JPH0696011B2 - Manufacturing method of acoustic coupler with holder - Google Patents

Description

The present invention relates to a method for manufacturing an acoustic coupler with a holder. More specifically, the present invention relates to a method for fixing a gel-like substance to a holder, which allows easy production of an acoustic coupler having easy handling and improved operability.

(Prior Art) An ultrasonic diagnostic apparatus is used in many diagnostic fields including an abdominal organ such as a heart and a liver because of its simplicity and non-invasiveness to a patient.

For example, in the case of heart disease, in order to perform an open heart surgery accurately, it is desirable that the position and shape of the lesion site and the relationship with a normal part adjacent to the lesion site be diagnosed in detail before surgery, especially for neonates and the like. In severe cases, this is an important issue that affects the outcome of surgery, and the accuracy of preoperative diagnosis using an ultrasonic diagnostic apparatus is very useful for improving recent surgical results. However, preoperative ultrasonography cannot obtain sufficient information on heart disease and lesions while applying a probe from above the chest wall to avoid lungs and bone tissue. Ultrasonography during open heart surgery can be considered as a method of performing more detailed ultrasound diagnosis beyond this limit. That is, if a probe is directly applied from the outside of the pericardium or the incision of the heart or blood vessel after the midline sternotomy to perform ultrasonic examination, a more detailed surgically useful diagnosis can be obtained for each lumen. In addition, it is possible to confirm intraoperatively whether or not the surgical procedure performed by the intraoperative ultrasonic examination was appropriate, which is important for prevention of reoperation and postoperative management.

In ultrasonic diagnosis, an ultrasonic pulse is radiated into the body from the surface of the body or the surface of an organ, and a reflected wave generated due to a difference in acoustic impedance between tissues in the body is received to obtain a tomographic image of the body. Therefore, in order to obtain an accurate tomographic image, it is necessary to bring the ultrasonic probe into close contact with the surface of the body or the surface of the organ without the presence of an air layer having a high reflectance for ultrasonic waves.

However, when such a probe is directly applied to the body surface, the shape of a tissue such as a blood vessel in the vicinity of the body surface in an obtained image is obtained by being deformed by compression. Further, when an ultrasonic examination is performed by directly applying a probe to the heart or blood vessel wall, the heart and blood vessels move in a non-uniform manner along with the heartbeat, and when pressure is applied by the probe, an arrhythmia and a decrease in blood pressure are likely to occur. Therefore, it is difficult to keep a conventional probe having a non-deformable contact surface in close contact with the surface of the pulsating heart, etc., and to use it safely. In practice, the usefulness of intraoperative real-time ultrasonic tomography is sufficient. The reality is that it has not been demonstrated.

Therefore, in these cases, an appropriate contact medium substance for use between the probe and the surface of the body or the surface of the organ is required, that is, a soft contact medium that follows its movement while closely adhering to the surface of the heart or the like. There is a need for an acoustic coupler with excellent bulk and ultrasonic characteristics.

(Problems to be Solved by the Invention) Conventionally, as such an acoustic coupler, there is one that is made of a synthetic rubber, and a soft material unit is brought into close contact with a diagnostic unit, and a probe of an ultrasonic diagnostic apparatus is attached thereto. It was applied and scanned to obtain a fault image. However, such an acoustic coupler made of a conventional material is expensive, and since the same one is repeatedly used, it has problems such as being dirty, deteriorating the acoustic characteristics, and pressing the diagnostic portion due to weight.

Therefore, the present inventors have previously proposed, as such an acoustic coupler, the use of a hydrogel that is flexible and lightweight, has excellent biocompatibility and ultrasonic characteristics, and can be provided at a low price ( Japanese Patent Application No. 62-128475). When a hydrogel is used as an acoustic coupler, it is extremely flexible and therefore produces a high degree of adhesion on the surface of the diagnostic part, but this acoustic coupler is also used as a single unit like the one described above, so its flexibility is also added. However, the handling was complicated and the operability was poor, and improvement was desired.

Therefore, it is an object of the present invention to provide an improved method of manufacturing an acoustic coupler with a holder. It is another object of the present invention to provide a method for fixing a gel-like substance to a holder, which allows easy production of an acoustic coupler that is easy to handle and has improved operability.

(Means for Solving the Problems) The above-mentioned objects are to fix a gel-like substance to a frame-shaped holder without substantially enclosing the side surface thereof, in a method for producing an acoustic coupler with a holder, the sol-like substance is The lower surface portion is brought into contact, and then the sol-like substance is introduced into the holes provided through the other surface from the lower surface of the holder,
Radiation irradiation is performed in this state to gel the sol-like substance and fix it to the holder, which is achieved by a method of manufacturing an acoustic coupler with a holder.

Therefore, in the acoustic coupler with a holder of the present invention, the holder having the probe insertion hole is provided with a hole penetrating from the lower surface to the other surface, and the inside of this hole is formed integrally with the hydrogel constituting the coupler. It is characterized in that it is filled with a hydrogel, and thereby a coupler made of a flexible hydrogel is fixed to a holder.

In the acoustic coupler with a holder of the present invention, the fixing of the coupler made of hydrogel to the holder is performed by the adhesive force between the hydrogel and the wall surface of the holder surrounding the hydrogel. It is a hole provided in, and can provide a large surface area effective for fixation by adhesion although it is small in volume. Therefore, by integrally forming a small volume of hydrogel that fills the inside of the pores with the hydrogel that constitutes the coupler, the side surface of the portion to be the coupler is fixed to the holder without being substantially surrounded by the holder. 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 an upper end surface of a coupler made of hydrogel is arranged at a lower surface portion of the probe insertion hole.

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

By the way, in the case of fixing the hydrogel to the holder by the structure as described above, the portion filled in the hole provided in the holder is previously formed integrally with the portion forming the acoustic coupler, and then the inside of the hole is formed. It is extremely difficult to insert it in the hydrogel because the hydrogel is a flexible material. Therefore, in the method of fixing the gel-like substance to the holder of the present invention, the portion filled in the holes provided in the holder and the portion constituting the acoustic coupler are arranged at a predetermined portion before gelation, that is, the sol. The lower surface portion of the holder is brought into contact with the solid substance, and then the sol-like substance is introduced into the pores formed through the lower surface of the holder to the other surface. It is possible to easily fix a gel-like substance such as hydrogel to the holder by gelling the substance.

In the acoustic coupler with a holder of the present invention, since the hydrogel and the holder are fixed by irradiation with radiation, a sufficient fixing force is generated with a relatively small area. By enclosing the hydrogel as a coupler, it is possible to fix the side surface of the portion serving as the coupler to the holder without being substantially enclosed by the holder, and the flexibility of the hydrogel as the coupler is not lost. Therefore, as in the case of the above-mentioned invention, if the ultrasonic probe is attached to the holder, the probe and the coupler made of a flexible hydrogel are integrated, and the operability of the acoustic coupler becomes extremely high. .

(Examples) Hereinafter, the present invention will be described more specifically with reference to Examples.

FIG. 1 is a sectional view of an embodiment of an acoustic coupler with a holder manufactured by the method of the present invention, and FIGS.
The drawings are drawings showing respective manufacturing steps of an embodiment of the acoustic coupler with a holder according to the present invention.

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

In the acoustic coupler with a holder of the present invention, the water-insoluble hydrogel 1 used as the acoustic coupler 2 is required to have excellent softness and sufficient strength and have excellent ultrasonic characteristics. 62-12
As shown in No. 8475 contains 50 to 99% by weight of water, polyvinyl alcohol and polyvinyl pyrrolidone and polyvinyl alcohol and polyvinyl pyrrolidone are cross-linked by irradiation with a degree of crosslinking such that this amount of water can be contained. The water-insoluble hydrogel and the like are preferably exemplified, but are not limited thereto.

The upper end portion of the acoustic coupler 2 is located at a lower surface 3 portion of a frame-shaped holder 6 having a probe insertion space 5 which is open from the lower surface 3 to the upper surface 4. The probe insertion space 5 of the holder 6 has a shape adapted to the outer shape of the probe 7 of the ultrasonic diagnostic apparatus, and a probe fixing means such as a set screw 8 for fixing the probe 7 to the holder 6 as necessary. Is provided.

Then, in order to fix the acoustic coupler 2 to the holder 6, a hole 9 is formed in the holder 6 so as to penetrate from the lower surface 3 to another surface, and the inside of the hole 9 is the acoustic hole. It is composed of a water-insoluble hydrogel 1 that constitutes the coupler 2, and is filled with a holding portion 10 that is integrally formed with a portion as the acoustic coupler 2.
It should be noted that in the embodiment shown in FIG.
Is formed so as to penetrate from the bottom surface 3 to the top surface 4, but as long as the hydrogel 1 can hold the part as the acoustic coupler 2 by the holding part 10 filled in the holes 9, the holes 9 are formed from the bottom surface 3. An inner peripheral surface 12 that surrounds the probe insertion space 5 from the lower surface 3 that penetrates to the outer peripheral surface 11
It may be one that penetrates. The cross-sectional shape and number of the holes 9 are arbitrary, but a shape having a larger surface area than the volume is desired. Further, it may have the same cross-sectional shape throughout, or may have a different cross-sectional shape between the opening and the inside. The holder 6 is made of metal such as stainless steel or synthetic resin such as polypropylene, polycarbonate, polystyrene and polymethylmethacrylate.

In the acoustic coupler with a holder obtained by the method of the present invention as described above, since the acoustic coupler 2 made of the flexible water-insoluble hydrogel 1 is fixed to the holder 6, the probe 7 of the ultrasonic diagnostic apparatus is inserted into the holder 6. When the probe 7 is inserted and fixed in the space 5, the probe 7 is brought into close contact with the acoustic probe located at the upper end portion of the lower surface 3 of the holder 6, whereby the acoustic coupler 2 is integrated with the probe 7, and the operation of the acoustic coupler is performed. The property is improved.

To prepare the acoustic coupler with a holder of the present invention, first, as shown in FIG. 2, a sol-like substance 14 which is a raw material of the water-insoluble hydrogel 1 is added to a gel mold 13 which gives a desired shape as an acoustic coupler. Then, the lower surface 3 of the holder is arranged so as to come into contact with the liquid surface of the sol substance 14. Next, as shown in FIG. 3, a tube 16 is connected to the opening 15 other than the lower surface 3 of the hole 9 and the sol-like substance 14 is introduced into the hole 9 by suction, so that the inside of the hole 9 is completely sol. In a state in which the sol-like substance 14 is guided into the tube 16 so as to be filled with the substance 14
Close the opening in tube 16. Then, in this state, the sol substance 14 is caused to gel. When the gelation is performed by irradiation with radiation as in the above water-insoluble hydrogel, the gelation is easy to control and the gelation is rapid, so that the holder 6 of the acoustic coupler 2 is
It can be easily fixed to. Finally, as shown in FIG. 4, by removing the gel mold 13 and cutting off the extra tube 16, the acoustic coupler 2 made of the water-insoluble hydrogel 1 formed by gelation is integrated with the acoustic coupler 2. The holder-equipped acoustic coupler fixed to the holder 3 by the formed holding portion 10 is obtained.

The present invention is to fix a gel-like substance to a frame-shaped holder without substantially enclosing the side surface thereof, in a method for producing an acoustic coupler with a holder, in which a lower surface portion of the holder is brought into contact with a sol-like substance, and then the holder is The sol-like substance is introduced into the holes provided through the lower surface to the other surface, and radiation is applied in this state to gel the sol-like substance and fix it to the holder. Therefore, for example, it is possible to easily create an acoustic coupler with a holder that exhibits excellent operability as described above, and further, in this fixing method, gelation of the sol-like substance If it is made by irradiation with radiation, it can be more easily created.

Further, according to the method of the present invention, a flexible acoustic coupler made of a water-insoluble hydrogel can be easily integrated with a probe of an ultrasonic diagnostic apparatus. Therefore, in the ultrasonic diagnosis, the acoustic coupler made of a hydrogel alone is used. The burden on the examinee, such as the complexity of operations and the sense of weight on the examinee, is eliminated. Therefore, when the acoustic coupler with a holder of the present invention is used, the excellent flexibility of hydrogel can be used to bring the acoustic coupler into close contact with the diagnostic site at all times without causing a change in the shape of the diagnostic site. Images can be obtained.

Further, in the holder-equipped acoustic coupler of the present invention, the water-insoluble hydrogel contains 50 to 99% by weight of water, and polyvinyl alcohols and polyvinylpyrrolidones and polyvinyl alcohols and polyvinyl alcohols with a degree of crosslinking such that this amount of water can be contained. A water-insoluble hydrogel obtained by cross-linking pyrrolidone by irradiation makes the acoustic coupler extremely flexible and has excellent acoustic properties, and also has excellent biocompatibility, and thus a better diagnostic operation. Will be able to do.

[Brief description of drawings]

FIG. 1 is a sectional view showing a structure of an embodiment of an acoustic coupler with a holder of the present invention, and FIGS. 2 to 4 are drawings showing respective manufacturing steps of an embodiment of an acoustic coupler with a holder of the present invention. Is. DESCRIPTION OF SYMBOLS 1 ... Water-insoluble hydrogel, 2 ... Acoustic coupler, 3 ... Lower surface of holder, 4 ... Upper surface of holder, 5 ... Probe insertion hole, 6 ... Holder, 7 ... Probe, 8 ... Set screw, 9 ... Hole, 10 ... Holding site , 13… gel type, 14… sol, 16… tube.

Claims (1)

[Claims] 1. A method for producing an acoustic coupler with a holder, wherein a gel-like substance is fixed to a frame-shaped holder without substantially enclosing the side faces thereof, and a lower surface portion of the holder is brought into contact with the sol-like substance, and then the holder. The sol-like substance is introduced into the pores formed through the lower surface of the sol to the other face, and radiation is performed in this state to fix the sol-like substance to the holder that gels the sol-like substance. A method of manufacturing an acoustic coupler with a holder characterized by: