Transfer device for microsphere drug loading and microsphere drug loading method

Abstract

The invention provides a transfer device for microsphere drug loading and a microsphere drug loading method. The transfer device comprises a valve body, a puncture needle, a first injector connector and a drug bottle connecting shell. A second injector connector is arranged on the first injector connector in a communicating manner, and a protective cap is detachably arranged on the second injector connector; a valve element is rotationally installed in a valve cavity of the valve body and provided with a first flow channel and a second flow channel which are arranged in a crossed mode. The first flow channel and the second flow channel are both used for communicating the puncture needle and the first injector connector, and one end of the second flow channel is provided with a liquid medicine filtering membrane; the valve element can be rotationally switched among a plurality of operation positions, so that the puncture needle and the first injector connector do not communicate with each other or communicate with each other through a first flow channel or communicate with each other through a second flow channel; the transfer device for microsphere medicine carrying is adopted to replace an injection needle to communicate the medicine bottle and the first syringe, the communication stability is effectively improved, the risk that the injection needle is broken in the medicine bottle washing process is avoided, the first syringe disassembling and assembling steps are reduced, and the medicine carrying efficiency is improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of microsphere drug delivery device, and particularly relates to a microsphere drug delivery device and a microsphere drug delivery method. BACKGROUND

[0002] In the medical field, in order to achieve targeted drug delivery and / or slow release of drugs, drug delivery is often carried out in the form of drug-loaded microspheres. At present, drug-loaded microspheres are mainly used in transarterial chemoembolization (TACE), the core of which is to inject drug-loaded microspheres into the tumor-feeding artery through a catheter, so that the drug-loaded microspheres can continuously and slowly release the chemotherapeutic drugs inside the tumor, continuously killing the tumor while reducing the blood supply of the tumor-feeding artery.

[0003] The conventional preparation method of drug-loaded microspheres is as follows: a 1# syringe is used to extract the microsphere solution in an inverted penicillin bottle; after the microspheres are precipitated, part of the supernatant is pushed back into the penicillin bottle for flushing and back extraction to avoid residual microspheres in the penicillin bottle, and the step is repeated 2-3 times; the 1# syringe is left in the inverted state for about 1 minute, then the needle of the 1# syringe is replaced with a filter needle, and the filter needle is removed after the supernatant is discharged; a three-way connecting tube is used to connect the 1# syringe and a 2# syringe containing a first drug, so as to transfer the first drug in the 2# syringe to the 1# syringe and make the first drug transfer and load on the microspheres; a three-way connecting tube is used to connect the 1# syringe and a 3# syringe containing a second drug, so as to transfer the second drug in the 3# syringe to the 1# syringe and make the second drug transfer and load on the microspheres, thus multiple drugs can be loaded on the microspheres to form drug-loaded microspheres. However, the above operation has the following problems:

[0004] Since the 1# syringe is only connected with the penicillin bottle storing the microsphere solution through the injection needle of the 1# syringe, when the plunger of the 1# syringe is repeatedly extracted and pushed to flush the bottle wall, the injection needle is easily broken and the operator is easily injured due to improper operation, which has certain safety risks; in addition, after the 1# syringe is connected with the penicillin bottle storing the microsphere solution to complete the transfer of the microspheres, the filter needle needs to be installed and removed, and then the 1# syringe needs to be connected with other syringes storing drugs, which has the technical problem of complicated operation steps. SUMMARY

[0005] In view of the above shortcomings of the prior art, the purpose of the present application is to provide a microsphere drug delivery device and a microsphere drug delivery method, which can not only avoid the safety risks caused by the breakage of the injection needle, but also reduce the disassembly steps of the 1# syringe in the process of microsphere drug delivery, and improve the drug loading efficiency.

[0006] To achieve the above object and other related objects, the present application provides a kind of microsphere drug-loading transfer device, including valve body, puncture needle located above valve body and first syringe connector located below valve body;The valve body is provided with medicine bottle connection shell that coaxially covers puncture needle outside;Second syringe connector is communicated and arranged on the outer wall of first syringe connector, and protective cap is detachably arranged on second syringe connector;Valve core is rotatably installed in the valve cavity of valve body, and valve core has first flow channel and second flow channel arranged in cross;First flow channel and second flow channel are used to connect puncture needle and first syringe connector, and one end of second flow channel is provided with liquid medicine filter film;Valve core can be rotated and switched between multiple operating positions, so that puncture needle and first syringe connector are not communicated or communicated through first flow channel or second flow channel.When microsphere drug-loading is needed, the penicillin bottle containing microspheres is first installed on the medicine bottle connection shell of liquid medicine transfer device, so that the puncture needle is pierced into the penicillin bottle;Then, No.1 syringe is connected to first syringe connector, and valve core is rotated, so that No.1 syringe is communicated with penicillin bottle through first flow channel, in this state, microsphere transfer, post-transfer precipitation and penicillin bottle flushing operation are carried out, to ensure that all microspheres in penicillin bottle are transferred into No.1 syringe;Then, valve core is rotated, so that No.1 syringe after standing precipitation is communicated with penicillin bottle through second flow channel, to discharge supernatant in No.1 syringe;Then, valve core is rotated, so that No.1 syringe and penicillin bottle are not communicated, and protective cap on second syringe connector is removed;Then, No.2 syringe containing medicine is connected to second syringe connector, to transfer medicine into No.1 syringe, to complete microsphere drug-loading, and the step can be repeated to load multiple drugs on microspheres;Since No.1 syringe does not need to be repeatedly disassembled during microsphere drug-loading, the operation steps of microsphere drug-loading are greatly reduced, and drug-loading efficiency is improved;In addition, the setting of liquid medicine transfer device makes No.1 syringe not need to be pierced by puncture needle to communicate with penicillin bottle, so that the risk of injection needle breakage during subsequent penicillin bottle flushing is avoided, and operation safety is improved.

[0007] Preferably, annular boss is formed in the valve cavity, and annular clamping groove is arranged on the outer wall of valve core and matched with annular boss;Through the cooperation of annular boss and annular clamping groove, valve core can only be rotatably installed in the valve cavity of valve body, so that the situation that valve core accidentally separates from valve body is avoided.

[0008] Preferably, indicator is arranged on valve core to indicate the angle position of first flow channel and / or the angle position of second flow channel, so as to facilitate user to accurately know the orientation of corresponding flow channel in valve cavity.

[0009] Preferably, the indicator comprises a radially extending indicator handle and an indicator rib plate; one of the indicator handle and the indicator rib plate is used to indicate the angular position of the first flow channel, and the other is used to indicate the position of the second flow channel; in addition to indicating the angular position of the corresponding flow channel, the indicator handle also facilitates user gripping, thereby improving operational convenience.

[0010] Preferably, a positioning mechanism is arranged between the valve body and the valve core, and is used to position the valve core when rotated to an operating position; thereby facilitating the operator to quickly and accurately determine whether the valve core is rotated into position, thereby improving the operation experience; in addition, since the valve core at the operating position is positioned and retained, the operator is less likely to cause the valve core to be accidentally rotated out of position when performing subsequent fluid transfer, thereby ensuring that the fluid transfer at the operating position can be smoothly completed.

[0011] Preferably, the positioning mechanism comprises a first positioning member arranged on the valve cavity and a second positioning member arranged on the outer wall of the valve core; one of the first positioning member and the second positioning member is a positioning protrusion, and the other is a positioning groove that is matched with or detached from the positioning protrusion; when the positioning protrusion enters the positioning groove, a "clicking sound" is generated to remind the operator that the rotation has been completed; at the same time, when the positioning protrusion is matched with the positioning groove, a jamming feeling is generated to provide a secondary reminder to the operator.

[0012] Preferably, the groove wall of the positioning groove is an arc-shaped groove, so as to reduce the wear of the positioning protrusion when entering or detaching from the positioning groove.

[0013] Preferably, the positioning mechanism comprises a first friction surface arranged on the valve core and a second friction surface arranged on the valve body; when the valve core is rotated to the operating position, the second friction surface is in contact with the second friction surface to generate a friction force that limits the rotation of the valve core; the friction force can not only increase the rotation difficulty of the operator to remind the operator that the syringe has been rotated into position, but also can position and retain the syringe connector to avoid accidental displacement during fluid transfer.

[0014] Preferably, the medicine bottle connecting shell has a stop device that abuts against the top of the medicine bottle, so as to limit the depth of the puncture needle penetrating into the medicine bottle and avoid the medicine bottle from being skewed during installation.

[0015] Preferably, the outer wall of the puncture needle near the puncture end is formed with a drainage port that is connected with the inside of the puncture needle; when the penicillin bottle is inverted, the remaining liquid below the puncture end can flow out along the drainage port, thereby avoiding waste of the liquid medicine.

[0016] The present application also provides a microsphere drug loading method, which uses the above-mentioned microsphere drug loading transfer device for microsphere drug loading; the microsphere drug loading method comprises the following steps:

[0017] S1, install the medicine bottle containing the microsphere solution on the medicine bottle connecting shell of the microsphere medicine loading transfer device, and install the empty No. 1 syringe on the first syringe connecting head;

[0018] S2, rotate the valve core to make the medicine bottle and the No. 1 syringe communicate through the first flow channel; in this state, the microsphere solution in the medicine bottle is transferred to the No. 1 syringe, and the supernatant in the No. 1 syringe is used to flush the medicine bottle;

[0019] S3, rotate the valve core to make the medicine bottle and the No. 1 syringe communicate through the second flow channel; in this state, the excess supernatant in the No. 1 syringe is discharged into the medicine bottle, and the drug liquid filtering membrane 700 in the second flow channel 210b prevents the microspheres from being discharged;

[0020] S4, remove the protective cap, install the No. 2 syringe containing the drug liquid on the second syringe connecting head, and rotate the valve core to make the medicine bottle and the No. 1 syringe not communicate with each other; in this state, the drug liquid in the No. 2 syringe is transferred to the No. 1 syringe for microsphere medicine loading.

[0021] Preferably, the microsphere medicine loading method further comprises: S5, install the No. 2 syringe containing other drug liquid on the second syringe connecting head, and in the state that the medicine bottle and the No. 1 syringe do not communicate with each other, transfer the drug liquid to the No. 1 syringe for microsphere medicine loading; repeat this step until the microsphere medicine loading of all drug liquids is completed.

[0022] As above, the microsphere medicine loading transfer device and the microsphere medicine loading method of the present application have the following beneficial effects:

[0023] The present application connects the No. 1 syringe, the penicillin bottle containing the microspheres and the No. 2 syringe containing the drug liquid through the drug liquid transfer device, and can make the No. 1 syringe communicate with the penicillin bottle through the first flow channel and the second flow channel in turn by rotating the valve core, so as to complete the transfer of the microspheres, the flushing of the penicillin bottle and the discharge of the supernatant; then, by rotating the valve core, the communication between the No. 1 syringe and the penicillin bottle is blocked, so that the No. 1 syringe only communicates with the second syringe connecting head for installing the No. 2 syringe, thereby facilitating the transfer of the drug to the No. 1 syringe and completing the microsphere medicine loading; since the No. 1 syringe does not need to be repeatedly disassembled during the microsphere medicine loading, the operation steps of the microsphere medicine loading are greatly reduced, and the medicine loading efficiency is improved.

[0024] The positioning mechanism provided in the present application can position and retain the syringe connecting member rotated to each operation position, and provide auditory and / or tactile feedback when rotated to the operation position, so that the operator can accurately perceive the position state of the valve core and improve the experience of the operator; at the same time, the valve core positioned and retained at the operation position is not easy to be mistakenly rotated, and the fluid transfer at the operation position can be smoothly completed. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a perspective view of a microsphere drug delivery device.

[0026] Figure 2 is an exploded perspective view of a microsphere drug delivery device.

[0027] Figure 3 is a perspective view of Figure 1 is a main cross-sectional view of the microsphere drug delivery device.

[0028] Figure 4 is a perspective view of Figure 1 is an isometric cross-sectional view of the microsphere drug delivery device after removing the valve core.

[0029] Figure 5 is a perspective view of a valve core with a handle

[0030] Figure 6 is a perspective view of Figure 5 is an isometric cross-sectional view of

[0031] Figure 7 is a schematic view of the structure of the positioning mechanism for positioning the valve core to a certain operating position.

[0032] Figure 8 is a schematic view of the state of transferring microspheres in a medicine bottle to a No. 1 syringe using a microsphere drug delivery device.

[0033] Figure 9 is a schematic view of the state of returning the excess supernatant in a No. 1 syringe to a medicine bottle using a microsphere drug delivery device.

[0034] Figure 10 is a schematic view of the state of transferring medicine liquid in a No. 2 syringe to a No. 1 syringe using a microsphere drug delivery device.

[0035] Explanation of Reference Signs

[0036] Medicine bottle 01, No. 1 syringe 02, No. 2 syringe 03, valve body 100, valve cavity 110, first rotating cavity 110a, second rotating cavity 110b, annular boss 111, valve core 200, first rotating shaft 200a, second rotating shaft 200b, first flow channel 210a, second flow channel 210b, annular clamping groove 220, indicating handle 230, indicating rib plate 240, puncture needle 300, medicine bottle connecting shell 400, elastic retaining member 410, stopper 420, first syringe connecting head 510, second syringe connecting head 520, protective cap 600, medicine liquid filter membrane 700, positioning protrusion 810, positioning groove 820, first friction surface 830. DETAILED DESCRIPTION

[0037] The following specific embodiments illustrate the implementation of the present application, and those skilled in the art can easily understand other advantages and effects of the present application from the disclosure of the specification.

[0038] Please refer to Figures 1 to 10 It should be understood that the structure, proportion, size, etc. shown in the drawings attached to the specification are only used to cooperate with the disclosed content for those skilled in the art to understand and read, and are not used to limit the defined conditions that the present application can be implemented, so they do not have technical significance. Any modification of the structure, change of the proportion relationship or adjustment of the size, without affecting the effects and purposes that the present application can produce, should still fall within the scope of the disclosed technology.

[0039] As Figures 1 to 3 shown, the present application provides a microsphere drug-loaded transfer device, which includes a valve body 100 having a valve cavity 110 and a valve core 200 rotatably installed in the valve cavity 110.

[0040] Specifically, the outer wall of the valve body 100 is provided with a puncture needle 300, a medicine bottle connecting shell 400 and a first syringe connecting head 510; wherein the puncture needle 300 and the first syringe connecting head 510 are both in communication with the valve cavity 110, and the medicine bottle connecting shell 400 is coaxially arranged with the puncture needle 300; the outer wall of the first syringe connecting head 510 is provided with a second syringe connecting head 520 in communication, and the second syringe connecting head 520 is detachably provided with a protective cap 600 by clamping or threaded connection.

[0041] The valve core 200 has a first flow channel 210a and a second flow channel 210b arranged in cross; the first flow channel 210a and the second flow channel 210b are both used to communicate the puncture needle 300 and the first syringe connecting head 510, and one end of the second flow channel 210b is provided with a liquid medicine filter membrane 700; when the valve core 200 rotates in the valve cavity 110, the valve core 200 can rotate and switch between multiple operating positions, so that the puncture needle 300 and the first syringe connecting head 510 are not in communication or are in communication through the first flow channel 210a or the second flow channel 210b.

[0042] It should be noted that the liquid medicine filter membrane 700 is a prior art, which is made of polypropylene liquid filter material.

[0043] In the present embodiment, the first injection connector 510 and the second injection connector 520 are both luer female connectors to be connected with a luer male connector on a conventional syringe; at this time, the protective cap 600 comprises a conical sealing head and / or a threaded cap to realize a sealed connection with the second injection connector 520.

[0044] In the present embodiment, as shown in Figure 3 , the first flow channel 210a and the second flow channel 210b are both radial flow channels, and the center line of each radial flow channel intersects the center line of the valve core 200 perpendicularly.

[0045] When it is necessary to load the microspheres with drugs, as shown in Figure 8 , first, the empty No. 1 syringe 02 is installed on the first injection connector 510 of the microsphere drug loading transfer device, and the medicine bottle 01 containing the microsphere solution is attached to the medicine bottle connecting shell 400 of the microsphere drug loading transfer device, and the puncture needle 300 pierces the bottle cap of the medicine bottle 01 to complete the communication between the puncture needle 300 and the medicine bottle 01; then, the valve core 200 is rotated to make the medicine bottle 01 and the No. 1 syringe 02 communicate through the first flow channel 210a, and the microsphere solution in the medicine bottle 01 is extracted through the No. 1 syringe 02; after the microspheres in the No. 1 syringe 01 are precipitated, part of the supernatant is pushed back into the medicine bottle 01 for flushing and back extraction to avoid the residual microspheres in the medicine bottle 01, and the step is repeated 2-3 times; as shown in Figure 9 , the valve core 200 is rotated to make the medicine bottle 01 and the No. 1 syringe 02 communicate through the second flow channel 210b with the drug solution filter membrane 700, and after the microspheres in the No. 1 syringe 02 are precipitated, the excess supernatant in the No. 1 syringe 02 is discharged; the arrangement of the drug solution filter membrane 700 can effectively avoid the discharge of the microspheres in the No. 1 syringe 02; as shown in Figure 10 , the valve core 200 is rotated to make the medicine bottle 01 and the No. 1 syringe 02 not communicate with each other, and then the protective cap 600 of the second injection connector 520 is removed, and the No. 2 syringe 03 containing the drug solution (such as adriamycin) is installed on the second injection connector 520 to transfer the drug solution into the No. 1 syringe 02 for microsphere drug loading; when other drug solutions (such as contrast agents) also need to be loaded, the No. 2 syringe 03 containing the corresponding drug solution is only needed to be installed on the second injection connector 520, and the drug solution is transferred into the No. 1 syringe 02; after all the drug loading is completed, the empty No. 3 syringe (not shown in the figure) can be installed on the second injection connector 520 to extract the drug-loaded microspheres (i.e. the microspheres after drug loading is completed).

[0046] The microsphere drug-loaded transfer device is used to replace the injection needle to connect the medicine bottle 01 and the first syringe 02, which can effectively improve the connection stability to avoid the risk of breaking the injection needle due to improper operation during the flushing process of the medicine bottle 01. At the same time, the microsphere drug-loaded transfer device can switch the medicine bottle 01 and the first syringe 02 between the state one of being connected through the first flow channel 210a, the state two of being connected through the second flow channel 210b with the drug liquid filter membrane 700, and the state three of not being connected, through the rotary valve core 200, so that the transfer of the microspheres, the discharge of the supernatant, and the transfer of the drug liquid can be smoothly completed without repeated disassembly of the first syringe 02, effectively reducing the operation steps of drug loading and improving the drug loading efficiency.

[0047] It should be noted that the model (such as 20ml, 1ml, 5ml, etc.) of the first syringe 02, the second syringe 02, and the third syringe mentioned above is selected according to the actual situation, and is not limited.

[0048] In the present application, the height direction of the valve core 200 in the horizontal state is defined as the up-down direction, the axis direction of the valve core 200 in the horizontal state is defined as the front-rear direction, and the direction perpendicular to the up-down direction and the front-rear direction is defined as the left-right direction. Based on this, Figure 3 in the drawings, the upper side and the lower side of the paper are the up-down direction and the down-up direction, respectively, the outer side and the inner side of the paper are the front-rear direction and the rear-front direction, respectively, and the left side and the right side of the paper are the left-right direction and the right-left direction, respectively.

[0049] When the microsphere drug-loaded transfer device is used to load the microspheres, the valve core 200 needs to be rotated to switch the puncture needle 300 and the first syringe connector 510 between the state one of being connected through the first flow channel 210a, the state two of being connected through the second flow channel 210b, and the state three of not being connected. In order to facilitate the operator to determine whether the valve core 200 is rotated to the operating position in the corresponding state, an indicator for indicating the angle position of the first flow channel and / or the angle position of the second flow channel needs to be provided on the valve core 200.

[0050] Specifically, as shown in Figure 5 , the indicator includes a radial extending indicating handle 230 and an indicating rib plate 240; one of the indicating handle 230 and the indicating rib plate 240 is used to indicate the angle position of the first flow channel 210a, and the other is used to indicate the position of the second flow channel 210b; at this time, the indicating handle 230 can also be gripped by the user to improve the operation convenience.

[0051] It should be noted that when the included angle of the first flow channel 210a and the second flow channel 210b is known (such as 90°), only the indicating handle 230 can be provided, which is used to indicate the angle position of the first flow channel 210a or the second flow channel 210b.

[0052] Further, the handle 230 is provided with anti-skid members such as anti-skid pads, anti-skid patterns, etc. to avoid slipping when being gripped.

[0053] In a preferred embodiment, a positioning mechanism is further arranged between the valve body 100 and the valve core 200 to position and hold the valve core 200 rotated to the operating position, so as to avoid accidental rotation of the valve core 200 away from the corresponding operating position, thereby interrupting the drug solution transfer step and affecting the smooth progress of the microsphere drug loading.

[0054] It can be understood that the positioning mechanism has various structural forms, including but not limited to the following two structural forms.

[0055] Structural form one:

[0056] As shown in Figure 4 , Figure 5 and Figure 7 , the positioning mechanism includes a first positioning member arranged on the cavity wall of the valve cavity 110 and a second positioning member arranged on the outer wall of the valve core 200; one of the first positioning member and the second positioning member is a positioning protrusion 810, and the other is a positioning groove 820 which cooperates with or is detached from the positioning protrusion 810. When the positioning protrusion 810 cooperates with the positioning groove 820, a "clicking sound" is produced, and a jamming feeling in the state of clamping can be provided, thereby providing double feedback of sound and touch for the operator and improving the experience of the operator; in addition, since a larger force is required to detach the positioning protrusion 810 from the positioning groove 820, the valve core 200 can be provided with an auxiliary positioning function when the two are cooperated, thereby avoiding accidental rotation of the valve core 200 during operation of the syringe.

[0057] It should be noted that the first positioning member and the second positioning member are both arranged in multiple numbers, and the multiple first positioning members are uniformly distributed on the cavity wall of the valve cavity 110, and the multiple second positioning members are uniformly distributed on the outer wall of the valve core 200, so as to ensure the stability of the force when the valve core 200 is rotated; the arrangement positions of the first positioning members and the second positioning members can be determined according to the arrangement directions of the first syringe connector 510, the first flow channel 210a and the second flow channel 210b, as long as at least one set of the positioning protrusion 810 and the positioning groove 820 is in the clamping state at each operating position.

[0058] In a preferred embodiment, the positioning groove 820 is an arc-shaped groove (i.e., the cross section is arc-shaped) or a spherical groove, so as to reduce the wear during the clamping or unclamping process of the positioning protrusion 810 and the positioning groove 820.

[0059] Structural form two:

[0060] As shown in Figure 2 and Figure 5As shown, the positioning mechanism comprises first friction surfaces 830 arranged on the valve core 200 and second friction surfaces (not shown in the figure) arranged on the valve body 100; the number and orientation of the first friction surfaces 830 and the second friction surfaces are determined according to the arrangement of the first syringe connector 510, the first flow channel 210a and the second flow channel 210b, as long as at least one first friction surface 830 can be in contact with the second friction surface to generate a friction force that limits the rotation of the valve core 200 when the valve core 200 is rotated to any operating position, which will cause a jamming feeling to the operator; in addition, when the first friction surface 830 is in contact with the second friction surface, the operator needs to exert a larger force to make the first friction surface 830 and the second friction surface disengage, so that the valve core 200 can be provided with auxiliary positioning function when the two are matched, avoiding accidental rotation of the valve core 200 during the liquid transfer process.

[0061] It can be understood that when the first friction surface 830 is misaligned with the second friction surface, the valve core 200 can be freely rotated without jamming under the action of a smaller force, and when the first friction surface 830 is aligned with the second friction surface, a jamming feeling will be generated, which will cause the valve core 200 to need a larger force to rotate; whether the operator feels a jamming feeling when passing through the valve core 200 can determine whether the valve core 200 is rotated to the right position.

[0062] The above two structural forms can be used alone or in combination, as long as the valve core 200 can be positioned and have a jamming feeling feedback when rotated to any operating position; in this embodiment, the combination of the two structural forms is preferred.

[0063] As shown in Figures 4 to 6 The valve cavity 110 comprises a cylindrical first rotation cavity 110a and a second rotation cavity 110b, the diameter of the first rotation cavity 110a is smaller than that of the second rotation cavity 110b, and the cavity wall of the first rotation cavity 110a is provided with through holes respectively communicating with the puncture needle 300 and the first syringe connector 510; the valve core 200 comprises a first rotation shaft 200a and a second rotation shaft 200b connected in sequence from front to back; the first rotation shaft 200a and the second rotation shaft 200b are both cylindrical bodies, and the first flow channel 210a and the second flow channel 210b are both arranged on the first rotation shaft 200a; the outer wall of the first rotation shaft 200a is formed with an annular clamping groove 220, and the cavity wall of the first rotation cavity 110a is formed with an annular protrusion 111; when the valve core 200 is inserted into the valve cavity 110, the first annular clamping groove 220 can cooperate with the annular protrusion 111 on the cavity wall of the valve cavity 110 to enable the valve core 200 to be installed in the valve cavity 110 only in rotation and not in axial movement. Among them, the first rotation shaft 200a and the first rotation cavity 110a are always in a sealed state to realize rotation connection, so as to avoid fluid leakage.

[0064] At this time, the first positioning member is arranged on the cavity wall of the second rotating cavity 110b, and the second positioning member is arranged on the outer wall of the second rotating shaft 200b.

[0065] In the present application, the drainage port is formed on the outer wall of the puncture needle 300 close to the puncture end and is in communication with the inside of the puncture needle, so that when the medicine bottle 01 is inverted, the residual liquid below the puncture end can flow out along the drainage port, avoiding waste caused by the residual liquid of the medicine bottle 01.

[0066] Since the medicine bottle 01 storing the microsphere solution is a vial or a vial-like structure, the medicine bottle connecting shell 400 and the medicine bottle 01 are connected in a buckle connection mode.

[0067] Specifically, as shown in Figure 4 and Figure 8 , the medicine bottle connecting shell 400 includes a plurality of elastic retaining members 410 uniformly arranged around the puncture needle 300; when the medicine bottle 01 is inserted into the medicine bottle connecting shell 400, each elastic retaining member 410 is bent and deformed outwardly under the extrusion of the medicine bottle 01; when the medicine bottle 01 is inserted in place, each elastic retaining member 410 will reset to form a anti-disengagement assembly abutting against the bottom of the bottle or the bottom of the cap of the medicine bottle 01, so as to prevent the medicine bottle 01 from disengaging from the medicine bottle connecting shell 400 and ensure the stability of the connection between the two.

[0068] In order to avoid the medicine bottle 01 from being skewed after being inserted into the medicine bottle connecting shell 400, a stop device abutting against the top of the medicine bottle 01 is arranged in the medicine bottle connecting shell 400; the stop device is an annular stop ring coaxially arranged with the puncture device 300 or a plurality of stop members 420 symmetrically arranged with respect to the puncture device 300, and the stop member 420 can be a plate-shaped structure or a T-shaped structure or any stop structure having a flat stop surface, which is not limited.

[0069] The present application also provides a microsphere drug loading method using the above-mentioned microsphere drug loading transfer device, which comprises the following steps:

[0070] S1, as shown in Figure 8 , the medicine bottle 01 containing the microsphere solution is installed on the medicine bottle connecting shell 400 of the microsphere drug loading transfer device, and the empty No. 1 syringe 02 is installed on the first syringe connecting head 510;

[0071] S2, as shown in Figure 8 , the valve core 200 is rotated, so that the medicine bottle 01 and the No. 1 syringe 02 are in communication through the first flow channel 210a; in this state, the microsphere solution in the medicine bottle 01 is transferred to the No. 1 syringe 02, and the supernatant in the No. 1 syringe 02 is used to flush the medicine bottle 01;

[0072] It should be noted that in the S2 step, the No. 1 syringe 02 needs to be in an inverted state (including vertical inversion and inclined inversion) to avoid the residual microspheres in the vial 01 when the microsphere solution is transferred and the vial 01 is washed.

[0073] It can be understood that the specification of the No. 1 syringe 02 is determined according to actual needs, and is not limited.

[0074] S3, as shown in Figure 8 and Figure 9 , the valve core 200 is rotated to make the vial 01 and the No. 1 syringe 02 communicate through the second flow channel 210b; in this state, the supernatant in the No. 1 syringe 02 is discharged into the vial 01, and the drug solution in the second flow channel 210b is used to prevent the microspheres from being discharged;

[0075] It should be noted that in the S3 step, 1 min to 3 min needs to be stationary before the supernatant is discharged to ensure that the microspheres are precipitated.

[0076] S4, as shown in Figure 9 and Figure 10 , the protective cap 600 is removed, the No. 2 syringe 03 containing the drug solution is installed on the second syringe connector 520, and the valve core 200 is rotated to make the vial 01 and the No. 1 syringe 02 not communicate with each other; in this state, the drug solution in the No. 2 syringe 03 is transferred to the No. 1 syringe 01 for microsphere drug loading.

[0077] It should be noted that in the S4 step, the drug solution in the No. 2 syringe 03 is a single component drug solution (such as doxorubicin) or a multi-component drug solution (such as a mixture of doxorubicin and contrast agent), which is not limited.

[0078] It can be understood that the specification of the No. 2 syringe 03 is determined according to actual needs, and is not limited.

[0079] When the drug solution in the No. 2 syringe 03 in the S4 step is a single component drug solution, and the microspheres need to be loaded with multiple component drugs, the microsphere drug loading method further comprises: S5, the No. 2 syringe 03 containing other single component drug solution is installed on the second syringe connector 520, and the drug solution is transferred to the No. 1 syringe 01 for microsphere drug loading under the condition that the vial 01 and the No. 1 syringe 02 do not communicate with each other; repeat this step until all drug solutions are loaded on the microspheres.

[0080] The microsphere drug-loaded transfer device can replace the injection needle to connect the medicine bottle 01 and the first syringe 02, effectively improve the connection stability between the medicine bottle 01 and the first syringe 02, and avoid the risk of breaking the injection needle due to improper operation during the flushing process of the medicine bottle 01. Meanwhile, the microsphere drug-loaded transfer device can switch the medicine bottle 01 and the first syringe 02 between the state one of being connected through the first flow channel 210a, the state two of being connected through the second flow channel 210b with the drug liquid filter membrane 700, and the state three of not being connected, through the rotary valve core 200, so that the transfer of the microspheres, the discharge of the supernatant and the transfer of the drug liquid can be smoothly completed without repeatedly disassembling the first syringe 02, the operation steps of loading the drug are effectively reduced, and the drug loading efficiency is improved.

[0081] The microsphere drug-loaded transfer device can replace the injection needle to connect the medicine bottle 01 and the first syringe 02, effectively improve the connection stability between the medicine bottle 01 and the first syringe 02, and avoid the risk of breaking the injection needle due to improper operation during the flushing process of the medicine bottle 01. Meanwhile, the microsphere drug-loaded transfer device can switch the medicine bottle 01 and the first syringe 02 between the state one of being connected through the first flow channel 210a, the state two of being connected through the second flow channel 210b with the drug liquid filter membrane 700, and the state three of not being connected, through the rotary valve core 200, so that the transfer of the microspheres, the discharge of the supernatant and the transfer of the drug liquid can be smoothly completed without repeatedly disassembling the first syringe 02, the operation steps of loading the drug are effectively reduced, and the drug loading efficiency is improved.

[0082] In summary, the present application effectively overcomes the shortcomings of the prior art and has high industrial utilization value.

[0083] The above embodiments only exemplarily illustrate the principles and effects of the present application, and are not used to limit the present application. Any person skilled in the art can modify or change the above embodiments without departing from the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical thought disclosed by the present application should be covered by the claims of the present application.

Claims

1. A microsphere drug delivery transfer device, characterized in that, The device includes a valve body (100), a puncture needle (300) located above the valve body (100), and a first syringe connector (510) located below the valve body (100). The valve body (100) has a vial connector (400) coaxially sleeved around the puncture needle (300). A second syringe connector (520) is connected to the outer wall of the first syringe connector (510), and a protective cap (600) is detachably mounted on the second syringe connector (520). A valve core (200) is rotatably mounted within the valve cavity (110) of the valve body (100). (200) has a first flow channel (210a) and a second flow channel (210b) arranged in a cross configuration; both the first flow channel (210a) and the second flow channel (210b) are used to connect the puncture needle (300) and the first syringe connector (510), and one end of the second flow channel (210b) is provided with a drug filter membrane (700); the valve core (200) can be rotated and switched between multiple operating positions so that the puncture needle (300) and the first syringe connector (510) are not connected to each other or are connected through the first flow channel (210a) or through the second flow channel (210b).

2. The microsphere drug delivery transferor according to claim 1, characterized in that, The valve cavity (110) is formed with an annular boss (111), and the outer wall of the valve core (200) is provided with an annular groove (220) that mates with the annular boss (111).

3. The microsphere drug delivery transferor according to claim 1 or 2, characterized in that, The valve core (200) is provided with an indicator for indicating the angular position of the first flow channel and / or the angular position of the second flow channel.

4. The microsphere drug delivery transferor according to claim 3, characterized in that, The indicator includes a radially extending indicator handle (230) and an indicator rib (240); one of the indicator handle (230) and the indicator rib (240) is used to indicate the angular position of the first flow channel (210a), and the other is used to indicate the position of the second flow channel (210b).

5. The microsphere drug delivery transferor according to claim 1 or 2, characterized in that, A positioning mechanism is provided between the valve body (100) and the valve core (200), which is used to position the valve core (200) when it is rotated to the operating position.

6. The microsphere drug delivery transferor according to claim 5, characterized in that, The positioning mechanism includes a first positioning element disposed on the valve cavity (110) and a second positioning element disposed on the outer wall of the valve core (200); one of the first positioning element and the second positioning element is a positioning protrusion (810), and the other is a positioning groove (820) that engages or disengages with the positioning protrusion (810).

7. The microsphere drug delivery transferor according to claim 5, characterized in that, The positioning mechanism includes a first friction surface (830) disposed on the valve core (200) and a second friction surface disposed on the valve body (100); when the valve core (200) rotates to the operating position, the first friction surface (830) contacts the second friction surface to generate a frictional force that restricts the rotation of the valve core (200).

8. The microsphere drug delivery transferor according to claim 1 or 2, characterized in that, The medicine bottle connecting shell (400) has a stop device that abuts against the top of the medicine bottle.

9. A method for loading drugs onto microspheres, characterized in that, Microsphere drug delivery is performed using a microsphere drug delivery transferor as described in any one of claims 1 to 8; the microsphere drug delivery method includes: S1. Install the vial (01) containing the microsphere solution onto the vial connector (400) of the microsphere drug transfer device, and install the empty No. 1 syringe (02) onto the first syringe connector (510); S2. Rotate the valve core (200) to connect the medicine bottle (01) and the No. 1 syringe (02) through the first flow channel (210a); in this state, transfer the microsphere solution in the medicine bottle (01) to the No. 1 syringe (02) and use the supernatant in the No. 1 syringe (02) to rinse the medicine bottle (01); S3. Rotate the valve core (200) to connect the medicine bottle (01) and the No. 1 syringe (02) through the second flow channel (210b); in this state, the excess supernatant in the No. 1 syringe (02) is drained into the medicine bottle (01), and the medicine filter membrane (700) in the second flow channel (210b) is used to prevent the microspheres from being discharged. S4. Remove the protective cap (600), install the No. 2 syringe (03) containing the drug solution on the second syringe connector (520), and rotate the valve core (200) so that the drug bottle (01) and the No. 1 syringe (02) are not connected to each other; in this state, transfer the drug solution in the No. 2 syringe (03) to the No. 1 syringe (01) for microsphere drug loading.

10. The microsphere drug loading method according to claim 9, characterized in that, The microsphere drug delivery method further includes: S5. Install the No. 2 syringe (03) containing other drug solutions on the second syringe connector (520), and transfer the drug solution to the No. 1 syringe (01) for microsphere loading while the drug bottle (01) and the No. 1 syringe (02) are not connected. Repeat this step until all drug solutions are loaded into microspheres.

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