WO2023273083A1 - Structure de fixation séparée pour électrode de capteur - Google Patents

Structure de fixation séparée pour électrode de capteur Download PDF

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Publication number
WO2023273083A1
WO2023273083A1 PCT/CN2021/128852 CN2021128852W WO2023273083A1 WO 2023273083 A1 WO2023273083 A1 WO 2023273083A1 CN 2021128852 W CN2021128852 W CN 2021128852W WO 2023273083 A1 WO2023273083 A1 WO 2023273083A1
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WO
WIPO (PCT)
Prior art keywords
sensor electrode
sensor
fixing part
structure according
fixing structure
Prior art date
Application number
PCT/CN2021/128852
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English (en)
Chinese (zh)
Inventor
钱成
Original Assignee
苏州百孝医疗科技有限公司
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Publication of WO2023273083A1 publication Critical patent/WO2023273083A1/fr

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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
    • 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
    • A61B5/14532—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 separate sensor electrode fixing structure.
  • 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.
  • Cikon patent CN110996775A discloses a transdermal analyte sensor, its applicator and related methods.
  • This patent discloses a pre-connected sensor structure, which will The sensor electrodes are electrically connected in the sensor carrier in advance, and are installed into the sensor housing through the sensor carrier. Therefore, the sensor electrodes for this structure need to use half-wall needles with one side open for sensor electrode implantation, so as to achieve sensor electrode implantation. Disengages from needle assembly after implantation.
  • the embodiment of the present application discloses a separate sensor electrode fixing structure.
  • the embodiment of the present application discloses a separate sensor electrode fixing structure, including a fixing part, the fixing part is configured in the sensor assembly, and the fixing part is configured as:
  • the sensor electrodes are supported in a first state, and the support of the sensor electrodes is released in a second state.
  • 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 the sensor of the 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 top view from another perspective of the sensor of the embodiment of the present application.
  • Fig. 7 is a cross-sectional view of the electrode seat of the embodiment of the present application.
  • Fig. 8 is an exploded view of the electrode seat of the embodiment of the present application.
  • Fig. 9 is an exploded view of the transmitter of the embodiment of the present application.
  • Fig. 10 is a schematic diagram of an implanter according to an embodiment of the present application.
  • Fig. 11 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. 12 is a schematic diagram of the driving assembly of the embodiment of the present application.
  • Fig. 13 is a schematic diagram of the installation of the insurance mechanism of the embodiment of the present application.
  • Fig. 14 is an exploded view of the assembly of the bracket and the return needle assembly of the embodiment of the present application.
  • Fig. 15 is an exploded view of the return needle assembly of the embodiment of the present application.
  • Fig. 16 is a cross-sectional view of the return needle assembly according to the embodiment of the present application.
  • Fig. 17 is another cross-sectional view of the return needle assembly according to the embodiment of the present application.
  • Fig. 18 is an assembly cross-sectional view of the drive housing and the guide post according to the embodiment of the present application.
  • Fig. 19 is a schematic diagram of the safety mechanism moving to the remote position according to the embodiment of the present application.
  • Fig. 20 is a schematic diagram of the safety mechanism moving to the proximal position according to the embodiment of the present application.
  • Fig. 21 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; 2201, first through hole; 221, first bayonet; 222, 223, fixing part; 224, dividing part; 230, adhesive patch; 240, release layer; 250, electrode mounting 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 slot; 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, implant 511, the upper shell of the implanter; 5111, the second through hole; 512, the lower shell of the implanter; 520, the safety mechanism; 521, the sliding part; 5211, the slider; 52
  • the sensor electrodes are pre-installed in the half-walled needles before implantation, since the opening side of the half-walled needles faces Therefore, during transportation or moving, the sensor electrodes are likely to be detached from the half-walled needles due to vibration, so that the sensor electrodes cannot be implanted smoothly.
  • the embodiment of the present application discloses a separate sensor electrode fixing structure.
  • 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 comprising an on-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 implanter 500 adapted to provide 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 an end that can be folded down and is easy to tear, and the corresponding release paper or 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 holder 260 attached to the sensor electrode 210 , and reference can also be made to the various components shown in FIG. 7 .
  • 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 seat 260 is attached to the second end 212 of the sensor electrode 210, and the attachment method here can be expressed as that the electrode seat 260 includes an upper shell of the electrode seat 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 puncture needle 553 ie, a half-walled needle
  • an opening on one side can be used for implantation.
  • a second sealing ring 265 is also arranged 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 211 and the extension line of the second end 212 of the bent sensor electrode 210 is 30-60°, so that the implantation direction of the sensor electrode 210 is in line with the sensor base.
  • the included angle between the lower surfaces of 220 is 30-60°. In one embodiment, the included angle is 45°.
  • a fixing part 223 made of rubber is arranged on the upper surface of the sensor base 220.
  • the fixing part 223 is located on the opening side of the puncture needle 553 and is limited to the upper surface of the sensor electrode 210 and the sensor base 220. between them, so as to support the sensor electrode 210 and prevent the sensor electrode 210 from falling off from the puncture needle 553 during transportation or handling.
  • FIGS. 5 and 6 show that in one embodiment, as shown in FIGS.
  • the fixing part 223 is integrally formed on the first sealing ring 280. After the sensor electrode 210 is implanted into the skin of the host 100, the fixing part 223 is removed from the first The sealing ring 280 is torn off and falls into the electrode installation groove 250 to release the supporting effect on the sensor electrode 210, so that the falling off fixing part 223 is left in the sensor base 220 to ensure safety. It should be understood that in order to ensure The fixing part 223 can be easily torn off from the first sealing ring 280 , and there is a slight weak connection between the fixing part 223 and the first sealing ring 280 , which can be torn off by spring force.
  • both ends of the fixing part 223 can be fixed on the upper surface of the sensor base 220, and a dividing part 224 is formed in the middle of the fixing part 223.
  • the part 223 is separated from the dividing part 224 into two mirror-symmetrical parts, and a channel for the sensor electrode 210 to pass is formed between the two parts, so as to release the supporting effect on the sensor electrode 210.
  • the dividing part The width of the portion 224 is smaller than that of the fixing portion 223 to ensure that it is easily disconnected, and the extension line of the dividing portion 224 intersects the sensor electrode 210 . Please continue to refer to FIG.
  • a pointed part 5521 is formed on the needle assembly 552 , during the implantation process of the sensor electrode 210 , the sharp part 5521 will tear off the fixing part 223 from the first sealing ring 280 or cut off the fixing part 223 from the dividing part 224 .
  • the fixing part 223 can be made of rubber, and its middle part (that is, the dividing part 224) is a weak connection, which will be broken due to force during the implantation of the sensor, and its shape is not unique, for example, it can be A partition 224 forming a weak connection is removed in the middle of the rectangular rubber strip.
  • the fixing part installation area can be, for example, two slopes formed on the upper surface of the sensor base 220 close to the first through hole 2201, and the fixing part 223 straddles between the two slopes.
  • a class of implementations in which the fixing portion 223 is installed between the sensor electrode 210 and the upper surface of the sensor base 220 is mainly limited here.
  • the split part 224 is an elongated weak connection part, and its extension line extends along its length direction, which can also be understood as the axial direction of the symmetry axis of the above-mentioned mirror-symmetrical two parts.
  • 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. 11 shows a schematic view of the internal components of the implanter 500 after the upper shell 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 first pivoting part 5314 is configured, the first driving part 5311, the first arm 5313, the first operating part 5312 and the first pivoting part 5314 cooperate to form a first lever structure, through which the first operating part
  • the action of 5312 is related to the action of the first driving part 5311; a second arm 5323 is arranged and connected between the second driving part 5321 and the second operating part 5322, and a second pivoting part 5324 is arranged on the second arm 5323.
  • the driving part 5321, the second arm 5323, the second operating part 5322 and the second pivoting part 5324 cooperate to form a second lever structure, through which the action of the second operating part 5322 is linked to the action of the second driving part 5321. action.
  • the first driving part 5311 and the second driving part 5321 move away from each other
  • the first driving part 5311 and the second driving part 5321 are close to each other.
  • 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 holes on the two arms 5323 and the second pivots on the lower housing 512 of the implanter.
  • 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 disposed 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. There are two second 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 second through holes 5111 and the two installation grooves 52111 in turn and are buckled on the slide On the lower surface of the block 5211, the safety mechanism 520 is installed on the upper shell 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 post 542 extending on the top and towards the proximal direction and the drive housing 543 sleeved on the guide post 542, a drive spring 5401 (see FIG.
  • a guide slot 544 is opened on the bracket 541 , and the driving housing 543 is partially defined 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
  • 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.
  • Cooperating with the limit position makes the drive assembly 540 in the state of being activated.
  • the drive housing 543 cannot move, the drive spring 5401 is in a compressed state, and the first bayonet and the second bayonet respectively engage with the two first elastic limit pins.
  • the distal end of 545 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
  • 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 limiting; specifically, the needle assembly 552
  • the response portion 557 responds to the driving provided by the driving terminal 549
  • the third hook portion 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, safety mechanism 520 and trigger mechanism 530 can be reused. For example, as shown in FIG. 12 , 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 19 and 20, 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 FIGS. Connect to the second guiding slope 55431 to drive the second elastic buckle 5543 to the uncoupling position.
  • 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 be loose from the base connecting portion 554 , and will not be detached from the base connecting portion 554 .
  • the first action 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 (that is, 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 separate sensor electrode fixing structure disclosed in the embodiment of the present application can deal with the situation that the sensor electrode 210 of the pre-connected structure and obliquely implanted in the related art is detached from the puncture needle 553 during transportation or moving.
  • the fixing part 223 of the present application can release the support to the sensor electrode 210 by being destroyed after the implantation of the sensor electrode 210 is completed, so as to ensure that the sensor electrode 210 can be fixed on the sensor base 220 .
  • a separate fixing structure of sensor electrodes disclosed in the embodiment of the present application 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

L'invention concerne également une structure de fixation séparée pour une électrode de capteur, comprenant au moins une partie de fixation (223). La partie de fixation (223) est disposée dans un ensemble capteur, et est configurée pour : supporter une électrode de capteur (210) dans un premier état, et libérer le support pour l'électrode de capteur (210) dans un second état.
PCT/CN2021/128852 2021-06-28 2021-11-05 Structure de fixation séparée pour électrode de capteur WO2023273083A1 (fr)

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CN202110718599.2A CN113499067B (zh) 2021-06-28 2021-06-28 分离式传感器电极固定结构

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CN113499067B (zh) * 2021-06-28 2024-03-01 苏州百孝医疗科技有限公司 分离式传感器电极固定结构
CN113499126B (zh) * 2021-06-28 2022-07-19 苏州百孝医疗科技有限公司 植入器及植入方法
CN114391836B (zh) * 2021-11-27 2024-04-12 苏州百孝医疗科技有限公司 经皮分析物传感器系统
CN114391839A (zh) * 2021-12-14 2022-04-26 苏州百孝医疗科技有限公司 体表附接单元及其装配方法
CN114403862A (zh) * 2021-12-20 2022-04-29 苏州百孝医疗科技有限公司 保险机构及其使用方法
CN117942144A (zh) * 2024-03-27 2024-04-30 北京智冉医疗科技有限公司 电极植入机构和具有其的电极植入设备

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