WO2013157207A1

WO2013157207A1 - Vascular insertion type treatment device

Info

Publication number: WO2013157207A1
Application number: PCT/JP2013/002285
Authority: WO
Inventors: 吏悟小林; 小林　淳一; 杉本　良太; 平原　一郎
Original assignee: テルモ株式会社
Priority date: 2012-04-20
Filing date: 2013-04-02
Publication date: 2013-10-24

Abstract

This vascular insertion type treatment device (100) is provided with an insertion body (103) and a first ultrasonic transducer (104). The insertion body (103) has a longitudinal shape, the two ends of which are a base end and an insertion end. The first ultrasonic transducer (104) is provided near the insertion end of the insertion body (103). The first ultrasonic transducer (104) produces cauterizing ultrasonic waves radially seen from the longitudinal direction of the longitudinal shape.

Description

Vascular insertion device

The present invention relates to a blood vessel insertion type treatment device, and particularly to a blood vessel insertion type treatment device that can be inserted into a blood vessel and cauterize a living tissue around the blood vessel from inside the blood vessel.

In recent years, it has been elucidated that abnormal renal artery sympathetic nerve activity causes congestive heart failure, renal failure, hypertension, and other cardiorenal diseases. It is also known to treat these diseases by removing renal artery sympathetic nerves. In order to cauterize the renal artery sympathetic nerve, a renal nerve control device has been proposed in which an electrode is inserted into the renal artery and a pulse output electric field is applied from the electrode to the renal artery replacement nerve (see Patent Document 1).

However, in the cauterization of the renal artery sympathetic nerve using the pulse output electric field by the renal nerve control device described in Patent Document 1, the current density of the intima becomes the largest. Therefore, the heat generated in the vascular intima is the largest. For this reason, the whole blood vessel wall including the intima of the blood vessel may be cauterized, and side effects such as intimal thickening and thrombus may occur.

Special table 2008-515544

Therefore, in the present invention made in view of the above problems, there is provided a blood vessel insertion type treatment device capable of cauterizing a living tissue around a blood vessel such as a renal artery sympathetic nerve around the renal artery while suppressing damage to the blood vessel. For the purpose of provision.

In order to solve the above-described problems, a blood vessel insertion type treatment device according to the present invention includes:
An elongated insert having a proximal end and an insertion end at both ends;
A first ultrasonic transducer that is provided in the vicinity of the insertion end and emits ultrasonic waves for ablation radially when viewed from the longitudinal direction of the longitudinal shape.

According to such a configuration, ultrasonic waves for cauterization are emitted radially from the first ultrasonic transducer as viewed from the longitudinal direction. Therefore, it is possible to cauterize the annular ablation target tissue existing around the blood vessel without changing the direction of the first ultrasonic transducer. Therefore, it is possible to omit a procedure for changing the direction of the first ultrasonic transducer.

According to the blood vessel insertion type treatment device according to the present invention configured as described above, it is possible to remove living tissue around the blood vessel while suppressing damage to the blood vessel.

It is a figure explaining the technique of renal artery sympathetic nerve removal using the blood vessel insertion type treatment device concerning a 1st embodiment of the present invention. FIG. 2 is an enlarged view of the vicinity of a renal artery in which a guiding catheter is inserted in FIG. 1. It is sectional drawing along the longitudinal direction of the insertion end vicinity of the blood vessel insertion type treatment device of 1st Embodiment. It is a perspective view of the acoustic balloon lens for demonstrating the structure of an acoustic balloon lens. It is sectional drawing along the longitudinal direction of the insertion end vicinity of the blood vessel insertion type treatment device of 2nd Embodiment. FIG. 6 is an enlarged view of the vicinity of a renal artery in which a guiding catheter is inserted in FIG. 5. (A) is sectional drawing along the longitudinal direction of the insertion end vicinity of the blood vessel insertion type treatment device of 3rd Embodiment, (b) is a 1st ultrasonic transducer | vibrator in Fig.7 (a). It is a figure explaining the ultrasonic wave to emit. It is a figure which shows the 1st modification of a mesh balloon. FIG. 9 is a cross-sectional view taken along line IX-IX in FIG. It is a figure which shows the 2nd modification of a mesh balloon. FIG. 11 is a cross-sectional view taken along line XI-XI in FIG. 10. It is sectional drawing of the blood vessel insertion type treatment device in the blood vessel along the direction perpendicular | vertical to a longitudinal direction for demonstrating the 3rd modification of a mesh balloon. It is sectional drawing of the blood vessel insertion type treatment device in the blood vessel along the direction perpendicular | vertical to a longitudinal direction for demonstrating the 4th modification of a mesh balloon.

Hereinafter, an embodiment of a blood vessel insertion type treatment device to which the present invention is applied will be described with reference to the drawings. FIG. 1 is a diagram for explaining a technique for removing a renal artery sympathetic nerve using the blood vessel insertion type treatment device according to the first embodiment of the present invention.

In order to remove the renal artery sympathetic nerve, the operator inserts the guiding catheter 200 from the patient's thigh into the femoral artery FA in advance and allows the distal end of the guiding catheter 200 to reach the renal artery RA. A guide wire (not shown) is used for reaching the guiding artery 200 to the renal artery RA.

The guiding catheter 200 is tubular, and a device for diagnosis and treatment can be inserted. The blood vessel insertion type treatment device 100 is generally string-shaped, has an insertion end and a proximal end, and can be inserted into the lumen of the guiding catheter 200 from the insertion end. The surgeon inserts the blood vessel insertion type treatment device 100 into the guiding catheter 200 and causes the insertion end to protrude from the guiding catheter 200 (see FIG. 2). In the protruding state, the acoustic balloon lens 101 provided in the vicinity of the insertion end of the blood vessel insertion type treatment device 100 is expanded to fix the blood vessel insertion type treatment device 100 in the renal artery RA.

As will be described later, the blood vessel insertion type treatment device 100 has an imaging function and an ablation function. In order to perform the imaging function, the blood vessel insertion type treatment device 100 can emit imaging ultrasound IUS. The surgeon executes an imaging function of the inserted blood vessel insertion type treatment device 100 to acquire an image around the renal artery from the renal artery RA.

The surgeon discriminates the sympathetic nerve SN to be cauterized based on the acquired image, and adjusts the position of the blood vessel insertion type treatment device 100 so that the cauterized ultrasound CUS is irradiated to the discriminated sympathetic nerve SN. . After the position adjustment, the surgeon performs the cauterization function of the blood vessel insertion type treatment device 100 to cauterize the desired sympathetic nerve SN.

Next, the configuration of the blood vessel insertion type treatment device 100 will be described with reference to FIG. The blood vessel insertion type treatment device 100 includes a sheath 102, an insert 103, a first ultrasonic transducer 104, an image acquisition unit 105, an acoustic balloon lens 101 (see FIG. 2), and the like.

The sheath 102 is formed of a member having acoustic properties and flexibility. The end of the sheath 102 on the insertion end side is open. Further, at the start of use, the inside of the sheath 102 is filled with a medium having acoustic transmission properties from the proximal end side.

The insert 103 is formed by a flexible member so as to extend from the vicinity of the proximal end of the sheath 102 to the insertion end. With the insertion end of the insertion body 103 reaching the insertion end of the sheath 102, the proximal end of the insertion body 103 protrudes from the proximal end of the sheath 102.

The outer diameter of the insert 103 is determined to be smaller than the inner diameter of the sheath 102, and the insert 103 can be displaced along the longitudinal direction in the sheath 102. Further, the insert 103 is rotatable within the sheath 102 about the longitudinal direction.

The first ultrasonic transducer 104 has a cylindrical shape, and the first ultrasonic transducer 104 is formed so that the inner diameter of the cylinder is substantially equal to the outer diameter of the insertion body 103. The first ultrasonic transducer 104 is fixed in the vicinity of the insertion end in a state where the insertion body 103 is inserted through the inner surface of the cylinder. The first ultrasonic transducer 104 emits ultrasonic waves CUS for cauterization radially from the outer surface about the axis of the cylinder.

The distance for transmitting ultrasonic waves and the amount of heat generated at the position where the ultrasonic waves converge are determined by the frequency. Therefore, the frequency of the ultrasound CUS for cauterization is determined in advance based on the approximate interval from the inside of the renal artery RA to the renal artery sympathetic nerve SN and the amount of heat generated for cauterization of the sympathetic nerve SN.

A signal line extending from the first ultrasonic transducer 104 to the proximal end is connected to an ablation control unit (not shown). The ablation control unit supplies a drive signal to the first ultrasonic transducer 104 so as to generate the ablation ultrasonic wave CUS at the aforementioned frequency.

The image acquisition unit 105 is provided near the insertion end of the insertion body 103. The image acquisition unit 105 has a single imaging ultrasonic transducer 106. The imaging ultrasonic transducer 106 is arranged so as to emit ultrasonic waves in a direction inclined by a predetermined angle from the direction perpendicular to the longitudinal direction of the insert 103 to the insertion end side.

From the imaging ultrasonic transducer 106, it is possible to generate imaging ultrasound IUS suitable for image acquisition. The imaging ultrasonic transducer 106 generates a pixel signal corresponding to the reflected wave of the imaging ultrasonic wave IUS. The resolution due to the reflected wave of the ultrasonic wave varies depending on the frequency. The frequency of the imaging ultrasound IUS is determined in advance based on the resolution necessary for confirmation and diagnosis of the position of a specific sympathetic nerve.

A signal line extending from the imaging ultrasonic transducer 106 to the base end is connected to an imaging control unit (not shown). The imaging control unit supplies a drive signal to the imaging ultrasonic transducer 106 so as to generate the imaging ultrasonic IUS at the above-described frequency.

Further, the imaging control unit receives a pixel signal generated by the imaging ultrasonic transducer 106. The imaging control unit creates an image based on pixel signals corresponding to a number of locations irradiated with imaging ultrasonic waves. Note that the irradiation position of the imaging ultrasonic wave can be determined by detecting the rotational position of the insertion body 103 and the displacement position along the longitudinal direction using an encoder or a position sensor, and is used for creating an image.

The acoustic balloon lens 101 is provided on the sheath 102 in the vicinity of the position where the first ultrasonic transducer 104 is disposed. By inflating the acoustic balloon lens 101 outside the sheath 102 and pressing the acoustic balloon lens 101 against the inner wall of the blood vessel, the blood vessel insertion type treatment device 100 can be fixed in the blood vessel.

As shown in FIG. 4, the acoustic balloon lens 101 has a double structure having an inner balloon 107 and an outer balloon 108. Different media are used to inflate the inner balloon 107 and the outer balloon 108, respectively. As the medium of the inner balloon 107, an object having a transmission speed of ultrasonic waves smaller than that of the medium of the outer balloon 108 is used.

In the configuration as described above, the ablation ultrasonic wave CUS emitted from the first ultrasonic transducer 104 changes the passing distance of the inner balloon 107 and the passing distance of the outer balloon 108 depending on the position along the cylindrical height direction. Therefore, the inner balloon 107 and the outer balloon 108 are formed so as to be able to converge the ultrasonic wave at a convergence position separated from the sheath 102 by a predetermined distance. The approximate distance from the renal artery to the renal artery sympathetic nerve is determined as a predetermined distance.

According to the blood vessel insertion type treatment device 100 of the first embodiment configured as described above, it is possible to maximize the heat generation energy at the convergence position of the ablation ultrasonic waves. Therefore, while it is possible to cauterize living tissue distributed from the inside of the blood vessel to the outside of the blood vessel, it is possible to suppress damage to the blood vessel interposed between the living tissue.

Further, according to the blood vessel insertion type treatment device 100 of the first embodiment, it is possible to emit ultrasonic waves for cauterization radially from the central axis of the cylinder from the cylindrical first ultrasonic transducer 104. Therefore, it is possible to easily cauterize an object extending in an annular shape or an arc shape outside the blood vessel without rotating the blood vessel insertion type treatment device 100.

Moreover, according to the blood vessel insertion type treatment device 100 of the first embodiment, the acoustic balloon lens 101 is used to fix the blood vessel insertion type treatment device 100 in the blood vessel and converge the ablation ultrasonic wave at a predetermined distance. Is feasible. Therefore, it is possible to reduce the number of components compared to the case where separate balloons and acoustic lenses are used.

Further, according to the blood vessel insertion type treatment device 100 of the first embodiment, since the image acquisition unit 105 is provided in the vicinity of the first ultrasonic transducer 104, confirmation of a living tissue to be ablated, and ablation status Confirmation is easy.

Next, a blood vessel insertion type treatment device according to a second embodiment of the present invention will be described. The second embodiment is different from the first embodiment in that a cylindrical acoustic lens and a mesh balloon are used without using an acoustic balloon lens. The second embodiment will be described below with a focus on differences from the first embodiment. In addition, the same code | symbol is attached | subjected to the site | part which has the same function and structure as 1st Embodiment.

As shown in FIG. 5, the blood vessel insertion type treatment device 1000 of the second embodiment includes a sheath 102, an insert 103, a first ultrasonic transducer 104, an image acquisition unit 105, a cylindrical acoustic lens 1090, and a mesh balloon. 1100 (see FIG. 6) and the like.

In the second embodiment, unlike the first embodiment, no acoustic balloon lens is provided. In the second embodiment, the configurations and functions of the sheath 102, the insert 103, the first ultrasonic transducer 104, and the image acquisition unit 105 are the same as those in the first embodiment.

As shown in FIG. 5, the cylindrical acoustic lens 1090 has a cylindrical side surface on the inner surface and a concave surface in the cylindrical axis direction on the outer surface, that is, a saddle shape with a concave center. Therefore, the cylindrical acoustic lens 1090 has a function of converging ultrasonic waves along the cylinder height direction.

The cylindrical acoustic lens 1090 is formed so that the length in the height direction of the cylindrical acoustic lens 1090 is the same as the cylindrical height of the first ultrasonic transducer 104. The cylindrical acoustic lens 1090 is fixed in a state where the entire first ultrasonic transducer 104 is accommodated inside the cylinder.

As shown in FIG. 6, the mesh balloon 1100 is provided on the sheath 102. The mesh balloon 1100 is provided closer to the proximal end than the image acquisition unit 105 in a state where the insertion body 103 has reached the insertion end of the sheath 102. By bending the wire constituting the mesh balloon 1100 outward from the blood vessel insertion type treatment device 1000 and pressing the wire against the inner wall of the blood vessel, the blood vessel insertion type treatment device 1000 can be fixed in the blood vessel.

Similarly to the first embodiment, the blood vessel insertion type treatment device 1000 of the second embodiment configured as described above can cauterize living tissue distributed from the inside of the blood vessel to the outside of the blood vessel. It is possible to suppress damage to blood vessels intervening between tissues. Further, similarly to the first embodiment, an object extending in an annular shape or an arc shape can be easily cauterized outside the blood vessel without rotating the blood vessel insertion type treatment device 1000. In addition, as in the first embodiment, it is easy to confirm a living tissue to be ablated, a condition of ablation, and the like.

Further, according to the blood vessel insertion type treatment device 1000 of the second embodiment, the vicinity of the insertion end of the blood vessel insertion type treatment device 1000 can be temporarily fixed in the blood vessel using the mesh balloon 1100. Further, since the mesh balloon 1100 is used, blood flow can be secured, and overheating of the inner wall of the blood vessel that irradiates the ultrasound CUS for cauterization while fixing the blood vessel insertion type treatment device 1000 in the blood vessel can be prevented. is there.

Next, a blood vessel insertion type treatment device according to a third embodiment of the present invention will be described. The third embodiment is different from the first embodiment in that a mesh balloon is used instead of the acoustic balloon lens and the configuration of the first ultrasonic transducer. The third embodiment will be described below with a focus on differences from the first embodiment. In addition, the same code | symbol is attached | subjected to the site | part which has the same function and structure as 1st Embodiment.

As shown in FIG. 7A, the blood vessel insertion type treatment device 1001 of the third embodiment includes a sheath 102, an insert 103, a first ultrasonic transducer 1041, an image acquisition unit 105, and a mesh balloon 1100 ( Etc.).

In the third embodiment, unlike the first embodiment, no acoustic balloon lens is provided. The configurations and functions of the sheath 102, the insertion body 103, and the image acquisition unit 105 are the same as those in the first embodiment. The configuration and function of the mesh balloon 1100 are the same as those in the second embodiment.

Unlike the first embodiment, the first ultrasonic transducer 1041 is annular. Similar to the first embodiment, the first ultrasonic transducer 1041 is formed so that the annular inner diameter of the first ultrasonic transducer 1041 is substantially equal to the outer diameter of the insert 103. Unlike the first embodiment, the plurality of first ultrasonic transducers 1041 are fixed so as to be evenly arranged along the longitudinal direction in the vicinity of the insertion end in a state where the insertion body 103 is inserted through the annular inner surface. Each first ultrasonic transducer 1041 emits ablation ultrasonic waves CUS radially from the outer peripheral surface around an annular axis.

The first ultrasonic transducer 1041 differs in the timing or phase of emitting ultrasonic waves depending on the position. The ablation control unit causes the first ultrasonic transducer 1041 to be delayed from the both ends of the first ultrasonic transducers 1041 arranged in the longitudinal direction toward the center when the ablation ultrasonic waves are emitted or transferred. Drive separately. By driving the first ultrasonic transducer 1041 as described above, it is possible to converge the ultrasonic wave at the convergence position without using an acoustic lens.

Similarly to the first embodiment, the blood vessel insertion type treatment device 1001 of the third embodiment configured as described above can cauterize living tissue distributed from the inside of the blood vessel to the outside of the blood vessel. It is possible to suppress damage to blood vessels intervening between tissues. Further, as in the first embodiment, an object extending in an annular shape or an arc shape can be easily cauterized outside the blood vessel without rotating the blood vessel insertion type treatment device 1001. In addition, as in the first embodiment, it is easy to confirm a living tissue to be ablated, a condition of ablation, and the like.

Also, according to the blood vessel insertion type treatment device 1001 of the third embodiment, the vicinity of the insertion end of the blood vessel insertion type treatment device 1000 is temporarily fixed in the blood vessel using the mesh balloon 1100 as in the second embodiment. Is possible. Further, since the mesh balloon 1100 is used, it is possible to prevent overheating of the inner wall portion of the blood vessel that is irradiated with the ultrasound CUS for cauterization while fixing the blood vessel insertion type treatment device 1000 in the blood vessel.

Further, according to the blood vessel insertion type treatment device 1001 of the third embodiment, since an element such as an acoustic lens for converging the ultrasonic waves for ablation is unnecessary, it is possible to reduce the number of components. Furthermore, according to the blood vessel insertion type treatment device 1001, it is possible to change the focal length by adjusting the delay time such as the time of generating the ultrasonic wave from the first ultrasonic transducer 1041. Therefore, according to the blood vessel insertion type treatment device 1001, it is possible to cauterize living tissue existing in a wide range with respect to the distance from the blood vessel.

As shown in FIG. 7B, from the first ultrasonic transducer 1041 located at A (x = 0, y = 0) toward the point C (x = 0, y = y ₀ ). The path difference Δl between the emitted ultrasonic wave and the ultrasonic wave emitted from the first ultrasonic transducer 1041 located at B (x = x, y = 0) is expressed by the following formula (1).

Further, the delay time τ (x) due to the path difference to be corrected is expressed by the following equation (2). Note that C is the speed of ultrasonic waves (sound speed).

Further, when this is expressed by the phase difference θ (x), the following equation (3) is obtained. Note that T is a period, C is a velocity (sound velocity) of ultrasonic waves, and λ is a wavelength at a driving frequency of the first ultrasonic transducer 1041. The drive frequency f of the first ultrasonic transducer 1041 is represented by 1 / T, and the wavelength λ at the drive frequency f of the first ultrasonic transducer 1041 is represented by CT.

Although the present invention has been described based on the drawings and embodiments, it should be noted that those skilled in the art can easily make various modifications and corrections based on the present disclosure. Therefore, it should be noted that these variations and modifications are included in the scope of the present invention.

For example, in the first to third embodiments, the first

ultrasonic transducers

104 and 1041 are cylindrical and annular, but it is possible to emit ultrasonic waves for cauterization radially when viewed from the longitudinal direction of the insert. Any other shape may be used. For example, it may be spiral.

In the second and third embodiments, the mesh balloon 1100 is provided. However, the blood vessel insertion

type treatment devices

1000 and 1001 may be temporarily fixed in the blood vessel using other balloons.

In particular, a balloon that prevents overheating of the inner wall of the blood vessel is preferable. For example, as shown in FIGS. 8 and 9, the same overheating prevention effect as that of the mesh balloon 1100 can be obtained by a configuration having a plurality of balloons 111 that can be expanded in different directions around the sheath 102. Further, for example, as shown in FIGS. 10 and 11, the mesh balloon 1100 and the mesh balloon 1100 may be configured to have a balloon 112 that can be inflated all around the sheath 102 and has a hole OH that penetrates in the longitudinal direction. It is possible to obtain the same overheating prevention effect.

Further, for example, as shown in FIG. 12, the same overheating prevention effect as that of the mesh balloon 1100 can be obtained by the configuration having the balloon 113 formed so that the cross section along the plane perpendicular to the longitudinal direction has a star shape. Is possible. For example, as shown in FIG. 13, the same overheating prevention effect as that of the mesh balloon 1100 can be obtained by a configuration in which the balloon 115 is partially inflated using a plurality of wires 114.

Alternatively, it is preferable to use a perfusion balloon or a cryoballoon that can cool the inner wall of the blood vessel using a refrigerant. In cauterization using ultrasonic waves, it is possible to maximize the heat generation energy at the focal point, but the blood vessel walls including the inner wall of the blood vessel that propagates the ultrasonic waves before convergence can also generate heat due to the ultrasonic waves. Therefore, it is possible to further reduce the possibility of damage that can occur on the inner wall of the blood vessel by using a cooled balloon.

In the first to third embodiments, the image acquisition unit 105 is configured to acquire an image using ultrasonic waves. However, the image acquisition unit 105 acquires an image based on optical information such as TD-OCT and HUD-OCT. It may be configured to.

100, 1000, 1001 Blood vessel insertion type treatment device 101 Acoustic balloon lens 102 Sheath 103

Insert

104, 1041 First ultrasound transducer 105 Image acquisition unit 106 Imaging ultrasound transducer 107 Internal balloon 108 External balloon 1090 Cylindrical acoustic lens 1100 Mesh balloon 111-113, 115 Balloon 114 Wire 200 Guiding catheter CUS Ultrasound for cauterization FA Femoral artery IUS Ultrasound for imaging OH Hole RA Renal artery SN Sympathetic nerve

Claims

An elongated insert having a proximal end and an insertion end at both ends;
A blood vessel insertion type treatment device comprising: a first ultrasonic transducer that is provided in the vicinity of an insertion end of the insertion body and emits ultrasonic waves for ablation radially when viewed from the longitudinal direction of the longitudinal shape.
2. The blood vessel insertion type treatment device according to claim 1, wherein the first ultrasonic transducer is cylindrical.
3. The acoustic lens according to claim 2, further comprising an acoustic lens that has a cylindrical shape that covers an outer periphery of the first ultrasonic transducer, and that converges the ablation ultrasonic waves that radiate along the height direction of the cylinder. Blood vessel insertion type treatment device.
A tubular sheath covering the insert and the first ultrasonic generator;
The ablation ultrasonic wave radiated along the longitudinal direction of the longitudinal shape of the inserted body in a state in which the first ultrasonic transducer is disposed in the sheath and expanded around the sheath. The blood vessel insertion type treatment device according to claim 2, further comprising an acoustic balloon lens for convergence.
The blood vessel insertion according to claim 1, wherein the first ultrasonic transducer is annular, and a plurality of the first ultrasonic transducers are provided in the insert along the longitudinal direction. Type treatment device.
A tubular sheath covering the insert and the first ultrasonic generator;
The blood vessel insertion type treatment device according to claim 1, further comprising a balloon that is provided in the vicinity of an end portion on the insertion end side of the sheath and is inflatable around the sheath.
The blood vessel insertion type treatment device according to claim 6, wherein the balloon is a cooling balloon that prevents overheating of a portion that contacts the balloon when the balloon is inflated.