DE102016000480B4 - Medical device - Google Patents

Abstract

Medical device with a housing (1) which has a receiving unit (2) which is designed such that at least a part of a disposable article (3) can be inserted into the receiving unit (2), wherein the medical device has various components (14) for operating the medical device and a control unit (13) for controlling the components (14), wherein a camera unit (19) is provided in the interior of the housing (2) which has an image sensor (20) which is arranged such that an image of at least a part of the disposable article (3) inserted into the receiving unit (2) is recorded, the medical device has an image processing unit (24) which evaluates the data of the image sensor (20) and generates characteristic data for the control unit (13) depending on the recorded image of the at least a part of the disposable article (3) inserted into the receiving unit, and the control unit (13) is configured such that at least one component (14) of the medical device is controlled depending on the data of the image processing unit (24);characterized in thatthe receiving unit (2) is designed to receive a liquid part (12) of a disposable article (32) and to receive an insert part (32) with a signature field (33), andthe image processing unit (24) is configured such that a signature on the signature field (33) of the insert part (32) is evaluated on the basis of image recognition, wherein characteristic data for the user's signature are generated.

Description

The invention relates to a medical device. Various devices are known in medical technology that are operated together with an article intended for single use. The medical devices have various components for carrying out different operations. In addition, the medical devices have a control unit with which the individual components are controlled. Various monitoring devices are known for monitoring a medical device, which have different sensors.

In a known device for automatic peritoneal dialysis, which is sold by the applicant under the product name "SleepSafe-Harmony", the housing has a receiving unit into which a part of a disposable article is inserted, which allows various treatment options to be carried out. The disposable article comprises a cassette and several containers filled with treatment liquids, whereby the cassette has several ports arranged next to one another, to which connectors of hose lines can be connected, which are connected to the containers.

The receiving unit of the peritoneal dialysis machine is designed as an automatically extendable and retractable drawer into which the cassette of the disposable item can be inserted. The drawer also holds the connectors of the hose lines that are connected to the ports of the cassette. The cassette contains pump chambers that are operated by actuators on the device to pump the liquids into and out of the containers.

To accommodate the ports and connectors, a receiving part is formed in the drawer, which has several recesses next to each other into which the connectors can be inserted. Each recess is assigned an independent reading unit for reading a barcode that is provided on the connector. The reading units thus allow the reading of all barcodes of the connectors inserted into the receiving part. However, the arrangement of the reading units involves a relatively large construction effort.

The EP 2 474 331 A1 describes a blood treatment device that has holders for medication containers, each of which has a channel, with sensors being assigned to the individual channels. The signals from the sensors are received by the control unit of the blood treatment device and the control unit controls individual components of the blood treatment device depending on the signals. In the EP 2 474 331 A1 There are indications that the sensors can not only detect whether the medication containers are present, but can also identify the medication. The sensors can also be photo sensors, such as cameras.

From the US 2009/0012449 A1 A medical device with a recording unit and an insert part is known, which has a camera that checks the correct fit of the connectors.

The invention is based on the object of creating a medical device that can be operated with a disposable article and that allows a relatively simple acquisition of data relevant to the operation of the medical device.

This object is achieved according to the invention with the features of patent claim 1. The dependent claims relate to advantageous embodiments of the invention.

The medical device according to the invention does not have a plurality of reading devices, but is characterized by a camera unit which is provided in the interior of the housing, wherein the camera unit has an image sensor which is arranged such that an image of at least a part of the disposable article inserted into the receiving unit is recorded.

In addition, the medical device has an image processing unit that evaluates the data from the image sensor and generates characteristic data for the control unit depending on the recorded image of at least part of the disposable article inserted into the recording unit.

The control unit is in turn configured such that at least one component of the medical device is controlled depending on the data from the image processing unit.

The advantage is that only one image sensor can capture a relatively large area of the recording unit, so that different characteristic data can be generated for the control unit when different image sections of the recorded image are evaluated. Consequently, all information can be read in with just one recording. For example, several barcodes can be read in at once. The use of only one image sensor simplifies the structural design, so that the construction effort and the manufacturing costs can be reduced.

In this context, an evaluation of the image data from the image sensor depending on the image recorded is understood to mean an analysis based on all known methods of pattern recognition or image recognition. The data can be characteristic data for all operating states or operating variables of the medical device that are relevant for controlling one or more components of the device. The evaluation of the data also includes the reading of barcodes that may be provided on the disposable article. Signatures can also be read.

The receiving unit is designed in such a way that it can accommodate both a disposable article, the liquid part of which comprises several hose line sections, and an insert part with a signature field.

The insert part with the signature field does not need to have the same dimensions as the part of the disposable article with the liquid part that is to be inserted into the receiving unit. It is sufficient if the receiving unit is designed in such a way that both disposable articles can be accommodated in the exception unit. The receiving unit is preferably designed to accommodate both articles. Both articles can be held in the receiving unit in a form-fitting and/or clamped manner. Guides, recesses, clamps or the like can be provided for this purpose.

The image processing unit is configured in such a way that a signature on the signature field of the insert part is evaluated on the basis of image recognition, whereby characteristic data for the authenticity of the user's signature is generated. This authentication data can be used, for example, to only allow the operation of the medical device in a certain operating mode if a specific person has authenticated themselves with the signature. For example, the medical device can provide a special operating mode for the technician (service mode) and an operating mode for normal operation, for example for peritoneal dialysis (normal or treatment mode). An operating mode for training purposes (demonstration mode) can also be provided. In the individual operating modes, safety-relevant components of the medical device can be activated or deactivated. The control unit only enables the respective operating mode if the corresponding person, for example the technician for the service mode or the patient for the treatment mode, has authenticated themselves.

One embodiment of the medical device provides that the image processing unit is configured such that certain properties of the disposable article, which are recognizable as characteristic image patterns in the recorded image of the article, are determined on the basis of image recognition, wherein one or more characteristic data describing certain properties of the disposable article are generated.

A preferred embodiment of the medical device is intended for operation with a disposable article that has a liquid part that is to be inserted into the receiving unit and that comprises a plurality of hose line sections of hose lines. In this embodiment, the receiving unit is designed such that the liquid part of the disposable article can be inserted into the receiving unit. The image sensor is arranged such that an image is recorded of at least the part of the liquid part of the disposable article in which the preferably transparent hose line sections are arranged. The image processing unit is configured such that one or more specific properties of the liquids in the hose lines are determined on the basis of image recognition, wherein characteristic data describing one or more specific properties of the liquids are generated.

The properties of the liquids can be any properties that can be recognized as characteristic image patterns in the captured image of the disposable article, for example the turbidity of the liquids and/or the presence of air bubbles in the liquids and/or the temperature of the liquids. Detecting the temperature requires that the image sensor receives light in a wavelength range that is in the infrared range.

A particularly preferred embodiment is intended for operation with a disposable article, the liquid part of which comprises a cassette with several ports and several hose line sections, which have connectors that can be connected to the ports. In this embodiment, the image sensor is arranged in such a way that an image is taken of the part of the liquid part of the disposable article in which the ports of the cassette and the connectors of the hose line sections are arranged. This makes it possible, for example, to check that the connectors are correctly connected to the ports.

To check that the connectors are correctly connected to the ports, the image processing unit is preferably configured in such a way that the position of the ports and connectors is detected on the basis of image recognition, whereby characteristic data is generated for the correct connection of the connectors to the ports. It is assumed that in the case of a faulty connection, the connectors and ports are not arranged at the correct distance and/or in the correct alignment to one another because, for example, the connector is not completely pushed onto the port or is tilted, so that a liquid-tight connection is not ensured.

Specifically, the medical device is a device for peritoneal dialysis, in particular a device for carrying out different treatment options for peritoneal dialysis so that the properties of the disposable item relevant to the respective option can be monitored or the peritoneal dialysis can be controlled depending on the properties of the disposable item. However, the medical device can also be any other device that is operated with a disposable item.

In the following, an embodiment of the invention is explained in more detail with reference to the drawings.

• 1 das medizintechnische Gerät zusammen mit einem Einmalartikel, der einen Flüssigkeitsteil aufweist, in vereinfachter schematischer Darstellung,
• 2 die Aufnahmeeinheit des medizintechnischen Geräts zusammen mit dem Flüssigkeitsteil des Einmalartikels in der Vorderansicht,
• 3 der von dem Bildsensor der Aufnahmeeinheit aufgenommene Bildausschnitt,
• 4 die Aufnahmeeinheit des medizintechnischen Geräts zusammen mit einem Einsatzteil, das ein Unterschriftenfeld aufweist, in vereinfachter Darstellung und
• 5 eine Seitenansicht des Einsatzteils mit dem Unterschriftenfeld

Show it:

• 1 the medical device together with a disposable article having a liquid part, in a simplified schematic representation,
• 2 the receiving unit of the medical device together with the liquid part of the disposable article in the front view,
• 3 the image section captured by the image sensor of the recording unit,
• 4 the receiving unit of the medical device together with an insert part that has a signature field, in a simplified representation and
• 5 a side view of the insert with the signature field

1 shows the essential components of a medical device in a simplified schematic representation. In the present embodiment, the medical device is a peritoneal dialysis machine.

The peritoneal dialysis machine has a 1 only shown in outline. The housing 1 has a receiving unit 2 into which at least part of a disposable article 3 intended for single use is inserted. The receiving unit 2 can be an automatically opening or closing drawer which appropriately receives at least part of the disposable article 3.

The disposable article 3, which is required for operating the peritoneal dialysis machine, has a cassette 4 in which pump chambers 5, 6 are formed. The cassette 4 has several ports 7.1 to 7.n, which are arranged next to one another in a row.

In addition, the disposable article 3 has several bags 8.1 to 8.n, which are filled with different liquids for peritoneal dialysis. The bags 8.1 to 8.n can be combined to form a common bag unit 8. Hose lines 9.1 to 9.n are connected to the bags 8.1 to 8.n, which have connectors 10.1 to 10.n at the free ends, which can be optionally connected to the ports 7.1 to 7.n. In 1 Not all ports, bags and hose lines with connectors are shown. For example, a total of 6 ports, bags and hose lines can be provided.

The cassette 4 with the ports 7.1 to 7.n, the connectors 10.1 to 10.n and the hose line sections 11.1 to 11.n adjacent to the connectors form the liquid part 12 of the disposable article 3, which is inserted into the receiving unit 2.

The medical device has a control unit 13, which can have a data processing unit on which a data processing program (software) runs in order to control the individual components 14 of the medical device that are required for the operation of the device. In the case of the peritoneal dialysis device, the components 14 can be, for example, device-side actuating elements 15, 16 with which pump chambers 5, 6 formed in the cassette 4 are actuated. The control unit 13 can also control an alarm unit 17, for example. All components 14 are mentioned only as examples.

When the actuating elements 15, 16 are actuated by the control unit 13, the corresponding liquids for carrying out the peritoneal dialysis are pumped out of the bags 8.1 to 8.n. The peritoneal dialysis machine allows the implementation of different treatment options, which can be specified by the control unit 13.

In 1 only the essential components of the medical device are shown. The The device may contain additional tubing, shut-off devices or the like. For example, the drainage bag for collecting used peritoneal dialysis solution is not shown for the sake of simplicity.

The receiving unit 2 comprises a receiving part 2A, into which the cassette 4 of the disposable article is suitably inserted, and a receiving part 2B, which suitably receives the ports 7.1 to 7.n and the connectors 10.1 to 10.n together with the associated hose line sections 11.1 to 11.n.

2 shows the receiving part 2B for inserting the ports and connectors. This receiving part 2B can be a connection strip 18, which has a series of adjacent recesses 18.1 to 18.n, into which the ports 7.1 to 7.n and connectors 10.1 to 10.n can be inserted. In 2 only a part of the recesses is shown.

The recording unit 2 has a camera unit 19, which has an image sensor 20, for example a CCD sensor, and an optical system 21. The camera unit 19 is arranged inside the housing 1 above the area of the recording unit 2 in which the liquid part 12 of the disposable article 3 is located. The camera unit 19 is arranged in such a way that an image section 22 is recorded, which can be divided into three image areas 22A, 22B and 22C.

The image area 22A covers a part of the cassette 4, the image area 22B the adjacent ports 7.1 to 7.n and the connectors 10.1 to 10.n and the image area 22C the adjacent hose line sections 11.1 to 11.n.

To illuminate the recording unit 12, a lighting device 23 is provided, which can have one or more lighting elements 23A, 23B, for example LEDs.

The data (video signals) of the camera unit 18 are processed by an image processing unit 24, which is connected to the control unit 13 via a data line 25. The image processing unit 24 can form a separate assembly or, together with the control unit 13, can be part of a central computing and control unit 26 of the peritoneal dialysis machine. The configuration of the image processing unit 24 for carrying out various control and monitoring functions is described below.

In a first embodiment, the image processing unit 24 is configured such that a barcode 27 located in the cassette 4 is recognized in the image area 22A. The barcode, which has a characteristic image pattern, is recognized on the basis of the known image recognition methods. The barcode is read in a section 28 of the image area 22A that coincides with the barcode on the cassette. Depending on the content of the barcode, the image processing unit 24 generates characteristic data (control signal) for the control unit 13, with which the individual components of the peritoneal dialysis machine are controlled accordingly. For example, different treatment options can be specified depending on the disposable item inserted, which can be a standard set or a pediatric set, for example.

The image area 22B is divided into several segments 29.1 to 29.n, whereby the individual segments correspond to the areas in which the connection points of the ports 7.1 to 7.n and the barcodes 30.1 to 30.n provided on the ports are located.

The image processing unit 24 is configured such that the individual segments 29.1 to 29.n of the image area 22B can be captured separately from the overall image in order to check the correct connection of the connectors 10.1 to 10.n to the ports 7.1 to 7.n or to be able to read the barcodes 30.1 to 30.n of the ports 7.1 to 7.n.

To check that the connectors are correctly connected to the ports, the position of the ports and connectors in the recesses 18.1 to 18.n of the connection strip 18 is checked. The correct position corresponds to a specific image pattern that is compared with the recorded image pattern. If the recorded image pattern deviates from the image pattern intended for the correct connection, it is concluded that the connection is faulty. If the connection is faulty, the image processing unit 24 generates an alarm signal that the control unit 13 receives, so that the control unit 13 controls the alarm unit 17, which gives an alarm. The image processing unit 24 can not only detect a faulty connection, but can also be used to detect whether a hose line is connected or not.

In addition, the image processing unit 24 is configured in such a way that certain properties of the liquids in the hose lines 9.1 to 9.n can be recognized. To do this, the image processing unit evaluates the image area 22C, which in turn is subdivided into individual segments 31.1 to 31.n assigned to the respective hose line sections 11.1 to 11.n. On the basis of the image recognition, the image processing unit 24 detects, for example, the turbidity ation of the liquids and/or the presence of air bubbles in the liquids. The image processing unit can also be used to measure the temperature of the liquids if the camera unit 19 is an infrared camera.

The image processing unit 24 also enables the optical detection of connectors damaged or deformed by marking lasers or during sterilization, the optical detection of leaks in the cassette made of foil, the detection of particles in the receiving unit which could damage the cassette, and the checking of the functionality of the automatically operated drawer.

If there are reference patterns on the cassette 4, the image processing unit 24 can detect an undesirable deformation of the cassette. The position of the cassette in the receiving unit 2 can also be checked. Finally, it is also possible to check a heating plate provided in the peritoneal dialysis machine for heating the liquids for cracks or breakage. For example, the travel speed of the automatically operated drawer can also be checked.

The medical device according to the invention also provides for the use of another disposable article 32, which is an insert part 32 that has a signature field 33. The signature field 33 can be written on, for example, with a felt-tip pen or ballpoint pen.

The insert part 32 is designed such that it can be inserted into the receiving unit 2. For example, the insert part can have fixing elements 34 that fit into the recesses 18.1 to 18.n of the connection strip 18, so that the insert part 32 is fixed in the connection strip 18.

In a preferred embodiment, the insert part 32 has a plate-shaped base carrier 35, which has the signature field 33 on the top and the fixing elements 34 on the bottom. The signature field 33 can be formed by the base carrier 35 itself or can be another carrier applied to the base carrier, which consists for example of paper or a film.

The image processing unit 24 is configured such that the signature on the signature field 32 is read and evaluated. The signature can be compared with signatures stored in a memory of the image processing unit 24. This makes it possible to authenticate the user of the device.

The control unit 13 provides various operating modes, for example a service mode can be provided that can only be selected by authorized personnel (technicians). In the service mode, certain safety-relevant components can be deactivated. The control unit 13 only enables the service mode if the technician has authorized himself with his signature. In addition, a treatment mode is provided in which peritoneal dialysis is carried out. This mode is only enabled by the control unit 13 if the patient has authorized himself. In addition, a demonstration mode can also be provided for training purposes in which the treatment is not carried out.

List of reference symbols:

1

Housing

2

Recording unit

2

Recording part 2A of the recording unit

2

Recording part 2B of the recording unit

3

Disposable items

4

cassette

5

Pump chamber

6

Pump chamber

7.1 to 7.n

port

8.1 to 8.n

bag

8th

Bag unit

9.1 to 9.n

Hose lines

10.1 to 10.n

Connection pieces

9.1 to 9.n

Hose line sections 11.1 to 11.n of the hose lines

12

Liquid part

13

Control unit

14

Components

15

Actuator

16

Actuator

17

Alarm unit

18

Connector bar

18.1 to 18.n

Recesses

19

Camera unit

20

Image sensor

21

Optical system

22

Image detail

22A

Image area

22B

Image area

22C

Image area

23

Lighting equipment

23A

Lighting fixtures

23B

Lighting fixtures

24

Image processing unit

25

Data line

26

central computing and control unit

4

Barcode 27 of the cassette

28

Segments

29.1 to 29.n

Segments

7.1 to 7.n

Barcode 30.1 to 30.n of port

31.1 to 31.n

Segments

32

Insert part

33

Signature field

34

Fixing element

35

Base carrier

Claims (12)

Medical device with a housing (1) which has a receiving unit (2) which is designed such that at least a part of a disposable article (3) can be inserted into the receiving unit (2), wherein the medical device has various components (14) for operating the medical device and a control unit (13) for controlling the components (14), wherein a camera unit (19) is provided in the interior of the housing (2) which has an image sensor (20) which is arranged such that an image of at least a part of the disposable article (3) inserted into the receiving unit (2) is recorded, the medical device has an image processing unit (24) which evaluates the data of the image sensor (20) and generates characteristic data for the control unit (13) depending on the recorded image of the at least a part of the disposable article (3) inserted into the receiving unit, and the control unit (13) is configured such that at least one component (14) of the medical device is controlled depending on the data of the image processing unit (24); characterized in that the receiving unit (2) is designed to receive a liquid part (12) of a disposable article (32) and to receive an insert part (32) with a signature field (33), and the image processing unit (24) is configured such that a signature on the signature field (33) of the insert part (32) is evaluated on the basis of image recognition, wherein characteristic data for the user's signature are generated. Medical device according to Claim 1 , characterized in that the image processing unit (24) is further configured such that certain properties of the disposable article (3), which are recognizable as characteristic image patterns in the recorded image of the disposable article, are determined on the basis of image recognition, wherein one or more characteristic data describing certain properties of the disposable article are generated. Medical device according to Claim 2 , characterized in that the receiving unit (2) is designed to receive a liquid part (12) of a disposable article (3), wherein the liquid part (12) comprises a plurality of hose line sections (11.1 to 11.n) of hose lines (9.1 to 9.n). Medical device according to Claim 3 , characterized in that the image sensor (20) is arranged such that an image is recorded of at least that part of the liquid part (12) of the disposable article (3) in which the hose line sections (11.1 to 11.n) are arranged. Medical device according to Claim 4 , characterized in that the image processing unit (24) is configured such that one or more specific properties of the liquids in the hose lines (9.1 to 9.n) are determined on the basis of image recognition, wherein characteristic data describing one or more specific properties of the liquids are generated. Medical device according to Claim 5 , characterized in that the properties of the liquids in the hose lines (9.1 to 9.n) are the turbidity of the liquids and/or the presence of air bubbles in the liquids and/or the temperature of the liquids. Medical device according to Claim 1 , characterized in that the receiving unit (2) is designed to receive a liquid part (12) of a disposable article (3), wherein the liquid part (12) comprises a cassette (4) with several ports (7.1 to 7.n) and several hose line sections (11.1 to 11.n) which are connected to the ports connectable connectors (10.1 to 10.n). Medical device according to Claim 7 , characterized in that the image sensor (20) is arranged such that an image is recorded of the part of the liquid part (12) of the disposable article (3) in which the ports (7.1 to 7.n) of the cassette (4) and the connecting pieces (10.1 to 10.n) of the hose line sections (11.1 to 11.n) are arranged. Medical device according to Claim 8 , characterized in that the image processing unit (24) is configured such that the position of the ports (7.1 to 7.n) and the connection pieces (10.1 to 10.n) is detected on the basis of image recognition, wherein characteristic data describing the state of the connection of the connection pieces to the ports are generated. Medical device according to one of the Claims 1 until 9 , characterized in that at least a part of a disposable article (3) is inserted into the receiving unit (2), which comprises a cassette (4) and several containers (8.1 to 8.n) filled with treatment liquids, wherein the cassette (4) has several ports (7.1 to 7.n) arranged next to one another, to which connecting pieces (10.1 to 10.n) of hose lines (9.1 to 9.n) can be connected, which are connected to the containers (8.1 to 8.n). Medical device according to one of the Claims 1 until 9 , characterized in that an insert part (32) with a signature field is inserted into the receiving unit (2). Medical device according to one of the Claims 1 until 11 , characterized in that the medical device is a device for peritoneal dialysis.

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