CN114391836A - Transcutaneous analyte sensor system - Google Patents
Transcutaneous analyte sensor system Download PDFInfo
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- CN114391836A CN114391836A CN202111439161.7A CN202111439161A CN114391836A CN 114391836 A CN114391836 A CN 114391836A CN 202111439161 A CN202111439161 A CN 202111439161A CN 114391836 A CN114391836 A CN 114391836A
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- analyte sensor
- body surface
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Images
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
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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
- A61B5/14532—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
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- 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
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- 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 present invention provides a transcutaneous analyte sensor system comprising an implanter unit including 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 including sensor electrodes; the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce portions of the sensor electrodes subcutaneously into the host and to apply the body surface attachment unit to the host skin surface 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 back into the housing when the body surface attachment unit is applied to the host skin surface.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a transcutaneous analyte sensor system.
Background
Some physiological diseases, which have long disease course and prolonged disease duration, need to monitor some physiological parameters of the host in real time to better track the treatment. Such as diabetes, require real-time monitoring of the host blood glucose. Accurate blood sugar self-monitoring is a key for realizing good blood sugar control, is beneficial to evaluating the degree of glucose metabolism disorder of a diabetic patient, formulating a blood sugar reduction scheme, and simultaneously reflecting the blood sugar reduction treatment effect and guiding the adjustment of the treatment scheme.
Currently, most commercially available instruments refer to blood glucose meters, and patients need to collect finger peripheral blood by themselves to measure the blood glucose level at that moment. However, this method has the following drawbacks: firstly, the change of the blood sugar level between two measurements cannot be known, and the peak value and the valley value of the blood sugar can be missed by a patient, so that complications are caused, and irreversible damage is caused to the patient; secondly, the finger tip puncture blood sampling is carried out for a plurality of times every day, which causes great pain for the diabetic. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring blood sugar of a patient, so that the patient can conveniently know the blood sugar status of the patient in real time, and take measures in time to effectively control the state of an illness and prevent complications, thereby achieving a high quality of life.
Aiming at the requirements, technical personnel develop a monitoring technology which can be implanted into subcutaneous tissues to continuously monitor subcutaneous blood sugar, the technology is characterized in that a sensor electrode is inserted into the subcutaneous tissues, the sensor electrode generates oxidation reaction between interstitial fluid of a patient and glucose in a body, an electric signal is formed during the reaction, the electric signal is converted into blood sugar reading through a transmitter, the blood sugar reading is transmitted to a wireless receiver every 1-5 minutes, corresponding blood sugar data are displayed on the wireless receiver, and a map is formed for the patient and a doctor to refer.
The penetration of sensor electrodes into the subcutaneous tissue requires the use of an implanter, and prior art implanter configurations, such as chinese patent CN112423665A, disclose an applicator (i.e., implanter) configuration that allows the sensor control device to be advanced into engagement with the skin by advancing the applicator toward a target monitoring location where the sheath collapses into the housing when engaging the skin, whereby the sensor (i.e., sensor electrode) is advanced percutaneously into the skin of the patient at the target monitoring location with the sharp object, which is automatically retracted when the housing is fully advanced to the target monitoring location, while the sensor remains in place to monitor the analyte level.
In the above solution, the implantation of the sensor requires the sheath to be completely retracted into the housing, and the process of piercing the skin with a sharp object, which is carried out by manually pushing the applicator, is demanding for the user to operate, and has the following drawbacks: 1. the sensor can not be implanted normally due to improper operation of a user in the implantation process; 2. the speed of manually puncturing the sharp object is slow, so that great pain is easily caused; 3. the manual puncturing easily brings great psychological pressure to the user and influences the user experience. In addition, the applicator and the sensor in the above scheme are sterilized and packaged separately, and a user needs to load the sensor into the applicator first when using the applicator, so that the sensor cannot be implanted normally due to improper installation of the user.
Disclosure of Invention
The invention aims to provide a transcutaneous 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 purpose of the invention, the technical scheme adopted by the invention is as follows: a transcutaneous analyte sensor system comprising an implanter unit including 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 including a sensor electrode;
the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce portions of the sensor electrodes subcutaneously into the host and to apply the body surface attachment unit to the host skin surface 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 back into the housing when the body surface attachment unit is applied to the host skin surface.
In the above solution, further comprising a cap coupled to the distal end of the housing, the cap configured to be removable prior to application of the implanter 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 technical solution, the body surface attaching unit is fixed by the sheath and the cap in cooperation before the cap is removed.
In the above solution, 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 implanter unit.
In the above technical solution, an annular supporting portion is configured inside the cap, a plurality of limiting ribs are configured on an outer surface of the supporting portion at equal intervals along the circumferential direction, a plurality of limiting blocks are configured on an inner surface of the distal end portion of the sheath at equal intervals, and at least a part of the limiting blocks are matched with the limiting ribs for limiting when the distal end portion of the sheath is coupled to the cap.
In the above technical solution, the proximal end of the sheath is provided with a plurality of first elastic hook portions, the housing of the implanter unit is internally provided with a plurality of first steps, and at least part of the first elastic hook portions hook the first steps when the proximal end of the sheath is coupled to the housing of the implanter unit.
In the above-described aspect, the first drive mechanism includes a first holding portion and a first drive spring, a distal end portion of the first holding portion is provided with a connection seat that is coupled to the body surface attachment unit;
the first drive spring is configured to provide a pre-stress that drives the first retention portion in a distal direction.
In the above technical solution, the proximal end of the first holding portion is configured with a plurality of second elastic hook portions, the housing of the implanter unit is configured with a plurality of limiting holes 423, and at least part of the second elastic hook portions hook the edges of the limiting holes 423.
In the above technical 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 into the housing.
In the above solution, the second drive mechanism comprises a second holding portion comprising resilient jaws coupled to the proximal end of the needle assembly and a second drive spring;
the second drive spring is configured to provide a pre-stress that drives the second retention portion in a proximal direction.
In the above-mentioned technical scheme, the proximal end of second holding portion is configured with a plurality of second step, the proximal end of first holding portion is configured with a plurality of third elastic hook portion, at least part the second step is hooked to third elastic hook portion.
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 host skin surface.
In the above technical solution, the second holding portion is configured with elastic arms corresponding to the number of the third elastic hook portions, and the elastic arms are configured to provide a prestress that pushes the third elastic hook portions radially outward.
In the above-described aspect, the needle assembly includes a puncture needle that penetrates the body surface attachment unit so that the part of the sensor electrode is attached inside the puncture needle, and a hub attached to the 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. the present invention uses the sheath as a trigger mechanism, and the operation is simplified and the user experience is improved by pushing the implanter unit until the sheath is at least partially retracted inside the housing of the implanter unit, triggering the first drive mechanism with the sheath to apply the body surface attachment unit to the host skin surface, and then retracting the needle assembly by the second drive mechanism;
2. the sheath and the body surface attachment unit of the present invention are preassembled on the cap, coupled together to the implanter unit 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 according to an embodiment of the present invention.
Fig. 2 is a schematic structural 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 according to an embodiment of the invention.
FIG. 4 is a perspective cross-sectional view of an analyte sensor system according to an embodiment of the invention.
Fig. 5 is a schematic structural view of an implanter unit according to an embodiment of the invention.
Fig. 6 is a schematic view of another angled configuration of an implanter unit in accordance with an embodiment of the invention.
Fig. 7 is an exploded view of the structure of the body surface attachment unit of the embodiment of the present invention.
Fig. 8 is a perspective cross-sectional view of a cap of an embodiment of the present invention.
Fig. 9 is a schematic view of the first holding portion and the body surface attaching unit mounting according to the embodiment of the present invention.
Fig. 10 is a schematic view of another angle at which the first holding portion and the body surface attachment unit are mounted according to the embodiment of the present invention.
Fig. 11 is an installation diagram of the first holding part and the second holding part according to the embodiment of the present invention.
FIG. 12 is a schematic structural view of a needle assembly of 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. positioning a groove; 300. a receiver; 400. an implanter unit; 410. a needle assembly; 411. puncturing 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. salient points; 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 section; 471. an elastic clamping jaw; 472. a second step; 473. a resilient arm; 480. a second drive spring; 500. a cap; 510. a support portion; 511. a spacing rib; 512. and (6) blocking strips.
Detailed Description
The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there may be many variations and modifications of the embodiments of the present invention.
Continuous blood Glucose Monitoring (CGM) system
FIG. 1 is a schematic illustration of a continuous blood glucose monitoring system attached to a host 100. A continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 is shown attached to the skin surface of a host 100 by an adhesive layer. The body surface attachment unit 200 houses a circuit module electrically connected to the sensor electrodes 210 for transmitting information on the glucose concentration monitored by the sensor electrodes 210 to the receiver 300, and the receiver 300 may be a smartphone, a smart watch, a dedicated device, and the like. During use, the sensor electrodes 210 are positioned partially beneath the skin of the host 100, in contact with subcutaneous interstitial fluid.
FIG. 2 is a schematic view of a continuous blood glucose monitoring system, which includes an implanter unit 400, a body surface attachment unit 200 and a cap 500, wherein the body surface attachment unit 200 is pre-assembled in the cap 500 and then assembled to the implanter unit 400 together with the cap 500, and when in use, the cap 500 is removed from the implanter unit 400 by rotating the cap 500, and at the same time, the release layer 220 covering the adhesive layer of the body surface attachment unit 200 is peeled off together with the removal of the cap 500; the open side of the implanter unit 400 is then fitted to the skin surface of the host 100, and the body surface attachment unit 200 inside the implanter unit 400 is applied to the skin surface of the host 100 by operating the implanter unit 400 while the sensor electrodes 210 are partially implanted under the skin of 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 grade nonwoven tape.
For example, the release layer 220 is release paper or release film, and the surface is coated with a release agent.
Referring to fig. 2-4, the present invention provides a transcutaneous analyte sensor system, exemplified by the above-described 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 portions of the sensor electrodes 210 subcutaneously into the host and to apply the body surface attachment unit 200 to the host skin surface while 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 the proximal direction to be separated from the sensor electrode 210 and retracted 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 triggers the first drive mechanism by pushing the implanter unit 400 to retract the sheath 430. In one embodiment, partial retraction of sheath 430 into housing 420 of implanter unit 400 produces a triggering effect. In another embodiment, retraction of the sheath 430 entirely within the housing 420 of the implanter unit 400 produces a triggering effect.
Referring to fig. 6, the distal end of the implanter unit 400 is provided with an opening 440, and the sheath 430 is nested within the opening 440 and is free to move in a proximal direction within the housing 420 of the implanter unit 400.
With continued reference to fig. 2-4, a cap 500 is also coupled to the distal end of the implanter unit 400, the cap 500 being configured to be removable prior to application of the implanter unit 400 to the body surface attachment unit 200. For example, the cap 500 is configured to be removed in a rotational manner.
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 edge of the carrier 230 protrudes beyond the edge of the cover 240. The body surface attachment unit 200 is fixed in the cap 500 before the cap 500 is removed. In one embodiment, body surface attachment unit 200 is cooperatively secured by sheath 430 and cap 500 prior to removal of cap 500. For example, the inside of cap 500 is configured with support portion 510 in a ring shape, carrier 230 of body surface attachment unit 200 is placed on the end face of the proximal end of support portion 510, the inner bottom face of the distal end of sheath 430 is pressed against the edge of carrier 230 of body surface attachment unit 200, and body surface attachment unit 200 is fixed in cap 500 by clamping the edge of carrier 230 of body surface attachment unit 200 by the end face of the proximal end of support portion 510 and the inner bottom face of the distal end of sheath 430. A plurality of limit ribs 511 are arranged on the outer surface of the support portion 510 at equal intervals in the circumferential direction, a plurality of limit blocks 431 are arranged on the inner surface of the distal end portion of the sheath 430 at equal intervals, the distance between two adjacent limit ribs 511 is greater than the length of any limit block 431 in the circumferential direction, the distance between two adjacent limit blocks 431 is greater than the length of any limit block 511 in the circumferential direction, so that when the distal end portion of the sheath 430 is coupled to the cap 500, the limit blocks 431 pass through the limit ribs 511, the cap 500 is rotated to move the limit blocks 431 in the circumferential direction to the position shielded by the limit ribs 511, at this time, the cap 500 is interlocked with the sheath 430, a barrier 512 is arranged on the limit ribs 511 in the distal direction in an extending manner, the barrier 512 plays a role of shielding the limit blocks 431, and the position relationship between the limit blocks 431 and the limit ribs 511 cannot be directly observed from the outside because the limit blocks 431 and the limit ribs 511 are members arranged inside the cap 500, when the cap 500 is rotated to move the stopper 431 in the circumferential direction to be blocked by the barrier 512 and thus cannot rotate any more, it indicates that the stopper 431 has reached a position interlocked with the stopper rib 511. Wherein at least a portion of the stop block 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 stopper 431 may cooperate with the stopper rib 511 for stopping, and the number of the stopper rib 511 is smaller than the number of the stopper 431. In another embodiment, all the stopper blocks 431 are matched with the stopper ribs 511 for limiting, and the number of the stopper ribs 511 is greater than or equal to the number of the stopper 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 interior of the housing 420 of the implanter unit 400 is configured with a plurality of first steps 421, and at least a portion of the first resilient hooks 432 hook over the first steps 421 when the proximal end of the sheath 430 is coupled to the housing 420 of the implanter unit 400. In one embodiment, only a portion of the first elastic hook 432 may hook the first step 421, and the number of the first steps 421 is smaller than the number of the first elastic hook 432. In another embodiment, all the first elastic hook portions 432 are hooked on the first steps 421, and the number of the first steps 421 is equal to or greater than the number of the first elastic hook portions 432.
With continued reference to fig. 3 and 4, the distal end of the housing 420 of the implanter unit 400 is provided with a base 422, the base 422 is hollow, and the base 422 is fixed to the inner wall of the housing 420 of the implanter unit 400 by a snap-fit 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, a connection seat 451 is disposed at a distal end portion of the first holding portion 450, the connection seat 451 is coupled to the body surface attachment unit 200, for example, the connection seat 451 may be coupled to the cover 240 of the body surface attachment unit 200, a protruding point 452 is disposed on an inner surface of the connection seat 451, a ring-shaped positioning groove 241 is formed on the cover 240 of the body surface attachment unit 200, and the protruding point 452 is snapped into the positioning groove 241 when the connection seat 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 retention 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 on a proximal end of the first retention portion 450 and the other end abutting on an inner surface of the housing 420 of the implanter unit 400.
The proximal end of the first holder 450 is configured with a plurality of second elastic hooks 453, and the housing 420 of the injector unit 400 is configured with a plurality of stopper holes 423, in one embodiment, the stopper holes 423 may be configured on the base plate 422, and at least a portion of the second elastic hooks 453 hook the edges of the stopper holes 423. In one embodiment, only a portion of the second elastic hooking portions 453 may hook the edges of the stopper holes 423, and the number of the stopper holes 423 may be smaller than the number of the second elastic hooking portions 453. In another embodiment, all the second elastic hooking portions 453 hook the edges of the stopper holes 423, and the number of the stopper holes 423 is equal to or greater than the number of the second elastic hooking portions 453.
Continuing to refer to fig. 3 and 4, second resilient catch 453 is configured to disengage from an edge of retaining hole 423 when sheath 430 is at least partially retracted inside housing 420. In one embodiment, the second elastic hook 453 may be a barb structure bent in a distal direction, the outer side of which is configured with a slope 454, the proximal end of the sheath 430 is configured with a push rod 433 acting on the slope 454, when the sheath 430 is retracted inside the housing 420 of the implanter unit 400, the push rod 433 pushes the second elastic hook 453 inwards along the slope 454, so that the second elastic hook 453 is disengaged from the stopper hole 423, thereby releasing the first holding part 450, and the first holding part 450 moves the body surface attachment unit 200 in the distal direction to apply the body surface attachment unit 200 to the skin surface of the host under the action of the first driving spring 460, at which time the portion of the sensor electrode 210 is penetrated into the subcutaneous of the host to be in fluid contact with the subcutaneous tissue. The sensor electrode 210 includes an extracorporeal portion and an intracorporeal portion, the intracorporeal portion penetrating into the skin of the host and the extracorporeal portion exposed to the outside of the skin of the host. The extracorporeal portion is attached within the body surface attachment unit 200, e.g., the extracorporeal portion may be attached to the carrier 230 of the body surface attachment unit 200. A circuit module is also configured on the carrier 230, through which subcutaneous analyte concentration information monitored by the sensor electrodes 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 elastic jaws 471, and the elastic jaws 471 are coupled to the 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 on the periphery of the elastic jaw, one end of which abuts on a surface of the proximal end of the first holding portion 450, and the other end of which abuts on 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 hook portions 455, and at least a part of the third elastic hook portions 455 are hooked on the second steps 472. In one embodiment, only a portion of the third elastic hook 455 may hook the second step 472, and the number of the second step 472 is smaller than the number of the third elastic hook 455. In another embodiment, all the third elastic hook portions 455 are hooked on the second steps 472, and the number of the second steps 472 is equal to or greater than the number of the third elastic hook portions 455.
The third elastic hook 455 is configured to be disengaged from the second step 472 when the body surface attachment unit 200 is applied to the host skin surface. For example, the second holding portion 470 is provided with elastic arms 473 corresponding to the number of the third elastic hook portions 455, and the elastic arms 473 are configured to provide a prestress that pushes the third elastic hook portions 455 radially outward. Accordingly, the interior of housing 420 of implanter unit 400 is configured with guide tube 424 extending in a distal direction from the interior surface of the proximal end of housing 420, second retainer 470 and third elastic hook 455 are positioned within guide tube 424 prior to activation of the first drive mechanism, and the side wall of guide tube 424 supports third elastic hook 455 on second step 472 against being spread by elastic arm 473. When the first drive mechanism is activated, the first holding portion 450 carries the second holding portion 470 together to move in the distal direction, when moving to the body surface attachment unit 200 to be applied to the skin surface of the host, the third elastic hook 455 leaves the guide cylinder 424, the third elastic hook 455 is pushed apart outward by the elastic arm 473 without the support of the side wall of the guide cylinder 424, so that the third elastic hook 455 is disengaged from the second step 472, at which time the second holding portion 470 carries the needle assembly 410 under the action of the second drive spring 480 to move in the proximal direction to cause the needle assembly 410 to leave the skin of the host and retract into the outer and inner portions of the implanter unit 400, at which time the body surface attachment unit 200 is detained on the skin surface of the host, 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 is provided with an elongated slot 413, the puncture needle 411 penetrates through the body surface attachment unit 200 so that a portion of the sensor electrode 210, which is referred to herein as an internal portion of the sensor electrode 210, is attached inside the puncture needle 411 through the slot 413. The jaws of the second retaining portion 470 are clamped onto the hub 412.
Distal and proximal of the terms "distal", "proximal", "distal", "proximal" and "proximal" of the present invention are relative to the skin of the host during application of the body surface attachment unit, and specifically, proximal to the skin of the host is defined as distal and distal to the skin of the host as proximal.
The foregoing description, in such full, clear, concise and exact terms, provides the best mode contemplated of carrying out the present invention, and the manner and process of making and using it, to enable any person skilled in the art to which it pertains, to make and use the same. The invention is, however, susceptible to modifications and alternative constructions from that described above which are fully equivalent. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. Rather, the invention is to cover all modifications and alternative constructions falling within the spirit and scope of the invention as 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) are to be given their ordinary and customary meaning to those skilled in the art, and are not to be taken as limiting to a specific or special meaning unless expressly defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to including any specific characteristics or aspects of the disclosure with which that terminology is associated. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, should be construed to be open ended and not limiting unless otherwise expressly stated. As an example of the foregoing, the term "including" shall mean "including but not limited to" or the like.
Furthermore, although 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 of ordinary skill in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed 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 (16)
1. A transcutaneous 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 disposed at a distal end of the housing, and first and second drive mechanisms disposed within the housing, the body surface attachment unit comprising a sensor electrode;
the first drive mechanism is configured to drive the needle assembly in a distal direction to introduce portions of the sensor electrodes subcutaneously into the host and to apply the body surface attachment unit to the host skin surface 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 back into the housing when the body surface attachment unit is applied to the host skin surface.
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 implanter unit to the body surface attachment unit.
3. The transdermal analyte sensor system of claim 2, wherein the cap is configured to be removed in a rotational manner.
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 cooperatively secured by a sheath and cap prior to cap removal.
6. The transdermal analyte sensor system of claim 5, wherein a distal end of the sheath is coupled to a cap and a proximal end of the sheath is coupled to a housing of an implanter unit.
7. The transdermal analyte sensor system of claim 6, wherein the cap is configured with an annular support portion on an interior surface thereof, the support portion having a plurality of retention ribs circumferentially equally spaced on an exterior surface thereof, the sheath having a distal end on an interior surface thereof having a plurality of retention stops equally spaced on an interior surface thereof, at least some of the retention stops cooperating with the retention ribs when the distal end of the sheath 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 first plurality of resilient hooks, the housing of the injector unit is configured with a first plurality of steps inside, and at least a portion of the first resilient hooks catch the first steps when the proximal end of the sheath is coupled to the housing of the injector unit.
9. The transdermal analyte sensor system of claim 1, wherein the first drive mechanism comprises a first retaining portion and a first drive spring, a distal end of the first retaining portion configured with a connection hub coupled to a body surface attachment unit;
the first drive spring is configured to provide a pre-stress that drives the first retention portion in a distal direction.
10. The transdermal analyte sensor system of claim 9, wherein the proximal end of the first retainer is configured with a plurality of second resilient hooks, the housing of the implanter unit is configured with a plurality of retention holes 423 therein, and at least some of the second resilient hooks engage edges of the retention holes 423.
11. The transdermal analyte sensor system of claim 10, wherein the second resilient hook is configured to disengage from an edge of the retention aperture 423 when the sheath is at least partially retracted inside the housing.
12. 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 a needle assembly;
the second drive spring is configured to provide a pre-stress that drives the second retention portion in a proximal direction.
13. The transdermal analyte sensor system of claim 12, wherein the proximal end of the second retainer is configured with a plurality of second steps, the proximal end of the first retainer is configured with a plurality of third resilient hooks, and at least a portion of the third resilient hooks hook over the second steps.
14. The transdermal analyte sensor system of claim 13, wherein the third elastic hook is configured to disengage from the second step when the body surface attachment unit is applied to the host skin surface.
15. The transdermal analyte sensor system of claim 13, wherein the second retention portion is configured with a corresponding number of resilient arms to the third resilient hook, the resilient arms configured to provide a pre-stress urging the third resilient hook radially outward.
16. The transdermal analyte sensor system of claim 1, wherein the needle assembly includes 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 the 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 |
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| CN202111439161.7A CN114391836B (en) | 2021-11-27 | 2021-11-27 | Transdermal analyte sensor system |
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| CN114391836A true CN114391836A (en) | 2022-04-26 |
| CN114391836B CN114391836B (en) | 2024-04-12 |
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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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| WO2023092914A1 (en) | 2023-06-01 |
| CN114391836B (en) | 2024-04-12 |
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