Detailed Description
As described above, in order to further miniaturize the conventional analyte detecting apparatus mounting unit, a length of the needle body is exposed outside the housing when the auxiliary needle is retracted, which may cause unnecessary damage, and thus the miniaturization and safety of the mounting unit cannot be achieved.
In order to solve the problem, the invention provides an analyte detection device mounting unit with a protective structure, after the mounting unit is used, a part of auxiliary needle is exposed out of a shell, the auxiliary needle module is incompletely retracted, so that the retraction stroke of the auxiliary needle module is reduced, the overall height of the mounting unit shell is reduced, and meanwhile, an elastic protective sleeve is sleeved outside the auxiliary needle to protect the auxiliary needle, so that unnecessary damage is avoided.
Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement of parts and steps, numerical expressions and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise.
Furthermore, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to actual scale, e.g., the thickness, width, length, or distance of some elements may be exaggerated relative to other structures for ease of description.
The following description of the exemplary embodiment(s) is merely illustrative, and is in no way intended to limit the invention, its application, or uses. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail herein, but where applicable, should be considered part of the present specification.
It should be noted that like reference numerals and letters refer to like items in the following figures, and thus once an item is defined or illustrated in one figure, no further discussion thereof will be necessary in the following figure description.
First embodiment
FIG. 1 is a schematic view showing the external structure of an analyte sensing device mounting unit according to an embodiment of the present invention. The outer structure of the mounting unit 100 includes a housing 101 and a protective cover 102, the housing 101 for carrying the inner structural member. The mounting unit 100 is, in use, proximal to the skin of a user and distal to the skin. A first opening is provided at the proximal end of the housing 101. The protective cover 102 is used to protect, seal, and prevent actuation of the internal structure and internal structural components of the housing 101.
Outside of the housing
Fig. 2a is a schematic view of the external structure of the housing according to the embodiment of the present invention, and fig. 2b is a schematic view of the structure of the protective cover. The protective cover 102 includes an outer cover 1021, a clip 1022, and an inner cover 1023. The outer cover 1021 is provided with a second opening in the distal direction, the second opening facing the first opening. In the second opening, the outer cover 1021 is connected to the clamp 1022 by frangible studs 10211, the studs 10211 being spaced between the outer cover 1021 and the clamp 1022. The post 10211 can be broken off when the outer cover 1021 is rotated relative to the clamp 1022, and the outer cover 1021 is separated from the clamp 1022.
The inner side of the outer cover 1021 is provided with an internal thread 10212, and correspondingly, the outer side of the inner cover 1023 is provided with an external thread 10231, and the internal thread 10212 and the external thread 10231 can be connected in a matching way so as to connect the outer cover 1021 and the inner cover 1023 together and keep fixed.
The clamp 1022 is provided with a protrusion 10221 on the inner side, and correspondingly, a groove 1011 is provided on the outer side of the housing 101, the groove 1011 is formed around the outer side of the housing to form a circumference, and the protrusion 10221 can be embedded into the groove 1011. The outer cover 1021 and the inner cover 1023 are fixed by screw-fit, and then connected to the housing 101 by the clips 1022, and the outer cover 1021 and the inner cover 1023 can protect, seal and prevent triggering of the internal structure of the housing 101, where the triggering preventing function will be further described below.
In other embodiments of the invention, the outer cover 1021 and the inner cover 1023 may be friction fit or snap fit to provide a secure connection.
In other embodiments of the invention, the connection between the clips 1022 and the housing 101 may also be made by friction fit, snap fit, or screw fit.
Inside the housing
FIG. 3 is a schematic view of an exploded view of an analyte sensing device mounting unit according to an embodiment of the present invention, with broken lines showing the mounting engagement of the various structural members. The internal structural components of the analyte sensing device mounting unit 100 include a parallel slider module 103, an analyte sensing device 104, an auxiliary needle module 105, a trigger module 106, and an elastic module 107, the elastic module 107 including a first elastic member 1071 and a second elastic member 1072.
Fig. 4 is a schematic diagram illustrating an internal structure of the housing 101 according to an embodiment of the present invention.
In the embodiment of the present invention, at least two first buckles 1012 are disposed in the housing 101, and the first buckles 1012 are integrally formed with the housing 101 and protrude toward the proximal end of the housing 101. The first clip 1012 is a flexible material, and the distal end may be bent or curved to the outside of the housing 101.
In the preferred embodiment of the present invention, the number of first hooks 1012 is two, symmetrically distributed inside the housing 101, with an angular interval of 180 ° therebetween.
In other preferred embodiments of the present invention, the number of first hooks 1012 is three or four, symmetrically distributed inside the housing 101, with an angular interval of 120 ° or 90 ° therebetween. The number of first catches 1012 may also be five or more, without limitation.
In the embodiment of the present invention, at least two limiting grooves 1013, at least two clamping grooves 1014 and an auxiliary needle limiting groove 1015 are further provided in the housing 101.
In the embodiment of the present invention, the limiting groove 1013 includes at least two ribs protruding from the inner wall of the housing 101. In a preferred embodiment of the invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.
In other embodiments of the present invention, the limiting groove 1013 is a groove recessed in the inner wall of the housing 101.
In the embodiment of the present invention, the clamping groove 1014 includes two clamping groove positions, namely a first clamping groove position 10141 and a second clamping groove position 10142, as shown in fig. 10a, the first clamping groove position 10141 is close to the proximal end relative to the second clamping groove position 10142.
In the preferred embodiment of the present invention, the number of the limiting grooves 1013 and the clamping grooves 1014 is two, and the limiting grooves 1013 and the clamping grooves 1014 are symmetrically distributed inside the housing 101 and are spaced apart from each other by 180 °.
In other preferred embodiments of the present invention, the number of the limiting grooves 1013 and the clamping grooves 1014 is three or four, and the limiting grooves 1013 and the clamping grooves 1014 are symmetrically distributed inside the housing 101 and are angularly spaced from each other by 120 ° or 90 °. The number of the limiting grooves 1013 and the locking grooves 1014 may be five or more, and is not limited herein.
Parallel slider module
Fig. 5a is a schematic structural view of the distal end face of the parallel slider module 103, and fig. 5b is a schematic structural view of the proximal end face of the parallel slider module 103.
In the embodiment of the present invention, the distal end surface 1031 of the parallel slider module 103 is provided with a circular groove 1032 protruding toward the distal end, and the circular groove 1032 is a cylindrical structure with an inner diameter d1 hollowed out. At least two slider clips 10321 extend distally from the side wall of the circular slot 1032, and the clip portion of the slider clip 10321 is planar or approximately planar and forms a fixed angle with the horizontal plane, and the extension ends m0 thereof converge at the distal end.
In the embodiment of the present invention, the slider clip 10321 is made of a flexible material, and thus can be bent or folded to the outside of the circular groove 1032.
In other embodiments of the invention, the slider catch 10321 may be provided directly on the distal end face of the parallel slider module 103 without the need for a circular groove structure.
In the embodiment of the present invention, a section of boss 10322 is further disposed at one end of the circular groove 1032 near the distal end surface 1031, and the boss 10322 is a cylindrical structure with an inner hollow, and the inner diameter of the cylindrical structure is d2, which can be understood that d1 is greater than d2. The hollow interior circular slot 1032 and boss 10322 define a through-hole 10323 extending from the distal face 1031 to the proximal face 1034 of the parallel slider module.
In the preferred embodiment of the present invention, the number of slider clips 10321 is two, symmetrically distributed on the side wall of the circular slot 1032, and the two slider clips 10321 are angularly spaced 180 ° from each other.
In other preferred embodiments of the present invention, the number of slider clips 10321 may be three or four, symmetrically distributed on the side walls of the circular slot 1032, with the slider clips 10321 being angularly spaced from each other by 120 ° or 90 °. The number of slider clips 10321 may also be five or more, without limitation.
With continued reference to fig. 5a, in an embodiment of the present invention, at least two second hooks 1033 are disposed on the side of the distal surface 1031 of the parallel slider module 103, and the second hooks 1033 are symmetrically distributed on the side of the distal surface 1031 and are spaced apart from each other by 180 °.
In other embodiments of the present invention, the number of second buckles 1033 is three or four, symmetrically distributed on the side of the distal end face 1031, and the angular interval between them is 120 ° or 90 °. The number of the second snaps 1033 may be five or more, which is not limited herein. In the mounting unit 100, the second clasp 1033 is coupled with the first clasp 1012. The second clasp 1033 is identical in position and number to the first clasp 1012.
Referring to fig. 5b, in an embodiment of the present invention, at least two T-shaped structures 1035 are provided on the side of the proximal surface 1034 of the parallel slider module 103, the vertical portion of the T-shaped structures 1035 is connected to the proximal surface 1034, the horizontal portion includes a T-shaped structure slider 10351 and a T-shaped structure clip 10352, and the T-shaped structure slider 10351 faces the outer side of the parallel slider module 103 and protrudes from the outer ring of the parallel slider module 103; the T-shaped structural catches 10352 face the inside of the parallel slider module 103 and protrude from the inner ring of the parallel slider module 103.
In the mounting unit 100, the T-shaped structure slider 10351 is positioned in the limit groove 1013 to limit the position of the parallel slider module 103 and prevent the parallel slider module 103 from rotating in the mounting unit 100. The number and positions of the T-shaped structure sliders 10351 are identical to those of the limit grooves 1013. During proximal sliding of parallel slider module 103, T-shaped structure slider 10351 slides within limit slot 1013.
In a preferred embodiment of the present invention, the vertical portion of the T-shaped structure 1035 is a flexible material, the vertical portion is integrally formed with the horizontal portion, and the horizontal portion is bendable or bendable about the vertical portion.
In other preferred embodiments of the present invention, the vertical portion of the T-shaped structure 1035 is made of elastic material, such as a spring, a spring sheet, etc., and the horizontal portion is fixedly connected to the vertical portion by a welding or hot melting process, etc., and the horizontal portion may also be bent or curved around the vertical portion.
Analyte detection device
FIG. 6 is a schematic diagram of an analyte sensing device according to an embodiment of the present invention.
Referring in conjunction with FIG. 3, in an embodiment of the invention, analyte detection device 104 includes a housing 1041, an emitter (not shown), a sensor 1042, and internal circuitry (not shown) disposed within housing 1041 and electrically coupled to the sensor. The sensor 1042 is configured to detect analyte parameter information of a user's body fluid, communicate the analyte parameter information to a transmitter via an internal circuit, and transmit the analyte parameter information from the transmitter to the external device 200.
In a preferred embodiment of the present invention, the analyte sensing device 104 transmits a signal to the external apparatus 200 at a first frequency f1 before being mounted to the user's skin surface, and transmits a signal to the external apparatus 200 at a second frequency f2 after being mounted to the user's skin surface, the second frequency f2 being greater than the first frequency f1. In a further preferred embodiment of the invention, the first frequency f1 is 0 to 12 times/hour and the second frequency f2 is 12 to 3600 times/hour.
In a more preferred embodiment of the present invention, the first frequency f1 is 0 times/hour, i.e., no signal is emitted to the external device 200 before the analyte sensing device 104 is mounted to the user's skin surface, which may save power consumption of the analyte sensing device 104 before installation.
In an embodiment of the present invention, the outer housing 1041 includes an upper outer housing 10411 and a lower outer housing 10413, where the upper outer housing 10411 and the lower outer housing 10413 are spliced to form an inner space. The sensor 1042 includes an extracorporeal portion (not shown) and an intracorporal portion (not shown), the extracorporeal portion, the transmitter, and the internal circuit being disposed in the interior space, the extracorporeal portion being electrically coupled to the internal circuit. The structures such as electrodes, membrane layers and the like are arranged on the inner body part, and the analyte parameter information can be detected after penetrating into the skin of a user. When the body part is penetrated subcutaneously, a correct angle, e.g. perpendicular to the skin surface, is required. After the end of life of the analyte sensing device 104, it is removed from the user's skin surface and discarded in its entirety.
In an embodiment of the present invention, the lower outer housing 10413 includes a first through hole 10414 therethrough, and correspondingly, the upper outer housing 10411 includes a second through hole (not shown) therethrough on an axis of the first through hole 10414, and the inner portion passes through the first through hole 10414 to the outside of the housing so as to penetrate the user's skin.
In an embodiment of the present invention, the side edge of the upper outer housing 10411 includes a hole 10412 corresponding to the T-shaped structure 10352, where "corresponding" means that the position and number of the hole 10412 are consistent with those of the T-shaped structure 10352. In the mounting unit 100, the upper outer housing 10411 is attached to the proximal face 1034, the T-shaped structural clasp 10352 forms a clasp connection with the clasp hole 10412, and the analyte sensing device 104 is secured to the parallel slider module 103. When the horizontal portion of the T-shaped structure is bent or curved around the vertical portion, the snap connection of the T-shaped structure snap 10352 and the snap hole 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103. Thus in the mounting unit 100, the analyte sensing device 104 is releasably connected to the parallel slider module 103.
Auxiliary needle module
Fig. 7 is a schematic structural diagram of an auxiliary needle module according to an embodiment of the invention.
In an embodiment of the present invention, the helper needle module 105 includes a helper needle securing structure 1051 and a helper needle 1052. In the mounting unit 100, the auxiliary needle fixing structure 1051 is located at the distal end and the auxiliary needle 1052 is located at the proximal end.
In an embodiment of the present invention, the supplemental needle attachment structure 1051 includes a supplemental needle sled 10511 and a supplemental needle attachment block 10512, the supplemental needle sled 10511 having a diameter or width that is greater than the supplemental needle attachment block 10512, forming a proximally facing convex surface 10513.
In an embodiment of the present invention, the auxiliary needle 1052 includes a full-surrounding needle 10521 and a half-surrounding needle 10522, and the full-surrounding needle 10521 is located between the auxiliary needle fixing block 10512 and the half-surrounding needle 10522 and is fixedly connected to the auxiliary needle fixing block 10512. The hollow structure of the semi-surrounding needle 10522 can be used to house the in-vivo portion of the sensor 1042, which can be pierced subcutaneously by the user when the semi-surrounding needle 10522 is pierced subcutaneously and does not affect the state of the in-vivo portion subcutaneously when the needle is retracted.
In other embodiments of the present invention, the auxiliary needle 1052 only includes the semi-enclosed needle body 10522, i.e., the semi-enclosed needle body 10522 is fixedly connected to the auxiliary needle fixing block 10512, which may reduce the material and cost of the auxiliary needle 1052, but also reduce the rigidity of the auxiliary needle 1052.
In the mounting unit 100, the auxiliary needle 1052 passes through the second through-hole and the first through-hole 10414 in sequence so as to penetrate the analyte detection device 104, and the in-vivo portion of the sensor 1042 is located in the semi-enclosed needle 10522.
Trigger module
Fig. 8 is a schematic structural diagram of a trigger module according to an embodiment of the invention.
In the embodiment of the present invention, at least two fixing buckles 1061 corresponding to the first buckle 1012 are disposed on the triggering module 106. In the mounting unit 100, the fixing clip 1061 contacts the first clip 1012 to prevent the first clip 1012 from being bent or folded toward the outside of the housing. The contact between the fixing buckle 1061 and the first buckle 1012 may be point contact, line contact or surface contact, and when the contact is surface contact, the contact surface between the fixing buckle 1061 and the first buckle 1012 forms a fixed angle with the horizontal plane, and is converged at the proximal end of the mounting unit 100. The number and positions of the fixing snaps 1061 are identical to those of the first snaps 1012.
In the embodiment of the present invention, at least two lugs 1062 are further disposed on the triggering module 106, and in the mounting unit 100, the lugs 1062 are in snap fit with the slots 1014 to fix the triggering module 106. The number and positions of the lugs 1062 are identical to those of the slots 1014. Referring to fig. 10a in combination, prior to use of the mounting unit 100, the catch 1062 is in the first catch position 10141, at which time the securing catch 1061 is in contact with the first catch 1012.
In the embodiment of the present invention, the triggering module 106 further includes an outer ring 1063, and the outer ring 1063 connects the fixing buckle 1061 and the clip 1062 into a whole. In the mounting unit 100, the outer ring 1063 is located near the proximal end with respect to the clip 1062, is located at the first opening, and protrudes from the first opening, and the outer ring 1063 is attached to the skin surface of the user when the mounting unit 100 is in use.
Elastic module
Referring to fig. 3, the elastic module 107 includes a first elastic member 1071 and a second elastic member 1072.
In the embodiment of the present invention, the first elastic member 1071 is located between the parallel slider module 103 and the housing 101, that is, one end of the first elastic member 1071 is located at the distal end surface of the parallel slider module 103, and the other end is located in the housing 101, and in the mounting unit 100, the first elastic member 1071 is in a compressed state and can provide elastic force.
In the embodiment of the present invention, the second elastic member 1072 is located between the parallel slider module 103 and the auxiliary needle module 105, that is, one end of the second elastic member 1072 is located on the boss 10322 of the parallel slider module 103, and the other end is located on the convex surface 10513 of the auxiliary needle module 105, and in the mounting unit 100, the second elastic member 1072 is in a compressed state and can provide elastic force.
In a preferred embodiment of the present invention, the first elastic member 1071 or the second elastic member 1072 is a metal spring.
In the embodiment of the present invention, the inner ring diameter of the first elastic member 1071 is larger than the outer ring diameters of the circular groove 1032 and the auxiliary needle slider 10511, and in the mounting unit 100, the first elastic member 1071 surrounds the auxiliary needle slider 10511 and the outside of the circular groove 1032, so that the inner space of the mounting unit 100 can be fully utilized.
In the embodiment of the present invention, the outer ring diameter of the second elastic member 1072 is larger than the outer diameter of the auxiliary needle fixing block 10512 and the inner diameter of the boss 10322 and smaller than the outer diameter of the auxiliary needle slider 10511 and the inner diameter of the circular groove 1032, so that one end of the second elastic member 1072 is placed in the circular groove 1032 and the other end is enclosed outside the auxiliary needle fixing block 10512, thereby making it possible to fully utilize the inner space of the mounting unit 100.
Mounting unit using method
Fig. 9 is a top view of a mounting unit according to an embodiment of the present invention.
FIG. 10a is a schematic view of the cross-sectional structure A of FIG. 9; FIG. 10B is a schematic view of the cross-sectional structure B of FIG. 9; FIG. 10C is a schematic view of the cross-sectional structure C of FIG. 9; fig. 11 is a schematic diagram of a first buckle bending under force.
Referring to fig. 10a and 10b in combination, in an embodiment of the present invention, the card slot 1014 is provided with two card slot positions, a first card slot position 10141 and a second card slot position 10142. Before the installation unit 100 is used, the trigger module 106 is fixed on the housing 101 through the snap fit between the clip ear 1062 and the first clip slot 10141, at this time, the fixed clip 1061 contacts the first clip 1012, preventing the first clip 1012 from bending or bending towards the outside of the housing 101, and the fixed clip 1061, the first clip 1012 and the second clip 1033 are located on the same horizontal line. In the preferred embodiment of the present invention, the second catch 1033, the first catch 1012, and the fixed catch 1061 are sequentially provided from the inside of the housing 101.
In the embodiment of the present invention, the contact between the fixing buckle 1061 and the first buckle 1012 is one of point contact, line contact or surface contact, and when the contact is surface contact, the extension line m1 of the contact surface converges at the proximal end, and this structural design can enable the fixing buckle 1061 to slide distally relative to the first buckle 1012.
In a preferred embodiment of the present invention, the coupling surface of the second buckle 1033 and the first buckle 1012 is a plane, and the plane forms a fixed angle with the horizontal plane, and the extension end m2 thereof converges at the proximal end.
Referring to fig. 11 in combination, this structural design may enable the second buckle 1033 to push the first buckle 1012 out of the housing 101 when sliding proximally with respect to the first buckle 1012, thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033.
In the embodiment of the present invention, the first elastic member 1071 is in a compressed state, and has elastic potential energy, and its own elastic force gives the parallel module slider 103 a pushing force Fr to the proximal end, the pushing force Fr acts on the first buckle 1012 through the coupling surfaces of the second buckle 1033 and the first buckle 1012, and generates a component force Fsin perpendicular to the plane of the first buckle 1012, and the component force Fsin can push the first buckle 1012 to the outside of the housing 101 to bend or buckle, so as to release the coupling state of the first buckle 1012 and the second buckle 1033.
In the embodiment of the present invention, when the mounting unit 100 is used, the outer cover 1021 is rotated to break the upright 10211, the protective cover 102 is separated from the housing 101, the proximal end of the mounting unit 100 is close to the skin of the user until the outer ring 1063 of the trigger module 106 is attached to the skin surface, the user presses the housing 101 at the distal end, the housing 101 slides toward the skin, and the trigger module 106 remains stationary, so that the trigger module 106 slides distally relative to the housing 101, the clip 1062 is disengaged from the first clip slot 10141 and enters the second clip slot 10142, and the fixing clip 1061 is no longer in contact with the first clip 1012, the first clip 1012 is bent or folded outward of the housing 101 due to the component force Fsin, and the coupling state of the first clip 1012 and the second clip 1033 is released.
In the embodiment of the present invention, after the decoupling state, the parallel slider module 103 is pushed by the elastic force of the first elastic member 1071 to continue to slide proximally, and simultaneously drives the analyte detection device 104 to slide proximally until the lower outer housing 10413 of the analyte detection device 104 contacts the skin surface of the user.
Referring to fig. 10c, in the embodiment of the present invention, the slider clip 10321 is in clip connection with the auxiliary needle slider 10511, and the first elastic member 1071 drives the auxiliary needle module 105 to slide together when pushing the parallel slider module 103 to slide proximally.
In the embodiment of the present invention, the connection between the slider clip 10321 and the auxiliary needle slider 10511 is a plane or an approximate plane, the plane forms a fixed angle with the horizontal plane, and the extension line m3 thereof is converged at the distal end. The second elastic member 1072 pushes the auxiliary needle slider 10511 distally, so that the auxiliary needle slider 10511 pushes the slider catch 10321 away from the housing 101, and the slider catch 10321 bends or bends, which is the same principle as fig. 11.
In the embodiment of the present invention, in the mounting unit 100, the side wall of the auxiliary needle limit groove 1015 prevents the slider clip 10321 from bending or bending, and the clip connection state of the slider clip 10321 and the auxiliary needle slider 10511 does not change. As the parallel slider module 103 and the helper needle module 105 slide proximally until the slider catch 10321 is disengaged from the helper needle limit groove 1015, the inner wall of the helper needle limit groove 1015 no longer prevents the slider catch 10321 from bending or flexing, the second elastic member 1072 pushes the helper needle slider 10511 distally, and simultaneously the helper needle slider 10511 pushes the slider catch 10321 to bend or flex outwardly, the catch connection between the slider catch 10321 and the helper needle slider 10511 is released, the second elastic member 1072 continues to push the helper needle slider 10511 to slide distally, and finally the helper needle module 105 returns to the initial position, the helper needle 1052 is retracted into the housing 101, the helper needle 1052 is prevented from being exposed outside the housing 101, and unnecessary injuries are avoided.
In an embodiment of the present invention, when the slider catch 10321 is disengaged from the auxiliary needle limit groove 1015, the auxiliary needle semi-surrounding needle body 10522 pierces the user's skin.
In the embodiment of the present invention, in the mounting unit 100, the T-shaped structure slider 10351 is located in the limit groove 1013, and the limit groove 1013 limits the position and direction of the parallel slider module 103 through the T-shaped structure slider 10351, so as to ensure that the parallel slider module 103 is kept perpendicular to the sliding direction thereof, so that the analyte detecting device 104 disposed at the front end of the parallel slider module 103 is kept perpendicular to the sliding direction thereof, and meanwhile, the auxiliary needle 1052 is kept parallel to the sliding direction thereof, so that the internal part of the sensor body of the auxiliary needle 1052 and the envelope thereof can penetrate into the skin of the user at a perpendicular angle, and pain feeling of the user is reduced.
In the embodiment of the present invention, during the proximal sliding process of the parallel slider module 103, the T-shaped structure slider 10351 slides in the limiting groove 1013 until contacting the outer ring 1063 of the trigger module 106, the parallel slider module 103 continues to slide proximally under the pushing of the first elastic member 1071, and the outer ring 1063 blocks the T-shaped structure slider 10351 from continuing to slide proximally, so that the T-shaped structure slider 10351 bends or bends around the vertical portion, the snap connection between the T-shaped structure snap 10352 and the snap hole 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103, so as to be installed on the skin surface of the user.
In an embodiment of the present invention, when the T-shaped structured slider 10351 contacts the outer ring 1063, the parallel slider module 103 is positioned at a predetermined location, where the lower outer housing 10413 of the analyte sensing device contacts the user's skin surface.
In an embodiment of the invention, the auxiliary needle 1052 passes through the second through hole and the first through hole 10414 in sequence, through the analyte detection device 104, while the auxiliary needle half surrounds the needle body 10522 enveloping the sensor 1042. During proximal sliding of the parallel slider module 103 and the auxiliary needle module 105, the semi-surrounding needle 10522 carries the sensor 1042 to penetrate the skin, and after the auxiliary needle 1052 is retracted, the inner part of the sensor 1042 remains under the skin, and the needle is retracted without affecting the state of the inner part of the sensor 1042.
In the embodiment of the present invention, when the user presses the housing 101 at the distal end, a force F is applied to the housing 101 to the proximal end, the outer ring 1063 of the trigger module 106 contacts the skin surface of the user, and the skin of the user applies a force F' opposite to the force F to the outer ring 1063, thereby realizing the relative sliding of the trigger module 106 and the housing 101. During the actual installation, the absolute position of the trigger module 106 remains unchanged and the housing 101 slides proximally.
Before the mounting operation, in order to prevent the trigger module 106 from sliding relative to the housing 101, the protective cover 102 is mounted at the proximal end of the housing 101, and the protective cover 102 surrounds the outer ring 1063 of the trigger module, so that the mounting operation at an incorrect position due to the erroneous touching of the outer ring 1063 can be prevented, and the triggering prevention function is achieved.
The distal surface 10232 of the inner cap 1023 contacts the analyte sensing device 104 while the auxiliary needle 1052 and the sensor 1042 extend into the inner cap recess 10233 to provide a seal against contamination by external dust, particles, etc. coming into contact with the needle and the sensor.
In an embodiment of the present invention, an adhesive tape (not shown) is further provided on the lower outer housing 10413 of the analyte sensing device for securing the analyte sensing device 104 to the surface of the user's skin.
Second embodiment
In the foregoing embodiment, after the user uses the mounting unit, the auxiliary needle is automatically retracted into the housing under the action of the second elastic member, so as to avoid unnecessary injury to the user. The complete retraction of the auxiliary needle into the interior of the housing requires a sufficient height to be reserved in the housing to accommodate the auxiliary needle module, which limits the miniaturized design of the mounting unit. In order to further reduce the overall height of the housing of the mounting unit and reduce the volume of the mounting unit, the embodiment of the invention considers reducing the retraction stroke of the auxiliary needle, and after the retraction stroke of the auxiliary needle is reduced, the needle tip of the auxiliary needle may be exposed outside the housing of the mounting unit, which is unsafe for a user, so that the protection measures for the auxiliary needle are also considered, and a needle body protection structure is designed for the auxiliary needle.
In the above technical background, in some embodiments of the present invention, after a user installs an analyte monitoring device using a mounting unit, an auxiliary needle is not completely retracted inside a housing, at least a portion of the auxiliary needle, for example, a needle tip is exposed outside the housing, and the user assembles a needle body protecting structure to the mounting unit to protect the exposed needle tip. Specific embodiments of the needle protection structure will be described in detail below.
In the embodiments of the present invention, the undescribed technical solution is considered to be the same as the foregoing embodiments, and will not be repeated here.
FIG. 12 is a schematic view of an exploded view of an analyte sensing device mounting unit according to an embodiment of the present invention. Fig. 13a is a schematic diagram of a separation structure of an outer cover and an inner cover according to an embodiment of the invention. Fig. 13b is a schematic diagram of an integral structure of the outer cover and the inner cover according to an embodiment of the present invention. Fig. 13c is a schematic structural view of the outer cover according to the embodiment of the present invention.
Referring to fig. 12, in some embodiments of the invention, the mounting unit 200 includes a housing 201 and a protective cover 202, as previously described, with the analyte sensing device 204 pre-mounted inside the housing 201 prior to installation, urged proximally by a resilient module (not shown, see fig. 17) for mounting to the skin surface of a user. A protective cover 202 is provided at the proximal end of the housing 201 and is releasably connected to the housing 201 for protecting the structural elements inside the housing 201 prior to installation.
Referring to fig. 13 a-13 c in combination, in some embodiments of the present invention, the protective cover 202 includes an outer cover 2021, an inner cover 2023, and a label paper 2024, wherein the inner cover 2023 is received in the outer cover cavity 20214 prior to installation in accordance with the relative positional relationship shown in fig. 13, and the outer cover cavity 20214 is sealed with the label paper 2024 to enclose the inner cover 2023 within the outer cover cavity 20214.
In some embodiments of the invention, the inner cover 2023 is in an active or releasably attached state relative to the outer cover 2021. When the inner cover 2023 is in a movable state relative to the outer cover 2021, the outer cover 2021 has no constraint structure on the inner cover 2023 to limit the state of the inner cover 2023 within the outer cover 2021, and a user can directly take out the inner cover 2023 from the outer cover 2021 when necessary. When the inner cover 2023 is in a releasable connection state relative to the outer cover 2021, the inner cover 2023 and the outer cover 2021 are fixed together by means of a buckle, a hook, a thread, a hook and loop fastener, and the like, and when needed, a user needs to release the fixed connection between the inner cover 2023 and the outer cover 2021, and then take out the inner cover 2023 from the outer cover 2021 after the inner cover 2023 is separated from the outer cover 2021. In a preferred embodiment of the present invention, for the convenience of a user, the inner cover 2023 is in a movable state with respect to the outer cover 2021 before using the mounting unit 200, so that the user can take out the inner cover 2023 from the outer cover 2021 while using the mounting unit 200.
In some embodiments of the present invention, to accommodate the inner cap 2023 within the outer cap 2021, the middle portion of the outer cap 2021 protrudes distally and forms an outer cap cavity 20214 with a proximal opening, the inner diameter of the outer cap cavity 20214 is slightly larger than the outer diameter of the inner cap 2023, for example, a gap of 0.5-5 mm is left between the inner wall of the outer cap cavity 20214 and the outer wall of the inner cap 2023, and at the same time, the depth of the outer cap cavity 20214 is not smaller than the height of the inner cap 2023, so that the inner cap 2023 protrudes out of the outer cap cavity 20214, so that the label paper 2024 is adhered to the proximal end face 20215 of the outer cap 2021, and sealing of the outer cap cavity 20214 is completed.
In some embodiments of the present invention, a plurality of raised semi-spheres 20234 are also provided on the proximal face 20232 of the inner cap body 2023. Before using the mounting unit 200, the inner cover 2023 is accommodated in the outer cover cavity 20214, the label paper 2024 is adhered to the proximal end face 20215 of the outer cover 2021, and the adhesive coating area of the label paper 2024 may exceed the contact area between the label paper 2024 and the outer cover 2021, so that the adhesive coating of the label paper 2024 contacts the proximal end face 20232 of the inner cover 2023, the inner cover 2023 is adhered to the label paper 2024, when the inner cover 2023 is taken out, the label paper 2024 is difficult to tear by a user, even the label paper 2024 is damaged when being torn, and the label paper is adhered to the inner cover 2023, thereby affecting the use experience of the user. Based on this, a plurality of protruding semi-spheres 20234 are provided on the proximal end face 20232 of the inner cover 2023, and contact with the label paper 2024, so that the contact area between the proximal end face 20232 of the inner cover 2023 and the label paper 2024 can be reduced, and the label paper 2024 can be prevented from adhering to the proximal end face 20232 of the inner cover 2023 in a large area, thereby facilitating the user to tear off the label paper 2024.
In some embodiments of the invention, the number of raised semi-spheres 20234 is at least 2, symmetrically or asymmetrically distributed on the proximal face of the inner cap 2023. Preferably, the raised semi-spheres 20234 are symmetrically and evenly distributed on the proximal face of the inner cap 2023.
In some embodiments of the invention, label paper 2024 may have printed thereon information related to the analyte sensing device 204, mounting unit 200, etc., such as a lot number, date of manufacture, instructions for use, a communication connection SN code, a trademark, a two-dimensional code, etc.
In some embodiments of the present invention, the protection cover 202 is releasably connected to the housing 201 before the mounting unit 200 is used, and the specific usage is described in the first embodiment, which is not repeated here. The needle receiving chamber 20213 in the outer cover 2021 receives the auxiliary needle 2052 when the protective cover 202 is mounted to the housing 201. The needle receiving chamber 20213 is a distally open (distally open seen in fig. 13 a), hollow truncated cone or cone having a diameter that decreases from the distal end to the proximal end when the needle receiving chamber 20213 is of a conical configuration. The inside of the needle housing chamber 20213 may be a hollow structure parallel to the outer structure, or may be a hollow structure having an inner diameter decreasing from the distal end to the proximal end. The auxiliary needle 2052 and the needle body accommodating chamber 20213 share a central axis so that the auxiliary needle 2052 can enter the hollow chamber from the distal end opening of the needle body accommodating chamber 20213, and the needle body accommodating chamber 20213 effectively utilizes the inner space of the housing 201 while protecting the auxiliary needle 2052, so that the structure is more compact.
Fig. 14 is a schematic view of a mounting unit according to an embodiment of the present invention after use.
Referring to fig. 14, in some embodiments of the present invention, a user places the mounting unit 200 on the skin surface, the trigger module 206 is in contact with the skin, the user applies pressure to the mounting unit 200 from the distal end to the proximal end, the housing 201 slides proximally relative to the trigger module 206, and the trigger module 206 releases the restriction of the elastic module (not shown) during the proximal sliding of the housing 201 relative to the trigger module 206, and the parallel slider module 203, the analyte sensing device 204, and the auxiliary needle 2052 are pushed to slide proximally together under the elastic force of the elastic module until the analyte sensing device 204 is in contact with the skin surface, and the auxiliary needle 2052 pierces the skin.
Referring to the orientation shown in fig. 14, in some embodiments of the invention, during proximal sliding movement of the parallel slider module 203, analyte sensing device 204, and auxiliary needle 2052 together, when the proximal face of analyte sensing device 204 is flush with the proximal face of trigger module 206, analyte sensing device 204 is in contact with the skin surface of the user, the elastic module still has a proximal thrust force on parallel slider module 203, and parallel slider module 203 carries analyte sensing device 204, auxiliary needle 2052, and continues to slide proximally relative to housing 201, and analyte sensing device 204 located at the proximal end of parallel slider module 203 presses against the skin surface. The proximal end of the analyte sensing device 204 is provided with a patch (not shown) and the analyte sensing device 204 presses the patch against the skin surface to increase the adhesion of the patch to the skin surface so that the analyte sensing device 204 adheres more securely to the skin surface.
In some embodiments of the present invention, during the continuous proximal sliding of the parallel slider module 203 relative to the housing 201, the position of the parallel slider module 203 is not changed due to the blocking of the skin surface, and if the elastic member in the elastic module is still not fully released, the elastic module pushes the housing 201 to slide distally relative to the parallel slider module 203 and carries the trigger module 206 away from the skin surface until the proximal surface of the trigger module 206 and the proximal surface of the parallel slider module 203 form a height difference h1, and the skin surface forms a pit under the extrusion action of the analyte detection device 204 and the parallel slider module 203.
In some embodiments of the invention, during continued proximal sliding of the parallel slider module 203 relative to the housing 201, the snap-fit connection of the parallel slider module 203 to the analyte sensing device 204 is decoupled, and at the end of the relative sliding of the parallel slider module 203 to the housing 201, the parallel slider module 203 has been separated from the analyte sensing device 204 while the parallel slider module 203 is still restrained within the housing 201, at which point the analyte sensing device 204 is in a separated state relative to the housing 201, the user can lift the housing 201 distally by hand and the analyte sensing device 204 is adhered to the skin surface by adhesive tape.
In some embodiments of the invention, when the parallel slider module 203 is slid proximally to a first predetermined position relative to the housing 201, the auxiliary needle module 205 is slid proximally to a terminus relative to the housing, at which point the auxiliary needle 2052 penetrates the skin and the in vivo portion of the sensor 2042 is delivered to a predetermined depth beneath the skin. The auxiliary needle module 205 is then retracted and slid distally relative to the housing 201 to a second predetermined position.
Fig. 15 is a schematic view showing a state after the auxiliary needle of the mounting unit according to the embodiment of the present invention is retracted.
Referring to fig. 15, in some embodiments of the invention, the auxiliary needle module 205 is slid distally to a second predetermined position, i.e., after the end of retraction, the auxiliary needle 2052 is withdrawn subcutaneously to facilitate removal of the housing 201 by the user. After the auxiliary needle 2052 is retracted, the in-vivo portion of the sensor 2042 remains subcutaneous.
In some embodiments of the present invention, after the auxiliary needle 2052 is retracted, a tip of the auxiliary needle 2052 is exposed to the outside of the housing 201, and as shown in fig. 15, a height difference h2 is formed between the tip of the auxiliary needle 2052 and the proximal end surface of the parallel slider module 203, that is, the length of the auxiliary needle 2052 exposed to the outside of the housing 201 is h2, and the preferable range of h2 is 0.1-5 mm. The auxiliary needle 2052 has an excessively long exposed length, and the needle tip is left subcutaneously when retracted, which may cause damage to the skin or body when the user removes the housing 201.
In some embodiments of the present invention, exposing a portion of the needle tip outside the housing 201 after the auxiliary needle 2052 is retracted, rather than fully retracted into the housing 201, may reduce the retraction stroke of the auxiliary needle 2052, thereby reducing the overall height of the housing 201, making the mounting unit 200 more compact and less massive, while also reducing the material usage of the housing 201 and reducing the manufacturing cost of the mounting unit 200. In fig. 15, the auxiliary needle module 205 shown by the broken line represents the final position of the auxiliary needle module 205 before and after the reduction of the retraction stroke, and the final position of the auxiliary needle module 205 before the reduction of the retraction stroke is near the distal end, and the final position of the auxiliary needle module 205 after the reduction of the retraction stroke is near the proximal end.
In some embodiments of the invention, the reduction in the retracting stroke of the auxiliary needle 2052 represents a reduction in the same retracting stroke of the auxiliary needle module 205. Referring to fig. 15, the reduced retraction stroke of the auxiliary needle module 205 is h3, and after the reduction of the retraction stroke of the auxiliary needle module 205, the overall height of the housing 201 may be reduced, and the overall height of the reduced housing 201 may be identical to the reduced retraction stroke of the auxiliary needle module 205, both being h3.
In some embodiments of the present invention, the auxiliary needle 2052 is exposed to the outside of the housing 201, and thus the needle tip may cause unnecessary injury to the human body, and thus, the exposed needle tip may be protected by the needle body protecting structure after the mounting unit 200 is used.
Fig. 16a to 16c are schematic views showing the inner cap as a needle body protecting structure according to the embodiment of the present invention.
Referring to fig. 16 a-16 c and 13c in combination, in some embodiments of the present invention, after using the mounting unit 200, the user may remove the inner cover 2023 from the outer cover 2021, the inner cover 2023 is assembled to the parallel slider module 203, the trigger module 206, or the housing 201, and a needle protecting cavity 20233 is provided in the inner cover 2023 to protect the exposed needle tip of the auxiliary needle 2052.
In some embodiments of the present invention, the assembly of the inner cover 2023 and the parallel slider module 203 is described as an embodiment, and the inner cover 2023 is a needle protection structure of the embodiment of the present invention. The proximal face of the parallel slider module 203 is larger in area relative to the proximal face of the trigger module 206 or housing 201, making it easier to machine the assembly structure.
In some embodiments of the invention, and referring to the orientation shown in fig. 16b, the needle guard lumen 20233 is a distally-opening hollow cavity, the interior of which may be adapted to receive the exposed tip of the auxiliary needle 2052. The outer side of the needle protecting chamber 20233 may be a cylinder, a cone, a rectangular parallelepiped or other irregular solid structure, but not limited thereto, and the inner side chamber may be the same or a different shape structure from the outer side, preferably, the inner side chamber is a cylinder or a cone, more preferably, the inner side chamber is a cone, the inner diameter of which gradually decreases from the distal end to the proximal end.
In some embodiments of the present invention, if the auxiliary needle 20522 is in an eccentric position relative to the parallel slider module 203, the needle protection cavity 20233 is also in an eccentric position on the inner cap 2023, i.e., the auxiliary needle 20522 shares a central axis with the needle protection cavity 20233. Before the user assembles the outer cover 2021 onto the parallel slider module 203, it is necessary to ensure that the distal opening of the needle protection cavity 20233 is aligned with the auxiliary needle 20522, avoiding misalignment of the needle protection cavity 20233 with the auxiliary needle 20522.
In some embodiments of the present invention, the inner cover 2023 and the parallel slider module 203 are assembled by one or more of a buckle, a hook, a fixture, a screw, a bolt, a hook and loop, and glue, and all the assembling modes that can assemble the inner cover 2023 to the parallel slider module 203 are included in the protection scope of the present invention. At least 2 structures for fitting connection are provided at corresponding positions of the inner cover body 2023 and the parallel slider module 203, and preferably, the fitting structures are symmetrically distributed on the inner cover body 2023 and the parallel slider module 203.
In some embodiments of the present invention, the fitting structure may be interchanged on the inner cover 2023 and the parallel slider module 203, for example, the distal end surface of the inner cover 2023 is provided with a hook 20231, and the proximal end surface of the parallel slider module 203 is provided with a corresponding hook hole 2037 for establishing fitting connection with the hook 20231. In other embodiments of the present invention, the hooks 20231 may be disposed on the parallel slider module 203, and the corresponding fastening holes 2037 are disposed on the inner cover 2023.
In some embodiments of the present invention, in order to facilitate the user's assembly of the inner cover 2023 and to increase the assembly firmness of the inner cover 2023, positioning structures are further provided on the inner cover 2023 and the parallel slider module 203. The positioning structure is composed of positioning posts 20232 and positioning holes 2036, and the positions and the number of the inner cover 2023 and the parallel slider modules 203 correspond.
In some embodiments of the invention, the positioning posts 20232 may be located on the distal end face of the inner cap body 2023, with the positioning holes 2036 located on the proximal end face of the parallel slider module 203. In other embodiments of the invention, the locating hole 2036 may be located on the distal end face of the inner cover 2023, where the locating post 20232 is located on the proximal end face of the parallel slider module 203.
In some embodiments of the present invention, the positioning structure is not limited to the combination of the positioning posts 20232 and the positioning holes 2036 shown in fig. 16a to 16c, but may be other types of positioning structures, such as a combination of a slider and a chute, and any structure involving a positioning function should be included in the protection enclosure of the present invention.
In some embodiments of the present invention, the user holds the inner cap 2023 and the housing 201 by hand and approaches each other, respectively, and aligns the assembly structure and the positioning structure, i.e., places the auxiliary needle 20522 on the central axis of the needle protecting cavity 20233, and then forcibly presses the inner cap 2023 and the housing 201, i.e., the inner cap 2023 is assembled to the parallel slider module 203, and the needle protecting cavity 20233 wraps the auxiliary needle 20522 to close and protect the exposed needle tip. A schematic view of the state in which the inner cover body 2023 is assembled to the parallel slider module 203 is shown in fig. 16 c.
Fig. 17 is a schematic cross-sectional structure of a mounting unit according to an embodiment of the present invention.
Referring to fig. 17, in some embodiments of the present invention, the elastic module includes a first elastic member 2071, a second elastic member 2072, and a third elastic member 2073. Before the mounting unit 200 is used, the first elastic member 2071 and the second elastic member 2072 are in a compressed state, and the third elastic member 2073 is in a normal state. The first elastic member 2071 is for pushing the parallel slider module 203 to slide proximally after releasing the elastic force, the second elastic member 2072 is for pushing the auxiliary needle module 205 distally to retract the auxiliary needle 2052 after releasing the elastic force, and the third elastic member 2073 is for adjusting the retraction stroke of the auxiliary needle module 205.
In some embodiments of the present invention, a third elastic member 2072 is provided in the housing 201, with one end abutting against the inside of the housing 201 and the other end facing the auxiliary needle module 205. After the first elastic member 2071 pushes the parallel slider module 203 proximally and the second elastic member 2072 pushes the auxiliary needle module 205 distally, the third elastic member 2073 blocks the auxiliary needle module 205 from continuing to slide distally, limiting the retraction of the auxiliary needle module 205 to reduce the retraction stroke thereof. If the third elastic member 2073 is not provided, the auxiliary needle module 205 will slide to the most distal end inside the housing 201 until it abuts against the housing 201 when it is retracted. After the third elastic member 2073 is provided, the retraction stroke of the auxiliary needle module 205 may be adjusted according to the preset relative elastic force and length of the second elastic member 2072 and the third elastic member 2073, thereby adjusting the exposed length of the tip of the auxiliary needle 2052.
In some embodiments of the present invention, the reduced amount h3 of the retracting stroke of the auxiliary needle module 205 is equal to the length L of the third elastic member 2073 after the elastic forces of the second elastic member 2072 and the third elastic member 2073 are balanced.
In some embodiments of the present invention, the initial state of the third elastic member 2073 is a normal state, not compressed or stretched, and the initial state of the second elastic member 2072 is a compressed state. After the second elastic member 2072 releases the elastic force, the auxiliary needle module 205 is pushed distally by the second elastic member 2072 until the auxiliary needle module 205 contacts the proximal end of the third elastic member 2073 and continues to slide distally by the elastic force of the second elastic member 2072. The third elastic member 2073 is compressed by the elastic force of the second elastic member 2072 and generates an elastic force until the elastic force of the third elastic member 2073 is the same as the elastic force of the second elastic member 2072 and reaches an equilibrium state, and the auxiliary needle module 205 stops sliding distally.
In some embodiments of the present invention, the second elastic member 2072 and the third elastic member 2073 are springs, and their elastic moduli and initial lengths are preset before shipment. After the auxiliary needle module 205 is retracted, the third elastic member 2073 is in a balanced state with the same elastic force as the second elastic member 2072, and the second elastic member 2072 is still in a compressed state. By adjusting the elastic modulus and the initial length of the second elastic member 2072 and the third elastic member 2073, it is possible to control the length L of the third elastic member 2073 when the second elastic member 2072 and the third elastic member 2073 reach the elastic balance, thereby controlling the retraction stroke of the auxiliary needle module 205 and the reduction amount h3 of the retraction stroke, and finally determining the length h2 of the tip of the auxiliary needle 2052 exposed out of the housing 201.
In some embodiments of the present invention, after the auxiliary needle module 205 stops sliding, the user lifts the housing 201 from the skin surface, the tip of the auxiliary needle 2052 is exposed outside the housing 201, and then the inner cover 2023 is assembled to the parallel slider module 203, the needle protection cavity 20233 encloses and seals the auxiliary needle 2052, and the inner cover 2023 performs its protective function for the auxiliary needle 2052.
Fig. 18a to 18c are schematic views showing a protective sheath as a needle body protective structure according to an embodiment of the present invention.
18 A-18 c, in some embodiments of the invention, the needle protection structure may also be a resilient protective sheath 20523. After the user uses the mounting unit 200, the flexible protective sheath 20523 may be fitted to the auxiliary needle 2052 to protect the needle tip exposed outside the housing 201, the detailed description of which will be described below.
Referring to the orientation shown in fig. 18b, in some embodiments of the invention, the flexible protective sheath 20523 is a hollow solid structure having a distal opening for receiving the auxiliary needle 2052. The auxiliary needle 2052 is set to have an outer diameter d3 and an inner diameter d4 at the distal end opening of the resilient protective sheath 20523, the inner diameter d4 being slightly larger than the outer diameter d3 of the auxiliary needle 2052, for example, by 0.1 to 2mm, in order to facilitate alignment of the auxiliary needle 2052 with the distal end opening of the resilient protective sheath 20523 by a user. The inner diameter of the elastic protective sheath 20523 gradually decreases from the distal end opening to the proximal end until the inner diameter is reduced to d5, and the inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052, for example, relatively smaller than 0.1-2 mm, and since the material of the elastic protective sheath 20523 has elasticity, the inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052, so that the elastic protective sheath 20523 and the auxiliary needle 2052 realize interference fit, and the friction force between the auxiliary needle 2052 and the elastic protective sheath 20523 is increased, so that the elastic protective sheath 20523 can be fixed relative to the auxiliary needle 2052 without falling off after the auxiliary needle 2052 is sleeved outside. That is, the elastomeric protective sheath 20523 and the auxiliary needle 2052 are sized with d4 > d3 > d5. The proximal end of the flexible protective sheath 20523 may optionally be open or closed and the overall length thereof should be no less than the length h2 of the auxiliary needle 2052 exposed outside the housing 201, e.g. 0.1-20 mm relatively long, so that the flexible protective sheath 20523 can completely enclose the exposed needle tip for protection of the auxiliary needle 2052. Preferably, the proximal end of the resilient protective sheath 20523 is closed to prevent the tip of the auxiliary needle 2052 from being exposed from the proximal end of the resilient protective sheath 20523.
In some embodiments of the present invention, the flexible protective sheath 20523 may be a structural member that is independent of the mounting unit 200 prior to use of the mounting unit 200 by a user, and the flexible protective sheath 20523 is configured to be integral with the mounting unit 200 after use of the mounting unit 200 by a user over the auxiliary needle 2052.
In some embodiments of the present invention, the resilient boot 20523 may be made of an elastomeric material such as silicone, rubber, etc., as the resilient boot 20523 needs to have a certain degree of resiliency to achieve an interference fit with the auxiliary needle 2052. Any material modification of the flexible boot 20523 is intended to be within the scope of the present invention.
In some embodiments of the invention, the resilient boot 20523 may not be limited to the straight bar-like structures described above and shown in fig. 18 a-18 c, but may be other solid structures such as spheres, cones, or other irregular solid structures. Any shape modification of the elastomeric protective sheath 20523 is intended to be within the scope of the present invention.
In summary, the embodiment of the invention discloses an analyte detecting device mounting unit with a protective structure, wherein after the mounting unit is used, a part of auxiliary needle is exposed out of a housing, and the auxiliary needle module is incompletely retracted, so that the retraction stroke of the auxiliary needle module is reduced, the overall height of the housing of the mounting unit is reduced, and meanwhile, an elastic protective sleeve is sleeved outside the auxiliary needle to protect the auxiliary needle, thereby avoiding unnecessary damage.
While certain specific embodiments of the invention have been described in detail by way of example, it will be appreciated by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.