An indwelling unit, component and monitoring system with a sterile barrier system

Abstract

The present invention relates to the field of medical device technology, and specifically to an indwelling unit, assembly and monitoring system with a sterile barrier system, wherein the indwelling unit includes an indwelling seat base, an indwelling soft needle and an indwelling seat upper cover, and the sterile barrier system includes a sealing sleeve, a first sealing member and a second sealing member. The combination of the sealing sleeve, the first sealing member and the second sealing member constitutes a sterile barrier system of an indwelling body implanted subcutaneously, and based on the sterile barrier system, the indwelling unit can be sterilized independently, especially when the indwelling body is a monitoring sensor, the assembly consisting of the indwelling unit, the puncture seat and the puncture steel needle can be sterilized independently by radiation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an indwelling unit, a component and a monitoring system with a sterile barrier system. Background Art

[0002] Patching-type indwelling needles are widely used in diabetic patients. The indwelling unit is adhered to the skin, and the indwelling soft needle is located under the skin for repeated medication.

[0003] Patients with symptoms such as diabetes need to monitor various indicators in their blood. Therefore, an analytical monitoring system for monitoring patient indicators has been developed based on the existing patch-type indwelling needles, in which the monitoring sensor needs to be implanted subcutaneously like an indwelling soft needle.

[0004] Devices implanted subcutaneously or positioned on the skin are required to be sterile when inserted. For indicator analysis and monitoring systems, due to the presence of electronic components and sensors, traditional ethylene oxide sterilization is not suitable, and radiation sterilization is used. However, radiation sterilization is harmful to electronic components. Therefore, electronic components and sensors are usually designed separately, and the sensors are sterilized by radiation separately.

[0005] The Chinese invention patent with publication number CN112423665A discloses a focused sterilization and sterilized subassembly for an analyte detection system. The invention patent provides two technical concepts, one of which is a two-piece architecture system, such as the one in CN112423665A. Figure 2 The sensor tray 202 shown in A and Figure 2 The sensor applicator 102 shown in B is provided to the user as a separate package. In this structure, although the sensor part can be sterilized by radiation alone, the user needs to open the two packages and assemble them when finally using it, which increases the difficulty of use for the user and is less convenient. In addition, during the assembly process, after the package is torn open, the packaging box as a sterile barrier has lost its function as a sterile barrier. If the user does not assemble and use it in time, the exposed sensor and the application part are at risk of being infected with bacteria and viruses.

[0006] The second technical concept provided by the above patent provides the Figure 1 The one-piece structure shown in FIG. 1 includes a sterilization technology specifically designed for the one-piece structure. Compared with the first two-piece structure, the single sealed package does not require any user assembly steps. However, the sterilization technology specifically designed for the one-piece structure is more complicated and costly. Although the sensor and electronic components are in the one-piece structure, when irradiating and sterilizing the sensor, the electronic components must be isolated, which undoubtedly increases the complexity of the structure and places higher technical requirements on sterilization. Summary of the invention

[0007] The technical problem to be solved by the present invention is to solve the technical defects in the prior art that the two-piece structure system is inconvenient for users to operate and the one-piece structure has high requirements for sterilization technology.

[0008] In order to solve the above technical problems, the technical solution provided by the present invention is as follows: a retention unit with a sterile barrier system, comprising at least a retention unit and a sterile barrier system, wherein the retention unit comprises at least a retention seat base and a retention body, wherein a retention base and a threaded connection cavity surrounding the retention base are arranged in the middle of the retention seat base, wherein an internal thread is arranged in the threaded connection cavity, and the retention body is located on the retention base;

[0009] The sterile barrier system comprises at least:

[0010] A sealing sleeve, the sealing sleeve at least comprising a sleeve body and a threaded connection end adapted to be connected with the internal thread of the threaded connection cavity, wherein a sealing cavity for being sleeved on the retention body is provided in the sleeve body;

[0011] A first sealing member, which is disposed between the sealing sleeve and the retaining seat base and seals the retaining body in the threaded connection cavity and the sealing cavity; and

[0012] A second sealing member is provided at an end of the retention base away from the retention body.

[0013] In a preferred embodiment, a ring platform is further provided between the sealing sleeve and the threaded connection end, and the outer diameter of the ring platform is larger than the outer diameter of the threaded connection end and the outer diameter of the sleeve body.

[0014] In a preferred embodiment, a sink groove adapted to the ring platform is provided on the base of the retention seat.

[0015] In a preferred embodiment, the first sealing member is disposed between the ring platform and the bottom of the groove, or between the threaded connection end and the bottom of the threaded connection cavity.

[0016] In a preferred embodiment, the first sealing member and / or the second sealing member is made of rubber or silicone.

[0017] A preferred embodiment further comprises a retention seat upper cover, wherein the retention seat upper cover is arranged on a side of the retention seat base away from the retention body, and the second sealing member is arranged between the retention seat upper cover and the retention base.

[0018] A preferred embodiment further includes an adhesive layer and a release paper, wherein the adhesive layer is fixed to a side surface of the retention seat base on which the retention body is provided, the middle portion of the release paper is sleeved on the sleeve and covers at least a portion of the sealing sleeve, and the release paper is provided with at least one cutting line extending spirally from a position close to the sealing sleeve to the periphery.

[0019] In a preferred embodiment, the indwelling body is an indwelling soft needle or a monitoring sensor.

[0020] A component is sterilized by radiation, and the component at least comprises the retention unit with the sterile barrier system and a puncture seat, wherein the puncture seat is provided with a puncture needle, and the puncture needle passes through the second sealing member and is combined with the retention body.

[0021] A monitoring system at least comprises the above-mentioned component and a transmitting unit.

[0022] The present embodiment has a retention unit of a sterile barrier system, which, through the combination of a sealing sleeve, a first seal and a second seal, constitutes a sterile barrier system of a retention body implanted subcutaneously. Based on the sterile barrier system, the retention unit can be sterilized independently. In particular, when the retention body is a monitoring sensor, the assembly consisting of the retention unit, the puncture seat and the puncture needle can be independently radiation sterilized.

[0023] Compared with the existing technology, the above structure and sterilization form have the following technical advantages:

[0024] (1) After the components are independently sterilized by radiation, based on the existence of the sterile barrier system, they can be assembled with the launch unit before leaving the factory, thus forming an integrated structure. Users do not need to assemble it, which is convenient to use and easy to operate.

[0025] (2) Based on the existence of the sterile barrier system, the assembly and packaging of radiation sterilized components and emission units can be carried out in a normal environment without the need for a sterile environment. In this way, the production cost of the product can be kept low.

[0026] (3) The sterile barrier system in this embodiment has a simple structure and low cost. At the same time, based on the independent sterilization of components, it has low requirements for the adaptation of other structures such as the launch unit. It can be widely adapted to different forms of launch units and has a wide range of applications.

[0027] (4) The sealing sleeve is threadedly connected to the base of the retention seat through a threaded connection end. When removing the sealing sleeve, the threaded connection not only plays a connecting role, but also plays a guiding role, ensuring that the sealing sleeve moves axially during removal, greatly reducing the risk of contact with the retention body and protecting the retention body from damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a cross-sectional structural schematic diagram of the assembly shown in Example 1;

[0029] Figure 2 This is a schematic structural diagram of the indwelling unit with a sterile barrier system in Example 1;

[0030] Figure 3 for Figure 2 A schematic diagram of the structure of the retention unit in an explosion state is shown;

[0031] Figure 4 Schematic diagram of the external structure of the sealing sleeve;

[0032] Figure 5 It is a schematic diagram of the cross-sectional structure of the sealing sleeve;

[0033] Figure 6 It is a schematic diagram of the structure of release paper;

[0034] Figure 7 It is a schematic cross-sectional structural diagram of the assembly shown in the second embodiment;

[0035] Figure 8 It is a schematic diagram of the cross-sectional structure of the components shown in Example 3. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0037] In the description of the present invention, it is necessary to understand that the terms "upper", "lower", "front", "back", "inside", "outside", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0038] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense. For example, it can be a fixed connection, an integral connection, or a detachable connection; it can be the internal connection of two components; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] Embodiment 1

[0040] A component for sterilization in this embodiment, such as Figure 1As shown, it includes a retention unit with a sterile barrier system, a puncture seat 80, and a puncture needle 81. It should be noted that the puncture seat and the puncture needle in this embodiment, as well as the transmitting unit for adaptation, all adopt the existing technology, which will not be described in detail here. The existing technology, such as the puncture seat, the puncture needle, and the transmitting unit disclosed in CN113082362A and CN112423665A, can be applied to this embodiment.

[0041] As an improvement of this embodiment, in the indwelling unit having a sterile barrier system, the indwelling unit is as follows Figure 2-Figure 3 As shown, it includes a retention seat base 10, a retention soft needle 60, an adhesive layer 30 and a retention seat upper cover 20, wherein the retention soft needle is the retention body of this embodiment.

[0042] Among them, the retention seat base 10 of this embodiment is provided with a retention base 12 and a threaded connection cavity 13 surrounding the retention base 12, and the threaded connection cavity is provided with an internal thread. The retention soft needle 60 is fixed on the retention base 12, and the adhesive layer 30 is fixed on the side surface of the retention seat base 10 where the retention soft needle 60 is provided.

[0043] It should be noted that the role of the adhesive layer 30 is to adhere the retention unit to the skin. As an equivalent embodiment, the adhesive layer 30 may not be provided, and the retention unit may be fixed to the skin by other means such as an external tape.

[0044] In this embodiment, a release paper 40 is disposed on the adhesive layer 30. The release paper 40 is as follows: Figure 6 As shown, a circular hole 42 is provided in the middle thereof, and two cutting lines 41 are provided which extend spirally from the position close to the sealing sleeve 50 to the periphery. In the process of removing the release paper 40, the release paper is gradually separated along the spirally extending cutting lines 41. The purpose of such a setting is that in the process of removing the release paper, the removal force required is small, and the external force on the adhesive layer is more balanced.

[0045] It should be noted that, in this embodiment, two cutting lines are a preferred setting method and are not the only number limitation.

[0046] The sterile barrier system of this embodiment, such as Figure 2-Figure 5 As shown, it includes a sealing sleeve 50, a first sealing member 71 and a second sealing member 70. The sealing sleeve 50 is provided with a sleeve body 51, a sealing cavity 53 is provided in the sleeve body 51, and is sleeved on the indwelling soft needle 60. The sealing sleeve 50 is provided with a threaded connection end 53 that is adapted to be connected with the internal thread of the threaded connection cavity 13, and the sealing sleeve 50 is threadedly connected to the indwelling seat base 10 through the threaded connection end 53.

[0047] Wherein, the first sealing member 71 is disposed between the sealing sleeve 50 and the retaining seat base 10. Preferably, in this embodiment, Figure 1 As shown, the first sealing member 71 is located between the threaded connection end 53 and the bottom of the threaded connection cavity 13. Usually, the first sealing member 71 is a sealing ring made of silicone or rubber.

[0048] The first sealing member is provided to seal the indwelling soft needle in the threaded connection cavity and the sealing cavity.

[0049] The second sealing member 70 of this embodiment is disposed between the retention seat upper cover 20 and the retention base 10, and is preferably made of silicone. In the assembled assembly, the puncture needle 81 passes through the second sealing member 70 and is combined with the retention soft needle 60. Usually, the second sealing member is made of rubber or silicone.

[0050] After the puncture needle passes through the second sealing member, the puncture portion of the puncture needle is sealed in the space where the indwelling soft needle is located. When the puncture needle is a hollow structure, the end thereof away from the needle tip is sealed by the puncture seat.

[0051] Preferably, in this embodiment, a ring stage 52 is further provided between the sleeve body 51 and the threaded connection end 53, wherein the middle portion of the release paper 40 is sleeved on the sleeve body 51 through the circular hole 42, and the diameter of the circular hole is larger than the outer diameter of the sleeve body 51 and smaller than the outer diameter of the ring stage 52, so that a portion of the release paper covers the ring stage 52.

[0052] After being configured in this way, when the sealing sleeve 50 is removed, the release paper 40 does not affect the rotation of the sealing sleeve 50. As the sealing sleeve 50 moves axially, the middle part of the release paper 40 moves axially away from the adhesive layer, and then gradually separates from the adhesive layer from the middle to the periphery along the cutting line.

[0053] Correspondingly, a sink 11 adapted to the ring platform is provided on the retaining seat base 10. In the assembled state, the surface of the ring platform 52 provided with the release paper 40 is flush with the surface of the adhesive layer 30 to ensure that the release paper 40 is on the same plane.

[0054] In addition, during the process of removing the sealing sleeve, the sealing sleeve can move axially based on the threaded connection to avoid contact with and damage to the indwelling soft needle.

[0055] Embodiment 2

[0056] A component for sterilization in this embodiment, such as Figure 7As shown, the difference from the first embodiment is that, the retention body is a monitoring sensor 61. It should be noted that, the monitoring sensor 61 is a prior art, and the existing common monitoring sensors 61 include but are not limited to sensors for monitoring amylase, bilirubin, hormones, glucose, peroxide, etc., which can be selected according to needs.

[0057] The components based on this embodiment are combined with the transmitting unit to form a monitoring system. The transmitting unit adopts the existing technology and will not be described in detail here. The transmitting units disclosed in the existing technology such as CN113082362A and CN112423665A can be applied to the monitoring system of this embodiment.

[0058] It should also be noted that the electronic components adapted to the monitoring sensor 61 are installed in the transmitting unit, which is not the invention point of the present application and will not be elaborated here.

[0059] After the components of this embodiment are independently irradiated and sterilized, based on the existence of the sterile barrier system, they can be assembled with the launch unit before leaving the factory, thus forming an integrated structure. Users do not need to assemble, and it is convenient to use and operate. Based on the existence of the sterile barrier system, the assembly and packaging of the radiation-sterilized components and the launch unit can be carried out in a normal environment, without the need for a sterile environment. In this way, the production cost of the product can be kept low. And there is no need to specially design a dedicated sterilization system or isolation components for electronic components, which greatly saves costs.

[0060] The sterile barrier system in this embodiment has a simple structure and low cost. At the same time, based on the independent sterilization of components, it has low adaptation requirements for other structures such as the launch unit, can be widely adapted to different forms of launch units, and has a wide range of applications.

[0061] Embodiment 3

[0062] A component for sterilization in this embodiment, such as Figure 8 As shown, the first difference from the second embodiment is that the position of the first sealing member 71 is different.

[0063] In this embodiment, the first sealing member is arranged between the ring platform and the bottom of the sink. After such arrangement, the thickness of the retention unit can be reduced compared with the first embodiment, which is more comfortable and convenient for users.

[0064] The second difference between this embodiment and the second embodiment is that no adhesive layer and release paper are provided, and the retention unit can be fixed on the skin by using an external adhesive tape or the like.

[0065] In short, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An indwelling unit with a sterile barrier system, characterized in that: At least comprises a retention unit and a sterile barrier system, wherein the retention unit at least comprises a retention seat base and a retention body, wherein a retention base and a threaded connection cavity surrounding the retention base are arranged in the middle of the retention seat base, wherein an internal thread is arranged in the threaded connection cavity, and the retention body is located on the retention base; The sterile barrier system comprises at least: A sealing sleeve, the sealing sleeve at least comprising a sleeve body and a threaded connection end adapted to be connected with the internal thread of the threaded connection cavity, wherein a sealing cavity for being sleeved on the retention body is provided in the sleeve body; A first sealing member, which is disposed between the sealing sleeve and the retaining seat base and seals the retaining body in the threaded connection cavity and the sealing cavity; and A second sealing member is provided at an end of the retention base away from the retention body.

2. The indwelling unit with a sterile barrier system according to claim 1, characterized in that: A ring platform is also arranged between the sealing sleeve and the threaded connection end, and the outer diameter of the ring platform is larger than the outer diameter of the threaded connection end and the outer diameter of the sleeve body.

3. The indwelling unit with a sterile barrier system according to claim 2, characterized in that: The retaining seat base is provided with a sink groove matched with the ring platform.

4. The indwelling unit with a sterile barrier system according to claim 3, characterized in that: The first sealing member is arranged between the ring platform and the bottom of the sink groove, or between the threaded connection end and the bottom of the threaded connection cavity.

5. The indwelling unit with a sterile barrier system according to claim 4, characterized in that: The first sealing member and / or the second sealing member is made of rubber or silicone.

6. The indwelling unit with a sterile barrier system according to claim 1, characterized in that: It also includes a retention seat upper cover, which is arranged on a side of the retention seat base away from the retention body, and the second sealing member is arranged between the retention seat upper cover and the retention base.

7. The indwelling unit with a sterile barrier system according to any one of claims 1 to 6, characterized in that: It also includes an adhesive layer and a release paper, wherein the adhesive layer is fixed to a side surface of the retention seat base on which a retention body is provided, the middle portion of the release paper is sleeved on the sleeve and covers at least a portion of the sealing sleeve, and the release paper is provided with at least one cutting line extending spirally from a position close to the sealing sleeve to the periphery.

8. The indwelling unit with a sterile barrier system according to any one of claims 1 to 6, characterized in that: The indwelling body is an indwelling soft needle or a monitoring sensor.

9. A component sterilized by radiation, characterized in that The assembly at least comprises the retention unit with a sterile barrier system as claimed in claim 8 and a puncture seat, wherein the puncture seat is provided with a puncture needle, and the puncture needle passes through the second sealing member and is combined with the retention body.

10. A monitoring system, characterized in that: At least comprising the assembly according to claim 9 and a transmitting unit.

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