WO2016031001A1

WO2016031001A1 - Instrument for aiding ultrasound-guided body surface puncture

Info

Publication number: WO2016031001A1
Application number: PCT/JP2014/072494
Authority: WO
Inventors: 中奥村
Original assignee: 中奥村
Priority date: 2014-08-27
Filing date: 2014-08-27
Publication date: 2016-03-03

Abstract

A dressing material (10) has a shape and size that completely covers a prescribed covering area including at least the leading end of the head section (102) of an ultrasound probe (100) and forms a flexible film at a chosen position, one surface being provided with a pressure sensitive-adhesive layer (12). A guide section (30) has guide holes (H1-H5) for linearly guiding a puncture needle in prescribed directions, and when in a state of use in which the covering area of the ultrasound probe (100) is covered by the dressing material (10) on the other surface of the dressing material (10), is fixed to an area that is disposed on the side surface of the head section (102). Furthermore, the guide holes (H1-H5) are formed so that when used, the direction of insertion of the puncture needle guided by the guide holes (H1-H5) is a prescribed insertion direction that corresponds to the depth of a target area (TG) in a subject's body.

Description

Echo lower body surface puncture aid

TECHNICAL FIELD The present invention relates to an auxiliary device for echocardiographic surface puncture used for assisting a puncture procedure in puncture of a body surface under an echo, and in particular, puncture by attaching to an ultrasonic probe in puncture aspiration cytology under an echo. The present invention relates to an auxiliary device for echocardiographic surface puncture suitable for use in assisting a suction technique.

As a pathological diagnosis in medical institutions, puncture aspiration cells can be used in areas such as otolaryngology, head and neck surgery, mammary gland endocrine surgery, etc., because cells collected from the lesion of the subject can be confirmed in a form close to the tissue type The diagnosis of Fine Needle Aspiration Cytology (FNAC) has become widespread. This puncture aspiration cytology has been established as an indispensable examination method for distinguishing benign and malignant for goiter, for example, because it can be repeatedly performed with minimal invasiveness. In this puncture cytodiagnosis, a doctor may puncture under palpation. However, since the puncture needle needs to be accurately inserted into the target site (lesion), the image resolution of the ultrasonic examination apparatus is reduced. Along with the improvement, there is also a large proportion of ultra-guided aspiration cytology under ultrasound (also called “under ultrasound guide” or “under echo guide”). It has become. On the other hand, even when the puncture needle is inserted toward the lesion while visually checking the echo image, since the echo image is two-dimensional, the puncture needle may not advance in the direction intended by the doctor. Skill is required to accurately insert the puncture needle into the target site of the lesion. In particular, in the case of cytodiagnosis of thyroid mass, since the puncture needle is inserted from the neck of the subject, the puncture needle is advanced to avoid the blood vessels and nerves of the neck and so on to the lesion. Techniques for accurate insertion are required. Therefore, in conventional echo-puncture aspiration cytology, a puncture guide device is attached to an ultrasonic probe (ultrasonic probe) of an ultrasonic diagnostic device as an auxiliary device, and the puncture needle of the puncture device is provided by the puncture guide device. Can be inserted from the body surface of the subject while guiding the needle, and the position of the needle tip of the puncture needle in the body surface portion of the subject can be confirmed with an echo image while avoiding blood vessels or the like to reach the target site Has been done.

As an invention relating to the puncture guide device as described above (that is, the guide device corresponding to the “echo lower body surface puncture auxiliary device” of the present invention), the invention described in Patent Document 1 (Applicant: Shibuco Medical Instruments) Company Incorporated, title of invention: puncture instrument guide system), invention described in Patent Document 2 (Applicant: Toshiba Corporation and Toshiba Medical Systems Corporation, title of invention: puncture needle adapter), Patent Document 3 There is an invention (applicant: Hitachi Medical Corporation, title of invention: puncture guide bracket).

Special table 2011-505277 gazette JP 2007-130399 A JP 2009-291387 A

As described above, echohypophyseal surface puncture is typically used in cytology for pathological diagnosis of mass changes in the thyroid and mammary glands, and as described above, the ultrasound probe used at that time is punctured. A guide device for wearing is attached to guide the insertion of the puncture needle. The conventional puncture guide device basically includes the puncture guide devices of Patent Documents 1 to 3, and a holding unit as an adapter that provides a function of mounting the ultrasonic probe at a predetermined position (for example, Patent Document 1). 1 and the adapter 22 of the guide system 20 for puncture shown in FIG. 1 and the like, and a guide portion as an attachment that is integrally connected to the holding portion and provides a guide function for guiding the puncture needle (for example, Patent Documents) 1 and the needle guide 24) shown in FIG. In addition, in each of the conventional puncture guide devices, the holding portion and the guide portion are each formed into a rigid body having a predetermined shape with a highly rigid material such as synthetic resin or metal, and the guide portion is further guided. The part is formed with a passage hole (for example, a linear passage 52 shown in FIG. 4 of Patent Document 1) for linearly inserting the puncture needle and restricting the traveling direction thereof. Further, in the conventional guide device for puncture, the holding portion is provided with a connection structure for securely mounting and fixing the ultrasonic probe (so as not to be displaced), and the holding portion further includes a guide portion. By providing a connection structure for securely mounting (not misaligning) and fixing, the holding portion and the guide portion reliably perform their functions. In addition, in the conventional echo lower body surface puncture, with the holding portion of the puncture guide device attached to the ultrasonic probe, the ultrasonic blow portion and the entire holding portion of the puncture guide device are made of a flexible film or the like. A bag-like probe cover (for example, the sterilization cover 12 shown in FIG. 1 of Patent Document 1) is completely covered so that the ultrasonic probe or the like is not contaminated by body fluids or the like during puncturing. This is because the ultrasonic probe is a very expensive medical device, and it is necessary to ensure that the ultrasonic probe can be used repeatedly for a certain long period of time. One of the reasons is that it is necessary to ensure that the probe can be used repeatedly over an appropriate period of time because it is a special purpose device dedicated to the probe, and is therefore somewhat expensive.

[Problems of conventional guide device for puncture]
Therefore, the conventional puncture guide device, including the puncture guide devices of Patent Documents 1 to 3, has a room for improvement in terms of being inconvenient due to the large structure as a whole. Since the puncture guide device has a large structure, it is difficult to confirm the puncture line, and there is room for improvement in terms of further improving safety.

[Problem 1: Puncture accuracy]
Specifically, first, a conventional puncture guide device has a holding portion attached to the distal end portion of an ultrasonic probe, and a puncture needle is inserted into a passage hole of a guide portion connected to the holding portion to puncture the puncture needle. The insertion angle is regulated to a predetermined setting angle, and the puncture depth (and the travel path) of the puncture needle is changed and adjusted by changing the insertion angle. For example, in a conventional puncture guide device, a plurality of types of guide portions (for example, as shown in FIG. 13 of Patent Document 1) in which passage holes for providing different insertion angles when mounted on an ultrasonic probe are used as guide portions. Seven needle guides 24A, 24B, 24C, 24D, 24E, 24F, and 24G) for providing seven different insertion angles are prepared, and the insertion angles corresponding to the required puncture depth are provided. The guide portion to be selected is selected, the guide portion is attached to the holding portion, and the puncture needle is guided along the passage hole of the guide portion (see, for example, FIG. 1 of Patent Document 1). Further, another conventional guide device for puncture is a single guide portion in which a plurality of passage holes providing different insertion angles when mounted on an ultrasonic probe are formed as a guide portion (for example, FIG. As shown in FIGS. 7 to 9, a single wedge-shaped body 140) having four slots 142, 144, 146, and 148 for providing four different insertion angles is prepared and the guide portion is held. A passage hole that is attached to the part and provides a puncture angle corresponding to a required puncture depth is selected, and the puncture needle is guided along the passage hole.

However, since the conventional guide device for puncture employs the above structure, the holding portion has a predetermined thickness, and the mounting position of the guide portion to the holding portion is a position corresponding to the thickness of the holding portion. Therefore, the guide portion is arranged at a position away from the outer surface of the ultrasonic probe (by a distance corresponding to the thickness of the holding portion), and the puncture needle protruding from the lower end opening of the passage hole of the guide portion is From the position away from the outer surface of the ultrasonic probe by a distance corresponding to the thickness of the holding portion, the blood proceeds from the position toward the puncture position of the subject's skin. For example, in the puncture guide device of Patent Document 1, as shown in FIG. 12, the needle advances from a position separated from the outer surface of the ultrasonic transducer 10. In addition, the visual field width of the echo image by the ultrasonic probe is a width corresponding to the installation range of the piezoelectric element inside the head portion of the ultrasonic probe (installation range in the longitudinal direction of the head portion of the ultrasonic probe). In the shallow part of the front part, the extension of the visual field width coincides with the extension of the installation range of the piezoelectric element (that is, a position slightly inside the longitudinal side edges of the head part of the ultrasonic probe). When the tip of the head part of the ultrasonic probe is substantially in contact with the skin of the subject (with a small unit interval corresponding to the coating thickness of the echo jelly), the puncture needle is the head of the ultrasonic probe. The skin of the subject is punctured at a position away from the outer surface of the body, and is inserted into the body surface. For example, in the puncture guide device disclosed in Patent Document 1, the needle is punctured into the skin of the subject at a position away from the outer surface of the ultrasonic transducer 10, as shown in FIG.

Therefore, after the puncture needle is inserted into the subject's skin and before entering the visual field width of the ultrasonic probe, the puncture needle passes through the region of the body surface portion that is not captured by the echo image. The position of the puncture needle (particularly the position of the needle tip) in the part cannot be visually confirmed with an echo image. In other words, the conventional guide device for puncture has a structure in which the monitor of the ultrasonic diagnostic apparatus is inserted between the time when the puncture needle is inserted into the subject and the direction from the subject's skin toward the target site. There is a certain region that cannot be confirmed on the screen (hereinafter referred to as “image unrecognizable region”), and the position of a blood vessel or the like on the advancing path of the puncture needle in the image unrecognizable region cannot be confirmed. However, in order to reliably prevent the puncture needle from coming into contact with an unintended part such as a blood vessel, the puncture needle is punctured into the skin of the subject as close as possible to the visual field width of the ultrasonic probe. It is preferable. Ideally, from the point of time when the puncture needle is punctured into the skin of the subject, it is desirable from the point of view of ensuring safety that the position of the puncture needle can be visually confirmed by an echo image. There is room for improvement in this point. In particular, in the conventional puncture guide device, as the puncture depth becomes larger (that is, as the puncture angle of the puncture needle becomes closer to perpendicular to the skin of the subject), the tip of the puncture needle becomes an echo image. In such a case, it is desirable to minimize the image unrecognizable area as much as possible (ideally zero). In short, the conventional guide device for puncture inevitably has a certain region where the image cannot be confirmed due to its structure, so that the inspection time becomes longer to ensure safety, and there is room for improvement in this respect. In addition, there is room for improvement in terms of puncture accuracy of the puncture needle (accuracy when the puncture needle is inserted into the body from the puncture position of the subject's skin along the desired path toward the target site). There is.

[Problem 2: Inspection range flexibility]
Next, as described above, the conventional guide device for puncture prepares a plurality of guide portions in which passage holes of different angles are formed so that the puncture angle of the puncture needle has a plurality of stages, or a single guide portion. Although a plurality of passage holes having different angles are formed, the insertion angle is selected from the prepared insertion angles, and the range of insertion angles that can be selected is still limited. End up. Therefore, the conventional puncture guide device can obtain only the puncture depth corresponding to the puncture angle prepared in advance, and the examination range is limited according to the puncture angle. Since the puncture depth of the target site (lesion) to be examined varies from subject to subject, the puncture angle of the puncture needle can be changed as much as possible according to the puncture depth of the target site. It is desirable that the conventional guide device for puncture has room for improvement in terms of selection or optionality of the puncture angle.

[Problem 3: Usability]
Next, the conventional puncture guide device is composed of a rigid holding portion and a guide portion made of a rigid body as described above, and the overall configuration is somewhat enlarged when mounted on an ultrasonic probe. If there is an uneven portion at the site, the puncture guide device attached to the ultrasonic probe may interfere with the uneven portion, and depending on the puncture site, the ultrasonic probe can be accurately placed at the intended position. There are cases where it is not possible. For example, in the case of hypochondral surface puncture for a thyroid mass, the puncture position is in the lower third of the neck, but the clavicle is present at that location, so the puncture guide device attached to the ultrasound probe May interfere with the clavicle, and the ultrasound probe may not be accurately positioned at the intended location on the neck. Therefore, in order to prevent such interference at the puncture site and improve the operability of the ultrasonic probe, the puncture guide device is as compact as possible, for example, by minimizing the number of protruding portions from the ultrasonic probe. The configuration is desirable, and the conventional puncture guide device has room for improvement in this respect as well. Further, in the conventional echo lower body surface puncture, as described above, the entire ultrasonic probe and the entire holding portion of the puncture guide device attached to the ultrasonic probe are used for antifouling of the ultrasonic probe. Covered with a large probe cover. Since this probe cover has a considerably larger external dimension than the ultrasonic probe, it will be deployed around the ultrasonic probe, but if the deployment location is on the path of travel of the puncture needle, Even when the probe cover is on the subject's puncture position, the puncture of the puncture needle is hindered, and the probe cover is appropriately pushed to a place where it does not get in the way. The puncture will proceed, and there is room for improvement in terms of the influence on the operability by the probe cover.

[Problem 4: Economic efficiency]
Next, in the case of echo lower body surface puncture using a conventional puncture guide device, a puncture guide device and a probe cover are required in addition to puncture devices such as an ultrasonic probe and a puncture needle. However, among these, the puncture guide device is very expensive because it is a highly specialized special instrument, so there is room for improvement in terms of economy (cost reduction). In addition, there are different types of ultrasonic probes, such as a linear type, a convex type, and a sector type, and the shape and size of the attachment site where the guide device for puncture is attached varies depending on the type of the ultrasonic probe. In addition, even with the same type of ultrasonic probe, the shape and dimensions of the mounting site may differ depending on the specifications and model number of the manufacturer. Therefore, the conventional guide device for puncture needs to design the mounting structure of the holding part individually according to the type and model number of the ultrasonic probe, and prepare a separate one for each type and model number, There is room for improvement in terms of economy due to lack of versatility.

Therefore, the present invention provides a compact configuration for guiding the puncture needle and enables puncture of the puncture needle from the nearest position of the ultrasonic probe, thereby puncturing the puncture line of the puncture needle by an echo image. It can be visually confirmed from the start position or its nearest position, further improving the safety in the puncture operation, and can improve the operability of the ultrasonic probe by eliminating interference with the uneven part in the puncture site, Furthermore, an object of the present invention is to provide an auxiliary device for echocardiographic surface puncture that can greatly reduce the manufacturing cost and improve the economy.

The echo lower body surface puncture auxiliary device according to the present invention includes a dressing material and a guide portion. The dressing material has a shape and a dimension that completely covers a predetermined covering range including at least the tip of the head portion of the ultrasonic probe, and has a flexible film shape at an arbitrary position on one side. An adhesive layer is provided. The guide portion has a guide passage for linearly guiding the puncture needle in a predetermined direction, and on the other side of the dressing material, the guide portion covers the coverage area of the ultrasonic probe with the dressing material. The sticking direction of the puncture needle that is fixed to the part arranged on the side surface of the head part and is guided by the guide passage in the use state corresponds to the depth position of the target part in the body of the subject. The guide passage is formed in a predetermined insertion direction. Here, the term “echo subsurface puncture” is used in the present application document as a comprehensive term for the case where a puncture device such as a puncture needle is inserted into the body surface of a subject under the above echo. In addition to the puncture in the above-mentioned echo-puncture aspiration cytology, the puncture for performing a percutaneous puncture operation for inserting a puncture device such as a puncture needle from the body surface of the subject under the echo is comprehensively performed. Include. Therefore, the echo hypodermic surface puncture targeted by the echo hypodermic surface puncture auxiliary device according to the present invention includes, for example, a puncture for a body organ organ such as a thyroid mass or a mammary mass, liver, kidney, prostate, etc. Including puncture for biopsy of abdominal organs or chest organs such as lungs, and in addition to puncture for the purpose of cell diagnosis and tissue diagnosis as described above, such as PEIT (ethanol injection therapy) Application to puncture for therapeutic purposes is also possible.

The echo hypodermic surface puncture auxiliary device according to the present invention is based on an echo image by allowing the puncture needle to be punctured from the nearest position of the ultrasonic probe by making the overall configuration for guiding the puncture needle a compact configuration. The puncture line of the puncture needle can be visually confirmed from the puncture start position or its nearest position, thereby further improving the safety of the puncture operation and eliminating the interference with the concavo-convex portion at the puncture site, and the operability of the ultrasonic probe In addition, the manufacturing cost can be greatly reduced and the economy can be improved.

FIG. 1 is a plan view showing an echo lower body surface puncture auxiliary device according to Embodiment 1 of the present invention. FIG. 2 is a bottom view showing the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention. FIG. 3 is a side view showing the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention. FIG. 4 is a front view showing the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention as viewed from the guide portion side. FIG. 5 is a side view showing a usage state of the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention. FIG. 6 is a front view showing a usage state of the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention. FIG. 7 is a perspective view showing a method for using the auxiliary apparatus for echocardiographic surface puncture according to Embodiment 1 of the present invention together with an ultrasonic probe. FIG. 8 shows a state in which the head part of the ultrasonic probe is brought close to the dressing material in the method of using the echo lower body surface puncture auxiliary device according to Embodiment 1 of the present invention, (a) is a side view of the main part, b) is a perspective view of an essential part. FIG. 9 shows a state in which the head part of the ultrasonic probe is brought into close contact with the dressing material in the method of using the echo lower body surface puncture auxiliary device according to Embodiment 1 of the present invention, (a) is a side view of the main part, b) is a perspective view of an essential part. FIG. 10 shows a state in which a dressing material is attached to the right side surface of the head portion of the ultrasonic probe in the method of using the echo esophageal surface puncture auxiliary device according to Embodiment 1 of the present invention, and FIG. FIG. 4B is a perspective view of the main part. FIG. 11 is a main part side view showing a state in which a dressing material is adhered to all sides of the head part of the ultrasonic probe in the method of using the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention. The material is shown in cross section. FIG. 12 is a side view of an essential part showing a mode in which a puncture needle is inserted into a target site in the method of using the ultrasonic probe equipped with the echo lower body surface puncture auxiliary device according to Embodiment 1 of the present invention. FIG. 13 shows a mode in which the puncture needle is inserted into target sites at different depth positions in the method of using the ultrasonic probe equipped with the echo lower body surface puncture auxiliary device according to Embodiment 1 of the present invention. FIG. 14 shows an auxiliary instrument for echocardiographic surface puncture according to Embodiment 2 of the present invention, (a) is a side view of a guide portion, (b) is a front view showing a mounting state on an ultrasonic probe, and (c). FIG. 5 is a side view for explaining a guide passage of the guide portion.

Hereinafter, modes for carrying out the present invention (hereinafter referred to as embodiments) will be described. Throughout each embodiment, the same members, elements, or parts are denoted by the same reference numerals, and the description thereof is omitted.

[Embodiment 1]
Hereinafter, the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention will be described. As shown in FIG. 7, the echo lower body surface puncture auxiliary device according to the first embodiment of the present invention is fixed to the ultrasonic probe 100 by adhesion so that it can be easily fixed and easily detached. Thus, the puncture technique of the puncture needle is assisted. The ultrasonic probe 100 itself has a known configuration, and includes a grip part 101 and a head part 102. Inside the head part 102, piezoelectric elements (not shown) as ultrasonic transmitting / receiving elements are arranged in an array. Then, as shown in FIG. 8, scanning of the inside of the subject's body is performed by transmitting / receiving ultrasonic waves having a predetermined slice width and visual field width from the transmitting / receiving surface 103 of the distal end surface (the lower surface in FIG. 1) of the head unit 102. By outputting a corresponding electrical signal to the ultrasonic diagnostic apparatus, an echo image corresponding to the monitor of the ultrasonic diagnostic apparatus is displayed. On the other hand, as shown in FIGS. 1 to 4, the auxiliary device for echo lower body surface puncture according to Embodiment 1 includes a dressing material 10, an echo gel portion 20, and a guide portion 30 as shown in FIGS. The echo gel part 20 is fixed to the lower surface of the dressing material 10. Further, the guide portion 30 is close to or close to one end in the length direction of the echo gel portion 20 so as to extend on the same line in a state where the echo gel portion 20 and the axial center and the width direction center position coincide with each other on the lower surface of the dressing material 10. And is fixed. Hereinafter, individual components of the auxiliary instrument for echo lower body surface puncture according to the first embodiment will be described in detail.

[Dressing material]
As shown in FIGS. 1 to 4, first, the dressing material 10 is formed in an adhesive film shape (or an adhesive sheet shape). Specifically, the dressing material 10 is formed by applying and forming the adhesive layer 12 on the entire surface of one side surface (the upper surface in FIGS. 3 and 4) of the base material layer 11, and the release film 13 covers the entire surface of the adhesive layer 12. It has a completely covered structure (laminated structure) and is formed into an adhesive film with the one side surface as an adhesive surface. More specifically, the base material layer 11 is formed of the same film material as a medical dressing material (also referred to as “wound dressing material”) so as to be a film of the predetermined size in the predetermined shape. Yes. In addition, the base material layer 11 can be formed from synthetic resin films, such as a polyurethane film and a PET film, and can also be made into any film of a transparent film, a translucent film, a colored transparent film, and an opaque film. Moreover, it is preferable to form the base material layer 11 from a waterproof film (which can prevent permeation or permeation of a liquid such as a body fluid that may be scattered during puncture). The adhesive layer 12 is applied and formed with a uniform thickness over the entire surface of one side surface of the base material layer 11, and the dressing material 10 is adhered to the outer surface of the ultrasonic probe 100 and can be fixed in place. In addition, by applying an external force in the peeling direction (such as turning the edge of the base material layer 11), the ultrasonic probe 100 can be peeled off from the outer surface. The pressure-sensitive adhesive layer 12 can be formed of a known pressure-sensitive adhesive (rubber-based pressure-sensitive adhesive, acrylic pressure-sensitive adhesive, silicon-based pressure-sensitive adhesive, urethane-based pressure-sensitive adhesive, etc.). Further, the release film 13 is on a film having the same outer shape and the same dimensions (and the same area) as the base material layer 11 and the adhesive layer 12, and is the echoing body surface puncture assisting device of the present embodiment. In an unused state, the adhesive layer 12 is preliminarily pasted or stuck on the entire surface to completely shield and protect the adhesive layer 12 from the outside. Then, by applying an external force in the direction of peeling from the adhesive layer 12 (such as turning the edge of the release film 13), the adhesive layer 12 is easily peeled off to expose the entire surface of the adhesive layer 12, and the adhesive layer 12 Is designed to exert an adhesive function. The release film 13 can be formed of a known release film (for example, a paper material or a synthetic resin film material having a release agent applied to the surface thereof).

[Dimensions and planar shape of dressing material]
Moreover, the dressing material 10 is formed so as to have a flexible adhesive film shape (or sheet shape) having a predetermined planar shape having a predetermined dimension. Specifically, when the dressing material 10 has a predetermined planar shape of the predetermined dimension and is in close contact with a predetermined range including at least the distal end portion of the head portion 102 of the ultrasonic probe 100, the predetermined range is completely (with no gap). ) It has a predetermined planar shape with dimensions that can be covered. (Hereinafter, for convenience of explanation, the range of the ultrasonic probe 100 covered by the dressing material 10 is simply referred to as “covering range”.) More specifically, the dressing material 10 has the predetermined dimensions as shown in FIG. 1 has a predetermined length dimension (dimension in the length direction) D1 and a predetermined width dimension (dimension in the width direction) D2, and the predetermined planar shape is a rectangular shape or a rectangular planar shape as shown in FIG. have. Here, the size of the dressing material 10 is set according to the size of the coverage area of the ultrasonic probe 100, and the shape of the dressing material 10 is set according to the shape of the coverage area of the ultrasonic probe 100. Further, the dressing material 10 completely covers the entire front end surface (including the transmission / reception surface 103) of the head 102 of the ultrasonic blow unit 100 by the central portion, and the head 102 by the peripheral portion around the central portion. Are formed in a predetermined shape having a predetermined dimension capable of completely covering the four sides. Specifically, when the shape of the front end surface of the head 102 is a horizontally long shape in the left-right direction, the length dimension D1 of the dressing material 10 is set to the left side surface of the head 102 (see FIG. 5). A predetermined position (for example, the upper end position) of the upper end portion of the right side surface (the right side surface in FIG. 5) from the predetermined position (for example, the upper end position or a position slightly below the upper end position) of the upper end portion of the left side surface through the tip surface. Alternatively, the length dimension is set to be equal to or longer than the length from the upper end position to a slightly lower position. Further, the width dimension D2 of the dressing material 10 is determined from a predetermined position (for example, an upper end position or a position slightly below the upper end position) of the upper end portion of the front side surface (the left side surface in FIG. 6) of the head 102 and the rear surface. The width dimension is set to be equal to or larger than the length reaching a predetermined position (for example, the upper end position or a position slightly below the upper end position) of the upper end portion of the side surface (the right side surface in FIG. 6).

Here, since the dressing material 10 has one of the main functions of preventing the body fluid of the subject from adhering to the surface of the ultrasonic probe 100 during puncturing (contamination prevention function), the size of the dressing material 10 and The shape is set to a size and shape that can cover at least all the parts of the ultrasonic probe 100 where the body fluid of the subject may scatter and adhere at the time of puncturing. Therefore, the dressing material 10 has an arbitrary shape other than the rectangular shape as long as it can cover all the parts of the ultrasonic probe 100 where the body fluid of the subject may scatter and adhere at the time of puncturing. And can have any dimensions. However, in normal puncture, the part up to the vicinity of the upper end of the head part 102 is assumed as the part of the ultrasonic probe 100 where the body fluid of the subject may scatter and adhere. In this embodiment, the dressing material 10 is dimensioned and shaped so as to completely cover the upper end position of the head portion 102 or a portion and range up to a position slightly below the upper end (for example, a position about 1 to 2 mm below). It is set.

[Possibility of changing the planar shape of the dressing material]
Further, in order to completely cover a predetermined covering range such as the head portion 102 of the ultrasonic probe 100, the dressing material 10 has a rectangular shape as shown in FIGS. 2 and a surplus portion between the portion adhering to the left and right side surfaces of the head portion 102 and the portion adhering to both the front and rear side surfaces (the portion divided by the one-dot chain line CL in FIG. 2) ) EX is folded (i.e., overlapped) with each other and attached to the corner portions of the front, rear, left, and right side surfaces of the head portion 102. Therefore, in the present invention, in order to eliminate such overlapping of the surplus portion EX of the dressing material 10, the dressing material 10 has a shape in which the surplus portion EX is cut in advance (that is, an inner portion of the dashed line CL in FIG. 2). It is also possible to use a cross-like shape. Further, a perforated cutting line process may be applied to the position of the alternate long and short dash line CL in FIG. 2, and the excess portion EX may be excised at the position of the alternate long and short dash line CL in FIG. In addition, since the dressing material 10 needs to completely cover at least the coverage of the head portion 102 of the ultrasonic probe 100, the surplus is assumed in consideration of the shape and dimensions of the head portion 102 of the ultrasonic probe 100 to be used. By setting the vertical and horizontal dimensions and range of the portion EX to be appropriately increased and decreased, the ultrasonic probe 100 of a different model is used as the ultrasonic probe 100, and the shape and dimensions of the head portion 102 are different, so that the covering range is increased. Even if is changed, the change can be flexibly dealt with. In any case, in the dressing material 10, even when the surplus portion EX is removed, the left and right portions and the front and rear portions, which are the peripheral portions of the center portion, are completely in close contact with each other (or their edge portions). Are partially overlapped) so that the four corners on the front, rear, left and right sides of the head portion 102 of the ultrasonic probe 100 are completely covered.

[Possibility of changing dressing thickness, material, etc.]
By the way, the planar shape of the dressing material 10 may be any planar shape other than the rectangular shape as described above as long as the predetermined coverage of the ultrasonic probe 100 to be coated can be completely covered. it can. That is, the planar shape of the dressing material 10 covers the entire surface of the ultrasonic probe 100 in a predetermined range without any gaps, thereby preventing substances such as body fluids from adhering to the ultrasonic probe 100 during puncture. Therefore, as long as this object can be achieved, the planar shape of the dressing material 10 can be appropriately changed according to the shape of the covering range of the ultrasonic probe 100. In particular, since the shape and dimensions of the head portion 102 of the ultrasonic probe 100 may differ depending on the model or the like, the dressing is performed so that the predetermined covering range can be completely covered for all the ultrasonic probes 100 that can be used. It is desirable to set the planar shape and dimensions of the material 10. That is, the size and the planar shape of the dressing material 10 are the entire surface of a predetermined range including the distal end portion of the head portion 102 (typically, as a predetermined covering range of an arbitrary ultrasonic probe 100 used in echo lower body surface puncture (typically Covers the entire front end surface and front / rear / left / right side surfaces of the head portion 102 without gaps, so that it is watertight or sealed against all liquids such as bodily fluids that may be scattered during puncture, or The size and the planar shape are set so that the airtight state can be maintained. On the other hand, the thickness dimension of the dressing 10 can be set to a dimension in units of microns (for example, on the order of several tens of micrometers or several hundreds of micrometers). Further, the dressing material 10 is preferably formed from a low stretch film material having a low elongation rate (tensile elongation) or a non-stretch film material having an elongation rate that is extremely small and substantially negligible, It is desirable that the ultrasonic probe 100 be prevented from being displaced with respect to the head unit 102 when adhered to the head unit 102 of the ultrasonic probe 100. In this sense, it is also preferable to relatively increase the thickness of the dressing material 10 to reduce the elongation. The dressing material 10 is provided with a first mark line L1, a second mark line L2, and a third mark line L3 as shown in FIG. Since it is a component related to the part 30, it will be described later in relation to the dressing material 10, the echo gel part 20, and the guide part 30.

[Echo gel part]
As shown in FIGS. 2 and 3, the echo gel portion 20 is formed to have a plate shape (or block shape) with a predetermined thickness, and a predetermined fixing means (adhesive, adhesive) at the center of the lower surface of the dressing material 10. Etc.). Specifically, the echo gel unit 20 is an ultrasonic gel (also referred to as “ultrasonic jelly” or “echo gel”) used in ultrasonic examination (diagnosis) and ultrasonic therapy, and is a biological tissue in the human body. A gel-like or gel-like material having a specific acoustic impedance that is the same as or close to the specific acoustic impedance of the same). Further, the echo gel portion 20 is different from a conventional ultrasonic gel (that is, of a type having a highly fluid jelly shape and is applied to the skin of a subject), and inherent acoustics of living tissue in the human body. It is integrally formed to be a viscoelastic body that has a plate shape of a predetermined size and a predetermined shape from a gel material having a specific acoustic impedance that is the same as or approximate to the impedance, and that can self-hold the predetermined size and the predetermined shape. Is. The echo gel portion 20 has a predetermined viscosity and elasticity (and viscoelasticity), can be flexibly deformed in any direction with respect to an external force, and has an original shape over time when the external force is removed. The viscoelasticity of the gel material is set so as to return to (the predetermined shape of the predetermined dimension). In addition, as a gel material which consists of such a self-holding type viscoelastic body, as long as it can be set as the above-mentioned viscoelastic body which can be self-holding shape, the conventional hydrogel material and (alcogel material are included, for example) ) Organogel materials can be used. In addition, “return to original shape with time when external force is removed” means that the shape returns to the original or original shape to some extent without returning to the original or original shape completely. It also includes the case where the shape approximates to. In addition to the dispersed gel material consisting of two components, a solid gel-forming substance and a liquid solvent, as in conventional hydrogel materials and organogel materials, a segment (polyol is cross-linked with isocyanate) It is also possible to use a segmented urethane-based gel material composed of one component such as a segmented polyurethane. When a urethane gel material is used as the material of the echo gel part 20, the surface of the echo gel part 20 (particularly due to the self-adhesiveness of the urethane resin (and the self-adhesive force being adjustable) can be adjusted. It is also possible that the surface adhering to the dressing material 10 has its own self-adhesive force and is adhered and held at a predetermined position on the lower surface of the dressing material 10.

[Dimensions in the planar direction and planar shape of the echo gel part]
Moreover, the echo gel part 20 is formed so as to have a plate shape of a predetermined plane shape having a predetermined dimension. Specifically, first, the planar dimension and planar shape of the echo gel part 20 are the planar dimension and planar shape corresponding to the dimension and planar shape (outer outline shape) of the distal end surface of the head part 102 of the ultrasonic probe 100. Thus, it is set to have a planar shape with a dimension in a planar direction that can be disposed so as to face the entire front end surface of the head portion 102 and cover the entire surface. That is, the echo gel part 20 has a planar shape that has a dimension and an outer contour shape corresponding to the dimension and outer contour shape of the distal end surface of the head portion 102 of the ultrasonic probe 100 as the predetermined planar shape. In the present embodiment, the echo gel unit 20 is a diagram (assuming that the outer shape of the distal end surface of the head unit 102 of the ultrasonic probe 100 is a rectangle extending in the horizontal direction in FIGS. 1 and 2). 1 and FIG. 2 has a rectangular planar shape extending in the left-right direction. Further, the echo gel part 20 is fixed to the central part of the lower surface of the dressing material 10 and is configured to be opposed to the distal end surface of the head part 102 of the ultrasonic probe 100 (covered with the dressing material 10). Therefore, the echo gel part 20 has the dimension in the plane direction (when the center part of the dressing material 10 is aligned with the front end surface of the head part 102 and bonded to cover the head part 102 with the dressing material 10). Opposite to the entire front end surface 102, the entire front end surface can be completely covered from below. Specifically, in the present embodiment, the echo gel portion 20 has a predetermined length dimension (dimension in the length direction) D3 and a predetermined width dimension as the dimension in the plane direction as shown in FIGS. (Dimension in the width direction) D4. The length dimension D3 of the echo gel part 20 is set to be the same as or slightly larger than the length dimension (dimension in the left-right direction) of the distal end surface of the head part 102 of the ultrasonic probe 100. Further, the width dimension D4 of the echo gel part 20 is set to be the same as or slightly larger than the width dimension (front-rear direction dimension) of the tip surface of the head part 102. In addition, since the echo gel part 20 is provided in the center of the front-back direction (up-down direction of FIG. 1) and the left-right direction (left-right direction of FIG. 1) of the dressing material 10, the right end (one length direction end) and dressing of the echo gel part 20 are provided. The 1st space | interval between the right side edge (length direction one side edge) of the material 10, the left end (length direction other end) of the echo gel part 20, and the left side edge (length direction other side edge) of the dressing material 10 And the second distance between the front end of the echo gel part 20 (one end in the width direction) and the front end edge (one side edge in the width direction) of the dressing material 10, and the echo gel The 4th space | interval between the rear end (width direction other end) of the part 20 and the rear side edge (width direction other side edge) of the dressing material 10 becomes the same. Further, the length dimension D1 and the width dimension D2 of the dressing material 10 (the length of the echo gel part 20) are set so that the first interval, the second interval, the third interval, and the fourth interval are the same interval. It is preferably set (in relation to the dimension D3 and the width dimension D4). In this way, when the dressing material 10 is attached to the head portion 102 of the ultrasonic probe 100, the peripheral portion at the center of the dressing material 10 covers the head portion 102 with the same length.

Here, the dimension in the planar direction and the planar shape of the echo gel portion 20 are determined when the dressing material 10 is bonded to the head portion 102 of the ultrasound probe 100 and the head portion 102 is covered with the dressing material 10. As long as the shape of the head portion 102 is opposite to the entire front end surface of the head portion 102 and can cover the whole surface, the size of the head portion 102 can be set in accordance with the dimensions of the head portion 102 and the outline shape. It can be a planar shape. For example, one or both of the length dimension D3 and the width direction dimension D4 of the echo gel part 20 is a dimension that is somewhat larger than the length dimension and the width direction dimension of the front end surface of the head part 102 (for example, a dimension that is larger by about 5 to 10 mm, or It can also be set to a dimension that is approximately 10 mm to 20 mm larger. In the present embodiment, the planar shape of the echo gel portion 20 is similar to or substantially similar to the shape of the distal end surface of the head portion 102 (for example, the ratio of the length-wise dimension to the width-wise dimension of the similar shape is changed). However, it may be a shape that is not similar to or substantially similar to the shape of the distal end surface of the head portion 102. For example, when the shape of the tip surface of the head portion 102 is a rectangle, the echo gel portion 20 has an arbitrary planar shape that surrounds the rectangle (for example, a rounded rectangular shape, an oval shape, a horizontally long polygon shape, etc.). It can be. Note that the transmission / reception surface 103 of the ultrasonic probe 100 is not provided on the entire front end surface of the head portion 102, and a slight peripheral portion 103 a (not an ultrasonic transmission / reception surface) on the outer peripheral side of the transmission / reception surface 103 in the head portion 102. Therefore, the size and shape of the echo gel portion 20 in the planar direction are generally opposed to at least the entire transmission / reception surface 103 of the tip surface of the head portion 102 of the ultrasonic probe 100. What is necessary is just to set to the planar shape of the plane direction dimension which can cover the whole surface. That is, the echo gel part 20 may be configured so as not to be opposed to the peripheral part 103a of the head part 102 as a planar dimension and a planar shape matching the contour of the outer peripheral edge of the transmission / reception surface 103 of the head part 102.

[Echo gel part thickness dimension]
On the other hand, the echo gel portion 20 has a predetermined thickness dimension (dimension in the thickness direction) D5 as the predetermined dimension, as shown in FIG. Specifically, when the head portion 102 of the ultrasonic probe 100 is covered with the dressing material 10, the echo gel portion 20 is first disposed below the head portion 100 so as to transmit and receive the distal end surface of the head portion 102. Between the surface 103 and the subject's skin, it is in an intervening state, and as a distance holding member, a constant interval (the thickness dimension of the dressing material 10 and the thickness dimension of the echo gel portion 20 is added together) between the transmission / reception surface 103 and the skin. The first function (interval maintaining function) for maintaining the interval) is exhibited. At this time, the echo gel unit 20 is the same as or similar to the living tissue between the transmitting / receiving surface 103 of the ultrasonic probe 100 and the skin of the subject as an acoustic coupling material, as in the case of a normal ultrasonic gel. A second function that dramatically increases the transmission efficiency of ultrasonic waves between the transmission / reception surface 103 and the body of the subject by preventing the mixture of air by filling with a gel-like substance having a specific acoustic impedance. Sound coupling function). Further, at this time, the echo gel part 20 serves as a sliding acceleration member between the skin of the subject and the tip surface (centered on the transmission / reception surface 103) of the head part 102 of the ultrasonic probe 100 in contact with the skin. The third function (sliding promotion function) for improving the operability of moving the ultrasonic probe 100 is ensured. Furthermore, as will be described later, the echo gel section 20 serves as a pre-puncture path securing member that passes the path of the puncture needle immediately before being inserted into the skin of the subject from the side of the ultrasonic probe 100. A fourth function (pre-puncture route securing function) for securing a backup route for confirmation by an echo image within the ultrasonic transmission / reception range is exhibited. Therefore, the echo gel portion 20 has its thickness dimension D5 set so as to surely exhibit these first to fourth functions. In particular, since the thickness D5 of the echo gel portion 20 is determined by the relationship with the angle of the guide passage of the puncture needle in the guide portion 30 (that is, the puncture angle of the puncture needle), The details will be described again. In some cases, the echo gel portion has a thickness D5 that is thicker on the guide portion 30 side and thinner on the opposite side. Thereby, the visibility of the target mass close to the skin surface is enhanced, and the puncture operation can be easily performed.

[Guide section]
As shown in FIG. 3, the guide portion 30 is formed in a sector block shape, and at least a part of one side surface in the circumferential direction (upper surface in FIG. 3) is on the lower surface of the dressing material 10. Is fixed to a predetermined position close to or close to one end in the length direction (right end in FIG. 1) by a predetermined fixing means (adhesive, adhesive, etc.). Further, as shown in the enlarged view on the upper side in FIG. 3, the guide portion 30 has a predetermined plurality (five in the illustrated example) guide holes H1, H2, H3 having a circular cross section as a guide passage for the puncture needle. H4 and H5. The guide holes H1, H2, H3, H4, and H5 are straight lines at different angles from the outer peripheral surface of the guide portion 30 toward the corners or apexes on the inner peripheral side (for example, at regular angular intervals). Extended. Further, each of the guide holes H1, H2, H3, H4, and H5 has a circular opening (the same as the cross-sectional shape) at one end on the outer peripheral surface of the guide portion 30, and the other end on the inner peripheral side of the guide portion 30. Are opened in a circular shape (same as the cross-sectional shape) at the corner or apex. Specifically, as shown in FIG. 4, the guide portion 30 is formed to have the sector block shape by closely fixing the right half portion 31 and the left half portion 32 to each other. The right half portion 31 and the left half portion 32 have a line-symmetric fan-shaped block shape (fan block shape having the same outer shape as the guide portion 30), and have the same predetermined thickness (half the thickness of the guide portion 30). have. Further, as shown in the enlarged view on the upper side in FIG. 4, a predetermined plurality (five in the illustrated example) of guide grooves 31 b having a semicircular cross section are different on the inner end surface 31 a of the right half portion 31. It is formed as a straight groove extending linearly from the outer peripheral surface of the right half portion 31 toward the inner peripheral corner at a predetermined angle. Similarly, on the inner end surface 32a of the left half portion 32, a plurality of symmetrical half-circular cross-sectional guide grooves 32b identical to the guide groove 31b of the right half portion 32 are respectively provided (right half portion 31). It is formed as a linear groove extending linearly from the outer peripheral surface of the left half 32 toward the inner peripheral corner at a different predetermined angle (which is the same angle as the guide groove 31b). Thus, the guide portion 30 is formed by joining and integrating the right half portion 31 and the left half portion 32, so that the guide holes 30, H2, H3, H4 and H5 are formed.

Here, the guide portion 30 guides the puncture needle used in the puncture operation along any one of the guide holes H1, H2, H3, H4, and H5, and the guide holes H1, H2, H3, H4, and H5. The diameter of the puncture needle is set to be slightly larger than the outer diameter of the puncture needle (for example, a dimension in units of microns) so that the puncture needle can be linearly guided along its inner peripheral surface in a sliding contact state. ing. For example, the diameter of the puncture needle used in the puncture is usually a minimum diameter when performing a freehand puncture with a diameter of 25 gauge (outer diameter 0.5 mm), but the guide portion 30 is used. Thus, when guiding the puncture needle, it is possible to use a puncture needle with a smaller diameter, and for example, it is possible to use a 27 gauge (outer diameter 0.4 mm) which is more desirable for puncture. In this case, the guide holes H1, H2, H3, H4, and H5 of the guide portion 30 are formed to have a diameter corresponding to the outer shape of the smaller diameter puncture needle. In the present invention, the guide hole is not formed of the right half portion 31 and the left half portion 32 as in the case of the guide portion 30, and the guide hole is formed in a single body formed as a whole. It is good also as the structure which carried out.

[Configuration for ultrasonic probe positioning]
The dressing material 10, the echo gel part 20, and the guide part 30 are members or elements that are operatively related to each other, and the ultrasonic probe 100 is in a predetermined position with respect to the echo gel part 20 and the guide part 30. Since they are members or elements that cooperate with each other for positioning, their relationship will be described in detail below. First, as one of the components for positioning the ultrasonic probe 100, the first mark line L1, the second mark line L2, and the third mark line L3 of the dressing material 10 will be described. The first mark line L1 is a straight line (arbitrary line such as a solid line, a broken line, or a chain line) that is disposed at the center in the width direction of the dressing material 10 and extends in the length direction of the dressing material 10. The second mark line L2 is arranged at a predetermined position overlapping one end in the length direction of the echo gel portion 20 on one side edge in the length direction of the dressing material 10 and extends in the width direction of the dressing material 10 (solid line, broken line) , Any straight line such as a chain line. Further, the third mark line L3 is arranged at a predetermined position overlapping one end in the width direction of the echo gel portion 20 on one side edge in the width direction of the dressing material 10 and extends in the length direction of the dressing material 10 (solid line, broken line, It consists of a straight line such as a chain line. These first to third mark lines L1, L2, and L3 are arranged to face each other by accurately aligning the tip surface of the head portion 102 of the ultrasonic probe 100 with the portion where the echo gel portion 20 is provided in the dressing material 10. It is a mark for the purpose. That is, a corner (corner angle) between one end in the length direction and one end in the width direction of the front end surface of the head portion 102 is a corner (corner angle) between the second mark line L2 and the third mark line L3. And one end in the length direction of the front end surface of the head portion 102 coincides with the second mark line L2, and one end in the width direction of the front end surface of the head portion 102 coincides with the third mark line L3. At least the entire transmission / reception surface 103 of the part 102 is completely opposed to the echo gel part 20 (via the dressing material 10) and is completely covered by the echo gel part 20. For this reason, as described above, the echo gel portion 20 is provided to have a size (and area) larger than that of the transmission / reception surface 103 of the head portion 102. Therefore, when the head portion 102 is aligned by the second and third mark lines L2 and L3 as described above, the tip surface of the head portion 102 is within the range of the outer contour of the echo gel portion 20, and at least The entire transmission / reception surface 103 of the head unit 102 is completely covered by the echo gel unit 20.

Here, when the ultrasonic probe 100 whose head part 102 is smaller than the size of the echo gel part 20 is used, a part of the echo gel part 20 (a part on the other end side in the length direction and / or a part on the other end side in the width direction). Part) does not oppose the front end surface of the head unit 102, but the other part opposes the entire front end surface of the head unit 102 and covers the entire surface. In this case, the head portion 102 is arranged slightly biased to one side edge side in the length direction and one side edge side in the width direction of the dressing material 20. Therefore, when the ultrasonic probe 100 having the head portion 102 smaller than the size of the echo gel portion 20 is used in this way, the center position in the width direction of the head portion 102 is made to coincide with the first mark line L1, and one end in the length direction is set. Is made to coincide with the second mark line L2, so that the head portion 102 can be arranged at the center portion of the dressing material 20.

The first mark line L1 is a mark function for aligning the head part 102 with the center part in the width direction of the dressing material 10 by visually overlapping the center part in the width direction of the head part 102 of the ultrasonic probe 100. 1 may be provided over the entire length in the length direction of the dressing material 10 as shown in FIG. 1, but if it is provided at least in the center in the length direction of the dressing material 10, the marking function is exhibited. be able to. Similarly, the second mark line L2 exhibits a mark function for aligning one end in the length direction of the head portion 102 with the boundary position between the echo gel portion 20 and the guide portion 30 in the dressing material 10. Therefore, it may be provided over the entire length in the width direction of the dressing material 10 as shown in FIG. 1, but if it is provided at least in the center of the width of the dressing material 10, the marking function can be exhibited. Similarly, the third mark line L3 aligns one end in the width direction of the head portion 102 with one end in the width direction of the echo gel portion 20 in the dressing material 10, thereby cooperating with the second mark line L2 in the head portion 102. 1, it exhibits a mark function for making the entire front end surface completely opposed to the echo gel portion 20, and may be provided over the entire length of the dressing material 10 as shown in FIG. 1, but at least the dressing material If it is provided so as to intersect the second mark line L2 at the center in the length direction of 10, the mark function can be exhibited. The first to third mark lines L1, L2, L3 may be formed by printing or the like on the upper surface of the base material layer 11 (before applying the adhesive), or the lower surface of the base material layer 11 It may be formed by printing or the like (before the echo gel portion 20 is attached).

[Positional relationship between dressing material, echo gel part and guide part]
In the pre-use state of the echo lower body surface puncture auxiliary device of the present embodiment, as shown in FIG. 3, the guide portion 30 is in the length direction of the echo gel portion 20 on the lower surface of the dressing material 10 (in a flat state). They are arranged close to each other with a minute gap. On the other hand, in the state of use of the echo lower body surface puncture auxiliary device of the present embodiment, as shown in FIG. 5, the guide portion 30 (from the distal end surface of the head portion 102 of the ultrasonic probe 100 to the front, rear, left and right side surfaces). On the outer surface of the dressing material 10 (attached so as to surround), the head portion 102 is disposed in a close contact with a predetermined position on the side of the right side surface of the head portion 102 (that is, separated only by an interval corresponding to the thickness of the dressing material 10). The At this time, the front end surface of the head portion 102 of the ultrasonic probe 100 is entirely opposed to the echo gel portion 20 in the central portion of the dressing material 10 using the first to third mark lines L1 to L3. After positioning and sticking the portion of the dressing material 10 provided with the echo gel portion 20 at the center portion to the tip surface of the head portion 102, the dressing material 10 is placed on each of the front, back, left, and right sides of the head portion 102. When pasted, the guide part 30 is automatically arranged at the predetermined position on the right side surface of the head part 102. In this use state (attached state to the head portion 102), as shown in the enlarged view of FIG. 5, the guide portion 30 has the guide holes H1 to H5 each having a leading end opening on the leading end surface of the head portion 102. Opposite to the right end surface of the echo gel portion 20 located below (with a gap of the thickness of the dressing material 10), or (with a slight gap generated between the dressing material 10 near the right edge of the head portion 102) And the upper surface of the echo gel portion 20 near the right end. That is, in the use state, the dressing material 10 and the echo gel portion are arranged so that the tip openings of the guide holes H1 to H5 of the guide portion 30 are located at positions facing the right end surface of the echo gel portion 20 or the upper end surface near the right end edge. The position of the guide part with respect to 20 (especially the echo gel part 20) is set.

Here, when the portion of the right side surface where the guide portion 30 is opposed to the head portion 102 of the ultrasonic probe 100 is a flat surface, the guide portion 30 has the entire surface on one side in the circumferential direction on the right side of the head portion 102. It is arranged to be opposed to the flat surface of the surface portion, and the state of being fixed to the dressing material 10 in that state is maintained. On the other hand, depending on the model of the ultrasonic probe 100 and the like, the guide portion 30 is opposed to the corner portion (particularly, the corner portion of the right side surface) of the front end surface of the head portion 102 and the front, rear, left and right side surfaces, and its peripheral portion. The predetermined portion to be formed may have a curved shape with a small curvature as shown in FIG. In this case, the guide part 30 will be arrange | positioned on the curved surface of the said predetermined site | part of the right side surface of the head part 102, and the circumferential direction one side surface (side surface fixed to the dressing material 10) of the guide part 30 Only a part of the range adheres to the dressing material 10 according to the curvature of the curved surface of the predetermined portion of the head portion 102. In this case, in the pre-use state, the guide part 30 is fixed to the dressing material 10 with the entire surface on one side in the circumferential direction, which is a fixing surface to the dressing material 10, and in the used state, Only the range can be maintained in a state of being fixed to the dressing material 10 (that is, the other range is peeled off from the dressing material 10). However, in any case, in the use state, the dressing so that the tip opening of each of the guide holes H1 to H5 of the guide portion 30 is located at a position facing the right end surface of the echo gel portion 20 or the upper end surface near the right end edge. The position of the guide part 30 with respect to the material 10 and the echo gel part 20 (especially the echo gel part 20) is set.

[Proximity placement of guide part to ultrasonic probe]
In particular, in the state of use, the guide portion 30 is disposed at a position closest to the side surface of the head portion 102 of the ultrasonic probe 100 (only for the minimum thickness of the dressing material 10, i.e., only at intervals of comma millimeters), In particular, the distal end openings of the guide holes H1 to H5 (where the distal end of the puncture needle is exposed) are arranged at positions closest to the corner between the distal end surface and the side surface (right side surface) of the head portion 102. That is, in the pre-use state of the echo lower body surface puncture auxiliary device of the present embodiment, the fixing position of the guide portion 30 on the lower surface of the dressing material 10 is set to the closest position to one end (right end) in the length direction of the echo gel portion 20. The tip surface of the head portion 102 of the ultrasonic probe 100 is arranged at a position facing the echo gel portion 20 on the upper surface side of the dressing material 10 in the use state of the echo lower body surface puncture auxiliary device. When the head unit 102 is covered, the guide unit 30 is automatically arranged at the closest position on the side surface of the head unit 102, and the tip openings of the guide holes H1 to H5 are positioned at the closest position to the corners of the head unit 102. Configured to be deployed. As a result, the echo lower body surface puncture auxiliary device of the present embodiment is guided by inserting the puncture needle into any of the guide holes H1 to H5 of the guide portion 30 in use, and punctures the body of the subject. When doing so, the puncture needle can be punctured into the skin of the subject from the position closest to the ultrasonic probe 100. That is, according to the echo lower body surface puncture auxiliary device of the present embodiment (for example, as in a conventional puncture guide device, the puncture needle is covered from a position where a certain thickness dimension of the puncture guide device is placed. The puncture needle (as compared with the case where it is punctured into the examiner's skin) is separated from the dressing material 10 by a minimum thickness, and the position closest to the right end of the distal end surface of the head portion 102 of the ultrasonic probe 100 (that is, super The skin of the subject is punctured from the position closest to the sound wave transmission / reception range UR). Therefore, according to the echo lower body surface puncture auxiliary device of the present embodiment, the puncture needle is positioned in the closest position of the ultrasonic transmission / reception range UR of the ultrasonic probe 100 as compared with the conventional case (that is, the closest to the field width of the echo image). The puncture position can be punctured only by slightly proceeding from the position) toward the subject's skin, and then the puncture position can be inserted into the subject's body. As a result, the puncture needle enters the ultrasonic transmission / reception range UR immediately after being inserted into the subject's skin (for example, even in the case where the echo gel portion 20 is not provided). Compared to the case of the guide device, the image unidentifiable area where the puncture needle cannot be confirmed with the echo image is greatly reduced. In particular, the echo lower body surface puncture auxiliary device according to the present embodiment can zero (disappear) the image unidentifiable region for the puncture needle due to the presence of the echo gel portion 20. This point will be described in detail below.

[Configuration for confirmation by echo image of puncture needle]
First, the guide angle of the puncture needle by the guide unit 30 (that is, the advance angle of the puncture needle into the body of the subject) will be described. The guide angle of the puncture needle is the same as in the case of the conventional puncture guide device. The puncture needle is inserted into the body of the subject at the same angle as the inclination angles of the guide holes H1 to H5 of the guide portion 30 at the same angle as the inclination angles of the guide holes H1 to H5. That is, as shown in the enlarged view in FIG. 5, the traveling paths P1, P2, P3, P4, and P5 of the puncture needle guided by the guide holes H1 to H5 of the guide portion 30 are the axial centers of the guide holes H1 to H5. It matches the extension line of. The inclination angles of the guide holes H1 to H5 of the guide portion 30 are inclined so that the depth position of the lesioned part of the subject who wants to reach the tip of the puncture needle can be obtained as in the case of the conventional puncture guide device. Each is set to be an angle. Here, the number and inclination angle of the guide holes H1 to H5 of the guide portion 30 are set according to the depth position of the lesioned portion that is the puncture needle arrival position, the number of depth positions, and the like. Then, by providing five guide holes H1 to H5 in the guide portion 30 at different inclination angles with a certain angular interval, a single guide portion 30 punctures a total of five different depth positions. The needle reaching position can be achieved. In addition, the echo hypodermic surface puncture auxiliary device of the present invention may be provided with a plurality of (four or less or six or more) different guide holes in one guide portion, and the guide holes are spaced at a constant angular interval. It may be provided at intervals which are not.

In any case, the tip of the puncture needle inserted and guided in the guide holes H1 to H5 of the guide portion 30 is the corner of the lower end edge of one side surface (right side surface in FIG. 5) of the head portion 102 of the ultrasonic probe 100. It is exposed from the tip opening of the guide holes H1 to H5 at a position closest to the corner (corner), and proceeds from the position closest to the corner of the lower end edge of the head portion 102 toward the skin of the subject. At this time, the echo gel portion 20 is interposed between the distal end surface of the head portion 102 of the ultrasonic probe 100 and the subject's skin, and the distal end surface of the head portion 102 and the subject's skin are disposed. The gap is spaced apart by an interval of the thickness dimension D5 of the echo gel portion 20. Therefore, immediately after the puncture needle is exposed from the distal end openings of the guide holes H1 to H5 of the guide portion 30, as described above, first, the right side surface of the echo gel portion 20 or the upper side surface of the right edge (or the corner between them). Part) enters the echo gel part 20 and then punctures the skin of the subject for the first time when the lower surface of the echo gel part 20 is reached. Therefore, according to the inclination angle of the guide holes H1 to H5 of the guide portion 30 (that is, the guide angle of the puncture needle), in particular, the guide hole having the maximum inclination angle with respect to the skin of the subject (in the case of FIG. 5). In accordance with the inclination angle of the guide hole H1), the thickness dimension D5 of the echo gel portion 20 is set to a predetermined value so that the puncture needle always passes through the ultrasonic transmission / reception range UR of the head portion 102 before puncturing the subject's skin. By setting the thickness dimension to be equal to or greater than the thickness, the tip position of the puncture needle is always set to a predetermined range inside the echo gel part 20 (precisely, inside the echo gel part 20 before puncturing the subject's skin). It can be confirmed by an echo image in a range overlapping the ultrasonic transmission / reception range UR). That is, before the puncture needle is punctured into the subject's skin by the echo gel part 20, the tip position of the puncture needle is confirmed in advance by an echo image by a distance corresponding to the thickness dimension D5 of the echo gel part 20. A region (hereinafter referred to as “preliminary confirmation region”) is provided between the distal end surface of the head unit 102 and the skin of the subject.

As a result, in consideration of the inclination angle of the guide holes H1 to H5 of the guide portion 30 (particularly, the inclination angle of the guide hole H1 that is the maximum inclination angle), the thickness dimension D5 of the echo gel portion 20 is used for the prior confirmation. The puncture needle is set immediately after being inserted into the subject's skin by setting the area so that the thickness dimension is equal to or greater than the thickness that is always ensured, and before the subject's skin is punctured. In the fixed region where the echo gel part 20 exists (that is, the region for preliminary confirmation), the ultrasonic wave transmission / reception range UR is advanced, whereby the tip position and the traveling direction of the puncture needle before puncturing the skin of the subject. In addition, the puncture needle can be inserted into the body of the subject while confirming the traveling angle with the echo image. As a result, the echo gel unit 20 eliminates the image unrecognizable region of the puncture needle before puncturing the subject's skin (which was unavoidable with the conventional puncture guide device). The inspection time for ensuring safety (necessary in some cases) (for example, the inspection time for confirming the presence or absence of blood vessels in the body surface portion as a conventional image unidentifiable region) can be significantly shortened. It is possible to perform the puncture technique more efficiently. Further, the advance direction and angle of the puncture needle are confirmed by an echo image from the stage before being inserted into the body of the subject by the region for prior confirmation by the echo gel unit 20, and then the puncture needle is attached to the subject. The needle can be inserted toward the target site in the body, so that the puncture accuracy of the puncture needle (the puncture needle is inserted into the body from the puncture position of the subject's skin toward the target site along the desired path. Accuracy) can be greatly improved.

Thus, in the present embodiment, when the puncture needle passes through the ultrasonic transmission / reception range UR (that is, the ultrasonic scanning range and echo image acquisition range) from the transmission / reception surface 103 of the ultrasonic probe 100, the echo gel is used. With the pre-confirmation area provided by the unit 20, it is possible to reliably confirm the insertion path of the puncture needle (particularly, the position of the tip of the puncture needle) from the echo image of the ultrasonic probe 100. In other words, the echo gel portion 20 is in a stage before the puncture needle reaches the skin of the subject (that is, before being punctured into the body of the subject), and the tip of the puncture needle is the echo gel portion 20. The thickness dimension D5 is set to a dimension that passes through the ultrasonic transmission / reception range UR. That is, the echo gel part 20 is a stage before the tip of the puncture needle passes through the ultrasonic transmission / reception range UR inside the echo gel part 20 at the stage before the puncture needle is punctured into the skin of the subject. The thickness dimension D5 is set so as to be inserted into the body from the skin. Thereby, before the puncture needle is inserted into the body of the subject, the advance confirmation region (that is, the ultrasonic transmission / reception range UR inside the echo gel portion 20) is necessarily a certain section in the echo gel portion 20. (Section), the advancement path P1 to P5 of the puncture needle can be confirmed in advance with an echo image, and the puncture procedure of the puncture needle is performed after confirming the puncture path into the body of the subject in advance. Therefore, the accuracy of the puncture technique can be greatly improved. That is, as described above, the echo gel unit 20 uses ultrasonic waves as the pre-puncture path securing member for the traveling paths P1 to P5 of the puncture needle immediately before being inserted into the subject's skin from the side of the ultrasonic probe 100. The fourth function (pre-puncture route securing function) for securing a reserve route for confirmation by echo images within the ultrasonic transmission / reception range UR of the probe 100 is exhibited.

From another point of view, the relationship between the thickness dimension D5 of the echo gel portion 20 and the inclination angles of the guide holes H1 to H5 of the guide portion 30 is set to a relationship that can secure the prior confirmation area. (That is, after the puncture needle has passed through the ultrasonic irradiation range UR in the echo gel portion 20 at the stage before puncturing the subject's skin, the puncture needle is inserted into the body from the subject's skin. Relationship, that is, a relationship in which the pre-puncture route securing function can be realized). At this time, among the guide holes H1, H2, H3, H4, and H5 of the guide part 30, the guide hole (that is, the guide hole H5) that maximizes the guide angle with respect to the skin of the subject is used. When inserted into the guide hole H5 and guided, the puncture needle passes through the outermost region in the ultrasonic transmission / reception range UR. Therefore, the thickness dimension D5 of the echo gel portion 20 (and the relationship between the thickness dimension D5 of the echo gel portion 20 and the angle of the guide hole H5) is set by inserting the puncture needle into the guide hole H5 having the maximum inclination angle. When the puncture needle passes through the ultrasonic transmission / reception range UR within the echo gel portion 20 at the stage before the puncture needle is punctured into the subject's skin, Set to be inserted into the body. That is, if the echo gel portion 20 can exhibit the pre-puncture route securing function for the guide hole H5 having the maximum inclination angle, the other guide holes H1 to H4 can reliably perform the pre-puncture route securing function. Can do. That is, according to the echo lower body surface puncture auxiliary device of the present embodiment, the problem described in the above-described conventional problem 1 (puncture accuracy) can be reliably solved by the echo gel unit 20.

[Easy change of guide angle of puncture needle by guide unit]
Next, the guide portion 30 is fixed to a predetermined position on the lower surface of the dressing material 10 by a predetermined fixing means (adhesive, adhesive, etc.). Possible fixing means can also be used. That is, the guide part 30 is fixed to the dressing material 10 by fixing means, and if necessary, an external force (tensile force) more than a predetermined value for intentionally peeling the dressing material 10 is applied to the guide part 30. The guide portion 30 can be configured to be detached from the dressing material 10. Further, in the case where the guide unit 30 is configured in this way, a plurality of types of guide units 30 having appropriate configurations may be prepared according to the type of the ultrasonic probe 100, the depth position of the target site to be punctured, and the like. (For example, if a plurality of types of guide portions 30 having different external shapes and dimensions and / or the number of guide holes, inclination angles, etc. are prepared), the type of ultrasonic probe 100 and the depth of a target site to be punctured If the position or the like has been changed (for example, immediately before the puncture procedure), the guide unit 30 having a more appropriate configuration can be dressed instead of the guide unit 30 that has been fixed to the dressing material 10 as necessary. By adhering to the material 10, the puncture technique for the puncture needle can be executed with high accuracy and efficiency at all times using the guide portion 30 having the optimum configuration according to the situation. . That is, in this configuration, the guide portion 30 is configured to be exchangeable with respect to the dressing material 10. Even when the guide portion 30 is not configured to be exchangeable with respect to the dressing material 10 (that is, when the guide portion 30 is fixed so as not to be detached), the auxiliary device for echo lower body surface puncture according to the present embodiment is the dressing material 10, echo gel. Since it has a very simple and compact configuration consisting only of the section 20 and the guide section 30, and the parts cost and manufacturing cost are also low, the type of the ultrasonic probe 100 and the depth of the target site to be punctured It is also a practical option to prepare a plurality of types of guide portions 30 having an appropriate configuration according to the position and the like, and to use the guide portion 30 having an optimal configuration according to the situation. The puncture technique can be performed with very high accuracy and efficiency. As a result, the echo lower body surface puncture auxiliary device according to the present embodiment (when using an expensive puncture guide device as in the prior art, the puncture angle of the puncture needle is limited to some extent from the viewpoint of cost. Since the guide portion 30 can be prepared in a variety of configurations, and the guide portion 30 can be configured to be exchangeable with respect to the dressing material 10. Compared with the prior art, when selecting the insertion angle of the puncture needle, the optimal insertion angle can be selected from the different insertion angles by the more guide units 30, and the target site The insertion angle can be arbitrarily changed as much as possible according to the puncture depth. That is, according to the echo lower body surface puncture auxiliary device of the present embodiment, the above-described configuration can surely solve the problem described in the above-described conventional problem 2 (flexibility of examination range).

[Compact configuration and cost reduction]
Next, as described above, the auxiliary device for echo lower body surface puncture according to the present embodiment is composed of only the dressing material 10, the echo gel part 20, and the guide part 30, so that the overall structure is very simple and compact. In addition, since the component cost of each element or member (dressing material 10, echo gel portion 20, guide portion 30) can be reduced, the overall manufacturing cost can also be reduced. And the echo lower body surface puncture auxiliary device according to the present embodiment configured as described above, for example, even when there is an uneven portion such as a clavicle (interfering with a conventional puncture guide device) at the puncture position The portion that comes into contact with the concavo-convex portion is mainly the echo gel portion 20 on the lower surface side of the dressing material 10, and the echo gel portion 20 is configured to be soft and flexible. Therefore, since the echo gel part 20 flexibly changes the shape according to the shape of the concavo-convex part around the puncture position of the subject, the ultrasonic probe 100 regardless of the presence of the concavo-convex part around the puncture position. Can be accurately arranged corresponding to the intended puncture position. That is, the echo lower body surface puncture auxiliary device of the present embodiment can greatly prevent the interference at the puncture site where such an uneven portion or the like exists, and greatly improve the operability of the ultrasonic probe 100. This is also due to the fact that the auxiliary device for echocardiographic surface puncture according to the present embodiment has a very compact configuration with as few protrusions as possible from the ultrasonic probe 100. In addition, the auxiliary device for echo lower body surface puncture according to the present embodiment does not require a probe cover having a large structure for antifouling of an ultrasonic probe, etc., unlike the conventional echo lower body surface puncture operation, A similar function can be exhibited by the dressing material 10 having a simple and compact configuration. Further, since the dressing material 10 is adhered and adhered to the head portion 102 of the ultrasonic probe 100, the dressing material 10 is not spread around the ultrasonic probe 100, and the dressing material 10 obstructs the progress of the puncture needle. And the puncture of the puncture needle is not hindered. As a result, an extra work (ie, processing of the probe cover) for proceeding with the puncture procedure (as compared with the case of using a conventional probe cover) is unnecessary, and the operability in the puncture principle can be greatly improved. . In addition, the echo lower body surface puncture auxiliary device of the present embodiment can be reduced in cost as described above. Further, even if the shape and size of the attachment site vary depending on the type of the ultrasonic probe, the dressing material 10 that is in the form of a flexible film is different while the auxiliary device for puncturing the lower body of the echo is used in the same configuration. Similarly, the covering range of the head portion and the like of the ultrasonic probe having a shape and size can be completely covered, and the dressing material 10 can absorb the difference depending on the type of the ultrasonic probe. As a result, the auxiliary device for echohypophyseal surface puncture according to the present embodiment is basically designed individually according to the type and model number of the ultrasonic probe, and needs to be prepared separately for each type and model number. However, versatility can be greatly improved and economic efficiency can be greatly improved.

[Other structural features]
A characteristic configuration other than the above will be described with respect to the auxiliary device for echohypophyseal surface puncture according to the present embodiment. First, the guide portion 30 is disposed on the lower surface of the dressing material 10 with a gap at a minute interval from one end of the echo gel portion 20 (the right end in FIGS. 3 and 5). This is to allow the dressing material 10 to be smoothly folded at the boundary position when the dressing material is folded at the boundary position between the echo gel portion 20 and the guide portion 30 and / or the guide. When the portion 30 is arranged on the side of the head portion 102 of the ultrasonic probe 100, the lower end of the guide portion 30 is arranged so as to substantially coincide with the lower end position of the side surface of the head portion 102 as shown in FIG. It is to make it. In addition, if necessary, it is also possible to eliminate the minute gap between the echo gel part 20 and the guide part 30 and bring them into close contact with each other. As shown in FIGS. 2 and 3, the guide portion 30 is collinear with the echo gel portion 20 and the axial center (center position in the width direction) on the lower surface of the dressing material 10 before use. The echo gel part 20 is fixed in close proximity or close to one end in the length direction so as to extend in the direction. Further, as shown in FIG. 5 and FIG. 6, the guide portion 30 is in the state of use in the state where the echo gel portion 20 and the center position in the width direction are matched with each other on the lower surface of the dressing material 10. The echo gel part 20 is fixed in close proximity or close to one end in the length direction so as to intersect with the upper surface of the part 20 at a predetermined angle and extend upward. That is, when the front end surface of the head portion 102 of the ultrasonic probe 100 is disposed opposite to the echo gel portion 20 in a pre-use state (for example, the first to third mark lines L1 to L3 of the dressing material 10 are used). In particular, the center position in the width direction of the head portion 102 is matched with the center position in the width direction of the echo gel portion 20, and the right side surface position of the head portion 102 is set to the right end position of the echo gel portion 20 (that is, the echo gel portion 20 and the guide portion). 30), the right side portion of the dressing material 10 (than the boundary position between the echo gel portion 20 and the guide portion 30) is bent upward to form the head portion 102. When pasted, the lower end of the guide portion 30 is automatically arranged to substantially coincide with the lower end position of the side surface of the head portion 102 as shown in FIG. To, a state in which the guide portion 30 is made to match the head portion 102 and a widthwise center position. Thus, the guide portion 30 can be accurately placed at a predetermined position on the side surface of the head portion 102 by simply placing the head portion 102 of the ultrasonic probe 100 opposite to the echo gel portion 20. Can be used to perform highly accurate puncture procedures. Regarding the width dimension of the guide part 30, in the example of FIG. 6, the width dimension of the guide part 30 is set to the same or approximate dimension as the width dimension D <b> 4 of the echo gel part 20. As long as the center position in the direction is aligned with the center position in the width direction of the echo gel portion 20, the dimensions can be different. The width of the guide portion 30 is preferably within the range of the width of the head portion 102 from the viewpoint of handling.

As shown in FIGS. 3 and 5, the left end surface and the right end surface of the outer peripheral end surface of the echo gel portion 20 are inclined end surfaces that increase in diameter from the upper end toward the lower end. Similarly, as shown in FIG. 6, the front end surface and the rear end surface of the outer peripheral end surface of the echo gel portion 20 are also inclined end surfaces that increase in diameter from the upper end toward the lower end. Thereby, as shown in FIG. 2, the echo gel portion 20 has the outer peripheral edge 21 formed on the lower surface side formed by the lower edge thereof disposed inside the outer peripheral edge 22 formed on the upper edge. become. Note that the inclined end surfaces of the left end surface and the right end surface of the echo gel portion 20 and the inclined end surfaces of the front end surface and the rear end surface are inclined at the same inclination angle. It is arranged inside the outer peripheral edge 21 on the side with a gap of a predetermined interval between it and the outer peripheral edge 21. Further, as shown in FIG. 3, the inclination angle of the inclined end surface of the echo gel portion 20 is the circumferential direction of the guide portion 30 (facing on the lower surface side of the dressing material 10), particularly on the right end surface facing the guide portion 30. One side surface (the inclined side surface on the left side in FIG. 3) is set to the same angle as the inclination angle made with respect to the dressing material 10 or an approximate angle. Thus, in the pre-use state, one circumferential side surface of the guide portion 30 is placed at a certain minute interval on the side (right side) of the inclined end surface on the right end side of the echo gel portion 20 as shown in FIG. In the use state, one circumferential side surface of the guide portion 30 is obliquely above the inclined end surface on the right end side of the echo gel portion 20 (that is, the side surface of the head portion 102), as shown in FIGS. (Upper) with a certain minute interval.

[how to use]
Next, a method for using the auxiliary apparatus for echocardiographic surface puncture according to the present embodiment will be described with reference to FIGS. First, as shown in FIGS. 7 and 8, the dressing material 10 is in a flat state before use, but the release film 13 of the dressing material 10 is peeled from the adhesive layer 12 to expose the adhesive layer 12. Then, the tip surface of the head part 102 of the ultrasonic probe 100 is disposed so as to face the echo gel part 20 above the dressing material 10 adhesive layer 12. Next, as shown in FIG. 9, using the first to third mark lines L 1 to L 3 of the dressing material 10, the entire front end surface of the head portion 102 of the ultrasonic probe 100 is completely covered by the echo gel portion 20. The head portion 102 is aligned so that the right end position of the head portion 102 matches the right end position of the echo gel portion 20, and the center position in the width direction of the head portion 102 matches the center position in the width direction of the echo gel portion 20, The front end surface of the head part 102 is brought into close contact with the adhesive layer 12 of the dressing material 10. As a result, the center position of the dressing material 10 (precisely, the position facing the echo gel portion 20) is not spaced from the front end surface of the head portion 102 by the adhesive layer 12 (that is, particularly with respect to the transmission / reception surface 103 of the head portion 102). With air completely removed). That is, at this time, a medium such as air that attenuates the ultrasonic waves from the transmission / reception surface 103 is completely excluded from between the head unit 102 and the dressing material 10. Next, as shown in FIG. 10, a predetermined portion on the right side of the center portion of the dressing material 10 (that is, a portion on the right side of the boundary position between the echo gel portion 20 and the guide portion 30) is bent upward, and the predetermined portion The portion is adhered to the right side surface of the head portion 102 by the adhesive layer 12. Thereby, the guide part 30 is reliably arrange | positioned in the above-mentioned predetermined position (namely, predetermined position for guiding a puncture needle correctly) in the right side surface of the head part 102. FIG.

Next, as shown in FIG. 11, the remaining portions (left side portion, front side portion, rear side portion) of the dressing material 10 are respectively attached to the remaining side surfaces (left side surface, front side surface, rear side surface) of the head portion 102. 12, and the portions between the front, rear, left and right portions of the dressing material 10 are respectively attached to the corner portions between the front, back, left and right side surfaces of the head portion 102 with the adhesive layer 12. At this time, when the dressing material 10 has the surplus portion EX as in the present embodiment, the surplus portion EX is attached to the corner portion of the head portion 102, but the surplus portion EX is cut off. In this case, the rectangular parts on the front, rear, left and right sides of the dressing material 10 (as defined by the cutting line CL in FIG. 1) are widened by a certain dimension larger than the width dimension of the front, rear, left and right side surfaces of the head part 102. By doing so, the width direction both ends of the wide front and rear, right and left rectangular parts of these dressing materials 10 can be stuck to the corner part of the head part 102. In this manner, the front end surface of the head portion 102 and the front, rear, left and right side surfaces (that is, a predetermined covering range of the ultrasonic probe 100) are completely covered with the dressing material 10. In this state, the echo gel unit 20 completely covers the transmission / reception surface 103 of the ultrasonic probe 100, and the extension of the ultrasonic transmission / reception range UR of the ultrasonic waves transmitted / received from the transmission / reception surface 103 is as shown in FIG. It is arranged on the inner side by a fixed distance from 20 outer extensions (in particular, the outer peripheral edge 22 on the upper surface side). In FIG. 11, the ultrasonic transmission / reception range UR is arranged on the inner side by a certain distance from the extension of the echo gel part 20 in the length direction of the echo gel part 20, but also in the width direction of the echo gel part 20 It is arranged on the inner side by a certain distance from the 20 extensions.

[Puncture technique]
Next, an example of a puncture technique using the echo lower body surface puncture auxiliary device of the present embodiment attached to the ultrasonic probe 100 as described above will be described with reference to FIGS. First, as shown in FIG. 12, the ultrasonic probe 100 equipped with the echo lower body surface puncture auxiliary device of the present embodiment is placed directly above the puncture target site (ie, the lesion) TG in the subject's skin SK. The echo gel part 20 on the lower side of the dressing material 10 covering the head part 102 is brought close to the skin SK of the subject. At this time, while confirming the target site TG in the body of the subject with the echo image by the ultrasound probe 100, the echo gel part 20 is slid on the skin SK of the subject and scanned by the ultrasound probe 100, The target site TG is positioned at a predetermined position (for example, the front / rear / right / left center position) immediately below the echo gel portion 20. Next, predetermined guide holes H1 to H5 corresponding to the depth position of the target part TG are selected from the guide holes H1 to H5 of the guide part 30 disposed on the side of the head part 102 of the ultrasonic probe 100. After the puncture needle is inserted from the proximal end opening of the guide holes H1 to H5 and exposed from the distal end opening, it is guided linearly through the guide holes H1 to H5 and punctured into the skin SK of the subject. Stab into the subject's body. At this time, the echo gel unit 20 functions as the prior confirmation region, and the position and progress of the tip of the puncture needle are detected by the echo image of the ultrasonic probe 100 before the puncture needle is punctured into the skin SK of the subject. The path can be confirmed in the ultrasonic transmission / reception range UR inside the echo gel unit 20. As a result, before inserting the puncture needle into the body of the subject, the puncture accuracy of the puncture needle can be confirmed with an echo image in advance, thereby greatly improving the puncture accuracy and making the puncture technique easier. Can be done. Thereafter, the puncture needle is inserted into the body of the subject while being guided through the guide holes H1 to H5 of the guide portion 30, and the tip of the puncture needle reaches the target site TG, and then the target site TG is detected by the puncture needle. The tissue is collected and the puncture needle is withdrawn from the subject's body. Also at this time, the puncture needle can be smoothly pulled out by guiding the puncture needle through the guide holes H1 to H5 of the guide portion 30.

Here, according to the echo lower body surface puncture auxiliary device of the present embodiment, as shown in FIG. 13, by selecting one of the guide holes H1 to H5 of the guide portion 30, the puncture needle is moved to the guide hole H1. While being guided by .about.H5, it is possible to insert into a plurality of target sites TG at different depth positions in the body of the subject. When the inclination angles of the guide holes H1 to H5 of the guide portion 30 are set at a constant angular interval, the arrival position of the tip of the puncture needle (the position of the target site TG in FIG. 13) is the transmission / reception of the ultrasonic probe 100. When they are at the same position in the plane direction of the surface 103 (when aligned in the vertical direction as shown in FIG. 13), the guide holes having a large inclination angle from the guide holes H5, H4, H3, etc. having a small inclination angle with respect to the skin SG. As H1, H2, H3, and the like increase, the rate of increase in the depth of the arrival position of the tip of the puncture needle increases. However, if the amount of insertion of the puncture needle into the body of the subject (insertion length) is the same, the tip of the puncture needle regardless of whether the inclination angle of the guide holes H1 to H5 is increased or decreased. The increase rate of the depth of the target part TG that reaches is equal. That is, FIG. 13 illustrates the case where the arrival position of the tip of the puncture needle is at the same position in the plane direction of the transmission / reception surface 103 of the ultrasonic probe 100, but this is limited to the actual puncture technique. It is not meant to be performed, but is merely an illustration for convenience of explanation. In FIG. 13, the shallowest target site TG is drawn so as to be the closest position of the skin SK, but this is also for convenience of explanation.

[Possibility of change of invention]
By the way, in the echo lower body surface puncture auxiliary device of the present invention, the ultrasonic probe 100 can be smoothly slid on the skin of the subject by the sliding function of the echo gel part 20 as in the above embodiment. Alternatively, a separate (slurry or gel) echo gel having a high fluidity may be additionally applied to the skin SK of the subject to further improve the slidability of the ultrasonic probe 100. Alternatively, the lower surface (contact surface with the skin) of the echo gel portion 20 may be processed to further increase the sliding property (for example, the lower surface of the echo gel portion 20 is provided with a sliding increase layer made of a material having low friction resistance. Etc.).

[Embodiment 2]
Hereinafter, an echo lower body surface puncture auxiliary device according to Embodiment 2 of the present invention will be described. As shown in FIG. 14, the echo lower body surface puncture assisting device according to the second embodiment is used as a means for guiding the puncture needle in the guide portion 30, and the individual guide holes H1 to H5 of the guide portion 30 of the first embodiment. Instead, a slit-shaped guide passage H is employed. The other configuration is the same as that of the auxiliary instrument for echo lower body surface puncture according to the first embodiment. As shown in FIG. 14A, the guide passage H has a fan shape or an arc shape corresponding to the side shape of the guide portion 30, the nearest position on one side surface in the circumferential direction on the outer peripheral surface side of the guide portion 30, and the other side surface. Are extended from the most recent position toward the center of the guide portion 30. The guide passage H converges on the center side of the guide portion 30 so that the tip of the puncture needle can be guided at a single point. According to such a slit-shaped guide passage H, as shown in FIG. 14C, the puncture needle can be guided at an arbitrary insertion angle (including the angles of the guide holes H1 to H5). Note that the “passage” of the “guide passage” is not the “hole” shape such as the guide holes H1 to H5 of the guide portion 30 of the first embodiment, but the guide passage of the guide portion 30 of the second embodiment. It includes a slit-like shape such as H, and besides that, it is used as a term for a wide range of concepts including an arbitrary slit-like or slot-like shape and a groove-like shape. That is, in the echo lower body surface puncture auxiliary device of the present invention, the guide passage includes the guide passages of all configurations as long as the puncture needle can be guided in a predetermined insertion direction.

[Effects of the invention]
As described above, the echo lower body surface puncture auxiliary device according to the present invention employs a so-called flexible structure attachment structure in which the puncture auxiliary device is attached to the ultrasonic probe with a flexible structure (flexible sheet structure) dressing material. Therefore, by bending the dressing material at an arbitrary site, it exhibits a specific effect that it can be fixed at the optimum position of any ultrasonic probe regardless of the type and type of the ultrasonic probe. Further, since the dressing material can be easily attached to the ultrasonic probe by the adhesive layer, the attachment / fixing operation of the entire echo lower body surface puncture auxiliary device is facilitated. Moreover, since the echo lower body surface puncture auxiliary device according to the present invention employs a flexible mounting structure using a dressing material, it can be universally used for all types of ultrasonic probes. Further, the echo lower body surface puncture auxiliary device according to the present invention can be punctured more safely because the distance between the ultrasonic probe and the puncture needle (guided by the guide portion) is short. In addition, the echo lower body surface puncture auxiliary device according to the present invention can visually recognize an actual puncture line by an echo image when the puncture needle passes through the echo gel portion, and can puncture with high accuracy. That is, the echo lower body surface puncture auxiliary device according to the present invention has an additional effect that an echo gel portion made of an ultrasonic gel agent is disposed on the lower surface of the dressing material, and the position of the puncture needle at the time of puncture can be confirmed in advance. Also effective. Moreover, the auxiliary device for echo lower body surface puncture according to the present invention can select the puncture angle at any time by the guide portion. Moreover, the auxiliary device for echo lower body surface puncture according to the present invention can be made disposable. In addition, the auxiliary device for echo lower body surface puncture according to the present invention does not require a large attachment structure like a conventional probe cover due to the dressing material, and does not require an operation for keeping the ultrasonic probe clean. Moreover, since the echo lower body surface puncture auxiliary device according to the present invention has a small number of parts as a whole, the cost can be kept relatively low. Furthermore, the auxiliary device for echocardiographic surface puncture according to the present invention does not require a separate dressing material treatment (which was necessary in the past) by simply attaching and fixing the dressing material as an attachment means to the ultrasonic probe. It exhibits the additional effect of becoming. In addition, the auxiliary device for echo lower body surface puncture according to the present invention exhibits the specific effects of the dressing material and the like as described above even when the echo gel part is not provided. It can also be embodied as a configuration without. Further, the auxiliary device for echohypophyseal surface puncture according to the present invention can be applied to all current (and future provided) ultrasonic probes that may be used in echocardiographic surface puncture. (For thyroid mass, mammary mass etc.) is not limited to a specific person.

INDUSTRIAL APPLICABILITY The present invention can be used in the medical industry as an auxiliary device for echocardiographic surface puncture that is used for assisting puncture techniques in body puncture under echo, and is particularly useful in puncture aspiration cytology under echo. It can be used in the medical industry as an auxiliary device for puncture of the lower surface of the body that is fixed to an acoustic probe and assists a puncture suction procedure.

10: Dressing material, 11: Base material, 12: Adhesive layer, 13: Release film 20: Echo gel part, 21: Outer peripheral edge, 22: Outer peripheral edge 30: Guide part, 31: Left half part, 32: Right half part H1 H5: Guide hole (guide passage), H: Guide passage 100: Ultrasonic probe, 101: Grip part, 102: Head part 103: Transmission / reception surface SK: Skin, TG: Target site

Claims

The ultrasonic probe has a shape and dimensions that completely cover a predetermined covering range including at least the tip of the head portion of the ultrasonic probe, and has a flexible film shape at an arbitrary position, and an adhesive layer is provided on one side surface. Dressing material,
A side surface of the head portion in a use state having a guide passage for linearly guiding the puncture needle in a predetermined direction and covering the covered area of the ultrasonic probe with the dressing material on the other side surface of the dressing material And the insertion direction of the puncture needle guided by the guide passage when in the use state is a predetermined puncture corresponding to the depth position of the target site in the body of the subject. An auxiliary device for echo lower body surface puncture, comprising: a guide portion in which the guide passage is formed so as to be in the entry direction.
Further, the ultrasonic gel is integrally formed to be a viscoelastic body having a predetermined length dimension, a predetermined width dimension, and a predetermined thickness dimension, and on a side surface adjacent to the guide portion on the other side surface of the dressing material. Echo gel part fixed,
In the other side of the dressing material, the guide portion is arranged adjacent to one end in the length direction of the echo gel portion, and the width direction center position of the guide gel portion coincides with the width direction center position of the echo gel portion. The auxiliary device for puncturing the lower surface of an echo according to claim 1, wherein
The echo gel portion is disposed so as to be completely opposite to the transmission / reception surface for ultrasonic transmission / reception of the head portion of the ultrasonic probe in the use state, and transmits / receives ultrasonic waves from the transmission / reception surface of the ultrasonic probe. The length dimension and the width dimension are set so that the extension of the range is located within the extension of the echo gel part, and the puncture needle guided by the guide passage of the guide part is applied to the skin of the subject. 3. The thickness dimension is set so that the tip of the puncture needle passes through the ultrasonic wave transmission / reception range within the extension range of the echo gel portion before puncturing. Echo lower body surface puncture aid.