WO2023065713A1 - 一种垂直式留置针组件及其基座结构 - Google Patents

一种垂直式留置针组件及其基座结构 Download PDF

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Publication number
WO2023065713A1
WO2023065713A1 PCT/CN2022/102229 CN2022102229W WO2023065713A1 WO 2023065713 A1 WO2023065713 A1 WO 2023065713A1 CN 2022102229 W CN2022102229 W CN 2022102229W WO 2023065713 A1 WO2023065713 A1 WO 2023065713A1
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WO
WIPO (PCT)
Prior art keywords
channel
base body
vertical
indwelling
needle assembly
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PCT/CN2022/102229
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English (en)
French (fr)
Inventor
周庆叙
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阿瑞医疗(广东)有限公司
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Application filed by 阿瑞医疗(广东)有限公司 filed Critical 阿瑞医疗(广东)有限公司
Priority to EP22882336.5A priority Critical patent/EP4385540A1/en
Publication of WO2023065713A1 publication Critical patent/WO2023065713A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585Needle inserters
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1586Holding accessories for holding infusion needles on the body
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1587Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient

Definitions

  • the invention relates to the technical field of medical devices, in particular to a vertical indwelling needle assembly and its base structure.
  • the indwelling needles of existing infusion pumps are divided into two types: soft indwelling needles and steel indwelling needles.
  • soft indwelling needles are harmful to the human body, which is easy to cause fear in patients and is not well accepted.
  • soft indwelling needles on the market at present.
  • the vertical indwelling needle is a kind of soft indwelling needle.
  • the vertical indwelling needle generally includes a base structure and a connector.
  • the bottom is formed with a soft indwelling infusion needle communicating with the liquid guiding chamber, and the connector is used to connect to the base structure, so that the medicinal liquid in the medicine reservoir of the infusion pump can be delivered to the liquid guiding chamber through the connector.
  • either the fluid guide chamber in the base structure occupies If the volume is too large, the strength of the base structure is insufficient and the base structure is easy to crack, which deteriorates the reliability of the vertical indwelling needle assembly; or the structure of the connector is relatively complicated, resulting in low production efficiency of the entire vertical indwelling needle assembly.
  • the purpose of the present invention is to provide a vertical indwelling needle assembly and its base structure to solve the problems of low reliability and complicated production process of the vertical indwelling needle assembly.
  • the present invention provides a base structure of a vertical indwelling needle assembly, including a base body for detachable connection with the connector of the vertical indwelling needle assembly, and a There are a liquid guiding chamber, a straight flow channel and a liquid guiding channel; the liquid guiding chamber is arranged close to the top of the base body, and the bottom of the base body is provided with a Soft indwelling infusion needle, the top of the linear flow channel communicates with the liquid guide chamber, the bottom of the linear flow channel communicates coaxially with the beginning of the soft indwelling infusion needle, and the liquid guide chamber
  • the upper cavity is provided with a first flexible seal for blocking the upper cavity, and the first flexible seal is used to allow the puncture needle of the needle aid to penetrate, so that the puncture needle can pass through the liquid guide
  • the chamber and the straight flow channel protrude from the end of the soft indwelling infusion needle; the liquid guiding channel includes a transverse channel and a connecting channel formed in the base body,
  • the liquid guiding chamber is a funnel-shaped structure arranged along the assembly axis of the base body, an opening is formed on the top of the funnel-shaped structure, and the opening constitutes the upper cavity, so A liquid leakage port is formed at the bottom of the funnel-shaped structure, and the upper port of the linear flow channel is connected with the liquid leakage port.
  • a groove connected to the opening is formed on the base body at a position above the opening corresponding to the opening, and the first flexible sealing member is embedded in the groove.
  • the top of the base body is also provided with an upper cover for restricting the first flexible seal in the groove, and the top of the upper cover is provided with an escape port for the puncture needle to pass through .
  • the upper cover is arranged on the top of the base body by ultrasonic welding.
  • the connecting channel includes a horizontally arranged first connecting channel and a vertically arranged second connecting channel, one end of the first connecting channel communicates with the liquid guiding chamber, and the other end of the first connecting channel One end communicates with one end of the second connecting channel, the other end of the second connecting channel communicates with the transverse channel, and the second flexible seal is located on the transverse channel and correspondingly communicates with the second connecting channel between the communication port and the external interface.
  • the side of the base body is provided with a second engaging portion for engaging with the first engaging portion of the connector, and when the connector and the base body are assembled in place, The first engaging portion is engaged with the second engaging portion in place.
  • the base structure of the above-mentioned vertical indwelling needle assembly in the actual application process, because the interior of the base structure is designed with a fluid guiding channel that communicates with the fluid guiding chamber, and the fluid guiding channel includes a transverse channel and the connecting channel, wherein the infusion needle of the connector can pierce the second flexible seal from the outer interface of the transverse channel and communicate with the inner side of the transverse channel.
  • the transverse channel can still be arranged close to the bottom of the base body, so that the infusion tube connected with the infusion needle on the connector is closer to the patient's skin surface, ensuring the patient's experience;
  • the way of direct horizontal connection with the horizontal channel can effectively reduce the longitudinal depth design of the liquid-guiding chamber when the overall height of the base structure is constant, thereby helping to reduce the occupied volume of the liquid-guiding chamber and improving the base structure
  • the overall strength of the base structure avoids the problem of easy cracking of the base structure and ensures the reliability of the vertical indwelling needle assembly; in addition, since there is no need to arrange a complicated flow channel structure on the connector matched with the above base structure, only the infusion needle needs to be designed That is, the structure of the connector is greatly simplified, thereby helping to improve the production efficiency of the entire vertical indwelling needle assembly.
  • the present invention also provides a vertical indwelling needle assembly, including a base structure and a connector detachably connected to the base structure, the base structure being the vertical indwelling needle assembly described in any of the above solutions base structure. Since the above-mentioned base structure has the above-mentioned technical effects, the vertical indwelling needle assembly with the base structure should also have corresponding technical effects, which will not be repeated here.
  • the vertical indwelling needle assembly further includes a protective cover, which can detachably cover the connector or the base structure.
  • the vertical indwelling needle assembly further includes a needle aid
  • the needle aid includes a case and a puncture needle disposed on the case
  • the base structure is provided with a needle for matching with the case.
  • Fig. 1 is a schematic diagram of the axial structure of the vertical indwelling needle assembly provided in the embodiment of the present invention
  • Figure 2 is a schematic top view of the vertical indwelling needle assembly provided in the embodiment of the present invention.
  • Fig. 3 is a schematic diagram of the cross-sectional structure of A-A of Fig. 2;
  • Fig. 4 is a schematic diagram of the axial side structure of the base structure provided in the embodiment of the present invention.
  • FIG. 5 is a schematic top view of the base structure provided in the embodiment of the present invention.
  • Fig. 6 is a schematic diagram of the B-B sectional structure of Fig. 5;
  • Fig. 7 is a schematic diagram of the axial side structure of the connector provided in the embodiment of the present invention.
  • FIG. 8 is a schematic top view of the connector provided in the embodiment of the present invention.
  • FIG. 9 is a schematic cross-sectional structure diagram along line C-C of FIG. 8 .
  • the core of the present invention is to provide a vertical indwelling needle assembly and its base structure to solve the problems of low reliability and complicated production process of the vertical indwelling needle assembly.
  • the embodiment of the present invention provides a base structure of a vertical indwelling needle assembly, including a base body 2 for detachable connection with the connector 1 of the vertical indwelling needle assembly.
  • a liquid guiding chamber 21, a straight flow channel 22 and a liquid guiding channel 23 are formed in the base body 2; the liquid guiding chamber 21 is arranged close to the top of the base body 2, and the bottom of the base body 2 is provided with a
  • the bottom surface of the soft indwelling infusion needle 3 is arranged, the top of the linear flow channel 22 communicates with the liquid guide chamber 21, the bottom of the linear flow channel 22 communicates coaxially with the beginning of the soft indwelling infusion needle 3, and the liquid guide chamber 21
  • the upper cavity is provided with a first flexible seal 4 for blocking the upper cavity, and the first flexible seal 4 is used to allow the puncture needle of the needle aid to penetrate, so that the puncture needle can pass through the liquid guide chamber 21 and the linear flow.
  • the liquid guide channel 23 includes a transverse channel 231 and a connecting channel 232 formed in the base body 2, the transverse channel 231 is arranged close to the bottom of the base body 2, and the connecting channel 232 Used to communicate with the liquid guide chamber 21 and the transverse channel 231, the transverse channel 231 extends laterally to the outer wall of the base body 2 to form an external interface, the second flexible seal 5 is arranged in the transverse channel 231, and the second flexible seal 5 is located between the communication port corresponding to the connecting channel 232 on the transverse channel 231 and the external interface.
  • the inside of the base structure is designed with a fluid guiding channel communicating with the fluid guiding chamber, and the fluid guiding channel includes a transverse channel and a connecting channel, wherein the connector
  • the infusion needle can pierce the second flexible sealing member from the outer interface of the transverse channel and communicate with the inner side of the transverse channel.
  • the liquid guiding chamber is located at the top of the base body, the transverse channel can still be close to it due to the existence of the connecting channel.
  • the bottom of the base body is arranged so that the infusion tube connected to the infusion needle on the connector is closer to the patient's skin surface, ensuring the patient's experience; at the same time, because the liquid guide chamber does not need to be designed to be directly connected to the transverse channel.
  • the design of the longitudinal depth of the liquid conducting chamber can be effectively reduced, thereby helping to reduce the volume occupied by the liquid conducting chamber, improving the overall strength of the base structure, and avoiding the
  • the problem of easy cracking ensures the reliability of the vertical indwelling needle assembly; in addition, since there is no need to arrange a complicated flow channel structure on the connector matched with the above-mentioned base structure, only the infusion needle needs to be designed, which greatly simplifies the connector
  • the structure helps to improve the production efficiency of the entire vertical indwelling needle assembly.
  • the connector is detachably connected to the side of the base body, making the operation easier.
  • the bottom surface of the base body 2 is applied to the patient's skin surface, and then the base structure assembled with the connector 1 is matched with the needle aid, and the puncture needle placed in the needle aid is passed Pass through the first flexible seal 4, the liquid guide chamber 21 and the straight flow channel 22, and extend the end of the soft indwelling infusion needle 3, so that the puncture needle can help send the soft indwelling infusion needle into the subcutaneous of the patient, and then take it away
  • the needle aid completes the fixing of the base structure to the patient.
  • the subcutaneous area can be isolated from the outside air.
  • the infusion needle (generally a hard probe needle) of the connector of the second flexible seal is transported to the connecting channel through the horizontal channel, and then reaches the vertically arranged liquid guiding chamber through the connecting channel, and then the drug solution can be passed through the soft tube.
  • the indwelling infusion needle is used to deliver it subcutaneously.
  • liquid guide channel 23 can be formed by integral casting with the base body 2.
  • other methods well known to those skilled in the art can also be used in the actual application process, such as inlaid hardware inside the base body.
  • this arrangement can avoid the complex production process of inlaying hardware inside the base body, which not only reduces the difficulty of production, but also improves reliability.
  • horizontal and horizontal refer to directions parallel to the bottom surface of the base body
  • vertical and the longitudinal direction refers to the direction perpendicular to the bottom surface of the base body.
  • the bottom surface of the base body is attached to the patient's skin surface.
  • first/second flexible seals can specifically be rubber plugs, or other flexible seals well known to those skilled in the art, which are not specifically limited here;
  • the aforementioned connector and infusion pump reservoir The medicine device is specifically connected through an infusion tube.
  • the infusion tube generally adopts a flexible conduit, and the connection between the infusion tube and the connector 1 can be detachable.
  • the connector 1 is provided with a joint, and the infusion tube It is sleeved on the joint; or it is embedded with a fixed connection, which is not specifically limited here;
  • the bottom surface of the base body is generally designed as a plane, mainly for better fit with the patient's skin surface, and
  • the bottom surface of the base body generally corresponds to the circumferential direction of the soft indwelling infusion needle, and there is also an annular groove.
  • the annular groove is mainly to make use of the elasticity of the skin surface when the bottom surface of the base contacts the patient's skin, and part of the epidermis will sink into the ring. In the groove, a good barrier effect is formed on the wound where the soft indwelling infusion needle penetrates the epidermis, reducing the risk of wound infection.
  • the above-mentioned liquid guiding chamber 21 can be specifically designed as a funnel-shaped structure arranged along the assembly axis of the base body 2, an open opening is formed on the top of the funnel-shaped structure, and the open opening constitutes the upper cavity.
  • a liquid leakage port is formed at the bottom of the funnel-shaped structure, and the upper port of the linear flow channel 22 is connected with the liquid leakage port.
  • a groove connected to the opening may also be formed at the position above the base body 2 corresponding to the opening, and the first flexible sealing member 4 is embedded in the groove.
  • the design of the groove makes the installation and fixing of the first flexible sealing member more convenient.
  • this method of fixing the flexible seal by embedding the groove is only a preferred example of the embodiment of the present invention, and other fixing methods commonly used by those skilled in the art can also be used in the actual application process.
  • the manner of bonding and fixing, etc. are not limited here in more detail.
  • the top of the above-mentioned base body 2 can also be provided with an upper cover 24 for limiting the first flexible seal 4 in the groove, and the top of the upper cover 24 is provided with an avoidance for the passage of the puncture needle. Mouth 241.
  • the way the upper cover is arranged on the base body can be connected in a detachable way, such as clamping or threaded connection, or in a fixed connection way, such as the way the upper cover is welded by ultrasonic waves.
  • a detachable way such as clamping or threaded connection
  • a fixed connection way such as the way the upper cover is welded by ultrasonic waves.
  • the connecting channel 232 may specifically include a horizontally arranged first connecting channel 232a and a vertically arranged second connecting channel 232b, one end of the first connecting channel 232a communicates with the liquid guiding chamber 21, the second The other end of a connecting channel 232a communicates with one end of the second connecting channel 232b, the other end of the second connecting channel 232b communicates with the transverse channel 231, and the second flexible seal 5 is located on the transverse channel 231 and communicates with the second connecting channel 232b between the connecting port and the external interface.
  • the connecting channel as the first connecting channel 232a arranged horizontally and the second connecting channel 232b arranged vertically, the processing of the connecting channel is more convenient. It can be designed as a curved channel or a special-shaped channel, but the processing is more complicated.
  • the side of the above-mentioned base body 2 may be provided with a second engaging portion 25 for engaging with the first engaging portion 12 of the connector 1, and when the connector 1 and the base When the main body 2 is assembled in place, the first engaging portion 12 and the second engaging portion 25 are engaged in place.
  • the first clamping part 12 may specifically be a tongue provided on the connector, and the second clamping part 25 may specifically be a clamping groove formed on the base body 2, and of course the reverse may also be possible.
  • the first clamping part 12 can specifically be a slot provided on the connector, and the second clamping part 25 can specifically be a tab formed on the base body 2.
  • it can be determined according to actual needs. selection, and no more specific limitations are made here.
  • the present invention also provides a vertical indwelling needle assembly, including a base structure and a connector detachably connected to the base structure, wherein the base structure is the vertical indwelling needle assembly described in any of the above solutions. base structure. Since the above-mentioned base structure has the above-mentioned technical effects, the vertical indwelling needle assembly with the base structure should also have corresponding technical effects, which will not be repeated here.
  • the vertical indwelling needle assembly is mainly used in the delivery of medical fluids in the subcutaneous tissue, such as insulin infusion, or other infusions of medical fluids that require precise dose control, and no more specific limitations are made here.
  • the general vertical indwelling needle assembly needs to be kept installed on the patient for a period of time, which can be several days, for example, 3-5 days or even a week, or even longer. During this period of time, patients will inevitably have contact with water such as bathing. At this time, the vertical indwelling needle assembly needs to be separated from the infusion pump system for a short time. Therefore, it is necessary to better protect the vertical indwelling needle assembly to avoid infection of the needle stick wound.
  • the vertical indwelling needle assembly can also include a protective cover, which can be detachably sealed and closed to the connector 1 or the base structure 2, when the patient has contact with water such as bathing When required, it is only necessary to disassemble the connector 1 and install the protective cover on the base structure 2 to achieve sealing.
  • the above-mentioned vertical indwelling needle assembly may also include a needle aid
  • the needle aid includes a case and a puncture needle arranged on the case
  • the base structure is provided with a piercing needle for cooperating with the case.
  • the needle seat and when the cover fits in place with the puncture needle seat, the puncture needle protrudes from the end of the soft indwelling infusion needle.
  • the matching between the puncture needle and the soft indwelling infusion needle is more convenient and accurate through the cooperation of the cover shell and the base.

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

Abstract

一种垂直式留置针组件及其基座结构,包括基座本体(2),基座本体(2)内形成有导液腔室(21)、直线流道(22)和导液通道(23);导液通道(23)包括形成于基座本体(2)内的横向通道(231)和连接通道(232),横向通道(231)贴近基座本体(2)的底部布置,连接通道(232)用于连通导液腔室(21)与横向通道(231),横向通道(231)横向延伸至基座本体(2)的外壁面以形成外接口,横向通道(231)内设置有第二柔性密封件(5),且第二柔性密封件(5)位于横向通道(231)上对应连通连接通道(232)的连通口与外接口之间。上述设置可以有效提升基座结构的整体强度,保证垂直式留置针组件的可靠性;与上述基座结构配合的连接器(1)上不需要布置复杂的流道结构,仅需要设计输液针头,可以简化连接器(1)的结构,从而有助于提升整个垂直式留置针组件的生产效率。

Description

一种垂直式留置针组件及其基座结构 技术领域
本发明涉及医疗器械技术领域,尤其涉及一种垂直式留置针组件及其基座结构。
背景技术
现有输注泵(如胰岛素泵)的留置针分为软质留置针和钢质留置针两种,其中,钢质留置针对人体有伤害,容易让患者心生恐惧,接受程度不高,因此目前市场上以软质留置针较多。
其中,垂直式留置针属于软质留置针的一种,针对于垂直式留置针而言,其一般包括基座结构和连接器,其中基座结构上形成有导液腔室,基座结构的底部形成有与导液腔室连通的软质留置输液针,连接器用于连接至基座结构,以使输液泵储药器内的药液能够通过连接器输送至导液腔室。
一般来说,连接器的输液管越是贴近患者的皮肤表面,患者的使用体验越好,但目前的垂直式留置针组件为满足患者的使用体验,要么基座结构内的导液腔室占据体积太大引起基座结构的强度不足导致基座结构容易开裂,使得垂直式留置针组件的可靠性变差;要么连接器的结构比较复杂,导致整个垂直式留置针组件的生产效率变低。
综上,如何解决垂直式留置针组件存在可靠性差和生产效率低的问题已经成为本领域技术人员亟待解决的技术问题。
发明内容
本发明的目的是提供一种垂直式留置针组件及其基座结构,以解决垂直式留置针组件存在可靠性低和生产工艺复杂的问题。
为了实现上述目的,本发明提供了一种垂直式留置针组件的基座结构,包括用于与所述垂直式留置针组件的连接器可拆卸连接的基座本体,所述基座本体内形成有导液腔室、直线流道和导液通道;所述导液腔室靠近所述基座本体的顶部布置,所述基座本体的底部设置有垂直于所述基座本体的底面布置的软质留置输液针,所述直线流道的顶端与所述导液腔室连通,所述直线流道的底部与所述软质留置输液针的始端同轴连通,所述导液腔室的上腔口设置有用于封堵所述上腔口的第一柔性密封件,所述第一柔性密封件用于允许助针器的刺针穿入,以使所述刺针能够穿过所述导液腔室及所述直线流道并伸出所述软质留置输液针的末端;所述导液通道包括形成于所述基座本体内的横向通道和连接通道,所述横向通道贴近所述基座本体的底部布置,所述连接通道用于连通所述导液腔室与所述横向通道,所述横向通道横向延伸至所述基座本体的外壁面以形成外接口,所述横向通道内设置有第二柔性密封件,且所述第二柔性密封件位于所述横向通道上对应连通所述连接通道的连通口与所述外接口之间,当所述连接器与所述基座本体装配到位时,所述连接器的输液针头自所述外接口刺穿所述第二柔性密封件并与所述横向通道的内侧连通。
优选地,所述导液腔室为沿所述基座本体的装配轴心布置的漏斗形结构,所述漏斗形结构的顶部形成有敞开口,所述敞开口构成所述上腔口,所述漏斗形结构的底部形成有漏液口,所述直线流道的上端口与所述漏液口衔接。
优选地,所述基座本体对应所述敞开口的上方位置形成有与所述敞开口衔接的凹槽,所述第一柔性密封件嵌设于所述凹槽内。
优选地,所述基座本体的顶部还设置有用于将所述第一柔性密封件限位于所述凹槽内的上盖,且所述上盖的顶部设置有用于所述刺针通过的避让口。
优选地,所述上盖采用超声波焊接的方式设置于所述基座本体的顶部。
优选地,所述连接通道包括水平布置的第一连接通道和竖向布置的第二连接通道,所述第一连接通道的一端与所述导液腔室连通,所述第一连接通道的另一端与所述第二连接通道的一端连通,所述第二连接通道的另一端与所述横向通道连通,且所述第二柔性密封件位于所述横向通道上对应连通所述第二连接通道的连通口与所述外接口之间。
优选地,所述基座本体的侧部设置有用于与所述连接器的第一卡接部卡合的第二卡接部,且当所述连接器与所述基座本体装配到位时,所述第一卡接部与所述第二卡接部卡合到位。
相比于背景技术介绍内容,上述垂直式留置针组件的基座结构,在实际应用过程中,由于基座结构内部设计有与导液腔室连通的导液通道,并且导液通道包括横向通道和连接通道,其中,连接器的输液针头可以自横向通道的外接口刺穿第二柔性密封件并与横向通道内侧连通,尽管导液腔室位于基座本体的顶部位置,但是由于连接通道的存在,使得横向通道仍可以贴近基座本体的底部布置,从而使得连接器上与输液针头连接的输液管更加贴近患者的皮肤表面,保证了患者的体验;同时由于导液腔室不需要设计成与横向通道直接横向连通过的方式,在基座结构整体高度一定的情况,能够有效的降低导液腔室的纵向深度设计,从而有助于缩减导液腔室的占用体积,提升基座结构的整体强度,避免基座结构容易开裂的问题,保证垂直式留置针组件的可靠性;另外,由于与上述基座结构配合的连接器上不需要布置复杂的流道结构,仅需要设计输液针头即可,大大简化了连接器的结构,从而有助于提升整个垂直式留置针组件的生产效率。
另外,本发明还提供了一种垂直式留置针组件,包括基座结构和与所述基座结构可拆卸连接的连接器,该基座结构为上述任一方案所描述的垂直式留置针组件的基座结构。由于前述基座结构具有上述技术效果,因此具有该基座结构的垂直式留置针组件,也应具有相应的技术效果,在此不再赘述。
优选地,所述垂直式留置针组件还包括保护盖,所述保护盖能够可拆卸地盖合于所述连接器或所述基座结构。
优选地,所述垂直式留置针组件还包括助针器,所述助针器包括罩壳和设置于所述罩壳的刺针,所述基座结构上设置有用于与所述罩壳配合的穿刺针座,且当所述罩壳与所述穿刺针座配合到位时,所述刺针伸出所述软质留置输液针的末端。
附图说明
图1为本发明实施例中提供的垂直式留置针组件的轴侧结构示意图;
图2为本发明实施例中提供的垂直式留置针组件的俯视结构示意图;
图3为图2的A-A剖视结构示意图;
图4为本发明实施例中提供的基座结构的轴侧结构示意图;
图5为本发明实施例中提供的基座结构的俯视结构示意图;
图6为图5的B-B剖视结构示意图;
图7为本发明实施例中提供的连接器的轴侧结构示意图;
图8为本发明实施例中提供的连接器的俯视结构示意图;
图9为图8的C-C剖视结构示意图。
在图1-图9中,
连接器1、输液针头11、第一卡接部12、基座本体2、导液腔室21、直线流道22、导液通道23、横向通道231、连接通道232、第一连接通道232a、第二连接通道232b、上盖24、第二卡接部25、软质留置输液针3、第一柔性密封件4、第二柔性密封件5。
具体实施方式
本发明的核心是提供一种垂直式留置针组件及其基座结构,以解决垂直式留置针组件存在可靠性低和生产工艺复杂的问题。
为了使本领域的技术人员更好地理解本发明提供的技术方案,下面将结合本申请实施例中的附图,对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。
如图1-图9所示,本发明实施例提供了一种垂直式留置针组件的基座结构,包括用于与垂直式留置针组件的连接器1可拆卸连接的基座本体2,基座本体2内形成有导液腔室21、直线流道22和导液通道23;导液腔室21靠近基座本体2的顶部布置,基座本体2的底部设置有垂直于基座本体2的底面布置的软质留置输液针3,直线流道22的顶端与导液腔室21连通,直线流道22的底部与软质留置输液针3的始端同轴连通,导液腔室21的上腔口设置有用于封堵上腔口的第一柔性密封件4,第一柔性密封件4用于允许助针器的刺针穿入,以使刺针能够穿过导液腔室21及直线流道22并伸出软质留置输液针3的末端;导液通道23包括形成于基座本体2内的横向通道231和连接通道232,横向通道231贴近基座本体2的底部布置,连接通道232用于连通导液腔室21与横向通道231,横向通道231横向延伸至基座本体2的外壁面以 形成外接口,横向通道231内设置有第二柔性密封件5,且第二柔性密封件5位于横向通道231上对应连通连接通道232的连通口与外接口之间,当连接器1与基座本体2装配到位时,连接器1的输液针头11自外接口刺穿第二柔性密封件5并与横向通道231的内侧连通。
上述垂直式留置针组件的基座结构,在实际应用过程中,由于基座结构内部设计有与导液腔室连通的导液通道,并且导液通道包括横向通道和连接通道,其中,连接器的输液针头可以自横向通道的外接口刺穿第二柔性密封件并与横向通道内侧连通,尽管导液腔室位于基座本体的顶部位置,但是由于连接通道的存在,使得横向通道仍可以贴近基座本体的底部布置,从而使得连接器上与输液针头连接的输液管更加贴近患者的皮肤表面,保证了患者的体验;同时由于导液腔室不需要设计成与横向通道直接横向连通过的方式,在基座结构整体高度一定的情况,能够有效的降低导液腔室的纵向深度设计,从而有助于缩减导液腔室的占用体积,提升基座结构的整体强度,避免基座结构容易开裂的问题,保证垂直式留置针组件的可靠性;另外,由于与上述基座结构配合的连接器上不需要布置复杂的流道结构,仅需要设计输液针头即可,大大简化了连接器的结构,从而有助于提升整个垂直式留置针组件的生产效率,此外,连接器与基座本体的侧部可拆卸连接,操作更加简便。
为了本领域技术人员更好的理解本发明的技术方案,下面对上述基座结构的使用过程进行简要说明:
在实际使用过程中,首先将基座本体2的底面贴敷于患者的皮肤表面,然后将已与连接器1装配到位的基座结构与助针器配合,通过置于助针器内的刺针穿过第一柔性密封件4、导液腔室21及直线流道22,并伸出软质留置输液针3的末端,从而刺针能够帮助把软质留置输液针送入患者皮下,然后取走助针器,即完成了基座结构固定至患者身上。此时操作过程中由于第一柔性密封件的存在,能够将皮下与外界空气隔绝,输液泵储药器通过输液管 将药液自连接器侧部横向布置的进液接口输入,通过已穿过第二柔性密封件的连接器的输液针头(一般为硬质探出针头),经横向通道输送至连接通道,在通过连接通道到达竖向布置的导液腔室,继而能够将药液通过软质留置输液针输送至皮下。
需要说明的是,导液通道23具体可以与基座本体2采用一体铸造成型的方式形成,当然实际应用过程中,还可以采用本领域技术人员所熟知的其他方式,比如基座本体内部镶嵌五金件的方式,只不过这样布置可以避免在基座本体内部镶嵌五金件的复杂生产工序,既降低了生产难度,同时也提升了可靠性。
还需要说明的是,前述中横向、竖向、水平及纵向是基于基座本体的底面所做出的的方位定义,具体地,横向和水平是指平行于基座本体的底面方向,竖向和纵向是指垂直于基座本体的底面方向。而一般来说,基座本体的底面贴合于患者的皮肤表面。
另外,前述中第一/第二柔性密封件,具体可以是橡胶塞,又或者是本领域技术人员所熟知的其他柔性密封件,在此不做更具体的限定;前述连接器与输液泵储药器具体通过输液管连通,该输液管一般采用柔性导管,而该输液管与连接器1之间的连接方式,可以采用可拆卸的连接方式,比如,连接器1上设置有接头,输液管套设在该接头上;又或者是,内嵌固定式连接,在此不做具体的限定;基座本体的底面一般设计成平面,主要是为了更好的与患者的皮肤表面贴合,并且基座本体的底面一般对应软质留置输液针的周向还会设置有环形凹槽,该环形凹槽主要是使基座底面与患者皮肤接触时,利用皮肤表层的弹性,部分表皮会陷入环形凹槽内,从而对软质留置输液针穿入表皮的伤口位置形成良好的屏障作用,减小伤口感染的风险。
在一些具体的实施方案中,上述导液腔室21具体可以设计成沿基座本体2的装配轴心布置的漏斗形结构,漏斗形结构的顶部形成有敞开口,敞开口构成上腔口,漏斗形结构的底部形成有漏液口,直线流道22的上端口与漏液口衔接。通过将导液腔室21设计成漏斗形结构,能够使得药液进入直线流道22及软质留置输液针3更加顺畅。当然可以理解的是,该种漏斗形结构的导液腔室仅仅是本发明实施例的优选举例而已,实际应用过程中,还可以采用其他的结构形式,比如半球形腔体等结构形式,在此不做更具体的限定。
进一步的实施方案中,上述基座本体2对应敞开口的上方位置还可以形成有与敞开口衔接的凹槽,第一柔性密封件4嵌设于凹槽内。通过设计凹槽使得第一柔性密封件的安装固定更加方便。当然可以理解的是该种通过凹槽嵌设的方式固定柔性密封件的方式,仅仅是本发明实施例的优选举例而已,实际应用过程中,还可以是本领域技术人员常用的其他固定方式,比如粘结固定的方式等,在此不做更具体的限定。
在一些具体的实施方案中,上述基座本体2的顶部还可以设置有用于将第一柔性密封件4限位于凹槽内的上盖24,且上盖24的顶部设置有用于刺针通过的避让口241。通过设计上盖结构使得第一柔性密封件4的安装固定及拆卸更加方便。
需要说明的是,上盖设置在基座本体上的方式,可以采用可拆卸的连接方式,比如卡接或螺纹连接的方式,也可以采用固定式连接的方式,比如上盖通过超声波焊接的方式设置于基座本体2的顶部等。
在一些具体的实施方案中,上述连接通道232具体可以包括水平布置的第一连接通道232a和竖向布置的第二连接通道232b,第一连接通道232a的一端与导液腔室21连通,第一连接通道232a的另一端与第二连接通道232b的一端连通,第二连接通道232b的另一端与横向通道231连通,且第二柔性 密封件5位于横向通道231上对应连通第二连接通道232b的连通口与外接口之间。通过将连接通道设计成水平布置的第一连接通道232a和竖向布置的第二连接通道232b的结构形式,使得连接通道的加工更加方便,当然可以理解的是,实际应用过程中,连接通道还可以设计成弧形通道或者异形通道的结构形式,只不过加工更加复杂而已。
在一些更具体的实施方案中,上述基座本体2的侧部可以设置有用于与连接器1的第一卡接部12卡合的第二卡接部25,且当连接器1与基座本体2装配到位时,第一卡接部12与第二卡接部25卡合到位。通过设计成第一卡接部12与第二卡接部25卡合连接的方式,也即卡扣方式,使得连接器的拆装更加便捷,当然实际应用过程中,也可以采用本领域技术人员常用的其他可拆卸连接方式,比如螺纹连接的方式等。当采用卡扣连接的方式时,第一卡接部12具体可以是设置于连接器的卡舌,第二卡接部25具体可以是形成于基座本体2上卡槽,当然也可以反过来设计,比如第一卡接部12具体可以是设置于连接器的卡槽,第二卡接部25具体可以是形成于基座本体2上的卡舌,实际应用过程中,可以根据实际需求进行选择,在此不做更具体的限定。
另外,本发明还提供了一种垂直式留置针组件,包括基座结构和与基座结构可拆卸连接的连接器,其中,基座结构为上述任一方案所描述的垂直式留置针组件的基座结构。由于前述基座结构具有上述技术效果,因此具有该基座结构的垂直式留置针组件,也应具有相应的技术效果,在此不再赘述。
需要说明的是,垂直式留置针组件主要应用于皮下组织的药液输送,比如胰岛素的输注,又或者,其它需要精准控制剂量的药液输注,在此不做更具体的限定。以应用至胰岛素的输注为例,一般垂直式留置针组件,需要在患者身上持续保持安装状态一段时间,具体可以为数天,比如,3-5天甚至一周,甚至更长时间。而患者在这段时间内,难免会有洗澡等接触水的行为。 此时垂直式留置针组件需要短暂脱离输液泵系统,因此,就需要对垂直式留置针组件进行较好的防护,以免造成针刺伤口感染。
为了避免接触水而造成感染的风险,该垂直式留置针组件还可以包括保护盖,该保护盖能够可拆卸地密封盖合于连接器1或基座结构2,当患者有洗澡等接触水的需求时,仅需将连接器1拆卸,同时将保护盖安装至基座结构2上即可实现密封。
在一些更具体的实施方案中,上述垂直式留置针组件,还可以包括助针器,助针器包括罩壳和设置于罩壳的刺针,基座结构上设置有用于与罩壳配合的穿刺针座,且当罩壳与穿刺针座配合到位时,刺针伸出软质留置输液针的末端。通过罩壳与基座配合,使得刺针与软质留置输液针的匹配更加方便准确。
以上对本发明所提供的垂直式留置针组件及其基座结构进行了详细介绍。需要说明的是,本说明书中的各个实施例均采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似的部分互相参见即可。
还需要说明的是,在本文中,诸如术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括上述要素的物品或者设备中还存在另外的相同要素。
本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的核心思想。应当指出,对于本技术领 域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。

Claims (10)

  1. 一种垂直式留置针组件的基座结构,包括用于与所述垂直式留置针组件的连接器(1)可拆卸连接的基座本体(2),其特征在于,所述基座本体(2)内形成有导液腔室(21)、直线流道(22)和导液通道(23);
    所述导液腔室(21)靠近所述基座本体(2)的顶部布置,所述基座本体(2)的底部设置有垂直于所述基座本体(2)的底面布置的软质留置输液针(3),所述直线流道(22)的顶端与所述导液腔室(21)连通,所述直线流道(22)的底部与所述软质留置输液针(3)的始端同轴连通,所述导液腔室(21)的上腔口设置有用于封堵所述上腔口的第一柔性密封件(4),所述第一柔性密封件(4)用于允许助针器的刺针穿入,以使所述刺针能够穿过所述导液腔室(21)及所述直线流道(22)并伸出所述软质留置输液针(3)的末端;
    所述导液通道(23)包括形成于所述基座本体(2)内的横向通道(231)和连接通道(232),所述横向通道(231)贴近所述基座本体(2)的底部布置,所述连接通道(232)用于连通所述导液腔室(21)与所述横向通道(231),所述横向通道(231)横向延伸至所述基座本体(2)的外壁面以形成外接口,所述横向通道(231)内设置有第二柔性密封件(5),且所述第二柔性密封件(5)位于所述横向通道(231)上对应连通所述连接通道(232)的连通口与所述外接口之间,当所述连接器(1)与所述基座本体(2)装配到位时,所述连接器(1)的输液针头(11)自所述外接口刺穿所述第二柔性密封件(5)并与所述横向通道(231)的内侧连通。
  2. 如权利要求1所述的垂直式留置针组件的基座结构,其特征在于,所述导液腔室(21)为沿所述基座本体(2)的装配轴心布置的漏斗形结构,所述漏斗形结构的顶部形成有敞开口,所述敞开口构成所述上腔口,所述漏斗 形结构的底部形成有漏液口,所述直线流道(22)的上端口与所述漏液口衔接。
  3. 如权利要求2所述的垂直式留置针组件的基座结构,其特征在于,所述基座本体(2)对应所述敞开口的上方位置形成有与所述敞开口衔接的凹槽,所述第一柔性密封件(4)嵌设于所述凹槽内。
  4. 如权利要求3所述的垂直式留置针组件的基座结构,其特征在于,所述基座本体(2)的顶部还设置有用于将所述第一柔性密封件(4)限位于所述凹槽内的上盖(24),且所述上盖(24)的顶部设置有用于所述刺针通过的避让口(241)。
  5. 如权利要求4所述的垂直式留置针组件的基座结构,其特征在于,所述上盖(24)采用超声波焊接的方式设置于所述基座本体(2)的顶部。
  6. 如权利要求1所述的垂直式留置针组件的基座结构,其特征在于,所述连接通道(232)包括水平布置的第一连接通道(232a)和竖向布置的第二连接通道(232b),所述第一连接通道(232a)的一端与所述导液腔室(21)连通,所述第一连接通道(232a)的另一端与所述第二连接通道(232b)的一端连通,所述第二连接通道(232b)的另一端与所述横向通道(231)连通,且所述第二柔性密封件(5)位于所述横向通道(231)上对应连通所述第二连接通道(232b)的连通口与所述外接口之间。
  7. 如权利要求1-6中任一项所述的垂直式留置针组件的基座结构,其特征在于,所述基座本体(2)的侧部设置有用于与所述连接器(1)的第一卡接部(12)卡合的第二卡接部(25),且当所述连接器(1)与所述基座本体(2)装配到位时,所述第一卡接部(12)与所述第二卡接部(25)卡合到位。
  8. 一种垂直式留置针组件,包括基座结构和与所述基座结构可拆卸连接的连接器,其特征在于,所述基座结构为如权利要求1-7中任一项所述的垂直式留置针组件的基座结构。
  9. 如权利要求8所述的垂直式留置针组件,其特征在于,还包括保护盖,所述保护盖能够可拆卸地盖合于所述连接器(1)或所述基座结构(2)。
  10. 如权利要求8所述的垂直式留置针组件,其特征在于,还包括助针器,所述助针器包括罩壳和设置于所述罩壳的刺针,所述基座结构上设置有用于与所述罩壳配合的穿刺针座,且当所述罩壳与所述穿刺针座配合到位时,所述刺针伸出所述软质留置输液针的末端。
PCT/CN2022/102229 2021-10-19 2022-06-29 一种垂直式留置针组件及其基座结构 WO2023065713A1 (zh)

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