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CN110548201B - An injection device - Google Patents

An injection device Download PDF

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Publication number
CN110548201B
CN110548201B CN201910849164.4A CN201910849164A CN110548201B CN 110548201 B CN110548201 B CN 110548201B CN 201910849164 A CN201910849164 A CN 201910849164A CN 110548201 B CN110548201 B CN 110548201B
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China
Prior art keywords
injection
needle
injection site
injection device
drive
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Active
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CN201910849164.4A
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Chinese (zh)
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CN110548201A (en
Inventor
郝云玲
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Individual
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Priority to CN201910849164.4A priority Critical patent/CN110548201B/en
Publication of CN110548201A publication Critical patent/CN110548201A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42Devices 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 desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/14Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers

Landscapes

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

Abstract

本公开实施例公开了一种注射装置。该注射装置配置为装入包括笔芯的注射器和针头,或者装入笔芯和针头,所述注射装置包括:注射部位固定器,其配置为固定注射部位的表皮和皮下组织;主机,其连接到所述注射部位固定器,且配置为对所述被固定的注射部位自动执行注射过程。该注射装置能够固定注射部位的表皮和皮下组织,使得针头穿刺深度尽量不进入肌肉组织,从而便于注射且减少使用者的疼痛感;且其能够自动执行注射过程,降低了操作难度,使得注射经验不足的使用者也能够方便高效地执行注射过程。

The embodiment of the present disclosure discloses an injection device. The injection device is configured to be loaded with a syringe including a refill and a needle, or a refill and a needle, and the injection device includes: an injection site fixer, which is configured to fix the epidermis and subcutaneous tissue of the injection site; a host, which is connected to the injection site fixer and is configured to automatically perform an injection process on the fixed injection site. The injection device can fix the epidermis and subcutaneous tissue of the injection site so that the needle puncture depth does not enter the muscle tissue as much as possible, thereby facilitating injection and reducing the user's pain; and it can automatically perform the injection process, reducing the difficulty of operation, so that users with insufficient injection experience can also perform the injection process conveniently and efficiently.

Description

Injection device
Technical Field
The present disclosure relates to an injection device, and more particularly, to an injection device for use with a syringe or with a cartridge and needle.
Background
China is the most diabetic world, and the number of people suffering from diabetes is increasing each year, 1.1 million diabetics exist in China at present, and 9000 ten thousand in 2011. According to the predictions of the world health organization, people with chinese diabetes will increase from the current 1.1 million to 1.5 million by 2040 years without taking urgent actions to reduce lifestyle-related risk factors such as unhealthy diet, and sedentary and lack of physical exercise. Simultaneously, china is the country with the largest number of diabetics, and the main reason is that the treatment rate and the control rate of the Chinese diabetics are very low. According to the investigation data of the diabetes science meeting of the China medical society, the blood sugar standard reaching rate of diabetics who are already treated by insulin in China is only 37%, and insulin injection and injection technology are not standardized according to the medical order rule, so that the blood sugar standard reaching rate of the diabetics in China is the main reason for low blood sugar control standard reaching rate.
Insulin secretion in the body of diabetic patients is relatively insufficient or insulin resistance exists, and early use of insulin therapy is necessary. Insulin injection allows temporarily resting the functioning of the islets B cells that are not functioning as if they were ill. Some diabetics are treated for a period of time, and islet B cell function may be restored to some extent, and some may even reduce or stop insulin injections. Insulin treatment can reduce blood sugar, avoid toxicity of oral medicine to liver and kidney, and reduce or delay complication.
With the continuous progress of the technology, the insulin pen is more convenient to use, the needle is thinner, the pain of injection is smaller, and the cost is lower. Even so, most diabetics are willing to take hypoglycemic drugs to control blood sugar rather than insulin injection, and the main reasons are that on one hand, the patients have fear on needles, the diabetics need to inject subcutaneously 1-4 times per day, the pain and fear of each injection can make many diabetics to be forgiving to insulin injection, on the other hand, the normative requirements of insulin injection on insulin pen operation are higher, and on the other hand, many middle-aged and elderly diabetics have poor eyesight, and cannot finish accurate operation, and the insulin injection pen cannot be independently used for finishing injection. In addition, the subcutaneous tissue thickness varies from part to part of the body and the injection method varies. If the injection method is not standard, not only the pain of injection is increased, but also the insulin injection dosage is inaccurate, so that the fluctuation range of blood sugar is large, and complications can also occur early.
In addition to insulin injections, other frequent subcutaneous injection procedures also present the above-described problems.
Disclosure of Invention
There is therefore a need for an injection device that solves the above problems in the prior art. There is a need for an injection device that can be used with a syringe and needle including a cartridge or cartridge and needle, and can fix epidermis and subcutaneous tissue of an injection site so that a penetration depth of the needle does not enter muscle tissue as much as possible, thereby facilitating injection and reducing pain of a user, and that can automatically perform an injection process, reducing operational difficulty, so that a user with insufficient injection experience can conveniently and efficiently perform an injection process.
According to a first aspect of the present disclosure, there is provided an injection device configured to fit into a syringe and needle including a cartridge, or to fit into a cartridge and needle. The injection device includes an injection site holder configured to hold epidermis and subcutaneous tissue of an injection site, and a host secured to the injection site holder and configured to automatically perform an injection procedure on the secured injection site.
In some embodiments, the injection site holder includes at least one of a negative pressure suction mechanism and a mechanical compression mechanism, a receiving portion configured to receive and fix epidermis and subcutaneous tissue of an injection site by the at least one of the negative pressure suction mechanism and the mechanical compression mechanism and provided with an opening to expose at least a portion of the received and fixed epidermis and subcutaneous tissue of the injection site, and a height limiting portion configured to limit a height of the at least a portion of the exposed epidermis and subcutaneous tissue of the injection site.
In some embodiments, where the injection site holder includes at least the negative pressure suction mechanism, the injection device further includes a pressure detector configured to detect pressure applied by the injection site holder to the injection site.
In some embodiments, the host computer further comprises a micro control unit configured to receive a signal from the pressure detector indicating a magnitude of pressure and, in the event that the pressure is within a preset range, send a pressure maintenance signal to the injection site holder.
In some embodiments, the injection site holder is configured such that the receiving portion is disc-shaped and arcuate in cross-section, and/or the height limiter is disposed outside the opening, and/or the height limiter includes an inward extension.
In some embodiments, where the injection site holder includes at least the negative pressure aspiration mechanism, the injection device further includes a needle sealing mechanism configured to seal between the needle and the injection site holder.
In some embodiments, the host computer further comprises a first drive mechanism configured to drive injection in response to an injection drive signal, a second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle penetration drive signal, and a micro control unit configured to receive a signal from the pressure detector indicative of the magnitude of the pressure and to send the needle penetration drive signal to the second drive mechanism and the injection drive signal to the first drive mechanism in tandem if the pressure is within a preset range.
In some embodiments, the injector is provided with a dose adjustment mechanism or the host is provided with a dose adjustment mechanism, the host further comprising a dose adjustment detection mechanism configured to detect an operational state of the dose adjustment mechanism and to send a corresponding dose adjustment indication signal, wherein the micro control unit is further configured to receive the dose adjustment indication signal, in case the dose adjustment indication signal indicates that a dose adjustment has been made, to allow actuation of the injection site holder to perform a fixation.
In some embodiments, the first drive mechanism is connected to a dose adjustment mechanism of the syringe or a dose adjustment mechanism on the host, and the operational status of the dose adjustment mechanism includes whether a dose adjustment has been made, whether the needle is jammed, and whether the dose adjustment mechanism has been pushed back to a zero position.
In some embodiments, the host further comprises an in-situ detection mechanism configured to detect if the syringe and needle are assembled in place if the injection device is configured to be loaded with the syringe and needle, and to detect if the cartridge and needle are assembled in place if the injection device is configured to be loaded with the cartridge and needle, and to send a corresponding in-situ detection signal, wherein the micro-control unit is configured to receive the in-situ detection signal, and to allow actuation of the injection site holder to perform a fixation if the in-situ detection signal indicates assembly in place.
In some embodiments, the host further comprises an on-site detection mechanism configured to detect if the syringe and needle are assembled in place with the injection device configured to be loaded into the syringe and needle, and to detect if the cartridge and needle are assembled in place with the injection device loaded into the cartridge and needle, and to send corresponding on-site detection signals, an injection button configured to send an activation signal upon depression, wherein the micro-control unit is further configured to actuate the dose adjustment detection mechanism and the on-site detection mechanism to perform detection upon receipt of the activation signal, and to actuate the injection site holder to perform fixation if the on-site detection signal indicates assembly in place and the dose adjustment indication signal indicates that a dose adjustment has been made.
In some embodiments, the host further comprises a first drive mechanism configured to drive injection in response to an injection drive signal, a second drive mechanism configured to drive the needle to penetrate an injection site in response to a needle drive signal, an injection button configured to send an activation signal upon depression, and a micro control unit configured to send the needle drive signal to the second drive mechanism in response to the activation signal if an injection site meets a needle activation condition.
In some embodiments, the needle-punch initiation condition includes at least one of a pressure within the injection site holder being within a preset range and being capable of being maintained when the injection site holder includes at least the negative pressure aspiration mechanism, and a mechanical compression mechanism completing injection site fixation when the injection site holder includes a mechanical compression mechanism.
In some embodiments, the second drive mechanism is further configured to drive the needle reset in response to a reset drive signal, and the micro-control unit is further configured to actuate the injection site holder to perform a release if an injection completion condition is met, and then send the reset drive signal to the second drive mechanism.
In some embodiments, the injection completion condition includes at least one of the dose adjustment mechanism returning to a zero position and the needle residence time in subcutaneous tissue reaching a set threshold, or needle occlusion being detected.
In some embodiments, the injection device, if configured to fit into a syringe and needle, further comprises a first cover, a second cover and a third cover removably connected to the host,
Wherein the first cover is configured to be used to mount the syringe to the host in a detached state, the second cover is configured to be used to mount or dismount the needle in a detached state, and the third cover is configured to be detachably connected to a side of the second cover opposite to the first cover and to expose the receiving portion of the injection site holder in a detached state.
In some embodiments, the injection device, when configured to receive a cartridge and a needle, further comprises a second cover and a third cover removably connected to the host, wherein the second cover is configured to load or remove the cartridge and needle in a removed state, and the third cover is configured to removably connect to a side of the second cover opposite the host and to expose the receiving portion of the injection site holder in a removed state.
In some embodiments, where the injection site holder includes at least the negative pressure suction mechanism, a needle sealing mechanism and the injection site holder are disposed within the second cover, the needle sealing mechanism assembling the needle in an airtight manner upon closing the second cover, effecting an airtight seal of the needle relative to the injection site holder.
By utilizing the injection device according to the embodiments of the present disclosure, the injection device can be used with an injector and a needle including a pen core or the pen core and the needle, so as to facilitate the puncture of the needle, reduce the pain of a user, and reduce the dependence on the experience of the user in an automated injection process, ensure that the injection process can be conveniently and efficiently executed at each suitable injection site of the body, and have lower cost and convenient popularization.
Drawings
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings illustrate various embodiments by way of example in general and not by way of limitation, and together with the description and claims serve to explain the disclosed embodiments. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive of the present apparatus or method.
FIG. 1 shows a schematic view of an injection device according to an embodiment of the present disclosure;
fig. 2 (a) and 2 (b) show illustrations of a first example of an injection site holder in an injection device according to an embodiment of the present disclosure in a natural state and an attractive state of the injection site, respectively;
fig. 3 (a), 3 (b) and 3 (c) show illustrations of a second example of an injection site holder in an injection device according to an embodiment of the present disclosure in a natural state, a compressed state, and a compressed and sucked state of an injection site, respectively;
Fig. 4 shows a cross-sectional view of an injection device according to an embodiment of the present disclosure;
fig. 5 shows an external schematic view of an injection device according to an embodiment of the present disclosure;
fig. 6 (a), 6 (b) and 6 (c) show schematic views of an injection device according to an embodiment of the present disclosure with the first, second and third covers removed, respectively;
FIG. 7 illustrates an exemplary injection flow chart using an injection device according to an embodiment of the present disclosure;
Fig. 8 shows an external schematic view of an injection device according to an embodiment of the present disclosure;
fig. 9 shows a schematic view of how an injection device is equipped with a cartridge and a needle according to an embodiment of the present disclosure, and
Fig. 10 shows an exemplary injection flow chart using an injection device according to an embodiment of the present disclosure.
Detailed Description
In order to better understand the technical solutions of the present disclosure, the following detailed description of the present disclosure is provided with reference to the accompanying drawings and the specific embodiments. Embodiments of the present disclosure will be described in further detail below with reference to the drawings and specific embodiments, but not by way of limitation of the present disclosure.
The terms "first," "second," and the like, as used in this disclosure, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises" and the like means that elements preceding the word encompass the elements recited after the word, and not exclude the possibility of also encompassing other elements. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.
In this disclosure, when a particular device is described as being located between a first device and a second device, there may or may not be an intervening device between the particular device and either the first device or the second device. When it is described that a particular device is connected to other devices, the particular device may be directly connected to the other devices without intervening devices, or may be directly connected to the other devices without intervening devices.
All terms (including technical or scientific terms) used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs, unless specifically defined otherwise. Note that in this document, the technical term "syringe" means an injection device that does not include a needle, such as an insulin injection pen or the like, excluding the needle. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but are intended to be part of the specification where appropriate.
Fig. 1 shows a schematic view of an injection device according to an embodiment of the present disclosure. As shown in fig. 1, the injection device 100 is configured to fit into a syringe 107 and needle 106 that include a cartridge 108 or into a cartridge 108 (rather than a syringe 107) and needle 106. The injection device 100 comprises an injection site holder 101 configured to hold an epidermis 103 and a subcutaneous tissue 104 of an injection site, and a host 102 (only a partial cross-section thereof is shown in fig. 1) secured to the injection site holder 101 and configured to automatically perform an injection procedure on the secured injection site. The injection site holder 101 may be placed at the injection site prior to injection, and when injection is to be initiated, an external force may be applied to the injection site by the injection site holder 101, thereby holding the epidermis 103 and subcutaneous tissue 104 of the injection site therein. As shown in fig. 1, since epidermis 103 and subcutaneous tissue 104 are at a shallower position than muscle tissue 105, less dense than muscle tissue 105, and significantly more soft and flexible than muscle tissue 105, it is mainly epidermis 103 and subcutaneous tissue 104 that enter and are held by injection site holder 101 under the external force of injection site holder 101, and muscle tissue 105 rarely enters therein, so that the penetration depth of needle 106 can be ensured to be limited within held subcutaneous tissue 104 and not into muscle tissue 105, thereby facilitating penetration of needle 106, and also significantly reducing the pain feeling of the user, and by holding and compressing epidermis 103 and subcutaneous tissue 104, slippage and deformation thereof upon needling are reduced, enabling more precise control of the needling operation.
The injection site holder 101 may be implemented in a variety of ways.
For example, the structure of the first example shown in fig. 2 (a) and 2 (b), respectively, may be employed. As shown in fig. 2 (a) and 2 (b), the injection site holder 200 may include a negative pressure suction mechanism (not shown) to generate a negative pressure, a receiving portion 203 configured to receive and fix the epidermis and subcutaneous tissue 204 of the injection site by the action of the negative pressure and provided with an opening to expose at least a portion of the received and fixed epidermis and subcutaneous tissue 204 of the injection site, and a height limiting portion 202 configured to limit the height of the at least a portion of the exposed epidermis and subcutaneous tissue 204 of the injection site. With the height limiter 202, a margin can be provided for the lifting of the epidermis and subcutaneous tissue 204 under negative pressure (as shown in fig. 2 (b)), the needling depth can be controlled more precisely, and the needle 205 can be prevented from unintentionally penetrating the exposed epidermis and subcutaneous tissue 204 except for penetration and injection, that is, the needle 205 can only actively and intentionally penetrate the epidermis and subcutaneous tissue 204 to a proper depth, and cannot be "passively" penetrated by the lifting of the epidermis and subcutaneous tissue 204, thereby improving the safety of the injection process.
In addition to the negative pressure suction mechanism, the injection site holder 101 may also employ a mechanical pressing mechanism, or may combine the negative pressure suction mechanism with a mechanical pressing mechanism (not shown), as shown in fig. 3 (a), 3 (b), and 3 (c), and the accommodating portion 303, the height limiting portion 302, the epidermis, and the subcutaneous tissue 304 may be similar to the accommodating portion 203, the height limiting portion 202, the epidermis, and the subcutaneous tissue 204 in fig. 2 (a) and 2 (b), respectively, and will not be described here. As shown in fig. 3 (a), the injection site holder 300 may be placed over the injection site such that the end of the receptacle 303 contacts the epidermis. In some embodiments, a mechanical compression mechanism may be secured to the receptacle 303 and configured to collapse the receptacle 303, as shown in fig. 3 (b), thereby applying pressure to the epidermal and subcutaneous tissue 304 contained within the receptacle 303. A negative pressure suction mechanism (not shown) is then activated to further receive and secure the epidermis and subcutaneous tissue 304 of the injection site by the action of the negative pressure, as shown in fig. 3 (c). The epidermis and subcutaneous tissue 304 entering the accommodating part 303 are gathered firstly and then sucked and fixed by the negative pressure, the received traction tension is smaller, the injection is facilitated, and the energy consumption of the negative pressure suction mechanism is remarkably reduced.
In some embodiments, where the injection site holder includes at least the negative pressure suction mechanism, the injection device may further include a pressure detector 305 configured to detect pressure applied by the injection site holder 300 to the injection site. The pressure detector 305 can monitor the pressure applied to the injection site to ensure that the pressure remains within a suitable range, and neither too high a pressure results in too high a tension in the subcutaneous tissue 304 within the injection site holder 300, which can prevent needle sticks and injections and affect the accuracy of the injected dose, nor too low a pressure results in loosening of the subcutaneous tissue 304, which can not accurately control the needle stick depth.
In some embodiments, the host 102 may include a micro control unit 306, and the micro control unit 306 may be implemented using any one or more of a single chip microcomputer, a system on a chip (SOC), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), or the like. The micro control unit 306 may be configured to receive a signal from the pressure detector 305 indicating the magnitude of the pressure and, in the event that the pressure is within a preset range, send a pressure maintenance signal to the injection site holder 300. That is, the pressure experienced by subcutaneous tissue 304 may be autonomously determined by micro-control unit 306, and if the pressure is within a preset range (i.e., the pressure is appropriate), injection site holder 300 may be instructed via a pressure maintenance signal to maintain the current appropriate pressure, such that the pressure may be continuously and stably maintained within the appropriate range so that there is sufficient time to accurately perform the needle stick and injection. In some embodiments, the micro-control unit 306 may also instruct in real time to adjust the pressure to within a suitable range based on the pressure signal from the pressure detector 305, for example, send a pressure release signal if the pressure is too high and a pressure increase signal if the pressure is too low, thereby enabling dynamic real-time adjustment of the tension of the subcutaneous tissue 304, thereby ensuring accurate control of the penetration depth and accuracy of the injected dose.
In some embodiments, the injection site holder 101 may be configured as a silicone device, thereby being more comfortable to use and being better able to conform to the epidermis. As an example, the receiving portion 303 may have a disk-shaped and arched cross-section, and as shown in fig. 3 (b) and 3 (c), the disk-shaped and arched cross-section structure conforms to the shape of the epidermis and subcutaneous tissue 304 after being pressed/sucked, thereby being better in fit therewith and better in fixation effect. As an example, the height limiter 302 may be disposed outside (peripherally) the opening (for allowing the needle to penetrate) so as to avoid impeding penetration of the needle and to expose the injection site to a greater extent.
In some embodiments, the height-limiting portion 302 may also include inward extensions (as shown in fig. 3 (a) -3 (c)), that is, the height-limiting portion 302 may extend at least partially inward (note that the opening for needle penetration is located inside the inward extension), which may act as a barrier to prevent upward irregular (e.g., intermittent) spills of epidermis and subcutaneous tissue 304 after being compacted/sucked, to maintain the surface of the exposed portion flat, to reduce obstruction and interference with needle sticks, and to enable more precise control of subcutaneous penetration depth.
In some embodiments, where the injection site holder includes at least a negative pressure aspiration mechanism (not shown), such as injection site holders 200 and 300, the injection device may further include a needle sealing mechanism, such as 201 or 301, configured to seal between the needle and the injection site holder 200 or 300, thereby preventing air leakage and improving the efficiency of negative pressure aspiration.
Fig. 4 shows a cross-sectional view of an injection device according to an embodiment of the present disclosure, note that the injection device of fig. 4 encloses a syringe 404 and a needle 414, but this is by way of example only, and in other embodiments a cartridge and needle 414 may be incorporated, with minor modifications to the relevant components.
As shown in fig. 4, the host 411 may include a first drive mechanism 403 configured to drive (e.g., a syringe 404) an injection in response to an injection drive signal, a second drive mechanism 406 configured to drive the needle 414 to pierce an injection site in response to a needle drive signal, and a micro control unit 415 configured to receive a signal from a pressure detector (not shown) indicative of a pressure magnitude and to sequentially send the needle drive signal to the second drive mechanism 406 and the injection drive signal to the first drive mechanism 403 if the pressure is within a preset range. In this way, the micro control unit 415 may be utilized to monitor the pressure applied to the injection site in real time, and automatically control the first driving mechanism 403 and the second driving mechanism 406 to perform the needling and injection operations sequentially without manual intervention in the case where the pressure is appropriate, i.e., the pressure is not too high to cause excessive tension in the subcutaneous tissue in the injection site holder 409, even to hinder the needle punching injection or affect the accuracy of the injection dose, and is not too low to cause relaxation of the subcutaneous tissue to cause failure in accurate control of the needling depth. In some embodiments, the second drive mechanism 406 may drive the needle 414 into the subcutaneous tissue at a suitable depth to avoid penetration into muscle tissue, resulting in impediment to penetration and pain.
In some embodiments, the injector 404 may be provided with a dose adjustment mechanism (e.g., an adjustment knob) 402, and a user may rotate the dose adjustment mechanism 402 to preset a dose to be injected. In the case of a refill and needle 414, the host 411 may be provided with a dose setting mechanism 402. The host 411 may further comprise a dose adjustment detection mechanism 401 configured to detect the operational status of the dose adjustment mechanism 402 and to send a corresponding dose adjustment indication signal, as an example the dose adjustment detection mechanism 401 may be implemented using a pressure sensitive element. Wherein the micro control unit 415 is further configured to receive the dose adjustment indication signal, to allow actuation of the injection site holder 409 to perform a fixation in case the dose adjustment indication signal indicates that a dose adjustment has been made. It is noted that the expression "in the case of..the term" allowed "throughout this document is intended to mean that confirmation of dose adjustment may be made as a sufficient condition for actuating the injection site holder 409, in some embodiments also just as a necessary condition for the injection site holder 409, e.g. the injection site holder 409 may be actuated to perform the fixation in case several other conditions are also met at the same time, including but not limited to the injector 404 and needle 414 being fitted in place, the user pressing the injection button such that an injection start signal is issued to the micro control unit 415, etc.
In some embodiments, via the dose adjustment detection mechanism 401, the micro control unit 415 may autonomously recognize whether the user has completed an injection dose adjustment, and if not, not initiate any injection steps, such as, but not limited to, injection site fixation, but rather give a prompt via visual or audible information prompting the user to adjust the injection dose. In this way, ineffective or erroneous injection site fixing, needling and injection operations without preset injection doses can be avoided, thereby saving energy consumption and improving safety.
In some embodiments, the first drive mechanism 403 may be coupled to the dose adjustment mechanism 402 of the syringe 404 such that as the first drive mechanism 403 drives the dose adjustment mechanism 402 of the syringe 404, the dose adjustment mechanism 402 will push the piston in the cartridge, injecting the medicament in the cartridge into the subcutaneous tissue accordingly, and when the preset injection dose is injected into the subcutaneous tissue, the dose adjustment mechanism 402 will return to the zero position accordingly. In some embodiments, the dose adjustment mechanism 402 may instead be provided on the host 411 instead of the syringe 404, and the first drive mechanism 403 may be connected to the dose adjustment mechanism 402 provided on the host 411.
For example, when the dose-adjusting mechanism 402 is stuck in a certain non-zero position, clogging of the needle 414 is likely to occur. In some embodiments, the (operational) status of the dose adjustment mechanism 402 is not limited to whether a dose adjustment has been made, but may include whether the needle 414 is jammed and the dose adjustment mechanism 402 is pushed back to a zero position, and the dose adjustment indication signal may reflect these operational status accordingly. The micro-control unit 415 may send corresponding control instructions to control the corresponding components to perform the corresponding operations according to the specific operation state, for example, prompting the occurrence of the blockage of the needle 414 or the completion of the injection via a status indicator light on the exterior of the injection device, actuating the injection site fixing bits 409 to release the pressure, and then sending a reset driving signal to the second driving mechanism 406 to perform the needle withdrawing operation, etc.
In some embodiments, the host 411 may further include an in-situ detection mechanism 407 configured to detect whether the syringe 404 and needle 414 are assembled in place if the injection device is configured to be loaded with the syringe 404 and needle 414 (and to detect whether the cartridge and needle are assembled in place if the injection device is configured to be loaded with the cartridge and needle), and to send a corresponding in-situ detection signal. Wherein the micro control unit 415 may be configured to receive the presence detection signal, in case the presence detection signal indicates that it is fitted in place, allowing actuation of the injection site holder 409 to perform a fixation, such that an ineffective or erroneous fixation operation may be avoided, thereby saving energy consumption and improving safety.
In some embodiments, a syringe locking mechanism 405 may be provided within the host 411 that is configured to lock and unlock the syringe 404. For example, when the syringe 404 is to be loaded, the syringe locking mechanism 405 may be unlocked in advance, and after the syringe 404 is assembled in place, the syringe locking mechanism 405 may automatically lock the syringe to avoid shaking of the syringe during subsequent needling, injection, etc., thereby improving the accuracy of the operation. For example, the syringe locking mechanism 405 may employ various implementations of snap-fit, magnetic engagement, and the like.
In some embodiments, as shown in FIG. 5, the host 511 may also include an injection button 503. The injection key 503 may be exposed from an outer surface of the injection device to facilitate a pressing operation by a user and transmit an activation signal in response to the pressing operation. Wherein the micro control unit 415 may be further configured to actuate the dose adjustment detection mechanism 401 and the on-position detection mechanism 407 to perform a detection upon receipt of the activation signal, and to actuate the injection site holder 409 to perform a fixation in case the on-position detection signal indicates fitting in place and the dose adjustment indication signal indicates that a dose adjustment has been performed. After the injection site is fixed, as previously described, the micro-control unit 415 may receive a signal from a pressure detector (not shown) indicating the magnitude of the pressure and, in case the pressure is within a preset range, send the needle drive signal to the second drive mechanism 406 and the injection drive signal to the first drive mechanism 403 in succession, so that the needle and injection are performed with the injection site subjected to the appropriate pressure, in order to precisely control the needle penetration depth while compromising the accuracy of the injected dose. In some embodiments, the micro-control unit 415 may be further configured to actuate the injection site holder 409 to perform a pressure release to loosen the epidermis and subcutaneous tissue of the injection site, and then send the reset drive signal to the second drive mechanism 406 to drive the needle 414 out of the loosened epidermis and subcutaneous tissue of the injection site, in case the injection completion condition is met, thereby avoiding a back flow of the medicament due to tension when the needle 414 is withdrawn from the tensioned injection site, the loss of medicament back flow being very considerable in applications of micro-medicaments such as insulin. Through the process, the injection device can realize the complete injection process of fixing, needling, injecting and needle pulling of the automatic injection part with extremely high user friendliness, a user only needs to adjust the dose adjusting mechanism 402 to preset the injection dose and put the injector 404 and the needle 414 into the injection device as required, then presses the injection button 503, the injection device can automatically fix the epidermis and subcutaneous tissue of the injection part without manual intervention and keep the born pressure of the injection part in a proper range dynamically, and simultaneously performs needling to a proper depth, performs precise injection of the preset injection dose, and then loosens the epidermis and subcutaneous tissue of the injection part and conveniently pulls the needle 414 out of the epidermis and subcutaneous tissue, so that the operation is simple and convenient, the pain of the user is obviously reduced, and the waste of medicaments is reduced.
In some embodiments, the micro-control unit 415 may also send the lancing drive signal to the second drive mechanism 406 if the lancing start condition is met by performing a determination of whether the injection site meets the lancing start condition in response to the start signal. In some embodiments, the needle actuation condition includes at least one of a pressure within the injection site holder 409 being within a preset range and being maintained when the injection site holder 409 includes at least the negative pressure aspiration mechanism, and a mechanical compression mechanism completing injection site fixation when the injection site holder 409 includes a mechanical compression mechanism. Especially in the case of a mechanical extrusion mechanism, the mechanical extrusion mechanism usually adopts inward feeding of the clamping piece to realize mechanical extrusion, the feeding amount can be preset, the injection part is fixed after the feeding amount is finished, and at the moment, the vibration of the needle injection part is started less, the accuracy is higher, and the needle is prevented from being punched in the middle of feeding. In the case of using the negative pressure suction mechanism, the pressure of the injection site holder 409 is maintained within a preset range for a predetermined period of time, and the subcutaneous tissue tension of the injection site is not excessively large to hinder needling, nor too low to cause relaxation of the subcutaneous tissue, facilitating accurate and precise execution of the needling operation. In the case where the injection site holder 409 incorporates both the negative pressure suction mechanism and the mechanical pressing mechanism, it is possible to determine whether or not both satisfy the above-described needling start condition, and if so, it is ensured that the fixed state of the injection site is ready for needling, and the needling operation is more accurate and precise.
In some embodiments, different injection completion conditions may be set, such as the dose-adjusting mechanism 402 returning to a zero position (i.e., the preset amount of injection has been injected), the needle 414 residing in subcutaneous tissue for a set threshold, or a needle occlusion being detected, such as, but not limited to, the dose-adjusting mechanism 402 stuck in a non-zero position. By taking into account abnormal injection completion conditions of needle 414 blockage, needle 414 can be reset and withdrawn in the event of needle 414 blockage, thereby avoiding the risks of ineffective injection, waste of medication, and continued ineffective injection while needle 414 is blocked.
Fig. 5 shows an external schematic view of an injection device 500 according to an embodiment of the present disclosure, the injection device 500 being for use with a syringe and needle, as an example, although it may be structurally adapted for use with a cartridge and needle. As shown in fig. 5, the injection device 500 may include a first cap 510 (identified as 410 in fig. 4), a second cap 512 (identified as 412 in fig. 4), and a third cap 513 (identified as 413 in fig. 4) that are removably connected to the host. Wherein the first cover 510 may be configured to be used to insert the syringe 507 into the host 511 (as shown in fig. 6 (a)) or to be removed from the host 511 in a disassembled state (e.g., an opened state). The second cover 512 is configured to load or unload the needle 508 in a disassembled state (e.g., an open state). When the needle 508 is to be removed after injection, the second cover 512 may be opened (as shown in fig. 6 (b)), the cap 514 closed to fit (screw or snap) with the needle 508, and the cap 514 may be held and unscrewed from the needle 508 and discarded. In this manner, the loading or removal of the needle 508 is facilitated, particularly while removing, to avoid the user from touching the needle 508, to improve safety, and to avoid environmental contamination of the needle 508 and the remaining medicament therein. The third cover 513 may be configured to be detachably coupled to a side of the second cover 512 opposite to the first cover 510, and to expose the receiving portion 509 of the injection site holder in a detached state (e.g., an opened state) (as shown in fig. 6 (c)). The first, second and third covers 510, 512 and 513 may encapsulate the syringe 507, needle 508 and injection site holder, respectively, in a closed state, avoiding contamination by or the outside environment.
In some embodiments, as shown in fig. 4, where the injection site holder 409 includes at least the negative pressure suction mechanism (not shown), a needle sealing mechanism 408 and the injection site holder 409 may be provided within the second cover 412, the needle sealing mechanism 408 being connected to the needle 414 in an airtight manner upon closing the second cover 412, effecting an airtight seal of the needle 414 with respect to the injection site holder 409, thereby enabling a significant increase in efficiency of use thereof when the injection site holder 409 employs at least the negative pressure suction mechanism.
Returning to fig. 5, an on/off button 502 and an injection button 503 are further provided on the exterior of the injection device 500, and the user can turn on or off the injection device 500 by pressing the on/off button 502. In addition, as described above, the injection device 500 can automatically perform injection site fixing, needling, injection and needle drawing operations accurately and smoothly in sequence, simply by the user assembling the syringe and needle with the set dose, and then pressing the injection button 503, and the pain feeling of the user is remarkably reduced.
The exterior of the injection device 500 may also be provided with an injection dose window 501, a status indicator light 504, a dose window 505, and a battery status indicator light 506. The injection dose window 501 may be used to see if the injector has been dose adjusted and the adjusted injection dose. The dose window 505 may be used to view the amount of remaining dose in the cartridge and whether there is a bubble to determine whether a bubble needs to be removed or a new cartridge needs to be replaced. The status indicator light 504 allows the user to clearly identify which of all the injector mounting, dose adjustment, injection site fixation, etc. the entire injection process is proceeding to, and/or also indicates the status of each of the steps, the successful operation being green, the failed operation being red, and if the step has not been reached, the corresponding indicator light is not illuminated. The battery status indicator 506 may be used to indicate the installed status of the battery (whether installed) and/or the remaining power status of the battery, for example, when the remaining power of the battery is too low, the battery status indicator 506 may be red and flash to indicate that the remaining power is too low to complete an injection, thereby avoiding ineffective injections (e.g., the injection process is not completed and is interrupted due to insufficient power), and for example, when the battery is not installed, the battery status indicator 506 may be red to indicate to the user that the battery is installed.
Fig. 7 shows an exemplary injection flow chart using an injection device according to an embodiment of the present disclosure. The injection flow 700 begins at step 701 with opening the syringe removal cover, loading the cartridge-loaded syringe into the host computer of the injection device and locking, and then closing the syringe removal cover. This step 701 is typically performed when the injection device or syringe is first used to replace a new cartridge, otherwise it may be skipped. In some embodiments, it may be desirable to align the dose display window of the syringe with a window on the host of the injection device when loading the syringe, and the adjusted dose cannot be seen if the two windows are not aligned. The syringe may be automatically locked in place using a locking mechanism.
At step 702, the needle assembly cover is opened, a new needle is installed, and the needle cap is removed. Then, in step 703, the syringe is opened to remove the cap, thereby completing the bubble removal operation. It may be determined whether the needle is jammed by a bleb operation (step 704), and if so, step 702 is returned to, the needle replaced and it is verified whether the needle is clear. If not, proceed to dose adjustment step 705, the injected dose may be adjusted by the dose adjustment mechanism of the syringe, and then the syringe removable cover and needle removable cover are closed (step 706).
An injection site fixation procedure is then performed. In step 707, the injection cap is opened to expose a receiving portion of the injection site holder (e.g., an injection disk). An injection tray may be placed at the injection site and an initiate injection button pressed (step 708). After the start injection button is pressed, a series of decisions are executed by a micro control unit in the host machine and corresponding components are automatically driven to execute fixing, needling, injection and needle pulling operations sequentially.
Specifically, at step 709, it is checked whether the syringe is in place (loaded and locked) and at step 710, it is determined whether the injection dose adjustment mechanism has completed dose adjustment. If the fact that the injector is not installed in place is detected, the injection part is not started to be fixed, and a state indicator lamp gives out prompt information that the injector is not installed well, so that a user is prompted to reinstall the injector. If the dose adjusting mechanism is detected to be still in the zero position, the injection position is not started to be fixed, and the user is prompted to adjust the injection dose through the status indicator lamp. If it is detected that the injector is in place and that the dose adjustment has been completed, then a determination is continued at step 711 as to whether the needle is properly loaded, and if so, the injection disk is driven to pressurize to secure the epidermis and subcutaneous tissue of the injection site.
In step 713 it is determined whether the injection site is well secured, specifically, the pressure in the injection disc may be detected via a pressure sensor, and when the pressure is within a suitable range, it is determined that the injection site is well secured, and if not, the pressure in the injection disc is adjusted until it is within a suitable range, achieving the fixation of the injection site. Next, at step 714, pressurization is stopped and the pressure applied to the injection site within the injection disc is maintained substantially constant and the injector is driven to complete the needle stick and injection. Specifically, after the injection site is fixed, the micro control unit of the injection device may issue a needle penetration instruction to the injector driving mechanism to drive the needle to penetrate the subcutaneous tissue at a rapid speed, and then start the injection driving mechanism in the detachable cover of the injector to smoothly perform injection until the dose adjusting mechanism of the injector is pushed to a zero position to complete injection of the preset dose.
After injection is completed, the needle is allowed to reside in the subcutaneous tissue for a few seconds and then the pressure applied to the injection site is released (step 715). At step 716, the syringe drive mechanism pushes the syringe to withdraw the needle and reset the syringe. At step 717, the injection device may be removed from the injection site, the injection cap closed, the needle assembly and disassembly cap opened, and the needle cap mounted to the needle, such that the needle is unscrewed along with the needle cap and discarded into a waste container. Next, at step 718, the needle is closed, the cap is removed, the injection device is stored, and an injection operation is completed.
Fig. 8 shows an external schematic view of an injection device 800 according to an embodiment of the present disclosure, the injection device 800 being used with a cartridge and a needle. As shown in fig. 8, the host 811 of the injection device 800 may include an on/off button 802, an injection button 803, an injection dose window 801, a status indicator light 804, a dose window 805, and a battery status indicator light 806, which are similar in structure and utility to the on/off button 502, the injection button 503, the injection dose window 501, the status indicator light 504, the dose window 505, and the battery status indicator light 506 of the host 511 of the injection device 500 of fig. 5, and are not repeated herein.
Unlike injection device 800 shown in fig. 5, injection dose adjustment mechanism 807 is not self-contained with the syringe, but is disposed within host 811 and exposes a portion from the housing of host 811 so that a user can conveniently rotate adjustment from outside host 811. In addition, injection device 800 may include two covers, namely a second cover 812 and a third cover 813. The second cover 812 is used for the attachment and detachment of both the cartridge and the needle, and the structure and utility of the third cover 813 are similar to the third cover 513 of fig. 5, and are not described here again.
Fig. 9 shows a schematic view of how injection device 900 assembles cartridge 904 and needle 906 according to an embodiment of the present disclosure. As shown in fig. 9, the injection device 900 may include a second cover 912 and a third cover 913 detachably coupled (e.g., openable or closable) to a host (not shown), wherein the second cover 912 may be configured to load or remove the cartridge 904 and the needle 906 in a detached (opened) state, and the third cover 913 may be configured to be detachably coupled to a side of the second cover 912 opposite to the host and to expose a receiving part (not shown, similar to that shown in fig. 6 (c)) of an injection site holder in a detached state.
A removable cartridge mount 905 may be provided in the injection device 900. The second cover 912 and the third cover 913 may be opened and the cartridge mount 905 removed, the cartridge 904 assembled to the cartridge mount 905, and the cartridge mount 905 containing the cartridge 904 may be reloaded into the injection device 900 and locked. For example, a securing mechanism and/or locking mechanism for cartridge mount 905 may be provided within the host of injection device 900 to facilitate the securing and/or locking of cartridge mount 905. In some embodiments, injection device 900 may be provided with an in-situ detection mechanism 907 configured to detect whether cartridge holder 905 and needle 906 are in place, and if so, and the injection dose is preset and the injection site is properly secured, needle 906 may be driven to perform a needle stick, then a piston within cartridge 904 may be driven to perform an injection of the preset dose, cartridge holder 905 may be driven to withdraw the needle after the injection is completed, and so on. In some embodiments, a piston 908 may be provided on the cartridge 904, an injection driving mechanism may push the piston 908 to perform an injection, and the injection driving mechanism may be connected to an injection dose adjusting mechanism and the piston 908 in the cartridge 904, with the injection driving mechanism pushing the piston 908, the injection dose adjusting mechanism rotates a corresponding scale toward a zero position, and just returns to the zero position when the injection is completed.
Fig. 10 shows a flow chart of an exemplary injection procedure 1000 using an injection device according to an embodiment of the present disclosure. As shown in fig. 10, the injection process 1000 starts at step 1001 with opening the cartridge and needle head cap, and if the cartridge is not yet loaded, the cartridge is loaded first and then the needle head is loaded on the cartridge, and if the cartridge is already loaded, only the new needle head is loaded. At step 1002, a de-bubbling operation is performed to ensure that the needle is not blocked. At step 1003, after the bubble removal operation is completed, the needle cap may be closed, the injection dose may then be adjusted by the dose adjustment mechanism to preset the dose to be injected.
At step 1004, the injection cap is opened to expose the receiving portion of the injection site holder. Here, description will be given taking an example in which a suction cup as a housing portion is exposed. At step 1005, a suction cup may be placed at the injection site, an injection button may be pressed, and then the entire process of fixing, needling, injecting, and withdrawing the needle may be automatically controlled by a micro-control unit within the injection device.
Specifically, after the start injection button is pressed, it is first checked whether the cartridge and the needle are mounted in place (step 1006), and whether the injection dose adjustment is completed (step 1007). If the pen core and the needle head are detected not to be installed in place, the injection part is not started to be fixed, and the state indicator lamp is used for giving out prompt information that the pen core and the needle head are not installed, so that a user is prompted to reinstall the pen core and the needle head. If the fact that the injection dosage adjustment is not finished is detected, the injection position fixing cannot be started, and the user is prompted to conduct the injection dosage adjustment through the state indicator lamp. If it is determined that the cartridge and needle are in place and the injection dose adjustment has been completed, the injection site holder may be actuated to secure the epidermis and subcutaneous tissue of the injection site, for example, pressure may be applied to an injection disc (which may be implemented as a suction cup) to compressively secure the epidermis and subcutaneous tissue of the injection site within the suction cup (see step 1008). It is possible to detect whether the pressure applied to the epidermis and subcutaneous tissue within the suction cup is within the appropriate range by means of the pressure sensor, and if so, determine that the injection site is well-fixed (see step 1009), and if not, continue to adjust the applied pressure to the injection site holder until the applied pressure is within the appropriate range and maintain the appropriate pressure for subsequent operation.
For example, at step 1010, the micro-control unit of the injection device may issue a needle stick instruction to the cartridge drive mechanism, which may drive the cartridge to pierce the subcutaneous tissue with the needle tip at a rapid rate in view of the cartridge and needle tip being assembled together, and then issue an injection instruction to the injection drive mechanism, which may push a piston on the cartridge to inject a preset dose of medicament into the subcutaneous tissue.
After the injection is completed, the needle may remain in the subcutaneous tissue for a few seconds and then release the pressure applied to the injection site (step 1011). Next, the micro control unit of the injection device may issue a needle withdrawal command to the cartridge driving mechanism, which may drive the cartridge together with the needle to withdraw the needle and reset the cartridge and the needle (step 1012).
The injection device may then be removed from the injection site, the injection cap closed, the needle assembly and disassembly cap opened, the needle cap closed to snap-fit with the needle, for example, and the needle cap may then be conveniently held to remove it along with the used needle and disposed of in a waste container (step 1013). Thus, the injection device can be stored well, and injection can be completed.
Furthermore, although exemplary embodiments have been described herein, the scope thereof includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of the various embodiments across schemes), adaptations or alterations based on the present disclosure. The elements in the claims are to be construed broadly based on the language employed in the claims and are not limited to examples described in the present specification or during the practice of the application, which examples are to be construed as non-exclusive. It is intended, therefore, that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.
The above description is intended to be illustrative and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. For example, other embodiments may be used by those of ordinary skill in the art upon reading the above description. In addition, in the above detailed description, various features may be grouped together to streamline the disclosure. This is not to be interpreted as an intention that the disclosed features not being claimed are essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with one another in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
The above embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention, the scope of which is defined by the claims. Various modifications and equivalent arrangements of this invention will occur to those skilled in the art, and are intended to be within the spirit and scope of the invention.

Claims (14)

1.一种注射装置,其配置为装入包括笔芯的注射器和针头,或者装入笔芯和针头,其特征在于,所述注射装置包括:1. An injection device, which is configured to be loaded with a syringe including a refill and a needle, or a refill and a needle, characterized in that the injection device comprises: 注射部位固定器,包括:Injection site retainer, including: 负压吸引机构和机械挤压机构中的至少一种;At least one of a negative pressure suction mechanism and a mechanical squeezing mechanism; 容纳部,其构造为:盘状且截面为拱形,通过负压吸引机构和机械挤压机构中的所述至少一种升起、收拢并固定注射部位的表皮和皮下组织,并且设有开口以露出所升起、收拢和固定的注射部位的表皮和皮下组织的至少一部分;The receiving portion is disc-shaped and has an arched cross section, and is used to lift, gather and fix the epidermis and subcutaneous tissue of the injection site by at least one of a negative pressure suction mechanism and a mechanical squeezing mechanism, and is provided with an opening to expose at least a part of the lifted, gathered and fixed epidermis and subcutaneous tissue of the injection site; 限高部,其构造为:具有向内延伸部,所述容纳部的开口位于所述向内延伸部的内侧,使得露出的注射部位的表皮和皮下组织的所述至少一部分的高度低于所述向内延伸部的高度,居中的针头只能主动刺入表皮和皮下组织中适当的深度处,而不因为表皮和皮下组织的升起而刺入;The height limiting portion is constructed as follows: having an inwardly extending portion, the opening of the accommodating portion is located inside the inwardly extending portion, so that the height of the at least a portion of the exposed epidermis and subcutaneous tissue of the injection site is lower than the height of the inwardly extending portion, and the centered needle can only actively penetrate into the epidermis and subcutaneous tissue at an appropriate depth, and will not penetrate due to the rise of the epidermis and subcutaneous tissue; 主机,其连接到所述注射部位固定器,且配置为驱动所述针头对被固定的注射部位自动执行注射过程;A host connected to the injection site fixer and configured to drive the needle to automatically perform an injection process on the fixed injection site; 所述注射装置还包括压力检测器,其设置于限高部底端且在注射部位的表皮和皮下组织升起时贴近注射部位的表皮,并配置为检测所述注射部位固定器对所述注射部位施加的压力;The injection device further comprises a pressure detector, which is arranged at the bottom end of the height limiting portion and is close to the epidermis of the injection site when the epidermis and subcutaneous tissue of the injection site are raised, and is configured to detect the pressure applied by the injection site fixer to the injection site; 所述主机还包括微控制单元,其配置为:接收来自所述压力检测器的指示压力大小的信号,在该压力处于预设范围内的情况下,发送压力维持信号给所述注射部位固定器;在该压力超出预设范围而过大时发送压力释放信号给所述注射部位固定器,在该压力超出预设范围而过小时发送压力增加信号给所述注射部位固定器,以实现对于皮下组织的张力的动态实时调整,以便精确控制针刺深度和注射剂量。The host also includes a microcontroller unit, which is configured to: receive a signal indicating the pressure size from the pressure detector, and send a pressure maintenance signal to the injection site fixator when the pressure is within a preset range; send a pressure release signal to the injection site fixator when the pressure exceeds the preset range and is too large, and send a pressure increase signal to the injection site fixator when the pressure exceeds the preset range and is too small, so as to achieve dynamic real-time adjustment of the tension of the subcutaneous tissue, so as to accurately control the acupuncture depth and injection dose. 2.根据权利要求1所述的注射装置,其特征在于,在所述注射部位固定器至少包括所述负压吸引机构的情况下,所述注射装置还包括针头密封机构,其构造为对所述针头和所述注射部位固定器之间进行密封。2. The injection device according to claim 1 is characterized in that, when the injection site fixer includes at least the negative pressure suction mechanism, the injection device also includes a needle sealing mechanism, which is configured to seal between the needle and the injection site fixer. 3.根据权利要求1所述的注射装置,其特征在于,所述主机还包括:3. The injection device according to claim 1, characterized in that the host further comprises: 第一驱动机构,其配置为响应于注射驱动信号驱动注射;a first drive mechanism configured to drive injection in response to an injection drive signal; 第二驱动机构,其配置为响应于针刺驱动信号驱动所述针头刺入注射部位;a second drive mechanism configured to drive the needle to penetrate the injection site in response to a needle penetration drive signal; 微控制单元,其配置为:接收来自所述压力检测器的指示压力大小的信号,并在该压力处于预设范围内的情况下,先后向所述第二驱动机构发送所述针刺驱动信号以及向所述第一驱动机构发送所述注射驱动信号。The microcontrol unit is configured to receive a signal indicating the pressure from the pressure detector, and when the pressure is within a preset range, send the acupuncture drive signal to the second drive mechanism and send the injection drive signal to the first drive mechanism. 4.根据权利要求3所述的注射装置,其特征在于,所述注射器设有剂量调节机构或者所述主机设有剂量调节机构,所述主机还包括:4. The injection device according to claim 3, characterized in that the syringe is provided with a dosage adjustment mechanism or the host is provided with a dosage adjustment mechanism, and the host further comprises: 剂量调节检测机构,其构造为检测剂量调节机构的状态,并发送相应的剂量调节指示信号;a dose adjustment detection mechanism, which is configured to detect the state of the dose adjustment mechanism and send a corresponding dose adjustment indication signal; 其中,所述微控制单元还配置为:接收所述剂量调节指示信号,在所述剂量调节指示信号指示进行了剂量调节的情况下,允许致动所述注射部位固定器以执行固定。Wherein, the micro control unit is further configured to: receive the dose adjustment indication signal, and allow the injection site fixer to be actuated to perform fixation when the dose adjustment indication signal indicates that the dose adjustment has been performed. 5.根据权利要求4所述的注射装置,其特征在于,所述第一驱动机构连接到所述注射器的剂量调节机构,或连接到所述主机上设有的剂量调节机构,并且所述剂量调节机构的状态包括是否进行了剂量调节、所述针头是否堵塞、以及所述剂量调节机构是否推回到零位。5. The injection device according to claim 4, characterized in that the first drive mechanism is connected to a dose adjustment mechanism of the syringe, or is connected to a dose adjustment mechanism provided on the host, and the state of the dose adjustment mechanism includes whether dose adjustment is performed, whether the needle is blocked, and whether the dose adjustment mechanism is pushed back to zero position. 6.根据权利要求3所述的注射装置,其特征在于,所述主机还包括:6. The injection device according to claim 3, characterized in that the host further comprises: 在位检测机构,其配置为:在所述注射装置配置为装入注射器和针头的情况下检测所述注射器和针头是否装配就位,而在所述注射装置配置为装入笔芯和针头的情况下则检测所述笔芯和针头是否装配就位,并发送相应的在位检测信号;an in-place detection mechanism, which is configured to: detect whether the syringe and the needle are assembled in place when the injection device is configured to be loaded with the syringe and the needle, and detect whether the pen core and the needle are assembled in place when the injection device is configured to be loaded with the pen core and the needle, and send a corresponding in-place detection signal; 其中,所述微控制单元被配置为:接收所述在位检测信号,在所述在位检测信号指示装配就位的情况下,允许致动所述注射部位固定器以执行固定。Wherein, the micro control unit is configured to: receive the in-place detection signal, and allow the injection site fixer to be actuated to perform fixation when the in-place detection signal indicates that the assembly is in place. 7.根据权利要求4所述的注射装置,其特征在于,所述主机还包括:7. The injection device according to claim 4, characterized in that the host further comprises: 在位检测机构,其配置为:在所述注射装置配置为装入注射器和针头的情况下检测所述注射器和针头是否装配就位,而在所述注射装置配置为装入笔芯和针头的情况下则检测所述笔芯和针头是否装配就位,并发送相应的在位检测信号;an in-place detection mechanism, which is configured to: detect whether the syringe and the needle are assembled in place when the injection device is configured to be loaded with the syringe and the needle, and detect whether the pen core and the needle are assembled in place when the injection device is configured to be loaded with the pen core and the needle, and send a corresponding in-place detection signal; 注射按键,其构造为在按下时发送启动信号;an injection button configured to send a start signal when pressed; 其中,所述微控制单元还配置为:在接收到所述启动信号后,致动所述剂量调节检测机构和所述在位检测机构以执行检测;在所述在位检测信号指示装配就位并且所述剂量调节指示信号指示进行了剂量调节的情况下,致动所述注射部位固定器以执行固定。Wherein, the microcontroller unit is further configured to: after receiving the start signal, actuate the dose adjustment detection mechanism and the in-place detection mechanism to perform detection; and actuate the injection site fixer to perform fixation when the in-place detection signal indicates that the assembly is in place and the dose adjustment indication signal indicates that the dose adjustment has been performed. 8.根据权利要求1所述的注射装置,其特征在于,所述主机还包括:8. The injection device according to claim 1, characterized in that the host further comprises: 第一驱动机构,其配置为响应于注射驱动信号驱动注射;a first drive mechanism configured to drive injection in response to an injection drive signal; 第二驱动机构,其配置为响应于针刺驱动信号驱动所述针头刺入注射部位;a second drive mechanism configured to drive the needle to penetrate the injection site in response to a needle penetration drive signal; 注射按键,其构造为在按下时发送启动信号;an injection button configured to send a start signal when pressed; 微控制单元,其配置为:响应于所述启动信号,在注射部位满足针刺启动条件的情况下,向所述第二驱动机构发送所述针刺驱动信号。The micro control unit is configured to: in response to the start signal, send the acupuncture drive signal to the second drive mechanism when the injection site meets the acupuncture start condition. 9.根据权利要求8所述的注射装置,其特征在于,所述针刺启动条件包括如下的至少一种:9. The injection device according to claim 8, characterized in that the acupuncture initiation condition comprises at least one of the following: 在所述注射部位固定器至少包括所述负压吸引机构的情况下,所述注射部位固定器内的压力处于预设范围内并能够得到维持;In the case where the injection site holder includes at least the negative pressure suction mechanism, the pressure in the injection site holder is within a preset range and can be maintained; 在所述注射部位固定器仅包括机械挤压机构的情况下,所述机械挤压机构完成注射部位固定。In case the injection site fixator comprises only a mechanical compression mechanism, the mechanical compression mechanism completes the injection site fixation. 10.根据权利要求4所述的注射装置,其特征在于,所述第二驱动机构还配置为:响应于复位驱动信号驱动所述针头复位;10. The injection device according to claim 4, characterized in that the second driving mechanism is further configured to: drive the needle to reset in response to a reset driving signal; 所述微控制单元还配置为:在满足注射完成条件的情况下,致动所述注射部位固定器以执行释放,然后向所述第二驱动机构发送所述复位驱动信号。The micro control unit is further configured to: when an injection completion condition is met, actuate the injection site fixture to perform release, and then send the reset drive signal to the second drive mechanism. 11.根据权利要求10所述的注射装置,其特征在于,所述注射完成条件包括如下的至少一种:11. The injection device according to claim 10, characterized in that the injection completion condition includes at least one of the following: 所述剂量调节机构返回到零位;The dosage adjustment mechanism returns to the zero position; 所述针头在皮下组织内停留时间达到设定阈值;The needle stays in the subcutaneous tissue for a time that reaches a set threshold; 检测到针头堵塞。Needle obstruction detected. 12.根据权利要求1所述的注射装置,其特征在于,所述注射装置在配置为装入注射器和针头的情况下,还包括以可拆卸方式连接到所述主机的第一盖、第二盖和第三盖,12. The injection device according to claim 1, characterized in that the injection device, when configured to accommodate a syringe and a needle, further comprises a first cover, a second cover and a third cover detachably connected to the main body, 其中,所述第一盖被构造为:在拆卸状态下,用于将所述注射器装入到所述主机;Wherein, the first cover is configured to: in a disassembled state, be used to load the syringe into the host; 所述第二盖被构造为:在拆卸状态下,用于装载或拆下所述针头;The second cover is configured to be used for loading or removing the needle in a disassembled state; 所述第三盖被构造为:以可拆卸方式连接到所述第二盖的与所述第一盖相对的一侧,且在拆卸状态下露出所述注射部位固定器的所述容纳部。The third cover is configured to be detachably connected to a side of the second cover opposite to the first cover, and to expose the receiving portion of the injection site holder in a detached state. 13.根据权利要求1所述的注射装置,其特征在于,所述注射装置在配置为装入笔芯和针头的情况下,还包括以可拆卸方式连接到所述主机的第二盖和第三盖,13. The injection device according to claim 1, characterized in that the injection device, when configured to accommodate a cartridge and a needle, further comprises a second cover and a third cover detachably connected to the main unit, 其中,所述第二盖被构造为:在拆卸状态下,用于装载或拆下所述笔芯和针头;Wherein, the second cover is configured to: in a disassembled state, be used to load or remove the pen core and the needle; 所述第三盖被构造为:以可拆卸方式连接到所述第二盖的与所述主机相对的一侧,且在拆卸状态下露出所述注射部位固定器的所述容纳部。The third cover is configured to be detachably connected to a side of the second cover opposite to the main body, and to expose the receiving portion of the injection site holder in a detached state. 14.根据权利要求12或13所述的注射装置,其特征在于,在所述注射部位固定器至少包括所述负压吸引机构的情况下,所述第二盖内设有针头密封机构和所述注射部位固定器,在关闭所述第二盖时,所述针头密封机构以气密方式连接到所述针头,实现所述针头相对于所述注射部位固定器的气密密封。14. The injection device according to claim 12 or 13 is characterized in that, when the injection site holder includes at least the negative pressure suction mechanism, a needle sealing mechanism and the injection site holder are provided in the second cover, and when the second cover is closed, the needle sealing mechanism is connected to the needle in an airtight manner to achieve an airtight seal of the needle relative to the injection site holder.
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