Patent Application
20160375185
The present invention relates in general to an autologous blood transfusion system and method for the recovery and washing of salvaged blood collected from a surgical site of a patient and relates particularly to an enhanced method for determining the liquid level of the salvaged blood in a blood collection reservoir of an autologous blood transfusion system.
Autologous blood transfusion systems (autotransfusion devices) are widely used for the recovery and washing of salvaged blood collected from a patient particularly at a surgical site, where a large volume blood loss can be expected—e.g. aneurysm, total joint replacement, and spinal surgeries. In such systems the salvaged blood is temporarily stored in a blood collection reservoir for re-use. A reliable determination of the liquid level or volume of the salvaged blood in the blood collection reservoir is crucial for surgeries. Inter alia it is important to avoid a complete depletion of the blood collection reservoir. Furthermore, a reliable process control in such systems requires exact information on the liquid level or volume of the salvaged blood in the blood collection reservoir.
For this purpose often the weight of the blood collection reservoir is monitored by means of a controller and upon reaching predetermined or pre-calibrated threshold values the controller outputs signals for further process control.
An example for such an approach is disclosed in U.S. Pat. No. 5,458,566, wherein the weight of the blood collection reservoir is monitored using a strain gage device to compute the volume of fluid present in the reservoir. When it is determined that a sufficient volume of fluid is present in the reservoir, the system initiates a new FILL cycle. The washing method of this autotransfusion device is not continuous but discontinuous. Thus, the response time of the volume measurement can be slower. The blood collection reservoir is supported vertically by a radially inner support member and is subject to vertical forces during system operation. The device further comprises a radially outer support member secured to a mounting surface. The strain gage is coupled between the inner support member and outer support member for sensing vertical strain forces therebetween and converting vertical forces originating with the tubes into horizontal forces. Around the blood collection reservoir many different conduits are arranged, to which personnel at the surgical site must have free and quick access e.g. for security reasons. This somehow contradicts the requirements of a smooth and steady environment required by the strain gage device itself. Thus, it is difficult to ensure a robust and reliable determination of the liquid level or volume of salvaged blood in the blood collection reservoir.
EP 2531823 A1 of the applicant discloses a method and apparatus for the capacitive level measurement of a liquid medium in a bubble trap of a dialysis machine.
U.S. Pat. No. 4,275,726 of the applicant discloses an apparatus and method for balancing the fluids withdrawn from a patient and the fluids simultaneously returned into the patient for use in exchange blood transfusion, infusion therapy in conjunction with forced diuresis or haemofiltration. In this approach the liquid level of a liquid reservoir used for temporarily storing a liquid is sensed by means of a row of radiation emitters and a row of radiation receivers disposed on a side of the liquid reservoir opposite to the radiation emitters, which generate an output signal representative of the transmission at the various different height levels of the collection reservoir. Use of this method for autotransfusion devices is not disclosed. Furthermore, problems caused by obstruction of the light beams transmitted through the reservoir caused e.g. by a blood or lipid film on the inner surface of the reservoir are not handled.
Thus, there exists a need for more robust and reliable concepts for determining the liquid level of salvaged blood in a blood collection reservoir of autologous blood transfusion systems (autotransfusion devices).
It is an object of the present invention to provide an enhanced autologous blood transfusion system and method using a robust and reliable apparatus and method for determining the liquid level of salvaged blood in a blood collection reservoir of such an autologous blood transfusion system. It is a further object of the present invention to provide a computer program product for use in such an autologous blood transfusion system for determining the liquid level of salvaged blood in a blood collection reservoir.
This problem is solved by an autologous blood transfusion system according to claim 1, by a method for determining the liquid level of salvaged blood in a blood collection reservoir of such an autologous blood transfusion system as claimed by claim 8 and by a computer program product as claimed by claim 15. Further advantageous embodiments are the subject-matter of the dependent claims.
According to the present invention there is provided an autologous blood transfusion system for the recovery and washing of salvaged blood collected from a surgical site of a patient, comprising a blood collection reservoir for storing the collected blood, an optical detection setup for periodically detecting the liquid level of the salvaged blood in said blood collection reservoir optically, particularly by means of measuring the transmission of light beams, particularly of pulsed light beams, passing through the blood collection reservoir and outputting a signal in correspondence to signals detected by said optical detection setup, and a processor for determining the liquid level of the salvaged blood in said blood collection reservoir based on said output signal of said sensing means, said optical detection setup comprising a plurality of light emitters disposed on a first side of said blood collection reservoir at different height levels for emitting light and a plurality of light receivers disposed on a second side of said blood collection reservoir opposite to said first side for sensing light emitted by said light emitters and transmitted through said blood collection reservoir and for outputting said output signal.
Use of an optical detection set-up enables a more robust and reliable determination of the liquid level of salvaged blood in a blood collection reservoir. In particular, no mechanical elements, coupling members or sensors are required. Furthermore, the optical set-up enables a fully opto-electronic signal detection and a fully electronic signal analysis, which offers additional advantages, such as simple but reliable variation of the measurement conditions and parameters used for signal analysis.
Preferably, the light emitters and light sensors are disposed at regular spacings along the vertical direction of the blood collection reservoir and are distributed over the entire height of the blood collection reservoir. According to further embodiments, however, the light emitters and light sensors may also be disposed at a given higher density in regions that are considered to be of particular importance for assessment of the process conditions in the blood collection reservoir or for a precise signal analysis. The light receivers (sensors) are disposed spaced apart from each other and may be disposed at the same different height levels as the light emitters.
According to a further embodiment the light emitters are pulsed light emitters for emitting light pulses, preferably infrared light pulses, particularly short light pulses of a duration of e.g. 50 μsec, so that the amount of energy, which is deposited in the salvaged blood, can be reduced significantly. Furthermore, the measurement can be performed periodically at frequencies that are significantly different to those of noise sources, such as mains current, fluorescent tubes or other kinds of light sources typically used at surgery sites. Furthermore, the processor is configured for switching the light emitters on and off individually in correspondence to a control signal, which switches on and off the light emitters, and said processor is further configured for analyzing signals output by light receivers that correspond to the light emitters individually and in correspondence with such a control signal. Thus, the conditions can be determined more reliable as a function of the vertical height level along the blood collection reservoir.
According to a further embodiment the processor is configured for a) reading output signals of said light receivers sequentially along a vertical direction of said blood collection reservoir, b) comparing said output signals with a predetermined threshold value, and c) determining the liquid level of the salvaged blood in said blood collection reservoir based on said comparing said output signals with said predetermined threshold value. The threshold value enables a reliable discrimination of transmission changes in the sequence of output signals read-out from the plurality of light receivers and can be varied and re-adjusted easily, so that the method can be used for various different process conditions.
According to a further embodiment the processor is configured for individually adjusting detection parameters associated with the plurality of light emitters and the plurality of light receivers. As will be shown in the following, this enables to suppress the disturbing effects particularly of absorptive films of contaminants, such as fat or clotted blood, on the inner surface of the blood collection reservoir, which otherwise could result in wrong or even misleading information. According to the present invention these detection parameters include at least one of an output power of the light emitters, a gain of an amplifier used for amplifying output signals output by the plurality of light receivers and a threshold value used by the determining means for analyzing the output signals output by the plurality of light receivers.
According to a further embodiment the processor is further configured for a) identifying a conspicuous signal out of said output signals of said light receivers based on a comparison of the output signals of at least two light receivers out of said plurality of light receivers (which may be directly adjacent light receivers), b) varying a detection parameter of a light emitter and/or of a light receiver and/or of an amplifier associated with said conspicuous signal, and c) repeating said step of determining the liquid level of the salvaged blood in said blood collection reservoir using said varied detection parameter. In the sense of the present application a conspicuous signal is a signal that indicates abnormal transmission changes between output signals of at least two (preferably at least three) directly adjacent light receivers or sequences of at least two (preferably at least three) transmission values that might be caused by blood or lipid films on the inner surface of the storage vessel or similar effects locally perturbing the optical transmission through the storage vessel.
According to a further embodiment the processor is further configured for determining the liquid level of the salvaged blood in said blood collection reservoir using said varied detection parameter if a signal of a light receiver or amplifier associated with said varied detection parameter is not identified as a conspicuous signal in said identifying step when repeating said step of sensing the liquid level of the salvaged blood in said blood collection reservoir using said varied detection parameter.
According to a further embodiment the processor further comprises a look-up-table for determining conditions of the collected blood collected in the blood collection reservoir based on a comparison of the respective output signal with contents of the look-up-table. The contents of the look-up-table may particularly reflect the typical transmission (or absorption) characteristics of typical process conditions or contaminants that might occur in the blood collection reservoir, and might be knowledge-based or result from an initial calibration or training method performed prior to the measurement method. As an example: if the output signals outputted by a series of light receivers are in accordance with a typical transmission expected to occur below the filling level, i.e. within the salvaged blood stored in the storage vessel of the system, and if the signal outputted by an intermediate light receiver of said series of light receivers indicates an exceptionally higher or lower transmission that would otherwise indicate air or a rather thick blood at the height level of the corresponding light receiver in the storage vessel, the output signal of this intermediate light received is considered as a conspicuous signal, indicating an abnormal or unusual transmission change at the height level of the intermediate light receiver that requires a specially dedicated measuring procedure at this height level for further discriminating the reason for this abnormal or unusual transmission change at the height level of the intermediate light receiver.
According to a further embodiment the processor is further configured for starting or controlling the washing process based on said filling level, particularly upon reaching preset filling levels in the storage vessel, or for generating a warning message and outputting said warning message via an interface, if the filing level measured indicates a complete or nearly complete depletion of the storage vessel.
A further aspect of the present invention relates to a corresponding method for determining the liquid level of salvaged blood in a blood collection reservoir of such an autologous blood transfusion system as described in the following.
A further aspect of the present invention relates to a corresponding computer program product for determining the liquid level of salvaged blood in a blood collection reservoir of such an autologous blood transfusion system as described in the following.
Hereinafter the invention will be described with reference to exemplary embodiments and referring to the enclosed drawings, wherein:
Throughout the drawings, identical reference numerals designate identical or substantially equivalent elements or groups of elements
Before describing a method for determining the liquid level of salvaged blood in a blood collection reservoir of an autologous blood transfusion system according to the present invention, in the following the general environment of utilizing such a method in an autologous blood transfusion system or autotransfusion device will be described briefly with reference to
More specifically salvaged blood that has been e.g. collected from a surgical site of a patient, enters a continuous washing process in which red blood cells are resuspended with a saline solution and blood plasma and other contaminants are removed. The salvaged blood is pumped by pump 28 from the reservoir for collected blood 11 via conduit 28 to enter the washing process together with a washing solution pumped by pump 28 from reservoir 22 via conduit 28. In this process blood is concentrated to a haematocrit (HCT) of e.g. approx. 80% and most of the blood plasma, cellular debris, white blood cells, platelets, anticoagulant and other unwanted constituents are separated out. Furthermore, a removal of non-emulsified fat as complete as possible is performed. Red cells from a red cell concentrate stored in reservoir 24 are packed to a HCT concentration of e.g. 60-65%. The recovered blood is then infused into the patient's body at a different site (not shown).
The blood collection reservoir 11 in this process is a transparent storage vessel and may be a standard reservoir utilizing a special double lumen suction tubing, wherein fluid is aspirated from the operative field and is mixed with an anticoagulant solution. Collected fluid is filtered in a sterile cardiotomy reservoir. The reservoir contains a filter and has a capacity of between two and three liters of fluid. The blood collection reservoir 11 may have a conical funnel-shaped bottom.
For measuring the filling level (volume) of the salvaged blood in the storage vessel 11, the transmission of light through the storage vessel 11 is measured by means of an optical setup. More specifically, a plurality of light emitters 12, such as light-emitting diodes (LEDs), are disposed on a first side of storage vessel 11 at different height levels indicated by reference numerals L1-L9, which emit light beams preferably in the infrared wavelength range to reduce deposition of radiation energy in the salvaged blood. The transmitted light intensity is measured by a plurality of light receivers 10, such as photodiodes, disposed on a side of the storage vessel 11 opposite to the light emitters 12. Hereinafter, in order to identify the light receivers 10 and light emitters 12, respectively, at the respective height levels L1, L2, . . . Ln, these light receivers and light emitters are named 10.1, 10.2, . . . 10.n and 12.1, 12.2, . . . 12.n, respectively. The light emitters 12 and light receivers 10 may be disposed in a protective housing that may be sleeved onto the storage vessel 11, which is usually a disposable, and is configured for re-use. The light emitters 12 and light receivers 10 may be disposed at the same height levels L1-L9.
An array of electronic switches 13 is associated with the light emitters 12 so that the light emitters can be switched on and off individually by means of control signals of controller 2 transmitted via transmission line 5. A further array of electronic switches 9 is associated with the light receivers 10 so that the transmission signals output by the light receivers 10 can be read-out individually via transmission line 4. The read-out transmission signals are amplified by an amplifier 3 using a gain factor that can be adjusted by the controller 2 via control line 7. More specifically, the transmission signals output by different light receivers 10.1, . . . 10.n can be amplified individually by means of gain factors individually adjusted for each of the light receivers 10.1, . . . 10.n.
For determining the filling level or volume of salvaged blood in the storage vessel 11, the output signals of the light receivers 10.1, . . . 10.n are analyzed for determining a transition from a relatively low transmission (indicating a certain absorption of light by salvaged blood) to a relatively high transmission (indicating no absorption of light by salvaged blood). More specifically, the output signals of the light receivers 10.1, . . . 10.n are read-out sequentially along a vertical direction of the storage vessel, e.g. in the order starting with the lowest sensor L.1 to the uppermost sensor L.n or in the opposite order, and a transition from relatively low transmission to relatively high transmission is determined, i.e. where a transition from dark regions to less absorptive regions occurs, which corresponds to the actual filling level in the storage vessel 11 or e.g. to the transition from salvaged blood to saline solution. For this purpose, algorithms may be used which use a threshold value for discriminating between signals indicating a relatively low transmission and signals a relatively high transmission. According to a first embodiment the light beams emitted by the light emitters 12 are collimated light beams or nearly collimated light beams having a small beam divergence. Thus, the light receivers 10 disposed on a side of the storage vessel 11 opposite to said light emitters 12 may be disposed at the same height levels L1-L9 as the light emitters 12 and may detect only of one light beam transmitted through the storage vessel 11 and emitted by the directly opposite light emitter. According to a preferred second embodiment, however, the light emitters 12 emit highly divergent light beams, e.g. of a divergence angle of 120°, in which case the light receivers 10 on the opposite side of the storage vessel 11 may detect the light beams emitted by several light emitters 12. More specifically, the light receivers 12 disposed in the central part of the storage vessel, such as light receivers 12 disposed at height levels L5 or L6, may detect the light beams emitted by two or even more of the directly opposite light emitters, such as light emitters 12 disposed at height levels L4-L6 (for the light receiver disposed at height level L5) and light emitters 12 disposed at height levels L5-L7 (for the light receiver disposed at height level L6). As will be shown in the following, according to the present invention the relatively high divergence angle of the light beams emitted by the light emitters may further assist to more easily and reliably discriminate conspicuous signals caused particularly by blood or lipid films on the inner surface of the storage vessel 11, which result in locally abnormal transmission changes.
Based on the above information the washing process may be started or performed e.g. upon reaching preset filling levels in the storage vessel 11 or at filing levels without saline solution supernatant. The bottom light receiver (at height level L1) or a bottom light receiver (at height level L0) are used for indicating a complete depletion of the storage vessel 11, in which case a warning message is generated by controller 2 and outputted via interface 1 to external devices, such as displays, alarm devices or the like. For this purpose, it may be of advantage, if the bottom of the storage vessel 11 is slanted, conically tapered and the bottom light receiver 10 at height level L0 measures the transmission in the region of the slanted, conically tapered bottom of the storage vessel 11.
More specifically, the washing process may be started only if a predetermined minimum filling level is initially provided in the storage vessel 11, which may correspond to a liquid volume of e.g. 0.75 l or 1 l. By means of the measured filling level the washing process is controlled such that a minimum filling level of e.g. 50 ml in the storage vessel 11 is ensured during the whole process or surgery and that a complete depletion of the storage vessel 11 is always prevented, e.g. in order to avoid the presence of air or foam in centrifuge used in the washing process or at the locations of sensors, which might otherwise give rise to wrong or misleading signals. Thus, the washing process may be interrupted temporarily, if a nearly complete depletion of the storage vessel 11 is determined based on the sensed filling level, e.g. if only the bottom light receiver 10 at height level L0 indicates a filling level but none of the other light receivers 10 at the other height levels L1-L9. As a result of such a temporary interruption of the washing process the filling level in the storage vessel 11 will rise again due to the collecting of additional salvaged blood from the patient at the surgical site, until a predetermined upper filling level is reached again finally, e.g. corresponding to a volume of 0.75 l or 1 l, which triggers again the washing process. The above loop may be repeated until a user, particularly an anesthetist, inputs a signal to controller 2 via interface 1 that the washing process shall be terminated, e.g. if it has been decided that the surgery will be terminated shortly.
According to the present invention the sequential reading-out of the transmission signals from the light receivers 10 along the vertical direction of the storage vessel 11 may be used to identify conspicuous signals at height levels, which are not in accordance with standard transmission profiles in the storage vessel to be expected under normal operating conditions and which otherwise might result in a wrong or even misleading discrimination of the actual filling level in the storage vessel 11 or of the transition from salvaged blood to saline solution inside the storage vessel 11. It should be noted that such standard transmission profiles in the storage vessel to be expected under normal operating conditions may be stored in a look-up table
If one assumes e.g. for the state shown in
As another example, if one assumes e.g. for the state shown in
In order to discriminate a conspicuous signal at height level L4 caused by a zero or abnormally low (conspicuous) transmission, the following approach may be pursued.
For this purpose, in the following it is assumed that usually the transmission values at the different height levels L3-L5 in
As will become apparent to a person skilled in the art, a similar discrimination may also be obtained, if the other parameters relevant for the detection of the light beams (hereinafter detection parameters) are varied, particularly the output power of the light emitters and/or the gain of amplifiers used for amplifying signals output by the respective light receivers and/or a threshold value used by the processor or controller 2 for analyzing the output signals of the light receivers.
As will become apparent to a person skilled in the art, a similar discrimination may also be obtained, if the light beams emitted by the light emitters are not highly divergent light beams but instead collimated or nearly collimated light beams.
As will become apparent to a person skilled in the art, a similar approach, which varies the detection parameters for detecting the transmission at the different height levels individually or collectively, may also be used to discriminate other conditions of the content of the storage vessel, such as the degree of dilution of the salvaged blood contained in the storage vessel 11.
Referring to
If no such conspicuous changes of transmission or conspicuous signals are determined in step S2, then the method proceeds with step S3, in which the controller 2 considers the measured transmissions at the height levels L1-Ln of light receivers 10 as correct and not-misleading and uses the measured transmissions for determining the actual filling level in the storage vessel 11 or the transition from salvaged blood to saline solution inside the storage vessel 11 for further signal processing.
The loop of steps S1-S3 is performed periodically, to thereby obtain information on the actual filling level in the storage vessel 11 or on the transition from salvaged blood to saline solution inside the storage vessel 11 periodically. For this purpose, the light emitters 12 preferably emit short light pulses, at a repetition rate that is substantially different to the frequency of a mains current, to the operation frequency of fluorescent tubes or other kinds of light sources typically used at surgery sites, or to higher harmonics thereof. Thus, disturbing background noise is suppressed and a higher signal-to-noise ratio can be accomplished. As an example, 100 μs infrared light pulses at a repetition rate of 25 Hz may be used in a method according to the present invention.
On the other hand, if in step S2 the controller 2 determines at least one conspicuous change of transmission based on the transmission values measured using the predetermined detection parameters, then the method proceeds with step S4 for varying the detection parameters and with steps S5 and S6 for repeating the above identification of conspicuous changes of transmission.
In the following, the state shown in
As a first example, the output power of light emitter 12 at height level L4 is selectively increased and/or the gain of amplifier 3 used for amplifying the signal output by light receiver 10 at height level L4 is increased and/or a threshold value used for analyzing the (amplified) output signal of the light receiver 10 at height level L4 in the controller 2 is selectively adjusted in step S4 and the transmission is measured and analyzed in step S5 using such varied detection parameters. If the controller analyzes a transmission for the varied detection parameters that is a typical transmission of salvaged blood, saline solution, foam or air and such a typical transmission behavior has already been observed in step S1 for the adjacent height levels L3 and L5, respectively, then in step S6 no such conspicuous change of transmission is identified at height level L4. Rather, the method proceeds with step S7 to adjust the detection parameters at height level L4 to the new detection parameters used in step S5 and proceeds again with step S1, in which case in step S2 no such conspicuous change of transmission will be identified anymore at height level L4, but rather the method will proceed with step S3.
As a second example, the output powers of light emitters 12 at height levels L3-L5 are selectively increased and/or the gain factor of amplifier 3 used for amplifying the signals output by light receiver 10 at height levels L3-L5 are selectively increased and/or the threshold values used for analyzing the (amplified) output signals of the light receiver 10 at height levels L3-L5 in the controller 2 are selectively adjusted in step S4 and the transmission is measured and analyzed in step S5 using such varied detection parameters. Using the varied detection parameters a far better signal-to-noise ratio is available for a more reliable determination whether the change in transmission at height level L4 results from an actual transition region in the storage vessel 11 or simply from an undesired film 14 on the inner surface of storage vessel 11. For this purpose, the transmission values at height levels L3-L5 are compared with each other in step S5 and analyzed further.
Thus, in the second example, if the controller analyzes a transmission for the varied detection parameters that is a typical transmission of salvaged blood, saline solution, foam or air and such a typical transmission behavior has already been observed in step S1 for the adjacent height levels L3 and L5, respectively, then in step S6 no such conspicuous change of transmission is identified at height level L4. Rather, the method proceeds with step S7 to adjust the detection parameters at height level L4 to the above varied detection parameters and to readjust the detection parameters at the adjacent height levels L3 and L5, respectively, to those detection parameters used previously in step S1. Then the method proceeds again with step S1, in which case in step S2 no such conspicuous change of transmission will be identified anymore at height level L4, but rather the method will proceed with step S3.
If finally, despite the variation of the detection parameters in step S4, still a conspicuous change of transmission is determined in step S6, an error handling routine S8 may be triggered, which will not be described here in detail, but which may comprise outputting an error signal for indicating an unreliable or error state of the measuring system, triggering a supplemental cleaning procedure for cleaning the inner surface of the storage vessel 11, e.g. by rinsing the inner surfaces with a washing solution, or for stopping operation of the washing procedure and issuing a warning/stop signal to the personnel at the surgical site.
The above loop of steps S1-S7 may be repeated several times, until the controller determines that at least one of the detection parameters runs beyond a predetermined parameter range. Then, the above error handling routine S8 may also be triggered. The process may then return to step S1.
As will become apparent to a person skilled in the art, in case of detection of a conspicuous change of transmission in step S2, the detection parameters may be varied in step S4 and/or the further transmission signal analysis may be performed based on knowledge data or calibration data on the typical transmission characteristics in the presence of the standard types of contaminants and conditions of the salvaged blood during the washing process. Such knowledge data may be stored e.g. in a look-up-table (not shown) to which the controller 2 has access or in a memory coupled to or integrated in controller 2.
By means of varying the detection parameters selectively at different height levels, the filling level (volume) of salvaged blood or the transition from salvaged blood to saline solution inside the storage vessel 11 may be determined reliably even under adverse conditions that otherwise would result in incorrect or even misleading measurements and signal analysis.
The approach of varying the detection parameters selectively at different height levels may also be used for calibrating the optical detection setup shown in
As will become apparent to a person skilled in the art, the possibility of selectively varying the detection parameters at height levels according to the present invention even makes it possible to derive additional information about the content of the storage vessel 11 at the height levels, such as an analysis of the HCT at the different height levels, the saline concentration at the different height levels or similar parameters of the salvaged blood.
| Number | Date | Country | Kind |
|---|---|---|---|
| 14156384.1 | Feb 2014 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2014/078124 | 12/17/2014 | WO | 00 |
