe shielding device. At this same end, an innovative, rotating, and also shielded system secures the positioning of the syringe. The syringe is present. The body of the syringe shield is further advantageously slightly truncated to allow for horizontal positioning on a work table. The entire syringe shield of the present invention, as well as the reading window, are advantageously made of radiation-protective materials. Positioning the syringe, securing its position, transporting the syringe-syringe shield assembly, and using the syringe are all carried out in a manner that is entirely protective for the operator.

[0019] More specifically, the present invention relates to a radiation protection device for a syringe having a finned tube and containing a radioactive solution comprising: - a cylindrical shielding body made of a radioprotective material, open at each end, an upstream end comprising a cylindrical section with an outside diameter smaller than that of the cylindrical shielding body, and a downstream end with a conical shape suitable for receiving the syringe tip; and - a rotating system made of radiation-resistant material for securing the position of the syringe in the cylindrical shielding body, capable of cooperating rotationally along the axis of the cylindrical shielding body with said upstream end to place the rotating securing system in a plurality of defined positions, including at least one position for releasing the syringe and at least one position for locking the syringe via its fins relative to the cylindrical shielding body; characterized in that: said section of the cylinder, with an outside diameter smaller than that of the cylindrical shielding body at the upstream end, has grooves and has at its summit two arched protuberances capable of conforming to the shape of the syringe fins and locking them as soon as the syringe is introduced into the cylindrical shielding body;and the rotating locking system includes a ring inserted into and integral with an external part, the external part having an opening; corresponding to the shape of the fins, the assembly being fixed in a movable manner on the upstream end of the cylindrical armor body by the insertion of pins through corresponding circular holes provided both in the ring and in the external part until they penetrate the grooves of the upstream end of the cylindrical armor body, said grooves cooperating with the pins to limit the stroke of the rotating securing system to said plurality of defined positions.

[0020] According to preferred embodiments of the invention, the device further comprises at least one of the following features or a suitable combination thereof: the radioprotective material of the cylindrical shielding body and the rotating safety system is selected from the group consisting of lead and tungsten; the device includes a shielded glass window disposed longitudinally with respect to the cylindrical shielding body, preferably of the same thickness as said cylindrical shielding body, to allow the reading of syringe graduations; the glazing of the shielded glass window is made of cerium oxide-filled glass or lead oxide-filled glass; the cylindrical shielding body further has on its external surface a truncation enabling the device to be stabilized when lying in a horizontal position; - Two studs are positioned on either side of the truncated face of the cylindrical shield body to increase the stability of the syringe shield in its horizontal position; the device has two positions defined by the rotating locking system: an open position allowing passage of the fins and permitting insertion or removal of the syringe, and a closed position, which places the opening of the part perpendicular to the syringe fins, thus securing the syringe within the syringe shield. rotation of the rotary locking system by a quarter turn or 90 degrees counterclockwise from the open position; the device includes a ball stop system enabling the positioning and locking of the rotary locking system in one of the permitted positions; the ball stop system includes a ball surmounting a spring positioned in a tubular notch present in the outer thickness of the syringe shield body, cooperating with two hemispherical notches present in the ring, the grooves being configured to limit the extension of the rotational movement to an interval [0-90 degrees]; - Inside the downstream end of the cylindrical shielding body, the internal diameter is reduced by means of a shoulder which prevents the syringe from coming out of the syringe shield at this end. Brief description of the figs

[0021] Figure 1 schematically shows an exploded view of an embodiment of the device of the present invention, exhibiting the main constituent and inventive elements of said device.

[0022] Figure 2A represents the ring 12 which is part of the rotating syringe securing system according to the present invention.

[0023] Figure 2B represents part 13 into which ring 12 is inserted to form the locking rotary system.

[0024] Figure 3 shows a top view and a bottom view of one embodiment of the rotary safety system 10 of the syringe.

[0025] Figure 4 shows an assembled view of an embodiment of the complete device according to the present invention.

[0026] Figure 5 shows the change of position of the rotating safety system according to the present invention between an original open position (left), allowing the insertion or removal of the syringe and a closed position (right), in which the syringe is blocked. detailed description of the invention

[0027] Taking into account the aforementioned drawbacks of state-of-the-art devices, the present invention aims to provide a syringe shield that limits the operator's exposure to radiation when handling a radioactive solution with a syringe. Handling a radioactive solution includes drawing the solution into the syringe and / or transporting it within the syringe from the sampling point to the injection point and / or expelling it from the syringe. Another object of the invention is to prevent any risk of accidental exposure by easily and reliably securing the syringe within the body of the syringe shield.

[0028] The present invention is illustrated in detail in the following non-limiting examples.

[0029] The syringe shield 1 according to an embodiment of the present invention comprises (Fig. 1): - a cylindrical shield body 2 open at each end. The downstream end 3 of the shield body, where the syringe tip will be located, has a conical shape 4, so that the outside diameter of this end 3 is smaller than that of the syringe shield body. Inside this end 3, the internal diameter is shortened by a shoulder (not shown) which prevents the syringe from protruding from the syringe shield at this end. The upstream end 5, which is a section of tube with an outside diameter smaller than the syringe shield body, has three grooves 6 and two curved protrusions 7 at its apex, which are adapted to fit and lock the syringe fins once the syringe is inserted into the shield body 2. The cylindrical syringe shield body 2 also has a slight truncation 8 to stabilize the device in a horizontal position; - a 9-inch thick armored glass window, preferably of the same thickness as the body of the syringe shield, to allow the syringe graduations to be read; and a shielded rotary system for securing the position of the syringe in the syringe body (see below).

[0030] In a preferred embodiment, two small studs 11 are positioned on either side of the truncated face of the syringe shield body to increase the stability of the syringe shield in a horizontal position.

[0031] The cylindrical shielding body 2 of the syringe shield, as well as the rotating system 10 for securing the syringe position, are made of radiation-resistant materials, such as lead or tungsten. In a preferred embodiment of the present invention, the radiation-resistant material is tungsten. The cylindrical shielding body 2 advantageously has a thickness of between 5 mm and 15 mm.

[0032] The armored glass must be sufficiently transparent to allow the syringe graduations to be read, while also being radiation-proof. According to a preferred embodiment of the present invention, the armored glass is made of glass filled with cerium oxide or lead oxide, with a thickness identical to that of the cylindrical shielding body 2 into which it is inserted, between 5 and 15 mm.

[0033] According to one embodiment of the present invention, the shielded rotating system 10 for securing the syringe within the syringe shielding body consists of a cylindrical ring 12 (Fig. 2A) that fits into a part 13 (Fig. 2B) whose opening in an upper portion 14 is similar in shape to the fins of a syringe, such that the syringe can only pass through this part in one direction. Optionally, the upper portion of the part 13 has slight notches 15 distributed symmetrically around its circumference to allow for a good grip. Both the ring 12 and the part 13 are made of a radiation-resistant material, such as lead or tungsten.In a preferred embodiment of the present invention, the external diameter of the part 13 is the same as that of the cylindrical armor body 2, and the internal diameter of the ring 12 is very slightly greater than the external diameter of the upstream end 5. of the cylindrical armor body 2 so as to ensure a fine insertion of this end 5 into the ring 12.

[0034] The assembly formed by inserting the ring 12 into the part 13, in such a way as to connect the corresponding small circular orifices 16 present in the ring 12 and the part 13, constitutes the rotary, shielded safety system 10 for the syringe shown in Figure 3. This assembly 10 is fixed to the upstream end 5 of the cylindrical shielding body 2 by inserting pins 17 through the circular orifices 16 until they penetrate the grooves 6 of the upstream end 5 of the cylindrical shielding body. The pins 17 are pushed in until they reach the outer stop of the part 13. Therefore, the safety system 10 is inseparable from the cylindrical shielding body 2, forming a single unit which constitutes the device 1 of the present invention as shown in Figure 4.

[0035] Advantageously, a ball 18 surmounting a spring 19 positioned in a tubular notch 20 present in the outer thickness of the syringe shield body 2, as well as two hemispherical notches 21 present in the opposite ring 12, allow the installation of a ball stop system which anchors the rotating locking system 10 in one of two permissible positions. Thanks to the grooves 6 which are designed to limit the possible range of rotation to an interval [0-90°] and to this ball stop system, the operator can easily change the relative position of the rotation system 10 between an original open position (Fig. 5 left), allowing the insertion or removal of the syringe, and a closed position (Fig.5 (right), which positions the opening 14 of part 13 perpendicular to the fins 22 of the syringe, which is thus secured in the syringe shield 1 by rotating the locking rotary system 10 a quarter turn counterclockwise from the open position. The ball stop system locks the locking rotary system 10 in one of these two positions, preventing any accidental rotation during transport of the syringe shield or during handling of the syringe. When transferring the radioactive solution from the syringe, the operator can release the syringe by repositioning the locking rotary system 10 to the open position by rotating it a quarter turn clockwise. During these operations, The operator is protected since the operation of the rotary safety system is done by positioning the fingers on part 13 perpendicular to the syringe, and not on a part of the syringe itself. List of reference symbols 1 syringe shield 2 cylindrical armor bodies 3 downstream end 4 conical part for syringe tip 5 upstream end 6 circular grooves (90°) 7 arcuate protuberance 8 truncation 9 panes of bulletproof glass 10 rotating locking system 11 plot 12 cylindrical ring 13 external parts of the rotating locking system 14 upper part with opening adapted to the fins 15 notches 16 circular orifice 17 pins 18 marbles 19 spring 20 tubular notch 21 hemispherical notch 22 syringe fins

Claims

DEMANDS 1. Radiation protection device (1) for a syringe having a winged tube (22) and containing a radioactive solution comprising: - a cylindrical shielding body (2) made of a radioprotective material, open at each of its ends (3, 5), an upstream end (5) comprising a cylindrical section with an outside diameter smaller than that of the cylindrical shielding body (2), and a downstream end (3) of conical shape adapted to receive the tip of the syringe; and - a rotating system made of radiation-resistant material (10) for securing the position of the syringe in the cylindrical shielding body (2) capable of cooperating rotationally along the axis of the cylindrical shielding body with said upstream end (5) to place the rotating securing system (10) in a plurality of defined positions, including at least one position for releasing the syringe and at least one position for locking the syringe via its fins (22) relative to the cylindrical shielding body (2), characterized in that: said section of cylinder with an outside diameter smaller than that of the cylindrical shielding body (2) at the upstream end (5) has grooves (6) and has at its top two arched protrusions (7) capable of conforming to the shape of the fins (22) of the syringe and locking them as soon as the syringe is introduced into the cylindrical shielding body (2);and the rotating locking system (10) comprises a ring (12) inserted into and integral with an external part (13), the external part (13) having an opening (14) corresponding to the shape of the fins (22), the assembly (10) being movably fixed to the upstream end (5) of the cylindrical armor body (2) by the insertion of pins (17) through corresponding circular holes (16) provided both in the ring (12) and in the external part (13) until they penetrate the grooves (6) of the upstream end (5) of the cylindrical armor body, said grooves (6) cooperating with the pins (17) to limit the stroke of the rotating locking system (10) to said plurality of defined positions.; 2. Device according to claim 1, characterized in that the radioprotective material of the cylindrical shielding body (2) and of the rotating securing system (10) is selected from the group consisting of lead and tungsten.

3. Device according to any one of claims 1 to 2, characterized in that it comprises a shielded glass window (9) arranged longitudinally with respect to the cylindrical shielding body (2), preferably of the same thickness as said cylindrical shielding body (2), to allow the reading of graduations of the syringe.

4. Device according to claim 3, characterized in that the glazing of the armored glass window (9) is made of glass loaded with cerium oxide or of glass loaded with lead oxide.

5. Device according to any one of claims 1 to 4, characterized in that the cylindrical armor body (2) further has on its external surface a truncation (8) allowing the device to be stabilized lying down in a horizontal position.

6. Device according to claim 5, characterized in that two studs (11) are positioned on either side of the truncated face (8) of the cylindrical shielding body (2) to increase the stability in horizontal position of the syringe shield.

7. A device according to any one of claims 1 to 6, characterized in that it comprises two positions defined by the rotating locking system (10): an open position allowing passage for the fins (22) and permitting the insertion or removal of the syringe, and a closed position which places the opening (14) of the part (13) perpendicular to the fins (22) of the syringe, the latter thus being secured in the syringe shield (1), by rotating the rotating locking system (10) a quarter turn or 90 degrees counterclockwise from the open position.

8. Device according to any one of claims 1 to 7, characterized in that it comprises a ball stop system (18, 19, 20, 21) allowing the positioning and locking of the rotary safety system (10) in one of the permitted positions.

9. Device according to claim 8, characterized in that the ball stop system comprises a ball (18) surmounting a spring (19) positioned in a tubular notch (20) present in the outer thickness of the syringe shield body (2), cooperating with two hemispherical notches (21) present in the ring (12), the grooves (6) being configured to limit the extension of the rotational movement to an interval [0-90 degrees], 10. Device according to any one of the preceding claims, characterized in that inside the downstream end (3) of the cylindrical shielding body (2), the internal diameter is reduced by means of a shoulder which prevents the syringe from coming out of the syringe shield by this end.

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