DISPOSABLE BLOOD METERING DEVICE
20220287606 · 2022-09-15
Assignee
Inventors
- Franciscus Feijen (Leeuwarden, NL)
- Johannes Anne Bruinsma (Drachten, NL)
- Samer Ahmed (Assen, NL)
- Roland Renkema (Drachten, NL)
- Daniel James Robertson (Leeuwarden, NL)
Cpc classification
A61B5/15074
HUMAN NECESSITIES
A61B5/153
HUMAN NECESSITIES
A61B5/150946
HUMAN NECESSITIES
International classification
Abstract
Measurement system which can be used at patients bedside to monitor the amount of blood drawn from the patient. The system uses disposable sensor and electronics to measure accurately and in real time the volume of the blood drawn from the patient using a paddlewheel sensor wherein the rotation of the paddle wheel is correlated with the volume of the blood that is drawn from the patient and collected.
Claims
1. A blood metering device comprising: an adapter unit comprising a housing that defines a blood flow pathway that is adapted to be connected to a blood collection set, wherein the adapter unit has disposed therein a volume indicator that measures a volume of blood flowing through the blood flow pathway; a sensor unit that is engaged with the adapter unit; the sensor unit comprising: i) a sensor that is configured to detect signals from the sensor in response to blood flowing through the blood flow pathway in the adapter unit; and ii) a processor that associates the sensor signals with a blood volume and controls the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit.
2. The blood metering device of claim 1, wherein the sensor unit is one of detachably engaged with the adapter unit or monolithically integrated with the adapter unit.
3. The blood metering device of claim 1, wherein the volume indicator is a paddle wheel that is disposed in the blood flow pathway but freely rotatable within the housing.
4. The blood metering device of claim 3, wherein the paddle wheel has an axis of rotation and the axis of rotation is orthogonal to a blood flow direction in the blood flow pathway.
5. The blood metering device of claim 3, wherein the paddle wheel has an axis of rotation that is in line with a blood flow direction in the blood flow pathway.
6. The blood metering device of claim 3, wherein the processor associates the rotation of the paddle wheel with a blood volume to determine a measured blood volume that has flowed through the blood metering device and controls the response of the sensor unit in response to the determination by the sensor unit that a predetermined volume blood has passed through the paddle wheel disposed in the adapter unit.
7. The blood metering device of claim 1, wherein the adaptor unit is attachable to a collection vessel, wherein the collection vessel is selected from the group consisting of blood culture bottles and sample collection tubes.
8. The blood metering device of claim 6, wherein the processor compares the measured blood volume with the predetermined volume of blood and, when the measured blood volume is equal to the predetermined volume, the processor is configured to send a signal to close a blood flow valve that shuts off the flow of blood to the blood metering device.
9. The blood metering device of claim 1, wherein the volume indicator is one of a hair sensor, an acoustic sensor, and an optical sensor.
10. The blood metering device of claim 3, wherein the sensor is one of an axial rotor sensor, a peristaltic pump sensor, a magnetic field sensor, and rotating sensors.
11. The blood metering device of claim 3, wherein the paddle wheel carries a magnet and the housing has a hall effect sensor disposed thereon that is actuated as the magnet passes by the hall effect sensor.
12. The blood metering device of claim 11, wherein the paddle wheel rotates freely in the housing on an integrated pin supported by the housing.
13. The blood metering device of claim 1, wherein the housing defines a blood flow pathway wherein the flow path exits the adapter unit through an outlet.
14. The blood metering device of claim 1, wherein the adaptor unit comprises an activation lever that activates the processor when the adapter unit is attached to a blood culture bottle.
15. The blood metering device of claim 1, wherein the sensor unit comprises a battery.
16. The blood metering device of claim 1, wherein the sensor unit comprises a valve actuator.
17. The blood metering device of claim 16, wherein the valve actuator is one of a moving magnet actuator, a micro actuator, a solenoid, or a paired magnet actuator.
18. The blood metering device of claim 1, wherein the volume indicator is a combination of a flowmeter and a pump.
19. The blood metering device of claim 18, wherein the pump comprises a motor, the motor comprising a rotor and wherein the housing forms a stator for the pump.
20. The blood metering device of claim 19, wherein the rotor comprises one or more magnets.
21. The blood metering device of claim 20, further comprising a hall effect sensor that measures a speed of rotation of the rotor.
22. The blood metering device of claim 21, wherein the processor determines the volume of blood flowing through the pump based on the speed of rotation of the motor.
23. The blood metering device of claim 22, wherein the blood collection set comprises a needle adapted for venipuncture and tubing.
24. The blood metering device of claim 23, wherein, in operation, when the speed of rotation of the motor falls below a predetermined speed of rotation, the processor indicates a vein collapse.
25. The blood metering device of claim 1, wherein the sensor unit has an indicator light that indicates that a predetermined volume of blood has passed through the adapter unit based on signal from the processor.
26. The blood metering device of claim 24, wherein the sensor unit has an indicator light that indicates that a vein collapse has occurred based on a signal from the processor.
27. A blood metering device comprising: an adapter unit comprising a housing that defines a blood flow pathway that is adapted to be connected to a blood collection set, wherein the adapter unit has disposed therein is a paddle wheel that is disposed in the blood flow pathway but freely rotatable within the housing; a sensor unit that is engaged with the adapter unit; the sensor unit comprising: i) a sensor that is configured to detect signals from the sensor in response to blood flowing through the blood flow pathway in the adapter unit; ii) a processor that associates the sensor signals with a blood volume and controls the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit; and iii) a valve actuator that is in signal communication with and is controlled by the processor.
28. The blood metering device of claim 27, wherein the adaptor unit comprises an activation lever that activates the processor when the adapter unit is attached to a blood culture bottle.
29. The blood metering device of claim 28, wherein the processor associates the rotation of the paddle wheel with a blood volume to determine a measured blood volume that has flowed through the blood metering device and controls the response of the sensor unit in response to the determination by the sensor unit that a predetermined volume blood has passed through the paddle wheel disposed in the adapter unit.
30. A method for determining a volume of blood flowing from a patient to a collection bottle the method comprising: providing an assembly of an adapter unit and a sensor unit, the adapter unit comprising a housing that defines a blood flow pathway that is adapted to be connected to a blood collection set, wherein the adapter unit has disposed therein is a paddle wheel that is disposed in the blood flow pathway but freely rotatable within the housing; wherein the sensor unit comprises: i) a sensor that is configured to detect signals from the sensor in response to blood flowing through the blood flow pathway in the adapter unit; ii) a processor that associates the sensor signals with a blood volume and controls the response of the sensor unit in response to the determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit; and iii) a valve actuator that is in signal communication with and is controlled by the processor; connecting the assembly to the blood collection set, the blood collection set comprising a needle adapted for venipuncture and tubing such that the blood collection set is in fluid communication with the blood flow pathway; connecting the adapter unit to a blood collection vessel such that the blood flow pathway in the adapter is in fluid communication with the blood collection vessel, wherein a pressure in the blood collection vessel is less than atmospheric pressure; collecting a blood sample from a patient by venipuncture of the patient with the needle, thereby causing blood to flow through the blood flow pathway to the blood collection vessel; flowing the blood through a paddle wheel sensor; measuring the rotation of the paddle wheel sensor; measuring the volume of blood flowing into the blood collection vessel from the blood flow pathway; and comparing the determined volume of blood with a predetermined volume of blood;
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
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[0045] During the process of collecting a blood sample from a patient, needle 110 is used to pierce a vein or an artery of the patient. Driven by the vacuum pressure created by collection bottle 160, blood from the patient is directed toward collection bottle 160 through tubing 120. A flow of blood is collected in collection bottle 160. Along the way, the blood passes through the adapter unit 150 and needle 152. The sensor unit is also referred to as the electronics portion herein as the sensor unit contains the device actuator and the sensor electronics.
[0046] Referring to
[0047] In one embodiment, the valve actuator 188 controls the flow of blood collected from the patient by keeping the valve 189 (
[0048] In an alternative embodiment, the sensor unit can be coupled (via wired or wireless communication) with a sensor 111 positioned near the needle 110. Should such sensor 111 detect flow conditions indicative of vein collapse or imminent vein collapse (i.e. a reduction in blood flow above predetermined threshold) the valve actuator 188 response is to shut the valve 189 followed by gradual reopening of the valve 189.
[0049] Suitable valve actuators are well known to one skilled in the art and are not described in detail herein. Such actuators include moving magnet actuators, micro actuators, solenoids, paired magnets, etc. that, in response to a signal, cause the valve 189 to open or close.
[0050] Suitable valves for use in the blood metering device disclosed herein are not described in detail herein and are well known to one skilled in the art. Examples of suitable valves include a shut off valve that advances a valve seat into a passage to turn off the valve and withdraws the valve seat from the passage to open the valve. Another suitable valve is a pinch tube valve 500. Such a valve is illustrated in
[0051] Referring to
[0052] The blood flow path 162 through the adapter unit 150 is illustrated in
[0053] Operation of the device is illustrated in
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[0057] Referring to
[0058] In one embodiment the blood metering device 130 is programmable to provide a few different selectable blood volume pre-sets of the blood volume passing through the paddle wheel 154. The pre-sets are the more common blood volumes (e.g. 10 mL) drawn from a patient.
[0059] Zhen, W., et al., “Computational study of the tangential type turbine flowmeter,” Flow Measurement and Instrumentation, Vol. 19, pp. 233-239 (2008), which is incorporated by reference herein, describes the calibration of a tangential type turbine flow meter. In
T.sub.r=ρQ(V.sub.1r cos α.sub.1−V.sub.2r cos α.sub.2) (1)
where ρ is fluid density, Q is volumetric flow rate, r is the radius of the rotor, α.sub.1 is the angle between V.sub.1 and U.sub.1 and α.sub.2 is the angle between V.sub.2 and U.sub.2. The absolute velocity V.sub.1 is determined by the equation:
V.sub.1=Q/A (2)
where A is the jet aperture. The rotary speed (n) is calculated by:
V.sub.2 cos α.sub.2=u=2πr.sub.on (3)
[0060] From the above, the rotor driving torque is calculated. Meter performance is then calculated from the following equation:
T.sub.r−T.sub.rm−T.sub.rf−T.sub.re=0 (4)
where T.sub.r is the rotor driving torque, T.sub.rm is journal bearing retarding torque, T.sub.rf is rotor-blade retarding torque due to fluid drag and T.sub.re is retarding torque due to the attractive force of the magnetic pick-up. As further described in Zhen et al. these values are used to calculate a value for turbine meter performance. This enable volumetric flow rate to be determined from the rotor speed, the dimensions of the paddle wheel flow meter, etc.
[0061] The dimensions of the paddle wheel 154 and the housing 156 are largely a matter of design choice. A smaller dimensioned paddle wheel 154 will make more revolutions per mL of blood passing through the paddle wheel than a larger dimensioned paddle wheel. The width of the individual paddles 154A (
[0062] An alternative in-line housing 156A configuration is illustrated in
[0063] The jet of blood is tangentially jetted on the paddle wheel 154, which causes a moment of force (or torque) on the paddle wheel 154 which, in turn, causes the paddle wheel 154 to turn. This is caused by the kinetic energy of the jet of blood. After first filling of the paddle wheel housing 156 with blood, air bubbles could form and obstruct the movement of the paddle wheel 154.
[0064] As described above, the relationship between the number of revolutions of the paddle wheel and the actual blood volume passed is not linear. Besides the driving jet of fluid on the paddle wheel there is also a dampening action of the paddle rotating in this fluid. This causes “slip”, which will vary due to differences in pressure and viscosity. Optionally, the behavior of the paddle wheel can be monitored and modeled to predict the slip based on flow conditions. Once the slip is determined, the flow conditions can be provided to the processor and the processor can factor in the slip to correct for the volume that is calculated based on the number of revolutions of the paddle wheel. This could lead to large fluctuations in the volume actually metered with the measured metered volume.
[0065] Optionally, the device will be calibrated to correlate the measured metered volume with the actual metered volume. This will ensure that the blood meter device described herein accurately draws the targeted blood volume (typically between 8 mL to 10 mL of blood) at all times. The speed at which the blood is drawn will also influence the accuracy of the volume measured. It is contemplated that the metering device described herein will be calibrated such that the effect of flow rate on measured volume is known. In one embodiment, the revolution of the paddle wheel is correlated with the volume of blood that flows through the paddle wheel. In an alternative embodiment, the speed of rotation (i.e. the RPM of the paddle wheel) is used to determine flow rate which in turn is used to calculate the volume of blood that is passing through the paddle wheel. Once calibrated, the metering device measures the speed of blood flow and adjusts the measured volume to compensate for known inaccuracies in volume measurement at certain blood flow rates. Optionally, the blood metering device has a switch to power up and reset the system every time a new blood culture bottle is presented for filling.
[0066] Although the embodiments herein describe a paddle wheel flow meter, other metering devices are contemplated such as a hair sensor, acoustic sensor, optical sensor, etc. Such sensors are well known to the skilled person and not described in detail herein. In some embodiments in which the sensor unit does not come into contact with the blood, the sensor unit could be reused.
[0067] As described previously, a combined flowmeter/pump the blood metering device described herein can be configured to detect a vein collapse (by detecting reduced or inadequate blood flow) and re-inflate veins (by stopping blood flow through the metering device but not removing the needle for blood draw from the patient). As stated above, the blood metering device described herein can be actuated when the device has determined that the target amount of blood has been drawn, thereby stopping the flow of blood through the metering device.
[0068] For actively metering the blood flow, a low intensity commutating magnetic field can be induced by the controller, to help the rotor turn at low flowrates. A disposable flow meter/pump 300 is illustrated in
[0069] The magnets 330 on the rotor 320 also function as paddles (such as the paddles 154A in
[0070] The motor 300 is provided with a commutated low power rotating magnetic field to help drive the paddle wheel in the device even at low flowrates. The rotor 320 is optionally made of a single piece of magnetizable material. The rotor 320 is optionally ring-shaped with protrusions 330 on the outer circumference that act as magnetic poles as well as paddles. The stator 310 has at least 2 poles, which is why two coils, 350, are illustrated. The coils 350 are positioned no more than 180 degrees apart on the stator. This ensures easy assembly/disassembly of rotor/housing 320 and stator 310. The illustrated device 300 can be incorporated into a device that measures blood flow and/or pumps blood, medicine, sample, reagents, etc. either into a patient or into a vessel such as a collection tube. The poles/magnets are oriented radially in the example, they could also be oriented axially. The motor is preferably synchronous, but can also be operated using asynchronous commutation.
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[0076] In this specification, the word “comprising” is to be understood in its “open” sense, that is, in the sense of “including”, and thus not limited to its “closed” sense, that is the sense of “consisting only of”. A corresponding meaning is to be attributed to the corresponding words “comprise”, “comprised” and “comprises” where they appear.
[0077] While particular embodiments of this technology have been described, it will be evident to those skilled in the art that the present technology may be embodied in other specific forms without departing from the essential characteristics thereof. The present embodiments and examples are therefore to be considered in all respects as illustrative and not restrictive. For example, whilst the disclosure has described the collection of blood in a blood culture bottle, the same principal is applicable to the collection of other fluids in other containers.
[0078] It will further be understood that any reference herein to subject matter known in the field does not, unless the contrary indication appears, constitute an admission that such subject matter is commonly known by those skilled in the art to which the present technology relates.