JP5839255B2 - Ultrasonic diagnostic probe mounting spacer - Google Patents

Description

  The present invention relates to an ultrasonic diagnostic probe mounting spacer and an ultrasonic diagnostic probe mounted with the spacer, and more particularly, an ultrasonic diagnosis that oscillates high frequency (10 MHz or higher) ultrasonic waves. The present invention also relates to a mounting spacer that can be easily and reliably mounted on a probe for use without using a mounting member, and an ultrasonic diagnostic probe having the spacer mounted thereon.

  Compared to other diagnostic methods, ultrasonic diagnostic methods are widely used for diagnosing tissues in various parts of the body because they use less expensive devices and can be easily implemented with less burden on patients. In this ultrasonic diagnostic method, an ultrasonic diagnostic probe called a probe is pressed against the body surface, and ultrasonic reflected waves generated from the probe are received by the probe to diagnose the body tissue. However, if air is present between the probe and the body surface, the propagation of ultrasonic waves is hindered, so by applying an irregularly shaped gel that is more fluid than conventional ones to the body surface, Increases adhesion. However, when using the gel, it is difficult to keep the distance between the probe and the body surface constant, and there is a drawback that a good ultrasonic diagnostic image cannot be obtained if air bubbles are mixed in the gel. .

  On the other hand, as a spacer interposed between the ultrasound diagnostic probe and the body surface, as shown in FIG. 9, the spacer is made of a gel elastic body 101, and the lower end portion 102a of the mounting member 102 is An ultrasonic wave embedded in the gel-like elastic body 101 and detachably attached to the ultrasonic diagnostic probe 103 so that the gel-like elastic body 101 is brought into close contact with the tip of the probe 103. A spacer for mounting a diagnostic probe is disclosed (Patent Document 1). This mounting spacer can solve the above-mentioned drawbacks when using gels, but with the development of ultrasonic diagnostic probes that oscillate ultrasonic waves of high frequency of 10 MHz or higher in recent years, the following Such a problem has arisen.

Japanese Patent Laid-Open No. 4-303433

  In other words, a recently developed diagnostic apparatus using an ultrasonic diagnostic probe having a high frequency of 10 MHz or higher uses a high frequency characteristic that the higher the frequency is, the higher the resolution is, and it is possible to separate finer biological tissues. The blood flow and muscle conditions near the body surface can be observed and diagnosed. Using such a high-frequency ultrasonic diagnostic probe, When observing and diagnosing tissue, the ultrasound diagnostic probe must fit the body surface, and high-frequency ultrasound has a short propagation distance due to large propagation attenuation in the living tissue. For this reason, the gel-like elastic body of the spacer attached to the ultrasonic diagnostic probe needs to be made as thin as about 10 mm or less.

  However, like the mounting spacer of Patent Document 1 shown in FIG. 9, the lower end portion 102a of the mounting member 102 is embedded in the gel-like elastic body 101, and the mounting member 102 is detachably attached to the probe 103 to form a gel. Since the gel-like elastic body 101 needs to have a thickness sufficient to embed the lower end portion 102a of the mounting member 102, the gel-like elastic body is configured so that the elastic-like body 101 is in close contact with the tip of the probe 103. Since it is difficult to reduce the thickness of 101, if the thickness is too thin, the distance D from the lower end surface (contact surface with the body surface) of the gel elastic body 101 to the lower end portion 102a of the mounting member 102 is greatly shortened. When the probe 103 is pressed against the body surface, the lower end portion 102a of the attachment member 102 looks like a squeeze and strongly presses the body surface, or in the worst case, the lower end portion 10 a occurs a problem that contact with the body surface. As described above, since the mounting spacer of Patent Document 1 is difficult to reduce the thickness of the gel elastic body 101, it is not suitable as a spacer to be mounted on an ultrasonic diagnostic probe that oscillates high-frequency ultrasonic waves. There is a problem that a good ultrasonic diagnostic image cannot be obtained even if it is worn.

  In addition, as in the mounting spacer disclosed in Patent Document 1, the gel-like elastic body 101 attached to the ultrasonic diagnostic probe 103 with the attachment member 102 is matched to the shape of the ultrasonic diagnostic probe. Therefore, there is a problem that a dedicated mounting member and a gel-like elastic body must be prepared for each ultrasonic diagnostic probe having a different shape.

  The present invention has been made under the circumstances described above, and the problem to be solved is simple without using an attachment member for an ultrasonic diagnostic probe that oscillates an ultrasonic wave having a high frequency of 10 MHz or higher. A spacer for mounting an ultrasonic diagnostic probe that can be securely mounted and used, and can be mounted in common even if the shape of the ultrasonic diagnostic probe is slightly different, and this spacer It is an object to provide an ultrasonic diagnostic probe equipped with.

In order to solve the above problems, a mounting spacer for an ultrasonic diagnostic probe according to the present invention is mounted on an ultrasonic diagnostic probe and used by being interposed between a body surface and the spacer. The probe is made of an elastic polyurethane gel elastic body obtained by reacting 40 to 70 parts by mass of a polyisocyanate component with 100 parts by mass of a polyol component, and the probe covers the tip of the probe. A probe tip covering portion and an adhesive fixing portion that is provided on both sides of the probe tip covering portion and is adhesively fixed to the outer surface of the probe. It is not embedded but embedded in the adhesive fixing part .

In mounting spacer ultrasonic diagnostic probe according to the present invention, have preferably be a pressure-sensitive adhesive fixing portion probe tip covering portion are integrally formed of the same polyurethane gel elastic body.

  The ultrasonic diagnostic probe according to the present invention covers the tip of the probe with the probe tip covering portion of the mounting spacer according to the present invention, and the adhesive fixing portion of the mounting spacer is provided. It is characterized in that the mounting spacer is mounted on the outer surface of the probe.

A probe tip covering portion that is made of an elastic polyurethane gel elastic body and covers the tip of the probe, like the spacer for mounting an ultrasonic diagnostic probe according to the present invention, and the probe A device having an adhesive fixing portion that is provided on both sides of the tip covering portion and is adhesively fixed to the outer surface of the probe covers the tip of the ultrasonic diagnostic probe with the probe tip covering portion. At the same time, the adhesive fixing portion is adhesively fixed to the outer surface of the probe, so that it can be easily and reliably attached to the ultrasonic diagnostic probe without using an attachment member. As described above, since the mounting spacer of the present invention does not require a mounting member, it is not necessary to have a thickness that allows the lower end portion of the mounting member to be embedded like the gel-like elastic body of the mounting spacer described in Patent Document 1. Since the whole or only the probe tip covering portion can be made thinner than the gel-like elastic body of Patent Document 1 and the thickness of the probe tip covering portion can be set to about 10 mm or less, for ultrasonic diagnosis with a frequency of less than 10 MHz. Of course, even if it is attached to the probe, even if it is attached to an ultrasonic diagnostic probe with a high frequency of 10 MHz or higher and diagnoses the blood flow state or the state of the living tissue near the body surface, the super A diagnostic ultrasound image can be obtained for accurate observation and diagnosis. Even if the entire spacer or only the probe tip covering portion is thinned as described above, there is no attachment member, so the lower end portion of the attachment member when the ultrasonic diagnostic probe is pressed against the body surface This eliminates the feeling of pressure like chicory. Moreover, since the polyurethane gel elastic body is prepared by reacting 40 to 70 parts by mass of the polyisocyanate component with respect to 100 parts by mass of the polyol component, as is clear from the results of the effect confirmation test described later, The mounting spacer is excellent in followability to the probe and detachable from the probe, and does not cause displacement during use.

  Also, like the mounting spacer of the present invention, the probe tip covering portion covers the tip of the ultrasonic diagnostic probe, and the adhesive fixing portion is adhesively fixed to the outer surface of the probe and mounted. Since the ultrasonic diagnostic probe can be mounted in common even if the shape is somewhat different, a dedicated mounting member for each ultrasonic diagnostic probe having a different shape, such as the mounting spacer of Patent Document 1. There is also an advantage that it is possible to eliminate the troublesomeness and uneconomical necessity of preparing the gel-like elastic body.

In addition, the mounting spacer, in which the probe tip covering portion and the adhesive fixing portion are integrally formed of the same polyurethane gel elastic body , injects an unreacted material solution into the mold as will be described later, and reacts and gels. Therefore, there is an advantage that it is possible to easily manufacture the probe tip covering portion and the adhesive fixing portion with different material liquids and avoid the troublesomeness.

In addition, the mounting spacer of the present invention in which the shape holding material is not embedded in the probe tip covering portion but is embedded in the adhesive fixing portion suppresses expansion and contraction of the adhesive fixing portion by the shape holding material, and adhesive fixing Because the strength of the waist of the part becomes moderate, the handling of the adhesive fixing part when installing the spacer is improved, and the probe tip cover is not embedded in the shape maintenance material at the tip of the probe for ultrasonic diagnosis There is an advantage that the adhesive fixing part can be adhesively fixed to the outer surface of the ultrasonic diagnostic probe without loosening by closely contacting the parts with no gap.

Then, as in the case of including a shape-retaining material on the surface of the adhesive fixing portion, a possibility that lowered the adhesive strength of the adhesive surface of the adhesive fixing portion by the shape-retaining material, the shape-retaining material from the adhesive fixing portion or disengaged a, there is an advantage that can be eliminated.

  The ultrasonic diagnostic probe according to the present invention covers the tip of the probe with the probe tip covering portion of the mounting spacer, and the adhesive fixing portion of the mounting spacer on the outer surface of the probe. Since it is adhesive-fixed and the mounting spacer is mounted, it does not give a feeling of pressure when pressed against the body surface and oscillates the body with high-frequency ultrasonic waves of 10 MHz or higher. Even when diagnosing the blood flow state or the state of living tissue in a region close to the table, it is possible to obtain a good ultrasonic diagnostic image and accurately observe and diagnose.

It is a top view of the spacer for mounting | wearing of the probe for ultrasonic diagnosis which concerns on one Embodiment of this invention. It is a longitudinal cross-sectional view of the mounting spacer. It is a front view of the probe for ultrasonic diagnosis which concerns on one Embodiment of this invention which mounted | wore the mounting spacer. It is a side view of the probe for ultrasonic diagnosis. It is a top view of the spacer for mounting | wearing with the probe for ultrasonic diagnosis which concerns on other embodiment of this invention. It is a longitudinal cross-sectional view of the mounting spacer. FIG. 6 is a front view of an ultrasonic diagnostic probe according to another embodiment of the present invention in which the mounting spacer is mounted. It is a side view of the probe for ultrasonic diagnosis. It is a front view of the probe for ultrasonic diagnosis equipped with the conventional mounting spacer, Comprising: Only the mounting spacer is cut | disconnected and shown in the center.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

  FIG. 1 is a plan view of a mounting spacer of an ultrasonic diagnostic probe according to an embodiment of the present invention, and FIG. 2 is a longitudinal sectional view of the mounting spacer.

A mounting spacer 1 shown in FIGS. 1 and 2 is a spacer that is mounted on an ultrasonic diagnostic probe and interposed between a body surface and a polyisocyanate with respect to 100 parts by mass of a polyol component. The polyurethane gel elastic body which has the adhesiveness which mix | blended 40-70 mass parts component and made it react was comprised. The mounting spacer 1 includes a probe tip covering portion 1a having a rectangular planar shape covering the tip of the probe when attached to the ultrasonic diagnostic probe, and the probe tip covering portion 1a. The adhesive fixing portions 1b and 1b that are connected to both sides of the probe and are adhesively fixed to both front and rear surfaces of the probe are integrally formed of a gel elastic body having the same gel composition, and both adhesive fixing portions Projections 1c and 1c are attached to 1b and 1b so as to be adhesively fixed to the neck portion of the ultrasonic diagnostic probe.

As shown in FIG. 2, shape holding materials 1d and 1d are embedded near one side of both adhesive fixing portions 1b and 1b including the protruding portions 1c and 1c. With these shape holding materials 1d and 1d, The expansion and contraction of the adhesive fixing portions 1b and 1b is suppressed, and the waist strength of the adhesive fixing portions 1b and 1b is appropriately adjusted. On the other hand, as shown in the figure, the shape holding material 1d is not embedded in the probe tip covering portion 1a. The opposite surfaces of the adhesive fixing portions 1b and 1b including the protruding portions 1c and 1c are covered with the covering films 1e and 1e as shown in FIG. Accordingly, since both the adhesive fixing portions 1b and 1b are easy to handle, the mounting operation of the spacer 1 on the ultrasonic diagnostic probe can be performed easily and accurately.

  The shape retaining material 1d can be provided so as to be exposed on one surface of the adhesive fixing portion 1b including the protruding portion 1c. In this case, the adhesive force on one surface of the adhesive fixing portion 1b is reduced, or the shape retaining material 1d is Since there is a possibility of detachment from the adhesive fixing part 1b, it is desirable to embed it near one side of the adhesive fixing part 1b as in this embodiment, or to embed it in the middle part in the thickness direction of the adhesive fixing part 1b. On the other hand, the covering film 1e only needs to be attached to the opposite surface of the adhesive fixing part 1b by the adhesive force of the adhesive fixing part 1b.

As the shape-retaining material 1d, a synthetic resin fiber or vegetable fiber nonwoven fabric, a net, a woven fabric, or the like is used. Among them, a synthetic resin fiber nonwoven fabric having a basis weight of about 10 to 75 g / m ² is preferably used. . Moreover, although various synthetic resin films are used as the covering film 1e, among them, a synthetic resin film having a thickness of about 5 to 100 μm is preferably used. More preferably, a synthetic resin film having a thickness of about 5 to 50 μm is used.

The gel elastic body constituting the mounting spacer 1 securely adheres and fixes the adhesive fixing portions 1b and 1b (adhesive fixing portions 1b and 1b including the protruding portions 1c and 1c) to the front and rear surfaces of the ultrasonic diagnostic probe. It is indispensable to have appropriate adhesiveness, but the spacer 1 is used because it is attached to an ultrasonic diagnostic probe and used in close contact with the body surface. In addition to adhesiveness, the gel elastic body has an appropriate flexibility or hardness that can follow the shape of the probe (preferably 20 to 80 degrees hardness according to Asker F type hardness tester). It must have mechanical strength, safety for the human body, water resistance, etc. that can withstand the attachment and detachment. Such conditions are satisfied gel elastic member is a polyurethane gel elastic below.

  It is a polyurethane gel elastic body obtained by reacting a polyol having an alkylene oxide chain as a polyol component and / or a polyurethane polyol prepolymer having an alkylene oxide chain and a polyurethane polyisocyanate prepolymer having an alkylene oxide chain as a polyisocyanate component. This is an interpenetrated network one-component segmented polyurethane gel elastomer that is structured by alkylene oxide segments. As will be described later, this polyurethane gel elastic body has a blending ratio of a polyol component and a polyisocyanate component (in other words, a ratio OH between a hydroxyl group as a functional group at the end of the polyol component and an isocyanate group as a functional group at the end of the polyisocyanate component). / NCO), the type of alkylene oxide, the segment length, etc., and a gel elastic body that is completely harmless to the human body that exhibits adhesiveness and flexibility (or hardness) that is extremely suitable for the mounting spacer 1 And mechanical strength and water resistance are sufficiently satisfactory.

  Said polyurethane gel elastic body is mixed with one or more of the polyol components shown in the following structural formulas 1 to 4 and one or more of the polyisocyanate components shown in the following structural formulas 5 to 9 together with the catalyst, This mixture can be easily obtained by pouring into a mold for spacer molding and reacting. The reaction conditions are not limited, but the reaction is preferably performed at 60 ° C. for 24 hours. As the catalyst, tertiary amines such as dibutyltin laurate, trialkylamine, and triethylenediamine are preferably used.

（式中、Ｒ_１、Ｒ_２はアルキル化合物、脂環式化合物、芳香族化合物のいずれかであり、（ＡＯ）はアルキレンオキサイド鎖である。）

(In the formula, R ₁ and R ₂ are any of an alkyl compound, an alicyclic compound, and an aromatic compound, and (AO) is an alkylene oxide chain.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、ｌは１又は４の整数である。）

(Wherein (AO) is an alkylene oxide chain, and l is an integer of 1 or 4.)

（式中、（ＡＯ）はアルキレンオキサイド鎖である。）

(In the formula, (AO) is an alkylene oxide chain.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、ＲはＨである。）

(Wherein (AO) is an alkylene oxide chain and R is H.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、Ｒはアルキル基、脂環式化合物、芳香族化合物のいずれかである。）

(In the formula, (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、Ｒはアルキル基、脂環式化合物、芳香族化合物のいずれかである。）

(In the formula, (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、Ｒはアルキル基、脂環式化合物、芳香族化合物のいずれかであり、ｌは１又は４の整数である。）

(In the formula, (AO) is an alkylene oxide chain, R is an alkyl group, an alicyclic compound, or an aromatic compound, and l is an integer of 1 or 4.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、Ｒはアルキル基、脂環式化合物、芳香族化合物のいずれかである。）

(In the formula, (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.)

（式中、（ＡＯ）はアルキレンオキサイド鎖であり、Ｒはアルキル基、脂環式化合物、芳香族化合物のいずれかである。）

(In the formula, (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.)

  The polyol component of the above structural formulas 1 to 4 will be described. Structural formula 1 is a polyurethane polyol prepolymer which is a reaction product of polyether polyol and diisocyanate, both terminal components are polyether polyols, and functional groups at both terminals are- OH group. The diisocyanate compound used here is the same as that in the polyurethane polyisocyanate prepolymer described later. For example, phenylene diisocyanate, 2,2,4-toluylene diisocyanate (TDI), 4,4′-diphenylmethane diisocyanate ( MDI), naphthalene 1,5-diisocyanate, hexamethylene diisocyanate (HMDI), tetramethylene diisocyanate (TMDI), lysine diisocyanate, xylylene diisocyanate (XDI), water-added TDI, water-added MDI, dicyclohexyldimethylmethane p, p'- Diisocyanate, diethyl fumarate diisocyanate, isophorone diisocyanate (IPDI) and the like can be arbitrarily used.

  Structural formula 2 is obtained by adding a polyether polyol to glycerol (l = 1) or sorbitol (l = 4).

Structural formula 3 is obtained by adding a polyether to trimethylolpropane. Similarly, 1,2,6-hexanetriol or trimethylolethane represented by the following structural formulas 10 and 11, or pentaerythlit C (CH ₂ OH) ₄ , or an adduct of a polyhydric alcohol such as polyglycerin represented by the following structural formula 12 or a partial ester thereof and a polyether polyol can also be used. In this case, (AO) may be a homopolymer, a block copolymer or a random copolymer.

（式中、ｎは２〜３０の整数である。）

(In the formula, n is an integer of 2 to 30.)

  Structural formula 4 is a polyether polyol having an alkylene oxide chain, which is a bifunctional polyol having both —OH groups at both ends, and can be easily obtained as a commercial product.

  Next, the polyisocyanate prepolymer having the structural formulas 5 to 9 will be described. The structural formula 5 is a tetrafunctional compound obtained by dimerizing two molecules of triisocyanate obtained by reacting diisocyanate with trimethylolpropane with one molecule of (AO). The polyisocyanate prepolymer of the structural formula 6 is obtained by using glycerol instead of the trimethylolpropane. This kind of tetraisocyanate cannot be obtained by the reaction of two or three molecules of (AO) and two molecules of triisocyanate, so the amount of (AO) must be less than the chemical equivalent to finely control the reaction. There is. Therefore, unreacted triisocyanate is mixed, but when this reacts with the polyol, the size of the segmented polyurethane molecule varies, which may act on the side that is convenient for controlling the hardness of the gel.

  Structural formula 7 is obtained by reacting a diisocyanate with a polyol of structural formula 2 and trifunctional is hexafunctional. Structural formula 8 is obtained by reacting a diisocyanate with a polyol of structural formula 3 and trifunctional. It is. Structural formula 9 is a reaction product of polyether polyol and diisocyanate and is bifunctional.

  In order to form a polyurethane gel elastic body having appropriate elasticity and flexibility (or hardness), the alkylene oxide chain represented by (AO) in the above structural formulas 1 to 9 is almost no alkylene oxide chain. It is desirable that all are liquid at room temperature and have sufficient flexibility. If most of the alkylene oxide chain is solid, there is little molecular motion and almost no flexibility, and it will not work as a dispersion medium for structuring (gelation) of the system, so polyurethane gel elasticity with elasticity and flexibility Getting a body becomes difficult.

  Examples of the compound constituting the alkylene oxide chain (AO) include polymethylene glycol, polyethylene glycol, polypropylene glycol, polybutylene glycol, polytetramethylene glycol, polypentamethylene glycol, polyhexamethylene glycol, and polyheptamethylene glycol. Among these, polyethylene glycol, polypropylene glycol, and low molecular weight polytetramethylene glycol are readily available as liquid substances at room temperature. Further, these copolymers, for example, block copolymers represented by the following structural formulas 13 and 14 and random copolymers can also be used. The segment in one prepolymer may be composed of different types of alkylene oxide chains.

（これらの式中、ｌ，ｍ，ｎは１以上の整数である。）

(In these formulas, l, m, and n are integers of 1 or more.)

  In order to obtain a polyurethane gel elastic body having adhesiveness and flexibility (or hardness) suitable for the mounting spacer 1, it is necessary to regulate the molecular weight of the compound constituting the alkylene oxide chain. If the molecular weight is too low even if the compound is liquid, the polyurethane gel elastic body becomes too hard because the crosslink density is too high, and the flexibility to follow the shape of the ultrasonic diagnostic probe is increased. It becomes difficult to obtain and the tackiness is also reduced. In addition, when the compound is in a liquid state but has a long chain having a too large molecular weight, the reaction probability is low, so even if blended in excess of the theoretical amount, the hardness of the polyurethane gel elastic body becomes too small, and sufficient shape retention and It becomes difficult to obtain mechanical strength, and it becomes difficult to obtain appropriate tackiness. An appropriate molecular weight range is about 150 to 1000 in the case of polyethylene glycol, and more preferably about 300 to 800. Further, in the case of liquid polypropylene glycol or polybutylene glycol even if the molecular weight is tens of thousands, the range of use is wide, but those having a molecular weight of about 200 to 3000 are preferably used for the above reasons. In the case of polytetramethylene glycol, a polymer having a molecular weight of about 200 to 1000, preferably about 400 to 800 is used because it becomes solid when the degree of polymerization is large. Further, in the case of these copolymers, those having a molecular weight of several hundred to several thousand are used.

  Next, the reaction ratio between the polyol component and the polyisocyanate component will be described. Empirically speaking, the polyurethane gel elastic body constituting the mounting spacer 1 of the present invention has a segment length or straight chain in which molecules having a relatively bulky structure have an appropriate molecular weight and can move freely. It is necessary to appropriately have a molecule whose (linear) end can move freely. Therefore, the polyol component and the polyisocyanate component must be a combination of compounds in which one is bifunctional and the other is trifunctional or higher. If either one is monofunctional, it will not be linked, and if it is bifunctional, it will be a linear molecule. That is, either one is difunctional and the other is polyfunctional with 3 or more functions, or a combination of 3 or more functions with each other is good. However, if the combination has too many functional numbers on both sides, the resulting reaction product has too high a network chain concentration, and thus a long liquid segment is required for gelation. However, the length of the segment is limited due to the probability of reaction. The number of functional groups in which a polyurethane gel elastic body can be easily obtained is a combination of 2 to 4, and a combination of bifunctional and trifunctional is easy to adjust especially in combination. In that case, in order to finely adjust the hardness and other physical properties of the gel elastic body, those having one functional group can be mixed and used as an internal dispersion medium. Also, when the polyol and polyisocyanate prepolymer have only a very long (AO) chain, polyfunctional polyhydric alcohol or polyisocyanate (both having no (AO) chain) are mixed. You may devise so that a gel elastic body may be obtained by adjusting a network chain | strand form.

  The blending ratio (reaction ratio) of the polyol component and the polyisocyanate component is the ratio of the functional groups of both components, that is, the hydroxyl group that is the terminal functional group of the polyol component and the isocyanate group that is the terminal functional group of the polyisocyanate component. It is regulated by the ratio (OH / NCO). If this OH / NCO ratio is less than 1, unreacted NCO groups remain in the gel and this unreacted NCO groups post-react with moisture, so the OH / NCO ratio must be greater than 1. . However, since the polyurethane gel elastic body constituting the mounting spacer 1 is a one-component system in a state of being covalently bonded in the molecule of the same polymer, basically, OH / NCO is 1 or The value is close. However, since it is a reaction between prepolymers, if the probability of reaction is actually taken into consideration, one slightly larger than 1 is included. Empirically, it is possible to obtain a polyurethane gel elastic body suitable for the mounting spacer 1 within a range of OH / NCO of 1.0 to 2.5, and the hardness of the polyurethane gel elastic body decreases as OH / NCO decreases. In addition, the tackiness decreases, and as OH / NCO increases, the hardness of the polyurethane gel elastic body decreases (flexibility increases) and the tackiness increases. Moreover, it is preferable that OH / NCO is 1.5 to 2.5 because it is excellent in followability to the ultrasonic diagnostic probe and detachable to the ultrasonic diagnostic probe.

  The range of the weight average molecular weight of the polyol component and the polyisocyanate component varies within a wide range depending on the alkylene oxide chain, the type of isocyanate, the molecular shape, and whether the alkylene oxide chain is a homopolymer or a copolymer. 6000, approximately 1400 to 10000 for the polyurethane polyol prepolymer, approximately 500 to 10000 for the polyurethane polyisocyanate prepolymer, and preferably approximately 200 to 3000, 1000 to 6000, and 800 to 5000, respectively.

  As described above, the gel elastic body constituting the mounting spacer 1 includes a polyol having an alkylene oxide chain as a polyol component and / or a polyurethane polyol prepolymer having an alkylene oxide chain, and a polyurethane having an alkylene oxide chain as a polyisocyanate component. Polyurethane gel elastic body obtained by reacting with a polyisocyanate prepolymer, which is an internally penetrating one-component segmented polyurethane gel elastic body structured by alkylene oxide segments, so that residual monomer It does not irritate the skin because it does not contain bleed-out ingredients such as residual solvents and residual solvents, and it does not propagate germs, so it does not cause skin irritation. In addition, even if it is used for a long time, it is completely harmless to the human body. In addition, this polyurethane gel elastic body has a mounting spacer 1 by adjusting the blending ratio of the polyol component and the polyisocyanate component (in other words, the ratio of OH / NCO), the type of alkylene oxide, the segment length (molecular weight), and the like. It can be made into a gel elastic body having adhesiveness and flexibility or hardness (hardness by Asker hardness meter: 20 to 80 degrees) that is extremely suitable for mechanical strength (tension, tearing, abrasion, etc.) and water resistance. The property is also good.

  Moreover, a glyme compound etc. can be added to said polyurethane gel elastic body. By adding a glyme compound or the like, it is possible to reduce the propagation attenuation of ultrasonic waves in the polyurethane gel elastic body. As the glyme-based compound, butyl diglyme, ethyl diglyme, methyl tetraglyme, methyl triglyme, methyl diglyme, methyl monoglyme, ethyl monoglyme and the like can be arbitrarily used.

  It is appropriate to set the thickness of the gel elastic body constituting the mounting spacer 1 within a range of 0.1 to 15 mm. If the thickness is within this range, the shape of the ultrasonic diagnostic probe is followed. Thus, the spacer 1 can be mounted in a close state while being bent. In particular, in the case of a spacer attached to an ultrasonic diagnostic probe that oscillates high frequency ultrasonic waves of 10 MHz or more, it is important to set the thickness of the gel elastic body within a range of 0.1 to 10 mm. When the thickness is set within this range, a good ultrasonic diagnostic image of a living tissue near the body surface can be obtained, and the followability to the ultrasonic diagnostic probe is further improved. When the thickness of the gel elastic body is further reduced to 0.1 to 5 mm, a clearer ultrasonic diagnostic image can be obtained, and the living tissue near the body surface can be observed and diagnosed more accurately. This is extremely preferable because the followability to the diagnostic probe is further improved.

  In addition to the polyurethane gel elastic body, acrylic water-containing gels, silicone-based and rubber-based elastic bodies can also be used.

The mounting spacer 1 having the above-described configuration can be easily manufactured, for example, by the following method.
First, the shape-retaining material 1d is laid on the inner bottom surface of the shallow mold except for its central portion (portion where the probe tip covering portion 1a is formed). Then, the polyol having an alkylene oxide chain or / and the polyurethane polyol prepolymer having an alkylene oxide chain, the polyurethane polyisocyanate prepolymer having an alkylene oxide chain, and the catalyst as necessary are mixed and stirred. The material mixed solution is poured into the mold so as to have a predetermined thickness, and reacted at, for example, 60 ° C. for about 24 hours to obtain a polyurethane gel elastic body having a predetermined thickness in which the shape holding material 1d is embedded near the lower surface. Then, a coating film 1e is deposited on the upper surface of the polyurethane gel elastic body taken out from the mold except for its central portion (the portion that becomes the probe tip covering portion 1a), and this polyurethane gel elastic body is shown in FIG. By punching into the spacer shape shown, the mounting spacer 1 is manufactured.

  The probe tip covering portion 1a at the center of the mounting spacer 1 and the adhesive fixing portions 1b and 1b (adhesive fixing portions including the protruding portions 1c and 1c) on both sides thereof are formed of polyurethane gel elastic bodies having different compositions. However, when the probe tip covering portion 1a and the adhesive fixing portions 1b, 1b are integrally formed of a polyurethane gel elastic body having the same composition, a common material mixture is injected into the mold as described above, Since it can be efficiently produced by reaction and gelation, and the trouble of separately preparing two types of material liquids having different compositions can be avoided, there is an advantage that productivity is improved.

  As shown in FIGS. 3 and 4, the mounting spacer 1 as described above covers the tip 2 a by bringing the center probe tip covering portion 1 a into close contact with the tip 2 a of the ultrasonic diagnostic probe 2, The adhesive fixing portions 1b and 1b are coated on the front and rear surfaces of the ultrasonic diagnostic probe 2 while bending the adhesive fixing portions 1b and 1b following the shape of the probe 2 with the coating films 1e and 1e facing outward. In addition to fixing, the protruding portions 1c, 1c of the adhesive fixing portions 1b, 1b are adhesively fixed to both front and rear surfaces of the neck portion 2b of the probe 2, so that an ultrasonic diagnostic probe can be used without using a dedicated mounting member. The child 2 can be easily and reliably attached. Therefore, it is not necessary to make the probe tip covering portion 1a thick enough to embed the lower end portion of the dedicated mounting member, and the thickness of the entire spacer 1 or the probe tip covering portion 1a is 0.1 to 0.1 as described above. Since it can be set as thin as 10 mm, preferably 0.1 to 5 mm, when mounting on an ultrasonic diagnostic probe having a frequency of less than 10 MHz, of course, mounting on an ultrasonic diagnostic probe 2 having a high frequency of 10 MHz or higher. Even in the case of diagnosing a blood flow state or a biological tissue state near a body surface, a good ultrasonic diagnostic image can be obtained and accurately observed and diagnosed. Even if the entire spacer 1 or only the probe tip covering portion 1a is thinned as described above, there is no dedicated mounting member, so when the ultrasonic diagnostic probe 2 is pressed against the body surface. A feeling of pressure like a crepe is not given by the lower end of the mounting member.

  In addition, in the case where the adhesive fixing portions 1b and 1b are attached to both the front and rear surfaces of the ultrasonic diagnostic probe 2 and attached like the mounting spacer 1, the shape of the ultrasonic diagnostic probe 2 is the same. Since they can be mounted in common even if they are slightly different, a dedicated mounting member and a gel-like elastic body must be prepared for each ultrasonic diagnostic probe having a different shape, such as the mounting spacer of Patent Document 1 described above. The troublesomeness and uneconomical that are not necessary can be eliminated. In addition, the adhesive fixing portions 1b and 1b including the projecting portions 1c and 1c are prevented from expanding and contracting by the shape holding materials 1d and 1d, and the outer surfaces of the adhesive fixing portions 1b and 1b are made easy to handle by the covering films 1e and 1e. Therefore, the spacer 1 can be mounted with good workability so that no slack or misalignment occurs.

  FIG. 5 is a plan view of a mounting spacer for an ultrasonic diagnostic probe according to another embodiment of the present invention, and FIG. 6 is a longitudinal sectional view of the mounting spacer.

The mounting spacer 10 shown in FIGS. 5 and 6 includes a probe tip covering portion 1a having a rectangular planar shape covering the tip of the probe when the probe is attached to an ultrasonic diagnostic probe, and the probe. Adhesive fixing portions 1b and 1b that are connected to both sides of the probe tip covering portion 1a and are fixed to the front and rear surfaces of the probe are integrally formed of the polyurethane gel elastic body having the same gel composition. The one adhesive fixing portion 1b is extended with bifurcated arm portions 1f and 1f which are hooked on both shoulder portions of the ultrasonic diagnostic probe. The shape holding materials 1d and 1d are embedded in the vicinity of one surface of both the adhesive fixing portions 1b and 1b including the arms 1f and 1f, and the opposite surfaces of the adhesive fixing portions 1b and 1b It is covered with films 1e and 1e.
The polyurethane gel elastic body, the shape-retaining material 1d, and the covering film 1e have been described in detail in the mounting spacer 1 of the above embodiment, and thus the description thereof is omitted.

  The mounting spacer 10 is mounted on the ultrasonic diagnostic probe in the following manner. That is, as shown in FIGS. 7 and 8, the center probe tip covering portion 1a is brought into close contact with the tip 2a of the ultrasonic diagnostic probe 2 to cover the tip 2a, and the adhesive fixing portions 1b, 1b Either the front or back of the ultrasound diagnostic probe 2 while bending the adhesive fixing portion 1b without the arm portions 1f, 1f to follow the shape of the probe 2 with the covering films 1e, 1e facing outward Adhere to one side. The adhesive fixing portion 1b having the arm portions 1f and 1f is adhesively fixed to the opposite surface of the ultrasonic diagnostic probe 2 while being bent following the shape of the probe 2, and the bifurcated arm portion. 1f and 1f are attached to both shoulders 2c and 2c of the probe 2 and fixed by adhesion. Further, the tip of the arm portions 1f and 1f is overlapped with the adhesive fixing portion 1b having no arm part and fixed by adhesion. By doing so, the ultrasonic diagnostic probe 2 is mounted.

  The mounting spacer 10 of this embodiment has bifurcated arm portions 1f and 1f hooked on both shoulders of the ultrasonic diagnostic probe 2 in addition to the function and effect of the mounting spacer 1 of the above embodiment. Since it is mounted in a state, it can be mounted on the ultrasonic diagnostic probe 2 having a small adhesive fixing area without causing a positional shift.

  As shown in FIGS. 3, 4, 7, and 8, the ultrasonic diagnostic probe 2 according to the present invention does not use a dedicated mounting member, and the probe for the mounting spacer 1 or 10 that is thinned is used. The tip 2a of the probe is covered with the probe tip covering portion 1a, and the adhesive fixing portions 1b and 1b (adhesive fixing portion including the protruding portions 1c and 1c or the arm portions 1f and 1f) of the spacer 1 or 10 are provided. Since the gel elastic body is adhesively fixed to the outer surface of the probe, ultrasonic waves with a high frequency of 10 MHz or higher are applied without pressing a crisp feeling when pressed against the body surface. Even when oscillating and diagnosing a blood flow state or a state of a living tissue near a body surface, a good ultrasonic diagnostic image can be obtained and observed and diagnosed accurately.

  Next, tests conducted to confirm the effects of the present invention will be described.

[Prototype mounting spacer]
As a polyisocyanate component, ethylene glycol propylene glycol random copolymer as a polyisocyanate component with respect to 100 parts (mass part, the same applies hereinafter) of ethylene glycol propylene glycol random copolymer (molar ratio 1: 1, Mw = 2000) as a polyol component. (Molar ratio 1: 1) and 35 parts and 40 parts of triisocyanate (Mw = 3100) having polyether polyol in a segment obtained by reacting hexamethylene diisocyanate with this, as shown in Table 1, respectively. 42 parts, 60 parts, 70 parts, and 75 parts were mixed, and 0.1 part of dibutyltin dilaurate was mixed as a catalyst and stirred well to prepare 6 types of material mixture.
A non-woven fabric of synthetic resin fibers (Sontara # 8005 manufactured by DuPont Co., Ltd.) is laid at a predetermined interval on the inner bottom surface of the mold as a shape-retaining material. Then, after reacting at 60 ° C. for 24 hours, the polyurethane gel elastic body was taken out from the mold, and a polyethylene film having a thickness of 10 μm was deposited thereon as a coating film, which is shown in FIG. By punching into a spacer shape, six types of mounting spacers (No. 1 to No. 6) having a thickness of 5 mm, each having a different ratio of the polyisocyanate component to the polyol component, were prototyped.

[Followability test for ultrasonic diagnostic probe]
Using an ultrasonic diagnostic probe (product number PLT-805AT, manufactured by Toshiba Medical Systems Co., Ltd.), the followability of the six types of mounting spacers (No. 1 to No. 6) with respect to this probe We investigated as follows.
That is, the probe tip covering portion of each mounting spacer covers the tip of the probe, and the adhesive fixing portion of each mounting spacer is bent while bending each mounting spacer along the shape of the probe. Adhered to both the front and back sides of the probe, whether each mounting spacer is bent and deformed following the shape of the probe, and whether each mounting spacer is not peeled off from the probe was examined. . Then, the adhesive is fixed while being bent and deformed following the probe without any problem, and the one that does not peel off from the probe over time is indicated by “◯”, and the probe is bent following the probe. Although it is adhesively fixed while deforming, it is indicated by “△” if it is likely to peel off over time, and it is indicated by “x” if it is not adhesively fixed even if it is bent and deformed following the probe. Table 1 below shows the evaluation of the followability of each mounting spacer.

[Removability test for ultrasonic diagnostic probe]
The mounting operation and the exfoliation operation of the six types of mounting spacers (No. 1 to No. 6) were repeated 10 times on the probe, and the detachability was checked.
“◎” indicates that the mounting and stripping operations can be performed 10 times without any problems, and “10” indicates that the mounting and stripping operations can be performed 10 times without any problems, but those that are slightly difficult to remove are normally searched. Those that need to be peeled slowly because there is a risk of breakage to be peeled off from the probe are indicated by “△”, and those that break when peeled off from the probe are indicated by “×”, and each mounting spacer The evaluation of detachability is also shown in Table 1 below.

[Mounting spacer displacement test during use]
Each of the six types of mounting spacers (No. 1 to No. 6) is mounted on the probe, and the mounting spacer is displaced after reciprocating a distance of about 5 cm while pressing against the body surface. The presence or absence was observed. The cases where no deviation occurred were indicated by “◯”, the cases where deviation occurred were indicated by “x”, and the presence or absence of deviation of each mounting spacer was also shown in Table 1 below.

From Table 1, it can be seen that as the blending amount of the polyisocyanate component with respect to the polyol component increases, the hardness of the polyurethane gel elastic body constituting the mounting spacer increases and the followability to the ultrasonic diagnostic probe decreases. I understand. And, as the blending amount of the polyisocyanate component with respect to the polyol component decreases, the adhesiveness of the polyurethane gel elastic body constituting the mounting spacer increases, and the attachment / detachment to the ultrasonic diagnostic probe, in particular, the exfoliation work becomes difficult. I understand that.
When the blending amount of the polyisocyanate component with respect to 100 parts of the polyol component is in the range of 35 to 75 parts, the spacer is not displaced at the time of use, so that the use is not hindered, but the blending amount of the polyisocyanate component is 35. Spacer No. No. 1 is difficult to exfoliate because of excessive tackiness, and spacer No. 1 having a polyisocyanate component content of 75 parts. No. 6 lacks the ability to follow an ultrasonic probe and is difficult to be adhesively fixed so that it does not peel off. Therefore, the gel composition of a polyurethane gel elastic body suitable for a mounting spacer is 100 parts by weight of the polyol component. It can be seen that the polyisocyanate component is in the range of 40 to 70 parts.
Among them, spacer No. 1 comprising a polyurethane gel elastic body obtained by reacting 42 to 70 parts of a polyisocyanate component with 100 parts of a polyol component was reacted. 3-No. No. 5 has good followability and detachability, and spacer No. 5 was prepared by reacting 60 to 70 parts of the polyisocyanate component with 100 parts of the polyol component. 4, no. No. 5 has extremely good detachability. Therefore, the preferred gel composition of the polyurethane gel elastic body constituting the mounting spacer is in the range of 42 to 70 parts of the polyisocyanate component with respect to 100 parts of the polyol component, and the more preferred gel composition is based on 100 parts of the polyol component. It can be said that the polyisocyanate component is in the range of 60 to 70 parts.

[Followability test of mounting spacers with different thicknesses]
For 100 parts of ethylene glycol propylene glycol random copolymer (molar ratio 1: 1, Mw = 2000) which is a polyol component, as a polyisocyanate component, ethylene glycol propylene glycol random copolymer (molar ratio 1: 1) as glycerin. 50 parts of triisocyanate (Mw = 3100) having a polyether polyol obtained by reacting hexamethylene diisocyanate with this segment and 0.1 part of dibutyltin dilaurate as a catalyst may be mixed. The material mixture was prepared by stirring.
As shown in Table 2 below, each of the material mixture liquids was poured into a mold at a thickness of 0.1 mm, 1 mm, 3 mm, 5 mm, 10 mm, and 15 mm, and reacted at 60 ° C. for 24 hours. The polyurethane gel elastic body was taken out and punched into the spacer shape shown in FIG. 1, thereby producing six types of spacers having different thicknesses and having no shape-retaining material and coating film.
For these spacers, the followability was examined in the same manner as the followability test for the ultrasonic diagnostic probe described above, and similarly evaluated by “◯”, “Δ”, and “×”.
Table 2 below describes the spacer thickness and evaluation.

From Table 2, the spacers made of polyurethane gel elastic bodies having a thickness in the range of 0.1 to 15 mm are all evaluated as “◯” or “Δ”, and followability to the probe for ultrasonic diagnosis. It can be seen that it can be mounted so as not to peel off. And it turns out that the followable | trackability of a spacer improves, so that thickness becomes thin.
Among them, a spacer having a thickness of 10 mm or less is attached to an ultrasonic diagnostic probe having a high frequency of 10 MHz or more as described above to obtain a good ultrasonic diagnostic image of a living tissue near the body surface. In particular, a spacer of 5 mm or less has a followability of “◯”, can be bent and deformed following the uneven outer surface of the probe, and can be adhesively fixed so that it does not peel off in a close state. From this, it can be said that the thickness suitable for the mounting spacer is 0.1 to 15 mm, the preferred thickness is 0.1 to 10 mm, and the more preferred thickness is 0.1 to 5 mm.

DESCRIPTION OF SYMBOLS 1,10 Mounting spacer 1a Probe tip covering portion 1b Adhesive fixing portion 1c Protruding portion 1d Shape holding material 1e Cover film 1f Arm portion 2 Probe for ultrasonic diagnosis 2a Probe tip 2b Probe neck Part 2c Both shoulders of the probe

Claims (3)

A mounting spacer that is mounted on an ultrasonic diagnostic probe and is interposed between the body surface and the spacer. The spacer contains 40 to 70 parts by mass of a polyisocyanate component per 100 parts by mass of a polyol component. The probe tip covering portion covering the tip of the probe, connected to both sides of the probe tip covering portion, and connected to the probe tip covering portion. An ultrasonic diagnostic probe comprising: an adhesive fixing portion that is adhesively fixed to an outer surface; and the shape-retaining material is not embedded in the probe tip covering portion but embedded in the adhesive fixing portion. Spacer for mounting.   2. The ultrasonic diagnostic probe mounting spacer according to claim 1, wherein the probe tip covering portion and the adhesive fixing portion are integrally formed of the same polyurethane gel elastic body. The probe tip covering portion of the mounting spacer according to claim 1 or 2 covers the tip of the probe, and the adhesive fixing portion of the mounting spacer is adhesively fixed to the outer surface of the probe. An ultrasonic diagnostic probe comprising the mounting spacer.

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