JP2006263125A - Agitating treatment device and catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an agitating treatment device and a catheter highly efficiently dissolving the thrombus in a short period of time despite of the size of the thrombus, removing the thrombus in the blood vessel and recanalizing the blood vessel, or easily determining the completion of the treatment by determining the level of the thrombus dissolution during the thrombus dissolution (treatment) in real time, and allowing a user to easily determine how to change a physical promotional method appropriately because the condition of the thrombus can be observed during the treatment. <P>SOLUTION: This agitating treatment device is provided with an outlet 14 for discharging dissolvent to a member to be dissolved for dissolving the member to be dissolved, and a suction port 18 for sucking the fine member to be dissolved left over without being dissolved. A tubular body 22 is provided with one fixed end, the other free end and a mechanical vibrating means 24 at the fixed end side. The mechanical vibrating means 24 (1) crushes the member to be dissolved and (2) measures at least one of the hardness/viscosity of a material to be in contact or the hardness/viscosity of an attachment from a change in impedance. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a stirring treatment device for dissolving and removing a substance to be dissolved, for example, a thrombus in a blood vessel, and a catheter provided with the stirring treatment device.

  Pathological thrombus is one of the causes of cerebral infarction and myocardial infarction, which are currently increasing as a cause of death. When a pathological thrombus is formed in the brain or heart, the blood vessels, that is, the cells ahead of them (for example, brain cells) will be necrotized. This is an infarction. Thrombosis mortality and sequelae depend on the time it takes for blood vessels to recanalize, so rapid thrombus dissolution is required. Until now, after injecting a thrombolytic agent, a method of accelerating dissolution of a thrombus by irradiating ultrasonic waves or the like has been attempted. An ultrasonic deep touch element is inserted into a blood vessel, and in that state, a dissolution agent is irradiated to increase dissolution efficiency (see Patent Document 1).

  When dissolving a thrombus in a blood vessel using a solubilizer, studies have been made to increase the dissolving action by irradiating the thrombus with ultrasound. Although the mechanism has not been completely elucidated, research results have shown that the degree of thrombus dissolution increases when the thrombus is irradiated with ultrasound in a state where a dissolution agent is supplied.

  However, an actual treatment system using such a solubilizer and ultrasonic waves has not been realized yet, and a system capable of performing ultrasonic treatment of an affected area including a thrombus is desired. In addition, in such a system, if ultrasonic diagnosis can be performed at the same time, the burden of inserting a new ultrasonic probe into the blood vessel and the burden on the patient can be reduced. There was a need for a system that could be used together.

  On the other hand, although it depends on the type of blood vessel, its diameter is generally very small, and an array transducer consisting of a large number of transducer elements and a transducer drive mechanism using motors and gears are provided inside the ultrasonic probe. There is a problem that it is difficult. However, when the thrombus is large, the thrombus cannot be efficiently dissolved in a short time, and the thrombus in the blood vessel can be removed to recanalize the blood vessel.

JP-A-4-17846

  The present invention has been made in view of the conventional drawbacks, and the present invention can efficiently dissolve a thrombus in a short time regardless of the size of the thrombus and remove the thrombus in the blood vessel to recanalize the blood vessel. However, it is possible to reduce the mortality rate and sequelae of thrombosis, and because it is possible to determine the thrombolysis in real time during thrombolysis (during treatment), it is easy to determine the end of treatment, Another object of the present invention is to provide an agitation device and a catheter that can easily determine how to change an appropriate physical promotion method because the state of the thrombus can be observed during treatment.

The agitation processing apparatus according to the first aspect of the invention sucks a discharge port for discharging a dissolving agent toward a member to be dissolved in order to dissolve the member to be dissolved, and a fine member to be dissolved that remains undissolved. A tubular body extending in the longitudinal direction, including a suction port for carrying out; the tubular body has one end fixed, the other end being a free end, and provided on the fixed end side, (1) The member to be melted is crushed, and (2) at least one of the solubility of the member to be melted, the viscosity in the solution in which the member to be melted is dissolved, the hardness / viscosity of the contacted object, or the hardness / viscosity of the deposit Measuring from change,
And a mechanical vibration applying means.

  The catheter according to the second invention includes a discharge port for discharging a dissolving agent toward the thrombus in order to dissolve the thrombus, and a suction port for sucking a fine thrombus remaining undissolved. A tube extending in the longitudinal direction; the tube having one end fixed, the other end being a free end, and provided on the fixed end side, (1) crushing a thrombus, (2) Mechanical vibration applying means for measuring at least one of the solubility of the thrombus, the viscosity in the blood in which the thrombus is dissolved, the hardness / viscosity of the thrombus, or the hardness / viscosity of the deposit on the blood vessel wall from the change in impedance; A thrombus agitation processing apparatus; a storage body that houses the thrombus agitation processing apparatus; and an elastic member that pushes the thrombus agitation processing apparatus outward from the storage body or pulls the thrombus agitation processing apparatus from the outside into the storage body. .

  The catheter according to a third aspect of the present invention is the catheter according to claim 2, further comprising control means for controlling a stirring trajectory and a dissolving agent injection amount from the change in impedance.

(1) Because of stirring by mechanical vibration, a larger stirring effect than ultrasonic waves can be obtained, and high-speed thrombus removal is possible.
(2) Fine clots that remain undissolved cause clogging of blood vessels with a smaller radius. These fine blood clots can be sucked out from the suction port, and safe and reliable thrombus removal can be performed.
(3) A large thrombus that cannot be sucked through the suction port can be melted until it becomes a size that can be sucked in while being sucked into the stirring treatment device. In this case, the degree of thrombus dissolution (whether it can be sucked in or whether it is sucked into the stirrer without being sucked in) is estimated from the change in the mechanical impedance of the stirrer it can.
(4) The effect of the stirring treatment device can be understood in real time. For this reason, it can be determined whether the stirring method in use is appropriate and the amount of the thrombolytic agent is appropriate. Accordingly, an effective stirring method and an appropriate amount of dissolving agent can be selected.
(5) Since it is possible to determine in real time whether the thrombus has been completely dissolved, it is possible to know when the treatment should be terminated.
(6) Because of items (3) and (4), high-speed treatment is possible. This reduces the burden on the doctor as well as the patient.
(7) Since the treatment does not end before the blood vessel is resumed, it helps to reduce the mortality rate and the sequelae rate of patients.
(8) Solubility measurement is based on looking at the mechanical impedance change of the stirrer. When the stirrer touches a hard substance such as a blood vessel, a sudden change in impedance is measured. Utilizing this fact, stirring can be performed while adjusting the stirring processing device so as not to touch the blood vessel. That is, minimally invasive treatment with less burden on the patient is possible.
(9) When a blood vessel is opened, blood flows suddenly. At this time, a sudden change in mechanical impedance of the stirring apparatus is measured. Therefore, the reopening of the blood vessel can be detected.
(10) Since the state of the blood around the thrombus can be estimated by looking at the change in mechanical impedance of the agitation processing apparatus, it is possible to estimate the health state of the patient's blood.
(11) Physical characteristics such as blood vessel rigidity can be measured. Thereby, a tumor formed in a blood vessel can be detected.
(12) Since the stirring treatment device is disposable, it is possible to prevent infections and the like.

  The agitation apparatus according to the present invention and a catheter having an agitation process function for dissolving and removing a thrombus in a blood vessel will be described in detail by way of examples. FIG. 1 is a schematic view showing a catheter provided with a cerebral thrombus agitation apparatus according to an embodiment of the present invention. FIG. 2 is an enlarged view showing a main part of the catheter.

  In FIG. 1, a catheter 10 includes a thrombus stirring treatment device 11. The thrombus stirring treatment device 11 includes a thrombus dissolving agent discharge tube 16 having a discharge port 14 for discharging a thrombus dissolving agent toward the thrombus 13 in order to dissolve the thrombus 13 in the blood vessel, and does not dissolve in the blood vessel. A tube housing 22 including a thrombus suction tube 20 having a suction port 18 for sucking the fine thrombus 13 remaining in the tube, and crushing the thrombus 13 to dissolve the thrombus 13 and dissolve the thrombus 13 The piezoelectric element 24 is provided as a mechanical vibration imparting means for measuring at least one of the viscosity in the blood, the hardness / viscosity of the thrombus, or the hardness / viscosity of the deposit on the blood vessel wall from the change in impedance. The tube housing 22 has a beam structure in which one end is fixed and the other end is a free end, and the piezoelectric element 24 is provided on the fixed end side of the tube housing 22. It should be noted that the thrombolytic agent discharge tube 16 and the thrombosis suction tube 20 may be formed by forming the thrombolytic agent discharge passage 16 and the thrombus suction passage as a projecting hole in the tubular body in addition to disposing individual tubes. Good.

  Further, in FIGS. 3A and 3A, the catheter 10 includes a spring 26 that is an elastic member that is pushed outward from the housing body or pulled into the housing body from the outside. The spring material extends the thrombus stirring treatment device 11 from the inside of the catheter 10 to the outside of the blood vessel, and draws the stirring member 11 a that has been extended into the catheter 10. The spring is provided between a plate member 28 that is movable in the longitudinal direction at the rear end of the tube housing 22 constituting the thrombus stirring treatment device 11 and a fixed plate 30 that is fixedly provided inside the catheter 10. . Thus, when a pressing force from the inside of the catheter 10 is applied to the movable plate, the plate 28 moves in the direction in which the spring 26 is compressed, and the tube housing 22 moves from the inside of the catheter 10 into the blood vessel 12. Pushed outward.

  The thrombus stirring treatment device 11 includes a thrombolytic agent passage 32 for discharging the thrombolytic agent into the tube and a thrombus inhalation passage 34 capable of sucking the thrombus 13. The thrombus stirring treatment device 11 includes a piezoelectric element 24 on the outer periphery of the tube, and can drive the piezoelectric element 24 to mechanically vibrate the tube.

  Moreover, the thrombus stirring treatment device 11 can stir the blood by mechanical vibration and ultrasonic waves generated accordingly. At this time, the thrombus 13 existing in the blood vessel can be dissolved by injecting the dissolving agent into the blood vessel from the thrombus dissolving agent passage 32 of the stirrer. The fine thrombus 13 that remains undissolved by stirring causes the blood vessel 12 having a small radius to be clogged when flowing through the blood vessel 12. Such a reduced thrombus 13 can be sucked from the suction port into the thrombus suction passage 34 of the thrombus stirring treatment device 11.

  If the thrombus 13 is so large that it cannot be sucked into the catheter 10, the stirrer 11 a is vibrated until the thrombus 13 is sucked into the suction port 18 until the thrombus 13 is sucked, and the thrombus 13 is dissolved. As a result, the thrombus 13 becomes small and can be sucked from the suction port 18. The diameter of the pipe for injection is assumed to be about 0.05 [mm]. Because the agitator body is disposable, it is possible to prevent infectious diseases.

  The change in mechanical vibration of the thrombus agitation processing apparatus 11 can be generated by changing the shape of the beam, the mode of the voltage application signal applied to the piezoelectric element 24, the type of waveform, and the vibration direction. Thus, since mechanical vibration can give a greater change in vibration than ultrasonic vibration, it can be efficiently destroyed and removed in a short time regardless of the size of the thrombus 13 in the blood vessel 12.

  The agitation processing device 11 has the configuration of the thrombus agitation processing device 11 and the locus of its movement in the case of including four piezoelectric elements 24 that operate independently at regular intervals around the agitator outside the tube housing 22. It shows in FIG.4 and FIG.5. The movement of the piezoelectric element 24 is represented by (1) V1Sin (ω1t + Φ1), (2) V2Sin (ω1t + Φ2), (3) V3Sin (ω2t + Φ3), and (4) V4Sin (ω2t + Φ4), respectively. Each piezoelectric element 24 has a different frequency and amplitude. In the figure, the horizontal axis indicates the displacement in the Z-axis direction, and the vertical axis indicates the displacement in the y-direction. Thus, the thrombus stirring processing device 11 operates so as to draw an elliptical locus on the yz plane (a plane perpendicular to the longitudinal direction of the beam). In the xy plane, an operation of generating an ultrasonic wave that moves only in the y direction (longitudinal direction of the beam) is performed. In FIG. 5, by changing the amplitude and frequency, stirring in various directions that can cover the inside of the rectangular area is possible. The stirring in the same direction is possible not only in the square area but also in the circular area.

  FIG. 6 is a schematic view when a piezoelectric element is inserted between two agitators. The operation of the piezoelectric element 24 is indicated by VSinwt, w = 957.894 Hz, and as shown in FIG. 7, the thrombus stirring processing device 11 moves to generate a shearing force.

  The change in mechanical vibration of the tube housing 22 can be obtained from the change in impedance of the piezoelectric element 24. That is, as the thrombus 13 dissolves, the viscosity increases as the concentration of red blood cells and plasma proteins in the blood increases. If the viscosity of the blood increases, the operation of the stirring processing device 11 becomes weaker. It reduces the mechanical impedance of the thrombus agitation device 11. Using mechanical impedance, (2) impedance of at least one of the solubility of the thrombus 13, the viscosity in the blood in which the thrombus 13 is dissolved, the hardness / viscosity of the thrombus 13, or the hardness / viscosity of the deposit on the blood vessel wall It can be measured from changes in

  FIG. 8 shows the result of stirring while actually measuring in real time. In the figure, the horizontal axis represents frequency and the vertical axis represents impedance. In the figure, (1) is the impedance measurement result before stirring, (2) is the impedance measurement result after stirring by the stirring processing device 11, and (3) is the impedance measured after stirring manually by the stirring processing device 11 It is a measurement result. From this result, the agitation effect of the agitation processing apparatus 11 can be understood and the effectiveness of the solubility measurement can be understood.

  The change in impedance is linearly related to the liquid concentration. From this, it is possible to estimate the blood concentration and the solubility of the thrombus 13 using the impedance. The above measurement method can be performed during treatment (during stirring). Control means for controlling the stirring method and the amount of the dissolving agent injected from the change in impedance is provided. In addition, as an agitating method, both an ultrasonic wave and mechanical vibration can be used.

  Since the stirring effect can be measured at any time during the treatment from the change in the impedance, it is possible to quickly determine the appropriateness of the stirring method and the appropriate amount of the dissolving agent injection. That is, a control means for controlling the agitation trajectory and the lysate injection amount, which can select an appropriate mechanical vibration according to the blood state of the patient and an appropriate lysate injection amount, is provided.

  It can be immediately determined whether the thrombus 13 has completely dissolved, that is, the end of the treatment. Moreover, it is possible to prevent the treatment from being completed in a state where the thrombus 13 is not dissolved. As a result, high-speed thrombolysis and an improvement in the reopening rate of the blood vessel 12 can be expected, leading to a reduction in the mortality rate and the incidence of sequelae. This also reduces the burden on doctors and patients.

  It is desirable that the stirring device 11 during treatment does not touch the blood vessel 12. This is because the patient's blood vessel 12 is damaged, and thus the thrombus 13 is formed again. When the stirrer 11 touches a hard substance such as the blood vessel 12, an abrupt change in impedance is measured. Utilizing this fact, stirring can be performed while adjusting the stirring processing device 11 so as not to touch the blood vessel 12. That is, a minimally invasive treatment with less burden is possible.

  When the agitation processing device 11 comes into contact with the blood vessel 12, the agitation processing device 11 is elastically deformed according to the rigidity and viscosity of the blood vessel 12. This deformation causes a change in mechanical impedance of the stirring processing device 11. By detecting this change by the piezoelectric element 24, the physical characteristics of the blood vessel 12 can be detected. Thereby, a tumor formed in the blood vessel 12 can be detected.

  When the blood vessel 12 restarts, the movement of the beam rapidly increases due to the rapid flow of blood. Therefore, the reopening of the blood vessel 12 can be detected using the same measurement method as described above. Since the blood viscosity and flow strength can be measured from the impedance of the piezoelectric element 24, the health state of the blood can be estimated before, during and after treatment.

  It can be used for a thrombolytic treatment device, a catheter for removing a thrombus in blood vessels such as the brain, and the like.

It is the schematic which shows the catheter provided with the stirring processing apparatus which concerns on this invention. It is sectional drawing which shows the catheter provided with the stirring processing apparatus which concerns on this invention. (A) is the schematic which shows operation | movement of the catheter provided with the stirring processing apparatus which concerns on this invention. (B) is the schematic which shows operation | movement of the catheter provided with the stirring processing apparatus which concerns on this invention. It is the schematic which shows the piezoelectric element of the stirring processing apparatus which concerns on this invention. It is a locus | trajectory figure which shows the behavior of the stirring processing apparatus which concerns on this invention. It is the schematic which shows the piezoelectric element of other arrangement | positioning of the stirring processing apparatus which concerns on this invention. It is the schematic which shows the behavior of the stirring processing apparatus which concerns on this invention. It is a figure which shows the relationship between the frequency and impedance of the stirring processing apparatus which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Catheter 11 Thrombus stirring processing apparatus 11a Stirring member 12 Blood vessel 13 Thrombus 14 Discharge port 16 Thrombus dissolution agent discharge tube Impedance frequency before stirring 18 Stirring member 18 Suction port 20 Thrombus suction tube Stirring member After hand stirring 22 tube Storage body 24 Piezoelectric element 26 Spring 28 Plate member 30 Fixing plate 32 Thrombus dissolution passage 34 Thrombus inhalation passage

Claims (3)

In the longitudinal direction, provided with a discharge port for discharging the dissolving agent toward the member to be melted in order to dissolve the member to be melted, and a suction port for sucking the fine member to be melted remaining without being melted An extending tube;
The tube has one end fixed, the other end is a free end, and provided on the fixed end side,
(1) The member to be melted is crushed,
(2) Measure at least one of the solubility of the member to be dissolved, the viscosity of the solution in which the member to be dissolved is dissolved, the hardness / viscosity of the contacted object, or the hardness / viscosity of the deposit from the change in impedance.
Mechanical vibration imparting means for;
A stirring treatment apparatus comprising: A longitudinally extending tube body comprising a discharge port for discharging a dissolving agent toward the thrombus to dissolve the thrombus, and a suction port for sucking a fine thrombus remaining undissolved; ;
The tube has one end fixed, the other end is a free end, and provided on the fixed end side,
(1) crush the thrombus,
(2) Measure at least one of the solubility of the thrombus, the viscosity in the blood in which the thrombus is dissolved, the hardness / viscosity of the thrombus, or the hardness / viscosity of the deposit on the blood vessel wall from the change in impedance.
Mechanical vibration imparting means for;
A thrombus agitation device comprising:
A housing for housing the thrombus stirring treatment device;
An elastic member for extruding the thrombus stirring treatment device outward from the storage body or drawing it into the storage body from the outside;
A catheter comprising:   The catheter according to claim 2, further comprising control means for controlling the agitation trajectory and the dissolving agent injection amount from the change in impedance.

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