Integral worm gear, driving worm, dose accumulation mechanism and injection device

WO2026041147A3PCT designated stage Publication Date: 2026-04-16SHENZHEN MEIHAO CHUANGYI MEDICAL TECH CO LTD
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Patent Information

Application Number
PCT/CN2025/116569
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-12-29
Filing Date
2025-08-22
Publication Date
2026-04-16

AI Technical Summary

Technical Problem

The dose accumulation mechanism of existing injection devices occupies a large axial space, and the accuracy of the accumulation element is greatly affected by dimensional errors.

Method used

The system employs a cross-arranged accumulation element and drive rib structure, and achieves dosage setting and injection through the cooperation of meshing teeth and meshing grooves. The first stop and the second stop define the starting position and the ending position, reducing the impact of dimensional errors on accuracy.

Benefits of technology

It reduces the axial space occupied by the injection device and improves the accuracy and control of dose accumulation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to an integral worm gear, a driving worm, a dose accumulation mechanism and an injection device. The dose accumulation mechanism comprises: a first element, which can rotate around a first axis and is provided with a driving rib, the driving rib extending spirally on the first element around the first axis; a second element, which is sleeved with the first element and can rotate around the first axis; and an accumulation element, which is connected to the second element and can rotate around a second axis relative to the second element, wherein the accumulation element is provided with a plurality of meshing teeth, and a meshing groove allowing the driving rib to mesh therein is formed between every two adjacent meshing teeth. During dose setting, the first element and the second element can rotate relative to each other; and during dose-based injection, the first element and the second element are connected to each other in an anti-rotation manner, and the accumulation element is stationary relative to the first element and the second element. The present application can accumulate and record, by means of the circular motion of the accumulation element, the sum of doses successively set by a user, thereby reducing the axial space occupied in the injection device.
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Description

Integral worm, drive worm, dose accumulation mechanism and injection device TECHNICAL FIELD

[0001] The present application relates to the technical field of injection devices, in particular to an integral worm, a drive worm, a dose accumulation mechanism and an injection device. BACKGROUND

[0002] When injecting a medicament, a specific injection device is used, which is usually referred to as a pen-type injector or injection pen. The injection device can be used by a user to set a dose based on a requirement and inject the set dose. Meanwhile, the process of setting a dose and injecting the set dose is regarded as a complete injection. Accordingly, the injection device is usually provided with a dose accumulation mechanism, which accumulates the total of the doses set by the user one by one and limits the accumulated dose to be no more than the total amount of the medicament contained in a cartridge, so as to ensure that the dose set by the user each time does not exceed the remaining dose of the medicament in the cartridge, thereby ensuring that the dose injected each time is consistent with the set dose.

[0003] In the related art, the dose accumulation mechanism for the injection device usually includes a scale element, a transmission element and an integral nut. The scale element and the transmission element can rotate relative to each other during dose setting, and the scale element and the transmission element are rotationally connected to rotate synchronously during dose injection. The integral nut is sleeved on the transmission element and is threadedly connected with the transmission element. Meanwhile, the integral nut is rotationally connected with the scale element and can move axially relative to the scale element.

[0004] In the above related art, during dose setting, the scale element drives the integral nut to rotate relative to the transmission element, so that the integral nut is displaced axially on the transmission element, and the displacement of the integral nut is associated with the set dose. During dose injection, the scale element, the transmission element and the integral nut are relatively stationary. Therefore, the axial displacement of the integral nut can be used to accumulate the total of the set doses, but this also requires the integral nut to occupy a large axial space in the injection device to meet the requirement of axial movement. SUMMARY

[0005] One of the purposes of the present application is to provide a dose accumulation mechanism which can meet the requirement of accumulating the set doses of a user and reduce the axial space occupied in the injection device. The dose accumulation mechanism adopts the following technical solution:

[0006] A dose accumulation mechanism, comprising:

[0007] a first element, the first element being provided with a drive rib, the drive rib extending around a first axis on the first element;

[0008] a second element, the second element being sleeved with the first element;

[0009] a cumulative element connected to the second element and rotatable relative to the second element about a second axis, the second axis being arranged transversely to the first axis, the cumulative element being provided with a plurality of engagement teeth, the plurality of engagement teeth being arranged in a circumferential direction of the second axis and forming engagement grooves between adjacent engagement teeth for the driving rib to engage with;

[0010] wherein during dose setting, the first element and the second element are rotatable relative to each other, the driving rib being configured to cooperate with the engagement teeth to drive the cumulative element to rotate; during dose injection, the first element and the second element are rotationally fixed, the cumulative element being stationary relative to the first element and the second element.

[0011] Further, the first element is rotatable relative to the second element in a first direction to increase a dose and in a second direction to decrease a dose, the cumulative element having a start position and an end position, a movement stroke of the cumulative element between the start position and the end position corresponding to a total amount of medicine that the injection device is capable of injecting, and the cumulative element being limited from further rotating relative to the second element in the first direction when in the end position.

[0012] Further, the first element is provided with a first stop portion that moves with the first element about the first axis, the cumulative element is provided with a second stop portion that moves with the cumulative element about the second axis, and the start position is formed when the first stop portion abuts against the second stop portion.

[0013] Further, the start position is formed when the second stop portion blocks the first stop portion from further moving about the first axis.

[0014] In actual use, the dose setting action is embodied as a relative rotation amount between the first element and the second element, and the relative rotation amount between the first element and the second element is converted into a rotation amount of the cumulative element via the cooperation between the driving rib on the first element and the engagement grooves on the cumulative element, which is similar to the cooperation between a worm screw and a worm wheel, and the movement transmission between the first element and the cumulative element is deceleration movement. Thus, the dose represented by a unit angle of movement of the first stop portion is smaller than the dose represented by a unit angle of movement of the second stop portion, and in actual manufacture, there are inevitably dimensional errors. In the above scheme, compared to limiting the movement of the second stop portion to define the start position or the end position, limiting the movement of the first stop portion to define the start position or the end position can reduce the adverse effects of dimensional errors on the control accuracy of the total stroke of the cumulative element, i.e., the stroke of the cumulative element between the start position and the end position has higher accuracy.

[0015] Further, the first stop portion comprises a first start portion, and the second stop portion comprises a second start portion; a movement direction of the first start portion when a dose is reduced is defined as a start approaching direction, and the start position of the accumulation element is formed when the second start portion moves to block the first start portion from continuously moving in the start approaching direction.

[0016] Further, the first start portion is configured as an end portion of the driving rib.

[0017] Further, the second start portion is arranged between two adjacent engagement teeth.

[0018] Further, the first element is provided with a first stop portion which moves with the first element around the first axis, and the accumulation element is provided with a second stop portion which moves with the accumulation element around the second axis; the end position is formed when the first stop portion abuts against the second stop portion.

[0019] Further, the end position is formed when the second stop portion blocks the first stop portion from continuously moving around the first axis.

[0020] In actual use, the action of dose setting is embodied as the relative rotation amount between the first element and the second element, and the relative rotation amount between the first element and the second element is converted into the rotation amount of the accumulation element via the cooperation between the driving rib on the first element and the engagement groove on the accumulation element, which is similar to the cooperation between the worm thread and the worm gear tooth groove, and the motion transmission between the first element and the accumulation element belongs to deceleration motion. Thus, the dose represented by one unit angle of the movement of the first stop portion is smaller than the dose represented by one unit angle of the movement of the second stop portion, and size errors inevitably exist in actual manufacturing. In the above scheme, compared with limiting the movement of the second stop portion to define the start position or the end position, limiting the movement of the first stop portion to define the start position or the end position can reduce the adverse effect of size errors on the control accuracy of the total stroke of the accumulation element, i.e., making the stroke of the accumulation element between the start position and the end position have higher accuracy.

[0021] Further, the first stop portion comprises a first start portion, and the second stop portion comprises a second start portion; a movement direction of the first start portion when a dose is reduced is defined as a start approaching direction, and the start position of the accumulation element is formed when the second start portion moves to block the first start portion from continuously moving in the start approaching direction.

[0022] Further, the first start portion is configured as an end portion of the driving rib.

[0023] Further, the second termination portion is arranged between two adjacent engagement teeth.

[0024] Further, the outer periphery of the accumulation element comprises an engagement arc segment formed by the engagement grooves arranged at intervals and a stop arc segment, a side wall of the stop arc segment serving as the second termination portion against which the first termination portion abuts.

[0025] Further, the termination position of the accumulation element is formed when the first stop portion blocks the second stop portion from continuing to move in the termination approach direction.

[0026] Further, the second stop portion is configured as a stop bar extending radially along the accumulation element, and the first stop portion is configured as a termination abutting portion on the side wall of the first element.

[0027] Further, the second element is provided with a first stop portion, and the accumulation element is provided with a second stop portion, and the start position or the termination position is formed when the first stop portion abuts against the second stop portion.

[0028] Further, the first stop portion is arranged on the second element, and the first stop portion is provided with opposite first and second stop surfaces, and the start position of the accumulation element is formed when the first stop surface abuts against the second stop portion, and the termination position of the accumulation element is formed when the second stop surface abuts against the second stop portion; wherein the first element is prevented from continuing to move in the second direction relative to the second element when the accumulation element is in the start position.

[0029] Further, the driving rib has opposite first and second ends in the extension direction thereof, and the circumferential angle formed by the first and second ends based on the first axis is less than or equal to 360°.

[0030] Further, the driving rib comprises a driving segment and an engagement segment at the end of the driving segment, the process from the start of the engagement segment engaging into the engagement groove to the start of the driving segment engaging into the engagement groove is defined as an engagement process, and the process from the complete disengagement of the driving segment from the engagement groove to the complete disengagement of the engagement segment from the engagement groove is defined as a disengagement process, and the accumulation element remains stationary in the engagement process and the disengagement process.

[0031] Further, the driving segment is configured as a helical segment arranged helically around the first axis.

[0032] Further, the engagement segment is configured as an arc segment arranged circumferentially around the first axis.

[0033] Further, the driving rib has opposite first and second ends along its extending direction, the first and second ends form an encompassing angle based on the first axis, the encompassing angle is greater than 360°, and the driving rib spirally extends around the first axis from the first end to the second end.

[0034] Further, a central angle formed by the center points of two adjacent engaging grooves on the accumulation element relative to the second axis is defined as a reference included angle, and the rotation angle of the accumulation element is one reference included angle when the first element and the second element relatively rotate 360°.

[0035] Further, the first element is sleeved outside the second element, and the driving rib is arranged on the inner side wall of the first element.

[0036] Further, the second element is provided with a clearance for the rotation of the accumulation element.

[0037] Further, the second element is sleeved outside the first element, and the driving rib is arranged on the outer side wall of the first element.

[0038] Further, an active cavity for the rotation of the accumulation element is formed between the first element and the second element.

[0039] The second object of the present application is to provide an injection device comprising the dose accumulation mechanism provided in the first object, which can meet the requirement of a user to accumulate record the total amount of dose setting, and the technical scheme is as follows:

[0040] An injection device comprising a clutch element and the dose accumulation mechanism described above, at least one of the first element and the second element can relatively rotate with the clutch element during dose setting; and the clutch element is rotationally connected to the first element and the second element in the direction of dose injection during dose injection.

[0041] The third object of the present application is to provide an integral worm, which is used to cooperate with a driving worm to meet the requirement of accumulating record the total amount of dose setting, and the technical scheme is as follows:

[0042] An integral worm, comprising:

[0043] A worm body capable of rotating around its own axis;

[0044] An engaging section on the outer periphery of the worm body and extending in the circumferential direction, the engaging section comprises a plurality of engaging grooves, the plurality of engaging grooves are arranged in the circumferential direction of the worm body, and the engaging grooves are used for engaging the driving rib of the driving worm.

[0045] Further, the integral worm further comprises a non-meshing section at the outer periphery of the worm body and extending in the circumferential direction, the non-meshing section forms a complete circumference with the meshing section, the non-meshing section has a first end and a second end opposite along the extending direction thereof, the first end and the second end are both provided with a stop portion, the stop portion of the first end is used for abutting one end of the driving rib to form a start position of the integral worm, and the stop portion of the second end is used for abutting the other end of the driving rib to form an end position of the integral worm.

[0046] By adopting the above technical scheme, during the dose setting, the driving worm is capable of driving the integral worm to rotate by matching the meshing groove in the meshing section with the driving rib of the driving worm, and the dose setting value of the injection device is accumulated by the rotation of the integral worm; when the end of the driving rib on the driving worm abuts against the stop portion, further rotation between the driving worm and the integral worm is prevented, specifically, one end of the driving rib abuts against the stop portion of the first end of the non-meshing section to form a start position, the other end of the driving rib abuts against the stop portion of the second end of the non-meshing section to form an end position, and under the cooperation of the driving worm, the integral worm is limited to rotate only between the start position and the end position; the total amount of rotation of the integral worm between the start position and the end position represents the total accumulation of the set dose of the injection device, thereby facilitating guaranteeing that the set dose accumulated by the integral worm is not greater than the total amount of the medicine contained in the cartridge.

[0047] Further, the meshing section and the non-meshing section are both provided with meshing teeth arranged in the circumferential direction, the meshing groove is formed between two adjacent meshing teeth in the meshing section, and a closing block is arranged between two adjacent meshing teeth in the non-meshing section, the closing blocks at the first end and the second end serve as the stop portions.

[0048] Further, the meshing section is provided with meshing teeth arranged in the circumferential direction, and the meshing groove is formed between two adjacent meshing teeth; the non-meshing section is provided with an arc-shaped blocking strip extending from the first end to the second end, and the part of the arc-shaped blocking strip at the first end and the second end serves as the stop portion.

[0049] Further, the non-meshing section comprises a vacancy section between the first end and the second end.

[0050] The fourth object of the present application is to provide a driving worm for cooperating with an integral worm to meet the requirement of accumulating and recording the total amount of dose setting, which adopts the following technical scheme:

[0051] A drive worm includes a rod body and a drive rib extending around a first axis on the rod body, the drive rib being configured to engage with engagement grooves on an indexing worm wheel.

[0052] Further, the drive rib has opposite first and second ends along its extension direction, the first and second ends defining an encircling angle with respect to the first axis being less than or equal to 360°.

[0053] Further, the drive rib includes a drive segment and an engagement segment at an end of the drive segment, a process of the engagement segment engaging into the engagement grooves from the drive segment engaging into the engagement grooves being defined as an engagement-in process, and a process of the drive segment disengaging from the engagement grooves from the engagement segment disengaging from the engagement grooves being defined as an engagement-out process, the indexing worm wheel being kept stationary during the engagement-in process and the engagement-out process.

[0054] Further, a central extension axis of the engagement segment is configured as an arc segment arranged around the first axis.

[0055] Further, the engagement segment has opposite first and second side walls with respect to the first axis, a direction of the engagement segment away from the drive segment being defined as an away direction, an axial distance between the first and second side walls being kept constant along the away direction.

[0056] Further, the engagement segment has opposite first and second side walls with respect to the first axis, a direction of the engagement segment away from the drive segment being defined as an away direction, an axial distance between the first and second side walls gradually decreasing along the away direction.

[0057] Further, the first and second ends of the drive rib are each provided with a transition chamfer.

[0058] It is a fifth object of the present application to provide a dose accumulation mechanism including the indexing worm wheel provided in the third object, capable of meeting the requirement of accumulating and recording the total amount of dose setting, which adopts the following technical solution:

[0059] A dose accumulation mechanism includes a drive worm and the indexing worm wheel in the above, the drive worm includes a rod body and a drive rib extending around a first axis on the rod body, the indexing worm wheel being rotatable around a second axis, the first axis and the second axis being arranged crosswise, the indexing worm wheel being provided with spaced engagement grooves along a circumferential direction of the second axis, the engagement grooves being configured to engage with the drive rib.

[0060] Further, the drive worm is rotatable around the first axis, the second axis being perpendicular to the first axis.

[0061] Further, the drive rib has opposite first and second ends along its extension direction, and an angle formed by the first and second ends around the first axis is less than 360°.

[0062] Further, the drive rib comprises a drive section and an engaging section at an end of the drive section, a process that the engaging section starts to engage into the engaging groove to the drive section starts to engage into the engaging groove is defined as an engaging process, and a process that the drive section completely disengages from the engaging groove to the engaging section completely disengages from the engaging groove is defined as a disengaging process, and the integral worm remains stationary during the engaging process and the disengaging process.

[0063] Further, a dose adjusted by one rotation of the drive worm around the first axis is defined as X, and a total sum of set doses that can be accumulated by the accumulated dose mechanism is defined as Y, wherein Y is configured as an integer multiple of X.

[0064] Further, the integral worm is arranged inside the drive worm, and the drive rib is arranged on an inner sidewall of the drive worm.

[0065] Further, the integral worm is arranged outside the drive worm, and the drive rib is arranged on an outer sidewall of the drive worm.

[0066] The sixth object of the present application is to provide an injection device which can meet the requirement of accumulating the total sum of set doses, and the following technical solution is adopted:

[0067] An injection device comprises:

[0068] a housing having a first axis;

[0069] a scale element rotatable relative to the housing around the first axis for dose setting;

[0070] a transmission element arranged in the scale element and rotatable around the first axis;

[0071] an accumulation element rotatable around a second axis intersecting the first axis, the accumulation element being provided with a second end stop and a plurality of engaging grooves arranged at intervals along a circumferential direction of the second axis;

[0072] a clutch element arranged between the scale element and the transmission element;

[0073] wherein one of the scale element and the transmission element is provided with a first end stop and a drive rib capable of engaging the engaging grooves, and the accumulation element is rotatably connected to the other one of the scale element and the transmission element;

[0074] During dose setting, one of the scale element and the transmission element is rotatable relative to the clutch element, the other is rotationally fixed to the clutch element; when the scale element and the transmission element rotate relative to each other, the drive rib drives the accumulation element to rotate, a termination position of the accumulation element is formed when the first termination portion abuts against the second termination portion, the scale element is prevented from rotating relative to the transmission element in the direction of dose upscaling when the accumulation element is in the termination position; during dose injection, the clutch element locks the scale element and the transmission element in the direction of rotation.

[0075] Further, a movement direction of the first termination portion during dose upscaling is defined as a termination approaching direction, a termination position of the accumulation element is formed when the second termination portion moves to block the first termination portion from continuously moving in the termination approaching direction.

[0076] Further, the first termination portion is configured as an end portion of the drive rib.

[0077] Further, the second termination portion is arranged on an outer periphery of the accumulation element for abutting against the end portion of the drive rib.

[0078] Further, a first starting portion is arranged on the element configured with the drive rib, and a second starting portion is arranged on the accumulation element, a movement direction of the first starting portion during dose downscaling is defined as a starting approaching direction, a starting position of the accumulation element is formed when the second starting portion moves to block the first starting portion from continuously moving in the starting approaching direction, the scale element is prevented from rotating relative to the transmission element in the direction of dose downscaling when the accumulation element is in the starting position.

[0079] Further, the drive rib is arranged on an outer side wall of the transmission element, and the accumulation element is rotatably connected to the scale element.

[0080] Further, the transmission element comprises a proximal element and a distal element distributed along an axial direction, the proximal element is arranged to extend into the scale element from a proximal end of the scale element, the distal element is arranged to extend into the scale element from a distal end of the scale element, and a distal end of the proximal element is fixedly connected to a proximal end of the distal element.

[0081] Further, the drive rib is arranged on an inner side wall of the scale element, and the accumulation element is rotatably connected to the transmission element.

[0082] Further, the drive rib extends around the first axis on the scale element, the drive rib has opposite first and second ends along its extension direction, and an encircling angle formed by the first and second ends based on the first axis is less than or equal to 360°.

[0083] Further, the driving rib comprises a driving section and an engaging section at the end of the driving section, the process that the engaging section starts to engage into the engaging groove to the driving section starts to engage into the engaging groove is defined as engaging process, the process that the driving section completely disengages from the engaging groove to the engaging section completely disengages from the engaging groove is defined as disengaging process, the cumulative element and the transmission element keep relatively static in the engaging process and the disengaging process.

[0084] Further, a connecting structure is arranged between the clutch element and the scale element, the connecting structure allows the scale element to rotate relative to the clutch element in the direction of dose increasing, and prevents the scale element from rotating relative to the clutch element in the direction of dose decreasing.

[0085] Further, the connecting structure comprises a ratchet tooth ring arranged inside the scale element and a ratchet arm arranged outside the clutch element, the ratchet tooth ring has ratchet tooth grooves arranged in circumferential direction, the ratchet arm comprises an arc-shaped elastic arm and a pawl at the free end of the arc-shaped elastic arm, the pawl is capable of being embedded into the ratchet tooth groove; the ratchet tooth groove has a first groove wall and a second groove wall opposite in circumferential direction, the pawl has a first side wall and a second side wall opposite in circumferential direction; when the scale element rotates relative to the clutch element in the direction of dose increasing, the first side wall abuts against the first groove wall and slides relative to the first groove wall as they continue to approach each other; when the scale element rotates relative to the clutch element in the direction of dose decreasing, the second side wall abuts against the second groove wall and prevents the second side wall from continuing to approach the second groove wall.

[0086] Further, the transmission element is provided with a first engaging part, the clutch element is provided with a second engaging part for engaging with the first engaging part, the clutch element is capable of moving axially from a first engaging position to a second engaging position relative to the transmission element, the first engaging part engages with the second engaging part when the clutch element is in the first engaging position, the first engaging part disengages from the second engaging part when the clutch element is in the second engaging position.

[0087] During dose increasing, the clutch element is in the first engaging position to prevent the clutch element from rotating relative to the transmission element in the direction of dose increasing.

[0088] During dose decreasing, the clutch element is capable of moving from the first engaging position to the second engaging position to allow the clutch element to rotate relative to the transmission element in the direction of dose decreasing.

[0089] During dose injection, the clutch element is prevented from moving from the first engaging position to the second engaging position to prevent the clutch element from rotating relative to the transmission element.

[0090] Further, the injection device further comprises a pushing element proximal to the clutch element and an elastic element between the pushing element and the elastic element;

[0091] The pushing element is axially movable relative to the scale element and has a first position and a second position relative to the scale element, the pushing element is in the first position during dose setting, the pushing element is moved from the first position to the second position by a pushing force during dose injection, the pushing element in the second position prevents the clutch element from moving from the first engagement position to the second engagement position;

[0092] The elastic element provides an elastic resistance for the clutch element to move from the first engagement position to the second engagement position, the elastic element provides an elastic resistance for the pushing element to move from the first position to the second position.

[0093] The seventh object of the present application is to provide a dose accumulation mechanism capable of accumulating the total amount of dose setting requirement, which adopts the following technical solution:

[0094] A dose accumulation mechanism comprises a worm gear provided on a torsion member and a helical track provided on a support member, the worm gear is engaged with the helical track; the torsion member is rotated during dose setting, the worm gear is rotated under the driving of the torsion member and the helical track; the total number of rotations of the worm gear is used to reflect the total number of rotations of the torsion member for all injection times.

[0095] Further, the worm gear is provided with a worm gear stop position, when the dose reaches the maximum dose during dose setting, the torsion member is in contact with the worm gear stop position to prevent dose setting.

[0096] Further, the torsion member rotates one circle, and the worm gear rotates one worm gear tooth.

[0097] Further, the torsion member is rotatably installed on the support member, during dose setting, the dose is set by rotating the torsion member in the forward direction, and the dose is corrected by rotating the torsion member in the reverse direction.

[0098] The eighth object of the present application is to provide an injection device comprising the dose accumulation mechanism provided in the eighth object, which is capable of accumulating the total amount of dose setting requirement, which adopts the following technical solution:

[0099] An injection device comprises a torsion member, a support member and the dose accumulation mechanism described above, the torsion member is rotatably installed on the support member, and the dose accumulation mechanism is provided between the torsion member and the support member.

[0100] Further, during dose setting, the dose is corrected by reverse adjustment of the dose by reverse rotation of the twist member to set the dose, and forward rotation of the twist member.

[0101] Further, the twist member comprises a pressure cap and a center column arranged on the pressure cap, the pressure cap being rotatably mounted on the support member.

[0102] Further, the injection device further comprises a pressing member, an elastic return member, an elastic force storage mechanism, a biasing device and a piston rod unit.

[0103] The support member is provided with an injection output end.

[0104] The twist member is provided with a first engagement part.

[0105] The elastic force storage mechanism is used to generate a bolus driving energy.

[0106] The piston rod unit is mounted in the support member and is provided with a second engagement part.

[0107] The biasing device is provided with a biasing engagement part; the biasing device is movable between a first working position and a second working position; when the biasing device is in the first working position, the biasing engagement part is separated from the second engagement part and is engaged with the first engagement part of the twist member to enable the elastic force storage mechanism to be rotated by the biasing device acting on the elastic force storage mechanism when the twist member is rotated; when the biasing device is in the second working position, the biasing engagement part is separated from the first engagement part and is engaged with the second engagement part of the piston rod unit to enable the bolus driving energy of the elastic force storage mechanism to be transmitted to the piston rod unit.

[0108] The pressing member is used to apply a pushing force to the biasing device to move the biasing device to the second working position when the pressing member is moved in a direction close to the injection output end.

[0109] The elastic return member is used to provide an elastic force to facilitate return of the biasing device to the first working position.

[0110] Further, the pressing member is provided with a pushing arm, and the twist member is provided with an insertion slot, the pushing arm being movably inserted into the insertion slot.

[0111] Further, an extension trajectory of the insertion slot is in the shape of a circular arc, and an extension trajectory of the pushing arm matches the insertion slot.

[0112] In summary, the present application at least has the following beneficial technical effects: in a complete injection process, the accumulation element or the integral worm gear can record the dose setting amount by the rotation of its circumference, accordingly, as the user performs the injection step by step, the accumulation element or the integral worm gear can convert the total dose setting amount into the circumferential movement of the accumulation element or the integral worm gear, i.e. to achieve the purpose of recording the total dose setting amount. Moreover, compared with the integral nut moving axially, the accumulation element or the integral worm gear of the present application can reduce the axial space occupied in the injection device. BRIEF DESCRIPTION OF DRAWINGS

[0113] Fig. 1 is a schematic view of an injection device with a dose accumulation mechanism according to some embodiments of the present application;

[0114] Fig. 2 is a schematic view of an injection device with a dose accumulation mechanism according to some embodiments of the present application;

[0115] Fig. 3 is a schematic view of a second element and an accumulation element according to some embodiments of the present application;

[0116] Fig. 4 is a schematic view of a first element and an accumulation element according to some embodiments of the present application;

[0117] Fig. 5 is a schematic view of a second element and an accumulation element according to some embodiments of the present application;

[0118] Fig. 6 is a schematic view of a first element, a second element and a clutch element according to some embodiments of the present application;

[0119] Fig. 7 is an exploded view of a first element, a second element and a clutch element according to some embodiments of the present application;

[0120] Fig. 8 is a schematic view of an axial tooth ring on a second element according to some embodiments of the present application;

[0121] Fig. 9 is a schematic view of a second element and an accumulation element forming a starting position according to some embodiments of the present application;

[0122] Fig. 10 is a schematic view of a second element and an accumulation element forming an ending position according to some embodiments of the present application;

[0123] Fig. 11 is a schematic view of a first element and an accumulation element forming a starting position according to some embodiments of the present application;

[0124] Fig. 12 is a schematic view of a first element and an accumulation element forming an ending position according to some embodiments of the present application;

[0125] Fig. 13 is a schematic view of a first element and an accumulation element forming a starting position according to some embodiments of the present application;

[0126] Fig. 14 is a schematic view for showing that the engagement teeth are arranged on the circumference of the accumulation element in some embodiments of the present application;

[0127] Fig. 15 is a schematic view for showing that the accumulation element comprises a stop arc segment and an engagement arc segment in some embodiments of the present application;

[0128] Fig. 16 is a schematic view for showing that the first element forms a stop position with the accumulation element by hiding part of the side wall of the first element in some embodiments of the present application;

[0129] Fig. 17 is a schematic view for showing the driving rib by hiding part of the side wall of the first element in some embodiments of the present application;

[0130] Fig. 18 is a schematic view for showing the reference angle on the accumulation element in some embodiments of the present application;

[0131] Fig. 19 is a schematic view for showing the engagement teeth on the clutch element in some embodiments of the present application.

[0132] Reference signs of the accompanying drawings 1 to 19: 110, first element; 111, driving rib; 111a, driving segment; 111b, engagement segment; 112, ratchet tooth ring; 113, initial abutting portion; 114, stop abutting portion; 115, first start portion; 116, first stop portion; 120, second element; 121, radial through slot; 122, axial tooth ring; 123, stop bar; 123a, first stop surface; 123b, second stop surface; 124, support seat; 130, accumulation element; 131, engagement tooth; 132, engagement groove; 133, rotation shaft; 134, protrusion; 134a, first abutting surface; 134b, second abutting surface; 135, stop bar; 136, second start portion; 137, second stop portion; 138, engagement arc segment; 139, stop arc segment; 140, clutch element; 141, ratchet arm; 142, engagement tooth; 142a, right angle surface; 142b, inclined surface; 150, driving rod; 160, push rod; 170, housing; 180, cartridge; 181, movable piston; 190, button; 100, spring.

[0133] Fig. 20 is a schematic view of an injection device with a dose accumulation mechanism in some embodiments of the present application;

[0134] Fig. 21 is a schematic view of an injection device with a dose accumulation mechanism in some embodiments of the present application;

[0135] Fig. 22 is a schematic view for showing that the driving rib and the stop portion form a start position in some embodiments of the present application;

[0136] Fig. 23 is a schematic view for showing that the driving rib and the stop portion form a stop position in some embodiments of the present application;

[0137] Fig. 24 is a schematic diagram for showing the integral worm in some embodiments of the present application;

[0138] Fig. 25 is a schematic diagram for showing the integral worm in some embodiments of the present application;

[0139] Fig. 26 is a schematic diagram for showing the integral worm in some embodiments of the present application;

[0140] Fig. 27 is a schematic diagram for showing the integral worm in some embodiments of the present application;

[0141] Fig. 28 is a schematic diagram for showing the integral worm in some embodiments of the present application;

[0142] Fig. 29 is a schematic diagram for showing the cooperation between the integral worm and the cooperating component in some embodiments of the present application;

[0143] Fig. 30 is a schematic diagram for showing the cooperation between the integral worm and the driving worm in some embodiments of the present application;

[0144] Fig. 31 is a schematic diagram for showing the cooperation between the integral worm and the cooperating component in some embodiments of the present application;

[0145] Fig. 32 is a schematic diagram for showing the hidden part of the side wall of the rod body to show the driving rib in some embodiments of the present application;

[0146] Fig. 33 is a schematic diagram for showing the driving rib in some embodiments of the present application;

[0147] Fig. 34 is a schematic diagram for showing the driving rib in some embodiments of the present application;

[0148] Fig. 35 is a schematic diagram for showing the reference included angle of the integral worm in some embodiments of the present application;

[0149] Fig. 36 is a schematic diagram for showing the dose accumulation mechanism and the clutch element in some embodiments of the present application;

[0150] Fig. 37 is a schematic diagram for showing the axial tooth ring on the cooperating component in some embodiments of the present application;

[0151] Fig. 38 is a schematic diagram for showing the dose accumulation mechanism and the clutch element in some embodiments of the present application;

[0152] Fig. 39 is a schematic diagram for showing the cooperating tooth on the clutch element in some embodiments of the present application.

[0153] Reference signs of the drawings 20 to 39: 210, drive worm; 211, drive rib; 211a, drive section; 211b, meshing section; 211c, first side wall; 211d, second side wall; 211e, transition chamfer; 212, rod body; 213, ratchet tooth ring; 220, fitting component; 221, radial through slot; 222, support seat; 223, axial tooth ring; 230, integral worm; 231, meshing tooth; 232, meshing groove; 233, rotation shaft; 234, worm body; 235, closing block; 236, arc-shaped stop bar; 237, stop block; 238, vacant section; 239, stop portion; 240, clutch element; 241, ratchet arm; 242, fitting tooth; 242a, right-angle face; 242b, inclined face; 250, drive rod; 260, push rod; 270, housing; 280, cartridge; 281, movable piston; 290, button; 200, spring.

[0154] Figure 40 is a schematic diagram of an injection device in some embodiments of the application;

[0155] Figure 41 is a schematic diagram of an injection device in some embodiments of the application;

[0156] Figure 42 is a schematic diagram of a hidden part of the side wall of the scale element to show the end position of the cumulative element in some embodiments of the application;

[0157] Figure 43 is a cross-sectional view of the scale element, the transmission element and the display clutch mechanism in some embodiments of the application;

[0158] Figure 44 is an exploded schematic diagram of the scale element, the transmission element and the display clutch mechanism in some embodiments of the application;

[0159] Figure 45 is a schematic diagram of the cumulative element in some embodiments of the application;

[0160] Figure 46 is a schematic diagram of the cumulative element in some embodiments of the application;

[0161] Figure 47 is a schematic diagram of a hidden part of the side wall of the scale element to show the start position of the cumulative element in some embodiments of the application;

[0162] Figure 48 is a schematic diagram of the cumulative element and the transmission element in some embodiments of the application;

[0163] Figure 49 is a schematic diagram of a hidden part of the side wall of the scale element to show the drive rib in some embodiments of the application;

[0164] Figure 50 is a schematic diagram of the reference included angle of the cumulative element in some embodiments of the application;

[0165] Figure 51 is a schematic diagram of the cumulative element and the transmission element in some embodiments of the application;

[0166] Figure 52 is a schematic diagram illustrating the accumulation element and the scale element in some embodiments of this application;

[0167] Figure 53 is a schematic diagram illustrating the clutch element in some embodiments of this application;

[0168] Figure 54 is a schematic diagram (2) illustrating the clutch element in some embodiments of this application;

[0169] Figure 55 is a schematic diagram illustrating a transmission element in some embodiments of this application.

[0170] Explanation of reference numerals in Figures 40 to 55: 310, housing; 320, dose accumulation mechanism; 321, scale element; 321a, support base; 321b, ratchet ring; 322, transmission element; 322a, proximal element; 322b, distal element; 322c, first engagement portion; 322d, radial through groove; 323, accumulation element; 323a, engagement tooth; 323b, engagement groove; 323c, second starting portion; 323d, second ending portion; 324, drive rib; 324a, drive section; 324b, engagement section; 324 c. First starting part; 324d. First ending part; 325. Stop arc segment; 330. Clutch mechanism; 331. Clutch element; 331a. Ratchet arm; 331b. Arc-shaped spring arm; 331c. Pawl; 331d. First side wall; 331e. Second side wall; 331f. Second engagement part; 331g. Right angle surface; 331h. Inclined surface; 332. Pushing element; 333. Elastic element; 340. Transmission mechanism; 341. Drive rod; 342. Push rod; 350. Cartridge bottle; 351. Movable piston; 360. Needle assembly.

[0171] Figure 56 is a cross-sectional view of the injection component in an embodiment of this application;

[0172] Figure 57 is an enlarged view of the upper part of Figure 56;

[0173] Figure 58 is a cross-sectional view of the injection component in another direction in some embodiments of this application;

[0174] Figure 59 is an exploded view of the injection component in some embodiments of this application;

[0175] Figure 60 is an exploded view of the elastic energy storage mechanism in some embodiments of this application;

[0176] Figure 61 is a schematic diagram of the meshing and engagement of the positioning element and the sound-generating element in some embodiments of this application;

[0177] Figure 62 is an enlarged view of the engagement between the positioning element and the sound-generating element in some embodiments of this application;

[0178] Figure 63 is a schematic view of the disengaged state of the positioning member and the sound production member in some embodiments of the application;

[0179] Figure 64 is a magnified view of the disengaged state of the positioning member and the sound production member in some embodiments of the application;

[0180] Figure 65 is a schematic view of the cooperation between the scale ring and the support member in some embodiments of the application;

[0181] Figure 66 is a schematic view of the torsion member in some embodiments of the application;

[0182] Figure 67 is a schematic view of the torsion member in another direction in some embodiments of the application;

[0183] Figure 68 is a schematic view of the positioning member in some embodiments of the application;

[0184] Figure 69 is a schematic view of the biasing member in some embodiments of the application;

[0185] Figure 70 is a schematic view of the sound production member in some embodiments of the application;

[0186] Figure 71 is a cross-sectional view of the biasing member in some embodiments of the application;

[0187] Figure 72 is a cross-sectional view of the pressing member in some embodiments of the application;

[0188] Figure 73 is a schematic view of the linkage member in some embodiments of the application.

[0189] Reference signs of Figs. 56-73: pressing piece 411; pushing arm 411a; worm wheel 412; torsion piece 413; first engaging part 413a; plug-in slot 413b; pressure cap 413c; center column 413d; gasket 414; positioning piece 415; one-way tooth 415a; third engaging part 415b; positioning collar 415c; outer convex ring 415d; linkage 421; second engaging part 421a; elastic arm 421b; matching sound-producing tooth 421c; piston rod 422; guide seat 423; piston 424; fixed seat 431; biasing device 432; biasing stop 432a; biasing action surface 432b; biasing engaging part 432c; flange part 432d; biasing guide slope 432e; first biasing convex part 432f; second biasing convex part 432g; sound-producing piece 433; slope tooth 433a; sound-producing piece stop 433b; sound-producing piece action surface 433c; sound-producing piece guide slope 433d; first sound-producing piece groove 433e; second sound-producing piece groove 433f; sound-producing piece convex 433g; elastic reset piece 434; rotating piece 435; torsional elastic element 436; scale ring 437; torsion spring seat 438; support member 440; support slot 441; limiting wall 442; termination stop 443; spiral track 444; injection output end 445; medicine bottle 450; medicine storage unit 460; injection needle 470. DETAILED DESCRIPTION

[0190] Embodiments of the present application are described below in detail, examples of which are shown in the drawings, wherein the same or similar notations represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary only, and are for the purpose of explanation of the present application, and cannot be understood as a limitation of the present application.

[0191] In the description of the present application, it is to be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation of the present application. In addition, the features defined as "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, unless otherwise stated, the meaning of "a plurality of" is two or more.

[0192] In the description of the application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting" should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integrally connected; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0193] When injecting a drug, a specific injection device is used, which is usually referred to as a pen-type injector or injection pen, which can be set by the user based on the demand and injected the set dose; at the same time, the process of setting the dose and injecting the set dose is regarded as a complete injection. Accordingly, the injection device is usually provided with a dose accumulation mechanism, which accumulates the total of the doses set by the user one by one and limits the accumulated dose to be no more than the total amount of the drug contained in the cartridge, so as to ensure that the dose set by the user each time does not exceed the remaining dose of the drug in the cartridge, thereby ensuring that the dose of each injection can be consistent with the set dose.

[0194] In the related art, the dose accumulation mechanism for the injection device usually includes a scale element, a transmission element and an integral nut, wherein the scale element and the transmission element can rotate relative to each other during dose setting, and the scale element and the transmission element are rotationally connected to make them rotate synchronously during dose injection. The integral nut is sleeved on the transmission element and is threadedly connected with the transmission element, and the integral nut is rotationally connected with the scale element and can axially move relative to the scale element.

[0195] For the above related technology, during dose setting, the scale element drives the integral nut to rotate relative to the transmission element, so that the integral nut is axially displaced on the transmission element, and the displacement of the integral nut is associated with the set dose; and during dose injection, the scale element, the transmission element and the integral nut are kept relatively stationary. Therefore, the axial displacement of the integral nut can be used to accumulate the total of the set dose, but this also requires the integral nut to occupy a large axial space in the injection device to meet the requirement of axial movement.

[0196] Based on the principle of worm gear transmission, the present application conceives a dose accumulation mechanism for accumulating the set dose, which accumulates the total of the set dose through the rotation of the worm gear, and can reduce the occupation of axial space in the injection device.

[0197] (First aspect)

[0198] In combination with FIGS. 1 to 19, the following embodiments of the present application disclose a dose accumulation mechanism and an injection device adopting the dose accumulation mechanism.

[0199] The embodiment of the present application discloses a dose accumulation mechanism.

[0200] The dose accumulation mechanism can accumulate the sum of the doses set by the user successively through the circumferential movement of the accumulation element, thereby reducing the occupation of the axial space in the injection device.

[0201] Referring to FIG. 1 and FIG. 2, the dose accumulation mechanism comprises a first element 110, a second element 120 and an accumulation element 130, and is installed in a housing 170 of an injection device, the central axis of the housing 170 is defined as a first axis.

[0202] The first element 110 can rotate around the first axis, and the first element 110 is provided with a driving rib 111 extending around the first axis on the first element 110; the second element 120 is sleeved with the first element 110, and the second element 120 can rotate around the first axis; the accumulation element 130 is connected to the second element 120, and the accumulation element 130 can rotate around a second axis relative to the second element 120, the second axis being the central axis of the accumulation element 130, and the second axis is arranged transversely to the first axis; meanwhile, the accumulation element 130 is provided with a plurality of meshing teeth 131, the plurality of meshing teeth 131 are arranged in the circumferential direction of the second axis at intervals, so that the meshing grooves 132 for the meshing of the driving rib 111 are formed between the adjacent two meshing teeth 131.

[0203] Specifically, during the dose setting, the first element 110 and the second element 120 can rotate relative to each other, and the dose setting includes the dose up and the dose down; accordingly, the first element 110 rotates relative to the second element 120 in the first direction for the dose up, and the first element 110 rotates relative to the second element 120 in the second direction for the dose down, the first direction being opposite to the second direction. Meanwhile, during the entire dose setting, the driving rib 111 is used to cooperate with the meshing teeth 131 to drive the accumulation element 130 to rotate. During the dose injection, the first element 110 and the second element 120 are rotationally connected to make the first element 110 and the second element 120 rotate synchronously or be stationary synchronously, and during this period, the accumulation element 130 is stationary relative to the first element 110 and the second element 120 without rotating around the second axis.

[0204] According to the above scheme, during dose setting, the first element 110 rotates relative to the second element 120 to cause the cumulative element 130 to rotate along the second axis, and the rotation angle of the cumulative element 130 corresponds to the dose setting amount, while during dose injection, the first element 110, the second element 120 and the cumulative element 130 all remain relatively static; thus, in one complete injection process, the cumulative element 130 can record the dose setting amount through its own circumferential rotation movement, and accordingly, as the user performs sequential injection, the cumulative element 130 can gradually convert the total dose setting amount into the circumferential movement amount of the cumulative element 130, i.e. achieve the purpose of cumulative recording of the total dose setting amount. Moreover, compared with the axial movement of the integral nut, the cumulative element 130 using the present scheme can reduce the axial space occupation in the injection device.

[0205] Further, in some embodiments, the cumulative element 130 has a starting position and an ending position of movement, the movement stroke of the cumulative element 130 between the starting position and the ending position corresponds to the total amount of drug that can be injected by the injection device, and the cumulative element 130 is in the ending position to limit the further rotation of the first element 110 relative to the second element 120 in the first direction, i.e. to limit further increasing of the dose. When the cumulative element 130 moves to the ending position, the first element 110 and the second element 120 cannot further rotate in the direction of dose increasing, thereby limiting further increasing of the set dose, and further limiting the maximum dose that can be set by accumulation. At the same time, the movement amount of the cumulative element 130 between the starting position and the ending position corresponds to the total amount of drug that can be injected by the injection device, and as the cumulative element 130 gradually moves from the starting position to the ending position, the remaining movement amount between the cumulative element 130 and the ending position always corresponds to the remaining drug dose that can be injected by the injection device; thus, it can be ensured that each set dose does not exceed the remaining drug dose that can be injected by the injection device, so that the actual injection dose corresponds to the set dose, avoiding the situation of injecting an incorrect dose, and further ensuring that the drug injection obtains its corresponding use effect.

[0206] It should be noted that the movement stroke of the accumulation element 130 between the starting position and the ending position corresponds to the total amount of the medicine that can be injected by the injection device, indicating that the movement stroke of the accumulation element 130 has a corresponding relationship with the total amount of the medicine in the injection device; for the convenience of description, the movement stroke of the accumulation element 130 is defined as U, and the ratio of the set dose to the movement amount of the accumulation element 130 is defined as T, that is, the total sum of the set dose corresponding to the entire movement stroke of the accumulation element 130 is UT, and the total amount of the medicine in the injection device is defined as S. In some specific embodiments, UT=S, indicating that the total sum of the set dose corresponding to the entire movement stroke of the accumulation element 130 is equal to the total amount of the medicine in the injection device, so that the medicine in the injection device can be completely injected at the last injection; in other specific embodiments, UT

[0207] It should also be noted that the intersection arrangement of the first axis and the second axis indicates that the first axis and the second axis are not parallel, that is, the first axis and the second axis are not in the same plane; specifically, if the plane where the first axis is located is defined as the first plane, the second axis will intersect the first plane at a point. In specific embodiments, the first axis is configured to be perpendicular to the second axis, so that the transmission of the driving force between the first element 110 and the accumulation element 130 has better transmission efficiency.

[0208] It can be understood that the sleeving of the second element 120 and the first element 110 can be that the first element 110 is sleeved outside the second element 120, or that the second element 120 is sleeved outside the first element 110.

[0209] Referring to FIG. 1 and FIG. 3, in some embodiments, the first element 110 is sleeved outside the second element 120. In which, the first element 110 is substantially cylindrical, and the driving ribs 111 are configured on the inner wall of the first element 110; the second element 120 is substantially cylindrical, and the second element 120 is at least partially accommodated in the first element 110, and the accumulation element 130 is completely accommodated in the first element 110 and is substantially worm gear-shaped, and the accumulation element 130 is rotatably connected with the second element 120 through the rotating shaft 133. Accordingly, the second element 120 is provided with a relief area for the accumulation element 130 to rotate freely. In some specific embodiments, the second element 120 is provided with a radial through slot 121 in the direction perpendicular to the first axis and the second axis, the accumulation element 130 is installed in the radial through slot 121, and the radial through slot 121 serves as the relief area for the accumulation element 130 to rotate freely on the second element 120; and the area of the accumulation element 130 installed in the radial through slot 121, which is provided with the meshing groove 132, can protrude from one slot opening of the radial through slot 121 and mesh with the driving ribs 111 on the inner wall of the first element 110.

[0210] In the above embodiments, the first element 110 rotates around the first axis during dose setting while the second element 120 remains stationary, and the first element 110 and the second element 120 rotate synchronously during dose injection. It can be understood that, if the first element 110 is defined to rotate clockwise relative to the housing 170 when increasing the dose and to rotate counterclockwise relative to the housing 170 when decreasing the dose, then the first element 110 rotates in the first direction relative to the second element 120 corresponds to the second element 120 stationary while the first element 110 rotates clockwise, and the first element 110 rotates in the second direction relative to the second element 120 corresponds to the second element 120 stationary while the first element 110 rotates counterclockwise; and the first direction is clockwise direction, and the second direction is counterclockwise direction.

[0211] Referring to FIG. 2, FIG. 4 and FIG. 5, in some embodiments, the second element 120 is sleeved outside the first element 110. In some embodiments, the second element 120 is substantially cylindrical, the accumulation element 130 is completely accommodated in the second element 120 and is substantially worm gear-shaped, and the inside of the second element 120 is provided with a support seat 124, and the accumulation element 130 is rotatably installed on the support seat 124 of the second element 120; the first element 110 is at least partially accommodated in the second element 120, and the driving rib 111 is arranged on the outside wall of the first element 110. Accordingly, the first element 110 and the second element 120 form a movable cavity for the free rotation of the accumulation element 130; in some specific embodiments, the inside wall of the second element 120 and the outside wall of the first element 110 provided with the driving rib 111 have a spacing, so that the first element 110 and the second element 120 form an annular cavity as a movable cavity for the free rotation of the accumulation element 130.

[0212] In the above embodiments, the second element 120 rotates around the first axis during dose setting while the first element 110 remains stationary, and the second element 120 and the first element 110 rotate synchronously during dose injection. If it is defined that the second element 120 rotates clockwise relative to the housing 170 when the dose is increased and rotates counterclockwise relative to the housing 170 when the dose is decreased; it can be understood that the rotation of the first element 110 relative to the second element 120 in the first direction corresponds to the rotation of the second element 120 clockwise while the first element 110 remains stationary, and the rotation of the first element 110 relative to the second element 120 in the second direction corresponds to the rotation of the second element 120 counterclockwise while the first element 110 remains stationary, and the first direction is counterclockwise and the second direction is clockwise.

[0213] Referring to FIG. 1 and FIG. 6, it should be noted that when the dose accumulation mechanism is arranged in the injection device, the first element 110 and the second element 120 are selectively connected in the rotation direction by the clutch element 140, so that the first element 110 and the second element 120 can rotate relative to each other during dose setting and can rotate synchronously during dose injection. In some embodiments, at least one of the first element 110 and the second element 120 can rotate relative to the clutch element 140 during dose setting, so that the first element 110 and the second element 120 can rotate relative to each other; during dose injection, the first element 110 and the second element 120 are rotationally connected with the clutch element 140, so that the first element 110 and the second element 120 can rotate synchronously or remain stationary synchronously.

[0214] Referring to Figures 6 and 7, in some specific embodiments, the first element 110 is sleeved outside the second element 120, and the proximal end of the second element 120 is accommodated within the proximal end of the first element 110. Simultaneously, the clutch element 140 is located at the proximal end of the first element 110 and presses against the proximal end of the second element 120. Furthermore, when the dosage is increased, the first element 110 rotates along a third direction; when the dosage is decreased, the first element 110 rotates along a fourth direction opposite to the third direction; during injection, both the first element 110 and the second element 120 rotate along the fourth direction. Specifically, the third direction is clockwise, and the fourth direction is counterclockwise.

[0215] Accordingly, referring to FIG6, the inner wall of the proximal end of the first element 110 is provided with a ratchet ring 112, and the clutch element 140 is provided with a ratchet arm 141 that cooperates with the ratchet ring 112. The ratchet ring 112 and the ratchet arm 141 cooperate to form a first connection. The first connection allows the first element 110 to rotate relative to the clutch element 140 in a third direction, while preventing the first element 110 from rotating relative to the clutch element 140 in a fourth direction.

[0216] Referring to Figures 7 and 8, the proximal end of the second element 120 is provided with an axially protruding axial toothed ring 122, and the clutch element 140 is provided with mating teeth 142 that mesh with the axial toothed ring 122. The axial toothed ring 122 and the mating teeth 142 cooperate to form a second connection. The second connection prevents the clutch element 140 from rotating relative to the second element 120 in a third direction, while allowing relative axial movement between the clutch element 140 and the second element 120 to allow the clutch element 140 to rotate relative to the second element 120 in a fourth direction. At the same time, during the dose injection, the clutch element 140 is subjected to axial force and pressed against the proximal end of the second element 120. At this time, the clutch element 140 and the second element 120 cannot move axially, so that the clutch element 140 and the second element 120 are relatively stationary.

[0217] In summary, when the first element 110 rotates in the third direction to increase the dose, the clutch element 140 and the second element 120 remain stationary. At this time, the first element 110 rotates relative to the second element 120 and the clutch element 140. When the first element 110 rotates in the fourth direction to decrease the dose, the first element 110 drives the clutch element 140 to rotate in the fourth direction, while the second element 120 remains stationary. At this time, the first element 110 and the clutch element 140 rotate relative to the second element 120. During the dose injection, the first element 110, the clutch element 140, and the second element 120 rotate synchronously in the fourth direction.

[0218] It can be understood that the accumulation element 130 can move relative to the first element 110 and also relative to the second element 120. Accordingly, the start position of the accumulation element 130 can be formed by the accumulation element 130 and the first element 110, and also by the accumulation element 130 and the second element 120, and the end position of the accumulation element 130 can be formed by the accumulation element 130 and the first element 110, and also by the accumulation element 130 and the second element 120.

[0219] In some embodiments, the start position and / or the end position of the accumulation element 130 is formed by the abutting structure between the accumulation element 130 and the second element 120.

[0220] Referring to FIG. 9, in some embodiments in which the accumulation element 130 and the second element 120 cooperate to form the start position, the accumulation element 130 has two side walls arranged opposite along the second axis, and a protrusion 134 is arranged on one of the side walls of the accumulation element 130, the protrusion 134 being capable of rotating with the accumulation element 130 and having a first abutting surface 134a. Correspondingly, the second element 120 is provided with a stopper 123 having a first stop surface 123a. When the first abutting surface 134a of the protrusion 134 abuts against the first stop surface 123a of the stopper 123, the accumulation element 130 is stationary relative to the second element 120 to form the start position of the accumulation element 130. Here, the stopper 123 is arranged on the second element 120 as a first stop portion, and the protrusion 134 is arranged on the accumulation element 130 as a second stop portion.

[0221] Referring to FIG. 10, in some embodiments in which the accumulation element 130 and the second element 120 cooperate to form the end position, the accumulation element 130 has two side walls arranged opposite along the second axis, and a protrusion 134 is arranged on one of the side walls of the accumulation element 130, the protrusion 134 being capable of rotating with the accumulation element 130 and having a second abutting surface 134b. Correspondingly, the second element 120 is provided with a stopper 123 having a second stop surface 123b. When the second abutting surface 134b of the protrusion 134 abuts against the second stop surface 123b of the stopper 123, the accumulation element 130 is stationary relative to the second element 120 to form the end position of the accumulation element 130.

[0222] Referring to FIG. 9 and FIG. 10, in some embodiments in which the accumulation element 130 cooperates with the second element 120 to form the start position and the end position, the accumulation element 130 has two side walls arranged opposite along the second axis, and a protrusion 134 is arranged on one of the side walls of the accumulation element 130, the protrusion 134 can rotate with the accumulation element 130, and the protrusion 134 has opposite first and second abutting surfaces 134a and 134b along the movement direction thereof; correspondingly, the second element 120 is provided with a blocking strip 123 having opposite first and second stop surfaces 123a and 123b. When the first abutting surface 134a of the protrusion 134 abuts against the first stop surface 123a of the blocking strip 123, the start position of the accumulation element 130 is formed, and when the second abutting surface 134b of the protrusion 134 abuts against the second stop surface 123b of the blocking strip 123, the end position of the accumulation element 130 is formed. In this case, the blocking strip 123 is arranged on the second element 120 as the first stop portion, and the protrusion 134 is arranged on the accumulation element 130 as the second stop portion.

[0223] In other embodiments, the accumulation element 130 cooperates with the first element 110 to form the start position and / or the end position by means of abutting structures. Specifically, the first element 110 is provided with a first stop portion which moves with the first element 110 around the first axis, and the accumulation element 130 is provided with a second stop portion which moves with the accumulation element 130 around the second axis; when the first stop portion abuts against the second stop portion, the start position is formed, or when the first stop portion abuts against the second stop portion, the end position is formed.

[0224] In some embodiments in which the accumulation element 130 cooperates with the first element 110 to form the start position, the second stop portion is blocked by the first stop portion from continuing to move with the accumulation element 130 around the second axis to form the start position; referring to FIG. 11, in a specific embodiment, the first stop portion includes an initial contact portion 113 arranged on the side wall of the first element 110, which can be configured as an arc-shaped protrusion, a protrusion ring surrounding the first element 110, or a part of the side wall of the first element 110, and the second stop portion includes a stop strip 135 protruding radially from the accumulation element 130; when the stop strip 135 moves with the accumulation element 130 to abut against the initial contact portion 113, the accumulation element 130 is prevented from further rotating, thereby forming the start position of the accumulation element 130.

[0225] In some embodiments, the first stop portion and the second stop portion cooperate to define a termination position of the accumulation element 130. In some embodiments, the first stop portion comprises a termination abutment 114 disposed on the sidewall of the first element 110. In some embodiments, the termination abutment 114 is configured as an arc-shaped protrusion, a protruding ring around the first element 110, or a portion of the sidewall of the first element 110. In some embodiments, the second stop portion comprises a stop bar 135 protruding radially from the accumulation element 130. In some embodiments, the stop bar 135 is configured to block the accumulation element 130 from further rotation when the stop bar 135 is abutted by the termination abutment 114, thereby defining the termination position of the accumulation element 130.

[0226] In some embodiments, the first stop portion and the second stop portion cooperate to define a start position of the accumulation element 130. In some embodiments, the first stop portion comprises a first start portion 115, and the second stop portion comprises a second start portion 136. In some embodiments, the first start portion 115 is configured to move in a start approaching direction during the dose reduction. In some embodiments, the second start portion 136 is configured to block the first start portion 115 from further movement in the start approaching direction when the second start portion 136 is abutted by the first start portion 115, thereby defining the start position of the accumulation element 130.

[0227] In some embodiments, the dose setting action is embodied as the relative rotation between the first element 110 and the second element 120. In some embodiments, the relative rotation between the first element 110 and the second element 120 is converted into the rotation of the accumulation element 130 via the cooperation between the driving rib 111 on the first element 110 and the engagement groove 132 on the accumulation element 130. In some embodiments, the cooperation between the driving rib 111 on the first element 110 and the engagement groove 132 on the accumulation element 130 is similar to the cooperation between a worm screw and a worm wheel. In some embodiments, the movement transmission between the first element 110 and the accumulation element 130 is deceleration movement. In some embodiments, the dose represented by one unit angle of the movement of the first stop portion is smaller than the dose represented by one unit angle of the movement of the second stop portion. In some embodiments, the size error is inevitable in the actual manufacturing process. In some embodiments, compared to limiting the movement of the second stop portion to define the start position, limiting the movement of the first stop portion to define the start position can reduce the adverse effect of the size error on the control accuracy of the total stroke of the accumulation element 130, i.e., the stroke of the accumulation element 130 between the start position and the termination position has higher accuracy.

[0228] In some embodiments, the first start portion 115 is configured as an end portion of the driving rib 111.

[0229] Specifically, referring to FIG. 14, in some embodiments, the engagement teeth 131 are arranged on the entire circumference of the accumulation element 130, i.e., the engagement teeth 131 are arranged in a full circle on the main body of the accumulation element 130; correspondingly, the second starting portion 136 is arranged between two adjacent engagement teeth 131. Referring to FIG. 15, in other embodiments, the outer circumference of the accumulation element 130 includes an engagement arc segment 138 provided with the engagement teeth 131 and a stop arc segment 139 not provided with the engagement teeth 131; correspondingly, the side wall of the stop arc segment 139 serves as the second starting portion 136.

[0230] In other embodiments in which the accumulation element 130 cooperates with the first element 110 to form the starting position, the first stop portion is blocked by the second stop portion to continue to move with the first element 110 around the first axis to form the ending position; referring to FIG. 16, in a specific embodiment, the first stop portion includes a first ending portion 16, and the second stop portion includes a second ending portion 137; the movement direction of the first ending portion 16 when the dose is increased is defined as the ending approach direction, and the ending position of the accumulation element 130 is formed when the second ending portion 137 moves to block the first ending portion 16 from continuing to move in the ending approach direction.

[0231] In actual use, the dose setting action is embodied as the relative rotation amount between the first element 110 and the second element 120, and the relative rotation amount between the first element 110 and the second element 120 is converted into the rotation amount of the accumulation element 130 via the cooperation between the driving rib 111 on the first element 110 and the engagement groove 132 on the accumulation element 130, which is similar to the cooperation between the worm thread and the worm gear tooth groove, and the motion transmission between the first element 110 and the accumulation element 130 is deceleration motion. Thus, the dose represented by one unit angle of movement of the first stop portion is smaller than the dose represented by one unit angle of movement of the second stop portion, and in the above scheme, compared with limiting the movement of the second stop portion to define the ending position, limiting the movement of the first stop portion to define the ending position can reduce the adverse effect of the dimensional error on the control accuracy of the total stroke of the accumulation element 130, i.e., the stroke of the accumulation element 130 between the starting position and the ending position has higher accuracy.

[0232] Specifically, in some embodiments, the first ending portion 16 is configured as the end portion of the driving rib 111.

[0233] Specifically, referring to FIG. 14, in some embodiments, the engagement teeth 131 are arranged on the entire circumference of the accumulation element 130, i.e., the engagement teeth 131 are arranged in a full circle on the main body of the accumulation element 130; correspondingly, the second termination portion 137 is arranged between two adjacent engagement teeth 131. Referring to FIG. 15, in other embodiments, the outer circumference of the accumulation element 130 includes an engagement arc segment 138 provided with the engagement teeth 131 and a stop arc segment 139 not provided with the engagement teeth 131; correspondingly, the side wall of the stop arc segment 139 serves as the second termination portion 137.

[0234] It should be noted that the extension of the driving rib 111 around the first axis on the first element 110 means that the driving rib 111 is arranged on the first element 110 and extends around the first axis as the helical axis in the axial direction; correspondingly, for the convenience of description, the two ends of the driving rib 111 opposite in the extension direction are defined as the first end and the second end, respectively, and the first end and the second end have an axial spacing in the direction of the first axis.

[0235] In some embodiments, the driving rib 111 extends around the first element 110 more than one turn, i.e., the driving rib 111 has an extension angle greater than 360° based on the first axis. It can be understood that this makes the axial projection of the driving rib 111 along the first axis present as a closed circular ring, and there is an overlapping area in the axial projection when the extension angle is greater than 360°. At the same time, the driving rib 111 is configured as a helical segment as a whole, i.e., the driving rib 111 extends helically around the first axis from the first end to the second end.

[0236] In other embodiments, the driving rib 111 extends around the first element 110 less than or equal to one turn, i.e., the driving rib 111 has an extension angle less than or equal to 360° based on the first axis. It can be understood that this makes the axial projection of the driving rib 111 along the first axis not have an overlapping area, i.e., the axial projection presents as an arc with a gap or exactly forms a complete circular ring; thus, when the first element 110 and the driving rib 111 thereon are prepared by injection molding, the axial opposite side walls of the driving rib 111 can be formed by using the axial opposite mold cores, and after injection molding, the axial opposite mold cores can be conveniently demolded by being axially extracted.

[0237] Further, referring to FIG. 17, in some embodiments in which the driving rib 111 spirals less than one turn, the driving rib 111 comprises a driving section 111a and two engaging sections 111b at the ends of the driving section 111a, i.e. the driving rib 111 comprises, in sequence along the extension direction thereof, an engaging section 111b, a driving section 111a, and an engaging section 111b; wherein the engaging section 111b is the part of the driving rib 111 that first engages the engaging groove 132 on the accumulation element 130 or the last part of the driving rib 111 to disengage from the engaging groove 132 on the accumulation element 130, and the driving section 111a is the part of the driving rib 111 that drives the rotation of the accumulation element 130.

[0238] Also, for the convenience of subsequent description, the process from the start of the engaging section 111b engaging the engaging groove 132 to the start of the driving section 111a engaging the engaging groove 132 is defined as the engaging process, the process from the start of the driving section 111a engaging the engaging groove 132 to the complete disengagement of the driving section 111a from the engaging groove 132 is defined as the driving process, and the process from the complete disengagement of the driving section 111a from the engaging groove 132 to the complete disengagement of the engaging section 111b from the engaging groove 132 is defined as the disengaging process; accordingly, the accumulation element 130 and the second element 120 remain relatively stationary during the engaging process and the disengaging process.

[0239] In the case where the driving rib 111 spirals less than one turn, there is a possibility that the driving rib 111 completely disengages from the engaging groove 132 on the accumulation element 130, i.e. there is a possibility that the first end disengages from the engaging groove 132 while the second end has not yet engaged another engaging groove 132, in which case the accumulation element 130 remains stationary; if the driving rib 111 is provided as a continuous spiral section, there is a possibility that the end of the driving rib 111 re-engages the engaging groove 132 on the accumulation element 130 is not completely aligned, which will cause the accumulation element 130 to rotate extra, and thus cause the accumulation element 130 to accumulate errors. By using the above scheme, the driving rib 111 can only drive the accumulation element 130 to rotate during the driving process of the driving section 111a, and the accumulation element 130 remains stationary during the engaging process and the disengaging process of the engaging section 111b, which can ensure that the end of the driving rib 111 re-engages the engaging groove 132 on the accumulation element 130 is positionally aligned, so as to avoid the accumulation element 130 from rotating extra and thus causing the accumulation element 130 to accumulate errors.

[0240] It should be noted that the angle of the first element 110 relative to the second element 120 during the total setting angle is defined, and the total dose that can be set by the injection device corresponds to the total setting angle; at the same time, in the embodiment in which the driving rib 111 includes the driving section 111a and the meshing section 111b, the total setting angle is set to an integer multiple of 360°, that is, when the maximum set dose is reached, the first element 110 rotates relative to the second element 120 by an integer number of turns.

[0241] Further, in some embodiments in which the driving rib 111 includes the driving section 111a and the meshing section 111b, the meshing section 111b is configured as an arc segment arranged circumferentially around the first axis, that is, the meshing section 111b as a whole is on a circle with a center located on the first axis. It should be noted that the driving rib 111 includes two meshing sections 111b, and both of the two meshing sections 111b are arc segments, but the two meshing sections 111b are located at different axial positions on the first axis.

[0242] Further, in some embodiments in which the driving rib 111 includes the driving section 111a and the meshing section 111b, the driving section 111a is configured as a helical segment arranged helically around the first axis; the helical segment is used to meshingly engage in the meshing groove 132, and when the helical segment rotates synchronously with the first element 110, the cumulative element 130 is driven to rotate.

[0243] Further, with reference to FIGS. 16 to 18, in some embodiments, when the first element 110 rotates relative to the second element 120 by one turn, the cumulative element 130 is driven to rotate by an angle of one tooth; specifically, the central angle of the center points of two adjacent meshing grooves 132 on the cumulative element 130 relative to the second axis is defined as a reference included angle a, and when the first element 110 rotates relative to the second element 120 by one turn, that is, 360°, the rotation angle of the cumulative element 130 is one reference included angle a.

[0244] The injection device disclosed in the embodiments of the present application.

[0245] The injection device adopts the dose accumulation mechanism disclosed in the first aspect based on FIGS. 1 to 19, which can ensure that the set dose is less than or equal to the remaining drug dose that can be injected, so that the actual injection dose corresponds to the set dose.

[0246] Referring to Fig. 1, the injection device comprises a housing 170, a clutch element 140, a dose accumulation mechanism of the first aspect disclosed based on Figs. 1-19, a drive rod 150 and a push rod 160, wherein the dose accumulation mechanism comprises a first element 110, a second element 120 and an accumulation element 130, and the dose accumulation mechanism is mounted in the housing 170 of the injection device, the central axis of the housing 170 is defined as the first axis; the clutch element 140, the dose accumulation mechanism, the drive rod 150 and the push rod 160 are all arranged in the housing 170. And, during dose setting, at least one of the first element 110 and the second element 120 can rotate relative to the clutch element 140; during dose injection, the clutch element 140 is rotationally connected to the first element 110 and the second element 120 in the dose injection direction. The first element 110, the second element 120, the drive rod 150 and the push rod 160 are sleeved from outside to inside, at the same time, the drive rod 150 is axially fixed and rotatably arranged in the housing 170, and the drive rod 150 is rotationally connected with the second element 120, while the push rod 160 is threadedly connected with the drive rod 150 and forms an axial guide fit with the housing 170, so that during dose injection, the first element 110 drives the second element 120 and the drive rod 150 to rotate in the dose injection direction, and in this way drives the push rod 160 to axially feed. Correspondingly, the distal end of the injection device is connected with a cartridge 180 containing a drug, the cartridge 180 is provided with a movable piston 181 at the proximal end, and a needle assembly is connected at the distal end, and the axially fed push rod 160 is used to push the movable piston 181 of the cartridge 180 to move to the distal end, so as to discharge the drug in the cartridge 180 through the needle assembly.

[0247] Specifically, referring to Figs. 1, 6 and 7, the proximal end of the second element 120 is accommodated in the proximal end of the first element 110, at the same time, the clutch element 140 is at the proximal end of the first element 110 and abuts against the proximal end of the second element 120. At the same time, the first element 110 rotates in the third direction when the dose is increased, rotates in the fourth direction opposite to the third direction when the dose is decreased, and both the first element 110 and the second element 120 rotate in the fourth direction when the dose is injected. At the same time, the injection device further comprises a button 190 and a spring 100, wherein the button 190 forms an anti-disengagement structure with the proximal end of the first element 110, the spring 100 is between the button 190 and the clutch element 140, and the spring 100 is used to maintain the clutch element 140 abutting against the proximal end of the second element 120.

[0248] Correspondingly, the first element 110 is provided with a ratchet ring 112 at the inner wall of the proximal end, and the clutch element 140 is provided with a ratchet arm 141 matched with the ratchet ring 112, the ratchet ring 112 and the ratchet arm 141 matched with each other form a first connection, which allows the first element 110 to rotate relative to the clutch element 140 in the third direction, and prevents the first element 110 from rotating relative to the clutch element 140 in the fourth direction.

[0249] The proximal end of the second element 120 is provided with an axially protruding axial tooth ring 122, and the clutch element 140 is provided with a matching tooth 142 engaged with the axial tooth ring 122, the axial tooth ring 122 and the matching tooth 142 matched with each other form a second connection under the elastic force of the spring 100, the second connection prevents the clutch element 140 from rotating relative to the second element 120 in the third direction, and allows the clutch element 140 to axially move relative to the second element 120 so that the clutch element 140 rotates relative to the second element 120 in the fourth direction. At the same time, during the dose injection, the clutch element 140 is pressed against the proximal end of the second element 120 under the axial force transmitted by the button 190, at this time the clutch element 140 and the second element 120 cannot axially move, so that the clutch element 140 and the second element 120 are relatively stationary.

[0250] In combination with FIG. 19, it should be noted that the axial tooth ring 122 and the matching tooth 142 are arranged as inclined teeth with a cross section similar to a right triangle, the inclined teeth have a right angle face 142a and an inclined face 142b, during the dose setting, when the right angle face 142a of the inclined teeth on the axial tooth ring 122 is in abutment with the right angle face 142a of the matching tooth 142, the clutch element 140 is prevented from rotating relative to the second element 120 in the third direction, when the inclined face 142b of the inclined teeth on the axial tooth ring 122 is in abutment with the inclined face 142b of the matching tooth 142, the clutch element 140 and the second element 120 axially move relative to each other and "jump teeth" under the elastic force of the spring 100, that is, the teeth jump from one groove to the adjacent groove.

[0251] In summary, when the first element 110 rotates in the third direction to increase the dose, the clutch element 140 and the second element 120 remain stationary, at this time the first element 110 rotates relative to the second element 120 and the clutch element 140; when the first element 110 rotates in the fourth direction to decrease the dose, the first element 110 drives the clutch element 140 to rotate in the fourth direction, and the second element 120 remains stationary, at this time the first element 110 and the clutch element 140 rotate relative to the second element 120. During the dose injection, the first element 110, the clutch element 140 and the second element 120 rotate synchronously in the fourth direction.

[0252] (Second aspect)

[0253] In combination with FIGS. 20-39, the following embodiments of the present application disclose a dose accumulation mechanism and an injection device employing the same.

[0254] The present application discloses a dose accumulation mechanism.

[0255] Referring to FIGS. 20 and 21, the dose accumulation mechanism comprises a drive worm 210, a cooperating component 220 and an integrating worm 230.

[0256] The drive worm 210 is rotatable about a first axis, which is a central axis of a housing 270, and comprises a rod body 212 and a drive rib 211 provided on the rod body 212 and extending around the first axis on the rod body 212. The cooperating component 220 is sleeved with the drive worm 210 and rotatable about the first axis. The integrating worm 230 is connected to the cooperating component 220 and rotatable about a second axis relative to the cooperating component 220, which is a central axis of the integrating worm 230, and the second axis is arranged transversely to the first axis.

[0257] Meanwhile, the integrating worm 230 comprises a worm body 234, an engaging section and a non-engaging section. The engaging section and the non-engaging section are both located at an outer periphery of the worm body 234 and extend in a circumferential direction, and the non-engaging section and the engaging section form a complete circumference to surround the worm body 234.

[0258] Specifically, referring to FIGS. 22-28, the engaging section comprises a plurality of engaging grooves 232, which are arranged at intervals in the circumferential direction of the worm body 234 and used for engaging the drive rib 211 of the drive worm 210. The non-engaging section has a first end portion and a second end portion opposite in the extending direction thereof, and the first end portion and the second end portion are both provided with a stop portion 239. The stop portion 239 of the first end portion is used for abutting one end portion of the drive rib 211 to form a starting position of the integrating worm 230, and the stop portion 239 of the second end portion is used for abutting another end portion of the drive rib 211 to form an ending position of the integrating worm 230.

[0259] During dosage setting, the engagement groove 232 in the engagement section engages with the drive rib 211 of the drive worm 210, enabling the drive worm 210 to drive the integrating worm wheel 230 to rotate. The rotation of the integrating worm wheel 230 accumulates the dosage setting value of the injection device. When the end of the drive rib 211 on the drive worm 210 abuts against the stop, further rotation between the drive worm 210 and the integrating worm wheel 230 is prevented. Specifically, one end of the drive rib 211 abuts against the stop at the first end in the non-engaging section to form a starting position, and the other end of the drive rib 211 abuts against the stop at the second end in the non-engaging section to form a stopping position. With the cooperation of the drive worm 210, the integrating worm wheel 230 is limited to rotating only between the starting position and the stopping position. The total rotation of the integrating worm wheel 230 between the starting position and the stopping position represents the cumulative total of the dosage set by the injection device, thereby ensuring that the dosage accumulated by the integrating worm wheel 230 does not exceed the total amount of drug contained in the vial.

[0260] Simultaneously, during dosage setting, the drive worm 210 and the mating component 220 can rotate relative to each other, and dosage setting includes increasing and decreasing the dosage; correspondingly, the drive worm 210 rotates relative to the mating component 220 in a first direction to increase the dosage, and rotates relative to the mating component 220 in a second direction to decrease the dosage, the first direction being opposite to the second direction. Meanwhile, throughout the dosage setting period, the drive rib 211 engages with the meshing groove 232 to drive the integrating worm wheel 230 to rotate. During dosage injection, the drive worm 210 and the mating component 220 are anti-rotationally connected so that the drive worm 210 and the mating component 220 rotate synchronously or remain stationary synchronously, during which time the integrating worm wheel 230 remains stationary relative to the drive worm 210 and the mating component 220. Furthermore, one end of the drive rib 211 abuts against the stop 239 at the first end of the non-engaging section to form a starting position, and the other end of the drive rib 211 abuts against the stop 239 at the second end of the non-engaging section to form a stopping position. With the cooperation of the drive worm 210, the integrating worm wheel 230 is limited to rotating only between the starting position and the stopping position. The total rotation of the integrating worm wheel 230 between the starting position and the stopping position represents the cumulative total of the set dose of the injection device, thereby ensuring that the set dose accumulated by the integrating worm wheel 230 does not exceed the total amount of drug contained in the cartridge 280.

[0261] It should be noted that the intersection of the first and second axes indicates that the first and second axes are not parallel, meaning they are not on the same plane. Specifically, if the plane containing the first axis is defined as the first plane, then the second axis will intersect the first plane at a single point. In a specific embodiment, the first axis is configured to be perpendicular to the second axis to ensure better transmission efficiency in the transmission of driving force between the drive worm 210 and the integral worm wheel 230.

[0262] It should be noted that the engagement section in the foregoing refers to a region capable of forming an engagement relationship with the driving rib 211, and the non-engagement section in the foregoing refers to a region incapable of forming an engagement relationship with the driving rib 211. It can be understood that the non-engagement section can include a stop section that prevents the driving rib 211 from moving, or can include a vacancy section 238 that avoids the driving rib 211.

[0263] Referring to FIGS. 24 and 25, in some specific embodiments, the engagement section and the non-engagement section are both provided with engagement teeth 231 arranged in the circumferential direction, and an engagement groove 232 is formed between adjacent two engagement teeth 231 in the engagement section. A closing block 235 is provided between adjacent two engagement teeth 231 in the non-engagement section. The provision of the closing block 235 causes the entire non-engagement section to be configured as a stop section that prevents the driving rib 211 from moving, and the closing block 235 at the first end portion serves as a stop portion 239 for the one end of the driving rib 211 to abut against, and the closing block 235 at the second end portion serves as a stop portion 239 for the other end of the driving rib 211 to abut against. In some embodiments, the non-engagement section is provided with a plurality of closing blocks 235, and the closing blocks 235 at the first end portion and the second end portion are used for the end portions of the driving rib 211 to abut against. In another specific embodiment, the non-engagement section is provided with only one closing block 235, which belongs to both the first end portion and the second end portion, and one side wall of the closing block 235 is used for the one end of the driving rib 211 to abut against, and the other side wall is used for the other end of the driving rib 211 to abut against.

[0264] Referring to FIGS. 26 and 27, in another specific embodiment, the engagement section is provided with engagement teeth 231 arranged in the circumferential direction, and an engagement groove 232 is formed between adjacent two engagement teeth 231. The non-engagement section is provided with an arc-shaped barrier 236 extending from the first end portion to the second end portion. The portion of the arc-shaped barrier 236 at the first end portion serves as a stop portion 239 for the one end of the driving rib 211 to abut against, and the portion of the arc-shaped barrier 236 at the second end portion serves as a stop portion 239 for the other end of the driving rib 211 to abut against.

[0265] Referring to FIG. 28, in another specific embodiment, the non-engagement section is provided with a stop block 237 at the first end portion as a stop portion 239, and a stop block 237 at the second end portion as a stop portion 239, and the vacancy section 238 that avoids the driving rib 211 is arranged between the first end portion and the second end portion.

[0266] It can be understood that the fitting component 220 can be sleeved with the driving worm 210, or the driving worm 210 can be sleeved with the fitting component 220.

[0267] Referring to FIG. 20 and FIG. 29, in some embodiments, the drive worm 210 is sleeved outside the matching component 220. In this case, the drive worm 210 is substantially cylindrical, and the drive ribs 211 are arranged on the inner wall of the rod body 212; the matching component 220 is substantially cylindrical, and the matching component 220 is at least partially accommodated in the drive worm 210, and the integrating worm 230 is completely accommodated in the drive worm 210, while the integrating worm 230 is rotationally connected with the matching component 220 through the rotating shaft 233. Accordingly, the matching component 220 is provided with a relief area for the integrating worm 230 to rotate freely. In some specific embodiments, the matching component 220 is provided with a radial through groove 221 in a direction perpendicular to the first axis and the second axis, the integrating worm 230 is installed in the radial through groove 221, and the radial through groove 221 serves as the relief area for the integrating worm 230 to rotate freely on the matching component 220; and the integrating worm 230 installed in the radial through groove 221 is provided with an engaging section of the engaging groove 232 which can protrude from one slot of the radial through groove 221 and engage with the drive ribs 211 on the inner wall of the drive worm 210.

[0268] In the above embodiments, the drive worm 210 rotates around the first axis during dose setting while the matching component 220 remains stationary, and the drive worm 210 rotates synchronously with the matching component 220 during dose injection. It can be understood that, if the drive worm 210 is defined to rotate clockwise when increasing the dose and to rotate counterclockwise when decreasing the dose, then the drive worm 210 rotates in the first direction relative to the matching component 220 corresponds to the matching component 220 remaining stationary while the drive worm 210 rotates clockwise, and the drive worm 210 rotates in the second direction relative to the matching component 220 corresponds to the matching component 220 remaining stationary while the drive worm 210 rotates counterclockwise; and the first direction is the same as the clockwise rotation direction, and the second direction is the same as the counterclockwise rotation direction.

[0269] Referring to FIG. 21, FIG. 30 and FIG. 31, in some other embodiments, the cooperating component 220 is sleeved outside the drive worm 210. In which, the cooperating component 220 is substantially cylindrical, the integral worm 230 is completely accommodated in the cooperating component 220 and outside the drive worm 210, while the inner side of the cooperating component 220 is provided with a support seat 222, and the integral worm 230 is rotatably installed on the support seat 222 of the cooperating component 220; the drive worm 210 is at least partially accommodated in the cooperating component 220, and the drive rib 211 is arranged on the outer side wall of the drive worm 210. Accordingly, the drive worm 210 and the cooperating component 220 form a movable cavity for the free rotation of the integral worm 230; in some specific embodiments, the inner side wall of the cooperating component 220 and the outer side wall of the drive worm 210 provided with the drive rib 211 have a spacing, so that the drive worm 210 and the cooperating component 220 form an annular cavity as a movable cavity for the free rotation of the integral worm 230.

[0270] In the above embodiments, the cooperating component 220 rotates around the first axis during dose setting while the drive worm 210 remains stationary, and the cooperating component 220 and the drive worm 210 rotate synchronously during dose injection. If it is defined that the cooperating component 220 rotates clockwise when increasing the dose and rotates counterclockwise when decreasing the dose, it can be understood that the rotation of the drive worm 210 relative to the cooperating component 220 in the first direction corresponds to the drive worm 210 being stationary while the cooperating component 220 rotates clockwise, the rotation of the drive worm 210 relative to the cooperating component 220 in the second direction corresponds to the drive worm 210 being stationary while the cooperating component 220 rotates counterclockwise, and the first direction is the same as the clockwise rotation direction, and the second direction is the same as the counterclockwise rotation direction.

[0271] It should be noted that the extension of the drive rib 211 around the first axis on the rod body 212 means that the drive rib 211 is arranged on the rod body 212 of the drive worm 210 and extends around the axial direction thereof with the first axis as the spiral axis; accordingly, for the convenience of description, the two ends of the drive rib 211 opposite in the extension direction thereof are defined as the first end and the second end, respectively, and the first end and the second end have an axial spacing in the direction of the first axis. Meanwhile, referring to FIG. 32, the number of revolutions of the drive rib 211 on the drive worm 210 is less than or equal to one, i.e., the wrapping angle of the first end and the second end based on the first axis is less than or equal to 360°. It can be understood that this makes the axial projection of the drive rib 211 along the first axis not have an area of staggered overlap, i.e., the axial projection presents a circular arc shape with a gap or is exactly a complete circular ring shape; thereby, when the drive worm 210 and the drive rib 211 thereon are prepared by injection molding, the axial opposite two side walls of the drive rib 211 can be formed by using the axial opposite mold cores, and after injection molding, the axial opposite mold cores can be conveniently removed by being axially extracted.

[0272] Further, referring to FIG. 22, in some embodiments, the first end and the second end of the driving rib 211 are each provided with a transition chamfer 211e, which can play a guiding transition role in the process of engaging the engagement groove 232.

[0273] Further, referring to FIGS. 32-34, in some specific embodiments, the driving rib 211 includes a driving section 211a and two engagement sections 211b at the ends of the driving section 211a, i.e., the driving rib 211 includes the engagement sections 211b, the driving section 211a and the engagement sections 211b connected in sequence along the extension direction of the driving rib 211; wherein the engagement sections 211b serve as the part of the driving rib 211 that first engages the engagement groove 232 on the integral worm wheel 230 or the last disengages the engagement groove 232 on the integral worm wheel 230, and the driving section 211a serves as the part of the driving rib 211 that drives the integral worm wheel 230 to rotate.

[0274] Also, for the convenience of subsequent description, the process from the beginning of the engagement of the engagement section 211b into the engagement groove 232 to the beginning of the engagement of the driving section 211a into the engagement groove 232 is defined as the engagement process, the process from the beginning of the engagement of the driving section 211a into the engagement groove 232 to the complete disengagement of the driving section 211a from the engagement groove 232 is defined as the driving process, and the process from the complete disengagement of the driving section 211a from the engagement groove 232 to the complete disengagement of the engagement section 211b from the engagement groove 232 is defined as the disengagement process; accordingly, the integral worm wheel 230 and the cooperating component 220 remain relatively stationary in the engagement process and the disengagement process.

[0275] In the case where the driving rib 211 spirally winds less than one turn, there is a possibility that the driving rib 211 completely disengages from the engagement groove 232 on the integral worm wheel 230, i.e., there is a possibility that the first end disengages from the engagement groove 232 while the second end has not yet engaged another engagement groove 232, in which case the integral worm wheel 230 remains stationary; if the driving rib 211 is entirely provided as a continuous spiral section, there can be a case that the end of the driving rib 211 re-engages the engagement groove 232 on the integral worm wheel 230 is not completely aligned with the engagement groove 232, which will cause the integral worm wheel 230 to rotate extra, and thus cause the integral worm wheel 230 to accumulate errors. By adopting the above scheme, the driving rib 211 can only drive the integral worm wheel 230 to rotate in the driving process of the driving section 211a, while the integral worm wheel 230 remains stationary in the engagement process and the disengagement process of the engagement section 211b, which can ensure that the end of the driving rib 211 re-engages the engagement groove 232 on the integral worm wheel 230 is aligned with the engagement groove 232 in position, so as to avoid the case that the integral worm wheel 230 rotates extra and thus causes the integral worm wheel 230 to accumulate errors.

[0276] Further, referring to FIG. 33 and FIG. 34, in some embodiments in which the driving rib 211 comprises the driving section 211a and the engaging section 211b, the central extension axis of the engaging section 211b is configured as an arc of a circle arranged circumferentially around the first axis. For ease of description, the engaging section 211b is defined as having a first side wall 211c and a second side wall 211d on opposite sides of the first axis, and the direction away from the driving section 211a is defined as the away direction.

[0277] Referring to FIG. 33, in some embodiments, the axial distance between the first side wall 211c and the second side wall 211d remains unchanged in the away direction, i.e., the engaging section 211b is configured as an arc section. It is to be noted that the driving rib 211 comprises two arc sections of engaging sections 211b, but the two arc sections of engaging sections 211b are at different axial positions on the first axis. Referring to FIG. 34, in other embodiments, the axial distance between the first side wall 211c and the second side wall 211d gradually decreases in the away direction, i.e., the engaging section 211b is configured as a tapered section with gradually decreasing width.

[0278] Further, in other embodiments in which the driving rib 211 comprises the driving section 211a and the engaging section 211b, the driving section 211a is configured as a helical section arranged helically around the first axis; the helical section is used to engage the engaging groove 232, and when the helical section rotates synchronously with the driving worm 210, the integral worm 230 is driven to rotate.

[0279] Further, in some embodiments, the dose adjusted by one rotation of the driving worm 210 around the first axis is defined as X, and the total sum of the set doses that can be accumulated by the dose accumulation mechanism is defined as Y, then Y is configured as an integer multiple of X, i.e., when the maximum set dose is reached, the driving worm 210 accumulatively rotates an integer number of turns relative to the cooperating component 220 in the direction of dose adjustment.

[0280] Further, referring to FIG. 22 and FIG. 35, in some embodiments, when the driving worm 210 rotates one turn relative to the cooperating component 220, the integral worm 230 is driven to rotate an angle of one tooth; specifically, the central angle between the center points of two adjacent engaging grooves 232 on the integral worm 230 relative to the second axis is defined as a reference included angle a, and when the driving worm 210 rotates one turn relative to the cooperating component 220, i.e., 360°, the rotation angle of the integral worm 230 is one reference included angle a.

[0281] The injection device can ensure that the set dose does not exceed the remaining drug dose that can be injected, so that the actual injection dose is consistent with the set dose.

[0282] The injection device can ensure that the set dose does not exceed the remaining drug dose that can be injected, so that the actual injection dose is consistent with the set dose.

[0283] Referring to Fig. 20, the injection device comprises a housing 270, a clutch element 240, a dose accumulation mechanism according to the second aspect disclosed in Figs. 20 to 39, a drive rod 250 and a push rod 260, wherein the clutch element 240, the dose accumulation mechanism, the drive rod 250 and the push rod 260 are all arranged in the housing 270, the dose accumulation mechanism comprises a drive worm 210, a cooperating component 220 and an integrating worm 230. And, during dose setting, at least one of the drive worm 210 and the cooperating component 220 is rotatable relative to the clutch element 240; during dose injection, the clutch element 240 is rotationally fixed to the drive worm 210 and the cooperating component 220 in a dose injection direction. The drive worm 210, the cooperating component 220, the drive rod 250 and the push rod 260 are arranged in this order from outside to inside, while the drive rod 250 is axially fixed and rotatable arranged in the housing 270, and the drive rod 250 is rotationally fixed to the cooperating component 220, while the push rod 260 is threadedly connected to the drive rod 250 and axially guided by the housing 270, so that during dose injection, the drive worm 210 drives the cooperating component 220 and the drive rod 250 to rotate in the dose injection direction, and in turn drives the push rod 260 to axially feed. Correspondingly, a cartridge 280 containing medicine is connected to a distal end of the injection device, the cartridge 280 is provided with a movable piston 281 at a proximal end, and a needle assembly is connected to a distal end of the cartridge 280, and the axially fed push rod 260 is used to push the movable piston 281 of the cartridge 280 to move distally, so that the medicine in the cartridge 280 is discharged through the needle assembly.

[0284] Specifically, referring to Figs. 36 to 39, the proximal end of the cooperating component 220 is accommodated in the proximal end of the drive worm 210, while the clutch element 240 is at the proximal end of the drive worm 210 and presses against the proximal end of the cooperating component 220. Meanwhile, the drive worm 210 rotates in a third direction when the dose is increased, rotates in a fourth direction opposite to the third direction when the dose is decreased, and rotates in the fourth direction with the cooperating component 220 when the dose is injected. Specifically, the third direction is a clockwise direction, and the fourth direction is an anticlockwise direction. Meanwhile, the injection device further comprises a button 290 and a spring 200, wherein the button 290 forms an anti-disengagement structure with the proximal end of the drive worm 210, the spring 200 is between the button 290 and the clutch element 240, and the spring 200 is used to maintain the clutch element 240 pressing against the proximal end of the cooperating component 220.

[0285] Correspondingly, the inner wall of the proximal end of the drive worm 210 is provided with a ratchet tooth ring 213, and the clutch element 240 is provided with a ratchet arm 241 cooperating with the ratchet tooth ring 213, the ratchet tooth ring 213 and the ratchet arm 241 cooperating to form a first connection, the first connection allowing the drive worm 210 to rotate relative to the clutch element 240 in the third direction, and preventing the drive worm 210 from rotating relative to the clutch element 240 in the fourth direction.

[0286] The proximal end of the mating component 220 is provided with an axially protruding toothed ring 223, and the clutch element 240 is provided with mating teeth 242 that mesh with the axial toothed ring 223. Under the action of the spring force of the spring 200, the axial toothed ring 223 engages with the mating teeth 242 to form a second connection. The second connection prevents the clutch element 240 from rotating relative to the mating component 220 in a third direction, but allows the clutch element 240 and the mating component 220 to move axially relative to each other so that the clutch element 240 rotates relative to the mating component 220 in a fourth direction. At the same time, during the dosage injection, the clutch element 240 is pressed against the proximal end of the mating component 220 by the axial force transmitted from the button 290. At this time, the clutch element 240 and the mating component 220 cannot move axially, so that the clutch element 240 and the mating component 220 are relatively stationary.

[0287] Referring to Figure 39, it should be noted that the axial toothed ring 223 and the mating tooth 242 are configured as inclined teeth with a cross section similar to a right triangle. The inclined teeth have a right angle surface 242a and an inclined surface 242b. During dosage setting, when the right angle surface 242a of the inclined tooth on the axial toothed ring 223 abuts against the right angle surface 242a of the mating tooth 242, it prevents the clutch element 240 from rotating relative to the mating component 220 in a third direction. When the inclined surface 242b of the inclined tooth on the axial toothed ring 223 abuts against the inclined surface 242b of the mating tooth 242, the clutch element 240 and the mating component 220 experience relative axial movement and "tooth skipping" occurs under the elastic force of the spring 200, that is, the tooth jumps from one slot to an adjacent slot.

[0288] In summary, when the drive worm 210 rotates in the third direction to increase the dosage, the clutch element 240 and the mating component 220 remain stationary. At this time, the drive worm 210 rotates relative to the mating component 220 and the clutch element 240. When the drive worm 210 rotates in the fourth direction to decrease the dosage, the drive worm 210 drives the clutch element 240 to rotate in the fourth direction, while the mating component 220 remains stationary. At this time, the drive worm 210 and the clutch element 240 rotate relative to the mating component 220. During dosage injection, the drive worm 210, the clutch element 240, and the mating component 220 rotate synchronously in the fourth direction.

[0289] (Third aspect)

[0290] Referring to Figures 40 to 55, the following embodiments of this application disclose an injection device.

[0291] With reference to Figs. 40 and 41, the injection device comprises a housing 310, a dose accumulation mechanism 320, a clutch mechanism 330 and a transmission mechanism 340, wherein the housing 310 is a cylindrical member having a first axis, and the dose accumulation mechanism 320, the clutch mechanism 330 and the transmission mechanism 340 are at least partially in the housing 310.

[0292] In particular, the dose accumulation mechanism 320 comprises a scale element 321, a transmission element 322 and an accumulation element 323.

[0293] The scale element 321 is rotatable relative to the housing 310 about the first axis for dose setting, the transmission element 322 is arranged in the scale element 321 and is rotatable about the first axis. Meanwhile, one of the transmission element 322 and the scale element 321 is provided with a drive rib 324, and the accumulation element 323 is rotatably connected to the other one of the transmission element 322 and the scale element 321 along a second axis, and the second axis is the central axis of the accumulation element 323, and the second axis is arranged transversely to the first axis; the accumulation element 323 is provided with a plurality of meshing teeth 323a, and the plurality of meshing teeth 323a are arranged in a circumferential direction of the second axis at intervals, so that an adjacent two meshing teeth 323a form a meshing groove 323b for the drive rib 324 to mesh into. Thus, when the transmission element 322 rotates relative to the scale element 321 in a dose increasing direction and a dose decreasing direction, the accumulation element 323 can be driven to rotate about the second axis by the drive rib 324, so as to record the dose setting amount by the rotation amount of the accumulation element 323. In addition, as shown in Fig. 42, the component provided with the drive rib 324 is further provided with a first stop portion 324d, and the accumulation element 323 is provided with a second stop portion 323d for the first stop portion 324d to abut against, when the first stop portion 324d abuts against the second stop portion 323d, a stop position of the accumulation element 323 is formed, and when the accumulation element 323 is in the stop position, the scale element 321 is prevented from rotating relative to the transmission element 322 in the dose increasing direction, i.e. further increasing the dose is limited.

[0294] Correspondingly, as shown in Figs. 43 and 44, the clutch mechanism 330 comprises a clutch element 331 arranged between the scale element 321 and the transmission element 322; during dose setting, one of the scale element 321 and the transmission element 322 is rotatable relative to the clutch element 331, so that the scale element 321 and the transmission element 322 rotate relative to each other during dose setting, and during dose injection, the clutch element 331 locks the scale element 321 and the transmission element 322 in the rotation direction.

[0295] Further, referring to Figs. 40 and 41, the transmission mechanism 340 comprises a driving rod 341 and a pushing rod 342, the driving rod 341 is located in the transmission element 322 and sleeved outside the pushing rod 342, meanwhile, the driving rod 341 is axially fixed and rotatably arranged in the housing 310, and the driving rod 341 is rotationally connected with the transmission element 322, while the pushing rod 342 is threadedly connected with the driving rod 341 and axially guided with the housing 310, so that during the dose injection, the scale element 321 drives the transmission element 322 and the driving rod 341 to rotate along the dose injection direction, and in turn drives the pushing rod 342 to axially feed. Correspondingly, the distal end of the injection device is connected with a cartridge 350 containing medicine, the cartridge 350 is provided with a movable piston 351 at the proximal end and a needle assembly 360 at the distal end, and the axially fed pushing rod 342 is used to push the movable piston 351 of the cartridge 350 to move to the distal end, so as to discharge the medicine in the cartridge 350 through the needle assembly 360.

[0296] With the above scheme, during the dose setting, the scale element 321 rotates relative to the transmission element 322 to make the cumulative element 323 rotate along the second axis, and the rotation angle of the cumulative element 323 corresponds to the dose setting amount realized by the scale element 321, while during the dose injection, the scale element 321, the transmission element 322 and the cumulative element 323 all remain relatively static; thus, in a complete injection process, the cumulative element 323 can record the dose setting amount by its own rotation, accordingly, with the user performing sequential injection, the cumulative element 323 can accumulate the total amount of dose setting, until the cumulative element 323 moves to the stop position where the first stop portion 324d abuts against the second stop portion 323d, the cumulative element 323 is limited from further rotating, at this time, the scale element 321 and the transmission element 322 cannot further rotate in the direction of increasing dose, so as to limit the further increase of the set dose, and in turn limit the final dose setting of the injection device, and accordingly, the final dose setting value is set to be less than or equal to the total amount of medicine that can be injected by the injection device, so as to ensure that the set dose is less than or equal to the remaining amount of medicine that can be injected by the injection device, so that the actual injection dose conforms to the set dose to avoid the situation that an incorrect dose is injected.

[0297] It should be noted that the first axis and the second axis are arranged to intersect, which means that the first axis and the second axis are not parallel, i.e., the first axis and the second axis are not in the same plane; specifically, if the plane where the first axis is located is defined as the first plane, the second axis will intersect the first plane at a point. In specific embodiments, the first axis is configured to be perpendicular to the second axis, so that the transmission of driving force between the element where the driving rib 324 is located and the cumulative element 323 has better transmission efficiency.

[0298] Further, referring to FIG. 42, in some embodiments, the movement direction of the first termination portion 324d when defining the enlarged dose is defined as the termination approaching direction, and the termination position of the accumulation element 323 is formed when the second termination portion 323d moves to block the first termination portion 324d from continuing to move in the termination approaching direction. It should be noted that the dose setting action is embodied as the relative rotation amount between the scale element 321 and the transmission element 322, and the relative rotation amount between the scale element 321 and the transmission element 322 is converted into the rotation amount of the accumulation element 323 via the cooperation between the driving rib 324 and the accumulation element 323, which is similar to the cooperation transmission structure of the worm thread and the worm gear tooth groove, and belongs to deceleration movement. Thus, the dose represented by one unit angle of the movement of the first termination portion 324d is smaller than the dose represented by one unit angle of the movement of the second termination portion 323d, and size errors inevitably exist in actual manufacturing. In the above scheme, compared with limiting the movement of the second termination portion 323d to limit the termination position, limiting the movement of the first termination portion 324d to limit the termination position can reduce the adverse effects of size errors on dose accumulation.

[0299] Referring to FIG. 42, in some specific embodiments, the first termination portion 324d is configured as the end of the driving rib 324. Correspondingly, the second termination portion 323d is configured on the outer periphery of the accumulation element 323 for the end of the driving rib 324 to abut against. Specifically, referring to FIG. 45, in some embodiments, the entire circumference of the accumulation element 323 is provided with the engagement teeth 323a, i.e., the engagement teeth 323a are arranged in one full circle on the main body of the accumulation element 323; correspondingly, the second termination portion 323d is arranged between two adjacent engagement teeth 323a. Referring to FIG. 46, in other embodiments, the outer circumference of the accumulation element 323 includes an engagement arc segment provided with the engagement teeth 323a and a stop arc segment 325 not provided with the engagement teeth 323a; correspondingly, the side wall of the stop arc segment 325 serves as the second termination portion 323d.

[0300] Further, in combination with FIG. 47, in some embodiments, the accumulation element 323 is further configured with a starting position, which prevents the scale element 321 from rotating relative to the transmission element 322 in the dose reduction direction when the accumulation element 323 is in the starting position. Moreover, the movement amount of the accumulation element 323 between the starting position and the termination position corresponds to the total amount of the drug that can be injected by the injection device, and the remaining movable amount between the accumulation element 323 and the termination position always corresponds to the remaining drug dose that can be injected by the injection device as the accumulation element 323 gradually moves from the starting position to the termination position; thus, it can be ensured that each set dose does not exceed the remaining drug dose that can be injected by the injection device, so that the actual injection dose is consistent with the set dose, avoiding the situation of injecting an incorrect dose, and further ensuring that the drug injection obtains its corresponding use effect.

[0301] In specific embodiments, the element configured with the driving rib 324 is further provided with a first starting portion 324c, and the accumulation element 323 is correspondingly provided with a second starting portion 323c; it can be understood that when the driving rib 324 is configured on the scale element 321, the first starting portion 324c is provided on the scale element 321, and when the driving rib 324 is configured on the transmission element 322, the first starting portion 324c is provided on the transmission element 322. At the same time, the movement direction of the first starting portion 324c when the dose is reduced is defined as the starting close direction, and when the second starting portion 323c moves to block the first starting portion 324c from continuing to move in the starting close direction, the starting position of the accumulation element 323 is formed.

[0302] Specifically, in some embodiments, the first starting portion 324c is configured as the end of the driving rib 324, and correspondingly, the first ending portion 324d is configured on the outer periphery of the accumulation element 323 for abutting the end of the driving rib 324. Specifically, referring to FIG. 45, in some embodiments, the entire circumference of the accumulation element 323 is provided with the meshing teeth 323a, i.e., the meshing teeth 323a are arranged in a whole circle on the main body of the accumulation element 323; correspondingly, the second starting portion 323c is arranged between two adjacent meshing teeth 323a. Referring to FIG. 46, in other embodiments, the outer circumference of the accumulation element 323 includes a meshing arc segment provided with the meshing teeth 323a and a blocking arc segment 325 not provided with the meshing teeth 323a; correspondingly, the side wall of the blocking arc segment 325 serves as the second starting portion 323c.

[0303] It should be noted that the movement stroke of the accumulation element 323 between the starting position and the ending position corresponds to the total amount of the medicine that can be injected by the injection device, which indicates that the movement stroke of the accumulation element 323 has a corresponding relationship with the total amount of the medicine in the injection device; for the convenience of description, the movement stroke of the accumulation element 323 is defined as U, and the ratio of the set dose to the movement amount of the accumulation element 323 is defined as T, that is, the total sum of the set dose corresponding to the entire movement stroke of the accumulation element 323 is UT, and the total amount of the medicine in the injection device is defined as S. In some specific embodiments, UT=S, which indicates that the total sum of the set dose corresponding to the entire movement stroke of the accumulation element 323 is equal to the total amount of the medicine in the injection device, so that the medicine in the injection device can be completely injected at the last injection; in another specific embodiment, UT<S, which indicates that the total sum of the set dose corresponding to the entire movement stroke of the accumulation element 323 is less than the total amount of the medicine in the injection device, so that there will be a residual part of the medicine in the injection device after the last injection. In another specific embodiment, the dose accumulation mechanism 320 is assembled to the injection device, which will be adjusted in size, which will make the accumulation element 323 move from the starting position to the ending position, and the movement amount of the accumulation element 323 during the assembly and adjustment is defined as u, and in some embodiments, the equation (U-u)T=S is satisfied, that is, the medicine in the injection device can be completely injected at the last injection; in another embodiment, the inequality (U-u)T<S is satisfied, that is, there will be a residual part of the medicine in the injection device after the last injection.

[0304] It can be understood that the driving rib 324 can be arranged on the scale element 321, and in this case, the accumulation element 323 is rotatably connected to the transmission element 322; the driving rib 324 can also be arranged on the transmission element 322, and in this case, the accumulation element 323 is rotatably connected to the scale element 321.

[0305] Referring to FIG. 40 and FIG. 48, in some embodiments, the driving rib 324 is arranged on the inner side wall of the scale element 321 and extends around the first axis on the scale element 321, and the accumulation element 323 is completely accommodated in the scale element 321 and is substantially in the shape of a worm gear, while the accumulation element 323 is rotationally connected to the transmission element 322 through a rotating shaft, and the transmission element 322 is provided with a relief area for the accumulation element 323 to rotate freely. In some specific embodiments, the transmission element 322 is provided with a radial through groove 322d in a direction perpendicular to the first axis and the second axis, the accumulation element 323 is mounted in the radial through groove 322d, and the radial through groove 322d serves as the relief area for the accumulation element 323 to rotate freely on the transmission element 322; and the accumulation element 323 mounted in the radial through groove 322d is provided with a region with the meshing groove 323b protruding from one slot of the radial through groove 322d and engaging with the driving rib 324 on the inner side wall of the scale element 321.

[0306] It should be noted that the driving rib 324 extending around the first axis on the scale element 321 means that the driving rib 324 is arranged on the scale element 321 and extends around the first axis as a spiral axis in the axial direction; accordingly, for ease of description, the two opposite ends of the driving rib 324 in the extending direction are defined as the first end and the second end, and the first end and the second end have an axial spacing in the direction of the first axis.

[0307] In some specific embodiments, the number of turns of the driving rib 324 around the scale element 321 is less than or equal to one, i.e., the turning angle of the first end and the second end based on the first axis is less than or equal to 360°. It can be understood that this makes the axial projection of the driving rib 324 along the first axis have no staggered overlapping area, i.e., the axial projection is in the shape of an arc with a gap or exactly forms a complete ring; thus, when the scale element 321 and the driving rib 324 thereon are prepared by injection molding, the axial opposite two side walls of the driving rib 324 can be formed by using axially opposite mold cores, and after injection molding, the axial opposite mold cores can be easily demolded by being axially separated.

[0308] Further, referring to FIG. 47 and FIG. 49, in some specific embodiments in which the driving rib 324 turns less than or equal to one turn, the driving rib 324 includes a driving segment 324a and two meshing segments 324b at the ends of the driving segment 324a, i.e., the driving rib 324 includes the meshing segments 324b, the driving segment 324a and the meshing segments 324b connected in sequence in the extending direction thereof; wherein the meshing segments 324b serve as the portions of the driving rib 324 that first engage with or last disengage from the meshing groove 323b on the accumulation element 323, and the driving segment 324a serves as the portion of the driving rib 324 for driving the accumulation element 323 to rotate.

[0309] Similarly, for the convenience of subsequent description, the process from the beginning of the engagement of the engagement segment 324b into the engagement groove 323b to the beginning of the engagement of the driving segment 324a into the engagement groove 323b is defined as an engagement process, the process from the beginning of the engagement of the driving segment 324a into the engagement groove 323b to the complete disengagement of the driving segment 324a from the engagement groove 323b is defined as a driving process, and the process from the complete disengagement of the driving segment 324a from the engagement groove 323b to the complete disengagement of the engagement segment 324b from the engagement groove 323b is defined as a disengagement process; correspondingly, the accumulation element 323 and the transmission element 322 remain relatively stationary during the engagement process and the disengagement process.

[0310] In the case where the driving rib 324 spirally winds around no more than one turn, there is a possibility that the driving rib 324 is completely disengaged from the engagement groove 323b on the accumulation element 323, i.e., there is a possibility that the first end is disengaged from the engagement groove 323b while the second end has not yet engaged into another engagement groove 323b, in which case the accumulation element 323 remains stationary; if the driving rib 324 is provided as a continuous spiral segment, there is a possibility that the end of the driving rib 324 is not completely aligned with the engagement groove 323b when it engages into the engagement groove 323b on the accumulation element 323 again, which will cause the accumulation element 323 to rotate additionally and thus cause the accumulation element 323 to have accumulation errors. By using the above scheme, the driving rib 324 can only drive the accumulation element 323 to rotate during the driving process of the driving segment 324a, while the accumulation element 323 remains stationary during the engagement process and the disengagement process of the engagement segment 324b, which can ensure that the end of the driving rib 324 is aligned with the engagement groove 323b when it engages into the engagement groove 323b on the accumulation element 323 again, so as to avoid the accumulation element 323 from rotating additionally and thus causing the accumulation element 323 to have accumulation errors.

[0311] It should be noted that the angle through which the scale element 321 rotates relative to the transmission element 322 during the dose setting is defined as a total setting angle, and the total dose that the injection device can be accumulated is corresponding to the total setting angle; meanwhile, in the embodiment in which the driving rib 324 includes the driving segment 324a and the engagement segment 324b, the total setting angle is set as an integer multiple of 360°, i.e., when the maximum set dose is reached, the scale element 321 rotates an integer number of turns relative to the transmission element 322.

[0312] Further, in some embodiments in which the driving rib 324 includes the driving segment 324a and the engagement segment 324b, the engagement segment 324b is configured as an arc segment that is circumferentially arranged around the first axis, i.e., the engagement segment 324b as a whole is on a circle with a center located on the first axis. It should be noted that the driving rib 324 includes two engagement segments 324b, both of which are arc segments, but the two engagement segments 324b are located at different axial positions on the first axis.

[0313] Further, in some embodiments in which the driving rib 324 comprises a driving segment 324a and an engaging segment 324b, the driving segment 324a is configured as a helical segment spirally arranged around the first axis; the helical segment is used to engage in the engaging groove 323b and to drive the cumulative element 323 to rotate when the helical segment rotates synchronously with the scale element 321.

[0314] Further, referring to FIGS. 47-50, in some embodiments, the cumulative element 323 is driven to rotate by an angle of one tooth when the scale element 321 rotates one circle relative to the transmission element 322; in particular, a central angle a is defined between the central points of two adjacent engaging grooves 323b on the cumulative element 323 relative to the second axis, and the cumulative element 323 is driven to rotate by an angle of one central angle a when the scale element 321 rotates one circle, i.e. 360°, relative to the transmission element 322.

[0315] Referring to FIGS. 41, 51 and 52, in some other embodiments, the driving rib 324 is arranged on the outer side wall of the transmission element 322, the scale element 321 is internally provided with a support seat 321a, and the cumulative element 323 is rotatably mounted on the support seat 321a; accordingly, the scale element 321 and the transmission element 322 form a movable cavity for the cumulative element 323 to freely rotate; in some specific embodiments, the inner side wall of the scale element 321 and the outer side wall of the transmission element 322 where the driving rib 324 is arranged have a spacing therebetween, so that the scale element 321 and the transmission element 322 form an annular cavity as the movable cavity for the cumulative element 323 to freely rotate.

[0316] Further, in some embodiments, the transmission element 322 comprises a proximal element 322a and a distal element 322b distributed along the axial direction, wherein the proximal element 322a is used to extend into the scale element 321 from the proximal end of the scale element 321, the distal element 322b is used to extend into the scale element 321 from the distal end of the scale element 321, the distal end of the proximal element 322a and the proximal end of the distal element 322b are fixedly connected, and the region where the proximal element 322a and the distal element 322b are connected forms a part of the cavity wall of the movable cavity.

[0317] Further, in some embodiments, a connection structure is provided between the clutch element 331 and the scale element 321, which allows the scale element 321 to rotate relative to the clutch element 331 in the dose up direction and prevents the scale element 321 from rotating relative to the clutch element 331 in the dose down direction; specifically, referring to FIGS. 44 and 53, the connection structure includes a ratchet tooth ring 321b provided inside the scale element 321 and a ratchet arm 331a provided outside the clutch element 331, the ratchet tooth ring 321b has ratchet tooth grooves arranged in the circumferential direction, the ratchet arm 331a includes an arc-shaped elastic arm 331b and a pawl 331c at the free end of the arc-shaped elastic arm 331b, the pawl 331c is capable of being embedded in the ratchet tooth grooves. At the same time, the ratchet tooth grooves have a first groove wall and a second groove wall opposite in the circumferential direction, and the pawl 331c has a first side wall 331d and a second side wall 331e opposite in the circumferential direction; when the scale element 321 rotates relative to the clutch element 331 in the dose up direction, the first side wall 331d abuts against the first groove wall and slides relative to each other as they continue to approach; when the scale element 321 rotates relative to the clutch element 331 in the dose down direction, the second side wall 331e abuts against the second groove wall and prevents further approach.

[0318] Further, referring to FIGS. 44, 54 and 55, in some embodiments, the transmission element 322 is provided with a first engagement part 322c, the clutch element 331 is provided with a second engagement part 331f for the first engagement part 322c to engage, and the clutch element 331 is capable of moving axially from a first engagement position to a second engagement position relative to the transmission element 322, the first engagement part 322c engages with the second engagement part 331f when the clutch element 331 is in the first engagement position, and the first engagement part 322c is separated from the second engagement part 331f when the clutch element 331 is in the second engagement position. Accordingly, the clutch mechanism 330 further includes a pushing element 332 and a resilient element 333, wherein the pushing element 332 is proximal to the clutch element 331, and the resilient element 333 is between the pushing element 332 and the resilient element 333 and is specifically configured as a linear spring; specifically, the pushing element 332 is capable of moving axially relative to the scale element 321 and has a first position and a second position relative to the scale element 321, the pushing element 332 is in the first position during dose setting, the pushing element 332 moves from the first position to the second position under the pushing force during dose injection, and the pushing element 332 in the second position prevents the clutch element 331 from moving from the first engagement position to the second engagement position; at the same time, the resilient element 333 provides elastic resistance for the clutch element 331 to move from the first engagement position to the second engagement position, and provides elastic resistance for the pushing element 332 to move from the first position to the second position.

[0319] With the above technical solution, during dose up-regulation, the clutch element 331 is in the first engagement position to prevent the clutch element 331 from rotating relative to the transmission element 322 in the dose up-regulation direction; during dose down-regulation, the clutch element 331 can move from the first engagement position to the second engagement position to allow the clutch element 331 to rotate relative to the transmission element 322 in the dose down-regulation direction; and during dose injection, the clutch element 331 is prevented from moving from the first engagement position to the second engagement position to prevent the clutch element 331 from rotating relative to the transmission element 322.

[0320] In combination with FIG. 54, it is to be noted that the first engagement portion 322c and the second engagement portion 331f are both provided as inclined teeth with a cross section similar to a right-angled triangle, and the inclined teeth have a right-angled surface 331g and an inclined surface 331h. During dose setting, when the right-angled surface 331g of the inclined teeth on the axial tooth ring abuts against the right-angled surface 331g of the mating teeth, the clutch element 331 is prevented from rotating relative to the transmission element 322 in the dose up-regulation direction, and when the inclined surface 331h of the inclined teeth on the axial tooth ring abuts against the inclined surface 331h of the mating teeth, the clutch element 331 and the transmission element 322 appear to have relative axial movement and appear to have “tooth skipping” under the elastic force of the elastic element 333, i.e., the teeth jump from one groove to the adjacent groove.

[0321] (Fourth aspect)

[0322] In combination with FIGS. 56 to 73, the following embodiments of the present application disclose a bolus injection assembly and an injection device employing the bolus injection assembly and comprising a dose accumulation mechanism.

[0323] The present application discloses a bolus injection assembly.

[0324] As shown in FIGS. 56 to 73, a bolus injection assembly comprises a support member 440, a torsion member 413, a pressing member 411, an elastic reset member 434, an elastic force storage mechanism, a biasing device 432, and a piston rod unit;

[0325] The support member 440 is provided with an injection output end 445;

[0326] The torsion member 413 is provided with a first engagement portion 413a;

[0327] The elastic force storage mechanism is used to generate bolus injection driving energy;

[0328] The piston rod unit is mounted in the support member 440 and is provided with a second engagement portion 421a;

[0329] The biasing member 432 is provided with a biasing engagement portion 432c; the biasing member 432 is movable between a first working position and a second working position; when the biasing member 432 is in the first working position, the biasing engagement portion 432c is separated from the second engagement portion 421a and is engaged with the first engagement portion 413a of the twisting member 413 for causing the elastic force storage mechanism to rotate by the biasing member 432 acting on the elastic force storage mechanism when the twisting member 413 rotates; when the biasing member 432 is in the second working position, the biasing engagement portion 432c is separated from the first engagement portion 413a and is engaged with the second engagement portion 421a of the piston rod unit for transmitting the bolus driving energy of the elastic force storage mechanism to the piston rod unit;

[0330] The pressing member 411 is used for applying a pushing force to the biasing member 432 to move the biasing member 432 to the second working position when the pressing member 411 moves in a direction close to the injection output end 445;

[0331] The elastic reset member 434 is used for providing an elastic force for causing the biasing member 432 to reset to the first working position.

[0332] During dose setting, the biasing member 432 is in the first working position, and the elastic force storage mechanism is caused to rotate positively by the biasing member 432 acting on the elastic force storage mechanism through positive rotation of the twisting member 413; during bolus injection, the elastic force storage mechanism releases the bolus driving energy which can be transmitted to the piston rod unit by the biasing member 432 to work the piston rod unit by moving the pressing member 411 in a direction close to the injection output end 445, at this time, the pressing member 411 applies a pushing force to the biasing member 432 to move the biasing member 432 to the second working position; after bolus injection, the biasing member 432 is caused to reset to the first working position by the elastic force of the elastic reset member 434; thus, during dose setting, the biasing member 432 is in the first working position, the biasing engagement portion 432c is engaged with the first engagement portion 413a of the twisting member 413 and is separated from the second engagement portion 421a, so that only the biasing member 432 acts on the elastic force storage mechanism, and the transmission between the biasing member 432 and the piston rod unit is cut off, which can avoid the biasing member 432 acting on the piston rod unit, thereby avoiding abnormal movement of the piston rod unit during dose setting, and the work is stable and reliable; during bolus injection, the bolus driving energy of the elastic force storage mechanism is transmitted to the piston rod unit through the biasing member 432, which can shorten the transmission path of the bolus driving energy of the piston rod unit and improve the efficiency.

[0333] The biasing device 432 is in the first working position, the biasing part 432c is separated from the second engaging part 421a, and the biasing part 432c engages with the first engaging part 413a of the torsion part 413 to drive the elastic force storage mechanism to rotate when the torsion part 413 rotates. The driving of the elastic force storage mechanism to rotate when the torsion part 413 rotates by the biasing device 432 can be that the elastic force storage mechanism rotates under the driving of the biasing device 432, or that the elastic force storage mechanism rotates under the elastic torsion force of the elastic force storage mechanism.

[0334] The elastic force storage mechanism includes a torsion elastic element 436 and a rotating part 435. The rotating part 435 is rotatably installed in a supporting member 440. One end of the torsion elastic element 436 is connected to the rotating part 435, and the other end is connected to the supporting member 440. When the biasing device 432 is in the first working position, the torsion part 413 is rotated in the forward direction, and the rotating part 435 of the elastic force storage mechanism is driven to rotate in the forward direction by the biasing device 432. During the rotation of the rotating part 435 in the forward direction, the torsion elastic element 436 is twisted in the forward direction to generate an elastic torsion force, thereby generating a bolus driving energy. When the biasing device 432 is in the second working position, the bolus driving energy can be released by the elastic recovery of the torsion elastic element 436. The rotating part 435 can be rotated to different rotation amplitudes, the torsion elastic element 436 can be twisted to different torsion states to generate different elastic torsion forces, different bolus driving energies can be generated, and different bolus amounts (i.e., doses) can be set. In the subsequent bolus process, the corresponding bolus driving energy can be transmitted to the piston rod unit, so that the piston rod unit can be driven by the corresponding bolus driving energy to perform bolus injection according to the preset dose.

[0335] In this embodiment, the torsion elastic element 436 can be a torsion spring or the like. The forward rotation is clockwise rotation, and the reverse rotation is counterclockwise rotation.

[0336] In this embodiment, the elastic force storage mechanism is located in the supporting member 440.

[0337] The elastic force storage mechanism is used to generate the injection driving energy in the forward rotation, and further comprises a sound generating member 433 which is in synchronous rotation cooperation with the rotating member 435 and is movable relative to the rotating member 435; the injection assembly further comprises a positioning member 415; the positioning member 415 is movably installed in the supporting member 440, and the third engaging portion 415b for engaging with the supporting member 440 is arranged on the positioning member 415; when the third engaging portion 415b of the positioning member 415 engages with the supporting member 440, the positioning member 415 is in anti-rotation cooperation with the supporting member 440 and is used to position the sound generating member 433; when the biasing device 432 is in the first working position, the third engaging portion 415b of the positioning member 415 engages with the supporting member 440; when the biasing device 432 is in the second working position, the third engaging portion 415b of the positioning member 415 is separated from the supporting member 440; the pressing member 411 is used to apply a pushing force to the positioning member 415 and the sound generating member 433 to move the positioning member 415 and the sound generating member 433 in the direction close to the injection output end 445 when the pressing member 411 moves in the direction close to the injection output end 445, so that the third engaging portion 415b is separated from the supporting member 440; the elastic reset member 434 is used to apply an elastic force to the sound generating member 433 which is directed to the positioning member 415, and is further used to provide an elastic force for promoting the positioning member 415 to reset to the state that the third engaging portion 415b engages with the supporting member 440.During dose setting, the biasing member 432 is in the first working position, by rotating the torsion member 413 in the forward direction, at this time, the elastic force storage mechanism is driven by the biasing member 432 to rotate the rotating member 435 and the sound generating member in the forward direction, the torsion elastic element 436 is rotated in the forward direction to generate the injection driving energy, then the sound generating member 433 is positioned by the positioning member 415, so that the elastic force storage mechanism is kept in the corresponding rotation range, the torsion elastic element 436 is kept in the corresponding torsion state to avoid the reverse rotation of the torsion elastic element 436 to restore the elasticity, thereby storing the corresponding injection driving energy to set the corresponding dose, while during injection, by pressing the pressing member 411 to move the pressing member 411 in the direction close to the injection output end 445, the biasing member 432 is applied with a pushing force to move to the second working position, the positioning member 415 and the sound generating member 433 are applied with a pushing force to move in the direction close to the injection output end 445 to separate the third engagement part 415b from the support member 440, because the third engagement part 415b is separated from the support member 440, the anti-rotation cooperation between the positioning member 415 and the support member 440 is released, at this time, the positioning member 415 can rotate relative to the support member 440, thereby releasing the positioning effect on the elastic force storage mechanism, the positioning member 415, the sound generating member 433 and the rotating member 435 are reversely rotated under the elastic torsion force of the torsion elastic element 436, and are transmitted to the piston rod unit through the biasing member 432, thereby realizing the injection driving energy transmission of the elastic force storage mechanism to the piston rod unit, when the pressing force of the pressing member 411 is removed, the elastic restoring member 434 applies the elastic force to the sound generating member 433 to reset the engagement state between the sound generating member 433 and the positioning member 415, and the biasing member 432 is reset to the first working position by the elastic force of the elastic restoring member 434, and the positioning member 415 is reset to the elastic force of the third engagement part 415b and the support member 440.

[0338] Wherein, the synchronous rotation cooperation means that when one object of the synchronous rotation cooperation is rotated, the remaining objects of the synchronous rotation cooperation are also rotated.

[0339] The positioning member 415 is circumferentially arranged with a plurality of one-way teeth 415a, and the sound generating member 433 is provided with a plurality of inclined teeth 433a for engaging with the one-way teeth 415a of the positioning member 415. When the biasing device 432 is in the first working position, the third engaging portion 415b of the positioning member 415 is engaged with the supporting member 440, and the torsion member 413 is rotated in the forward direction, at this time, the sound generating member 433 is rotated in the forward direction relative to the positioning member 415 under the driving of the biasing device 432, and in the process of the forward rotation of the sound generating member, the inclined teeth 433a slide along the tooth incline surface of the one-way teeth 415a, and each time the inclined teeth 433a pass one one-way tooth 415a, the inclined teeth 433a move relative to the one-way teeth 415a of the positioning member 415 towards the injection output end 445, and a short separation is formed between them, and then the sound generating member 433 is pushed by the elastic reset member 434 towards the positioning member 415, the inclined teeth 433a engage with the next one-way tooth 415a, that is, each time the sound generating member is rotated in the forward direction by one tooth relative to the positioning member 415, the two continue to engage after rotation, and the sound is generated through the sliding impact of the inclined teeth 433a and the one-way teeth 415a, which can play the role of dose forward setting sound generating member, and the forward rotation of the sound generating member 433 can drive the rotating member 435 to rotate in the forward direction, so as to drive the torsion elastic element 436 to twist and generate injection driving energy. After the torsion member 413 is rotated in place during dose setting, the sound generating member driven by the torsion elastic element 436 has a reverse rotation tendency, at this time, the inclined teeth 433a of the sound generating member engage with the one-way teeth 415a, and the reverse rotation tendency of the sound generating member is blocked, so that the sound generating member 433 is positioned through the engagement of the one-way teeth 415a of the positioning member 415 and the plurality of inclined teeth 433a of the sound generating member 433, so that the sound generating member 433 and the rotating member 435 remain at the corresponding rotation amplitude, and the torsion elastic element 436 remains in the corresponding torsion state to avoid reverse rotation of the torsion elastic element 436.

[0340] Among them, the one-way tooth 415a of the positioning member 415 can adopt the structure of the existing one-way transmission, for example, provided with an inclined tooth surface and a straight blocking surface.

[0341] Of course, in addition to the above, the positioning member 415 can also have other structures, as long as the sound generating member positioning can be achieved, for example, the positioning member 415 can have a positioning seat provided with a plurality of positioning holes, and the sound generating member is provided with a plurality of balls and springs matched with the positioning holes, etc., but the positioning member 415 is circumferentially arranged with a plurality of one-way teeth 415a, and the sound generating member is provided with a plurality of inclined teeth 433a for engaging with the one-way teeth 415a of the positioning member 415, which is the most preferred embodiment of the present application. On the one hand, when the third engaging portion 415b of the positioning member 415 is engaged with the support member 440, and the torsion member 413 is rotated into place during the dose setting period, the engagement of the one-way teeth 415a and the inclined teeth 433a can ensure stable positioning. On the other hand, during the dose setting period, the biasing device 432 is in the first working position, and when the torsion member 413 is rotated in the forward direction, the inclined teeth 433a can slide along the tooth slope of the one-way teeth 415a to reach other one-way teeth 415a to achieve one-way transmission, and the sliding impact of the inclined teeth 433a and the one-way teeth 415a produces sound, which can play a role in sound generation during forward adjustment, and has the advantages of simple structure, convenient forward adjustment, etc.

[0342] In the present embodiment, the positioning member 415 is a ratchet. Of course, in addition to the above, other components can also be used, as long as a plurality of one-way teeth 415a are circumferentially arranged thereon.

[0343] The support member 440 is provided with a support engaging portion for the third engaging portion 415b. The third engaging portion 415b is a plurality of ratchet teeth circumferentially arranged on the positioning member 415. The support engaging portion includes a plurality of support slots 441 circumferentially arranged on the inner wall of the support member 440 and for the plurality of ratchet teeth to be respectively inserted therein. By inserting the plurality of ratchet teeth into the plurality of support slots 441 one by one, the third engaging portion 415b can be engaged with the support member 440, thereby limiting the rotation of the positioning member 415 relative to the support member 440, achieving the anti-rotation cooperation between the positioning member 415 and the support member 440. When the positioning member 415 moves to separate the ratchet teeth from the support slots 441, the positioning member 415 can rotate relative to the support member 440.

[0344] Of course, in addition to the above, the third joint 415b can also have other structures, as long as the positioning member 415 and the support member 440 can be rotationally engaged, for example, the third joint 415b is a plurality of ratchet slots circumferentially arranged on the positioning member 415, and the inner wall of the support member 440 is circumferentially arranged with a plurality of support teeth which are respectively and one-to-one inserted into the plurality of ratchet slots, so that the third joint 415b and the support member 440 are engaged by the plurality of support teeth respectively and one-to-one inserted into the plurality of ratchet slots, thereby limiting the rotation of the positioning member 415 relative to the support member 440, achieving the rotationally engaged positioning member 415 and the support member 440, and when the positioning member 415 moves to separate the ratchet slot and the support tooth, the positioning member 415 can rotate relative to the support member 440.

[0345] The support joint is provided with a limiting wall 442 for blocking and limiting the third joint 415b away from the injection output end 445. The positioning member 415 includes a positioning sleeve 415c, the one-way tooth 415a is arranged at the bottom of the positioning sleeve 415c, and the positioning sleeve 415c is provided with an outwardly extending outer convex ring 415d, and the ratchet teeth are circumferentially arranged on the outer convex ring 415d.

[0346] In this embodiment, one end of the sound generating member close to the injection output end 445 is located in the rotating member 435. Specifically, the rotating member 435 is provided with a rotating slot extending along its axial direction, and the sound generating member is provided with a sound generating member protrusion 433g embedded in the rotating slot and movable along the extension direction of the rotating slot, so that the sound generating member and the rotating member 435 are synchronously rotationally engaged and movable relative to the rotating member 435 through the embedded cooperation of the sound generating member protrusion 433g and the rotating slot.

[0347] Of course, in addition to the above, the sound generating member is provided with a sound generating member slot, and the rotating member 435 can also be provided with a rotating protrusion extending along its axial direction, which is embedded in the sound generating member slot and movable along the extension direction of the sound generating member slot, which also enables the sound generating member and the rotating member 435 to be synchronously rotationally engaged and movable relative to the rotating member 435.

[0348] The elastic reset member 434 abuts against the rotating member 435 and the sound generating member; the biasing device 432 is provided with a flange portion 432d for abutting against the positioning member 415 and the sound generating member; the pressing member 411 is provided with a pushing arm 411a facing the positioning member 415, when the pressing member 411 is pressed to move the pressing member 411 in the direction close to the injection output end 445, the pushing force applied to the positioning member 415 by the pushing arm 411a can be transmitted to the biasing device 432 and the sound generating member, so as to promote the positioning member 415, the biasing device 432 and the sound generating member to move in the direction close to the injection output end 445 under the pushing force of the positioning member 415, so as to move the biasing device 432 to the second working position, and move the positioning member 415 to the third engaging portion 415b to separate from the supporting member 440, at this time, the elastic reset member 434 is compressed along with the movement of the sound generating member in the direction close to the injection output end 445, and when the pressing force on the pressing member 411 is removed, the elastic reset member 434 is elastically stretched, the positioning member 415, the biasing device 432 and the sound generating member move in the direction away from the injection output end 445 under the elastic force of the elastic reset member 434, so as to promote the sound generating member and the positioning member 415 to reset from the engaged state, the biasing device 432 to reset to the first working position, and the positioning member 415 to reset to the third engaging portion 415b to engage with the supporting member 440.

[0349] In the embodiment, the elastic reset member 434 can be a spring, an elastic sheet or the like.

[0350] In the embodiment, the bolus injection assembly further comprises a gasket 414 for abutting against the positioning member 415 and the pushing arm 411a, so that when the pressing member 411 is pressed to move the pressing member 411 in the direction close to the injection output end 445, the pushing force of the pushing arm 411a can be indirectly applied to the positioning member 415, the biasing device 432 and the sound generating member through the gasket 414.

[0351] In the embodiment, the torsion member 413 is rotatably installed on the supporting member 440, and the pressing member 411 is movably installed on the torsion member 413. Specifically, the torsion member 413 is provided with a plug-in slot 413b, and the pushing arm 411a is movably plugged into the plug-in slot 413b, so that the pressing member 411 can move relative to the torsion member 413, and the installation is facilitated, so that the structure is more compact. In the embodiment, the extension trajectory of the plug-in slot 413b is in the shape of a circular arc, and the extension trajectory of the pushing arm 411a is matched.

[0352] Of course, the pressing member 411 can also be movably mounted on the supporting member 440, as long as the pushing force can be applied to the positioning member 415, the biasing member 432 and the sound producing member to realize their functions when the pressing member 411 moves along the direction close to the injection output end 445. However, the movable mounting of the pressing member 411 on the torsion member 413 is the most preferred embodiment of the present application, which can make the structure compact and reduce the volume.

[0353] The sound producing member 433 movably covers the biasing member 432, and the sound producing member 433 is provided with a sound producing member acting surface 433c, and the biasing member 432 is provided with a biasing acting surface 432b for pushing the sound producing member acting surface 433c to make the sound producing member rotate forward when the biasing member 432 rotates forward. When the biasing member 432 is in the second working position, the sound producing member acting surface 433c is used to push the biasing acting surface 432b to make the biasing member 432 rotate reversely when the sound producing member rotates reversely. During the forward setting of the dose, the biasing member 432 is in the first working position, and when the torsion member 413 rotates forward, the torsion member 413 drives the biasing member 432 to rotate forward, and the biasing acting surface 432b of the biasing member 432 pushes the sound producing member acting surface 433c during the forward rotation of the biasing member 432, so that the sound producing member and the rotating member 435 rotate forward to make the torsion elastic element 436 rotate and twist with the forward rotation of the rotating member 435 to generate the elastic torsion force, thereby generating the injection driving energy. During the injection, the pressing member 411 is pressed to move along the direction close to the injection output end 445, and the pushing force of the pressing member 411 moves the positioning member 415, the biasing member 432 and the sound producing member together towards the direction away from the injection output end 445 to make the biasing member 432 move to the second working position, and the positioning member 415 moves to the third engaging part 415b to separate from the supporting member 440, at this time, the elastic return member 434 is compressed, and since the third engaging part 415b separates from the supporting member 440, the anti-rotation cooperation between the positioning member 415 and the supporting member 440 is released, at this time, the positioning member 415 can rotate relative to the supporting member 440, so that the positioning member 415, the sound producing member and the rotating member 435 rotate reversely under the action of the elastic torsion force of the torsion elastic element 436, and then the sound producing member acting surface 433c of the sound producing member pushes the biasing acting surface 432b to make the biasing member 432 rotate reversely, and the biasing member 432 transmits the reverse rotation to the piston rod unit, thereby realizing the transmission of the injection driving energy of the elastic force storage mechanism to the piston rod unit in the form of transmission through the biasing member 432. When the pressing force of the pressing member 411 is removed, the positioning member 415, the biasing member 432 and the sound producing member move together towards the direction away from the injection output end 445 under the action of the elastic force of the elastic return member 434, so as to reset the engagement state of the sound producing member and the positioning member 415, reset the biasing member 432 to the first working position, and reset the positioning member 415 to the third engaging part 415b to engage with the supporting member 440.

[0354] The sound production member is provided with a sound production member guide slope 433d; the biasing device 432 is provided with a biasing guide slope 432e for sliding cooperation with the sound production member guide slope 433d and for pushing against the sound production member guide slope 433d to displace the sound production member and separate it from the positioning member 415 when the biasing device 432 is reversely rotated in the first working position. During dose setting, the biasing device 432 is in the first working position, when the torsion member 413 is reversely rotated, the torsion member 413 reversely rotates the biasing device 432, in the process of reverse rotation of the biasing device 432, the sound production member is blocked by the positioning member 415, the biasing guide slope 432e of the biasing device 432 pushes against the sound production member guide slope 433d, so that the sound production member is displaced and separated from the positioning member 415, at this time, the positioning effect of the positioning member 415 on the sound production member is lost, the sound production member and the rotating member 435 are reversely rotated under the elastic torsion of the torsion elastic element 436, and then the sound production member is reset to engage with the positioning member 415 under the elastic force of the elastic reset member 434, thus, reverse dose adjustment for dose correction can be realized, and when the sound production member moves to engage with the positioning member 415, the slope teeth 433a of the sound production member impact the one-way teeth 415a of the positioning member 415 to produce sound, thereby achieving sound production during reverse dose adjustment. By providing the sound production member with the sound production member guide slope 433d and the biasing device 432 with the biasing guide slope 432e for sliding cooperation with the sound production member guide slope 433d, when the torsion member 413 is reversely rotated, the biasing guide slope 432e of the biasing device 432 pushes against the sound production member guide slope 433d, so that the sound production member is displaced and separated from the positioning member 415, thereby reducing the injection driving energy when the torsion member 413 is reversely rotated, that is, when the set dose is too large during forward dose setting, reverse dose adjustment can be performed to reduce the set dose, thereby achieving injection dose correction effect.

[0355] In the embodiment, the biasing guide slope 432e and the sound production member guide slope 433d are inclined in the reverse direction towards the direction away from the injection output end 445. The inclination of the biasing guide slope 432e and the sound production member guide slope 433d is consistent. The sound production member acting surface 433c and the biasing acting surface 432b are vertically arranged.

[0356] Of course, the biasing guide slope 432e, the sound production member guide slope 433d, the sound production member acting surface 433c and the biasing acting surface 432b are not limited to this, and their shapes and sizes can be set according to actual needs, as long as their functional requirements can be met.

[0357] Further optimization, the biasing device 432 is provided with a first biasing protrusion 432f and a second biasing protrusion 432g, the biasing action surface 432b is arranged on one side of the first biasing protrusion 432f, the other side of the first biasing protrusion 432f is formed as a biasing stop position 432a, the biasing guide slope 432e is formed on the second biasing protrusion 432g, the sound generating member is provided with a first sound generating member groove 433e for active embedding of the first biasing protrusion 432f and a second sound generating member groove 433f for embedding of the second biasing protrusion 432g, the groove side wall opposite to the biasing action surface 432b of the first sound generating member groove 433e is formed as a sound generating member action surface 433c, the groove side wall opposite to the biasing stop position 432a of the first sound generating member groove 433e is formed as a sound generating member stop position 433b, the groove wall corresponding to the biasing guide slope 432e of the second sound generating member groove 433f is formed as a sound generating member guide slope 433d; when the sound generating member action surface 433c is in close contact with the biasing action surface 432b, there is a gap between the biasing stop position 432a and the sound generating member stop position 433b; when the biasing device 432 is reversely rotated from the first working position and the biasing guide slope 432e pushes the sound generating member guide slope 433d, the sound generating member is separated from the positioning member 415 when the biasing stop position 432a is in close contact with the sound generating member stop position 433b. During dose setting, the biasing device 432 is in the first working position, when the reverse rotation torsion member 413 is reversely rotated, the torsion member 413 drives the biasing device 432 to reversely rotate, in the process of reverse rotation of the biasing device 432, the biasing guide slope 432e of the biasing device 432 pushes the sound generating member guide slope 433d, the sound generating member has a tendency of reverse rotation and moving towards the injection output end 445, but the inclined teeth 433a of the sound generating member are engaged with the one-way teeth 415a at this time, the reverse rotation is blocked by the positioning member 415, the sound generating member can only move towards the injection output end 445, at this time, the sound generating member generates displacement towards the injection output end 445 to press the elastic reset member 434, when the biasing device 432 is reversely rotated to the biasing stop position 432a in close contact with the sound generating member stop position 433b, the sound generating member moves to the state that the inclined teeth 433a are completely disengaged from the one-way teeth 415a, at this time, the sound generating member is separated from the positioning member 415, because the sound generating member loses the positioning effect of the positioning member 415, under the elastic torsion of the torsion elastic element 436, the sound generating member begins to reversely rotate, the biasing guide slope 432e of the biasing device 432 is disengaged from the sound generating member guide slope 433d, there is an axial gap between the biasing device 432 and the sound generating member, the elastic reset member 434 pushes the sound generating member to move towards the positioning member 415, the sound generating member and the positioning member 415 return to the engaged state, in this embodiment, that is, the sound generating member reversely rotates one one-way tooth 415a distance relative to the positioning member 415 each time, after rotation, the two continue to engage.The sound generating member is separated from the positioning member 415 once per rotation of a tooth, and then the two are engaged again, so as to realize the reverse setting of the dose in the above manner, and the injection driving energy is generated when the torsion member 413 rotates in the forward direction, and the injection driving energy is released when the torsion member 413 rotates in the reverse direction, so as to reduce the set dose, thereby playing a role of injection dose correction.

[0358] The first biasing protrusions 432f and the second biasing protrusions 432g are arranged alternately and at intervals on the outer side wall of the biasing member 432 along the circumferential direction thereof, and the sound generating member has at least two first sound generating member grooves 433e corresponding to the at least two first biasing protrusions 432f respectively and at least two second sound generating member grooves 433f corresponding to the at least two second biasing protrusions 432g respectively on the inner side thereof.

[0359] In the embodiment, the first biasing protrusions 432f are in a rectangular shape, and the first biasing protrusions 432f and the second biasing protrusions 432g are both provided as two.

[0360] The shapes and the number of the first biasing protrusions 432f and the second biasing protrusions 432g can be set according to actual requirements, and the first sound generating member grooves 433e and the second sound generating member grooves 433f are correspondingly provided.

[0361] Specifically, the biasing member 432 comprises a biasing main cylinder, and the first biasing protrusions 432f and the second biasing protrusions 432g are formed on the outer side wall of the biasing main cylinder. The flange portion 432d is arranged on the side of the first biasing protrusions 432f and the second biasing protrusions 432g away from the injection output end 445. The sound generating member comprises a sound generating member main cylinder, and the first sound generating member grooves 433e and the second sound generating member grooves 433f are correspondingly arranged on the inner side of the sound generating member main cylinder. The bevel teeth 433a are arranged on the end of the sound generating member main cylinder away from the injection output end 445, so as to facilitate processing. The rotating member 435 is provided with a stroke groove extending along the axial direction thereof, and the sound generating member is provided with an anti-disengagement hook movably matched with the stroke groove. When the sound generating member moves relative to the rotating member 435, the anti-disengagement hook moves along the stroke groove, and the groove wall at the end of the stroke groove away from the injection output end 445 can play a limiting role and can prevent the anti-disengagement hook from disengaging, so as to prevent the sound generating member from being separated from the rotating member 435.

[0362] Specifically, when the biasing engaging portion 432c is engaged with the first engaging portion 413a, the torsion member 413 is synchronously rotated with the biasing member 432, and when the biasing engaging portion 432c is engaged with the second engaging portion 421a, the biasing member 432 is synchronously rotated with the piston rod unit.

[0363] In the embodiment, the biasing joint 432c comprises a first biasing pin and a second biasing pin, the first joint 413a comprises a plurality of first joint slots for respectively corresponding insertion of the first biasing pin, and the second joint 421a comprises a plurality of second joint slots for respectively corresponding insertion of the second biasing pin; thus, when the first biasing pin is inserted into the first joint slots of the first joint 413a, the biasing device 432 is rotationally coupled with the torsion member 413, and when the second biasing pin is inserted into the second joint slots of the second joint 421a, the biasing device 432 is rotationally coupled with the piston rod unit.

[0364] Of course, in addition to the above, the biasing joint 432c, the first joint 413a, and the second joint 421a can also have other structures, for example, the biasing joint 432c is a plurality of biasing slots arranged in a circle, the first joint 413a and the second joint 421a each comprise a plurality of joint pins for respectively corresponding insertion into the plurality of biasing slots, and the biasing device 432 can also be rotationally coupled with the torsion member 413 and the piston rod unit.

[0365] The piston rod unit comprises a linkage 421, a piston rod 422, and a piston 424, the linkage 421 is rotationally mounted in a support member 440, and the second joint 421a is arranged on the linkage 421; the piston rod 422 is threadedly connected with the support member 440, and the piston rod 422 is rotationally coupled with the linkage 421 and can move relative to the linkage 421; the piston 424 is arranged on the piston rod 422, when the linkage 421 is rotated by the biasing device 432, the piston rod 422 is rotated by the linkage 421 and is helically advanced under the thread action of the support member 440, so that the piston can be used for injection. The inner side of the support member 440 is circumferentially provided with a plurality of one-way sound teeth, the linkage 421 is provided with an elastic arm 421b, and the elastic arm 421b is provided with a matching sound tooth 421c engaged with the one-way sound teeth, so that when the linkage 421 rotates, the matching sound tooth 421c is sequentially slid and struck against the one-way sound teeth to produce sound, which can play a role of injection sound.

[0366] The bolus assembly further comprises a scale ring 437 movably mounted on the rotating member 435 and threadedly connected with the supporting member 440. The supporting member 440 is provided with a window corresponding to the scale ring 437. When the rotating member 435 rotates, the scale ring 437 is guided to move spirally by the thread of the supporting member 440, and the set scale value (not shown) on the scale ring 437 can be observed through the window of the supporting member 440. The supporting member 440 is provided with an initial stop position and a terminal stop position 443, which are sequentially arranged in a direction away from the injection output end 445. In the initial state, the scale ring 437 is in abutment with the initial stop position, so that the scale ring 437, the rotating member 435 and the sound generating member 433 cannot be reversely rotated. In the dose setting, the scale ring 437 moves to the terminal stop position 443, so that the dose value cannot be increased, thereby improving the safety in use.

[0367] The torsion member 413 comprises a pressing cap 413c and a central column 413d arranged on the pressing cap 413c. The pressing cap 413c is rotatably mounted on the supporting member 440. The first engaging portion 413a is arranged on the central column 413d. The central column 413d is located on the side of the linkage 421 away from the injection output end 445. The biasing device 432 can slide axially to the central column 413d and the linkage 421, so as to be movable to the first working position and the second working position.

[0368] In the embodiment, the piston rod unit is arranged inside the rotating member 435, and the central column 413d is arranged inside the positioning member 415.

[0369] The supporting member 440 can comprise a housing, a torsion spring seat 438 arranged in the housing, a fixing seat 431 arranged in the housing, and a guide seat 423 arranged in the housing. The supporting engaging portion can be formed on the fixing seat 431. The torsion elastic element 436 is connected to the torsion spring seat 438, and the one-way sound generating tooth is arranged on the torsion spring seat 438. The piston rod is threadedly connected with the guide seat 423.

[0370] Of course, in addition to the above, the supporting member 440 can be arranged according to actual needs, but the supporting member 440 is most preferably implemented in the combination of the housing, the torsion spring seat 438 and the fixing seat 431, which is convenient for processing.

[0371] The actual dose setting process of the bolus assembly: rotate the twisting member 413, the twisting member 413 is engaged with the biasing member 432 through the first engaging part 413a and the biasing engaging part 432c of the biasing member 432, so as to rotate the biasing member 432, the sound generating member 433, the rotating member 435 and the scale ring 437 by the twisting member 413, the scale ring 437 is guided to move spirally by the thread of the supporting member 440; one end of the torsional elastic element 436 is connected with the rotating member 435, and the other end is fixed by the supporting member 440, when the rotating member 435 rotates forward, the torsional elastic element 436 is twisted to generate injection driving energy.

[0372] The actual injection process of the bolus assembly: press the pressing member 411, the pressing member 411 pushes the gasket 414, the positioning member 415, the biasing member 432 and the sound generating member 433 to move towards the injection output end 445, the biasing engaging part 432c of the biasing member 432 is engaged with the second engaging part 421a of the piston rod unit, the biasing engaging part 432c of the biasing member 432 is disengaged with the first engaging part 413a of the twisting member 413, continue to press the pressing member 411 until the third engaging part 415b of the positioning member 415 is disengaged with the fixed seat 431, at this time, the torsional elastic element 436 releases the injection driving energy, drives the rotating member 435, the scale ring 437, the sound generating member 433, the biasing member 432, the positioning member 415, the linkage 421 and the piston rod 422 to rotate, the scale ring 437 is guided to move back to the original position by the thread of the supporting member 440, the piston rod 422 is guided to move by the thread of the supporting member 440, and the bolus injection is performed.

[0373] The injection device is disclosed in the embodiments of the present application.

[0374] As shown in FIGS. 56-58, the injection device comprises a dose accumulation mechanism and a fourth aspect bolus assembly based on the bolus assembly disclosed in FIGS. 56 to 73, the bolus assembly comprises a supporting member 440, a twisting member 413, a pressing member 411, an elastic reset member 434, an elastic force storage mechanism, a biasing member 432 and a piston rod unit, the dose accumulation mechanism is arranged between the twisting member 413 and the supporting member 440; the supporting member 440 is provided with a drug storage unit 460, and the piston rod unit is used to push the drug liquid in the drug storage unit 460 towards the injection output end 445.

[0375] In the embodiments, the injection output end 445 can be provided with an injection needle 470. The drug storage unit 460 comprises a drug chamber and a drug bottle 450 arranged in the drug chamber. Of course, the drug storage unit 460 can also be arranged in other forms as long as the drug can be stored.

[0376] Specifically, the dose accumulation mechanism comprises a worm wheel 412 rotatably mounted on the twisting member 413, and a spiral track 444 arranged on the supporting member 440, the worm wheel 412 meshes with the spiral track 444. During the dose setting process, the twisting member 413 is rotated, the worm wheel 412 is rotated under the driving of the twisting member 413 and the spiral track 444, so that the total rotation number of the worm wheel 412 can embody the total over-rotation number of the twisting member 413 for all injection times. The worm wheel 412 is further provided with a worm wheel stop position, in the embodiment, the twisting member 413 drives the worm wheel 412 to rotate, the twisting member 413 rotates one circle, the worm wheel 412 rotates one worm wheel tooth, when the dose reaches the maximum dose value, the twisting member 413 abuts against the worm wheel stop position and cannot rotate, at this time, the dose setting cannot be performed, so that the total maximum injection amount of all injection times can be limited by the dose accumulation mechanism, and the safety of use can be ensured.

[0377] In the description of the present specification, the description of the terms "one embodiment", "some embodiments", "exemplary embodiment", "example", "specific example", or "some examples" and the like means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present specification, the exemplary description of the above terms does not necessarily mean the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0378] Although the embodiments of the present application have been shown and described, those skilled in the art can understand that various changes, modifications, replacements and variations can be made to the embodiments without departing from the principles and purposes of the present application, the scope of the present application is defined by the claims and their equivalents.

Claims

A dose accumulation mechanism characterized in that, Comprising: a first element provided with a drive rib extending around a first axis on the first element; a second element coupled with the first element; an accumulation element connected to the second element and rotatable relative to the second element around a second axis arranged transversely to the first axis, the accumulation element being provided with a plurality of engagement teeth spaced apart along a circumferential direction of the second axis and forming between adjacent engagement teeth an engagement groove for the drive rib to engage; wherein during dose setting the first element and the second element are rotatable relative to each other, the drive rib being configured to cooperate with the engagement teeth to drive the accumulation element to rotate; during dose injection, the first element and the second element are rotationally coupled, the accumulation element being stationary relative to the first element and the second element. The dose accumulation mechanism according to claim 1, characterized in that The first element is rotatable relative to the second element in a first direction to increase a dose and in a second direction to decrease a dose, the accumulation element having a start position and an end position, a movement stroke of the accumulation element between the start position and the end position corresponding to a total amount of drug that the injection device is capable of injecting, and the accumulation element being limited from further rotation relative to the second element in the first direction when in the end position. The dose accumulation mechanism according to claim 2, characterized in that The first element is provided with a first stop portion that moves with the first element around the first axis, the accumulation element is provided with a second stop portion that moves with the accumulation element around the second axis, the start position being formed when the first stop portion abuts against the second stop portion. Dose accumulating mechanism according to claim 3, characterized in that The start position is formed when the second stop portion blocks the first stop portion from further movement around the first axis. Dose accumulating mechanism according to claim 4, characterized in that The first stop portion comprises a first start portion, the second stop portion comprises a second start portion, a movement direction of the first start portion when decreasing a dose is defined as a start approaching direction, the start position of the accumulation element being formed when the second start portion moves to block the first start portion from further movement in the start approaching direction. The dose accumulation mechanism according to claim 5, characterized in that The first start portion is configured as an end portion of the drive rib. The dose accumulation mechanism according to claim 5, characterized in that The second start portion is arranged between adjacent engagement teeth. The dose accumulation mechanism according to claim 2, characterized in that The first element is provided with a first stop portion that moves with the first element around the first axis, the accumulation element is provided with a second stop portion that moves with the accumulation element around the second axis, the end position being formed when the first stop portion abuts against the second stop portion. The dose accumulation mechanism according to claim 8, characterized in that The end position is formed when the second stop portion blocks the first stop portion from further movement around the first axis. The dose accumulation mechanism according to claim 9, characterized in that The first stop portion comprises a first end portion, the second stop portion comprises a second end portion, a movement direction of the first end portion when increasing a dose is defined as an end approaching direction, the end position of the accumulation element being formed when the second end portion moves to block the first end portion from further movement in the end approaching direction. The dose accumulation mechanism according to claim 10, characterized in that The first end portion is configured as an end portion of the drive rib. The dose accumulation mechanism according to claim 10, characterized in that The second termination part is arranged between two adjacent engagement teeth. The dose accumulation mechanism according to claim 10, characterized in that The outer periphery of the accumulation element comprises an engagement arc segment formed by the engagement grooves arranged at intervals and a stop arc segment, and the side wall of the stop arc segment serves as the second termination part against which the first termination part abuts. The dose accumulation mechanism according to claim 8, characterized in that The termination position of the accumulation element is formed when the first stop part blocks the second stop part from continuing to move in the termination approach direction. The dose accumulation mechanism according to claim 14, characterized in that The second stop part is configured as a stop bar extending radially along the accumulation element, and the first stop part is configured as a termination abutting part on the side wall of the first element. The dose accumulation mechanism according to claim 2, characterized in that The second element is provided with a first stop part, and the accumulation element is provided with a second stop part, and the start position or the termination position is formed when the first stop part abuts against the second stop part. The dose accumulation mechanism according to claim 16, characterized in that The first stop part is arranged on the second element, and the first stop part is provided with opposite first and second stop surfaces, and the start position of the accumulation element is formed when the first stop surface abuts against the second stop part, and the termination position of the accumulation element is formed when the second stop surface abuts against the second stop part; wherein the first element is prevented from continuing to move in the second direction relative to the second element when the accumulation element is in the start position. The dose accumulation mechanism according to claim 1, characterized in that The driving rib has opposite first and second ends in the extension direction thereof, and the circumferential angle formed by the first and second ends based on the first axis is less than or equal to 360°. The dose accumulation mechanism according to claim 18, characterized in that The driving rib comprises a driving segment and an engagement segment at the end of the driving segment, the process from the start of the engagement segment engaging into the engagement groove to the start of the driving segment engaging into the engagement groove is defined as an engagement process, and the process from the complete disengagement of the driving segment from the engagement groove to the complete disengagement of the engagement segment from the engagement groove is defined as a disengagement process, and the accumulation element remains stationary in the engagement process and the disengagement process. The dose accumulation mechanism according to claim 19, characterized in that The driving segment is configured as a helical segment arranged helically around the first axis. The dose accumulation mechanism according to claim 19, characterized in that The engagement segment is configured as an arc segment arranged circumferentially around the first axis. The dose accumulation mechanism according to claim 1, characterized in that The driving rib has opposite first and second ends in the extension direction thereof, and the circumferential angle formed by the first and second ends based on the first axis is greater than 360°, and the driving rib extends helically around the first axis from the first end to the second end. The dose accumulation mechanism according to claim 1, characterized in that The central angle formed by the center points of two adjacent engagement grooves on the accumulation element relative to the second axis is defined as a reference included angle, and the rotation angle of the accumulation element is one reference included angle when the first element and the second element rotate relative to each other by 360°. Dose accumulating mechanism according to any of claims 1 to 23, characterized in that The first element is sleeved outside the second element, and the driving rib is arranged on the inner side wall of the first element. The dose accumulation mechanism according to claim 23, characterized in that The second element is provided with a clearance for the rotation of the accumulation element. Dose accumulating mechanism according to any of claims 1 to 23, characterized in that The second element is sleeved outside the first element, and the driving rib is arranged on the outer side wall of the first element. The dose accumulation mechanism according to claim 26, characterized in that An active cavity for the rotation of the accumulation element is formed between the first element and the second element. An injection device characterized in that The dose accumulation mechanism according to any one of claims 1 to 27, wherein at least one of the first element and the second element is rotatable relative to the clutch element during dose setting; The clutch element is rotationally fixed to the first element and the second element in the dose injection direction during dose injection. An integral worm gear, characterized by The clutch element comprises: a worm body rotatable about its own axis; a meshing section at the outer periphery of the worm body and extending in the circumferential direction, the meshing section comprising a plurality of meshing grooves spaced along the circumferential direction of the worm body, the meshing grooves for engaging with the driving ribs of the driving worm. The integral worm gear according to claim 29, characterized in that The integral worm further comprises a non-meshing section at the outer periphery of the worm body and extending in the circumferential direction, the non-meshing section forming a complete circumference with the meshing section, the non-meshing section having a first end and a second end opposite along its extension direction, the first end and the second end each being provided with a stop portion, the stop portion of the first end for abutting with one end of the driving rib to form a start position of the integral worm, the stop portion of the second end for abutting with the other end of the driving rib to form an end position of the integral worm. The integral worm gear according to claim 30, wherein The meshing section and the non-meshing section are each provided with meshing teeth arranged along the circumferential direction, the meshing grooves being formed between adjacent two meshing teeth in the meshing section, the non-meshing section being provided with a closing block between adjacent two meshing teeth, the closing block at the first end and the second end serving as the stop portion. The integral worm gear according to claim 30, wherein The meshing section is provided with meshing teeth arranged along the circumferential direction, the meshing grooves being formed between adjacent two meshing teeth; the non-meshing section is provided with an arc-shaped barrier extending from the first end to the second end, the part of the arc-shaped barrier at the first end and the second end serving as the stop portion. The integral worm gear according to claim 30, wherein The non-meshing section comprises a missing section between the first end and the second end. A drive worm, characterized in that The driving rib comprises a rod body and a driving rib extending around the first axis on the rod body, the driving rib for engaging with the meshing grooves on the integral worm. The drive worm according to claim 34, wherein The driving rib has opposite first end and second end along its extension direction, the surrounding angle formed by the first end and the second end based on the first axis being less than or equal to 360°. The drive worm according to claim 35, wherein The driving rib comprises a driving section and an engaging section at the end of the driving section, the process of the engaging section starting to engage into the meshing groove to the process of the driving section starting to engage into the meshing groove being defined as the engaging process, the process of the driving section completely disengaging from the meshing groove to the process of the engaging section completely disengaging from the meshing groove being defined as the disengaging process, the integral worm remaining stationary during the engaging process and the disengaging process. The drive worm according to claim 36, wherein The central extension axis of the engaging section is configured as an arc segment circumferentially arranged around the first axis. The drive worm according to claim 37, wherein The engaging section has a first side wall and a second side wall opposite along the first axis, and the axial distance between the first side wall and the second side wall remains unchanged along the direction away from the driving section. The drive worm according to claim 37, wherein The engaging section has a first side wall and a second side wall opposite along the first axis, and the axial distance between the first side wall and the second side wall gradually decreases along the direction away from the driving section. The drive worm according to claim 35, wherein The first end and the second end of the driving rib are provided with a transition chamfer. A dose accumulation mechanism characterized in that, The drive worm includes a rod body and a driving rib extending around a first axis on the rod body, and the integrating worm gear is rotatable around a second axis, the first axis and the second axis are cross-arranged, the integrating worm gear is provided with a plurality of engaging grooves arranged at intervals along the circumferential direction of the second axis, and the engaging grooves are used for engaging the driving rib. The dose accumulation mechanism according to claim 41, characterized in that The drive worm is rotatable around a first axis, and the second axis is perpendicular to the first axis. The dose accumulation mechanism according to claim 41, characterized in that The driving rib has a first end and a second end opposite along the extension direction of the driving rib, and the surrounding angle formed by the first end and the second end based on the first axis is less than 360°. The dose accumulation mechanism according to claim 43, characterized in that The driving rib includes a driving section and an engaging section at the end of the driving section, the process that the engaging section starts to engage into the engaging groove to the process that the driving section starts to engage into the engaging groove is defined as an engaging process, the process that the driving section completely disengages from the engaging groove to the process that the engaging section completely disengages from the engaging groove is defined as a disengaging process, and the integrating worm gear remains stationary during the engaging process and the disengaging process. The dose accumulation mechanism according to claim 41, characterized in that The dose adjusted by one rotation of the drive worm around the first axis is defined as X, and the total sum of the set doses that can be accumulated by the dose accumulation mechanism is defined as Y, wherein Y is configured as an integer multiple of X. The dose accumulation mechanism according to claim 41, characterized in that The integrating worm gear is arranged inside the drive worm, and the driving rib is arranged on the inner side wall of the drive worm. The dose accumulation mechanism according to claim 41, characterized in that The integrating worm gear is arranged outside the drive worm, and the driving rib is arranged on the outer side wall of the drive worm. An injection device characterized in that It comprises: a housing having a first axis; a scale element rotatable relative to the housing around the first axis for dose setting; a transmission element arranged in the scale element and rotatable around the first axis; an accumulation element rotatable around a second axis, the second axis being cross-arranged with the first axis, the accumulation element being provided with a second end stop and a plurality of engaging grooves arranged at intervals along the circumferential direction of the second axis; a clutch element arranged between the scale element and the transmission element; wherein one of the scale element and the transmission element is provided with a first end stop and a driving rib capable of engaging the engaging grooves, and the accumulation element is rotatably connected to the other one of the scale element and the transmission element. During dose setting, one of the scale element and the transmission element is rotatable relative to the clutch element, the other is rotationally fixed relative to the clutch element; when the scale element and the transmission element rotate relative to each other, the drive rib drives the accumulation element to rotate, the termination position of the accumulation element is formed when the first termination portion abuts against the second termination portion, the scale element is prevented from rotating relative to the transmission element in the direction of dose up-sizing when the accumulation element is in the termination position; during dose injection, the clutch element locks the scale element and the transmission element in the direction of rotation. The injection device of claim 48, wherein The direction of movement of the first termination portion when the dose is up-sized is defined as the termination approaching direction, the termination position of the accumulation element is formed when the second termination portion moves to block the first termination portion from continuously moving in the termination approaching direction. The injection device of claim 49, wherein The first termination portion is configured as the end of the drive rib. The injection device of claim 50, wherein The second termination portion is arranged on the outer periphery of the accumulation element for the end of the drive rib to abut against. The injection device of claim 49, wherein The element configured with the drive rib is further provided with a first starting portion, the accumulation element is provided with a second starting portion, the direction of movement of the first starting portion when the dose is down-sized is defined as the starting approaching direction, the starting position of the accumulation element is formed when the second starting portion moves to block the first starting portion from continuously moving in the starting approaching direction, the scale element is prevented from rotating relative to the transmission element in the direction of dose down-sizing when the accumulation element is in the starting position. The injection device of claim 48, wherein The drive rib is arranged on the outer side wall of the transmission element, and the accumulation element is rotatably connected to the scale element. The injection device of claim 53, wherein The transmission element comprises a proximal element and a distal element distributed in the axial direction, the proximal element is arranged to extend into the scale element from the proximal end of the scale element, the distal element is arranged to extend into the scale element from the distal end of the scale element, and the distal end of the proximal element is fixedly connected to the proximal end of the distal element. The injection device of claim 58, wherein The drive rib is arranged on the inner side wall of the scale element, and the accumulation element is rotatably connected to the transmission element. The injection device of claim 55, wherein The drive rib extends around the first axis on the scale element, the drive rib has opposite first and second ends along its extension direction, and the circumferential angle formed by the first and second ends based on the first axis is less than or equal to 360°. The injection device of claim 56, wherein The drive rib comprises a drive segment and an engaging segment at the end of the drive segment, the process that the engaging segment starts to engage into the engaging groove to the process that the drive segment starts to engage into the engaging groove is defined as the engaging process, and the process that the drive segment completely disengages from the engaging groove to the process that the engaging segment completely disengages from the engaging groove is defined as the disengaging process, and the accumulation element and the transmission element remain relatively stationary during the engaging process and the disengaging process. The injection device of claim 48, wherein A connection structure is arranged between the clutch element and the scale element, the connection structure allows the scale element to rotate relative to the clutch element in the direction of dose up-sizing, and prevents the scale element from rotating relative to the clutch element in the direction of dose down-sizing. The injection device of claim 58, wherein The connection structure comprises a ratchet tooth ring arranged inside the scale element and a ratchet arm arranged outside the clutch element, the ratchet tooth ring has ratchet tooth grooves arranged along the circumferential direction, the ratchet arm comprises an arc-shaped elastic arm and a pawl at the free end of the arc-shaped elastic arm, the pawl can be embedded into the ratchet tooth groove; The ratchet tooth groove has a first groove wall and a second groove wall which are opposite along the circumferential direction, the pawl has a first side wall and a second side wall which are opposite along the circumferential direction; when the scale element rotates relative to the clutch element in the direction of dose increase, the first side wall abuts against the first groove wall and slides relative to the first groove wall as the two continue to approach each other; when the scale element rotates relative to the clutch element in the direction of dose decrease, the second side wall abuts against the second groove wall and prevents the two from continuing to approach each other. The injection device of claim 48, wherein The transmission element is provided with a first engaging part, the clutch element is provided with a second engaging part for engaging with the first engaging part, the clutch element can be axially moved relative to the transmission element from a first engagement position to a second engagement position, the first engaging part engages with the second engaging part when the clutch element is in the first engagement position, and the first engaging part is separated from the second engaging part when the clutch element is in the second engagement position; During dose increase, the clutch element is in the first engagement position to prevent the clutch element from rotating relative to the transmission element in the direction of dose increase; During dose decrease, the clutch element can be moved from the first engagement position to the second engagement position to allow the clutch element to rotate relative to the transmission element in the direction of dose decrease; During dose injection, the clutch element is prevented from moving from the first engagement position to the second engagement position to prevent the clutch element from rotating relative to the transmission element. The injection device of claim 60, wherein The injection device further comprises a pushing element and an elastic element, the pushing element is proximal to the clutch element, and the elastic element is between the pushing element and the elastic element; The pushing element can be axially moved relative to the scale element and has a first position and a second position relative to the scale element, the pushing element is in the first position during dose setting, the pushing element is moved from the first position to the second position by a pushing force during dose injection, and the pushing element in the second position prevents the clutch element from moving from the first engagement position to the second engagement position; The elastic element provides elastic resistance for the clutch element to move from the first engagement position to the second engagement position, and the elastic element provides elastic resistance for the pushing element to move from the first position to the second position. A dose accumulation mechanism characterized in that, The injection device further comprises a pushing element and an elastic element, the pushing element is proximal to the clutch element, and the elastic element is between the pushing element and the elastic element; The dose accumulation mechanism according to claim 62, characterized in that The pushing element can be axially moved relative to the scale element and has a first position and a second position relative to the scale element, the pushing element is in the first position during dose setting, the pushing element is moved from the first position to the second position by a pushing force during dose injection, and the pushing element in the second position prevents the clutch element from moving from the first engagement position to the second engagement position; The dose accumulation mechanism according to claim 62, characterized in that The elastic element provides elastic resistance for the clutch element to move from the first engagement position to the second engagement position, and the elastic element provides elastic resistance for the pushing element to move from the first position to the second position. The worm gear is provided with a worm gear stop position, during dose setting, when the dose reaches the maximum dose, the torsion member abuts against the worm gear stop position to prevent dose setting. The worm gear rotates one worm gear tooth when the torsion member rotates one circle. The dose accumulation mechanism according to claim 62, characterized in that The torsion member is rotatably mounted on the support member, during dose setting, by forward rotation of the torsion member to set a dose, and by reverse rotation of the torsion member to achieve reverse dose adjustment for dose correction. An injection device characterized in that The dose setting device comprises a torsion member, a support member, and a dose accumulation mechanism as claimed in any one of claims 62 to 64, the torsion member being rotatably mounted on the support member, the dose accumulation mechanism being arranged between the torsion member and the support member. The injection device of claim 66, wherein During dose setting, by forward rotation of the torsion member to set a dose, and by reverse rotation of the torsion member to achieve reverse dose adjustment for dose correction. The injection device of claim 66, wherein The torsion member comprises a cap and a central column arranged on the cap, the cap being rotatably mounted on the support member. The injection device of claim 66, wherein The injection device further comprises a pressing member, an elastic return member, an elastic force storage mechanism, a biasing device, and a piston rod unit; The support member is provided with an injection output end; The torsion member is provided with a first engagement portion; The elastic force storage mechanism is used to generate a bolus driving energy; The piston rod unit is mounted in the support member and is provided with a second engagement portion; The biasing device is provided with a biasing engagement portion; the biasing device is movable between a first working position and a second working position; when the biasing device is in the first working position, the biasing engagement portion is separated from the second engagement portion and is engaged with the first engagement portion of the torsion member for, when the torsion member rotates, the elastic force storage mechanism to be rotated by the biasing device acting on the elastic force storage mechanism; when the biasing device is in the second working position, the biasing engagement portion is separated from the first engagement portion and is engaged with the second engagement portion of the piston rod unit for the bolus driving energy of the elastic force storage mechanism to be transmitted to the piston rod unit; The pressing member is used to, when moving in a direction close to the injection output end, apply a pushing force to the biasing device to move the biasing device to the second working position; The elastic return member is used to provide an elastic force to facilitate the biasing device to return to the first working position. The injection device of claim 69, wherein The pressing member is provided with a pushing arm, and the torsion member is provided with an insertion slot, the pushing arm being movably inserted in the insertion slot. The injection device of claim 70, wherein The extension track of the insertion slot is in the shape of an arc, and the extension track of the pushing arm matches the insertion slot. The extension track of the insertion slot is in the shape of an arc, and the extension track of the pushing arm matches the insertion slot.

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