WO1997009075A1

WO1997009075A1 - Medical installation

Info

Publication number: WO1997009075A1
Application number: PCT/DE1996/001714
Authority: WO
Inventors: Anke Helmdach
Original assignee: Anke Helmdach
Priority date: 1995-09-05
Filing date: 1996-09-04
Publication date: 1997-03-13
Also published as: EP0848622A1; AU7560296A; DE19534502A1; DE19534502C2

Abstract

The invention relates to a medical installation with several interconnected lines conveying fluids, e.g. blood, and connect e.g. blood treating and/or pumping devices and/or containers together, and with devices for measuring and controlling pressure, temperature, gas content and fluid quantities for the treatment of patients, in which the containers consist of at least two superimposed, adjacent and/or partitioned foils and/or plates. The purpose of the invention is to reduce the quantities of fluids used by shortening the line lengths while retaining the control facilities, increasing the compactness of the installation and reducing the assembly times in preparations for medical operations. This aim is achieved in that several or all the lines (14) and housings of the devices (2; 3; 4; 5; 6) are integrated into the foil and/or plate arrangement in such a way that an upper section (19) of the lines and housings of the devices are formed by the upper foil and/or plate (17) and a lower section (20) by the lower foil and/or plate (18).

Description

Medical facility

The invention relates to a medical system with a plurality of interconnected lines which carry fluids, for example blood, and connect fluids, for example blood-treating and / or pumping devices and / or containers, and to devices for measuring and controlling pressure, temperature and gas content and amount of fluid for the treatment of patients, with the container before. at least two foils and / or plates lying one on top of the other and / or fastened by partition walls are formed.

In the case of medical systems, the individual system parts are connected to one another by more or less long lines. Heart-lung machines are known to enable blood to flow through the body artificially when the cardiac and pulmonary blood flow is switched off during cardiac surgery while maintaining the circulatory, respiratory and metabolic functions. The system parts of such a heart-lung machine consist essentially of a blood container, the so-called

Reservoir that receives the patient's own blood or is supplied with suitable blood supplies, an oxygenator, a heat exchanger, filters and pumps. The arterialized blood of the patient is returned by a pump, for example a peristaltic pump, into an artificial vessel of the patient after passing through a filter.

Before this happens, the patient's venous blood collected in the container of the heart-lung machine is supplied to the oxygenator, in which the blood is enriched with oxygen, carbon dioxide is removed and anesthetic gases are supplied to the blood. The blood is kept at body temperature via the heat exchanger and then returned to the filter, which also serves as an air trap, as mentioned at the beginning.

In addition to this blood circulation, there is a second circulation in which the blood is passed through the hemofilter, in which the metabolites are excreted from the blood by ultrafiltration.

A tube system is necessary for both circuits, which must be filled with donor blood and which has a not negligible filling volume. The known hose system is composed of a large number of hoses, connecting pieces and clamping and regulating devices. Its arrangement within the heart-lung machine is also confusing and time-consuming to install. The set-up times for preparing and reworking the machine for the operation are correspondingly high. From DE 38 34 952 AI is also a blood oxidizing device for use in an extracorporeal having a blood pumping device and a blood oxidizer

Blood circulation system known. This blood circulation system is formed in one piece and comprises a rigid reservoir for the blood, an oxidizing chamber and a heat exchanger. This known system also uses a hose system consisting of suction pump lines, lines to the suction pumps and suction pumps. It also has the disadvantages mentioned above.

Furthermore, a blood oxygenator is described in US Pat. No. 4,612,170 which comprises a reusable rigid container which can be plugged together with a blood treatment device and which accommodates a heat exchanger. The blood treatment device is connected from two injection-molded, interconnected plastic halves that form several containers in which the blood is defoamed and collected, the heat exchanger being a separate component that can be connected to the container. Although a direct connection between the blood treatment device and the container is established in this prior art, and thus the conduction path is omitted, the regulating capacity of the blood flow is lost at this point. In addition, the disadvantages of the relatively long hose connections between the still necessary external devices and components remain.

In this prior art, the invention has for its object to improve a medical system of the type mentioned in such a way that the fill quantities, for example for blood, blood substitutes or other fluids that are required for operating the system, by shortening the Cable routes are significantly reduced while maintaining the regulation options, the compactness is increased and the set-up times for the preparation of medical interventions are reduced.

This object is achieved in that several or all lines and housings of the devices are integrated into the film and / or plate arrangement such that an upper region of the lines and housings of the devices from the upper film and / or plate and a lower region the lines and the housing of the devices is formed by the lower film and / or plate.

In a preferred feature of the system according to the invention, the upper and lower film and / or plate with the whole

Line and tank system designed as a compact unit. The upper and lower film and / or plate is then a deep-drawn part or in-mold blow part.

According to a further feature of the system according to the invention, at least a larger area of the film and / or plate lies in a plane which is located above the compact unit, which in turn is located below the heart level of the patient.

In a preferred embodiment of the plant according to the invention form the upper and lower film and / or

Plate formed lines a wiring harness leading to

Compact unit belongs.

The wiring harness is evenly or non-uniformly falling from the patient's heart level, but is arranged continuously to the device, the pumps being at the lowest point in the compact unit. This ensures that any air bubbles can be drawn out of the container. In a further preferred feature of the system according to the invention, the container lies at its highest point in the

Compact unit above the level of the air trap, at which point a vent valve is provided.

In a further preferred feature of the invention, the compact unit is arranged on or on a mobile device in which a computer is integrated, with which the temperature, the pressures, blood gas values and the delivery volume of the pumps can be controlled.

The compact unit is stored according to a preferred one

Embodiment of the invention on the table of this device, the inclination of which corresponds to the drop in the wiring harness. It is also within the scope of the invention if the compact unit is attached to the device in a hanging manner.

For the purpose of heat exchange, for example heating or cooling of the fluid, the lines and containers or parts thereof formed by the upper and lower film or plate or at least parts thereof are enclosed by at least one further film or plate, which in turn acts like a double jacket, the heat transfer medium, for example water, take up.

The supply of the devices, for example the

Oxygenators, hemofilters and heat exchangers with operating media such as oxygen, water, etc. are carried out by corresponding supply lines, which are also formed by the top and bottom film and / or plate. For easy transportation of the compact unit with cable harness, the compact unit has handles that are arranged in the edge area by punching or perforation.

The upper and lower film and / or plate are connected to one another in a liquid-tight and pressure-tight manner to form the lines and the housing of the devices.

This is advantageously achieved in that the upper and lower film and / or plate are connected to one another in one piece.

The lines leading to and from the operating table, forming a line, are at least partially stiffened in the area of the upper and lower film and / or plate. This is necessary so that the lines are not kinked and an unimpeded flow of the fluid, preferably blood, is ensured.

The stiffening can be achieved in such a way that, for example, the lower region of the film has support profiles which are uniformly distributed over their length and are approximately in the form of an arc and which have stops which are separated from one another and which permit only a bend in the direction of the upper region of the line. This enables the cables to be transported safely without being squeezed.

But it is also part of the invention if the wiring harness is flexible and is supported on a support. It is of particular importance for the system according to the invention that axial flow pumps with an external stator are arranged in the lines formed by the upper and lower foil and / or plate, which serve to supply the containers, the hemofilter, the oxygenator, the filter and for cardioplegia . According to a further feature of the invention, the stator for operating the pumps is designed in two parts, one part being arranged in or on the machine table of the mobile device and the other part being foldable over the upper film and / or plate of the line.

According to a further feature of the invention, these pumps which supply the blood vessels, the hemofilter, the oxygenator etc., preferably also peristaltic pumps, are arranged from the outside on the lines formed by the upper and lower film and / or plate. This enables the pumps to be replaced quickly and easily.

All essential parts of the system according to the invention, such as the blood container, the container for body fluids, water, medication or the housing for the oxygenator, filter and heat exchanger for cooling and heating the fluid streams, are at least as part of the upper and lower film and / or the connecting lines. or plate formed.

According to a further feature of the invention, the fluid flow in the lines formed by the upper and lower film and / or plate can be disconnected or regulated by a clamping device. At least the upper film and / or plate has a flexible design in the clamping area and thus allows the fluid flow to be interrupted without problems.

In the same way, it is also possible, without departing from the invention, to shut off the flow of current through valves inserted into the lines formed by the upper and lower film and / or plate. It only has to be ensured that the valve has a liquid-tight and pressure-tight seat in the line.

During operations, it is often necessary not to completely shut off the fluid flow, but only to restrict it. In this case, corresponding throttling devices are inserted into the lines formed by the upper and lower film and / or plate.

In a further embodiment of the invention, on the lines formed by the upper and lower film and / or plate, the housings for the devices and the containers, liquid-tight and pressure-resistant plug contacts for the connection of measuring and control devices for pressure, temperature and blood gas content, the flow rate and the amount of fluid, preferably blood, the blood substitute solution and the medication.

It is of particular advantage that the lines formed by the upper and lower film and / or plate are connected to one another by bridges, which are always effective when, for example, the artificial reflux has to be disconnected or by oxygenator, artificial filters and heat exchanger after termination of the procedure.

In a special embodiment of the system according to the invention, the lines, housing for devices and containers formed by the upper and lower film and / or plate can be irradiated for further applications. In a further feature of the invention, the upper and lower film and / or plate can be connected to one another by adhesive bonding and / or welding.

The lines formed by the upper and lower foils and / or plates together form a line strand which starts from the compact unit and leads to the operating table via a table hose set.

In order to be able to connect the cable harness to the table hose set, according to a further feature of the invention, this has connection pieces at the ends, whereby through in the

Perforations incorporated into the wiring harness which enable the wiring harness to be separated into individual wires.

It is also advantageous that at least the blood container is formed as a bellows. The other containers also have bellows formation without departing from the invention.

Through all of these features, the system according to the invention achieves an advantageous compactness, which is characterized by short line paths, a clear arrangement and clearness of the lines, similar to a cable harness, and easy disposal.

The line volume and thus the amount of blood that must be taken from the body or made available in addition decreases significantly. Instead of a large number of individual components and connecting parts, in the system according to the invention all parts which come into contact with blood are combined to form one unit. This also increases safety when setting up in the operating room. Possible sources of error in operation and setup are eliminated.

The compactness achieved reduces the amount of work involved in preparing and reworking the machine.

Another advantage of the system according to the invention is that the entire compact unit with its line and container system and the housings for the devices can be filled and vented before the operation, since the compact unit is intended for single use. This leads to the avoidance of time-consuming preparatory work.

With all these features it is achieved that the solution according to the invention better meets the complex requirements for a medical system, for example a heart-lung machine, with high security, clarity and compactness.

Further advantages and details emerge from the following description with reference to the attached drawings.

The invention will be explained in more detail below using an exemplary embodiment of a heart-lung machine.

Show it:

1 shows a section through the system according to the invention,

2 shows a functional diagram of a heart-lung machine,

Fig. 3 is a plan view of the system according to the invention 4 shows the section through a line with an axial pump,

5 shows a section through the folding mechanism with divided stator,

Fig. 6 versions of the clamping areas with the

Details X, Y and Z,

7 is a view of the wiring harness with connections,

8 shows the arrangement of the system according to the invention for the operating table with detail W.

Figures 1 to 8 show an embodiment of the invention.

The system according to the invention for a heart-lung machine consists essentially of a container or reservoir 1, a hemofilter 2, an oxygenator 3, a heat exchanger 4, filter 5 with air trap 6, pumps 7 to 11 and 24, one

Throttle device 12, the devices 13 for measuring pressure, temperature and blood gas content (Fig. 2 and 3). Container 1, hemofilter 2, oxygenator 3, heat exchanger 4, filter 5 with air trap 6, the container 16 for body fluid, the container 23 for the cardioplegia solution are connected via lines 14.

All these parts of the system according to the invention, like the lines 14, are formed by an upper film 17 and a lower film 18, which are integrally bonded to one another at the respective delimitation points, an upper one

Area 19 of the upper film 17 and a lower area 20 of the system according to the invention are fastened to one another by the lower film 18 (see FIG. 1). The upper film 17 and lower film 18 can also by a

Plate to be replaced. It is of course also possible to design the lower area 20 as a plate and the upper area

Form region 19 with a film 17.

If the compactness so requires, the connection between the upper film 17 and the lower film 18 can be established by an intermediate wall 38 (see FIG. 1). The containers can be easily divided into chambers.

The pumps required for the conveyance of the blood are arranged in the lines 14 formed by the upper film 17 and lower film 18. The artificial pump 7 (see FIG. 4) —also called the main pump — which conveys blood from the container 1 into the oxygenator 3, is designed as an electric motor-driven axial pump 7 of miniaturized design and is arranged directly in one of the lines 14. The stator of the motor is designed in two parts and with its upper part 31 removably and foldably grips around the outside of the line 14 (FIG. 5). The lower part 31 of the stator lies approximately in the support plane of the machine table 37 of the device 25.

This enables the construction of a corresponding one

Magnetic field and thus the contact-free drive of the rotor in line 14 on the outside of this line 14 are the

Pump 7 assigned to light sensors 21, which allow the

Flow rate of blood to measure and the pump in the

Control dependence of the river.

Such axial flow pumps achieve flow rates up to 12 1 / min.

The pump 8 for the hemofilter 2 can also do this

Be an axial flow pump. The pump 9 for the suction of the blood from the operating table, the pump 10 for the ventricular suction device and the pump 11 for the oxygenator 3 are commercially available peristaltic pumps which periodically squeeze the line 14 from the outside. The pump 10 can also be replaced by a pump with a Venturi effect, which is then arranged so that it can be inserted into the table hose set 33.

The lines 14 have clamping areas 22 (see FIG. 3), which are for hurry. Disconnecting the lines 14 are provided. In these areas, the lines 14 are flexible and thus allow the fluid flow to be closed and opened quickly.

The individual clamping areas 22 are each shown as a detail X, Y and Z in FIG. The detail X shows the disconnection of the line 14 at the terminal points F and G, wherein either the line 14 is disconnected at G and open at F or closed at F or open at G. Also for the detail ±, the clamping points D and E are either open or disconnected. In detail Z it is shown that either d ^{1 '} e clamping points A and B are open and the clamping point C is closed or A and B are closed and C is open.

The clamping is achieved in that the lines 14 are clamped at the clamping points 22 with a gill frame (not shown) which can be simply folded over onto the lines 14.

Likewise, other shut-off devices, such as shut-off valves or throttle valves 27, are integrated in the lines 14.

For the determination of the blood gas content, the temperature, the pressure, the amount of medication, and the volume of blood delivered and water are arranged, for example, in the lines 14, pressure-resistant and liquid-tight measuring points for the individual sensors or sensors.

Without leaving the invention, temperature, pressure and concentration can also be measured without contact.

The temperature measuring points for the blood are placed so that the temperature can be measured at least before and after flowing through the heat exchanger 4.

The lines 14, the blood, blood substitutes, etc. Transport to and from the containers are, as shown in FIG. 7, combined in a wiring harness 26 in a manner similar to a wire harness. The individual lines 14 are transparent so that the fluid flow can be observed accordingly. To make it easier to distinguish the lines 14 when they are connected to the individual parts of the system, the lines 14 have colored markings.

At the end, the cable harness 26 has connections 35 for the hose table set 33. In order to be able to connect the connections 35 better to the hoses of the hose table set 33, the cable harness 26 has perforations 39 over a certain length, which enables the cable harness 26 to be separated into its lines 14.

FIG. 3 shows a top view of the system according to the invention, from which the compact unit 29 of container 1, container 16 and container 23, hemofilter 2, oxygenator 3, heat exchanger 4, filter 5 with air trap 6 and lines 14 with pumps 7 to 11 and 24 is particularly clearly recognizable. The parts of the system are arranged close to each other and the line routes are extremely short. Bridges 30 are provided between the lines 14, which make it possible, for example, to empty the oxygenator 3, the arterial filter 5 and the heat exchanger 4 at the end of the surgical intervention. This bridge 30 also enables the backflow of the filtered blood.

The cable run 26 leads from the compact unit 29 to the operating table via a table hose set 33. The connection is made with the connecting pieces 36 which can be seen particularly well in FIG. 7. The wiring harness 26 with its wires 14 is reinforced in the lower region. Either the lower region of the film has uniformly distributed over its length, approximately formed as arches support profiles 34, each of which have stops 35 which are divided from one another and which only permit a bend in the direction of the upper region 19 of the lines 14, or the line run 26 is of flexible design . In this case, the strand 26 must be supported accordingly. This enables the cables to be transported safely without squeezing the cable harness. The cable harness 26 connected to the table hose set 33 opens into the compact unit 29 starting from the operating table, and the cable harness 26 and compact unit 29 are formed in one piece. The drop is linear in order to ensure a steady blood flow from the patient to the compact unit 29.

The compact unit 29 is placed on the machine table 37 of the mobile device 25 and has approximately the same inclination as the cable line 26. The blood container 1 is at its level, i.e. at its lowest point in the compact unit 29 higher than that in

Air line 6 arranged in the wiring harness 6. The artificial pump 7 and the pump 8 for the hemofilter 2, on the other hand, are located in the lowest point of the compact unit 29. A computer (not shown) with a touch screen 32 is integrated in the device 25, with which the temperature, the pressure and the individual blood gas values of the patient and the flow rate of the blood can be regulated, among other things. For example, the control can be carried out by a cardio technician who acts independently of the operating table.

The device 25 is designed for transport, so that, for example, a trouble-free approach to the operating table is possible. Various operating variants can be carried out with the mobile device 25.

List of the reference symbols used

Tray 1

Hemofilter 2

Oxygenator 3

Heat exchanger 4 Artificial filter 5

Air trap 6 type pump or axial pump 7

Pump for hemofilter 8

Pump for suction from the operating table 9 Pump for ventricular suction 10

Pump for oxygenator 11

Throttle device 12 devices for pressure, temperature

Conveyor volume measurement 13 lines 14

Blood bank 15

Body fluid container 16 upper film or plate 17 lower film or plate 18 upper area 19 lower area 20

Light sensors 21

Clamping areas 22

Cardioplegia container 23 Pump for container 23 24

Mobile device 25

Wiring harness 26

Shut-off or throttle valves 27

Vent valve 28 Compact unit 29

Bridges 30

Upper and lower part of the stator 31

Touch screen 32 Table tube set 33

Support profiles 34

Stops 35

Connector 36

Machine table 37

Partition 38

Perforation 39

Terminal points A, B, C, D, E, F, G

Claims

claims

1. Medical system with several interconnected lines that carry fluids, for example blood, and fluids, for example blood, for treating and / or pumping

Connect devices and / or containers to one another, and to devices for measuring and controlling pressure, temperature, gas content and quantity of fluid for the treatment of patients, the containers being fastened by at least two superimposed ones, to one another and / or by partition walls (38) Films and / or plates (17; 18) are formed, characterized in that several or all lines (14) and housings of the devices (2; 3/4; 5; 6) are integrated in the film and / or plate arrangement in such a way that that an upper region (19) of the lines and the housing of the devices from the upper film and / or plate (17) and a lower region (20) of the lines and housing of the devices from the lower film and / or plate (18) is formed.

2. Plant according to claim 1.- characterized in that the upper and lower film and / or plate (17, -18) with the entire line and container system and the housings for the devices (2; 3; 4; 5; 6) is designed as a compact unit (29).

3. Plant according to claim 1 and 2, characterized in that at least a larger area of the film and / or plate (17; 18) lies in a plane which is above the compact unit (29), which in turn is arranged below the heart level of the patient is.

4. System according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the lines (14) formed by the upper and lower film and / or plate (17, -18) form a wiring harness (26) which belongs to the compact unit (29).

5. Installation according to one of the preceding claims, characterized in that the line (26) from the patient's heart level is arranged to the device (25) and the pumps (7, -8) are arranged at the lowest point in the compact unit (29) .

6. Plant according to claim 5, d a d u r c h g e k e n n z e i c h n e t that the waste is uniform or uneven, but steady.

7. Installation according to one of the preceding claims, characterized in that the container (1) at its highest point in the compact unit (29) lies above the level of the air trap (6) and a vent valve (28) is provided at this point.

8. Installation according to one of the preceding claims, characterized in that the compact unit (29) is arranged on or on the device (25) in which a computer is integrated, with which the temperature, pressures, blood values and the delivery volume of the pumps can be controlled .

9. System according to claim 8, d a d u r c h g e k e n n z e i c h n e t that the device (25) is mobile.

10. Plant according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that at least the container (1) is formed like a bellows.

11. Plant according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the lines (14), the housing for the devices (2; 3; 4; 5; 6) and

Containers (1; 16; 23) can be designed for different volumes.

12. Plant according to one of the preceding claims, characterized in that the upper and lower film and / or plate (17; 18) is at least partially stiffened.

13. Plant according to one of the preceding claims, characterized in that the lower region of the film (20) has uniformly distributed over its length, approximately as an arch formed support profiles (34) which have mutually divided stops (35) which have only one bend in Allow direction of the upper area of the line.

14. Plant according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the lower and upper film and / or plate (17; 18) are flexible.

15. Plant according to one of the preceding claims, characterized in that the upper and lower film and / or plate (17; 18) to form the lines (14), the housing of the devices (2; 3; 4; 5; 6) liquid-tight and are pressure-tightly connected to each other.

16. Plant according to one of the preceding claims, characterized in that in the lines formed by the upper and lower film and / or plate (17, -18) (14) are arranged axial flow pumps (7) which supply the oxygenate (3), the hemofilter (2), the blood container (1), the container (16) for

Body fluid, the container (23) for

Cardioplegia fluid and the artificial filter (5) are used.

17. Plant according to claim 16, characterized in that the stator of the axial flow pump (7) is formed in two parts (31), one part on or in the machine table (37) of the mobile device (25) and the other part via the upper film and / or plate (17) of the line (14) can be folded.

18. Plant according to one of the preceding claims, characterized in that on the outside of the upper and lower film and / or plate (17, -18) formed lines (14) pumps (7; 8; 24) are arranged, which are used for supply the oxygenator (3), the hamofilter (2), the blood container (1), the container (16), the container (23), the artificial filter (5).

19. Plant according to one of the preceding claims. That means that at least part of the upper and lower foil and / or plate (17; 18) is designed as a container for blood, blood substitute solution, body fluid and care solution, medication, water and a housing for the oxygenator, filter and heat exchanger.

20. System according to one of the preceding claims, characterized in that the lines (14) formed by the upper and lower film and / or plate (17, -18) can be clamped off by a clamping mechanism or regulated by throttle devices (12).

21. Plant according to claim 20, so that at least the upper film or plate (17) in the clamping area (22) of the lines (14) is flexible.

22. An age ^l according to one of the preceding speech, characterized in that the lines formed by the upper and lower film and / or sheet (17,18) (14) can be shut off by valves (27).

23. System according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that m the lines (14) formed by the lower and upper film and / or plate (17, -18) throttle devices (12) are arranged.

24. Installation according to one of the preceding claims, characterized in that on the lines formed by the lower and upper folio and / or plate (17, -18) (14) and housings of the devices (2; 3; 4; 5; 6) liquid-tight and pressure-resistant plug contacts for the

Connection of measuring and control devices (13) for pressure, temperature and blood gas content, flow rate and amount of blood, the blood substitute solution and the medication are provided.

25. System according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that liquid-tight and temperature-resistant supply lines are provided on the housings of the devices, which are formed from upper and lower film and / or plate (17; 18).

26. System according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the lines (14) formed by the upper and lower film and / or plate (17/18) are interconnected by bridges (30).

27. Plant according to one of the preceding claims, characterized in that the lines (14) and housing of the devices (2; 3; 4; 5; 6) formed by the upper and lower film and / cder plate (17, -18) can be irradiated .

28. Plant according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the upper film and / or plate (17) is enclosed by at least one further film or plate.

29. Plant according to claim 24, characterized in that the upper and lower film and / or plate (17, -18) is a deep-drawn part or an in-mold blow part.

30. System according to one of the preceding claims, d a d u r c h g e k e n n z e i c h n e t that the line string (26) has end pieces (36) at the end, the line string (26) being separable into lines (14) by perforations (39) arranged in it.