WO2023124496A1

WO2023124496A1 - Subcutaneously implantable medical unit, subcutaneously implantable medical device, and irradiation sterilization shielding device

Info

Publication number: WO2023124496A1
Application number: PCT/CN2022/128531
Authority: WO
Inventors: 刘文杰; 陈勋; 丁志刚; 傅向阳; 裘丹
Original assignee: 上海微创生命科技有限公司
Priority date: 2021-12-29
Filing date: 2022-10-31
Publication date: 2023-07-06
Also published as: CN114305405A

Abstract

A subcutaneously implantable medical unit (1), a subcutaneously implantable medical device, and an irradiation sterilization shielding device. The subcutaneously implantable medical unit (1) comprises a housing (10), a sensing implantation portion (33), and a circuit assembly (14), wherein the circuit assembly (14) is accommodated in the housing (10); the housing (10) is provided with a bottom hole (114); one end of the sensing implantation portion (33) is connected to the circuit assembly (14), and the other end thereof passes out of the bottom hole (114); and the circuit assembly (14) avoids a projection area of the bottom hole (114) in the extension direction of the sensing implantation portion (33). By means of such a configuration, since the circuit assembly (14) which is not resistant to irradiation avoids the range of the bottom hole (114), irradiation sterilization can be performed on the range of the bottom hole (114) in the extension direction of the sensing implantation portion (33) by means of local precise irradiation, so as to realize irradiation sterilization of the sensing implantation portion (33) requiring sterilization, without damaging the circuit assembly (14) which is not resistant to irradiation; thus, the sensing implantation portion (33) and the circuit assembly (14) can be integrally arranged in the housing (10).

Description

Subcutaneous implantable medical unit, medical device and radiation sterilization shielding device

technical field

The present application relates to the technical field of medical devices, in particular to a subcutaneous implantable medical unit, a medical device and a radiation sterilization shielding device.

Background technique

A biosensor is an instrument that is sensitive to biologically active substances and converts the perceived concentration of biologically active substances into electrical signals for detection, and the sensing method is generally to open a wound on a living body.

Among them, the glucose sensor is a relatively common type of biosensor. CGM (Continuous Glucose Monitoring) is a technical means to indirectly reflect the blood sugar level by continuously monitoring the glucose concentration in the subcutaneous interstitial fluid through a glucose sensor. CGM products need to have puncture needles and sensor pins to pierce the human skin to test blood sugar. The bio-enzyme on the sensor reacts electrochemically with the subcutaneous tissue fluid, converts it into an electrical signal, and provides it to the user through conversion into blood sugar value. Since the product has a part that punctures the human skin, the product needs to be sterilized before leaving the factory to avoid the risk of infection caused by pathogenic bacteria on the product.

At present, the commonly used sterilization methods include high temperature and high humidity sterilization, ethylene oxide gas sterilization, radiation sterilization, ultraviolet sterilization and so on. For CGM products, the sensor components, batteries and circuit boards in the transmitter are not resistant to high temperature and high humidity, and ultraviolet rays can only kill bacterial colonies on the product surface, so only ethylene oxide and radiation sterilization are left as options. The biological enzymes on the sensor will react with ethylene oxide. After the battery and circuit board are sterilized by radiation, they will be destroyed by electrostatic breakdown. If an additional radiation shielding layer is added, the size and weight of the product will be increased. This is very unfavorable for the CGM that needs to be worn on human skin for a long time. In response to this situation, the CGM products on the market generally adopt the design that the sensor and the transmitter are separately packaged. However, when the user uses it, the sensor component is implanted into the human skin through a needle aid, and then the transmitter and the sensor component are buckled and connected. This adds a step for the user to use. If the user is not skilled and the buckle connection is unsuccessful, the product will fail to use.

Contents of the invention

The purpose of this application is to provide a subcutaneous implantable medical unit, a medical device and a radiation sterilization shielding device, so as to solve the problem that the existing subcutaneous implantable medical device needs to be arranged separately due to the sterilization process.

In order to solve the above technical problems, the first aspect of the present application provides a subcutaneous implantable medical unit, including: a housing, a sensor implant and a circuit assembly;

The circuit assembly is accommodated in the housing, the housing has a bottom hole, one end of the sensing implant part is connected to the circuit assembly, and the other end passes through the bottom hole; the circuit assembly avoids A projected area of the bottom hole along the extending direction of the sensing implant part is opened.

In some embodiments, the housing includes a lower case and an upper cover, the bottom hole is located in the lower case; the lower case is fitted and connected with the upper cover to form a first cavity; the circuit assembly Accommodated in the first cavity; the upper cover has a top hole, and the top hole and the bottom hole are arranged in alignment along the extending direction of the sensing implant part.

In some embodiments, the housing includes an isolation structure, and the two ends of the isolation structure are respectively connected to the lower case and the upper cover; the isolation structure has a second cavity, and the second cavity communicate with the top hole and the bottom hole respectively, and the second cavity is isolated from the first cavity.

In some embodiments, one end of the isolation structure is fixedly connected to one of the lower case and the upper cover, the other end of the isolation structure has a third sealing structure, and the lower case and the upper cover The other of the covers has a fourth sealing structure compatible with the third sealing structure; when the upper cover is assembled with the lower case, the third sealing structure is sealingly connected with the fourth sealing structure .

In some embodiments, the angle between the extending direction of the sensing implant and the lower shell is 45°-90°.

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

In order to solve the above technical problems, the second aspect of the present application also provides a subcutaneous implantable medical device, which includes: a base body, a puncture unit, and the subcutaneous implantable medical unit according to any one of the preceding embodiments; The puncture unit includes a puncture needle; the puncture needle can movably pass through the bottom hole along the extending direction of the sensing implant part, so as to be detachably connected with the sensing implant part;

The base body is detachably connected with the housing; the base body has an accommodating structure arranged along the extending direction of the sensing implant part, the accommodating structure has a third cavity, and the third cavity One end of the body is open for penetration of the puncture needle and the sensor implant; the other end of the third cavity is closed;

After the base body is connected to the housing, the housing closes the open end of the third cavity, so that the open end of the third cavity communicates only with the bottom hole.

In some embodiments, the subcutaneous implantable medical device further includes a first seal disposed around the accommodating structure, and the base body is detachably connected to the housing through the first seal.

In some embodiments, the puncture unit further includes a needle hub connected to the puncture needle and a second seal disposed around the puncture needle, the needle hub is detachably separated from the puncture needle through the second seal. The housing connection.

In some embodiments, the subcutaneous implantable medical device further includes a needle assisting unit connected to the puncture unit for driving the puncture needle along the extending direction of the sensing implant part The bottom hole can be movably passed through; the needle assisting unit is detachably connected with the base body.

In some embodiments, the accommodating structure allows radiation rays to enter the third cavity.

In order to solve the above technical problems, the third aspect of the present application also provides a radiation sterilization shielding device, which is used to protect the subcutaneous implantable medical device described in any one of the foregoing embodiments during radiation sterilization; The radiation sterilization shielding device includes a shielding body and a transmission structure; the shielding body at least shields the circuit assembly along the direction of radiation rays; the transmission structure allows the radiation rays to pass through, and the transmission structure and the housing The structures are aligned and arranged along the extending direction of the sensing implant part.

In some embodiments, the radiation sterilization shielding device includes: a positioning body, the positioning body has a fourth cavity, and the fourth cavity is used to accommodate the subcutaneous implantable medical device; The positioning body is detachably connected with the shielding body to limit the position of the subcutaneous implantable medical device.

In summary, in the subcutaneous implantable medical unit, medical device and radiation sterilization shielding device provided by the present application, the subcutaneous implantable medical unit includes: a housing, a sensor implant and a circuit assembly; The circuit assembly is accommodated in the housing, the housing has a bottom hole, one end of the sensor implant is connected to the circuit assembly, and the other end passes through the bottom hole; the circuit assembly avoids A projected area of the bottom hole along the extending direction of the sensing implant part is opened.

With such a configuration, since the circuit components that are not resistant to radiation avoid the range of the bottom hole, the range of the bottom hole can be irradiated and sterilized along the extension direction of the sensor implantation in the way of local precise irradiation, so as to realize the need for sterilization. The radiation sterilization of the sensor implanted part will not damage the radiation-resistant circuit components, so that the sensor implanted part and the circuit component can be integrated in the housing, which solves the problem of the existing subcutaneous implanted Due to the sterilization process of the medical device, the sensing implant and the circuit assembly need to be separately arranged.

Description of drawings

Those of ordinary skill in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation to the scope of the present application. in:

1 is a schematic diagram of a subcutaneous implantable medical unit according to an embodiment of the present application;

Fig. 2 is an exploded schematic diagram of the subcutaneous implantable medical unit of the embodiment of the present application;

Fig. 3 is an exploded schematic diagram of another angle of the subcutaneous implantable medical unit of the embodiment of the present application;

Fig. 4 is the schematic diagram of the substrate of the embodiment of the present application;

Fig. 5 is a schematic diagram of another angle of the substrate of the embodiment of the present application;

Fig. 6 is a schematic diagram of a puncture unit according to an embodiment of the present application;

Fig. 7 is a combined schematic diagram of the puncture unit, the subcutaneous implantable medical unit and the base body of the embodiment of the present application;

Fig. 8 is a schematic diagram before the combination of the needle assisting unit and the base in the embodiment of the present application;

Fig. 9 is a schematic diagram of the combination of the needle assisting unit and the base in the embodiment of the present application;

Fig. 10 is a schematic diagram of the radiation sterilization shield of the embodiment of the present application before being combined with the subcutaneous implantable medical device;

Fig. 11 is a schematic diagram of the combination of the radiation sterilization shield and the subcutaneous implantable medical device according to the embodiment of the present application.

In the attached picture:

1-subcutaneous implantable medical unit; 10-shell; 11-lower shell; 111-positioning column; 112-first sealing structure; 113-fourth sealing structure; 114-bottom hole; 12-top cover; 121- Corrugated top block; 122-second sealing structure; 123-isolation structure; 124-top hole; 125-third sealing structure; 13-battery; 14-circuit assembly; 140-main circuit board; 141-second positioning hole; 142-second contact; 143-avoidance hole; 15-elastic pad; 2-adhesive; 31-first positioning hole; 32-first contact; 33-sensing implant; Accommodating structure; 410-third cavity; 42-first seal; 43-buckle; 5-puncture unit; 51-puncture needle; 52-second seal; ; 61 - card slot; 7 - positioning body; 71 - fourth cavity; 8 - shielding body; 81 - transmission structure.

Detailed ways

In order to make the purpose, advantages and features of the application clearer, the application will be further described in detail below in conjunction with the drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present application. In addition, the structures shown in the drawings are often a part of the actual structure. In particular, each drawing needs to display different emphases, and sometimes uses different scales.

As used in this application, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined as "first", "second", and "third" may expressly or implicitly include one or at least two of these features, "one end" and "another end" and "near end" and "near end" "Distal end" generally refers to the corresponding two parts, and it includes not only the endpoint. In addition, as used in this application, "mounting", "connecting", "connecting", and one element being "disposed" on another element should be interpreted in a broad sense and usually only mean that there is connection, coupling, Fitting or transmission relationship, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, but shall not be understood as indicating or implying a spatial positional relationship between two elements, that is, one element may be in another Any orientation of the inside, outside, top, bottom, or side of an element, unless the content clearly indicates otherwise. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations. Furthermore, directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with an upward or upward direction toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding drawing.

Description is made below with reference to the accompanying drawings.

1 to 3 show a subcutaneous implantable medical unit 1, which includes: a housing 10, a sensing implant 33, and a 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 sensor implant 33 is connected to the circuit assembly 14, and the other end passes through the bottom hole 114; the circuit assembly 14 is implanted along the sensor The extending direction of the portion 33 avoids the projected area of the bottom hole 114 . What needs to be explained here is that the sensing implant part 33 refers to the part used to be implanted under the skin of the human body together with the puncture needle 51 of the puncture unit 5 (see FIG. direction of extension. After the circuit assembly 14 avoids the projected area of the bottomed hole 114 along the extension direction of the sensor implant 33, the range of the bottom hole 114 can be irradiated along the extension direction of the sensor implant 33 by means of local precise irradiation. Irradiation sterilization, realize the radiation sterilization of the sensing implant part 33 to be sterilized without damaging the radiation-resistant circuit assembly 14, thus enabling the sensing implant part 33 and the circuit assembly 14 to be integrally arranged In the casing 10, the problem that the sensor implant part 33 and the circuit assembly 14 need to be arranged separately due to the sterilization process of the existing subcutaneous implantable medical device is solved.

In particular, the direction along the extension of the sensor implant 33 described herein should be broadly understood as roughly along the extension direction of the sensor implant 33 and is not limited to be strictly parallel to the sensor implant 33 in a narrow sense. . Specifically, if there is a small included angle, for example within a deviation range of ±15°, it should also be regarded as being along the extending direction of the sensing implant part 33 .

In this embodiment, the shape of the housing 10 is not limited, and the housing 10 may be open, semi-closed or fully closed. Preferably, the casing 10 is a closed casing, the casing 10 includes a lower casing 11 and an upper cover 12, the bottom hole 114 is located in the lower casing 11; the lower casing 11 is adapted to the upper cover 12 connected 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 along the sensor The extending directions of the implanted parts 33 are arranged in alignment. The top hole 124 is aligned with the bottom hole 114 , and is used for the puncture needle 51 of the puncture unit 5 to pass through.

Please refer to Fig. 2 and Fig. 3, in an exemplary embodiment, circuit assembly 14 comprises battery 13, main circuit board 140 and sensor circuit board 3, wherein sensor circuit board 3 is positioned at the bottom of main circuit board 140 (referring to closer One side of the lower shell 11), and electrically connected with the main circuit board 140; the main circuit board 140 is also electrically connected with the battery 13, and the sensor circuit board 3 is electrically connected with the sensor implant part 33. Optionally, the main circuit board 140 includes a transmitting module, which can be used to transmit signals to an external receiving device. Thus, the monitored signal obtained by implanting the sensor implant part 33 into the human body can be transmitted to the main circuit board 140 through the sensor circuit board 3 , and can be emitted 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 sensor implantation part 33 , such as the blood sugar signal and the like. It should be understood that the blood glucose monitoring here is only an exemplary application of the subcutaneous implantable medical unit 1 , and corresponding applications can also be carried out in other subcutaneous 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 sensor implantation part 33 can be directly displayed through the display module without being emitted externally.

Preferably, the sensor circuit board 3 has several first positioning holes 31, and the lower shell 11 has several raised positioning posts 111, and the main circuit board 140 has several second positioning holes 141, and the positioning posts 111 Through the first positioning hole 31 and the second positioning hole 141 in sequence, the main circuit board 140 and the sensor circuit board 3 are positioned. Further, the upper surface of the sensor circuit board 3 (referring to the surface facing the upper cover 12) has several first contacts 32, and the lower surface of the main circuit board 140 (referring to the surface facing the lower shell 11) has The plurality of second contacts 142, after the sensor circuit board 3 and the main circuit board 140 are stacked and assembled, the first contacts 32 and the second contacts 142 are in contact with each other to realize circuit communication. Optionally, in an alternative example, the main circuit board 140 has an avoidance hole 143, and along the extension direction of the sensing implant part 33, the range of the avoidance hole 143 is not smaller than the projected area of the bottom hole 114 . The setting of the escape hole 143 is beneficial to fully utilize the space in the housing 10 . Of course, in some other embodiments, the main circuit board 140 can also avoid the projected area of the bottom hole 114 by setting the avoidance area as a notch.

Further, the upper cover 12 has several raised corrugated top blocks 121 for pressing the main circuit board 140 . After the lower shell 11 and the upper cover 12 are assembled, the corrugated top block 121 can abut against the main circuit board 140 to limit its upward movement (referring to the direction of the upper cover 12), so as to ensure the fixing of the sensor circuit board 3 and the main circuit board 140 Well squeezed. Furthermore, an elastic pad 15 is provided below the sensor circuit board 3, and the elastic pad 15 can be made of silica gel, which can tightly press the sensor circuit board 3 and the main circuit board 140 after the lower case 11 and the upper cover 12 are assembled. Together, they ensure a reliable electrical connection.

Optionally, the lower shell 11 has a first sealing structure 112, and the upper cover 12 has a second sealing structure 122 adapted to the first sealing structure 112. When the upper cover 12 is assembled with the lower shell 11, the first sealing structure 112 is in sealing connection with the second sealing structure 122 . 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 fit into the groove to achieve sealing. Preferably, the first sealing structure 112 is continuously arranged around the lower shell 11 , and the second sealing structure 122 is continuously arranged around the upper cover 12 . Preferably, when the upper cover 12 and the lower case 11 are assembled, glue is filled between the first sealing structure 112 and the second sealing structure 122 to improve the sealing performance of the connection between the first sealing structure 112 and the second sealing structure 122 . After the glue is cured, the airtight and leak-proof effect of the casing 10 can be realized. It can be understood that the connection between the first sealing structure 112 and the second sealing structure 122 is not limited to buckle and glue, and in some other embodiments, the first sealing structure 112 and the second sealing structure 122 can also use ultrasonic Welding, laser welding, etc., or using elastic seals such as rubber rings in conjunction with buckles and screws, can achieve airtight and leak-proof effects.

Preferably, the housing 10 includes an isolation structure 123, the two ends of the isolation structure 123 are respectively connected to the lower case 11 and the upper cover 12; the isolation structure 123 has a second cavity, and the first The two cavities communicate with the top hole 124 and the bottom hole 114 respectively, and the second cavity is isolated from the first cavity. The second cavity of the isolation structure 123 is used for passing through the puncture needle 51, so the second cavity should be configured as a sterile cavity, and the setting of the isolation structure 123 isolates the second cavity from the first cavity, by The circuit assembly 14 located in the first cavity does not need to be sterilized.

In an alternative example, the isolation structure 123 is a tubular member, and one end of the isolation structure 123 is fixedly connected with one of the lower shell 11 and the upper cover 12, preferably integrally formed; the other end of the isolation structure 123 has a third The sealing structure 125 , the other of the lower shell 11 and the upper cover 12 has a fourth sealing structure 113 matching with the third sealing structure 125 . When the upper cover 12 is assembled with the lower case 11 , the third sealing structure 125 is in sealing connection with the fourth sealing structure 113 . The structure of the third sealing structure 125 and the fourth sealing structure 113 can refer to the above-mentioned first sealing structure 112 and the second sealing structure 122, such as adopting the buckle connection method of grooves and protrusions, and further sealing can be strengthened with glue, which is not mentioned here. Repeat. It can be understood that, in some other embodiments, the isolation structure 123 is not limited to be fixedly connected to one of the lower shell 11 and the upper cover 12, but is detachably and airtightly connected to the other, and the isolation structure 123 can also be in the Both ends are detachably and airtightly connected to the lower case 11 and the upper cover 12 respectively, that is, the isolation structure 123 may be a component independent of the upper cover 12 and the lower case 11, and both ends thereof have a third sealing structure 125, and A fourth sealing structure 113 is provided at the corresponding parts of the upper cover 12 and the lower shell 11 .

Preferably, the lower shell 11 is a plane, and the angle between the extension direction of the sensor implant 33 and the lower shell 11 is 45°-90° (that is, where the sensor implant 33 and the bottom hole 114 are located). The included angle of the plane), so that it can be widely applied to implant objects that need to be placed obliquely into the sensing implant part 33 and implant objects that need to be configured to be placed vertically into the sensing implant part 33. Correspondingly, no matter What is the angle between the extending direction of the sensing implant part 33 and the lower shell 11? Achieve precise sterilization.

Optionally, the circuit assembly 14 is parallel to the lower case 11 . Such configuration is beneficial to reduce the volume of the subcutaneously implantable medical unit 1 .

Further, the subcutaneous implantable medical unit 1 further includes an adhesive patch 2, which is arranged on the side of the lower shell 11 away from the upper cover 12, and is used for sticking on the skin. The adhesive sticker 2 can be connected with the lower shell 11 using ultrasonic technology or double-sided adhesive tape, for example. Preferably, the lower surface of the sticker 2 (that is, the side away from the connection with the lower shell 11) also has a protective film, which can be torn off before use. It can be understood that the adhesive patch 2 has a hole for the puncture needle 51 and the sensor implant 33 to pass through, and it will not cover the bottom hole 114 to hinder the passage of the puncture needle 51 and the sensor implant 33 .

Please refer to FIG. 4 to FIG. 7 , based on the subcutaneous implantable medical unit 1 described above, this embodiment also provides a subcutaneous implantable medical device, which includes: a base body 4, a puncture unit 5 and the subcutaneous implantable medical device as described above. Implantable medical unit 1; the puncture unit 5 includes a puncture needle 51; the puncture needle 51 can move through the bottom hole 114 along the extension direction of the sensor implant 33, so as to communicate with the sensor The sensing implant part 33 is detachably connected; the base body 4 is detachably connected to the housing 10; the base body 4 has an accommodating structure 41 arranged along the extending direction of the sensing implant part 33, so The accommodating structure 41 has a third cavity 410, one end of the third cavity 410 is open for the penetration of the puncture needle 51 and the sensor implant 33; the other end of the third cavity 410 One end is closed; after the base body 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 connected to the bottom The holes 114 communicate.

In an alternative example, the cross-section of the puncture needle 51 is U-shaped, which is a semi-surrounding structure. The sensory implanted part 33 pierced through the center can be attached to the U-shaped concave area of the puncture needle 51, so that the puncture needle 51 and the sensory implanted part 33 can penetrate the skin together. Of course, in some other embodiments, the puncture needle 51 and the sensing implant part 33 may also adopt other shapes, which are not limited in the present application.

The base body 4 is used for placing the subcutaneous implantable medical unit 1 on it, and the puncture needle 51 and the sensing implant part 33 passing through the bottom hole 114 can extend into the third cavity 410 from the open end of the third cavity 410 middle. Since the other end of the third cavity 410 is closed, the casing 10 can close the open end of the third cavity 410 , so that the third cavity 410 is configured as a closed cavity except for communicating with the bottom hole 114 . And the bottom hole 114 is restricted by the isolation structure 123, and only communicates with the top hole 124 through the second cavity. An independent airtight chamber isolated from the environment. If the cleanliness and sterility in the closed cavity can be guaranteed, the sterility safety of the product can be guaranteed.

Furthermore, the thickness of the accommodating structure 41 at the closed end of the third cavity 410 is relatively thin, which can allow radiation rays to pass through; the thickness of the lower case 11 is also relatively thin, which can allow radiation rays to pass through. When carrying out radiation sterilization on the housing structure 41, the radiation rays penetrate the end of the housing structure 41 and inject into the third cavity 410, and then penetrate the lower shell 11 and inject into the second cavity, and the puncture needle 51 and sensor implant 33 are sterilized by irradiation. Since the third cavity 410 and the second cavity are configured as a closed cavity, which is isolated from the external environment, the closed cavity is a sterile environment, thereby ensuring the sterility of the puncture needle 51 and the sensor implant 33 safety. When in use, the subcutaneous implantable medical unit 1 is separated from the base body 4, and the puncture needle 51 and the sensing implant part 33 are taken out from the third cavity 410 and the second cavity, and then it can be used.

Preferably, the subcutaneous implantable medical device further includes a first seal 42 disposed around the accommodating structure 41 , and the base 4 is detachably connected to the housing 10 through the first seal 42 . The arrangement of the first sealing member 42 improves the sealing performance between the base body 4 and the lower case 11 . Please refer to Fig. 5 and Fig. 7, in one example, there is a recessed sealing part accommodating area on the upper surface of the base body 4, and the first sealing part 42 is an elastic annular body, and its material can be rubber, silicone or Teflon, the first seal 42 can snap into the seal receiving area. The lower shell 11 of the subcutaneously implantable medical unit 1 can be in contact with the upper surface of the base 4 (or the lower shell 11 can be in contact with the upper surface of the base 4 through the adhesive sticker 2 with a protective film). Thus, the lower shell 11 can press the first sealing member 42 , so that the housing 10 can close the open end of the third cavity 410 , so that the third cavity 410 only communicates with the bottom hole 114 .

Please refer to FIG. 6 together with reference to FIG. 7 , further, the puncture unit 5 further includes a needle base 53 connected to the puncture needle 51 , and the needle base 53 can be formed by injection molding, for example. The puncture needle 51 and the needle base 53 can be connected by embedding injection molding or glue bonding, so that the two form a hermetic connection. The radial profile of the needle base 53 can cover the top hole 124. After the puncture needle 51 penetrates the isolation structure 123 from the top hole 124 and passes out from the bottom hole 114, the needle base 53 can abut against the upper cover 12 to close the top hole 124 , thereby closing the second cavity.

Preferably, the puncture unit 5 includes a second seal 52 disposed around the puncture needle 51 , and the needle hub 53 is detachably connected to the housing 10 through the second seal 52 . The arrangement of the second sealing member 52 improves the sealing performance between the needle hub 53 and the upper cover 12 . The shape, material and arrangement principle of the second sealing member 52 can refer to the above-mentioned first sealing member 42 and will not be repeated here.

Please refer to FIG. 8 and FIG. 9. Optionally, the subcutaneous implantable medical device further includes a needle assisting unit 6 connected to the puncture unit 5 for driving the puncture unit 5 along the The puncture needle 51 punctures in the extending direction; the needle assisting unit 6 is detachably connected to the base 4 . Since the subcutaneous implantable medical unit 1 is small in size and flat in shape, it is difficult for the user to grasp it directly. Therefore, preferably, the needle assisting unit 6 can be used to help the subcutaneous implantable medical unit 1 and Grasping and piercing of the piercing unit 5 . In the examples shown in FIGS. 8 and 9 , the needle assisting unit 6 is a cylindrical body with an opening at one end for connecting with the base body 4 . Preferably, the base body 4 has several buckles 43 , and correspondingly, the needle assisting unit 6 has corresponding locking grooves 61 . When the needle assisting unit 6 is assembled and connected with the base body 4 , the buckle 43 can be snapped into the slot 61 to form a snap connection, thereby defining the connection position of the needle assisting unit 6 and the base body 4 . Preferably, the needle base 53 of the puncture unit 5 has a hook, such as two separated elastic feet on the upper part of the needle base 53 in FIG. Of course, reference may be made to the prior art for the specific structure inside the needle assisting unit 6, which is not limited in the present application.

When assembling, the puncture unit 5, the subcutaneous implantable medical unit 1 and the needle aid unit 6 can be assembled and connected first, so that the puncture needle 51 passes through the housing 10, and the needle holder 53 is airtightly connected with the upper cover 12 through the second sealing member 52 . Then, the needle assisting unit 6 is fastened together with the puncture unit 5 and the subcutaneous implantable medical unit 1 on the base 4 until the buckle 43 can be snapped into the slot 61, and the lower shell of the subcutaneous implantable medical unit 1 11 can compress the first sealing member 42, so that the second cavity and the third cavity 410 are reliably sealed. Further, the scope of the second cavity and the third cavity 410 is irradiated and sterilized along the extension direction of the sensing implant part 33 by means of local precise irradiation, that is, the production and assembly process of the product is completed.

When in use, the buckle 43 can be withdrawn from the card slot 61, and the connection restriction between the needle aid unit 6 and the base body 4 can be released, and the needle aid unit 6 can be removed from the base body together with the puncture unit 5 and the subcutaneous implantable medical unit 1. 4 and pull it out. Tear off the protective film on the sticker 2, place the needle assisting unit 6 on the human skin, press the button on the needle assisting unit 6, the subcutaneous implantable medical unit 1 and the puncture unit 5 can be ejected toward the human body together, and the sticker 2 Pasted on the skin, the puncture needle 51 and the sensor implant 33 penetrate the skin together, and then the puncture unit 5 is removed from the subcutaneous implantable medical unit 1, so that only the sensor implant 33 remains in the skin, and the process is completed. implant.

Please refer to Fig. 10 and Fig. 11, based on the above-mentioned subcutaneous implantable medical device, this embodiment also provides a radiation sterilization shielding device, which is used to protect the above-mentioned subcutaneous implant during radiation sterilization. The radiation sterilization shielding device includes: a shielding body 8; the shielding body 8 at least shields the circuit assembly 14 along the direction of the radiation; the shielding body 8 has The transmissive structure 81 is provided in the extension direction of the insertion part 33 , and the transmissive structure 81 allows radiation to pass through; It can be understood that those skilled in the art can select the type and radiation intensity of radiation rays (or electron beams) according to the prior art and common knowledge, and then select the material and The thickness and the structure of the transmission structure 81 are selected so that the shielding body 8 can shield the passage of radiation rays. The transmission structure 81 may be a transmission hole, or may be a material that allows radiation to pass through, which is not limited in the present application.

Since the transmission structure 81 that allows the radiation to pass through is aligned with the accommodation structure 41 along the extension direction of the sensor implant 33, the radiation can pass through the transmission structure 81 and the end of the accommodation structure 41 to enter the third The cavity 410 enters the second cavity through the lower casing 11 to sterilize the puncture needle 51 and the sensor implant 33 by radiation. On the other hand, since the shielding body 8 at least shields the circuit assembly 14 along the direction of the radiation, it is ensured that the circuit assembly 14 will not be damaged by the radiation.

Optionally, the assembled subcutaneous implantable medical device can be arranged along the irradiation direction of the puncture needle 51 facing the radiation. For example, in the example shown in FIG. 10 , the irradiation direction of the radiation is from Up and down, the subcutaneous implantable medical device is arranged along the upward direction of the puncture needle 51, so that the radiation can directly enter the third cavity 410 and the second cavity. Of course, in some other embodiments, if the radiation rays are strong enough, and the materials of the needle aid unit 6 and the needle holder 53 are not enough to shield the radiation rays, the subcutaneous implantable medical device can also be placed along the puncture needle 51 The irradiation direction of the radiation rays is arranged, and irradiation sterilization can also be realized at this time.

Preferably, the radiation sterilization shielding device further includes: a positioning body 7, the positioning body 7 has a fourth cavity 71, and the fourth cavity 71 is used for accommodating The subcutaneous implantable medical device is arranged in the direction of the irradiation line; the positioning body 7 is detachably connected to the shielding body 8 to limit the position of the subcutaneous implantable medical device. In an alternative example, the shielding body 8 and the positioning body 7 can be fixed by several bolts. Further, in order to increase production capacity, the positioning body 7 has multiple fourth cavities 71 that can accommodate multiple subcutaneous implantable medical devices at the same time, and accordingly, the shielding body 8 has multiple transmission structures 81 . Simultaneous irradiation sterilization of multiple subcutaneous implantable medical devices can be realized.

In summary, in the subcutaneous implantable medical unit, medical device and radiation sterilization shielding device provided by the present application, the subcutaneous implantable medical unit includes: a housing, a sensor implant and a circuit assembly; The circuit assembly is accommodated in the housing, the housing has a bottom hole, one end of the sensor implant is connected to the circuit assembly, and the other end passes through the bottom hole; the circuit assembly avoids A projected area of the bottom hole along the extending direction of the sensing implant part is opened. With such a configuration, since the circuit components that are not resistant to radiation avoid the range of the bottom hole, the range of the bottom hole can be irradiated and sterilized along the extension direction of the sensor implantation in the way of local precise irradiation, so as to realize the need for sterilization. The radiation sterilization of the sensor implanted part will not damage the radiation-resistant circuit components, so that the sensor implanted part and the circuit component can be integrated in the housing, which solves the problem of the existing subcutaneous implanted Due to the sterilization process of the medical device, the sensing implant and the circuit assembly need to be separately arranged.

It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application. Any changes and modifications made by those of ordinary skill in the field of the present application based on the above disclosure shall fall within the protection scope of the claims.

Claims

A subcutaneous implantable medical unit, characterized by comprising: a housing, a sensing implant and a circuit assembly;

The circuit assembly is accommodated in the housing, the housing has a bottom hole, one end of the sensing implant part is connected to the circuit assembly, and the other end passes through the bottom hole; the circuit assembly avoids A projected area of the bottom hole along the extending direction of the sensing implant part is opened.
The subcutaneous implantable medical unit according to claim 1, wherein the housing comprises a lower case and an upper cover, the bottom hole is located in the lower case; the lower case is adapted to the upper cover connected to form a first cavity; the circuit assembly is accommodated in the first cavity; the upper cover has a top hole, and the top hole and the bottom hole are along the extension of the sensing implant part Orientation alignment settings.
The subcutaneous implantable medical unit according to claim 2, wherein the housing includes an isolation structure, and the two ends of the isolation structure are respectively connected with the lower shell and the upper cover; the isolation structure There is a second cavity, the second cavity communicates with the top hole and the bottom hole respectively, and the second cavity is isolated from the first cavity.
The subcutaneous implantable medical unit according to claim 3, wherein one end of the isolation structure is fixedly connected to one of the lower shell and the upper cover, and the other end of the isolation structure has a second Three sealing structures, the other of the lower case and the upper cover has a fourth sealing structure compatible with the third sealing structure; when the upper cover is assembled with the lower case, the first The triple sealing structure is in sealing connection with the fourth sealing structure.
The subcutaneous implantable medical unit according to claim 2, characterized in that the angle between the extension direction of the sensing implant part and the lower shell is 45°-90°.
The subcutaneous implantable medical unit according to claim 2, wherein the lower shell has a first sealing structure, and the upper cover has a second sealing structure adapted to the first sealing structure, so When the upper cover is assembled with the lower case, the first sealing structure is in sealing connection with the second sealing structure.
A subcutaneous implantable medical device, characterized in that it comprises: a base body, a puncture unit, and the subcutaneous implantable medical unit according to any one of claims 1 to 6; the puncture unit includes a puncture needle; the The puncture needle can movably pass through the bottom hole along the extending direction of the sensing implant, so as to be detachably connected with the sensing implant;

The base body is detachably connected with the housing; the base body has an accommodating structure arranged along the extending direction of the sensing implant part, the accommodating structure has a third cavity, and the third cavity One end of the body is open for penetration of the puncture needle and the sensor implant; the other end of the third cavity is closed;

After the base body is connected to the housing, the housing closes the open end of the third cavity, so that the open end of the third cavity communicates only with the bottom hole.
The subcutaneous implantable medical device according to claim 7, characterized in that, the subcutaneous implantable medical device further comprises a first sealing member arranged around the accommodating structure, and the base body passes through the first sealing The component is detachably connected with the housing.
The subcutaneous implantable medical device according to claim 7, wherein the puncture unit further comprises a needle seat connected to the puncture needle and a second sealing member arranged around the puncture needle, the needle seat The second seal is detachably connected to the housing.
The subcutaneous implantable medical device according to claim 7, characterized in that, the subcutaneous implantable medical device further comprises a needle assisting unit connected to the puncture unit for driving the puncture The needle can movably pass through the bottom hole along the extension direction of the sensing implant part; the needle assisting unit is detachably connected with the base body.
The subcutaneous implantable medical device according to claim 7, wherein the accommodating structure allows radiation to enter the third cavity.
A radiation sterilization shielding device, characterized in that it is used to protect the subcutaneous implantable medical device according to any one of claims 7-10 during radiation sterilization; the radiation sterilization shielding device It includes a shielding body and a transmission structure; the shielding body at least shields the circuit assembly along the direction of the radiation; the transmission structure allows the radiation radiation to pass through, and the transmission structure and the accommodating structure along the sensing The extending directions of the implanted parts are arranged in alignment.
The radiation sterilization shielding device according to claim 11, characterized in that, the radiation sterilization shielding device comprises: a positioning body, the positioning body has a fourth cavity, and the fourth cavity is used to accommodate The subcutaneous implantable medical device is placed; the positioning body is detachably connected with the shielding body to limit the position of the subcutaneous implantable medical device.