CN114983818B - Radiopharmaceutical injection system and uses thereof - Google Patents

Radiopharmaceutical injection system and uses thereof Download PDF

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Publication number
CN114983818B
CN114983818B CN202210611059.9A CN202210611059A CN114983818B CN 114983818 B CN114983818 B CN 114983818B CN 202210611059 A CN202210611059 A CN 202210611059A CN 114983818 B CN114983818 B CN 114983818B
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China
Prior art keywords
sub
injection system
sleeve
groove
container
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CN202210611059.9A
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Chinese (zh)
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CN114983818A (en
Inventor
郝晋
齐慧
崔巍
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Guotong Chengdu New Drug Technology Co ltd
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Guotong Chengdu New Drug Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

An injection system of a radiopharmaceutical, and use thereof, the injection system comprising: the container of holding radiopharmaceutical medicine bottle and push pin subassembly, the container includes container body and lid, the lid includes lid and from lid bottom surface along keeping away from the bellying that the direction of lid top surface extends, the bellying is used for the butt the medicine bottle top, makes the medicine bottle is in the internal fixed position of container, the lid has runs through the lid body reaches the through-hole of bellying, push pin subassembly is configured to insert in the through-hole with the lid block is connected. The push needle assembly comprises a sleeve and a liquid guide needle assembly, at least one part of the liquid guide needle assembly is arranged in the sleeve and is configured to slide relative to the sleeve, a first clamping part is arranged on the inner side wall of the through hole, and a second clamping part matched with the first clamping part is arranged on the side wall of the sleeve to enable the push needle assembly to be clamped in the through hole.

Description

Radiopharmaceutical injection system and uses thereof
Technical Field
The present disclosure relates to the field of radiopharmaceuticals, to a radiopharmaceutical injection system 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.
It is also because of the radioactivity that it places special demands on the packaging container. Firstly, the packaging container needs to meet the related requirements of radiation protection, namely, can play a role of enough radiation shielding, so that the medicine in the packaging container does not cause irradiation to surrounding people; second, radiopharmaceuticals are typically packaged in penicillin bottles and the manufacture of the medicament is completed in a radioprotective isolation system. Therefore, the radiopharmaceuticals radiation protection containers can ensure that the radiopharmaceuticals can accurately fall into the radiation protection containers when the radiation protection packaging is carried out after the production of the pharmaceutical preparations is finished; finally, the radiopharmaceutical is administered without removing the container in order to avoid additional irradiation to surrounding medical personnel. The prior art solutions are to remove the pharmaceutical formulation from the radiation-shielding container for administration, or to remove the radiation-shielding container lid for administration. This approach does not provide adequate radiation protection, is cumbersome to operate, and inevitably introduces additional irradiation with ionizing radiation.
Disclosure of Invention
Some embodiments of the present disclosure provide an injection system of a radiopharmaceutical, the injection system comprising:
a container for holding a radiopharmaceutical vial, comprising:
the container comprises a container body, wherein an open accommodating groove is formed in the container body and is configured to accommodate the medicine bottle; and
a cap configured to be snapped onto the container body, comprising a cap body and a protrusion extending from a bottom surface of the cap body in a direction away from a top surface of the cap body, the protrusion being configured to abut against a top of the vial in response to the cap body being snapped onto the container body such that the vial is positionally fixed within the container body, the cap having a through hole penetrating the cap body and the protrusion, and
a push pin assembly configured to be inserted into the through hole to be snap-connected with the cover body, comprising:
a sleeve;
a introducer needle assembly, at least a portion of which is disposed within the cannula and is configured to be slidable relative to the cannula such that the introducer needle assembly is inserted into the vial,
the inner side wall of the through hole is provided with a first clamping part, and the side wall of the sleeve is provided with a second clamping part matched with the first clamping part to be clamped, so that the push pin assembly is clamped in the through hole.
In some embodiments, the first engagement portion includes:
the first groove is arranged on the inner side wall of the through hole;
the clamping piece is slidably arranged in the first groove; and
one end of the elastic component is fixedly connected with the bottom of the first groove, the other end of the elastic component is fixedly connected with the clamping piece, under the action of the elastic component, at least one part of the clamping piece protrudes out of the inner side wall of the through hole,
the second clamping part comprises a second groove arranged on the side wall of the push pin assembly, and the second groove is configured to accommodate at least one part of the clamping piece so as to be clamped with the first clamping part.
In some embodiments, the engaging member includes a first surface and a second surface sequentially away from the top surface of the cover, the first surface and the second surface each being inclined with respect to the axis of the cover, and the first surface and the second surface gradually approaching each other in a direction away from the bottom of the first groove, and the second groove includes a first inner surface and a second inner surface, the first inner surface and the second inner surface being in mating engagement with the first surface and the second surface, respectively, in response to the at least a portion of the engaging member entering the second groove and the second groove.
In some embodiments, the first angle α of the first surface to the axis of the cover is less than the second angle β of the second surface to the axis of the cover.
In some embodiments, at least one of the first surface and the second surface is a cambered surface.
In some embodiments, the inner side wall of the through hole comprises a step-shaped limiting portion, the limiting portion is located on one side, close to the top surface of the cover body, of the first groove, the sleeve further comprises a protruding portion extending along the axis direction away from the sleeve, and the limiting portion is configured to abut against the protruding portion to limit the push pin assembly during insertion of the push pin assembly into the through hole.
In some embodiments, the top surface of the limiting portion is a plane, and the top surface is perpendicular to the axis of the cover body.
In some embodiments, the introducer needle assembly includes: a slider; and
the liquid guide needle is fixedly connected with the sliding piece, at least one part of the liquid guide needle is arranged in the sliding piece,
the sliding part comprises a sleeve, and is characterized in that a convex part is arranged on the side wall of the sliding part, a sliding groove extending along the length direction of the sleeve is formed in the side wall of the sleeve, the convex part is slidably accommodated in the sliding groove, and the sliding part further comprises a handle part extending away from the convex part from the side wall, exposed by the sliding groove, of the convex part.
In some embodiments, a first clamping groove is formed in a side wall of the protruding portion, which faces the corresponding sliding groove, an elastic protruding portion matched with the first clamping groove is formed in the inner side wall of the sliding groove, and the elastic protruding portion is clamped with the first clamping groove in response to the sliding piece sliding to the end portion, away from the top of the sleeve, of the sliding groove.
In some embodiments, the chute extends from the cannula top away from the cannula top along the cannula length, and the push pin assembly further comprises a top plug removably mounted to the cannula top such that an end of the chute at the cannula top is closed.
In some embodiments, the protrusions comprise a first protrusion and a second protrusion, and the catheter comprises:
the liquid inlet needle comprises a first sub-part and a second sub-part which are connected with each other, the first sub-part penetrates through the side wall of the first protruding part exposed by the sliding groove and extends along the direction away from the sliding piece, the second sub-part penetrates through the bottom surface of the sliding piece and extends along the extending direction of the sleeve, and the connecting part of the first sub-part and the second sub-part is positioned in the sliding piece; and
the liquid outlet needle comprises a third sub-part and a fourth sub-part which are connected with each other, the third sub-part penetrates through the side wall of the second protruding part exposed by the sliding groove to extend along the direction far away from the sliding part, the fourth sub-part penetrates through the bottom surface of the sliding part to extend along the extending direction of the sleeve, and the connecting part of the third sub-part and the fourth sub-part is positioned in the sliding part.
In some embodiments, the liquid outlet of the liquid inlet needle is further away from the slider than the liquid inlet of the liquid outlet needle.
In some embodiments, the cannula comprises:
a first sub-sleeve in which the slider is disposed; and
a second sub-sleeve, adjacent to the first sub-sleeve, comprising two parallel pipelines, the two pipelines respectively accommodating a second sub-part of the liquid inlet needle and a fourth sub-part of the liquid outlet needle,
in response to the protrusion of the slider sliding from the end of the chute near the top of the cannula to the end of the chute remote from the top of the cannula, at least a portion of the second sub-portion of the liquid inlet needle and the fourth sub-portion of the liquid outlet needle protrude from the two lines through the through-hole and are inserted into the vial.
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:
the radiopharmaceutical injection system includes a container housing a vial of radiopharmaceutical and a push-pin assembly, the container including: the utility model provides a container body and lock of holding radiopharmaceutical medicine bottle are in lid on the container body, the lid includes the lid and follows from lid bottom surface is kept away from the bellying that the direction of lid top surface extends, bellying is used for the butt the medicine bottle top makes the medicine bottle firm, push pin subassembly can insert in the through-hole of the lid of container with lid block is connected, realizes under the medicine bottle of holding radiopharmaceutical is located the circumstances of radiation protection's container, will the medicine bottle inserts injection system, has reduced medical personnel and the contact of radiopharmaceutical, supplies radiation protection for medical personnel.
Through setting up the concrete matching structure of first block portion and second block portion for medical personnel uses less power can insert push pin assembly in the through-hole of lid and lock solid, after injection operation is accomplished, medical personnel can exert great power, pulls out push pin assembly from in the through-hole of lid.
The sliding groove on the side wall of the sleeve in the injection needle component and the sliding piece also have a specific locking mode, so that the state that the liquid guide needle is stably inserted into the medicine bottle in the process of injecting the radioactive medicine is avoided.
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.
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.
The present disclosure provides an injection system of a radiopharmaceutical, the injection system comprising: a container for holding a radiopharmaceutical vial, comprising: the container comprises a container body, wherein an open accommodating groove is formed in the container body and is configured to accommodate the medicine bottle; and a cap configured to be snapped onto the container body, including a cap body and a boss extending from a bottom surface of the cap body in a direction away from a top surface of the cap body, the boss configured to be abutted against a top of the medicine bottle in response to the cap body being snapped onto the container body so that the medicine bottle is fixed in position in the container body, the cap having a through hole penetrating through the cap body and the boss, and a push pin assembly configured to be inserted into the through hole to be snap-coupled with the cap body, comprising: a sleeve; the liquid guide needle assembly is arranged in the sleeve, at least one part of the liquid guide needle assembly is arranged in the sleeve and can slide relative to the sleeve, so that the liquid guide needle assembly is inserted into the medicine bottle, a first clamping part is arranged on the inner side wall of the through hole, and a second clamping part matched with the first clamping part is arranged on the side wall of the sleeve, so that the push needle assembly is clamped in the through hole. Under the condition that a medicine bottle containing the radioactive medicine is positioned in a radiation-proof container, the medicine bottle is connected into an injection system, so that the contact between medical staff and the radioactive medicine is reduced, and radiation protection is provided for the medical staff.
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 side wall 1311 is matched and attached to the first outer side wall 2111, and the second side wall 1321 is matched and attached to at least a portion of the second outer side wall 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 greater 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 coincides with the second axis m2 of the cover 20, and penetrates the boss 21 of the 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 the airtight and isolated storage of the vial 300 containing 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 placing the vial with radiopharmaceutical into the container body 10, the vial 300 may be placed directly into the third receiving space 133 of the container body 10 while the axis of the vial 300 is preferably aligned with the first axis m1 of the container body 10. When the axis of the medicine bottle 300 deviates greatly from the first axis m1 of the container body 10, the bottom of the medicine bottle 300 may first contact the second sidewall 1321 of the second accommodating space 132, and since the included angle α between the second sidewall 1321 and the first axis is 20 ° to 30 °, the medicine bottle 300 may slide into the third accommodating space 133 under the guidance of the second sidewall 1321.
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 in 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 accommodating space 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 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 shape of the third receiving space 133 substantially matches the shape of the vial 300 of 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, due to a specific structure of the accommodation groove 13 in the container body 10, i.e., a 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 distance between the second protrusion 212 and the medicine bottle 300 in the first axis direction m1 is less than a predetermined distance, for example, 50mm. 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 drug vial 300.
In some embodiments, when the inner body 12 is installed in the outer body 11, the inner body 12 and the outer body 11 are in interference fit, so that the inner body 12 is prevented from shaking in the first accommodating groove 111 in the outer body 11, and the medicine bottle 300 is ensured to be stably placed in the container body 10.
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 vial 300 of the radiopharmaceutical and the cap 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 of the radiopharmaceutical in the holding groove after being inserted into the through hole in the cap, so that the vial of the radiopharmaceutical is connected to the injection system with the vial of the radiopharmaceutical in the radiation-proof container, thereby reducing contact between medical staff and the radiopharmaceutical and protecting the medical staff from radiation.
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 cover 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 take the form of 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 package cover 303 abuts against the bottom surface of the first groove 21231, and the projection of the first through hole 21232 on the package 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.
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 side wall 1311 is matched and attached to the first outer side wall 2111, and the second side wall 1321 is matched and attached to at least a portion of the second outer side wall 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.
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.
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, 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. 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 10. 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 202 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 201, 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 gradually approach each other in a direction away from the bottom of the first groove 2311, the second 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 through hole 23 of the cover 20 and locked, and the pin assembly 200 can be easily pulled out of the through hole 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 pushing process of 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 assembly 200 needs to be pulled out of the through hole 23, the operator needs to apply a large force, the second inner surface 20112 of the second groove 2011 applies a component force to the second surface 23132 of the engaging member 2313 toward the bottom of the first groove 2311, so that the engaging member 2313 moves toward the bottom of the first groove 2311, and the first engaging portion 231 is out of contact with the second engaging 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 recess 2011 may also have a matched arc surface including a first inner surface 20111 and a 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 limiting portion 232 is located on a side of the first groove 2311 near the top surface of the cover body, the sleeve 201 further includes a protruding portion 2012 extending along 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.
In some embodiments, as shown in fig. 10, the distance between the liquid outlet of the liquid inlet needle 20221 and the inner bottom surface of the medicine bottle 300 may be the same or different with respect to the liquid inlet of the liquid outlet needle 20222, and when the medicine bottle 300 is a radioactive particle, the liquid outlet of the liquid inlet needle 20221 is closer to the inner bottom surface of the medicine bottle 300 with respect to the liquid inlet of the liquid outlet needle 20222, that is, the liquid outlet of the liquid inlet needle 20221 is further away from the slider 2021 with respect to the liquid inlet of the liquid outlet needle 20222.
In the foregoing embodiments, the push pin assembly having the double-needle structure of the parallel liquid inlet needle and the liquid outlet needle is illustrated as an example, in other embodiments, the liquid inlet needle and the liquid outlet needle may be integrated on a single needle body, for example, a liquid inlet passage and a liquid outlet passage are provided in the single needle body, a liquid outlet of the liquid inlet passage and a liquid inlet of the liquid outlet passage are provided on a side wall of one end portion of the single needle body, and a distance between a liquid outlet of the liquid inlet passage and a liquid inlet of the liquid outlet passage and an inner bottom surface of the medicine bottle 300 may be the same or different, and when the medicine bottle 300 is a radioactive particle, a liquid outlet of the liquid inlet passage is closer to the inner bottom surface of the medicine bottle 300 than a liquid inlet of the liquid outlet passage.
Some embodiments of the present disclosure also provide for the use of an injection system of a radiopharmaceutical, such as the injection system of a radiopharmaceutical described in the previous embodiments, for injection of a radiopharmaceutical.
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 (14)

1. A radiopharmaceutical injection system, said injection system comprising:
a container for holding a radiopharmaceutical vial, comprising:
the container comprises a container body, wherein an open accommodating groove is formed in the container body and is configured to accommodate the medicine bottle; and
a cap configured to be snapped onto the container body, comprising a cap body and a protrusion extending from a bottom surface of the cap body in a direction away from a top surface of the cap body, the protrusion being configured to abut against a top of the vial in response to the cap body being snapped onto the container body such that the vial is positionally fixed within the container body, the cap having a through hole penetrating the cap body and the protrusion, and
A push pin assembly configured to be inserted into the through hole to be snap-connected with the cover body, comprising:
a sleeve;
the liquid guide needle assembly is arranged in the sleeve, at least one part of the liquid guide needle assembly is arranged in the sleeve and can slide relative to the sleeve, so that the liquid guide needle assembly is inserted into the medicine bottle, a first clamping part is arranged on the inner side wall of the through hole, and a second clamping part matched with the first clamping part is arranged on the side wall of the sleeve, so that the push needle assembly is clamped in the through hole.
2. The injection system of claim 1, wherein the first engagement portion comprises:
the first groove is arranged on the inner side wall of the through hole;
the clamping piece is slidably arranged in the first groove; and
one end of the elastic component is fixedly connected with the bottom of the first groove, the other end of the elastic component is fixedly connected with the clamping piece, under the action of the elastic component, at least one part of the clamping piece protrudes out of the inner side wall of the through hole,
the second clamping part comprises a second groove arranged on the side wall of the push pin assembly, and the second groove is configured to accommodate at least one part of the clamping piece so as to be clamped with the first clamping part.
3. The injection system of claim 2, wherein the engagement member comprises a first surface and a second surface that are sequentially spaced apart from the top surface of the cap, the first surface and the second surface each being inclined relative to the axis of the cap, and the first surface and the second surface gradually approaching each other in a direction spaced apart from the bottom of the first recess, the second recess comprising a first inner surface and a second inner surface that matingly engage the first surface and the second surface, respectively, in response to the at least a portion of the engagement member entering the second recess.
4. The injection system of claim 3, wherein a first angle α of the first surface to the axis of the cap is less than a second angle β of the second surface to the axis of the cap.
5. The injection system of claim 3 or 4, wherein at least one of the first surface and the second surface is a cambered surface.
6. The injection system of claim 1 or 2, wherein the inner sidewall of the through hole comprises a stepped stop portion located on a side of the first recess adjacent to the top surface of the cap, the cannula further comprising a projection extending in a direction away from the cannula axis, the stop portion being configured to abut the projection to stop the push pin assembly during insertion of the push pin assembly into the through hole.
7. The injection system of claim 6, wherein the top surface of the stopper is planar and the top surface of the stopper is perpendicular to the axis of the cap.
8. The injection system of claim 1 or 2, wherein the introducer needle assembly comprises: a slider; and
the liquid guide needle is fixedly connected with the sliding piece, at least one part of the liquid guide needle is arranged in the sliding piece,
the sliding part comprises a sleeve, and is characterized in that a convex part is arranged on the side wall of the sliding part, a sliding groove extending along the length direction of the sleeve is formed in the side wall of the sleeve, the convex part is slidably accommodated in the sliding groove, and the sliding part further comprises a handle part extending away from the convex part from the side wall, exposed by the sliding groove, of the convex part.
9. The injection system of claim 8, wherein the side walls of the protrusions facing the respective runners are provided with first detents, and the inside walls of the runners are provided with resilient protrusions that mate with the first detents, the resilient protrusions engaging with the first detents in response to the slider sliding to the end of the runner distal from the top of the sleeve.
10. The injection system of claim 8, wherein the runner extends from the cannula top away from the cannula top along the cannula length, the push pin assembly further comprising a top plug removably mounted to the cannula top such that an end of the runner at the cannula top is closed.
11. The injection system of claim 8, wherein the boss comprises a first boss and a second boss, the liquid guide needle comprising:
the liquid inlet needle comprises a first sub-part and a second sub-part which are connected with each other, the first sub-part penetrates through the side wall of the first protruding part exposed by the sliding groove and extends along the direction away from the sliding piece, the second sub-part penetrates through the bottom surface of the sliding piece and extends along the extending direction of the sleeve, and the connecting part of the first sub-part and the second sub-part is positioned in the sliding piece; and
the liquid outlet needle comprises a third sub-part and a fourth sub-part which are connected with each other, the third sub-part penetrates through the side wall of the second protruding part exposed by the sliding groove to extend along the direction far away from the sliding part, the fourth sub-part penetrates through the bottom surface of the sliding part to extend along the extending direction of the sleeve, and the connecting part of the third sub-part and the fourth sub-part is positioned in the sliding part.
12. The injection system of claim 11, wherein the outlet of the access needle is further from the slider than the access of the access needle.
13. The injection system of claim 11, wherein the cannula comprises:
a first sub-sleeve in which the slider is disposed; and
A second sub-sleeve, adjacent to the first sub-sleeve, comprising two parallel pipelines, the two pipelines respectively accommodating a second sub-part of the liquid inlet needle and a fourth sub-part of the liquid outlet needle,
in response to the protrusion of the slider sliding from the end of the chute near the top of the cannula to the end of the chute remote from the top of the cannula, at least a portion of the second sub-portion of the liquid inlet needle and the fourth sub-portion of the liquid outlet needle protrude from the two lines through the through-hole and are inserted into the vial.
14. Use of an injection system of a radiopharmaceutical for injection of the radiopharmaceutical, wherein the injection system is as claimed in any one of claims 1 to 13.
CN202210611059.9A 2022-05-31 2022-05-31 Radiopharmaceutical injection system and uses thereof Active CN114983818B (en)

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FR2906638B1 (en) * 2006-09-29 2008-12-19 Lemer Prot Anti X Par Abrevati NEW ARMORED CONTAINER STRUCTURE FOR TRANSPORTING AND STORING A RADIOACTIVE SOURCE FOR MEDICAL USE
CN212847709U (en) * 2020-04-14 2021-03-30 原子高科股份有限公司 Radiopharmaceutical transport container based on sealing strip type

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