WO2011088731A1 - 自动回缩式非液态物安全注射装置 - Google Patents

自动回缩式非液态物安全注射装置 Download PDF

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Publication number
WO2011088731A1
WO2011088731A1 PCT/CN2010/080537 CN2010080537W WO2011088731A1 WO 2011088731 A1 WO2011088731 A1 WO 2011088731A1 CN 2010080537 W CN2010080537 W CN 2010080537W WO 2011088731 A1 WO2011088731 A1 WO 2011088731A1
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WO
WIPO (PCT)
Prior art keywords
hollow
needle
rod
injection device
retracting
Prior art date
Application number
PCT/CN2010/080537
Other languages
English (en)
French (fr)
Inventor
林李李
郭铭宗
Original Assignee
明辰股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 明辰股份有限公司 filed Critical 明辰股份有限公司
Priority to CN2010800594508A priority Critical patent/CN102711877A/zh
Priority to JP2012549241A priority patent/JP2013517072A/ja
Publication of WO2011088731A1 publication Critical patent/WO2011088731A1/zh

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Classifications

    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • 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
    • A61M5/5066—Means for preventing re-use by disconnection of piston and piston-rod

Definitions

  • This invention relates to a safe injection device, and more particularly to an automatically retractable medically safe injector (Automatically Retractable Medically Safety Injector) that can be operated with one hand and can automatically retract with a needle. The risk of needle sticking. Background technique
  • Taiwan Patent No. 520995 Automatic Retractable Safety Syringe
  • U.S. Patent No. 6,712,793 B1 Needle Guard Assembly for the Needle of A Syringe Body
  • the syringe includes a hollow syringe 12, a needle hub 11 that engages the needle 10, a ring-shaped retraction spring 13, and a crushable inner-retractable rod 14.
  • the inner-retractable rod 14 can be crushed, including the integrally formed front-end rod body 17, the fracture portion 18, and a hollow rear-end rod body 19.
  • the retractable rod 14 can be crushed and assembled into the hollow syringe 12, after the injection of the liquid medicine is completed, the user continuously applies a force to the needle to cause the broken portion 18 to be broken, resulting in the front rod 17 being retracted.
  • the hollow portion of the hollow rear portion of the rod body 19 makes room for the needle holder 11, and the needle 10 is driven to be accommodated in the hollow needle cylinder 12 together.
  • the above-mentioned crushable and contractible rod body is required to have a high degree of symmetry and precision in the fracture portion of the rod in consideration of the direction of application of force and the operability of the person, and the size of the mold for integral injection molding in the production process of the rod body is caused.
  • the tolerance range of the error is small, and it is difficult to prevent the breakage of the rod during assembly and handling, so that the yield and the yield are difficult to increase, and the mold cost cannot be lowered. Furthermore, since the precise design of the broken portion of the rod needs to match the effective angle of application, the safety retracting function can be exerted. Therefore, when the medicine is applied, the organ is a part with a large curvature or a fine body, such as the head and the back of the ear. In the eyes, mouth, etc., the medical staff is not only difficult to single-handed injection, but also because the angle of the application is limited, it is not easy to operate, and the syringe function is accidentally damaged, resulting in discomfort.
  • an automatic retractable non-liquid material safety injection device comprising: a needle hub to which a needle is attached, a hollow syringe, and a pusher assembly disposed in the hollow syringe.
  • the needle hub includes an insertion portion and a hollow passage connecting the insertion portions, and the needle is embedded in the insertion portion.
  • the intermediate passage further includes a distal end and a proximal end, and the diameter of the distal end is greater than the diameter of the proximal end.
  • the hollow needle cylinder holds the needle holder, and the needle hub is retracted into the hollow needle cylinder after the automatic retracting non-liquid material safety injection device completes the injection.
  • the pusher assembly includes a rod, a retracting rod and a hollow rod, and the rod extends from the end of the retracting rod to the needle seat.
  • the hollow rod includes a first socket portion, and the inner sleeve portion includes a second socket portion, and the first socket portion and the second socket portion are sleeved with each other.
  • the second socket portion is formed with a convex portion on the outer side wall, and a concave portion is formed on the inner side wall of the first socket portion, and the convex portion is correspondingly engaged in the concave portion.
  • the present invention also discloses another automatic retractable non-liquid material safety injection device, comprising: a needle hub connected with a needle, a hollow syringe, and a push rod assembly disposed in the hollow syringe.
  • the needle hub includes an insertion portion and a hollow passage connecting the insertion portions, and the needle is embedded in the insertion portion.
  • the hollow channel further includes a distal end and a proximal end, and the diameter of the distal end is greater than the diameter of the proximal end.
  • the hollow needle cylinder holds the needle holder and guides the needle holder after the automatic retractable non-liquid material safety injection device completes the injection Retract into the hollow syringe.
  • the pusher assembly includes a rod body, a retracting rod and a hollow rod, and the rod body extends from the end of the hollow rod to the needle seat.
  • the hollow rod includes a first socket portion, and the inner sleeve portion includes a second socket portion, and the first socket portion and the second socket portion are sleeved with each other.
  • the second socket portion is formed with a convex portion on the outer side wall, and a concave portion is formed on the inner side wall of the first socket portion, and the convex portion is correspondingly engaged in the concave portion.
  • Another object of the present invention is to provide an automatic retractable non-liquid material safety which is difficult to damage the syringe during assembly, improve product quality and yield, increase product reliability, reduce waste of raw materials and process cost. Injection device.
  • a further object of the present invention is to provide an automatic retractable non-liquid material safety which is convenient for plastic injection molding, can reduce the precision of the mold, and allows the error tolerance of the product quality to fall within a reasonable range, thereby reducing the process cost. Injection device.
  • Still another object of the present invention is to provide an automatic retractable non-liquid material safety injection device which has a force applying cushioning and a lateral shear resistance function, improves the convenience of an operator during injection, and reduces an injection failure rate and patient suffering.
  • a further object of the present invention is to provide an automatic retractable non-liquid safe injection device for injecting non-liquid substances for medical or non-medical use in human or animal, which can be applied to subcutaneous injection of solid drugs. Or implant a biochip.
  • a further object of the present invention is to provide an automatic retractable non-liquid material safety injection device which can increase the throughput of a single batch of a mold and greatly increase the production quantity of the product.
  • Still another object of the present invention is to provide an automatic retractable non-liquid material safety injection device that allows the rod body to achieve a predetermined mechanical strength and good maneuverability, and is convenient for automatic retraction with a needle.
  • a further object of the present invention is to provide an automatic retractable non-liquid safe injection for non-liquid substances for medical use or non-medical use, which is used for injecting non-liquid substances into a few meats, subcutaneous, and for single use only.
  • Another object of the present invention is to provide an automatic retracting non-liquid material safety injection device, wherein the push rod assembly adopts a separate design, and the inner and outer rods of elastic material such as plastic or rubber are separately injection molded. It is then assembled again, unlike the one-piece splitter pusher provided by conventional technology.
  • the automatic retracting non-liquid material safety injection device can reduce the accidental collision damage during assembly, reduce the injection error caused by the damage of the push rod before and during the unpacking, and
  • the two-piece push rods are separately formed and assembled again.
  • the precision requirements of the push rods for the forming molds may not be as loose as the integral forming type of the push rods, and the force balance of the joints is considered to be loose, so the mold development cost is small and the mold is improved.
  • the reliability and quality of the product are stable and the balance of the force of the push rod. Therefore, when the patient applies the one hand or the medical staff to inject the hard-to-force part, the operation is not affected by the angle or posture limitation.
  • FIGS. 1A and 1B are schematic cross-sectional views of an automatic retracting safety syringe having a fracture portion.
  • Fig. 2A is a schematic exploded perspective view of the automatic retractable non-liquid material safety injection device of the first embodiment of the present invention.
  • Fig. 2B is a schematic cross-sectional view showing the automatic retracting non-liquid material safety injection device of the first embodiment of the present invention.
  • Fig. 2C is a partially enlarged cross-sectional view showing the needle holder of the self-retracting non-liquid material safety injection device of the first embodiment of the present invention.
  • Fig. 2D is a partially enlarged cross-sectional view showing the hollow push rod and the inner shrink rod of the automatic retracting non-liquid material safety injection device according to the first embodiment of the present invention.
  • Fig. 2E is a schematic view showing the push-in injection of the self-retracting non-liquid material safety injection device of the first embodiment of the present invention.
  • Fig. 2F is a schematic view showing the push-in injection of the self-retracting non-liquid material safety injection device of the first embodiment of the present invention.
  • 2G is a schematic cross-sectional view showing the automatic retracting non-liquid material safety injection device of the first embodiment of the present invention when the injection is completed.
  • 2H is a schematic cross-sectional view showing the retracting rod and the needle holder in the automatic retracting non-liquid material safety injection device according to the first embodiment of the present invention.
  • Fig. 21 is a schematic cross-sectional view showing the retracting rod and the needle holder in the automatic retracting non-liquid material safety injection device according to the first embodiment of the present invention.
  • Fig. 2J is a schematic cross-sectional view showing the retracting rod and the needle holder of the automatic retracting non-liquid material safety injection device according to the first embodiment of the present invention.
  • 2K is a schematic cross-sectional view and a partial enlarged view of a shrink rod and a hollow rod of the automatic retractable non-liquid material safety injection device according to the first embodiment of the present invention.
  • Fig. 2L is a schematic cross-sectional view and a partial enlarged view of the hollow rod of the self-retracting non-liquid material safety injection device of the first embodiment of the present invention.
  • Fig. 3A is a schematic cross-sectional view showing a self-retracting non-liquid material safety injection device according to a second embodiment of the present invention.
  • Fig. 3B is a partially enlarged cross-sectional view showing the inner and outer rods of the self-retracting non-liquid material safety injection device according to the second embodiment of the present invention.
  • Fig. 3C is a schematic cross-sectional view showing the push-in injection of the self-retracting non-liquid material safety injection device of the second embodiment of the present invention.
  • Fig. 3D is a schematic cross-sectional view showing the retraction rod and the needle holder after the retraction of the automatic retracting non-liquid material safety injection device according to the second embodiment of the present invention.
  • Angled structure 2123 Groove 213 slope 214 steering chute 215 retraction guide chute 216 hollow cylinder 12, 22, front end 220, 320 raised portion 221 buckle 222 rear end 223, 323 side wing portion 324 annular retracting spring 13, 23 crushable inner push rod 14, push rod assembly 24, 34 rod body 241, 341 rubber plug head 242 inner shrink rod 25, 35 stress adjustment port 251, 261 second sleeve portion 25a, 35a boss 250, 350 hollow rods 26, 36 recessed portions 260, 360 first set of joints 26a, 36a rod bottom edge 262 exhaust opening 264, 364 blocking member 265 injection 27 front push rod 17, broken portion 18, rear push Rod 19, Tip diameter D1
  • the automatic retractable non-liquid material safety injection device 2 of the first embodiment of the present invention includes at least a syringe cover 200, a needle 20, a needle hub 21 connecting the needles, and a hollow syringe connecting the needle holders. 22 and a pusher assembly 24 disposed within the hollow syringe 22.
  • the pusher assembly 24 includes a rod 241, a retracting rod 25 and a hollow rod 26.
  • the inner retracting rod 25 further includes a rubber plug head 242.
  • the rod 241 extends from the end of the retracting rod (e.g., the rubber head 242) toward the needle holder 21.
  • the automatic retractable non-liquid material safety injection device 2 of the first preferred embodiment of the present invention can be applied to inject liquid medical drugs into the human skin, muscles and veins or blood, and is only for single use.
  • the pusher assembly 24 is disposed within the hollow barrel 22.
  • the hollow needle cylinder 22 can hold the needle holder 21.
  • the elastic restoring force of the annular retracting spring 23 pushes the needle holder 21 to move in the opposite direction of the injection, so that the needle holder 21 is retracted into the hollow needle barrel 22.
  • the inner wall of the hollow syringe 22 includes a protrusion 221, and the protrusion 221 is disposed on the inner wall of the hollow barrel 22 and away from the needle 20.
  • the protrusion 221 can provide the rubber head 242 stress, so that the rubber head 242 and the protruding portion 221 are sleeved, so that the push rod assembly 24 cannot be easily pushed into the hollow needle barrel 22 to prevent the injection 27 from being mistaken. Infused into the patient.
  • the needle hub 21 includes an insertion portion 211 and a hollow channel 212 connecting the insertion portions 211 .
  • the needle 20 is embedded in the embedding portion 211.
  • the hollow channel further includes a distal end 2121 and a proximal end 2122, and the diameter D1 of the distal end 2121 is greater than the diameter D2 of the proximal end 2122; further, the bottom of the needle holder 21 further includes an angled structure 2123, and the curved corner structure 2123 can be more easily
  • the guiding rod 241 (shown in Figure 2B) enters the hollow channel 212 and the infusate 27 has been placed in the hollow channel 212 prior to injection.
  • the hollow needle barrel 22 includes a front end 220 and a rear end 223 (as shown in FIG. 2B). Show).
  • the front end 220 of the hollow needle barrel 22 includes a plurality of buckles 222, and the buckles 222 face the center of the hollow needle cylinder 22.
  • the needle hub 21 further includes a plurality of sequentially connected grooves 213, a slope 214, a steering chute 215 and a retracting guide chute 216 (please refer to FIG. 2A). Before and during use of the self-retracting non-liquid safe injection device 2, the hook 222 is connected to the groove 213 to hold the needle holder 21.
  • the buckle between the hook 222 and the groove 213 is released to release the buckle with the groove 213.
  • the buckle 222 slides along each slope 214 into each of the steering slide 215 and the retracting guide slide 216, thereby retracting the needle holder 21 to the hollow needle cylinder. 22 inside.
  • the annular retracting spring 23 is further stressed.
  • the annular retracting spring 23 is released, and the hub 21 is retracted into the hollow cylinder 22 by the loose annular retracting spring 23.
  • the hollow rod 26 includes a first socket portion 26a, and the inner rod portion 25 includes a second sleeve portion 25a, and the first socket portion 26a and the second socket portion 25a are sleeved with each other.
  • the second socket portion 25a is formed with at least a convex portion 250 on the outer side wall, and at least one concave portion 260 is formed on the inner side wall of the first socket portion 26a, and the convex portion 250 is correspondingly engaged in the concave portion 260.
  • Fig. 2G is an automatic retractable non-liquid material safety injection device 2 before the needle 20, the needle hub 21 and the retraction rod 25 have not started the retraction mechanism after the injection is completed.
  • the buckle 222 slides along the slope 214 into each of the steering slide 215 and the retracting guide slide 216, thereby making the needle
  • the seat 21 is retracted into the hollow syringe 22.
  • the annular retracting spring 23 is further compressed by the user's thrust.
  • the annular retracting spring 23 will stretch.
  • the needle holder 21 is retracted into the hollow barrel 22 by the extended annular retracting spring 23.
  • the buckle 222 is elastically expanded and then unfastened from the groove 213 and has been slid into the steering chute 215 along the slope 214.
  • the user continues to apply force to the hollow rod 26, and the engagement of the boss portion 250 and the recess portion 260 is released by the force deformation, so that the inner contracting rod 25 is retracted to the hollow.
  • the hollow cylinder 22 originally occupied by the inner contracting rod 25 can be vacated to accommodate the needle holder 21.
  • the needle 20, the needle holder 21 and the rod body 241 are retracted into the hollow needle barrel 22.
  • the outer wall of the hollow rod 26 may further have two blocking members 265 arranged laterally, and the two blocking members 265 are away from the first socket portion 26a.
  • the blocking member 265 that engages the rear end 223 of the hollow barrel 22 prevents the hollow rod 26 from being pushed further into the hollow barrel 22.
  • At least one lateral stress adjustment port 251 may be provided at the core of the second socket portion 25a.
  • the stress adjustment port 251 can be a recess, a blind hole or a through hole.
  • the depth position of the lateral stress adjustment opening 251 is generally preferably at a position close to but not reaching the outer side wall boss portion 250 of the inner contraction rod 25. In this way, when the automatic retractable non-liquid material safety injection device 2 completes the injection and the push rod assembly 24 continues to be stressed, the lateral stress adjustment port 251 is allowed to deform and thereby the convex portion 250 and the recess portion 260 are released.
  • the bottom edge 262 of the hollow rod 26 can also be selectively provided with a stress adjustment opening 261.
  • the stress adjustment port 261 can also be a recess, a blind hole or a through hole.
  • the depth position of the lateral stress adjustment port 261 is generally preferably in a position close to but not reaching the inner wall recess 260 of the hollow rod 26.
  • the hollow rod 26 may additionally be provided with at least one exhaust opening 264 (not shown in FIG. 2C).
  • the exhaust opening 264 is appropriately exhausted. Function, to avoid air resistance affecting the feel of the thumb, and thus easy for personnel to operate.
  • the convex portion 250 in this embodiment may be a bump formed when the inner shrink rod 25 is formed by injection molding, and the shape, size, number, and arrangement of the bumps are not significantly limited, but the first comparison
  • the preferred embodiment is a six-symmetric convex, as an example of a preferred embodiment, and for example, the outer convex ring rib is also included within the equivalent range of the raised portion 250 described in the first preferred embodiment.
  • the hollow rod 26 is further formed with a plurality of accommodating portions 250 in the vicinity of the inner side wall of the rod and the inner retracting rod 25 being sleeved.
  • the recesses 260 may be grooves, recesses, or partial or complete inner W-ring ribs, and the recesses 260 may be C-shaped, angular, or irregular in cross section.
  • the present invention provides a second preferred embodiment, which is also an automatic retractable automatic retracting non-liquid material safety injection device.
  • FIG. 3A a cross-sectional view of a self-retracting non-liquid material safety injection device 3 according to a second preferred embodiment of the present invention is shown.
  • the difference between the second preferred embodiment and the first preferred embodiment is that the positions of the retracting rod 35 and the hollow rod 36 of the second preferred embodiment are mutually interchangeable compared with the first preferred embodiment. That is, the inner retracting rod 35 is closer to the needle holder 31, and the hollow rod 36 is disposed at a position away from the needle holder 31.
  • the rod body 341 extends from the one end of the hollow rod 36 toward the needle holder 31.
  • the remaining components of the automatic retractable non-liquid material safety injection device 3 of the second preferred embodiment and their connection relationship are substantially the same as those of the first preferred embodiment.
  • the convex portion 350 of the inner wall end of the inner retracting rod 35 is The caliper of the recessed portion 360 will be released by the force deformation, forcing the retracting rod 35 to retreat into the hollow rod 36.
  • the sidewall of the hollow stem 36 has at least one venting opening 364 (shown in Figure 3A) and the venting opening 364 is remote from the first ferrule 36a.
  • the needle holder 31 is retracted toward the inner contracting rod 35 to be retracted to the hollow in the opposite direction of the hollow rod 36.
  • the rear end 323 of the hollow syringe 32 optionally includes a side wing 324 to block the retracting rod 35. The bottom end is further pushed into the hollow needle barrel 32, and the distance of the inner contraction rod 35 to retract into the hollow needle barrel 32 can also be controlled to make room in the hollow needle barrel 32 to accommodate the retracted needle holder 31.
  • the push rod assembly which is formed by the hollow rod and the inner retracting rod in two stages, regardless of the hollow rod and the inner portion Variations such as the nesting sequence, the snapping manner, or the segmental engagement of the reduction bar are included in the equivalent range of the present invention which is easily conceivable and can be reasonably expanded.
  • the automatic retracting non-liquid material safety injection device of the present invention is on the inner and outer rods of the push rod assembly, Various reinforcement designs as described above are also provided.

Description

自动回缩式非液态物安全注射装置
技术领域
本发明是关于一种安全注射装置， 特别是指一种得以单手操作并可自 动让用毕针头回缩的自动回缩式非液态物安全注射装置 （Automatically Retractable Medically Safety Injector ) 以降低注射后针头扎伤的风险。 背景技术
传统药物注射时， 为降低如艾滋病、 B 型肝炎、 C 型肝炎等血液交互 感染疾病的罹患风险， 杜绝药物成瘾者重复使用， 目前广泛使用的注射针 筒多半采用需由使用者以双手操作， 将针筒之推杆折断， 以防止重复使用 的自毁式设计， 也就是一次使用完毕后即行毁损的可抛式针筒。 然而， 这 种一次性使用的自毁式针筒， 在注射完成后， 已污染之针头仍然暴露在针 筒外， 极易造成对医护人员之针扎伤害， 在使用上， 亦必须以两手操作才 能完成自毁功能。 公元 2000 年美国率先全球完成针扎安全防治法案之立 法， 规定一定要使用有安全机制的注射针筒之后， 有不少称为安全针筒之 产品问市， 但其中绝大部份均为须以两手操作三至五个步骤才能完成安全 功能之启动。 医护人员须双手操作的安全针筒， 针扎伤的风险较单手操作 的安全针筒高出甚多， 故医护人员对双手操作的安全针筒接受度较低。
为此， 台湾专利第 520995号案「 自动回缩式安全注射器」及美国专利 第 6,712,793 B1号 " Needle Guard Assembly for the Needle of A Syringe Body " 提出一种方便单手操作的新颖安全针筒。 如图 1A及图 1B所示， 此针筒包含中空针筒 12，、 衔接针头 10，的针座 11，、 环形回缩弹簧 13，及可 压断内缩式棒体 14，。 其中， 可压断内缩式棒体 14，包括一体形成的前段棒 体 17，、 断裂部 18，， 及一空心的后段棒体 19，。 当可压断内缩式棒体 14，组 装到中空针筒 12，内完成药液注射以后，使用者持续朝针头施力可令该断裂 部 18，破裂， 导致该前段棒体 17，缩入中空后段棒体 19，的空心处而腾出空 间让针座 11，带动用毕针头 10，一起收纳至中空针筒 12，内。 然而， 上述可压断内缩式棒体考虑施力方向及人员操作性， 在棒体断 裂部的对称性以及精密度上要求很高， 导致棒体制作过程中一体射出成型 所用的模具的尺寸误差的容许范围很小， 并且很难防止棒体在组装搬运过 程中造成的断裂， 如此良率及产量难以提升， 模具成本也无法下降。 再则， 由于棒体断裂部的精密设计需配合有效的施力角度才能发挥安全回缩功 能， 因此， 当药物施打部位属于弯曲度较大或人体较为精细的器官， 如头 部、 耳后、 眼睛、 口腔等部位时， 医护人员不仅难以单手注射， 更容易因 为施打角度受限、 不容易操作而不慎损及针筒功能， 造成患者不适。
此外， 由于近年来医药发展之进步， 有许多长效型药剂， 须要做成固 体剂型， 但是传统注射针筒是无法用于注射固体剂型剂型药物的。 发明内容
为解决上述问题，本发明揭露一种自动回缩式非液态物安全注射装置， 包括： 连接有针头的针座、 中空针筒， 以及安置于中空针筒内的推杆组合 件。 针座包含嵌入部与连接嵌入部的中空道， 针头嵌设于该嵌入部中。 中 空道进一步包含末梢端与近侧端， 且末梢端的直径大于近侧端的直径。 中 空针筒扣持针座， 并且在自动回缩式非液态物安全注射装置完成注射后引 导针座回缩至中空针筒内。 推杆组合件包含棒体、 内缩杆及中空杆， 棒体 自内缩杆的末端向针座延伸。 中空杆包含第一套接部， 内缩杆包含第二套 接部， 第一套接部与第二套接部互相套接。 第二套接部在外侧壁上形成有 凸起部， 第一套接部内侧壁上形成有凹陷部， 凸起部对应卡嵌于凹陷部中。 其中， 当推杆组合件于注射完成后， 中空杆继续受力时， 凸起部与 陷部 的卡嵌会因受力变形而解除， 迫使内缩杆顺势退入中空杆， 藉以在中空针 筒内腾出空间收容回缩的针座。
此外， 本发明亦揭露另一种自动回缩式非液态物安全注射装置， 包括: 连接有针头的针座、 中空针筒， 以及安置于中空针筒内的推杆组合件。 针 座包含嵌入部与连接嵌入部的中空道， 针头嵌设于该嵌入部中。 中空道进 一步包含末梢端与近侧端， 且末梢端的直径大于近侧端的直径。 中空针筒 扣持针座， 并且在自动回缩式非液态物安全注射装置完成注射后引导针座 回缩至中空针筒内。 推杆组合件包含棒体、 内缩杆及中空杆， 棒体自中空 杆的末端向针座延伸。 中空杆包含第一套接部， 内缩杆包含第二套接部， 第一套接部与第二套接部互相套接。第二套接部在外侧壁上形成有凸起部， 第一套接部内侧壁上形成有凹陷部， 凸起部对应卡嵌于凹陷部中。 其中， 当推杆组合件于注射完成后， 中空杆继续受力时， 凸起部与 陷部的卡嵌 会因受力变形而解除， 迫使内缩杆顺势退入中空杆， 藉以在中空针筒内腾 出空间收容回缩的针座。
因此， 本发明的主要目的， 在于提供一种方便单手操作， 不易因为人 员操作角度或姿势而导致针筒于注射当中毁损的自动回缩式非液态物安全 注射装置。
本发明的另一目的， 在于提供一种组装过程中不易使针筒受损， 提高 产品质量及良率， 增加产品可靠度， 减少原物料的浪费以及处理成本的自 动回缩式非液态物安全注射装置。
本发明的再一目的， 在于提供一种便于塑料射出成型， 并可降低模具 精密度要求， 让产品质量的误差容许率落在合理范围内， 进而降低制程成 本的自动回缩式非液态物安全注射装置。
本发明的又一目的， 在于提供一种具备施力緩沖及抗横向剪力功能， 提升人员注射时操作的便利性， 减少注射失败率及患者痛苦的自动回缩式 非液态物安全注射装置。
本发明的再一目的， 在于提供一种注射医药用或非医药用的非液态 (non-liquid)物质于人体或动物的自动回缩式非液态物安全注射装置， 可应 用于皮下注入固体药物或植入生物芯片。
本发明的复一目的， 在于提供一种可增加模具单一批次产能， 大幅提 高产品生产数量的自动回缩式非液态物安全注射装置。
本发明的再一目的， 在于提供一种让棒体达到预设力学强度及良好操 作性， 方便用毕针头自动回缩的自动回缩式非液态物安全注射装置。
本发明的再一目的， 是提供一种用于医药用途或非医药用途， 将非液 态物质注入几肉、 皮下， 且仅供单次使用 （Single use ) 的自动回缩式非液 态物安全注射装置。 本发明的又一目的在于提供一种自动回缩式非液态物安全注射装置， 其推杆组合件采用分离式设计， 将塑料或橡胶等弹性材质的内缩杆和中空 杆分别射出成型， 完成之后再行组装， 与传统技术所提供的一体成型式断 裂部推杆不同。 本发明所提供的自动回缩式非液态物安全注射装置， 可以 减少在组装时不慎碰撞受损， 降低拆封前及使用过程中， 肇因于推杆毁损 所产生的注射失误， 而且， 两件式推杆分别成型完成再行组装， 推杆对于 成型模具的精密度要求可以不像一体成型式断裂部推杆需考虑接合部位的 力平衡而较为宽松， 因此模具开发成本少， 并提高产品的可靠度及质量稳 推杆的力平衡特性， 因此患者自行以单手施打或医护人员注射较难施力的 部位时， 亦不致因为施打角度或姿势限制而影响操作性。 附图说明
图 1A及图 1B是已知具有断裂部的自动回缩式安全注射器的剖面示意 图。
图 2A 是本发明第一实施例的自动回缩式非液态物安全注射装置的立 体分解示意图。
图 2B 是本发明第一实施例的自动回缩式非液态物安全注射装置的剖 面示意图。
图 2C 是本发明第一实施例的自动回缩式非液态物安全注射装置针座 的局部剖面放大示意图。
图 2D 是本发明第一实施例的自动回缩式非液态物安全注射装置中空 推杆与内缩杆套接处的局部剖面放大示意图。
图 2E 是本发明第一实施例的自动回缩式非液态物安全注射装置推入 注射物示意图。
图 2F 是本发明第一实施例的自动回缩式非液态物安全注射装置推入 注射物示意图。
图 2G 是本发明第一实施例的自动回缩式非液态物安全注射装置注射 完成时剖面示意图。 图 2H 是本发明第一实施例的自动回缩式非液态物安全注射装置内缩 杆与针座回缩时的剖面示意图。
图 21是本发明第一实施例的自动回缩式非液态物安全注射装置内缩杆 与针座回缩时的剖面示意图。
图 2J是本发明第一实施例的自动回缩式非液态物安全注射装置内缩杆 与针座回缩后的剖面示意图。
图 2K是本发明第一实施例的自动回缩式非液态物安全注射装置内缩 杆与中空杆剖面示意图以及局部放大图。
图 2L 是本发明第一实施例的自动回缩式非液态物安全注射装置中空 杆剖面示意图以及局部放大图。
图 3A 是本发明第二实施例的自动回缩式非液态物安全注射装置的剖 面示意图。
图 3B 是本发明第二实施例的自动回缩式非液态物安全注射装置内缩 杆与中空杆局部剖面放大示意图。
图 3C 是本发明第二实施例的自动回缩式非液态物安全注射装置推入 注射物剖面示意图。
图 3D 是本发明第二实施例的自动回缩式非液态物安全注射装置内缩 杆与针座回缩后的剖面示意图。
【主要组件符号说明】
自动回缩式非液态物安全注射装置 2、 3
针头 10，、 20、 30
针筒盖 200
针座 11，、 21、 31
嵌入部 211
末梢端 2121
近侧端 2122
弯角结构 2123 凹沟 213 斜坡 214 转向滑道 215 回缩导引滑道 216 中空针筒 12，、 22、 前端 220、 320 凸起部 221 扣勾 222 后端 223、 323 侧翼部 324 环形回缩弹簧 13，、 23 可压断内缩式推杆 14， 推杆组合件 24、 34 棒体 241、 341 胶塞头 242 内缩杆 25、 35 应力调节口 251、 261 第二套接部 25a, 35a 凸起部 250、 350 中空杆 26、 36 凹陷部 260、 360 第一套接部 26a, 36a 杆体底缘 262 排气开孔 264、 364 阻挡件 265 注入物 27 前段推杆 17， 断裂部 18， 后段推杆 19， 末梢端的直径 D1
近侧端的直径 D2 具体实施方式
由于本发明是揭露一种自动回缩式非液态物安全注射装置， 其中所利 用物理原理以及注射装置相关制程， 已为相关技术领域具有通常知识者所 能明了， 故以下文中的说明， 不再作完整描述。 同时， 以下文中所对照的 附图， 是表达与本发明特征有关的含义， 并未亦不需要依据实际情形完整 绘制， 在先声明。
首先， 请参见图 2A, 本发明第一实施例的自动回缩式非液态物安全注 射装置 2至少包括有针筒盖 200、 针头 20、 连接针头的针座 21、 连接针座 的中空针筒 22以及安置于中空针筒 22内的推杆组合件 24。 其中， 推杆组 合件 24包含棒体 241、 内缩杆 25与中空杆 26。 内缩杆 25进一步包含胶塞 头 242。 棒体 241由内缩杆的末端（如胶塞头 242), 向针座 21方向延伸。 本 发明的第一较佳实施例的自动回缩式非液态物安全注射装置 2 , 可应用于 将液态医疗药物注入人体皮下、 肌肉及静脉或抽血， 并且仅供单次使用。
请参见图 2B , 推杆组合件 24设置于中空针筒 22内。 中空针筒 22可 扣持针座 21 , 当注射完成， 环形回缩弹簧 23的弹性恢复力是推动针座 21 朝注射反方向移动， 使针座 21回缩至中空针筒 22内。 其中， 中空针筒 22 的内壁包含有一凸出部 221 , 且凸出部 221设置于中空针筒 22的内壁上且 远离该针头 20处。 凸出部 221能提供胶塞头 242应力， 使胶塞头 242与凸 出部 221套接， 使推杆组合件 24无法被轻易地推入中空针筒 22中， 以避 免注入物 27被误注入病人体内。
请参见图 2B及图 2C,针座 21包含嵌入部 211与连接嵌入部 211的中 空道 212。 其中， 针头 20嵌设于嵌入部 211中。 中空道进一步包含末梢端 2121与近侧端 2122,且末梢端 2121的直径 D1大于近侧端 2122的直径 D2; 此外， 针座 21的底部进一步包含有弯角结构 2123 , 弯角结构 2123能更易 引导棒体 241(如图 2B所示）进入中空道 212, 且注入物 27已在注射前置入 于中空道 212内。 此外， 中空针筒 22包含前端 220与后端 223(如图 2B所 示）。 且中空针筒 22的前端 220包含多个扣勾 222, 且该等扣勾 222面向中 空针筒 22的中心。 此外， 针座 21进一步包含多个依序连接的凹沟 213、 斜坡 214、转向滑道 215与回缩导引滑道 216(请参照图 2A)。在自动回缩式 非液态物安全注射装置 2使用之前与使用期间， 扣勾 222连接凹沟 213以 挟持针座 21。 其中， 中空杆 26于注射完成后继续受力时， 扣勾 222与 沟 213间的卡扣解除， 以解除与 沟 213间的卡扣。 扣勾 222与 沟 213 间的卡扣解除后， 扣勾 222会沿着各斜坡 214滑入各转向滑道 215与回缩 导引滑道 216, 藉此使针座 21回缩至中空针筒 22内。 当扣勾 222滑入转 向滑道 215时， 环形回缩弹簧 23会进一步受力。 而当扣勾 222滑入回缩导 引滑道 216时， 松脱环形回缩弹簧 23 , 针座 21 即藉由松脱的环形回缩弹 簧 23回缩至中空针筒 22内。
请参见图 2D, 中空杆 26包含第一套接部 26a, 内缩杆 25包含第二套 接部 25a, 且第一套接部 26a与第二套接部 25a互相套接。 第二套接部 25a 在外侧壁上形成有至少凸起部 250,第一套接部 26a内侧壁上至少有一凹陷 部 260, 且凸起部 250对应卡嵌于凹陷部 260中。
请参见图 2E、 2F、 2G、 2H、 21与 2J。 如图 2E与 2F所示， 在注射时， 棒体 241能从中空道 212中， 将注入物 27(无论是固态物或胶状物)推入针 头 20内。 最终， 注入物 27能经由针头 20进入病人体中。 图 2G为在注射 完成后， 针头 20、 针座 21与内缩杆 25仍未启动回缩机制前的自动回缩式 非液态物安全注射装置 2。
此时， 如前所述， 扣勾 222与凹沟 213间的卡扣解除后， 扣勾 222会 沿着斜坡 214滑入各转向滑道 215与回缩导引滑道 216 , 藉此使针座 21回 缩至中空针筒 22内。 当扣勾 222沿着斜坡 214滑入各转向滑道 215的过程 中， 环形回缩弹簧 23 是进一步受到使用者的推力而被压缩的。 而当扣勾 222滑入回缩导引滑道 216时， 环形回缩弹簧 23即会伸张。 此外， 针座 21 藉由伸张的环形回缩弹簧 23回缩至中空针筒 22 内。 如图 2H所示， 扣勾 222弹性扩张后与凹沟 213解除扣合， 且已沿斜坡 214滑入转向滑道 215。
如图 21 所示， 在注射完成后， 使用者继续施力于中空杆 26 , 凸起部 250与凹陷部 260的卡嵌会因受力形变而解除， 以使内缩杆 25回缩至中空 杆 26内。 因此， 原本由内缩杆 25占据的中空针筒 22空间， 能被空出以容 纳针座 21。 如图 2J所示， 最终， 针头 20、 针座 21与棒体 241 , 皆回缩至 中空针筒 22内。
如图 2G及 21中皆有显示， 中空杆 26的外壁上可进一步具有横向排列 的两个阻挡件 265 ,且两个阻挡件 265远离第一套接部 26a。当注射完成后， 衔接于中空针筒 22后端 223的阻挡件 265能避免中空杆 26被更进一步推 入中空针筒 22。
请参见图 2K, 为维持推杆组合件 24(如图 2B所示）的压力平衡， 在第 二套接部 25a的核心处可以设置有至少一个横向应力调节口 251。应力调节 口 251可以是凹穴、 盲孔或是通孔。 同时， 横向应力调节口 251的纵深位 置，一般来说是以接近但并未到达内缩杆 25外侧壁凸起部 250的位置为佳。 如此一来， 当自动回缩式非液态物安全注射装置 2完成注射且推杆组合件 24继续受力时，将容许横向应力调节口 251发生形变并藉以解除凸起部 250 与凹陷部 260的卡箝。 此外， 如图 2L所示， 中空杆 26的杆体底缘 262也 能选择性地开设有应力调节口 261。 应力调节口 261 亦可为凹穴、 盲孔或 是通孔。 同时， 横向应力调节口 261 的纵深位置， 一般来说亦是以接近但 并未到达中空杆 26内侧壁 陷部 260的位置为佳。
请再参考图 2B , 中空杆 26可额外设置至少一个排气开孔 264(未见于 图 2C) , 让内缩杆 25回缩至中空杆 26时， 藉由排气开孔 264发挥适当排 气功能， 以避免空气阻力影响拇指手感， 进而便于人员操作。
进一步来说，本实施例中的凸起部 250可以是在内缩杆 25射出成型时 一并形成的凸点， 而凸点的形状、 大小、 数量、 排列均无明显限制， 惟第 一较佳实施例是以六个对称凸,、作为较佳态样的示例， 而且例如外凸环肋 也包含在第一较佳实施例所述的凸起部 250的等效范围内。
请参考图 2L, 为达成其与内缩杆 25套接并且紧密卡箝的目的， 中空 杆 26在其杆体内侧壁与内缩杆 25套接的附近， 进一步形成有多个可与凸 起部 250对位卡箝的凹陷部 260。 这些凹陷部 260可为凹槽、 凹洞， 或是 部份或完整的内 W环肋， 而 陷部 260截面则可为 C形、 角圓形或不规则 形。举凡可与内缩杆 25相对应的凸起部 250(如图 2D所示）紧密卡箝的构形， 皆为第一较佳实施例凹陷部 260的等效范围所包含。
此外， 本发明还提供第二较佳实施例， 也为一种自动回缩式自动回缩 式非液态物安全注射装置。 请参考图 3A, 为本发明第二较佳实施例自动回 缩式非液态物安全注射装置 3 的剖面示意图。 第二较佳实施例与第一较佳 实施例不同处， 是在于第二较佳实施例的内缩杆 35与中空杆 36的位置与 第一较佳实施例相比， 是互相调换， 亦即内缩杆 35较靠近针座 31 , 而中 空杆 36则设置于远离针座 31的位置。棒体 341 自中空杆 36的一端向针座 31延伸。 而第二较佳实施例自动回缩式非液态物安全注射装置 3其余所具 有的各部构件及其连接关系与第一较佳实施例大致相同。
如此一来， 当自动回缩式非液态物安全注射装置 3完成注射且使用者 继续施力于推杆组合件 34时， 如图 3B所示， 内缩杆 35内壁顶端的凸起部 350与凹陷部 360的卡箝将会因受力变形而解除， 迫使内缩杆 35顺势退入 中空杆 36。 此外， 中空杆 36侧壁上具有至少一排气开孔 364(示于图 3A) , 且排气开孔 364远离第一套接部 36a。
同时， 如图 3C与图 3D所示， 当凸起部 350与凹陷部 360的卡嵌受力 变形解除后，针座 31朝内缩杆 35回缩至中空杆 36的反方向回缩至中空针 筒 32内。 而如图 3D所示， 为确使较佳单手操作自动回缩式非液态物安全 注射装置 3 , 中空针筒 32的后端 323另选择性包含有一侧翼部 324以阻止 内缩杆 35的底端被进一步推入中空针筒 32, 亦能控制内缩杆 35回缩入中 空针筒 32的距离， 以在中空针筒 32腾出空间收容回缩的针座 31。
前述的各种实施态样， 均属于本发明的较佳实施态样而非据以为限， 举凡由中空杆与内缩杆两段式套接而成的推杆组合件， 无论中空杆及内缩 杆的套接顺序、 卡扣方式或分段接合等变化， 均包含于本发明易于想到且 能合理扩张的等效范围内。 同时为配合使用者在注射过程中， 单手施力的 强度或角度等各种可能， 本发明的自动回缩式非液态物安全注射装置在推 杆组合件的内缩杆与中空杆上， 亦提供了如前述的各式强化设计。
以上所述仅为本发明较佳实施例而已， 并非用以限定本发明申请专利 权利； 同时以上的描述对于熟知本技术领域的专门人士应可明了与实施， 因此其它未脱离本发明所揭示的精神下所完成的等效改变或修饰， 均应包 含于下述的申请专利范围。

Claims

权利要求书
1、 一种自动回缩式非液态物安全注射装置， 包括：
一针座， 连接有一针头， 该针座包含一嵌入部与一连接嵌入部的中空 道， 该针头嵌设于该嵌入部中； 该中空道进一步包含一末梢端与一近侧端， 且该末梢端的直径大于近侧端的直径；
一中空针筒， 其扣持该针座， 并且在该自动回缩式非液态物安全注射 装置完成注射后引导该针座回缩至该中空针筒内； 以及
一安置于该中空针筒内的推杆组合件， 该推杆组合件包含一棒体、 一 内缩杆及一中空杆， 该棒体自该内缩杆的末端向该针座延伸， 该中空杆包 含一第一套接部， 该内缩杆包含第二套接部， 该第一套接部与该第二套接 部互相套接， 该第二套接部在外侧壁上形成有至少一凸起部， 该第一套接 部内侧壁上形成有至少一凹陷部， 该凸起部是对应卡嵌于该凹陷部中； 其 中， 当该推杆组合件于注射完成后， 中空杆继续受力时， 该凸起部与该凹 陷部的卡嵌会因受力变形而解除， 迫使该内缩杆顺势退入该中空杆， 已在 该中空针筒内腾出空间收容回缩的该针座。
2、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该第一套接部包含至少一应力调节口。
3、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该第二套接部包含至少一应力调节口。
4、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该针座进一步包含多个依序连接的 沟、 斜坡、 转向滑道与回缩导引滑道； 且中空针筒包含多个扣勾， 且该等扣勾连接该等 沟以夹持该针座； 其中， 当该中空杆于注射完成后继续受力时， 该等扣勾与凹沟间的卡扣解除， 该 等扣勾各自沿着斜坡滑入各转向滑道与回缩导引滑道以使该针座回缩至中 空针筒内。
5、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该针座的底部进一步包含有一弯角结构。
6、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该中空针筒包含有一凸出部， 该凸出部设置于该中空针筒的内壁上， 且远 离该针头处。
7、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 中空杆具有至少一排气开孔， 且该排气开孔远离该第一套接部。
8、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该中空杆的外壁至少具有一阻挡件， 且该阻挡件远离第一套接部。
9、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该凸起部为一体成型于该内缩杆上的外侧壁上， 且该凸起部选自由多个凸 点及复数排相邻排列的横向外凸环肋所组成的族群。
10、 根据权利要求 1所述的自动回缩式非液态物安全注射装置， 其中， 该凹陷部为选自于由一凹洞、 一凹槽、 多个凹洞及多排相邻排列的环状凹 槽所组成的族群。
11、 一种自动回缩式非液态物安全注射装置， 包括：
一针座， 连接有一针头， 该针座包含一嵌入部与一连接嵌入部的中空 道， 该针头嵌设于该嵌入部中； 该中空道进一步包含一末梢端与一近侧端， 且该末梢端的直径大于近侧端的直径；
一中空针筒， 其扣持该针座， 并且在该自动回缩式非液态物安全注射 装置完成注射后引导该针座回缩至该中空针筒内； 以及
一安置于该中空针筒内的推杆组合件， 该推杆组合件包含一棒体、 一 内缩杆及一中空杆， 该棒体自该内缩杆的末端向该针座延伸， 该中空杆包 含一第一套接部， 该内缩杆包含第二套接部， 该第一套接部与该第二套接 部互相套接， 该第二套接部在外侧壁上形成有至少一凸起部， 该第一套接 部内侧壁上形成有至少一凹陷部， 该凸起部对应卡嵌于该凹陷部中； 其中， 当该推杆组合件于注射完成后， 内缩杆继续受力时， 该凸起部与该凹陷部 的卡嵌会因受力变形而解除， 迫使该内缩杆顺势退入该中空杆， 以在该中 空针筒内腾出空间收容回缩的该针座。
12、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该第一套接部包含至少一应力调节口。
13、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该第二套接部包含至少一应力调节口。
14、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该针座进一步包含多个依序连接的 沟、 斜坡、 转向滑道与回缩导引滑道； 且中空针筒包含多个扣勾， 且该等扣勾连接该等 沟以挟持针座； 其中， 当该内缩杆于注射完成后继续受力时，该等扣勾与该等 沟间的卡扣解除， 该等扣勾各自沿着各斜坡滑入各转向滑道与回缩导引滑道， 藉此使该针座 回缩至中空针筒内。
15、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该针座的底部进一步包含有一弯角结构。
16、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该中空针筒包含有一凸出部， 该凸出部设置于该中空针筒的内壁上， 且远 离该针头处。
17、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 中空杆具有至少一排气开孔， 且该排气开孔远离该第一套接部。
18、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该中空针筒包含有一侧翼部分在近侧端。
19、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该凸起部为一体成型于该内缩杆上的外侧壁上， 且该凸起部选自由多个凸 点及多排相邻排列的横向外凸环肋所组成的族群。
20、根据权利要求 11所述的自动回缩式非液态物安全注射装置，其中， 该凹陷部选自于由一凹洞、 一凹槽、 多个凹洞及多排相邻排列的环状凹槽 所组成的族群。
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