Patent Description:
When performing percutaneous treatment of a stenosed site causing a myocardial infarction or the like occurring in a body lumen such as a blood vessel and a vessel, in order to observe characteristics of the stenosed site or to observe condition after the treatment, a diagnostic catheter for acquiring an image of the body lumen by using an inspection wave such as ultrasound or light is used.

In an intra vascular ultrasound (IVUS) diagnosis, it is common that an imaging core having an ultrasound transducer at a distal end of an insertion portion is provided in a rotatable manner and inserted into a body-cavity, and then scanning (radial scan) is performed while being rotated through a drive shaft or the like extending from a drive unit on a hand-side.

In optical coherence tomographic (OCT) diagnosis utilizing wavelength sweeping, an optical probe unit having an imaging core inserted therein and equipped with an optical lens and an optical mirror (transceiver) attached at a distal end of an optical fiber is inserted into a blood vessel, measurement light is emitted into the blood vessel from the transceiver at the distal end while rotating the imaging core, and radial scanning in the blood vessel is performed by receiving reflected light from a biological tissue. Generally, a cross-sectional image of a blood vessel is drawn based on interference light generated by causing the received reflected light and reference light to interfere with each other.

In OCT, an image with high resolution is obtained with respect to a vascular lumen surface, but only an image of the relatively shallow tissue from the vascular lumen surface can be obtained. On the other hand, in a case of the IVUS, although it is lower than the OCT in terms of the resolution of the obtained image, conversely, an image of a vascular tissue deeper than the OCT can be obtained. Therefore, recently, an image diagnosis apparatus having an imaging core equipped with a dual sensor combining a function of the IVUS and a function of the OCT (an image diagnosis apparatus including an ultrasound transceiver capable of transmitting and receiving ultrasound, and an optical transceiver capable of transmitting and receiving light) is proposed (see PTL <NUM>).

From <CIT> there is already known
a control device comprising:
receiving means for receiving a signal from an imaging core including an optical transceiver and an ultrasound transceiver;.

However, in a case of a dual sensor, it is necessary to check whether foreign matter such as air bubbles remains before acquiring an IVUS image, and it is also necessary to execute an optical path adjustment before acquiring an OCT image. At that time, although it is necessary to execute the optical path adjustment after a priming is surely performed, there is a possibility that a user may mistake a procedure and eventually leading to an erroneous diagnosis.

The present invention has been made in view of the above problems, and it is an object thereof to provide a technology for reducing a burden of prior confirmation by a user and preventing an occurrence of an erroneous diagnosis.

In order to achieve the above object, the present invention provides a control device according to independent claim <NUM>. The dependent claims relate to advantageous embodiments.

According to the present invention, it is possible to reduce a burden of prior confirmation by a user, and to prevent an occurrence of an erroneous diagnosis.

Other features and advantages of the present invention will become apparent from the following description with reference to the accompanying drawings. Note that in the accompanying drawings, the same or similar configuration is denoted by the same reference numeral.

The accompanying drawings are included in the specification, constitute a part of the specification, illustrate embodiments of the present invention, and are used to explain the principles of the present invention, together with the description.

Hereinafter, each embodiment of the present invention will be described with reference to the drawings. Throughout the drawings, the same reference numerals refer to the same components.

An image diagnosis apparatus according to the present embodiment will be described as having an IVUS function and an OCT function. <FIG> is a diagram showing an external appearance configuration of an image diagnosis apparatus <NUM> according to an embodiment of the present invention. As shown in <FIG>, the image diagnosis apparatus <NUM> includes a probe <NUM>, a scanner and pull-back unit <NUM>, a control device <NUM>, and a display apparatus <NUM>. The scanner and pull-back unit <NUM> and the control device <NUM> are connected to each other via a connector <NUM> by a cable <NUM> accommodating a signal line and an optical fiber. Note that in the present embodiment, the control device <NUM> and the display apparatus <NUM> are described as separate bodies, but the control device <NUM> may include the display apparatus <NUM>.

The probe <NUM> is directly inserted into a blood vessel. A catheter accommodating an imaging core that includes an ultrasound transceiver for receiving a reflected wave from the inside of the blood vessel in addition to transmit an ultrasound based on a pulse signal and an optical transceiver for continuously receiving reflected light from the inside of the blood vessel in addition to continuously transmit the transmitted light (measurement light) into the blood vessel, is inserted in the probe <NUM>. The image diagnosis apparatus <NUM> measures a state inside the blood vessel by using the imaging core.

The probe <NUM> is detachably attached to the scanner and pull-back unit <NUM>, and by driving a built-in motor, the scanner and pull-back unit <NUM> defines an axial motion and a rotary direction motion in the blood vessel of the imaging core in the catheter inserted in the probe <NUM>. Further, the scanner and pull-back unit <NUM> acquires a reflected wave signal received by the ultrasound transceiver in the imaging core and reflected light received by the optical transceiver, and transmits the signal and the light to the control device <NUM>.

Upon measurement, the control device <NUM> processes a function for inputting various setting values, or ultrasound data or optical interference data obtained by the measurement, and includes a function for displaying various blood vessel images.

In the control device <NUM>, reference numeral <NUM> denotes a main control unit. The main control unit <NUM> generates line data from a reflected wave signal of the ultrasound obtained by the measurement, and generates an ultrasound tomographic image (IVUS image) through an interpolation processing. Furthermore, the main control unit <NUM> generates interference light data by causing the reflected light from the imaging core and the reference light obtained by separating light from a light source to interfere with each other, and also generates line data based on the interference light data and an optical tomographic image of the blood vessel based on an optical interference through the interpolation processing.

Reference numeral <NUM>-<NUM> denotes a printer and a DVD recorder, which print a processing result in the main control unit <NUM> and store the processing result as data. Reference numeral <NUM> denotes an operation panel, and a user inputs various setting values and instructions via the operation panel <NUM>. Reference numeral <NUM> denotes an LCD monitor as a display apparatus, which displays various cross-sectional images generated by the main control unit <NUM>. Reference numeral <NUM> denotes a mouse as a pointing device (coordinate input device).

Subsequently, a functional configuration of the image diagnosis apparatus <NUM> (mainly the control device <NUM>) will be described. <FIG> is a block configuration diagram of the image diagnosis apparatus <NUM>. Hereinafter, the functional configuration for implementing a wavelength sweeping type optical coherent tomographic diagnosis will be described with reference to the same figure.

In the figure, reference numeral <NUM> denotes a signal processing unit which controls an entire image diagnosis apparatus, and is configured with a microprocessor and number of circuits. Reference numeral <NUM> denotes a nonvolatile storage device typified by a hard disk, and stores various programs or data files to be executed by the signal processing unit <NUM>. Reference numeral <NUM> denotes a memory (RAM) provided in the signal processing unit <NUM>. Reference numeral <NUM> denotes a wavelength swept light source, which is a light source that repeatedly generates light having a wavelength that changes within a preset range along a time axis. Reference numeral <NUM> denotes an image acquisition unit which acquires an ultrasound tomographic image (IVUS image) or an optical tomographic image photographed by an imaging core <NUM> described later. Reference numeral <NUM> denotes a control unit which performs various processes and controls display on the display apparatus <NUM>. Reference numeral <NUM> denotes a selection receiving unit which receives an input from a user via the display apparatus <NUM>, the mouse <NUM> or the like when the operation panel <NUM> and the display apparatus <NUM> have a touch function, and performs various selection processing.

The light output from the wavelength swept light source <NUM> is incident on one end of a first single mode fiber <NUM> and is transmitted toward a distal side. The first single mode fiber <NUM> is optically coupled to a fourth single mode fiber <NUM> in the middle optical fiber coupler <NUM>.

The light that is incident on the first single mode fiber <NUM> and is emitted toward the distal side from the optical fiber coupler <NUM> is guided to a second single mode fiber <NUM> via a connector <NUM>. The other end of the second single mode fiber <NUM> is connected to an optical rotary joint <NUM> in the pull-back unit <NUM>.

On the other hand, the probe <NUM> has an adapter 101a for connecting with the pull-back unit <NUM>. Then, by connecting the probe <NUM> to the pull-back unit <NUM> by using the adapter 101a, the probe <NUM> is stably held in the pull-back unit <NUM>. Furthermore, an end portion of the third single mode fiber <NUM> accommodated in the probe <NUM> in a rotatable manner is connected to the optical rotary joint <NUM>. As a result, the second single mode fiber <NUM> and the third single mode fiber <NUM> are optically coupled. An imaging core <NUM> is provided on the other end of the third single mode fiber <NUM> (a head part side of the probe <NUM>). The imaging core <NUM> is equipped with the optical transceiver including a mirror and a lens for emitting light in a direction substantially orthogonal to a rotation axis.

As a result, the light emitted from the wavelength swept light source <NUM> is guided to the imaging core <NUM> provided at the end portion of the third single mode fiber <NUM> via the first single mode fiber <NUM>, the second single mode fiber <NUM>, and the third single mode fiber <NUM>. The optical transceiver of the imaging core <NUM> emits the light in a direction orthogonal to the axis of the fiber and receives the reflected light. The received reflected light is guided in reverse this time, and returned to the control device <NUM>.

On the other hand, an optical path length adjustment mechanism <NUM> for finely adjusting an optical path length of the reference light is provided at an opposite end portion of the fourth single mode fiber <NUM> coupled to the optical fiber coupler <NUM>. The optical path length adjustment mechanism <NUM> functions as an optical path length change means that changes the optical path length corresponding to a fluctuation in length so as to be able to absorb the fluctuation in length of each probe <NUM>, such as when the probe <NUM> is exchanged. Therefore, a collimating lens <NUM> positioned at the end portion of the fourth single mode fiber <NUM> is provided on a movable one-axis stage <NUM> as indicated by an arrow <NUM> which is an optical axis direction of the collimating lens.

Specifically, the one-axis stage <NUM> functions as an optical path length change means having a variable range of the optical path length that can absorb a fluctuation of the optical path length of the probe <NUM> when the probe <NUM> is exchanged. Furthermore, the one-axis stage <NUM> also includes a function as an adjusting means for adjusting an offset. For example, even when the distal end of the probe <NUM> is not in contact with the surface of the biological tissue, interference with the reflected light from the surface position of the biological tissue can be created by slightly changing the optical path length with the one-axis stage.

The optical path length is finely adjusted by the one-axis stage <NUM> and light reflected by a mirror <NUM> via a grating <NUM> and a lens <NUM> is guided to the fourth single mode fiber <NUM> again. The light is mixed with light obtained from the second single mode fiber <NUM> side at the optical fiber coupler <NUM> and received by a photodiode <NUM> as interference light.

The interference light received by the photodiode <NUM> in this manner is photoelectrically converted, amplified by an amplifier <NUM>, and then input to a demodulator <NUM>. The demodulator <NUM> performs demodulation processing for extracting only a signal component of the interfered light, and an output thereof is input to an A/D converter <NUM> as an interference light signal.

The A/D converter <NUM> generates single line digital data (interference light data) by sampling the interference light signal, for example, at <NUM> for <NUM> points. The reason why the sampling frequency is set to <NUM> is based on the premise that about <NUM>% of the wavelength sweeping cycle (<NUM>µsec) is extracted as digital data of <NUM> points when the wavelength sweeping repetition frequency is set to <NUM>. However, there is no particular limitation to this.

The line by line interference light data generated by the A/D converter <NUM> is input to the signal processing unit <NUM> and temporarily stored in the memory <NUM>. Then, the signal processing unit <NUM> performs a frequency decomposition of the interference light data by using fast Fourier transform (FFT) to generate data (line data) in a depth direction, constructs an optical tomographic image at each position in the blood vessel by coordinate-conversion of the data, and outputs the image to the display apparatus <NUM> at a predetermined frame rate.

The signal processing unit <NUM> is further connected to an optical path length adjustment drive unit <NUM> and a communication unit <NUM>. The signal processing unit <NUM> performs control (optical path length control) of a position of the one-axis stage <NUM> via the optical path length adjustment drive unit <NUM>.

The communication unit <NUM> includes several drive circuits and communicates with the pull-back unit <NUM> under the control of the signal processing unit <NUM>. More specifically, the communication unit <NUM> is used for supplying a drive signal to a radial scanning motor for rotating the third single mode fiber <NUM> by the optical rotary joint in the pull-back unit <NUM>, receiving a signal from an encoder unit <NUM> for detecting a rotational position of the radial motor, and supplying a drive signal to a linear drive unit <NUM>.

Note that the above processing in the signal processing unit <NUM> is also realized by executing a predetermined program by a computer.

With the above configuration, the probe <NUM> is positioned at a blood vessel position (coronary artery or the like) of a patient to be diagnosed, and transparent flush liquid is discharged into the blood vessel through a guiding catheter or the like toward the distal end of the probe <NUM> by a user operation. It is to exclude the influence of blood. Then, when the user inputs an instruction to start scanning, the signal processing unit <NUM> drives the wavelength swept light source <NUM> to drive the radial scanning motor <NUM> and the linear drive unit <NUM> (hereinafter, light irradiation and light receiving processing by driving of the radial scanning motor <NUM> and the linear drive unit <NUM> are also referred to as scanning). As a result, wavelength swept light is supplied from the wavelength swept light source <NUM> to the imaging core <NUM> through the above-described path. At this time, since the imaging core <NUM> at the distal position of the probe <NUM> moves along the rotation axis while rotating, the imaging core <NUM> performs emission of light to the vascular lumen surface and reception of the reflected light thereof while rotating and while moving along a blood vessel axis.

Here, processing for generating one optical tomographic image will be briefly described with reference to <FIG>. The figure is a diagram for explaining reconstruction processing of a tomographic image of a vascular lumen surface <NUM> where the imaging core <NUM> is positioned. While the imaging core <NUM> makes one rotation (<NUM> degrees), transmission and reception of the measurement light are performed a plurality of times. By transmitting and receiving light one time, single line data in a direction irradiated with the light can be obtained. Therefore, during one rotation, for example, by transmitting and receiving light <NUM> times, <NUM> pieces of line data extending radially from a rotation center <NUM> can be obtained. The <NUM> pieces of line data are dense in the vicinity of the rotation center position and become sparsely apart from each other as they are away from the rotation center position. Therefore, with respect to pixels in a vacant space of each line, known interpolation processing is performed to generate, and a two-dimensional tomographic image which can be visually perceived by a human is generated.

Then, as shown in <FIG>, by connecting generated two-dimensional tomographic images <NUM> along the blood vessel axis, a three-dimensional blood vessel image <NUM> can be obtained. Note that a center position of the two-dimensional tomographic image coincides with a rotation center position of the imaging core <NUM>, but not a center position of the blood vessel cross-section. Although it is feeble, since the light is reflected by a lens surface of the imaging core <NUM>, a surface of the catheter, or the like, several concentric circles occur with respect to the rotation center axis as indicated by reference numeral <NUM>.

Next, a configuration and processing contents relating to an image formation using an ultrasound will be described. Scanning using an ultrasound is performed simultaneously with the above-described optical interference scanning. That is, the ultrasound transceiver accommodated in the imaging core <NUM> performs an emission of ultrasound and a detection of the reflected wave while performing the scanning, rotating the imaging core <NUM>, and moving in the catheter sheath of the probe <NUM>. Therefore, it is necessary to generate a drive signal for driving the ultrasound transceiver accommodated in the imaging core <NUM>, and receive a detection signal of an ultrasound output by the ultrasound transceiver. An ultrasound transmitting and receiving control unit <NUM> performs transmission of the drive signal and reception of the detected signal. The ultrasound transmitting and receiving control unit <NUM> and the imaging core <NUM> are connected via signal line cables <NUM>, <NUM>, and <NUM>. Since the imaging core <NUM> rotates, the signal line cables <NUM> and <NUM> are electrically connected via a slip ring <NUM> provided in the pull-back unit <NUM>. Note that in the drawing, the signal line cables <NUM> to <NUM> are indicated as being connected by one line, but actually, a plurality of signal lines are accommodated.

The ultrasound transmitting and receiving control unit <NUM> operates under the control of the signal processing unit <NUM>, drives the ultrasound transceiver accommodated in the imaging core <NUM>, and generates an ultrasound pulse wave. The ultrasound transceiver converts the reflected wave from the vascular tissue into an electric signal, and supplies the electric signal to the ultrasound transmitting and receiving control unit <NUM>. The ultrasound transmitting and receiving control unit <NUM> outputs the received ultrasound signal to the amplifier <NUM> and amplifies the ultrasound signal. Thereafter, the amplified ultrasound signal is supplied to the signal processing unit <NUM> as ultrasound data via a detector <NUM> and the A/D converter <NUM>, and is temporarily stored in the memory <NUM>. The A/D converter <NUM> performs a sampling the ultrasound signal output by the detector <NUM> at <NUM> for <NUM> points, and generates single line digital data (ultrasound data). Note that although <NUM> is used here, it is calculated on the premise that <NUM> points are sampled for a depth of <NUM> when a sound speed is <NUM>/sec. Therefore, the sampling frequency is not particularly limited to this.

The signal processing unit <NUM> generates an ultrasound image at each position in the blood vessel by converting the ultrasound data stored in the memory <NUM> to grayscale.

Next, with reference to the flowchart of <FIG>, a procedure of processing performed by the control device <NUM> according to the embodiment of the present invention will be described. The user executes the priming operation before the start of the processing in <FIG>. In some cases, however, foreign matter such as air bubbles remains. In such cases, it is not in a state where the ultrasound transceiver can properly execute transmission and reception of signals, and accordingly, it is necessary to prompt the priming operation again.

In step S501, the control device <NUM> determines whether or not the catheter accommodating the imaging core <NUM> is connected to the control device <NUM>. If the connection is detected, the processing proceeds to S502. On the other hand, if the connection is not detected, the processing waits until the connection is detected. In step S502, the control device <NUM> receives a signal from the imaging core <NUM>. The signal received here is at least one of a signal from the optical transceiver and a signal from the ultrasound transceiver.

In step S503, the control device <NUM> determines whether or not it is in a state where the ultrasound transceiver in the imaging core <NUM> can properly execute the transmission and reception of signals. The state where the ultrasound transceiver can properly execute the transmission and reception of signals may be, for example, a state where no foreign matter such as air bubbles remains in the catheter accommodating the imaging core <NUM>. In the processing in S502 and S503, it is possible to make a determination based on a signal of the ultrasound transceiver, or to make a determination based on a signal of the optical transceiver, or to make a determination using signals of both of the transceivers. More details of the processing in S502 and S503 will be described later. If it is in a state where the transmission and reception can be properly executed, the processing proceeds to S504. On the other hand, if it is not in a state where the transmission and reception can be properly executed, the processing proceeds to S506.

In step S504, the control device <NUM> moves the imaging core <NUM> toward the distal side of the catheter before executing the optical path length adjustment processing described later. In step S505, the control device <NUM> performs control so as to execute the optical path length adjustment for imaging using the optical transceiver of the imaging core <NUM>. More specifically, the control (optical path length control) of a position of the one-axis stage <NUM> is performed via the optical path length adjustment drive unit <NUM>. After executing the optical path length adjustment processing, the catheter is inserted into the blood vessel, and processing such as an image acquisition in the blood vessel is performed.

In step S506, the control device <NUM> announces a message prompting the execution of the priming operation (re-operation) to remove air bubbles in the catheter accommodating the imaging core <NUM>. The control device <NUM> announces a message by any method such as voice output, a text display on the display apparatus <NUM>, an output of a warning sound, and lighting of an LED. Thereafter, the processing returns to S502. This completes a series of processing in <FIG>. Note that the series of processing in <FIG> may be started when the control device <NUM> detects the execution of the previous priming operation.

Next, with reference to the flowchart in <FIG> and <FIG>, the details of the processing in S502 and S503 will be described. In this example, it is determined whether or not it is in a state where the ultrasound transceiver can properly execute the transmission and reception, based on a received signal from the ultrasound transceiver of the imaging core <NUM>. The signal from the optical transceiver is not used.

In step S601, the control device <NUM> receives a signal from the ultrasound transceiver of the imaging core <NUM>. In step S602, the control device <NUM> acquires a signal intensity of an outside region of an outer surface of the catheter sheath.

In step S603, the control device <NUM> determines whether or not the signal intensity acquired in step S602 is equal to or greater than a previously stored threshold value (for example, a predetermined normal value). <FIG> shows an example of an ultrasound tomographic image that can be obtained when the priming is correctly performed and air bubbles are not mixed. If the air bubbles are not mixed, as shown in <FIG>, multiple reflected signals of the catheter sheath are detected, and if the air bubbles are mixed, an ultrasound is not transmitted, so that a reflected signal is not obtained and a black image is obtained. If it is determined that the signal intensity is equal to or greater than the previously stored threshold value, the processing proceeds to S604. On the other hand, if it is determined that the signal intensity is less than the previously stored threshold value, the processing proceeds to S605. Alternatively, it may be configured to be determined whether or not a signal received from the ultrasound transceiver includes the reflected signals from the inner surface and the outer surface of the catheter sheath or the multiple reflected signals, and if the reflected signals or the multiple reflected signals are included, it may be determined that it is in a state where the ultrasound transceiver can properly execute the transmission and reception.

In step S604, the control device <NUM> determines that it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals, and terminates the processing. In step S605, the control device <NUM> determines that it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals, and terminates the processing. This completes a series of processing in <FIG>.

Next, with reference to the flowchart in <FIG> and <FIG>, the details of the processing in S502 and S503 will be described. In this example, it is determined whether or not it is in a state wherein the ultrasound transceiver can properly execute the transmission and reception, based on a received signal from the optical transceiver of the imaging core <NUM>. The signal from the ultrasound transceiver is not used.

In step S801, the control device <NUM> receives a signal from the optical transceiver of the imaging core <NUM>. In step S802, the control device <NUM> acquires a signal intensity of a region from a lens surface constituting a part of the optical transceiver to an inner surface of the catheter sheath. <FIG> show examples of acquired intensity distribution of interference light. In <FIG>, reference numeral <NUM> denotes the lens surface, <NUM> denotes the inner surface of the catheter sheath, and <NUM> denotes the outer surface of the catheter sheath. As shown in <FIG>, it can be seen that the intensities of the interference light are increased near the lens surface <NUM>, the catheter sheath inner surface <NUM>, and the catheter sheath outer surface <NUM>. A normal value without mixed air bubbles is distributed as shown in <FIG>.

In step S803, the control device <NUM> determines whether or not the signal intensity acquired in step S802 is equal to or less than the previously stored threshold value. <FIG> shows a vertical cross-sectional diagram of a distal portion of the imaging core <NUM> when air bubbles (air) are mixed. When the air bubbles are mixed as described above, as indicated by a broken line in <FIG>, the value becomes larger in a range of Δd than the normal value in <FIG> (that is, the region from the lens surface to the inner surface of the catheter sheath). The fact that the signal intensity acquired in S802 is equal to or less than the previously stored threshold value can be considered to indicate a state where the ultrasound transceiver can properly execute the transmission and reception of signals (a state where no air bubbles are present). A solid line in <FIG> shows the same as the interference light intensity distribution in <FIG>.

In the processing in S803, it may be configured to compare an integrated value of the signal intensity in the range of Δd with an integrated value of the normal value in the same range, or to compare average values in the range of Δd with each other. Also, it may be configured to compare signal intensities at specific coordinates within the range of Δd with each other. At that time, in order to reduce the influence of error, it may be determined that the air bubbles are mixed when the difference between the two compared values is equal to or greater than the threshold value.

If it is determined that the signal intensity is equal to or less than the previously stored threshold value, the processing proceeds to S804. On the other hand, if it is determined that the signal intensity is greater than the previously stored threshold value, the processing proceeds to S805.

In step S804, the control device <NUM> determines that it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals, and terminates the processing. In step S805, the control device <NUM> determines that it is in a state wherein the ultrasound transceiver can properly execute the transmission and reception of signals, and terminates the processing. This completes a series of processing in <FIG>.

As described above, referring to <FIG>, there have been described examples, in which whether or not it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals is determined based on the signal of the ultrasound transceiver or determined based on the signal of the optical transceiver. The present invention is not limited to these examples, and it may be determined by using the signals of both of these transceivers. Specifically, the processes in <FIG> and <FIG> may each be executed, and when it is determined in both processes that it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals, it may be determined that it is not in a state where the ultrasound transceiver can properly execute the transmission and reception of signals in S503. Also, it may be determined whether or not it is in a state where the ultrasound transceiver can properly execute the transmission and reception, based on an intensity of the received signal or a signal interval from the inner surface of the catheter sheath or the inside region of the inner surface of the catheter sheath which are received from the optical transceiver.

As described above, a control device according to the present embodiment receives signals from an imaging core including an optical transceiver and an ultrasound transceiver, determines whether or not it is in a state where the ultrasound transceiver can properly execute transmission and reception, based on at least one of the signal from the optical transceiver and the signal from the ultrasound transceiver which are received by the receiving unit, and controls execution of an optical path length adjustment for imaging with the optical transceiver when it is determined that the ultrasound transceiver can properly execute the transmission and reception.

In this way, it is possible to automatically execute a series of operations such as a confirmation operation of whether or not air bubbles remain before acquiring the IVUS image, and an optical path adjustment operation necessary before acquiring the OCT image. It is necessary to perform the optical path length adjustment after the priming is surely performed and it is confirmed that no air bubble is mixed. However, according to the processing of the present invention, it is possible to prevent a user from performing an erroneous procedure and thus to prevent an occurrence of an erroneous diagnosis. In this way, it is possible to reduce a burden of prior confirmation by a user, and to prevent an occurrence of an erroneous diagnosis.

Although a dual sensor having the IVUS function and the OCT function has been described in the present embodiment, it may not be always necessary to operate both functions at the time of diagnosis, and there may be a case where it is desired to operate only one function.

It may be configured to receive a mode selection in accordance with a user operation from among a first mode in which imaging using the optical transceiver is executed, a second mode in which imaging using the ultrasound transceiver is executed, and a third mode in which imaging using the optical transceiver and imaging using the ultrasound transceiver are executed. Further, when the second mode is selected, the optical path length adjustment may not be executed. This makes it possible to reduce the time required for unnecessary processing.

Subsequently, with reference to <FIG>, description will be given of turned-back of signals according to the embodiment of the present invention. In OCT, turned-back of a signal may occur by performing Fourier transformation. Since a positional relationship of each signal on the lens surface, on the inner surface of the catheter sheath, and on the outer surface of the catheter sheath changes when a turned-back signal is generated, it is necessary to determine whether or not it is in a state where there is no turned-back signal. In a state where the optical path adjustment is not performed, the three signals obtained from the lens surface, the inner surface of the catheter sheath and the outer surface of the catheter sheath, have various positional relationships due to variations in the fiber length of the catheter.

In <FIG>, a horizontal axis represents an optical path difference, and for each reflected signal from the lens surface, the inner surface of the catheter sheath, and the outer surface of the catheter sheath, numbers are assigned as a first signal, a second signal, and a third signal in order from a signal having a larger optical path difference. When each waveform of a state <NUM> shifts to a left side, a state <NUM> is obtained, and in the state <NUM> and the state <NUM>, no turned-back of a signal has occurred.

When each waveform of the state <NUM> shifts to the left side, the state <NUM> is obtained, and a waveform of the lens surface is turned back with using an origin as a boundary. In order to distinguish the waveform of the lens surface which is turned back from the waveforms of the inner surface of the catheter sheath and outer surface of the catheter sheath (shown in a triangle) which are not turned back, the waveform of the lens surface which is turned back is shown in a parabolic form. As a state <NUM> transitions to a state <NUM>, the waveforms of the inner surface of the catheter sheath and the outer surface of the catheter sheath are also turned back with using the origin as a boundary.

Determination processing should be performed in the absence of such turned-back to determine whether or not it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals. An interval between a signal on the inner surface of the catheter sheath and a signal on the outer surface of the catheter sheath is always constant. In addition, when the three signals obtained from the lens surface, the inner surface of the catheter sheath and the outer surface of the catheter sheath are turned back, the signal on the lens surface occurs on the side where the optical path difference is large.

When the signal on the inner surface of the catheter sheath and the signal on the outer surface of the catheter sheath are each positioned at a position larger than a certain optical path difference (threshold value), it is determined that it is in a state where there is no turned-back signal. In an example of <FIG>, it is determined that the state <NUM> is such that there is no turned-back signal and other states <NUM> to <NUM> are such that there are turned-back signals.

The turned-back of a signal is not actually occurred in the state <NUM>. However, in order to clearly distinguish between the state <NUM> and the state <NUM>, it is conditional that the signal on the inner surface of the catheter sheath and the signal on the outer surface of the catheter sheath are each positioned at a position greater than a certain optical path difference (threshold value). As a result, it is determined that only the state <NUM> is such that there is no turned-back signal.

As described above, before executing the determination processing as to whether or not it is in a state where the ultrasound transceiver can properly execute the transmission and reception of signals, if reflected signals obtained from the optical transceiver are set to be a first signal and a second signal in order from a signal having a larger optical path difference, it can be determined that it is in a state where turned-back does not occur (state <NUM>) when an interval between the first signal and the second signal is a predetermined value, and an optical path difference of the first signal and the optical path difference of the second signal are equal to or greater than a threshold value respectively. Therefore, in this case, it is configured so as to execute the determination processing.

Next, with reference to <FIG>, a relationship between a signal interval and a signal intensity, and a state of the ultrasound receiver according to the embodiment of the present invention will be described. In <FIG>, a horizontal axis represents an optical path difference and a vertical axis represents a signal intensity. In addition, a triangle with a letter L represents a waveform of the lens surface, a triangle with a letter I represents a waveform of the inner surface of the catheter sheath, and a triangle with a letter O represents a waveform of the outer surface of the sheath.

A state <NUM> is a case where a region inside the catheter is water (physiological salt solution) and a region outside the catheter is also water. The region inside the catheter is filled with water, and it is in a proper priming state, that is, a state where the ultrasound transceiver can properly execute the transmission and reception of signals. A state <NUM> is a case where a region inside the catheter is water and a region outside the catheter is air. The region inside the catheter is filled with water, and it is in a proper priming state, that is, a state where the ultrasound transceiver can properly execute the transmission and reception of signals. Note that a signal intensity of the outer surface of the sheath in which air exists becomes high.

A state <NUM> is a case where a region inside the catheter is air and a region outside the catheter is also air. Inside the catheter is filled with air, and it is not in a proper priming state, that is, it is not in a state where the ultrasound transceiver can properly execute the transmission and reception of signals. Note that a signal intensity of the outer surface of the sheath and a signal intensity of the inner surface of the sheath, in which air exists, become high. Also, an interval between the signal of the lens surface and the signal of the inner surface of the sheath becomes small.

A state <NUM> is a case where a region inside the catheter is air and a region outside the catheter is water. Inside the catheter is filled with air, and it is not in a proper priming state, that is, it is not in a state where the ultrasound transceiver can properly execute the transmission and reception of signals. Note that a signal intensity of the inner surface of the sheath in which air exists becomes high. Also, an interval between the signal of the lens surface and the signal of the inner surface of the sheath becomes small.

A state <NUM> is a case where a region inside the catheter is air and water (that is, a part of the inside the catheter is water), and a region outside the catheter is water. Air is included in the region inside the catheter, and it is not in a proper priming state, that is, it is not in a state where the ultrasound transceiver can properly execute the transmission and reception of signals. Note that another signal is detected between the signal of the lens surface and the signal of the inner surface of the catheter sheath.

Therefore, when an interval between the reflected signal from the lens surface received from the optical transceiver and the reflected signal from the inner surface of the catheter sheath is equal to or greater than the threshold value (state <NUM> and state <NUM>), it is possible to determine that it is in a state where the ultrasound transceiver can properly execute the transmission and reception. Further, when an intensity of a reflected signal from the inner surface of the catheter sheath received from the optical transceiver is equal to or less than the threshold value (state <NUM> and state <NUM>), it is possible to determine that it is in a state where the ultrasound transceiver can properly execute the transmission and reception. On the other hand, when a signal received within a region from the lens surface to the inner surface of the catheter sheath is a reflected signal where an intensity of the signal is equal to or greater than a threshold value (state <NUM>), it is possible to determine that it is in a state where the ultrasound transceiver can properly execute the transmission and reception.

Claim 1:
A control device (<NUM>) comprising:
receiving means for receiving a signal from an imaging core (<NUM>) including an optical transceiver and an ultrasound transceiver;
determination means for determining whether or not it is in a state where the ultrasound transceiver is able to properly execute transmission and reception, based on
- a signal from the optical transceiver and a signal from the ultrasound transceiver which are received by the receiving means,
- or the signal from the ultrasound transceiver which are received by the receiving means; and
control means for performing control so that an optical path length adjustment for imaging with the optical transceiver is executed when the determination means determines that the ultrasound transceiver is able to properly execute transmission and reception, wherein
the control device (<NUM>) further comprises:
detection means for detecting a connection of a catheter accommodating the imaging core (<NUM>),
wherein the determination means executes determination processing in response to detecting the connection of the catheter by the detection means,
wherein when the signals received from the ultrasound transceiver include a reflected signal or multiple reflected signals from an inner surface (<NUM>) and an outer surface (<NUM>) of a catheter sheath, the determination means determines that it is in a state where the ultrasound transceiver is able to properly execute the transmission and reception.