WO2024077771A1 - 一种生物传感器辅助植入装置 - Google Patents

一种生物传感器辅助植入装置 Download PDF

Info

Publication number
WO2024077771A1
WO2024077771A1 PCT/CN2022/141234 CN2022141234W WO2024077771A1 WO 2024077771 A1 WO2024077771 A1 WO 2024077771A1 CN 2022141234 W CN2022141234 W CN 2022141234W WO 2024077771 A1 WO2024077771 A1 WO 2024077771A1
Authority
WO
WIPO (PCT)
Prior art keywords
sliding member
sensor
needle seat
needle
ejection
Prior art date
Application number
PCT/CN2022/141234
Other languages
English (en)
French (fr)
Inventor
张绍达
郑伟
郑星语
Original Assignee
深圳可孚生物科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳可孚生物科技有限公司 filed Critical 深圳可孚生物科技有限公司
Publication of WO2024077771A1 publication Critical patent/WO2024077771A1/zh

Links

Images

Classifications

    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
    • Y02E60/10—Energy storage using batteries

Definitions

  • the present invention relates to the field of biosensor equipment, and in particular to a biosensor auxiliary implantation device.
  • Diabetes is a syndrome of carbohydrate, fat and protein metabolism disorders caused by relative or absolute insulin deficiency and varying degrees of insulin resistance. Sustained high blood sugar is its biochemical characteristic. With the aging of the population, eating disorders, reduced exercise and the continuous increase in the number of obese people, the incidence of diabetes will continue to increase.
  • a method that can provide continuous blood glucose monitoring is needed so that patients can know their blood glucose status at any time and take timely measures to most effectively control the disease, prevent complications, and achieve a higher quality of life.
  • the method of measuring tissue fluid is a continuous monitoring method that can be used in reality. Implanting sensors into blood vessels as devices that patients carry daily does not introduce high risks such as infection or blood loss, and can effectively provide necessary data, so it has become an important direction for the development of clinical monitoring.
  • the Chinese invention patent with authorization announcement number CN103750818B discloses a subcutaneous implantable biosensor, which is implanted into the subcutaneous tissue for detection.
  • Existing implantable biosensors are very small, and when implanted into the skin, they are wrapped with a hard needle tube and sent into the subcutaneous tissue together, and then the hard needle tube is withdrawn, leaving the implantable biosensor in the subcutaneous tissue.
  • the implanter used has a slow implantation speed and is not accurate enough in the implantation position. During implantation, it takes a long time to insert and withdraw the implant, which makes the user feel a tingling sensation and increases the user's pain. In addition, the slow implantation speed can also cause damage to the subcutaneous tissue, which has an adverse effect on the detection effect of the implantable biosensor.
  • the present invention provides a biosensor auxiliary implantation device.
  • a biosensor-assisted implantation device comprising:
  • the launch tube assembly is used to drive the sliding member to launch the sensor toward the human body through elastic force, and to push the sliding member back through elastic force to quickly separate it from the sensor;
  • a battery assembly used to fix the sensor and provide power to the entire device
  • the transmitter component is assembled with the battery component and electrically connected to the sensor, and transmits the monitoring signal of the sensor to the wireless terminal device.
  • the launch tube assembly includes an ejection tube, a launch spring, a needle seat, a needle withdrawal spring and a sliding member
  • the needle seat and the sliding member are both located inside the ejection tube and slide up and down along the ejection tube, the sliding member is clamped with the needle seat and can rotate relative to the needle seat, the sliding member is also clamped with the sensor, and the vertically extending end of the sensor is sleeved in the guide needle at the bottom of the needle seat;
  • the launching spring is located between the ejection tube and the needle seat, and the upper end of the launching spring abuts against the top of the ejection tube, and the lower end of the launching spring abuts against the sliding member, and the launching spring is used to drive the needle seat and the sliding member to eject along the ejection tube;
  • the needle withdrawal spring is located inside the needle seat, with its top abutting against the top end of the needle seat and its bottom abutting against the sliding member.
  • the needle withdrawal spring is used to drive the needle seat to rebound.
  • the ejection tube includes an ejection tube body and an ejection fastener located on the ejection tube body, and when the sliding member is in a non-ejecting state, the ejection fastener is connected to the sliding member.
  • the ejection fastener includes a pressing portion and a hooking portion located at opposite ends, the pressing portion is suspended relative to the ejection tube body, and the hooking portion is engaged with the sliding member.
  • a protruding sliding member outer clamping block is provided on the outer side of the sliding member, and the sliding member outer clamping block is engaged with the hooking portion, so that when the sliding member is not in the ejection state, the sliding member is engaged with the ejection fastener.
  • a limit ring is sleeved on the outer side of the ejection tube body, and the limit ring includes a limit ring body and a closing limit protrusion and an unlocking area located on the limit ring body, and the inner surface of the pressing part abuts against the closing limit protrusion, or the pressing part is suspended on the periphery of the unlocking area.
  • a protruding ejection tube fixing convex strip is provided at the lower end of the ejection tube body, and the battery upper cover of the battery assembly is provided with an arc groove running through from top to bottom, and a protruding upper cover fixing convex strip is provided at the arc groove, and the upper cover fixing convex strip is clamped with the ejection tube fixing convex strip.
  • a guide column extending downward is provided on the top of the ejection tube body, and a guide slot hole penetrating up and down is provided on the top of the needle seat.
  • the guide column extends into the guide slot hole, so that the needle seat slides up and down along the guide column.
  • the needle seat includes a needle seat body for driving the sensor to be implanted and the needle to be withdrawn, and a guide needle located at the lower end of the needle seat for guiding the sensor, the lower end of the needle seat body is open, and the inner top of the needle seat body is provided with a middle column extending downward, the bottom of the middle column is provided with a needle seat inner protrusion, and the interior of the sliding member is provided with a sliding member inner block corresponding to the needle seat inner protrusion, when the needle seat and the sliding member are in the ejection state, the sliding member inner block is interlocked with the needle seat inner protrusion, and when the needle seat is in the rebound state, the sliding member inner block and the needle seat inner protrusion are misaligned and separated.
  • the bottom of the sliding member is provided with an assembly groove for the sensor to pass through, and the side wall of the assembly groove is provided with a protruding assembly clip for the sensor to be clipped.
  • the beneficial effect of the present invention according to the above scheme is that the present invention can realize the rapid implantation of the sensor and automatic needle withdrawal through the application of multiple snap structures and launching springs and needle withdrawal springs, avoiding the risk of needle withdrawal failure due to misoperation.
  • the miniaturized design realizes the convenience of one-handed operation, and the internal spring and snap of the implanter can be unlocked and released automatically during the puncture and retrieval of the guide needle, without the user applying external force, making it more convenient to use.
  • FIG1 is a schematic diagram of the connection between the launch tube assembly and the battery assembly in the present invention.
  • FIG2 is a structural exploded view of a launch tube assembly and a battery assembly in the present invention.
  • FIG3 is a schematic diagram of the launch tube assembly before launching the sensor in the present invention.
  • FIG4 is a schematic diagram of the launch tube assembly after launching the sensor in the present invention.
  • FIG5 is a schematic diagram of another viewing angle of the launch tube assembly after the sensor is launched in the present invention.
  • FIG6 is a cross-sectional view of the launch tube assembly of the present invention.
  • FIG7 is a cross-sectional view of the launch tube assembly of the present invention from another perspective
  • FIG8 is an exploded view of the launch tube assembly of the present invention.
  • FIG9 is a schematic structural diagram of a projectile-shooting tube in the present invention.
  • FIG10 is a schematic diagram of the ejection tube of the present invention from another perspective
  • FIG11 is a schematic diagram of the structure of the needle holder in the present invention.
  • FIG12 is a schematic diagram of the needle holder of the present invention from another viewing angle
  • FIG13 is a schematic diagram of the structure of a sliding member in the present invention.
  • FIG14 is a schematic diagram of a sliding member in the present invention from another viewing angle
  • FIG15 is a schematic diagram of the structure of the sensor and the probe base in the present invention.
  • FIG16 is a schematic diagram of the structure of the limit ring in the present invention.
  • FIG17 is a schematic diagram of the connection between the battery assembly and the transmitter assembly in the present invention.
  • FIG18 is a schematic diagram showing the connection between the battery assembly and the transmitter assembly from another perspective in the present invention.
  • FIG19 is a disassembled diagram of a battery assembly and a transmitter assembly in the present invention.
  • FIG20 is an exploded view of a battery assembly according to the present invention.
  • FIG21 is a schematic diagram of another viewing angle of the battery assembly after being disassembled in the present invention.
  • FIG22 is a schematic diagram of the structure of the battery cover in the present invention.
  • FIG23 is an exploded view of a transmitter assembly according to the present invention.
  • FIG. 24 is a schematic diagram of another perspective of the transmitter assembly after being decomposed in the present invention.
  • 100 launching tube assembly; 110, ejection tube; 111, ejection tube body; 112, ejection fastener; 1121, pressing portion; 1122, hooking portion; 113, slideway; 114, guide slope; 115, needle withdrawal limit groove; 116, ejection tube clamping convex strip; 117, groove ring; 118, inner slide groove; 119, guide column; 120, launching spring; 130, needle seat; 131, needle seat body; 1311, guide slot hole; 1312, middle column; 1313, guide slide groove; 1314, inner protrusion of needle seat; 132, guide needle; 1321 , tip; 1322, guide groove; 140, needle spring; 150, sliding member; 151, sliding member body; 152, sliding member outer block; 153, sliding member inner block; 154, assembly groove; 155, assembly card strip; 160, sensor; 170, probe seat; 171, probe seat body; 172, first sensor perforation; 173, sensor clamping part; 174, assembly part; 1741, assembly card
  • 200 battery assembly; 210, battery upper cover; 211, upper cover hook edge; 212, upper cover receiving groove; 213, second sensor perforation; 214, first electrode sheet clamping point; 215, first electrode sheet perforation; 216, second electrode sheet perforation; 217, ejection tube clamping strip; 2171, clamping strip convex point; 218, upper cover clamping convex strip; 220, battery lower cover; 221, third sensor perforation; 222, first electrode sheet support platform; 223, second electrode sheet support platform; 224, second electrode sheet clamping point; 230, battery; 240, first electrode sheet; 250, second electrode sheet;
  • transmitter assembly 310, transmitter cover; 320, transmitter base; 321, base hook groove; 322, base receiving groove; 330, PCBA; 331, metal shrapnel; 332, shrapnel contact; 340, sealing ring.
  • the present invention can monitor the user's subcutaneous tissue fluid, such as blood sugar.
  • a biosensor auxiliary implant device including a launch tube assembly 100, a battery assembly 200 and a transmitter assembly 300.
  • the launch tube assembly 100 is used to drive the sliding member 150 to launch the sensor to the human body through elastic force, and pull back the sliding member 150 through elastic force to quickly separate it from the sensor;
  • the battery assembly 200 is used to fix the sensor and power the entire device;
  • the transmitter assembly 300 is assembled with the battery assembly 200 and electrically connected to the sensor, and sends the monitoring signal of the sensor to the wireless terminal device.
  • the transmitter tube assembly 100 is first assembled on the battery assembly 200, and then the battery assembly 200 is positioned at the human epidermis; after the sensor is implanted under the skin of the human body through the transmitter tube assembly 100, the transmitter tube assembly 100 and the battery assembly 200 are detached, and the transmitter assembly 300 is assembled on the battery assembly 200.
  • the transmitter assembly 300 sends the blood sugar data monitored by the sensor to a wireless terminal device (such as a mobile phone, etc., wirelessly connected to the transmitter assembly 300 via Bluetooth, WIFI, etc.) for monitoring.
  • a wireless terminal device such as a mobile phone, etc., wirelessly connected to the transmitter assembly 300 via Bluetooth, WIFI, etc.
  • the launch tube assembly 100 includes an ejection tube 110, a launch spring 120, a needle seat 130, a needle withdrawal spring 140, and a sliding member 150.
  • the ejection tube 110 is used to provide a basis for the sensor 160 to assist in the implantation process and the needle withdrawal process;
  • the launch spring 120 is used to provide the sensor 160 with power to assist in the implantation process and to achieve rapid implantation;
  • the needle seat 130 is used to position the sensor 160 and drive the sensor 160 to achieve implantation;
  • the needle withdrawal spring 140 is used to provide power for the needle seat 130 to withdraw the needle, and the sliding member 150 is used to drive the needle seat 130 and the sensor 160 to be implanted under the action of the launch spring 120, and provide support for the needle seat 130 to withdraw the needle.
  • the ejection tube 110 includes an ejection tube body 111 and an ejection fastener 112 located on the ejection tube body 111.
  • the ejection fastener 112 is connected to the sliding member 150.
  • the ejection fastener 112 includes a pressing portion 1121 and a hooking portion 1122 located at opposite ends.
  • the pressing portion 1121 is suspended relative to the ejection tube body 111, and the hooking portion is connected to the sliding member 150. After the pressing portion 1121 is pressed, the hooking portion is separated from the connected position of the sliding member 150.
  • the outer side of the ejection tube body 111 is covered with a limiting ring 180, which includes a limiting ring body 181 and a closing limiting protrusion 182, an opening limiting protrusion 183, and an unlocking area 184 located on the limiting ring body 181.
  • the unlocking area 184 is located between the opening limiting protrusion 183 and the closing limiting protrusion 182.
  • the closing limiting protrusion 182 and the opening limiting protrusion 183 are both protruding from the surface of the limiting ring body 181, so that the unlocking area 184 is concave relative to the closing limiting protrusion 182 and the opening limiting protrusion 183.
  • the ejection fastener 112 When the ejection fastener 112 is in a locked state, the inner surface of the pressing portion 1121 abuts against the closing limiting protrusion 182. When the ejection fastener 112 is in an unlocked state, the pressing portion 1121 is suspended on the periphery of the unlocking area 184.
  • the present invention can achieve locking and unlocking of the ejection fastener 112 through the limiting ring 180, ensuring that no accidental triggering occurs during transportation, and can also prevent misoperation during use to avoid secondary injuries.
  • a protruding groove ring 117 is provided on the periphery of the ejection tube body 111 in the present invention, and a concave ring corresponding to the groove ring 117 is provided on the inner side of the limiting ring body 181.
  • the limiting ring body 181 is clamped to the periphery of the ejection tube body 111 through the cooperation of the concave ring and the groove ring 117.
  • a track for guiding the movement of the sliding member 150 is provided on the ejection tube body 111, and the sliding member 150 is provided with a corresponding sliding clamp.
  • the sliding clamp is a protruding sliding member outer clamp 152 provided on the outer side of the sliding member 150
  • the track includes a slideway 113 extending up and down along the ejection tube body 111, and a needle extraction limiting groove 115 located at the lower end of the slideway 113 and extending laterally, and the needle extraction limiting groove 115 is connected to the slideway 113 through an inclined guide slope 114.
  • the sliding member's outer clamping block 152 When the sliding member 150 is in the non-ejection state, the sliding member's outer clamping block 152 is engaged with the hooking portion 1122, so that the sliding member 150 is engaged with the ejection fastener 112; when the sliding member 150 is ejected, the sliding member's outer clamping block 152 slides downward along the slideway 113, and when it slides down to the bottom, it is engaged with the needle withdrawal limit groove 115, so that when the needle seat 130 withdraws the needle and rebounds, the sliding member 150 will not rebound together.
  • an inner slide groove 118 is also provided on the inner side surface of the ejection tube body 111, and the inner slide groove 118 is aligned with the extension direction of the slide 113, so that the outer block 152 of the sliding member slides into the slide 113 through the inner slide groove 118.
  • a guide column 119 extending downward is provided at the top of the ejection tube body 111 for guiding the implantation ejection and needle withdrawal rebound of the needle seat 130 to prevent the needle seat 130 from tilting during the ejection and rebound process and affecting the implantation quality of the sensor 160 and the safety of the human body.
  • the lower end of the ejection tube body 111 is provided with a protruding ejection tube fixing convex strip 116 , and the ejection tube body 111 is connected to the battery assembly 200 through the ejection tube fixing convex strip 116 and is separated after the sensor 160 is implanted.
  • the launching spring 120 is located between the ejection tube 110 and the needle seat 130 , with its upper end abutting against the top of the ejection tube 110 and its lower end abutting against the sliding member 150 .
  • the launching spring 120 is used to drive the needle seat 130 and the sliding member 150 to eject along the ejection tube 110 .
  • the launch spring 120 is in a compressed state, so that the elastic potential energy of the launch spring 120 is converted into the kinetic energy of the sliding member 150 and the needle seat 130, and then the sensor 160 can be quickly implanted under the human body. Since the elastic distribution of the launch spring 120 is more uniform, the sliding member 150 and the needle seat 130 can be more stable during the ejection process.
  • the needle seat 130 is located inside the ejection tube 110 and slides up and down along the ejection tube 110. It includes a needle seat body 131 for driving the sensor 160 to be implanted and realize the needle withdrawal, and a guide needle 132 located at the lower end of the needle seat 130 for realizing the guidance of the sensor 160.
  • the lower end of the needle seat body 131 is open, and the inner top of the needle seat body 131 is provided with a middle column 1312 extending downward, and the guide needle 132 is located at the bottom end of the middle column 1312.
  • the main part of the guide needle 132 is provided with a guide groove 1322, so that the cross section of the entire guide needle 132 is U-shaped, and the vertical extension end of the sensor 160 is sleeved in the guide groove 1322, so that the sensor 160 can be implanted under the human body with the guide groove 1322;
  • the lower end of the guide needle 132 is provided with a tip 1321, and the tip 1321 is formed by the bottom wall of the guide groove 1322 extending forward, and the tip 1321 can pierce the human epidermis, which is convenient for rapid implantation.
  • a guide slot 1311 is provided on the top of the needle seat 130 and extends upward and downward, and the guide post 119 extends into the guide slot 1311, so that the needle seat 130 slides up and down along the guide post 119.
  • a vertically extending guide slot 1313 is provided inside the needle seat 130, and the guide slot 1313 is opposite to the guide slot 1311, so that the guide post 119 slides up and down along the guide slot 1313, so that during the sliding process of the needle seat 130, the guide post 119 is always in a state of being in contact with the guide slot 1313, and the insertion position of the guide post 119 and the guide slot 1311 can ensure that the needle seat 130 slides in the same orientation, further increasing the stability of the sliding of the needle seat 130.
  • a needle seat inner protrusion 1314 is provided at the bottom of the middle column 1312 in the present invention.
  • the function of the needle seat inner protrusion 1314 is as follows: during the assembly and ejection process of the needle seat 130 and the sliding member 150, the needle seat inner protrusion 1314 is engaged with the sliding member 150, so that the needle seat 130 and the sliding member 150 are engaged, and during the rebound process of the needle seat 130, the needle seat inner protrusion 1314 is separated from the sliding member 150.
  • the needle withdrawal spring 140 is located inside the needle seat 130, with its top abutting against the top of the needle seat 130 and its bottom abutting against the sliding member 150.
  • the needle withdrawal spring 140 is in a compressed state and is used to drive the needle seat 130 and the sensor 160 to rebound.
  • the bottom position of the needle withdrawal spring 140 remains unchanged, and its top end provides a rebound force for the inner top end of the needle seat 130. After the needle seat 130 is separated from the sliding member 150, it rebounds under the action of the needle withdrawal spring 140.
  • the sliding member 150 is located inside the ejection tube 110 and slides up and down along the ejection tube 110.
  • the sliding member 150 is engaged with the needle seat 130 and can rotate relative to the needle seat 130, thereby realizing the linkage and rebound of the sliding member 150 and the needle seat 130.
  • the sliding member 150 in the present invention includes a sliding member body 151, and the sliding member body 151 includes a hollow cylindrical outer wall and an inner wall. The cavity between the outer wall and the inner wall is used to match the bottom of the needle seat 130, and the sliding member outer block 152 is located outside the outer wall of the sliding member body 151.
  • a corresponding inner blocking block 153 of the sliding member is provided inside the sliding member 150.
  • the inner blocking block 153 of the sliding member is interlocked with the inner protrusion 1314 of the needle seat 130.
  • the inner blocking block 153 of the sliding member and the inner protrusion 1314 of the needle seat are misaligned and separated.
  • the sliding member 150 slides into the slideway 113 under the interaction of the sliding member outer block 152 and the inner slide groove 118 of the ejection tube body 111.
  • the sliding member inner block 153 is relative to and engaged with the needle seat inner protrusion 1314; because the needle seat 130 does not rotate circumferentially, the sliding member 150 will produce circumferential rotation under the action of the guide ramp 114 after ejection and slide into the needle withdrawal limit groove 115. At this time, the sliding member inner block 153 and the needle seat inner protrusion 1314 are misaligned with each other and separated.
  • the sliding member 150 is also engaged with the sensor 160, so that the sliding member 150 drives the sensor 160 to be implanted, thereby providing power for the implantation process of the sensor 160.
  • the bottom of the sliding member 150 of the present invention is also provided with an assembly groove 154 for the sensor 160 to pass through, and the side wall of the assembly groove 154 is provided with a protruding assembly clamping strip 155 for the sensor 160 to be engaged.
  • the probe seat 170 includes a probe seat body 171, a first sensor through-hole 172 that passes through the probe seat body 171 from top to bottom and for the sensor 160 to pass through, and the vertical extension end of the sensor 160 passes through the first sensor through-hole 172.
  • a plurality of sensor fixing parts 173 are also provided above the probe seat body 171, and the top of the sensor 160 is limited within the range of the sensor fixing part 173, so that the probe seat 170 can serve as a stable limiting basis for the sensor 160 to prevent the sensor 160 from shaking and affecting the implantation effect.
  • a protruding assembly portion 174 is provided at the upper end of the probe seat body 171, and an assembly card point 1741 is provided on the assembly portion 174.
  • the probe seat 170 is clamped with the assembly card strip 155 through the assembly card point 1741.
  • the assembly card point 1741 and the assembly card strip 155 are misaligned and separated.
  • the battery assembly 200 provides a positioning basis for the sensor 160 and the probe seat 170, and provides electrical energy for the entire biosensor auxiliary implantation device.
  • the battery assembly 200 includes a battery upper cover 210, a battery lower cover 220, a battery 230, a first electrode sheet 240, and a second electrode sheet 250.
  • One end of the first electrode sheet 240 contacts the battery 230, and the other end thereof passes through the battery upper cover 210 to be electrically connected to the transmitter assembly 300.
  • One end of the second electrode sheet 250 contacts the battery 230, and the other end thereof passes through the battery upper cover 210 to be electrically connected to the transmitter assembly 300.
  • the first electrode sheet 240 is a positive electrode sheet
  • the second electrode sheet 250 is a negative electrode sheet.
  • a first electrode sheet slot for positioning the first electrode sheet 240 is provided on the inner top of the battery upper cover 210, and a first electrode sheet clamping point 214 for fastening the first electrode sheet 240 is provided in the first electrode sheet slot, and a second electrode sheet clamping point 224 for fastening the second electrode sheet 250 is provided on the inner bottom side of the battery lower cover 220.
  • the battery upper cover 210 is provided with a first electrode sheet through-hole 215 for accommodating the first electrode sheet 240 to pass through, and a second electrode sheet through-hole 216 for accommodating the second electrode sheet 250 to pass through.
  • the battery lower cover 220 is provided with a first electrode sheet support platform 222 for supporting the first electrode sheet 240, and a second electrode sheet support platform 223 for supporting the second electrode sheet 250.
  • the first electrode sheet support platform 222 corresponds to the position of the first electrode sheet through-hole 215, and the second electrode sheet support platform 223 corresponds to the position of the second electrode sheet through-hole 216.
  • the end of the first electrode sheet 240 is supported on the first electrode sheet support platform 222 and exposed by the first electrode sheet through-hole 215, and the end of the second electrode sheet 250 is supported on the second electrode sheet support platform 223 and exposed by the second electrode sheet through-hole 216.
  • the battery assembly 200 can also realize the positioning of the sensor 160 and the probe seat 170.
  • the upper surface of the battery upper cover 210 is provided with an upper cover receiving groove 212 which is concave downwards, and the upper cover receiving groove 212 is used to receive and fix the probe seat 170; and the battery upper cover 210 is provided with a second sensor through hole 213 which penetrates from top to bottom, and the battery lower cover 220 is provided with a third sensor through hole 221 which penetrates from top to bottom, and the vertically extending end of the sensor 160 penetrates the second sensor through hole 213 and the third sensor through hole 221 and is then implanted into the human skin.
  • the battery assembly 200 provides a positioning function, so the battery assembly 200 also needs to be snapped with the launch tube assembly 100.
  • the battery upper cover 210 of the battery assembly 200 is provided with an arc groove running through from top to bottom, and a protruding upper cover snapping convex strip 218 is provided at the arc groove, so that when the battery assembly 200 and the ejection tube 110 are assembled, the ejection tube snapping convex strip 116 passes through the arc groove and snaps with the upper cover snapping convex strip 218; after the sensor 160 is implanted, the ejection tube 110 is twisted to disengage the ejection tube snapping convex strip 116 from the upper cover snapping convex strip 218.
  • an elastic ejection tube clamping strip 217 is provided on the inner side of the arc groove, and a protruding clamping strip convex point 2171 is provided on the outer end of the ejection tube clamping strip 217, and the clamping strip convex point 2171 limits the ejection tube snapping convex strip 116, so that the ejection tube 110 and the battery upper cover 210 are more tightly limited to avoid disengagement.
  • the battery cover 210 is also provided with a cover hook edge 211 for snapping with the transmitter assembly 300.
  • the transmitter base 320 of the transmitter assembly 300 is provided with a base hook groove 321 corresponding to the position of the cover hook edge 211.
  • the cover hook edge 211 is connected to the base hook groove 321, so that the battery assembly 200 is snapped with the transmitter assembly 300.
  • the battery assembly 200 also includes a skin-friendly tape, one side of which is connected to the lower surface of the battery lower cover 220, and the other side is used to contact the human epidermis, so that the battery assembly 200 can be closely attached to the human body surface.
  • the transmitter assembly 300 includes a transmitter upper cover 310, a transmitter base 320, and a PCBA 330 located between the transmitter upper cover 310 and the transmitter base 320.
  • the PCBA 330 is provided with a spring contact 332 for contacting and connecting with a metal spring 331.
  • the metal spring 331 is injection-molded and connected with the transmitter base 320, and the electrode spring in the metal spring 331 is in contact with the first electrode sheet 240 and the second electrode sheet 250 in the battery assembly 200.
  • the PCBA 330 can communicate with the user's wireless terminal device (such as Bluetooth communication) to send the detection results of the sensor 160 to the wireless terminal device for data analysis and display. Since the functions of the PCBA 330 receiving data from the sensor 160 and sending data to the wireless terminal device are all known technologies in the art, the present invention does not make improvements, so the specific implementation circuit of the PCBA 330 will not be described in detail.
  • the lower side of the transmitter base 320 is provided with an upwardly recessed base receiving groove 322, and the base receiving groove 322 is used to accommodate and fix the probe seat 170, so that the probe seat 170 is positioned in the space enclosed by the upper cover receiving groove 212 and the base receiving groove 322.
  • a sealing ring 340 is provided on the lower side of the transmitter base 320, and the transmitter base 320 is sealed and connected to the battery assembly 200 through the sealing ring 340.
  • a concave sealing groove is provided at the bottom of the transmitter base 320, and the sealing ring 340 is embedded in the sealing groove;
  • a protruding convex ring is provided on the upper surface of the battery upper cover 210, and the convex ring extends into the sealing groove and abuts against the sealing ring 340, thereby achieving a good sealing effect and avoiding affecting the detection sensitivity of the sensor 160 during long-term monitoring.
  • the assembly process of the present invention is:
  • the guide needle 132 is passed through the first sensor through hole 172 so that the vertically extending end of the sensor 160 is placed in the guide groove 1322 , and then the assembly clamping point 1741 of the probe base 170 is clamped with the assembly clamping strip 155 of the sliding member 150 .
  • the battery assembly 200 is placed on the lower side of the launch tube assembly 100 so that the guide needle 132 together with the vertically extending end of the sensor 160 passes through the second sensor through-hole 213;
  • the present invention also provides a method for implementing the biosensor-assisted implantation device, which specifically includes:
  • each component is in the sterile package. Open the sterile package, tear off the protective layer of the skin-friendly tape, align the battery assembly 200 with the part of the human body where the sensor 160 needs to be implanted; rotate the limit ring 180 so that the pressing part 1121 of the ejection fastener 112 is adjusted to the unlocking area 184.
  • the needle seat 130 rebounds quickly under the elastic thrust of the needle withdrawal spring 140, and the sliding member 150 does not rebound under the elastic force of the launching spring 120 and the limiting action of the needle withdrawal limiting groove 115.
  • the implantation process lasts for a very short time, and can achieve rapid implantation and needle withdrawal, which can effectively reduce the user's pain; and through the positioning function of the ejection tube 110 and the battery assembly 200, the implantation position is accurate and will not deviate, and it is not easy to cause secondary damage to the human body.
  • S4. Connect PCBA330 via a wireless terminal device (such as connecting PCBA330 via Bluetooth) and activate the transmitter to start working.
  • the data collected by the sensor 160 and PCBA330 are sent to the wireless terminal device.
  • the present invention adopts an internal spring and a buckle to unlock and release automatically, thereby achieving rapid implantation and automatic needle withdrawal.
  • the user does not feel obvious tingling, and the present invention does not require the user to apply external force. Children and the elderly can also use it by themselves under the guidance of a guardian. The whole process is fast and accurate, and is not prone to deviation, and will not cause secondary damage to the user.
  • the present invention adds a safety device and a fixed buckle to ensure that accidental triggering will not occur during transportation or in the hands of consumers.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种生物传感器辅助植入装置，包括发射筒组件（100）、电池组件（200）以及发射器组件（300），发射筒组件（100）用于通过弹力驱动滑动件（150）向人体发射传感器（160），并通过弹力拨回针座（130），使其与传感器（160）快速分离，电池组件（200）用于固定传感器（160）并为整个装置供电，发射器组件（300）与电池组件（200）装配并与传感器（160）电连接，并将传感器（160）的监测信号发送至无线终端设备。生物传感器辅助植入装置可以实现传感器（160）的快速植入与自动抽针，不需使用者施加外力，使用更加方便，避免误操作导致抽针失败的风险，微型化设计实现单手操作的便捷性。

Description

一种生物传感器辅助植入装置 技术领域
本发明涉及生物传感器设备领域，具体的，是涉及一种生物传感器辅助植入装置。
背景技术
糖尿病是由于胰岛素相对或绝对缺乏以及不同程度的胰岛素抵抗，引起碳水化合物、脂肪及蛋白质代谢紊乱的综合症，持续高血糖是其生化特征。随着人口老龄化、饮食失调、运动减少和肥胖人数的持续增多，糖尿病的发病率将越来越高。
因此，需要一个能够提供连续血糖监测的方法，使患者随时知道自己血糖状况，及时采取措施，才能够最有效地控制病情，防止并发症，得到较高的生活质量。为了获得实时数据，测量组织液的方法是现实中可用的连续监测手段，将传感器植入血管内，作为日常患者携带的器械，不会引入感染或失血等高风险，又能够有效提供必需的数据，所以已经成为临床监测发展的重要方向。
授权公告号CN103750818B的中国发明专利就公开了一种皮下植入式生物传感器，在检测的时候将传感器植入皮下组织内，进行检测。现有的植入式生物传感器十分细小，在植入皮肤内部的时候都是通过硬质的针管将植入式生物传感器包裹住，一起送入皮下组织内，然后硬质的针管再退出来，将植入式生物传感器留在皮下组织内。
现有产品在植入硬质的针管和植入式生物传感器的时候，使用的植入器其植入速度慢、植入的位置不够准确，植入时其花费在植入和退出的时间比较久，使得使用者有刺痛感，增加了使用者的痛苦，而且比较慢的植入速度还会造成皮下组织的损伤，对植入式生物传感器检测的效果造成不利影响。
发明内容
为了克服当前的辅助植入器存在使用上的风险，如因误操作导致弹射机构过早弹出，硬针容易扎伤使用者，且硬针在体内停留过久，使用者有明显刺痛感，增加使用者的痛感和异物感，易造成误伤等不足，本发明提供一种生物传感器辅助植入装置。
本发明技术方案如下所述：
一种生物传感器辅助植入装置，其特征在于，包括：
发射筒组件，用于通过弹力驱动滑动件向人体发射传感器，并通过弹力拨回滑动件，使其与传感器快速分离；
电池组件，用于固定所述传感器并为整个装置供电；
发射器组件，与电池组件装配并与所述传感器电连接，并将所述传感器的监测信号发送至无线终端设备。
根据上述方案的本发明，其特征在于，所述发射筒组件包括弹射筒、发射弹簧、针座、抽针弹簧以及滑动件，所述针座、所述滑动件均位于所述弹射筒内部并沿着所述弹射筒上下滑动，所述滑动件与所述针座卡接并可与所述针座相对旋转，所述滑动件还与传感器卡接，且所述传感器竖向延伸端套在所述针座底部的导引针内；
所述发射弹簧位于所述弹射筒与所述针座之间，且所述发射弹簧的上端与所述弹射筒的顶部抵接，其下端与所述滑动件抵接，所述发射弹簧用于带动所述针座、所述滑动件沿着所述弹射筒弹射；
所述抽针弹簧位于所述针座内部，其顶部与所述针座的顶端抵接，其底部与所述滑动件抵接，所述抽针弹簧用于带动所述针座回弹。
进一步的，弹射筒包括弹射筒主体、位于所述弹射筒主体上的弹射扣件，所述滑动件未弹射状态时，所述弹射扣件与所述滑动件卡连。
更进一步的，弹射扣件包括位于相对两端的按压部、勾合部，所述按压部相对于所述弹射筒主体悬空，所述勾合部与所述滑动件卡接。
更进一步的，滑动件的外侧设有凸出的滑动件外卡块，所述滑动件外卡块与所述勾合部卡接，使得所述滑动件未弹射状态时，所述滑动件与所述弹射扣件卡连。
更进一步的，弹射筒主体的外侧套有限位圈，所述限位圈包括限位圈主体及位于所述限位圈主体上的关限位凸起和解锁区，所述按压部的内表面与所述关限位凸起抵接，或按压部悬空于所述解锁区的外围。
进一步的，弹射筒主体的下端设有凸出的弹射筒卡固凸条，所述电池组件的电池上盖设有上下贯穿的弧形槽，且弧形槽处设有凸出的上盖卡固凸条，所述上盖卡固凸条与所述弹射筒卡固凸条卡接。
进一步的，弹射筒主体顶部设有向下延伸的导向柱，所述针座顶部设有上下贯穿的导向槽孔，所述导向柱伸入所述导向槽孔内，使得所述针座沿所述导向柱上下滑动。
进一步的，针座包括用于带动传感器植入并抽针的针座主体、位于所述针座下端用于引导传感器的导引针，所述针座主体的下端开口，且所述针座主体的内部顶端设有向下延伸的中柱，所述中柱的底部设有针座内凸起，所述滑动件的内部设有与所述针座内凸起相对应的滑动件内卡块，所述针座与所述滑动件弹射状态时，所述滑动件内卡块与所述针座内凸起相扣，所述针座回弹状态时，所述滑动件内卡块与所述针座内凸起错位并分离。
进一步的，滑动件的底部设有供传感器穿过的装配槽，所述装配槽的侧壁设有凸出的、供所述传感器卡接的装配卡条。
根据上述方案的本发明，其有益效果在于，本发明通过多个卡扣结构与发射弹簧、抽针弹簧的应用，可以实现传感器的快速植入与自动抽针，避免误操作导致抽针失败的风险，同时微型化设计，实现单手操作的便捷性，并且在穿刺及回收导引针的过程实现植入器内部弹簧和卡扣自行解锁释放，不需使用者施加外力，使用更加方便。
附图说明
图1为本发明中发射筒组件与电池组件连接的示意图；
图2为本发明中发射筒组件与电池组件的结构拆分图；
图3为本发明中发射筒组件发射传感器之前的示意图；
图4为本发明中发射筒组件发射传感器之后的示意图；
图5为本发明中发射筒组件发射传感器之后另一视角的示意图；
图6为本发明中发射筒组件的剖面图；
图7为本发明中发射筒组件另一视角的剖面图；
图8为本发明中发射筒组件的分解图；
图9为本发明中弹射筒的结构示意图；
图10为本发明中弹射筒另一视角的示意图；
图11为本发明中针座的结构示意图；
图12为本发明中针座另一视角的示意图；
图13为本发明中滑动件的结构示意图；
图14为本发明中滑动件另一视角的示意图；
图15为本发明中传感器与探头座的结构示意图；
图16为本发明中限位圈的结构示意图；
图17为本发明中电池组件与发射器组件连接的示意图；
图18为本发明中电池组件与发射器组件连接的另一视角示意图；
图19为本发明中电池组件与发射器组件的拆分图；
图20为本发明中电池组件的分解图；
图21为本发明中电池组件拆分后的另一视角示意图；
图22为本发明中电池上盖的结构示意图；
图23为本发明中发射器组件的分解图；
图24为本发明中发射器组件分解后的另一视角示意图。
在图中，各个附图标号为：
100、发射筒组件；110、弹射筒；111、弹射筒主体；112、弹射扣件；1121、按压部；1122、勾合部；113、滑道；114、导向斜坡；115、抽针限位槽；116、弹射筒卡固凸条；117、槽圈；118、内滑槽；119、导向柱；120、发射弹簧；130、针座；131、针座主体；1311、导向槽孔；1312、中柱；1313、导向滑槽；1314、针座内凸起；132、导引针；1321、尖端；1322、导引槽；140、抽针弹簧；150、滑动件；151、滑动件主体；152、滑动件外卡块；153、滑动件内卡块；154、装配槽；155、装配卡条；160、传感器；170、探头座；171、探头座主体；172、第一传感器穿孔；173、传感器卡固部；174、装配部；1741、装配卡点；180、限位圈；181、限位圈主体；182、关限位凸起；183、开限位凸起；184、解锁区；
200、电池组件；210、电池上盖；211、上盖勾边；212、上盖容纳槽；213、第二传感器穿孔；214、第一电极片卡点；215、第一电极片穿孔；216、第二电极片穿孔；217、弹射筒夹紧条；2171、夹紧条凸点；218、上盖卡固凸条；220、电池下盖；221、第三传感器穿孔；222、第一电极片支撑台；223、第二电极片支撑台；224、第二电极片卡点；230、电池；240、第一电极片；250、第二电极片；
300、发射器组件；310、发射器上盖；320、发射器底座；321、底座勾槽；322、底座容纳槽；330、PCBA；331、金属弹片；332、弹片触点；340、密封圈。
具体实施方式
下面结合附图以及实施方式对本发明进行进一步的描述：
如图1至图24所示，本发明的可以对使用者皮下组织液进行监测，例如血糖等。为了避免现有传感器的辅助植入装置使用上的风险，提出了一种生物传感器辅助植入装置，包括发射筒组件100、电池组件200以及发射器组件300。其中，发射筒组件100用于通过弹力驱动滑动件150向人体发射传感器，并通过弹力拨回滑动件150，使其与传感器快速分离；电池组件200用于固定传感器并为整个装置供电；发射器组件300与电池组件200装配并与传感器电连接，并将传感器的监测信号发送至无线终端设备。
在使用过程中，先将发射筒组件100装配于电池组件200上，再将电池组件200定位于人体表皮处；通过发射筒组件100将传感器植入人体皮下后拆离发射筒组件100和电池组件200，并将发射器组件300装配于电池组件200。在后续过程中，发射器组件300将传感器监测到的血糖数据发送至无线终端设备(如手机等，通过蓝牙、WIFI等与发射器组件 300无线连接)进行监控。
一、发射筒组件
如图1至图16所示，发射筒组件100包括弹射筒110、发射弹簧120、针座130、抽针弹簧140以及滑动件150。弹射筒110用于提供传感器160辅助植入过程、抽针过程的基础；发射弹簧120用于提供传感器160辅助植入过程的动力，并实现快速植入；针座130用于定位传感器160并带动传感器160实现植入；抽针弹簧140用于提供针座130抽针过程的动力，滑动件150用于在发射弹簧120的作用下带动针座130、传感器160植入，并为针座130抽针过程提供支撑力。
1、弹射筒
弹射筒110包括弹射筒主体111、位于弹射筒主体111上的弹射扣件112，滑动件150未弹射状态时，弹射扣件112与滑动件150卡连。具体的，弹射扣件112包括位于相对两端的按压部1121、勾合部1122，需要进行辅助植入时，按压部1121相对于弹射筒主体111悬空，勾合部与滑动件150卡接，按下按压部1121后，勾合部与滑动件150卡接位置分离。
弹射筒主体111的外侧套有限位圈180，限位圈180包括限位圈主体181及位于限位圈主体181上的关限位凸起182、开限位凸起183、解锁区184，解锁区184位于开限位凸起183与关限位凸起182之间，关限位凸起182、开限位凸起183均凸出于限位圈主体181的表面，使得解锁区184相对于关限位凸起182、开限位凸起183内凹。当弹射扣件112处于锁定状态时，按压部1121的内表面与关限位凸起182抵接。当弹射扣件112处于解锁状态时，按压部1121悬空于解锁区184的外围。本发明通过限位圈180可以实现弹射扣件112的锁定与解锁，确保运输途中不会发生误触发的情况，同时可以放置使用过程中的误操作，避免产生二次伤害。
优选的，为了实现弹射扣件112的限位，本发明中的弹射筒主体111的外围设有凸出的槽圈117，限位圈主体181的内侧设有与槽圈117对应的凹圈，限位圈主体181通过凹圈与槽圈117的配合卡接于弹射筒主体111的外围。
为了实现滑动件150、针座130等结构的弹射及抽针，弹射筒主体111上设有引导滑动件150运动的轨道，滑动件150设有相应的滑动卡件。具体的，滑动卡件为设于滑动件150外侧的凸出的滑动件外卡块152，轨道包括于沿着弹射筒主体111上下延伸的滑道113、位于滑道113下端并横向延伸的抽针限位槽115，抽针限位槽115与滑道113之间通过倾斜的导向斜坡114连接。当滑动件150未弹射状态时，滑动件外卡块152与勾合部1122卡接，使得滑动件150与弹射扣件112卡连；当滑动件150弹射时，滑动件外卡块152沿着滑 道113向下滑动，下滑到底端时与抽针限位槽115卡接，使得针座130抽针回弹时滑动件150不会一并回弹。
优选的，为了使得滑动件150能顺利装配于弹射筒主体111内，弹射筒主体111的内侧面还设有内滑槽118，内滑槽118与滑道113的延伸方向对齐，使得滑动件外卡块152有内滑槽118滑入滑道113内。
弹射筒主体111的顶部设有向下延伸的导向柱119，用于对针座130的植入弹射、抽针回弹进行导向，避免针座130在弹射和回弹的过程中发生歪斜而影响传感器160的植入质量，并影响人体安全性。
弹射筒主体111的下端设有凸出的弹射筒卡固凸条116，弹射筒主体111通过弹射筒卡固凸条116与电池组件200卡接并在传感器160植入完成后实现分离。
2、发射弹簧
发射弹簧120位于弹射筒110与针座130之间，其上端与弹射筒110的顶部抵接，其下端与滑动件150抵接，发射弹簧120用于带动针座130、滑动件150沿弹射筒110弹射。
在实现过程中，发射弹簧120处于压缩状态，使得发射弹簧120的弹性势能转化为滑动件150、针座130的动能，进而可以将传感器160快速的植入人体皮下。又由于发射弹簧120的弹性分布更加均匀，可以使得滑动件150、针座130在弹射过程中更加平稳。
3、针座
针座130位于弹射筒110内部并沿着弹射筒110上下滑动，其包括用于带动传感器160植入并实现抽针的针座主体131、位于针座130下端用于实现传感器160引导的导引针132，针座主体131的下端开口，且针座主体131的内部顶端设有向下延伸的中柱1312，导引针132位于中柱1312的底端。该导引针132的主体部分设有导引槽1322，使得整个导引针132的截面呈U字形，传感器160竖向延伸端套在导引槽1322内，使得传感器160可以随着导引槽1322植入人体皮下；导引针132的下端设有尖端1321，并且尖端1321有导引槽1322的底壁向前延伸形成，该尖端1321可以刺破人体表皮，便于实现快速植入。
与弹射筒主体111内部的导向柱119相配合的，本发明中，针座130的顶部设有上下贯穿的导向槽孔1311，导向柱119伸入导向槽孔1311内，使得针座130沿着导向柱119上下滑动。优选的，针座130内部设有竖向延伸的导向滑槽1313，导向滑槽1313与导向槽孔1311相对，使得导向柱119沿着导向滑槽1313上下滑动，使得针座130滑动过程中，导向柱119一直处于与导向滑槽1313贴合的状态，配合导向柱119与导向槽孔1311的穿插位置，可以保证针座130处于相同的方位滑动，进一步增加针座130滑动的平稳性。
为了实现针座130与滑动件150的同步弹射，本发明中的中柱1312的底部设有针座内凸起1314，针座内凸起1314的作用为：针座130与滑动件150装配及弹射过程中，针座内凸起1314与滑动件150卡接，使得针座130与滑动件150卡接，而在针座130回弹过程中，针座内凸起1314与滑动件150分离。
4、抽针弹簧
抽针弹簧140位于针座130内部，其顶部与针座130的顶端抵接，其底部与滑动件150抵接，抽针弹簧140处于压缩状态，并用于带动针座130、传感器160回弹。
在实现过程中，由于滑动件150受到抽针限位槽115的限位作用，故抽针弹簧140的底部位置不变，其顶端为针座130的内侧顶端提供回弹力，针座130与滑动件150分离后，在抽针弹簧140的作用下实现回弹。
5、滑动件
滑动件150位于弹射筒110内部并沿着弹射筒110上下滑动，滑动件150与针座130卡接并可与针座130相对旋转，进而实现滑动件150与针座130的联动及回弹。本发明中的滑动件150包括滑动件主体151，滑动件主体151包括空心圆柱状的外侧壁和内侧壁，外侧壁和内侧壁之间的空腔用于与针座130的底部相匹配，滑动件外卡块152位于滑动件主体151的外侧壁的外侧。
与针座130中的针座内凸起1314相对应的，滑动件150的内部设有与之对应的滑动件内卡块153，针座130与滑动件150装配及弹射状态时，滑动件内卡块153与针座130内凸起1314相扣，针座回弹状态时，滑动件内卡块153与针座内凸起1314错位并分离。在具体实现过程中，在装配滑动件150与针座130的时候，滑动件150在滑动件外卡块152与弹射筒主体111的内滑槽118相互作用下滑入滑道113内，此时滑动件内卡块153与针座内凸起1314相对并卡接；由于针座130不会周向转动，使得滑动件150在弹射后会在导向斜坡114的作用下产生周向转动并滑入抽针限位槽115内，此时滑动件内卡块153与针座内凸起1314相互错位并实现分离。
另外，由于针座130仅能对传感器160的植入起到导引作用，因此滑动件150还与传感器160卡接，实现滑动件150带动传感器160的入射，进而为传感器160的植入过程提供动力。本发明的滑动件150的底部还设有供传感器160穿过的装配槽154，装配槽154的侧壁设有凸出的、供传感器160卡接的装配卡条155。
由于传感器160为软性材质，故传感器160通过探头座170与滑动件150卡接，并且植入完成之后，探头座170装配在电池组件200与发射器组件300内，可以通过探头座 170实现传感器160的定位作用。探头座170包括探头座主体171、上下贯穿探头座主体171并供传感器160穿过的第一传感器穿孔172，传感器160竖向延伸端穿过第一传感器穿孔172。优选的，探头座主体171的上方还设有多个传感器卡固部173，传感器160的顶部限位于传感器卡固部173的范围内，使得探头座170可以对传感器160起到稳定的限位基础，避免传感器160发生晃动，影响植入效果。
另外，探头座主体171的上端设有凸出的装配部174，装配部174上设有装配卡点1741，滑动件150与传感器160弹射状态时，探头座170通过装配卡点1741与装配卡条155卡接，探头座170回弹状态时，装配卡点1741与装配卡条155错位并分离。
二、电池组件
如图17至图22所示，电池组件200为传感器160、探头座170提供定位基础，并为整个生物传感器辅助植入装置提供电能。电池组件200包括电池上盖210、电池下盖220、电池230、第一电极片240以及第二电极片250，第一电极片240的一端与电池230接触，其另一端穿过电池上盖210与发射器组件300电连接，第二电极片250的一端与电池230接触，其另一端穿过电池上盖210与发射器组件300电连接。在本实施例中第一电极片240为正极电极片，第二电极片250为负极电极片。
为了方便第一电极片240、第二电极片250的装配，并且实现第一电极片240、第二电极片250的定位，电池上盖210的内侧顶部设有用于定位第一电极片240的第一电极片卡槽，第一电极片卡槽内设有用于紧固第一电极片240的第一电极片卡点214，电池下盖220的内部底侧设有用于定位第二电极片250的第二电极片卡槽，第二电极片卡槽内设有用于紧固第二电极片250的第二电极片卡点224。
另外，电池上盖210上设有用于容纳第一电极片240穿过的第一电极片穿孔215、用于容纳第二电极片250穿过的第二电极片穿孔216，电池下盖220上设有用于支撑第一电极片240的第一电极片支撑台222、用于支撑第二电极片250的第二电极片支撑台223，第一电极片支撑台222与第一电极片穿孔215位置对应，第二电极片支撑台223与第二电极片穿孔216位置对应。装配完成后，第一电极片240的端部支撑于第一电极片支撑台222上并由第一电极片穿孔215露出，第二电极片250的端部支撑于第二电极片支撑台223上并由第二电极片穿孔216露出。
该电池组件200还可以实现对传感器160、探头座170的定位。具体的：电池上盖210的上表面设有向下凹陷的上盖容纳槽212，上盖容纳槽212用于容纳固定探头座170；并且电池上盖210上设有上下贯穿的第二传感器穿孔213，电池下盖220上设有上下贯穿的 第三传感器穿孔221，传感器160竖向延伸端贯穿第二传感器穿孔213、第三传感器穿孔221后植入人体皮肤内。
传感器160植入的过程中，电池组件200提供定位作用，因此电池组件200还需与发射筒组件100卡接。电池组件200的电池上盖210设有上下贯穿的弧形槽，且弧形槽处设有凸出的上盖卡固凸条218，使得电池组件200与弹射筒110装配状态时，弹射筒卡固凸条116穿过弧形槽并与上盖卡固凸条218卡接；传感器160植入后拧动弹射筒110，使得弹射筒卡固凸条116与上盖卡固凸条218脱离。优选的，弧形槽的内侧设有弹性的弹射筒夹紧条217，弹射筒夹紧条217的外侧端部设有凸出的夹紧条凸点2171，夹紧条凸点2171对弹射筒卡固凸条116进行限位，使得弹射筒110与电池上盖210限位更加紧固，避免脱离。
电池上盖210上还设有用于与发射器组件300卡接的上盖勾边211，发射器组件300的发射器底座320上设有与上盖勾边211位置对应的底座勾槽321，上盖勾边211与底座勾槽321连接，使得电池组件200与发射器组件300卡接。
电池组件200还包括有亲肤胶带，亲肤胶带的一侧与电池下盖220的下表面连接，另一侧用于与人体表皮接触，实现电池组件200紧贴于人体表面的目的。
三、发射器组件：
如图17至图19、图23、图24所示，发射器组件300包括发射器上盖310、发射器底座320以及位于发射器上盖310与发射器底座320之间的PCBA330，PCBA330上设有用于与金属弹片331接触连接的弹片触点332，金属弹片331与发射器底座320注塑连接，且金属弹片331中的电极弹片与电池组件200内的第一电极片240、第二电极片250接触。另外PCBA330可以与用户的无线终端设备通信(如蓝牙通信)，用于将传感器160检测结果发送至无线终端设备进行数据分析与显示。由于PCBA330由传感器160处接收数据、向无线终端设备发送数据等功能均为本领域已知技术，本发明并未做出改进，故不再对PCBA330的具体实现电路进行详述。
与电池组件200中的上盖容纳槽212位置对应的，发射器底座320的下侧设有向上凹陷的底座容纳槽322，底座容纳槽322用于容纳固定探头座170，使得探头座170定位于上盖容纳槽212、底座容纳槽322围成的空间内。
优选的，发射器底座320的下侧设有密封圈340，发射器底座320通过密封圈340与电池组件200密封连接。具体的，发射器底座320的底部设有凹陷的密封槽，密封圈340内嵌于该密封槽内；电池上盖210的上表面设有凸出的凸圈，该凸圈伸入密封槽内与密封圈340抵接，实现了良好的密封效果，避免在长期监测过程中影响传感器160的检测灵敏度。
本发明的装配过程为：
1、电池组件200的装配
将亲肤胶带粘贴于电池下盖220的底部；将第二电极片250固定于的第二电极片卡槽内；安装纽扣电池，使电池负极与第二电极片250抵接；将第一电极片240固定于第一电极片卡槽内；盖上电池上盖210，使电池正极与第一电极片240抵接。
2、发射器组件300的装配
将密封圈340紧固于发射器底座320的密封槽内；将PCBA330放置于发射器底座320内，并将发射器上盖310置于发射器底座320上。
3、发射筒组件100的装配
将限位圈180由弹射筒主体111的顶部装配于槽圈117处，并调节其方向至关限位凸起182与按压部1121相扣；
将发射弹簧120放置于发射筒主体内，并将抽针弹簧140放置于针座主体131内，安装抽针弹簧140时避免抽针弹簧140与导引针132接触，避免导引针132损坏，影响装配及植入效果；
将滑动件150盖在针座130的底部，按压滑动件150使得滑动件内卡块153与针座内凸起1314相扣，进而抽针弹簧140被压缩；
将针座130连同滑动件150一并放置于弹射筒主体111及发射弹簧120的内部，按压滑动件150，使得滑动件外卡块152沿着内滑槽118滑入滑道113内，继续按压滑动件150并压缩发射弹簧120，直至滑动件外卡块152与弹射扣件112的勾合部1122卡接；
将传感器160装于探头座170上，使传感器160的竖向延伸端穿过第一传感器穿孔172；
将导引针132穿过第一传感器穿孔172，使得传感器160的竖向延伸端置于导引槽1322内，后将探头座170的装配卡点1741与滑动件150的装配卡条155卡接。
4、电池组件200与发射筒组件100的装配
将电池组件200置于发射筒组件100的下侧，使得导引针132连同传感器160的竖向延伸端穿过第二传感器穿孔213；
按压或旋转电池组件200，使得弹射筒卡固凸条116穿过弧形槽并与上盖卡固凸条218卡接，完成电池组件200与发射筒组件100的装配。
本发明还提供了该生物传感器辅助植入装置的实现方法，具体包括：
S1、解锁：初始状态时，各个组件位于无菌包装内。打开无菌包装，撕下亲肤胶带的保护层，将电池组件200对准需要植入传感器160的人体部位；转动限位圈180，使得弹射扣件 112的按压部1121位调节至解锁区184。
S2、植入
S21、按压弹射扣件112的按压部1121，使得弹射扣件112的勾合部1122与滑动件外卡块152解锁；
S22、滑动件150连同针座130、传感器160在发射弹簧120的弹性推力下快速下压，传感器160的竖向延伸端在导引针132的导向作用下穿刺进入皮下组织；
S23、当滑动件150下滑至最下端的时候，滑动件外卡块152沿着滑道113-导向斜坡114-抽针限位槽115的轨道运动，并于导向斜坡114和抽针限位槽115处发生旋转，同时滑动件内卡块153与针座内凸起1314分离、解锁，并且滑动件150的装配卡条155与探头座170的装配卡点1741分离、解锁；
S24、针座130在抽针弹簧140的弹性推力下快速回弹，此时滑动件150在发射弹簧120的弹力、抽针限位槽115的限位作用下不会回弹。
该植入过程持续时间极短，能够实现快速植入与抽针，可以有效减轻使用者的痛感；并且通过弹射筒110、电池组件200的定位作用，植入位置准确，不会发生偏离，不易对人体造成二次损伤。
S3、供电
S31、转动弹射筒主体111，使得弹射筒卡固凸条116与电池组件200的上盖卡固凸条218分离，抽离弹射筒主体111；
S32、将发射器组件300该在电池组件200上，使得发射器底座320的底座勾槽321与电池上盖210的上盖勾边211勾边连接，此时，探头座170的顶部密封于发射器组件300与电池组件200之间，并且电池组件200为发射器组件300内部的PCBA330供电。
S4、使用：通过无线终端设备连接PCBA330(如通过蓝牙连接PCBA330)并激活发射器开始工作，传感器160、PCBA330采集到的数据发送至无线终端设备中。
本发明采用内部弹簧和卡扣自行解锁释放的方式，实现了快速植入与自动抽针，使用者无明显刺痛感，并且本发明不需使用者施加外力，小孩和老人也可以在监护人的指导下下自行使用，整个过程快速、准确，不易发生偏离，不会对使用者造成二次损伤；另外，本发明增加了保险装置和固定卡扣，确保运输途中、消费者手中不会发生误触发的情况。
上面结合附图对本发明专利进行了示例性的描述，显然本发明专利的实现并不受上述方式的限制，只要采用了本发明专利的方法构思和技术方案进行的各种改进，或未经改进将本发明专利的构思和技术方案直接应用于其它场合的，均在本发明的保护范围内。

Claims (10)

  1. 一种生物传感器辅助植入装置，其特征在于，包括：
    发射筒组件，用于通过弹力驱动滑动件向人体发射传感器，并通过弹力拨回滑动件，使其与传感器快速分离；
    电池组件，用于固定所述传感器并为整个装置供电；
    发射器组件，与电池组件装配并与所述传感器电连接，并将所述传感器的监测信号发送至无线终端设备。
  2. 根据权利要求1所述的生物传感器辅助植入装置，其特征在于，所述发射筒组件包括弹射筒、发射弹簧、针座、抽针弹簧以及滑动件，
    所述针座、所述滑动件均位于所述弹射筒内部并沿着所述弹射筒上下滑动，所述滑动件与所述针座卡接并可与所述针座相对旋转，所述滑动件还与传感器卡接，且所述传感器竖向延伸端套在所述针座底部的导引针内；
    所述发射弹簧位于所述弹射筒与所述针座之间，且所述发射弹簧的上端与所述弹射筒的顶部抵接，其下端与所述滑动件抵接，所述发射弹簧用于带动所述针座、所述滑动件沿着所述弹射筒弹射；
    所述抽针弹簧位于所述针座内部，其顶部与所述针座的顶端抵接，其底部与所述滑动件抵接，所述抽针弹簧用于带动所述针座回弹。
  3. 根据权利要求2所述的生物传感器辅助植入装置，其特征在于，所述弹射筒包括弹射筒主体、位于所述弹射筒主体上的弹射扣件，所述滑动件未弹射状态时，所述弹射扣件与所述滑动件卡连。
  4. 根据权利要求3所述的生物传感器辅助植入装置，其特征在于，所述弹射扣件包括位于相对两端的按压部、勾合部，所述按压部相对于所述弹射筒主体悬空，所述勾合部与所述滑动件卡接。
  5. 根据权利要求4所述的生物传感器辅助植入装置，其特征在于，所述滑动件的外侧设有凸出的滑动件外卡块，所述滑动件外卡块与所述勾合部卡接，使得所述滑动件未弹射状态时，所述滑动件与所述弹射扣件卡连。
  6. 根据权利要求4所述的生物传感器辅助植入装置，其特征在于，所述弹射筒主体的外侧套有限位圈，所述限位圈包括限位圈主体及位于所述限位圈主体上的关限位凸起和解锁区，所述按压部的内表面与所述关限位凸起抵接，或按压部悬空于所述解锁区的外围。
  7. 根据权利要求2所述的生物传感器辅助植入装置，其特征在于，所述弹射筒主体的下端设有凸出的弹射筒卡固凸条，所述电池组件的电池上盖设有上下贯穿的弧形槽，且弧形槽处 设有凸出的上盖卡固凸条，所述上盖卡固凸条与所述弹射筒卡固凸条卡接。
  8. 根据权利要求2所述的生物传感器辅助植入装置，其特征在于，所述弹射筒主体的顶部设有向下延伸的导向柱，所述针座的顶部设有上下贯穿的导向槽孔，所述导向柱伸入所述导向槽孔内，使得所述针座沿着所述导向柱上下滑动。
  9. 根据权利要求2所述的生物传感器辅助植入装置，其特征在于，所述针座包括用于带动传感器植入并实现抽针的针座主体、位于所述针座下端用于实现传感器引导的导引针，所述针座主体的下端开口，且所述针座主体的内部顶端设有向下延伸的中柱，所述中柱的底部设有针座内凸起，所述滑动件的内部设有与所述针座内凸起相对应的滑动件内卡块，所述针座与所述滑动件弹射状态时，所述滑动件内卡块与所述针座内凸起相扣，所述针座回弹状态时，所述滑动件内卡块与所述针座内凸起错位并分离。
  10. 根据权利要求2所述的生物传感器辅助植入装置，其特征在于，所述滑动件的底部设有供传感器穿过的装配槽，所述装配槽的侧壁设有凸出的、供所述传感器卡接的装配卡条。
PCT/CN2022/141234 2022-10-11 2022-12-23 一种生物传感器辅助植入装置 WO2024077771A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211239570.7 2022-10-11
CN202211239570.7A CN116058937A (zh) 2022-10-11 2022-10-11 一种生物传感器辅助植入装置

Publications (1)

Publication Number Publication Date
WO2024077771A1 true WO2024077771A1 (zh) 2024-04-18

Family

ID=86168918

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/141234 WO2024077771A1 (zh) 2022-10-11 2022-12-23 一种生物传感器辅助植入装置

Country Status (3)

Country Link
US (1) US20240115169A1 (zh)
CN (1) CN116058937A (zh)
WO (1) WO2024077771A1 (zh)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118490217A (zh) * 2024-07-09 2024-08-16 深圳刷新生物传感科技有限公司 一种一体型侵入式生物传感器组件

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018222014A1 (ko) * 2017-06-02 2018-12-06 주식회사 아이센스 연속 혈당 측정기용 센서 어플리케이터 조립체
CN109938785A (zh) * 2019-04-30 2019-06-28 三诺生物传感股份有限公司 一种植入式传感器的植入工具
KR20210132281A (ko) * 2020-04-24 2021-11-04 (주) 로아메드 무통 채혈침 전용 당김 장전식 채혈기
CN216495292U (zh) * 2021-11-18 2022-05-13 苏州中星医疗技术有限公司 血糖检测仪上的值针结构
CN114767229A (zh) * 2022-04-14 2022-07-22 深圳可孚生物科技有限公司 一种生物传感器辅助敷贴器
CN114795194A (zh) * 2022-04-17 2022-07-29 深圳刷新生物传感科技有限公司 一种植入式生物传感器的一体式植入组件
CN218852787U (zh) * 2022-10-11 2023-04-14 深圳可孚生物科技有限公司 一种准确定位且方便植入的生物传感器助针装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018222014A1 (ko) * 2017-06-02 2018-12-06 주식회사 아이센스 연속 혈당 측정기용 센서 어플리케이터 조립체
CN109938785A (zh) * 2019-04-30 2019-06-28 三诺生物传感股份有限公司 一种植入式传感器的植入工具
KR20210132281A (ko) * 2020-04-24 2021-11-04 (주) 로아메드 무통 채혈침 전용 당김 장전식 채혈기
CN216495292U (zh) * 2021-11-18 2022-05-13 苏州中星医疗技术有限公司 血糖检测仪上的值针结构
CN114767229A (zh) * 2022-04-14 2022-07-22 深圳可孚生物科技有限公司 一种生物传感器辅助敷贴器
CN114795194A (zh) * 2022-04-17 2022-07-29 深圳刷新生物传感科技有限公司 一种植入式生物传感器的一体式植入组件
CN218852787U (zh) * 2022-10-11 2023-04-14 深圳可孚生物科技有限公司 一种准确定位且方便植入的生物传感器助针装置

Also Published As

Publication number Publication date
CN116058937A (zh) 2023-05-05
US20240115169A1 (en) 2024-04-11

Similar Documents

Publication Publication Date Title
WO2023273062A1 (zh) 植入器及植入方法
US7572237B2 (en) Automatic biological analyte testing meter with integrated lancing device and methods of use
CN109998555A (zh) 一种受体生理参数测量系统
CN113499067B (zh) 分离式传感器电极固定结构
WO2024077771A1 (zh) 一种生物传感器辅助植入装置
JP2008220961A (ja) 挿入ヘッド、特に輸液セットのための挿入器具
CN113499127B (zh) 传感器底座的固定结构及取下传感器底座的方法
CN110664415A (zh) 一种敷贴装置
CN218852787U (zh) 一种准确定位且方便植入的生物传感器助针装置
JP2023519513A (ja) 連続血糖測定装置
CN113456066B (zh) 一种经皮分析物传感器插入装置
KR20240112241A (ko) 연속 혈당 측정장치용 어플리케이터
CN211094137U (zh) 一种敷贴装置
CN219166416U (zh) 一种持续血糖监测装置
CN217525120U (zh) 一种微型传感器、含有该微型传感器的底座组件及专用推送装置
WO2024125057A1 (zh) 一种传感器组件、含有该传感器组件的针盒及专用无痛敷贴器
CN219206948U (zh) 用于植入式生物传感器的一体式植入装置
CN215227654U (zh) 植入器中回针组件的固定装置
CN215261825U (zh) 传感器底座
US20240156376A1 (en) Applicators for glucose monitors, methods for applying glucose monitors, and glucose monitors for use with such applicators
CN219166412U (zh) 一种持续血糖监测装置
CN118662129A (zh) 生物传感器的植入装置
CN118452905A (zh) 一种用于植入传感器的助针器
CN115844389A (zh) 一种生物监测传感器植入装置及持续血糖监测器
CN114451889A (zh) 一种经皮分析物传感器插入装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22961949

Country of ref document: EP

Kind code of ref document: A1