JPH0263015B2 - - Google Patents

Description

Detailed Description of the Invention [Industrial Application Field] The present invention uses ultrasonic vibrations of a flexible ultrasonic probe to crush undesirable substances such as tumor tissue, blood clots, and calcium lumps in the body, and to aspirate and The present invention relates to an ultrasonic surgical device for removal.

[Prior art]

Conventionally, methods for removing thrombus include injecting and dissolving a thrombolytic agent, such as streptokinase, through a catheter into the thrombus section (for example, Japanese Patent Application Laid-open No. 173065/1982), and inflating a balloon in a balloon catheter. A method in which the catheter is pulled out and the thrombus is removed at the same time (for example,
16472), a method in which the thrombus site is sandwiched between two inflated balloons, a thrombolytic agent is injected to soften the thrombus, the catheter is pulled out, and the thrombus is removed at the same time (Japanese Patent Publication No. 58-501983). be.

However, even if a thrombolytic agent is locally injected through a catheter, there is a drawback that the thrombolytic agent flows into normal peripheral blood vessels, leading to the risk of bleeding in the peripheral blood vessels. If the catheter is pulled out while the catheter remains in place and the thrombus is removed from the body at the same time, there is a risk of damage to the inner wall of the blood vessel because no safety measures are taken against the tensile stress applied to the inner wall of the blood vessel. When using a catheter equipped with two balloons for a similar thrombus removal method, when a thrombus 27 is sandwiched between two balloons 31 and 32 as shown in FIG. 7, the balloon 32 near the tip of the catheter 30 is Since the thrombus 27 must be inserted from a position 34 in front of the thrombus 27 to a position 35 behind the thrombus 27, the balloon 32 pushes the thrombus 27 in the insertion direction 33 and inserts the thrombus 27 into other parts, such as peripheral blood vessels. There was a danger of being moved.

Furthermore, as a method for mechanically removing thrombi,
There is a method in which a drill blade is attached to the tip of a thin rod, and the drill blade rotates by rotating the rod, and the rotation crushes the blood clot, but this applies torsional stress to the inner wall of the blood vessel, causing the blood vessel to become twisted. There was a drawback that it was difficult to adjust the rotation speed, etc.

Recently, surgical devices using ultrasonic waves have been developed, in which an ultrasonic probe is connected to an ultrasonic vibration source, and cells, calcium lumps, blood clots, etc. are crushed by mechanical vibration at the ultrasonic frequency at the tip of the ultrasonic probe. 2. Description of the Related Art Devices are known that remove crushed cells, calcium lumps, blood clots, and the like through a lumen provided in an ultrasonic probe. (For example, JP-A-60-5139, JP-A-49-21989) However, in these devices, the ultrasonic probe that has a working part that vibrates mechanically at ultrasonic frequencies is not flexible. Therefore, it has the disadvantage that it is difficult to insert it into curved blood vessels or tubular tissues in the body.

[Purpose of the invention]

The present invention addresses the problems in conventional thrombus removal methods, such as the risk of bleeding due to thrombolytic agents, the risk of blood vessel damage due to tensile stress or torsional stress on the inner wall of the blood vessel caused by a balloon catheter, or the movement of a blood clot when inserting a balloon catheter. We have been conducting intensive studies with the aim of eliminating these drawbacks and making it possible to crush and remove blood clots, calcium lumps, etc. in tubular tissues such as curved blood vessels, which are difficult to operate with current ultrasonic surgical equipment. As a result, a flexible ultrasound probe is inserted directly into the affected area, and undesirable substances in the body, such as blood clots and calcium lumps, are crushed by mechanical vibrations at ultrasound frequencies without affecting the surrounding normal tissue. This led to the completion of an ultrasonic surgical device that performs suction removal.

[Structure of the invention]

That is, the present invention provides an ultrasonic vibration source that generates ultrasonic vibrations, an oscillation device that supplies high-frequency electrical energy to the ultrasonic vibration source, and an oscillation device that is connected to the ultrasonic vibration source and transmits and amplifies mechanical vibrations at the ultrasonic frequency. An ultrasonic surgical device consisting of a horn that causes vibration and a suction device that suctions and removes undesirable substances from the surgical site, one end of which is fixed to the tip of the horn, and the other end that emits mechanical vibrations at ultrasonic frequencies. An ultrasonic probe consisting of a flexible linear transmitter having a working part, a horn cover at least partially made of a flexible material, and one or more lumens communicating with the lumen. or having two or more branch tubes and a flexible tube connected to the horn cover, an ultrasound probe placed in one of the lumens, and a suction device in one of the branch tubes. This is an ultrasonic surgical device characterized by being connected to.

Hereinafter, the present invention will be explained in detail with reference to the drawings. FIG. 1 is a diagram showing the entirety of an ultrasonic surgical device according to an embodiment of the present invention. As shown in FIG. 1, this device includes an oscillating device 1, a mechanical vibration generating section at an ultrasonic frequency consisting of a hand piece 36, a suction section consisting of a suction device 11 and a suction bottle 12, and a liquid injection device 14.
It consists of four parts: a liquid injection part consisting of a flexible tube 8 and a catheter part consisting of a flexible tube 8 and branch pipes 7, 9, and 47.

High frequency electrical energy is supplied from the oscillation device 1 to the handpiece 36 through the cables 2 and 3. As shown in FIG. 2, the handpiece 36 consists of an ultrasonic vibration source 4, a horn 5, a horn cover 6, and an ultrasonic probe 17. High-frequency electrical energy is supplied to the ultrasonic vibration source 4, and the ultrasonic vibration source 4
The ultrasonic frequency generates mechanical vibrations, which are transmitted to the horn 5. The mechanical vibrations are amplified by the horn 5 and transmitted to the ultrasound probe 17.

The oscillation device 1 includes a horn 5 and an ultrasonic probe 1
It has an oscillation circuit that can supply high-frequency electrical energy corresponding to changes in the mechanical load state of the ultrasonic probe 17, and a suitable oscillation frequency is 15 to 40 KHz. Considering the performance, 20 to 30KHz is suitable.

Although the ultrasonic vibration source 4 and the horn 5 are connected by a screw method, the connection is not limited to this. The ultrasonic vibration source 4 is not particularly limited as long as it is a magnetostrictive type, electrostrictive type, etc. that converts high frequency electric energy into mechanical vibrations at an ultrasonic frequency. A metal material that can transmit and amplify mechanical vibrations and has fatigue strength that can withstand mechanical vibrations is suitable, and stainless steel, duralumin, titanium alloys, etc. are preferable.

Furthermore, suitable methods for connecting the horn 5 and the ultrasonic probe 17 include screws, welding, and the like. The ultrasonic probe 17 includes a fixture 43 and a flexible linear transmitter 4.
4, and suitable methods for connecting the fixture 43 and the linear transmission body 44 include welding, adhesion, etc. Fixture 4
3 and the linear transmitter 44 are not particularly limited as long as they can transmit mechanical vibrations at ultrasonic frequencies and have fatigue strength that can withstand mechanical vibrations, but materials that do not transmit X-rays may be used. A horn cover 6 is provided around the horn 5 and the flexible ultrasonic probe 17, which is preferably made of a metal material such as stainless steel, duralumin, or a titanium alloy, or a composite material such as carbon fiber reinforced plastic. , one end of the horn cover 6 is connected to the ultrasonic vibration source 4
The other end is connected to the branch pipe 7 with an adhesive to maintain airtightness, but the connection method is not particularly limited to this. The inside of the horn cover 6 is divided into a compartment 23 and a compartment 45 by a rubber O-ring 22, and the rubber O-ring 22 is installed at a node where the amplitude of the mechanical vibration of the horn 5 in the vertical direction 46 is smallest. The flow of liquid is blocked. Further, by providing a bellows part 10 made of a flexible material in a part of the horn cover 6, it is possible to move the branch pipe 7 back and forth by expanding and contracting the bellows part 10 in the vertical direction 46. .

Ultrasonic probe 17 is installed through branch tube 7 into the lumen of flexible tube 8 shown in FIG. As shown in FIG. 3a, the tip of the ultrasonic probe 17 is dimensioned so that it does not protrude beyond the tip 16 of the flexible tube 8 when the bellows section 10 is extended. As a result, when the flexible tube 8 is inserted into the body, the tip of the ultrasound probe 17 is located within the lumen of the flexible tube 8, and the tip of the ultrasound probe 17 does not damage blood vessels or the like. can be prevented.

Next, the suction device 11 includes the inner lumen of the flexible tube 8, the branch pipe 9, the switching valve 13,
It is connected via the suction bottle 12 and tubes 38, 39, 40, and is also connected to the liquid injection device 14.
is connected to the inner cavity of the flexible tube 8 via a branch pipe 47, a pipe 37, a switching valve 15, and a tube 41. As for how to arrange the branch pipes 9 and 47, FIG. 4 shows an example in which the branch pipes 9 and 47 are fixed to a suitable adhesive horn cover 6, but any shape that is easy for the operator to use may be used. It is not limited by this.

To use this device, first, in order to make the linear transmitting body 44 installed in the branch pipe and the flexible tube 8 slip easily, the compartment 23 and the inner cavity 42,
20 is filled by suitable means with a liquid that is not harmful to body tissues, such as physiological saline. For example, a passage connected to the compartment 23 is provided on the side surface of the horn cover 6,
A liquid such as physiological saline is injected into the compartment 23 and the inner cavities 42 and 20 through the passage, and the passage is closed. In addition, the suction lumen 19 of the flexible tube 8 and the lumen of the branch pipe 9 communicating with the suction device 11 are connected to the suction device 1.
1 and the switching valve 13, the liquid such as physiological saline is filled. Regarding the liquid injection device, the branch pipe 47 and lumen 20 are similarly filled with physiological saline liquid.

Next, the flexible tube 8 is inserted into the body while confirming the position of the distal end of the linear transmitter 44 under X-ray fluoroscopy, and is inserted to the surgical site, for example, to the thrombus area. For example, as shown in FIG. To determine the position, the balloon 26 is temporarily inflated using the balloon lumen provided in the flexible tube 8 to the extent that blood flow is not affected, and the tip 16 is fixed. At this point, the mutual relationship between the flexible tube 8 and the linear transmission body 44 is as shown in FIG. 3a. Next, bellows part 1
By holding a part of the horn cover 6 on the side of the branch pipe 7 from 0 and contracting the bellows part 10 in the direction of the arrow 28, the working part 21 of the ultrasonic probe 17 becomes flexible as shown in FIG. 3b. sex tube 8 tip 16
After adjusting the position with the thrombus 27, the balloon 26 is deflated, and the ultrasonic probe 17 is mechanically vibrated at an ultrasonic frequency as shown in FIG. 27 to crush the thrombus 27, and small pieces of the crushed thrombus are placed in the sixth
The suction device 11 is inserted into the suction device lumen 19 shown in Figure a.
suction and remove it from the body. Also, thrombus 2
If the position of thrombus 27 is unclear, use the liquid injection device 14 to inject a contrast medium or the like from the liquid injection lumen 18 shown in FIG. Let's do it.

The material of the flexible tube 8 may be one commonly used for medical catheters such as soft vinyl chloride resin, and the materials of the branch tubes 7, 9 and 47 are not particularly limited. A material that can be bonded to the flexible tube 8 is preferable. The lumen and outer periphery of the flexible tube 8 and the lumens of the branch tubes 7, 9, and 47 are coated with an antithrombotic substance, such as polyurethane, hydrogel, pepalinized polymer, urokinase polymer, etc. is preferred, but is not particularly limited.

Furthermore, the number of lumens in the flexible tube 8 is not particularly limited. For example, even in the case where there is only one lumen 20 as shown in FIG.
1 and the liquid injection device 14 for use.

The working part 21 at the tip of the ultrasonic probe 17 has an acute angle removed to prevent damage to the inner wall of the blood vessel, etc. The end face shape is not particularly limited, but it is preferable to have an obtuse angle or an arc shape. good.

Here, as an example of the device according to the present invention, the case where it is used to remove blood clots in blood vessels has been described in detail, but the use of the device is not limited to this, and the device can be used to remove other undesirable substances in the body. Naturally, it can be widely applied to crushing and removal.

〔Effect of the invention〕

As described above, according to the present invention, an ultrasound probe is directly inserted into the affected area where undesirable substances such as thrombi, calcium lumps, tumors, etc. that have occurred in thin tubular tissues such as curved blood vessels are present, and the surrounding Desired substances can be crushed and immediately removed from the body by mechanical vibrations at ultrasonic frequencies without affecting normal tissue, and the incision on the body surface can contain an ultrasound probe. It is suitable as an ultrasonic surgical device because it only needs to be slightly larger than the diameter of the flexible tube, allows extremely minimally invasive surgery to be performed in a short time, and greatly reduces the burden on the patient after surgery. .

[Brief explanation of drawings]

Fig. 1 is a diagram showing the overall configuration of an ultrasonic surgical device that is an embodiment of the present invention, Fig. 2 is an enlarged view of the handpiece portion and shows the structure inside the horn cover, and Fig. 3 is a diagram showing the structure inside the horn cover. In the enlarged views, a shows a state in which the bellows part is extended, and b shows a state in which the bellows part is contracted. FIG. 4 shows an example of the shape of the handpiece, and FIG. 5 shows the present invention. FIG. 6 is a diagram showing an example of the cross-sectional structure of a flexible tube. Further, FIG. 7 is a diagram showing a conventional method.

Claims (1)

[Claims] 1. An ultrasonic vibration source that generates ultrasonic vibrations, an oscillation device that supplies high-frequency electrical energy to the ultrasonic vibration source, and an oscillation device that is connected to the ultrasonic vibration source and transmits mechanical vibrations at the ultrasonic frequency. , an ultrasonic surgical device consisting of a horn for enlarging the area, and a suction device for suctioning and removing undesirable substances from the surgical site, one end of which is fixed to the tip of the horn, and the other end of which is provided with mechanical vibrations at ultrasonic frequencies. an ultrasonic probe consisting of a flexible linear transmitter having a working part that communicates with the lumen; a horn cover at least partially made of a flexible material; and one or more lumens communicating with the lumen. one or more branch tubes having a flexible tube connected to the horn cover, an ultrasound probe placed in one of the internal vagina, and a suction device inserted into one of the branch tubes.
An ultrasonic surgical device characterized by being connected to. 2. The ultrasonic surgical device according to claim 1, characterized in that a portion of the horn cover made of a flexible material is provided with a bellows shape so that the horn cover can be expanded and contracted. 3. The ultrasonic surgical device according to claim 1 or 2, wherein all angular parts in the working part of the ultrasonic probe are obtuse angles or circular arc shapes. 4. The ultrasonic surgical device according to any one of claims 1 to 3, characterized in that a liquid injection device for injecting irrigation liquid or the like is connected to a branch pipe of the flexible tube. . 5 the flexible tube has a balloon near the working part of the ultrasound probe placed within its lumen;
5. An ultrasonic surgical device according to any one of claims 1 to 4, characterized in that the balloon is inflated and deflated through one of the lumens. 6. The ultrasonic device according to any one of claims 1 to 5, characterized in that an antithrombotic substance is coated on the inner lumen and outer surface of the flexible tube in which the ultrasonic probe is installed. Sonic surgery device.