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WO2014024286A1 - Écarteur pour montage d'une sonde de diagnostic à ultrasons - Google Patents

Écarteur pour montage d'une sonde de diagnostic à ultrasons Download PDF

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Publication number
WO2014024286A1
WO2014024286A1 PCT/JP2012/070300 JP2012070300W WO2014024286A1 WO 2014024286 A1 WO2014024286 A1 WO 2014024286A1 JP 2012070300 W JP2012070300 W JP 2012070300W WO 2014024286 A1 WO2014024286 A1 WO 2014024286A1
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WO
WIPO (PCT)
Prior art keywords
probe
spacer
ultrasonic diagnostic
mounting
adhesive fixing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2012/070300
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English (en)
Japanese (ja)
Inventor
厚 吉田
信昭 宮本
谷口　雅彦
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takiron Co Ltd
Original Assignee
Takiron Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takiron Co Ltd filed Critical Takiron Co Ltd
Priority to PCT/JP2012/070300 priority Critical patent/WO2014024286A1/fr
Publication of WO2014024286A1 publication Critical patent/WO2014024286A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4411—Device being modular

Definitions

  • the present invention relates to an ultrasonic diagnostic probe mounting spacer and an ultrasonic diagnostic probe mounted with this spacer, and more specifically, can be mounted easily and reliably without using an attachment member.
  • the present invention relates to a mounting spacer and an ultrasonic diagnostic probe equipped with the spacer.
  • the ultrasonic diagnostic method is used for diagnosis of tissues in various parts of the body because the device used is less expensive than other diagnostic methods and can be easily performed with less burden on the patient.
  • 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.
  • 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.
  • the spacer is made of a gel elastic body 101, and the lower end 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 eliminate the above-mentioned drawbacks when using gel.
  • a device in which the gel elastic body 101 is mounted on the ultrasonic diagnostic probe 103 by the mounting member 102 is the ultrasonic diagnostic probe 103. Since the mounting member 102 and the gel elastic body 101 matched to the shape of the probe are required, a dedicated mounting member and the gel elastic body must be prepared for each ultrasonic diagnostic probe having a different shape. There was a problem that it was inferior and the number of parts increased.
  • the mounting spacer disclosed in Patent Document 1 is such that the lower end portion 102a of the mounting member 102 embedded in the gel-like elastic body 101 is creaking when the ultrasonic diagnostic probe 103 is pressed against the body surface. If the gel-like elastic body 101 is thickened in order to eliminate this fear, the probe of the ultrasonic diagnostic apparatus having a high frequency of 10 MHz or more can obtain good ultrasonic waves. There was a problem that it was difficult to obtain diagnostic images. That is, an ultrasonic diagnostic apparatus 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 present invention has been made under the above circumstances, and the problem to be solved is a general purpose that can be easily and reliably mounted without using a mounting member even if the shape of the ultrasonic diagnostic probe is slightly different. It is an object of the present invention to provide an ultrasonic diagnostic probe mounting spacer and an ultrasonic diagnostic probe mounted with the spacer.
  • a mounting spacer for an ultrasonic diagnostic probe is mounted on an ultrasonic diagnostic probe and used by being interposed between a body surface and the spacer.
  • the spacer is made of an adhesive gel elastic body, and is connected to the probe tip covering portion that covers the tip of the ultrasonic diagnostic probe and to both sides of the probe tip covering portion. And an adhesive fixing portion that is adhesively fixed to the outer surface of the probe.
  • the mounting spacer of the present invention may be one in which the thickness of the probe tip covering portion and the thickness of the adhesive fixing portion are the same, and the whole is formed in a flat plate shape, or the thickness of the adhesive fixing portion is the probe. It may be thinner than the thickness of the child tip covering portion. In the latter case, in the mounting spacer where the thickness of the adhesive fixing part is thinner than the thickness of the probe tip covering part, the surface of the boundary part between the probe tip covering part and the adhesive fixing part is concave. It is preferable that the thickness of the boundary portion decreases from the probe tip covering portion side to the adhesive fixing portion side so that it becomes a curved surface or a slope, and the probe tip covering portion protrudes at least on one side. Just do it.
  • fixed part is equipped with the shape holding material, and it is preferable that this shape holding
  • the ultrasonic diagnostic probe covers the tip of the ultrasonic diagnostic probe with the probe tip covering portion of the mounting spacer and ultrasonically applies the adhesive fixing portion of the mounting spacer.
  • the mounting spacer is attached to the outer surface of the diagnostic probe by adhesion.
  • the mounting spacer made of an adhesive gel elastic body according to the present invention covers the tip of the probe by covering the tip of the probe with the tip covering portion of the probe for ultrasonic diagnosis.
  • By attaching and fixing the adhesive fixing parts connected to both sides of the covering part to the outer surface of the ultrasonic diagnostic probe it can be easily and securely attached to the ultrasonic diagnostic probe without using an attachment member. be able to.
  • the mounting spacer of the present invention does not require a mounting member, the lower end of the mounting member when the ultrasonic diagnostic probe is pressed against the body surface, like the mounting spacer of Patent Document 1, is attached.
  • 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.
  • the mounting spacer which has the same thickness as the tip of the probe and the thickness of the adhesive fixing part and is entirely flat, has a thinner adhesive fixing part than the thickness of the probe tip covering part. Compared with the formed mounting spacer, as described later, it can be manufactured with a smaller number of steps.
  • the mounting spacer with the adhesive fixing part thinner than the probe tip covering part has a thin adhesive fixing part that is flexible and flexible. Because it is easy to follow the undulations on the outer surface of the probe for easy deformation and tight adhesion so that it does not peel off, the attachment to the ultrasonic diagnostic probe is greatly improved. Since the ultrasonic diagnostic probe can be easily grasped by reducing the thickness of the adhesive fixing portion, the operability is also improved.
  • the thickness of the boundary portion decreases from the probe tip covering portion side to the adhesive fixing portion side so that the surface of the boundary portion between the probe tip covering portion and the adhesive fixing portion becomes a concave curved surface or an inclined surface.
  • the mounting spacer that is used is difficult to concentrate stress on the boundary between the probe tip cover and adhesive fixing part when operating the ultrasonic diagnostic probe (during ultrasonic diagnosis). Cracks and the like can be prevented from occurring.
  • the mounting spacer with the probe tip cover protruding at least on one side is mounted with the tip of the probe cover covered inside and the tip of the ultrasonic diagnostic probe covered. Then, since the force in the tearing direction does not act on the stepped boundary between the probe tip covering portion and the adhesive fixing portion, it is possible to prevent the occurrence of cracks and the like.
  • the mounting spacer in which the coating layer for reducing or eliminating the adhesiveness of the gel elastic body is laminated on one surface on the body surface side is the one on the body surface side even if the gel elastic body is highly adhesive. Since the adhesiveness of the surface is reduced or eliminated by the coating layer, the outer surface (surface on the body surface side) of the probe tip covering part adheres to the body surface during ultrasonic diagnosis, or the outer surface (surface on the body surface side) of the adhesive fixing part ) Does not stick to the hand, improving the operability during ultrasonic diagnosis.
  • the covering layer also serves as a shape-retaining material, so that the mounting spacers are prevented from expanding and contracting, and there is an advantage that mounting properties and handling properties are improved.
  • the mounting spacer with the adhesive fixing part provided with a shape-retaining material is mounted with a spacer because the shape-retaining material suppresses expansion and contraction of the adhesive fixing part and the waist strength of the adhesive fixing part becomes appropriate.
  • Ultrasonic diagnostic probe without loosening the adhesive fixing part so that the handling of the adhesive fixing part is improved and the probe cover of the spacer probe is in close contact with the tip of the ultrasonic diagnostic probe without gaps Can be adhesively fixed to the outer surface.
  • the mounting spacer with the shape retaining material embedded in the adhesive fixing part eliminates the risk of the adhesive force on the adhesive surface of the adhesive fixing part being reduced by the shape retaining material or the shape retaining material being detached from the adhesive fixing part. can do.
  • the mounting spacer in which the probe tip covering portion and the adhesive fixing portion are integrally formed of the same gel elastic body, injects an unreacted liquid mixed material into the container and reacts and gels as described later. Therefore, it can be easily manufactured, and the troublesomeness of forming the probe tip covering portion and the adhesive fixing portion with different liquid mixed materials can be avoided.
  • 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. Because it is attached with the above mounting spacers, it is ultrasonically diagnosed when it is pressed against the body surface without giving a feeling of pressure like a crisp by the lower end of the mounting member as before. Even if the probe oscillates ultrasonic waves with a high frequency of 10 MHz or more, a good ultrasonic diagnostic image can be obtained and diagnosed accurately, and the mounting spacer may be displaced or peeled off during the ultrasonic diagnosis. And there will be no trouble.
  • FIG. 1 It is a top view of the mounting spacer which concerns on other embodiment of this invention. It is a longitudinal cross-sectional view of the mounting spacer. It is a side view of the probe for ultrasonic diagnosis equipped with the same mounting spacer. It is a partial expanded sectional view of the mounting spacer which concerns on other embodiment of this invention.
  • (A) is the elements on larger scale of the mounting spacer which concerns on further another embodiment of this invention,
  • (b) is the elements on larger scale of the mounting spacer which concerns on further another embodiment of this invention.
  • (A) is a longitudinal sectional view of a mounting spacer according to still another embodiment of the present invention, and (b) is a sectional view taken along line AA of (a). It is a side view of the probe for ultrasonic diagnosis equipped with the same mounting spacer. It is a longitudinal cross-sectional view of the mounting spacer which concerns on other embodiment of this invention. It is explanatory drawing which shows an example of the manufacturing method of the spacer for mounting
  • FIG. 1 is a plan view of a mounting spacer of an ultrasonic diagnostic probe according to an embodiment of the present invention
  • FIG. 2 is a longitudinal sectional view of the mounting spacer
  • FIG. 3 is an ultrasonic wave mounted with the mounting spacer.
  • FIG. 4 is a front view of the diagnostic probe
  • FIG. 4 is a side view of the ultrasonic diagnostic probe.
  • a mounting spacer 1 shown in FIGS. 1 and 2 is a spacer that is mounted on an ultrasonic diagnostic probe 2 as shown in FIGS. It is made of a gel elastic body having adhesiveness. As shown in FIGS. 1 to 4, the mounting spacer 1 has a rectangular planar shape covering the tip 2 a of the ultrasonic diagnostic probe 2 when mounted on the ultrasonic diagnostic probe 2. A probe tip covering portion 1a, and adhesive fixing portions 1b and 1b that are connected to both sides of the probe tip covering portion 1a and are adhesively fixed to the front and rear outer surfaces of the ultrasonic diagnostic probe 2.
  • the adhesive fixing portions 1b and 1b are not particularly limited in the planar shape as long as they can be adhesively fixed to the outer surfaces of at least the front and rear wide portions 2c of the ultrasonic diagnostic probe 2.
  • a desired shape can be obtained according to the shape of the outer surface before and after the portion 2c.
  • the extending portions 1c, 1c have any planar shape as long as they can be adhesively fixed to the front and rear outer surfaces of the neck portion 2b (the base end side narrow portion) of the ultrasonic diagnostic probe 2. It may be a thing and may be abbreviate
  • the mounting spacer 1 has the same thickness D1 of the probe tip covering portion 1a as the thickness D2 of the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c.
  • the entire spacer is formed as a flat plate having a constant thickness. It is appropriate to set the thickness of the mounting spacer 1 (that is, the thickness D1 of the probe tip covering portion 1a and the thickness D2 of the adhesive fixing portions 1b and 1b) within a range of 0.3 to 15 mm. If the thickness is within this range, the adhesive fixing portions 1b and 1b and the extending portions 1c and 1c are extended while bending the mounting spacer 1 so as to follow the contoured shape of the outer surface of the ultrasonic diagnostic probe 2.
  • the sound diagnostic probe 2 can be securely attached to the outer surface of the probe 2 by being adhesively fixed in a close state.
  • the thickness is preferably set within a range of 0.3 to 10 mm.
  • the thickness is set to, a good ultrasonic diagnostic image of a living tissue near the body surface can be obtained, and the followability to the contoured shape of the outer surface of the ultrasonic diagnostic probe 2 is further improved.
  • the thickness (D1, D2) of the mounting spacer 1 is set to be 0.3-5 mm, it is possible to obtain a clearer ultrasonic diagnostic image for more accurate observation and diagnosis. Since the followability to the undulation shape of the outer surface of the diagnostic probe 2 is further improved, it is extremely preferable.
  • the gel elastic body constituting the mounting spacer 1 has appropriate adhesiveness that can be securely fixed to the ultrasonic diagnostic probe 2 and follows the undulating shape of the outer surface of the ultrasonic diagnostic probe 2. It has appropriate flexibility (flexibility) that it can do, has mechanical strength that can withstand multiple attachments / detachments to the ultrasonic diagnostic probe 2, has safety and water resistance to the human body, etc. Therefore, the following polyurethane gel elastic body satisfying these conditions is preferably used.
  • the polyurethane gel elastic body preferably used as 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 polyisocyanate component.
  • This polyurethane gel elastic body is harmless to the human body and sufficiently satisfies mechanical strength and water resistance.
  • the polyurethane gel elastic body reacts by mixing one or more of the polyol components represented by the following structural formulas 1 to 4 and one or more of the polyisocyanate components represented by the following structural formulas 5 to 9 together with a catalyst. By making it, it can obtain easily. Although reaction conditions are not particularly limited, for example, it is preferable to react at 60 ° C. for 24 hours.
  • tertiary amines such as dibutyltin laurate, trialkylamine, and triethylenediamine are preferably used.
  • 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.
  • (AO) is an alkylene oxide chain.
  • (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.
  • (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.
  • (AO) is an alkylene oxide chain
  • R is an alkyl group, an alicyclic compound, or an aromatic compound
  • l is an integer of 1 or 4.
  • (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.
  • (AO) is an alkylene oxide chain, and R is an alkyl group, an alicyclic compound, or an aromatic compound.
  • the polyol component represented by the structural formulas 1 to 4 will be described.
  • the structural formula 1 is a polyurethane polyol prepolymer which is a reaction product of a polyether polyol and a diisocyanate, wherein 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.
  • 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.
  • TDI 2,2,4-toluylene diisocyanate
  • MDI 4,4′-diphenylmethane diisocyanate
  • MDI naphthalene 1,5-diisocyanate
  • Structural formula 3 is obtained by adding a polyether to trimethylolpropane.
  • 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.
  • (AO) may be a homopolymer, a block copolymer or a random copolymer.
  • 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.
  • 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 is trifunctional or hexafunctional.
  • Structural formula 8 is obtained by reacting a diisocyanate with a polyol of structural formula 3 in the same manner. It is.
  • Structural formula 9 is a reaction product of polyether polyol and diisocyanate and is bifunctional.
  • the alkylene oxide chain represented by (AO) in the above structural formulas 1 to 9 is almost all of the alkylene oxide chain in order to form a polyurethane gel elastic body having appropriate elasticity and flexibility (or hardness). 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.
  • polyethylene glycol, polypropylene glycol, and low molecular weight polytetramethylene glycol are readily available as liquid substances at room temperature.
  • 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.
  • 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 having a molecular weight of tens of thousands, the range of use is wide, but for the above reasons, those having a molecular weight of about 200 to 3000 are preferably used.
  • 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.
  • 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.
  • 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.
  • the length of the segment is limited due to the probability of reaction.
  • the number of functional groups from which a polyurethane gel elastic body can be easily obtained is a combination of 2 to 4, and the combination of bifunctional and trifunctional is particularly easy to adjust in terms of formulation. 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.
  • polyol and polyisocyanate prepolymer have only a very long (AO) chain
  • polyfunctional polyhydric alcohol or polyisocyanate both having no (AO) chain
  • 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. .
  • 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. From experience, 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.
  • OH / NCO is 1.2 to 2.5 because it is excellent in followability and detachability to the ultrasonic diagnostic probe.
  • the range of the weight average molecular weight of the polyol component and the polyisocyanate component varies in a wide range depending on the alkylene oxide chain, the kind of isocyanate, the molecular shape, and whether the alkylene oxide chain is a homopolymer or a copolymer.
  • 6000 approximately 1400 to 10,000 for the polyurethane polyol prepolymer, approximately 500 to 10,000 for the polyurethane polyisocyanate prepolymer, and preferably approximately 200 to 3000, 1000 to 6000, and 800 to 5000, respectively.
  • this segmented polyurethane gel elastic body is obtained by adjusting the blending ratio of the polyol component and the polyisocyanate component (in other words, the ratio of OH / NCO), the type of the alkylene oxide, the segment length (molecular weight), and the like.
  • adhesiveness is required. There is a tendency to become larger than this, and if the adhesiveness is controlled so as to match the mounting spacer 1, the flexibility tends to decrease and the hardness tends to increase, so both flexibility and adhesiveness are compatible with the mounting spacer. It is not easy to control as you do.
  • a segmented polyurethane gel elastic body comprising a glyme compound represented by the following structural formula 15 that does not participate in the urethane reaction as an additive. It is preferable to improve the flexibility while suppressing the adhesiveness, and to control both the flexibility and the adhesiveness so as to fit the mounting spacer 1.
  • R is an alkyl group, and n is an integer of 1 or more.
  • the glyme compound include methyltetraglyme in which R is a methyl group and n is 4 in the above structural formula 15, methyl triglyme in which R is a methyl group and n is 3, and R is a methyl group and n is n 2, methyl diglyme, R is a methyl group and n is 1, butyl diglyme, where R is a butyl group and n is 2, ethyl diglyme where R is an ethyl group and n is 2 Can be mentioned.
  • the content of the glyme compound in the polyurethane gel elastic body is not particularly limited, but if the content exceeds 70% by mass, the adhesiveness of the polyurethane gel elastic body is excessively lowered. It is preferable to determine the content so as to obtain adhesiveness and flexibility suitable for the above.
  • the segmented polyurethane gel elastic body containing the above-mentioned glyme compound increases in flexibility and decreases in tackiness as the content of glyme compound increases, and increases in OH / NCO ratio.
  • the ratio of OH / NCO is adjusted within the range of 1.2 to 2.4 and the content of the glyme compound is adjusted within the range of 70% by mass or less as shown in the test data described later.
  • the torque in the rheometer Controlling the tackiness of the polyurethane gel elastic body so that the value is 7.0 to 520 g. It can be adapted to 1.
  • the glyme compound is non-volatile, there is no concern that the adhesiveness or flexibility of the polyurethane gel elastic body will change due to volatilization, and the glyme compound will reduce the propagation attenuation of ultrasonic waves in the polyurethane gel elastic body. You can also.
  • germs do not grow on polyurethane gel elastic bodies containing glyme compounds, they do not cause skin irritation, are harmless to the human body even when used for a long time, and may deteriorate due to moisture on the body surface. Absent.
  • the gel elastic body constituting the mounting spacer 1 in addition to the polyurethane gel elastic body, an acrylic water-containing gel, an elastic body such as a silicone system or a rubber system, and the like can be used.
  • the mounting spacer 1 having the above-described configuration is manufactured, for example, by the following method.
  • the catalyst and the glyme compound of the structural formula 15 are mixed with the polyol having the alkylene oxide chain of the structural formulas 1 to 4 and / or the polyurethane polyol prepolymer having the alkylene oxide chain.
  • this mixture and the polyurethane polyisocyanate prepolymer having an alkylene oxide chain of the structural formulas 5 to 9 are mixed, defoamed, and the ratio of OH / NCO is 1.2 to 2.4.
  • a liquid mixed material having a composition in which the content is adjusted to 70% by mass or less is obtained.
  • the glyme compound may be omitted.
  • a release film (release film) is laid on the inner bottom surface of the square dish-shaped container, and the liquid mixed material is poured into the dish-shaped container so as to have a predetermined thickness, and reacted at 60 ° C. for about 24 hours.
  • a rectangular polyurethane gel elastic sheet having a predetermined thickness is formed.
  • by attaching a release film on the upper surface of the polyurethane gel elastic sheet, taking out the polyurethane gel elastic body from the dish-shaped container and punching it into the spacer shape shown in FIG. 1 is manufactured.
  • the release films on the upper and lower surfaces are peeled off when the mounting spacer 1 is mounted on the ultrasonic diagnostic probe 2. Note that the upper and lower release films may be omitted.
  • the probe tip covering portion 1a at the center of the mounting spacer 1 and the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c on both sides thereof are formed of polyurethane gel elastic bodies having different compositions as will be described later.
  • the polyurethane gel elastic body of the same composition is formed integrally, it can be efficiently manufactured by injecting a common liquid mixed material into a dish-shaped container as described above, and reacting and gelling. There is an advantage that productivity can be improved because it is possible to avoid troublesome preparation of two kinds of liquid mixed materials different from each other.
  • the mounting spacer 1 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 adhesively fixed while bending and deforming following the concave and convex shapes of the front and rear surfaces of the ultrasonic diagnostic probe 2, and the extending portions 1c and 1c are fixed to the neck portion 2b of the probe 2.
  • the ultrasonic diagnostic probe 2 can be easily and reliably mounted without using a dedicated mounting member.
  • the polyurethane gel elastic body adjusts the ratio of OH / NCO, the type and length (molecular weight) of the alkylene oxide, and appropriately contains a glyme compound, whereby the hardness by an Asker F-type hardness meter is 16 or more, and When the flexibility is controlled so that the hardness by the Asker C2 type hardness tester is 15 or less, the adhesiveness is controlled so that the torque value in the rheometer is 7.0 to 520 g, and the mounting spacer is used. Since it has extremely suitable flexibility and adhesiveness, the mounting property to the ultrasonic diagnostic probe 2 is very good.
  • the mounting spacer 1 does not require a dedicated mounting member, when the ultrasonic diagnostic probe 2 is pressed against the body surface, the lower end of the mounting member gives a feeling of pressure like a scour.
  • the thickness (D1, D2) can be reduced to 0.3 to 15 mm, preferably 0.3 to 10 mm, more preferably 0.3 to 5 mm, as described above, When attached to an ultrasonic diagnostic probe having a frequency of less than 10 MHz, of course, it is attached to an ultrasonic diagnostic probe 2 having a high frequency of 10 MHz or more, and the blood flow state or biological tissue in a region close to the body surface. Even when diagnosing a condition, it is possible to obtain a good ultrasonic diagnostic image and accurately observe and diagnose it.
  • the mounting spacer 1 can be mounted in common even if the shape of the ultrasonic diagnostic probe 2 is slightly different, the mounting spacer 1 is excellent in versatility, and is similar to the mounting spacer of Patent Document 1 described above. In addition, it is possible to eliminate the troublesomeness and uneconomical necessity of preparing a dedicated attachment member and a gel-like elastic body for each ultrasonic diagnostic probe having a different shape.
  • FIG. 5 is a longitudinal sectional view of a mounting spacer according to another embodiment of the present invention.
  • the mounting spacer 10 shown in FIG. 5 is made of the same polyurethane gel elastic body as the mounting spacer 1, and has a thickness D1 of the center probe tip covering portion 1a and is continuously provided on both sides thereof.
  • the thickness D2 of the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extending portions 1c and 1c) is the same, and the entire spacer is formed in a flat plate shape having a constant thickness. Then, the adhesiveness of the polyurethane gel elastic body is reduced over the entire area of one surface (the lower surface in FIG. 5) of the mounting spacer 10 which is the outer side (the body surface side) when the ultrasonic diagnostic probe is mounted.
  • the covering layer 1e to be eliminated is laminated, and the shape holding materials 1d and 1d are embedded in the entire area of the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c.
  • the coating layer 1e for reducing or eliminating the adhesiveness of the polyurethane gel elastic body include a synthetic resin film, a coating layer and the like, and those having a thickness of 50 ⁇ m or less, preferably about 5 to 25 ⁇ m are suitable. used.
  • Various known synthetic resin films can be used as the synthetic resin film, and among them, a polyethylene terephthalate film, a polyethylene film, a polypropylene film, and the like are preferably used.
  • coating layers such as synthetic resin films caused reflection and attenuation of ultrasonic waves, and it was thought that laminating them was not good.
  • coating layers such as thin synthetic resin films with a thickness of 50 ⁇ m or less It has been confirmed by the present inventors that the lamination does not substantially adversely affect the ultrasonic diagnosis.
  • a synthetic resin fiber or vegetable fiber nonwoven fabric, a net, a woven fabric, or the like is used as the shape-retaining material 1d.
  • a synthetic resin fiber nonwoven fabric having a basis weight of about 10 to 75 g / m 2 is preferably used. .
  • the mounting spacer 10 is Even if the polyurethane gel elastic body is highly adhesive, the adhesiveness of one surface (the surface on the body surface) is reduced or eliminated by the coating layer 1e, so that the probe tip is covered during ultrasonic diagnosis.
  • the width of the coating layer 1e may be expanded in some cases to cover the both side surfaces of the mounting spacer 10 with the coating layer 1e. May be.
  • the gel applied to the body surface at the time of ultrasonic diagnosis is repelled by the covering layers 1e on both sides of the mounting spacer 10, and enters between the mounting spacer 10 and the ultrasonic diagnostic probe 2. Therefore, it is possible to eliminate the possibility that the adhesion of the mounting spacer 10 to the ultrasonic diagnostic probe 2 is hindered by the gel. Such an effect becomes remarkable when a coating layer having excellent gel repellency is provided as the coating layer 1 e on both side surfaces of the mounting spacer 10.
  • the main purpose of laminating the covering layer 1e is to reduce or eliminate the adhesiveness of the surface on the body surface so that the mounting spacer 10 adheres to the body surface and does not interfere with ultrasonic diagnosis. It is only necessary to be laminated on the outer surface (surface on the body surface side) of the probe tip covering portion 1a that comes into contact with the body surface at least during ultrasonic diagnosis.
  • the shape retaining materials 1d and 1d are embedded in the entire area of the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extending portions 1c and 1c) as in the mounting spacer 10 described above, the shape retaining material Since the expansion and contraction of the adhesive fixing portions 1b and 1b is suppressed by 1d and 1d, and the waist strength of the adhesive fixing portions 1b and 1b becomes appropriate, the handling of the adhesive fixing portions 1b and 1b when the spacer 10 is mounted And the adhesive fixing portions 1b and 1b are not loosened so that the probe tip covering portion 1a of the mounting spacer 10 is in close contact with the tip of the ultrasonic diagnostic probe without gaps. Can be adhesively fixed to the front and rear outer surfaces.
  • the shape holding materials 1d and 1d are the other surfaces (surfaces opposite to the coating layer 1e) of the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extending portions 1c and 1c) on the ultrasonic diagnostic probe side.
  • the adhesive force of the other surface of the adhesive fixing portions 1b and 1b may be reduced, or that the shape holding materials 1d and 1d may be detached from the adhesive fixing portions 1b and 1b. Therefore, as in the mounting spacer 10, it is embedded in the vicinity of the other surface of the adhesive fixing portions 1 b, 1 b, or is embedded in the middle portion in the thickness direction of the adhesive fixing portions 1 b, 1 b. It is desirable to prevent a decrease in the adhesive strength of the other surface of the parts 1b and 1b and the separation of the shape-retaining material.
  • the covering layer 1e serves to reduce or eliminate the adhesiveness of one surface on the body surface side of the mounting spacer 10, it also plays a role of a shape retaining material and suppresses expansion and contraction of the mounting spacer.
  • the shape holding materials 1d and 1d can be omitted.
  • the resistance against external force that deforms the mounting spacer when performing ultrasonic diagnosis while moving the ultrasonic diagnostic probe with spacer attached against the body surface is from a synthetic resin film, etc. Since the shape-retaining material 1d made of a synthetic resin fiber non-woven fabric or the like is superior to the covering layer 1e, the covering layer 1e and the shape-retaining material 1d are preferably provided side by side like the mounting spacer 10.
  • the mounting spacer 10 is manufactured by the following method, for example. First, the shape-retaining material 1d is laid on the inner bottom surface of the shallow dish-shaped container except for its central portion (portion where the probe tip covering portion 1a is formed). Then, the above-mentioned liquid mixed material is poured into a dish-shaped container so as to have a predetermined thickness, and is reacted for about 24 hours at 60 ° C., for example, and a polyurethane gel with a predetermined thickness in which the shape-retaining material 1d is embedded near the lower surface Get an elastic body.
  • a synthetic resin film is applied as a coating layer 1e on the upper surface of the polyurethane gel elastic body taken out from the dish-shaped container, and the polyurethane gel elastic body is punched into a spacer shape as shown in FIG.
  • the spacer 10 for manufacturing is manufactured.
  • FIG. 6 is a plan view of a mounting spacer according to still another embodiment of the present invention
  • FIG. 7 is a longitudinal sectional view of the mounting spacer
  • FIG. 8 is an ultrasonic diagnostic probe mounted with the mounting spacer.
  • FIG. 9 is a front view
  • FIG. 9 is a side view of the ultrasonic diagnostic probe.
  • the mounting spacer 11 shown in FIGS. 6 and 7 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, Adhesive fixing portions 1b and 1b that are connected to both sides with the same thickness as the probe tip covering portion 1a and that are adhesively fixed to both front and rear surfaces of the probe are integrated with the polyurethane gel elastic body having the same gel composition.
  • Adhesive fixing portions 1b and 1b that are connected to both sides with the same thickness as the probe tip covering portion 1a and that are adhesively fixed to both front and rear surfaces of the probe are integrated with the polyurethane gel elastic body having the same gel composition.
  • bifurcated arm portions 1f and 1f that are hooked on both shoulders of the ultrasonic diagnostic probe are extended. Then, the coating layer that reduces or eliminates the adhesiveness over the entire area of the one surface (the lower surface in FIG.
  • Such a mounting spacer 11 can be manufactured by changing the final punching shape to the spacer shape shown in FIG. 6 in the manufacturing method of the mounting spacer 10 described above.
  • the polyurethane gel elastic body, the shape-retaining material 1d, and the covering layer 1e have been described in detail at the mounting spacers 1 and 10, and thus the description thereof is omitted here.
  • the mounting spacer 11 is mounted on the ultrasonic diagnostic probe in the following manner. That is, with the covering layer 1e of the mounting spacer 11 facing outside, the center probe tip covering portion 1a is brought into close contact with the tip 2a of the ultrasonic diagnostic probe 2 as shown in FIGS. Either the front or back of the ultrasonic diagnostic probe 2 while covering the tip 2a and bending the adhesive fixing portion 1b without the arm portions 1f, 1f following the undulating shape of the ultrasonic diagnostic probe 2 Adhere to one side. Then, the adhesive fixing portion 1b having the arm portions 1f, 1f is adhesively fixed to the opposite surface of the ultrasonic diagnostic probe 2 while being bent following the undulating shape of the ultrasonic diagnostic probe 2, and bifurcated.
  • the arm portions 1f and 1f are hooked on the shoulder portions 2d and 2d of the ultrasonic diagnostic probe 2 to be adhesively fixed, and the tip portions of the arm portions 1f and 1f are further fixed to the side without the arm portion.
  • the adhesive fixing portion 1b is overlapped and adhesively fixed, the mounting spacer 11 can be securely mounted on the ultrasonic diagnostic probe 2.
  • the mounting spacer 11 has bifurcated arms 1f and 1f on both shoulders of the ultrasonic diagnostic probe 2 in addition to the function and effect of the mounting spacers 1 and 10 according to the above embodiment. Since it is mounted in a worn state, the ultrasonic diagnostic probe 2 having a small adhesive fixing area can be reliably mounted without causing a positional shift.
  • the ultrasonic diagnostic probe 2 of the present invention has an ultrasonic diagnostic probe at the probe tip covering portion 1 a of the mounting spacer 1, 10, or 11. Covers the tip 2a of the touch element 2, and the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extension portions 1c and 1c or the arm portions 1f and 1f) of the mounting spacer 1, 10 or 11 for ultrasonic diagnosis
  • the adhesive fixing portions 1b and 1b adheresive fixing portions including the extension portions 1c and 1c or the arm portions 1f and 1f
  • the ultrasonic diagnostic probe 2 of the present invention has an ultrasonic diagnostic probe at the probe tip covering portion 1 a of the mounting spacer 1, 10, or 11. Covers the tip 2a of the touch element 2, and the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extension portions 1c and 1c or the arm portions 1f and 1f) of the mounting spacer 1, 10 or 11 for ultrasonic diagnosis
  • a thin thickness of 0.3 to 15 mm preferably 0.3 to 10 mm,
  • FIG. 10 is a plan view of a mounting spacer according to still another embodiment of the present invention
  • FIG. 11 is a longitudinal sectional view of the mounting spacer
  • FIG. 12 is an ultrasonic diagnostic probe mounted with the mounting spacer. It is a side view.
  • the mounting spacer 12 shown in FIGS. 10 and 11 is made of a polyurethane gel elastic body having the same adhesiveness as the mounting spacers 1, 10, and 11, and has a probe tip covering portion at the center.
  • the thickness D2 of the adhesive fixing portions 1b and 1b (adhesive fixing portions including the extending portions 1c and 1c) provided on both sides is thinner than the thickness D1 of 1a.
  • One side of the covering portion 1a (the lower surface in FIG. 11) and one side of the adhesive fixing portions 1b and 1b (the lower surface in FIG. 11) are flush with each other, and the probe tip covering portion 1a is on the opposite side (the upper surface in FIG. 11). Side) and has a flat convex cross-sectional shape.
  • the thickness D1 of the probe tip covering portion 1a is not particularly limited, but if it is too thick, it becomes difficult to obtain a clear ultrasonic diagnostic image, and the mountability of the spacer 12 also deteriorates. Therefore, it is preferable to set the thickness to about 2 to 20 mm. A more preferable thickness of the probe tip covering portion 1a is 3 to 10 mm. However, in the case of diagnosing the vicinity of the body surface by attaching the spacer 12 to the probe of the ultrasonic diagnostic apparatus having a low frequency of 1.5 to 3.5 MHz, the probe tip covering portion 1a is thicker than the above. Since the spacer 12 may be necessary, in this case, the thickness D1 of the probe tip covering portion 1a is preferably set to about 30 mm.
  • the thickness D2 of the adhesive fixing portions 1b, 1b including the extending portions 1c, 1c is not particularly limited as long as it is thinner than the thickness D1 of the probe tip covering portion 1a, but if it is too thin, the adhesive fixing portions 1b, 1b
  • the thickness of the spacer is larger than 15 mm, the flexibility and flexibility of the adhesive fixing portions 1b and 1b are reduced, and the ultrasonic spacer is used for ultrasonic diagnosis. Since it becomes difficult to bend and deform following the undulating shape of the outer surface of the probe 2 and the mounting property of the mounting spacer 12 to the ultrasonic diagnostic probe 2 is lowered, as shown in the data of the examples described later. It is preferable to set the thickness to 0.3 mm or more and less than 10 mm. A more preferable thickness of the adhesive fixing portions 1b and 1b is 0.5 to 5 mm.
  • the mounting spacer 12 in which the thickness D2 of the adhesive fixing portions 1b, 1b including the extending portions 1c, 1c is thinner than the thickness D1 of the probe tip covering portion 1a is adhesively fixed.
  • the flexibility and flexibility of the parts 1b and 1b and the extending parts 1c and 1c are improved, and the adhesive fixing parts 1b and 1b and the extending parts 1c and 1c are undulated on the front and rear surfaces of the ultrasonic diagnostic probe 2. Since it can be adhered and fixed in close contact with the shape, the mounting property and fixing strength of the spacer 12 are improved.
  • the upper surface of the probe tip covering portion 1 a that is, the contact surface 1 g with the tip 2 a of the ultrasound diagnostic probe 2 is formed on the tip 2 a of the ultrasound diagnostic probe 2. It is preferable to form a concave curved surface corresponding to the convex curved surface, and in this way, the tip 2a of the ultrasonic diagnostic probe 2 is fitted into the contact surface 1g of the probe tip covering portion 1a without any gap. Because of the close contact, a clear ultrasonic diagnostic image is obtained, and the mounting stability of the mounting spacer 12 is improved.
  • the contact surface 1g of the probe tip covering portion 1a is a flat surface, the tip end of the ultrasonic diagnostic probe 2 is elastically deformed while the probe tip covering portion 1a made of a polyurethane gel elastic body is elastically deformed. Needless to say, a clear ultrasonic diagnostic image can be obtained because it adheres closely to 2a.
  • the probe tip covering portion 1a may be formed so as to protrude from both the upper and lower surfaces like the mounting spacer 13 shown in FIG. 15.
  • the mounting spacer 13 is used as the probe for ultrasonic diagnosis.
  • the step-shaped boundary 1h between the probe tip covering portion 1a and the adhesive fixing portions 1b and 1b, particularly, the opposite side (body surface side) of the tip 2a of the ultrasound diagnostic probe 2 It is difficult to say that there is no possibility of causing a crack or the like in the boundary portion 1h located at the position.
  • the mounting spacer 12 shown in FIG. 11 covers the tip 2a of the ultrasound diagnostic probe 2 with the protruding portion of the probe tip covering portion 1a inside as shown in FIG.
  • the stepless boundary portion 1i where the cracks are difficult to occur is formed on the outside (body surface side). Since the step-like boundary portion 1h between the child tip covering portion 1a and the adhesive fixing portion 1b, 1b is on the inner side, no tearing force acts on the inner boundary portion 1h, so that the occurrence of cracks and the like can be prevented. There are advantages.
  • the thickness of the boundary portion 1h is decreased from the probe tip covering portion 1a side to the adhesive fixing portion 1b side so that the surface of the step-like boundary portion 1h between 1a and the adhesive fixing portion 1b, 1b becomes a concave curved surface
  • the thickness of the boundary portion 1h is changed from the probe tip covering portion 1a side so that the surface of the stepped boundary portion 1h becomes a slope (preferably a 45 ° slope). It is preferable to decrease toward the adhesive fixing part 1b side.
  • the thickness of the probe tip cover portion 1a In the case where the probe tip cover portion 1a protrudes up and down from both the upper and lower surfaces of the adhesive fixing portions 1b and 1b as in the mounting spacer 13 shown in FIG. 15, the thickness of the probe tip cover portion 1a. It is preferable that D1 and the thickness D2 of the adhesive fixing portions 1b and 1b are set within the above-described range, and the upper step size D3 and the lower step size D4 are set to be the same.
  • the mounting spacer 12 shown in FIGS. 10 and 11 is mounted on the ultrasonic diagnostic probe 2 as shown in FIG. 12, that is, the lower surface where the probe tip covering portion 1a does not protrude.
  • the covering layer 1e such as the above-described synthetic resin film (reducing adhesiveness) is formed on the entire outer surface on the body surface side like the mounting spacer 14 shown in FIG.
  • the shape-retaining materials 1d and 1d such as the above-mentioned nonwoven fabric may be embedded in the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c.
  • the covering layer 1e may be extended to both sides of the mounting spacer 14 to cover both sides, and when the expansion and contraction of the mounting spacer 14 is appropriately suppressed by the coating layer 1e,
  • the shape retaining materials 1d and 1d may be omitted.
  • the mounting spacer 12 in which the probe tip covering portion 1a protrudes from one side is attached to the ultrasonic diagnostic probe 2 with the protruding portion of the probe tip covering portion 1a inside.
  • gaps G and G having a substantially triangular cross section are formed between the mounting spacer 12 and the ultrasonic diagnostic probe 2 on both sides of the probe tip covering portion 1a.
  • the gel applied to the gaps G and G penetrates into the gaps G and G, and adhesion of the mounting spacer 12 to the ultrasonic diagnostic probe 2 may be hindered by the entered gel.
  • a device devised so as to eliminate this fear is a mounting spacer 15 shown in FIGS. 17 (a) and 17 (b).
  • the mounting spacer 15 shown in FIGS. 17A and 17B includes a central probe tip covering portion 1a having a large thickness and adhesive fixing portions 1b and 1b having a small thickness on both sides thereof.
  • the adhesive fixing portion including the protruding portions 1c and 1c is integrally formed of a polyurethane gel elastic body having the same composition, and the outer surface (body surface side) of the mounting spacer 15 where the probe tip covering portion 1a does not protrude.
  • a synthetic resin film is laminated as a coating layer 1e that reduces or eliminates the adhesiveness from the lower surface to the both side surfaces, and the probe tip is coated at the center of the rising portions on both sides of the coating layer 1e (synthetic resin film).
  • the inverted trapezoidal fins 10e and 10e are formed integrally so as to cover both side surfaces of the portion 1a.
  • such a mounting spacer 15 has a coating layer 1e on the outside, covers the tip 2a of the ultrasonic diagnostic probe 2 with the probe tip covering portion 1a, and adheres to the adhesive fixing portion.
  • 1b, 1b and the extension portions 1c, 1c are adhesively fixed while being bent and deformed following the undulating shapes of the front and rear surfaces of the ultrasonic diagnostic probe 2, and the probe tip covering portion is provided by the fins 10e, 10e.
  • the ultrasonic diagnostic probe 2 is mounted in a state in which both side surfaces of 1a, both side openings of the gaps G and G, and both side surfaces of the distal end portion of the ultrasonic diagnostic probe 2 are covered.
  • the penetration of the gel applied to the body surface at the time of ultrasonic diagnosis into the gaps G and G is blocked by the fins 10e and 10e. Therefore, the ultrasonic diagnostic probe 2 of the mounting spacer 15 by the penetration of the gel. The fear that the adhesion to may be hindered can be eliminated. If the inner surfaces of the fins 10e and 10e are adhesive surfaces and the fins 10e and 10e are adhesively fixed to both side surfaces of the distal end portion of the ultrasonic diagnostic probe 2, the fins 10e and 10e will not swell, and the gel can be more reliably invaded. This is preferable.
  • a gel-repellent resin coating layer may be formed on both sides of the mounting spacer 15 as the covering layer 1e.
  • the gel is repelled by the resin coating layer and enters the gaps G and G. This makes it difficult to eliminate the possibility that the adhesion of the mounting spacer 15 to the ultrasonic diagnostic probe 2 due to the penetration of the gel may be hindered.
  • the mounting spacer 15 does not embed a shape-retaining material in the adhesive fixing portions 1b and 1b (adhesive fixing portion including the extending portions 1c and 1c), but embeds a shape-retaining material as necessary. Needless to say.
  • the probe tip covering portion 1a and the adhesive fixing portions 1b and 1b including the extending portion 1c are formed of a polyurethane gel elastic body having the same composition.
  • the probe tip covering portion 1a and the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c are made of polyurethane gel elastic bodies having different compositions. May be formed.
  • the probe tip covering portion 1a is formed of a polyurethane gel elastic body having a composition containing a glyme compound having a small OH / NCO ratio, and adhesive fixing portions 1b and 1b including the extending portions 1c and 1c.
  • the mounting spacer 16 includes the fixing portions 1b and 1b (adhesive fixing portions including the extending portions 1c and 1c).
  • the catalyst having the alkylene oxide chain of the structural formulas 1 to 4 and / or the polyurethane polyol prepolymer having the alkylene oxide chain is added to the catalyst.
  • the glyme compound of the structural formula 15 are mixed.
  • this mixture and the polyurethane polyisocyanate prepolymer having an alkylene oxide chain of the structural formulas 5 to 9 are mixed, defoamed, and the ratio of OH / NCO is 1.2 to 2.4.
  • a liquid mixed material having a composition in which the content is adjusted to 70% by mass or less is obtained.
  • the glyme compound may be omitted.
  • the liquid mixed material is injected into the deployable rectangular parallelepiped box-shaped container 3 for forming the probe tip covering portion so as to have a predetermined thickness.
  • the probe tip covering portion 1a made of a polyurethane gel elastic body is formed, the box-shaped container 3 is developed, and the probe tip covering portion 1a is taken out.
  • a release film (release film) 1j is laid on the inner bottom surface of the deployable square dish-shaped container 4, and the above-mentioned probe tip covering portion 1a is placed at the center thereof.
  • the liquid mixed material is poured into the dish-shaped container 4 so as to have a predetermined thickness (thickness smaller than the probe tip covering portion 1a), and is similarly reacted at 60 ° C. for about 24 hours.
  • a rectangular polyurethane gel elastic body sheet 1k thinner than the probe tip cover portion 1a is formed integrally with the probe tip cover portion 1a.
  • the dish-shaped container 4 is unfolded and the release film 1m is overlaid on the upper surface of the polyurethane gel elastic body sheet 1k around the probe tip covering portion 1a, the molded product of this polyurethane gel elastic body is used as the dish-shaped container 4. Take out from.
  • this polyurethane gel elastic product is punched into a planar shape of a mounting spacer as shown in FIG. 20 (c), and a rectangular shape as shown by a virtual line on the surface of the probe tip covering portion 1a.
  • the release film 1n By superposing the release film 1n, the entire outer surface (lower surface) on the body surface side is covered with the release film 1j, and the inner surfaces (upper surface) of the adhesive fixing portions 1b and 1b including the extending portion 1c and the tip of the probe A mounting spacer 12 is obtained in which the inner surface (upper surface) of the covering portion 1a is covered with release films 1m and 1n, respectively.
  • Each of the release films 1j, 1m, and 1n is peeled and removed when the mounting spacer 12 is mounted on the ultrasonic diagnostic probe 2. Note that the release films 1j, 1m, and 1n may be omitted.
  • the mounting spacer 13 shown in FIG. 15 uses a dish-shaped container in which a recess is formed in the center of the inner bottom surface in the manufacturing method described above, and a release film is formed on the bottom surface of the recess and the inner bottom surface of the dish-shaped container.
  • the lower portion of the probe tip covering portion 1a is fitted into the concave portion, and the liquid mixed material is injected into the dish-shaped container and allowed to react. Thereafter, the manufacturing may be performed in the same manner as described above.
  • the mounting spacer 14 shown in FIG. 16 has a synthetic resin film serving as the covering layer 1e instead of the release film 1j laid on the inner bottom surface of the dish-shaped container 4, and a probe at the center thereof.
  • the tip covering portion 1a is installed to inject the liquid mixed material, and the shape holding material 1d is embedded around the probe tip covering portion 1a in the course of the injection to react the liquid mixed material. What is necessary is just to manufacture similarly.
  • the mounting spacer 16 shown in FIG. 19 is prepared by preparing two types of liquid mixed materials having different compositions, and in the manufacturing method described above, the probe tip covering portion 1a formed with one liquid mixed material is used as a release film. Is placed in the center of the inner bottom surface of the dish-shaped container 4 and the other liquid mixed material is poured into the dish-shaped container 4 and reacted, and thereafter, the same process as described above may be performed.
  • the mounting spacer 15 shown in FIG. 17 has a slightly wide synthetic resin film (covering layer 1e) having fins 10e and 10e on both sides on the inner bottom surface of a shallow spacer mold, and both side edges thereof are formed on the mold.
  • the probe tip covering portion 1a formed in advance is placed at the center of the synthetic resin film, and the liquid mixed material is deposited to a predetermined thickness (from the probe tip covering portion 1a). (Thin thickness) may be injected, reacted, and removed from the mold.
  • the above mounting spacers 12, 13, 14, 15, 16 are all made of a polyurethane gel elastic body, and the probe has the thickness D2 of the adhesive fixing portions 1b, 1b including the extending portions 1c, 1c.
  • the tip covering portion 1a thinner than the thickness D1
  • the flexibility of the adhesive fixing portions 1b, 1b and the extending portions 1c, 1c is enhanced.
  • the polyurethane gel elastic body has an Asker F-type hardness meter by adjusting the ratio of OH / NCO, the type and length (molecular weight) of alkylene oxide, and appropriately containing a glyme compound.
  • the adhesiveness is controlled so that the torque value in the rheometer is 7.0 to 520 g. It has flexibility and adhesiveness that are extremely suitable for mounting spacers. Therefore, these mounting spacers 12, 13, 14, 15, and 16 are used for the ultrasonic diagnostic probe at the probe tip covering portion 1 a even if the outer shape of the ultrasonic diagnostic probe 2 is slightly different.
  • the tip 2a of the child 2 is covered, and the adhesive fixing portions 1b and 1b and the extending portions 1c and 1c are in close contact with each other while flexibly deforming by following the undulating shape of the front and rear surfaces of the ultrasonic diagnostic probe 2.
  • the ultrasonic diagnostic probe 2 can be easily and reliably mounted without using an attachment member. Accordingly, these mounting spacers 12, 13, 14, 15, and 16 are all versatile, and there is no fear of giving a feeling of pressure by the lower end portion of the mounting member as in the mounting spacer of Patent Document 1.
  • the thickness D2 of the adhesive fixing portions 1b and 1b including the extending portion 1c is made thinner than the thickness D1 of the probe tip covering portion 1a, the ultrasonic diagnostic probe 2 can be easily gripped. Operability is also improved.
  • the polyurethane gel elastic body does not grow germs even if it does not contain a glyme compound, it does not cause skin irritation, it is safe to use for a long time, and it has excellent water resistance. Many effects are obtained, such as no deterioration due to moisture on the body surface.
  • the ultrasonic diagnostic probe 2 of the present invention does not give a feeling of pressure like scouring at the time of diagnosis, and is less than 10 MHz or 10 MHz. While oscillating the above high-frequency ultrasonic waves, it is possible to obtain a clear ultrasonic diagnostic image of the blood flow state and tissue state of a living body and accurately observe and diagnose it.
  • a non-woven fabric of synthetic resin fibers (Sontara # 8005 manufactured by DuPont) as a shape-retaining material is laid at a predetermined interval on the inner bottom surface of the shallow dish-shaped container, and each liquid mixed material is placed in a dish-shaped container by 5 mm. Then, the polyurethane gel elastic body is taken out of the dish-shaped container and a polyethylene film having a thickness of 10 ⁇ m serving as a coating layer is deposited thereon. Is punched into the spacer shape shown in FIG. 1, and the six types of mounting spacers (No. 1) in which the probe tip covering portion and the adhesive fixing portion have the same thickness of 5 mm and the ratio of the polyisocyanate component to the polyol component is different. To No. 6) were prototyped.
  • 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.
  • ⁇ the one that does not peel off from the probe over time
  • x the probe is bent following the probe.
  • the spacer does not shift during use, so that the use is not hindered.
  • the blending amount of the polyisocyanate component is 35 Part mounting spacer No. No. 1 is difficult to exfoliate because of excessive tackiness, and the mounting amount of the polyisocyanate component is 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.
  • the polyisocyanate component is in the range of 40 to 70 parts.
  • the mounting 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 to 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.
  • 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.
  • the material mixture is poured into a dish-shaped container to a thickness of 0.3 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 By removing the polyurethane gel elastic body and punching it into the spacer shape shown in FIG. 1, six types of mounting spacers (probe tip coverings) having different thicknesses without the shape-retaining material and the covering layer (synthetic resin film) are obtained. And the adhesive fixing part have the same thickness).
  • These mounting spacers were examined for followability in the same manner as the followability test for the ultrasonic diagnostic probe described above, and were similarly evaluated with “ ⁇ ”, “ ⁇ ”, and “ ⁇ ”. Table 2 below describes the spacer thickness and evaluation.
  • the mounting spacers of 5 mm or less can be obtained, and the followability is “ ⁇ ”, which 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 closely It is. From this, it can be said that the thickness suitable for the mounting spacer is 0.3 to 15 mm, the preferred thickness is 0.3 to 10 mm, and the more preferred thickness is 0.3 to 5 mm.
  • the thickness D1 of the probe tip covering portion 1a is set as follows. As shown in Table 3, the thickness D2 of the adhesive fixing portions 1b and 1b including the extending portions 1c and 1c is changed to 0.3 to 8 mm as shown in Table 3 below. 11 types of mounting spacers (No. 7 to No. 17) with different thicknesses of D1 and D2 were made as prototypes by changing within the range. Further, by using the above-mentioned liquid mixed material, the mounting spacer having the shape shown in FIG. 15 and having the dimensions D1, D2, D3, and D4 shown in Table 3 by the above-described manufacturing method is used. No.
  • a mounting spacer No. 19 having the shape shown in FIGS.
  • the probe tip covering part of the mounting spacer With the protruding part of the probe tip covering part of the mounting spacer (No. 8 to No. 18) inside, the probe tip covering part is an ultrasonic diagnostic probe (manufactured by Toshiba Medical Systems Co., Ltd.). , Part number PLT-805AT) is adhered to the tip and covered, and the adhesive fixing part and the extension part are adhesively fixed to the front and back surfaces of the ultrasonic diagnostic probe, so that each mounting spacer (No. 8 to No. 18) are mounted on the ultrasonic diagnostic probe, and (1) the adhesive fixing part and the extending part of the mounting spacer follow the contoured shape of the front and rear surfaces of the ultrasonic diagnostic probe.
  • an ultrasonic diagnostic probe manufactured by Toshiba Medical Systems Co., Ltd.
  • the mounting spacers (No. 7 to No. 18) in which the thickness D2 of the adhesive fixing part including the extension part is smaller than the thickness D1 of the probe tip covering part and in the range of 0.3 to 8 mm are as follows. As shown in FIG. 3, it is easy to wear, and can be securely fixed and adhesively peeled off while the adhesive fixing part and the extension part are bent and deformed following the undulating shape of the front and rear surfaces of the ultrasonic diagnostic probe. The installation and exfoliation work could be repeated without any problems. Further, even when the distance of about 10 cm was reciprocated 30 times while pressing the probe tip covering portion against the body surface, the mounting spacer did not shift, but the thickness D2 of the adhesive fixing portion including the extending portion was 0.
  • the mounting spacer No. 13 with the thinnest thickness of 3 mm tended to be displaced. From this, it can be determined that the lower limit of the thickness D2 of the adhesive fixing portion including the extending portion is about 0.3 mm.
  • the mounting spacer No. 19 in which the thickness D1 of the probe tip covering portion and the thickness D2 of the adhesive fixing portion including the extension portion are both 10 mm has poor mounting properties as shown in Table 3. As described in the remarks column, it was difficult to follow the undulating shapes of the front and rear surfaces of the ultrasonic diagnostic probe.
  • the mounting spacer No. 17 in which the thickness D2 of the adhesive fixing portion including the extending portion is 8 mm has good mounting properties, and the adhesive fixing portion and the extending portion are arranged on the front and rear surfaces of the ultrasonic diagnostic probe. It was possible to adhere to and fix the undulating shape of the film. From this, in the mounting spacer made of the polyurethane gel elastic body having the above composition, it can be estimated that the upper limit of the thickness D2 of the adhesive fixing portion including the extending portion is about 9 mm.
  • glycerin which is a polyisocyanate component.
  • Liquids with various blending ratios of triisocyanate (Mw 3100) having a polyether polyol obtained by reacting it with hexamethylene diisocyanate in the segment and tetraglyme (tetraethylene glycol dimethyl ether) as a glyme compound.
  • the mixed material was poured into a container and allowed to react at 60 ° C.
  • each of the above samples (samples other than No. 1, No. 14, No. 22, and No. 23) having a hardness by an Asker F hardness meter of 16 or more and a hardness by an Asker C2 type hardness meter of 15 or less;
  • Both mounting spacers with the same composition (the probe tip covering part and adhesive fixing part are 5 mm thick) follow the undulation shape of the front and rear surfaces of the ultrasonic diagnostic probe with the adhesive fixing part.
  • the adhesive can be securely fixed while being bent and deformed without being peeled off naturally.
  • the mounting operation and the exfoliation operation can be repeated without any problem.
  • the distance of about 10 cm can be set to 30 while pressing the probe tip covering portion against the body surface. There was no displacement of the mounting spacer even when reciprocating.
  • the mounting spacer of the same composition as No. 23 (the probe tip covering part and the adhesive fixing part having a thickness of 5 mm) is too soft, so the distance of about 10 cm while pressing the probe tip covering part against the body surface When the sample is reciprocated, the spacer is easily displaced.
  • the mounting spacer of the same composition as No. 1 (the probe tip covering part and the adhesive fixing part is 5 mm in thickness) is too hard, so the adhesive fixing part is undulated on the front and rear surfaces of the ultrasonic diagnostic probe. It was difficult to fix the adhesive while bending and following the above.
  • glycerin which is a polyisocyanate component.
  • Liquids with various blending ratios of triisocyanate (Mw 3100) having a polyether polyol obtained by reacting it with hexamethylene diisocyanate in the segment and tetraglyme (tetraethylene glycol dimethyl ether) as a glyme compound.
  • the mixed material is sandwiched between a metal flat plate and a glass plate on which a PET film is pasted, reacted at 60 ° C.
  • a cylindrical jig (weight: 10 g) made of SUS304 is attached to the upper chuck of a rheometer (NRM-3002D manufactured by Rheotech), and the flat plate on which the above sample is prepared is fixed to the lower chuck.
  • NEM-3002D manufactured by Rheotech
  • the lower chuck is lowered at a speed of 50 mm / min from the upper surface of the sample.
  • the maximum load (torque value) when peeling the jig was measured as the adhesive strength. No. 24-No.
  • the adhesive strength of each of the 32 samples is shown in Table 5 below.
  • the polyurethane gel when peeled off It can be seen that the maximum load (torque value) of the elastic body can be set to 7.0 to 520 g, and the adhesiveness of the polyurethane gel elastic body can be controlled to fit the mounting spacer.
  • the mounting spacer (the probe tip covering part and the adhesive fixing part have the same thickness as the above samples (No. 24 to No. 32) having a maximum load (torque value) of 7.0 to 520 g. 5mm) can be securely fixed to the adhesive fixing part while bending and deforming following the undulations on the front and rear surfaces of the ultrasonic diagnostic probe, and will not peel off naturally.
  • the exfoliation work could be repeated without problems.
  • the mounting spacer according to the present invention has excellent mountability to an ultrasonic diagnostic probe, and since there is no feeling of pressure such as scouring at the time of diagnosis, it is possible to receive an ultrasonic diagnosis with peace of mind.
  • an ultrasonic diagnostic image of a good biological tissue or the like can be obtained accurately even when attached to an ultrasonic diagnostic probe with a high frequency of 10 MHz or higher. Therefore, it is more useful than a conventional mounting spacer and has a large industrial applicability.
  • Probe tip covering portion 1,10,11,12,13,14,15,16 Mounting spacer 1a Probe tip covering portion 1b Adhesive fixing portion 1c Extension portion 1d Shape holding material 1e Coating layer 1f Arm portion 1h Probe tip covering portion Step-like boundary between the adhesive fixing part and the probe 2 Ultrasonic diagnostic probe 2a Probe tip 2b Probe neck 2d Probe shoulder D1 Thickness of probe tip covering D2 Thickness of adhesive fixing part

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PCT/JP2012/070300 2012-08-09 2012-08-09 Écarteur pour montage d'une sonde de diagnostic à ultrasons Ceased WO2014024286A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112351741A (zh) * 2018-06-25 2021-02-09 皇家飞利浦有限公司 具有移动式散热器和线缆应变消除件的超声探头

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02243137A (ja) * 1989-03-17 1990-09-27 Toyo Medical Kk 超音波探触子用接触端子
JPH02504356A (ja) * 1988-08-30 1990-12-13 富士通株式会社 超音波カプラ
EP0800788A1 (fr) * 1996-04-10 1997-10-15 Lec Tec Corporation Feuille solide de transmission d'ultrasons biomédicaux
US6132378A (en) * 1998-08-10 2000-10-17 Marino; Sharon Cover for ultrasound probe
JP2001507603A (ja) * 1996-12-31 2001-06-12 ダイアグノスティック・ウルトラサウンド・コーポレーション 医療用超音波装置と共に用いる結合パッド
US20030149359A1 (en) * 2002-02-07 2003-08-07 Smith Larry L. Adhesive hydrophilic membranes as couplants in ultrasound imaging applications
US20050288581A1 (en) * 2004-06-29 2005-12-29 Ajay Kapur Acoustic coupling gel for combined mammography and ultrasound image acquisition and methods thereof
WO2008135011A2 (fr) * 2007-05-03 2008-11-13 3Mach Gmbh Revêtement et gaine
WO2009077176A1 (fr) * 2007-12-19 2009-06-25 Udo Heisig Gmbh Revêtement de films tubulaires pour appareils médicaux

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02504356A (ja) * 1988-08-30 1990-12-13 富士通株式会社 超音波カプラ
JPH02243137A (ja) * 1989-03-17 1990-09-27 Toyo Medical Kk 超音波探触子用接触端子
EP0800788A1 (fr) * 1996-04-10 1997-10-15 Lec Tec Corporation Feuille solide de transmission d'ultrasons biomédicaux
JP2001507603A (ja) * 1996-12-31 2001-06-12 ダイアグノスティック・ウルトラサウンド・コーポレーション 医療用超音波装置と共に用いる結合パッド
US6132378A (en) * 1998-08-10 2000-10-17 Marino; Sharon Cover for ultrasound probe
US20030149359A1 (en) * 2002-02-07 2003-08-07 Smith Larry L. Adhesive hydrophilic membranes as couplants in ultrasound imaging applications
US20050288581A1 (en) * 2004-06-29 2005-12-29 Ajay Kapur Acoustic coupling gel for combined mammography and ultrasound image acquisition and methods thereof
WO2008135011A2 (fr) * 2007-05-03 2008-11-13 3Mach Gmbh Revêtement et gaine
WO2009077176A1 (fr) * 2007-12-19 2009-06-25 Udo Heisig Gmbh Revêtement de films tubulaires pour appareils médicaux

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112351741A (zh) * 2018-06-25 2021-02-09 皇家飞利浦有限公司 具有移动式散热器和线缆应变消除件的超声探头

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