WO2021093503A1 - 一种自动注射器 - Google Patents

一种自动注射器 Download PDF

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Publication number
WO2021093503A1
WO2021093503A1 PCT/CN2020/120851 CN2020120851W WO2021093503A1 WO 2021093503 A1 WO2021093503 A1 WO 2021093503A1 CN 2020120851 W CN2020120851 W CN 2020120851W WO 2021093503 A1 WO2021093503 A1 WO 2021093503A1
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WO
WIPO (PCT)
Prior art keywords
sliding sleeve
sleeve
protrusion
syringe
flange
Prior art date
Application number
PCT/CN2020/120851
Other languages
English (en)
French (fr)
Inventor
唐熠达
熊长艳
陈红丹
舒乐
易林川
刘慧林
Original Assignee
苏州嘉树医疗科技有限公司
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Publication date
Application filed by 苏州嘉树医疗科技有限公司 filed Critical 苏州嘉树医疗科技有限公司
Publication of WO2021093503A1 publication Critical patent/WO2021093503A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2026—Semi-automatic, e.g. user activated piston is assisted by additional source of energy

Definitions

  • the present invention relates to the field of medical equipment, in particular to disposable automatic injection equipment.
  • CN110237366A discloses a medical injection device, comprising an outer tube and a pen cap.
  • One end of the outer tube is provided with a detachable medicine bin, and a replaceable standard cartridge medicine bottle is arranged in the medicine bin.
  • the inside of the outer tube is close to one end of the medicine bin.
  • a fixed sleeve is provided, and the inside of the fixed sleeve is provided with a push rod seat for axial movement, and the inside of the push rod seat is provided with a transmission ring that can engage with the end of the transmission rod, and the outside of the transmission rod is sleeved with an axially slidable Ratchet ring, one end surface of the ratchet ring is unidirectionally meshed with the inside of the outer cylinder, the other end of the ratchet ring is axially provided with a first spring, and one end of the push rod seat is axially provided with a push rod seat to withstand the outer cylinder A spring, one end of the push rod extends through the push rod seat into the standard cassette medicine bottle and is connected with the push block.
  • CN109999272A discloses a disposable adjustable injection device for insulin injection, which includes a protective cover, a disposable needle, a refill sleeve, a main body shell, a refill and an adjustment component.
  • One end of the main body shell is provided with a second boss
  • a refill sleeve is installed on the outside of the second boss, one end of the refill sleeve is provided with a thread groove, the external thread of the second boss and the thread groove are screwed to each other, and the other of the refill sleeve
  • One end is provided with a first boss, the outside of the first boss is connected with a disposable needle through a thread, the inside of the disposable needle is inserted with a steel needle, the inside of the refill sleeve is installed with a refill, so
  • a protective cover is sleeved on the outer part of the refill sleeve, the other end of the main body shell is provided with an adjusting component, a fixed sleeve is installed inside the main
  • CN102264417A discloses an injection device, which includes: a long housing; a container carrier with a medicament container to which a needle is mounted; a puncture device, which includes a separation sleeve, a preloaded puncture spring device, and a puncture holder Device, wherein the preloaded puncture spring device can act on the separation sleeve and thus on the container carrier to make the container and the needle make a sliding movement, and the puncture holding device can move the The puncture spring device is maintained in a loaded state; the injection device includes a plunger rod, a preloaded injection spring device, and an injection holding device, wherein the plunger rod is configured as a stopper acting on the medicine container, the The preloaded injection spring device can act on the plunger rod to cause the stopper to be displaced in the container, and the injection holding device can keep the injection spring device in a loaded state; the retracting device, which It includes a preloaded retraction spring and a retraction holding device, wherein the preload retraction spring
  • the technical problem to be solved by the present invention is to overcome the shortcomings of the prior art, and provide a disposable automatic injector with simple structure, significantly reduced number of parts, and high reliability of each injection step, and an injection method using the injector.
  • the present invention provides:
  • An auto-injector is characterized by comprising a propulsion assembly, an activation assembly, a trigger assembly and a housing;
  • the propulsion assembly is located in the activation assembly, the propulsion assembly includes a propulsion component and a limiting component, the propelling component passes and the limiting component
  • the engagement realizes the limit, and the starter assembly ensures the braking of the propulsion assembly before injection by fixing the limit form of the propulsion assembly;
  • the trigger assembly accommodates the pre-filled syringe, and pushes the starter assembly out of the brake after the injection starts Position;
  • the housing is wrapped around the propulsion assembly, the activation assembly and the trigger assembly;
  • the propulsion component of the propulsion assembly includes a main spring sleeve and a main spring
  • the limit component of the propulsion component includes a main shaft
  • the activation component includes a start sliding sleeve and an auxiliary spring
  • the shaft body of the main shaft is hollow, one end of which is closed and has a first flange, and the shaft body is respectively provided with a number of elastic first and second bumps according to the distance from the first flange from near to far.
  • the first protrusion protrudes toward the outer surface of the shaft, and has an axial guide slope toward the first flange direction, and the second protrusion protrudes toward the inner surface of the shaft, which faces the first flange direction.
  • the main spring sleeve is located in the main shaft shaft body, one end of which is closed and the other end is open. The closed end can be inserted into the pre-filled syringe.
  • the sleeve body of the main spring sleeve is provided with a slot matching the second protrusion , One end of the pre-tensioned main spring abuts the closed end of the main spring sleeve, and the other end abuts the closed end of the main shaft, and the second protrusion is locked into the slot;
  • the starting sliding sleeve is sleeved outside the main shaft, the distal end of the sliding sleeve has a second flange, the inner surface of the sliding sleeve is axially opened with a groove that can accommodate the first protrusion to slide therein, and one end of the groove is open, and the other One end is closed, and the opening is located at the flange end of the sliding sleeve.
  • the first protrusion and the second protrusion are completely located inside the starting sliding sleeve, and the first flange and the second flange are provided between There is an auxiliary spring, and the first protrusion is clamped at the closed end of the groove;
  • the sleeve body of the starting sliding sleeve tightly presses the second protrusion, so that the second protrusion of the spindle shaft body and the locking groove of the main spring sleeve It is stuck, so that the starting assembly can be reliably fixed in the locked state.
  • the trigger component includes a syringe sliding sleeve
  • the syringe sliding sleeve allows the prefilled syringe to slide freely in the sleeve, and the sleeve body is provided with a number of through grooves. One end of the syringe sliding sleeve is against the starting sliding sleeve, and the other end is longer than the prefilled needle. Barrel of needle
  • the housing is sleeved on the outside of the autoinjector, one end of which is fixed on the first flange, and the other end has a length shorter than the needle of the pre-filled syringe.
  • the length of the other end of the shell shorter than the needle determines the depth of puncture;
  • the shaft wall part where the first and second bumps are located is hollowed out to form an elastic strip
  • the width of the strips of the second protrusions is greater than the width of the grooves in the starting sliding sleeve, so that the strips of the second protrusions It will not lie in the space of the groove as a whole to ensure that the inner wall of the starting sliding sleeve can tightly press the second bump;
  • the opening at the closed end of the main spring sleeve facilitates the timely discharge of air between the main spring sleeve and the piston of the pre-filled syringe.
  • the main spring sleeve and the piston can quickly and unimpededly contact;
  • the housing and the first flange are fixed by clamping
  • the shaft body of the main shaft is further provided with a plurality of elastic third protrusions, which protrude toward the outer surface of the shaft body, and the distance from the first flange is greater than that of the first and second protrusions.
  • the function of the third bump is to facilitate assembly, and temporarily fix the starting sliding sleeve and auxiliary spring on the main shaft before the main spring sleeve and main spring are assembled on the main shaft;
  • the end of the needle cylinder sliding sleeve against the starting sliding sleeve has an inwardly protruding barb.
  • a pre-filled syringe is included.
  • the present invention also provides a method for injection using the above syringe, which is characterized in that the specific steps are:
  • Step 1 In the start-up phase, place the sliding sleeve end of the syringe barrel on the skin to be injected and press it down;
  • Step 2 In the puncture phase, the needle cylinder sliding sleeve 31 pushes the starter sliding sleeve 21 to move upward relative to the needle until the needle contacts the skin and continues to apply pressure.
  • the needle begins to puncture into the skin, and the needle sliding sleeve pushes the starter sliding sleeve to continue upward movement until the needle
  • the sliding sleeve completely enters the shell, and the predetermined subcutaneous puncture depth is reached at this time, and the puncture is completed; during the puncture process, the lower end of the sliding sleeve is started to move above the second protrusion, and the locked state of the second protrusion and the slot is Released, under the thrust of the main spring, the groove of the main spring sleeve slides along the axial guide slope of the second protrusion, and the second protrusion is elastically deformed outwards until the groove completely leaves the second protrusion. In the engaged position, the main spring pushes the main spring sleeve to continue forward, and the
  • Step 3 In the injection stage, the pre-filled syringe and the housing are locked and fixed.
  • the main spring continues to push the main spring sleeve and piston to inject the medicine in the pre-filled syringe under the patient's skin until the piston reaches the bottom end of the syringe. End of injection;
  • Step 4 In the reset phase, move the auto-injector away, the auxiliary spring pushes the needle sliding sleeve and the starting sliding sleeve to retreat.
  • the upper end of the starting sliding sleeve touches the first protrusion
  • the upper end of the starting sliding sleeve is along the first protrusion
  • the axial guide slope slides, the first protrusion deforms elastically inward, and then comes out of the starting sliding sleeve until the barb of the syringe sliding sleeve clamps the flange of the pre-filled syringe, and the injection procedure ends.
  • the first bump has come out of the starting sliding sleeve and is enclosed in the housing. Because it does not have a guiding slope, the first bump cannot re-enter the starting sliding sleeve in the reverse direction. If the injector repeats step 1, The entire injection process will be blocked, avoiding the repeated use of the auto-injector.
  • the present invention has the following beneficial effects:
  • the syringe is designed as a propulsion component, a start component, a trigger component and a housing.
  • the components cooperate with each other to make the entire syringe structure simple and greatly reduce parts;
  • the propulsion component is engaged with the limit component to realize the limit, and the start component ensures the braking of the propulsion component before injection by fixing the limit form of the propulsion component, and realizes the reliable braking of the start component before injection;
  • the first bump is designed to have a one-way guide slope, which can effectively avoid the repeated use of the auto-injector after being matched with the starting sliding sleeve;
  • the second bump is designed to have a one-way guiding slope surface, and it can simply and ingeniously realize the switching of the braking and the propulsion state of the propulsion assembly after cooperating with the starting sliding sleeve.
  • Figure 1 Exploded view of the components of the syringe of the present invention
  • Figure 2 A cross-sectional view of the internal structure of the syringe of the present invention in an assembled state
  • Figure 3 Side view of the main shaft of the syringe of the present invention
  • Figure 4 Side view of the main spring sleeve of the syringe of the present invention.
  • Figure 5 Side view of the starting sliding sleeve of the syringe of the present invention.
  • Figure 6 Side view of the syringe barrel sliding sleeve of the present invention
  • Figure 7 A pre-fixed state diagram of the syringe propelling assembly and the starting assembly of the present invention
  • Figure 8 A diagram of the final assembly state of the syringe propulsion component and the starting component of the present invention
  • Figure 9 A cross-sectional view of the internal structure of the syringe of the present invention in an assembled state
  • Figure 10-14 A diagram of the injection process of the syringe of the present invention.
  • an auto-injector includes a main shaft 11, a main spring sleeve 12, a main spring 13, a starting sliding sleeve 21, an auxiliary spring 22, a syringe sliding sleeve 31, a housing 4, and a pre-filled syringe 51 ;
  • the shaft body of the main shaft 11 is hollow, one end of which is closed and has a first flange 14.
  • the shaft body 11 is provided with a plurality of elastic first protrusions from near to far away from the first flange 14 15 and the second protrusion 16, the first protrusion 15 protrudes toward the outer surface of the shaft, and has an axial guide slope toward the first flange 14, and the second protrusion 16 faces toward the inner surface of the shaft A protrusion, which has an axial guide slope toward the first flange 14;
  • the main spring sleeve 12 is located in the shaft body of the main shaft 11, one end of which is closed and the other end is open. The closed end can be inserted into the prefilled syringe 51.
  • the sleeve body of the main spring sleeve 12 is provided with and The second convex block matches the slot 17, one end of the pre-tensioned main spring 13 abuts the closed end of the main spring sleeve 12, and the other end abuts the closed end of the main shaft 11, and the second convex block 16 is locked into the slot 17 ;
  • the starting sliding sleeve 21 is sleeved outside the main shaft 11, and its distal end has a second flange 23.
  • the inner surface of the sliding sleeve is axially opened with a groove 24 that can accommodate the first protrusion 15 to slide therein.
  • the groove 24 is open at one end and closed at the other end.
  • the opening is located at the end of the starting sliding sleeve 21 with a flange.
  • the first projection 15 and the second projection 16 are completely located inside the starting sliding sleeve 21, and the first projection
  • An auxiliary spring 22 is provided between the rim 14 and the second flange, and the first protrusion 15 is clamped at the closed end of the groove;
  • the sleeve body of the starting sliding sleeve 21 tightly presses the second protrusion 16 so that the second protrusion of the shaft body of the main shaft 11 16 and the card slot of the main spring sleeve 12 are stuck, so that the main spring sleeve 12 is reliably fixed in the locked state with the pretension force of the main spring 13;
  • the needle cylinder sliding sleeve 31 allows the prefilled needle cylinder 51 to slide freely in the sleeve.
  • a number of through grooves 32 are opened on the sleeve body.
  • One end of the needle cylinder sliding sleeve 31 abuts the starting sliding sleeve 21, and the other end
  • a needle with a length longer than the pre-filled syringe 51 wraps the pre-filled syringe 51 as a whole; the end of the syringe slide 31 against the starter slide 21 has an inwardly protruding barb;
  • the pre-filled syringe 51 It has a piston 52, preferably a needle protection sleeve 53;
  • the housing 4 is sleeved on the outside of the autoinjector, one end of which is fixed on the first flange 14.
  • the fixing method is preferably clipped, and the length of the other end is shorter than that of the prefilled syringe 51.
  • the other end of the housing 4 is shorter than the length of the needle to determine the depth of puncture;
  • the auto-injector also has a protective pen cap 54 that is pulled out during use.
  • the needle protective sleeve 53 is present, it is connected to the needle protective sleeve 53.
  • the pen cap 54 is pulled out, the needle protective sleeve is pulled out at the same time. 53.
  • the shaft wall part where the first and second bumps 15 and 16 are located is hollowed out to form an elastic strip, and the first and second bumps 15, 16 are located in the long
  • the width of the strips of the second protrusion 16 is greater than the width of the groove 24 in the starting sliding sleeve 21, so The long strip of the second protrusion 16 will not be located in the space of the groove 24 as a whole, which ensures that the inner wall of the starting sliding sleeve 21 can tightly press the second protrusion 16.
  • the opening at the closed end of the main spring sleeve 12 facilitates the timely exhaust of the air between the main spring sleeve 12 and the piston of the pre-filled syringe 51. After the injection is started, the main spring sleeve 12 and the piston 52 quickly Accessible without obstacles.
  • the shaft body of the main shaft 11 is also provided with a number of elastic third bumps 18, which protrude toward the outer surface of the shaft body, and are separated from the first flange 14 The distance between is greater than the first and second bumps 15, 16.
  • the function of the third protrusion 18 is to facilitate assembly, and temporarily fix the starting sliding sleeve 21 and the auxiliary spring 22 on the main shaft 11 before the main spring sleeve 12 and the main spring 13 are assembled on the main shaft 11.
  • Step 1 In the start-up phase, as shown in Figure 10, place the end of the syringe sleeve 31 of the syringe on the skin to be injected and press it down;
  • Step 2 In the puncture phase, as shown in Figure 11, the syringe slide 31 pushes the starter slide 21 to move upward relative to the needle until the needle touches the skin and continues to apply pressure. The needle begins to penetrate into the skin, and the needle slide 31 pushes the starter slide. The sleeve 21 continues to move upwards until the needle sliding sleeve 31 completely enters the housing 4, at which time it reaches the predetermined subcutaneous piercing depth, and the puncture ends; during the puncturing process, the lower end of the sliding sleeve 21 is activated to move above the second bump 16 , The locked state of the second projection 16 and the locking groove 17 is released.
  • the locking groove 17 of the main spring sleeve 12 slides along the axial guide slope of the second projection 16.
  • the second protrusion 16 is elastically deformed outwards until the slot 17 completely leaves the engagement position of the second protrusion 16, the main spring 13 pushes the main spring sleeve 12 to continue forward, and the front part of the main spring sleeve 12 contacts and abuts against the preset Filling the piston 52 of the syringe 51;
  • Step 3 In the injection stage, as shown in Figure 12, the pre-filled syringe 51 and the housing 4 are locked and fixed, and the main spring 13 continues to push the main spring sleeve 12 and the piston 52 to inject the medicine in the pre-filled syringe 51 Go to the patient's skin until the piston 52 reaches the bottom end of the pre-filled syringe 51, and the injection ends;
  • Step 4 Reset stage, as shown in Figure 13-14, move the auto-injector away, the auxiliary spring 22 pushes the needle sliding sleeve 31 and the starting sliding sleeve 21 back, when the upper end of the starting sliding sleeve 21 touches the first bump At 15 o'clock, the upper end of the starting sliding sleeve 21 slides along the axial guide slope of the first projection 15, and the first projection 15 is elastically deformed inward, and then comes out of the starting sliding sleeve 21 until the needle cylinder sliding sleeve 31 The barb 33 clamps the flange 55 of the pre-filled syringe, and the injection procedure ends.
  • the first protrusion 15 has already escaped from the starting sliding sleeve 21 and is enclosed in the housing 4. Because it does not have a guiding slope, the first protrusion 15 cannot re-enter the starting sliding sleeve 21 in the reverse direction. If step one is repeated, the entire injection process will be blocked, avoiding repeated use of the auto-injector.

Abstract

一种自动注射器，包括推进组件、启动组件、触发组件和壳体(4)；推进组件位于启动组件中，推进组件包括推进部件和限位部件，推进部件通过和限位部件卡合实现限位，启动组件通过固定推进组件的限位形态确保推进组件在注射前的制动；触发组件容纳预填充针筒(51)，并在注射开始后，推动启动组件使其脱离制动位置；壳体(4)包裹整个注射器。

Description

一种自动注射器 技术领域
本发明涉及医疗器械领域，特别涉及一次性自动注射设备。
背景技术
现有的一次性自动注射器，设计原理都非常复杂，导致零部件繁多，普遍在15个以上，因此可靠性不高，装配难度大，而且最后产品成本太高。
CN110237366A公开了一种医用注射装置，包括外筒和笔帽，外筒的一端设置有可拆卸的药仓，药仓内设置有可更换的标准卡式药瓶，外筒的内部靠近药仓的一端设置有固定套，固定套的内部轴向移动设置有推杆座，推杆座的内部设置有可与传动杆的端部相啮合的传动环，传动杆的外侧套接有可轴向滑动的棘齿环，棘齿环的一端端面与外筒内部单向啮合，棘齿环的另一端轴向设置有第一弹簧，推杆座的一端轴向设置有与外筒顶住的推杆座弹簧，推杆的一端穿过推杆座伸入到标准卡式药瓶内与推块相连。
CN109999272A公开了一种用于胰岛素注射的一次性可调式注射装置，包括保护盖、一次性针头、笔芯套、主体外壳、笔芯和调节组件，所述主体外壳的一端设置有第二凸台，所述第二凸台的外部安装有笔芯套，所述笔芯套的一端开设有螺纹槽，所述第二凸台的外螺纹与螺纹槽相互螺接，所述笔芯套的另一端设置有第一凸台，所述第一凸台的外部通过螺纹连接有一次性针头，所述一次性针头的内部插接有钢针，所述笔芯套的内部安装有笔芯，所述笔芯套的外部套接有保护盖，所述主体外壳的另一端设置有调节组件，所述主体外壳的内部安装有固定套筒，所述固定套筒的一端向外凸出有凸缘部。
CN102264417A公开了一种注射设备，其包括：长的壳体；容器载运器，其具有药剂容器，针头安装到所述药剂容器；穿刺装置，其包括分离套管、预加载穿刺弹簧装置和穿刺保持装置，其中，所述预 加载穿刺弹簧装置能够作用于所述分离套管且由此作用于所述容器载运器以使所述容器和针头做滑动运动，并且所述穿刺保持装置能够将所述穿刺弹簧装置保持在加载状态；注射装置，其包括柱塞杆、预加载注射弹簧装置和注射保持装置，其中，所述柱塞杆设置为作用在所述药剂容器中的限位器，所述预加载注射弹簧装置能够作用于所述柱塞杆而使得所述限位器在所述容器内产生位移，并且所述注射保持装置能够将所述注射弹簧装置保持在加载状态；退回装置，其包括预加载回缩弹簧和退回保持装置，其中，所述预加载回缩弹簧被布置为作用于所述分离套管且由此作用于所述容器载运器，并且所述退回保持装置能够将所述回缩弹簧保持在加载状态；穿刺序列启动装置，其能够作用于穿刺触发装置，所述穿刺触发装置被布置在所述分离套管上用于断开所述穿刺保持装置；注射触发装置，其设置在所述分离套管上并能够断开所述注射保持装置以当分离套管和柱塞杆移动到特定位置时启动注射序列；以及退回触发装置，其布置在所述分离套管上并能够在所述柱塞杆已经移动到一定位置时断开所述退回保持装置用于启动针头退回；其特征在于，所述设备还包括阻尼装置，所述阻尼装置包括隔室，该隔室包含一定体积的高粘性液体并且由所述柱塞杆的外表面和帽的内表面部分地限定，其中所述隔室布置有通道，所述液体仅在所述注射序列启动时被强制通过该通道，使得在所述隔室内的体积在整个注射序列期间随所述柱塞杆在所述容器的移动而减小，并由此产生阻尼剪切力。
发明内容
本发明所要解决的技术问题是克服现有技术的不足，提供一种结构简单，零部件数量显著减少，且各注射步骤可靠性高的一次性自动注射器及使用该注射器的注射方法。
为了实现以上目的，本发明提供了：
一种自动注射器，其特征在于，包括推进组件、启动组件、触发组件和壳体；所述推进组件位于启动组件中，所述推进组件包括推进部件和限位部件，推进部件通过和限位部件卡合实现限位，启动组件通过固定推进组件的限位形态确保推进组件在注射前的制动；所述触发组件容纳预填充针筒，并在注射开始后，推动启动组件使其脱离制动位置；所述壳体包覆在所述推进组件、启动组件和触发组件外部；
优选地，所述推进组件的推进部件包括主弹簧套和主弹簧，所述推进部件的限位部件包括主轴，所述启动组件包括启动滑套和辅助弹簧；
所述主轴的轴体为中空，其一端封闭并具有第一凸缘，所述轴体上按照距离第一凸缘由近到远分别设有若干个具有弹性的第一凸块和第二凸块，所述第一凸块向轴体外表面方向凸起，其朝向第一凸缘方向具有轴向引导坡面，所述第二凸块向轴体内表面方向凸起，其朝向第一凸缘方向具有轴向引导坡面；
所述主弹簧套位于主轴轴体内，其一端封闭，另一端开放，所述封闭端可插进预填充针筒，所述主弹簧套的套体上设有和第二凸块匹配的卡槽，预紧的主弹簧一端抵住主弹簧套的封闭端，另一端抵住主轴的封闭端，所述第二凸块卡入卡槽中；
所述启动滑套套接在所述主轴外，其远端具有第二凸缘，滑套内表面轴向开有可容纳第一凸块在其中滑动的凹槽，所述凹槽一端开口，另一端封闭，所述开口位于滑套的凸缘端，装配状态下，第一凸块和第二凸块完全位于所述启动滑套内部，所述第一凸缘和第二凸缘之间设有辅助弹簧，所述第一凸块卡在所述凹槽的封闭端；
主弹簧套的卡槽与主轴轴体的第二凸块卡合后，启动滑套的套体紧紧压住第二凸块，使得主轴轴体的第二凸块和主弹簧套的卡槽卡死，由此实现启动组件可靠地固定在锁止状态。
优选地，所述触发组件包括针筒滑套；
所述针筒滑套可以使预填充针筒在套内自由滑动，其套体上开有若干贯穿槽，所述针筒滑套的一端抵住启动滑套，另一端的长度超过预填充针筒的针头；
优选地，所述壳体套设在所述自动注射器外部，其一端固定在第一凸缘上，另一端的长度短于预填充针筒的针头，壳体内部有若干卡块，所述卡块可穿过针筒滑套的贯穿槽卡住预填充针筒的凸缘，使预填充针筒无法朝注射方向移动。壳体另一端短于针头的长度决定了穿刺的深度；
优选地，所述第一和第二凸块所在的轴体壁部分镂空，形成具有弹性的长条；
优选地，所述第一和第二凸块的弹性长条位于一条直线时，所述第二凸块的长条宽度大于启动滑套内的凹槽的宽度，这样第二凸块的长条不会整体位于凹槽的空间内，确保启动滑套的内壁能够紧紧压住第二凸块；
优选地，所述主弹簧套的封闭端开孔，有利于主弹簧套和预填充针筒的活塞之间的空气及时排出，注射启动后，主弹簧套与活塞快速无障碍地接触；
优选地，壳体和第一凸缘通过卡接固定；
优选地，所述主轴的轴体上还设有若干个具有弹性的第三凸块，其向轴体外表面方向凸起，距离第一凸缘的距离大于第一和第二凸块。第三凸块的作用是便于装配，在主弹簧套和主弹簧装配在主轴上之前将启动滑套、和辅助弹簧临时固定在主轴上；
优选地，所述针筒滑套抵住启动滑套的一端具有向内凸起的倒钩。
优选地，包括预填充针筒。
本发明同时提供了一种利用上述注射器进行注射的方法，其特征在于，具体的步骤为：
步骤一：启动阶段，将注射器的针筒滑套端放置在待注射皮肤上，并下压；
步骤二：穿刺阶段，针筒滑套31推动启动滑套21相对于针头向上运动，直到针头接触皮肤，继续施加压力，针头开始穿刺进入皮肤，针头滑套推动启动滑套继续向上运动，直到针头滑套完全进入壳体，此时到达预定的皮下刺穿深度，穿刺结束；在穿刺过程中，启动滑套下端运动至第二凸块之上，第二凸块和卡槽的锁死状态被解除，在主弹簧推力作用下，主弹簧套的卡槽沿着第二凸块的轴向引导坡面滑动，所述第二凸块向外弹性形变，直到卡槽完全离开第二凸块的卡合位置，主弹簧推动主弹簧套继续向前，主弹簧套的前部接触并抵住预填充针筒的活塞；
步骤三：注射阶段，预填充针筒和壳体卡合固定不动，主弹簧继续推动主弹簧套和活塞，将预填充针筒中的药物注射到病人皮下，直到活塞到达针筒最底端，注射结束；
步骤四：复位阶段，将自动注射器移开，辅助弹簧推动针头滑套和启动滑套回退，当启动滑套上端接触到所述第一凸块时，启动滑套上端沿着第一凸块的轴向引导坡面滑动，所述第一凸块向内弹性形变，随后从启动滑套中脱出，直到针筒滑套的倒钩卡住预填充针筒凸缘，注射程序结束。此时，第一凸块已经从启动滑套中脱出，且被封闭在壳体中，因不具有引导坡面，第一凸块无法反向重新进入启动滑套，注射者如果重复步骤一，整个注射过程将被卡止，避免了自动注射器的重复使用。
本发明相对于现有技术具有如下有益效果：
1、将注射器设计成推进组件、启动组件、触发组件和壳体，各部件互相配合，使整个注射器结构简单，零部件大幅减少；
2、推进部件通过和限位部件卡合实现限位，启动组件通过固定推进组件的限位形态确保推进组件在注射前的制动，实现注射前启动 部件的可靠制动；
3、第一凸块设计成具有单向的引导坡面，和启动滑套配合后能有效避免自动注射器的重复使用；
4、第二凸块设计成具有单向的引导坡面，和启动滑套配合后简单巧妙地实现推进组件的制动和推进状态的切换。
附图说明
下面结合附图，通过对本发明的具体实施方式详细描述，将使本发明的技术方案及其有益效果显而易见。
图1：本发明注射器各部件爆炸图；
图2：本发明注射器装配状态内部结构剖面图；
图3：本发明注射器主轴侧视图；
图4：本发明注射器主弹簧套侧视图；
图5：本发明注射器启动滑套侧视图；
图6：本发明注射器针筒滑套侧视图；
图7：本发明注射器推进组件和启动组件装配预固定状态图；
图8：本发明注射器推进组件和启动组件装配最终状态图；
图9：本发明注射器装配状态内部结构剖面图；
图10-14：本发明注射器注射过程图。
图中部件编号如下：
11-主轴、12-主弹簧套、13-主弹簧、14-第一凸缘、15-第一凸块、16-第二凸块、17-卡槽、18-第三凸块、21-启动滑套、22-辅助弹簧、23-第二凸缘、24-凹槽、31-针筒滑套、32-贯穿槽、33-倒钩、4-壳体、41-卡块、51-预填充针筒、52-活塞、53-针头保护套、54-笔帽,55-预填充针筒凸缘。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方 案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例一：
如图1-6所示，一种自动注射器，包括主轴11、主弹簧套12、主弹簧13、启动滑套21、辅助弹簧22、针筒滑套31、壳体4和预填充针筒51；
所述主轴11的轴体为中空，其一端封闭并具有第一凸缘14，所述轴体11上按照距离第一凸缘14由近到远分别设有若干个具有弹性的第一凸块15和第二凸块16，所述第一凸块15向轴体外表面方向凸起，其朝向第一凸缘14方向具有轴向引导坡面，所述第二凸块16向轴体内表面方向凸起，其朝向第一凸缘14方向具有轴向引导坡面；
装配状态下，所述主弹簧套12位于主轴11轴体内，其一端封闭，另一端开放，所述封闭端可插进预填充针筒51，所述主弹簧套12的套体上设有和第二凸块匹配的卡槽17，预紧的主弹簧13一端抵住主弹簧套12的封闭端，另一端抵住主轴11的封闭端，所述第二凸块16卡入卡槽17中；
所述启动滑套21套接在所述主轴11外，其远端具有第二凸缘23，滑套内表面轴向开有可容纳第一凸块15在其中滑动的凹槽24，所述凹槽24一端开口，另一端封闭，所述开口位于启动滑套21具有凸缘的一端，第一凸块15和第二凸块16完全位于所述启动滑套21内部，所述第一凸缘14和第二凸缘之间设有辅助弹簧22，所述第一凸块15卡在所述凹槽的封闭端；
主弹簧套12的卡槽17与主轴11轴体的第二凸块16卡合后，启动滑套21的套体紧紧压住第二凸块16，使得主轴11轴体的第二凸块16和主弹簧套12的卡槽卡死，使得主弹簧套12带着主弹簧13 的预紧力可靠地固定在锁止状态；
所述针筒滑套31可以使预填充针筒51在套内自由滑动，其套体上开有若干贯穿槽32，所述针筒滑套31的一端抵住启动滑套21，另一端的长度超过预填充针筒51的针头，将预填充针筒51整体包裹在内部；针筒滑套31抵住启动滑套21的一端具有向内凸起的倒钩；所述预填充针筒51具有活塞52，优选地还可以具有针头保护套53；
如图9所示，所述壳体4套设在所述自动注射器外部，其一端固定在第一凸缘14上，固定方式优选为卡接，另一端的长度短于预填充针筒51的针头，壳体4内部有若干卡块41，所述卡块41穿过针筒滑套31的贯穿槽32卡住预填充针筒51的凸缘，使预填充针筒51无法朝注射方向移动，壳体4另一端短于针头的长度决定了穿刺的深度；
优选地，自动注射器还具有起保护作用的笔帽54，该笔帽54在使用时拔掉，当针头保护套53存在时，其和针头保护套53连接，拔掉笔帽54的同时拔掉针头保护套53。
实施例二
如图3所示，该实施例中，第一和第二凸块15、16所在的轴体壁部分镂空，形成具有弹性的长条，所述第一和第二凸块15、16位于长条上，当所述第一和第二凸块15、16的弹性长条位于一条直线时，所述第二凸块16的长条宽度大于启动滑套21内的凹槽24的宽度，这样第二凸块16的长条不会整体位于凹槽24的空间内，确保启动滑套21的内壁能够紧紧压住第二凸块16。
实施例三
该实施例中，所述主弹簧套12的封闭端开孔，有利于主弹簧套12和预填充针筒51的活塞之间的空气及时排出，注射启动后，主弹 簧套12与活塞52快速无障碍地接触。
实施例四
如图7-8所示，该实施例中，所述主轴11的轴体上还设有若干个具有弹性的第三凸块18，其向轴体外表面方向凸起，距离第一凸缘14的距离大于第一和第二凸块15、16。第三凸块18的作用是便于装配，在主弹簧套12和主弹簧13装配在主轴11上之前将启动滑套21和辅助弹簧22临时固定在主轴11上。
实施例五
如图10-14所示，一种利用上述注射器进行注射的方法，具体的步骤为：
步骤一：启动阶段，如图10所示，将注射器的针筒滑套31端放置在待注射皮肤上，并下压；
步骤二：穿刺阶段，如图11所示，针筒滑套31推动启动滑套21相对于针头向上运动，直到针头接触皮肤，继续施加压力，针头开始穿刺进入皮肤，针头滑套31推动启动滑套21继续向上运动，直到针头滑套31完全进入壳体4，此时到达预定的皮下刺穿深度，穿刺结束；在穿刺过程中，启动滑套21的下端运动至第二凸块16之上，第二凸块16和卡槽17的锁死状态被解除，在主弹簧13推力作用下，主弹簧套12的卡槽17沿着第二凸块16的轴向引导坡面滑动，所述第二凸块16向外弹性形变，直到卡槽17完全离开第二凸块16的卡合位置，主弹簧13推动主弹簧套12继续向前，主弹簧套12的前部接触并抵住预填充针筒51的活塞52；
步骤三：注射阶段，如图12所示，预填充针筒51和壳体4卡合固定不动，主弹簧13继续推动主弹簧套12和活塞52，将预填充针筒51中的药物注射到病人皮下，直到活塞52到达预填充针筒51最 底端，注射结束；
步骤四：复位阶段，如图13-14所示，将自动注射器移开，辅助弹簧22推动针头滑套31和启动滑套21回退，当启动滑套21上端接触到所述第一凸块15时，启动滑套21上端沿着第一凸块15的轴向引导坡面滑动，所述第一凸块15向内弹性形变，随后从启动滑套21中脱出，直到针筒滑套31的倒钩33卡住预填充针筒凸缘55，注射程序结束。此时，第一凸块15已经从启动滑套21中脱出，且被封闭在壳体4中，因不具有引导坡面，第一凸块15无法反向重新进入启动滑套21，注射者如果重复步骤一，整个注射过程将被卡止，避免了自动注射器的重复使用。
以上所述仅为本发明的示例性实施例，并非因此限制本发明专利保护范围，凡是利用本发明说明书及附图内容所作的等效结构或等效流程变换，或直接或间接运用在其他相关的技术领域，均同理包括在本发明的专利保护范围内。

Claims (12)

  1. 一种自动注射器，其特征在于，包括推进组件、启动组件、触发组件和壳体；
    所述推进组件位于启动组件中，所述推进组件包括推进部件和限位部件，推进部件通过和限位部件卡合实现限位，启动组件通过固定推进组件的限位形态确保推进组件在注射前的制动；
    所述触发组件容纳预填充针筒，并在注射开始后，推动启动组件使其脱离制动位置；
    所述壳体包覆在所述推进组件、启动组件和触发组件外部。
  2. 如权利要求1所述的自动注射器，其特征在于，所述推进组件的推进部件包括主弹簧套和主弹簧，所述推进部件的限位部件包括主轴，所述启动组件包括启动滑套和辅助弹簧；
    所述主轴的轴体为中空，其一端封闭并具有第一凸缘，所述轴体上按照距离第一凸缘由近到远分别设有若干个具有弹性的第一凸块和第二凸块，所述第一凸块向轴体外表面方向凸起，其朝向第一凸缘方向具有轴向引导坡面，所述第二凸块向轴体内表面方向凸起，其朝向第一凸缘方向具有轴向引导坡面；
    所述主弹簧套位于主轴轴体内，其一端封闭，另一端开放，所述封闭端可插进预填充针筒，所述主弹簧套的套体上设有和第二凸块匹配的卡槽，预紧的主弹簧一端抵住主弹簧套的封闭端，另一端抵住主轴的封闭端，所述第二凸块卡入卡槽中；
    所述启动滑套套接在所述主轴外，其远端具有第二凸缘，滑套内表面轴向开有可容纳第一凸块在其中滑动的凹槽，所述凹槽一端开口，另一端封闭，所述开口位于滑套的凸缘端，装配状态下，第一凸块和第二凸块完全位于所述启动滑套内部，所述第一凸缘和第二凸缘之间设有辅助弹簧，所述第一凸块卡在所述凹槽的封闭端。
  3. 如权利要求1-2任一项所述的自动注射器，其特征在于，所述触发组件包括针筒滑套；
    所述针筒滑套可以使预填充针筒在套内自由滑动，其套体上开有若干槽，所述针筒滑套的一端抵住启动滑套，另一端的长度超过预填充针筒的针头。
  4. 如权利要求1-3任一项所述的自动注射器，其特征在于，所述壳体套 设在所述自动注射器外部，其一端固定在第一凸缘上，另一端的长度短于预填充针筒的针头，壳体内部有若干卡块，所述卡块可穿过针筒滑套的槽卡住预填充针筒的凸缘。
  5. 如权利要求2所述的自动注射器，其特征在于，所述第一和第二凸块所在的轴体壁部分镂空，形成具有弹性的长条。
  6. 如权利要求5所述的自动注射器，其特征在于，所述第一和第二凸块的弹性长条位于一条直线时，所述第二凸块的长条宽度大于启动滑套内的凹槽的宽度。
  7. 如权利要求2所述的自动注射器，其特征在于，所述主弹簧套的封闭端开孔。
  8. 如权利要求4所述的自动注射器，其特征在于，壳体和第一凸缘通过卡接固定。
  9. 如权利要求2所述的自动注射器，其特征在于，所述主轴的轴体上还设有若干个具有弹性的第三凸块，其向轴体外表面方向凸起，距离第一凸缘的距离大于第一和第二凸块。
  10. 如权利要求2所述的自动注射器，其特征在于，所述针筒滑套抵住启动滑套的一端具有向内凸起的倒钩。
  11. 如权利要求1-10任一项所述的自动注射器，其特征在于，包括预填充针筒。
  12. 一种使用如权利要求11所述的自动注射器的注射方法，其特征在于，具体的步骤为：
    步骤一：启动阶段，将注射器的针筒滑套端放置在待注射皮肤上，并下压；
    步骤二：穿刺阶段，针筒滑套31推动启动滑套21相对于针头向上运动，直到针头接触皮肤，继续施加压力，针头开始穿刺进入皮肤，针头滑套推动启动滑套继续向上运动，直到针头滑套完全进入壳体，此时到达预定的皮下刺穿深度，穿刺结束；在穿刺过程中，启动滑套下端运动至第二凸块之上，第二凸块和卡槽的锁死状态被解除，在主弹簧推力作用下，主弹簧套的卡槽沿着第二凸块的轴向引导坡面滑动，所述第二凸块向外弹性形变，直到卡槽完全离开第二凸块的卡合位置，主弹簧推动主弹簧套继续向前，主弹簧套的前部接触并抵 住预填充针筒的活塞；
    步骤三：注射阶段，预填充针筒和壳体卡合固定不动，主弹簧继续推动主弹簧套和活塞，将预填充针筒中的药物注射到病人皮下，直到活塞到达针筒最底端，注射结束；
    步骤四：复位阶段，将自动注射器移开，辅助弹簧推动针头滑套和启动滑套回退，当启动滑套上端接触到所述第一凸块时，启动滑套上端沿着第一凸块的轴向引导坡面滑动，所述第一凸块向内弹性形变，随后从启动滑套中脱出，直到针筒滑套的倒钩卡住预填充针筒凸缘，注射程序结束。
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CN110681004A (zh) * 2019-11-15 2020-01-14 苏州嘉树医疗科技有限公司 一种自动注射器
CN111282094B (zh) * 2020-03-05 2020-11-10 苏州恒瑞宏远医疗科技有限公司 自动注射装置及其使用方法

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