A medical device sterilization method and system

Abstract

The application discloses a medical instrument sterilization method and system, which is applied to medical instruments which need electron beam irradiation sterilization and contain sensitive devices which cannot bear irradiation. The medical instruments contain sealed sterilization spaces, and the sterilization spaces also contain sealed isolation spaces. The sensitive devices are arranged in the isolation spaces. A shield is arranged between an electron beam irradiation emitting source and the sensitive devices. Two or more times of electron beam irradiation sterilization are carried out. The electron beam irradiation directions of the sterilization are different. Therefore, all regions of the medical instruments except the isolation space where the sensitive devices are arranged are sterilized by electron beam penetration. Through two times of bidirectional electron beam sterilization, all regions of the medical instruments except the shield region containing the sensitive devices are sterilized by electron beam penetration. Microorganisms in the region of the shield region which is not sterilized by irradiation cannot invade the outside of the isolation space. The problem that the sensitive devices are not irradiated is solved during sterilization.

Description

Technical Field

[0001] This invention relates to a method and system for sterilizing medical devices. Background Technology

[0002] Some medical devices for detecting bodily fluids need to come into close contact with the human body or even be partially implanted in the body. This requires that the implanted part be strictly sterilized. At the same time, in order to meet the function, the device needs to carry precision and sensitive electronic components such as chips.

[0003] For example, continuous glucose monitoring (CGM) requires a thin glucose sensor to be implanted under the skin. Therefore, the implanted part must be sterilized, and the sterilization process has strict requirements. The signal is transmitted to the transmitter that is applied to the skin. An electronic chip inside the transmitter processes the signal before it is sent to the receiver, such as a handheld receiver or mobile phone.

[0004] CGM primarily uses irradiation as its sterilization method because irradiation can penetrate medical devices to sterilize them. When the dose reaches a certain level, it can completely sterilize both the exterior and interior of the medical device. However, this presents a contradiction: because the dose needs to be sufficiently high, some sensitive internal components, especially electronic chips, may undergo changes during irradiation, affecting overall performance and even causing failure.

[0005] In order to prevent the sensitive device from being affected by irradiation during CGM irradiation sterilization, the existing technical solution often separates the part to be irradiated from the sensitive device. The irradiated part (the implanted part with the sensor) is sealed to form a sterile barrier. After being sterilized by irradiation, it is then combined with the sensitive device part to become a whole and realize its function.

[0006] In recent years, some companies have proposed a new approach: integrating the implanted sensor and the sensitive device into a single component, albeit in different areas. An electron beam shield is placed between the sensitive device and the irradiation source, while the implanted portion is designed as a small, sealed sterile barrier, unshielded in front. During electron beam sterilization, the sensitive device remains unaffected by the shielding, while the implanted portion, unshielded, undergoes electron beam sterilization, and its sterility is maintained by the sealed barrier.

[0007] The original technical solution required the later integration of the implanted sterilization part and the sensitive device part. This increased the process, complexity, and size due to the need for later integration, both in the production and user stages.

[0008] While the new method appears to solve the problems of the original technical solution, in practice, it involves several issues. Firstly, it implants a small area to create a movable, sealed sterile barrier, while other areas remain unsterilized. If the sterile barrier is inadequate, contamination is easily achieved. Secondly, irradiation shielding is not simply a matter of placing a shield along the electron beam's path. Considering the irradiation's penetrating power, the shield needs sufficient density and thickness. Secondly, considering the electron beam's scattering, interference, and diffraction properties, protecting sensitive devices requires a sufficiently large shield area. However, a large shield area, in turn, negatively impacts the sterilization effect of the implanted area. Therefore, this new method remains only a concept and has not yet been commercialized. Summary of the Invention

[0009] In view of this, the present invention proposes a sterilization method and system for medical devices, which solves the problems of sterilization and protection of sensitive devices at the same time.

[0010] The present invention adopts the following technical solution: a sterilization method for medical devices, applied to medical devices that require electron beam irradiation sterilization and contain sensitive devices that cannot withstand irradiation, wherein the medical device contains a sealed sterilization space, the sterilization space contains a sealed isolation space, and the sensitive device is disposed within the isolation space; a shielding material is placed between the electron beam irradiation source and the sensitive device; two or more electron beam irradiation sterilizations are performed, each with a different electron beam irradiation direction, so that the sterilization space of the medical device, except for the isolation space, is sterilized, while the sensitive device is shielded and not irradiated in each sterilization.

[0011] Optionally, two electron beam irradiation sterilization processes are performed, with the directions of the two sterilization electron beam irradiations intersecting perpendicularly.

[0012] This invention also discloses a medical device sterilization system applicable to medical devices that require electron beam irradiation sterilization but contain sensitive components that cannot withstand irradiation. The medical device sterilization system allows the medical device to undergo sterilization twice or more with electron beam irradiation directions different from the intended direction. The system includes the medical device, an electron beam irradiation source, and a shielding material, wherein: the shielding material is disposed between the electron beam irradiation source and the sensitive components; the medical device contains a sealed sterilization space, which in turn contains a sealed isolation space, and the sensitive components are disposed within the isolation space.

[0013] Optionally, the emission sources for two or more electron beam irradiation sterilizations are located in two perpendicularly intersecting directions.

[0014] Optionally, the medical device is an implantable sensor delivery system, which includes an applicator and a wireless signal transmitter, wherein: the wireless signal transmitter has two closed sealing rings, with an isolation space formed between the two sealing rings; the chip inside the wireless signal transmitter is located within the isolation space formed by the two sealing rings; and the guide needle and implantable sensor are located outside the isolation space.

[0015] Optionally, the wireless signal transmitter is enclosed inside the applicator, and the applicator has an integral sealing structure on the outside to form a sterile barrier.

[0016] Optionally, the overall sealing structure includes an applicator housing, a button sealing gasket, and an aluminum foil, wherein: a button opening is provided at the top of the applicator housing, and a button sealing gasket is provided at the button opening, and the button sealing gasket is squeezed to seal; an opening is provided at the bottom of the applicator housing, and the bottom opening is sealed by the aluminum foil.

[0017] Optionally, the shield is disposed outside the applicator, or outside the wireless signal transmitter inside the applicator, or inside the wireless signal transmitter.

[0018] Alternatively, a metal can be chosen as the shielding material to achieve shielding in a smaller volume.

[0019] According to the technical solution of the present invention, a medical device sterilization method and system are applied to medical devices that require electron beam irradiation sterilization and contain sensitive devices that cannot withstand irradiation. The medical device contains a sealed sterilization space, which contains a sealed isolation space, and the sensitive device is located within the isolation space. A shield is placed between the electron beam irradiation source and the sensitive device. Two or more electron beam irradiation sterilization processes with different irradiation directions are performed, so that all areas of the sterilization space except the isolation space are sterilized. The sensitive device is shielded and not irradiated in each sterilization process, and microorganisms in the shielded areas that are not irradiated cannot invade the sealed space. This solves the problem of sensitive devices not being irradiated while sterilizing. Attached Figure Description

[0020] For illustrative and not limiting purposes, the invention will now be described with reference to preferred embodiments thereof, particularly the accompanying drawings, in which:

[0021] Figure 1 This is a schematic diagram of the external structure of a wireless signal transmitter;

[0022] Figure 2 This is a schematic diagram of the internal structure of a wireless signal transmitter;

[0023] Figure 3 This is a schematic diagram of the sealing groove distribution;

[0024] Figure 4 This is a schematic diagram of the sealing ring;

[0025] Figure 5 This is a schematic diagram of the structure where the bottom of the applicator is sealed with an aluminum film;

[0026] Figure 6 This is a schematic diagram of the structure where the top opening of the applicator is sealed by a button sealing gasket;

[0027] Figure 7 This is a typical depth dose distribution curve of an electron beam in a homogeneous material;

[0028] Figure 8 This is a schematic diagram of the initial sterilization shielding.

[0029] Figure 9 This is a top view of the electron beam distribution during the first sterilization process;

[0030] Figure 10 This is a front view of the electron beam distribution during the first sterilization process;

[0031] Figure 11 This is a schematic diagram of the second sterilization shielding;

[0032] Figure 12 This is a schematic diagram of the electron beam distribution during the second sterilization process;

[0033] Figure 13 This is a schematic diagram showing how sensitive devices are shielded and protected during the two sterilization processes.

[0034] In the diagram, 1-guide pin, 2-lower shell, 3-upper shell, 4-implanted sensor, 5-battery, 6-circuit board, 7-chip, 8-first sealing groove, 9-first sealing ring, 10-aluminum foil, 11-applier housing, 12-button sealing gasket, 13-shielding material A, 14-shielding material B, 15-shielding area, 16-second sealing groove, 17-second sealing ring. Detailed Implementation

[0035] In this embodiment of the invention, sterilization is achieved by two or more bidirectional electron beam irradiations, ensuring that all areas except the isolation space where the sensitive device is located are penetrated and sterilized by the electron beam, thereby protecting the sensitive device. This will be explained in detail below.

[0036] This invention discloses a sterilization method for medical devices, applicable to medical devices that require electron beam irradiation sterilization and contain sensitive components that cannot withstand irradiation. The medical device contains a sealed sterilization space, which in turn contains a sealed isolation space, within which the sensitive components are located. A shielding material is placed between the electron beam irradiation source and the sensitive components. Two or more electron beam irradiation sterilization processes are performed, each with a different irradiation direction, ensuring that all areas of the sterilization space of the medical device, except for the isolation space, are sterilized, while the sensitive components are shielded and not irradiated during each sterilization process.

[0037] The preferred sterilization method involves two electron beam irradiation sterilization processes, with the directions of the two electron beam irradiations intersecting perpendicularly.

[0038] The present invention also discloses a medical device sterilization system, which is applied to medical devices that require electron beam irradiation sterilization and contain sensitive components that cannot withstand irradiation. The medical device sterilization system enables the medical device to undergo sterilization by two or more electron beam irradiations with different directions.

[0039] The medical device sterilization system includes a medical device, an electron beam irradiation source, and a shielding device. The shielding device is placed between the electron beam irradiation source and the sensitive device. The medical device contains a sealed sterilization space, which contains a sealed isolation space, and the sensitive device is located within the isolation space.

[0040] In the medical device sterilization system of this invention, the emission sources for two or more electron beam irradiation sterilizations are preferably located in two perpendicularly intersecting directions.

[0041] The following describes the sterilization process before use of implantable sensor delivery systems, including continuous glucose monitoring (CGM).

[0042] like Figure 1 , Figure 2 As shown, the wireless signal transmitter of the implantable sensor delivery system includes a lower shell 2, an upper shell 3, an implantable sensor 4, a guide pin 1, a battery 5, a circuit board 6, and a chip 7 on the circuit board 6. The implantable sensor 4 and the guide pin 1 are components that must be sterilized, while the chip 7 is a sensitive device that cannot withstand irradiation sterilization.

[0043] like Figure 3 , Figure 4 As shown, in the wireless signal transmitter, a first sealing groove 8 is provided between the lower shell 1 and the upper shell 2, and a second sealing groove 16 is provided around the guide pin 1. After being bonded with waterproof sealant, two closed first sealing rings 9 and second sealing rings 17 are formed respectively. The components inside the shell, including the chip 7, are sealed inside, while the guide pin 1 and the implanted sensor 4 are outside the isolation space of this wireless signal transmitter.

[0044] Outside the wireless signal transmitter, there is an applicator that surrounds it. The applicator can be used to insert and release the wireless signal transmitter. In this embodiment of the invention, the applicator is an integrally sealed structure, thereby forming a sealed sterilization space. Figure 5 , Figure 6 As shown, a button is provided at the top of the applicator housing 11, and the top is sealed by a button sealing gasket 12, which is squeezed to seal; a wireless signal transmitter implantation outlet is provided at the bottom of the applicator housing 11, and the bottom wireless signal transmitter implantation outlet is sealed by an aluminum foil 10.

[0045] In the sterilization process, electron beam irradiation sterilization is used. Electron beam irradiation sterilization is a high-energy physical sterilization method that can penetrate the product to irradiate and sterilize its interior. However, the sterilization ability weakens as the penetration density increases. Figure 7 This is a typical depth-dose distribution curve of an electron beam in a homogeneous material. Sufficient shielding can block the electron beam so that it does not affect sensitive devices.

[0046] like Figures 8 to 12 As shown, unlike existing irradiation sterilization methods, this invention performs two sterilization processes. The electron beam irradiation for the two sterilization processes uses two different directions with an included angle, preferably two perpendicularly intersecting directions. Alternatively, more than two sterilization processes in two or more directions can be used, but this would make the system more complex and the actual increase in effectiveness would be limited.

[0047] A shield is placed between the electron beam irradiation source and the sensitive device. There are three possible locations for the shield: outside the applicator, outside the wireless transmitter inside the applicator, and inside the wireless transmitter. Preferably, the shield is placed outside the applicator, as this allows for reuse and reduces the structure, cost, and weight of both the applicator and the wireless transmitter. The shield is preferably made of metal to achieve shielding in a smaller volume.

[0048] Through two bidirectional electron beam sterilization processes, the entire internal area of ​​the applicator, except for the square area containing the sensitive device shielded by the shielding material, is sterilized by the electron beam penetration. Since the applicator is sealed from the outside world, external microorganisms cannot invade. The unsterilized part containing the sensitive device is inside the sealing ring of the wireless signal transmitter. Even if it is not sterilized, the microorganisms inside cannot invade the outside of the sealing ring. Thus, the guide needle and implantable sensor are both sterilized by electron beam irradiation and prevented from being invaded by microorganisms from other environments, maintaining a sterile environment.

[0049] like Figure 13As shown, after two rounds of bidirectional sterilization, the shielded area 15 is protected both times, and the chip 7 is located in this area, while other areas within its applicator are sterilized by electron beam irradiation. Furthermore, the shielded area 15 is within the sealing ring, preventing microorganisms from invading the areas requiring sterilization, thus solving both the sterilization and protection issues.

[0050] According to the technical solution of the present invention, a bidirectional sterilization method for medical devices places the sensitive device in an isolation space and the part to be sterilized outside the isolation space; a shield is placed between the electron beam irradiation source and the sensitive device; two sterilization processes are adopted, with the electron beam irradiation directions of the two sterilization processes being two different directions with an included angle. Through two bidirectional electron beam sterilization processes, all parts except the shielded area containing the sensitive device are penetrated and sterilized by the electron beam, while the parts of the shielded area that are not irradiated and sterilized are sealed off, preventing microorganisms from invading outside the sealed space, thus solving the two problems of sterilization and protection of the sensitive device at the same time.

[0051] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can occur depending on design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this invention should be included within the scope of protection of this invention.

Claims

1. A sterilization method for medical devices, applied to medical devices that require both electron beam irradiation sterilization and contain sensitive components that cannot withstand irradiation, characterized in that, The medical device includes a sealed sterilization space, which contains a sealed isolation space, and the sensitive device is disposed within the isolation space. A shield is placed between the electron beam irradiation source and the sensitive device; The medical device is sterilized by two or more electron beam irradiation sterilization processes, each with a different electron beam irradiation direction, so that all areas of the sterilization space except the isolation space are sterilized, while the sensitive device is shielded and not irradiated in each sterilization process. When performing two electron beam irradiation sterilization processes, the directions of the two sterilization electron beam irradiations intersect perpendicularly. By using two bidirectional electron beam sterilization processes, all areas except the shielded area containing sensitive devices are sterilized by the electron beam. The unsterilized parts of the shielded area are sealed off, preventing microorganisms from entering the sealed space. This solves both the sterilization and sensitive device protection problems.

2. A medical device sterilization system according to the medical device sterilization method of claim 1, applied to medical devices that require both electron beam irradiation sterilization and contain sensitive components that cannot withstand irradiation, characterized in that, The medical device sterilization system enables medical devices to undergo sterilization two or more times with different electron beam irradiation directions. The medical device sterilization system includes a medical device, an electron beam irradiation source, and a shielding material, wherein: A shield is placed between the electron beam irradiation source and the sensitive device; The medical device includes a sealed sterilization space, which contains a sealed isolation space, and the sensitive device is disposed within the isolation space.

3. The medical device sterilization system according to claim 2, characterized in that, The emission sources for two or more electron beam irradiation sterilizations are located in two perpendicularly intersecting directions.

4. The medical device sterilization system according to claim 3, characterized in that, The medical device is an implantable sensor delivery system, which includes an applicator and a wireless signal transmitter, wherein: The wireless signal transmitter has two closed sealing rings inside, forming an isolation space between the two sealing rings. The chip (7) inside the wireless signal transmitter is located within the isolation space formed by the two sealing rings, while the guide pin (1) and the implantable sensor (4) are located outside the isolation space.

5. The medical device sterilization system according to claim 4, characterized in that, The wireless signal transmitter is enclosed inside the applicator, and the applicator is provided with an integrally sealed structure to form a sterile barrier.

6. The medical device sterilization system according to claim 5, characterized in that, The overall sealing structure includes an applicator housing (11), a button sealing gasket (12), and an aluminum foil (10), wherein: A button opening is provided at the top of the applicator housing (11), and a button sealing gasket (12) is provided at the button opening. The button sealing gasket (12) is squeezed and sealed. An opening is provided at the bottom of the applicator housing (11), and the bottom opening is sealed by aluminum foil (10).

7. The medical device sterilization system according to claim 2, characterized in that, The shield is located outside the applicator, or outside the wireless signal transmitter inside the applicator, or inside the wireless signal transmitter.

8. The medical device sterilization system according to claim 7, characterized in that, The shielding material is made of metal to achieve shielding in a smaller volume.

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