Blood mixing device for gentle mixing of blood samples with simultaneous tilting and rotating movement and high electromagnetic compatibility (EMC)

Abstract

Blood mixing device for veterinary and human medicine, comprising a pivoting table (1) for tube storage of at least one blood collection tube (2) and a drive unit (3), characterized in that the drive unit (3) and the gear mechanism (4) are coupled such that they simultaneously generate a rotational movement of the tube storage (2) and a pivoting movement of the pivoting table (1).

Description

[0001] A technical bifunctional device in the low voltage range for use in medical diagnostics for the automatic mixing of blood samples, characterized in that 1. by means of a simultaneous rotation and swivel movement, a uniform, thorough mixing without reflex shock waves is carried out in such a gentle manner that damage to blood cells and the associated falsification of diagnostic results is avoided. 2. The simple design with easily separable modules that are easy to clean and disinfect significantly reduces the risk of contamination with infectious blood material and the time required for daily cleaning. 3. the device is powered by at least one electric drive unit which is supplied with energy in the low-voltage range either via an external mains connection or by means of an integrated power storage device. 4. the device has a high level of electromagnetic compatibility (EMC) and can therefore be used in all medical facilities without causing interference with other devices (and patient-related medical technology, e.g. ECG). Description of the problems of previous pre-analytical methods

[0002] Preanalytics refers to the step from blood sampling to analytical determination. Its importance for accurate diagnostic results has so far received little attention in both human and veterinary medicine, as well as in laboratory medicine. Preanalytics is characterized by various sources of danger. Case studies: Human and veterinary medical practice 1. Forgetting to mix the collection tube immediately after drawing blood. The consequences are: The anticoagulant does not mix with the blood or does not mix completely, meaning that both blood clotting and metabolic processes cannot be stopped, or cannot be stopped quickly enough. 2. Insufficient manual mixing of the collection tube immediately after blood collection results in fibrin and microclots forming in the tubes, which can clog the aspiration needles or narrow tubes of automated analyzers during subsequent diagnostic tests and lead to misdiagnoses when using modern measurement methods. 3. Mixing too vigorously by hand or with a standard mechanical mixing device. The inevitable reflex shock waves that result can damage the relatively thin membrane of red blood cells. If their contents leak out, they can attach to other blood cells, such as platelets, or the leaked hemoglobin can interfere with other photometric measurements due to the artificially enhanced color of the sample. Furthermore, remnants of ruptured red blood cells, called fragmentocytes, can generally lead to false measurements. If detected, repeat measurements and differential diagnoses cause avoidable costs. Otherwise, they lead to incorrect diagnoses in the patient, with the risk of incorrect treatment. 4. When samples are taken outside medical facilities as part of on-site medical care for patients, such as by emergency services, blood donation services, or veterinarians, blood samples can currently only be mixed by hand. While immediate mixing would be necessary, traditional mixing devices are unsuitable due to their relatively heavy weight and the need for mains power, and manual mixing is associated with the risks outlined in points 2 and 3 above. Application in smaller laboratories in medical practice 1. Mixing in the collection tube in the laboratory immediately before analysis is neglected. The consequences are: Due to sedimentation, only or primarily blood cells from the bottom of the tube are absorbed. This leads to a falsely pathological result in the subsequent hematological analysis. 2. Mixing is excessively vigorous by hand or with a standard mechanical mixer. The possible consequences are described in section 3 of "Human and Veterinary Medical Practice." State of the art - problem description

[0003] Conventional mixing devices are electrically driven by standard mains power. This limits their use to stationary facilities such as doctor's offices, hospitals, and blood donation centers. They cannot be used outside of fixed facilities. Furthermore, they are difficult to control due to the alternating current required and high energy consumption. Therefore, they generate shock waves that are reflected back from the tube wall during vigorous mixing in the blood tube. These shock waves can damage blood cells. Furthermore, commercially available devices are not easy to clean, which is desirable for reasons of sterility in blood tubes that occasionally leak.

[0004] Due to their relatively high energy and power requirements, they cause electromagnetic interference with other devices in medical facilities. Surprisingly, electromagnetic compatibility (EMC) has received little attention in medical practice, even in larger facilities.

[0005] A solution to these problems is therefore desirable. This can be achieved with the invention filed here. Problem solving

[0006] The new invention filed here operates using low-voltage direct current and is therefore easily controlled. The combination of slow rotation and swivel movements mixes the tube contents gently but thoroughly. This keeps the blood cells intact and prevents the blood count from being distorted, meaning it produces neither positive nor false negative results.

[0007] The avoidance of unwanted mutual interference via electromagnetic effects, which is desirable in medical clinics and practices, extends the possible applications to all medical facilities. Execution

[0008] The device consists of: 1. Engine housing - Motor, power connection with or without power storage, main switch, decentralized drive gear (see technical drawing front view point 6) 2. Swivel table with eleven rollers for holding ten tubes 3. Support frame - Frame that connects the swivel table and motor housing 4. Gear mechanism - Interlocking gears for driving the rollers Operating principle 1. Rotational movement

[0009] The central gear drives the adjacent transmission gears on both sides, which in turn drive the gears of the rollers below them (see technical drawing "Mechanism"). The meshing of the gears described here results in the uniform control of all eleven rollers of the device. 2. Swivel movement

[0010] The smooth pivoting motion is achieved by the motor's drive shaft being mounted off-center at approximately two-thirds the distance from the center to the edge of the gear, which, like a connecting rod, transfers rotary motion into the linear movement of the pivoting table. The tiltable pivoting table rests on this drive gear, which is weighted in the upper section and thus remains firmly in place even when filled blood sample tubes place a load on the lower section of the pivoting table. List of reference numbers for file number 20 2025 000 541.3 1 → Motor housing 2 → On / Off switch 3 → Front of the drive motor 4 → Drive pin 5 → Decentralized drive gear 6 → Cover of the gear mechanism 7 → Frame 8 → Plastic roller 9 → Balance weight 10 → Base frame 11 → Bore 12 → Mounting block of the gear mechanism 13 → Acceptance gear 14 → roller gear 15 → Transmission gear

Claims

[1] Blood mixing device for veterinary and human medicine, comprising a swivel table (1) for tube storage of at least one blood collection tube (2) and a drive unit (3), characterized by that the drive unit (3) and the gear mechanism (4) are coupled in such a way that they simultaneously generate a rotational movement of the tube holder (2) and a pivoting movement of the pivoting table (1). [2] Blood mixing device according to claim 1, characterized by that the gear mechanism (4) is designed so that the speed of the pivoting and rotational movement is not variable. [3] Blood mixing device according to one of the preceding claims, characterized by that the drive unit (3) comprises an electric motor in the low-voltage range (5) with a high electromagnetic compatibility (EMC). [4] Blood mixing device according to claim 2, characterized bythat the drive unit (3) with a low-voltage motor (5) is operated either by a mains power source (6) or an integrated power storage device (7).

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