JP2019055012A - Medical device - Google Patents

Abstract

To provide a medical device capable of making ultrasonic waves effectively act on an organism in order to grow or newly generate blood vessels.SOLUTION: A medical device 10 for growing or newly generating blood vessels through irradiation of ultrasonic waves includes: a long-sized cylindrical part 20; a support part 50 provided at the distal side of the cylindrical part 20, and having a support base 57 capable of changing a tilt angle β to a shaft center X of the cylindrical part 20; an irradiation part 30 arranged on the support base 57 and emitting ultrasonic waves; and an operation wire 61 whose at least one part is stored in the cylindrical part 20, whose distal portion is connected to the support part 50, and whose proximal part is positioned at a proximal side with respect to the cylindrical part 20. It is possible to change an irradiation direction of the irradiation part 30 by changing the tilt angle β of the support base 57 by pulling the proximal part of the operation wire 61.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a medical device for improving an ischemic condition.

  For ischemic heart diseases such as myocardial infarction, treatment for expanding the stenosis using a balloon catheter or stent is common. However, if the disease is in a microvessel, devices such as balloons and stents cannot be inserted and treatment may be difficult.

  For thrombotic stenotic lesions such as acute myocardial infarction, treatment with a drug-eluting stent is common. However, at the time of stent placement, the thrombus at the lesion site may fall off, and the more peripheral microvessels may be occluded. The embolization of the microvessel formed by this is called Slow-flow or No-reflow and causes a worse prognosis. When the microvessels are embolized, the myocardium can become necrotic and cause heart failure.

  In recent years, studies have shown that ischemia can be resolved by inducing angiogenesis from the coronary artery by irradiating the coronary artery with ultrasound. For example, Patent Document 1 describes a device that can be inserted into a blood vessel and can be irradiated with ultrasonic waves from within the blood vessel. This device induces angiogenesis by irradiating the ischemic myocardium with ultrasound, and can eliminate ischemia.

  Patent Document 2 describes a diagnostic ultrasonic probe using ultrasonic echoes and a catheter provided with a therapeutic ultrasonic transducer capable of removing intravascular thrombi by vibration. The ultrasonic probe for diagnosis and the ultrasonic transducer for treatment are provided at the distal portion of the catheter probe so as to be able to irradiate ultrasonic waves toward the distal side.

JP, 2006-101273, A International Publication No. 06/117923

  The device described in Patent Document 1 irradiates ultrasonic waves in a direction substantially perpendicular to the axis of a long device. However, in many cases, the infarct region exists in a portion where the lumen of the blood vessel is narrow and the device cannot be inserted. For this reason, even if the device described in Patent Document 1 is approached from the responsible blood vessel in the infarct region, it is not possible to efficiently irradiate the embolic region with ultrasonic waves.

  When the device cannot be inserted into the infarct region, it is necessary to insert the device into a nearby blood vessel such as a coronary vein and irradiate ultrasonic waves from different blood vessels. However, there is not always a blood vessel into which the device can be inserted in the vicinity of the infarct region.

  The ultrasonic transducer for treatment of a catheter described in Patent Document 2 can irradiate ultrasonic waves toward the distal side. However, since the irradiation direction of the ultrasonic waves cannot be changed, the ultrasonic waves cannot be efficiently applied to the embolic region.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device capable of effectively applying ultrasonic waves to a living body in order to develop or regenerate a blood vessel. To do.

  A medical device that achieves the above-described object is a medical device for irradiating an ultrasonic wave to develop or regenerate a blood vessel, and is provided on a long cylindrical portion and a distal side of the cylindrical portion. A support portion including a support base capable of changing an inclination angle with respect to an axis of the cylindrical portion, an irradiation portion arranged on the support base and radiating ultrasonic waves, and at least a part of the cylindrical portion is accommodated. An operation wire having a distal portion coupled to the support portion and a proximal portion positioned on a more proximal side than the tubular portion, and pulling the proximal portion of the operation wire Thus, the irradiation direction of the irradiation unit can be changed by changing the inclination angle of the support base.

  Since the medical device configured as described above is provided with an irradiation unit on the support base that can change the tilt angle with respect to the axis of the cylindrical part, the ultrasonic irradiation direction can be changed by changing the tilt angle. It is. For this reason, it is possible to adjust the irradiation direction of the ultrasonic wave in an optimum direction, and to effectively apply the ultrasonic wave to the living body in order to develop or regenerate a blood vessel.

  The irradiation unit may include a concave vibrator. As a result, the ultrasonic waves can be focused with directivity, and the ultrasonic waves can be efficiently irradiated to the target location. Moreover, since the irradiation part can be reduced in size, it can be inserted into a small-diameter blood vessel.

  The irradiation unit may include an acoustic lens. Accordingly, the ultrasonic lens can be focused with directivity by the acoustic lens, and the ultrasonic wave can be efficiently irradiated to the target place. Moreover, since the irradiation part can be reduced in size, it can be inserted into a small-diameter blood vessel.

  The medical device may include an imaging unit that is provided on a distal side of the cylindrical part and transmits and receives ultrasonic waves. Thereby, the position and orientation of the distal portion of the medical device can be specified in three dimensions in real time from the image obtained by the imaging unit. Therefore, the irradiation direction and irradiation position of the ultrasonic wave from the irradiation unit can be accurately adjusted.

  The medical device may have an X-ray contrast marker on a distal side of the cylindrical portion. Thereby, the position of the distal part of a cylindrical part can be correctly grasped under X-ray fluoroscopy. Therefore, the irradiation direction of the ultrasonic wave from the irradiation unit can be accurately adjusted.

  The support portion has a plurality of inclined plates whose outer peripheral portion is thinner than the central portion, the inclined plate has at least two through holes at different positions on the outer peripheral portion, and the operation wire is At least two of the operation wires are sequentially penetrated from the proximal side through the through holes of the plurality of the inclined plates that overlap each other, and the distalmost distal plate or the distal plate is more distal than the inclined plate. It is connected to a member on the side, and the support base may be disposed on the tilting plate on the most distal side. Thus, by pulling any of the operation wire rods, the thin outer peripheral portions of the adjacent tilt plates approach each other at the circumferential position of the tilt plate where the pulled operation wire rods are located. Thereby, the adjacent inclination board inclines relatively. Therefore, the support base can be tilted in an arbitrary direction at an arbitrary inclination angle depending on the selection of the operation wire to be pulled and the distance to be pulled.

  The support portion includes a spring portion that is elastically deformable, a distal connection portion that is located on the distal side of the spring portion and connected to the tubular portion, and is closer to the spring portion. A proximal connection portion located on the distal side and connected to the operating wire, and the support base may be disposed between the spring portion and the distal connection portion. Thereby, by pulling the wire for operation, it can extend so that the bending of a spring part may be opened, and a support stand can be inclined by arbitrary inclination angles. In addition, after pulling the operation wire, by stopping the pulling of the operation wire, the bending of the spring portion returns to the original state by its own elastic force. For this reason, the inclination | tilt angle of a support stand can be changed repeatedly.

It is a top view which shows the medical device which concerns on 1st Embodiment. It is a top view which shows the distal part of a medical device. It is a figure which shows a tilting board, (A) is a top view, (B) is a perspective view. It is sectional drawing which shows the distal part of a medical device, (A) shows the state which orient | assigned the irradiation part to the distal direction, (B) shows the state which inclined the irradiation part. It is sectional drawing which shows the proximal part of a medical device. It is the schematic which shows the medical device inserted in the left coronary artery. It is a top view which shows the medical device which concerns on 2nd Embodiment. It is a top view which shows the distal part of a medical device. It is sectional drawing which shows the distal part of a medical device, (A) shows the state which orient | assigned the irradiation part to the distal direction, (B) shows the state which inclined the irradiation part.

Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.
<First Embodiment>

  The medical device 10 according to the first embodiment is a device that is percutaneously inserted into a blood vessel. The medical device 10 is used to improve or improve the ischemic state of the heart by developing or regenerating coronary arteries or microvessels in the myocardium extending from the coronary arteries by irradiating ultrasonic waves. In this specification, the side to be inserted into the lumen of a living body is referred to as “distal side”, and the proximal side for operation is referred to as “proximal side”.

  The medical device 10 supports the cylindrical part 20, the irradiation part 30 which irradiates an ultrasonic wave, the imaging part 40 which acquires an image, and the irradiation part 30, as shown in FIGS. A support unit 50 and an operation unit 60 for operating the support unit 50 are provided.

  The cylindrical portion 20 is a long portion that is inserted into a blood vessel lumen. The cylindrical portion 20 includes a long body tube 21 and a tip tube 22 provided on a side surface of the distal portion of the body tube 21. The main body tube 21 includes four wire lumens 23, one imaging lumen 24, and one irradiation lumen 25. The four wire lumens 23 accommodate four operation wire members 61 connected to the support portion 50. The imaging lumen 24 accommodates an imaging cable 41 provided in the imaging unit 40. The irradiation lumen 25 accommodates an irradiation cable 31 provided in the irradiation unit 30. The main body tube 21 includes a distal end portion 28 that extends distally from an end surface 29 in which a wire lumen 23, an imaging lumen 24, and an irradiation lumen 25 open on the distal side. The tip 28 protrudes from a part of the end surface 29 in the circumferential direction. Note that the number of lumens provided in the cylindrical portion 20 is not limited. Therefore, the operation wire 61, the imaging cable 41, and the irradiation cable 31 may be accommodated in the same lumen.

  The distal end tube 22 is fixed to the outer surface of the distal end portion 28 of the main body tube 21, and extends distally from the main body tube 21. The distal tube 22 has a guide wire lumen 27 penetrating in the axial direction. The distal tube 22 includes an X-ray contrast marker 26. The marker 26 is not particularly limited as long as it has X-ray contrast properties (X-ray opacity). For example, the marker 26 is formed into a coil shape by winding a wire made of an X-ray contrast material. The marker 26 is embedded in the material of the distal tube 22 so as to surround the guide wire lumen 27. Examples of the X-ray contrasting material include barium sulfate, bismuth oxide, tungsten, gold, platinum, and tantalum. The medical device 10 passes a guide wire W inserted into a blood vessel in advance through the guide wire lumen 27 and is guided along the guide wire W to the affected part.

  The imaging unit 40 is a part that acquires a tomographic image of a living body using ultrasonic echoes. The imaging unit 40 includes an imaging ultrasonic transducer 42 that transmits and receives ultrasonic waves, an imaging cable 41 that is connected to the imaging ultrasonic transducer 42, and an imaging connector 43 that is connected to an external device. Yes.

  The imaging ultrasonic transducer 42 is fixed to the inner surface of the tip portion 28 and is located on the distal side of the end surface 29. The imaging ultrasonic transducer 42 has a surface that oscillates an ultrasonic wave in a direction perpendicular to the axis X of the cylindrical portion 20. Therefore, the imaging ultrasonic transducer 42 oscillates ultrasonic waves in a direction substantially orthogonal to the axis X. The imaging ultrasonic transducer 42 oscillates an ultrasonic wave by an electrical signal received from the imaging cable 41. Further, the imaging ultrasonic transducer 42 receives a reflected wave (echo) of the oscillated ultrasonic wave, converts it into an electrical signal (echo signal), and transmits it to the imaging connector 43. The imaging ultrasonic transducer 42 is disposed at a position that coincides with the marker 26 in the direction along the axis X. The position of the marker 26 is not particularly limited.

  The imaging cable 41 passes through the imaging lumen 24 of the main body tube 21. The distal end of the imaging cable 41 is connected to the imaging ultrasonic transducer 42. The proximal end of the imaging cable 41 is led out from the operation unit 60.

  The imaging connector 43 is electrically connected to the proximal end of the imaging cable 41. The imaging connector 43 connects the imaging cable 41 to an external ultrasonic imaging apparatus (not shown). The ultrasonic imaging apparatus transmits a signal for generating ultrasonic waves to the imaging ultrasonic transducer 42 via the imaging connector 43 and receives an echo signal from the imaging ultrasonic transducer 42. The ultrasonic imaging apparatus can generate a tomographic image of a living body from the received echo signal and display it on a display.

  The support part 50 is a site | part which supports the irradiation part 30 so that a movement is possible, as shown to FIGS. The support unit 50 includes a plurality of disk-shaped inclined disks 51. The inclined plate 51 includes a flat plate portion 52 located at the center and an inclined portion 53 surrounding the outer periphery of the flat plate portion 52. The flat plate portion 52 has a uniform plate thickness. A central hole 54 through which the irradiation cable 31 passes is formed at the center of the flat plate portion 52. In the inclined portion 53, the inclined surfaces 56 on both sides are inclined so that the plate thickness becomes thinner toward the outer side in the radial direction. The angle α of each inclined surface 56 with respect to the surface of the flat plate portion 52 is set according to the maximum value of the inclination angle β (see FIG. 4B) for inclining the irradiation unit 30.

  The inclined portion 53 is formed with four through holes 55 arranged at a uniform angle (90 degrees) in the circumferential direction. The operation wire 61 passes through each through hole 55.

  The plurality of inclined plates 51 are arranged from the end surface 29 of the main body tube 21 toward the distal side along the axis X of the main body tube 21. Adjacent flat plate portions 52 of the plurality of inclined plates 51 are in contact with each other. Since the thickness of the flat plate portion 52 is uniform, the overlapping inclined plates 51 are arranged straight from the end surface 29 in the distal direction. The four through holes 55 of each inclined plate 51 overlap the four through holes 55 of the other inclined plates 51 along the axis X. Therefore, the linear operation wire 61 can penetrate the through holes 55 of the plurality of inclined plates 51. The surface on the distal side of the flat plate portion 52 of the inclined plate 51 located on the most distal side functions as a support base 57 that supports the irradiation unit 30.

  As shown in FIG. 4B, the inclined portion 53 can be inclined so that the inclined surfaces 56 facing each other approach each other. Thereby, the irradiation direction of the ultrasonic wave of the irradiation part 30 can be changed. The maximum value of the inclination angle β at which the irradiation unit 30 is desired to be inclined is 2 × (N−1) × α when the number of the inclined plates 51 is N. Therefore, when the maximum value of the inclination angle β is 90 degrees and the number of the inclined plates 51 is 6, the angle α of the inclined surface 56 with respect to the flat plate portion 52 (see FIG. 3A) is 9 degrees.

  The operation unit 60 is a part that operates the direction of the irradiation unit 30 that oscillates ultrasonic waves. As shown in FIGS. 1, 4 and 5, the operation unit 60 rotates with respect to the four operation wires 61, the operation main body 62 fixed to the proximal end of the main body tube 21, and the operation main body 62. A handle 63 is provided which can be connected.

  Each operation wire 61 passes through the wire lumen 23 of the main body tube 21. The distal portion of the operation wire 61 passes through the through holes 55 of all the inclined plates 51 and is fixed to the most distal inclined plate 51. Note that the distal end of the operation wire 61 may be fixed to a member (for example, the irradiation unit 30 or another plate member) on the distal side of the most distal inclined plate 51. The proximal portion of the operation wire 61 is led out from the wire lumen 23 of the main body tube 21 to the inside of the operation main body 62 and fixed to the handle 63.

  The operation main body 62 is fixed to the proximal end of the main body tube 21. The operation main body 62 includes a space 64 that communicates with the wire lumen 23, the imaging lumen 24, and the irradiation lumen 25 of the main body tube 21. The operation main body 62 is formed with four lead-out holes 65 for leading the operation wire 61 led out from the wire rod lumen 23 to the space 64 to the outside. The four outlet holes 65 are arranged at a uniform angle (90 degrees) in the circumferential direction on the distal side of the handle 63. A convex portion 66 that protrudes 360 degrees is formed on the outer peripheral surface of the operation main body portion 62. The convex portion 66 has a certain radius of curvature.

  The handle 63 includes a ring-shaped sliding portion 67 that covers the convex portion 66 and slides with respect to the convex portion 66, and an operation projecting portion 68 that projects from the outer peripheral surface of the sliding portion 67. A concave surface 69 that covers the convex portion 66 so as to be slidable is formed on the inner peripheral surface of the sliding portion 67. The radius of curvature of the concave surface 69 is slightly larger than the radius of curvature of the convex portion 66 so that the concave surface 69 can slide with the convex portion 66. The proximal end of the operation wire 61 led out from the lead-out hole 65 is fixed to the distal portion of the sliding portion 67. The handle 63 is rotatable (tiltable) with respect to the convex portion 66 in both clockwise and counterclockwise directions in all cross sections passing through the axis X of the main body tube 21. The operation protrusion 68 is a part that the operator operates with a finger to rotate the handle 63. The operation protrusion 68 protrudes from the outer peripheral surface of the sliding portion 67 and is formed in a disc shape.

  The irradiation unit 30 is a part that emits ultrasonic waves to promote the development or new generation of blood vessels. The irradiation unit 30 includes an irradiation ultrasonic transducer 32, an acoustic lens 33, an irradiation cable 31 connected to the irradiation ultrasonic transducer 32, and an irradiation connector 34.

  The irradiation ultrasonic transducer 32 is fixed to the distal surface of the flat plate portion 52 of the inclined plate 51 located on the most distal side, that is, the support base 57. The irradiation ultrasonic transducer 32 has a surface that oscillates ultrasonic waves in a direction parallel to the axis X. Therefore, the irradiation ultrasonic transducer 32 irradiates ultrasonic waves in a direction parallel to the axis X. The irradiation ultrasonic transducer 32 irradiates ultrasonic waves with an electrical signal received from the irradiation cable 31. The irradiation ultrasonic transducer 32 is a planar transducer or a concave transducer.

  The acoustic lens 33 focuses the ultrasonic waves emitted from the irradiation ultrasonic transducer 32. When the irradiation ultrasonic transducer 32 is a plane transducer, the acoustic lens 33 is effective. If the diameter of the ultrasonic transducer is 0.8 mm, the ultrasonic wave goes straight about 1 mm due to the nature of the ultrasonic wave, but then diffuses. On the other hand, by combining the irradiating ultrasonic transducer 32 with the acoustic lens 33, the ultrasonic wave can reach farther. Although the constituent material of the acoustic lens 33 is not limited, for example, silicone rubber, polyetherimide, polyetheretherketone, cross-linked polystyrene, polyolefin, and any combination thereof are suitable. When the irradiation ultrasonic transducer 32 is a concave transducer, the acoustic lens 33 may or may not be provided. The concave vibrator can focus ultrasonic waves without the acoustic lens 33. Further, the focusing of the ultrasonic wave may be performed by an electronic focusing method.

The frequency of the ultrasonic wave irradiated by the irradiation ultrasonic transducer 32 is preferably 0.1 to 50 MHz, more preferably 0.5 to 10 MHz, and further preferably 1.0 to 5 MHz. When irradiating an ultrasonic wave in a pulse form from the irradiation part 30, 10-100,000 Hz is preferable, 100-50000 Hz is more preferable, 1000-10000 Hz is further more preferable. _{I SPTA} (delay Ted intensity, spatial peak temporal average) of the ultrasonic wave irradiation section 30 irradiates is preferably 0.001~200mW / cm ^2, more preferably 0.005~150mW / cm ^2, 0. 01-100 mW / cm ² is more preferable. The irradiation time of the ultrasonic wave irradiated by the irradiation ultrasonic transducer 32 is preferably 1 to 180 minutes, more preferably 5 to 120 minutes, and further preferably 10 to 60 minutes. By irradiating a blood vessel in the ischemic region or in the vicinity thereof with an ultrasonic wave to give a stimulus, eNOS, which is a vascular endothelial nitric oxide synthase, is generated, and blood vessel development or neoplasia is promoted. Further, cardiomyocyte division can be promoted by irradiating ultrasonic waves.

  The irradiation cable 31 passes through the central hole 54 of the support portion 50 and the irradiation lumen 25 of the main body tube 21. The distal end of the irradiation cable 31 is connected to the irradiation ultrasonic transducer 32. The proximal end of the irradiation cable 31 is led out from the operation unit 60 to the outside.

  The irradiation connector 34 is electrically connected to the proximal end of the irradiation cable 31. The irradiation connector 34 connects the irradiation cable 31 to an external ultrasonic generator (not shown). The ultrasonic generator transmits a signal for generating therapeutic ultrasonic waves to the irradiation ultrasonic transducer 32 via the irradiation connector 34.

  Next, the operation of the medical device 10 according to the first embodiment will be described.

  The medical device 10 is used by being percutaneously inserted into a blood vessel and pushed into a blood vessel such as a coronary artery causing an ischemic state in the heart. As an example, as shown in FIG. 6, the medical device 10 is inserted into the left coronary artery and ultrasonic waves are emitted from the irradiation unit 30 to the ischemic region A in the periphery of the left coronary artery caused by the occlusion site B of the left coronary artery. Can be irradiated.

  Referring to FIGS. 1, 2, 4, and 5, when the imaging connector 43 is connected to the ultrasonic imaging apparatus, ultrasonic waves are generated from the ultrasonic imaging apparatus to the imaging ultrasonic transducer 42 via the imaging cable 41. It is possible to transmit a signal for causing the The imaging ultrasonic transducer 42 that has received the signal irradiates ultrasonic waves inside the blood vessel. Further, the imaging ultrasonic transducer 42 receives a reflected wave of the irradiated ultrasonic wave and transmits an echo signal to the ultrasonic imaging apparatus via the imaging cable 41. The ultrasonic imaging apparatus creates a tomographic image from the obtained signal and displays it on the display. The ultrasonic imaging apparatus can display the obtained tomographic image on a display in combination with an angio image or CT (Computed Tomography) image during operation. Therefore, the ultrasonic irradiation position and irradiation direction can be confirmed in three dimensions in real time. The imaging ultrasonic transducer 42 is disposed at a position that coincides with the marker 26 in the direction along the axis X. For this reason, it is easy to specify the position of the imaging ultrasonic transducer 42 from the angio image or CT image. And since the irradiation direction of the ultrasonic wave from the imaging ultrasonic transducer 42 is a direction substantially orthogonal to the axis X, the direction of the distal portion of the medical device 10 can be accurately specified. Note that the direction in which the imaging ultrasonic transducer 42 irradiates ultrasonic waves is not limited to the direction orthogonal to the axis X, for example, a direction inclined at an angle of less than 90 degrees with respect to the axis X. Also good. The position where the imaging ultrasonic transducer 42 is fixed with respect to the distal end portion 28 is the inner surface side of the distal end portion 28, that is, the side where the irradiation ultrasonic transducer 32 is provided. That is, it is the lower side in the drawing of FIGS. For this reason, the imaging unit 40 can easily identify the position of the irradiation ultrasonic transducer 32 with an image, and obtain an image of the ischemic region A or the occlusion site B where the ultrasonic irradiation is performed by the irradiation ultrasonic transducer 32. It's easy to do. If the irradiation ultrasonic transducer 32 exists within a range where the image of the imaging unit 40 can be acquired, the state of the inclination angle β of the irradiation ultrasonic transducer 32 can be confirmed from the image.

  As shown in FIG. 5, when an arbitrary position in the circumferential direction of the operation protrusion 68 is pressed toward the proximal side, the handle 63 is tilted so that the pressed position moves toward the proximal side. As a result, the operation wire 61 fixed in the vicinity of the pressed position of the handle 63 is pulled. As shown in FIGS. 4B and 5, the pulled operation wire 61 slides within the wire lumen 23 and presses the operation protrusion 68 of the inclined plate 51 located on the most distal side. Pull the circumferential position in common with the position. Thereby, the some inclined board 51 inclines so that the inclined surfaces 56 which the adjacent inclined board 51 faces may approach. Therefore, the irradiation direction and the inclination angle β of the irradiation unit 30 can be arbitrarily set by arbitrarily adjusting the position where the operation protrusion 68 is pressed and the angle of inclination. In addition, when operating the operation protrusion 68, an arbitrary position in the circumferential direction of the operation protrusion 68 may be pressed to the distal side rather than to the proximal side. In this case, the position opposite to the pressed position of the operating projection 68 and the position opposite to the circumferential direction moves to the proximal side and tilts.

  When the irradiation connector 34 (see FIG. 1) is connected to the ultrasonic generator, a signal for generating an ultrasonic wave can be transmitted from the ultrasonic generator to the irradiation ultrasonic transducer 32 via the irradiation cable 31. It becomes. The irradiation ultrasonic transducer 32 that has received the signal irradiates ultrasonic waves inside the blood vessel. The irradiated ultrasonic wave is focused by the acoustic lens 33 and irradiated. The ultrasonic wave is irradiated in an arbitrary direction in which the irradiation ultrasonic transducer 32 is directed by the support unit 50. As a result, the development or new generation of blood vessels irradiated with ultrasonic waves is promoted.

  As described above, the medical device 10 according to the first embodiment is a medical device 10 for irradiating an ultrasonic wave to develop or regenerate a blood vessel, and includes a long cylindrical portion 20 and a cylindrical shape. The support part 50 provided with the support stand 57 which is provided in the distal side of the part 20 and can change the inclination angle β with respect to the axis X of the cylindrical part 20 and the irradiation part which is arranged on the support stand 57 and radiates ultrasonic waves 30 and an operation wire 61 in which at least a part is accommodated in the tubular portion 20, a distal portion is connected to the support portion 50, and a proximal portion is located on the proximal side of the tubular portion 20. It is possible to change the irradiation direction of the irradiation unit 30 by changing the inclination angle β of the support base 57 by pulling the proximal portion of the operation wire 61.

  In the medical device 10 configured as described above, since the irradiation unit 30 is provided on a support base that can change the inclination angle β with respect to the axis X of the cylindrical portion 20, ultrasonic waves can be obtained by changing the inclination angle β. The irradiation direction can be changed. For this reason, it is possible to adjust the irradiation direction of the ultrasonic wave in an optimum direction, and to effectively apply the ultrasonic wave to the living body in order to develop or regenerate a blood vessel. Therefore, it is possible to efficiently irradiate ultrasonic waves to the myocardium in the ischemic region A from the responsible blood vessel at the occlusion site B where the approach is difficult.

  The irradiation unit 30 may have a concave vibrator. As a result, the ultrasonic waves can be focused with directivity, and the ultrasonic waves can be efficiently irradiated to the target location. Moreover, since the irradiation part 30 can be reduced in size, it can be inserted into a small-diameter blood vessel.

  The irradiation unit 30 may include an acoustic lens 33. Thereby, the acoustic lens 33 can focus the ultrasonic wave with directivity, and can efficiently irradiate the ultrasonic wave to the target place. Moreover, since the irradiation part 30 can be reduced in size, it can be inserted into a small-diameter blood vessel.

  The medical device 10 includes an imaging unit 40 that is provided on the distal side of the cylindrical portion 20 and transmits and receives ultrasonic waves. Thereby, the position and orientation of the distal portion of the medical device 10 can be specified in three dimensions in real time from the image obtained by the imaging unit 40. Therefore, the irradiation direction and irradiation position of the ultrasonic wave from the irradiation unit 30 can be accurately adjusted.

  The medical device 10 has an X-ray contrast marker 26 on the distal side of the cylindrical portion 20. Thereby, the position of the distal part of the cylindrical part 20 can be correctly grasped under X-ray fluoroscopy. Therefore, the irradiation direction of the ultrasonic wave from the irradiation unit 30 can be accurately adjusted.

The support portion 50 includes a plurality of inclined plates 51 whose outer peripheral portions are thinner than the central portion, and the inclined plates 51 have at least two through holes 55 at different positions on the outer peripheral portions, and the operation wire 61 Are provided at least two, and each operation wire 61 sequentially penetrates through holes 55 of a plurality of overlapping inclined plates 51 from the proximal side, and the most distal inclined plate 51 or the inclined plate 51 is provided. The support base is disposed on the most distal tilting platen 51, and is connected to the more distal member. By providing at least two operation wire rods 61, by pulling any one of the operation wire rods 61, at the circumferential position of the inclined plate 51 where the pulled operation wire rod 61 is located, the adjacent inclined plate 51 Thin outer peripheries approach each other. Thereby, the adjacent inclination board 51 inclines relatively. Therefore, the support base can be tilted in an arbitrary direction at an arbitrary inclination angle β depending on the selection of the operating wire 61 to be pulled and the distance to be pulled.
Second Embodiment

  As shown in FIGS. 7 to 9, the medical device 70 according to the second embodiment is different from the first embodiment in the structure of the cylindrical portion 80, the support portion 90, and the operation portion 100. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  The cylindrical portion 80 of the medical device 70 according to the second embodiment includes a long body tube 81 and a tip tube 22 provided on a side surface of the distal portion of the body tube 81. The main body tube 81 includes a wire rod lumen 82 and a cable lumen 83. The wire rod lumen 82 accommodates one operation wire rod 101 connected to the support portion 90. The cable lumen 83 accommodates the imaging cable 41 and the irradiation cable 31.

  The support portion 90 is formed by bending an elastically deformable plate material. The support portion 90 includes an elastically deformable spring portion 91, a support base 92 that supports the irradiation ultrasonic transducer 32, and a facing portion 93 that is located on the proximal side of the support base 92. The support part 90 further includes a distal connection part 94 connected to the inner surface of the tip part 28 and a proximal connection part 95 connected to the operation wire 101.

  The distal connecting portion 94 is located at the most distal end of the support portion 90 and is fixed to the outer peripheral surface of the tip tube 22. The support base 92 is located on the proximal side of the distal connecting portion 94. The support base 92 is a plate-like part having a surface substantially orthogonal to the axis X. The irradiation ultrasonic transducer 32 is fixed to the distal surface of the support base 92. The support base 92 is formed with a first hole 96 through which the imaging cable 41 and the irradiation cable 31 pass. The spring portion 91 is bent and folded so that the support base 92 and the facing portion 93 substantially overlap in a natural state where no load is applied. The facing portion 93 is located on the proximal side of the spring portion 91. The facing portion 93 is a plate-like portion having a surface substantially orthogonal to the axis X. The facing portion 93 is opposed to the support base 92 on the proximal side of the support base 92. The facing portion 93 is formed with a second hole 97 through which the imaging cable 41 and the irradiation cable 31 pass. The imaging cable 41 and the irradiation cable 31 that pass through the first hole portion 96 and the second hole portion 97 are disposed along surfaces of the support base 92 and the facing portion 93 that face each other. The proximal connecting portion 95 is located on the proximal side of the facing portion 93 and at the closest position of the support portion 90. The proximal connecting portion 95 is connected to the distal end of the operation wire 101.

  The constituent material of the support portion 90 is not limited as long as it can be elastically deformed. For example, a shape memory alloy, stainless steel, or the like to which a shape memory effect or superelasticity is imparted by heat treatment is preferable. As the shape memory alloy, a Ni-Ti system, a Cu-Al-Ni system, a Cu-Zn-Al system, or a combination thereof is suitable.

  The operation unit 100 includes one operation wire 101, an operation main body 102 fixed to the proximal end of the main body tube 81, and a grip 103. The operation wire 101 passes through the wire lumen 82 of the main body tube 81. The distal end of the operation wire 101 is connected to the proximal connection part 95. The proximal end of the operation wire 101 is connected to the grip portion 103. The grip part 103 is a part that is gripped to pull the operation wire 101. The grip portion 103 is a columnar member having an outer diameter larger than the outer diameter of the operation wire 101 so that the operator can easily grip the grip portion 103. In addition, the shape of a holding part is not specifically limited. Further, the gripping part may not be provided.

  Next, the operation of the medical device 70 according to the second embodiment will be described.

  When the grip portion 103 (see FIG. 7) is pulled, the operation wire 101 connected to the grip portion 103 moves to the proximal side, as shown in FIG. 9B. The operation wire 101 slides inside the wire lumen 82 and moves the proximal connecting portion 95 of the support portion 90 to the proximal side. Thereby, while the proximal connection part 95 leaves | separates from the distal connection part 94, the opposing part 93 leaves | separates from the support stand 92, and it extends so that the bending of the spring part 91 may open. For this reason, the support base 92 is tilted, and the irradiation direction of the ultrasonic waves from the irradiation unit 30 fixed to the support base 92 changes so as to be tilted with respect to the axis X. Further, when the operation wire 101 is pulled after the operation wire 101 is pulled, the bending of the spring portion 91 returns to the original state by its own elastic force as shown in FIGS. For this reason, the direction of the support base 92 can be repeatedly changed by adjusting the amount of movement of the grip portion 103 relative to the operation main body portion 102.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the blood vessel to be inserted is not particularly limited.

  In addition, when cardiac stem cells are administered (or injected into a tissue), the cells are activated by applying ultrasonic waves to the administration site and the surroundings, and then the cardiac stem cells are administered via coronary veins / arteries. (Or injection into the tissue). By doing so, cell mobility (cell mobility) and surrounding angiogenesis ability are synergistically exhibited, and heart tissue is regenerated faster.

  In the embodiment described above, the irradiation ultrasonic transducer and the imaging ultrasonic transducer are exposed to the outside of the cylindrical portion. However, if the cylindrical portion can transmit ultrasonic waves, the cylindrical portion is cylindrical. You may arrange | position inside a part.

  The imaging unit is not limited as long as it can acquire a tomographic image of a living body. For example, an optical coherence tomography (OCT: Optical Coherence Tomography), an optical frequency domain imaging method (OFDI: Optical Frequency Domain Imaging), or the like is used. The device used may be used.

DESCRIPTION OF SYMBOLS 10, 70 Medical device 20, 80 Cylindrical part 26 Marker 30 Irradiation part 33 Acoustic lens 40 Imaging part 50, 90 Support part 51 Inclination board 55 Through-hole 57, 92 Support base 60, 100 Operation part 61, 101 Operation wire 91 Spring part X-axis center β Inclination angle

Claims (7)

A medical device for irradiating an ultrasonic wave to develop or develop a blood vessel,
A long tubular part;
A support portion provided on a distal side of the tubular portion, and provided with a support base capable of changing an inclination angle with respect to an axis of the tubular portion;
An irradiating unit disposed on the support table and radiating ultrasonic waves;
An operation wire that is at least partially housed in the tubular part, a distal part is connected to the support part, and a proximal part is located closer to the proximal side than the tubular part,
The medical device which can change the irradiation direction of the said irradiation part by changing the inclination-angle of the said support stand by pulling the proximal part of the said operation wire.   The medical device according to claim 1, wherein the irradiation unit includes a concave vibrator.   The medical device according to claim 1, wherein the irradiation unit includes an acoustic lens.   The medical device according to any one of claims 1 to 3, further comprising an imaging unit that is provided on a distal side of the cylindrical part and transmits and receives ultrasonic waves.   The medical device according to any one of claims 1 to 4, further comprising an X-ray contrast marker on a distal side of the cylindrical portion. The support part has a plurality of inclined plates whose outer peripheral part is thinner than the central part,
The inclined plate has at least two through holes at different positions on the outer periphery,
At least two of the operation wires are provided,
Each of the operating wire rods sequentially penetrates the through holes of the plurality of overlapping inclined plates from the proximal side, and is connected to the distalmost distal plate or a member more distal than the inclined plate. ,
The medical device according to any one of claims 1 to 5, wherein the support base is disposed on the inclined plate on the most distal side. The support portion includes a spring portion that is elastically deformable, a distal connection portion that is located on the distal side of the spring portion and connected to the tubular portion, and is closer to the spring portion. A proximal connecting portion located on the distal side and connected to the operating wire,
The medical device according to claim 1, wherein the support base is disposed between the spring portion and the distal connection portion.

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