JP3300419B2 - Thrombolysis treatment device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a thrombolysis treatment apparatus for dissolving a thrombus generated in a blood vessel by using a thrombolytic agent and ultrasonic waves in combination.

[0002]

2. Description of the Related Art In Europe and the United States, vascular diseases such as arteriosclerosis and thrombosis have been extremely frequently observed and are increasing. On the other hand, cerebral infarction in Japan
Thrombotic ischemic heart disease such as myocardial infarction is increasing and is one of the two leading causes of death along with cancer. In treating this ischemic heart disease, it is necessary to remove the thrombus that causes the disease. Surgical removal of thrombus or vascular transplantation is particularly unsuitable for elderly people who are susceptible to this type of disease because of the high invasiveness of the patient. In addition, blood clots formed in blood vessels of the brain and coronary arteries of the heart, if not removed promptly, will cause infarction of brain cells and cardiomyocytes. Therefore, it is required to remove as quickly as possible.

[0003] Therefore, PTCR (percutaneous thrombolysis in the coronary artery), intravenous injection (a method of administering a large amount of a high-concentration thrombolytic agent over a long period of time by intravenous drip or the like), and arterial injection (catheter artery via a catheter) And thrombolytic treatments such as PTCA (percutaneous coronary dilatation) are attracting attention as less invasive, faster and more effective thrombosis treatments than surgery etc. I'm taking a bath. Among them, PTCR is a method of rapidly injecting a thrombolytic agent near a thrombus while putting a catheter into a coronary artery and using an X-ray contrast agent to perform fluoroscopic observation of the position of the blood vessel and the catheter. Low rate and X-ray exposure. The intravenous injection method has a relatively high vascular communication rate, but has a side effect that a large amount of thrombolytic agent makes it difficult for blood to coagulate. Furthermore, PTCA is a method of plastically expanding the inner wall of a blood vessel using a balloon catheter, so that the blood vessel communication rate is good, but the thrombotic recurrence rate is high.

Recently, administration of a thrombolytic agent by intravenous injection,
It has been reported that the combined use of extracorporeal ultrasonic irradiation on thrombus enhances the effect of thrombolytic agent, and reduces the dose of thrombolytic agent, thereby reducing side effects (" Medical Electronics and Biotechnology "Vo
l. 26, p. 536, 1988). However, even when using such a method, it is desirable to minimize the dose of the thrombolytic agent. To do so, efficiently irradiate the therapeutic ultrasonic waves to the thrombus site and monitor the therapeutic effect of thrombolysis, so that if the thrombus is completely dissolved, no extra administration of thrombolytic agent is made. Is required. It is also desired that the therapeutic effect of thrombolysis can be quantitatively determined in order to perform more accurate and efficient treatment.

[0005]

As described above, the thrombolysis treatment method using both administration of a thrombolytic agent and irradiation with ultrasonic waves has the advantages of having a high therapeutic effect and few side effects in principle. In order to maximize its advantages, it is necessary to efficiently and reliably irradiate the therapeutic ultrasonic waves to the affected thrombus site, and monitor the thrombotherapeutic effect to avoid unnecessary administration of thrombolytic agents. It is necessary to proceed in the treatment by more accurately determining the therapeutic effect.

According to the present invention, it is possible to efficiently irradiate therapeutic ultrasonic waves and monitor the effect of thrombolytic treatment when thrombolytic treatment is carried out by using a combination of administration of a thrombolytic agent and irradiation of ultrasonic waves. It is an object of the present invention to provide a thrombolytic therapy device which has a high therapeutic effect and can minimize the side effects by minimizing the dose of a thrombolytic agent.

[0007]

SUMMARY OF THE INVENTION In order to solve the above-mentioned problems, the present invention relates to a thrombolysis treatment apparatus for dissolving a thrombus by irradiating a therapeutic ultrasonic wave to a thrombus site in a blood vessel into which a thrombolytic agent has been injected. An ultrasonic irradiator for irradiating a therapeutic ultrasonic wave to a thrombus site, an ultrasonic probe for obtaining tomographic image information in a patient, and a first ultrasonic wave for imaging and displaying tomographic image information from the ultrasonic probe An imaging device, a catheter inserted into a blood vessel, an ultrasonic transducer installed on the catheter to obtain tomographic image information in the blood vessel, and a second image for displaying and displaying tomographic image information from the ultrasonic transducer It is a basic feature to have an ultrasonic imaging device.

According to the present invention, in such a basic configuration, the ultrasonic transducer is provided with a function of detecting ultrasonic waves from the ultrasonic probe, and the ultrasonic transducer output from the ultrasonic transducer is output from the ultrasonic probe. The apparatus further comprises a position detecting means for processing a detection signal of a sound wave to detect a position of the catheter, and a means for displaying a detection result of the position detecting means on a display image of the first ultrasonic imaging apparatus. And

In this case, the ultrasonic transducer is preferably constituted by at least one strip-shaped piezoelectric body installed along the longitudinal direction of the catheter, and the piezoelectric body has a thickness, a circumferential length of the catheter, and a catheter shaft. Any two of the lengths in the direction correspond to the ultrasonic frequency for obtaining the tomographic image information in the blood vessel and the ultrasonic frequency for obtaining the tomographic image information in the patient used by the ultrasonic probe, respectively. And It is preferable that the thickness, the length in the catheter circumferential direction, and the remaining length in the axial direction of the catheter correspond to the frequency of the ultrasonic wave emitted by the ultrasonic wave irradiator.

Further, in the present invention, in addition to the above-described basic configuration, a calculating means for calculating a numerical value indicating a thrombolytic treatment effect based on tomographic image information from an ultrasonic transducer, and this calculating means calculated value is characterized by comprising a means for stopping the therapeutic ultrasound irradiation from the ultrasonic irradiation elevation device when it reaches a predetermined value.
Further, a means may be provided for stopping the injection of the thrombolytic agent into the blood vessel when the numerical value calculated by the calculation means reaches a predetermined value.

[0011]

In the first ultrasonic imaging apparatus, for example, a B-mode tomographic image is displayed as a tomographic image in the patient's body, and the thrombus site can be known from this display. On the other hand, in the second ultrasonic imaging apparatus, a tomographic image of a cross section is displayed as a tomographic image in a blood vessel, and the thrombolysis treatment status can be understood from this display. Therefore, it is possible to reliably irradiate the therapeutic ultrasonic wave to the thrombus site to enhance the therapeutic effect, and to stop unnecessary use of the thrombolytic agent when the thrombus is sufficiently dissolved, thereby avoiding unnecessary side effects.
That is, it is possible to accurately grasp the position of the thrombus which is difficult to see in the ultrasonic simple B-mode image, and to avoid unnecessary irradiation of the therapeutic ultrasonic waves.

Further, numerical values indicating the therapeutic effect of thrombus, obtained by calculation, for example, patency rates, or to stop the therapeutic irradiation ultrasound from the ultrasonic irradiation elevation device when this reaches a predetermined value,
Further, by stopping the injection of the thrombolytic agent into the blood vessel, the treatment can be automatically stopped when the thrombus is sufficiently dissolved, thereby enabling more efficient treatment with less side effects.

Further, in the present invention, the ultrasonic transducer detects ultrasonic waves from the ultrasonic probe, processes the detection signal to detect the position of the catheter, that is, the distance and direction from the ultrasonic probe, and detects the position. By superimposing and displaying the result on the tomographic image of the inside of the patient displayed on the first ultrasonic imaging apparatus, it is possible to confirm whether or not the catheter is correctly inserted into the thrombus site.

In this case, any one of the thickness, the length in the catheter circumferential direction, and the length in the catheter axial direction of the strip-shaped piezoelectric body disposed along the longitudinal direction of the catheter constituting the ultrasonic transducer is determined by the intravascular treatment. If the frequency of the ultrasonic wave for obtaining the tomographic image information of the patient and the frequency of the ultrasonic wave for obtaining the tomographic image information of the inside of the patient used by the ultrasonic probe correspond to each other, the piezoelectric body can convert the tomographic image of the blood vessel. It can serve two functions: the function of monitoring and the function of informing the position of the catheter, ie the position of the ultrasound transducer itself.

[0015] Accordingly, the ultrasonic transducer requires only a small number of piezoelectric members, has a simple structure, has a small volume, and is easily mounted on a catheter. Further, if the thickness of the piezoelectric body, the length in the catheter circumferential direction and the remaining length in the catheter axial direction are made to correspond to the frequency of the ultrasonic wave emitted by the ultrasonic wave irradiator, the ultrasonic function may be provided to monitor the irradiation position of the therapeutic ultrasonic waves from irradiation morphism device.

[0016]

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a block diagram of a thrombolysis apparatus according to a first embodiment of the present invention. This thrombus dissolving device is an ultrasonic irradiator 20 for irradiating a therapeutic ultrasonic wave to a thrombus site from outside the body.
And an ultrasonic probe 21 for monitoring the position of the thrombus from outside the body, and a catheter 2 inserted percutaneously at the position of the thrombus
2, an ultrasonic transducer 23 mounted on the outer periphery of the distal end of the catheter 22, and a system main body 25. The system main body 25 is connected to the ultrasonic irradiator 20, the ultrasonic probe 21 and the ultrasonic transducer 23, and converts the tomographic image information obtained by the ultrasonic probe 21 and the tomographic image of the blood vessel cross section obtained by the ultrasonic transducer 23. It has a function of imaging, displaying the position of the ultrasonic transducer 23, and controlling the ultrasonic wave irradiated to the thrombus.

That is, the ultrasonic irradiator 20 receives a drive signal from the irradiator drive circuit 38 in the system main body 25 and has a frequency of several kHz to 1 MHz, for example, 450 kHz.
Is irradiated from outside the body of the patient P toward the thrombus 31. In addition, the catheter 2
Numeral 2 is provided with a thrombolytic agent injection tube, which is connected to a thrombolytic agent injection device 93. Therefore, the thrombus 31 is lysed and treated by the combined use of the administration of the thrombolytic agent and the irradiation of the therapeutic ultrasonic waves.

The ultrasonic probe 21 is composed of an array vibrator in which a plurality of ultrasonic vibrators are arranged in a line, is installed in close contact with the body surface of the patient P, and is provided with a predetermined signal from an extracorporeal probe drive circuit 26 in the system main body 25. The drive signal is supplied with the relative delay time of (1) to perform a sector scan of the body of the patient P (the scan range is indicated by reference symbol SS). The frequency of the ultrasonic wave transmitted and received by the ultrasonic probe 21 is, for example, 5 MHz. This ultrasonic probe 21
Is transmitted from the body tissue of the patient P,
The reflected wave is received by the same ultrasonic probe 21 and converted into an electric signal (echo signal). The echo signal obtained by each transducer of the ultrasonic probe 21 is sent to the in-vivo probe receiving circuit 27 in the system main body 25, where a relative delay time similar to that at the time of transmission is given. Processing such as phasing addition, detection, and amplitude compression is performed by the circuit 28, and is supplied to the tissue image CRT 29 to display a B-mode image of the body tissue. The extracorporeal probe drive circuit 26, the extracorporeal probe reception circuit 27, the tissue image processing circuit 28 and the tissue image CRT 29 constitute a first ultrasonic imaging device 41.

On the other hand, the catheter 22 is connected to the blood vessel 3 of the patient P.
It is inserted into the position of the thrombus 31 generated within 0. The ultrasonic transducer 23 mounted on the distal end of the catheter 22 has, as a first function, a blood vessel 30 along with an in-vivo probe driving circuit 34 and a receiving circuit 35 in the system main body 25.
It is used to obtain tomographic image information in the inside. That is, the ultrasonic transducer 23 performs a so-called radial scan in the circumferential direction of the catheter 22. The ultrasonic transducer 23 is composed of a plurality of strip-shaped piezoelectric elements arranged in the circumferential direction of the catheter 22, and these piezoelectric elements are sequentially selectively driven by the in-vivo probe driving circuit 34 to perform radial scanning by electronic scanning. The signal obtained from the ultrasonic transducer 23 is transmitted to the blood vessel image processing circuit 36.
Is sent to the blood vessel image CRT 37 and displayed as a cross-sectional image of the blood vessel 30. By observing the cross-sectional image of the blood vessel, the dissolution state of the thrombus 31 at this position can be determined. The above-described in-vivo probe driving circuit 34, in-vivo probe receiving circuit 27, blood vessel image processing circuit 36, and blood vessel image C
The RT 37 constitutes a second ultrasonic imaging device 42. The frequency of the ultrasonic wave transmitted and received by the ultrasonic transducer 23 is different from that of the ultrasonic wave 21, for example, 20 MHz.
z.

The ultrasonic transducer 23 plays the role of a locator as a second function. That is, the ultrasonic transducer 23 receives the ultrasonic beam transmitted from the ultrasonic probe 21 and converts it into an electric signal. This signal is amplified and detected by the locator receiving circuit 32 in the system main body 25, and then sent to the catheter position detecting circuit 33. The catheter position detecting circuit 33 detects the position of the catheter 22, that is, the distance and direction of the ultrasonic transducer 23 from the ultrasonic probe 21 based on the output signal of the locator receiving circuit 32. The detection results of the distance and the direction are supplied to the tissue image processing circuit 28 and added in synchronization with the signal from the in-vivo probe receiving circuit 27, so that the results are superimposed on the B-mode image of the in-vivo tissue in the tissue image CRT29. Is displayed.

As another embodiment, a locator drive circuit is connected to the ultrasonic transducer 23, and this locator drive circuit is operated to synchronize with the transmission / reception system of the ultrasonic probe 21 by an ultrasonic pulse signal (dashed arrow). USX), the signal may be received by the ultrasonic probe 21, and the position of the ultrasonic transducer 23 may be displayed on the tissue image CRT 29 together with the B-mode image of the body tissue.

Furthermore, the ultrasonic transducer 23 as a third function, has a function of reception of the therapeutic ultrasound CUS from ultrasonic irradiation elevation 20. Therapeutic signals corresponding to ultrasound from the ultrasonic irradiation elevation 20 obtained from the ultrasonic transducer 23 is amplified and detected by the therapeutic ultrasound receiving circuit 39 is sent to the irradiation position detection circuit 40. The irradiation position detection circuit 40 detects the irradiation position of the treatment ultrasonic wave from the reception intensity of the treatment ultrasonic wave. This detection result is transmitted to the tissue image C via the tissue image processing circuit 28.
The display is superimposed on the body tissue image at RT37.

Next, the treatment procedure in this embodiment will be described. First, the operator operates the catheter 22 while observing the position of the thrombus 31 in the B-mode image of the in-vivo tissue by looking at the tissue image CRT 29 to thereby obtain the ultrasonic transducer 2.
Move 3 Then, the position of the ultrasonic transducer 23 also displayed on the tissue image CRT 29 is changed to the thrombus 3.
Match the position of 1. At this time, the blood vessel image CR
At T37, a cross-sectional image of the blood vessel 30 including the thrombus 31 is also observed.

Thereafter, the thrombolytic agent injecting device 93 is operated, and the thrombolytic agent (urokinase, t
-PA, etc.) into the blood vessel 30 to be injected, and the irradiator drive circuit 38 to operate so that the ultrasonic irradiator 2
From 0, the therapeutic ultrasound CUS is irradiated toward the site of the thrombus 31. At this time, while observing the B-mode image on the tissue image CTR 29, the ultrasonic irradiator 23 is moved on the body surface so that the therapeutic ultrasonic CUS is accurately irradiated on the thrombus 31. Then, when the thrombus 31 is sufficiently dissolved in the cross-sectional blood vessel image of the blood vessel image CRT 37, the thrombolytic agent injection device 93 is stopped to stop the release of the thrombolytic agent from the catheter 22.

Next, the ultrasonic transducer 23 will be described with reference to FIG. FIG. 2 is a perspective view of the ultrasonic wave 23. The components of the thrombolysis treatment apparatus shown in FIG. A thrombolytic agent injection tube 43 is inserted into the catheter 22, and each component of the system main body 25 is connected to the ultrasonic transducer 23 via a cable 44. The ultrasonic transducer 23 of the present embodiment is composed of an array transducer in which a plurality of rectangular (rectangular) piezoelectric bodies 24 are arranged in the circumferential direction of the catheter 22 so that the longitudinal direction thereof is aligned with the axial direction of the catheter 22.

FIG. 3 is an enlarged perspective view of one strip-shaped piezoelectric body 24. In FIG. 3, reference numeral 45 represents the in-vivo probe drive circuit 34, the in-vivo probe reception circuit 35, the locator drive circuit 32, and the therapeutic ultrasonic reception circuit 39 in FIG.

The thickness L _d of the strip-shaped piezoelectric body 24 and the longitudinal width L _l
And Tantehaba L _s is, ultrasonic frequency for radial scan for each obtain a tomographic image information of the blood vessel cross-section is a first function, as a locator of the ultrasonic transducer 23 which is a second function The length corresponds to the frequency (that is, the frequency of the ultrasonic wave transmitted by the ultrasonic probe 21) and the frequency of the therapeutic ultrasonic wave CUS to be received as the third function.

In this embodiment, the ultrasonic frequency for the radial scan, the frequency of the transmitted ultrasonic wave of the ultrasonic probe 21 and the frequency of the therapeutic ultrasonic CUS are 5 MHz, 20 MHz and 450 kHz, respectively. Therefore, λ between the dimension d of the piezoelectric body 24 in one direction (one of the thickness L _d , the short width L _s, and the long width L ₁ ) and the wavelength λ of the ultrasonic wave transmitted in that direction. / 2 = d, the sound speed in each direction is 3,000 m / s,
Assuming 2,700 m / s and 1,800 m / s, the thickness L
_d, Tantehaba L _s and a longitudinal width L _l are each 0.07
Set to 5 mm, 0.27 mm and 2 mm. However, these dimensions can be changed to some extent by changing the piezoelectric material (having various strength characteristics) even when the frequency is the same.

As described above, according to the present embodiment, the ultrasonic transducer 23 in which only one type of piezoelectric body 24 is arranged
Accordingly, all of the above three functions can be performed, so that the number and the overall volume of the piezoelectric bodies are reduced, and only one cable 44 connecting the system main body 25 and the ultrasonic transducer 23 is required, so that the configuration is simplified. Therefore, the catheter 22 equipped with the ultrasonic transducer 23
Can be easily inserted into a blood vessel compared to a catheter provided with an ultrasonic transducer transducer for performing each of the above three functions.

FIG. 4 is a perspective view of an ultrasonic transducer 50 according to a second embodiment of the present invention. Parts corresponding to those in FIG. 2 are denoted by the same reference numerals, and description thereof is omitted. When the therapeutic ultrasonic waves are not of a converging type, the irradiation position of the ultrasonic waves rarely shifts from the thrombus, so that it is not necessary to monitor the irradiation position of the therapeutic ultrasonic waves. Therefore, in the present embodiment, the ultrasonic transducer 50 is connected after removing the components related to the irradiation position monitoring of the therapeutic ultrasonic waves in the thrombus dissolving apparatus of FIG.

Then, the ultrasonic transducer 50
Is for a plurality of strip-shaped piezoelectric bodies 51 constituting the
On the combined thickness L _d to the ultrasonic frequency of the radial scan, the longitudinal width L _l or Tantehaba L ultrasonic probe 21 one of _s may be made to correspond to the frequency of the ultrasonic wave transmitting. Therefore, the ultrasonic transducer 50 is easier to manufacture.

In each of the above embodiments, the case where the ultrasonic transducer is an arrayed transducer for electronic scanning has been described. However, only one strip-shaped piezoelectric body (length, width, and thickness dimensions are (Corresponding to a target frequency for each function), and a mechanical scan type vibrator for mechanically rotating this may be used.

FIG. 5 shows the configuration of a thrombolysis apparatus according to a third embodiment of the present invention. Parts corresponding to those in FIG. 1 are denoted by the same reference numerals, and detailed description is omitted. The greatest danger of thrombus formation is ischemic heart disease caused by impaired or blocked blood flow in the coronary arteries, but in particular, coronary arteries are surrounded by ribs, and converge from outside the body. It is difficult to irradiate therapeutic ultrasound. Therefore, in the present embodiment, the ultrasonic transducer 60 attached to the catheter 22 has a function of irradiating therapeutic ultrasonic waves.
The ultrasonic transducer 60 is composed of a locator (also referred to as a transponder) 62, an array transducer (working as an in-body ultrasound probe) 63, and a treatment transducer 64, which are sequentially mounted on the outer periphery of the catheter 22 from the distal end. The locator 62 and the treatment oscillator 64 are annular.

In this embodiment, the ultrasonic probe 21
, An ultrasonic beam having a center frequency of 3.75 MHz, for example, is radiated and received by the locator 62. That is, the resonance frequency of the piezoelectric vibrator of locator 62 is set to 3.75 MHz. The received signal corresponding to the ultrasonic beam received by the locator 62 is sent to a locator receiving circuit 65, where it is amplified and detected, and then shaped into a rectangular wave by a waveform shaper 66. The position of the locator 62 (distance and direction from the ultrasonic probe 21) is obtained by being sent to 33.

The catheter position detecting circuit 33 is constituted by using a counter. The ultrasonic probe 21 emits an ultrasonic beam in response to a driving signal from the extracorporeal probe driving circuit 26 and simultaneously inputs the ultrasonic beam to the extracorporeal probe driving circuit 26. The counter starts counting clocks in response to the trigger signal. The counter keeps counting up until the reception signal from locator 62 is input. The position of the locator 62 is calculated from the count of this counter. The position information of the locator 62 is transferred to the tissue image processing circuit 28, and at the same time, the counter is reset to prepare for the next position detection of the locator 62. Tissue image processing circuit 2
The position information of the catheter tip input to 8 is superimposed on the B-mode image of the in-vivo tissue on the tissue image CRT 29 and displayed in the form of a focus, a marker, or the like.

The position of the locator 62 can be detected by connecting a locator drive circuit to the locator 62 and connecting the locator drive circuit to the waveform shaper 66 shown in FIG. That is, when there is an input to the waveform shaper 66, the locator drive circuit is activated, and conversely, the locator 62 emits the same 3.75 MHz ultrasonic beam. Then, the ultrasonic beam is transmitted to the ultrasonic probe 22.
, The position of the locator 62 can be displayed on the tissue image CRT 29 in accordance with the signal processing for obtaining a tomographic image of the body tissue.

The array transducer 63 emits an ultrasonic beam having a center frequency of 25 MHz in this embodiment, and
Is displayed on the blood vessel image CRT37. And
The therapeutic transducer 64 is driven by the therapeutic ultrasonic drive circuit 67, emits therapeutic ultrasonic waves of a relatively low frequency of 450 kHz by radial resonance, and dissolves the thrombus 31 together with the thrombolytic agent. The administration of the thrombolytic agent is performed using the catheter 22.
A thrombolytic agent injection tube may be passed through the inside of the catheter, and a local injection may be performed from the tip of the catheter 22 at the position of the thrombus. It may be.

The determination of the therapeutic effect, that is, the determination of the dissolution state of the thrombus, is performed by one of the following two methods. One is a method of calculating the patency rate of a blood vessel based on the area blocked by a thrombus with respect to the cross-sectional area (lumen cross-sectional area) of the cross-sectional image of the blood vessel displayed on the blood vessel image CRT37. As a result, when a predetermined opening rate is obtained, the administration of the thrombolytic agent and the irradiation of the therapeutic ultrasonic wave are stopped at the discretion of the operator. The other is a method of observing the blood flow of the thrombus in the color Doppler mode and judging the dissolution state of the thrombus from the degree of blood flow or the degree of turbulence. In any case, the therapeutic ultrasonic waves are emitted from the position of the thrombus in this embodiment, so that the therapeutic ultrasonic waves are accurately and reliably irradiated to the thrombus, and the thrombus can be efficiently dissolved. Therefore, according to the present embodiment, even for coronary artery disease including myocardial infarction with high urgency and risk,
The propagation of the ultrasonic beam is not hindered or disturbed by the ribs or the tissue near the body surface, so that the treatment time is significantly shortened and a remarkable effect can be obtained. In addition, the amount of thrombolytic agent used can be kept to a minimum necessary, and side effects are prevented.

In this embodiment, the array vibrator 6
Ceramic or polymer is used as the material of No. 3. Specifically, lead zirconate titanate represented by PZT as a ceramic, lead titanate based, lead metaniobate based, etc.
As the polymer, polyvinylidene fluoride (PVD)
F), a copolymer of vinylidene fluoride (VDF) and ethylene trifluoride, and vinylidene cyanide. Further, a composite piezoelectric material of ceramic and polymer may be used.

When a polymer material is used for the ultrasonic transducer, the ultrasonic transducer is formed in a sheet shape, so that the ultrasonic transducer is wound around a catheter, and cannot be formed into an array transducer. In this case, as shown in FIG. 6, a single transducer 70 for the in-body ultrasonic probe and the reflector 71 are combined, and the reflector 71 is indicated by an arrow 7.
As shown by 2, the radial scan may be performed by rotating the catheter 22 around the axis of the catheter 22 by the motor 73.

When performing radial scanning with continuous wave Doppler, if the above-described reflector is used, different vibrators are required for transmission and reception, and thus, for example, two vibrators for a half circumference are connected. , May be transmitted and received, respectively.

Further, the locator 62 and the array vibrator 63
And the treatment vibrator 64 may be formed of a composite piezoelectric body arranged on the outer periphery of the catheter by alternately connecting a strip-shaped ceramic piezoelectric body and a resin, both made of a suitable material,
The same vibrator can be shared. In this case, the dimensions of the composite piezoelectric body and the ceramic piezoelectric body in each direction are appropriately determined, the radial resonance of the entire composite piezoelectric body is treated as therapeutic ultrasonic waves, and the thickness vibration perpendicular to the array direction of the ceramic piezoelectric bodies is placed on the blood vessel. The resonance in the axial direction of the catheter can be used as the ultrasonic wave for observing the cross-sectional image and the ultrasonic wave for displaying the position of the distal end of the catheter. In addition, one vibrator can have any two functions of the locator 62, the array vibrator 63, and the therapeutic vibrator 64.

Next, another embodiment of the present invention will be described with reference to FIGS. The same parts as those in FIG. 1 are denoted by the same reference numerals, and only different points will be described. In this embodiment, as shown in FIG. 7, an ultrasonic irradiator 80 for irradiating therapeutic ultrasonic waves is used.
Is composed of piezoelectric elements arranged in a spherical shell shape, an acoustic matching layer 81 is attached to the front surface thereof, and a water bag 82 with a bellows is attached. At the tip of the water bag 82, a membrane 83 that is in contact with the body surface of the patient P is attached.

The ultrasonic probe 21 is detachably fixed by a cylindrical probe holder 84 to the ultrasonic irradiation elevation 80 as shown in FIG. A water bag 82 is attached to the holder 84.
And water tightness of holding the inner, and packing 87 for fixing the ultrasonic irradiation elevation 80 the positional relationship between the ultrasonic probe 21 at a predetermined position is attached. The packing 87 is shown in FIG.
As shown in FIG. 8, a spring 88 provided on the inner periphery of the holder 84 is provided.
And an O-ring 89 urged in the center direction by this. The O-ring 89 enters a groove 21a provided along a circumferential direction at a predetermined position of the ultrasonic probe 21 to maintain and fix watertightness. Do. A water inlet 85 and a water outlet 86 are connected to the water bag 82, and water is taken in and out through the water inlet 85 and the water outlet 86, and the bellows expands and contracts by adjusting the amount of water in the water bag 82. As a result, the distance between the ultrasonic probe 21 and the body surface of the patient P changes, and as a result, the focal position of the probe 21 in the patient can be changed.

[0046] Although the ultrasonic probe 21 in FIG. 7 and 8 is positioned in the center of the ultrasonic irradiation morphism 80, FIG. 1
It may be located at a position closer to one side from the center as shown in FIG. It is also as a method of fixing by the holder 84 from the outside of the ultrasonic probe 21 to the ultrasonic irradiation morphism 80 as shown in FIG. 11.

[0047] Further, when configured with the piezoelectric vibrator of so-called Annular array type located in the ultrasonic irradiation elevation 80 a plurality of annular transducers concentrically as shown in FIG. 12, the phase of each oscillator The focal position can be electronically changed by driving the laser beam with a shift. This way,
Since there is no need to increase or decrease the amount of water in the water bag as in the previous embodiment, the water bag can be replaced with the gel-like pad 90, and a water treatment device becomes unnecessary, thereby improving operability.

[0048] The ultrasonic irradiation morphism instrument in the description so far 8
0 changes the focal position in the depth direction, but if a two-dimensional array type piezoelectric vibrator is used as shown in FIG. 13, the focal position can be changed by electronic scanning. The gel pad 90 can be made smaller, and the operability is further improved.

[0049] In FIG. 7, the driving waveform supplied from the irradiation drive circuit 38 to the ultrasonic irradiation morphism 80, FIG. 14 (a)
(C) is appropriately selected from continuous waves, burst waves, and pulse waves. For example, if the thrombus site to be treated is relatively shallow and there is no tissue that strongly generates ultrasonic waves, such as bones and lungs, that generates heat and is on the propagation path of the therapeutic ultrasound, use continuous waves and make the thrombus deeper. If there is a bone or the like in the middle of propagation of the ultrasonic wave and a relatively large energy is required for one wave, a pulse wave is used. Other, ultrasonic irradiation morphism 80
May be appropriately selected and used according to the treatment situation.

Returning to FIG. 7, in the present embodiment, the lysis treatment effect quantitative operation circuit 9 is added to the blood vessel image processing circuit 36.
1 is connected. The arithmetic circuit 91 determines the area of the opened part in the blood vessel by dissolving the blood vessel cross-sectional area and the thrombus by the image processing technique from the blood vessel cross-sectional image data obtained in the blood vessel image processing circuit 36. Calculate the rate. The calculated opening rate is calculated based on the blood vessel image CRT37.
To be displayed in numerical values.

The opening ratio is compared with a predetermined threshold value by a determination circuit 92. If the opening ratio is larger than the threshold value, it is determined that the opening treatment is completed and the irradiation device driving circuit 38 is stopped and controlled. Stop irradiation of therapeutic ultrasound. Further, in the present embodiment, when the determination circuit 92 determines that the treatment is completed, the dissolving agent injection device 93 is stopped and controlled to inject the dissolving agent into the blood vessel from the dissolving agent injection port 94 provided at the distal end of the catheter 22. To stop. In addition,
The dissolving agent injection device does not have to be injected from the tip of the catheter, and may be of the drip type.

FIG. 15 shows a tissue image CRT according to this embodiment.
29 shows display examples on the display 29 and the blood vessel image CRT37. In the tissue image CRT 29, a B-mode image 11 inside the body of the patient P is displayed. In the blood vessel image CTR37, the image 12 of the blood vessel cross section is displayed, and the penetration rate is displayed as 13. By displaying not only the B-mode tomographic image 11 but also the blood vessel cross-sectional image 12 and displaying the patency ratio 13 in this way, it is difficult to discriminate only with the B-mode image and can be confirmed only by X-ray imaging. Since the degree of vascular opening can be clearly and quantitatively determined, it is possible to give a suggestion to the judgment of the therapeutic effect. In particular, the arithmetic circuit 91
If the opening rate is determined quantitatively, the determination circuit 92 compares and determines this with the threshold value, whereby the thrombolytic treatment can be automatically stopped as described above.

In the above embodiment, information on the cross-sectional image of the blood vessel is obtained in order to check the patency state in the blood vessel. However, the blood flow in the blood vessel is measured using a Doppler catheter to determine whether or not the blood vessel has been opened. It is also possible to make a determination. In this case, the numerical value display 14 or the bar graph display 15 of the flow velocity is performed on the B-mode tomographic image 11 as shown in FIG. Furthermore, it is also possible to directly monitor the internal state by in-vivo imaging using an optical fiber and check the open state of the blood vessel.

[0054]

According to the present invention, the thrombus site can be confirmed by displaying the tomographic image of the inside of the patient on the first ultrasonic imaging device, and the tomographic image in the blood vessel can be confirmed on the second ultrasonic imaging device. By displaying it, you can see the status of thrombolysis treatment.
The therapeutic effect can be enhanced by reliably irradiating the therapeutic thrombus to the thrombus site, and when the thrombus is sufficiently dissolved, useless administration of the thrombolytic agent can be stopped and unnecessary side effects can be avoided.

[0055] Further, determined by calculation a numerical value indicating the thrombolytic therapeutic such patency rates of blood vessels, which or stops the therapeutic ultrasound irradiation from the ultrasonic irradiation elevation device when it reaches a predetermined value, further blood vessel By stopping the infusion of the thrombolytic agent into the system, the treatment can be automatically stopped when the thrombus has been sufficiently dissolved, thereby enabling more efficient treatment with fewer side effects.

Further, the position of the catheter is detected by detecting the therapeutic ultrasonic wave from the ultrasonic probe with the ultrasonic transducer inserted into the blood vessel, and the detection result is superimposed and displayed on the tomographic image inside the patient. By doing so, it is possible to confirm whether or not the catheter is correctly inserted into the thrombus site. In this case, by appropriately selecting the dimensions of the strip-shaped piezoelectric body used for the ultrasonic transducer, one strip-shaped piezoelectric body can perform two functions of a blood vessel tomographic image monitoring function and a catheter position detection function. The size of the transducer can be reduced, and the transducer can be easily mounted on the catheter.

[Brief description of the drawings]

FIG. 1 is a configuration diagram of a thrombolysis treatment apparatus according to a first embodiment of the present invention.

FIG. 2 is a diagram showing a main part of FIG. 1;

FIG. 3 is an explanatory diagram of a piezoelectric body used for an ultrasonic transducer.

FIG. 4 is a configuration diagram of a main part according to a second embodiment of the present invention.

FIG. 5 is a configuration diagram of a thrombolysis treatment apparatus according to a third embodiment of the present invention.

FIG. 6 is a perspective view of an ultrasonic transducer according to a fourth embodiment of the present invention.

FIG. 7 is a configuration diagram of a thrombolysis treatment apparatus according to a fifth embodiment of the present invention.

8 is a configuration diagram of a main part of FIG. 7;

FIG. 9 is an enlarged view of a main part of FIG. 8;

Diagram showing another example of the mounting state of FIG. 10 ultrasonic probe for ultrasonic irradiation morphism device

11 is a diagram showing still another example of the mounting state of the ultrasonic probe for ultrasonic irradiation morphism device

12 is a diagram showing another example of the ultrasonic irradiation morphism device

FIG. 13 is a diagram illustrating still another example of the ultrasonic irradiation morphism device

14 illustrates the various drive waveforms of the ultrasonic irradiation morphism device

FIG. 15 is a diagram showing a display example on a tissue image CRT and a blood vessel image CRT in the fifth embodiment.

FIG. 16 is a view showing another display example on a tissue image CRT.

[Explanation of symbols]

20 ... ultrasonic irradiation morphism 21 ... ultrasonic probe 22 ... catheter 23 ... ultrasonic transducer 24 ... rectangular piezoelectric member 41 ... first ultrasonic image apparatus 42 ... the second ultrasonic image apparatus 50 ... ultrasonic transducer 51 ... strip-like piezoelectric element 60 ... ultrasonic transducer 80 ... ultrasonic irradiation morphism 91 ... dissolved therapeutic effect quantitative calculation circuit 92 ... judging circuit 93 ... solubilizers implanter

──────────────────────────────────────────────────続 き Continuation of the front page (72) Katsuhiko Fujimoto, Inventor 1 Tokoba, Komukai Toshiba-cho, Sachi-ku, Kawasaki-shi, Kanagawa Prefecture (56) References JP-A-4-17846 (JP, A) JP-A-4-20349 (JP, A) JP-A-4-307054 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61B 18/00 A61B 8/00 A61B 8/12 A61N 7 / 00

Claims (7)

(57) [Claims] 1. A thrombolysis treatment device for irradiating a therapeutic thrombus to a thrombus site into which a thrombolytic agent in a blood vessel is injected to dissolve a thrombus, wherein the thrombus site is irradiated with a therapeutic ultrasonic wave. Device, an ultrasonic probe that obtains tomographic image information of the inside of a patient, a first ultrasonic imaging device that images and displays tomographic image information from the ultrasonic probe, and a catheter that is inserted into the blood vessel, An ultrasonic transducer installed on the catheter and for obtaining tomographic image information in the blood vessel, and a second ultrasonic imaging device for imaging and displaying tomographic image information from the ultrasonic transducer. Thrombolysis therapy device. 2. A thrombolysis treatment apparatus for irradiating a therapeutic thrombus to a thrombus site into which a thrombolytic agent is injected in a blood vessel to dissolve the thrombus, wherein the ultrasonic thrombus irradiates the thrombus site to the therapeutic thrombus. An irradiator, an ultrasonic probe that obtains tomographic image information in a patient using ultrasonic waves of a predetermined frequency, a first ultrasonic imaging device that images and displays tomographic image information from the ultrasonic probe, A catheter inserted into a blood vessel, and tomographic image information in the blood vessel is obtained by using an ultrasonic wave having a frequency different from that of the ultrasonic probe, the ultrasonic wave being detected from the ultrasonic probe. An ultrasonic transducer, a second ultrasonic imaging device for imaging and displaying tomographic image information from the ultrasonic transducer, and the ultrasonic output from the ultrasonic transducer. Position detecting means for processing a detection signal of an ultrasonic wave from an ultrasonic probe to detect the position of the catheter, and means for displaying a detection result of the position detecting means on a display image of the first ultrasonic imaging apparatus; A thrombolysis treatment device comprising: 3. The ultrasonic transducer has at least one strip-shaped piezoelectric body provided along a longitudinal direction of the catheter, and the piezoelectric body has a thickness, a length in a circumferential direction of the catheter, and a length in a catheter axial direction. Any two of the lengths correspond to the frequency of the ultrasonic wave for obtaining the tomographic image information in the blood vessel and the frequency of the ultrasonic wave for obtaining the tomographic image information in the patient used by the ultrasonic probe, respectively. The thrombolysis treatment device according to claim 2, characterized in that: 4. The piezoelectric device according to claim 1, wherein the thickness, the length in the circumferential direction of the catheter and the remaining length in the axial direction of the catheter correspond to the frequency of the ultrasonic waves emitted by the ultrasonic irradiator. The thrombolytic treatment device according to claim 3, wherein Wherein said ultrasonic irradiation go, thrombolytic therapy apparatus according to any one of claims 1 to 4, characterized in that attached to the catheter. 6. A thrombolysis treatment device for irradiating a therapeutic thrombus to a thrombus site into which a thrombolytic agent is injected in a blood vessel to dissolve the thrombus, wherein the thrombus site is irradiated with a therapeutic ultrasonic wave. Device, an ultrasonic probe that obtains tomographic image information of the inside of a patient, a first ultrasonic imaging device that images and displays tomographic image information from the ultrasonic probe, and a catheter that is inserted into the blood vessel, An ultrasonic transducer installed on the catheter to obtain tomographic image information in the blood vessel; a second ultrasonic imaging device for imaging and displaying tomographic image information from the ultrasonic transducer; and calculating means for calculating a numerical value indicating the solubility therapeutic effects of thrombus on the basis of the tomographic image information, the ultrasonic irradiation elevation unit when the numerical values calculated by the calculating means reaches a predetermined value Thrombolytic therapy apparatus characterized by further comprising a means for stopping the irradiation of al of therapeutic ultrasound. 7. The thrombolysis according to claim 6, further comprising means for stopping the injection of the thrombolytic agent into the blood vessel when the numerical value calculated by the calculation means reaches a predetermined value. Treatment device.