BLOCKING DEVICE FOR A HOSE CLAMP OF A BLOOD TREATMENT MACHINE

Description

[0001] The present invention relates to a blocking device for a hose clamp for a blood treatment machine, a blood treatment machine with such a blocking device and a method in which a blocking device according to the invention is used.

[0002] Conventionally, blood treatment machines have at least one hose clamp as a safety feature, particularly an electromagnetically driven hose clamp, which serves particularly to clamp a hose of the extracorporeal blood circuit. The clamp makes it possible to disconnect the patient from the extracorporeal blood circuit during the course of treatment, particularly to prevent blood loss. For safety reasons, it is known to design the clamp so that it closes in the de-energized state, which can be caused, for example, by a power failure, thus disconnecting the patient from the extracorporeal blood circuit.

[0003] In the conventional three-shift operation of blood treatment centers and, for example, dialysis centers, the blood treatment machines are prepared for the following day after the last treatment in the evening and the tubing set serving as the extracorporeal blood circuit is arranged on the blood treatment machine and inserted into the tubing clamp.

[0004] However, since the blood treatment machine is regularly de-energized overnight, the clamp frequently clamps the tubing for extended periods. This leads to permanent compression of the tubing, causing irreversible deformation in the affected area. This can cause undesirable turbulence during operation.

[0005] The object of the present invention is to avoid this disadvantage.

[0006] This object is achieved by the subject matter of the independent claims. Further advantageous developments of the invention are the subject matter of the dependent claims.

[0007] A blocking device according to the invention for a hose clamp of a blood treatment machine is designed to be arranged in the hose clamp when a hose is inserted in the hose clamp in such a way that the hose clamp is held in an open position without the hose inserted in the hose clamp being clamped by the hose clamp and / or the blocking device. Preferably, the clamping force of the hose clamp on the hose is such that the hose is deformed by up to approximately 20%, preferably only up to 10%, of its outer diameter. This allows the hose to be held tightly enough to prevent it from slipping off overnight, without compromising the functionality of the hose or patient safety.

[0008] The core idea of ​​the invention is therefore that after the blood treatment machine has been prepared for the following day after the last treatment in the evening and the tube set serving as extracorporeal blood circulation has been arranged on the blood treatment machine and inserted into the tube clamp, a blocking device is introduced into the tube clamp, which prevents the tube clamp from clamping the tube and thus deforming it.

[0009] When the blocking device is inserted, the blood treatment machine is prepared and ready for the next blood treatment (the tubing for the next blood treatment is already attached to the blood treatment machine).

[0010] Before the actual start of the blood treatment, all that needs to be done is to remove the blocking device from the tube clamp so that the tube clamp can close again. The presence of the blocking device in the tube clamp overnight prevents unwanted deformation of the tube, allowing the new blood treatment to begin quickly the next morning, without the time lost due to preparing the blood treatment machine.

[0011] It has proven advantageous if the blocking device according to the invention has a plate-shaped, preferably substantially U-shaped base body, which is designed to be inserted into the hose clamp, and an adapter section, preferably arranged at an apex of the substantially U-shaped base body, by means of which adapter section the blocking device can be connected to a further component, preferably a dialyzer, in particular a cap of a dialyzer.

[0012] For use with a blood treatment machine that has multiple hose clamps, the blocking device is preferably connected to at least one other blocking device by means of a cable, rope, or band. This allows a user to remove all of the connected blocking devices, for example, from a blood treatment machine, with just one movement of the cable, rope, or band. It also prevents individual small parts from getting lost. Any number of connected blocking devices can be used.

[0013] Furthermore, a blocking device according to the invention has at least one coding, wherein the coding is preferably a near field communication (NFC), radio frequency identification (RFID), quick response (QR), barcode coding, or a coding in the form of an electrical conductor with a predetermined electrical resistance and is designed to be detected or read by a corresponding detection device of a blood treatment machine. The blood treatment machine preferably stores read information as part of a blockchain coding.

[0014] In addition, the blocking device can be uniquely assigned to a predetermined tube clamp, for example the arterial or venous tube clamp, and / or a predetermined tube or tube set, for example the arterial or venous branch of an extracorporeal circuit of a blood treatment machine.

[0015] Furthermore, it has proven advantageous if the blocking device is designed as a single-piece and / or as a disposable component for single use. Preferably, the blocking device is made of plastic and / or metal.

[0016] Furthermore, the present invention relates to a cap for a dialyzer, wherein the cap has a receptacle that is connectable or connectable to at least one blocking device according to the invention, preferably by means of an adapter portion of the blocking device. In other words, the blocking device can be arranged on the cap or be part of the cap.

[0017] The blocking device may be detachably or permanently connected to the cap and may also be formed integrally with the cap.

[0018] Furthermore, the cap can be attached to a dialyzer or screwed onto it. The locking device attached to the cap can serve as a handle section by means of which the cap can be removed or unscrewed from the dialyzer.

[0019] In addition, the present invention relates to a blood treatment machine with a blocking device according to the invention and / or a cap according to the invention for a dialyzer.

[0020] Furthermore, the blood treatment machine can have at least one receptacle designed to accommodate a blocking device. Since many blood treatment machines have two hose clamps (arterial and venous hose clamps), it has proven advantageous for a blood treatment machine according to the invention to have two corresponding receptacles.

[0021] However, the number of holders is arbitrary and can be flexibly adapted to the number of blocking devices or hose clamps.

[0022] Preferably, such a receptacle is substantially U-shaped and thus adapted to the shape of a blocking device according to the invention.

[0023] For reasons of improved hygiene, a drainage opening is preferably provided at an apex of the substantially U-shaped receptacle for draining liquid contained in the receptacle.

[0024] A further aspect of the invention relates to a method for checking the operational readiness of a blood treatment machine before a blood treatment, comprising a step of checking whether a blocking device according to the invention for a hose clamp is arranged in at least one hose clamp of the blood treatment machine or is not arranged or has been removed from the hose clamp.

[0025] The check can be carried out by measuring and preferably subsequently analyzing the current consumption and / or the current profile of the hose clamp in response to actuation of the hose clamp, as shown in the figures Figs. 4 and 5 is shown.

[0026] Alternatively or additionally, the check can be carried out by measuring and preferably subsequently analyzing the pressure curve in the tube inserted in the tube clamp when the blood pump of the blood treatment machine is activated.

[0027] Alternatively or additionally, the check can be carried out by measuring and preferably by subsequently analyzing the current consumption and / or the current profile of the blood pump

[0028] Furthermore, the analysis can include an analysis of the sign of a measured pressure change of a pressure curve, by means of which it can be determined whether a tube clamp arranged in the venous section of the blood treatment machine and / or a tube clamp arranged in the arterial section of the blood treatment machine is open or closed. The blood treatment machine has an extracorporeal circuit with an arterial and a venous section. The blood treatment machine also has an arterial and a venous tube clamp. Furthermore, the blood treatment machine can have a venous and / or an arterial pressure sensor.

[0029] In addition, a method according to the invention comprises the following steps: blocking the start of a blood treatment as long as the check shows that at least one blocking device for a hose clamp is arranged in at least one hose clamp of the blood treatment machine, and / or enabling the start of a blood treatment if the check shows that no blocking device is arranged in any hose clamp of the blood treatment machine.

[0030] According to the invention, the start of a blood treatment is only enabled if the at least one blocking device is arranged in a predetermined receptacle of the blood treatment device, wherein the presence of the at least one blocking device in the receptacle of the blood treatment machine is detected by means of a detection device of the blood treatment device.

[0031] Furthermore, the presence of the at least one blocking device in the receptacle of the blood treatment machine can be detected by reading a code of the at least one blocking device, preferably by the detection device of the blood treatment device, wherein the code is preferably an NFC, RFID, QR, barcode code or a code in the form of an electrical conductor interacting with the detection device of the blood treatment machine.

[0032] Furthermore, a method according to the invention can comprise the step of storing information relating to the at least one blocking device using blockchain technology. In other words, tracking information relating to the at least one blocking device (or multiple blocking devices) is stored using blockchain technology.

[0033] In everyday clinical practice, blood treatment facilities are often set up the evening before with tubing sets or cassette systems to which tubing is attached. The machine is de-energized overnight, meaning the tubing clamp, which is preferably electromagnetically operated, is closed (normal state when de-energized) and squeezes the tubing overnight, so that the tubing cross-section is altered the next morning, even with the clamp open.

[0034] The solution to this problem is as follows: A (e.g. U-shaped) blocking device, preferably designed as a clamping chip, is inserted into the hose clamp with the inserted hose, which fixes the hose clamp in the open position without pinching the hose.

[0035] The clamp chip must be removed before treatment. Checking whether the clamp chip has been removed can be done by measuring the current consumption or the current profile when operating the tube clamp, for example, during a preparatory process before performing a blood treatment, after the blood treatment device is energized and ready for use. The clamp of the tube clamp is moved to the open position after the blood treatment device is started up. The current profile or current consumption of the electromagnetically operated tube clamp differs depending on whether the clamp chip is in the clamp or not, see Figures 4 and 5 .

[0036] The normal state of the energized tube clamp is open. After the blood treatment machine is energized and started, the tube clamp is moved from the closed position to the open position. During this process, the tube clamp must perform work. Fig. 4 shows a high amplitude (large peak) in the current waveform when the blood treatment machine is initially switched on. This means that there is no blocking device in the tube clamp and the tube clamp has to perform a relatively high amount of work to open the clamp (the travel distance from closed to open is long).

[0037] In Fig. 5The amplitude is low (small peak) because the blocking device is inserted into the hose clamp, and the hose clamp has to perform less work and travel a shorter distance to move into the open position, since it is already largely held open by the blocking device. The hose clamp then performs work to remain in the open position (i_halte).

[0038] Thus, based on the current consumption of the preferably electromagnetically operated tube clamp, it can be detected as soon as the blood treatment machine is switched on whether the blocking device is inserted in the tube clamp.

[0039] Alternatively, after commissioning, the hose clamp can be opened and moved to the closed position.

[0040] This also results in different current profiles. The hose clamp can advantageously open and close several times to enable the ejection of an inserted blocking device and to detect the ejection based on the evaluation of the current profile.

[0041] In any case, it is possible to detect whether a blocking device / clamping chip is arranged in a hose clamp based on the current curve and / or an integral calculation based on the current consumption curve and / or the detection of a peak in the current curve.

[0042] In addition to the amplitude of the peaks in the current profile, the temporal component of the current profile can also be used to detect whether a blocking device / clamp chip is located in a hose clamp. This is based on the fact that the peak in the open and unblocked state occurs later than in the open and blocked state, since the hose clamp or solenoid has to travel a longer distance. Thus, the time offset (in Fig. 5 represented by ΔT) up to the peak may be an indication of an inserted blocking device / clamping device.

[0043] Another way to check the clamps is via the blood pump. When the clamps are closed and the blood pump is running, a pressure alarm (pressure increase or pressure decrease) occurs quite quickly, as volume is pumped into or out of a closed system. The pressure alarm can be triggered by the venous and / or arterial pressure sensor provided in the blood treatment machine.

[0044] The pressure curves or the pressure curve in the tubes with closed and open clamps differ so greatly that detection is also possible via the current consumption of the blood pump.

[0045] The direction of the drive torque of the blood pump's pump rollers (sign) can be used to detect whether the venous or arterial clamps are open individually or together. The arterial clamp is positioned downstream of the blood pump, i.e., before the blood pump, while the venous clamp is positioned upstream, i.e., after the blood pump.

[0046] When there is a pressure difference in the tubing—in other words, when a closed clamp creates a pressure difference between the fluid in the tubing—a driving torque is exerted on the blood pump rollers (each rotation of the pump results in more or less flow; when the clamp is closed, there is less flow). The driving torque thus changes its sign, and continuous rotation is not possible. A constant sign therefore means or requires continuous rotation of the pump rollers.

[0047] The machine software of the blood treatment machine preferably specifies that treatment cannot be started until the tube clamp is free (from a blocking device or clamp chip).

[0048] In the case of two or more tube clamps, the clamp chips or blocking devices can be connected by a cable / rope so that they can be handled or removed from a blood treatment machine with one hand.

[0049] In another variant, the clamp chips are part of the cover caps of a dialyzer and can also be used as a "handle" for removing / unscrewing the caps.

[0050] In one variant, the clamp chips must be inserted into two corresponding receptacles on the blood treatment machine before treatment can begin.

[0051] The mounts preferably have an eyelet that opens downwards to allow liquid to pass through and to provide a geometry that is easy to clean.

[0052] In addition, the geometry is such that the dialyzer closure side or the side of each clamping chip / blocking device facing the dialyzer always points downwards (in the direction of insertion of the blood treatment machine holder) and is thus largely protected from coarse dirt and dust.

[0053] Furthermore, corresponding contacts in the receptacles can detect the blocking devices or clamping chips used.

[0054] According to the invention, the clamping chips or blocking devices are coded (preferably NFC, RFID, QR, barcode, electrical resistance within a clamping chip or between the two clamping chips connected by an electrical line (with special resistance)), preferably uniquely assigned to a predetermined tube set and can only be used once ("single use").

[0055] The tracking of the blocking devices or clamp chips and thus of the dialyzer can be done using blockchain technology.

[0056] Further advantages, features and effects of the present inventions will become apparent from the following description of currently preferred embodiments with reference to the Figures 1 to 5 Identical or similar components are designated by the same reference numerals.

[0057] This shows: Fig. 1 several different blocking devices according to the invention; Fig. 2a blocking device according to the invention arranged in a hose clamp; Fig. 3 a blocking device according to the invention arranged on a cap of a dialyzer; Fig. 4 a current curve of a hose clamp without a blocking device according to the invention arranged therein; Fig. 5 a current curve of a hose clamp with a blocking device according to the invention arranged therein.

[0058] Fig. 1 shows a plurality of blocking devices 1 for a hose clamp, which are designed to be arranged in the hose clamp with a hose inserted therein in such a way that the hose clamp is held in an open position without the hose inserted in the hose clamp being clamped by the blocking device.

[0059] As in Fig. 1As shown, a blocking device 1 according to the invention preferably has a plate-shaped, preferably substantially U-shaped base body 1a, which is designed to be inserted into the hose clamp, and an adapter section 1b, which is preferably arranged at an apex of the substantially U-shaped base body 1a and by means of which adapter section the blocking device 1 can be connected to a further component, preferably a dialyzer 2, in particular a dialyzer cap 2a.

[0060] As from Fig. 1 As can be seen, the plate-shaped, substantially U-shaped base body 1a of a blocking device 1 according to the invention is preferably designed such that a preferably slot-shaped or notch-like recess 1c is formed in a substantially square plate.

[0061] Alternatively, a substantially U-shaped base body 1a with rounded corners could also be provided. The slot-shaped or notch-like recess 1c can be continuous, forming a passage between the two legs of the substantially U-shaped base body 1a.

[0062] Alternatively, the slot-shaped or notch-like recess 1c can also only have the shape of a partial material removal or the shape of a depression, so that the two legs of the essentially U-shaped base body 1a are materially connected to one another and only the thickness of the plate-shaped base body varies between the legs and the recess 1c arranged between them.

[0063] As in Fig. 1 As shown, the adapter section 1b has a substantially cylindrical shape and preferably extends at right angles from an apex of the base body 1a. As shown in Fig. 1As shown, the adapter section 1b can be connected to a cap 2a of a dialyzer 2. Preferably, the adapter section 1b is inserted into a corresponding receptacle on the cap 2a. The shape of the adapter section 1b is arbitrary and can be flexibly adapted to corresponding receptacles of a cap 2a.

[0064] Fig. 2 shows a blocking device 1 according to the invention, which is inserted into a hose clamp 3 in which a hose 4 is inserted. As can be seen from Fig. 2 The two legs of the essentially U-shaped base body 1a of the blocking device 1 are shown inserted / introduced / plugged into the hose clamp 3. The hose clamp 3 is thus held in the open position and neither the hose clamp 3 nor the blocking device 1 exerts pressure on the hose 4, which would result in a deformation of the hose 4.

[0065] Fig. 3shows a blocking device 1 according to the invention arranged on a cap 2a of a dialyzer 2. The blocking device is attached to the cap 2a by means of the adapter section 1b, in that the adapter section 1b is inserted / inserted into a corresponding receptacle of the cap 2a.

[0066] In Fig. 3 It is also clear to what extent the blocking device 1 can serve as a handle section: The cap 2a is, for example, plugged or screwed onto the dialyzer 2, and the blocking device 1 serves as a lever and / or handle for a user who wishes to remove the cap 2a from the dialyzer 2. The handling of the dialyzer is thus simplified or facilitated by the blocking device.

[0067] In the Figs. 4 and 5It is illustrated how, by recording and analyzing the current profiles of the tube clamps, it can be checked whether all blocking devices present on the tube clamps of the blood treatment machine have been removed before starting a blood treatment.

[0068] This check is important for patient safety, because only when the blocking device is removed can a tube clamp on the blood treatment machine close in an emergency to disconnect the patient from the extracorporeal blood circuit and thus prevent blood loss.

[0069] The normal state of the de-energized tube clamp is closed. The normal state of the energized tube clamp is open. After the blood treatment machine is energized and started, the tube clamp is moved from the closed position to the open position. The tube clamp must perform work during this process.

[0070] Fig. 4 shows a high amplitude in the current waveform when the blood treatment machine is initially switched on. This means that no blocking device / clamp chip is present and the tube clamp has to perform a relatively high amount of work to open it (the travel distance from closed to open is long).

[0071] In Fig. 5 the amplitude is low because the blocking device / clamping chip is in the hose clamp and the hose clamp has to do less work and travel a shorter distance to be moved into the open position, since it is already largely held open by the blocking device / clamping chip.

[0072] The clamp then performs work to remain in the open position (i_halte).

Claims

1. A method for checking the readiness for use of a blood treatment machine prior to a blood treatment, comprising the step of - checking whether a blocking device for a tube clamp is arranged in at least one tube clamp of the blood treatment machine or has been removed from the tube clamp, wherein the blocking device is arranged in the tube clamp, with tube placed therein, in such a way that the tube clamp is held in an open position without the tube placed in the tube clamp being clamped by the tube clamp, - blocking the start of a blood treatment if the check reveals that at least one blocking device for a tube clamp is arranged in at least one tube clamp of the blood treatment machine, characterised in that the start of a blood treatment is enabled only if the at least one blocking device is arranged in a predetermined receptacle of the blood treatment device, wherein the presence of the at least one blocking device in the receptacle of the blood treatment machine is detected by means of a detection unit of the blood treatment device.

2. The method according to claim 1, characterised in that the blocking device has a planar, preferably substantially u-shaped main body, which is configured to be introduced into the tube clamp, and in that the blocking device has an adapter portion preferably arranged at an apex of the substantially u-shaped main body, by means of which adapter portion the blocking device is connectable to a further component, preferably a dialyser, in particular a cap of a dialyser.

3. The method according to claim 1 or 2, characterised in that the blocking device is preferably connected to at least one further blocking device by means of a cable, cord or band.

4. The method according to any one of the preceding claims, characterised in that the blocking device has at least one coding, wherein the coding is preferably an NFC, RFID, QR, barcode coding or a coding in the form of an electrical conductor with a predetermined electrical resistance and preferably is configured to be detected or read by a corresponding detection unit of a blood treatment machine.

5. The method according to any one of the preceding claims, characterised in that the blocking device is formed in one piece and / or as a throw-away component.

6. The method according to any one of the preceding claims, characterised in that the check is performed by a measurement and preferably a subsequent analysis of the power consumption and / or the power profile of a tube clamp in response to an actuation of the tube clamp, and / or the check is performed by a measurement and preferably a subsequent analysis of the pressure profile in the tube placed in the tube clamp when the blood pump is activated, and / or the check is performed by a measurement and preferably a subsequent analysis of the power consumption and / or the power profile of the blood pump, and / or the check is performed by a measurement and preferably a subsequent analysis of the sign of a drive moment acting on at least one roller of the blood pump of the blood treatment machine, by means of which it can be determined whether a tube clamp arranged in the venous circuit of the blood treatment machine and / or a tube clamp arranged in the arterial circuit of the blood treatment machine is open or closed.

7. The method according to any one of the preceding claims, characterised in that the presence of the at least one blocking device in the receptacle of the blood treatment machine is detected by the detection unit of the blood treatment device by the reading of a coding of the at least one blocking device, wherein the coding is preferably an NFC, RFID, QR, barcode coding or a coding in the form of an electrical conductor interacting with the detection unit of the blood treatment machine.

8. A blocking device for a tube clamp, wherein the blocking device is arranged in the tube clamp, with tube placed therein, in such a way that the tube clamp is held in an open position without the tube placed in the tube clamp being clamped by the tube clamp, characterised in that the blocking device has at least one coding which is configured to be detected or read by a corresponding detection unit of a blood treatment machine.

9. The blocking device according to claim 8, comprising a planar, preferably substantially u-shaped main body, which is configured to be introduced into the tube clamp, and an adapter portion which is preferably arranged at an apex of the substantially u-shaped main body and by means of which the blocking device is connectable to a further component, preferably a dialyser, in particular a cap of a dialyser.

10. The blocking device according to claim 8 or 9, characterised in that the blocking device is preferably connected to at least one further blocking device by means of a cable, cord or band.

11. The blocking device according to any one of claims 8-10, characterised in that the coding is preferably an NFC, RFID, QR, barcode coding or a coding in the form of an electrical conductor with a predetermined electrical resistance and preferably is configured to be detected or read by a corresponding detection unit of a blood treatment machine.

12. The blocking device according to any one of claims 8-11, characterised in that the blocking device is formed in one piece and / or as a throw-away component.

13. A cap for a dialyser, characterised in that the cap has a receptacle which is connected to at least one blocking device according to any one of claims 8 to 12.

14. The cap for a dialyser according to claim 13, characterised in that the cap is arranged on a dialyser and the at least one blocking device serves as a grip portion by means of which the cap can be removed or unscrewed from the dialyser.

15. A blood treatment machine with a blocking device according to any one of claims 8 to 12 and / or a cap for a dialyser according to any one of claims 13 or 14.

16. The blood treatment machine according to claim 15, characterised in that the blood treatment machine has at least one receptacle which is configured to receive a blocking device and is preferably substantially u-shaped, wherein a drainage opening for discharging liquid located in the receptacle is preferably provided at an apex of the substantially u-shaped receptacle.