CN114391836B - Transdermal analyte sensor system - Google Patents
Transdermal analyte sensor system Download PDFInfo
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- CN114391836B CN114391836B CN202111439161.7A CN202111439161A CN114391836B CN 114391836 B CN114391836 B CN 114391836B CN 202111439161 A CN202111439161 A CN 202111439161A CN 114391836 B CN114391836 B CN 114391836B
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- 239000012491 analyte Substances 0.000 title claims abstract description 24
- 230000007246 mechanism Effects 0.000 claims abstract description 27
- 239000007943 implant Substances 0.000 claims description 32
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 210000004369 blood Anatomy 0.000 description 23
- 239000008280 blood Substances 0.000 description 23
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 22
- 239000008103 glucose Substances 0.000 description 22
- 238000012544 monitoring process Methods 0.000 description 16
- 206010033675 panniculitis Diseases 0.000 description 6
- 210000004304 subcutaneous tissue Anatomy 0.000 description 6
- 239000000758 substrate Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- 238000012986 modification Methods 0.000 description 5
- 230000004048 modification Effects 0.000 description 5
- 230000004888 barrier function Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 239000012530 fluid Substances 0.000 description 4
- 238000007920 subcutaneous administration Methods 0.000 description 4
- 230000001960 triggered effect Effects 0.000 description 4
- 239000012790 adhesive layer Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 238000009434 installation Methods 0.000 description 3
- 239000010410 layer Substances 0.000 description 3
- 230000035515 penetration Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000009471 action Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000010241 blood sampling Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/06—Accessories for medical measuring apparatus
Abstract
The invention provides a percutaneous analyte sensor system, comprising an implanter unit, a needle assembly and a body surface attachment unit, wherein the implanter unit comprises a housing, a sheath movably arranged at the distal end of the housing, and a first driving mechanism and a second driving mechanism arranged inside the housing, and the body surface attachment unit comprises a sensor electrode; the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce a portion of the sensor electrode subcutaneously into the host and apply the body surface attachment unit to the skin surface of the host when the sheath is at least partially retracted inside the housing; the second drive mechanism is configured to drive the needle assembly in a proximal direction away from the sensor electrode and retract into the housing when the body surface attachment unit is applied to a host skin surface.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a percutaneous analyte sensor system.
Background
Some physiological diseases have long disease course and prolonged illness, and certain physiological parameters of a host need to be monitored in real time so as to be better tracked and treated. Such as diabetes, requires real-time monitoring of the host's blood glucose. Accurate blood glucose self-monitoring is a key for realizing good blood glucose control, is beneficial to evaluating the degree of glucose metabolic disturbance of diabetics, and makes a blood glucose reducing scheme, and simultaneously reflects the blood glucose reducing treatment effect and guides the adjustment of the treatment scheme.
Currently, the most widely used blood glucose meter is available on the market, and the patient needs to collect finger peripheral blood by himself to measure the blood glucose level at that time. However, this method has the following drawbacks: 1. the condition of the blood glucose level change between two measurements cannot be known, and a patient may miss blood glucose peaks and valleys, so that complications are caused, and irreversible injury is caused to the patient; 2. the finger tips puncture and blood sampling for many times every day causes great pain to diabetics. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring the blood sugar of a patient, which is convenient for the patient to know his or her blood sugar status in real time and to take countermeasures accordingly in time, so as to effectively control the illness state, prevent complications and obtain higher quality of life.
In response to the above-mentioned needs, the skilled person has developed a monitoring technology capable of being implanted into subcutaneous tissue to continuously monitor subcutaneous blood sugar, the technology is characterized in that a sensor electrode is penetrated into subcutaneous tissue, the sensor electrode generates an electric signal when the liquid between tissues of a patient and glucose in the body react, the electric signal is converted into blood sugar readings through a transmitter, the blood sugar readings are transmitted to a wireless receiver every 1-5 minutes, and corresponding blood sugar data are displayed on the wireless receiver and a map is formed for reference of the patient and doctors.
The penetration of the sensor electrode into the subcutaneous tissue requires the use of an implant, an existing implant structure, such as that disclosed in chinese patent application CN112423665a, an applicator (i.e., an implant) structure that collapses into the housing upon engagement of the skin at the target monitoring location, allowing the sensor control device to advance into engagement with the skin, with the aid of a sharp object, the sensor (i.e., the sensor electrode) advances percutaneously into the patient's skin at the target monitoring location, with the sharp object automatically retracting when the housing is fully advanced to the target monitoring location, and the sensor remains in place to monitor analyte levels.
In the above solution, the implantation of the sensor requires the sheath to be completely retracted into the housing, and the penetration of the sharp object into the skin is carried out by means of manual pushing of the applicator, which is highly demanding for the user operation and has the following drawbacks: 1. the sensor is easy to be improperly operated by a user in the implantation process, so that the sensor cannot be implanted normally; 2. the manual penetration of sharp objects is slow, which is easy to cause great pain; 3. manual puncturing is easy to bring great psychological pressure to users, and influences user experience. In addition, the applicator and the sensor in the above proposal are sterilized and packaged separately, and the user needs to put the sensor into the applicator when using the sensor, which is easy to cause the sensor to be implanted abnormally due to improper installation of the user.
Disclosure of Invention
The invention aims to provide a percutaneous analyte sensor system, which improves the comfort and convenience of implantation of a sensor electrode and improves the user experience.
In order to achieve the aim of the invention, the invention adopts the following technical scheme: a transdermal analyte sensor system comprising an implanter unit comprising a housing, a sheath movably disposed at a distal end of the housing, and first and second drive mechanisms disposed inside the housing, a needle assembly, and a body surface attachment unit comprising sensor electrodes;
the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce a portion of the sensor electrode subcutaneously into the host and apply the body surface attachment unit to the skin surface of the host when the sheath is at least partially retracted inside the housing;
the second drive mechanism is configured to drive the needle assembly in a proximal direction away from the sensor electrode and retract into the housing when the body surface attachment unit is applied to a host skin surface.
In the above-described aspect, the implant unit further comprises a cap coupled to the distal end of the housing, the cap configured to be removable prior to application of the implant unit to the body surface attachment unit.
In the above solution, the cap is configured to be removed in a rotational manner.
In the above-described aspect, the body surface attachment unit is fixed in the cap before the cap is removed.
In the above-described technical solution, the body surface attachment unit is fixed by the sheath and the cap fitting before the cap is removed.
In the above aspect, the distal end of the sheath is coupled to the cap and the proximal end of the sheath is coupled to the housing of the implant unit.
In the technical scheme, the annular supporting part is arranged in the cap, the plurality of limiting ribs are arranged on the outer surface of the supporting part at equal intervals along the circumferential direction, the plurality of limiting blocks are arranged on the inner surface of the distal end of the sheath at equal intervals, and at least part of the limiting blocks are matched with the limiting ribs to limit when the distal end of the sheath is coupled to the cap.
In the above technical solution, the proximal end of the sheath is configured with a plurality of first elastic hooks, the housing of the implant unit is internally configured with a plurality of first steps, and at least part of the first elastic hooks hook the first steps when the proximal end of the sheath is coupled to the housing of the implant unit.
In the above technical solution, the first driving mechanism includes a first holding portion and a first driving spring, a distal end of the first holding portion is configured with a connection seat, and the connection seat is coupled to the body surface attachment unit;
the first drive spring is configured to provide a pre-stress that drives the first retaining portion in a distal direction.
In the above technical solution, the proximal end of the first retaining portion is configured with a plurality of second elastic hooks, and the housing of the implant unit is internally configured with a plurality of limiting holes 423, and at least a portion of the second elastic hooks hook the edges of the limiting holes 423.
In the above solution, the second elastic hook is configured to be disengaged from the edge of the limiting hole 423 when the sheath is at least partially retracted inside the casing.
In the above aspect, the second driving mechanism includes a second holding portion including a resilient jaw coupled to a proximal end of the needle assembly, and a second driving spring;
the second drive spring is configured to provide a pre-stress that drives the second retaining portion in a proximal direction.
In the above technical solution, a plurality of second steps are disposed at a proximal end of the second holding portion, a plurality of third elastic hooks are disposed at a proximal end of the first holding portion, and at least a portion of the third elastic hooks hook the second steps.
In the above-described aspect, the third elastic hook portion is configured to be disengaged from the second step when the body surface attachment unit is applied to the skin surface of the host.
In the above-described aspect, the second holding portion is provided with elastic arms corresponding to the number of the third elastic hooks, and the elastic arms are configured to provide a prestress pushing the third elastic hooks radially outward.
In the above-described aspect, the needle assembly includes a puncture needle penetrating through the body surface attachment unit such that a portion of the sensor electrode is attached within the puncture needle, and a hub attached to a proximal end portion of the puncture needle.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
1. according to the invention, the sheath is used as a triggering mechanism, the implanter unit is pushed until the sheath is at least partially retracted into the shell of the implanter unit, the sheath triggers the first driving mechanism to apply the body surface attachment unit to the surface of the skin of a host, and then the needle assembly is retracted through the second driving mechanism, so that the operation is simplified, and the user experience is improved;
2. the sheath and the body surface attachment unit of the present invention are preloaded on the cap, and are coupled to the implanter unit together when the cap is coupled to the implanter unit, and transferred from the cap to the implanter unit when the cap is removed, simplifying the assembly process, and particularly facilitating the installation of the body surface attachment unit.
Drawings
Fig. 1 is a schematic diagram of a continuous blood glucose monitoring system in accordance with an embodiment of the present invention.
Fig. 2 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.
FIG. 3 is a cross-sectional view of an analyte sensor system of an embodiment of the present invention.
FIG. 4 is a perspective cross-sectional view of an analyte sensor system of an embodiment of the present invention.
Fig. 5 is a schematic structural view of an implanter unit according to an embodiment of the present invention.
Fig. 6 is a schematic view of another angle configuration of an implanter unit according to an embodiment of the present invention.
Fig. 7 is a structural exploded view of the body surface attachment unit of the embodiment of the present invention.
Fig. 8 is a perspective cross-sectional view of a cap according to an embodiment of the present invention.
Fig. 9 is a schematic view of the first holding portion and body surface attachment unit mounting of the embodiment of the present invention.
Fig. 10 is a schematic view of another angle at which the first holding portion of the embodiment of the present invention is mounted with the body surface attachment unit.
Fig. 11 is a schematic view illustrating the installation of the first holding portion and the second holding portion according to the embodiment of the present invention.
Fig. 12 is a schematic view of the structure of a needle assembly according to an embodiment of the present invention.
Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 220. a release layer; 230. a carrier; 240. a cover body; 241. a positioning groove; 300. a receiver; 400. an implanter unit; 410. a needle assembly; 411. a puncture needle; 412. a hub; 413. a groove; 420. a housing; 421. a first step; 422. a substrate; 423. a limiting hole; 424. a guide cylinder; 430. a sheath; 431. a limiting block; 432. a first elastic hook portion; 433. a push rod; 440. an opening; 450. a first holding portion; 451. a connecting seat; 452. a bump; 453. a second elastic hook portion; 454. a slope surface; 455. a third elastic hook portion; 460. a first drive spring; 470. a second holding portion; 471. an elastic clamping jaw; 472. a second step; 473. an elastic arm; 480. a second drive spring; 500. a cap; 510. a support part; 511. a limit rib; 512. and a barrier strip.
Detailed Description
The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that many variations and modifications may exist to the embodiments of the present invention.
Continuous blood glucose monitoring (CGM, continuous Glucose Monitoring) system
Referring to fig. 1, a schematic diagram of a continuous blood glucose monitoring system attached to a host 100 is shown. There is shown a continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 attached to the skin surface of a host 100 by an adhesive layer. The body surface attachment unit 200 is built-in with a circuit module electrically connected to the sensor electrode 210 for transmitting the glucose concentration information monitored by the sensor electrode 210 to the receiver 300, and the receiver 300 may be a smart phone, a smart watch, a dedicated device, and the like in general. In use, the sensor electrode 210 is partially positioned under the skin of the host 100 and in contact with the subcutaneous tissue fluid.
Referring to fig. 2, which is a schematic structural diagram of a continuous blood glucose monitoring system, the continuous blood glucose monitoring system comprises an implant unit 400, a body surface attachment unit 200 and a cap 500, wherein the body surface attachment unit 200 is preloaded into the cap 500, and then the cap 500 is mounted on the implant unit 400 together, and when in use, the cap 500 is removed from the implant unit 400 by rotating the cap 500, and at the same time, a release layer 220 covering an adhesive layer of the body surface attachment unit 200 is peeled along with the removal of the cap 500; the open side of the implant unit 400 is then adhered to the skin surface of the host 100, and the body surface attachment unit 200 within the implant unit 400 is applied to the skin surface of the host 100 by operating the implant unit 400, at which time the sensor electrode 210 is partially implanted subcutaneously in the host 100, in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid.
For example, the adhesive layer may be a medical nonwoven tape.
For example, the release layer 220 is a release paper or a release film, and a surface is coated with a release agent.
Referring to fig. 2 to 4, the present invention provides a transdermal analyte sensor system exemplified by the above-mentioned continuous blood glucose monitoring system, comprising an implanter unit 400, a needle assembly 410 and a body surface attachment unit 200, the implanter unit 400 comprising a housing 420, a sheath 430 movably disposed at a distal end of the housing 420, and a first driving mechanism and a second driving mechanism disposed inside the housing 420, the body surface attachment unit 200 comprising a sensor electrode 210; the first drive mechanism is configured to drive the needle assembly 410 in a distal direction to introduce a portion of the sensor electrode 210 subcutaneously into the host and apply the body surface attachment unit 200 to the skin surface of the host when the sheath 430 is at least partially retracted inside the housing 420; the second drive mechanism is configured to drive the needle assembly 410 in a proximal direction away from the sensor electrode 210 and back into the housing 420 when the body surface attachment unit 200 is applied to the host skin surface.
Referring to fig. 5, the present invention activates the first drive mechanism by pushing the implanter unit 400 to retract the sheath 430. In one embodiment, the sheath 430 is partially retracted inside the housing 420 of the implanter unit 400 to create a triggering effect. In another embodiment, the sheath 430 is fully retracted inside the housing 420 of the implanter unit 400 to create a triggering effect.
Referring to fig. 6, the distal end of the implant unit 400 is configured with an opening 440, and the sheath 430 is embedded in the opening 440 and is free to move in a proximal direction within the housing 420 of the implant unit 400.
With continued reference to fig. 2-4, a cap 500 is also coupled to the distal end of the implant unit 400, the cap 500 being configured to be removable prior to application of the implant unit 400 to the body surface attachment unit 200. For example, cap 500 is configured to be rotationally removed.
Referring to fig. 7 and 8, the body surface attachment unit 200 includes a carrier 230 and a cover 240 coupled to the carrier 230. In one embodiment, the outer diameter of the carrier 230 is greater than the outer diameter of the cover 240 such that the edges of the carrier 230 protrude beyond the edges of the cover 240. The body surface attachment unit 200 is fixed in the cap 500 before the cap 500 is removed. In one embodiment, the body surface attachment unit 200 is matingly secured by the sheath 430 and cap 500 prior to removal of the cap 500. For example, the inside of the cap 500 is provided with an annular support 510, the carrier 230 of the body surface attachment unit 200 is placed on the end face of the proximal end of the support 510, the inner bottom face of the distal end of the sheath 430 is pressed against the edge of the carrier 230 of the body surface attachment unit 200, and the body surface attachment unit 200 is fixed in the cap 500 by the end face of the proximal end of the support 510 and the inner bottom face of the distal end of the sheath 430 clamping the edge of the carrier 230 of the body surface attachment unit 200. A plurality of limit ribs 511 are circumferentially and equally spaced on the outer surface of the support portion 510, a plurality of limit bars 431 are circumferentially and equally spaced on the inner surface of the distal end portion of the sheath 430, the distance between two adjacent limit ribs 511 is larger than the circumferential length of any limit rib 511, the distance between two adjacent limit ribs 431 is larger than the circumferential length of any limit rib 511, when the distal end portion of the sheath 430 is coupled to the cap 500, the limit ribs 511 are penetrated by the limit ribs 431, the cap 500 is rotated so that the limit ribs 431 move circumferentially to a position shielded by the limit ribs 511, at this time, the cap 500 is interlocked with the sheath 430, the limit ribs 511 extend in the distal direction to be provided with barrier bars 512, the barrier bars 512 play a role of shielding the limit ribs 431, and since the limit ribs 431 and the limit ribs 511 are members arranged inside the cap 500, the positional relationship between the limit ribs cannot be directly observed from the outside, and when the cap 500 is rotated so that the limit ribs 431 move circumferentially to be shielded by the barrier bars 512 and cannot continue rotating, the limit ribs 431 reach the position interlocked with the limit ribs 511. Wherein at least a portion of the stop 431 cooperates with the stop rib 511 to stop when the distal end of the sheath 430 is coupled to the cap 500. In one embodiment, only a portion of the stoppers 431 may be engaged with the stopper ribs 511 to stop, and the number of the stopper ribs 511 is smaller than the number of the stoppers 431. In another embodiment, all the limiting blocks 431 are matched with the limiting ribs 511 for limiting, and the number of the limiting ribs 511 is equal to or greater than the number of the limiting blocks 431.
With continued reference to fig. 3 and 4, the proximal end of the sheath 430 is configured with a plurality of first resilient hooks 432, the housing 420 of the implant unit 400 is internally configured with a plurality of first steps 421, and at least a portion of the first resilient hooks 432 catch on the first steps 421 when the proximal end of the sheath 430 is coupled to the housing 420 of the implant unit 400. In one embodiment, only a portion of the first elastic hooks 432 may be hooked to the first steps 421, and the number of the first steps 421 is smaller than the number of the first elastic hooks 432. In another embodiment, all the first elastic hooks 432 hook the first steps 421, and the number of the first steps 421 is equal to or greater than the number of the first elastic hooks 432.
With continued reference to fig. 3 and 4, the distal end of the housing 420 of the implant unit 400 is configured with a substrate 422, the substrate 422 is hollowed out in the middle, and the substrate 422 is fixedly connected to the inner wall of the housing 420 of the implant unit 400 by a snap connection. In one embodiment, the first step 421 may be disposed on the substrate 422.
Referring to fig. 9 and 10, the first driving mechanism includes a first holding portion 450 and a first driving spring 460, the distal end portion of the first holding portion 450 is provided with a connection base 451, the connection base 451 is coupled to the body surface attachment unit 200, for example, the connection base 451 may be coupled to the cover 240 of the body surface attachment unit 200, the connection base 451 is provided with a protruding point 452 on an inner surface thereof, the cover 240 of the body surface attachment unit 200 is formed with an annular positioning groove 241, and the protruding point 452 is caught in the positioning groove 241 when the connection base 451 is coupled to the cover 240 of the body surface attachment unit 200;
with continued reference to fig. 3 and 4, the first drive spring 460 is configured to provide a pre-stress that drives the first retaining portion 450 in a distal direction, e.g., the first drive spring 460 is in a compressed state prior to being triggered, with one end of the first drive spring 460 abutting against a proximal end of the first retaining portion 450 and the other end abutting against an inner surface of the housing 420 of the implant unit 400.
The proximal end of the first holding portion 450 is provided with a number of second elastic hooks 453, and the housing 420 of the implant unit 400 is internally provided with a number of limiting holes 423. In an embodiment, the limiting holes 423 may be provided on the substrate 422, at least part of the second elastic hooks 453 hooking the edges of the limiting holes 423. In one embodiment, only a portion of the second elastic hooks 453 may be hooked to the edge of the limiting hole 423, and the number of the limiting holes 423 is smaller than the number of the second elastic hooks 453. In another embodiment, all the second elastic hooks 453 hook the edges of the limiting holes 423, and the number of the limiting holes 423 is equal to or greater than the number of the second elastic hooks 453.
With continued reference to fig. 3 and 4, the second resilient hook 453 is configured to disengage from the edge of the limiting aperture 423 when the sheath 430 is at least partially retracted inside the housing 420. In one embodiment, the second resilient hook 453 may be a barb structure that curves in a distal direction, with a ramp surface 454 disposed on the outside thereof, and a push rod 433 acting on the ramp surface 454 disposed on the proximal end of the sheath 430, when the sheath 430 is retracted inside the housing 420 of the implanter unit 400, the push rod 433 pushes the second resilient hook 453 inward along the ramp surface 454, such that the second resilient hook 453 disengages from the limiting aperture 423, releasing the first retaining portion 450, under the action of the first drive spring 460, the first retaining portion 450 moves the body surface attachment unit 200 in a distal direction to apply the body surface attachment unit 200 to the host skin surface, at which time the portion of the sensor electrode 210 is penetrated into subcutaneous contact with the subcutaneous tissue fluid. The sensor electrode 210 includes an extracorporeal portion and an intracorporeal portion, which penetrate the subcutaneous portion of the host and are extracorporeal portions exposed to the outside of the skin of the host. The extracorporeal portion is attached within the body surface attachment unit 200, for example, the extracorporeal portion may be attached to the carrier 230 of the body surface attachment unit 200. The carrier 230 is also provided with a circuit module by which subcutaneous analyte concentration information monitored by the sensor electrode 210 is transmitted to the receiver 300.
Referring to fig. 11, the second driving mechanism includes a second holding portion 470 and a second driving spring 480, the second holding portion 470 includes a resilient jaw 471, and the resilient jaw 471 is coupled to a proximal end of the needle assembly 410;
the second drive spring 480 is configured to provide a pre-stress that drives the second holding portion 470 in a proximal direction, e.g., the second drive spring 480 is in a compressed state before being triggered, the second drive spring 480 is sleeved around the resilient jaw with one end abutting against a surface of the proximal end of the first holding portion 450 and the other end abutting against an inner surface of the second holding portion 470.
The proximal end of the second holding portion 470 is provided with a plurality of second steps 472, the first driving mechanism is provided with a plurality of third elastic hooks 455, and at least part of the third elastic hooks 455 hook the second steps 472. In one embodiment, only a portion of the third elastic hook 455 hooks the second step 472, and the number of the second steps 472 is smaller than the number of the third elastic hook 455. In another embodiment, all of the third elastic hooks 455 hook the second steps 472, and the number of the second steps 472 is equal to or greater than the number of the third elastic hooks 455.
The third elastic hook 455 is configured to disengage from the second step 472 when the body surface attachment unit 200 is applied to the skin surface of the host. For example, the second holding portion 470 is configured with a number of elastic arms 473 corresponding to the third elastic hook portions 455, the elastic arms 473 being configured to provide a prestress pushing the third elastic hook portions 455 radially outward. Accordingly, the housing 420 of the implant unit 400 is internally configured with a guide cylinder 424 extending in a distal direction from the inner surface of the proximal end of the housing 420, the second retaining portion 470 and the third resilient hook 455 being located within the guide cylinder 424 prior to the first drive mechanism being triggered, the side walls of the guide cylinder 424 supporting the third resilient hook 455 on the second step 472 from being distracted by the resilient arms 473. When the first driving mechanism is triggered, the first holding portion 450 moves the second holding portion 470 together in the distal direction, and when moved to the body surface attachment unit 200 to be applied to the surface of the host skin, the third elastic hook portion 455 leaves the guide cylinder 424, and the third elastic hook portion 455 is outwardly spread by the elastic arm 473 without the support of the side wall of the guide cylinder 424, so that the third elastic hook portion 455 is separated from the second step 472, at which time the second holding portion 470 moves in the proximal direction with the needle assembly 410 under the action of the second driving spring 480 to cause the needle assembly 410 to leave the host skin and retract into the outer interior of the implanter unit 400, at which time the body surface attachment unit 200 is left on the surface of the host skin, and the needle assembly 410 is separated from the body surface attachment unit 200.
Referring to fig. 12, the needle assembly 410 includes a puncture needle 411 and a hub 412 attached to a proximal end of the puncture needle 411, the puncture needle being provided with an elongated slot 413, the puncture needle 411 penetrating the body surface attachment unit 200 such that a portion of the sensor electrode 210, herein referred to as an in-vivo portion of the sensor electrode 210, is attached within the puncture needle 411 via the slot 413. The jaws of the second holding portion 470 are clamped to the hub 412.
The term "distal", "proximal", "distal end", "proximal end" as used herein is intended to refer to both far and near relative to the host skin during application of the body surface attachment unit, in particular, near the host skin is defined as far and far from the host skin as near.
The foregoing description provides the best mode contemplated for carrying out the present invention, as well as the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the same. However, the invention is susceptible to fully equivalent modifications and alternative constructions from the above description. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. On the contrary, the invention is intended to cover all modifications and alternative constructions falling within the spirit and scope of the invention, which is generally expressed by the following claims, which particularly point out and distinctly define the subject matter of the invention. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative and not restrictive.
Unless otherwise defined, all terms (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art and are not intended to be limited to one of ordinary skill in the art to which this invention belongs unless explicitly defined herein. It should be noted that the use of a particular term when describing certain disclosed features or aspects should not be taken to imply that the term is being redefined herein to be restricted to including any disclosed features or aspects with which that term is associated. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, should be construed in an open-ended, and not limiting sense, unless expressly stated otherwise. As an example of the foregoing, the term "comprising" shall mean "including but not limited to" or the like.
Furthermore, while the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be considered as limiting the scope of the invention to the particular embodiments and examples described herein, but rather as covering all modifications and alternatives falling within the true scope and spirit of the invention.
Claims (13)
1. A transdermal analyte sensor system comprising an implant unit, a needle assembly and a body surface attachment unit, wherein the implant unit comprises a housing, a sheath movably disposed at a distal end of the housing, and first and second drive mechanisms disposed inside the housing, the body surface attachment unit comprising sensor electrodes;
the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce a portion of the sensor electrode subcutaneously into the host and apply the body surface attachment unit to the skin surface of the host when the sheath is at least partially retracted inside the housing;
the second drive mechanism is configured to drive the needle assembly in a proximal direction away from the sensor electrode and retract into the housing when the body surface attachment unit is applied to the host skin surface;
the first driving mechanism includes a first holding portion and a first driving spring, a distal end of the first holding portion being configured with a connection seat coupled to the body surface attachment unit;
the first drive spring is configured to provide a pre-stress that drives the first retaining portion in a distal direction;
a plurality of second elastic hook parts are arranged at the proximal end part of the first holding part, a plurality of limiting holes (423) are arranged in the shell of the implant unit, and at least part of the second elastic hook parts hook the edges of the limiting holes (423);
the second resilient hook is configured to disengage from an edge of the limiting aperture (423) when the sheath is at least partially retracted inside the housing;
wherein the distal side is the side closest to the skin of the host and the proximal side is the side distal from the skin of the host.
2. The transdermal analyte sensor system of claim 1, further comprising a cap coupled to the distal end of the housing, the cap configured to be removable prior to application of the implant unit to the body surface attachment unit.
3. The transdermal analyte sensor system of claim 2, wherein the cap is configured to be rotationally removed.
4. The transdermal analyte sensor system of claim 2, wherein the body surface attachment unit is secured in the cap prior to cap removal.
5. The transdermal analyte sensor system of claim 4, wherein the body surface attachment unit is secured by a sheath and cap fit prior to cap removal.
6. The transdermal analyte sensor system of claim 5, wherein the distal end of the sheath is coupled to a cap and the proximal end of the sheath is coupled to the housing of the implanter unit.
7. The transdermal analyte sensor system of claim 6, wherein the cap is internally configured with an annular support, wherein the support has a plurality of circumferential spacing ribs equally spaced on an outer surface thereof, wherein the sheath has a plurality of stop blocks equally spaced on an inner surface of the distal end thereof, and wherein at least a portion of the stop blocks cooperate with the spacing ribs when the sheath distal end is coupled to the cap.
8. The transdermal analyte sensor system of claim 6, wherein the proximal end of the sheath is configured with a number of first resilient hooks, the housing of the implant unit is internally configured with a number of first steps, at least a portion of the first resilient hooks hooking the first steps when the proximal end of the sheath is coupled to the housing of the implant unit.
9. The transdermal analyte sensor system of claim 1, wherein the second drive mechanism comprises a second holder and a second drive spring, the second holder comprising a resilient jaw coupled to a proximal end of the needle assembly;
the second drive spring is configured to provide a pre-stress that drives the second retaining portion in a proximal direction.
10. The transdermal analyte sensor system of claim 9, wherein the proximal end of the second retaining portion is configured with a plurality of second steps, the proximal end of the first retaining portion is configured with a plurality of third resilient hooks, at least a portion of the third resilient hooks hooking over the second steps.
11. The transdermal analyte sensor system of claim 10, wherein the third resilient hook is configured to disengage from the second step when the body surface attachment unit is applied to the host skin surface.
12. The transdermal analyte sensor system of claim 10, wherein the second retaining portion is configured with a corresponding number of resilient arms to the third resilient hooks, the resilient arms configured to provide a pre-stress pushing the third resilient hooks radially outward.
13. The transdermal analyte sensor system of claim 1, wherein the needle assembly comprises a puncture needle and a hub attached to a proximal end of the puncture needle, the puncture needle penetrating the body surface attachment unit such that a portion of the sensor electrode is attached within the puncture needle.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111439161.7A CN114391836B (en) | 2021-11-27 | 2021-11-27 | Transdermal analyte sensor system |
| PCT/CN2022/082905 WO2023092914A1 (en) | 2021-11-27 | 2022-03-25 | Percutaneous analyte sensor system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111439161.7A CN114391836B (en) | 2021-11-27 | 2021-11-27 | Transdermal analyte sensor system |
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| CN114391836A CN114391836A (en) | 2022-04-26 |
| CN114391836B true CN114391836B (en) | 2024-04-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202111439161.7A Active CN114391836B (en) | 2021-11-27 | 2021-11-27 | Transdermal analyte sensor system |
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| CN (1) | CN114391836B (en) |
| WO (1) | WO2023092914A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116195995A (en) * | 2021-11-30 | 2023-06-02 | 上海微创生命科技有限公司 | Implanter, sensor base assembly and implantation system |
| WO2024007516A1 (en) * | 2022-07-05 | 2024-01-11 | 深圳硅基传感科技有限公司 | Method for sterilizing medical instrument kit |
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2023092914A1 (en) | 2023-06-01 |
| CN114391836A (en) | 2022-04-26 |
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