CN217066374U

CN217066374U - Subcutaneous implantation type medical unit, medical device and irradiation sterilization shielding device

Info

Publication number: CN217066374U
Application number: CN202123379307.1U
Authority: CN
Inventors: 刘文杰; 丁志刚; 傅向阳; 裘丹; 其他发明人请求不公开姓名
Original assignee: Shanghai Microport Lifesciences Co Ltd
Current assignee: Shanghai Microport Lifesciences Co Ltd
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2022-07-29
Anticipated expiration: 2031-12-29

Abstract

The utility model provides a subcutaneous implanted medical unit, medical device and irradiation sterilization shield assembly, subcutaneous implanted medical unit includes: the sensor comprises a shell, a sensing implantation part and a circuit assembly; the circuit assembly is accommodated in the shell, the shell is provided with a bottom hole, one end of the sensing implantation part is connected with the circuit assembly, and the other end of the sensing implantation part penetrates out of the bottom hole; the circuit component avoids a projection area of the bottom hole along the extension direction of the sensing implantation part. So the configuration, because the bottom hole scope has been avoided to the circuit subassembly of not nai irradiation, can adopt the mode of local accurate irradiation to carry out the radiation sterilization to the scope of bottom hole along the extending direction of sensing implantation portion, the realization needs the radiation sterilization of the sensing implantation portion of sterilization and can not damage the circuit subassembly of not nai irradiation, but makes sensing implantation portion and circuit subassembly integration set up in the casing from this.

Description

Subcutaneous implantation type medical unit, medical device and irradiation sterilization shielding device

Technical Field

The utility model relates to the technical field of medical equipment, in particular to subcutaneous implanted medical unit, medical device and irradiation sterilization shield assembly.

Background

A biosensor is an apparatus that senses a bioactive substance and converts the sensed concentration of the bioactive substance into an electrical signal for detection, and the sensing method is generally to make a wound in a living body.

Among them, the glucose sensor is a common biosensor. CGM (continuous blood glucose monitoring) is a technical means of indirectly reflecting blood glucose levels by continuously monitoring the glucose concentration of subcutaneous interstitial fluid through a glucose sensor. The CGM product needs a puncture needle and a sensor pin to puncture the skin of a human body when testing blood sugar, generates electrochemical reaction with subcutaneous tissue fluid through biological enzyme on the sensor, converts the electrochemical reaction into an electric signal, and provides the electric signal for a user through converting the electric signal into a blood sugar value. Because the product has a part which punctures the skin of a human body, the product needs to be sterilized before leaving the factory, and the infection risk of a user caused by pathogenic bacteria on the product is avoided.

The common sterilization modes at present comprise high-temperature high-humidity sterilization, ethylene oxide gas sterilization, irradiation sterilization, ultraviolet sterilization and the like. Aiming at CGM products, the battery and the circuit board in the sensor assembly and the emitter cannot resist high temperature and high humidity, and ultraviolet rays can only kill bacterial colonies on the surface of the products, so that ethylene oxide is only left and irradiation sterilization is optional. The biological enzyme on the sensor can generate chemical reaction with ethylene oxide, the battery and the circuit board can be damaged by electrostatic breakdown after being irradiated and sterilized, and if an irradiation shielding layer is additionally arranged, the size and the weight of the product can be increased, which is very unfavorable for the CGM which needs to be worn on the skin of a human body for a long time. In view of the situation, CGM products on the market generally adopt a design in which the sensor and the emitter are separately packaged, but when the CGM products are used by users, the sensor assembly is implanted into the skin of the human body through the needle assisting device, and then the emitter and the sensor assembly are buckled and pressed together, which increases a user using step, and if the user is unskilled and the buckling and pressing connection is unsuccessful, the product use fails.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a subcutaneous implanted medical unit, medical device and irradiation sterilization shield assembly to solve the problem that current subcutaneous implanted medical device need the components of a whole that can function independently to set up because of sterilization process.

In order to solve the above technical problem, a first aspect of the present invention provides a subcutaneous implantable medical unit, including: the sensor comprises a shell, a sensing implantation part and a circuit assembly;

the circuit assembly is accommodated in the shell, the shell is provided with a bottom hole, one end of the sensing implantation part is connected with the circuit assembly, and the other end of the sensing implantation part penetrates out of the bottom hole; the circuit component avoids a projection area of the bottom hole along the extending direction of the sensing implantation part.

In some embodiments, the housing includes a lower shell and an upper cover, the bottom hole being located in the lower shell; the lower shell is in adaptive connection with the upper cover to form a first cavity; the circuit assembly is accommodated in the first cavity; the upper cover is provided with a top hole, and the top hole and the bottom hole are arranged in an alignment mode along the extending direction of the sensing implantation part.

In some embodiments, the housing includes a separation structure, and both ends of the separation structure are connected with the lower case and the upper cover, respectively; the isolation structure is provided with a second cavity, the second cavity is respectively communicated with the top hole and the bottom hole, and the second cavity is isolated from the first cavity.

In some embodiments, one end of the isolation structure is fixedly connected with one of the lower shell and the upper cover, the other end of the isolation structure is provided with a third sealing structure, and the other of the lower shell and the upper cover is provided with a fourth sealing structure matched with the third sealing structure; when the upper cover is assembled with the lower shell, the third sealing structure is connected with the fourth sealing structure in a sealing mode.

In some embodiments, the sensing implant extends at an angle of 45 ° to 90 ° to the inferior shell.

In some embodiments, the lower case has a first sealing structure, the upper cover has a second sealing structure matching the first sealing structure, and the first sealing structure is in sealing connection with the second sealing structure when the upper cover is assembled with the lower case.

In order to solve the above technical problem, a second aspect of the present invention further provides a subcutaneous implantable medical device, which includes: a base body, a puncture unit and a subcutaneously implantable medical unit according to any of the preceding embodiments; the puncture unit comprises a puncture needle; the puncture needle can movably penetrate out of the bottom hole along the extension direction of the sensing implantation part so as to be detachably connected with the sensing implantation part;

the base body is detachably connected with the shell; the base body is provided with an accommodating structure arranged along the extending direction of the sensing implantation part, the accommodating structure is provided with a third cavity, and one end of the third cavity is open and is used for the puncture needle and the sensing implantation part to penetrate; the other end of the third cavity is closed;

after the base body is connected with the shell, the shell seals the open end of the third cavity, so that the open end of the third cavity is only communicated with the bottom hole.

In some embodiments, the subcutaneously implantable medical device further comprises a first seal disposed about the containment structure, the base being detachably coupled to the housing by the first seal.

In some embodiments, the puncture unit further comprises a hub connected to the puncture needle and a second seal disposed around the puncture needle, the hub being detachably connected to the housing via the second seal.

In some embodiments, the subcutaneous implantable medical device further comprises a needle assisting unit, wherein the needle assisting unit is connected with the puncture unit and used for driving the puncture needle to movably penetrate out of the bottom hole along the extending direction of the sensing implant part; the needle assisting unit is detachably connected with the base body.

In some embodiments, the containment structure allows irradiated radiation to enter the third cavity.

In order to solve the above technical problem, a third aspect of the present invention further provides an irradiation sterilization shielding device for protecting the subcutaneous implantable medical device according to any one of the above embodiments during irradiation sterilization; the radiation sterilization shielding device comprises a shielding body and a transmission structure; the shielding body at least shields the circuit component along the direction of the irradiation ray; the transmission structure allows irradiation rays to pass through, and the transmission structure and the accommodating structure are arranged in alignment along the extending direction of the sensing implant part.

In some embodiments, the radiation sterilization shield comprises: the positioning body is provided with a fourth cavity, and the fourth cavity is used for accommodating the subcutaneous implantable medical device; the positioning body is detachably coupled to the shield to limit the position of the subcutaneously implantable medical device.

To sum up, in the utility model provides an among subcutaneous implanted medical unit, medical device and irradiation sterilization shield assembly, subcutaneous implanted medical unit includes: the sensor comprises a shell, a sensing implantation part and a circuit assembly; the circuit assembly is accommodated in the shell, the shell is provided with a bottom hole, one end of the sensing implantation part is connected with the circuit assembly, and the other end of the sensing implantation part penetrates out of the bottom hole; the circuit component avoids a projection area of the bottom hole along the extension direction of the sensing implantation part.

So dispose, because the circuit module of intolerance radiation has avoided the bottom outlet scope, can adopt the mode of local accurate irradiation to carry out the radiation sterilization to the scope of bottom outlet along the extending direction of sensing implantation portion, the circuit module of intolerance radiation can not be damaged in the radiation sterilization of the sensing implantation portion that realizes needing the sterilization, makes sensing implantation portion and circuit module integration set up in the casing from this, has solved current subcutaneous implantation type medical device and has need the problem that sets up sensing implantation portion and circuit module components of a whole that can function independently because of sterilization process.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:

fig. 1 is a schematic view of a subcutaneously implantable medical unit of an embodiment of the invention;

fig. 2 is an exploded schematic view of a subcutaneously implantable medical unit of an embodiment of the invention;

fig. 3 is an exploded schematic view from another perspective of a subcutaneously implantable medical unit of an embodiment of the invention;

fig. 4 is a schematic view of a substrate according to an embodiment of the invention;

FIG. 5 is a schematic view of another angle of the base of an embodiment of the present invention;

fig. 6 is a schematic view of a lancing unit according to an embodiment of the present invention;

fig. 7 is a schematic view of the combination of the puncture unit, the subcutaneously implantable medical unit and the base body according to the embodiment of the present invention;

FIG. 8 is a schematic view of the needle assist unit of an embodiment of the present invention before it is combined with the base;

FIG. 9 is a schematic view of the needle assist unit of an embodiment of the present invention in combination with a base;

fig. 10 is a schematic view of an irradiation sterilization shield according to an embodiment of the present invention prior to combination with a subcutaneously implantable medical device;

fig. 11 is a schematic view of a radiation sterilization shield in combination with a subcutaneously implantable medical device in accordance with an embodiment of the present invention.

In the drawings:

1-a subcutaneously implantable medical unit; 10-a housing; 11-a lower shell; 111-a locating post; 112-a first sealing structure; 113-a fourth seal configuration; 114-bottom hole; 12-upper cover; 121-corrugation top block; 122-a second sealing structure; 123-an isolation structure; 124-top hole; 125-a third seal configuration; 13-a battery; 14-circuit components; 140-a main circuit board; 141-a second positioning hole; 142-a second contact; 143-avoidance holes; 15-an elastic pad; 2-gluing; 31-a first locating hole; 32-a first contact; 33-a sensing implant; 4-a substrate; 41-a containment structure; 410-a third cavity; 42-a first seal; 43-buckling; 5-a puncture unit; 51-puncture needle; 52-a second seal; 53-needle seat; 6-a needle assisting unit; 61-card slot; 7-a positioning body; 71-a fourth cavity; 8-a shield; 81-transmissive structure.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this application, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a", "an" and "the" are generally employed in a sense including "at least one", the terms "at least two" and "two or more" are generally employed in a sense including "two or more", and moreover, the terms "first", "second" and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or imply that there is a number of technical features being indicated. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature, "one end" and "the other end" and "proximal end" and "distal end" generally refer to the corresponding two parts, including not only the endpoints. Furthermore, as used in the present application, the terms "mounted," "connected," and "disposed" on another element should be construed broadly, and generally only mean that there is a connection, coupling, fit, or drive relationship between the two elements, and that the connection, coupling, fit, or drive between the two elements can be direct or indirect through intervening elements, and should not be construed as indicating or implying any spatial relationship between the two elements, i.e., an element can be located in any orientation within, outside, above, below, or to one side of another element unless the content clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. Moreover, directional terminology, such as above, below, up, down, upward, downward, left, right, etc., is used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure and the downward or downward direction being toward the bottom of the corresponding figure.

The following description refers to the accompanying drawings.

Fig. 1 to 3 show a subcutaneous implantable medical unit 1 comprising: housing 10, sensing implant 33, and circuit assembly 14; the circuit assembly 14 is accommodated in the housing 10, the housing 10 has a bottom hole 114, one end of the sensing implantation part 33 is connected with the circuit assembly 14, and the other end penetrates through the bottom hole 114; the circuit assembly 14 is offset from the projected area of the bottom hole 114 in the direction of extension of the sensor implant 33. It should be noted that the sensing implant 33 is a member for implanting under the skin of a human body together with the puncture needle 51 (see fig. 6 and the following description) of the puncture assembly 5, and generally extends in a straight line shape, and thus has a specific extending direction. After the circuit assembly 14 leaves away the projection area of the bottom hole 114 along the extending direction of the sensing implant 33, the range of the bottom hole 114 can be subjected to radiation sterilization along the extending direction of the sensing implant 33 by adopting a local precise radiation mode, so that the radiation sterilization of the sensing implant 33 needing sterilization is realized without damaging the circuit assembly 14 which is not resistant to radiation, and therefore, the sensing implant 33 and the circuit assembly 14 can be integrally arranged in the shell 10, and the problem that the sensing implant 33 and the circuit assembly 14 are required to be separately arranged in the conventional subcutaneous implanted medical device due to a sterilization process is solved.

In particular, the directions described herein along which the sensing implants 33 extend should be broadly construed as generally along the direction of extension of the sensing implants 33 and not by way of limitation must be strictly parallel to the sensing implants 33. In particular, if there is a small included angle, for example within a deviation of ± 15 °, it should also be considered to be along the extension direction of the sensing implant 33.

The shape of the housing 10 is not limited in this embodiment, and the housing 10 may be open, semi-closed, or fully closed. Preferably, the housing 10 is a closed housing, the housing 10 includes a lower housing 11 and an upper cover 12, and the bottom hole 114 is located in the lower housing 11; the lower shell 11 is in fit connection with the upper cover 12 to form a first cavity; the circuit assembly 14 is accommodated in the first cavity; the upper cover 12 has a top hole 124, and the top hole 124 and the bottom hole 114 are aligned along the extending direction of the sensing implant 33. The top aperture 124 and the bottom aperture 114 are aligned therethrough for passage of the spike 51 of the spike assembly 5 therethrough.

Referring to fig. 2 and 3, in an exemplary embodiment, circuit assembly 14 includes battery 13, main circuit board 140, and sensor circuit board 3, where sensor circuit board 3 is located below main circuit board 140 (referring to the side closer to lower case 11) and is electrically connected to main circuit board 140; the main circuit board 140 is also electrically connected to the battery 13, and the sensor circuit board 3 is electrically connected to the sensor implant 33. Optionally, the main circuit board 140 includes a transmitting module, which can be used to transmit signals to an external receiving device. Therefore, signals monitored by the human body implanted through the sensing implant part 33 can be transmitted to the main circuit board 140 through the sensor circuit board 3, and can be emitted to the outside after being processed by the main circuit board 140. The user can receive the signal transmitted by the main circuit board 140 through the corresponding receiving device, so as to obtain the signal monitored by the sensing implant 33, such as the blood glucose signal. It is to be understood that blood glucose monitoring is only an exemplary application of the subcutaneously implantable medical unit 1, and that corresponding applications are possible in other subcutaneously implantable medical fields. In addition, the main circuit board 140 is not limited to include a transmitting module, and may also include a display module, etc., and the signal monitored by the sensing implant 33 may be directly displayed by the display module without being transmitted to the outside.

Preferably, the sensor circuit board 3 has a plurality of first positioning holes 31, and is adapted to the first positioning holes 31, the lower case 11 has a plurality of protruding positioning posts 111, the main circuit board 140 has a plurality of second positioning holes 141, and the positioning posts 111 sequentially pass through the first positioning holes 31 and the second positioning holes 141, so as to position the main circuit board 140 and the sensor circuit board 3. Further, the upper surface (the surface facing the upper cover 12) of the sensor circuit board 3 is provided with a plurality of first contacts 32, and correspondingly, the lower surface (the surface facing the lower shell 11) of the main circuit board 140 is provided with a plurality of second contacts 142, and after the sensor circuit board 3 and the main circuit board 140 are assembled in an overlapping manner, the first contacts 32 and the second contacts 142 are abutted and contacted, so that the circuit is communicated. Optionally, in an alternative example, the main circuit board 140 has an avoiding hole 143, and along the extending direction of the sensing implant 33, the range of the avoiding hole 143 is not smaller than the projection area of the bottom hole 114. The avoiding hole 143 is provided to fully utilize the space in the housing 10. Of course, in other embodiments, the main circuit board 140 may also avoid the projection area of the bottom hole 114 by providing an avoidance area with a missing corner.

Further, the upper cover 12 has a plurality of raised ridge blocks 121, and the ridge blocks 121 are used for pressing the main circuit board 140. After the lower case 11 and the upper case 12 are assembled, the ridge top block 121 can abut against the main circuit board 140, and restrict upward movement (in a direction toward the upper case 12) thereof, thereby ensuring fixation and compression of the sensor circuit board 3 and the main circuit board 140. Further, an elastic pad 15 is disposed below the sensor circuit board 3, and the elastic pad 15 may be made of, for example, silicone rubber, and can tightly press the sensor circuit board 3 and the main circuit board 140 together after the lower case 11 and the upper case 12 are assembled, thereby ensuring reliability of electrical connection.

Optionally, the lower shell 11 has a first sealing structure 112, the upper cover 12 has a second sealing structure 122 matching with the first sealing structure 112, and when the upper cover 12 is assembled with the lower shell 11, the first sealing structure 112 is connected with the second sealing structure 122 in a sealing manner. Optionally, one of the first sealing structure 112 and the second sealing structure 122 is a groove, and the other is a protrusion, and the protrusion can be adapted to be snapped into the groove, so as to achieve sealing. Preferably, the first sealing structure 112 is continuously disposed around a circumference of the lower case 11, and the second sealing structure 122 is continuously disposed around a circumference of the upper cover 12. Preferably, when the upper cover 12 and the lower cover 11 are assembled, glue is filled between the first sealing structure 112 and the second sealing structure 122, so as to improve the sealing performance of the connection between the first sealing structure 112 and the second sealing structure 122. The airtight and leak-proof effect of the shell 10 can be realized after the glue is cured. It is understood that the first sealing structure 112 and the second sealing structure 122 are not limited to the connection manner of the snap and the glue, and in other embodiments, the first sealing structure 112 and the second sealing structure 122 may be welded together by using ultrasonic welding, laser welding, or the like, or may be used in combination with the snap and the screw by using an elastic sealing member, such as a rubber ring, which can achieve the effect of sealing and leakage prevention.

Preferably, the housing 10 includes a separation structure 123, and two ends of the separation structure 123 are respectively connected with the lower shell 11 and the upper cover 12; the isolation structure 123 has a second cavity, which is respectively communicated with the top hole 124 and the bottom hole 114, and is isolated from the first cavity. The second cavity of the isolation structure 123 is used for the puncture needle 51 to pass through, so the second cavity should be configured as a sterile cavity, and the isolation structure 123 is arranged to isolate the second cavity from the first cavity, so that the circuit assembly 14 in the first cavity does not need to be sterilized.

In an alternative embodiment, the isolation structure 123 is a tubular member, and one end of the isolation structure 123 is fixedly connected to one of the lower shell 11 and the upper cover 12, preferably integrally formed; the other end of the partition structure 123 has a third seal structure 125, and the other of the lower case 11 and the upper cover 12 has a fourth seal structure 113 fitted with the third seal structure 125. When the upper cover 12 is assembled with the lower case 11, the third seal structure 125 is sealingly coupled to the fourth seal structure 113. The structure of the third sealing structure 125 and the fourth sealing structure 113 can refer to the first sealing structure 112 and the second sealing structure 122, such as a snap-fit connection with a groove and a protrusion, and further, the sealing can be strengthened by glue, which is not repeated here. It is understood that in other embodiments, the isolation structure 123 is not limited to being fixedly connected to one of the lower casing 11 and the upper casing 12, but is detachably and hermetically connected to the other, and the isolation structure 123 may be detachably and hermetically connected to the lower casing 11 and the upper casing 12 at two ends thereof, that is, the isolation structure 123 may be a component independent from the upper casing 12 and the lower casing 11, and has third sealing structures 125 at two ends thereof, and the fourth sealing structures 113 are disposed at corresponding positions of the upper casing 12 and the lower casing 11.

Preferably, the lower shell 11 is a plane, and the extending direction of the sensing implantation part 33 and the lower shell 11 form an included angle of 45 ° -90 ° (i.e. the included angle between the sensing implantation part 33 and the plane of the bottom hole 114), so as to be widely applicable to the implantation objects that need to be configured as the slant implantation sensing implantation part 33 and the implantation objects that need to be configured as the perpendicular implantation sensing implantation part 33, and correspondingly, no matter what angle the extending direction of the sensing implantation part 33 and the included angle of the lower shell 11 are, the transmission structure 81 and the accommodation structure 41 are both aligned along the extending direction of the sensing implantation part, so as to achieve precise sterilization.

Alternatively, the circuit assembly 14 is parallel to the lower case 11. So configured, it is advantageous to reduce the volume of the subcutaneously implantable medical unit 1.

Further, the subcutaneous implantable medical unit 1 further comprises a sticker 2, and the sticker 2 is arranged on one surface of the lower shell 11, which is far away from the upper cover 12, and is used for being attached to the skin. The adhesive patch 2 may be attached to the lower shell 11 using ultrasonic techniques or double-sided tape, for example. Preferably, the lower surface (i.e. the surface away from the connection with the lower housing 11) of the sticker 2 is further provided with a protective film, which can be torn off before use. It will be appreciated that the sticker 2 has holes for the puncture needle 51 and the sensing implant 33 to pass through, which do not cover the bottom hole 114 and prevent the puncture needle 51 and the sensing implant 33 from passing through.

Referring to fig. 4 to 7, based on the subcutaneous implantable medical unit 1 as described above, the present embodiment further provides a subcutaneous implantable medical device, which includes: a base body 4, a puncture unit 5 and a subcutaneously implantable medical unit 1 as described above; the puncture unit 5 includes a puncture needle 51; the puncture needle 51 movably penetrates out of the bottom hole 114 along the extending direction of the sensing implant part 33 so as to be detachably connected with the sensing implant part 33; the base body 4 is detachably connected with the housing 10; the base 4 is provided with an accommodating structure 41 arranged along the extending direction of the sensing implant part 33, the accommodating structure 41 is provided with a third cavity 410, and one end of the third cavity 410 is open for the puncture needle 51 and the sensing implant part 33 to penetrate; the other end of the third cavity 410 is closed; after the base 4 is connected to the housing 10, the housing 10 closes the open end of the third cavity 410, so that the open end of the third cavity 410 is only communicated with the bottom hole 114.

In an alternative example, the puncture needle 51 has a U-shaped cross section, which is a semi-enclosed structure, and after the puncture needle 51 passes through the housing 10 and out of the bottom hole 114, the sensing implant 33, which also passes out of the bottom hole 114, can be attached to the puncture needle 51 in the U-shaped recessed area, so that the puncture needle 51 and the sensing implant 33 can be inserted into the skin together. Of course, in other embodiments, the puncture needle 51 and the sensing implant 33 may also have other shapes, but the present invention is not limited thereto.

The base 4 is used for placing the subcutaneous implantable medical unit 1 thereon, and the puncture needle 51 and the sensing implant 33 which penetrate through the bottom hole 114 can extend into the third cavity 410 from the open end of the third cavity 410. Since the other end of the third cavity 410 is closed, the housing 10 can close the open end of the third cavity 410, so that the rest of the third cavity 410 is configured as a closed cavity except the communication with the bottom hole 114. The bottom hole 114 is only communicated with the top hole 124 through the second cavity under the limitation of the isolation structure 123, and after the top hole 124 is sealed by the puncture unit 5, the third cavity 410 and the second cavity form an independent sealed cavity isolated from the external environment. If the cleanness and the sterility in the closed cavity can be ensured, the aseptic safety of the product can be ensured.

Further, the thickness of the end of the accommodating structure 41 closed by the third cavity 410 is relatively thin, which can allow the irradiated radiation to pass through; the lower case 11 is also thin in thickness, and can allow the passage of the irradiation rays. When the accommodating structure 41 is subjected to radiation sterilization, radiation rays penetrate through the end of the accommodating structure 41 and enter the third cavity 410, and further penetrate through the lower shell 11 and enter the second cavity, so that the puncture needle 51 and the sensing implantation part 33 are subjected to radiation sterilization. Since the third cavity 410 and the second cavity are configured as a closed cavity, and are isolated from the external environment, the closed cavity is a sterile environment, so that the sterile safety of the puncture needle 51 and the sensing implantation portion 33 can be ensured. When in use, the subcutaneous implantation type medical unit 1 is separated from the substrate 4, and the puncture needle 51 and the sensing implantation part 33 are taken out from the third cavity 410 and the second cavity, so that the subcutaneous implantation type medical unit can be used.

Preferably, the subcutaneous implantable medical device further comprises a first sealing member 42 disposed around the accommodating structure 41, and the base 4 is detachably connected to the housing 10 through the first sealing member 42. The provision of the first seal member 42 improves the sealability between the base body 4 and the lower case 11. Referring to fig. 5 and 7, in an exemplary embodiment, the upper surface of the base 4 has a recessed seal receiving area, the first seal 42 is an elastic ring-shaped body made of rubber, silicon rubber or teflon, and the first seal 42 can be clamped in the seal receiving area. The lower case 11 of the subcutaneous-implantable medical unit 1 can be in contact with the upper surface of the base 4 (or the lower case 11 is in contact with the upper surface of the base 4 through the sticker 2 with a protective film). Thereby, the lower case 11 can press the first sealing member 42, so that the case 10 can close the open end of the third cavity 410, and the third cavity 410 communicates only with the bottom hole 114.

Referring to fig. 6 in combination with fig. 7, further, the puncture unit 5 further includes a needle holder 53 connected to the puncture needle 51, and the needle holder 53 may be formed by injection molding, for example. The puncture needle 51 and the needle seat 53 can be connected in a manner of embedding injection molding or glue bonding, so that the puncture needle and the needle seat form a sealed connection. The radial profile of the needle seat 53 can cover the top hole 124, and after the puncture needle 51 penetrates into the isolation structure 123 from the top hole 124 and penetrates out of the bottom hole 114, the needle seat 53 can abut against the upper cover 12 to close the top hole 124, so that the second cavity is closed.

Preferably, the puncture unit 5 comprises a second sealing member 52 arranged around the puncture needle 51, and the needle hub 53 is detachably connected to the housing 10 via the second sealing member 52. The second sealing element 52 is arranged to improve the sealing performance between the needle seat 53 and the upper cover 12. The shape, material and principle of arrangement of the second seal 52 can be referred to the first seal 42 described above and will not be repeated here.

Referring to fig. 8 and 9, optionally, the subcutaneous implantable medical device further includes a needle assisting unit 6, where the needle assisting unit 6 is connected to the puncture unit 5, and is used for driving the puncture unit 5 to puncture along the extending direction of the puncture needle 51; the needle unit 6 is detachably connected to the base body 4. Since the subcutaneous implantable medical unit 1 has a small volume and a flat shape, and a user has a certain difficulty in directly grasping the subcutaneous implantable medical unit, the grasping and puncturing of the subcutaneous implantable medical unit 1 and the puncturing unit 5 are preferably assisted by the needle assisting unit 6. In the example shown in fig. 8 and 9, the booster needle unit 6 is a cylindrical body having an opening at one end for connection with the base body 4. Preferably, the base body 4 has a plurality of catches 43, and the needle assisting unit 6 is adapted to have corresponding catching grooves 61. When the needle assisting unit 6 is assembled and connected with the base body 4, the buckle 43 can be clamped into the clamping groove 61 to form a clamping connection, so that the connection position of the needle assisting unit 6 and the base body 4 is limited. Preferably, the hub 53 of the puncture unit 5 has a catch, such as two spaced apart resilient legs at the upper part of the hub 53 in fig. 6, which can be adapted to a corresponding structure in the needle assisting unit 6. Of course, the specific structure inside the needle assisting unit 6 can refer to the prior art, and the present invention is not limited thereto.

During assembly, the puncture unit 5, the subcutaneous implantable medical unit 1 and the needle assisting unit 6 can be assembled and connected firstly, so that the puncture needle 51 penetrates through the shell 10, and the needle seat 53 is hermetically connected with the upper cover 12 through the second sealing element 52. And then the needle assisting unit 6 together with the puncture unit 5 and the subcutaneously implantable medical unit 1 are buckled on the base body 4 until the buckle 43 can be clamped into the clamping groove 61, the lower shell 11 of the subcutaneously implantable medical unit 1 can compress the first sealing member 42, so that the second cavity and the third cavity 410 are reliably sealed. And then the range of the second cavity and the third cavity 410 is irradiated and sterilized along the extending direction of the sensing implantation part 33 by adopting a local precise irradiation mode, and the production and assembly process of the product is completed.

When in use, the buckle 43 can be withdrawn from the clamping groove 61, the connection limitation between the assistant needle unit 6 and the base body 4 is released, and the assistant needle unit 6 with the puncture unit 5 and the subcutaneous implantation type medical unit 1 can be pulled out from the base body 4. Tearing off the protective film on the sticker 2, placing the needle assisting unit 6 on the skin of a human body, pressing a button on the needle assisting unit 6, ejecting the subcutaneously implanted medical unit 1 and the puncture unit 5 towards the human body together, sticking the sticker 2 on the skin, puncturing the skin by the puncture needle 51 and the sensing implantation part 33 together, subsequently removing the puncture unit 5 from the subcutaneously implanted medical unit 1, and only keeping the sensing implantation part 33 in the skin to complete implantation.

Referring to fig. 10 and 11, based on the subcutaneous implantable medical device as described above, the present embodiment further provides a radiation sterilization shield device for protecting the subcutaneous implantable medical device as described above during radiation sterilization; the radiation sterilization shield includes: a shield 8; the shield body 8 shields at least the circuit component 14 in the direction of the irradiation ray; the shield 8 has a transmission structure 81 arranged along the extension direction of the sensing implant 33, the transmission structure 81 allowing passage of the irradiation radiation; the transmissive structure 81 is aligned with the receiving structure 41 along the extending direction of the sensing implant 33. It is understood that, according to the prior art and the common general knowledge, a person skilled in the art can select the type and the radiation intensity of the irradiation ray (or the electron beam), and further select the material and the thickness of the shielding body 8 according to the type and the radiation intensity of the irradiation ray, and select the structure of the transmission structure 81, so that the shielding body 8 can shield the irradiation ray from passing through. The transmission structure 81 may be a transmission hole or a material that allows the irradiated radiation to pass through, which is not limited by the present invention.

Since the transmission structure 81 allowing the irradiation radiation to pass through is aligned with the receiving structure 41 along the extending direction of the sensing implant 33, the irradiation radiation can pass through the transmission structure 81 and the end of the receiving structure 41 in sequence and enter the third cavity 410, and then pass through the lower shell 11 and enter the second cavity, and the puncturing needle 51 and the sensing implant 33 are subjected to irradiation sterilization. On the other hand, since the shielding body 8 shields at least the circuit component 14 in the direction of the irradiation ray, it is ensured that the circuit component 14 is not damaged by the irradiation ray.

Alternatively, the assembled subcutaneously implantable medical device may be arranged along the puncture needle 51 facing the irradiation direction of the irradiation radiation, for example, in the example shown in fig. 10, the irradiation direction of the irradiation radiation is from top to bottom, and then the subcutaneously implantable medical device is arranged along the puncture needle 51 in the upward direction, so that the irradiation radiation can be directly injected into the third cavity 410 and the second cavity. Of course, in other embodiments, if the irradiation radiation is strong enough and the materials of the needle assisting unit 6 and the needle holder 53 are not enough to shield the irradiation radiation, the subcutaneous implantable medical device may be arranged along the puncture needle 51 along the irradiation direction of the irradiation radiation, and the irradiation sterilization may be realized.

Preferably, the radiation sterilization shield further comprises: the positioning body 7 is provided with a fourth cavity 71, and the fourth cavity 71 is used for accommodating the subcutaneous implantable medical device arranged along the direction that the puncture needle 51 faces the irradiation ray; the positioning body 7 is detachably connected with the shielding body 8 to limit the position of the subcutaneously implantable medical device. In an alternative example, the shielding body 8 and the positioning body 7 may be fixed by a plurality of bolts. Furthermore, in order to increase the productivity, the positioning body 7 has a plurality of fourth cavities 71, which can simultaneously accommodate a plurality of subcutaneously implantable medical devices, and the shielding body 8 is adapted to have a plurality of transmission structures 81 thereon. Can realize the irradiation sterilization of a plurality of subcutaneous implanted medical devices at the same time.

To sum up, in the utility model provides an among subcutaneous implanted medical unit, medical device and irradiation sterilization shield assembly, subcutaneous implanted medical unit includes: the sensor comprises a shell, a sensing implantation part and a circuit assembly; the circuit assembly is accommodated in the shell, the shell is provided with a bottom hole, one end of the sensing implantation part is connected with the circuit assembly, and the other end of the sensing implantation part penetrates out of the bottom hole; the circuit component avoids a projection area of the bottom hole along the extension direction of the sensing implantation part. So dispose, because the circuit module of intolerance radiation has avoided the bottom outlet scope, can adopt the mode of local accurate irradiation to carry out the radiation sterilization to the scope of bottom outlet along the extending direction of sensing implantation portion, the circuit module of intolerance radiation can not be damaged in the radiation sterilization of the sensing implantation portion that realizes needing the sterilization, makes sensing implantation portion and circuit module integration set up in the casing from this, has solved current subcutaneous implantation type medical device and has need the problem that sets up sensing implantation portion and circuit module components of a whole that can function independently because of sterilization process.

It should be noted that, several of the above embodiments may be combined with each other. The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure are all within the scope of the claims.

Claims

1. A subcutaneously implantable medical unit, comprising: the sensor comprises a shell, a sensing implantation part and a circuit assembly;

the circuit assembly is accommodated in the shell, the shell is provided with a bottom hole, one end of the sensing implantation part is connected with the circuit assembly, and the other end of the sensing implantation part penetrates out of the bottom hole; the circuit component avoids a projection area of the bottom hole along the extension direction of the sensing implantation part.

2. The subcutaneously implantable medical unit of claim 1, wherein the housing comprises a lower shell and an upper cover, the bottom aperture being located in the lower shell; the lower shell is in adaptive connection with the upper cover to form a first cavity; the circuit assembly is accommodated in the first cavity; the upper cover is provided with a top hole, and the top hole and the bottom hole are arranged in an alignment mode along the extending direction of the sensing implantation part.

3. The subcutaneously implantable medical unit of claim 2, wherein the housing comprises an isolation structure, both ends of which are connected with the lower shell and the upper cover, respectively; the isolation structure is provided with a second cavity, the second cavity is respectively communicated with the top hole and the bottom hole, and the second cavity is isolated from the first cavity.

4. The subcutaneously implantable medical unit of claim 3, wherein one end of the isolation structure is fixedly connected to one of the lower housing and the upper cover, the other end of the isolation structure has a third sealing structure, and the other of the lower housing and the upper cover has a fourth sealing structure adapted to the third sealing structure; when the upper cover is assembled with the lower shell, the third sealing structure is in sealing connection with the fourth sealing structure.

5. The subcutaneously implantable medical unit of claim 2, wherein the sense implant extends at an angle of 45 ° -90 ° to the inferior shell.

6. The subcutaneous implantable medical unit according to claim 2, wherein said lower housing has a first sealing structure, said upper cover has a second sealing structure that mates with said first sealing structure, and said first sealing structure sealingly engages said second sealing structure when said upper cover is assembled with said lower housing.

7. A subcutaneously implantable medical device, comprising: a base body, a puncture unit and a subcutaneously implantable medical unit according to any one of claims 1-6; the puncture unit comprises a puncture needle; the puncture needle can movably penetrate out of the bottom hole along the extension direction of the sensing implantation part so as to be detachably connected with the sensing implantation part;

8. The subcutaneously implantable medical device of claim 7, further comprising a first seal disposed about the containment structure, wherein the base is detachably coupled to the housing via the first seal.

9. The subcutaneously implantable medical device of claim 7, wherein the puncture unit further comprises a hub coupled to the puncture needle and a second seal disposed about the puncture needle, the hub being detachably coupled to the housing via the second seal.

10. The subcutaneously implantable medical device according to claim 7, further comprising a needle assist unit connected to the puncture unit for driving the puncture needle movably out of the bottom hole along the extending direction of the sensing implant; the needle assisting unit is detachably connected with the base body.

11. The subcutaneously implantable medical device of claim 7, wherein said containment structure allows irradiation radiation to enter said third lumen.

12. A radiation sterilization shield for protecting a subcutaneously implantable medical device according to any one of claims 7 to 11 during radiation sterilization; the radiation sterilization shielding device comprises a shielding body and a transmission structure; the shielding body at least shields the circuit component along the direction of the irradiation ray; the transmission structure allows irradiation rays to pass through, and the transmission structure and the accommodating structure are arranged in alignment along the extending direction of the sensing implant part.

13. The radiation sterilization shield of claim 12, wherein the radiation sterilization shield comprises: the positioning body is provided with a fourth cavity, and the fourth cavity is used for accommodating the subcutaneous implantable medical device; the positioning body is detachably coupled to the shield to limit the position of the subcutaneously implantable medical device.