Patent ID: 12207914

DETAILED DESCRIPTION

Set forth below with reference to the accompanying drawings is a detailed description of embodiments of a diagnostic method, a diagnostic system, and a control method of a diagnostic system that are used for an intervention procedure representing examples of the inventive diagnostic method, diagnostic system, and control method disclosed here. Note that dimensions of the drawings are exaggerated and are different from actual dimensions in some cases for convenience of description. Furthermore, in the present disclosure and the drawings, regarding constituent elements having substantially the same functions, overlapping description is omitted by giving the same numeral thereto. In the present disclosure, the side inserted in a lumen will be referred to as “the distal side” and the hand side on which operation is carried out will be referred to as “the proximal side.”

First Embodiment

A diagnostic system10according to a first embodiment depicted inFIGS.1and2can be used to detect a tortuosity of a guiding catheter30and a treatment catheter40inserted in a blood vessel. The treatment catheter40treats a stenosis X of an artery V5of the lower limb through a lumen of the guiding catheter30that has been introduced in a radial artery V1of an arm of a patient and reached the artery V5of the lower limb. The tortuosity means that, when the treatment catheter40and the guiding catheter30that are elongated are made to advance, the treatment catheter40and the guiding catheter30meander into a U-shape toward the upstream side of an ascending aorta V2and the movement amount of the distal portion becomes smaller than the advancement amount of the proximal portion or the treatment catheter40and the guiding catheter30suddenly drop into the upstream side of the ascending aorta V2and a catheter main body31kinks. The tortuosity rather easily occurs in a blood vessel having an inner diameter larger than the outer diameters of the treatment catheter40and the guiding catheter30, for example, the ascending aorta V2or the like. Therefore, when the treatment catheter40and the guiding catheter30are inserted from the radial artery V1into an artery and are introduced into the ascending aorta V2, as depicted inFIG.3, the treatment catheter40and the guiding catheter30rather easily get tortuous in such a manner as to drop in the direction in which the aortic valve is located (upstream direction of blood flow) in the region from the ascending aorta V2to an aortic arch V3.

Note that the treatment to which the diagnostic system10is applied is not limited to the treatment of the artery V5of the lower limb with introduction from the radial artery V1of an arm since it may be difficult to accurately grasp the behavior of the elongated body inserted in a biological lumen with only motion in an X-ray contrast image, specifically, for example, it may be difficult to simultaneously observe tortuosities of the treatment site and the elongated body. For example, the case is disclosed in which the elongated body is introduced from the radial artery V1and goes through the inside of the aorta to treat blood vessels of the head, for example, vertebral artery, carotid artery, arteries in the brain as peripheries of them, and so forth. Alternatively, the case is disclosed in which the elongated body is introduced from the radial artery V1and goes through the inside of the aorta to treat blood vessels of the abdomen, celiac artery, renal artery, superior mesenteric artery, inferior mesenteric artery, and peripheral blood vessels of them, or the case of treating blood vessels of the head, for example, vertebral artery, carotid artery, and arteries in the brain as peripheries of them, from an artery of the lower limb, for example, common femoral artery. Alternatively, the case is disclosed in which the elongated body is introduced from the radial artery V1or an artery of the lower limb to treat lumbar artery, splenic artery, left gastric artery, testicular artery, prostatic artery, uterine artery, artery of the lower limb, and so forth. As the treated arteries of the lower limb, aortoiliac bifurcation, common iliac artery, external iliac artery and internal iliac artery, common femoral artery, superficial femoral artery, deep femoral artery, popliteal artery (BTK), anterior tibial artery, peroneal artery, posterior tibial artery, dorsal artery of foot, plantar artery, and other peripheral arteries or collateral flow and so forth are disclosed.

First, the guiding catheter30, the treatment catheter40, and a guide wire50will be described.

As depicted inFIG.2, the guiding catheter30includes the elongated catheter main body31, a tubular distal tip32fixed to the distal portion of the catheter main body31, and a hub33fixed to the proximal portion of the catheter main body31. The distal tip32may be softer than the catheter main body31so that biological tissue may be kept from being damaged and the distal tip32includes X-ray contrast property. The distal tip32is formed through mixing of a material with relatively high X-ray contrast property into a soft resin material, for example. The material with relatively high X-ray contrast property (X-ray radiopacity), can be, for example, a metal such as platinum, gold, silver, iridium, titanium, or tungsten or an alloy of platinum, gold, silver, iridium, titanium, or tungsten. Furthermore, it is preferable that the catheter main body31also have X-ray radiopacity. However, the configuration of the catheter main body31is not limited to the catheter main body31as disclosed above.

The catheter main body31includes a lumen into which the treatment catheter40can be inserted from the hub33. Thus, the guiding catheter30can guide the treatment catheter40to an intended position in a biological body.

The treatment catheter40can be a device that treats the stenosis X. The treatment catheter40can be a balloon catheter including a balloon42that can inflate, for example. The treatment catheter40includes a treatment catheter main body41, the balloon42that is disposed at the distal portion of the treatment catheter main body41and can inflate, and a treatment hub43disposed at the proximal portion of the treatment catheter main body41. Note that the treatment catheter40does not have to be a balloon catheter.

The guide wire50is inserted into the treatment catheter40and the guiding catheter30, and the treatment catheter40and the guiding catheter30are made to advance to the intended position along the guide wire50.

Next, the diagnostic system10will be described. As depicted inFIG.1, the diagnostic system10includes an irradiating unit11that carries out irradiation with X-rays, a detecting unit12that detects the X-rays, a control unit20that identifies the occurrence of a tortuosity from the detected X-rays, a display unit13(notifying unit), a sound output unit14(notifying unit), and an input unit15.

An X-ray angiography can generated by the irradiating unit11being supplied electrical power. As depicted inFIG.2, the irradiating unit11irradiates a predetermined irradiation range A of the body of the patient with the X-rays. In accordance with an embodiment, it can be preferable that the irradiation range A be limited to only part of the body of the patient in order to set the exposure range of the patient as small as possible. The irradiation range A may be, for example, a range including the lower side of a descending aorta V4, an aortoiliac bifurcation V6, the upper side of the artery V5of the lower limb, and the stenosis X.

As depicted inFIG.1, the detecting unit12may be a planar FPD (Flat Panel Detector) or the like that receives X-rays and outputs an electrical signal. The detecting unit12is disposed at a position opposed to the irradiating unit11and a patient can be arranged between the irradiating unit11and the detecting unit12.

The control unit20can include a calculating section21, an image processing section22, and a system control section23that comprehensively controls the whole of the system. The control unit20includes a storing circuit and an arithmetic circuit. The storing circuit stores a program and various parameters. The arithmetic circuit can be a CPU (Central Processing Unit), for example, and reads the program and various parameters from the storing circuit to execute arithmetic processing.

The image processing section22converts the electrical signal detected in the detecting unit12to image data that can be displayed on the display unit13as an image and causes the display unit13to display an X-ray image. Furthermore, the image processing section22can cause the display unit13to display a result calculated in the calculating section21.

The calculating section21identifies the position of the distal end of the guiding catheter30from the electrical signal detected in the detecting unit12. The calculating section21may identify the position of the distal end of the guiding catheter30from the image data resulting from processing in the image processing section22. The calculating section21further calculates an amount D of deviation of the distal end of the guiding catheter30. As depicted inFIG.3, the amount D of deviation is an amount substantially proportional to a length L from an expected position P1of the distal end of the guiding catheter30in the proper state in which an abnormality such as a tortuosity has not occurred to a position P2of the distal end of the guiding catheter30in the state in which an abnormality such as a tortuosity has occurred.

The display unit13is a monitor that can display a visually-recognizable image. The displayed image may be a moving image, or alternatively, may be a still image. The display unit13displays an image based on an image signal received from the image processing section22.

The sound output unit14may be a speaker or buzzer that outputs sound or voice that can be recognized by the auditory sense. The sound output unit14can notify a result calculated in the calculating section21by sound or voice.

The input unit15is used for the user to input data to the control unit20. The input unit15can include a keyboard, a mouse, a microphone, a medium reading device, and so forth, for example.

Next, a diagnostic method using the diagnostic system10according to the first embodiment will be described with reference to a flowchart of the control unit20depicted inFIG.4. Here, the description will be made by taking as an example the case of treating the stenosis X of the artery V5of the lower limb of a patient as depicted inFIG.2.

First, before the intervention procedure, the physician operates the input unit15depicted inFIG.1to start operation of the diagnostic system10. When the operation of the diagnostic system10is started, the control unit20causes irradiation with X-rays from the irradiating unit11and causes the detecting unit12to detect X-rays that have passed through the body of the patient. The control unit20controls the image processing section22in such a manner that an electrical signal output based on a result detected in the detecting unit12is received in the image processing section22. The image processing section22that has received the electrical signal creates two-dimensional image data that can be displayed on the display unit13for every sampling time when each image configuring a moving image is acquired. The image processing section22transmits the created image data to the display unit13. When receiving the image data from the image processing section22, the display unit13displays an image on a screen. In accordance with an embodiment, the created image may be a three-dimensional image.

Next, as depicted inFIG.2, the physician carries out puncture on the right radial artery V1, for example, by a puncture needle and disposes a mini-guide wire in the blood vessel. Next, a sheath introducer60in which a dilator is inserted is introduced into the blood vessel along the mini-guide wire. Next, the dilator and the mini-guide wire are withdrawn. Subsequently, the guiding catheter30in which the guide wire50is inserted is introduced into the blood vessel through the sheath introducer60. Alternatively, after the guide wire50is inserted into the sheath introducer and the sheath introducer is withdrawn, a guiding sheath with a lumen in which the dilator is inserted may be inserted along the guide wire50.

Next, the guiding catheter30is pushed and advanced along the guide wire50to at least the inside of the aortic arch V3of the patient. Specifically, the distal tip32of the guiding catheter30is advanced through the right radial artery, the right brachial artery, the right subclavian artery, and the brachiocephalic artery and reach the aortic arch V3. The distal tip32may further be advanced to go beyond the aortoiliac bifurcation V6from the descending aorta V4and be disposed in front of the stenosis X of the artery V5of the lower limb. Next, the guide wire50is made to reach a position beyond the stenosis X. The physician can operate the guiding catheter30and the guide wire50while checking (i.e., observing) a moving image that falls within the irradiation range A and is displayed on the display unit13.

Next, the proximal end of the guide wire50is inserted into a guide wire lumen of the treatment catheter40and the guide wire50is inserted into the guiding catheter30. Next, the treatment catheter40is protruded from an opening part of the distal tip32. The physician can carry out operation while making visual contact with the guiding catheter30, the guide wire50, and the treatment catheter40that fall within the irradiation range A and are displayed on the display unit13.

Next, in the state in which the guiding catheter30is fixed at a position desirable for treatment by the treatment catheter40, the physician operates the input unit15to start processing of detecting the occurrence of a tortuosity. When the processing of detecting the occurrence of a tortuosity is started, the control unit20determines whether or not the present time is the sampling time (step S10), and controls the calculating section21in such a manner that an electrical signal output in the detecting unit12based on a detection result is received in the calculating section21every sampling time (step S11).

The calculating section21that has received the electrical signal creates image data as depicted inFIG.5Aand identifies the guiding catheter30. Because the guiding catheter30has the distal tip32having X-ray contrast property, the calculating section21can determine the existence of the guiding catheter30by known image recognition techniques by comparing information on the distal tip32(for example, dimensions and shape) stored in the storing circuit of the control unit20in advance with the image data (step S12). When determining that the guiding catheter30exists in the irradiation range A, the calculating section21identifies the position of the guiding catheter30in the blood vessel (step S13). In the present embodiment, the position of the guiding catheter30is identified based on the position of the distal end of the guiding catheter30. The position of the distal end of the guiding catheter30can be represented by various parameters. For example, as depicted inFIGS.5A and5B, the position of the distal end of the guiding catheter30can be represented by the area of occupation of the guiding catheter30(distal tip32and catheter main body31) in the image data. That is, when the area of the guiding catheter30is larger in the image data, the distal end of the guiding catheter30reaches the distal side. Note that the catheter main body31located on the proximal side of the distal tip32has X-ray contrast property similarly to the distal tip32and therefore the catheter main body31can be identified from the X-ray image. The area of the guiding catheter30is substantially proportional to the length in the longitudinal direction regarding the guiding catheter30located in the irradiation range A and therefore is preferable as a parameter depicting the position of the distal end of the guiding catheter30. Note that it is also possible for the calculating section21to identify the position of the distal end of the distal tip32based on coordinates from the image data. The calculating section21calculates the position of the distal end of the guiding catheter30every sampling time and causes the storing circuit to store the calculation result (step S14). Note that the calculating section21may calculate the position of the distal end of the guiding catheter30directly from the electrical signal of the detecting unit12without creating the image data from the electrical signal.

The calculating section21calculates the amount D of deviation by which the guiding catheter30has moved in the proximal direction from the expected position P1of the guiding catheter30desirable for procedure of the treatment catheter40(step S15). The expected position P1of the guiding catheter30is the position of the guiding catheter30when the physician has started the processing of detecting the occurrence of a tortuosity. Therefore, the physician can optionally set the expected position P1of the distal end of the guiding catheter30by optionally starting the processing in the desirable state. Note that the expected position P1of the distal end of the guiding catheter30may be automatically acquired as the position of the guiding catheter30in the state in which the guiding catheter30has been made to advance to the intended position after the processing by the calculating section21is started.

The calculated amount D of deviation is processed by the image processing section22and is transmitted to the display unit13together with X-ray image data to be displayed on the display unit13(step S16). For example, as depicted inFIG.6A, the amount D of deviation of the distal end of the guiding catheter30in the proximal direction is displayed as a bar graph in which the length of a bar changes depending on the amount. In accordance with another embodiment, the amount D of deviation of the distal end of the guiding catheter30in the proximal direction may be displayed by another method. For example, the amount D of deviation may be displayed by a line graph, characters such as numerical values, colors that change depending on the value, and so forth.

When the physician advances the treatment catheter40toward the distal side in the state in which the position of the introduction into the patient regarding the proximal portion of the guiding catheter30is fixed, the distal end of the treatment catheter40reaches the stenosis X as depicted inFIG.2. When the treatment catheter40further advances toward the distal side so that the balloon42of the treatment catheter40may pass through the stenosis X, the balloon42receives resistance from the stenosis X. At this time, when the resistance which the balloon42receives from the stenosis X is high, the treatment catheter40bends and the movement length of the distal portion of the treatment catheter40becomes smaller than the advancement length of the proximal portion. Thus, the treatment catheter40may causes a tortuosity at any position in the longitudinal direction. When the treatment catheter40causes a tortuosity, the guiding catheter30in which the treatment catheter40is inserted also causes a tortuosity at the same position as the treatment catheter40. When the treatment catheter40advances into the artery, the guiding catheter30is fixed at a position appropriate for use of the treatment catheter40differently from the treatment catheter40. That is, the position of the proximal portion of the guiding catheter30does not move relative to the patient. For this reason, as depicted inFIGS.3and5B, when a tortuosity occurs in the guiding catheter30, the distal side of the guiding catheter30moves to return to the proximal side. Thus, by monitoring the distal end of the guiding catheter30, a tortuosity that occurs not only in the irradiation range A but outside the irradiation range A can be detected. As depicted inFIGS.6A and6B, the physician can determine the tortuosity from the amount D of deviation of the guiding catheter30displayed on the display unit13.

It is also possible for the calculating section21to cause the display unit13to display a warning according to the value of the amount D of deviation. The calculating section21reads out a threshold S stored in the storing circuit in advance and compares the threshold S with the calculated amount D of deviation (step S17). If the amount D of deviation exceeds the threshold S (or if the amount D of deviation is equal to or larger than the threshold S), the calculating section21causes the display unit13to display the warning (step S18). As the displayed warning, for example, the color of the part that exceeds the threshold S in the bar of the bar graph can be displayed as a different color as depicted inFIG.6B, or characters depicting the warning can be displayed. Furthermore, it is also possible for the calculating section21to cause a sound or voice representing the warning to be output from, for example, the sound output unit14rather than the display unit13. The threshold S is selected as appropriate and can be, for example, 20 mm to 150 mm, preferably 50 mm to 100 mm, in the present embodiment.

Furthermore, for example, when the guiding catheter30tilts in the irradiation direction of X-rays as depicted inFIG.7, a thickness T along the irradiation direction of the guiding catheter30becomes larger and therefore the color depth of the two-dimensional image becomes larger in the two-dimensional image data. Therefore, the calculating section21can identify the tilt of the guiding catheter30with respect to the irradiation direction of X-rays by comparing the color density of the image data with a value set in advance. Accordingly, when the tilt of the guiding catheter30in the irradiation direction of X-rays is undesirable, the calculating section21can cause the display unit13and the sound output unit14to output a warning.

Moreover, coordinate data of the blood vessel travel of the patient may be acquired in advance by CT (Computed Tomography) or the like and at least part of the coordinate data of the blood vessel travel may be employed as the expected position P1. The deviation of the guiding catheter30can be detected by the amount D of deviation from the expected position P1in the blood vessel from, which allows the physician to detect specific behavior such as perforation of the blood vessel by the guiding catheter30rather easily and with relatively high accuracy. The coordinate data of the blood vessel travel may be stored in the storing circuit of the control unit20. However, the coordinate data may be stored in another device that can communicate with the control unit20.

The physician can continue or review the procedure based on the notification of the amount D of deviation and the warning. For example, if the amount D of deviation exceeds the threshold S, the physician can move at least one of the guiding catheter30and the treatment catheter40to the proximal side and eliminate the tortuosity. After eliminating the tortuosity, the physician can operate the input unit15again and reset and resume the processing of detecting the occurrence of a tortuosity.

When the balloon42is inserted into the stenosis X, the physician attaches an inflator to the treatment hub43and injects a liquid. Thereby, the balloon42inflates and dilates the stenosis X. Next, the inflator is operated to drain the liquid and contract the balloon42.

The physician can operate the input unit15at a timing desirable for the physician oneself and stop the processing of detecting the occurrence of a tortuosity (step S19). Due to this, the control unit20stops the processing by the calculating section21. The physician moves the treatment catheter40, the guide wire50, and the guiding catheter30to the proximal side and withdraws the treatment catheter40, the guide wire50, and the guiding catheter30to outside of the body, which ends the treatment of the stenosis X.

As above, the diagnostic method of the first embodiment is a diagnostic method for diagnosing the behavior of the guiding catheter30having a distal end and a proximal end in a biological lumen. The diagnostic method includes inserting the guiding catheter30into the biological lumen from the distal end and detecting energy that has passed through a body outside the body after irradiating the inside of the body with the energy from the outside of the body. The diagnostic method also includes identifying the position of the guiding catheter30in the body by the detected energy and comparing the identified position of the guiding catheter30with an expected position P1that is the position of the guiding catheter30in proper behavior and detecting specific behavior of the guiding catheter30from the amount D of deviation of the position of the guiding catheter30with respect to the expected position P1.

The diagnostic method configured in the aforesaid manner can detect the specific behavior of the guiding catheter30rather easily and with relatively high accuracy by detecting the amount D of deviation of the guiding catheter30with respect to the expected position P1.

In the diagnostic method, a tortuosity of the guiding catheter30outside the irradiation range A of the energy is detected from the amount D of deviation of the distal end of the guiding catheter30toward the proximal side in the detecting of the specific behavior of the guiding catheter30, which allows the present diagnostic method to detect a tortuosity of the guiding catheter30outside the irradiation range of the energy rather easily and with relatively high accuracy even when the irradiation range A of the energy is limited.

In the diagnostic method, the guiding catheter30may be inserted from the radial artery V1and be made to reach the artery V5of the lower limb in the inserting of the guiding catheter30into the body, and a tortuosity of the guiding catheter30in the ascending aorta V2may be detected in the detecting of the specific behavior of the guiding catheter30. Due to this, while the guiding catheter30located in the artery V5of the lower limb in which treatment is carried out is observed in the irradiation range A of the energy, the occurrence of a tortuosity of the guiding catheter30in the ascending aorta V2distant from the artery V5of the lower limb can be detected rather easily and with relatively high accuracy.

The expected position P1may be at least part of coordinate data of the biological lumen set in advance and that the guiding catheter30is out of the biological lumen may be detected from the amount D of deviation in the detecting of the specific behavior of the guiding catheter30. Due to this, through detecting that the guiding catheter30is out of the biological lumen, the occurrence of perforation or the like of the biological lumen by the guiding catheter30can be detected rather easily and with relatively high accuracy.

The diagnostic method includes notifying a warning that can be recognized by the visual sense or the auditory sense when the amount D of deviation is equal to or larger than the threshold S set in advance or exceeds the threshold S. The warning notification by the visual sense or the auditory sense can allow the physician the ability to properly grasp the risk of the procedure, which can improve the relative safety of the procedure.

The elongated body detected by the detecting unit12is the guiding catheter30in which another elongated body can be inserted. Due to this, the specific behavior of the guiding catheter30can be detected rather easily and with relatively high accuracy by detecting the amount D of deviation of the guiding catheter30with respect to the expected position P1. Furthermore, in the guiding catheter30, the proximal portion does not normally move relative to the biological body when another elongated body such as the treatment catheter40or the guide wire50passes through the inside of the guiding catheter30. In this case, because the expected position P1of the guiding catheter30does not move, the detection of the amount D of deviation of the guiding catheter30with respect to the expected position P1is rather easy. Therefore, by detecting the guiding catheter30, a tortuosity of another elongated body operated inside the guiding catheter30can be detected rather easily and with relatively high accuracy.

Moreover, the diagnostic system10according to the first embodiment is the diagnostic system10that diagnoses the behavior of the guiding catheter30having a distal end and a proximal end in a living body. The diagnostic system10has the irradiating unit11that irradiates the inside of the body with energy from the outside of the body, the detecting unit12that detects the energy that has passed through the body outside the body, the control unit20that identifies the position of the guiding catheter30in the body by the energy detected in the detecting unit12, and a notifying unit that carries out notification that can be recognized by the visual sense or the auditory sense of the physician. The control unit20reads or calculates the expected position P1, the expected position P1being the position of the guiding catheter30in proper behavior (i.e., without tortuosity) and calculates the amount D of deviation of the identified position of the guiding catheter30with respect to the expected position P1to cause the notifying unit to output a notification according to the calculated amount D of deviation.

The diagnostic system10configured in the aforesaid manner detects and notifies the amount D of deviation of the guiding catheter30with respect to the expected position P1and therefore can detect the specific behavior of the guiding catheter30rather easily and with relatively high accuracy.

The control unit20calculates the amount D of deviation of the distal end of the guiding catheter30toward the proximal side, which allows the diagnostic system10to detect a tortuosity at any position between the distal end and the proximal end of the guiding catheter30from the amount D of deviation of the distal end of the guiding catheter30toward the proximal side. Therefore, the diagnostic system10can detect not only a tortuosity of the guiding catheter30in the irradiation range A of the energy but also a tortuosity of the guiding catheter30outside the irradiation range A.

The control unit20may employ at least part of coordinate data of a biological lumen as the expected position P1. Due to this, through detecting that the guiding catheter30is out of the biological lumen, specific behavior such as perforation or the like of the biological lumen by the guiding catheter30can be detected rather easily and with relatively high accuracy.

The control unit20causes the notifying unit to output a warning that can be recognized by the visual sense or the auditory sense when the amount D of deviation is equal to or larger than the threshold S set in advance or exceeds the threshold S, which allows the physician to properly grasp the risk of the procedure from the notified warning, which can help improve the safety of the procedure.

Furthermore, a control method of the diagnostic system10according to the first embodiment is a control method of the diagnostic system10that diagnoses the behavior of the guiding catheter30having a distal end and a proximal end in a body. The control method includes causing the irradiating unit11to carry out irradiation with energy, causing the detecting unit12to detect the energy, and receiving information on the detected energy from the detecting unit12and identifying the position of the guiding catheter30from the information. The control method can also include identifying the expected position P1that is the position of the guiding catheter30in proper behavior, calculating the amount D of deviation of the position of the guiding catheter30with respect to the expected position P1, and causing a notifying unit that carries out notification that can be recognized by the visual sense or the auditory sense of the physician to notify a notification according to the calculated result.

The control method of the diagnostic system10configured in the aforesaid manner causes the notifying unit to notify the notification according to the amount D of deviation of the guiding catheter30with respect to the expected position P1. Therefore, the physician that has received the notification can detect specific behavior of the guiding catheter30rather easily and with relatively high accuracy.

Second Embodiment

The diagnostic system10according to a second embodiment is different from the first embodiment in that the diagnostic system10includes a proximal detecting unit16as depicted inFIG.8.

In accordance with an embodiment, the proximal detecting unit16detects a position at which the guiding catheter30is inserted into the skin of the patient. The proximal detecting unit16can be a camera that can take a moving image, for example. Note that the proximal detecting unit16may image the proximal portion of the treatment catheter40or the proximal portion of the guide wire50.

The calculating section21identifies a proximal length that is the length in the longitudinal direction regarding the guiding catheter30located outside the body of the patient from an electrical signal detected in the proximal detecting unit16. The calculating section21identifies and stores the proximal length every sampling time and calculates the variation amount of the proximal length. Therefore, when the treatment catheter40is made to advance into an artery, the position of the proximal portion of the guiding catheter30may move relative to the patient. The calculating section21can relatively accurately calculate the expected position P1at which the distal end of the guiding catheter30should exist according to the variation amount of the proximal length. The calculating section21may identify the proximal length by using a depth marker disposed on the surface of the catheter main body31of the guiding catheter30. Furthermore, the proximal detecting unit16that detects the proximal length of the proximal portion of the guiding catheter30may be, for example, a sensor configured to capture motion attached to a hand of the physician or a sensor attached to the proximal portion of the guiding catheter30by coupling means such as a clip. The sensor attached to the proximal portion of the guiding catheter30can be a sensor that can be detected by another piece of detecting equipment. Moreover, the proximal detecting unit16that detects the proximal length of the guiding catheter30is disposed on an instrument around which the guiding catheter30is wound in order to hold the guiding catheter30and can detect the length by which the guiding catheter30is wound. The sensor can be, for example, a revolution indicator or the like.

As above, the diagnostic system10according to the second embodiment has the proximal detecting unit16that detects the guiding catheter30located outside the body of the patient. The control unit20receives the detection result from the proximal detecting unit16and calculates the proximal length that is the length in the longitudinal direction regarding the guiding catheter30located outside the body of the patient. In addition, the control unit20calculates the expected position P1based on the position of the distal end of the guiding catheter30identified by energy detected in the detecting unit12and the proximal length. Due to this, even when the proximal length of the guiding catheter30changes, the accurate expected position P1that moves can be set in consideration of the proximal length. Therefore, the amount D of deviation of the guiding catheter30with respect to the accurate expected position P1that moves can be detected and thus specific behavior of the guiding catheter30can be detected rather easily and with relatively high accuracy.

Note that the method in which the detection result of the proximal detecting unit16is used for the calculation of the expected position P1is particularly effective in the case of identifying a tortuosity of the treatment catheter40and the guide wire50whose proximal portions move.

The present disclosure is not limited to only the above-described embodiments and various changes can be made by those skilled in the art within the technical idea of the present disclosure. For example, the apparatus to acquire image data is not limited to the X-ray angiography and may be CT (Computed Tomography), MRI (Magnetic Resonance Imaging), ultrasound computed tomography, imaging using infrared rays, imaging using visible light, or the like. Furthermore, the image data to be acquired may be three-dimensional image data instead of two-dimensional image data.

Moreover, in the above-described embodiments, a tortuosity of the guiding catheter30is detected in order to identify a tortuosity of the treatment catheter40. However, the configuration is not limited to the detecting of the guiding catheter30is detected in order to identify the tortuosity of the treatment catheter40. For example, a tortuosity of the guiding catheter30may be detected in order to identify a tortuosity of the guide wire50. Furthermore, a tortuosity of the treatment catheter40may be detected in order to identify a tortuosity of the guide wire50. In addition, the elongated body about which a tortuosity is detected may be used alone and be detected instead of being used in combination with another elongated body.

Furthermore, continuation or review of the procedure based on the amount D of deviation and notification of a warning is not limited to determination by the physician and may be carried out by a third party or may be automatically carried out with reference to a past surgical operation record or big data. Alternatively, regularity or relevance may be found out from a large amount of data by using an artificial intelligence (hereinafter, AI) made to have learned past data and determination and prediction may be carried out. Moreover, with use of a multi-layered algorithm “deep neural network” modeled after the cranial nerve circuit of the human, correction and decision of setting of a threshold may be carried out by an AI.

Furthermore, the image data may be acquired from not one direction but different two or more directions. For example, as in a modification example depicted inFIG.9, the diagnostic system10includes a first irradiating unit11A, a second irradiating unit11B that carries out irradiation with energy from a different direction from the first irradiating unit11A, a first detecting unit12A that detects energy with which the irradiation is carried out from the first irradiating unit11A, and a second detecting unit12B that detects the energy with which the irradiation is carried out from the second irradiating unit11B. For example, as depicted inFIGS.10A and10B, when a micro-catheter60(elongated body) is made to advance into a blood vessel V8that branches at an acute angle from a main blood vessel V7, it is impossible to favorably detect the part that has entered the blood vessel V8in the micro-catheter60from an image obtained by the first detecting unit12A (seeFIG.10A) in some cases. However, there is a possibility that the part that has entered the blood vessel B8in the micro-catheter60can be favorably detected from an image obtained by the second detecting unit12B (seeFIG.10B). Therefore, movement of an X-ray marker61of the micro-catheter60can be detected by using the pieces of image data obtained from the different first detecting unit12A and second detecting unit12B, which make it possible to detect that the micro-catheter60overruns in the main blood vessel V7as depicted by one-dot-chain lines inFIG.10. In the first embodiment, the diagnostic system10may be used to prevent the guiding catheter30from advancing to the ascending aorta V2. In the present modification example, the diagnostic system10may be used to suppress excessive advancement of the micro-catheter60beyond necessity in the specific main blood vessel V7.

Moreover, the diagnostic system10may also be used for puncture under ultrasound guide. When puncture with a puncture needle is carried out from skin, an ultrasound tomographic image can be acquired by an ultrasound probe that outputs ultrasound and detects an ultrasound echo. The ultrasound probe can be a detecting unit as well as an irradiating unit. In the puncture needle, a cut surface is formed through oblique cutting in order to form a sharp needle tip. For this reason, in the puncture needle, a force of a vector toward the opposite direction to the cut surface acts on the needle tip at the time of puncture. Thus, the puncture needle gradually changes its direction and warps to deviate from the target. For this reason, due to the warpage of the puncture needle and penetration of the puncture needle to the outside of the target, the detection of the needle tip of the puncture needle by the ultrasound tomographic image becomes difficult in some cases. Even in such a case, by detecting the puncture needle by using the diagnostic system10, specific behavior (for example, warpage) of the puncture needle can be rather easily detected through detection of the amount of deviation of the puncture needle. Note that the diagnostic system10may detect the movement speed of the puncture needle instead of detecting the amount of deviation of the puncture needle.

Furthermore, if machine learning is caused to determine the amount D of deviation and notification of a warning, signals obtained in the detecting unit12, the first detecting unit12A, the second detecting unit12B, and the proximal detecting unit16do not need to be converted to images. Note that the machine learning may use image information similarly to the human and may use non-image information that cannot be determined by the human eye if the non-image information can be recognized and classified as a feature (for example, hardness of a lesion site).

Here, the image information refers to information that can be recognized and understood with the human eye and be used for diagnosis and refers to what is obtained by image conversion in electromagnetic wave information. Therefore, the non-image information refers to what is in such a state as to be impossible to recognize and understand as the shape of a blood vessel or a lesion site by the human eye and therefore be impossible to use for diagnosis, such as data such as digital bits described with “0” and “1” and quantum bits in which both states of “0” and “1” used in a quantum computer are superimposed on each other and DICOM information itself that is not displayed on a data structure or GUI. Alternatively, the non-image information may be information beyond the resolution of the human eye, such as what is relatively small and cannot be recognized by the human eye even when being enlarged because being beyond the resolution of the human eye, what cannot be separated into two points and is recognized as one point, and difference between light and shade in which difference in the grayscale cannot be recognized. The warning means that transmits deviation may be, in addition to displaying on a screen, sound, vibration (equivalent to vibration for notification by a smartphone put in a pocket), or a combination of two or more of them. The displaying, sound, and vibration may be set larger according to the amount D of deviation and the warning means may be increased like displaying on a screen and vibration.

The detailed description above describes embodiments of a diagnostic method, a diagnostic system, and a control method of a diagnostic system that are used for an intervention procedure. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.