JPH02189137A - Audio coupler with holder and manufacture thereof - Google Patents

Abstract

PURPOSE:To provide an audio coupler which facilitates handling and improves operability by a method wherein the audio coupler is secured to a holder in a way that an opening formed in the frame part of a holder is closed with hydrogel making contact therewith and the interior of a suction space is kept in a pressure reduced state. CONSTITUTION:A suction space 10 having an opening part 9 formed in its under surface is formed in a frame part 8 with which a probe insertion hole 5 of a holder 6 is surrounded. The opening is closed with water soluble hydrogel, by which an audio coupler 1 making contact with the frame part is formed, the interior of the suction space 10 is kept in a pressure reduced state, and the coupler 1 formed by flexible hydrogel is secured to the holder 6. Since the audio coupler 1 is extremely flexible and has excellent audio characteristics and excellent biological suitability, excellent diagnosing operation can take place.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to an acoustic coupler with a holder and a method for manufacturing the same. More specifically, the present invention relates to an acoustic coupler that is easy to handle and has improved operability, and a method for fixing a gel-like substance to a holder by which the acoustic coupler can be easily produced.

(Prior Art) Ultrasonic diagnostic devices are used in many fields of diagnosis, including abdominal organs such as the heart and liver, due to their simplicity and non-invasiveness to patients.

For example, for heart disease, in order to perform open-heart surgery accurately, it is desirable to have a detailed diagnosis of the location and shape of the lesion and its relationship to adjacent normal areas before surgery. In severe cases, this is an important problem that affects the surgical outcome, and the accuracy of preoperative diagnosis using ultrasonic diagnostic equipment has recently been of great help in improving surgical outcomes.

However, it is not possible to obtain sufficient information about heart disease or lesions through preoperative sonography, which involves applying a probe from above the chest wall to avoid the lungs and bone tissue.

Ultrasound examination during open heart surgery may be considered as a method for exceeding this limit and performing more detailed ultrasound diagnosis.

That is, if an ultrasonic examination is performed by shining a probe directly from the outside of the 6 membranes or the heart or blood vessels after a median sternotomy, a more detailed surgically useful diagnosis can be obtained regarding each internal cavity.

In addition, it is possible to confirm during the surgery whether the surgical treatment was accurate using this intraoperative ultrasound examination.
This is important for prevention of reoperation and postoperative management.

In ultrasonic diagnosis, ultrasonic pulses are emitted into the body from the body surface or organ surface, and a tomographic image of the living body is obtained by receiving reflected waves generated due to differences in acoustic impedance at each jflv & in the living body. . Therefore, in order to obtain accurate tomographic images, it is necessary to bring the ultrasonic probe into close contact with the body surface or organ surface without creating an air layer that is highly reflective to ultrasonic waves.

However, when the probe is applied directly to the body surface in this manner, the shape of tissues such as blood vessels near the body surface will be deformed due to compression in the image obtained. Furthermore, when performing ultrasound examinations by applying a probe directly to the heart or blood vessel walls, the heart and blood vessels move irregularly as the heart beats, and when compressed by the probe, arrhythmia and a drop in blood pressure are likely to occur. Therefore, it is difficult to keep a conventional probe with an undeformable contact surface in constant contact with the surface of a beating heart and use it safely, and in reality, the usefulness of intraoperative real-time ultrasonic tomography is insufficient. The reality is that they are not fully utilized.

Therefore, in these cases, a suitable contact medium material is required to be used between the probe and the body surface or organ surface, i.e., a soft material that follows the movement of the heart while remaining in close contact with the surface. An acoustic coupler with excellent bulk and ultrasonic properties is required.

(Problem to be Solved by the Invention) Conventionally, such acoustic couplers have been made of synthetic rubber, and this soft material alone is brought into close contact with the diagnostic section, and from the second point, the probe of the ultrasonic diagnostic device is used. was used to scan and obtain tomographic images.

However, acoustic couplers made of such conventional materials are expensive, and because the same ones are used repeatedly, there are problems such as getting dirty, deteriorating the acoustic characteristics, and putting pressure on the diagnostic section due to the weight. Ta.

For this reason, the present inventors have previously proposed the use of hydrogel as such an acoustic coupler, which is flexible, lightweight, has excellent biocompatibility and ultrasonic properties, and can be provided at a low price ( (Patent Application No. 128475/1982). When a hydrogel is used as an acoustic coupler, it is extremely flexible and thus produces high adhesion to the surface of the diagnostic section, but since this acoustic coupler is also used alone, like the above-mentioned ones, its flexibility is also added. However, the handling was complicated and the operability was poor, and improvements were desired.

Accordingly, it is an object of the present invention to provide an improved acoustic coupler and method for making the same. Another object of the present invention is to provide an acoustic coupler that is easy to handle and has improved operability, and a method for fixing a gel-like substance to a holder that allows the acoustic coupler to be easily produced.

(Problems to be Solved by the Invention) The second object is to provide a frame-shaped acoustic coupler made of water-insoluble hydrogel having a predetermined wall thickness, which has a probe insertion space at the upper end that extends from the lower surface to the upper surface. The acoustic coupler is activated by abutting the lower surface of the holder and closing the opening of a suction space provided in the frame of the holder, which has an opening on the lower surface, with the abutting water-insoluble hydrogel to maintain a reduced pressure state inside the suction space. This is achieved by an acoustic coupler with a holder that is fixed to the holder.

The present invention also provides that the water-insoluble hydrogel contains 50 to 99% water by weight, and irradiates polyvinyl alcohols with each other, polyvinylpyrrolidones with each other, and polyvinylalcohol and polyvinylpyrrolidone with a degree of crosslinking that allows this amount of water to be contained. This figure shows an acoustic coupler with a holder, which is a water-insoluble hydrogel crosslinked with.

- The purpose of notation is further provided in a method for manufacturing an acoustic coupler with a holder in which a gel-like substance is fixed to a frame-shaped holder without substantially surrounding the sides thereof, wherein the frame of the holder has an opening on the lower surface. A suction space having an intake hole is provided on the surface of the holder, and the lower surface of the holder is brought into contact with a gel-like substance, and in this state, suction is applied through the intake hole to close the lower opening of the suction space with the gel-like substance, and further the suction space is closed. This can also be achieved by a method for manufacturing an acoustic coupler with a holder, which is characterized in that the holder is fixed to a gel-like substance by reducing the pressure inside the space and then closing the intake hole to maintain the reduced pressure in the suction space.

(Function) In the acoustic coupler with holder of the present invention, a suction space having an opening on the lower surface is provided in the frame surrounding the probe insertion hole of the holder having the probe insertion hole, and the lower surface of the suction space is The opening is closed by a water-insoluble hydrogel constituting the abutting acoustic coupler to keep the suction space in a reduced pressure state, thereby fixing the coupler made of flexible hydrogel to the holder.

In the acoustic coupler with a holder of the present invention, the coupler made of hydrogel is fixed to the holder by suction due to negative pressure in a space having an opening in contact with the hydrogel, but since hydrogel is a flexible material, It is easily deformed at the portion that abuts the opening, and comes into airtight contact with the opening to close the opening. Therefore, the reduced pressure state within the closed suction space is maintained extremely well, and acts to generate a strong holding force against the abutting hydrogel. Therefore, the coupler made of hydrogel only touches the holder at its upper end, in other words,
The hydrogel is fixed in the holder without being surrounded by the sides, and the flexibility of the hydrogel as a coupler is not lost.

The holder is provided with a probe insertion hole, so that the ultrasonic probe can be easily attached and fixed to the holder, and the upper end surface of a coupler made of hydrogel is arranged on the lower surface of the probe insertion hole.

Therefore, when the ultrasonic probe is attached to the holder, the probe and the above-described coupler made of flexible hydrogel are integrated, and the operability of the acoustic coupler becomes extremely high.

By the way, when attempting to fix the hydrogel to the holder using the above structure, it is difficult to maintain the desired degree of vacuum in the suction space until the opening is sealed by the hydrogel. For this reason, in the manufacturing method of the acoustic coupler with a holder of the present invention, an intake hole communicating with the suction space is separately provided on a surface other than the bottom surface of the frame of the holder, and a gel-like substance such as hydrogel is used to close the bottom opening of the suction space. The interior of the suction space is suctioned through the suction hole until the suction space is closed and reaches a predetermined degree of decompression, thereby easily reducing the pressure of the suction space during fixation. Note that if the suction hole is then closed, the suction space becomes a sealed space.

(Example) Hereinafter, the present invention will be explained in more detail with reference to Examples.

Fig. 1 is a cross-sectional view of an embodiment of the acoustic coupler with a holder of the present invention in use, Fig. 2 is a perspective view of the embodiment in use, and Fig. 3 is a bottom view of the holder used in the embodiment. 4 to 6 are drawings showing each manufacturing process of an embodiment of the acoustic coupler with a holder of the present invention.

As shown in FIGS. 1 and 2, the acoustic probe with a holder of the present invention has an acoustic coupler 1 made of water-insoluble hydrogel having a predetermined wall thickness.

In the acoustic coupler with holder of the present invention, the water-insoluble hydrogel used as the acoustic coupler 1 must exhibit excellent softness, sufficient strength, and excellent ultrasonic properties. -1
28475, containing 50 to 99% by weight of water, and crosslinking polyvinyl alcohols with each other, polyvinylpyrrolidones with each other, and polyvinylalcohol with polyvinylpyrrolidone by radiation irradiation to a degree of crosslinking that allows this amount of water to be contained. Preferred examples include water-insoluble hydrogels, but of course the present invention is not limited thereto.

The upper end 2 of this acoustic coupler 1 has a lower surface 4 than a lower surface 3.
It is located at three parts of the lower surface of a frame-shaped holder 6 having an open probe insertion space 5. The probe insertion space 5 of this holder 6 has a shape that adapts to the outer shape of the probe 7 of the ultrasonic diagnostic apparatus.

However, the frame part 8 of the lever holder 6 is shown in FIGS. 1 and 3.
As shown in the figure, a suction space 10 having an opening 9 on the lower surface 3
is provided. The opening 9 of this suction space 10 is closed by the hydrogel constituting the abutting acoustic coupler 1, and the suction space 10 becomes a sealed space, and the inside of the suction space 10 is maintained in a reduced pressure state, so that the acoustic coupler 1 generates negative pressure. It is fixed to the holder 6 by suction force. The shape of the opening 9 of the suction space 10 is not particularly limited as long as it can stably fix the acoustic coupler 1 to the three parts of the lower surface of the holder 6; for example, it may have a continuous linear shape. They may be in the form of a single dot or a plurality of intermittent dots, but preferably they are continuous in an annular shape surrounding the holder insertion hole 5 as shown in FIG. Further, the internal shape of the suction space 10 is not particularly limited as long as it can stably obtain a degree of decompression sufficient to suction and hold the acoustic coupler.
Further, for example, in the case of having a plurality of openings 9, it may be divided into a plurality of sections corresponding to the plurality of openings 9.

Furthermore, in the acoustic coupler with holder of this embodiment, the suction space 10 is attached to the holder 6 from a surface other than the lower surface 3.
An intake hole 11 is provided which communicates with the. This intake hole 1
1, when fixing the acoustic coupler 1 to the holder 6, it is easy to bring the water-insoluble hydrogel constituting the acoustic coupler 1 into close contact with the opening 9 to bring the inside of the suction space 10 to a predetermined degree of decompression, as described later. After the acoustic coupler 1 is fixed, it is closed to make the suction space 10 a closed space, as shown in FIGS. 1 and 2.

In addition, in order to bring the water-insoluble hydrogel constituting the acoustic coupler 1 into close contact with the opening 9 and achieve a predetermined degree of decompression in the suction space 10, for example, a portion of the wall surrounding the suction space 10 must be is made of a highly flexible material, and when the water-insoluble hydrogel is brought into close contact with the opening 9, the volume of the suction space 10 is changed by elastic deformation of the part, and a predetermined degree of decompression is obtained using the elastic restoring force. This method is also possible.

Further, in this embodiment, the outer peripheral surface of the holder 6 is provided with locking protrusions 12a and 12b as shown in FIG. The frame is an elastic band such as a rubber band 1
3 to the locking protrusions 12a and 12b, the probe 7 can be reliably fixed to the holder. The holder 6 having such a configuration is made of a material such as a metal such as stainless steel or a synthetic resin such as polypropylene, polycarbonate, polystyrene, or polymethyl methacrylate.

As described above, in the acoustic coupler with holder of the present invention, since the acoustic coupler 2 made of flexible water-insoluble hydrogel is fixed to the holder 6, the probe 7 of the ultrasonic diagnostic device can be inserted into the probe insertion space 5 of the holder 6. When fixed, the probe 7 will come into close contact with the acoustic probe whose upper end is located on the three parts of the lower surface of the holder 6, thereby integrating the acoustic coupler 1 and the probe 7, improving the operability of the acoustic coupler. do.

The acoustic coupler with holder of the present invention can be produced, for example, as follows. That is, first, as shown in FIG. 4, the lower surface 3 of the holder 6 having the shape described above is brought into contact with the upper end 2 of the acoustic coupler 1 made of water-insoluble hydrogel and having a predetermined wall thickness. Next, as shown in FIG. 5, a suction device (not shown) is connected to the suction hole 11 to suction the air inside the suction space 10. When suction is performed, the water-insoluble hydrogel constituting the acoustic coupler 1 is easily deformed at the portion where it contacts the lower surface 131 of the suction space 10 and the opening 9, and the water-insoluble hydrogel that makes up the acoustic coupler 1 deforms easily at the portion that contacts the opening 9 of the suction space 10, and tightly adheres to the opening 9 to close the opening 9. do. When the opening 9 is closed and the degree of vacuum in the suction space 10 reaches a predetermined degree of vacuum that can sufficiently suction and fix the acoustic coupler 1, the intake hole 11 is hermetically closed as shown in FIG. Then, the suction space 10 is made into a closed space, and the inside of the suction space 10 is reduced in pressure to a predetermined degree to obtain a product.

(Effects of the Invention) As described above, the acoustic coupler with holder of the present invention has a probe insertion space that is open from the lower surface to the upper surface at the upper end of the acoustic coupler made of water-insoluble hydrogel having a predetermined wall thickness. By abutting the lower surface of a frame-shaped holder and closing the opening of a suction space having an opening on the lower surface provided in the frame of the holder with the abutting water-insoluble hydrogel, the inside of the suction space is kept in a reduced pressure state. Because it is made by fixing an acoustic coupler to a holder,
A flexible acoustic coupler made of water-insoluble hydrogel can be easily integrated with the probe of an ultrasound diagnostic device, which eliminates the complexity of operation that would be required when using a stand-alone acoustic coupler made of hydrogel in ultrasound diagnosis. The burden on the examinee, such as the examinee feeling heavy, is eliminated. Therefore, by using the acoustic coupler with a holder of the present invention, the acoustic coupler can be kept in close contact with the diagnostic site at all times without causing any change in the shape of the diagnostic site by taking advantage of the excellent flexibility of hydrogel, allowing for easy operation and good diagnosis. You can get the image.

Furthermore, in the acoustic coupler with a holder of the present invention, the water-insoluble hydrogel contains 50 to 99% by weight of water, and the crosslinking degree between polyvinyl alcohols, polyvinylpyrrolidones, and polyvinyl alcohols is such that this amount of water can be contained. Water-insoluble hydrogels made by cross-linking polyvinylpyrrolidone with radiation irradiation make the acoustic couplers extremely flexible and have excellent acoustic properties, as well as excellent biocompatibility, allowing for better diagnosis. It becomes possible to perform operations.

The present invention also provides a method for manufacturing an acoustic coupler with a holder in which a gel-like substance is fixed to a frame-shaped holder without substantially surrounding the side surfaces, in which the frame of the holder has an opening on the lower surface and the other surface has an opening. A suction space is provided with a suction hole, the lower surface of the holder is brought into contact with a gel-like substance, and in this state, suction is applied through the suction hole to close the lower opening of the suction space with the gel-like substance, and the inside of the suction space is further closed. The holder is fixed to a gel-like substance by closing the suction hole and maintaining the suction space in a depressurized state after the pressure is reduced, so as mentioned above, the acoustic coupler is made of flexible hydrogel. In producing an acoustic coupler with a holder in which the hydrogel is fixed to a holder, it is possible to easily form a reduced pressure suction space that suctions and holds the hydrogel by negative pressure.

[Brief explanation of the drawing]

Fig. 1 is a cross-sectional view of an embodiment of the acoustic coupler with a holder of the present invention in use, Fig. 2 is a perspective view of the embodiment in use, and Fig. 3 is a bottom view of the holder used in the embodiment. 4 to 6 are drawings showing each manufacturing process of an embodiment of the acoustic coupler with a holder of the present invention. 1...Acoustic coupler, 2...-upper end, 3...
Holder bottom surface, 4... Holder top surface, 5... Holder insertion hole, 6... Holder, 7... Probe, 8... Frame, 9... Opening, 10... Suction space , 11... Intake hole, 12... Locking protrusion.

Claims (3)

[Claims] (1) The lower surface of a frame-shaped holder, which has a probe insertion space that is open from the lower surface to the upper surface, is brought into contact with the upper end of an acoustic coupler made of water-insoluble hydrogel having a predetermined wall thickness, and the frame of the holder is An acoustic coupler with a holder, in which the acoustic coupler is fixed to a holder by closing the opening of a suction space having an opening on the lower surface with a water-insoluble hydrogel in contact with the suction space to maintain a reduced pressure state inside the suction space. (2) The water-insoluble hydrogel contains 50 to 99% by weight of water, and crosslinks polyvinyl alcohols with each other, polyvinylpyrrolidones with each other, and polyvinylalcohol with polyvinylpyrrolidone with radiation irradiation to a degree of crosslinking that allows this amount of water to be contained. The acoustic coupler with a holder according to claim 1, which is a water-insoluble hydrogel consisting of a water-insoluble hydrogel. (3) In a method for manufacturing an acoustic coupler with a holder in which a gel-like substance is fixed to a frame-shaped holder without substantially surrounding the sides, the frame of the holder has an opening on the lower surface and an intake hole on the other surface. A suction space is provided, the lower surface of the holder is brought into contact with a gel-like substance, and in this state suction is applied through the suction hole to close the lower opening of the suction space with the gel-like substance, further reducing the pressure in the suction space. A method for manufacturing an acoustic coupler with a holder, characterized in that the holder is fixed to a gel-like substance by closing the intake hole and keeping the suction space in a reduced pressure state.