Patent Application
20200008688
The present invention is in the field of hemodynamic sensing, especially in the sensing of blood flow related parameters. In particular, it relates to a signal processing unit, to an intravascular blood flow sensor system and to a method for operating a signal processing unit for determining a value of a blood flow quantity characterizing blood flow inside a blood vessel, and to a computer program.
US 2014/0276137 A1 describes systems and methods for determining coronary flow reserve (CFR) using a flow reserve index obtained at rest and during hyperemia. A method described therein includes obtaining a resting value for a flow reserve index from a patient, obtaining a hyperemic value for the flow reserve index from the patient, computing the coronary flow reserve based on the resting value and the hyperemic value, and providing the coronary flow reserve to a user.
It would be desirable to provide an alternative way for determination of a blood flow quantity.
According to a first aspect of the present invention, a signal processing unit for determining a value of a blood flow quantity characterizing blood flow inside a blood vessel is provided. The signal processing unit comprises:
The signal processing unit for determining a value of a blood flow quantity characterizing blood flow inside a blood vessel allows a particularly fast, easy, and reliable determination of a blood flow quantity.
The signal processing unit is based on the recognition that blood flow quantities can be determined using vibration sensor signals, and in particular vibration sensor signal components that are caused by blood flow oscillations of intravascular blood flow. With a suitable intravascular device that influences the flow pattern and velocity of blood flow or merely by the presence of naturally-occurring non-streamlined parts of a blood vessel including narrowings or turns of the blood vessel, blood-flow oscillations, such as, but not limited to vortices can be generated. These turbulences in the blood flow are caused which are indicated by the vibration sensor signal components. While known principles of flow sensor operation try to minimize this effect by using streamlined shapes and minimizing the size of the intravascular device, the inventor found out that it is in fact possible to use vibration sensor signals indicative of such disturbances in the blood flow caused by the intravascular device or/and the vessel structure to determine blood flow quantities such as a blood flow velocity with the aid of the signal processing unit of the first aspect of the present invention.
In particular, the signal processing unit receives, at a vibration sensor signal input, the vibration sensor signals from an intravascular vibration sensor at two different measuring times. The vibration sensor is not part of the signal processing unit. It may form a part of an external blood flow sensor that provides the vibration sensor signals to the signal processing unit. In the signal processing unit of the first aspect, the blood flow determination unit is connected to the vibration sensor signal input and determines, using the vibration sensor signals, the vibration sensor signal components that is caused by blood flow oscillations of intravascular blood flow at a respective one of the measuring times. Blood flow oscillations generated inside the vessel cause a vibration sensor signal component of the vibration sensor signal. Signal components include those caused, for example, by vortex-shedding due to the presence of a non-streamlined object, or by non-streamlined parts of the blood vessel, by blood flow alterations due to heartbeat, or by relative movement of the intravascular blood flow sensor with respect to the living being in whose vessel the sensor is located.
The blood flow determination unit also determines, using the vibration sensor signal components, a respective oscillation frequency of the blood flow oscillations at the two different measuring times, and further determines and provides a frequency ratio of the determined oscillation frequencies at the two different measuring times as the value of the blood flow quantity, using the determined oscillation frequencies.
The signal processing unit of the first aspect makes use of the recognition of the present inventor that relative changes in blood flow over time allow determining values of a flow velocity ratio despite an unknown geometry and size of the blood vessel, in which the blood flow is to be measured. In particular, the inventors have recognized that use can be made of the fact that the parameters required for determining the value of the blood flow quantity the characteristic size of the blood vessel, are sufficiently stable over time, even if not known in absolute values, as long as the intravascular device is not moved during the measurement. This recognition opens up embodiments of blood flow measurements, in which the vibration sensor provides respective vibration sensor signals comprising the vibration sensor signal component caused by (e.g., vortex-generated) blood flow oscillations of intravascular blood flow measured at two different measuring times. In such embodiments, the signal processing unit, which receives the vibration sensor signals, is configured to determine respective oscillation frequencies of the blood flow oscillations at at least two different measuring times and to determine and provide as an output a frequency ratio of the determined oscillation frequencies at the two measuring times as the value of the blood flow quantity.
Thus, a new source of information on blood flow quantities is opened up by the by signal processing unit of the present invention.
In the following, embodiments of the signal processing unit will be described.
Several blood flow quantities are known, which can be determined using the signal processing unit. For instance, a volume flow quantity, given for instance in units of in ml/s, or a flow velocity quantity, expressed in units of m/s, or a CFR can be determined.
The determination of a frequency ratio (r) of the determined oscillation frequencies at the two measuring times, allows direct conclusions on blood flow quantities such as a flow velocity ratio or, in particular embodiments, a CFR with particular ease and reliability. In particular, based on the applicability of the assumptions explained above, the flow velocity ratio is identical to the ratio of the measured oscillation frequencies at two different times, as it is show in the following equation:
wherein
Such blood flow quantities provide important information regarding the current physiological state of a blood vessel, and advantageously assist in particular in the identification and quantitative characterization of a stenosis or of the coronary microcirculation.
In some embodiments of the signal processing unit, the blood flow determination unit comprises a signal transformation unit, which is configured to determine a frequency-domain representation of the vibration sensor signal received during a predetermined measuring time span and to determine the oscillation frequency of the blood flow oscillations using the frequency-domain representation. The frequency-domain representation can be determined and provided for instance by a signal transformation unit applying a Fourier transform, suitably a Fast Fourier Transform (FFT) of the received vibration sensor signal.
For typical coronary flows and geometry an oscillation frequency associated with blood flow oscillations of a few 100 Hz is to be expected. These blood flow oscillations are typically (but not necessarily) vortex-generated, i.e., caused by the presence of a non-streamlined object inside the vessel, or by the presence of naturally-occurring non-streamlined parts of a blood vessel including narrowings or turns of the blood vessel. However, this will be superimposed with other frequencies caused by heart beat (around 1 Hz) or other disturbances. In preferred embodiments, therefore, the blood flow determination unit of the signal processing unit comprises a filter unit configured to filter out frequency components of the vibration sensor signal that are associated with a heartbeat frequency. In one example, after subjecting the vibration sensor signals to an FFT all frequency components of the vibration sensor signal smaller than 100 Hz are attenuated or fully eliminated from the vibration sensor signal by the filter unit. The remaining vibration sensor signal components in the desired frequency range can then be used to identify a frequency component associated with, for example, the vortex-generated blood flow oscillations. Suitably, the vibration sensor signal component having the strongest amplitude to the remaining filtered signal comprising frequency components above 100 Hz can be identified as that associated with relevant blood flow oscillations, such as vortex-generated blood flow oscillations. Thus, by providing a frequency filtering, it is made sure that the frequencies significant for determination of the blood flow quantity are identified and selected for further signal processing.
In order to provide an absolute value of a blood flow velocity as the value of the blood flow quantity, geometrical data such as a characteristic size of the blood vessel at a measurement position of the vibration sensor is provided in some embodiments. In such embodiments, the blood flow determination unit is preferably further configured to hold or receive the geometrical data indicative of the characteristic size of the blood vessel at the intravascular position of the vibration sensor. In general, for intravascular applications, the can be characteristic size is equivalent to a hydraulic diameter, which is a common quantity used in the characterization of flow in channels of non-circular cross section. For blood vessels of nearly circular diameter, the hydraulic diameter can be approximated by the diameter of the tube or channel.
In some embodiments, the blood flow determination unit is further configured to hold or receive geometrical data indicative of a characteristic size of the blood vessel at a current intravascular position of the vibration sensor during measurement. The geometrical data is in some embodiments held or stored in a storage unit, whereas in other embodiments, the geometrical data is received by an input unit. The input unit may for instance be a user interface allowing manual input of the geometrical data. In yet other embodiments, the geometrical data is provided by an external image-processing device configured to determine the characteristic size from image data taken of the blood vessel in-situ, i.e., at the current intravascular position of an intravascular blood flow sensor comprising the vibration sensor.
For instance, in some embodiments, the blood flow determination unit is configured to determine and provide, using the determined oscillation frequency of the vortex-generated blood flow oscillation and the geometrical data, the value of the blood flow quantity as a flow velocity according to:
wherein
The Strouhal number is a dimensionless number that describes oscillating flow mechanisms. For a range of Reynolds number covering the interval applicable for blood, the Strouhal number is suitably approximated by a constant value, suitably a value of 0.2. At this value of the Strouhal number, oscillations in fluid flow are characterized by a buildup and subsequent rapid shedding of vortices in the presence of a bluff body inside the blood vessel, such as a suitably shaped blood flow sensor, which will be described further below.
Experimental data obtained by the inventor show that the above equation is a useful approximation also in situations where blood flow oscillations are not vortex-generated. Also in such cases the oscillation frequency exhibits an approximately linear dependence on the flow velocity.
The signal processing unit of one embodiment is configured to determine a value of a CFR from the frequency ratio, using respective received vibration sensor signals at a first measuring time corresponding to a state of normal blood flow, in particular at a time of rest of the patient, and at a second measuring time corresponding to a state of hyperemia. The blood flow determination unit is configured to determine and output, in particular display a value of a coronary flow reserve from the frequency ratio the CFR value by determining the ratio between the oscillation frequencies determined for the two different states. However, this is only a special example. Any other flow velocity ratio may be determined using corresponding measurements at any two different states, generally referred to as a state A and a state B.
In some of these embodiments, the blood flow determination unit is configured to determine the frequency ratio of the determined oscillation frequencies at the two measuring times as an average value from frequency ratios of the determined oscillation frequencies at respective two measuring times of a plurality of measurement iteration cycles. This can be done by measuring the vibration sensor signal over one heart cycle or multiple heart cycles or in a time resolved way. Generally, and especially where the CFR shall be determined and state A is a state of normal blood flow and state B a state of hyperemia, it is better for the patient to induce each state only once and perform a respective plurality of measurements for obtaining a suitable number of frequency samples in each of the two states A and B. If circumstances allow, the measurements may be determined by performing two or more iteration cycles, i.e., iteratively changing between the states A and B.
To provide a user with a possibility to control the individual measuring times, the signal processing unit of some embodiments additionally comprises a user interface. The user interface is preferably configured to allow a user triggering a measurement and providing a first vibration sensor signal associated with a first measuring time. The blood flow determination unit, in response to receiving the user input, is configured to receive a sequence of vibration sensor signals at different measuring times, and to determine and provide the frequency ratio of the determined oscillation frequencies for the given measuring times with respect to the oscillation frequency determined from the first vibration sensor signal. Typically, in operation of signal processing unit, a user such as medical staff selects the first measuring time and from then on the signal processing unit provides the current value of the blood flow quantity as relative values. In other embodiment, the user marks both measuring times corresponding to states A and B by suitable user input.
In some of these embodiments, the signal processing unit is further configured to provide relative changes in blood flow over time in comparison with a user-defined reference point in time. In such embodiments, the signal processing unit, in response to receiving the user input, is suitably configured to receive a sequence of vibration sensor signals, beginning at the user-defined first measuring time and then at subsequent measuring times after the first measuring time, which may be quasi-continuous or determined automatically by a preset sampling frequency. The signal processing unit determines and provides the respective frequency ratio of the determined oscillation frequencies for the different measuring times with respect to the oscillation frequency determined from the first vibration sensor signal. In other words, the user can select the first measuring time or first measuring time span for which the blood flow is to be considered 100%, and the signal processing unit will after that determine and provide current blood flow as relative values with reference to the blood flow at that selected first measuring time.
In other embodiments, the signal processing unit is further configured to extract the vibration sensor signals from a wireless carrier signal.
According to a second aspect of the present invention, an intravascular blood flow sensor system is provided. The intravascular blood flow sensor system includes an intravascular blood flow sensor that comprises:
Flow determination makes use of the fact that the frequency of blood flow oscillations in general and particularly of vortex-generated blood flow oscillations, is a measurable quantity that is related to the flow velocity by parameters known as the Strouhal number and the characteristic size of the blood vessel guiding the blood flow.
In the following, embodiments of the second aspect of the present invention will be described. These different embodiments are based on different techniques for providing the vibration sensor signals.
In some embodiments of the intravascular blood flow sensor system, the guidewire or catheter for intravascular insertion has a bluff part that is shaped for generation of vortices propagating along a main direction of intravascular blood flow.
The blood flow in the coronary arteries has a reported Reynolds number between 50 and 1000. The inventors make use of the per-se known fact that fluids having Reynolds numbers typically larger than 50 tend to exhibit vortex shedding when the fluid moves past a suitably shaped part of the blood vessel or a suitably shaped bluff part of the intravascular blood flow sensor, such as a bluff or a barrier on or in its body, as opposed to an intravascular blood flow sensor having a body of streamlined shape. Such a suitably shaped part of a catheter or guidewire is provided in the intravascular blood flow sensor. This bluff part may in different embodiments be a part of an intravascular guidewire or catheter, in particular micro-catheter.
Vortex shedding, as mentioned, describes a periodic formation of vortices, also known as Kármán vortices, behind the bluff part of the catheter or guidewire comprised by the intravascular blood flow sensor, wherein “behind the bluff part” refers to a view in a main direction of blood flow at the bluff part. The vortices propagate along a main direction given by the blood flow direction. At any given time, the vortices are distributed behind the bluff part showing a respective spatial distribution. Generally, vortex-generated blood flow oscillations of intravascular blood flow can be detected in a direction substantially perpendicular to a main direction of blood flow along the blood vessel.
For creating vortex-generated blood flow oscillations, the bluff part that is shaped for generation of vortices propagating along a main direction of intravascular blood flow preferably comprises a barrier section that protrudes from the guidewire or catheter in the direction perpendicular to the main direction of intravascular blood flow. In particular embodiments, the barrier section forms a bluff body section, such as a ball-shaped body section. Generally, any non-streamlined shape can be used to encourage the formation of the vortices.
In some embodiments of the intravascular blood flow sensor system, the vibration sensor is arranged in a tip section of the guidewire or catheter.
In some of these embodiments the tip section is elastically deformable in the direction perpendicular to the main direction of intravascular blood flow by the blood flow oscillations.
In other embodiments, a tip section of the guidewire or catheter for intravascular insertion and is itself elastically deformable in the direction perpendicular to the main direction of intravascular blood flow by the blood flow oscillations. Here, the vibration sensor, suitably arranged in the tip section of the guidewire, measures the vibration of the tip section of the guidewire or the catheter, i.e., its oscillation frequency in response to, for example, vortex-generated blood flow oscillations in a direction perpendicular to the main direction of intravascular blood flow.
In other embodiments of the intravascular blood sensor system the vibration sensor comprises a flagellum that extends from the catheter or guidewire in the main direction of intravascular blood flow and is elastically deformable in the direction perpendicular to the main direction of intravascular blood flow by the blood flow oscillations. In these embodiments, the frequency of the vibrations behind the bluff part is determined using a vibration sensor that comprises a flagellum. The flagellum extends from the catheter or guidewire of the intravascular blood flow sensor in the main direction of intravascular blood flow and is elastically deformable in the direction perpendicular to the main direction of intravascular blood flow by the blood flow oscillations. The flagellum is floppy so as not to pose any risk of damage to vascular tissue.
In a subset of these embodiments the flagellum is made of an electro-active polymer material and configured to generate and provide the vibration sensor signal in the form of a time-varying electrical signal having an amplitude depending on a deformation amount in the direction perpendicular to the main direction of intravascular blood flow. A flagellum of this kind is configured to generate and provide the vibration sensor signal in the form of a time-varying electrical signal having an amplitude depending on a current deformation amount in the direction perpendicular to the main direction of intravascular blood flow. From the oscillating amplitude of this electrical signal as a function of time, a frequency of blood flow oscillation can be determined.
Alternatively, an optoelectronic solution can be employed to measure the oscillation frequency. For instance, in another subset of these embodiments the flagellum is an optical fiber segment configured to receive and guide light to and from a reflective fiber-segment tip, and the intravascular blood flow sensor system further comprises a light source configured to provide light for coupling into the fiber segment and a light sensor arranged to receive light reflected from the fiber-segment tip and modulated in intensity by oscillating deformation of the fiber segment, the light sensor being configured to provide the vibration sensor signal in the form of a light-sensor signal indicative of a time-varying reflected light intensity. Thus, a modulation of the light intensity reflected from the fiber-segment tip provides an electrical vibration sensor signal that can be used for evaluation of the oscillation frequency of the blood flow oscillations.
In yet other embodiments of the second aspect, the vibration sensor comprises one or more pressure sensors arranged on a surface of the catheter or guidewire, the pressure sensor being arranged and configured to measure a time-varying pressure exerted in the direction perpendicular to the main direction of intravascular blood flow by the blood flow oscillations and to generate and provide the vibration sensor signal in the form of a time-varying electrical signal depending on the measured pressure. Thus, the pressure sensor of this embodiment is preferably arranged on a circumferential surface section of the intravascular blood flow sensor, and not on a front surface section at the tip of the guidewire or catheter. Some embodiments using pressure sensing are advantageously configured to additionally determine a value of a fractional flow reserve (FFR). This determination is based on a low frequency band of the time-varying electrical signal depending on the measured pressure and provided by the pressure sensor. Relevant components such as vortex-induced frequency components within the vibration sensor signal typically are at frequencies of a few 100 Hz, and are overlaid with low frequency signal components associated with a heartbeat. The latter components have a frequency of around 1 Hz. FFR can thus be determined from the low frequency pressure signal that depicts the pressure changes over the heart cycle while the blood flow ratios can be determined from the oscillation frequencies at a higher frequency band obtained at the two measuring times.
In other embodiments, the bluff part comprises a barrier section that protrudes from the catheter or guidewire in the direction perpendicular to the main direction of intravascular blood flow for generation of vortices propagating along the main direction of intravascular blood flow.
In other embodiments, the intravascular blood flow sensor system further comprises a signal communication unit configured to receive the vibration sensor signals and to transmit the vibration sensor signals via a wireless carrier signal to the signal processing unit. In these embodiments, the signal processing unit is further configured to extract the vibration sensor signals from the carrier signal.
The intravascular blood flow sensor can be implemented as an add-on device that can be mechanically and electrically mounted to a guidewire or catheter shaft. In preferred embodiments, however, at least the bluff part that is suitably shaped for generation of vortices propagating along a main direction of intravascular blood flow intravascular flow sensor, and the vibration sensor arranged and configured to provide a vibration sensor signal indicative of the oscillation frequency of blood flow oscillations, form an integral part of a guidewire or catheter for intravascular insertion.
The signal processing unit is preferably located outside a guidewire or catheter comprised by the intravascular blood flow sensor. When implemented as such a unit of an external control and/or evaluation device that is not for intravascular insertion, the signal processing unit is suitably provided in the form of a programmed processor unit and configured to be in communicative connection with the vibration sensor during intravascular operation for receiving the vibration sensor signals via a wired or wireless communication channel, implementations of which are per se known in the art. Thus the intravascular part of the intravascular blood flow sensor also comprises suitable communication unit for wired or wireless communication of the vibration sensor signals.
Thus, some embodiments of the intravascular blood flow sensor additionally comprise a signal communication unit that is configured to receive the vibration sensor signals and to transmit the vibration sensor signals as a wired or wireless, i.e., electrical or electromagnetic signal to the signal processing unit, in particular using a suitable carrier signal where useful. In these embodiments, the signal processing unit is further configured to extract the vibration sensor signals from the carrier signal. Different embodiments make use of different wireless communication techniques, such as those based on any of the IEEE 802.11 standards (WiFi, WLAN), ZigBee, Bluetooth, wireless communication in an infrared frequency band, etc. The choice of the wireless communication technique inter alia depends on whether the signal communication unit is for intravascular use or for use outside the living being. In the former case, wireless radio communication techniques such are preferred. In the latter case, other wireless communication techniques such as those based on infrared data transmission may also be used.
In other embodiments, the intravascular blood flow sensor is arranged on or embedded in an intravascular ultrasound device for intravascular ultrasound imaging.
According to a third aspect of the present invention, a method for operating a signal processing unit for determining a value of a blood flow quantity characterizing blood flow inside a blood vessel is presented. The method comprises:
A forth aspect of the present invention is formed by a computer program comprising executable code for performing a method of the third aspect of the invention when executed by a programmable processor of a computer.
According to a fifth aspect of the present invention, a method for controlling operation of an intravascular blood flow sensor system is provided. The method comprises:
It shall be understood that signal processing unit of claim 1, the intravascular blood flow sensor system of claim 7 and the computer program of claim 15 have similar and/or identical preferred embodiments, in particular, as defined in the dependent claims.
It shall be understood that a preferred embodiment of the present invention can also be any combination of the dependent claims or above embodiments with the respective independent claim.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.
In the following drawings:
Generally, vortex shedding is known per se as an oscillating flow that occurs under suitable circumstances when a fluid flows past a bluff body. The parameters relevant for vortex shedding to occur comprise a viscosity of the fluid, a flow velocity, as well as a size and shape of the object. The former can be characterized, for example, by a Reynolds number. The vortex shedding induced by the presence of the bluff body 100.b in the blood flow 102 generates a so-called Kármán vortex street 104.b downstream of the bluff body 100.b. Existing vortices propagate to positions further away from the bluff body along the main direction of blood flow indicated by the arrows 102, while new vortices are generated close to the body 100.b. Vortices are generated at alternating sides of the body and are associated with oscillations in the blood flow in a direction perpendicular to the main flow direction. At a given time, the vortices generated are distributed as exemplarily shown in
It is noted that the use of vortex-generated blood flow oscillations forms an advantageous embodiment. However, blood flow oscillations generated by other causes can be used to the same effect in other embodiments. The generation of such blood flow oscillations may be due to the inserted guidewire or catheter, or it may be due to intrinsic causes such as the geometry of the blood vessel. The present description of embodiments with reference to the drawings focuses in some parts on the example of vortex-generated blood flow oscillations without intention to thereby restrict the scope of the invention to such cases.
Some signal processing units include a blood flow determination unit that additionally comprises a signal transformation unit (212), which is configured to determine a frequency-domain representation of the vibration sensor signal received during a predetermined measuring time span and to determine the oscillation frequency of the (e.g. vortex-generated) blood flow oscillations using the frequency-domain representation. To this end, the signal transformation unit 212 receives the vibration sensor signals from the vibration sensor signal input over a predetermined measuring time span associated with a given measuring time. The signal transformation unit 212 determines the oscillation frequency for the given measuring time using a frequency-domain representation of the vibration sensor signal during the respective measuring time span. Suitably, the signal transformation unit 212 is a Fast Fourier Transform unit that determines the Fourier Transform of the vibration sensor signal. From the transformed vibration sensor signal, an oscillation frequency can be determined in a simple manner as a frequency of a Fourier component having a maximum amplitude in an expected oscillation frequency range above 100 Hz, typically in the range of a few hundred Hz.
To make detection of the oscillation frequency easier, some signal processing units of the present embodiment further comprises a filter unit 214 that is configured to filter out frequency components from the vibration sensor signal that are associated with heart beat frequency. The heart beat frequency range is typically below 100 Hz.
The signal processing unit determines a frequency ratio of the determined oscillation frequencies at two measuring times. This way, blood flow quantities can be determined. Such blood flow quantities provide important information regarding the current physiological state of a blood vessel, and assist in the identification and quantitative characterization of a stenosis. For calculation and output of the CFR value, the measurements are made in a state of hyperemia and in a state of normal blood flow (e.g., at rest). The coronary flow reserve (CFR) is then determined and provided by the signal-processing unit with particular ease and reliability as the frequency ratio of respective vibration sensor signals at the measuring time corresponding to the state of hyperemia and at the measuring time corresponding to the state of normal blood flow.
In some signal processing units, a user interface 210 is provided for user input of control signals, such as for triggering the oscillation measurements by controlling the operation of the vibration sensor signal input, and for output of the value of the blood flow quantity determined. The user interface is in some embodiments used to provide geometrical data indicative of a characteristic size of the blood vessel at a current intravascular position of the intravascular blood flow sensor, which is required to provide a value of a flow velocity according to:
wherein
In other signal processing units, the geometrical data is locally stored in a storage unit 215 which is accessed by the blood flow determination unit 213 for determining the value of the flow velocity v.
In other embodiments, the signal processing unit receives the geometrical data from an external imaging device or an external image processing device that is configured to image the blood vessel at a current intravascular position of the intravascular blood flow sensor and to determine and provide the geometrical data at that position.
As another mode of operation, which is available to a user as an alternative to the CFR determination, the signal processing unit 208 determines and provides relative changes in blood flow over time from a sequence of measurements, as compared to a first measurement of the sequence that can be triggered by user input.
The intravascular blood flow sensor system 200 comprises an intravascular blood flow sensor 203. In this particular intravascular blood flow sensor system, the intravascular blood flow sensor includes an intravascular guidewire 202 that has a guidewire body 204 with an atraumatic tip section 204.1 comprising a bluff part 205 that is suitably shaped for generation of vortices propagating along a main direction L of intravascular blood flow. It is noted that the bluff part 205 of the intravascular blood flow sensor need not necessarily be different in shape from other parts of the guide wire body 204 for enabling the formation of vortices. However, to facilitate reliable generation of vortices even at low blood flow velocities, it is advantageous to add features that shape the body of a typical guide wire or catheter in a less stream-lined way, such as for example providing a guidewire or a catheter comprising a bluff part.
The guidewire body 204 may have a rotational symmetry along its longitudinal direction, which in
The tip section 204.1 includes a vibration sensor 206. The vibration sensor 206 comprises a flagellum 206.1 extending from a front surface of the tip section 204.1 in the main direction L of the intravascular blood flow. The flagellum 206.1 is elastically deformable in a direction P perpendicular to L which in the present example are the two mutually opposite directions P. An oscillating bending motion of the flagellum 206.1 in the direction P is driven by the vortex-generated oscillating motion of blood, as explained with reference to
In a real 3D vessel, more complex vortex configurations are possible that cannot be faithfully represented in a 2D illustration such as
The flagellum 206.1 is shown in
The flagellum 206.1 comprised by the vibration sensor 206 can be made of an electro-active polymer material and configured to generate and provide the vibration sensor signal in the form of a time-varying electrical signal having an amplitude depending on a deformation amount in the direction perpendicular to the main direction of intravascular blood flow.
In a variant of the intravascular blood flow sensor of
A further variant of the intravascular blood flow sensor of
The vibration sensor signals are provided by the vibration sensor 306 and received by a signal processing unit 308, which is arranged outside the body of the patient. Details of signal communication and signal processing have been described in the context of the embodiment of
A variant of the intravascular blood flow sensor system of
A variant of the intravascular blood flow sensor system of
The intravascular blood flow sensor system 400 comprises a microcatheter 402 with a catheter body 404 for intravascular insertion. A tip section 404.1 of the catheter body comprises a barrier section 405 that protrudes from the catheter body in a direction P perpendicular to the main direction of intravascular blood flow, in order to enhance the generation of vortices propagating along the main direction L of intravascular blood flow. Such a barrier 405 may also be present in the tip section in variants of the embodiments of
A vibration sensor is provided in the form of a pressure sensor 406 located on a surface of the tip section 404.1 of the catheter body 404. The pressure sensor 406 is arranged and configured to measure pressure exerted in the direction P perpendicular to the main direction L of the turbulent intravascular blood flow, and thus particularly detects the vortex-generated blood flow oscillations as corresponding pressure oscillations. The pressure sensor 406 generates a vibration sensor signal in the form of a time-varying electrical signal depending on the pressure currently sensed. The pressure sensor 406 provides the vibration sensor signal to a signal processing unit 408, using one of the signal communication techniques explained in the context of the embodiment of
Intravascular blood flood devices comprising one or more pressure sensors such as the pressure sensor 406 can additionally determine a value of a fractional flow reserve (FFR). Fractional flow reserve is the ratio of blood pressure after i.e., distal to a stenosis and the blood pressure before the stenosis. This determination is based on evaluating a low frequency band of the measured time-varying electrical signal. As mentioned, Vortex-induced frequencies within the vibration signal typically are at frequencies in the range of a few 100 Hz and are overlaid with low-frequency signal components associated with the heartbeat. The latter components have a frequency clearly below 100 Hz, typically around 1 Hz. FFR can thus be determined from the low frequency pressure signal that depicts the pressure changes over the heart cycle while CFR can be determined from the high frequency vortex-induced component.
A variant of the intravascular blood flow sensor system of
A variant of the intravascular blood flow sensor system of
The blood flow sensor system 500 further comprises a signal communication unit 508 that is configured to receive the vibration sensor signals from the vibration sensor 506 and to perform wireless transmission of the vibration sensor signals to the signal processing unit 510 using a carrier signal. The signal processing unit 510 has a corresponding signal communication unit, of which only an antenna 511 is shown, that is configured to receive the carrier signal and to extract the vibration sensor signals from the carrier signal. The signal processing unit 510 then determines respective oscillation frequencies of vortex-generated blood flow oscillations at at least two different measuring times and determines and provides as an output a frequency ratio of the determined oscillation frequencies at the two measuring times. A user may interact with the blood flow sensor 500 via a user interface 512, as explained above. The user input may also be provided using wireless communication.
As shown in
In a step 604, a vibration sensor signal is measured at two different measuring times using the vibration sensor. In a step 606, respective oscillation frequencies of the vortex-generated blood flow oscillations at the two different measuring times are determined. In a final step 608, a frequency ratio of the determined oscillation frequencies at the two measuring times is determined.
Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims.
In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.
A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium, supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.
Any reference signs in the claims should not be construed as limiting the scope.
| Number | Date | Country | Kind |
|---|---|---|---|
| 17162723.5 | Mar 2017 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/056645 | 3/16/2018 | WO | 00 |
