WO2023273078A1 - 传感器底座的固定结构及方法 - Google Patents

传感器底座的固定结构及方法 Download PDF

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Publication number
WO2023273078A1
WO2023273078A1 PCT/CN2021/127861 CN2021127861W WO2023273078A1 WO 2023273078 A1 WO2023273078 A1 WO 2023273078A1 CN 2021127861 W CN2021127861 W CN 2021127861W WO 2023273078 A1 WO2023273078 A1 WO 2023273078A1
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WO
WIPO (PCT)
Prior art keywords
sensor base
operating mechanism
implanter
sensor
elastic buckle
Prior art date
Application number
PCT/CN2021/127861
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English (en)
French (fr)
Inventor
钱成
Original Assignee
苏州百孝医疗科技有限公司
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Publication of WO2023273078A1 publication Critical patent/WO2023273078A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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

Definitions

  • the present application relates to the technical field of medical devices, for example, to a fixing structure and method of a sensor base.
  • 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.
  • Blood glucose meters are widely used in the market, and patients need to collect blood from the tip of their fingers to measure the blood sugar level at that moment.
  • 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.
  • 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 penetration of the sensor electrodes into the subcutaneous tissue requires the use of an implanter, and after subcutaneous implantation, the sensor needs to be removed from the implanter to leave the sensor on the skin of the host.
  • the US patent US9044199B2 discloses a transcutaneous analyte sensor. When the installation unit needs to be removed from the applicator, decouple the installation unit from the applicator by pressing the release latch on the installation unit. This structure needs to be manually decoupled, and the release needs to be pressed continuously when decoupling Latching and pulling the applicator away from the mounting unit is cumbersome and not a good user experience.
  • the Chinese invention patent CN206777328U discloses an applicator and a sensor insertion assembly for applying the sensor assembly on the skin to the recipient's skin, and the disposable housing (i.e. the sensor base) is fixed to the applicator through the cooperation of the cannula and the seal
  • the applicator can be pulled directly away from the disposable shell to complete the detachment of the disposable shell from the applicator.
  • the friction between the tubes is fixed, and when the release paper on the adhesive patch is torn off, it is easy to involve the disposable shell due to improper operation, resulting in the instability of wearing the disposable shell.
  • the embodiment of the present application discloses a fixing structure and method of a sensor base.
  • the embodiment of the present application discloses a fixing structure of a sensor base, the fixing structure is configured to couple the sensor base to the implanter, and the sensor base is operatively coupled to the implanter;
  • the implanter is configured with a first operating mechanism and a second operating mechanism, the first operating mechanism is configured to partially decouple the sensor base from the implanter, and the second operating mechanism is configured to fully decouple the sensor base and implanter;
  • the operation priority of the first operating mechanism is higher than that of the second operating mechanism.
  • the embodiment of the present application discloses a method for removing the sensor base from the implanter, based on the above-mentioned fixing structure of the sensor base, the method includes:
  • the first operating mechanism is used to partially decouple the sensor base from the implanter, and then the second operating mechanism is used to fully decouple the sensor base from the implanter.
  • 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 diagram of an assembly of a sensor and a transmitter according to an embodiment of the present application.
  • Fig. 3 is a cross-sectional view of the assembly of the sensor and the transmitter according to the embodiment of the present application.
  • Fig. 4 is a cross-sectional view of a sensor according to an embodiment of the present application.
  • Fig. 5 is a top view of the sensor of the embodiment of the present application.
  • Fig. 6 is a cross-sectional view of the electrode seat of the embodiment of the present application.
  • Fig. 7 is an exploded view of the electrode seat of the embodiment of the present application.
  • Fig. 8 is an exploded view of the transmitter of the embodiment of the present application.
  • Fig. 9 is a schematic diagram of an implanter according to an embodiment of the present application.
  • Fig. 10 is a top view of the arrangement of the safety mechanism and the trigger mechanism in the implanter according to the embodiment of the present application.
  • Fig. 11 is a schematic diagram of the driving assembly of the embodiment of the present application.
  • Fig. 12 is a schematic diagram of the installation of the insurance mechanism of the embodiment of the present application.
  • FIG. 13 is an exploded view of the assembly of the bracket and the needle assembly of the embodiment of the present application.
  • Fig. 14 is an exploded view of the return needle assembly of the embodiment of the present application.
  • Fig. 15 is a cross-sectional view of the return needle assembly according to the embodiment of the present application.
  • Fig. 16 is another sectional view of the return needle assembly according to the embodiment of the present application.
  • Fig. 17 is an assembly sectional view of the drive housing and the guide post according to the embodiment of the present application.
  • Fig. 18 is a schematic diagram of the safety mechanism moving to the remote position according to the embodiment of the present application.
  • Fig. 19 is a schematic diagram of the safety mechanism moving to the proximal position according to the embodiment of the present application.
  • Fig. 20 is a schematic diagram of the needle assembly moving to the proximal position according to the embodiment of the present application.
  • 100 host; 200, sensor; 210, sensor electrode; 211, first end; 212, second end; 220, sensor base; 221, first bayonet; 222, second bayonet; 230, Adhesive patch; 240, release layer; 250, electrode installation groove; 260, electrode seat; 261, electrode seat upper shell; 262, electrode seat lower shell; 263, flexible conductive sheet; 264, electrode terminal; 265, second sealing ring; 270, battery module; 271, battery installation groove; 272, battery; 273, battery cover; 274, power supply terminal; 280, first sealing ring; 300, receiver; 400, transmitter; 410 , transmitter shell; 420, integrated circuit module; 430, data receiving terminal; 440, power receiving terminal; 500, implanter; 510, implanter shell; 511, implanter upper shell; 5111, through hole; 512, the lower shell of the implanter; 520, the insurance mechanism; 521, the sliding part; 5211, the slider; 52111, the installation groove; 5212, the slider switch; Functional
  • CGM Continuous Glucose Monitoring
  • FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system attached to a host 100 .
  • a continuous glucose monitoring system is shown in FIG. 1 that includes an above-the-skin sensor 200 secured to the skin of a host 100 by a disposable sensor mount 220 (not shown in FIG. 1 ).
  • the system includes a sensor 200 and a transmitter 400 for sending blood glucose information monitored by the sensor 200 to a receiver 300, which can generally be a smart phone, a smart watch, a dedicated device and the like.
  • the sensor electrodes 210 are partially located under the skin of the host 100 , and the sensor electrodes 210 are electrically connected to the transmitter 400 .
  • Transmitter 400 is engaged with sensor base 220 , which is attached to adhesive patch 230 and secured to the skin of host 100 by adhesive patch 230 .
  • adhesive patch 230 may be a medical grade non-woven adhesive tape.
  • the sensor 200 can be attached to the skin of the host 100 with an implant 500 that provides a convenient and safe implantation procedure.
  • an implanter 500 may also be used to insert the sensor electrodes 210 through the skin of the host 100 . Once the sensor electrodes 210 have been inserted, the implanter 500 is disengaged from the sensor 200 .
  • a structure of a sensor 200 which includes a disposable sensor base 220, an electrode assembly disposed on the sensor base 220, and a transmitter 400 bonded to the sensor base 220.
  • the sensor An adhesive patch 230 is attached to the lower surface of the base 220 and fixed to the skin of the host 100 by the adhesive patch 230 .
  • the transmitter 400 snaps onto the sensor mount 220 .
  • the release layer 240 is pre-attached to the adhesive patch 230.
  • the release layer 240 is torn off first, and then the sensor base 220 is passed through the adhesive patch 230. Just attach it to the skin of the host 100.
  • the release layer 240 adopts a release paper or a release film, and a layer of release agent is coated on the surface.
  • the release layer 240 may be composed of two pieces of release paper or film, one of the two pieces of release paper is larger than the other, and the larger part covers the smaller part.
  • Figure 3 shows the end that can be turned down and is easy to tear, and the corresponding release paper or release film can be torn off by pinching the end.
  • the upper surface of the sensor base 220 is configured with an electrode installation groove 250 , and the electrode assembly is operably coupled in the electrode installation groove 250 .
  • the electrode assembly is separated from the sensor base 220 ;
  • the coupling can be realized by snap-fitting.
  • the electrode assembly includes a sensor electrode 210 and an electrode seat 260 attached to the sensor electrode 210 , and reference can also be made to the various components shown in FIG. 6 .
  • one end of the sensor electrode 210 passes through the sensor base 220 and is partially exposed on the lower surface of the sensor base 220, and the other end of the sensor electrode 210 is located in the sensor base 220, and one end of the sensor electrode 210 is defined here as The first end 211, the other end of the sensor electrode 210 is the second end 212, under this premise, the first end 211 enters the skin of the host 100 to reach the subcutaneous interstitial fluid, at this time, the first end 211 and glucose in the body generate The oxidation reaction produces an electrical signal.
  • an electrode holder 260 is attached to the second end 212 of the sensor electrode 210 .
  • the body 261 and the electrode seat lower case 262, the electrode seat upper case 261 is coupled with the electrode seat lower case 262, and the second end 212 of the sensor electrode 210 is clamped between the electrode seat upper case 261 and the electrode seat.
  • two flexible conductive sheets 263 are arranged in the electrode seat 260, and the two flexible conductive sheets 263 are respectively electrically connected to the working electrode and the reference electrode of the second end 212 of the sensor electrode 210, and the electrode seat 260
  • Two electrode terminals 264 are also arranged on the top, and the two electrode terminals 264 are arranged on the upper casing 261 of the electrode base and are respectively electrically connected to the two flexible conductive sheets 263.
  • the sensor electrodes 210 transmit the monitored blood glucose data through the electrode terminals 264 transmitted to the transmitter 400.
  • the sensor electrode 210 in this embodiment is pre-packaged in the electrode seat 260, that is, the second end 212 of the sensor electrode 210 is pre-connected to the two flexible conductive sheets 263, compared with the sensor in the related art 200 structure, the flexible conductive sheet 263 in this embodiment does not need to be penetrated by the intubation tube, so the flexible conductive sheet 263 can be more tightly wrapped on the sensor electrode 210, so that the sensor electrode 210 is firmly fixed, and it is not easy to dislodge from the electrode holder 260. fall off, and the electrical connection between the sensor electrode 210 and the flexible conductive sheet 263 is more reliable.
  • the sensor 200 with this structure can complete the inspection of the electrical connection reliability in the factory.
  • One type of inspection operation is to immerse the first end 211 of the sensor electrode 210 in the glucose solution, and then measure the continuity between the two electrode terminals 264 .
  • a second sealing ring 265 is also disposed on the upper casing 261 of the electrode holder 260, and the two electrode terminals 264 are limited by the second sealing ring. 265, so that when the transmitter 400 is assembled on the sensor base 220 of the sensor 200, please continue to refer to FIGS.
  • a sealed cavity is formed to waterproof the electrode terminals 264 .
  • the sensor electrodes 210 are implanted obliquely, for example, the sensor electrodes 210 are bent and fixed in the electrode seat 260 .
  • the angle between the extension line of the first end portion 211 and the extension line of the second end portion 212 of the bent sensor electrode 210 is 30-60°. In one embodiment, the included angle is 45°.
  • the transmitter 400 includes a transmitter housing 410 and an integrated circuit module 420 disposed in the transmitter housing 410, the received blood glucose data is processed by the integrated circuit module 420 and the processed The blood glucose data is sent wirelessly to receiver 300 .
  • the lower surface of the transmitter housing 410 is equipped with two data receiving terminals 430, the data receiving terminals 430 are electrically connected to the integrated circuit module 420 and serve as the data input end of the integrated circuit module 420, when the transmitter 400 is bonded to the sensor base 220,
  • the two data receiving terminals 430 are respectively electrically connected to the two electrode terminals 264 to form a data transmission path.
  • the senor 200 also includes a battery module 270 that supplies power to the integrated circuit module 420 of the transmitter 400.
  • the battery module 270 is configured in the sensor base 220, and the battery The module 270 includes a battery installation groove 271, a battery 272 embedded in the battery installation groove 271, and a battery cover 273 configured on the battery installation groove 271 to close the battery 272.
  • the power supply terminal 274, the two power supply terminals 274 are respectively electrically connected to the positive pole and the negative pole of the battery 272, the battery module 270 outputs electric energy through the two power supply terminals 274, correspondingly, the lower surface of the transmitter housing 410 is also equipped with Two power receiving terminals 440, the two power receiving terminals 440 are electrically connected to the integrated circuit module 420 and serve as the power input end of the integrated circuit module 420, when the transmitter 400 is connected to the sensor base 220, the two power receiving terminals 440 are respectively It is electrically connected with two power supply terminals 274 to form a power supply path.
  • a first sealing ring 280 is disposed on the upper surface of the battery module 270 , and the two power supply terminals 274 are defined in the first sealing ring 280 . It is set so that when the transmitter 400 is assembled on the sensor base 220 of the sensor 200, a sealed cavity is formed between the battery cover 273, the first sealing ring 280 and the lower surface of the transmitter 400, so as to waterproof the power supply terminal 274 role.
  • the implanter 500 includes an implanter shell 510 and internal components disposed in the implanter shell 510, wherein the internal components include a safety mechanism 520 , a trigger mechanism 530 and a drive assembly 540 , and the safety mechanism 520 is partially configured on the implanter shell 510 .
  • the implanter housing 510 includes an implanter upper housing 511 and an implanter lower housing 512, and the implanter upper housing 511 and the implanter lower housing 512 are fixed and assembled on the Together.
  • FIG. 10 shows a schematic view of the internal components of the implanter 500 after the upper casing 511 of the implanter is removed.
  • the internal components include a safety mechanism 520, a trigger mechanism 530, a drive assembly 540, and an operatively coupled to the return needle assembly 550 in the implanter housing 510.
  • the trigger mechanism 530 includes a mirror-image configuration of a first trigger member 531 and a second trigger member 532 , wherein the first trigger member 531 includes a second distal end relative to the implantation direction of the sensor electrode 210 .
  • the action of the first drive part 5311 is related to the action of the first drive part 5311;
  • the second arm 5323 is connected between the second drive part 5321 and the second operation part 5322, the second pivot part 5324 is arranged on the second arm 5323, and the second drive part 5321 , the
  • the first pivoting part 5314 includes a first shaft hole located on the first arm 5313 and a first pivot located on the lower casing 512 of the implanter;
  • the second pivoting part 5324 includes a first shaft hole located on the second The second shaft hole on the two arms 5323 and the second pivot on the lower implanter housing 512 of the implanter 500 .
  • the positions of the first shaft hole and the first pivot can be reversed, and the positions of the second shaft hole and the second pivot can be reversed.
  • a first flange protruding toward the second arm 5323 is arranged on the first arm 5313 between the first operating portion 5312 and the first pivoting portion 5314 5315, the second arm 5323 is located between the second operating portion 5322 and the second pivoting portion 5324 and is configured with a second flange 5325 protruding toward the first arm 5313; the first flange 5315 and the second flange 5325 are configured In order to prevent the first operating part 5312 and the second operating part 5322 from approaching each other when the safety mechanism 520 moves between the first flange 5315 and the second flange 5325 .
  • the trigger mechanism 530 supports the reset function, for example, it can be expressed that the first elastic part 5316 extends from between the first pivot part 5314 and the first flange 5315 to the first operating part 5312 on the first arm 5313; On the arm 5323, a second elastic portion 5326 extends from between the second pivot portion 5324 and the second flange 5325 to the second operation portion 5322; the first elastic portion 5316 and the second elastic portion 5326 are configured to operate when the first operation When the first operating portion 5312 and the second operating portion 5322 are close to each other, the first elastic portion 5316 elastically abuts against the second elastic portion 5326 to provide a restoring force that makes the first operating portion 5312 and the second operating portion 5322 move away from each other, and when the first When the operation part 5312 and the second operation part 5322 are away from each other, a gap is formed between the first elastic part 5316 and the second elastic part 5326 for the safety mechanism 520 to pass through.
  • one end of the first elastic part 5316 is disposed on the first arm 5313 and located between the first pivot part 5314 and the first flange 5315, and the other end of the first elastic part 5316 extends toward the first operating part 5312 and faces
  • the second operating part 5322 is offset;
  • one end of the second elastic part 5326 is disposed on the second arm 5323 and is located between the second pivot part 5324 and the second flange 5325, and the other end of the second elastic part 5326 faces the second
  • the operating part 5322 is extended and shifted toward the first operating part 5312
  • the safety mechanism 520 includes a sliding part 521 coupled to the upper casing 511 of the implanter and a limiting part 522 arranged on the lower surface of the sliding part 521 ,
  • the limiting portion 522 is configured such that when the safety mechanism 520 moves between the first flange 5315 and the second flange 5325 , the two ends of the limiting portion 522 respectively abut against the first flange 5315 and the second flange 5325 to prevent the first operating part 5312 and the second operating part 5322 from approaching each other.
  • the sliding part 521 includes a sliding block 5211 and a sliding block switch 5212 detachably coupled to the sliding block 5211, the sliding block 5211 and the limiting part 522 are integrally formed, Two parallel installation grooves 52111 are arranged on the slider 5211, and the extension direction of the two installation grooves 52111 is parallel to the moving direction of the safety mechanism 520.
  • Two through-holes 5111, two buckles 52121 are arranged on the lower surface of the slider switch 5212, and the two buckles 52121 pass through the two through-holes 5111 and the two installation grooves 52111 in sequence and are buckled under the slider 5211 surface, so as to install the safety mechanism 520 on the upper housing 511 of the implanter.
  • the first driving part 5311 is configured with a first bayonet socket (not shown in the figure), and the second driving part 5321 is configured with a second bayonet socket (not shown in the figure), the openings of the first bayonet and the second bayonet are set downwards;
  • the driving assembly 540 includes a bracket 541 coupled to the implanter lower housing 512 of the implanter 500, formed on the bracket 541 The guide column 542 extending on and toward the proximal direction and the drive housing 543 sleeved on the guide column 542, a drive spring 5401 (see FIG.
  • a guide slot 544 is opened on the bracket 541 , and the driving housing 543 is partially limited in the guide slot 544 to move in the guide slot 544 towards the proximal direction.
  • the distal end of the driving housing 543 is mirrored to form two first elastic limit pins 545, and the two first elastic limit pins 545 have a tendency to approach each other, and the distal end of each first elastic limit pin 545
  • the inner surface of the part is formed with a first hook 546, and the bracket 541 is mirror-imaged with two position-limiting posts 547, and each first elastic position-limiting pin 545 passes through one first hook 546 and one position-limiting post 547. Cooperate with the limit so that the driving assembly 540 is in the activation state to be triggered.
  • the driving housing 543 cannot move, the driving spring 5401 is in a compressed state, and the first bayonet of the first driving part 5311 and the second card of the second driving part 5321 The mouths are respectively engaged with the distal ends of the two first elastic limiting pins 545 .
  • the proximal end of the bracket 541 is operatively coupled to a fixing member 548, and the fixing member 548 is configured to fix the back needle assembly 550 on the bracket 541 and to detach the back needle assembly 550 from the bracket 541. freed.
  • the needle return assembly 550 includes a needle return housing 551 and a needle assembly 552 disposed in the needle return housing 551 , and a puncture needle 553 is disposed in the needle assembly 552 , Needle assembly 552 is configured to drive piercing needle 553 within needle housing 551 in a proximal direction to partially implant sensor electrode 210 into the skin of host 100 .
  • the proximal end of the needle housing 551 is formed with a base connection portion 554 to which the sensor base 220 is operatively coupled, and the sensor electrode 210 can be removed from the needle housing when implantation of the sensor electrode 210 is completed. Take it off on 551.
  • the needle assembly 552 includes a needle assembly housing 555 and a needle return mechanism 556 disposed in the needle assembly housing 555.
  • the distal end of the needle assembly housing 555 is formed with a response portion 557 extending toward the distal direction.
  • the response portion 557 is Configured to respond to drivers provided by driver component 540 .
  • a drive terminal 549 is formed on the lower surface of the drive housing 543 , and the drive terminal 549 is in drive connection with the response part 557 , that is, the response part 557 provides a response to the drive terminal 549 .
  • the driving terminal 549 pushes the needle assembly 552 toward the proximal direction by applying the driving force to the response portion 557 .
  • the proximal end of the needle assembly housing 555 is formed with an electrode mounting portion 558, and the electrode assembly of the sensor 200 is operatively coupled to the electrode mounting portion 558.
  • the electrode assembly is coupled to
  • the sensor electrode 210 is partially embedded in the puncture needle 553, so that the sensor electrode 210 moves together with the needle assembly 552.
  • Assembly 552 is transferred to sensor base 220.
  • the puncture needle 553 is formed with a narrow and long opening on the side facing the electrode mounting part 558, and the opening is configured to allow the sensor electrode 210 to pass through, that is, after the electrode assembly is transferred from the needle assembly 552 to the sensor base 220, the puncture needle 553 needs to Retracting from the implantation site, during retraction, the sensor electrode 210 passes through the opening of the puncture needle 553 to be removed from the puncture needle 553 .
  • the return needle mechanism 556 includes a needle seat 5561 and a needle return spring 5562, the puncture needle 553 is configured on the needle seat 5561, and the return needle spring 5562 is configured to make the needle seat 5561 drive
  • the introduction needle 553 moves from the proximal end to the distal end of the needle assembly housing 555, ie, the process referred to above as retraction.
  • two second elastic limit pins 5563 are formed as mirror images on both sides of the needle seat 5561, and the second elastic limit pins 5563 have a tendency to move away from each other, and each second elastic limit pin A second hook 5564 is respectively formed on the outer surface of 5563; correspondingly, two stoppers 5551 are arranged as a mirror image on the needle assembly housing 555, and each stopper 5551 is respectively connected to a second hook.
  • Part 5564 cooperates to limit; for example, when the needle base 5561 is located at the proximal end of the needle assembly housing 555, the limit block 5551 cooperates with the second hook portion 5564 to limit the position, so as to lock the needle base 5561 on the needle assembly housing 555 Proximal end; the inner surface of the proximal end of the return needle housing 551 is mirror-imaged with two bumps 5511 configured to move the needle assembly 552 to the proximal side of the return needle housing 551 At the end, the second hook 5564 is unlocked from the limit block 5551 .
  • two third elastic limit pins 5571 are formed as mirror images on both sides of the response portion 557.
  • the third elastic limit pins 5571 have a tendency to move away from each other.
  • the outer surfaces of the third elastic limit pins 5571 A third hook 5572 is formed on it; the distal end of the return needle housing 551 is mirrored with two limiting holes 5512, and the third hook 5572 cooperates with the limiting holes 5512; for example, in the needle assembly 552
  • the response part 557 responds to the driving provided by the driving terminal 549
  • the third hook part 5572 disengages from the limiting hole 5512, so that the needle assembly 552 can move toward the proximal direction.
  • the return needle assembly 552 of the embodiment of the present application can be removed from the implanter housing 510 after the puncture needle 553 is withdrawn from the skin of the host 100, so that only the used sensor base 220 and the return needle assembly 552 can be discarded.
  • the implanter 500 with the drive assembly 540, the safety mechanism 520 and the trigger mechanism 530 can be reused. For example, as shown in FIG. 11 , it is sufficient to push the driving housing 543 toward the distal end until the first hook portion 546 hooks the limit post 547 again, and move the safety mechanism 520 to the distal position.
  • a base mounting groove 5541 is disposed on the lower surface of the base connecting portion 554, and a first elastic buckle 5542 and a second elastic buckle 5543 are disposed on the base connecting portion 554.
  • the elastic buckle 5542 is disposed on the operating path of the safety mechanism 520
  • the second elastic buckle 5543 is disposed on the operating path of the needle assembly 552, wherein the first elastic buckle 5542 is disposed with a first guiding slope facing the safety mechanism 520 55421, the second elastic buckle 5543 is equipped with a second guide slope 55431 facing the needle assembly 552, please continue to refer to Figures 18 and 19, the safety mechanism 520 is equipped with a first function terminal 523 and passes through the first function terminal 523 Abut against the first guide inclined surface 55421 to drive the first elastic buckle 5542 to the uncoupling position, please continue to refer to refer to Fig. 524 abuts against the second guiding slope 55431 to drive the second elastic buckle 5543 to the uncoupling position.
  • the first elastic buckle 5542 and the second elastic buckle 5543 are embedded in the bottom surface of the implanter 500 .
  • the fixing structure includes a first elastic buckle 5542 and a second elastic buckle 5543 .
  • the sensor base 220 is provided with a first bayonet 221 corresponding to the first elastic buckle 5542 and a second bayonet 222 corresponding to the second elastic buckle 5543, when the first elastic buckle
  • the buckle 5542 is disengaged from the first bayonet 221 when driven to the uncoupling position, and disengages from the second bayonet 222 when the second elastic buckle 5543 is driven to the decoupling position.
  • the sensor base 220 is firmly fixed on the implanter 500, for example, the sensor base 220 is firmly fixed on the base connecting portion 554 of the return needle assembly 552, at this time, when the release layer 240 is torn off , the sensor base 220 will not loosen from the base connecting portion 554 , and will not be detached from the base connecting portion 554 .
  • the first active terminal 523 on the safety mechanism 520 abuts against the first guide slope 55421 and the first elastic snaps
  • the buckle 5542 is driven to disengage from the first bayonet socket 221 to complete the decoupling (ie partial decoupling) of the first section of the sensor base 220, and at this time, as shown in FIG. 5315 and the second flange 5325, so that the first flange 5315 and the second flange 5325 can approach each other.
  • pressing the first operating part 5312 and the second operating part 5322 can make the first driving part 5311 and the second
  • the driving parts 5321 are separated from each other, thereby driving the two first elastic limiting pins 545 engaged by the first driving part 5311 and the second driving part 5321 to open to both sides until the first hook part 546 disengages from the limiting post 547, and then At this time, the driving housing 543 moves toward the proximal direction along the guide post 542 under the action of the driving spring 5401 , thereby driving the needle assembly 552 of the implanter 500 to implant the sensor electrode 210 into the skin of the host 100 .
  • the second active terminal 524 on the needle assembly 552 abuts against the second guiding slope 55431 and drives the second elastic buckle 5543 to disengage from the second bayonet 222,
  • the second stage of decoupling of the sensor base 220 (that is, complete decoupling) is completed.
  • the automatic decoupling of the sensor base 220 is completed, and only the implanter 500 needs to be removed from the sensor base 220 .
  • the automatic decoupling mentioned in the embodiment of the present application means that after the sensor electrode 210 is implanted into the skin of the host 100 , the sensor base 220 is already decoupled from the implanter 500 without additional manual operation.
  • the first operating part 5312 and the second operating part 5322 are configured as elliptical buttons.
  • the pressing surface of the elliptical button is formed with a recess that fits the pulp of the finger (not shown in the figure). out).
  • the first operating mechanism is configured to partially decouple the sensor base 220 from the implanter 500
  • the second operating mechanism is configured to partially decouple the sensor base 220 from the implanter 500 after the first operating mechanism partially decouples the sensor base 220 from the implanter 500. , completely decouple the sensor base 220 from the implanter 500 .
  • the fixing structure of the sensor base and the method for removing the sensor base from the implanter disclosed in the embodiments of the present application can deal with the situation that the sensor base and the implanter are not firmly fixed and are inconvenient to be removed from the implanter.
  • the sensor base of the embodiment of the present application is fixed to the implanter by means of coupling.
  • a buckle connection is used, which can fix the sensor base more firmly than using the friction between the cannula and the seal. , especially when the release paper is torn off, it can effectively prevent the sensor base from loosening or even falling off;
  • the fixing structure of the sensor base of this application adopts a two-stage decoupling method.
  • the first stage of decoupling is realized when the insurance is released, and the second stage of decoupling is realized after the implantation is completed and the sensor base is detached from the implanter. , which is easier and more convenient than manual decoupling operation after the implantation is completed, which is conducive to improving user experience;
  • the embodiment of the present application adopts a two-stage decoupling method, which not only simplifies the internal structure of the implanter, reduces production costs, but also can effectively ensure the success rate of decoupling.
  • the fixing structure of the sensor base disclosed in the embodiment of the present application (the sensor base can be fixed to the implanter) and the method for removing the sensor base from the implanter can be applied to a continuous blood glucose monitoring system.
  • distal part distal part
  • proximal part distal position
  • proximal position distal end
  • distal end proximal end

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Abstract

一种传感器底座(220)的固定结构及方法，固定结构被配置为将传感器底座(220)耦接到植入器(500)上，传感器底座(220)以操作方式耦接到植入器(500)上；植入器(500)中配置有第一操作机构和第二操作机构，第一操作机构被配置为部分解耦传感器底座(220)与植入器(500)，第二操作机构被配置为全部解耦传感器底座(220)与植入器(500)；第一操作机构的操作优先级高于第二操作机构的操作优先级。

Description

传感器底座的固定结构及方法
本申请要求在2021年06月28日提交中国专利局、申请号为202110718602.0的中国专利申请的优先权，以上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，例如涉及一种传感器底座的固定结构及方法。
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。
血糖仪在市面上广泛使用，患者使用血糖仪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，并在植入皮下之后需要将传感器从植入器上取下以将传感器留置在宿主皮肤上。传感器或传感器底座与植入器的固定方式多种多样，如美国发明专利US9044199B2公开了一种经皮分析物传感器，通过将安装单元(即传感器底座)通过卡扣耦接到施加器上，当需要将安装单元从施加器上取下时，通过按压安装单元上的释放闩锁将安装单元从施加器上解耦，这种结构需要手动解耦，且在解耦时需要持续按压住释放闩锁 并向远离安装单元的方向拉动施加器，操作繁琐，用户体验不佳。又如中国发明专利CN206777328U公开了用于将皮肤上传感器组件施加到受体皮肤的施加器和传感器插入组件，通过插管与密封件配合将一次性壳体(即传感器底座)固定到施加器上，这种结构在传感器电极植入完成后可以直接向远离一次性壳体的方向拉动施加器即可完成一次性壳体与施加器的脱离，虽然简化了操作，但是由于只通过密封件与插管之间的摩擦力进行固定，在撕去粘合剂贴片上的离型纸时，容易因操作不当而牵扯到一次性壳体，导致一次性壳体佩戴的不稳定性。
发明内容
本申请实施例公开一种传感器底座的固定结构及方法。
本申请实施例公开一种传感器底座的固定结构，所述固定结构被配置为将传感器底座耦接到植入器上，所述传感器底座以操作方式耦接到植入器上；
所述植入器中配置有第一操作机构和第二操作机构，所述第一操作机构被配置为部分解耦传感器底座与植入器，所述第二操作机构被配置为全部解耦传感器底座与植入器；
所述第一操作机构的操作优先级高于第二操作机构的操作优先级。
本申请实施例公开一种将传感器底座从植入器上取下的方法，基于如上所述的传感器底座的固定结构，所述方法包括：
先通过第一操作机构部分解耦传感器底座与植入器，再通过第二操作机构全部解耦传感器底座与植入器。
附图说明
图1是本申请实施例的连续血糖监测系统的示意图。
图2是本申请实施例的传感器与发射器装配的示意图。
图3是本申请实施例的传感器与发射器装配的剖面图。
图4是本申请实施例的传感器的剖面图。
图5是本申请实施例的传感器的俯视图。
图6是本申请实施例的电极座的剖面图。
图7是本申请实施例的电极座的爆炸图。
图8是本申请实施例的发射器的爆炸图。
图9是本申请实施例的植入器的示意图。
图10是本申请实施例的保险机构和触发机构布置在植入器中的俯视图。
图11是本申请实施例的驱动组件的示意图。
图12是本申请实施例的保险机构安装示意图。
图13是本申请实施例的支架与回针组件的装配爆炸图。
图14是本申请实施例的回针组件的爆炸图。
图15是本申请实施例的回针组件的剖面图。
图16是本申请实施例的回针组件的另一剖面图。
图17是本申请实施例的驱动壳体与导向柱的装配剖面图。
图18是本申请实施例的保险机构移动至远端位置的示意图。
图19是本申请实施例的保险机构移动至近端位置的示意图。
图20是本申请实施例的针组件移动至近端位置的示意图。
其中：100、宿主；200、传感器；210、传感器电极；211、第一端部；212、第二端部；220、传感器底座；221、第一卡口；222、第二卡口；230、粘合剂贴片；240、离型层；250、电极安装槽；260、电极座；261、电极座上壳体；262、电极座下壳体；263、柔性导电片；264、电极端子；265、第二密封圈；270、电池模块；271、电池安装槽；272、电池；273、电池盖；274、供电端子；280、第一密封圈；300、接收器；400、发射器；410、发射器外壳；420、集成电路模块；430、数据接收端子；440、受电端子；500、植入器；510、植入器外壳；511、植入器上壳体；5111、通孔；512、植入器下壳体；520、保险机构；521、滑动部；5211、滑块；52111、安装槽；5212、滑块开关；52121、卡扣；522、限位部；523、第一作用端子；524、第二作用端子；530、触发机构；531、第一触发部件；5311、第一驱动部；5312、第一操作部；5313、第一臂；5314、第一枢转部；5315、第一凸缘；5316、第一弹性部；532、第二触发部件；5321、第二驱动部；5322、第二操作部；5323、第二臂；5324、第二枢转部；5325、第二凸缘；5326、第二弹性部；540、驱动组件；5401、驱动弹簧；541、支架；542、导向柱；543、驱动壳体；544、导向槽；545、第一弹性限位销；546、第一钩部；547、限位柱；548、固定构件；549、驱动端子；550、回针组件；551、回针壳体；5511、凸点；5512、限位孔；552、针组件；553、穿刺针；554、底座连接部；5541、底座安装槽；5542、第一弹性卡扣；55421、第一导向斜面；5543、第二弹性卡扣；55431、第二导向斜面；555、针组件壳体；5551、限位块；556、回针机构；5561、针座；5562、回针弹簧；5563、第二弹性限位销；5564、第二钩部；557、响应部；5571、第三弹性限位销；5572、第三钩部；558、 电极安装部。
具体实施方式
以下描述和例子说明了所公开的申请的一些示例性实施例。本领域技术人员将认识到，本申请实施例存在许多变化和修改。
连续血糖监测(CGM，Continuous Glucose Monitoring)系统
请参见图1所示，是附接到宿主100上的连续血糖监测系统的示意图。图1中示出了包括皮肤上方的传感器200的连续血糖监测系统，其通过一次性传感器底座220(图1未示出)固定到宿主100的皮肤。系统包括传感器200和用于将传感器200监测到的血糖信息发送到接收器300的发射器400，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。继续参见图1和图2，在使用过程中，传感器电极210部分位于宿主100皮肤的下方，并且传感器电极210电性连接至发射器400。发射器400与传感器底座220接合，该传感器底座220附接到粘合剂贴片230，并通过粘合剂贴片230固定到宿主100的皮肤。
例如，粘合剂贴片230可为医用无纺胶布。
传感器200可以用植入器500附接到宿主100皮肤，该植入器500提供便利和安全的植入操作。这样的植入器500还可以用于穿过宿主100的皮肤将传感器电极210插入。一旦传感器电极210已经插入，植入器500就从传感器200脱开。
传感器200
请参见图2至5所示，示出了一种传感器200的结构，其包括一次性的传感器底座220、配置在传感器底座220上的电极组件和接合到传感器底座220上的发射器400，传感器底座220的下表面附接有粘合剂贴片230，并通过粘合剂贴片230固定到宿主100的皮肤。在一种实施方式中，发射器400扣合到传感器底座220上。
在一种实施方式中，粘合剂贴片230上预先附接有离型层240，当需要使用传感器200时，先撕去离型层240，再将传感器底座220通过粘合剂贴片230贴附在宿主100皮肤即可。
例如，离型层240采用离型纸或者离型膜，表面涂有一层离型剂。
例如，离型层240可由两片离型纸或离型膜组合而成，两片离型纸中的一片的尺寸大于另一片，且尺寸大的部分覆盖在尺寸小的部分之上。
图3中示出了可朝下翻折的便于撕扯的端部，通过捏住该端部即可撕下对 应的离型纸或离型膜。
请继续参见图4所示，传感器底座220的上表面配置有电极安装槽250，电极组件可操作地耦接在电极安装槽250中。例如，当电极组件处于植入初始状态时，电极组件与传感器底座220分离；当电极组件处于植入完成状态时，电极组件耦接在传感器底座220的电极安装槽250中。在一种实施方式中，耦接的方式可以通过卡扣扣合实现。
在一实施例中，电极组件包括传感器电极210以及附接到传感器电极210上的电极座260，还可参考图6所示出的多个部件。
请继续参见图4所示，传感器电极210的一端穿过传感器底座220并部分露出于传感器底座220的下表面，传感器电极210的另一端位于传感器底座220中，此处定义传感器电极210的一端为第一端部211，传感器电极210的另一端为第二端部212，在此前提下，第一端部211进入宿主100皮肤到达皮下组织间液，此时第一端部211与体内葡萄糖发生氧化反应并产生电信号。在一种实施方式中，请参见图6和7所示，传感器电极210的第二端部212上附接有电极座260，此处附接方式可表现为，电极座260包括电极座上壳体261和电极座下壳体262，电极座上壳体261与电极座下壳体262耦接，并将传感器电极210的第二端部212夹持在电极座上壳体261与电极座下壳体262之间，电极座260中配置有两个柔性导电片263，两个柔性导电片263分别与传感器电极210的第二端部212的工作电极和参比电极电性连接，电极座260上还配置有两个电极端子264，两个电极端子264配置在电极座上壳体261上并分别与两个柔性导电片263电性连接，传感器电极210通过电极端子264将监测到的血糖数据传输到发射器400中。本实施方式中的传感器电极210是被预先封装在电极座260中的，即，传感器电极210的第二端部212与两个柔性导电片263是预连接的，相比于相关技术中的传感器200的结构，本实施方式中的柔性导电片263无需被插管贯穿，因而柔性导电片263能够更加紧密地包裹在传感器电极210上，使得传感器电极210被牢牢固定住，不易从电极座260上脱落，且传感器电极210与柔性导电片263的电性连接更加可靠。此外，该种结构的传感器200，能够在工厂内部完成电性连接可靠性的检验。一类检验操作为，将传感器电极210的第一端部211浸入葡萄糖溶液中，再测量两个电极端子264之间的通断即可。
请继续参见图5、6和7所示，在一种实施方式中，在电极座260的上壳体261上还配置有第二密封圈265，两个电极端子264被限定在第二密封圈265中，以使得发射器400装配到传感器200的传感器底座220上时，请继续参见图3 和4所示，电极座上壳体261、第二密封圈265和发射器400的下表面之间形成一密封的腔体，起到对电极端子264防水的作用。
在一种实施方式中，传感器电极210采用斜向植入的方式，例如传感器电极210被折弯固定在电极座260中。例如，折弯后的传感器电极210的第一端部211的延长线与第二端部212的延长线之间的夹角为30～60°。在一实施例中，该夹角为45°。通过采用该种植入方式，能够增大传感器电极210与皮下组织间液的接触面积，更有利于传感器电极210的稳定检测。
请继续参见图3和8所示，发射器400包括发射器外壳410和配置在发射器外壳410内的集成电路模块420，通过集成电路模块420对接收到的血糖数据进行处理并将处理后的血糖数据无线发送到接收器300。发射器外壳410的下表面配置有两个数据接收端子430，数据接收端子430电连接到集成电路模块420并作为集成电路模块420的数据输入端，当发射器400接合到传感器底座220上时，两个数据接收端子430分别与两个电极端子264电性连接，构成数据传输通路。
请继续参见图3、4和8所示，传感器200还包括给发射器400的集成电路模块420供电的电池模块270，在一种实施方式中，电池模块270被配置在传感器底座220中，电池模块270包括电池安装槽271、嵌入在电池安装槽271中的电池272和配置在电池安装槽271上以封闭电池272的电池盖273，电池安装槽271上位于电池盖273的边缘配置有两个供电端子274，两个供电端子274分别电性连接到电池272的正极和负极，电池模块270通过两个供电端子274将电能输出，与之对应地，在发射器外壳410的下表面还配置有两个受电端子440，两个受电端子440电连接到集成电路模块420并作为集成电路模块420的电能输入端，当发射器400接合到传感器底座220上时，两个受电端子440分别与两个供电端子274电性连接，构成电能供应通路。
请继续参见图3和5所示，在一种实施方式中，电池模块270的上表面还配置有第一密封圈280，两个供电端子274被限定在第一密封圈280中。如此设置以使得发射器400装配到传感器200的传感器底座220上时，电池盖273、第一密封圈280和发射器400的下表面之间形成一密封的腔体，起到对供电端子274防水的作用。
植入器500
请参见图9和10所示，示出了植入器500的外部结构，植入器500包括植入器外壳510和配置在植入器外壳510内的内部构件，其中，内部构件包括保 险机构520、触发机构530和驱动组件540，且保险机构520部分配置在植入器外壳510上。在一种实施方式中，植入器外壳510包括植入器上壳体511和植入器下壳体512，植入器上壳体511与植入器下壳体512通过卡扣固定组装在一起。
请参见图10所示，示出了植入器500揭开植入器上壳体511后的内部构件示意图，内部构件包括保险机构520、触发机构530、驱动组件540、以及以操作方式耦接到植入器外壳510中的回针组件550。在一种实施方式中，触发机构530包括镜像配置的第一触发部件531和第二触发部件532，其中，第一触发部件531包括相对于传感器电极210的植入方向的远侧端部的第一驱动部5311和相对于传感器电极210的植入方向的近侧端部的第一操作部5312，第二触发部件532包括相对于传感器电极210的植入方向的远侧端部的第二驱动部5321和相对于传感器电极210的植入方向的近侧端部的第二操作部5322，第一驱动部5311和第一操作部5312之间连接有第一臂5313，第一臂5313上配置有第一枢转部5314，第一驱动部5311、第一臂5313、第一操作部5312和第一枢转部5314配合构成第一杠杆结构，通过该第一杠杆结构将第一操作部5312的动作关联到第一驱动部5311的动作；第二驱动部5321和第二操作部5322之间连接有第二臂5323，第二臂5323上配置有第二枢转部5324，第二驱动部5321、第二臂5323、第二操作部5322和第二枢转部5324配合构成第二杠杆结构，通过该第二杠杆结构将第二操作部5322的动作关联到第二驱动部5321的动作。例如表现为，第一操作部5312与第二操作部5322彼此靠近时，第一驱动部5311与第二驱动部5321彼此远离，以及当第一操作部5312与第二操作部5322彼此远离时，第一驱动部5311与第二驱动部5321彼此靠近。在一种实施方式中，第一枢转部5314包括位于第一臂5313上的第一轴孔和位于植入器下壳体512上的第一枢轴；第二枢转部5324包括位于第二臂5323上的第二轴孔和位于植入器500的植入器下壳体512上的第二枢轴。在另一种实施方式中，第一轴孔与第一枢轴的位置可以对调，第二轴孔与第二枢轴的位置可以对调。
请参见图10和图11所示，在一种实施方式中，第一臂5313上位于第一操作部5312和第一枢转部5314之间配置有朝向第二臂5323隆起的第一凸缘5315，第二臂5323上位于第二操作部5322和第二枢转部5324之间配置有朝向第一臂5313隆起的第二凸缘5325；第一凸缘5315和第二凸缘5325被配置为当保险机构520移动至第一凸缘5315和第二凸缘5325之间时，阻止第一操作部5312与第二操作部5322彼此靠近。此外，触发机构530支持复位功能，例如可表现为， 第一臂5313上自第一枢转部5314和第一凸缘5315之间向第一操作部5312延伸出第一弹性部5316；第二臂5323上自第二枢转部5324和第二凸缘5325之间向第二操作部5322延伸出第二弹性部5326；第一弹性部5316和第二弹性部5326被配置为当第一操作部5312与第二操作部5322彼此靠近时，第一弹性部5316与第二弹性部5326弹性抵接以提供使得第一操作部5312与第二操作部5322彼此远离的回复力，以及当第一操作部5312与第二操作部5322彼此远离时，第一弹性部5316与第二弹性部5326之间形成供保险机构520通过的间隙。例如，第一弹性部5316的一端配置在第一臂5313上并位于第一枢转部5314和第一凸缘5315之间，第一弹性部5316的另一端向第一操作部5312延伸并朝向第二操作部5322偏移；第二弹性部5326的一端配置在第二臂5323上并位于第二枢转部5324和第二凸缘5325之间，第二弹性部5326的另一端向第二操作部5322延伸并朝向第一操作部5312偏移
请继续参见图10和12所示，在一种实施方式中，保险机构520包括耦接到植入器上壳体511的滑动部521和配置在滑动部521下表面上的限位部522，限位部522被配置为当保险机构520移动至第一凸缘5315和第二凸缘5325之间时，限位部522的两端分别抵接在第一凸缘5315和第二凸缘5325上，从而阻止第一操作部5312与第二操作部5322彼此靠近。
请参见图12所示，在一种实施方式中，滑动部521包括滑块5211和以可拆卸方式耦接到滑块5211上的滑块开关5212，滑块5211与限位部522一体成型，滑块5211上配置有两条平行的安装槽52111，两条安装槽52111的延伸方向平行于保险机构520的移动方向，植入器上壳体511上配置有与两个安装槽52111分别对应的两个通孔5111，滑块开关5212的下表面上配置有两个卡扣52121，两个卡扣52121依次穿过两个通孔5111和两个安装槽52111并扣接在滑块5211的下表面上，以将保险机构520安装到植入器上壳体511上。
请继续参见图10、11和13所示，在一种实施方式中，第一驱动部5311配置有第一卡口(图中未示出)，第二驱动部5321配置有第二卡口(图中未示出)，第一卡口和第二卡口的开口均朝下设置；驱动组件540包括耦接到植入器500的植入器下壳体512的支架541、形成于支架541上并朝向近端方向延伸的导向柱542和套接到导向柱542上的驱动壳体543，驱动壳体543与导向柱542之间配置有一驱动弹簧5401(参见图17)，驱动弹簧5401提供使得驱动壳体543沿着导向柱542朝向近端方向移动的弹力。在一种实施方式中，支架541上开设有导向槽544，驱动壳体543被部分限定在导向槽544中以在导向槽544中朝 向近端方向移动。驱动壳体543的远侧端部镜像形成有两个第一弹性限位销545，两个第一弹性限位销545具有彼此靠近的趋势，每个第一弹性限位销545的远侧端部的内侧表面形成有第一钩部546，支架541上镜像配置有两个限位柱547，每个第一弹性限位销545通过1个第一钩部546与1个限位柱547的配合限位使得驱动组件540处于待触发激活状态，此时，驱动壳体543无法移动，驱动弹簧5401处于压缩状态，第一驱动部5311的第一卡口和第二驱动部5321的第二卡口分别咬合在两个第一弹性限位销545的远侧端部。
请参见图13所示，支架541的近侧端部以操作方式耦接有一固定构件548，固定构件548被配置为将回针组件550固定到支架541上以及将回针组件550从支架541上释放。
请参见图14至16所示，在一种实施方式中，回针组件550包括回针壳体551和配置在回针壳体551内的针组件552，穿刺针553配置在针组件552中，针组件552被配置为在回针壳体551中朝向近端方向驱动穿刺针553移动以将传感器电极210部分植入宿主100皮肤。回针壳体551的近侧端部形成有底座连接部554，传感器底座220以操作方式耦接到底座连接部554上，在传感器电极210植入完成时，传感器电极210可以从回针壳体551上取下。针组件552包括针组件壳体555和配置在针组件壳体555内的回针机构556，针组件壳体555的远侧端部形成有朝向远端方向延伸的响应部557，响应部557被配置为响应于驱动组件540提供的驱动。请参见图16和17所示，在一种实施方式中，驱动壳体543的下表面形成有驱动端子549，该驱动端子549与响应部557传动连接，即响应部557响应于驱动端子549提供的驱动力，例如，驱动端子549通过将驱动力作用在响应部557将针组件552朝向近端方向推动。
请继续参见图14和15所示，针组件壳体555的近侧端部形成有电极安装部558，传感器200的电极组件以操作方式耦接到电极安装部558上，当电极组件耦接到电极安装部558上时，传感器电极210部分嵌入穿刺针553中，从而使得传感器电极210跟随针组件552一起移动，当穿刺针553带着传感器电极210植入宿主100皮肤时，电极组件被从针组件552上转移到传感器底座220上。穿刺针553上面向电极安装部558的一侧形成有狭长的开口，该开口被配置为允许传感器电极210通过，即电极组件被从针组件552上转移到传感器底座220上之后，穿刺针553需要从植入位置缩回，在缩回的过程中，传感器电极210从穿刺针553的开口通过以从穿刺针553中移出。例如，回针机构556包括针座5561和回针弹簧5562，穿刺针553被配置在针座5561上，回针弹簧5562被 配置为在传感器电极210部分植入宿主100皮肤后使得针座5561带动穿刺针553从针组件壳体555的近侧端部移动至远侧端部，即，上述所称缩回的过程。请继续参见图14和16所示，针座5561的两侧镜像形成有两个第二弹性限位销5563，第二弹性限位销5563具有彼此远离的趋势，每个第二弹性限位销5563的外侧表面上分别形成有1个第二钩部5564；与之对应的，针组件壳体555上镜像配置有两个限位块5551，每个限位块5551分别与1个第二钩部5564配合限位；例如，在针座5561位于针组件壳体555的近侧端部时限位块5551与第二钩部5564配合限位，以将针座5561锁定在针组件壳体555的近侧端部；回针壳体551的近侧端部的内表面上镜像形成有两个凸点5511，两个凸点5511被配置为在针组件552移动至回针壳体551的近侧端部时使得第二钩部5564从限位块5551上解锁。请继续参见图16所示，响应部557的两侧镜像形成有两个第三弹性限位销5571，第三弹性限位销5571具有彼此远离的趋势，第三弹性限位销5571的外侧表面上形成有第三钩部5572；回针壳体551的远侧端部镜像配置有两个限位孔5512，第三钩部5572与限位孔5512配合限位；例如，在针组件552的响应部557响应于驱动端子549提供的驱动时第三钩部5572从限位孔5512中脱离，从而使得针组件552能够朝向近端方向移动。
本申请实施例的回针组件552在使得穿刺针553从宿主100皮肤退出后可以从植入器外壳510取下，从而只需将使用完的传感器底座220和回针组件552丢弃即可，配置有驱动组件540、保险机构520和触发机构530的植入器500可被重复使用。例如，参见图11所示，朝向远端方向推动驱动壳体543至第一钩部546再次钩住限位柱547，并将保险机构520移动至远端位置即可。
请继续参见图13至15所示，在底座连接部554的下表面配置有底座安装槽5541，在底座连接部554上还配置有第一弹性卡扣5542和第二弹性卡扣5543，第一弹性卡扣5542配置在保险机构520的操作路径上，第二弹性卡扣5543配置在针组件552的操作路径上，其中，第一弹性卡扣5542上配置有面向保险机构520的第一导向斜面55421，第二弹性卡扣5543上配置有面向针组件552的第二导向斜面55431，请继续参见图18和19所示，保险机构520上配置有第一作用端子523并通过第一作用端子523抵接第一导向斜面55421以将第一弹性卡扣5542驱动至解耦位置，请继续参见图18、19和20所示，针组件552上配置有第二作用端子524并通过第二作用端子524抵接第二导向斜面55431以将第二弹性卡扣5543驱动至解耦位置。
在一实施例中，第一弹性卡扣5542、第二弹性卡扣5543内嵌于植入器500 的底面。
在一实施例中，固定结构包括第一弹性卡扣5542和第二弹性卡扣5543。
请继续参见图3和4所示，在传感器底座220上设置有对应第一弹性卡扣5542的第一卡口221和对应第二弹性卡扣5543的第二卡口222，当第一弹性卡扣5542被驱动至解耦位置时从第一卡口221中脱离，当第二弹性卡扣5543被驱动至解耦位置时从第二卡口222中脱离。
请参见图3、18所述，当保险机构520位于远端位置时，第一弹性卡扣5542配合固定在第一卡口221中，第二弹性卡扣5543配合固定在第二卡口222中，此时，传感器底座220被牢牢固定在植入器500上，例如，传感器底座220被牢牢固定在回针组件552的底座连接部554上，此时，在撕下离型层240时，传感器底座220不会从底座连接部554上松动，更不会从底座连接部554上脱离。
请参见图3、19所示，当将保险机构520从远端位置移动至近端位置时，保险机构520上的第一作用端子523抵接到第一导向斜面55421上并将第一弹性卡扣5542驱动至从第一卡口221中脱离，完成传感器底座220的第一段解耦(即部分解耦)，并且此时，请参见图10所示，限位部522从第一凸缘5315和第二凸缘5325之间移走，使得第一凸缘5315和第二凸缘5325彼此可以靠近。
请参见图10、11和20所示，在将保险机构520从远端位置移动至近端位置之后，按压第一操作部5312和第二操作部5322，可使得第一驱动部5311和第二驱动部5321彼此分开，从而带动被第一驱动部5311和第二驱动部5321咬合的两个第一弹性限位销545向两侧打开至第一钩部546从限位柱547上脱离，此时，驱动壳体543在驱动弹簧5401的作用下沿着导向柱542朝向近端方向移动，从而带动植入器500的针组件552将传感器电极210植入宿主100的皮肤。当传感器电极210被植入宿主100皮肤时，针组件552上的第二作用端子524抵接到第二导向斜面55431上并将第二弹性卡扣5543驱动至从第二卡口222中脱离，完成传感器底座220的第二段解耦(即全部解耦)。此时，完成了传感器底座220的自动解耦，只需要将植入器500从传感器底座220上取下即可。应当理解的是，本申请实施例所称自动解耦，是指在将传感器电极210植入宿主100的皮肤后，无需额外的人工操作，传感器底座220即已与植入器500解耦。
在一种实施方式中，第一操作部5312和第二操作部5322被配置为椭圆形按钮，为提升操作体验，椭圆形按钮的按压面上形成有贴合指腹的凹部(图中 未示出)。
在一种实施例中，第一操作机构被配置为部分解耦传感器底座220与植入器500，第二操作机构被配置为在第一操作机构部分解耦传感器底座220与植入器500后，全部解耦传感器底座220与植入器500。
本申请实施例公开的传感器底座的固定结构、将传感器底座从植入器上取下的方法，可应对传感器底座与植入器固定不牢和从植入器上取下不便的状况。
由于上述实施例的运用，本申请实施例与相关技术相比具有下列特点：
1、本申请实施例的传感器底座通过耦接的方式固定到植入器上，如采用卡扣连接的方式，相比于采用插管与密封件的摩擦力固定，能够更牢固地固定传感器底座，尤其在撕下离型纸时，能够有效防止传感器底座松动甚至脱落；
2、本申请传感器底座的固定结构采用两段式的解耦方式，在解除保险时实现第一段解耦，在植入完成后实现第二段解耦并实现传感器底座从植入器上脱离，相比于在植入完成后手动解耦操作更加简单方便，有利于提升用户体验；
3、本申请实施例采用两段式的解耦方式，不但简化了植入器的内部结构，降低了生产成本，而且能够有效确保解耦的成功率。
本申请实施例公开的传感器底座的固定结构(可将传感器底座固定到植入器上)、将传感器底座从植入器上取下的方法，可应用于连续血糖监测系统。
本申请所称“远端部”、“近端部”、“远端位置”、“近端位置”、“远侧端部”、“近侧端部”中的远和近是在植入传感器组件过程中相对于传感器组件而言的，例如，将靠近传感器组件定义为近，将远离传感器组件定义为远。
然而，本申请易于做出对上述说明进行完全等同的修改和替换构造。虽然在附图和前面的说明中对本申请进行了图示和描述，但此类图示和描述应视为示例性的，而不是限制性的。
除非另外限定，否则所有的术语(包括技术和科学术语)取其对于本领域技术人员而言普通且习惯的意义。当描述公开的某些特征或方面时，使用特定术语不应当暗指该术语在本文中被重新定义，而被限制为包括与该术语相关的任何公开的特定特征或方面。本申请中所用的术语和短语及其变型，尤其在所存在的权利要求中，除非另外明确表明，否则应当构成为开放式的而非限制性的。作为前述的例子，术语“包括”应当指的是“包括但不限于”或类似意义。
此外，尽管已经借助于图示和例子描述了前述内容，但是对于本领域技术人员而言，可以实施某些变化和改变。

Claims (15)

  1. 一种传感器底座的固定结构，所述固定结构被配置为将传感器底座(220)耦接到植入器(500)上，所述传感器底座(220)以操作方式耦接到植入器(500)上；
    所述植入器(500)中配置有第一操作机构和第二操作机构，所述第一操作机构被配置为部分解耦传感器底座(220)与植入器(500)，所述第二操作机构被配置为全部解耦传感器底座(220)与植入器(500)；
    所述第一操作机构的操作优先级高于第二操作机构的操作优先级。
  2. 根据权利要求1所述的传感器底座的固定结构，其中，所述传感器底座(220)与植入器(500)之间配置有第一耦合结构和第二耦合结构；
    所述第一操作机构被配置为解耦第一耦合结构，所述第二操作机构被配置为解耦第二耦合结构。
  3. 根据权利要求2所述的传感器底座的固定结构，其中，所述第一耦合结构包括配置在植入器(500)的下表面上的第一弹性卡扣(5542)和配置在传感器底座(220)的下表面上的第一卡口(221)；
    所述第二耦合结构包括配置在植入器(500)的下表面上的第二弹性卡扣(5543)和配置在传感器底座(220)的下表面上的第二卡口(222)。
  4. 根据权利要求3所述的传感器底座的固定结构，其中，所述第一弹性卡扣(5542)配置在第一操作机构的操作路径上；
    所述第二弹性卡扣(5543)配置在第二操作机构的操作路径上。
  5. 根据权利要求4所述的传感器底座的固定结构，其中，所述第一弹性卡扣(5542)上配置有面向第一操作机构的第一导向斜面(55421)，所述第一操作机构被配置为作用在第一导向斜面(55421)上，以将第一弹性卡扣(5542)与第一卡口(221)分离；
    所述第二弹性卡扣(5543)上配置有面向第二操作机构的第二导向斜面(55431)，所述第二操作机构被配置为作用在第二导向斜面(55431)上，以将第二弹性卡扣(5543)与第二卡口(222)分离。
  6. 根据权利要求5所述的传感器底座的固定结构，其中，所述第一操作机构上配置有第一作用端子(523)，所述第一操作机构被配置为作用在第一导向斜面(55421)上时，所述第一作用端子(523)与第一导向斜面(55421)抵接；
    所述第二操作机构上配置有第二作用端子(524)，所述第二操作机构被配置为作用在第二导向斜面(55431)上时，所述第二作用端子(524)与第二导向斜面(55431)抵接。
  7. 根据权利要求1所述的传感器底座的固定结构，其中，所述第一操作机构 为配置在植入器(500)上的保险机构(520)，所述保险机构(520)被配置为在植入器(500)上的远端位置和近端位置之间以操作方式移动。
  8. 根据权利要求7所述的传感器底座的固定结构，其中，所述保险机构(520)被配置为移动至近端位置时部分解耦传感器底座(220)与植入器(500)。
  9. 根据权利要求1所述的传感器底座的固定结构，其中，所述第二操作机构为配置在植入器(500)内的针组件(552)，所述针组件(552)被配置为驱动穿刺针(553)将传感器电极(210)植入宿主皮肤。
  10. 根据权利要求9所述的传感器底座的固定结构，其中，所述针组件(552)被配置为将传感器电极(210)植入宿主皮肤时全部解耦传感器底座(220)与植入器(500)。
  11. 根据权利要求4所述的传感器底座的固定结构，其中，所述第一弹性卡扣(5542)上配置有面向第一操作机构的第一导向斜面(55421)，所述第一操作机构被配置为作用在第一导向斜面(55421)上，以将第一弹性卡扣(5542)与第一卡口(221)分离。
  12. 根据权利要求4所述的传感器底座的固定结构，其中，所述第二弹性卡扣(5543)上配置有面向第二操作机构的第二导向斜面(55431)，所述第二操作机构被配置为作用在第二导向斜面(55431)上，以将第二弹性卡扣(5543)与第二卡口(222)分离。
  13. 一种将传感器底座从植入器上取下的方法，基于权利要求1～12中任一项所述的传感器底座的固定结构，所述方法包括：先通过第一操作机构部分解耦传感器底座(220)与植入器(500)，再通过第二操作机构全部解耦传感器底座(220)与植入器(500)。
  14. 根据权利要求13所述的将传感器底座从植入器上取下的方法，还包括：将所述第一操作机构在植入器(500)上从远端位置移动至近端位置以部分解耦传感器底座(220)与植入器(500)。
  15. 根据权利要求13所述的将传感器底座从植入器上取下的方法，还包括：将所述第二操作机构从远端位置移动至近端位置以全部解耦传感器底座(220)与植入器(500)。
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