CN114983820B

CN114983820B - Radiopharmaceutical injection system

Info

Publication number: CN114983820B
Application number: CN202210611121.4A
Authority: CN
Inventors: 杜泽天; 黄曾�; 田佳乐; 李刚; 郝晋; 熊晓玲; 阳国桂; 杨宇川
Original assignee: Guotong Chengdu New Drug Technology Co ltd; Institute of Nuclear Physics and Chemistry China Academy of Engineering Physics
Current assignee: Guotong Chengdu New Drug Technology Co ltd; Institute of Nuclear Physics and Chemistry China Academy of Engineering Physics
Priority date: 2022-05-31
Filing date: 2022-05-31
Publication date: 2023-08-22
Anticipated expiration: 2042-05-31
Also published as: CN117357399A; CN114983820A

Abstract

An injection system of a radiopharmaceutical, a shield therefor, and use thereof, the injection system comprising: a container configured to house a vial of the radiation-sensitive drug; a push pin assembly comprising a liquid inlet end and a liquid outlet end configured to be inserted into a vial in the container; a medical fluid bag configured to provide a medical fluid to the push needle assembly; the pumping device is connected with the medical liquid bag and the push needle assembly and is configured to pump medical liquid in the medical liquid bag to a liquid inlet end of the push needle assembly; and the patient end retention needle is configured to be detachably connected with the liquid outlet end of the push needle assembly through the joint assembly.

Description

Radiopharmaceutical injection system

Technical Field

The present disclosure relates to the field of radiopharmaceuticals, to a radiopharmaceutical injection system and shield therefor, and uses thereof.

Background

Radiopharmaceuticals are a special type of medicines containing radionuclides and capable of providing diagnosis or treatment in medicine, diagnostic radiopharmaceuticals usually mainly emit gamma photons, have strong gamma photon penetrability, are easily detected in vitro by a nuclear medicine detection instrument after being introduced into a body, and can record the positions and changes of the radiopharmaceuticals in the body; the therapeutic radiopharmaceuticals mainly emit electrons, have long half-life and short range compared with diagnostic radiopharmaceuticals, and can intensively irradiate lesion parts to obtain good therapeutic effects.

Also because of the radioactivity, there is usually no or only one piece of lead glass to protect the health care provider during the traditional drug administration process. This operation only serves as part of the protection, or may cause additional radiation to the medical personnel involved in the administration, which requires the administration system to be able to meet the radiation protection requirements, reducing the administration preparation time and thus minimizing the radiation dose to the medical personnel. Meanwhile, the medical staff cannot be prevented from observing the drug administration process necessarily, the requirement of convenience is met, and the drug administration can be conveniently and protectively carried out.

Disclosure of Invention

Some embodiments of the present disclosure provide an injection system of a radiopharmaceutical, the injection system comprising:

a container configured to house a vial of the radiation-sensitive drug;

a push pin assembly comprising a liquid inlet end and a liquid outlet end configured to be inserted into a vial in the container;

a medical fluid bag configured to provide a medical fluid to the push needle assembly;

the pumping device is connected with the medical liquid bag and the push needle assembly and is configured to pump medical liquid in the medical liquid bag to a liquid inlet end of the push needle assembly; and

a patient-side retention needle configured to access an artery or vein of a patient and configured to be removably coupled to a catheter coupled to the fluid outlet side of the push pin assembly via a connector assembly.

In some embodiments, the pumping device comprises a syringe, the syringe is connected with the medical fluid bag and the fluid inlet end of the push needle assembly through a three-way two-way valve, and the syringe, the medical fluid bag and the fluid inlet end of the push needle assembly are respectively connected with the first end, the second end and the third end of the three-way two-way valve, so that the syringe is configured to be pressurized and injected into the fluid inlet end of the push needle assembly after the syringe is used for pumping medical fluid from the medical fluid bag.

In some embodiments, the injection system further comprises:

the exhaust pipeline, exhaust pipeline one end sets up the malleation and connects, disposes with push pin assembly's play liquid end detachably connects, the exhaust pipeline other end through first tee bend with the third end of tee bend two check valves and push pin assembly's feed liquor end intercommunication.

In some embodiments, a second tee is arranged between the third end of the two one-way valves of the tee and the first tee, the first end and the second end of the second tee are respectively connected with the third end of the two one-way valves of the tee and the first tee,

the injection system further comprises: the waste liquid bottle is connected with the third end of the second tee joint through a pressure relief valve.

Some embodiments of the present disclosure provide a shield configured to support the injection system of the previous embodiments, the shield comprising:

a base, a base seat and a base seat,

the side wall extends from the top surface of the base along the direction away from the base, the base and the side wall enclose a containing space, and the containing space is used for containing the container and the push pin assembly; and

a top cover configured to be buckled on the end part of the side wall far away from the base to close the accommodating space,

the front projection of the accommodating space on the base falls into the base, and the side wall is spaced from the edge of the base by a preset distance.

In some embodiments, the side walls include a first sub-side wall, a second sub-side wall, a third sub-side wall, and a fourth sub-side wall, the orthographic projections of the first sub-side wall, the second sub-side wall, the third sub-side wall, and the fourth sub-side wall on the base form a rectangle,

the top cover includes:

the first panel is configured to be buckled on the side wall to close the accommodating space; and

a second panel extending from the first panel in a direction at a predetermined angle to the first panel, the predetermined angle being an obtuse angle,

wherein the connection portion of the first panel and the second panel is pivotally connected to the end portion of the first sub-sidewall remote from the base.

In some embodiments, the end of the second sub-sidewall distal to the base is provided with a slide, and the shield further comprises a cantilever slidably coupled to the slide, one end of the cantilever being provided with a clamp configured to clamp a catheter connected to the liquid outlet end of the push pin assembly.

In some embodiments, the shield further comprises:

the bracket socket is arranged on the top surface of the base and is adjacent to the second sub side wall;

and one end of the telescopic bracket is fixed in the bracket socket, and the other end of the telescopic bracket is configured to hang the medical fluid bag.

In some embodiments, the shield further comprises:

the waste liquid bottle seat is arranged on the top surface of the base, is adjacent to the side wall of the third sub-body and is configured to accommodate a waste liquid bottle.

In some embodiments, a clamping seat is arranged on the outer surface of the side wall of the third sub-body and configured to accommodate the radioactivity detecting device.

In some embodiments, a clip is provided on the fourth sub-sidewall configured to clip the positive pressure fitting.

In some embodiments, the third sub-sidewall is provided with a first opening configured to allow a catheter, which communicates the first tee and the liquid inlet end of the push pin assembly, to pass through, the liquid inlet end of the push pin assembly being located in the accommodating space, the first tee being suspended on an outer wall of the third sub-sidewall.

In some embodiments, the first sub-sidewall is provided with a second opening configured to allow a catheter in communication with the outlet end of the push-pin assembly to pass therethrough, wherein the outlet end of the push-pin assembly is positioned within the receiving space.

In some embodiments, the shield further comprises:

the container seat is arranged on the top surface of the base, is positioned in the accommodating space and is configured to accommodate the container.

In some embodiments, the base bottom surface is provided with a metal block.

In some embodiments, the base of the shield is integrally formed with the sidewall using plexiglas.

Some embodiments of the present disclosure also provide for the use of an injection system of a radiopharmaceutical for injection of the radiopharmaceutical described in the previous embodiments.

Compared with the related art, the method has at least the following technical effects:

in an injection system, a push-pin assembly is inserted into a radiopharmaceutical vial in a container, a medical fluid is withdrawn by means of a syringe and pressurized into the push-pin assembly, such that the medical fluid carries the radiopharmaceutical in the vial through a patient-end retention needle into a patient, and the operation of the injection system is performed under radiation protection.

The injection system is supported by the protective cover, so that the injection effect is prevented from being influenced by accidental contact with a container for accommodating the radiopharmaceutical bottle and the push pin assembly in the injection process.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, a brief description will be given below of the drawings required for the embodiments or the description of the prior art, and it is obvious that the drawings in the following description are some embodiments of the present disclosure, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic illustration of a structure of a container provided in some embodiments of the present disclosure;

FIG. 2 is a schematic view of an exploded construction of a container provided in some embodiments of the present disclosure;

fig. 3 is a schematic view of a container access injection system provided in some embodiments of the present disclosure containing a vial containing a radiopharmaceutical;

FIG. 4 is a schematic cross-sectional view of FIG. 3;

FIG. 5 is an exploded block diagram of a container body provided in some embodiments of the present disclosure;

FIG. 6 is a schematic view of the structure of a different inner body provided in some embodiments of the present disclosure;

FIG. 7 is a schematic view of an exploded structure of a container provided in further embodiments of the present disclosure;

Fig. 8 is a schematic perspective view of a rubber pad provided in some embodiments of the present disclosure;

FIG. 9 is a cross-sectional view of a cushion portion provided in some embodiments of the present disclosure;

FIG. 10 is a schematic cross-sectional view of FIG. 3 in other embodiments;

FIG. 11 is a schematic view of a vial provided in some embodiments of the present disclosure;

FIG. 12 is a schematic cross-sectional view of a vial provided in some embodiments of the present disclosure;

FIG. 13 is a schematic top view of a vial according to some embodiments of the present disclosure;

FIG. 14 is an exploded cross-sectional view of the cover of FIG. 7;

FIG. 15 is a schematic diagram of an injection system provided in some embodiments of the present disclosure;

FIG. 16 is a schematic structural view of a push pin assembly provided in some embodiments of the present disclosure;

FIG. 17 is an enlarged schematic view of area M of FIG. 10;

FIG. 18 is a schematic cross-sectional view of the N region of FIG. 16;

FIG. 19 is a schematic diagram of an injection system provided in some embodiments of the present disclosure;

FIG. 20A is a schematic structural view of a protective cover provided by some embodiments of the present disclosure;

FIG. 20B is a schematic structural view of a protective cover provided by some embodiments of the present disclosure, wherein the top cover is not shown;

FIG. 21A is a schematic structural view of a shield provided by some embodiments of the present disclosure, wherein an injection system supported by the shield is shown;

FIG. 21B is a schematic structural view of a shield provided by some embodiments of the present disclosure, wherein an injection system supported by the shield is shown, the top cover of the shield is not shown; and

fig. 22 is a schematic structural view of an injection system provided in some embodiments of the present disclosure.

Detailed Description

For the purpose of promoting an understanding of the principles and advantages of the disclosure, reference will now be made in detail to the drawings, in which it is apparent that the embodiments described are only some, but not all embodiments of the disclosure. Based on the embodiments in this disclosure, all other embodiments that a person of ordinary skill in the art would obtain without making any inventive effort are within the scope of protection of this disclosure.

The terminology used in the embodiments of the disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used in this disclosure of embodiments and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise, the "plurality" generally includes at least two.

It should be understood that the term "and/or" as used herein is merely one relationship describing the association of the associated objects, meaning that there may be three relationships, e.g., a and/or B, may represent: a exists alone, A and B exist together, and B exists alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship.

It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a product or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such product or apparatus. Without further limitation, an element defined by the phrase "comprising" does not exclude the presence of other like elements in a commodity or device comprising such element.

In the medical field, radioprotection is required for pharmaceutical vials containing radiopharmaceuticals, such as penicillin bottles, which are typically placed in a radiation-shielding container, such as a lead tank. The container is used as a carrier to transport or transfer the vial containing the radiopharmaceutical. However, when a medical practitioner needs to access a vial containing a radiopharmaceutical to an injection system for injecting the radiopharmaceutical into a human body, it is often necessary for the medical practitioner to remove the vial from the radiation protected container and then manually access the injection system, such as by manually inserting a liquid-guiding needle of a push-pin assembly of the injection system into the vial from the cap of the vial, and then delivering the radioactive substance into the patient through a catheter or the like, to complete the treatment. In this case, the medical staff inevitably comes into close contact with the vial containing the radiopharmaceutical, with the risk of receiving radiation.

To overcome the above problems, the present disclosure provides a radiopharmaceutical injection system and a shield therefor. In an injection system, a push-pin assembly is inserted into a radiopharmaceutical vial in a container, a medical fluid is withdrawn by means of a syringe and pressurized into the push-pin assembly, such that the medical fluid carries the radiopharmaceutical in the vial through a patient-end retention needle into a patient, and the operation of the injection system is performed under radiation protection. Moreover, the injection system is supported by the protective cover, so that the injection effect is prevented from being influenced by accidental contact with a container for accommodating the radiopharmaceutical bottle and the push pin assembly in the injection process.

Alternative embodiments of the present disclosure are described in detail below with reference to the drawings.

Fig. 1 is a schematic structural view of a container according to some embodiments of the present disclosure, and fig. 2 is a schematic explosive structural view of a container according to some embodiments of the present disclosure, in which a cover body is separated from a container body. As shown in fig. 1 and 2, the container 100 includes a container body 10 and a lid 20, and when the lid 20 is engaged with the container body 10, a relatively airtight space is formed inside the container 100. In some embodiments, the body 10 and the cover 20 may be made of a radiation-proof material, and may be one or a combination of lead, lead alloy, or tungsten alloy, such as lead. Thus, the container 100 may be used to house a vial containing a radiopharmaceutical, such as a penicillin vial. The container 100 may be used as a carrier for movement or transport of the vial of radiopharmaceutical to prevent radiation leakage during movement or transport and to prevent environmental contamination.

As shown in fig. 1 and 2, an open accommodating groove 13 is provided in the container body 10, and the accommodating groove 13 includes a first accommodating space 131, a second accommodating space 132 and a third accommodating space 133 sequentially adjacent to the bottom of the accommodating groove, wherein the third accommodating space 133 is configured to accommodate at least a portion of a medicine bottle containing a radiopharmaceutical.

The first sidewall 1311 of the first accommodating space 131 extends along a first direction, such as a vertical direction Y, the first direction is parallel to the first axis m1 of the container body 10, the second sidewall 1321 of the second accommodating space 132 gradually tapers from an end of the first sidewall 1311 near the second accommodating space 132 toward the first axis m1 of the container body 10 in the first direction, and the third sidewall 1331 of the third accommodating space 133 extends from an end of the second sidewall 1321 far from the first accommodating space 131 along the first direction. In some embodiments, the size of the third receiving space is substantially slightly larger than the size of the vial, such that the vial is prevented from substantially shaking in a horizontal direction during transportation when placed in the third receiving space.

The cover 20 includes a cover body 22 and a protruding portion 21 extending from a bottom surface of the cover body 22 in a direction away from a top surface of the cover body, and the protruding portion 21 includes a first protruding portion 211 and a second protruding portion 212 sequentially away from the top surface of the cover body. The first outer sidewall 2111 of the first protruding portion 211 extends along a second direction, such as a vertical direction Y, which is parallel to the second axis m2 of the cover 20, and the second outer sidewall 2121 of the second protruding portion 212 gradually tapers from an end portion of the first outer sidewall 2111 near the second protruding portion 212 toward the second axis m2 of the cover 20 in the second direction.

When the cover 20 is fastened to the container body 10, the first protruding portion 211 and the second protruding portion 212 are respectively received in the first receiving space 131 and the second receiving space 132, the first outer sidewall 1311 is matched and attached to the first sidewall 2111, and the second sidewall 1321 is matched and attached to at least a portion of the second outer sidewall 2121, so that the first axis m1 is substantially collinear with the second axis m 2.

Fig. 3 is a schematic view of a container access injection system containing a vial containing a radiopharmaceutical in accordance with some embodiments of the disclosure, and fig. 4 is a schematic cross-sectional view of fig. 3. As shown in connection with fig. 1 to 4, the medicine bottle 300 containing the radiopharmaceutical is accommodated in the accommodation groove 13 of the container body 10, specifically, a cylindrical body below the neck of the medicine bottle 300 is accommodated in the third accommodation space 133. The push pin assembly 200 in the injection system can be threaded into the vial 300 through the through hole of the cap 20 so that, with the vial 300 containing the radiopharmaceutical in the radiation-protected container 100, access to the injection system with the vial 300 reduces contact of the healthcare worker with the radiopharmaceutical, providing radiation protection to the healthcare worker, but such operation requires a relatively precise alignment of the push pin assembly 200 with the vial 300 in the container 100.

In the present disclosure, the inner side wall of the accommodating groove in the container body and the outer side wall of the protruding portion of the cover body have specific shapes that are matched with each other, so that when the cover body is buckled on the container body, the first axis of the container body is substantially collinear with the second axis of the cover body, so that the cover body and the container body are aligned and buckled, and a large deviation exists in the horizontal direction when the cover body and the container body are buckled. So can make when the medicine bottle that will be equipped with the radiopharmaceutical inserts injection system later, push pin subassembly inserts the through-hole on the lid after can be basically with the medicine bottle of holding the radiopharmaceutical in the holding groove alignment to realize under the medicine bottle that holds the radiopharmaceutical is located the circumstances of radiation protection in the container, will the medicine bottle inserts injection system, reduced medical personnel and the contact of radiopharmaceutical, for medical personnel's supply radiation protection.

Fig. 5 is an exploded structural view of a container body provided in some embodiments of the present disclosure. As shown in connection with fig. 1-5, the container body 10 includes an outer body 11 and an inner body 12. The outer body is internally provided with an open first accommodating groove 111, the inner body 12 is detachably accommodated in the first accommodating groove 111, and the inner body 12 is internally provided with a second accommodating groove 121 with an opening. When the inner body 12 is mounted in the first accommodating groove 111 of the outer body 11, the second accommodating groove 121 includes the second accommodating space 132 and the third accommodating space 133, and in the first accommodating groove 111, a space from the top of the inner body 12 to the top of the outer body 11 constitutes the first accommodating space 131.

Since the inner body 12 and the outer body 11 are detachable, different inner bodies 12 can be mounted in the same outer body, and different inner bodies 12 can have different second receiving grooves for receiving different sizes of medicine bottles 300. When the container 100 is used to house different size vials 300, only the inner body 12 is replaced differently, and the container 100 is not replaced as a whole, thereby reducing the cost.

For example, the inner body includes multiple types of inner bodies, including, for example, a first inner body and a second inner body of different types FIG. 6 is a schematic structural view of the different inner bodies provided in some embodiments of the present disclosure. Fig. 6 (a) is a schematic structural view of the first inner body 12', and (B) is a schematic structural view of the second inner body 12 ". As shown in fig. 5 to 6, the first inner body 12' has the same outer diameter and the same height as the second inner body 12", and the inclination of the side wall of the second accommodating space 132' corresponding to the first inner body 12' is the same as the inclination of the side wall of the second accommodating space 132" corresponding to the second inner body 12 ". Thus, both can be mounted into the first receiving groove 111 in the outer body 11, and the cover 20 can be matingly snapped onto the container body 10.

The height of the second accommodating space 132 'corresponding to the first inner body 12' is different from the height of the second accommodating space 132 "corresponding to the second inner body 12", for example, the height of the second accommodating space 132 'corresponding to the first inner body 12' is smaller than the height of the second accommodating space 132 "corresponding to the second inner body 12". The outer diameter of the third accommodating space 133 'corresponding to the first inner body 12' is also different from the outer diameter of the third accommodating space 133 "corresponding to the second inner body 12", for example, the outer diameter of the third accommodating space 133 'corresponding to the first inner body 12' is smaller than the outer diameter of the third accommodating space 133 "corresponding to the second inner body 12". The second inner body 12 "may house a vial having a larger outer diameter than the first inner body 12'.

In some embodiments, the material of the outer body is a high density metal material, which may be at least one or a combination of lead, lead alloy or tungsten alloy, such as lead, and the material of the inner body may be at least one or a combination of lead, lead alloy, tungsten alloy or organic polymer material, such as plexiglas, which produces high energy beta decay when the radiopharmaceutical, such as radioactive glass microspheres, impinges on elements with high atomic numbers, which release very strong bremsstrahlung. The protection against beta rays is first achieved with low Z materials. Therefore, the inner body material is selected as the organic glass with low Z material, which is favorable for reducing the bremsstrahlung radiation of the radioactive glass microspheres.

In some embodiments, referring to fig. 1-4, the cap 20 has a through hole 23 extending through the cap 20, the through hole 23 configured to insert a push pin assembly 200, and the container further includes a plug (not shown) mated to the through hole, the plug configured to be inserted into the through hole 23. The axis of the through hole 23 then coincides with the second axis m2 of the cover 20, passing through the boss 21 of said cover 20. When the container 100 stores the vial 300 containing the radiopharmaceutical, the cap 20 is engaged with the container body, and the stopper is inserted into the through hole 23 of the cap 20 to block the through hole 23, thereby realizing sealed storage of the vial 300 of the radiopharmaceutical. In some embodiments, the cover and plug may each be made of a radiation resistant material, such as lead, to avoid radiation leakage. When the radiopharmaceutical in the radiopharmaceutical vial 300 is to be injected into the patient for treatment, the medical staff can pull the stopper out of the cap 20, insert the push-pin assembly 200 in the injection system into the through hole 23 of the cap 20, and insert the liquid guide needle of the push-pin assembly 200 into the vial 300 located in the third accommodating space 133 of the container 100 from the cap of the vial, so that the vial with the radiopharmaceutical is connected into the injection system under the condition that the vial with the radiopharmaceutical is located in the radiation-proof container, thereby reducing the contact between the medical staff and the radiopharmaceutical and providing radiation protection for the medical staff.

In some embodiments, as shown in fig. 1-4, in a cross section through the first axis m1, the second sidewall 1321 of the second accommodating space 132 forms an angle α with the first axis of 20 ° to 30 °. In the process of placing the vial with the radiopharmaceutical into the container body 10, when the axis of the vial 300 is preferably aligned with the first axis m1 of the container body 10, the vial 300 may be directly placed into the third receiving space 133 of the container body 100. When the axis of the medicine bottle 300 is preferably deviated from the first axis m1 of the container body 10 greatly, the bottom of the medicine bottle 300 may first contact the second sidewall 1321 of the second accommodating space 132, and the medicine bottle 300 may slide into the third accommodating space 133 under the guidance of the second sidewall 1321 due to the included angle α of the second sidewall 1321 with the first axis being 20 ° to 30 °.

In some embodiments, as shown in fig. 1-4, the side wall of the cover body 22 of the cover body 20 is provided with a groove 221, for example, a continuous annular groove, and the groove 221 may also be a discontinuous annular groove provided on the periphery of the side wall of the cover body 22. The loading of the radiopharmaceutical vial with the radiopharmaceutical into the container 100 of the present disclosure may be accomplished by using a robot arm, for example, the cap 20 may be first separated from the container body 10 by using the robot arm, at which time the robot arm may be inserted into the recess 221 to remove the cap 20 from the container body 10, then the robot arm may pick up the radiopharmaceutical vial 300 with the radiopharmaceutical into the third receiving portion 133 of the container body 10, and then the cap 20 may be fastened to the container body 10 by using the robot arm, and the entire process may be automatically accomplished by using the robot arm without manual operations, for example, in a closed space with radiation protection, thereby avoiding injury to the human body by radiation.

In some embodiments, as shown in fig. 1-4, the container 100 is, for example, substantially cylindrical, as are the container body 10 and the lid body 22 of the lid 20. The first accommodating space 131 is cylindrical, the second accommodating space 132 is inverted truncated cone-shaped, and the third accommodating space 133 is cylindrical. The third receiving space 133 has a shape substantially matching the shape of the vial 300 of the radiopharmaceutical. In some embodiments, as shown in fig. 4, when the vial 300 of the radiopharmaceutical is loaded into the third accommodation space 133 in the container body 10, a portion below the neck of the vial 300 is accommodated in the third accommodation space 133, and a portion above the neck is accommodated in the second accommodation space 132, because of the specific structure of the accommodation groove 13 in the container body 10, i.e., the specific combination of the first accommodation space 131, the second accommodation space 132 and the third accommodation space 133, it is convenient for the robot arm to clamp the neck of the vial 300 to put the vial 300 into the container body 10 or to remove the vial 300 from the container body 10.

In some embodiments, when the cap 20 is snapped onto the container body 10, the second protrusion 212 is spaced from the vial 300 by a distance less than a predetermined distance, such as 50mm, in the first axial direction m 1. To avoid a large amount of shaking of the vial 300 accommodated in the container 100 in the vertical direction. In some embodiments, when the cap 20 is snapped onto the container body 10, the second protrusion 212 abuts the vial 300.

In some embodiments, when the inner body 12 is assembled in the outer body 11, the inner body 12 and the outer body 11 are in interference fit, so as to avoid the inner body 12 from shaking in the first accommodating groove 111 in the outer body 11, and ensure that the medicine bottle 300 is stably placed in the container body 100.

Fig. 7 is an exploded view of a container according to other embodiments of the present disclosure, in which a container body is separated from a cap body, a rubber pad portion of a boss of the cap body is separated from other portions of the cap body, and a medicine bottle 300 accommodated in the container is shown in fig. 7. If the rubber pad is mounted at the end of the protruding portion, the overall structure of the cover is similar to that of the cover shown in fig. 2, and the same points are not described here again.

As shown in fig. 1 and 7, the container 100 includes a container body 10 and a lid 20, and when the lid 20 is engaged with the container body 10, a relatively airtight space is formed inside the container 100. In some embodiments, the container body 10 and the cap 20 may each be made of a radiation resistant material, such as lead, and the like, whereby the container 100 may be used to house a vial containing a radiopharmaceutical, such as a penicillin bottle. The container 100 may be used as a carrier for movement or transport of the vial of radiopharmaceutical to prevent radiation leakage during movement or transport and to prevent environmental contamination.

As shown in fig. 1 and 7, an open receiving slot 13 is provided in the container body 10, the receiving slot 13 being configured to receive at least a portion of a vial 300 containing a radiopharmaceutical. The accommodating groove comprises, for example, the aforementioned first accommodating space 131, the second accommodating space 132 and the third accommodating space 133 which are sequentially adjacent to the bottom of the accommodating groove, wherein the third accommodating space 133 is configured to accommodate at least a portion of a medicine bottle containing a radiopharmaceutical. The cover 20 includes a cover body 22 and a boss 21 extending from a bottom surface of the cover body 22 in a direction away from a top surface of the cover body 22. The end of the protruding portion 21 away from the cover body 22 is provided with a rubber pad 2123.

Fig. 8 is a schematic perspective view of a rubber pad provided in some embodiments of the present disclosure, and fig. 9 is a cross-sectional view of a rubber pad provided in some embodiments of the present disclosure. As shown in fig. 1 and 7-9, the end of the rubber pad 2123 away from the cover body is provided with a first groove 21231, and the side wall of the first groove 21231 gradually moves away from the axis of the cover body, namely, the second axis m2 along with moving away from the cover body. When the cap 20 is fastened to the container body 10, the first groove 21231 accommodates the top of the vial 300, so that the second axis m2 of the cap 20 is collinear with the axis of the vial 300, hereinafter referred to as the third axis.

In this case, when the container 100 is used to hold the container 300 of the radiopharmaceutical vial, and the cover 20 is aligned and fastened to the container body 10, the top surface of the vial is restrained in the first groove 21231, so that it can be stably placed in the container, and the push pin assembly can be substantially aligned with the vial containing the radiopharmaceutical in the holding groove after being inserted into the through hole in the cover, so that the vial is connected to the injection system with the vial containing the radiopharmaceutical in the radiation-proof container, thereby reducing contact between medical staff and the radiopharmaceutical and providing radiation protection to the medical staff.

Specifically, referring to fig. 1,7-9, the size of the third receiving space 133 in the receiving groove 13 in the container body 10 in the second direction, for example, the horizontal direction X, will generally be slightly larger than the size of the vial 300 in the horizontal direction, for example, the inner diameter of the third receiving space 133 is slightly larger than the diameter of the vial 300. This arrangement allows the vial 300 to be conveniently placed into the third receiving space 133 by a robot, allowing the robot holding the vial 300 to have a certain deviation in alignment of the third receiving space 133. In this case, the third axis of the medicine bottle 300 does not necessarily coincide with the axis of the third receiving space 133, i.e., the first axis m1 of the container body 10, which is disadvantageous in terms of alignment with the medicine bottle after inserting the push pin assembly into the through hole of the cap body during the subsequent process of inserting the medicine bottle into the injection system.

With these embodiments, as the cap 20 is engaged with the container body with the medicine bottle 300, at least a portion of the sidewall of the first groove 21231 first contacts the top of the medicine bottle 300 as the protrusion 21 of the cap 20 gradually moves toward the bottom of the receiving groove 13 in the container body 10, and as the protrusion 21 continues to extend deeper into the receiving groove 13, the sidewall of the first groove 21231 pushes the top of the medicine bottle 300 as the sidewall of the first groove 21231 gradually moves away from the second axis m2 of the cap 20 away from the cap body 22, so that the top of the medicine bottle 300 is gradually aligned with the first groove 21231, and as the protrusion 21 continues to move toward the bottom of the receiving groove 13, the top of the medicine bottle 300 gradually enters the first groove 21231 of the rubber pad 2123, so that the third axis of the medicine bottle 300 is substantially collinear with the second axis of the cap 20. On the one hand, the medicine bottle 300 can be stably placed in the container 100 to avoid shaking in the horizontal direction, and on the other hand, the push pin assembly can be basically aligned with the medicine bottle containing the radioactive medicine in the containing groove after being inserted into the through hole in the cover body, so that the medicine bottle is connected into the injection system under the condition that the medicine bottle containing the radioactive medicine is located in the radiation-proof container, the contact between medical staff and the radioactive medicine is reduced, and the radiation protection is provided for the medical staff.

In some embodiments, the pad 2123 is made of, for example, an elastic material so that damage to the vial is avoided when the pad abuts the vial.

In some embodiments, as shown in fig. 9, the sidewall of the first groove portion 21231 has an arc shape, for example, an arc shape, protruding toward the axis of the cover in a section passing through the axis. The sliding abutment sliding between the side wall of the first groove portion 21231 and the top of the vial 300 can thereby be made more compliant.

In some embodiments, the bottom surface of the first groove 21231 is substantially the same shape and size as the top surface of the vial 300, e.g., both are circular in shape and substantially the same diameter. So can make the top of medicine bottle 300 hold when first slot portion 21231, the top surface of medicine bottle 300 with the bottom surface of first slot portion 21231 can the looks butt, be favorable to the stable placing of medicine bottle 300.

In some embodiments, as shown in fig. 9, the rubber pad 2123 has a first through hole 21232, the first through hole 21232 is coaxial with the first groove 21231 and the cover 20, the first through hole 21232 communicates with the first groove 21231, and a cross-sectional area of the first through hole 21232 in a plane perpendicular to the second axis m2 of the cover 20 is smaller than a cross-sectional area of the first groove 21231 in a plane perpendicular to the second axis m2 of the cover 20, for example, an inner diameter of the first through hole 21232 is smaller than an inner diameter of the first groove 21231. The first through-hole 21232 is a portion of the through-hole 23 penetrating the lid 20. Fig. 10 is a schematic cross-sectional view of fig. 3 in other embodiments, as shown in fig. 10, in which a medicine bottle 300 containing a radiopharmaceutical is accommodated in the accommodation groove 13 of the container body 10, specifically, a cylindrical body below the neck of the medicine bottle 300 is accommodated in the third accommodation space 133. When the push needle assembly 200 in the injection system can be inserted into the medicine bottle 300 through the through hole of the cover 20, the liquid guide needle of the push needle assembly 200 can be inserted into the medicine bottle 300 through the first through hole 21232. Thus, in the case where the vial 300 containing the radiopharmaceutical is located within the radiation-protected container 100, the vial 300 is accessed into the injection system, reducing contact between the healthcare worker and the radiopharmaceutical, and providing radiation protection to the healthcare worker.

Fig. 11 is a schematic structural view of a medicine bottle according to some embodiments of the present disclosure, fig. 12 is a schematic sectional structural view of a medicine bottle according to some embodiments of the present disclosure, and fig. 13 is a schematic structural view of a top surface of a medicine bottle according to some embodiments of the present disclosure. As shown in fig. 11-13, the vial 300 includes a vial body 301, a glue cap 302, and a packaging cap 303. The vial body is, for example, a glass vial body, which may be a V-shaped vial as shown in fig. 12, i.e., the bottom of the cavity in the vial body is substantially V-shaped, such as a penicillin vial for containing a radiopharmaceutical, such as a radioactive glass microsphere. When the medicine bottle is connected into an injection system, the radioactive glass microspheres in the medicine bottle can be uniformly discharged from the medicine bottle under the impact of medical liquid. The rubber cover 302 is buckled at the opening of the medicine bottle body 301 and is used for sealing the medicine bottle body 301. The packaging cover has an opening 3031, the packaging cover 303, for example, an aluminum cover, is used to cover and lock the peripheral area of the glue cover 302 on the medicine bottle body 301, and the opening 3031 exposes the middle portion of the glue cover 302.

As shown in connection with fig. 7-13, the first through hole 21232 has substantially the same shape and size as the opening 3031 in a cross section on a plane perpendicular to the second axis m2 of the cover 20, for example, both have a circular shape and substantially the same diameter. In response to the cover 20 being snapped onto the container body 10, the top surface of the packaging cover 303 abuts against the bottom surface of the first groove 21232, and the projection of the first through hole 3031 on the packaging cover 303 substantially coincides with the opening 3031. Thereby facilitating penetration of the liquid guide needle of the push needle assembly 200 through the first through hole 21232 into the middle portion of the cap 302 of the medicine bottle 300 exposed by the packing cap 303 and into the medicine bottle 300 when the push needle assembly 200 in the injection system can be penetrated through the through hole of the cap 20 into the medicine bottle 300.

Fig. 14 is an exploded cross-sectional view of the cover of fig. 7. As shown in fig. 14, the convex portion 21 includes a rubber pad portion 2123 and includes a hard portion 213 detachably connected to the rubber pad portion 2123. The side wall of the hard portion 213 is provided with a locking groove 2131, and the end of the rubber pad 2123 near the cover body 22 is provided with an engaging portion 21233 matching the locking groove 2131. For example, the engagement portion of the rubber pad portion encloses a second groove portion 21234, and the hard portion 213 is accommodated in the second groove portion 21234 away from the top of the cover body. By engaging the engaging groove 2131 with the engaging portion 21233, the rubber pad 2123 can be attached to the end of the hard portion 213 to constitute the protruding portion 21. The side wall of the rubber pad 2123 and the side wall of the hard portion 213 smoothly transition, for example, the side wall of the rubber pad 2123 and the side wall of the hard portion 213 away from a part of the cover body 22 together form the same rotational arc surface. The rubber pad 2123 and a portion of the hard portion 213 apart from the cover body 22 constitute a second convex portion 212, and a portion of the hard portion 213 close to the cover body 22 serves as a first convex portion 211.

In some embodiments, referring to fig. 7, 10 and 14, the clamping groove 2131 is provided on the outer periphery of the side wall of the hard portion, and has a continuous ring shape, and correspondingly, the clamping portion 21233 on the rubber pad 2123 is also a continuous ring-shaped portion.

In some embodiments, the engaging groove 2131 may be in a discontinuous ring shape, for example, a plurality of spaced engaging grooves are provided on the outer periphery of the side wall of the hard portion, and correspondingly, the engaging portion 21233 on the rubber pad 2123 is also in a discontinuous ring shape, for example, including a plurality of spaced engaging portions provided on the circumferential direction of the rubber pad.

Referring to fig. 7-14, similar to the corresponding embodiments of fig. 1-6, in these embodiments, the receiving slot 13 includes a first receiving space 131, a second receiving space 132, and a third receiving space 133 that are sequentially adjacent to the bottom of the receiving slot and are sequentially adjacent, wherein the third receiving space 133 is configured to receive at least a portion of a vial 300 containing a radiopharmaceutical.

The first sidewall 1311 of the first accommodating space 131 extends along a first direction, such as a vertical direction Y, the first direction is parallel to the first axis m1 of the container body 10, the second sidewall 1321 of the second accommodating space 132 gradually tapers from an end of the first sidewall 1311 near the second accommodating space 132 toward the first axis m1 of the container body 10 in the first direction, and the third sidewall 1331 of the third accommodating space 133 extends from an end of the second sidewall 1321 far from the first accommodating space 131 along the first direction.

When the cover 20 is fastened to the container body 10, the first protruding portion 211 and the second protruding portion 212 are respectively received in the first receiving space 131 and the second receiving space 132, the first outer sidewall 1311 is matched and attached to the first sidewall 2111, and the second sidewall 1321 is matched and attached to at least a portion of the second outer sidewall 2121, so that the first axis m1 is substantially collinear with the second axis m 2. The inner side wall of the accommodating groove in the container body and the outer side wall of the protruding part of the cover body are provided with specific shapes which are matched with each other, so that when the cover body is buckled on the container body, the first axis of the container body is basically collinear with the second axis of the cover body, the cover body and the container body are aligned and buckled, and larger deviation exists in the horizontal direction when the cover body and the container body are buckled. The first slot portion as previously described is incorporated to accommodate the top of the vial in the container such that the axis of the cap is substantially collinear with the axis of the vial, in which case the axes of the cap, container body, and vial are substantially collinear. So can make when the medicine bottle that will be equipped with the radiopharmaceutical inserts injection system later, push pin subassembly inserts the through-hole on the lid after can be basically with the medicine bottle of holding the radiopharmaceutical in the holding groove alignment to realize under the medicine bottle that holds the radiopharmaceutical is located the circumstances of radiation protection in the container, will the medicine bottle inserts injection system, reduced medical personnel and the contact of radiopharmaceutical, for medical personnel's supply radiation protection.

As shown in connection with fig. 5,7-14, similar to the corresponding embodiments of fig. 1-6, in these embodiments the container body 10 comprises an outer body 11 and an inner body 12. The outer body is internally provided with an open first accommodating groove 111, the inner body 12 is detachably accommodated in the first accommodating groove 111, and the inner body 12 is internally provided with a second accommodating groove 121 with an opening. When the inner body 12 is mounted in the first accommodating groove 111 of the outer body 11, the second accommodating groove 121 includes the second accommodating space 132 and the third accommodating space 133, and in the first accommodating groove 111, a space from the top of the inner body 12 to the top of the outer body 11 constitutes the first accommodating space 131.

In some embodiments, the material of the outer body is lead and the material of the inner body is plexiglass, which produces high energy beta decay when the radiopharmaceutical is, for example, a radioactive glass microsphere, the beta rays impinging on the element with the higher atomic number releasing very strong bremsstrahlung. The protection against beta rays is first achieved with low Z materials. Therefore, the inner body material is selected as the organic glass with low Z material, which is favorable for reducing the bremsstrahlung radiation of the radioactive glass microspheres.

Fig. 15 is a schematic diagram of an injection system provided in some embodiments of the present disclosure, as shown in fig. 15, an injection system 1000 for injecting a radiopharmaceutical, such as a radioactive microsphere, into a patient, such as a container 100 including a vial of the radiopharmaceutical, a push-needle assembly 200, a medical fluid bag 400, such as a saline bag, a syringe 500, a waste collection container 600, and a patient-side retention needle 700.

In performing an injection operation, the push needle assembly 200 is inserted into a medicine bottle containing a radiopharmaceutical in the container 100, physiological saline in the medical fluid bag 400 is pumped into the syringe by the syringe, then a push rod of the syringe is pushed, the physiological saline is injected into the medicine bottle containing the radiopharmaceutical at high pressure through the push needle assembly, the push needle assembly has a double-needle structure, for example, the push needle assembly comprises a liquid inlet needle and a liquid outlet needle, the high-pressure fluid output by the liquid inlet needle fully impacts the radiopharmaceutical in the medicine bottle, the radiopharmaceutical is discharged out of the medicine bottle through the liquid outlet needle under the driving of the fluid, and the radiopharmaceutical is injected into a patient through the patient-end retention needle 700. When the pressure of the normal saline pushed by the syringe is too high, the normal saline enters the waste liquid recovery container 600 via the pressure release valve, and the excessive pressure in the medicine bottle is avoided.

In some embodiments, the container 100 of the radiopharmaceutical vial is, for example, the container 100 of the previous embodiment, and in the following description, the container 100 of the corresponding embodiment of fig. 7 is described.

Fig. 16 is a schematic view of the structure of a push needle assembly provided in some embodiments of the present disclosure, and in conjunction with fig. 7, 10, 14-16, an injection system 1000 includes a container 100 housing a radiopharmaceutical vial 300, a push needle assembly 200, a medical fluid bag 400, such as a saline bag, a syringe 500, a waste retrieval container 600, and a patient-side retention needle 700.

The container 100 includes a container body 10 and a lid 20, and when the lid 20 is engaged with the container body 10, the interior of the container 100 forms a relatively airtight space. In some embodiments, the container body 10 and the cap 20 may each be made of a radiation resistant material, such as lead, and the like, whereby the container 100 may be used to house a vial containing a radiopharmaceutical, such as a penicillin bottle. An open receiving recess 13 is provided in the container body 10, the recess 13 being configured to receive at least a portion of a vial 300 containing a radiopharmaceutical. The cover 20 includes a cover body 22 and a protruding portion 21 extending from a bottom surface of the cover body 22 in a direction away from a top surface of the cover body 22, wherein the protruding portion 21 is configured to abut against a top of the medicine bottle 300 when the cover 20 is buckled on the container body 10, so that the medicine bottle 300 is fixed in position in the container body 100. The boss 21 includes, for example, a rubber pad 2123 at an end thereof remote from the cover body 22. With this arrangement, breakage of the vial can be avoided when the boss 21 abuts the vial 300. The cover 20 has a through hole 23 penetrating the cover body 22 and the boss 21.

The push-pin assembly 200 is configured to be inserted into the through hole 23 to be in snap-fit connection with the cover 20, and the push-pin assembly 200 includes a cannula 201 and a liquid guide pin assembly 202. At least a part of the liquid guiding needle assembly is disposed in the sleeve 201 and is configured to slide relative to the sleeve 201, so that the liquid guiding needle assembly 201 is inserted into the medicine bottle 300, a first clamping portion 231 is disposed on an inner side wall of the through hole 23, and a second clamping portion 2011 matched with the first clamping portion is disposed on a side wall of the sleeve 301, so that the push needle assembly 200 is clamped in the through hole 23.

Fig. 17 is an enlarged view of the area M in fig. 10, as shown in fig. 10/16 and 17, the first engaging portion 231 includes a first groove 2311, an engaging member 2313 and an elastic member 2312.

The first groove 2311 is provided on an inner sidewall of the through hole, and an extending direction of the first groove 2311 is perpendicular to an axis of the cover 20, that is, the second axis m2, for example. In some embodiments, first groove 2311 may be, for example, a rectangular groove, and in other embodiments, may also be an annular groove about the axis of cover 20. The engaging member 2313 is slidably disposed in the first groove 2311. One end of the elastic member 2312 is fixedly connected to the bottom of the first groove 2311, the other end is fixedly connected to the engaging member 2313, and at least a portion of the engaging member 2313 protrudes out of the inner sidewall of the through hole 23 under the action of the elastic member 2312, such as a spring.

The second engaging portion 2011 includes a second groove on the sidewall of the push pin assembly, hereinafter referred to as a second groove 2011, and when the push pin assembly 200 is inserted into the through hole 23 and inserted to a predetermined depth, the second groove 2011 accommodates at least a portion of the engaging member 2313 and engages with the first engaging portion 231.

In this case, the push needle assembly 200 is locked in the through hole 23 of the cover 20, and the liquid guide needle is inserted into the medicine bottle 300 in the container 100, so that the push needle assembly 200 is prevented from moving or even separating relative to the medicine bottle 300 and the through hole when the medical staff uses the injection system 1000 to inject the radioactive medicine into the patient, thereby ensuring the smooth injection operation.

In some embodiments, the engaging member 2313 includes a first surface 23131 and a second surface 23132 sequentially away from the top surface of the cover 20, and the first surface 23131 and the second surface 23132 are inclined with respect to the second axis m2 of the cover 20, and the dotted line in fig. 17 is parallel to the second axis m2 of the cover 20. The first surface 23131 and the second surface 23132 are gradually approaching each other in a direction away from the bottom of the first groove 2311, the second clamping groove 2011 includes a first inner surface 20111 and a second inner surface 20112, and when the at least a portion of the engaging member 2313 enters the second groove 2011 to engage with the second groove 2011, the first inner surface 20111 and the second inner surface 20112 are respectively matched and fit with the first surface 23131 and the second surface 23132. With this design, the pin assembly 200 can be inserted into the groove 23 of the cover 20 and locked, and the pin assembly 200 can be easily pulled out of the groove 23 of the cover 20. After injection of the radiopharmaceutical is typically completed, the push-pin assembly requires disposal due to contamination with the radiopharmaceutical. The container 100 and the cover 20 thereof are manufactured at high cost and can be reused.

In some embodiments, the first angle α of the first surface 23131 to the second axis m2 of the cover 20 (a dashed line parallel to the second axis m2 is shown in fig. 17) is less than the second angle β of the second surface 23132 to the second axis m2 of the cover 20. In this case, a small force is required to push the push pin assembly 200 into the through hole 23. During the process of pushing the push pin assembly 200 into the through hole 23, the outer side of the sleeve 201 abuts against the first surface of the engaging member 2313, the engaging member 2313 is pressed into the first groove 2311, and when the second groove 2011 on the sidewall of the sleeve 201 is substantially aligned with the first recess 2311, the engaging member 2313 is engaged into the second groove 2011 under the action of the elastic member 2312, so that the push pin assembly 200 is locked with the cover 20. When the push pin 200 needs to be pulled out of the through hole 23, a large force is applied by an operator, and the second inner surface 20112 of the second clamping groove 2011 applies a component force to the second surface 23132 of the clamping member 2313 toward the bottom of the first groove 2311, so that the clamping member 2313 moves toward the bottom of the first groove 2311, and the first clamping portion 231 is out of contact with the second clamping portion 2011.

In some embodiments, as shown in fig. 16, the second engaging portion 2011 is, for example, a circumferential annular groove.

In some embodiments, at least one of the first surface 23131 and the second surface 23132 of the engaging member 2313 is an arc surface, and the second slot 2011 may also have a matched arc surface with the first inner surface 20111 and the second inner surface 20112.

In some embodiments, as shown in fig. 7, 10, and 14-16, the inner side wall of the through hole 23 includes a stepped limiting portion 232, the stepped portion 232 is located on a side of the first groove 231 near the top surface of the cover body, the sleeve 201 further includes a protruding portion 2012 extending in a direction away from the axis of the sleeve, and the limiting portion 232 is configured to abut against the protruding portion 2012 to limit the push pin assembly 200 during the insertion of the push pin assembly into the through hole 23. In some embodiments, the top surface of the limiting portion 232 is a plane, and the top surface is perpendicular to the second axis m2 of the cover.

Referring to fig. 7, 10, 14-16, the introducer needle assembly 202 includes: slider 2021 and introducer needle 2022. The liquid guiding needle 2022 is fixedly connected with the sliding member 2021, and at least a part of the liquid guiding needle 2022 is disposed in the sliding member 2021. The side wall of the sliding member 2021 is provided with a protruding portion 20211, the side wall of the sleeve 201 is provided with a sliding groove 2013 extending along the length direction of the sleeve, the protruding portion 20211 is slidably accommodated in the sliding groove 2013, and the sliding member 2021 further comprises a handle portion 20212 extending away from the protruding portion from the side wall of the protruding portion 20211 exposed by the sliding groove. When an external force is applied to the handle portion 20212, the slider 2021 may slide along the extending direction of the slide groove 2013, and the length of the slide groove 2013 defines a distance by which the slider 2021 can slide.

In some embodiments, the number of protrusions is one, and the number of corresponding sliding grooves 2013 is one, and the number of handles 20212 is one.

Fig. 18 is a schematic cross-sectional view of the N region in fig. 16, as shown in fig. 16 and 18, in some embodiments, a first clamping groove 202113 is provided on a side wall of the protruding portion 20211 facing the corresponding sliding groove, an elastic protruding portion 20131 matching the first clamping groove is provided on an inner side wall of the sliding groove 2013, and when the sliding piece 2021 slides to an end of the sliding groove 2013 away from the top of the sleeve, the elastic protruding portion 20131 is engaged with the first clamping groove 202113. In this case, the push needle assembly 200 is locked in the through hole 23 of the cover 20, and the liquid guide needle is inserted into the medicine bottle 300 in the container 100, so that the liquid guide needle assembly 202 is prevented from moving relative to the catheter 201 when the medical staff uses the injection system 1000 to inject the radioactive medicine into the patient, thereby ensuring the smooth injection operation.

In some embodiments, the number of first detents and resilient protrusions may be 2 or more.

In some embodiments, as shown in fig. 16, the chute 2013 extends from the top of the cannula 201 away from the cannula top in the cannula length direction, and the push pin assembly 200 further includes a top plug 203 removably mounted on the cannula 201 top such that the end of the chute 2013 at the cannula top is closed. In this case, the introducer needle assembly 202 may be removed from the cannula 201 by removing the top plug from the top of the cannula 201, facilitating replacement of the introducer needle assembly 202.

In some embodiments, as shown in fig. 10 and 16, the number of the protrusions 20211 of the slider 2021 is two, for example, including a first protrusion 202111 and a second protrusion 202112 disposed opposite to each other, and the liquid guiding needle 2022 is a double needle structure, including a liquid inlet needle 20221 and a liquid outlet needle 20222.

In some embodiments, the fluid intake needle 20221 includes a first sub-portion 202211 and a second sub-portion 202212 connected to each other, the first sub-portion 202211 extending through a sidewall of the first protrusion 202111 exposed by the runner in a direction away from the slider, the second sub-portion 202212 extending through a bottom surface of the slider in the sleeve extending direction, the connection of the first sub-portion 202211 and the second sub-portion 202212 being located in the slider; the liquid outlet needle 20222 includes a third sub-portion 202221 and a fourth sub-portion 202222 connected to each other, the third sub-portion 202221 extending in a direction away from the slider through a side wall of the second protrusion 202112 exposed by the chute, the fourth sub-portion 202222 extending in the sleeve extending direction through a bottom surface of the slider, and a connection portion of the third sub-portion 202221 and the fourth sub-portion 202222 being located in the slider.

In some embodiments, the second sub-portion 202212 is disposed parallel to the fourth sub-portion 202222, and the first sub-portion 202211 is disposed parallel to the third sub-portion 202221 and extends in an opposite direction.

In some examples, as shown in fig. 10 and 16, the sleeve 201 includes a first sub-sleeve 2014 and a second sub-sleeve 2015. The slider 2021 is disposed in the first sub-sleeve. The second sub-sleeve 2015 is adjacent to the first sub-sleeve 2014 and comprises two parallel pipes, which respectively house the second sub-portion 202212 of the liquid inlet needle 20221 and the fourth sub-portion 202222 of the liquid outlet needle 20222. When the boss 20211 of the slider 2021 slides from the end of the chute near the top of the sleeve to the end of the chute away from the top of the sleeve, at least a portion of the second sub-portion 202212 of the inlet needle 20221 and the fourth sub-portion 202222 of the outlet needle 20222 protrude from the two lines through the through-hole 23 and are inserted into the vial 300.

Some embodiments of the present disclosure also provide an injection system of a radiopharmaceutical, the injection system comprising: a container configured to house a vial of the radiation-sensitive drug; a push pin assembly comprising a liquid inlet end and a liquid outlet end configured to be inserted into a vial in the container; a medical fluid bag configured to provide a medical fluid to the push needle assembly; the pumping device is connected with the medical liquid bag and the push needle assembly, is configured to pump medical liquid in the medical liquid bag to a liquid inlet end and a patient end retention needle of the push needle assembly, is configured to be accessed into an artery or a vein of a patient, and is configured to be detachably connected with a liquid guide tube connected with a liquid outlet end of the push needle assembly through a joint assembly. With such an injection system, radiopharmaceuticals, such as radioactive microspheres, may be conveniently injected into a patient. The pumping means comprise, for example, syringes, peristaltic pumps, etc. Fig. 19 is a schematic diagram of an injection system provided in some embodiments of the present disclosure, as shown in fig. 19, an injection system 1000 for injecting a radiopharmaceutical, such as a radioactive microsphere, into a patient, including, for example, a container 100, a push needle assembly 200, a medical fluid bag 400, a syringe 500, and a patient-side retention needle 700.

The container 100 is configured to hold a vial of a radiopharmaceutical, such as may be the container of the previous embodiments. The push-pin assembly 200 includes a liquid inlet end 210 and a liquid outlet end 220 configured to be inserted into a vial containing a radiopharmaceutical in the container 100, such as the push-pin assembly of the previous embodiments. The medical fluid bag 400, for example a physiological saline bag, is configured to provide a medical fluid, for example physiological saline, to the push needle assembly 200. The syringe 500 is connected with the medical fluid bag 400 and the fluid inlet end 210 of the push needle assembly through the three-way two-way valve 801, the syringe 500, the medical fluid bag 400 and the fluid inlet end 210 of the push needle assembly 200 are respectively connected with the first end, the second end and the third end of the three-way two-way valve through the liquid guide tube, so that after the syringe 500 pumps medical fluid from the medical fluid bag 400, the medical fluid is pressurized and injected into the fluid inlet end 210 of the push needle assembly 200, and then the pressurized medical fluid is injected into a medicine bottle filled with the radioactive medicine, so that the medical fluid can be discharged from the fluid outlet end 220 of the push needle assembly 200 with the radioactive medicine, and the patient end retention needle 700 is configured to be detachably connected with the fluid outlet end 220 of the push needle assembly 200 through a connector assembly 806 at the E position, such as a luer connector, for injecting the medical fluid with the radioactive medicine discharged from the fluid outlet end 220 into a patient for treatment.

In some embodiments, the injection system 1000 further comprises a vent line 810 having one end, e.g., at position C in fig. 19, provided with a positive pressure connector 805 configured to be detachably connected to the outlet end 220 of the push needle assembly 200, and the other end of the vent line 810 is in communication with the third end of the three-way two-way valve 801 and the inlet end 210 of the push needle assembly 200 via a first three-way valve 802 at position a. When the needle assembly 200 is not inserted into a vial containing a radiopharmaceutical in the container 100, the positive pressure connector 805 at one end of the vent line may be first connected to the connector assembly 806 disposed at the E-position such that the vent line communicates with the liquid outlet end 220 of the push needle assembly 200, pressurized medical fluid is applied by the syringe 500, and the medical fluid enters the push needle assembly 200 via the liquid inlet end 210 and the liquid outlet end 220 of the push needle assembly 200 for venting air from the push needle assembly 200 and its communicating catheter.

In some embodiments, in the injection system 1000, a second tee 803 is disposed between the third end of the two-way three-way valve 801 and the first tee 802, the first end and the second end of the second tee 803 are respectively connected to the third end of the two-way three-way valve 801 and the first tee 802, the injection system 1000 further includes a waste liquid bottle 600, and the waste liquid bottle 600 is connected to the third end of the second tee 803 through a pressure release valve 804. The pressure of the medical fluid provided to the push needle assembly 200 by the pressurization of the syringe should not be excessive, which may cause problems such as disengagement of the push needle assembly 200 from the vial in the container. When the pressure is greater than a predetermined value, the pressure relief valve 804 opens, allowing a portion of the medical fluid to flow into the waste bottle.

In some embodiments, as shown in fig. 19, the catheter to which the liquid inlet end 210 of the push needle assembly 200 is connected is provided with a connector assembly 807, such as a luer connector, at position B, which may be used to connect catheters of different tube diameters.

In some embodiments, as shown in fig. 19, a catheter connected to the outlet end 220 of the push needle assembly 200 may be provided with an on-off valve 808 between the D position and the E position for controlling the on-off of the catheter.

In some embodiments, as shown in fig. 19, a one-way valve 809 is provided at the outlet of the medical fluid bag 400 to prevent backflow of medical fluid into the medical fluid bag 400.

When a medical staff performs an injection operation by using the injection system, firstly, under the condition that the push needle assembly 200 is not inserted into a medicine bottle filled with a radiopharmaceuticals in the container 100, the forward connector 805 at the C position is connected with the connector assembly 806 at the E position, medical liquid, such as physiological saline, is extracted from the medical liquid bag 400 by using the syringe 500, then is injected into the first tee joint 802 at the A position, the medical liquid is divided into two paths after passing through the first tee joint 802, one path enters the push needle assembly 200 from the liquid inlet end 210 of the push needle assembly 200 via the B position, and the other path enters the push needle assembly 200 from the liquid outlet end 220 of the push needle assembly 200 via the C position, the E position and the D position, so that air in the push needle assembly 200 is completely discharged, that is, and no air exists in the liquid inlet needle and the liquid outlet needle in the push needle assembly 200. The push needle assembly 200 is then inserted into the radiopharmaceutical vial in the container 100, the forward connector 805 at position C is disconnected from the connector assembly 806 at position E, the disconnected forward connector 805 is in a blocked state, and the connector assembly 806 at position E is disconnected from the patient-side retention needle 700. The syringe is used to pump the physiological saline in the medical fluid bag 400 into the syringe, then the push rod of the syringe is pushed, the physiological saline is injected into the medicine bottle filled with the radiopharmaceuticals under high pressure through the push needle assembly, for example, the push needle assembly is of a double-needle structure, the liquid inlet needle and the liquid outlet needle are included, the radiopharmaceuticals in the medicine bottle are fully impacted by the high-pressure liquid output by the liquid inlet needle, the radiopharmaceuticals are discharged out of the medicine bottle through the liquid outlet needle under the driving of the liquid, and the radiopharmaceuticals are injected into a patient through the retention needle 700 at the patient end. When the pressure of the physiological saline pushed by the syringe is too high, the physiological saline enters the waste liquid recovery container 600 via the pressure release valve 804, so that the excessive pressure in the medicine bottle is avoided.

Some embodiments of the present disclosure also provide a shield for an injection system that avoids accidentally touching a container containing a radiopharmaceutical vial and a push-pin assembly during an injection process, affecting the injection results.

Fig. 20A is a schematic structural view of a protective cover provided by some embodiments of the present disclosure, and fig. 20B is a schematic structural view of a protective cover provided by some embodiments of the present disclosure, wherein a top cover is not shown. Fig. 21A is a schematic structural view of a shield provided by some embodiments of the present disclosure, wherein an injection system is supported by the shield, and fig. 21B is a schematic structural view of a shield provided by some embodiments of the present disclosure, wherein an injection system is supported by the shield, and a top cover is not shown.

As shown in fig. 20A to 21B, the shield 900 is used to support the injection system 1000 in the previous embodiment, and the shield 900 includes a base 910, side walls 920, and a top cover 930. The side wall 920 extends from the top surface of the base 910 in a direction away from the base 910, and the base 910 and the side wall 920 enclose a receiving space, where the receiving space is used for receiving the container 100 and the push pin assembly 200. The top cover 930 is configured to be fastened to an end of the side wall 920 away from the base 910 to close the accommodating space. The orthographic projection of the accommodating space on the base 910 falls into the base 910, and the side wall 920 is spaced from the edge of the base 910 by a predetermined distance. So that the protection cover 900 protects the container 100 and the push pin assembly 200 in the injection system 1000, and avoids the accidental contact with the container and the push pin assembly for accommodating the radiopharmaceutical vial during the injection process, thereby affecting the injection effect.

In some embodiments, the sidewall 920 includes a first sub-sidewall 921, a second sub-sidewall 922, a third sub-sidewall 923, and a fourth sub-sidewall 924, and orthographic projections of the first sub-sidewall 921, the second sub-sidewall 922, the third sub-sidewall 923, and the fourth sub-sidewall 924 on the base form a rectangle. The container space is substantially rectangular parallelepiped. The top cover 903 includes a first panel 931 and a second panel 932. The first panel 931 is configured to be fastened on the side wall 920 to close the accommodating space; the second panel 932 extends from the first panel 931 along a direction having a predetermined angle with the first panel 932, the predetermined angle being an obtuse angle, and an area of the second panel 932 is smaller than an area of the butterfly panel 931. The connection of the first panel 931 and the second panel 932 is pivotally connected to the end of the first sub-sidewall 921 remote from the base. Thus, the cap 930 can be opened by simply pressing the second panel 932 to expose the accommodating space, which is convenient for medical staff to insert the push needle assembly 200 into the medicine bottle in the container 100. When the medical staff finishes the operation, the second panel 932 is released, and the top cover 930 can be restored to be buckled to the side wall 920 to close the accommodating space under the action of gravity.

In some embodiments, as shown in fig. 20A-21B, the end of the base 910 distal to the second sub-sidewall 922 is provided with a slide 9221, the shield further comprises a cantilever 9222, the cantilever 9222 is slidably connected to the slide 9221, one end of the cantilever 9222 is provided with a clamp 9223, and the clamp 9223 is configured to clamp the patient-end retention needle 700. The patient end retention needle 700 is conveniently picked up or placed by a healthcare worker.

In some embodiments, as shown in fig. 20A-21B, the protective cover further comprises a stand-off receptacle 9224 and a retractable stand-off 9225, the stand-off receptacle 9224 being disposed on the top surface of the base 910 adjacent to the second sub-side wall 922, between the second side wall 922 and an edge of the base 910 adjacent to the second side wall 922; one end of the telescopic support 9225 is fixed in the support socket 9224, and the other end is configured to hang the medical fluid bag 400. The medical fluid bag 400 may be suspended at different heights according to actual needs.

In some embodiments, as shown in fig. 20A to 21B, the protection cover further includes a waste liquid bottle seat 9231, where the waste liquid bottle seat 9231 is disposed on the top surface of the base 910, is adjacent to the third sub-side wall 923, is located on a side of the third sub-side wall 923 away from the accommodating space, and is configured to accommodate a waste liquid bottle, and fixedly places the waste liquid bottle in the injection system 1000.

In some embodiments, as shown in fig. 20A to 21B, the outer surface of the third sub-sidewall 923 is provided with a holder 9232, and the holder 9232 is configured to accommodate the radiation detection device 9233, and the radiation detection device 9233 is configured to monitor the radiation amount in the environment in real time, and to send out an alarm when the radiation amount exceeds a predetermined value.

In some embodiments, the outer surface of the third sub-sidewall 923 is provided with a support 9235 for supporting and fixing the second tee 803.

In some embodiments, as shown in fig. 20A-21B, a clip 9241 is provided on the fourth sub-sidewall 924, the clip 9241 being configured to clip the positive pressure fitting 805. Positive pressure structure 805 is picked up to interface with connector assembly 806 when an operation is performed with injection system 1000.

In some embodiments, as shown in fig. 20A to 21B, the third sub-sidewall 923 is provided with a first opening 9234, where the first opening 9234 is configured to allow a catheter that communicates the first tee 802 and the liquid inlet end 210 of the push pin assembly 200 to pass through, the liquid inlet end 210 of the push pin assembly 200 is located in the accommodating space, and the first tee 802 is suspended on an outer wall of the third sub-sidewall 923.

In some embodiments, a baffle 9236 is disposed on the third sub-sidewall 923, and an orthographic projection of the baffle 9236 on the third sub-sidewall 923 covers the first opening 9234 for shielding the first opening 9234 in a direction perpendicular to the third sub-sidewall 923.

In some embodiments, the first sub-sidewall 921 has a second opening 9211, and the second opening 9211 is configured to allow a catheter that communicates with the liquid outlet end 220 of the push pin assembly 200, i.e., a catheter at the D position and a catheter at the E position, to pass through, and the liquid outlet end 220 of the push pin assembly 200 is located in the accommodating space.

In some embodiments, the bottom surface of the base 910 of the protective cover is provided with a metal block, which increases the weight of the base, so that the protective cover is more stable.

In some embodiments, the base 910 of the shield is integrally formed with the side wall 920 using plexiglas.

In some embodiments, the shield 900 further includes a receptacle 911 disposed on the top surface of the base 910 and positioned in the receiving space, the receptacle 911 being configured to securely hold the container 100 for facilitating insertion of the push pin assembly 200 into a vial in the container 100 by a healthcare worker.

The foregoing embodiments illustrate the structure and function of the injection system and its shield using a pumping device as an example of a syringe. In other embodiments, the pumping means may also be, for example, peristaltic pumps. Fig. 22 is a schematic structural view of an injection system provided in some embodiments of the present disclosure. As shown in FIG. 22, an injection system 1000' is used to inject a radiopharmaceutical, such as a radioactive microsphere, into a patient, which includes, for example, a container 100, a push-needle assembly 200, a medical fluid bag 400, a peristaltic pump 811, and a patient-end retention needle 700. The following mainly describes the differences between the injection system 1000' of the present embodiment and the injection system 1000 of the previous embodiment, and the same parts of the two are not described herein.

As shown in fig. 22, the injection system 1000' employs peristaltic pump 811 to pump medical fluid in a medical fluid bag 400 into tubing, as compared to the injection system 1000 of the previous embodiment. Specifically, the medical fluid bag 400 is connected to the fluid inlet end 210 of the push needle assembly 200 via the peristaltic pump 811, and a three-way two-way valve is not required, so that the pipeline can be further simplified. And the pumping speed of the peristaltic pump can be adjusted to adjust the flow speed of the medical liquid in the pipeline, so that the accurate adjustment of the flow speed of the medical liquid is realized.

In embodiments where the medical fluid bag 400 may be located at a higher position, the gravity of the medical fluid itself may be used to provide sufficient pressure to fill the tubing, and peristaltic pump 811 may be omitted.

The shield shown in fig. 20A and 20B may also support the injection system 1000' shown in fig. 22, and is not described in detail herein.

In the injection system, a push needle assembly is inserted into a radioactive drug bottle in a container, medical liquid is extracted by using a syringe and is injected into the push needle assembly under pressure, so that the radioactive drug in the medical liquid carrying drug bottle is injected into a patient through a patient end retention needle, and the operation of the injection system is performed under the condition of radiation protection. Moreover, the injection system is supported by the protective cover, so that the injection effect is prevented from being influenced by accidental contact with a container for accommodating the radiopharmaceutical bottle and the push pin assembly in the injection process.

The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

Finally, it should be noted that: in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. The system or the device disclosed in the embodiments are relatively simple in description, and the relevant points refer to the description of the method section because the system or the device corresponds to the method disclosed in the embodiments.

The above embodiments are merely for illustrating the technical solution of the present disclosure, and are not limiting thereof; although the present disclosure has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present disclosure.

Claims

1. A radiopharmaceutical injection system, said injection system comprising:

a container configured to house a vial of the radiation-sensitive drug;

a patient-side retention needle configured to access an artery or vein of a patient and configured to removably couple a catheter coupled to the fluid-delivery side of the push-pin assembly via a connector assembly,

the push needle assembly further comprises a liquid inlet needle and a liquid outlet needle which are respectively communicated with the liquid inlet end and the liquid outlet end, the liquid inlet needle and the liquid outlet needle are configured to be inserted into the medicine bottle so that the medical liquid is pumped to the liquid inlet end and enters the medicine bottle through the liquid inlet needle to impact the radioactive medicine, the radioactive medicine is a radioactive glass microsphere, the radioactive medicine is discharged out of the medicine bottle through the liquid outlet needle under the drive of the medical liquid and is provided to a patient end retention needle through the liquid outlet end,

the pumping device comprises a syringe, the medical liquid bag and the liquid inlet end of the push needle component are respectively connected with the first end, the second end and the third end of the three-way two-way valves through the three-way two-way valves, so that the syringe is configured to be pressurized and injected into the liquid inlet end of the push needle component after the medical liquid bag is pumped into the medical liquid,

The injection system further comprises:

the exhaust pipeline, exhaust pipeline one end sets up the malleation and connects, disposes with the play liquid end detachably of pushing pin subassembly is connected, the exhaust pipeline other end through first tee bend with the third end of two check valves of tee bend and the feed liquor end of pushing pin subassembly when exhaust pipeline passes through the malleation connect with the play liquid end of pushing pin subassembly is connected, the syringe disposes the pumping medical liquid and passes through respectively the feed liquor end and play liquid end get into the pushing pin subassembly.

2. The injection system of claim 1, wherein a second tee is provided between the third end of the two-way valve and the first tee, the first and second ends of the second tee being connected to the third end of the two-way valve and the first tee, respectively,