MEDICAL DEVICE WITH GALVANIC SEPARATION DEVICE

Description

[0001] The invention relates to a medical device with an application device that can be brought into contact with a patient to be treated and a galvanic isolation device that can be connected to the application device, having the features specified in the preamble of claim 1.

[0002] For medical devices operating with potentially hazardous voltages (PGS), it must be ensured that no direct, electrically conductive connection exists between a voltage source and the patient. For example, endoscopic cameras require at least one galvanic isolator between the power supply and the endoscopic optics to prevent a direct, electrically conductive connection. The IEC 60601-1 standard, among others, specifies requirements for clearances, creepage distances, dielectric strength, and potential leakage currents from a patient. Implementing electromagnetic shielding or ensuring compatibility against irradiation and emission of electromagnetic interference is particularly challenging for electrical devices with galvanic isolation and involves higher manufacturing and development costs.One challenge is that not all electronic components can be connected to the same ground plane defined by the power grid, which is typically used for shielding. Even connecting a low-voltage device, such as a standard computer mouse, could lead to unwanted interference.

[0003] In addition to galvanic isolation, there is often a need to transmit large amounts of data. While components exist that can transmit data across galvanic isolation gaps, these are either expensive or significantly limited in their achievable data rates. US 2019 / 0372276 A1 describes galvanic isolation within a cable connector of a patient monitoring system.

[0004] Against this background, the invention is based on the objective of proposing a medical device that enables an easy-to-implement yet effective galvanic isolation, allows high data rates, is cost-effective to manufacture and is also easy to verify.

[0005] This problem is solved according to the invention by a medical device having the features specified in claim 1. Advantageous embodiments of the invention are described in the dependent claims, the following description, and the drawings.

[0006] The medical device according to the invention comprises an application device that can be brought into contact with a patient to be treated, and a galvanic isolation device that can be connected to the application device, wherein the isolation device has at least one application port for connection to the application device and at least one supply port for connection to a device, wherein the isolation device is designed to galvanically isolate the application port from the supply port.According to the invention, the isolating device comprises at least one first radio unit with a first antenna connected to the application port and at least one second radio unit with a second antenna connected to the supply port, wherein the respective first antenna and the respective second antenna are fixed on a carrier spaced apart from each other and directed towards each other in a manner visible to the naked eye, and wherein the at least one first radio unit and the at least one second radio unit are configured to transmit signals or data between the application port and the supply port.

[0007] The feature that the respective first and second antennas are visibly spaced apart from each other on a support "with the naked eye" can, for example, mean that the antennas do not need to be removed for microscopic examination to determine the distance between them. This typically applies to distances greater than 0.5 mm. Preferably, however, the distance between the antennas is at least 0.5 cm, which is visible to the naked eye with normal vision and without any optical aid. Preferably, the distance is arranged so that it is clearly visible and not obscured, i.e., directly visible when testing the device without prior disassembly of any components, apart from the possible opening of a housing of the device. According to the invention, the respective first and second antennas are fixed in a directionally oriented manner relative to each other.This can be understood, for example, as follows: the first antenna defines a first main direction of transmission for sending and / or receiving radio signals, and the second antenna defines a second main direction of transmission for sending and / or receiving radio signals, with the first main direction of transmission being coaxially opposite to the second main direction of transmission.

[0008] The application device can be designed in a variety of different ways. For example, it could include an endoscope and / or a sensor, electrodes, image transducer, ultrasound transducer, and the like. Due to its specific design, the application device can enable the provision of signals or data. Any other devices that can come into direct contact with a patient and into which a galvanic isolation device can be integrated are conceivable. Alternatively, the galvanic isolation device could also be integrated into a component that can be connected to an application device, such as a processing unit. For example, the galvanic isolation device could also enable data or signal transmission between directly adjacent devices. The devices could have metallic housings with a cutout through which signal or data transmission occurs.If the devices are correctly aligned with each other, data transmission could therefore be achieved. Alignment could be facilitated by guides, recesses, or magnets. A galvanic isolation device could, for example, be integrated into one side of a housing base.

[0009] The galvanic isolation device serves to transmit signals or data between the application device and a device that is to be connected to the application device. The isolation device thus forms an interface that enables electrically safe operation of the application device at the patient's site.

[0010] A key feature is the use of at least one first radio unit and at least one second radio unit, each connected to an antenna and visibly spaced apart on the carrier. Mechanical and electrical separation between two galvanically isolated areas is therefore perfectly obvious and easily verifiable without complex testing. Consequently, approval for a medical device can be granted without the technically complex testing required for previously mentioned devices based on the prior art.

[0011] The radio-based connection can be established via short-range radio with low power. It is conceivable to achieve a power output in the range of 0.01 µW to 300 mW, and particularly from 0.02 µW to 193 mW. Suitable modules are already known for data transmission. The short-range radio can operate in the GHz range, for example, in the 60 GHz V-band with radio frequencies in the 57 GHz and 64 GHz ranges. This has the advantage that the transmission can be easily shielded by metallic layers. Consequently, the galvanic isolation device itself does not emit any interfering radiation when surrounded by a conductive housing.

[0012] A gap between the first and second antennas acts as an isolation and transmission path. This gap can be designed to meet at least the usual standards for clearance and creepage distances. It can be filled with air only, or it can contain certain materials, such as plastics and, in particular, a circuit board material.

[0013] It is preferred if a particularly preferably two-phase switch and / or a preferably two-phase device fuse are additionally provided at the supply connection.

[0014] The isolation device could comprise two first radio units and two second radio units, with the first and second radio units facing each other in pairs, and with one pair being configured to transmit signals or data from the first radio unit to the second radio unit, and the other pair being configured to transmit signals or data from the second radio unit to the first radio unit. Consequently, the isolation device can implement duplex transmission, in which signals or data can be transmitted in both directions. Signals or data can be transmitted in both directions simultaneously.

[0015] The first and second radio units could each be configured as transmitters and receivers. Signal and data transmission can therefore occur in both directions. If only a single pair consisting of a first and a second radio unit is present, a semi-duplex connection can be implemented.

[0016] A radio link between the first and second antennas could have a length of 0.5 to 60 cm, and particularly preferably 1 to 40 cm. The length of the radio link over a distance of at least 0.5 cm is easily visible to the naked eye. This significantly simplifies the testing of the isolation device. A maximum length of 60 cm, specified here, can considerably limit the required radio power. Especially with highly directional antennas, this allows for both effective galvanic isolation and a minimization of the radio power.

[0017] The carrier could be designed as a single circuit board on which at least one first radio unit and at least one second radio unit are mounted at a predetermined distance from each other. This is mechanically very simple, as the first and second radio units, or rather their antennas, only need to be attached to designated positions on the circuit board to establish the desired radio connection. Furthermore, the shape of the carrier can be easily adapted to the medical device and could, in particular, be integrated into the application equipment.

[0018] The circuit board could have a recess between the first and second radio units. This recess could serve to achieve even better visual verification of the galvanic isolation. In particular, the recess could have a rectangular cutout that clearly separates the first and second radio units with the naked eye. The antennas are preferably arranged at the edges of the recess, on opposite sides, and thus form their radio link across the recess.

[0019] The carrier could comprise a first circuit board and a second circuit board arranged at a predetermined distance from each other and mechanically connected, with the at least one first radio unit located on the first circuit board and the at least one second radio unit located on the second circuit board. Particularly in the case of larger or longer medical devices, it may be advantageous to use two separate circuit boards instead of a single one, mechanically arranged and secured at a predetermined distance from each other. For example, it may be suitable to position one circuit board at a distal end of the application device and the other circuit board towards a proximal end. The application device can include a housing that encloses the two circuit boards and has internal mounting points for securing them.

[0020] The first and second antennas could be printed onto the substrate. This printing could be achieved by applying and fixing conductive particles, by etching, or by another manufacturing process. This results in a particularly easy-to-manufacture separation device that is cost-effective and compact. This is especially suitable for use in applications with small cross-sections.

[0021] Furthermore, both the first and second antennas could each feature a horn structure to establish a directional radio link. The horn structure enhances the antennas' strong directional characteristics. This can increase data rates. It is conceivable to implement multi-link applications using two different horn structures with vertical and horizontal polarization to further increase data rates. In addition to horn structures, horn antennas with an integrated antenna could also be used.

[0022] The isolation device could comprise a first coupling unit connected to the application port and a second coupling unit connected to the supply port, both configured to transmit electrical power inductively and / or capacitively from the supply port to the application port. The two coupling units thus enable the wireless transmission of electrical power. This would allow a distally located lighting device, a sensor device, or any other type of load to be supplied with electrical power without requiring a direct connection between the supply port and the application device. An inductive transmission system comprising two interconnectable coils is particularly advantageous in this context.The two coils can be aligned so that a voltage applied to the supply terminal is induced in a corresponding coil that is connected to the application device.

[0023] The isolation device could be enclosed in a housing. This housing could be a separate enclosure that can be placed within the application device. It is also conceivable to enclose the isolation device in such a way that the radio link between the antennas is visible from the outside. For example, the housing could be filled with a transparent, non-conductive plastic. Alternatively, the housing could be an enclosure belonging to the application device, containing only the isolation device, and not necessarily a separate, independent enclosure.

[0024] A housing that completely or partially surrounds the radio link could be metallically conductive, with conductivities greater than 0.0004 S / m, to achieve electromagnetic shielding. The housing could also be made of plastic. The preferred wall thickness can exceed 0.5 mm and, for example, be up to approximately 3 mm. It is particularly preferred to provide chemical resistance of the housing surface to alcohols, aldehydes, water, and surfactants to ensure good cleanability.

[0025] It is advantageous if the ratio v=d / L between a distance d between the at least one first radio unit and the at least one second radio unit, and a wavelength L of the signals, lies in the range of 1.73 to 127 MHz. This allows for excellent signal and data transmission.

[0026] A region between the at least one first radio unit and the at least one second radio unit could be at least partially filled with a material having a permittivity of 1 to 23 F / m and a conductivity of 0 to 0.01 S / m. This could particularly preferably be air, a plastic, or a circuit board material.

[0027] The area may still preferably be filled with media whose absorption coefficient I / I 0 for light in the range 400nm-750nm along the radio link does not exceed the value 0.7.

[0028] The separation device is preferably designed such that the attenuation of the transmission power at room temperature and normal pressure is between 0.01 and 10 dB / km.

[0029] The invention is explained in more detail below with reference to the exemplary embodiment shown in the drawings. The drawings show: Fig. 1 a schematic overview of the medical device, Figs. 2 to 6 each a schematic representation of a galvanic isolation device, Fig. 7 a schematic representation of an application device.

[0030] Fig. 1 Figure 1 shows a medical device 2 for treating a patient 4. The medical device 2 has an application unit 6 that can be brought into contact with the patient 4. A galvanic isolation device 8, which can be connected to the application unit 6, is shown very schematically. The isolation device 8 has an application terminal 10 for connecting to the application unit 6 and a supply terminal 12 for connecting to a device 14. The isolation device 8 is designed to galvanically isolate the application terminal 10 from the supply terminal 12. Here, the isolation device 8 is designed as part of the device 14. However, it is also conceivable that the isolation device 8 is part of the application unit 6.

[0031] The isolating device 8 comprises a first radio unit 16 connected to the application port 10 and a second radio unit 18 connected to the power supply port 12. The first radio unit 16 has a first antenna 17, while the second radio unit 18 comprises a second antenna 19. The isolating device 8 is shown here only schematically, so the exact antenna structure is not visible in this representation. This will be shown in more detail in subsequent figures.

[0032] The first antenna 17 and the second antenna 19 are arranged on a support 20 at a distance from each other that is visibly discernible to the naked eye and are directed towards each other. This enables the first radio unit 16 and the second radio unit 18 to transmit signals or data between the application port 10 and the power supply port 12. There is no direct electrical connection between the application port 10 and the power supply port 12.

[0033] An arrangement of circuit boards 22 is provided at the supply connection 12, which are connected to a voltage source 24 and supply the supply connection 12 with a corresponding voltage or electrical power. However, the patient 4 does not come into direct contact with the voltage source 24 due to the galvanic isolation device 8.

[0034] The first radio unit 16 and the second radio unit 18 are each designed as a circuit board connected to each other by means of mechanical fixings 21. The circuit boards and the fixings 21 thus form the carrier 20.

[0035] Fig. 2 Figure 1 shows an embodiment of the galvanic isolation device 8 in a slightly more detailed representation. A first circuit board 26 with a first radio unit 16 mounted on it is shown. The first antenna 17 is oriented to the right in the plane of the drawing and points towards the second antenna 19 of the second radio unit 18, which in turn is located on a second circuit board 28. Another first radio unit 16a is located on the first circuit board 26 and has another first antenna 17a. A second antenna 19a, which is associated with another second radio unit 18a, is directed towards this antenna. This arrangement allows a bidirectional radio connection between the power supply connection 12 and the application connection 10 to be established even when using two unidirectional first radio units 16 and 16a, as well as two unidirectional second radio units 18 and 18a.

[0036] In addition, a coupling device 30 is provided, comprising a first coupling unit 32 and a second coupling unit 34. Both are designed as coils arranged in alignment with each other and configured to wirelessly transmit electrical power from the supply terminal 12 to the application terminal 10.

[0037] An isolation gap 36, or radio gap 36, is provided between the two circuit boards 26 and 28. This gap is visible to the naked eye and has a length of at least 0.5 cm. The radio units 16, 16a, 18, and 18a, as well as the coupling units 32 and 34, wirelessly transmit signals or data and electrical power across this isolation gap 36, thus providing galvanic isolation. The mechanical fixings 21 are non-conductive. These can be made of a circuit board material, plastic, or another non-conductive material and simply allow for convenient fixing of the components relative to each other.

[0038] Fig. 3 Figure 1 shows a modification in the form of a galvanic isolation device 38, in which only a single first radio unit 16 and a single second radio unit 18 are provided. These can operate bidirectionally, for example, and thus allow bidirectional communication in a simpler arrangement. A switch 40, connected to the voltage source 24 and the supply terminal 12, is shown only as an example.

[0039] Fig. 4 Figure 1 schematically shows a galvanic isolation device 42 in which a first radio unit 16 and a second radio unit 18 can communicate bidirectionally and are arranged on a single circuit board 44. This circuit board has a cutout 46 above the isolation gap 36, which is visually perceptible.

[0040] Fig. 5 shows some galvanic isolation device 48 which is mounted on the isolation device 42. Fig. 4 This is based on a horn structure 50, which is arranged on the first radio unit 16 and the second radio unit 18, respectively. Both horn structures 50 serve to align the radio waves emanating from the respective radio units 16 and 18. This allows for higher data rates while simultaneously reducing the radio power.

[0041] Alternatively, a galvanic isolation device 52 could be used in accordance with Fig. 6 also have printed antennas 54 and 56, which are arranged at the edge of the space 36 and aligned with each other.

[0042] Fig. 7Figure 1 shows an application device 58 in the form of an endoscope. Here, a distal electronic device 60, for example, an image sensor with an attached optic 61, is arranged at a distal end and coupled to a proximally arranged power supply connection 12 via a galvanic isolation device 62. A proximal electronic device 63 is provided directly at the power supply connection 12 and can be connected directly to a voltage connection or a processing unit via a cable 64. The application device 58 can be quite long, up to approximately 60 cm. In this embodiment, the isolation gap 36 can extend over a substantial portion of this length and thus be up to approximately 60 cm. The application device 58 can include a housing 66, which is at least partially made of a metallic material.A line 68 for supplying power to the distal electronic unit 60 can be connected to a coupling device 30 which is integrated into the proximal electronic unit 63 or an external processing unit. Reference symbol list

[0043] 2 Medical device 4 Patient 6 Application device 8 Isolation device 10 Application connection 12 Power supply connection 14 Device 16, 16 First radio unit 17, 17 First antenna 18, 18 Second radio unit 19, 19 Second antenna 20 Carrier 21 Mechanical fixing 22 Circuit board 24 Power source 26 First circuit board 28 Second circuit board 30 Coupling device 32 First coupling unit 34 Second coupling unit 36 ​​Isolation gap 38 Galvanic isolation device 40 Switch 42 Galvanic isolation device 44 Single circuit board 46 Cutout 48 Galvanic isolation device 50 Horn structure 52 Galvanic isolation device 54 Printed first antenna 56 Printed second antenna 58 Application device 60 Electronic device 61 Optics 62 Galvanic isolation device 63 Proximal electronic device 64 Cable 66 Housing 68 Conductor

Claims

1. A medical apparatus (2) comprising: an application device (6, 58) which can be brought into contact with a patient (4) to be treated, and a galvanic isolator (8, 38, 42, 48, 52, 62) which can be connected to the application device (6, 58), the isolator (8, 38, 42, 48, 52, 62) comprising at least one application connector (10) for connection to the application device (6, 58) and at least one supply connector (12) for connection to a device (14), the isolator (8, 38, 42, 48, 52, 62) being configured to galvanically isolate the application connector (10) from the supply connector (12), characterised in that the isolator (8, 38, 42, 48, 52, 62) has at least one first radio unit (16), which is connected to the application connector (10) and has a first antenna (17, 17a), and at least one second radio unit (18), which is connected to the supply connector (12) and has a second antenna (19, 19a), the respective first antenna (17, 17a) and the respective second antenna (19, 19a) being fixed on a carrier (20, 44) at a distance from each other that is visible to the naked eye and being fixed facing each other, and the at least one first radio unit (16) and the at least one second radio unit (18) being configured to transmit signals and / or data between the application connector (10) and the supply connector (12).

2. The medical apparatus (2) according to claim 1, characterised in that the isolator (8, 38, 42, 48, 52, 62) has two first radio units (16) and two second radio units (18), the first radio units (16) and second radio units (18) facing each other in pairs, and one of the pairs being configured to transmit signals and / or data from the two first radio unit (16) to the second radio unit (18) and the other of the pairs being configured to transmit signals and / or data from the second radio unit (18) to the first radio unit (16).

3. The medical apparatus (2) according to claim 1 or 2, characterised in that the at least one first radio unit (16) and the at least one second radio unit (18) are each embodied as a transmitting and receiving unit.

4. The medical apparatus (2) according to any one of the preceding claims, characterised in that a radio path (36) present between the first antenna (17, 17a) and the second antenna (19, 19a) has an extent of from 0.5 to 60 cm and particularly preferably of from 1 to 40 cm.

5. The medical apparatus (2) according to any one of the preceding claims, characterised in that the carrier (20, 44) is embodied as a single circuit board (44) on which the at least one first radio unit (16) and the at least one second radio unit (18) are mounted at a predetermined distance from each other.

6. The medical apparatus (2) according to claim 5, characterised in that the circuit board (44) comprises a recess (46) between the first radio unit (16) and the second radio unit (18).

7. The medical apparatus (2) according to any one of claims 1 to 4, characterised in that the carrier (20, 44) has a first circuit board (26) and a second circuit board (28), which are arranged at a predetermined distance from each other, the at least one first radio unit (16) being arranged on the first circuit board (26) and the at least one second radio unit (18) being arranged on the second circuit board (28).

8. The medical apparatus (2) according to any one of the preceding claims, characterised in that the first antenna (17, 17a) and the second antenna (19, 19a) are printed on the carrier (20, 44).

9. The medical apparatus (2) according to any one of the preceding claims, characterised in that the first antenna (17, 17a) and the second antenna (19, 19a) each have a horn structure (50) for establishing a directional radio connection.

10. The medical apparatus (2) according to any one of the preceding claims, characterised in that the isolator (8, 38, 42, 48, 52, 62) has a first coupling unit (32) connected to the application connector (10) and a second coupling unit (34) connected to the supply connector (12), which coupling units are configured to inductively and / or capacitively transmit electrical power from the supply connector (12) to the application connector (10).

11. The medical apparatus (2) according to any one of the preceding claims, characterised in that a ratio v=d / L between a distance (d) between the at least one first radio unit (16) and the at least one second radio unit (18) and a wavelength (L) of the signals lies in a range of from 1.73 to 127.

12. The medical apparatus (2) according to any one of the preceding claims, characterised in that an area between the at least one first radio unit (16) and the at least one second radio unit (18) is at least partially filled with a material that has a permittivity of from 1 to 23 F / m and has a conductivity of from 0 to 0.01 S / m.