CN115192825B - Prefilled syringe and reservoir for generating different injection forces - Google Patents

Prefilled syringe and reservoir for generating different injection forces Download PDF

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Publication number
CN115192825B
CN115192825B CN202110901788.3A CN202110901788A CN115192825B CN 115192825 B CN115192825 B CN 115192825B CN 202110901788 A CN202110901788 A CN 202110901788A CN 115192825 B CN115192825 B CN 115192825B
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Prior art keywords
plunger
plunger rod
syringe
pressure
syringe barrel
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CN115192825A (en
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陈红丹
阮铁铭
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/48Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for varying, regulating, indicating or limiting injection pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3327Measuring

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to the field of drug delivery devices, in particular to a prefilled syringe and a liquid storage device which generate different injection forces. Wherein the prefilled syringe generating different injection forces comprises a syringe barrel, a plunger and a plunger rod assembly; the plunger may be connected to the plunger rod assembly and the connection of the plunger and the plunger rod assembly may be provided within the syringe barrel; the plunger rod assembly is used to adjust the pressure of the plunger against the syringe barrel in the radial direction to one of the pressure thresholds. By adjusting the shape of the plunger by the plunger rod assembly, the pressure of the plunger before adjustment on the syringe barrel and the pressure of the plunger after adjustment on the syringe barrel can be respectively one of the pressure thresholds, wherein the sum of the friction force formed by one pressure and the liquid resistance generated by one liquid is used as a first resistance, the sum of the friction force formed by the other pressure and the liquid resistance generated by the other liquid is used as a second resistance, and the first resistance and the second resistance can be adjusted to be similar or the same.

Description

Prefilled syringe and reservoir for generating different injection forces
Technical Field
The invention relates to the field of drug delivery devices, in particular to a prefilled syringe and a liquid storage device which generate different injection forces.
Background
In the double-blind test (double blind CLINICAL TRIAL), how to hide information is an important precondition for obtaining the accuracy of the double-blind test result.
In the course of a double blind test using syringes, two syringes of the same model were provided, and the subject could not distinguish the difference between the two syringes themselves in appearance. However, the first syringe is filled with the liquid of the first component and the second syringe is filled with the liquid of the second component, and the difference in viscosity between the liquid of the first component and the liquid of the second component causes the subject to feel a significant difference in the two injections by the resistance of the syringe during the injection by pushing the syringe, which results in information being known to the subject by touch.
In the above, in the case that the viscosities of the two liquids are different, the resistance of the syringe is directly affected by the viscosities of the two liquids, so that the 'resistance of the syringe filled with the liquid with higher viscosity' is obviously perceived as different from the 'resistance of the syringe filled with the liquid with lower viscosity'.
Therefore, how the 'resistance of the syringe filled with the higher viscosity liquid' is set to be the same as the 'resistance of the syringe filled with the lower viscosity liquid' in the same type of syringe becomes a technical problem to be solved in the prior art.
Disclosure of Invention
In order to solve the technical problem that how the resistance of the syringe filled with the liquid with higher viscosity is the same as the resistance of the syringe filled with the liquid with lower viscosity in the syringe of the same model in the prior art, the invention provides a pre-filling and sealing syringe and a liquid storage device which generate different injection forces.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
according to one aspect of the present invention, there is provided a pre-filled syringe that produces different injection forces, comprising a syringe barrel, a plunger and a plunger rod assembly;
the plunger may be connected to the plunger rod assembly, and the connection of the plunger and the plunger rod assembly may be provided within the syringe barrel;
the plunger rod assembly is configured to adjust a pressure of the plunger against the syringe barrel in a radial direction to one of the pressure thresholds.
Further, the plunger rod assembly includes a first plunger rod and a second plunger rod;
one end of the first plunger rod is a first mounting end, one end of the second plunger rod is a second mounting end, and the diameter of the first mounting end is different from that of the second mounting end;
the first mounting end and the second mounting end are alternatively used for adjusting the radial pressure of the plunger acting on the syringe barrel to one of pressure thresholds.
Further, the plunger is provided with a blind hole, and the direction of the opening of the blind hole is the axial direction of the plunger;
the first mounting end and the second mounting end are alternatively arranged in the blind hole.
Further, the inner wall of the blind hole is provided with an internal thread;
The first mounting end and the second mounting end are respectively provided with external threads, and the external threads of the first mounting end and the external threads of the second mounting end are alternatively connected with the internal threads of the blind hole.
Further, the plunger rod assembly comprises a plunger rod sleeve and a plunger rod pin;
One end of the plunger rod sleeve is a deformation end, the plunger rod pin can be arranged in the plunger rod sleeve, the plunger rod pin can be inserted into the deformation end, and the deformation end inserted by the plunger rod pin is used for adjusting the radial pressure of the plunger acting on the syringe barrel to be one of pressure thresholds.
Further, the deformation end is provided with at least two deformation positions, and a gap is formed between two adjacent deformation positions;
When the plunger rod pin is inserted into the deformation end, any deformation part forms an expansion trend along the radial direction of the deformation end, and when the plunger rod pin is moved out of the deformation end, any deformation part forms a contraction trend along the radial direction of the deformation end.
Further, the other end of the plunger rod sleeve is a retreating end;
The non-return end has a deformed state and a non-deformed state, and the plunger rod pin is used for forcing the non-return end to transition between the deformed state and the non-deformed state;
when the plunger rod pin penetrates through the retaining end and is in a non-deformation state, the retaining end is used for blocking the plunger rod pin from moving relative to the plunger rod sleeve.
Further, the inner contour of the deformation end is provided with a plurality of step parts, all the step parts are coaxially communicated, any one step part can form one inner end surface contour respectively, and the axial inner end surface spacing of two adjacent inner end surface contours is the same;
The retaining end is provided with a plurality of deformable cantilever hooks, and any cantilever hook is respectively provided with a plurality of bulges inwards along the radial direction, wherein the axial bulge spacing between two adjacent bulges of any cantilever hook is the same;
The axial protrusion spacing between two adjacent protrusions is the same as the axial inner end face spacing of two adjacent inner end face contours.
Further, the injection needle is hollow;
The injection needle penetrates through and is fixedly arranged in the syringe barrel, wherein two ends of the injection needle are respectively a liquid inlet end and a liquid outlet end, the liquid outlet end is positioned outside the syringe barrel, and the liquid inlet end is positioned inside the syringe barrel.
According to one aspect of the present invention there is provided a reservoir comprising a pre-filled syringe as described above which produces different injection forces.
The technical scheme has the following advantages or beneficial effects:
the pre-filling and sealing injector for generating different injection forces provided by the invention can enable the pressure of the plunger before adjustment on the injector cylinder and the pressure of the plunger after adjustment on the injector cylinder to be respectively one of pressure thresholds through the plunger rod assembly adjusting the shape of the plunger, wherein the sum of friction force formed by one pressure and liquid resistance generated by one liquid is used as a first resistance, the sum of friction force formed by the other pressure and liquid resistance generated by the other liquid is used as a second resistance, and the first resistance and the second resistance can be adjusted to be similar or identical.
Drawings
Fig. 1 is a schematic diagram of a split structure of a prefilled syringe for generating different injection forces according to embodiment 1 of the present invention;
Fig. 2 is a schematic structural diagram of a prefilled syringe for generating different injection forces according to embodiment 1 of the present invention;
FIG. 3 is a cross-sectional view of a prefilled syringe according to example 1 of the present invention, producing different injection forces;
fig. 4 is a schematic view showing the structure of a plunger and plunger rod assembly according to embodiment 1 of the present invention;
fig. 5 is a cross-sectional view of a plunger and plunger rod assembly provided in embodiment 1 of the present invention;
fig. 6 is a schematic diagram of a split structure of a prefilled syringe for generating different injection forces according to embodiment 2 of the present invention;
FIG. 7 is a cross-sectional view of a prefilled syringe according to example 2 of the present invention, producing different injection forces;
fig. 8 is a schematic structural diagram of a plunger rod sleeve according to embodiment 2 of the present invention;
FIG. 9 is a cross-sectional view of a plunger rod sleeve provided in embodiment 2 of the present invention;
fig. 10 is a schematic structural view of a plunger rod pin according to embodiment 2 of the present invention;
fig. 11 is a cross-sectional view of a plunger and plunger rod assembly provided in embodiment 2 of the present invention;
fig. 12 is a cross-sectional view of a plunger and plunger rod assembly provided in embodiment 2 of the present invention;
fig. 13 is a cross-sectional view of a plunger and plunger rod assembly provided in embodiment 2 of the present invention.
Detailed Description
The present invention provides a prefilled syringe generating different injection forces, see fig. 1, 2, 6 or 7, comprising a syringe barrel 1, a plunger 2 and a plunger rod assembly 3;
The plunger 2 may be connected to the plunger rod assembly 3 and the connection of the plunger 2 and the plunger rod assembly 3 may be provided within the syringe barrel 1;
the plunger rod assembly 3 is used to adjust the pressure of the plunger 2 against the radial direction of the syringe barrel 1 to one of the pressure thresholds.
The plunger rod assembly 3 is used to push or pull the plunger 2 such that the plunger 2 is capable of reciprocating within the syringe barrel 1; a receiving chamber is formed between the inner wall of the syringe barrel 1 and the plunger 2, in which liquid can be received, and the plunger rod assembly 3 pushing the plunger 2 can move liquid from the receiving chamber to the outside of the receiving chamber.
The plunger 2 applies pressure to the syringe barrel 1 in the radial direction thereof so that a plunger 2 friction force can be formed between the plunger 2 and the syringe barrel 1; after the receiving chamber of the syringe barrel 1 is filled with the liquid, the viscosity of the liquid acts on the inner wall of the syringe barrel 1, thereby forming liquid resistance; the plunger 2 friction and fluid resistance are each one of the resistances that the pre-filled syringe can feel or can be detected.
When the syringe barrel 1 is filled with a liquid with high viscosity, the liquid resistance increases relatively, and if the friction force of the plunger 2 remains unchanged, the resistance of the prefilled syringe increases;
When the syringe barrel 1 is filled with a less viscous liquid, the liquid resistance is relatively reduced, and if the plunger 2 friction remains the same, the pre-filled syringe resistance is reduced.
From the above, if it is desired to keep the 'resistance of the syringe filled with the liquid having high viscosity' and the 'resistance of the syringe filled with the liquid having low viscosity' in agreement, the following modification methods can be adopted:
in the first aspect, the liquid having different original viscosity is reformed to have uniform viscosity, so that the liquid resistance when the liquid is poured into the syringe barrel 1 is uniform, and the effect of keeping the syringe resistance uniform can be finally achieved under the condition that the friction force of the plunger 2 is unchanged.
In the second aspect, the effect of keeping the resistance of the syringe consistent is finally achieved by modifying the friction of the plunger 2 without modifying the viscosity of the liquid.
In the present invention, the modification of the 'second aspect' is performed with respect to the prior art syringe.
A plunger rod assembly 3 is connected to the plunger 2, the plunger rod assembly 3 being capable of changing the radial shape of the plunger 2 and thereby the radial pressure acting on the syringe barrel 1;
The process by which the plunger rod assembly 3 can change the radial shape of the plunger 2 is visually observable if the plunger 2 and the plunger rod assembly 3 are located outside the syringe barrel 1, respectively, before the plunger rod assembly 3 adjusts the radial shape of the plunger 2; then, when the plunger 2 of which shape is changed is set in the syringe barrel 1, the plunger 2 is pressed by the syringe barrel 1, and the shape of the plunger 2 is changed again by the syringe barrel 1;
If the plunger 2 and the plunger rod assembly 3 are disposed within the syringe barrel 1 before the plunger rod assembly 3 adjusts the radial shape of the plunger 2, the radial shape of the plunger 2 cannot be visually observed as the process of being changed by the plunger rod assembly 3; this is because the plunger 2 has been restricted by the syringe barrel 1 so that the radially outer circumferential profile of the plunger 2 can only produce a 'tendency to change shape', whereas the substantial restriction by the syringe barrel 1 results in a failure to change shape and thus cannot be visually observed; the radially inner portion of the plunger 2 is in direct contact with the plunger rod assembly 3, and during the process of changing the radial shape of the plunger 2 by the plunger rod assembly 3, the radially inner portion of the plunger 2 is actually driven by the plunger rod assembly 3 to generate a 'trend of changing the shape', and simultaneously, the deformation process of the plunger 2 by the plunger rod assembly 3 along the radial extrusion is generated, and the deformation position is the radially inner portion of the plunger 2, so that the deformation process is shielded by the radially outer circumference of the plunger 2 and cannot be visually observed.
The plunger rod assembly 3, during changing the radial shape of the plunger 2, increases the pressure of the plunger 2 against the syringe barrel 1 if the deformation or deformation tendency of the plunger 2 is in a direction along the interior to the exterior of the plunger 2; conversely, if the deformation or direction of the deformation tendency of the plunger 2 is in the direction from the outside to the inside of the plunger 2, the pressure of the plunger 2 acting on the syringe barrel 1 is reduced.
In the case where the pressure of the plunger 2 acting on the syringe barrel 1 increases, the contact area between the plunger 2 and the syringe barrel 1 is unchanged, so that the frictional force between the plunger 2 and the syringe barrel 1 increases; conversely, in the case where the pressure of the plunger 2 acting on the syringe barrel 1 is reduced, the contact area between the plunger 2 and the syringe barrel 1 is unchanged, so that the frictional force between the plunger 2 and the syringe barrel 1 is reduced.
It should be understood that the pre-filled syringe according to the present invention, which generates different injection forces, should be understood as 'injection force' as follows: when using a prefilled syringe filled with liquid, the user drives the plunger rod assembly 3 with respect to the syringe barrel 1 with an applied thrust force;
It should be understood that the pre-filled syringe according to the present invention that generates different injection forces should be understood as' generating different injection forces: when the user pushes the plunger rod assembly 3 before the pressure of the plunger 2 against the syringe barrel 1 is not changed by the plunger rod assembly 3, the pushing force applied by the user is a first injection force, which is actually the sum of the friction force of the plunger 2 and the liquid resistance before the change; after the pressure of the plunger 2 on the syringe barrel 1 is changed by the plunger rod assembly 3, when the user pushes the plunger rod assembly 3, the pushing force applied by the user is a second injection force, and the second injection force is the sum of the friction force of the plunger 2 and the liquid resistance after the change; since the friction force of the plunger 2 before the change is different from the friction force of the plunger 2 after the change, the first injection force and the second injection force are different under the condition that the liquid resistance of the filled liquid is unchanged.
The pre-filling and sealing injector capable of generating different injection forces provided by the invention can meet the following specific use scenes in the process of being practically applied to double-blind experiments:
Using scenario a: the double-blind test is set as two liquids, wherein the first liquid is liquid medicine, the second liquid is placebo, the viscosity of the first liquid is higher, the viscosity of the second liquid is lower, and the same type of pre-filled and sealed injector which generates different injection forces is adopted;
Dividing the pre-filled syringes generating different injection forces into two groups, the first group of syringes being filled with a first liquid and the second group of syringes being filled with a second liquid; the first liquid resistance of the first liquid in the syringe barrel 1 of the first set of syringes is relatively high and the second liquid resistance of the second liquid in the syringe barrel 1 of the second set of syringes is relatively low before the plunger 2 has been deformed by the plunger rod assembly 3, but the first plunger 2 friction of the first set of syringes is the same as the second plunger 2 friction of the second set of syringes, at which point the resistance of the first set of syringes is greater than the resistance of the second set of syringes; in this case, the second plunger 2 friction of the second group of syringes may be increased, i.e. the shape of the plunger 2 is changed by the plunger rod assembly 3 of the second group of syringes, thereby increasing the second plunger 2 friction of the second group of syringes; finally, the resistance of the first set of syringes may be set to be the same as the resistance of the second set of syringes.
Using scenario B: the double-blind test is set as two liquids, wherein the first liquid is liquid medicine, the second liquid is placebo, the viscosity of the first liquid is higher, the viscosity of the second liquid is lower, and the same type of pre-filled and sealed injector which generates different injection forces is adopted;
Dividing the pre-filled syringes generating different injection forces into two groups, the first group of syringes being filled with a first liquid and the second group of syringes being filled with a second liquid; the first liquid resistance of the first liquid in the syringe barrel 1 of the first set of syringes is relatively high and the second liquid resistance of the second liquid in the syringe barrel 1 of the second set of syringes is relatively low before the plunger 2 has been deformed by the plunger rod assembly 3, but the first plunger 2 friction of the first set of syringes is the same as the second plunger 2 friction of the second set of syringes, at which point the resistance of the first set of syringes is greater than the resistance of the second set of syringes; in this case, the first plunger 2 friction of the first group of syringes may be reduced, i.e. the shape of the plunger 2 is changed by the plunger rod assembly 3 of the first group of syringes, thereby reducing the first plunger 2 friction of the first group of syringes; finally, the resistance of the first set of syringes may be set to be the same as the resistance of the second set of syringes.
Using scenario C: the double-blind test is set as two liquids, wherein the first liquid is a first liquid medicine, the second liquid is a second liquid medicine, the viscosity of the first liquid is higher, and the viscosity of the second liquid is lower, and the same type of pre-filling and sealing injector which generates different injection forces is adopted;
in the usage scenario C, except that specific components of the two liquids are different from those in the usage scenario a, the other adjustment modes and effects are the same as those in the usage scenario a, and are not repeated here.
Using scenario D: the double-blind test is set as two liquids, wherein the first liquid is a first liquid medicine, the second liquid is a second liquid medicine, the viscosity of the first liquid is higher, and the viscosity of the second liquid is lower, and the same type of pre-filling and sealing injector which generates different injection forces is adopted;
In the usage scenario D, except for the specific components of the two liquids being different from those in the usage scenario B, the other adjustment modes and effects are the same as those in the usage scenario B, and are not repeated here.
In the actual design and manufacture of the prefilled syringe of the present invention, which generates different injection forces, the pressure threshold of the plunger 2 acting on the syringe barrel 1 can be specifically measured and/or calculated based on the viscosity of the medicament or placebo required for the double blind test; the pressure threshold should be understood as a set of a plurality of pressure values.
For example: the pressure that the plunger 2 acts on the syringe barrel 1 before the plunger rod assembly 3 does not change the shape of the plunger 2 is a first pressure, the pressure that the plunger 2 is acted on the syringe barrel 1 after the plunger rod assembly 3 changes the shape of the plunger 2 is a second pressure, the pressure threshold should include the first pressure and the second pressure, and the maximum pressure in the pressure threshold should be greater than or equal to the greater of the first pressure and the second pressure, and the minimum pressure in the pressure threshold should be less than or equal to the lesser of the first pressure and the second pressure.
Another example is: the pressure of the plunger 2 against the syringe barrel 1 before the plunger rod assembly 3 does not change the shape of the plunger 2 is a first pressure, a second pressure, a third pressure, a fourth pressure … … nth pressure may be formed during the plunger rod assembly 3 changing the plunger 2, the pressure threshold should include the first pressure, the second pressure, the third pressure, the fourth pressure … … nth pressure, and the maximum pressure in the pressure threshold should be greater than or equal to the greater of the first pressure and the nth pressure, and the minimum pressure in the pressure threshold should be less than or equal to the lesser of the first pressure and the nth pressure.
After measuring and/or calculating the pressure threshold of the plunger 2 acting on the syringe barrel 1, the specific structure of the plunger 2 and the specific structure of the plunger 2 rod matching the pressure threshold can be obtained in a simple experimental manner, which is known to the person skilled in the art and will not be described in detail here.
In the process of actually using the prefilled syringe of the present invention for generating different injection forces, the shape of the plunger 2 is adjusted by the plunger rod assembly 3, so that the pressure of the plunger 2 acting on the syringe barrel 1 before adjustment and the pressure of the plunger 2 acting on the syringe barrel 1 after adjustment are respectively one of the pressure thresholds, wherein the sum of the friction force formed by one pressure and the liquid resistance generated by one liquid is taken as a first resistance, and the sum of the friction force formed by the other pressure and the liquid resistance generated by the other liquid is taken as a second resistance, and the first resistance and the second resistance can be adjusted to be similar or identical, thereby solving the technical problem how the resistance 'of the syringe filled with higher viscosity liquid and the resistance' of the syringe filled with lower viscosity liquid are set to be identical in the prior art in the same syringe.
The pre-filled syringes provided by the present invention that generate different injection forces are further described below by way of example.
Example 1:
in this embodiment, referring to fig. 1-5, a pre-filled syringe is provided that produces different injection forces, including a syringe barrel 1, a plunger 2, and a plunger rod assembly 3;
The plunger 2 may be connected to the plunger rod assembly 3 and the connection of the plunger 2 and the plunger rod assembly 3 may be provided within the syringe barrel 1;
the plunger rod assembly 3 is used to adjust the pressure of the plunger 2 against the radial direction of the syringe barrel 1 to one of the pressure thresholds.
Wherein the plunger rod assembly 3 comprises a first plunger rod and a second plunger rod;
One end of the first plunger rod is a first mounting end, one end of the second plunger rod is a second mounting end, and the diameter of the first mounting end is different from that of the second mounting end;
the first mounting end and the second mounting end are alternatively used for adjusting the radial pressure of the plunger 2 acting on the syringe barrel 1 to one of the pressure thresholds.
The prefilled syringe of this embodiment, which generates different injection forces, has plunger rod assemblies 3 provided in two, a first plunger rod and a second plunger rod, respectively, the first plunger rod and the second plunger rod being different in that the diameter of the first mounting end of the first plunger rod is different from the diameter of the second mounting end of the second plunger rod, so that the pressure of the plunger 2 acting on the syringe barrel 1 is changed by replacing the first plunger rod connected to the plunger 2 with the second plunger rod, or so that the pressure of the plunger 2 acting on the syringe barrel 1 is changed by replacing the second plunger rod connected to the plunger 2 with the first plunger rod.
It will be appreciated that the pressure exerted by the plunger 2 connected to the first plunger rod on the syringe barrel 1 and the pressure exerted by the plunger 2 connected to the second plunger rod on the syringe barrel 1 are each one of the pressure thresholds.
Referring to fig. 3 or 5, the plunger 2 is provided with a blind hole, and the direction of the opening of the blind hole is the axial direction of the plunger 2;
the first mounting end and the second mounting end are alternatively arranged in the blind hole.
The plunger 2 is provided with a blind hole structure such that the blind hole can accommodate a first mounting end of the first plunger rod or a second mounting end of the second plunger rod, such that the first mounting end and/or the second mounting end can force the plunger 2 in a radial direction, deforming or deforming tendency from the inside of the plunger 2 to the outside of the plunger 2.
The inner wall of the blind hole is provided with an internal thread (not shown in the figure);
the first mounting end and the second mounting end are respectively provided with an external thread 301 (see fig. 1), and the external thread 301 of the first mounting end and the external thread 301 of the second mounting end are alternatively connected with the internal thread of the blind hole.
Setting the blind hole as an internal threaded hole and setting the first mounting end and the second mounting end as external threads 301 respectively can simplify the positioning and connection of the first mounting end and the second mounting end relative to the blind hole, thereby facilitating the connection of the first plunger rod and the second plunger rod to the plunger 2; in addition, by connecting the internal thread of the blind hole with the external thread 301 of the first plunger rod or the second plunger rod, the negative effect of the first plunger rod or the second plunger rod being separated relative to the plunger 2 during the pulling of the plunger 2 can be reduced or avoided.
Referring to fig. 1 to 3, the prefilled syringe generating different injection forces further comprises a hollow injection needle 4;
The injection needle 4 penetrates and is fixedly arranged in the syringe barrel 1, wherein two ends of the injection needle 4 are respectively a liquid inlet end and a liquid outlet end, the liquid outlet end is positioned outside the syringe barrel 1, and the liquid inlet end is positioned inside the syringe barrel 1.
The connection between the syringe barrel 1 and the injection needle 4 may be any connection known in the art, and will not be described here.
Example 2:
in this embodiment, referring to fig. 6-13, a pre-filled syringe is provided that produces different injection forces, including a syringe barrel 1, a plunger 2, and a plunger rod assembly 3;
The plunger 2 may be connected to the plunger rod assembly 3 and the connection of the plunger 2 and the plunger rod assembly 3 may be provided within the syringe barrel 1;
the plunger rod assembly 3 is used to adjust the pressure of the plunger 2 against the radial direction of the syringe barrel 1 to one of the pressure thresholds.
Referring to fig. 6-13, plunger rod assembly 3 includes plunger rod sleeve 310 and plunger rod pin 311;
One end of the plunger rod sleeve 310 is a deformation end 312, the plunger rod pin 311 can be arranged in the plunger rod sleeve 310, the plunger rod pin 311 can be inserted into the deformation end 312, and the deformation end 312 inserted by the plunger rod pin 311 is used for adjusting the pressure of the plunger 2 acting on the radial direction of the syringe barrel 1 to one of pressure thresholds.
The prefilled syringe of this embodiment, which generates different injection forces, has a plunger rod assembly 3 arranged in an adjustable state, in particular: plunger rod sleeve 310 is sleeved with plunger rod pin 311, and plunger rod pin 311 is positioned at different positions relative to plunger rod sleeve 310, so that deformation end 312 inserted by plunger rod pin 311 generates different deformation or deformation trend, and the pressure of plunger 2 acting on syringe barrel 1 is changed.
Specifically, referring to fig. 8 or 9, the deformed end 312 is provided with at least two deformed positions X, and a gap is formed between two adjacent deformed positions X;
When the plunger rod pin 311 is inserted into the deformed end 312, any one of the deformed positions X forms an expansion trend along the radial direction of the deformed end 312, and when the plunger rod pin 311 is removed from the deformed end 312, any one of the deformed positions X forms a contraction trend along the radial direction of the deformed end 312.
Where deformation X is to be understood as a portion of plunger rod sleeve 310, when plunger rod pin 311 is inserted into deformation end 312, plunger rod pin 311 may actually contact the inner surface of deformation X, such that plunger rod pin 311 may apply a radial force to deformation X, forcing deformation X.
It should be appreciated that deformation X is in the first state before plunger rod pin 311 is not inserted into deformed end 312; at this time, a gap should be formed between two adjacent deformation positions X, so that when the plunger 2 is pressed by the acting force of the syringe barrel 1, the deformation positions X may slightly deform inward in the radial direction; or a gap should be formed between two adjacent deformation positions X at this time, but any deformation position X does not generate deformation.
It should be appreciated that after plunger rod pin 311 is inserted into deformed end 312, deformed portion X may be in either the first state or the second state; when the deformation position X is in the first state, the acting force applied to the deformation position X by the plunger rod pin 311 is smaller, which is insufficient to cause the deformation of the deformation position X, or when the deformation position X is in the first state, the acting force applied to the deformation position X by the plunger rod pin 311 is smaller, which causes the deformation position X to generate deformation trend but is influenced by the acting force of the syringe barrel 1 without deformation; when the deformation X is in the second state, it is indicated that the force applied to the deformation X by the plunger rod pin 311 is sufficiently large, so that the deformation X is caused to deform or deform in the radial direction from the inside of the plunger 2 to the outside of the plunger 2, so that the deformation X is changed from the first state to the second state at that time, and the gap at that time is influenced by the deformation of the deformation X to have an increasing tendency.
Further, referring to fig. 7 to 9 and 11 to 13, the other end of the plunger rod sleeve 310 is a retreating end 313;
the retaining end 313 has a deformed state and a non-deformed state, and the plunger rod pin 311 is used to force the retaining end 313 to transition between the deformed state and the non-deformed state;
When the plunger rod pin 311 penetrates the retaining end 313 and the plunger rod pin 311 is in the non-deformed state, the retaining end 313 is used to block movement of the plunger rod pin 311 relative to the plunger rod sleeve 310.
The plunger rod pin 311 can apply a radial acting force and an axial acting force to the deformation position X of the plunger rod sleeve 310, and the plunger rod pin 311 can receive a radial reaction force and an axial reaction force applied by the plunger rod sleeve 310; in the case where the axial reaction force is sufficiently large, the plunger rod pin 311 may move along the direction from the deformed end 312 to the retaining end 313, resulting in separation of the plunger rod pin 311 from the deformed end 312, which may result in insufficient deformation amount or deformation tendency of the deformed end 312, and thus, the pressure of the plunger 2 acting on the syringe barrel 1 may not be changed. In order to avoid such negative effects, the retaining end 313 is adopted to be mutually matched with the plunger rod pin 311, so that a structure for preventing the plunger rod pin 311 from moving relative to the plunger rod sleeve 310 is formed, the mutual separation of the plunger rod pin 311 and the deformation end 312 of the plunger rod sleeve 310 can be avoided or the mutual separation trend can be reduced, and the pressure of the plunger 2 acting on the syringe barrel 1 can be changed.
Further, referring to fig. 9, 11 to 13, the inner contour of the deformed end 312 is provided as a plurality of stepped portions, all of the stepped portions are provided to be coaxially communicated, any one of the stepped portions may form one inner end surface contour, and the axial inner end surface pitches of the adjacent two inner end surface contours are the same;
The retaining end 313 is provided as a plurality of deformable cantilever hooks, any one of which is provided with a plurality of protrusions radially inward, respectively, wherein the axial protrusion spacing between two adjacent protrusions of any one cantilever hook is the same;
The axial protrusion spacing between two adjacent protrusions is the same as the axial inner end face spacing of two adjacent inner end face contours.
Wherein, the inner end surface contour of any one of the step parts can be penetrated by the plunger rod pin 311 respectively, and one end of the plunger rod pin 311 can contact the inner end surface contour of any one of the step parts;
Along the direction from the retaining end 313 to the deforming end 312, the inner diameters of the plurality of steps gradually decrease, that is, the inner diameter of the inner end surface contour close to the retaining end 313 is relatively large, and the inner diameter of the inner end surface contour far away from the retaining end 313 is relatively small, so that in the process that one end of the plunger rod pin 311 penetrates through the plurality of inner end surface contours, the acting force applied by the plunger rod pin 311 to the deforming end 312 gradually increases, so that the acting force applied by the deforming end 312 to the plunger 2 forms a plurality of acting forces, the plunger 2 forms a plurality of deformations according to the different acting forces, and the acting force of the plunger 2 on the syringe barrel 1 is changed into a plurality of acting forces.
Referring to fig. 11, plunger rod pin 311 is in a first position relative to plunger rod sleeve 310, wherein one end of plunger rod pin 311 contacts the inner end face profile at the closest first step;
Referring to fig. 12, plunger rod pin 311 is in a first position relative to plunger rod sleeve 310, wherein one end of plunger rod pin 311 contacts the inner end face profile of the second step located in the middle;
referring to fig. 13, plunger rod pin 311 is in a first position relative to plunger rod sleeve 310, wherein one end of plunger rod pin 311 contacts the inner end surface profile of the third most distant step;
The plunger rod pin 311 contacts with the inner end surface contour of different stepped parts, which can cause different diameters of deformed ends, so that the deformation or deformation trend of the plunger 2 is different, and further, the friction force of the plunger 2 acting on the syringe barrel 1 is different.
When one end of the plunger rod pin 311 contacts the inner end surface contour of one of the stepped portions, the plunger rod pin 311 is practically limited between the deformed end 312 and the retaining end 313, so that the plunger rod pin 311 cannot move in the axial direction relative to the plunger rod sleeve 310; specifically, one end of the plunger rod pin 311 is blocked by the contour of the inner end surface, the plunger rod pin 311 cannot move along the direction from the retaining end 313 to the deforming end 312 under the action of no additional external force, and the other end of the plunger rod pin 311 is restricted by two adjacent protrusions on the cantilever hooks, so that the axial reaction force of the plunger 2 on the plunger rod pin 311 is counteracted, and the plunger rod pin 311 cannot move along the direction from the deforming end 312 to the retaining end 313. In practical application, the position of one end of the plunger rod pin 311 relative to the contour of the inner end surface of any one of the stepped portions is an adjustment mode for adjusting the acting force of the plunger 2 on the syringe barrel 1; stated another way, for the purpose of plunger 2 applying sufficient and reasonable pressure to syringe barrel 1, one end of plunger rod sleeve 310 must be constrained to a 'state of contacting the inner end surface profile of one of the steps' at which time the other end of plunger rod sleeve 310 should be constrained by two adjacent ones of the projections of either cantilever hook; therefore, it is necessary to set the pitch between the adjacent two projections of any one cantilever hook to be the same as the pitch between the inner end surface contours of the adjacent two stepped portions.
In this embodiment, referring to fig. 6 or 7, the prefilled syringe generating different injection forces further comprises a hollow injection needle 4;
The injection needle 4 penetrates and is fixedly arranged in the syringe barrel 1, wherein two ends of the injection needle 4 are respectively a liquid inlet end and a liquid outlet end, the liquid outlet end is positioned outside the syringe barrel 1, and the liquid inlet end is positioned inside the syringe barrel 1.
The connection between the syringe barrel 1 and the injection needle 4 may be any connection known in the art, and will not be described here.
Example 3:
in this embodiment, a reservoir device is provided comprising a pre-filled syringe as in previous embodiments 1 or 2 that generates different injection forces.
The reservoir is a prefilled syringe for filling with a liquid that generates different injection forces, such as: an automatic injection device having pre-filled syringes that generate different injection forces, a manual injection device having pre-filled syringes that generate different injection forces, a medicament container having pre-filled syringes that generate different injection forces, and the like.
The foregoing description is only of the preferred embodiments of the present invention and is not intended to limit the scope of the invention, and all equivalent structural changes made by the present invention and the accompanying drawings, or direct or indirect application in other related technical fields, are included in the scope of the present invention.

Claims (10)

1. A prefilled syringe for generating different injection forces, comprising a syringe barrel, a plunger and a plunger rod assembly;
the plunger may be connected to the plunger rod assembly, and the connection of the plunger and the plunger rod assembly may be provided within the syringe barrel;
The plunger rod assembly is used for adjusting the radial pressure of the plunger on the syringe barrel to one of pressure thresholds, wherein the plunger rod assembly can change the radial shape of the plunger, thereby changing the radial pressure on the syringe barrel;
The pressure threshold is specifically a set of a plurality of pressure values.
2. The pre-filled syringe of claim 1, wherein the plunger rod assembly comprises a first plunger rod and a second plunger rod;
one end of the first plunger rod is a first mounting end, one end of the second plunger rod is a second mounting end, and the diameter of the first mounting end is different from that of the second mounting end;
the first mounting end and the second mounting end are alternatively used for adjusting the radial pressure of the plunger acting on the syringe barrel to one of pressure thresholds.
3. The prefilled syringe of claim 2, wherein the plunger is provided with a blind hole, the direction of the opening of which is the axial direction of the plunger;
the first mounting end and the second mounting end are alternatively arranged in the blind hole.
4. A pre-filled and sealed syringe according to claim 3, wherein the inner wall of the blind hole is provided with an internal thread;
The first mounting end and the second mounting end are respectively provided with external threads, and the external threads of the first mounting end and the external threads of the second mounting end are alternatively connected with the internal threads of the blind hole.
5. The pre-filled syringe of claim 1, wherein the plunger rod assembly comprises a plunger rod sleeve and a plunger rod pin;
One end of the plunger rod sleeve is a deformation end, the plunger rod pin can be arranged in the plunger rod sleeve, the plunger rod pin can be inserted into the deformation end, and the deformation end inserted by the plunger rod pin is used for adjusting the radial pressure of the plunger acting on the syringe barrel to be one of pressure thresholds.
6. The prefilled syringe of claim 5, wherein said deformed end is provided with at least two deformed portions, a gap being formed between adjacent deformed portions;
When the plunger rod pin is inserted into the deformation end, any deformation part forms an expansion trend along the radial direction of the deformation end, and when the plunger rod pin is moved out of the deformation end, any deformation part forms a contraction trend along the radial direction of the deformation end.
7. The prefilled syringe of claim 6, wherein said plunger rod sleeve has its other end retracted;
The non-return end has a deformed state and a non-deformed state, and the plunger rod pin is used for forcing the non-return end to transition between the deformed state and the non-deformed state;
when the plunger rod pin penetrates through the retaining end and is in a non-deformation state, the retaining end is used for blocking the plunger rod pin from moving relative to the plunger rod sleeve.
8. The prefilled syringe of claim 7, wherein the inner contour of said deformed end is configured as a plurality of steps, all of said steps being configured to communicate coaxially, any one of said steps being configured to form an inner end contour, respectively, with the axial inner end surfaces of adjacent two inner end surface contours being equally spaced;
The retaining end is provided with a plurality of deformable cantilever hooks, and any cantilever hook is respectively provided with a plurality of bulges inwards along the radial direction, wherein the axial bulge spacing between two adjacent bulges of any cantilever hook is the same;
The axial protrusion spacing between two adjacent protrusions is the same as the axial inner end face spacing of two adjacent inner end face contours.
9. The pre-filled and sealed syringe of any one of claims 1 to 8, further comprising a hollow needle;
The injection needle penetrates through and is fixedly arranged in the syringe barrel, wherein two ends of the injection needle are respectively a liquid inlet end and a liquid outlet end, the liquid outlet end is positioned outside the syringe barrel, and the liquid inlet end is positioned inside the syringe barrel.
10. A reservoir comprising a pre-filled syringe according to any one of claims 1 to 9 generating different injection forces.
CN202110901788.3A 2021-04-13 2021-08-06 Prefilled syringe and reservoir for generating different injection forces Active CN115192825B (en)

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US63/258,120 2021-04-13

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4194505A (en) * 1978-09-15 1980-03-25 Vac-O-Cast, Inc. Containerized hypodermic module
US4452251A (en) * 1982-11-05 1984-06-05 Medrad, Inc. Syringe content indicating device
JPH0648677U (en) * 1992-12-15 1994-07-05 毅 青木 Gravity-type automatic intravenous injection device flow measurement and adjustment device
CN101417152A (en) * 2007-09-18 2009-04-29 科迪斯公司 Local vascular delivery with the mTOR inhibitor of peroxisome Proliferator-activated receptor stimulant associating
CN102612381A (en) * 2009-03-20 2012-07-25 安塔瑞斯制药公司 Hazardous agent injection system
CN102654192A (en) * 2012-05-07 2012-09-05 中国重型机械研究院有限公司 System and method for eliminating thread clearance
CN202761828U (en) * 2012-06-29 2013-03-06 新乡市驼人医疗器械有限公司 Novel low resistance injector
CA2808875A1 (en) * 2013-03-08 2014-09-08 Teva Pharmaceutical Industries Ltd. Re-useable injector device for syringe

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4194505A (en) * 1978-09-15 1980-03-25 Vac-O-Cast, Inc. Containerized hypodermic module
US4452251A (en) * 1982-11-05 1984-06-05 Medrad, Inc. Syringe content indicating device
JPH0648677U (en) * 1992-12-15 1994-07-05 毅 青木 Gravity-type automatic intravenous injection device flow measurement and adjustment device
CN101417152A (en) * 2007-09-18 2009-04-29 科迪斯公司 Local vascular delivery with the mTOR inhibitor of peroxisome Proliferator-activated receptor stimulant associating
CN102612381A (en) * 2009-03-20 2012-07-25 安塔瑞斯制药公司 Hazardous agent injection system
CN102654192A (en) * 2012-05-07 2012-09-05 中国重型机械研究院有限公司 System and method for eliminating thread clearance
CN202761828U (en) * 2012-06-29 2013-03-06 新乡市驼人医疗器械有限公司 Novel low resistance injector
CA2808875A1 (en) * 2013-03-08 2014-09-08 Teva Pharmaceutical Industries Ltd. Re-useable injector device for syringe

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