WO2017125445A1

WO2017125445A1 - Medical device

Info

Publication number: WO2017125445A1
Application number: PCT/EP2017/051001
Authority: WO
Inventors: Frank Hedmann; Stefan Saal; Olga Sperling; Torsten Hochrein
Original assignee: Fresenius Medical Care Deutschland Gmbh
Priority date: 2016-01-20
Filing date: 2017-01-18
Publication date: 2017-07-27
Also published as: DE102016000480A1

Abstract

The invention relates to a medical device. The medical device according to the invention is characterized by a camera unit 19 which is provided in the interior of the housing 1 of the medical device. The camera unit 19 has an image sensor 20 which is arranged such that at least one part of the disposable article 3 inserted into the receiving unit 2 is captured. The medical device further has an image processing unit 24 which evaluates the data of the image sensor and which generates characteristic data for a control unit 13 on the basis of the captured image of the at least one part of the disposable article 3 inserted into the receiving unit 2. The control unit 13 is configured such that at least one component 14 of the medical device is controlled on the basis of the data of the image processing unit 24. Advantageously, a single image sensor can detect a relatively large region of the receiving unit such that different characteristic data can be generated for the control unit when different image sections of the captured image are evaluated.

Description

Medical device

The invention relates to a medical device. In medical technology, various devices are known, which are operated together with an article intended for single use. The medical devices have various components for performing different operations.

In addition, the medical devices have a control unit with which the individual components are controlled. For monitoring a medical device various monitoring devices are known which have different sensors.

In a known automatic peritoneal dialysis device marketed by the Applicant under the product name "SleepSafe-Harmony", the housing includes a receiving unit into which a portion of a disposable article is permitted to allow for the implementation of various treatment options a cassette and a plurality of containers filled with treatment liquids, wherein the cassette has a plurality of juxtaposed ports are connectable to the fittings of hose lines, 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 suitably inserted. The drawer also receives the fittings of the tubing that connect to the ports of the cassette. The cassette includes

Pumping chambers, which are actuated by device-side actuators to pump the liquids in and out of the containers.

For receiving the ports and fittings a receiving part is formed in the drawer, which has a plurality of adjacent recesses into which the fittings can be inserted properly. Each recess is associated with a standalone reading unit for reading a bar code provided on the connector is. The reading units thus allow the detection of all barcodes of the inserted into the receiving part fittings. However, the arrangement of the reading units is associated with a relatively large design effort.

The invention has for its object to provide a to be operated with a disposable medical device, which allows a relatively simple detection of relevant for the operation of the medical device data.

The solution of this object is achieved according to the invention with the features of

Claim 1. The dependent claims relate to advantageous embodiments of the invention.

The medical device of the invention does not have a plurality of readers, but is characterized by a camera unit, which is provided in the interior of the housing, wherein the camera unit comprises an image sensor which is arranged such that an image of at least a portion of the in the recording unit

used once.

In addition, the medical device has an image processing unit which evaluates the data of the image sensor and generates characteristic data for the control unit as a function of the recorded image of the at least one 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 in dependence on the data of the image processing unit.

The advantage is that only a single image sensor a relatively large area of

Capture unit can capture so that different characteristic data for the control unit can be generated when different image sections of the

recorded image are evaluated. Consequently, all information can be read in with just one shot. For example, you can have multiple barcodes be read once. The use of only one image sensor simplifies the structural design, so that the design effort and the

Reduce manufacturing costs.

An evaluation of the image data of the image sensor as a function of the recorded image is understood in this context to be an analysis on the basis of 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 used to control one or more

Components of the device are relevant. The evaluation of the data also captures the reading of barcodes which may be provided on the disposable article. It can too

Signatures are read.

An embodiment of the medical device provides that the

Image processing unit is configured such that certain properties of the

Disposable items that are characteristic in the picture taken of the article

Identify patterns are determined on the basis of image recognition, wherein one or more specific properties of the disposable article descriptive characteristic data are generated.

A preferred embodiment of the medical device is intended for operation with a disposable article, the one to be inserted into the receiving unit

Liquid part comprising a plurality of hose line sections of hose lines. The receiving unit is formed in this embodiment 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 of at least the part of the liquid part of the disposable article is received, in which the preferably transparent

Hose line sections are arranged. The image processing unit is configured to determine, on the basis of an image recognition, one or more specific properties of the liquids in the tubing, one or more characteristic characteristics describing the liquids Data are generated.

The properties of the liquids may be any of the characteristics recognizable in the recorded image of the disposable article as characteristic image patterns, for example the turbidity of the liquids and / or the presence of air bubbles in the liquids and / or the temperature of the liquids. The detection of the temperature assumes that the image sensor receives light in a wavelength range that lies in the infrared range.

A particularly preferred embodiment is intended for operation with a disposable article, the liquid part of which is a cassette with several ports and several

Includes hose line sections that have connectable connectors on the ports. The image sensor is in this embodiment arranged such that an image of the part of the liquid part of the disposable article is received, in which the ports of the cassette and the fittings of the hose line sections are arranged. This makes it possible, for example, to check the correct connection of the connecting pieces to the ports.

For checking the correct connection of the connection pieces to the ports, the image processing unit is preferably configured in such a way that the position of the ports and connection pieces is detected on the basis of image recognition, characteristic data being generated for the correct connection of the connection pieces to the ports. It is assumed that in case of a faulty connection

Connectors and ports not in the correct distance and / or the right one

Alignment are arranged to each other, for example, because the connector are not completely pushed or tilted on the port, so that a liquid-tight connection is not ensured.

In a further particularly preferred embodiment, the receiving unit is designed to receive an insert with a signature field. Preferably, the receiving unit is designed such that it both a disposable article whose Liquid part comprises a plurality of hose line sections of hose lines, as well as an insert with a signature field record.

The insert part with the signature field does not need to have the same dimensions as the part of the disposable article to be inserted into the receptacle unit with the liquid part. It is sufficient if the receiving unit is designed such that both disposable items find room in the exceptional unit. Preferably, the receiving unit is designed to accommodate both items. In the receiving unit both articles can be held positively and / or clamped. For this purpose, guides, recesses, clamps or the like may be provided.

The image processing unit is preferably configured in such a way that a signature is evaluated on the signature field of the insert part on the basis of an image recognition, characteristic data being generated for the authenticity of the signature of the user. These authentication data can be used, for example, to allow the operation of the medical device in a certain operating mode only if a certain person with the

Signature has authenticated. For example, the medical device can be a special operating mode for the technician (service mode) and a mode of operation for normal operation, for example, for peritoneal dialysis (normal or

Treatment mode). Also, an operation mode for training purposes (demonstration mode) may be provided. In the individual operating modes, safety-relevant components of the medical device can be activated or deactivated. The control unit only releases the respective operating mode if the corresponding person, for example the service mode technician or the patient, has authenticated himself for the treatment mode.

In particular, the medical device is a device for peritoneal dialysis, in particular a device for performing different treatment options of a Perionateldialyse, so that can be monitored for each option relevant properties of the disposable article or the peritoneal dialysis depending on control the properties of the disposable article. The medical device can also be any other device that is operated with a disposable item.

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

Show it:

1 shows the medical device together with a disposable article having a liquid part, in a simplified schematic representation,

Fig. 2, the receiving unit of the medical device together with the

Liquid part of the disposable article in front view,

3 shows the image section taken by the image sensor of the recording unit,

Fig. 4, the receiving unit of the medical device together with a

Insert part, which has a signature field, in a simplified representation and

Fig. 5 is a side view of the insert part with the signature field

Fig. 1 shows the essential components of a medical device in a simplified schematic representation. In the present embodiment, this is

medical device a peritoneal dialysis machine.

The peritoneal dialysis machine has a housing 1, which is shown only schematically in FIG. 1. 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 may be an automatically opening or closing drawer, which accommodates at least a part of disposable article 3. The disposable article 3, which is required for the operation of the peritoneal dialysis machine, has a cassette 4 in which pumping chambers 5, 6 are formed. The cassette 4 has a plurality of ports 7.1 to 7.n, which are arranged side by side in a row.

In addition, the disposable article 3 has a plurality of 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. At the bags 8.1 to 8.n hose lines 9.1 to 9.n are connected, which have at the free ends fittings 10.1 to 10. n, which are optionally connected to the ports 7.1 to 7.n. In Fig. 1 are not all ports, bags and hoses with

Connectors 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 connecting pieces 10.1 to 10. n and the adjacent to the fittings hose line sections 11.1 to l l.n 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, the one

Data processing unit can run on which a data processing program (software) is running to control the individual components 14 of the medical device, which are required for the operation of the device. In the peritoneal dialysis machine, the components 14 may be, for example, device-side actuators 15, 16 with which pumping chambers 5, 6 formed in the cassette 4 are actuated. The

Control unit 13 may also control, for example, an alarm unit 17. All components 14 are given as an example only.

When the actuators 15, 16 are actuated by the control unit 13, the corresponding liquids for the performance of peritoneal dialysis are pumped from the bags 8.1 to 8. n. The peritoneal dialysis machine allows the implementation

different treatment options that can be specified by the control unit 13. In Fig. 1, only the essential components of the medical device are shown. The device may contain other hose lines, shut-off devices or the like. For example, the drainage bag for consumption is more consumed

Peritoneal dialysis solution 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 inserted appropriately, and a receiving part 2B, the matching ports 7.1 to 7.n and the fittings 10.1 to lO.n together with the associated

Hose line sections 11.1 to 11 n receives.

Fig. 2 shows the receiving part 2B for inserting the ports and fittings. This receiving part 2B may be a Konnektionsleiste 18, which has a number of adjacent recesses 18.1 to 18. n, in which the ports 7.1 to 7.n and fittings 10.1 to 10. n can be inserted properly. In Fig. 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 inside the housing 1 above the area of

Receiving unit 2 is arranged, in which the liquid part 12 of the disposable article 3 is located. The camera unit 19 is arranged such that an image section 22 is taken, which can be subdivided into three image areas 22A, 22B and 22C.

The image area 22A covers part of the cassette 4, the image area 22B

adjacent ports 7.1 to 7.n and the connecting pieces 10.1 to lO.n and the image area 22C, the adjacent hose line sections 11.1 to 11. n from.

For illuminating the receiving unit 12, a lighting device 23 is provided, which may have one or more lighting bodies 23 A, 23 B, 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 may form a separate module or together with the control unit 13 part of a central computing and control unit 26 of the

Peritoneal dialysis machine. Below is the configuration of the

Image processing unit 24 for performing various control and

Monitoring functions described.

In a first embodiment, the image processing unit 24 is configured such that a barcode 27 located in the cassette 4 is detected in the image area 22A. The recognition of the bar code having a characteristic image pattern is based on the known image recognition method. The bar code is read in a section 28 of the image area 22A which coincides with the bar code on the cassette. The image processing unit 24 generates depending on the content of the bar code characteristic data (control signal) for the control unit 13, with which the individual components of the peritoneal dialysis machine are driven accordingly. For example, different treatment options depending on the inserted disposable, which may be, for example, a standard set or pediatric set, are given.

The image area 22B is divided into a plurality of segments 29.1 to 29.n, the individual segments corresponding 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 at 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 detected separately from the overall image in order to check the correct connection of the connection pieces 10.1 to 10.n to the ports 7.1 to 7.n or Barcodes 30.1 to 30. n of ports 7.1 to 7.n can read.

To check the correct connection of the connecting pieces to the ports, the position of the ports and the connecting pieces in the recesses 18.1 to 18.n of the connection strip 18 are checked. The correct position corresponds to a specific one Image pattern that is compared with the recorded image pattern. At a

Deviation of the recorded image pattern from the image pattern intended for the correct connection is inferred from a faulty connection. In the event of a faulty connection, the image processing unit 24 generates an alarm signal, which the control unit 13 receives, so that the control unit 13 activates the alarm unit 17 which gives an alarm. The image processing unit 24 not only can detect a bad connection, but also be used to detect if a

Hose line is connected or not.

In addition, the image processing unit 24 is configured such that certain properties of the liquids in the hose lines 9.1 to 9.n can be detected. For this purpose, 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 l.l. On the basis of

Image recognition detects the image processing unit 24, for example, the turbidity of the liquids and / or the presence of air bubbles in the liquids. The image processing unit may also be used to measure the temperature of the liquids when the camera unit 19 is an infrared camera.

With the image processing unit 24 is also the optical recognition of

Labeling laser or damaged or deformed during sterilization

Connectors, the optical detection of leaks of the cassette made of films, the detection of particles in the receiving unit, with which the cartridge could be damaged, and the verification of the operability of the automatically operated drawer possible.

When reference patterns are on the cassette 4, the image processing unit 24 can detect unwanted deformation of the cassette. Also, the position of the cassette in the receiving unit 2 can be checked. Finally, one too

Checking a provided in the peritoneal dialyzer heating plate for heating the liquids for cracks or breakage possible. For example, the

Traversing speed of the automatically operated drawer to be checked. The medical device according to the invention also provides for the use of another disposable article 32, which is an insert 32, which is a

Signature field 33 has. The signature field 33 can be labeled, for example, with a felt-tip pen or ball-point pen.

The insert member 32 is formed such that it can be fitted into the receiving unit 2. For example, the insert part may have fixing elements 34 which 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 32 has a plate-shaped base support 35 which has on the top of the signature panel 33 and the fixing elements 34 has on the underside. The signature field 33 may be formed by the base support 35 itself or may be another support applied to the base support, for example made of paper or foil.

The image processing unit 24 is configured such that the signature located on the signature field 32 is read and evaluated. The signature may be compared with signatures stored in a memory of the image processing unit 24. This allows authentication of the user of the device.

The control unit 13 provides various modes of operation, for example, a

Service mode may be provided, which may be selected only by an authorized personnel (technicians). Certain security-related components may be deactivated in the service mode. The control unit 13 releases the service mode only when the technician has authorized himself with his signature. In addition, a treatment mode is provided in which the peritoneal dialysis is performed. This mode is enabled by the control unit 13 only when the patient has authorized. In addition, for training purposes, a demonstration mode may be provided in which the treatment is not performed. LIST OF REFERENCE NUMBERS

Housing 1

Recording unit 2

Receiving part 2A of the receiving unit 2

Receiving part 2B of the receiving unit 2

Disposable items 3

Cassette 4

Pumping chamber 5

Pumping chamber 6

Port 7.1 to 7.n

Bags 8.1 to 8. n

Bag unit 8

Hose lines 9.1 to 9.n

Fittings 10.1 to 10. n

Hose line sections 11.1 to 11. n of the hose lines 9.1 to 9.n

Liquid part 12

Control unit 13

Components 14

Actuator 15

Actuator 16

Alarm unit 17

Connector strip 18

Recesses 18.1 to 18. n

Camera unit 19

Image sensor 20

Optical system 21

Image section 22

Image area 22A

Image area 22B

Image area 22C

Lighting device 23 Lighting fixture 23 A Lighting fixture 23B

Image processing unit 24

Data line 25

central computing and control unit 26

Barcode 27 of the cassette 4

Segments 28

Segments 29.1 to 29.n

Barcode 30.1 to 30. n of port 7.1 to 7.n

Segments 31.1 to 31.n

Insert 32

Signature field 33

Fixing element 34

Basic carrier 35

Claims

Claims:

1. medical device with a housing (1) having a receiving unit (2) which is designed such that at least a portion of a disposable article (3) in the receiving unit (2) can be inserted, wherein the medical device, various components (14 ) for the operation of the medical device and a control unit (13) for controlling the components (14), characterized in that in the interior of the housing (2) a camera unit (19) is provided having 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 taken, and the medical device has an image processing unit (24) evaluating the data of the image sensor (20)

recorded image of the at least part of the disposable article (3) used in the recording unit generates characteristic data for the control unit (13), wherein the control unit (13) are configured such that at least one

Component (14) of the medical device in response to the data of the image processing unit (24) is controlled.

2. A medical device according to claim 1, characterized in that the image processing unit (24) is configured such that certain properties of the disposable article (3), which are recognizable in the recorded image of the disposable article as characteristic image patterns, based on a

Image recognition are determined, with one or more specific Characteristics of the disposable descriptive characteristic data are generated.

3. Medical device according to claim 1 or 2, characterized in that the receiving unit (2) for receiving a liquid part (12) of a

Disposable Article (3) is formed, wherein the liquid part (12) more

Hose line sections (11.1 to l l.n) of hose lines (9.1 to 9.n) includes.

4. Medical device according to claim 3, characterized in that the image sensor (20) is arranged such that an image of at least the part of the liquid part (12) of the disposable article (3) is received, in which the hose line sections (11.1 to l ln) are arranged.

5. A medical device according to claim 4, characterized in that the image processing unit (24) is configured such that on the basis of image recognition one or more specific properties of the liquids in the hose lines (9.1 to 9.n) are determined, one or several specific characteristics of the liquids descriptive characteristic data are generated.

6. 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.

7. Medical device according to claim 1 or 2, characterized in that the receiving unit (2) for receiving a liquid part (12) of a

Disposable article (3) is formed, wherein the liquid part (12) comprises a cassette (4) with a plurality of ports (7.1 to 7.n) and a plurality of hose line sections (11.1 to l ln), which connectable to the ports connecting pieces (10.1 to 10. n) exhibit.

8. Medical device according to claim 7, characterized in that the image sensor (20) is arranged such that an image of the part of the liquid part (12) of the disposable article (3) is received, in which the ports (7.1 to 7.n) the cassette (4) and the fittings (10.1 to lO.n) of the

Hose line sections (11.1 to 11 n) are arranged.

9. Medical device according to claim 8, characterized in that the image processing unit (24) is configured such that on the basis of an image recognition, the position of the ports (7.1 to 7.n) and the connection pieces (10.1 to 10. n) is detected wherein characteristic data describing the state of connection of the terminals to the ports is generated.

10. Medical device according to claim 1 or 2, characterized in that the receiving unit (2) for receiving an insert part (3) with a

Signature field (33) is formed.

11. Medical device according to claim 3, characterized in that the receiving unit (2) for receiving a liquid part (12) of a

Disposable article (3) and for receiving an insert (32) with a

Signature field (33) is formed.

12. Medical device according to claim 10 or 11, characterized in that the image processing unit (24) is configured such that on the

Based on an image recognition a signature on the signature field (33) of the insert part (3) is evaluated, wherein characteristic data are generated for the signature of the user.

13. Medical device according to one of claims 1 to 12, characterized

characterized in that in the receiving unit (2) at least a part of a Disposable Article (3) is inserted.

14. Medical device according to claim 13, characterized in that the disposable article (3) comprises a cassette (4) and a plurality of treatment liquids filled containers (8.1 to 8.n), wherein the cassette (4) a plurality of juxtaposed ports (7.1 to 7.n), to the fittings (10.1 to lO.n) of hose lines (9.1 to 9.n) can be connected, which are connected to the containers (8.1 to 8.n).

15. Medical device according to claim 13, characterized in that the disposable article (3) is an insert part (32) with a signature field (33).

16. Medical device according to one of claims 1 to 15, characterized

in that the medical device has a device for

Peritoneal dialysis is.