WO2023092914A1 - 经皮分析物传感器系统 - Google Patents

经皮分析物传感器系统 Download PDF

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Publication number
WO2023092914A1
WO2023092914A1 PCT/CN2022/082905 CN2022082905W WO2023092914A1 WO 2023092914 A1 WO2023092914 A1 WO 2023092914A1 CN 2022082905 W CN2022082905 W CN 2022082905W WO 2023092914 A1 WO2023092914 A1 WO 2023092914A1
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WIPO (PCT)
Prior art keywords
sensor system
unit
body surface
analyte sensor
housing
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PCT/CN2022/082905
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English (en)
French (fr)
Inventor
钱成
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苏州百孝医疗科技有限公司
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Publication of WO2023092914A1 publication Critical patent/WO2023092914A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus

Definitions

  • the present application relates to the technical field of medical devices, for example, to a transdermal analyte sensor system.
  • the course of the disease is long and the disease is protracted. It is necessary to monitor certain physiological parameters of the host in real time, so as to better track the treatment.
  • diabetes requires real-time monitoring of the host's blood sugar. Accurate self-monitoring of blood sugar is the key to achieving good blood sugar control. It is helpful to assess the degree of glucose metabolism disorder in diabetic patients, formulate a hypoglycemic plan, reflect the effect of hypoglycemic treatment and guide the adjustment of the treatment plan.
  • the blood glucose meter is the most widely used on the market. Patients need to collect blood from the tip of their finger to measure the blood sugar level at that moment. However, this method has the following defects: 1. It is impossible to know the change of blood glucose level between two measurements, and the patient may miss the peak and valley of blood glucose, which will cause some complications and cause irreversible damage to the patient; 2. Multiple fingertip punctures for blood collection have caused great pain to diabetic patients. In order to overcome the above defects, it is necessary to provide a method that can continuously monitor the blood sugar of patients, so that patients can know their blood sugar status in real time, and take timely countermeasures accordingly, so as to effectively control the disease and prevent complications, so as to obtain a higher blood sugar level. Quality of Life.
  • the implanter structure in the related art such as the Chinese invention patent CN112423665A discloses an applicator (i.e. implanter) structure, by making the applicator move toward the target monitoring position, Upon engaging the skin at the target monitoring location, the sheath collapses into the housing, thereby allowing the sensor control device to advance into engagement with the skin, the sensor (i.e., the sensor electrodes) is advanced percutaneously into the patient's skin at the target monitoring location by means of a sharp object, When the housing is fully advanced to the target monitoring location, the sharp is automatically retracted while the sensor remains in place to monitor analyte levels.
  • an applicator i.e. implanter
  • the implantation of the sensor requires the sheath to be completely retracted into the shell, and the process of piercing the skin with sharp objects needs to be achieved by manually pushing the applicator.
  • This process has high requirements for user operations and has the following disadvantages: 1. 1. During the implantation process, the sensor may not be implanted normally due to improper operation by the user; 2. The speed of manually piercing sharp objects is slow, which is likely to cause greater pain; 3. Manual piercing is likely to bring greater pain to the user. The psychological pressure affects the user experience.
  • the applicator and the sensor in the above solution are sterilized and packaged separately, and the user needs to put the sensor into the applicator before use, and the sensor may not be implanted normally due to improper installation by the user.
  • the present application provides a transdermal analyte sensor system, which can improve the comfort and convenience of sensor electrode implantation, and improve user experience.
  • One embodiment provides a transdermal analyte sensor system comprising an implanter unit including a housing, a sheath movably disposed at a distal end of the housing, and a sheath disposed within the housing.
  • a first drive mechanism and a second drive structure including a needle assembly; and a body surface attachment unit, the body surface attachment unit including sensor electrodes;
  • the first drive mechanism is configured to at least partially When retracted inside the housing, driving the needle assembly in a distal direction guides the sensor electrode portion into the subcutaneous portion of the host and applies the body surface attachment unit to the skin surface of the host;
  • the The second drive mechanism is configured to drive the needle assembly in a proximal direction to separate from the sensor electrode and retract into the housing when the body surface attachment unit is applied to the skin surface of the host ; wherein, the far side is the side close to the skin of the host, and the proximal side is the side away from the skin of the host.
  • FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.
  • FIG. 2 is a schematic structural diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.
  • FIG. 3 is a cross-sectional view of an analyte sensor system according to an embodiment of the present application.
  • FIG. 4 is a perspective cross-sectional view of an analyte sensor system according to an embodiment of the present application.
  • Fig. 5 is a schematic structural diagram of an implanter unit according to an embodiment of the present application.
  • Fig. 6 is a structural schematic diagram of another angle of the implanter unit according to an embodiment of the present application.
  • Fig. 7 is a structural exploded view of a body surface attachment unit according to an embodiment of the present application.
  • Fig. 8 is a perspective sectional view of a cap according to an embodiment of the present application.
  • Fig. 9 is a schematic diagram of the installation of the first holding part and the body surface attachment unit according to an embodiment of the present application.
  • Fig. 10 is a schematic diagram of another angle of installation of the first holding part and the body surface attachment unit according to an embodiment of the present application.
  • Fig. 11 is a schematic diagram of the installation of the first holding part and the second holding part according to an embodiment of the present application.
  • Fig. 12 is a schematic structural view of a needle assembly according to an embodiment of the present application.
  • 100 host; 200, body surface attachment unit; 210, sensor electrode; 220, release layer; 230, carrier; 240, cover body; 241, positioning groove; 300, receiver; 400, implanter unit ;410, needle assembly; 411, puncture needle; 412, hub; 413, groove; 420, shell; 421, first step; 422, base plate; 423, limit hole; 424, guide cylinder; 430, sheath; 431 , limit block; 432, first elastic hook portion; 433, push rod; 440, opening; 450, first holding portion; 451, connecting seat; 452, convex point; 453, second elastic hook portion; 454, slope 455, the third elastic hook; 460, the first driving spring; 470, the second holding part; 471, the elastic jaw; 472, the second step; 473, the elastic arm; 480, the second driving spring; 500, Cap; 510, support portion; 511, limit rib; 512, retaining strip.
  • FIG. 1 is a schematic diagram of a continuous glucose monitoring system attached to a host 100 .
  • a continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 attached to the skin surface of a host 100 through an adhesive layer is shown in FIG. 2 .
  • the body surface attachment unit 200 has a built-in circuit module electrically connected to the sensor electrode 210.
  • the circuit module is configured to send the glucose concentration information monitored by the sensor electrode 210 to the receiver 300.
  • the receiver 300 can usually be a smart phone, smart watch, Special equipment and the like.
  • the sensor electrode 210 is partially located under the skin of the host 100, in contact with the subcutaneous tissue fluid.
  • FIG. 2 is a schematic structural diagram of a continuous blood glucose monitoring system, including an implanter unit 400, a body surface attachment unit 200, and a cap 500.
  • the body surface attachment unit 200 is pre-installed in the cap 500, and then It is installed on the implanter unit 400 along with the cap 500.
  • the cap 500 is removed from the implanter unit 400 by turning the cap 500.
  • the adhesive layer covering the body surface attachment unit 200 The release layer 220 on the top will be peeled off together with the removal of the cap 500; then the opening side of the implanter unit 400 is attached to the skin surface of the host 100, and the implanter unit 400 is removed by operating the implanter unit 400.
  • the body surface attachment unit 200 is attached to the skin surface of the host 100.
  • the sensor electrode 210 is partially implanted under the skin of the host 100, and is in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid.
  • the adhesive layer can be medical non-woven adhesive tape.
  • the release layer 220 is a release paper or a release film, and a layer of release agent is coated on the surface.
  • the present application provides a transdermal analyte sensor system taking the above-mentioned continuous blood glucose monitoring system as an example, including an implanter unit 400, a needle assembly 410 and a body surface attachment unit 200, implanted
  • the sensor unit 400 includes a housing 420, a sheath 430 movably disposed at the distal end of the housing 420, and a first driving mechanism and a second driving structure disposed inside the housing 420.
  • the body surface attachment unit 200 includes a sensor electrode 210;
  • a driving mechanism is configured to drive the needle assembly 410 in a distal direction when the sheath 430 is at least partially retracted inside the housing 420 to guide the sensor electrode 210 partially into the host's skin and apply the body surface attachment unit 200 thereto.
  • the host skin surface; the second drive mechanism is configured to drive the needle assembly 410 in a proximal direction to separate from the sensor electrode 210 and retract into the housing 420 when the body surface attachment unit 200 is applied to the host skin surface.
  • the sheath 430 is used as the triggering mechanism, and by pushing the implanter unit 400 until the sheath 430 is at least partially retracted into the shell 420 of the implanter unit 400, the first driving mechanism is triggered by the sheath 430 to attach the body surface.
  • the unit 200 is applied to the skin surface of the host, and then the needle assembly 410 is retracted through the second driving mechanism, which simplifies the operation and improves the user experience.
  • the sheath 430 and the body surface attachment unit 400 of the present application are pre-installed on the cap 500, and when the cap 500 is coupled to the implanter unit 400, the sheath 430 and the body surface attachment unit 200 are coupled together onto the implanter unit 400, and when the cap 500 is removed, the sheath 430 and the body surface attachment unit 400 are transferred from the cap 500 to the implanter unit 400, which simplifies the assembly process, especially facilitating the body surface Attachment unit installation.
  • the present application triggers the first driving mechanism by pushing the implanter unit 400 to retract the sheath 430 .
  • the sheath 430 is partially retracted inside the housing 420 of the implanter unit 400 to produce the triggering effect.
  • the sheath 430 is fully retracted inside the housing 420 of the implanter unit 400 to produce a triggering effect.
  • the distal end of the implanter unit 400 is configured with an opening 440 , and the sheath 430 is embedded in the opening 440 , and can be inside the housing 420 of the implanter unit 400 in the proximal direction. Move freely.
  • the distal end of the implanter unit 400 is also coupled with a cap 500 configured to be removable before the implanter unit 400 is applied to the body surface attachment unit 200 .
  • cap 500 is configured to be removed in a rotational manner.
  • the body surface attachment unit 200 includes a carrier 230 and a cover 240 coupled to the carrier 230 .
  • the outer diameter of the carrier 230 is larger than the outer diameter of the cover 240, so that the edge of the carrier 230 protrudes beyond the edge of the cover 240.
  • the body surface attachment unit 200 is fixed in the cap 500 before the cap 500 is removed. In one embodiment, the body surface attachment unit 200 is secured by the cooperation of the sheath 430 and the cap 500 before the cap 500 is removed.
  • the inside of the cap 500 is configured with an annular support portion 510, the carrier 230 of the body surface attachment unit 200 is placed on the end face of the proximal end of the support portion 510, and the distal end of the sheath 430
  • the inner bottom surface of the body surface attachment unit 200 is pressed against the edge of the carrier 230 of the body surface attachment unit 200, and the carrier of the body surface attachment unit 200 is clamped by the end surface of the proximal end of the support part 510 and the inner bottom surface of the distal end of the sheath 430
  • the edge 230 secures the body surface attachment unit 200 in the cap 500 .
  • a plurality of limiting ribs 511 are arranged at equal intervals along the circumferential direction on the outer surface of the support part 510, and a plurality of limiting blocks 431 are arranged at equal intervals on the inner surface of the distal end of the sheath 430, two adjacent limiting ribs
  • the distance between the ribs 511 is greater than the length of any limiting block 431 along the circumferential direction, and the distance between two adjacent limiting blocks 431 is greater than the length of any limiting rib 511 along the circumferential direction, so that the distance between the sheath 430
  • the stop block 431 passes between the stop ribs 511, and the cap 500 is turned so that the stop block 431 moves to a position blocked by the stop rib 511 in the circumferential direction.
  • the cap 500 is interlocked with the sheath 430, and the limiting rib 511 is extended with a bar 512 in the direction toward the far side.
  • the bar 512 plays the role of blocking the limiting block 431. They are all components arranged inside the cap 500, so the positional relationship between the two cannot be directly observed from the outside.
  • the cap 500 is turned to make the limit block 431 move in the circumferential direction until it is blocked by the bar 512 and cannot continue to rotate, it means The limiting block 431 has reached the position of interlocking with the limiting rib 511 .
  • at least part of the limiting block 431 cooperates with the limiting rib 511 to limit when the distal end of the sheath 430 is coupled to the cap 500 .
  • only a part of the limiting blocks 431 can cooperate with the limiting ribs 511 to limit the position. At this time, the number of the limiting ribs 511 is less than the number of the limiting blocks 431 . In another embodiment, all the limiting blocks 431 cooperate with the limiting ribs 511 to limit the position. At this time, the number of the limiting ribs 511 is greater than or equal to the number of the limiting blocks 431 .
  • the proximal end of the sheath 430 is provided with a plurality of first elastic hooks 432
  • the housing 420 of the implanter unit 400 is provided with a plurality of first steps 421.
  • a resilient hook 432 hooks onto the first step 421 when the proximal end of the sheath 430 is coupled to the housing 420 of the implanter unit 400 .
  • only a part of the first elastic hooks 432 can hook the first steps 421 , and at this time, the number of the first steps 421 is smaller than the number of the first elastic hooks 432 .
  • all the first elastic hooks 432 hook the first steps 421 , and the number of the first steps 421 is greater than or equal to the number of the first elastic hooks 432 .
  • the distal end of the housing 420 of the implanter unit 400 is equipped with a base plate 422, the middle of the base plate 422 is hollowed out, and the base plate 422 is connected to the inner wall of the housing 420 of the implanter unit 400 by buckling. fixed.
  • the first step 421 may be configured on the substrate 422 .
  • the first driving mechanism includes a first holding part 450 and a first driving spring 460, the distal end of the first holding part 450 is configured with a connecting seat 451, and the connecting seat 451 is coupled to the body surface
  • the connection seat 451 can be coupled to the cover 240 of the body surface attachment unit 200, and the inner surface of the connection seat 451 is provided with bumps 452, as shown in FIG. 7, the body surface attachment
  • An annular positioning groove 241 is formed on the cover 240 of the unit 200 , and when the connecting seat 451 is coupled to the cover 240 of the body surface attachment unit 200 , the protrusion 452 is snapped into the positioning groove 241 .
  • the first driving spring 460 is configured to provide a prestress to drive the first retaining portion 450 in the distal direction, for example, the first driving spring 460 is in a compressed state before being triggered, A first end of the first driving spring 460 abuts on the proximal end of the first holding part 450 , and a second end of the first driving spring 460 abuts on the inner surface of the housing 420 of the implanter unit 400 .
  • a plurality of second elastic hooks 453 are disposed on the proximal end of the first holding portion 450, and a plurality of limiting holes 423 are configured inside the shell 420 of the implanter unit 400.
  • the limiting holes 423 It may be configured on the base plate 422 , at least part of the second elastic hook portion 453 is hooked to the edge of the limiting hole 423 .
  • only a part of the second elastic hooks 453 can hook the edge of the limiting hole 423 , and the number of the limiting holes 423 is smaller than the number of the second elastic hooks 453 .
  • all the second elastic hooks 453 hook the edges of the limiting holes 423 , and the number of limiting holes 423 is greater than or equal to the number of the second elastic hooks 453 .
  • the second elastic hook portion 453 is configured to disengage from the edge of the limiting hole 423 when the sheath 430 is at least partially retracted into the housing 420 .
  • the second elastic hook portion 453 can be a barb structure bent in the direction toward the distal side, and a slope surface 454 is arranged on the outside of the second elastic hook portion 453 , and the sheath 430 A push rod 433 acting on the ramp surface 454 is configured on the proximal end of the implanter unit 400.
  • the push rod 433 pushes the second elastic hook inwardly along the ramp surface 454. part 453, so that the second elastic hook part 453 is detached from the limiting hole 423, thereby releasing the first holding part 450, and under the action of the first driving spring 460, the first holding part 450 drives the body surface attachment unit 200 along the Move toward the distal direction until the body surface attachment unit 200 is applied to the skin surface of the host, and at this time, the sensor electrode 210 is partially pierced into the host's skin to contact the subcutaneous interstitial fluid.
  • the sensor electrode 210 includes an external part and an internal part, the internal part penetrates into the skin of the host, and the external part is exposed outside the skin of the host.
  • the extracorporeal part is attached into the body surface attachment unit 200 , for example, the extracorporeal part may be attached to the carrier 230 of the body surface attachment unit 200 .
  • a circuit module is also configured on the carrier 230 , and the subcutaneous analyte concentration information monitored by the sensor electrodes 210 is sent to the receiver 300 through the circuit module.
  • the second driving mechanism includes a second holding portion 470 and a second driving spring 480 , the second holding portion 470 includes an elastic clamping claw 471 , and the elastic clamping claw 471 is coupled to the proximal side of the needle assembly 410 Ends.
  • the second driving spring 480 is configured to provide a prestress to drive the second holding part 470 in a proximal direction, for example, the second driving spring 480 is in a compressed state before being triggered, and the second driving spring 480 is sleeved on the elastic clip Around the claw 471 , the first end of the second driving spring 480 abuts against the surface of the proximal end of the first holding portion 450 , and the second end of the second driving spring 480 abuts against the inner surface of the second holding portion 470 .
  • a plurality of second steps 472 are disposed on the proximal end of the second holding portion 470 , and a plurality of third elastic hooks 455 are disposed on the first driving mechanism, and at least part of the third elastic hooks 455 hook the second steps 472 .
  • only a part of the third elastic hooks 455 can hook the second steps 472 , and at this time, the number of the second steps 472 is smaller than the number of the third elastic hooks 455 .
  • all the third elastic hooks 455 hook the second steps 472 , and the number of the second steps 472 is greater than or equal to the number of the third elastic hooks 455 .
  • the third elastic hook portion 455 is configured to disengage from the second step 472 when the body surface attachment unit 200 is applied to the skin surface of the host.
  • the second holding portion 470 is configured with a number of elastic arms 473 corresponding to the number of the third elastic hooks 455 , and the elastic arms 473 are configured to provide prestress to push the third elastic hooks 455 outward in the radial direction.
  • the housing 420 of the implanter unit 400 is equipped with a guide cylinder 424 extending from the inner surface of the proximal end of the housing 420 in the direction toward the distal side, and the second holding part 470 and the third elastic hook part 455 Before the first driving mechanism is triggered, it is located in the guide tube 424 , and the side wall of the guide tube 424 supports the third elastic hook 455 on the second step 472 to prevent being stretched by the elastic arm 473 .
  • the first holding part 450 drives the second holding part 470 to move in the direction toward the distal side.
  • the third elastic The hook portion 455 leaves the guide cylinder 424, without the support of the side wall of the guide cylinder 424, the third elastic hook portion 455 is stretched outward by the elastic arm 473, so that the third elastic hook portion 455 is separated from the second step 472, thus
  • the second holding part 470 moves the needle assembly 410 in a proximal direction under the action of the second driving spring 480 so that the needle assembly 410 leaves the skin of the host and retracts into the outer, inner, and inner parts of the implanter unit 400.
  • the body surface attachment unit 200 is left on the skin surface of the host, and the needle assembly 410 is separated from the body surface attachment unit 200 .
  • the needle assembly 410 includes a puncture needle 411 and a hub 412 attached to the proximal end of the puncture needle 411 , the puncture needle is provided with a narrow slot 413 , and the puncture needle 411 passes through the body surface attachment unit 200 Part of the sensor electrode 210 is attached to the puncture needle 411 through the slot 413 , and the part of the sensor electrode 210 attached to the puncture needle 411 refers to the internal body part of the sensor electrode 210 .
  • the jaws of the second holding part 470 are clamped on the hub 412 .
  • the far and near in the "distal side”, “proximal side”, “distal end”, and “proximal end” in this application are relative to the skin of the host in the process of applying the body surface attachment unit Specifically, define close to the host skin as far, and define far away from the host skin as near.

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Abstract

一种经皮分析物传感器系统，包括植入器单元（400）、针组件（410）和体表附接单元（200），植入器单元（400）包括外壳（420）、活动配置在外壳（420）的远侧端部的护套（430）以及配置在外壳（420）内部的第一驱动机构和第二驱动结构，体表附接单元（200）包括传感器电极（210）；第一驱动机构被配置为在护套（430）至少部分缩回到外壳（420）内部时，沿朝向远侧的方向驱动针组件（410）将传感器电极（210）的部分导引入宿主（100）皮下并将体表附接单元（200）敷贴到宿主（100）皮肤表面；第二驱动机构被配置为在体表附接单元（200）被敷贴到宿主（100）皮肤表面时沿朝向近侧的方向驱动针组件（410）与传感器电极（210）分离并缩回到外壳（420）内；其中，远侧为靠近宿主（100）皮肤的一侧，近侧为远离宿主（100）皮肤的一侧。

Description

经皮分析物传感器系统
本申请要求申请日为2021年11月27日、申请号为202111439161.7的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，例如涉及一种经皮分析物传感器系统。
背景技术
一些生理性的疾病，病程长且病情迁延不愈，需要实时地对宿主的某些生理参数进行监测，以能更好的跟踪治疗。比如糖尿病，需要对宿主血糖进行实时的监测。准确的血糖自我监测，是实现良好血糖控制的关键，有助于评估糖尿病患者糖代谢紊乱的程度，制定降糖方案，同时反映降糖治疗效果并指导对治疗方案的调整。
市面上使用最多的是指血血糖仪，患者需要自行采集手指末梢血来测量该时刻的血糖水平。但这种方法存在以下缺陷：一、无法获知两次测量之间的血糖水平变化情况，患者可能会遗漏血糖峰值和谷值，从而引起一些并发症，对患者造成不可逆的伤害；二、每日多次的指尖穿刺采血，给糖尿病患者造成了很大的痛楚。为克服上述缺陷，需要提供一种能够进行连续监测患者血糖的方法，方便患者实时了解自己的血糖状况，并据此及时采取应对措施，从而有效地控制病情，防止并发症，以获得较高的生活质量。
针对上述需求，技术人员开发了可以植入皮下组织进行持续监测皮下血糖的监测技术，该技术通过在皮下组织刺入一个传感器电极，传感器电极在患者的组织间液与体内葡萄糖发生氧化反应，反应时会形成电信号，通过发射器将电信号转换为血糖读数，并每隔1-5分钟将血糖读数传输到无线接收器上，在无线接收器上显示相应的血糖数据以及形成图谱，供患者及医生参考。
传感器电极刺入皮下组织需要使用植入器，相关技术中的植入器结构，如中国发明专利CN112423665A公开了一种施加器(即植入器)结构，通过使施加器朝向目标监测位置前进，在目标监测位置处接合皮肤时，护套坍缩到壳体中，从而允许传感器控制装置前进与皮肤接合，借助尖锐物，传感器(即传感器电极)在目标监测位置处经皮前进到患者皮肤中，当壳体完全前进到目标监测位 置处时，尖锐物自动缩回，而传感器留在适当位置以监测分析物水平。
上述方案中，传感器的植入需要护套完全缩回到外壳中，且尖锐物刺入皮肤的过程需要依靠手动推动施加器来实现，该过程对用户操作的要求高，且存在以下缺点：1、在植入过程中容易因用户操作不当而导致传感器无法正常植入；2、手动刺入尖锐物的速度较慢，容易造成较大的痛感；3、手动刺入容易给用户带来较大的心理压力，影响用户体验。此外，上述方案中的施加器和传感器被分开灭菌和包装，用户在使用时需要先将传感器装入施加器中，容易因用户安装不当而导致传感器无法正常植入。
发明内容
本申请提供了一种经皮分析物传感器系统，能够提高传感器电极植入的舒适性和便捷性，以及提升用户体验。
一实施例提供了一种经皮分析物传感器系统，包括植入器单元，所述植入器单元包括外壳、活动配置在所述外壳的远侧端部的护套以及配置在所述外壳内部的第一驱动机构和第二驱动结构；针组件；和体表附接单元，所述体表附接单元包括传感器电极；其中，所述第一驱动机构被配置为在所述护套至少部分缩回到所述外壳内部时，沿朝向远侧的方向驱动所述针组件将所述传感器电极部分导引入宿主皮下并将所述体表附接单元敷贴到宿主皮肤表面；其中，所述第二驱动机构被配置为在所述体表附接单元被敷贴到宿主皮肤表面时，沿朝向近侧的方向驱动所述针组件与所述传感器电极分离并缩回到所述外壳内；其中，所述远侧为靠近宿主皮肤的一侧，所述近侧为远离宿主皮肤的一侧。
附图说明
图1是本申请一实施例的持续血糖监测系统的示意图。
图2是本申请一实施例的持续血糖监测系统的结构示意图。
图3是本申请一实施例的分析物传感器系统的剖面图。
图4是本申请一实施例的分析物传感器系统的立体剖面图。
图5是本申请一实施例的植入器单元的结构示意图。
图6是本申请一实施例的植入器单元的另一角度的结构示意图。
图7是本申请一实施例的体表附接单元的结构爆炸图。
图8是本申请一实施例的帽的立体剖面图。
图9是本申请一实施例的第一保持部与体表附接单元安装示意图。
图10是本申请一实施例的第一保持部与体表附接单元安装的另一角度的示意图。
图11是本申请一实施例的第一保持部与第二保持部安装示意图。
图12是本申请一实施例的针组件的结构示意图。
其中：100、宿主；200、体表附接单元；210、传感器电极；220、离型层；230、载体；240、盖体；241、定位槽；300、接收器；400、植入器单元；410、针组件；411、穿刺针；412、毂；413、槽；420、外壳；421、第一台阶；422、基板；423、限位孔；424、导向筒；430、护套；431、限位块；432、第一弹性钩部；433、推杆；440、开口；450、第一保持部；451、连接座；452、凸点；453、第二弹性钩部；454、斜坡面；455、第三弹性钩部；460、第一驱动弹簧；470、第二保持部；471、弹性夹爪；472、第二台阶；473、弹性臂；480、第二驱动弹簧；500、帽；510、支撑部；511、限位肋；512、挡条。
具体实施方式
持续血糖监测(CGM，Continuous Glucose Monitoring)系统请参见图1所示，是附接到宿主100上的持续血糖监测系统的示意图。图2中示出了包括带有传感器电极210的体表附接单元200的持续血糖监测系统，体表附接单元200通过粘合剂层附接到宿主100的皮肤表面。体表附接单元200内置电性连接到传感器电极210的电路模块，电路模块设置为将传感器电极210监测到的葡萄糖浓度信息发送到接收器300，接收器300通常可以为智能电话、智能手表、专用设备和类似物。在使用过程中，传感器电极210部分位于宿主100皮肤的下方，与皮下组织液接触。
请参见图2所示，图2是持续血糖监测系统的结构示意图，包括植入器单元400、体表附接单元200和帽500，体表附接单元200被预装在帽500中，再跟随帽500一同安装到植入器单元400上，使用时，通过转动帽500将帽500从植入器单元400上移除，与此同时，覆盖在体表附接单元200的粘合剂层上的离型层220会跟随帽500的移除一同被剥离；随后将植入器单元400的开口侧贴合到宿主100皮肤表面，通过操作植入器单元400将植入器单元400内的体表附接单元200敷贴到宿主100皮肤表面，此时传感器电极210被部分植入到宿主100皮下，与皮下组织液接触以持续监测组织液中的葡萄糖浓度。
在一实施例中，粘合剂层可为医用无纺胶布。
在一实施例中，离型层220采用离型纸或者离型膜，表面涂有一层离型剂。
请参见图2至4所示，本申请提供一种以上述持续血糖监测系统为例的经皮分析物传感器系统，包括植入器单元400、针组件410和体表附接单元200，植入器单元400包括外壳420、活动配置在外壳420的远侧端部的护套430以及配置在外壳420内部的第一驱动机构和第二驱动结构，体表附接单元200包括传感器电极210；第一驱动机构被配置为在护套430至少部分缩回到外壳420内部时沿朝向远侧的方向驱动针组件410将传感器电极210部分导引入宿主皮下并将体表附接单元200敷贴到宿主皮肤表面；第二驱动机构被配置为在体表附接单元200被敷贴到宿主皮肤表面时沿朝向近侧的方向驱动针组件410与传感器电极210分离并缩回到外壳420内。
本申请以护套430作为触发机构，通过推动植入器单元400至护套430至少部分缩回到植入器单元400的外壳420内部，以护套430触发第一驱动机构将体表附接单元200敷贴到宿主皮肤表面，并随后通过第二驱动机构将针组件410缩回，简化了操作，提升了用户体验。
本申请的护套430和体表附接单元400被预装在帽500上，在将帽500耦接到植入器单元400上时，护套430和体表附接单元200被一同耦接到植入器单400元上，并在移除帽500时，护套430和体表附接单元400被从帽500转移到植入器单元400上，简化了装配工艺，尤其方便了体表附接单元的安装。
请参见图5所示，本申请通过推动植入器单元400使护套430缩回来触发第一驱动机构。在一种实施方式中，护套430部分缩回到植入器单元400的外壳420内部即产生触发效果。在另一种实施方式中，护套430全部缩回植入器单元400的外壳420内部产生触发效果。
请参见图6所示，植入器单元400的远侧端部配置有开口440，护套430内嵌在开口440中，并能够在植入器单元400的外壳420内部沿朝向近侧的方向自由移动。
请继续参见图2至4所示，植入器单元400的远侧端部还耦接有帽500，帽500被配置为在植入器单元400敷贴体表附接单元200之前可移除。例如，帽500被配置为以转动方式移除。
请参见图7和8所示，体表附接单元200包括载体230和耦接到载体230上的盖体240。在一种实施方式中，载体230的外径大于盖体240的外径，从而使得载体 230的边缘突出于盖体240的边缘。体表附接单元200在帽500移除之前被固定在帽500中。在一种实施方式中，体表附接单元200在帽500移除之前被护套430和帽500配合固定。在一实施例中，帽500的内部配置有环形的支撑部510，体表附接单元200的载体230被放置在支撑部510的近侧端部的端面上，护套430的远侧端部的内底面压在体表附接单元200的载体230的边缘，通过支撑部510的近侧端部的端面与护套430的远侧端部的内底面夹紧体表附接单元200的载体230的边缘将体表附接单元200固定在帽500中。支撑部510的外表面上沿周向等间隔配置有多个限位肋511，护套430的远侧端部的内表面上等间隔配置有多个限位块431，相邻两个限位肋511之间的间距大于任一限位块431沿周向的长度，相邻两个限位块431之间的间距大于任一限位肋511沿周向的长度，使得护套430的远侧端部在耦接到帽500上时，限位块431穿过限位肋511之间，转动帽500使得限位块431在周向上移动至被限位肋511遮挡的位置，此时，帽500与护套430互锁，限位肋511上沿朝向远侧的方向延伸配置有挡条512，挡条512起到遮挡限位块431的作用，由于限位块431和限位肋511都是配置在帽500内部的构件，因此无法从外部直接观察两者之间的位置关系，当转动帽500使限位块431沿周向移动至被挡条512遮挡而无法继续转动时，表示限位块431已到达与限位肋511互锁的位置。其中，至少部分限位块431在护套430的远侧端部耦接到帽500上时与限位肋511配合限位。在一种实施方式中，可以只有部分限位块431与限位肋511配合限位，此时限位肋511的数量小于限位块431的数量。在另一种实施方式中，全部限位块431与限位肋511配合限位，此时限位肋511的数量大于等于限位块431的数量。
请继续参见图3和4所示，护套430的近侧端部配置有多个第一弹性钩部432，植入器单元400的外壳420内部配置有多个第一台阶421，至少部分第一弹性钩部432在护套430的近侧端部耦接到植入器单元400的外壳420上时钩住第一台阶421。在一种实施方式中，可以只有部分第一弹性钩部432钩住第一台阶421，此时第一台阶421的数量小于第一弹性钩部432的数量。在另一种实施方式中，全部第一弹性钩部432钩住第一台阶421，此时第一台阶421的数量大于等于第一弹性钩部432的数量。
请继续参见图3和4所示，植入器单元400的外壳420的远侧端部配置有基板422，基板422中间镂空，基板422与植入器单元400的外壳420的内壁经卡扣连接固定。在一种实施方式中，第一台阶421可以被配置在基板422上。
请参见图9和10所示，第一驱动机构包括第一保持部450和第一驱动弹簧460， 第一保持部450的远侧端部配置有连接座451，连接座451耦接到体表附接单元200上，例如，连接座451可以耦接到体表附接单元200的盖体240上，连接座451的内表面上配置有凸点452，如图7所示，体表附接单元200的盖体240上形成有环形的定位槽241，当连接座451耦接到体表附接单元200的盖体240上时，凸点452卡入定位槽241中。
请继续参见图3和4所示，第一驱动弹簧460被配置为提供沿朝向远侧的方向驱动第一保持部450的预应力，例如，第一驱动弹簧460在被触发之前处于压缩状态，第一驱动弹簧460的第一端抵接在第一保持部450的近侧端部上，第一驱动弹簧460的第二端抵接在植入器单元400的外壳420的内表面上。
第一保持部450的近侧端部配置有多个第二弹性钩部453，植入器单元400的外壳420内部配置有多个限位孔423，在一种实施方式中，限位孔423可以被配置在基板422上，至少部分所述第二弹性钩部453钩住限位孔423的边缘。在一种实施方式中，可以只有部分第二弹性钩部453钩住限位孔423的边缘，此时限位孔423的数量小于第二弹性钩部453的数量。在另一种实施方式中，全部第二弹性钩部453钩住限位孔423的边缘，此时限位孔423的数量大于等于第二弹性钩部453的数量。
请继续参见图3和4第二弹性钩部453被配置为在护套430至少部分缩回到外壳420内部时从限位孔423的边缘脱离。在一种实施方式中，如图11所示，第二弹性钩部453可以为沿朝向远侧的方向弯曲的倒钩结构，且第二弹性钩部453外侧配置有斜坡面454，护套430的近侧端部上配置有作用于斜坡面454上的推杆433，当护套430缩回植入器单元400的外壳420内部时，推杆433沿斜坡面454向内推动第二弹性钩部453，使得第二弹性钩部453从限位孔423上脱离，从而将第一保持部450释放，在第一驱动弹簧460的作用下，第一保持部450带动体表附接单元200沿朝向远侧的方向移动至将体表附接单元200敷贴到宿主皮肤表面，此时将传感器电极210部分刺入宿主皮下与皮下组织间液接触。传感器电极210包括体外部分和体内部分，刺入宿主皮下的为体内部分，露出到宿主皮肤外面的为体外部分。体外部分附接到体表附接单元200内，例如，体外部分可以附接到体表附接单元200的载体230上。载体230上还配置有电路模块，通过电路模块将传感器电极210监测到的皮下分析物浓度信息发送给接收器300。
请参见图11所示，所述第二驱动机构包括第二保持部470和第二驱动弹簧480，第二保持部470包括弹性夹爪471，弹性夹爪471耦接到针组件410的近侧端 部。
第二驱动弹簧480被配置为提供沿朝向近侧的方向驱动第二保持部470的预应力，例如，第二驱动弹簧480在被触发之前处于压缩状态，第二驱动弹簧480套设在弹性夹爪471外围，第二驱动弹簧480第一端抵接在第一保持部450的近侧端部的表面上，第二驱动弹簧480第二端抵接在第二保持部470的内表面上。
第二保持部470的近侧端部配置有多个第二台阶472，第一驱动机构上配置有多个第三弹性钩部455，至少部分第三弹性钩部455钩住第二台阶472。在一种实施方式中，可以只有部分第三弹性钩部455钩住第二台阶472，此时第二台阶472的数量小于第三弹性钩部455的数量。在另一种实施方式中，全部第三弹性钩部455钩住第二台阶472，此时第二台阶472的数量大于等于第三弹性钩部455的数量。
第三弹性钩部455被配置为在体表附接单元200敷贴到宿主皮肤表面时从第二台阶472上脱离。例如，第二保持部470配置有对应第三弹性钩部455数量的弹性臂473，弹性臂473被配置为提供沿径向向外推开第三弹性钩部455的预应力。相应的，植入器单元400的外壳420内部配置有从外壳420的近侧端部的内表面沿朝向远侧的方向延伸的导向筒424，第二保持部470和第三弹性钩部455在第一驱动机构被触发之前位于导向筒424内，导向筒424的侧壁将第三弹性钩部455支撑在第二台阶472上，防止被弹性臂473撑开。当第一驱动机构被触发后，第一保持部450带动第二保持部470一起沿朝向远侧的方向移动，当移动至体表附接单元200被敷贴到宿主皮肤表面时，第三弹性钩部455离开导向筒424，在没有导向筒424的侧壁的支撑下，第三弹性钩部455被弹性臂473向外撑开，从而使得第三弹性钩部455脱离第二台阶472，此时第二保持部470在第二驱动弹簧480的作用下带着针组件410沿朝向近侧的方向移动至使得针组件410离开宿主皮肤并缩回到植入器单元400的外内内部，此时，体表附接单元200被留置在宿主皮肤表面，针组件410与体表附接单元200分离。
请参见图12所示，针组件410包括穿刺针411和附接到穿刺针411的近侧端部的毂412，穿刺针上开设有狭长的槽413，穿刺针411贯穿体表附接单元200使得传感器电极210部分经槽413附接在穿刺针411内，这里所称传感器电极210的附接在穿刺针411内的部分即指传感器电极210的体内部分。第二保持部470的夹爪夹持在毂412上。
本申请中所称“远侧”、“近侧”、“远侧端部”、“近侧端部”中的远和近是 在敷贴体表附接单元过程中相对于宿主皮肤而言的，具体为，将靠近宿主皮肤定义为远，将远离宿主皮肤定义为近。

Claims (16)

  1. 一种经皮分析物传感器系统，包括：
    植入器单元，所述植入器单元包括外壳、活动配置在所述外壳的远侧端部的护套以及配置在所述外壳内部的第一驱动机构和第二驱动结构；
    针组件；和
    体表附接单元，所述体表附接单元包括传感器电极；
    其中，所述第一驱动机构被配置为在所述护套至少部分缩回到所述外壳内部时，沿朝向远侧的方向驱动所述针组件将所述传感器电极部分导引入宿主皮下并将所述体表附接单元敷贴到宿主皮肤表面；
    其中，所述第二驱动机构被配置为在所述体表附接单元被敷贴到宿主皮肤表面时，沿朝向近侧的方向驱动所述针组件与所述传感器电极分离并缩回到所述外壳内；
    其中，所述远侧为靠近宿主皮肤的一侧，所述近侧为远离宿主皮肤的一侧。
  2. 根据权利要求1所述的经皮分析物传感器系统，还包括耦接到所述外壳的远侧端部的帽，所述帽被配置为在所述植入器单元敷贴所述体表附接单元之前可移除。
  3. 根据权利要求2所述的经皮分析物传感器系统，其中，所述帽被配置为以转动方式移除。
  4. 根据权利要求2所述的经皮分析物传感器系统，其中，所述体表附接单元设置为在所述帽移除之前被固定在所述帽中。
  5. 根据权利要求4所述的经皮分析物传感器系统，其中，所述体表附接单元设置为在所述帽移除之前被所述护套和所述帽配合固定。
  6. 根据权利要求5所述的经皮分析物传感器系统，其中，所述护套的远侧端部耦接到所述帽上，所述护套的近侧端部耦接到所述植入器单元的所述外壳上。
  7. 根据权利要求6所述的经皮分析物传感器系统，其中，所述帽的内部配置有环形的支撑部，所述支撑部的外表面上沿周向等间隔配置有多个限位肋，所述护套的远侧端部的内表面上等间隔配置有多个限位块，至少部分所述限位块在所述护套的远侧端部耦接到所述帽上时与所述限位肋配合限位。
  8. 根据权利要求6所述的经皮分析物传感器系统，其中，所述护套的近侧端部配置有多个第一弹性钩部，所述植入器单元的所述外壳内部配置有多个第一台阶，至少部分所述第一弹性钩部设置为在所述护套的近侧端部耦接到所述 植入器单元的所述外壳上时，钩住所述第一台阶。
  9. 根据权利要求1所述的经皮分析物传感器系统，其中，所述第一驱动机构包括第一保持部和第一驱动弹簧，所述第一保持部的远侧端部配置有连接座，所述连接座耦接到所述体表附接单元上；
    所述第一驱动弹簧被配置为提供沿朝向远侧的方向驱动所述第一保持部的预应力。
  10. 根据权利要求9所述的经皮分析物传感器系统，其中，所述第一保持部的近侧端部配置有多个第二弹性钩部，所述植入器单元的所述外壳内部配置有多个限位孔，至少部分所述第二弹性钩部设置为钩住所述限位孔的边缘。
  11. 根据权利要求10所述的经皮分析物传感器系统，其中，所述第二弹性钩部被配置为在所述护套至少部分缩回到所述外壳内部时，从所述限位孔的边缘脱离。
  12. 根据权利要求1所述的经皮分析物传感器系统，其中，所述第二驱动机构包括第二保持部和第二驱动弹簧，所述第二保持部包括弹性夹爪，所述弹性夹爪耦接到所述针组件的近侧端部；
    所述第二驱动弹簧被配置为提供沿朝向近侧的方向驱动所述第二保持部的预应力。
  13. 根据权利要求12所述的经皮分析物传感器系统，其中，所述第二保持部的近侧端部配置有多个第二台阶，所述第一保持部的近侧端部配置有多个第三弹性钩部，至少部分所述第三弹性钩部设置为钩住第二台阶。
  14. 根据权利要求13所述的经皮分析物传感器系统，其中，所述第三弹性钩部被配置为在所述体表附接单元敷贴到宿主皮肤表面时从所述第二台阶上脱离。
  15. 根据权利要求13所述的经皮分析物传感器系统，其中，所述第二保持部配置有对应所述第三弹性钩部数量的弹性臂，所述弹性臂被配置为提供沿径向向外推开所述第三弹性钩部的预应力。
  16. 根据权利要求1所述的经皮分析物传感器系统，其中，所述针组件包括穿刺针和附接到所述穿刺针的近侧端部的毂，所述穿刺针设置为贯穿体表附接单元使得所述传感器电极部分附接在所述穿刺针内。
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