WO2021020185A1

WO2021020185A1 - Puncture aid

Info

Publication number: WO2021020185A1
Application number: PCT/JP2020/027932
Authority: WO
Inventors: 芳樹澤; 裕司阪下; 宙治桐野; 寿稔安部; 史哉二松
Original assignee: 国立大学法人大阪大学; 株式会社クリスタル光学; 株式会社クアトロメディカルテクノロジーズ
Priority date: 2019-07-29
Filing date: 2020-07-17
Publication date: 2021-02-04
Also published as: JP2021019955A

Abstract

Provided is a puncture aid for percutaneously puncturing a blood vessel of a living body with a puncture needle, the puncture aid comprising a body including a regulating part that regulates the direction of travel of the puncture needle relative to a blood vessel the placement in the living body of which has been confirmed in advance, and a fixing means for fixing the body to the skin of the living body. The puncture aid is applicable regardless of the shape of an ultrasonic probe or the axial direction thereof when performing ultrasonically guided puncturing, and is also applicable when not performing ultrasonically guided puncturing, such as the landmark method. The puncture aid is capable of preventing erroneous puncturing of the carotid artery and the like by enabling, for example, stable insertion of the puncture needle along the placement line direction of the jugular vein.

Description

Puncture aid

The present invention relates to a puncture aid used when a puncture needle is percutaneously punctured into a blood vessel or the like in a living body.

Conventionally, the act of puncturing a living body with a puncture needle for the purpose of collecting blood, administering a drug or a nutritional supplement, inserting a catheter, collecting a living tissue, etc. has been widely performed in the medical field. Such puncture with a puncture needle is often performed under non-perspective by imagining the structure of the puncture site based on the experience of a doctor, X-ray image, anatomy, and the like. Even with such a puncture, in many cases, the target site is punctured and appropriate medical treatment is performed. However, for example, in the case of a doctor who has little experience in puncturing, the structure of the puncture site is special and difficult. In the case of a subject or the like, serious complications may be caused by damaging a living tissue other than the intended purpose. Taking percutaneous puncture of the central vein (central vein puncture) as an example, the puncture of a blood vessel of a living body is described in detail as follows.

Central vein puncture is a basic medical procedure and is performed in various fields of medical treatment. For example, central venous puncture is performed when a catheter is inserted and placed in the central vein for systemic management by administering a high-calorie infusion solution, a vasoactive drug, or the like, and measuring the central venous pressure. The internal jugular vein, subclavian vein, femoral vein, and elbow vein are used as the puncture site for placing the catheter in the central vein. Of these, when performing puncture in the operating room / intensive care unit, the right internal jugular vein is the first choice because of its good access and few serious complications. In central vein puncture, a procedure called the landmark method, in which puncture is performed based on an anatomical index on the body surface, has been generally performed. In recent years, ultrasonic-guided puncture, which will be described later, has become common, but the landmark method is still a practiced puncture technique. The success rate of the landmark method is said to be about 90%, and it is considered that the procedure is performed safely with a relatively high probability. On the other hand, there are reports that the incidence of complications is 0 to 20%. In addition, when the puncture site is the internal jugular vein, the risk of erroneous puncture of the common carotid artery running parallel to it has been pointed out. Thus, while the landmark method has a high success rate, it is said to be a procedure that can cause serious complications.

From the viewpoint of avoiding such complications by the landmark method, after grasping the running of the central vein and the cross-sectional structure of the puncture site in advance by ultrasonic waves, (1) puncture is performed by the landmark method, or (2) super Techniques such as puncturing under ultrasonic guidance are performed. However, in the case of (1), although the running and cross-sectional structure of the blood vessel are known in advance, it is not always easy to perform percutaneous puncture into the central vein without any guide. In addition, since central vein puncture is a basic procedure for systemic management performed before performing major surgery, for example, it is often performed by an inexperienced doctor. Therefore, the doctor who performs the central vein puncture is subject to great psychological pressure such as failure is not allowed and the procedure must be completed accurately and promptly, and the hand may be slightly out of order. As a result, for example, puncture along the running line direction of the internal jugular vein may not be possible, and the parallel common carotid artery may be punctured by mistake. In the case of (2), it is possible to puncture while grasping the cross-sectional structure of the puncture site in real time, but the puncture doctor holds the ultrasonic probe with one hand and the puncture needle with the other hand. It is necessary to insert the puncture needle from a predetermined puncture position while checking the ultrasonic tomographic image by ultrasonic waves on the monitor. In this way, with both hands closed, the puncture route must be determined while looking at both the monitor and the puncture position, and puncture must be performed based on the puncture route, so that appropriate puncture may not be possible. Further, when the same psychological pressure as in the case of (1) above is applied, proper puncture may become more difficult. As a result, as in the case of (1), the common carotid artery may be punctured by mistake.

When puncturing under the ultrasonic guide of (2) above, it can be attached to and detached from the ultrasonic probe for the purpose of eliminating such a situation and assisting puncture along the determined puncture route. A puncture guide used by fixing has been proposed (Patent Document 1).

Japanese Patent No. 5514119

For example, Patent Document 1 describes a bracket including an annular member for accommodating the tip of an ultrasonic transducer (ultrasonic probe) and a puncture device that is easily attached to the bracket and allows the patient's body to penetrate to a desired depth. A guide system is described that includes a puncture device guide (a puncture guide) that is accepted and configured to construct a path with a predetermined angle. As described above, in the invention described in Patent Document 1, a bracket for fixing the puncture device guide to the ultrasonic probe is required. However, the shape of the ultrasonic probe differs depending on the model, and it is necessary to prepare a bracket having a shape suitable for the model. Further, the puncture guide that can be attached to such a bracket is complicated to attach the bracket to the ultrasonic probe, and the selection of the puncture guide and its attachment are also complicated, and the selection of the axial direction to which the ultrasonic probe is applied is complicated. It is not in line with the actual situation in the medical field, such as restrictions on the number of patients.

Therefore, an object of the present invention is that when puncturing under ultrasonic guidance, it can be applied regardless of the shape of the ultrasonic probe and its axial direction, and puncture under ultrasonic guidance as in the landmark method. It can be applied even when the procedure is not performed. For example, by enabling the puncture needle to be stably inserted along the traveling line direction of the jugular vein, it is possible to prevent erroneous puncture of the carotid artery. To provide possible puncture aids.

The present inventor conducted a diligent study in order to solve the above-mentioned problems. As a result, it was found that it is effective to adopt a configuration that enables fixation of the living body to the skin, instead of attaching the puncture guide to the ultrasonic probe as in the prior art. Then, for example, by adopting a configuration that regulates the course of the puncture needle along the traveling line direction of the blood vessel to be punctured such as the internal jugular vein, it is possible to suppress erroneous puncture of other organs such as the carotid artery. I found that. From these findings, the present invention has been completed.

Aspect of the present invention is a puncture assisting tool for percutaneously puncturing a blood vessel of a living body, and regulates the traveling direction of the puncture needle with respect to a blood vessel whose running in the living body has been confirmed in advance. The present invention relates to a puncture assisting tool including a main body having a portion and a fixing means for fixing the main body to the skin of a living body.

In the aspect of the present invention, the restricting portion may have a straight traveling direction regulating portion that regulates the straight traveling direction of the puncture needle with respect to the traveling line direction of the blood vessel assumed on the skin surface.

Here, the "straight direction with respect to the traveling line direction of the puncture needle" means the traveling line direction of the blood vessel and the traveling direction of the puncture needle in a plan view on a plane parallel to the skin surface.

In the aspect of the present invention, the straight-ahead direction regulating portion is provided so as to be in contact with the side surface of the puncture needle from both sides in a direction orthogonal to the traveling direction of the puncture needle and can be locked at least in a portion separated in the traveling line direction. It may have a locking portion.

In the embodiment of the present invention, the locking portion is selected from a wall surface that is continuous along the traveling line direction, a wall surface that is discontinuous along the traveling line direction, and a columnar body that can make point contact with the puncture needle. It may have a seed locking portion.

In the aspect of the present invention, the locking portion may have wall surfaces that continuously face each other along the traveling line direction.

In the aspect of the present invention, the locking portion may have a portion in which the distance between the facing wall surfaces becomes narrower as it approaches the skin side in a direction orthogonal to the traveling direction of the puncture needle.

In the aspect of the present invention, the regulating unit may have a traveling angle regulating unit that regulates the traveling angle of the puncture needle with respect to the skin.

Here, the "advance angle of the puncture needle with respect to the skin" means the angle formed by the puncture needle with respect to the skin surface when the puncture needle is punctured into the skin.

In the embodiment of the present invention, when the restricting portion has the locking portion, the advancing angle restricting portion is provided between the locking portions on the traveling line, and the advancing angle of the puncture needle with respect to the skin is determined in advance. It may be provided so that it can be locked by contacting the puncture needle from the skin side so as to be adjustable to a set angle.

In the aspect of the present invention, the advancing angle regulating portion has an inclined portion that continuously inclines so that the height from the skin surface decreases as the puncture position on the skin approaches along the traveling line direction. You may.

In the aspect of the present invention, the inclined portion may have at least one shape selected from a straight line, a convex folding line, and a convex curve as a shape on the traveling line.

In the embodiment of the present invention, the fixing means has a joint portion that is detachably joined to the skin, a connecting portion that is connected to the main body, and the joint portion that is fixed to one surface and the opposite surface. It may have a sheet-like base material portion to which the connecting portion is fixed.

In the aspect of the present invention, the main body may have a support portion for supporting the regulation portion on a side close to the skin.

In the aspect of the present invention, when the main body has the support portion, the fixing means may be fixed to at least a part of the support portion of the main body.

In the embodiment of the present invention, when the main body has the support portion, the support portion has a plate-shaped portion extending toward the puncture position, and the plate-shaped portion has a through hole through which a puncture needle can puncture the skin. Alternatively, a notch may be provided.

In the aspect of the present invention, concave portions and / or convex portions may be formed on the outer surface of the main body except for the skin side along the traveling line.

In the aspect of the present invention, when the inclined portion is provided, the shape of the inclined portion on the traveling line may be formed on the outer side between the advancing angle restricting portions.

Another aspect of the present invention is a puncture method in which a puncture needle is percutaneously punctured into a blood vessel of a living body by using any of the above-mentioned puncture aids, and the puncture target is formed by using an ultrasonic probe. The process of confirming the running in the body and the depth from the skin surface, the mark indicating the running line assumed on the skin surface along the running of the blood vessel and the mark indicating the planned puncture position of the blood vessel in the living body are on the skin surface. It is assumed that the straight direction along the traveling line direction of the puncture needle and the direction of the straight direction restricting portion of the puncture assisting tool are parallel to each other and from the planned puncture position of the blood vessel in the living body. The step of fixing the puncture assisting tool to the skin surface by the fixing means in the vicinity of the puncturing position on the skin surface, and the step of puncturing the blood vessel with the puncture needle along the straight-ahead direction restricting portion of the puncturing assisting tool are included. Regarding the puncture method.

The puncture assisting tool according to the present invention can be applied regardless of the shape of the ultrasonic probe and its axial direction when puncturing is performed under ultrasonic guidance, and is under ultrasonic guidance as in the landmark method. It can be applied even when puncture is not performed. Therefore, the surgeon can stably puncture the puncture needle along the traveling line direction of the jugular vein, for example. As a result, for example, it is possible to prevent erroneous puncture of the carotid artery running parallel to the jugular vein.

It is a perspective view for demonstrating the structure of the main body 6b of the puncture aid which concerns on Example 1. FIG. FIG. 1A is a one-sided cross-sectional view taken along the line IV-IV. It is a perspective view for demonstrating the structure of the main body 7b of the puncture aid which concerns on Example 2. FIG. FIG. 2A is a cross-sectional view taken along the VI-VI line in FIG. 2A. It is a perspective view for demonstrating the structure of the main body 8a of the puncture aid which concerns on Example 3. FIG. FIG. 3A is a cross-sectional view taken along the VII-VII line in FIG. 3A. It is a perspective view for demonstrating the structure of the main body 8b of the puncture aid which concerns on Example 4. FIG. FIG. 4A is a one-sided cross-sectional view taken along the line VIII-VIII in FIG. 4A. It is a perspective view for demonstrating the structure of the puncture aid 9A which concerns on Example 5. FIG. It is a perspective view for demonstrating the structure of the puncture aid 9B which concerns on Example 6. FIG. It is a perspective view for demonstrating the structure of the puncture aid 10A which concerns on Example 7. FIG. It is a perspective view for demonstrating the structure of the puncture aid 10B which concerns on Example 8. FIG. It is explanatory drawing which schematically showed the running of the main vein which is the object of puncture when performing central vein puncture around the human neck. Around the human neck, when a mark indicating a traveling line assumed on the skin surface along the traveling of the internal jugular vein and a mark indicating a planned puncture position of a blood vessel in the living body are attached to the skin surface. It is explanatory drawing which showed the state schematically. It is explanatory drawing which shows typically the state when the puncture aid was fixed to the skin surface in accordance with the mark shown in FIG. 8A. It is explanatory drawing which shows typically the state when the puncture needle is punctured toward the internal jugular vein by using the puncture aid under ultrasonic guidance.

The puncture aid according to the embodiment of the present invention is for percutaneously puncturing a blood vessel of a living body with a puncture needle. The puncture aid includes a main body having a regulating portion that regulates the traveling direction of the puncture needle with respect to a blood vessel whose running in the living body has been confirmed in advance, and a fixing means for fixing the main body to the skin of the living body. To be equipped. The regulation unit has a straight-ahead direction regulation unit that regulates the straight-ahead direction of the puncture needle with respect to the travel line direction of the blood vessel assumed on the skin surface.

As described above, since the puncture aid is provided with a fixing means for fixing the predetermined main body to the skin of the living body, the puncture aid is directly fixed to the skin regardless of the presence or absence of the ultrasonic probe and the shape of the ultrasonic probe. , Can be used when puncturing a puncture needle. Further, since the regulating unit has a straight-ahead direction regulating unit capable of accepting the puncture needle and regulating its traveling direction in a predetermined direction, the operator stabilizes the puncture needle along the traveling line direction of the blood vessel. It is possible to puncture a blood vessel.

The straight-ahead direction regulating unit is not particularly limited as long as it has a structure capable of regulating the straight-ahead direction of the puncture needle with respect to the traveling line direction of the blood vessel assumed on the skin surface. As a structure having such a structure, for example, at least in a portion separated in the traveling line direction, the puncture needle is provided so as to be in contact with the side surface of the puncture needle and lockable from both sides in a direction orthogonal to the traveling direction of the puncture needle. Those having a locking portion can be mentioned. For example, at two points separated from each other in the traveling line direction, the side surface of the puncture needle is in contact with the side surface of the puncture needle from one of the directions orthogonal to the traveling direction of the puncture needle at one point, and puncture is performed at the other point. Contact the side surface of the puncture needle from the other side of the direction orthogonal to the traveling direction of the needle, that is, contact one point each so as to face each other at two points separated from each other in the traveling line direction. Therefore, the straight-ahead direction of the puncture needle with respect to the traveling line direction can be regulated, and the traveling direction thereof can be regulated. Further, from the viewpoint of restricting the straight-ahead direction of the puncture needle, the contact between the puncture needle and the straight-ahead direction restricting portion can occur at at least two separated points that are opposed to each other. It is good, but from the viewpoint of ensuring better operability of the operator, two locking portions that are opposed to each other at at least one of the two separated points are provided, and the other point is provided. In the above, it is preferable to provide one locking portion having an opposite relationship as described above, and to provide a total of three locking portions. Further, in this case, the two locking portions provided on the same side in the direction orthogonal to the traveling direction of the puncture needle at the two separated points may have a continuous structure along the traveling line direction. From the viewpoint of ensuring better operability of the operator, it is more preferable to provide two locking portions facing each other at at least two separated points, and to provide a total of four locking portions. Further, in this case as well, the two locking portions provided on the same side in the direction orthogonal to the traveling direction of the puncture needle at the two separated points may have a continuous structure along the traveling line direction.

The structure of such a locking portion is selected from, for example, a wall surface that is continuous along the traveling line direction, a wall surface that is discontinuous along the traveling line direction, and a columnar body that can make point contact with the puncture needle. An example has one type of locking portion. These can be combined as appropriate. For example, a structure in which only the columnar body or only the discontinuous wall surface or a combination of the columnar body and the discontinuous wall surface is provided so as to abut the puncture needle as described above, only the columnar body or the discontinuous wall surface. Examples thereof include a structure in which only the wall surface is provided in combination with the continuous wall surface, and a structure in which the continuous wall surface is provided so as to face each other along the traveling line direction. The position and number of the columnar body and the discontinuous wall surface can be determined in consideration of contact with the puncture needle as described above. Of these, from the viewpoint of better operability of the operator and from the viewpoint of satisfactorily restricting the straight-ahead direction of the puncture needle with respect to the traveling line direction, the traveling direction of the puncture needle in the vicinity of both ends of the main body along the traveling line direction. It is preferable that locking portions are provided so that they can come into contact with the puncture needle from both sides in the direction orthogonal to the puncture needle. As the structure of such a locking portion, only the columnar body or only the discontinuous wall surface or the discontinuous wall surface is provided on both sides in the direction orthogonal to the traveling direction of the puncture needle in the vicinity of both ends of the main body along the traveling line direction. A structure in which a columnar body and the discontinuous wall surface are combined and provided at a total of four locations, and a structure in which continuous wall surfaces are provided facing each other along the traveling line direction are preferable, and the wall surface continuous along the traveling line direction is preferable. A structure provided so as to face each other is more preferable. Examples of the structure in which continuous wall surfaces are provided facing each other along the traveling line direction include a cylindrical shape that opens at both ends in the traveling line direction, a structure having planes that face each other along the traveling line direction, and the like. Examples of the cylindrical shape include a cylinder having a constant inner diameter, a funnel shape in which the inner diameter gradually decreases from one end to the other, and the like. Examples of the structure having planes facing each other along the traveling line direction include a square cylinder shape having openings at both ends in the traveling line direction, a structure having facing plate-shaped portions, and the like. The square tube shape has, for example, a shape having the same cross section over the entire length in the running line direction, parallel to the running line direction and orthogonal to the skin surface, having opposite planes, and a cross-sectional area toward the puncturing side. An example has a structure in which is gradually reduced. Further, in the case of a tubular shape, an opening that can be opened and closed over the entire length in the traveling line direction may be formed.

The locking portion is provided so as to be in contact with the side surface of the puncture needle from both sides in the direction orthogonal to the traveling direction of the puncture needle and to be locked at least in a portion separated in the traveling line direction. Then, the traveling angle of the puncture needle with respect to the traveling line direction is regulated so as to follow the traveling line of the blood vessel assumed on the skin surface. From the viewpoint of restricting the traveling angle of the puncture needle, the position of the locking portion is assumed to be a straight line along the traveling line on the main body, and if this straight line is used as a reference line, the locking portion abuts on the side surface of the puncture needle. The shortest distance from the reference line of the part should be at least half the outer diameter of the puncture needle, and less than the total length of half the outer diameter of the puncture needle and the gap where the puncture needle can move. Is preferable. When the locking portion has two structures facing each other in a direction orthogonal to the traveling direction of the puncture needle, the shortest distance between the two opposing structures is larger than the outer diameter of the puncture needle, and this outer diameter and the puncture needle move. It is preferably less than or equal to the total length with the possible gap. Further, as long as the locking portion is installed in such a positional relationship in consideration of the relationship with the puncture needle, the side of the two locking portions that is close to the skin side along the traveling line direction. The structure of the bottom of the surface is not particularly limited, and may be, for example, a flat surface, a curved surface, a multifaceted surface, or the like.

On the other hand, the outer diameter of the puncture needle used for puncturing a blood vessel has a plurality of sizes, and there is a difference between the maximum and the minimum. Therefore, when the position of the locking portion is set according to the maximum outer diameter of the applied puncture needle and the puncture needle having the minimum outer diameter is applied, the gap between the puncture needle and the locking portion becomes large, and the puncture occurs. Regulations may be weaker than when the needle travel angle is the maximum outer diameter. Therefore, from the viewpoint of application regardless of the outer diameter of the puncture needle, the contact portion of the locking portion facing the locking portion as it approaches the skin side in the direction orthogonal to the traveling direction of the puncturing needle. It is preferable to have a portion where the distance between them is narrowed. It should be noted that such a structure is also good from the viewpoint of making it easy to align the center line in the length direction of the puncture needle with the traveling line. Such a configuration is more effective when the structure of the locking portion is a structure in which continuous wall surfaces are provided facing each other along the traveling line direction. Examples of such a structure include, but are not limited to, a structure having a V-shaped structure in a cross section in a direction orthogonal to the traveling direction of the puncture needle. Such a V-shaped structure in a predetermined cross section may be a V-shaped structure in the entire cross section, or is adopted in the bottom portion near the skin side of the cross section orthogonal to the traveling direction of the puncture needle and the vicinity thereof, and the skin. The cross section of the portion far from the side may be composed of two parallel lines continuous from the V shape. The opening angle of the V-shape of the V-shaped structure is not particularly limited, but is preferably 10 ° to 90 ° from the viewpoint of advancing the puncture needle along the traveling line without deviation. Further, when a structure in which continuous wall surfaces are provided facing each other along the traveling line direction is formed in the locking portion of the straight-ahead direction regulating portion, it can also function as a traveling angle regulating portion described later.

Further, the configuration of the locking portion according to the outer diameter of the puncture needle may be formed in advance as described above, but may be provided detachably. When it is detachably provided, it is not limited to the one having a portion where the distance between the contact portions of the opposing locking portions is narrowed, and even the one having a parallel contact portion according to the outer diameter of the puncture needle. Good.

It is preferable that the puncture needle assisting tool according to the embodiment has a traveling angle regulating portion that regulates the traveling angle of the puncturing needle with respect to the skin. As a result, in addition to the traveling line direction, the traveling angle of the puncture needle with respect to the skin is also regulated, so that the blood vessel existing at the depth from the skin confirmed in advance can be pierced more reliably. Therefore, the possibility of erroneous puncture into other organs can be further reduced. Such a traveling angle regulating unit has a configuration in which the traveling angle of the entire regulating unit or the straight-ahead direction regulating unit with respect to the skin can be arbitrarily or stepwise changed by a mechanical structure using an elastic body such as a spring. Examples thereof include a configuration in which a structure such as a locking portion that can be locked by contacting the puncture needle from the side is provided. From the viewpoint of the operator's operability, the degree of freedom of angle adjustment, the simplicity of the three-dimensional structure, and the sterilization, a structure such as a locking portion that can be locked by contacting the puncture needle from the skin side is provided. The configuration is preferred.

When the traveling angle regulating portion is provided, the traveling angle regulating portion is provided between the locking portions on the traveling line from the viewpoint of simultaneously efficiently and easily regulating the traveling line direction and the traveling direction of the puncture needle with respect to the skin. Therefore, it is preferable that the traveling angle of the puncture needle with respect to the skin can be adjusted to a preset angle so that the puncture needle can be locked by contacting the puncture needle from the skin side. Examples of such a traveling angle regulating portion include a portion that can function as a fulcrum at at least one point on the side surface of the puncture needle, a portion that contacts the puncture needle over a predetermined length in the length direction, and the like. Structures that can function as the fulcrum include, for example, one columnar body having a predetermined height from the skin surface, two or more columnar bodies whose height from the skin surface decreases as the height approaches the puncture position, and the skin surface. A stepped structure in which the height from the skin gradually decreases as it approaches the puncture position on the skin, and an inclined structure in which the height from the skin surface decreases continuously as it approaches the puncture position on the skin. Be done. Of these, from the viewpoint of the degree of freedom of the operator's angle adjustment according to the situation, those having an inclined portion having an inclined structure tend to be preferable. The inclined structure is not particularly limited, and examples thereof include those having at least one shape selected from a straight line, a convex polygonal line, and a convex curve as the shape on the traveling line. In the case of a straight line, the angle with respect to the skin has a constant angle. This angle can be determined according to the depth of the blood vessel from the skin and the puncture method. For example, when puncturing a human jugular vein by the landmark method, it is generally 30 °.
It is set to ~ 45 °. When puncturing a human jugular vein under ultrasonic guidance, the temperature is generally set to 60 °, but it may be larger than this. In the case of a convex fold line, the angle of advance with respect to the skin gradually increases as the puncture position on the skin approaches. As such a configuration, for example, from the side closest to the puncture position, a specific angle of 50 ° to 70 °, 40 °
Examples thereof include, but are not limited to, a specific angle of up to 60 °, a specific angle of 20 ° to 50 °, and the like. Further, a portion opposite to the puncture position and having a portion of 0 ° as a portion parallel to the skin surface may be provided continuously on the inclined portion. More specifically, for example, when 60 °, 45 °, and 0 ° are set in order from the side closest to the puncture position, 60 °, 4
Examples include, but are not limited to, 5 °, 60 °, 45 °, and 0 °. In the case of a convex curve, for example, an arc, an elliptical arc, and the like can be mentioned. The lengths of the arc and the elliptical arc can be appropriately selected, and examples thereof include, but are not limited to, a 1/4 arc and a 1/4 elliptical arc partitioned by a major axis and a minor axis portion. When combining a curved line and a straight line, it is preferable to make them continuous at both ends of the arc so that a recess is not formed. Further, as the shape of the inclined portion including the shape on the traveling line, an inclined surface or the like can be mentioned.

If necessary, the main body may have a support portion that supports the regulation portion on the side close to the skin. As a result, when the main body is fixed to the skin, the main body is more stably fixed to the skin, so that more stable puncture can be performed without shifting the direction of the regulating portion.

The shape and structure of the support portion are not particularly limited, and can be appropriately determined according to the shape and structure of the regulation portion and the fixing means described later. For example, the straight-ahead direction regulating portion of the regulating portion is a member having a plate-like structure having a wall surface continuous along the traveling line direction, or a rod-shaped member having a discontinuous wall surface along the traveling line direction as described above. When a member having a plate-like structure or a columnar body capable of point contact with a puncture needle is provided, a structure having a plate-like structure capable of placing these and supporting them from the skin side may be adopted. it can. Further, also in the case of a member having two plate-like structures having wall surfaces continuously facing each other along the traveling line direction, these members can be placed and supported from the skin side. A structure having a structure can be adopted. Further, a structure in which the straight-ahead direction regulating portion of the regulating portion extends from a portion of a plate-like structure close to the skin side that forms a wall surface that continuously faces the traveling line direction and connects the two to form a bottom portion. In the case of a member having a plate-like structure on which this member can be placed and supported from the skin side, or a portion having a plate-like structure forming a wall surface, the bottom portion thereof. A plate-like structure that is connected in the vicinity and extends along the skin surface can be adopted. Further, even when the regulating portion has the various straight-ahead direction regulating portions and the advancing angle regulating portion described above, a plate-like structure capable of mounting the entire portion including the regulating portion and supporting it from the skin side is provided. It is possible to adopt a structure having a structure, or a structure having a plate-like structure that is connected in the vicinity of the bottom portion close to the skin and extends along the skin surface among the portions including the regulation portion. Further, the structure having such a plate-like structure is provided along the skin surface from the outer peripheral portion of the portion close to the skin side of the portion including the regulation portion from the viewpoint of better supporting the portion including the regulation portion. It is desirable that a plate-shaped portion is formed so as to extend. The position where such a plate-shaped portion is provided is not particularly limited, and may be provided on the entire circumference along the outer circumference of the portion including the regulation portion, or may be provided on a part of the outer circumference thereof. The shape, size, etc. of the plate-like structure can be determined according to the structure of the skin surface to be applied, the structure of the fixing means, the arrangement, and the like. Further, these members may be formed separately and combined, or may be integrally formed. When the fixing means and the supporting portion are integrally formed, it tends to be advantageous to form the supporting portion or a part of the supporting portion separately so as to be detachable together with the fixing means. When adopting a simple structure from the viewpoint of molding cost, detergency, and sterility, it tends to be advantageous to integrally form the main body. Further, when the fixing means is provided on the support portion, from the viewpoint of ensuring the bonding force with the skin and ensuring the workability of puncture, the support is larger in the direction orthogonal to the traveling line direction than in other directions. It may be advantageous to provide a section.

As the structure of the support portion, for example, the above-mentioned structure can be adopted, but from the viewpoint of facilitating the identification of the puncture position on the skin, the support portion has a plate-shaped portion extending toward the puncture position on the skin and the plate. It is preferable that the shape portion is provided with a through hole or a notch portion through which the puncture needle can puncture the skin. A plurality of through holes may be provided so as to correspond to the positions corresponding to the advancing angles from the viewpoint of facilitating the selection of the advancing angle of the puncture needle with respect to the skin according to the depth of the blood vessels from the skin surface. Further, in the case of the cutout portion, an angle display or the like may be provided at a position corresponding to the traveling angle from the same viewpoint. However, it is not always necessary to provide the travel angle when the travel angle is specified by the travel angle regulation unit of the regulation unit.

From the viewpoint of ensuring visibility in the traveling line direction, it is preferable that the outer surface of the main body excluding the skin side has concave portions and / or convex portions formed on the outer surface along the traveling line. Further, from the viewpoint of improving visibility, it is more preferable that these concave portions and convex portions are given a color different from that of other portions.

Further, it is preferable that the shape of the inclined portion of the advancing angle regulating portion on the traveling line is also formed on the outer side between the locking portions in the main body. Thereby, the structure of the inclined portion can be easily confirmed visually or by the tactile sense of the hand without directly confirming the structure of the inclined portion. The shape of the inclined portion on the traveling line reproduces all or part of the shape of the surface of the inclined portion facing the puncture needle on the traveling line from the viewpoint of confirming the structure of the inclined portion that can come into contact with the puncture needle. It is preferably provided on the outer surface of the main body on the outside between the locking portions so as to have a positional relationship corresponding to the inclined portion.

The fixing means may be any as long as the main body can be directly fixed to the skin. For example, (i) having an adhesive layer that can be detachably adhered to the skin and the main body, (ii) a physical fastener such as an adhesive layer that can be detachably adhered to the skin and a surface fastener that can be detachably fixed to the main body. Those with a fixing part, (iii) a sucker that can be attached to and detached from the skin and an adhesive layer or a physical fixing part that fixes the sucker to the main body, (iv) can be detachably adhered to the skin Those having an adhesive layer and having an adhesive layer that is non-detachably connected to the main body, (v) a through hole or the like is provided in the main body, and a needle is pierced through the through hole or the like is sewn to the skin through a thread to sew the main body. Those that are fixed to the skin, (vi) The magnets are fixed to the skin and the main body and can be attached and detached by magnetic force. The main body is fixed to the skin (vii) and can be wrapped around the living body such as the neck. Examples include those that fix the main body to the skin with an adhesive belt. From the viewpoint of cleaning, sterilizing, and reusing the main body, it is preferable that such an adhesive layer, a physical fixing portion, and the like are removable to the skin and the main body. Examples of (i) include (i-1) a single-sided tape having an adhesive layer on one surface of the sheet-like base material, and (i-2) one surface of the sheet-like base material as the main body. Examples thereof include those provided with a double-sided tape capable of bonding the other surface to the skin, (i-3) a combination of the single-sided tape and the double-sided tape, and the like. As (i-1), a single-sided tape provided with a general adhesive layer such as a sadical tape, a moisture-absorbing gel layer having adhesiveness is provided at a joint portion to be bonded to the skin, and a sadical tape or the like is provided at a portion connected to the main body. Examples thereof include a single-sided tape provided with a general adhesive layer. As (i-2), a joint portion that is detachably joined to the skin, a connecting portion that connects to the main body, and the joint portion are fixed to one surface, and the connecting portion is located on the opposite surface. An example having a fixed sheet-like base material portion. Examples of the joint include a general adhesive layer similar to that of a sadical tape, the hygroscopic gel layer, and the like. Examples of the connecting portion include a general adhesive layer similar to a sadical tape or the like. As the base material portion, those used for general single-sided tape or double-sided tape can be used. The adhesive layer constituting the joint portion is preferably formed on the entire base material portion from the viewpoint of securing the joint area with the skin. The adhesive layer constituting the connecting portion is preferably formed only on the portion to be joined to the main body (corresponding to (i-3)), but the portion to be joined to the main body is covered with a protective film. You may. As for (ii), the adhesive layer that can be detachably adhered to the skin can adopt the same structure as that of (i). Examples of the physically fixing portion that can be detachably fixed to the main body include a hook-and-loop fastener. The adhesive layer and the physical fixing portion are formed on, for example, a sheet-shaped base material portion. The hook-and-loop fastener has a hook surface and a loop surface, and it is preferable that one of them is fixed to the main body and the other to the base material portion by an adhesive or the like. Examples of (iii) include a suction cup used when connecting an electrocardiogram electrode to the skin, and a suction cup provided with an adhesive layer or a physical fixing portion for fixing such a suction cup to the main body. Examples of the physically fixed portion include a clip and the like. Examples of (iv) include those in (i-2) above, in which the connecting portion with the main body is used as an adhesive layer such as an adhesive to be detachably connected to the main body. Examples of (v) include those in which a plurality of through holes are provided on the peripheral edge of the main body close to the skin, sutures are passed through the through holes, and the main body is sutured and fixed to the skin by the sutures. .. As (vi), for example, a magnet is fixed to a part of the main body close to the skin with tape, an adhesive or a physical mechanism, and the magnet is detachably fixed to the skin with tape or the like corresponding to this. And so on.

Of these fixing means, (i) and (iv) are preferable from the viewpoint of convenience and certainty of fixing the main body to the skin. Further, among (i), (i-2) is more preferable.

The fixing means is preferably fixed to at least a part of the support portion of the main body from the viewpoint of certainty of fixing to the skin of the main body. Further, from the viewpoint of ensuring the joint strength between the fixing means and the main body, a connecting portion between the fixing means and the main body may be formed in a portion other than the support portion.

The main body or the fixing means may be connected to an auxiliary sheet on which a reference line indicating a puncture position of a blood vessel in a living body, a puncture position on the skin, or an installation position of an ultrasonic probe assisting the puncture is displayed. This makes it possible to more accurately insert the puncture needle into the blood vessel in the living body confirmed in advance.

The material of the main body may be any of synthetic resin, metal, ceramics and the like, but synthetic resin is preferable. Further, the dimensions of the main body and each part constituting the fixing means can be appropriately determined in consideration of the dimensions of the puncture needle, the target on which the puncture aid is installed, the installation position, and the like. The main body may have a solid structure or may have a space formed inside, as long as it has an external shape having the above-mentioned structure.

Hereinafter, an example of the puncture assisting tool will be described with reference to the drawings.

(Example 1)
FIG. 1A is a perspective view for explaining the structure of the main body 6b of the puncture assisting tool according to the first embodiment, and FIG. 1B is a one-sided sectional view taken along line IV-IV in FIG. 1A. The puncture assisting tool according to the first embodiment includes a main body 6b having a regulating portion 38 and fixing means.

The main body 6b has a structure in which a notch portion capable of following a plane including a running line of a blood vessel assumed on the skin surface is formed as a regulation portion 38. The cutout portion (regulating portion 38) has a wall surface 36 and a wall surface 37 that can be continuous along the traveling line. The wall surface 36 and the wall surface 37 are formed so as to face each other and parallel to each other, and form a gap in the main body 6b that can accept the puncture needle. The straight-ahead direction regulating portion 38a is formed by the facing wall surface 36 and the wall surface 37. Further, the vicinity of the end portion 36a orthogonal to the traveling line direction of the wall surface 36, the vicinity portion of the end portion 36b parallel to the traveling line direction of the wall surface 36 or the entire wall surface 36, and orthogonal to the traveling line direction of the wall surface 37. A portion near the end portion 37a to be formed, a portion near the end portion 37b parallel to the traveling line direction of the wall surface 36, or the entire wall surface 37 may form a locking portion. The portion near the end of the wall surface and the wall surface can be locked while abutting with the side surface of the puncture needle from both sides in the direction orthogonal to the traveling direction of the puncture needle. An inclined portion 39 is formed between the wall surface 36 and the wall surface 37 so as to be continuously inclined so that the height from the skin surface becomes smaller as the puncture position on the skin is approached along the traveling line direction. The advancing angle regulating portion 38b is formed by the inclined portion 39. In this example, the side of the skin that is close to the puncture position is the side of one end indicated by

reference numerals

36a and 37a. The inclined portion 39 is formed as an inclined surface continuously from one

end portion

36a, 37a to the

other end portion

36b, 37b along the traveling direction of the puncture needle. The angle of inclination β of the inclined portion 39 with respect to the skin can be generally set to 30 ° to 45 ° when puncturing a human jugular vein by the landmark method, for example. Also, when puncturing a human jugular vein under ultrasound guidance, it can generally be set to 60 °. In this example, it is 60 °. The inclined portion 39 is formed with a portion 40 in which the distance between the facing wall surfaces becomes narrower as the skin approaches the skin side in a direction orthogonal to the traveling direction of the puncture needle. In this example, the portion indicated by the reference numeral 40 has a V-shaped cross section. The regulating portion 38 opens at both ends (one end and the other end indicated by

reference numerals

36a, 37a, 36b, 37b) along the traveling direction of the puncture needle, and also opens a surface on the side facing the inclined portion 39. , Accepts the puncture needle and forms a slidable gap along the travel line.

The main body 6b is provided with the shape of the inclined portion 39 on the traveling line as a display surface 43 including a display line 43a on the outside of the wall surface 36 and the wall surface 37. Wall surfaces 36f and 37f parallel to the wall surfaces 36 and 37 are formed on the side opposite to the side where the inclined portion 39 is provided with respect to the wall surfaces 36 and 37, and the wall surfaces 36 and 37 and the wall surfaces 36f and 37f form a flat plate. A plate-like body is formed. Further, the wall surfaces 36g and 37g parallel to the wall surfaces 36 and 37 are formed so as to be separated from the wall surfaces 36f and 37f to the outside. The display surface 43 is continuous with the wall surfaces 36f and 37f and the wall surfaces 36g and 37g.

The main body 6b is formed with a recess 51 that is linearly continuous in parallel with the wall surfaces 36 and 37 on the back surface of the side opposite to the side where the regulation portion 38 is provided. The recess 51 is formed on the back surface of the main body 6b over the entire length in the height direction from the side of the main body 6b close to the skin. The recess 51 makes it easy to grasp the position of the traveling line even from the back side of the main body 6b. The recess 51 may be colored differently from other parts.

The main body 6b extends along the skin surface from the wall surfaces 36 g and 37 g in the direction orthogonal to the wall surfaces 36 and 37 toward the wall surfaces 36 g and 37 g, and the puncture position is parallel to the wall surfaces 36 and 37. A support portion 52b having a flat plate-like structure is formed so as to extend along the skin surface toward the side of the skin. The support portion 52b has a plate-shaped protrusion 52c extending along the skin surface in the facing direction of the wall surfaces 36g and 37g, and a portion along the skin surface from a portion close to the puncture position of the regulation portion 38 to the puncture position side. It has a plate-shaped protrusion 53 extending from the surface. Further, the protruding portion 53 is provided with a notch portion 54 between the wall surface 36 and the wall surface 37 so that the puncture needle can puncture the skin on the extension in the direction in which the puncture needle advances. A bottom surface 55 is formed on the side of the support portion 52b facing the skin.

As the fixing means, for example, those shown in the above (i) to (vii) can be adopted depending on the situation. Among them, for example, the above-mentioned various double-sided tapes and the like can be provided on the bottom surface 55. In this case, the double-sided tape may be provided on the entire bottom surface 50, may be provided on a part of the bottom surface 50, or may be provided on the entire or a part of the bottom surface 55, and for example, the same as shown in FIG. 5A described later. May include a portion extending from the bottom surface 55 to the outside of the support portion 52b. Further, the various single-sided tapes described above may be provided so as to be continuous from the surface of the display surface 43, the wall surfaces 36f, 36g, 37f, 37g, the protruding portion 52c of the support portion 52b, and the like and extend to the skin surface (for example,). See FIG. 5B for an example of installation of the fixing means). Further, the fixing means may be provided with notches (

reference numerals

100, 102, 103) as shown in FIGS. 6A or 6B described later.

(Example 2)
2A (a) is a perspective view for explaining the structure of the main body 7b of the puncture assisting tool according to the second embodiment, and FIG. 2B is a one-sided cross-sectional view of the VI-VI line perspective in FIG. 2A. The puncture assisting tool according to the second embodiment is the puncturing assisting tool according to the first embodiment, in which the recess 51 and the support portion 52b are not provided, and the shape of the inclined portion 39 on the traveling line is changed from a straight line to a convex curve shape. The shape on the traveling line is also provided on the outside of the wall surface 36 and the wall surface 37. The puncture assisting tool according to the second embodiment includes a main body 7b having a regulating portion 65 and fixing means. The regulation unit 65 has a wall surface 63 and a wall surface 64 that are continuous along the traveling line. The wall surface 63 and the wall surface 64 are formed so as to face each other and parallel to each other, and form a gap in the main body 7b that can accept the puncture needle. The straight-ahead direction regulating portion 65a is formed by the facing wall surface 63 and the wall surface 64. The portions of the wall surface 63 and the wall surface 64 corresponding to the wall surface 36 and the wall surface 37 of the first embodiment may form a locking portion. Between the wall surface 63 and the wall surface 64, an inclined portion 66 that continuously inclines so that the height from the skin surface decreases as the puncture position on the skin approaches along the traveling line direction is a traveling angle regulating portion. Formed as 65b. Further, the inclined portion 66 has a depth-direction locking portion capable of contacting the puncture needle. The inclined portion 66 has a convex curve shape on the traveling line. In this example, it is a quarter arc, but it is not limited to this. The inclined portion 66 is formed with a continuous recess 67 having a structure having a V-shaped cross section. The shape of the inclined portion 66 on the traveling line is provided as a display surface 69 including a display line 69a on the outside side opposite to the direction in which the wall surface 63 and the wall surface 64 face each other. The portion of the body 7b close to the skin has a bottom surface 61. The bottom surface 61 may form a support portion that supports the regulation portion 65 from the skin side. As the fixing means, for example, those shown in the above-mentioned (i) to (vii) may be provided on the bottom surface 61 depending on the situation. Of these, for example, the various double-sided tapes described above can be provided. The double-sided tape may be provided on the entire bottom surface 61, may be provided on a part of the bottom surface 61, may be provided on the entire or a part of the bottom surface 61, and the bottom surface may be provided, for example, as shown in FIG. 5A described later. It may include a portion extending from 61 to the outside of the main body 7b. Further, the fixing means may be, for example, the above-mentioned various single-sided tapes that are continuous from the

surfaces

63g and 64g opposite to the wall surfaces 63 and 64 and extend to the skin surface. Further, the fixing means may be provided with notches (

reference numerals

100, 102, 103) as shown in FIGS. 6A or 6B described later.

(Example 3)
FIG. 3A is a perspective view for explaining the structure of the main body 8a of the puncture assisting tool according to the third embodiment, and FIG. 3B is a one-sided cross-sectional view taken along the line VII-VII in FIG. 3A. The puncture assisting tool according to the third embodiment includes a main body 8a having a regulating portion 72 and a supporting portion 77, and a fixing means. The regulation unit 72 has a wall surface 70 and a wall surface 71 that are continuous along the traveling line. The wall surface 70 and the wall surface 71 are formed so as to face each other and parallel to each other, and form a gap in the main body 8a that can accept the puncture needle. The straight-ahead direction regulating portion 72a is formed by the facing wall surface 70 and the wall surface 71. The portions of the wall surface 70 and the wall surface 71 may form a locking portion. Between the wall surface 70 and the wall surface 71, an inclined portion 73 that continuously inclines so that the height from the skin surface decreases as the puncture position on the skin approaches along the traveling line direction is a traveling angle regulating portion. It is formed as 72b. Further, the inclined portion 73 has a traveling angle regulating portion capable of contacting the puncture needle. The inclined portion 73 has an angle of α (45 °) with respect to the skin, and has a straight shape on the traveling line. A continuous portion 74 having a structure having a V-shaped cross section is formed on the inclined portion 73. The main body 8a is formed with a display surface 75 including a display line 75a corresponding to the shape of the inclined portion 73 on the traveling line on the outside of the wall surface 70 and the wall surface 71. A recess 76 that is linearly continuous in parallel with the wall surfaces 70 and 71 is formed on the back surface of the main body 8a on the side opposite to the side on which the regulation portion 72 is provided. The recess 76 makes it easy to grasp the position of the traveling line even from the back side of the main body 8a. A flat plate-shaped support portion 77 is formed on the entire circumference of the main body 8a on the side close to the skin. A notch 78 is provided on the side extending from the inclined portion 73 of the support portion 77 and close to the puncture position, and the puncture needle can be punctured through the notch 78. Further, the recess 76 provided on the back surface of the main body 8a extends to the support portion 77 and forms a notch in the support portion 77. The main body 8a has a space 79 formed inside other than the support portion 77 from the viewpoint of reducing the amount of raw materials used. On the bottom surface side of the support portion 77 close to the skin, for example, those shown in (i) to (vii) described above can be adopted as fixing means depending on the situation. Among them, for example, the above-mentioned various double-sided tapes and the like can be provided. The double-sided tape may be provided on the entire bottom surface side of the support portion 77, may be provided on a part of the bottom surface side, or may be provided on the entire or a part of the bottom surface side, and is shown, for example, in FIG. 5A described later. Similarly, it may include a portion extending from the bottom surface portion to the outside of the support portion 77. Further, the fixing means may be provided so as to be continuous from the surface of the support portion 77 and the other outer surface of the main body 8a and extend to the skin surface (see, for example, FIG. 5B as an installation example of the fixing means). Further, the fixing means may be provided with notches (

reference numerals

100, 102, 103) as shown in FIGS. 6A or 6B described later.

(Example 4)
FIG. 4A is a perspective view for explaining the structure of the main body 8b of the puncture assisting tool according to the fourth embodiment, and FIG. 4B is a one-sided sectional view taken along line VIII-VIII in FIG. 4A. The puncture assisting tool according to the fourth embodiment is a modified example of the puncturing assisting tool according to the third embodiment. The main difference from the third embodiment is that the tilt angle of the tilted portion 73 of the third embodiment is increased. The puncture assisting tool according to the fourth embodiment includes a main body 8b having a regulating portion 82 and a supporting portion 77, and a fixing means. The regulation unit 82 has a wall surface 80 and a wall surface 81 that are continuous along the traveling line. The wall surface 80 and the wall surface 81 are formed so as to face each other and parallel to each other, and form a gap in the main body 8b that can accept the puncture needle. The straight-ahead direction regulating portion 82a is formed by the facing wall surface 80 and the wall surface 81. The portions of the wall surface 80 and the wall surface 81 may form a locking portion. Between the wall surface 80 and the wall surface 81, an inclined portion 83 that continuously inclines so that the height from the skin surface decreases as the puncture position on the skin approaches along the traveling line direction is a traveling angle regulating portion. It is formed as 82b. Further, the inclined portion 83 has a depth-direction locking portion capable of contacting the puncture needle. The inclined portion 83 has an angle of β (60 °) with respect to the skin, and has a straight shape on the traveling line. The inclined portion 83 is formed with a continuous recess 84 having a structure having a V-shaped cross section. The main body 8b is formed with a display surface 85 including a display line 85a corresponding to the shape of the inclined portion 83 on the traveling line on the outside of the wall surface 80 and the wall surface 81. A recess 86 is formed on the back surface of the main body 8b on the side opposite to the side on which the regulation portion 82 is provided, which is linearly continuous in parallel with the wall surfaces 80 and 81. The recess 86 makes it easy to grasp the position of the traveling line even from the back side of the main body 8a. A flat plate-shaped support portion 87 is formed on the entire circumference of the main body 8b on the side close to the skin. A notch 88 is provided on the side of the support 87 extending from the inclined portion 83 and close to the puncture position, and the puncture needle can be punctured through the notch 88. Further, the recess 86 provided on the back surface of the main body 8b extends to the support portion 87 and forms a notch in the support portion 87. In the main body 8b, a space 89 is formed inside the main body 8b other than the support portion 87 from the viewpoint of reducing the amount of raw materials used. As the fixing means, the same configuration as in the third embodiment can be adopted.

(Example 5)
FIG. 5A is a perspective view for explaining the structure of the puncture assisting tool 9A according to the fifth embodiment. The puncture assisting portion 9A is an example in which a specific one is adopted as the fixing means of the puncture assisting tool 8B according to the fourth embodiment. The puncture assisting tool 9A includes the main body 8b of the fourth embodiment and the fixing means 90. The fixing means 90 is composed of double-sided tape. The double-sided tape 90 is bonded by covering the tape body 91, the outer surface coating film 92 that covers the outside of the tape body 91 opposite to the skin side to protect the adhesive surface, and the skin side of the tape body 91. It has a skin-side covering film 93 that protects the surface. In the tape main body 91, a joint portion that is detachably joined to the skin, a connecting portion that connects to the main body 8b, and the joint portion are fixed to one surface, and the connecting portion is fixed to the surface on the opposite side. It has a sheet-shaped base material portion and. The joint portion to be joined to the skin is preferably formed on one surface side of the base material portion over the entire surface. The connecting portion connected to the support portion 87 of the main body 8b may be provided only at the portion connected to the bottom surface of the support portion 87 of the main body 8b. In this embodiment, the connecting portion is formed over the entire surface on the other surface side of the base material. The main body 8b is connected by a bottom surface of the support portion 87 and a connecting portion of the tape main body 91. When the puncture aid 9A is fixed to the skin surface, the skin-side coating film 93 is peeled off to join the skin and the joint portion.

(Example 6)
FIG. 5B is a perspective view for explaining the structure of the puncture assisting tool 9B according to the sixth embodiment. The puncture assisting portion 9B is an example in which a specific one is adopted as the fixing means of the puncture assisting tool according to the first embodiment. The puncture assisting tool 9B includes the main body 6b of the first embodiment and the fixing means 94. The fixing means 94 is composed of a single-sided tape 94. The single-sided tape 94 has a tape body 95 and a coating film 96 that covers and protects the adhesive surface of the tape body 95 with the skin. The main body 6b is connected to the adhesive surface of the tape main body 95 on the surface side of the support portion 52b. The single-sided tape 94 covers the support portion 52b from the outside and connects to the support portion 52b, and extends from the support portion 52b so as to be in contact with the skin. When the puncture aid 9B is fixed to the skin surface, the skin-side coating film 96 is peeled off to join the skin and the joint portion.

(Example 7)
FIG. 6A is a perspective view for explaining the structure of the puncture assisting tool 10A according to the seventh embodiment. The puncture assisting tool 10A is a modified example of the main body 6b of the puncturing assisting tool according to the first embodiment, and an example in which a specific one is adopted as the fixing means. The puncture aid 10A includes a main body 6c and a fixing means 97. The main body 6c is provided with a support portion 52d having a narrow width in a direction orthogonal to the traveling line direction of the support portion 52b of the main body 6b, and a protruding portion 53a having a large width in the traveling line direction of the protruding portion 53 of the supporting portion 52b. It is an orthogonal one. Other than these, it has the same configuration as the main body 6b. Therefore, for configurations other than these, the main body 6b will be referred to, and the description thereof will be omitted. The fixing means 97 has a sheet-like structure that is joined to the bottom surface of the main body 6c and extends in the radial direction from the peripheral edge of the support portion 52d of the main body 6c. The fixing means 97 is formed with a notch 100 along a traveling line so as to be continuous with the notch 54a provided in the protrusion 53a of the main body 6c. Such a configuration having notches 98 and 100 is suitable for puncture by the landmark method. A joint portion that is detachably joined to the skin is provided on the side of the fixing means 97 that comes into contact with the skin, and a coating film that covers and protects the joint portion is formed.

(Example 8)
FIG. 6B is a perspective view for explaining the structure of the puncture assisting tool 10B according to the eighth embodiment. The puncture assisting portion 10B is another example in the case where another means is adopted as the fixing means of the puncture assisting tool 10A according to the seventh embodiment. The puncture aid 10B includes a main body 6c and a fixing means 101. Since the main body 6c is the same as that of the seventh embodiment, the description thereof will be omitted. The fixing means 101 has a sheet-like structure in which, for example, a U-shaped or hook-shaped notch 103 having a width similar to that of the support portion 52d is provided on the side of the main body 6c close to the puncture position of the support portion 52d. Have. Since it has the notch 103, it is possible to easily perform puncture under ultrasonic guidance. Further, the fixing means 101 is provided with a cutout portion 102 having a structure corresponding to the cutout portion 54a provided in the protruding portion 53a of the support portion 52d. The joining of the fixing means 101 to the main body 6c is the same as in the seventh embodiment.

The puncture assisting tool according to the first to eighth embodiments is an embodiment in which a straight-ahead direction regulating section and a traveling angle regulating section are provided in the regulating section. In each of the embodiments, the traveling angle regulating portion is provided with an inclined portion having a predetermined inclination angle. This tilted portion regulates the tilt angle only from the direction close to the skin. In addition, the structure has an open gap except for the inclined portion. Therefore, the puncture needle is easily attached, and the angle of advance of the puncture needle with respect to the skin can be easily finely adjusted by the operator. The surgeon can advance the puncture needle while sliding along the entire length direction of the inclined portion, or slide along a part of the length direction at a desired position of the inclined portion. It is also possible to proceed while letting it proceed. That is, since the inclined portion enables the puncture needle to proceed while being supported from the skin side, stable puncture can be performed at a desired angle with respect to the skin. Therefore, if the puncture position on the skin surface is specified, the puncture needle can be easily advanced in the straight direction of the puncture needle along the traveling line direction of the puncture needle by the straight direction regulation unit, and the puncture needle can be easily advanced by the advance angle regulation unit. Stable puncture is possible while being supported. Therefore, it becomes possible to puncture a blood vessel in a living body that effectively suppresses erroneous puncture.

As described above, various specific examples of the puncture aid have been described, but the present invention is not limited to these embodiments.

How to use the puncture aid when puncturing a blood vessel in the living body using the above puncture aid, in other words, how to puncture the blood vessel in the living body using the puncture aid and , Treatment and diagnosis method using the puncture method will be described. Examples of the target organism include humans and non-human mammals.

The method of puncturing a puncture needle into a blood vessel in the living body using a puncture assisting tool is as follows: (i) A step of confirming the running of the blood vessel to be punctured in the living body and the depth from the skin surface using an ultrasonic probe. ii) A step of attaching a mark indicating a traveling line assumed on the skin surface along the traveling of the blood vessel and a mark indicating a planned puncture position of the blood vessel in the living body to the skin surface, (iii) the traveling line of the puncture needle. The fixation is made so that the straight direction along the direction and the direction of the straight direction restricting portion of the puncture aid are parallel to each other and in the vicinity of the puncture position on the skin surface assumed from the planned puncture position of the blood vessel in the living body. It includes a step (iv) of fixing the puncture assisting tool to the skin surface by means and (v) a step of puncturing a blood vessel with a puncture needle along a straight-ahead direction regulating portion of the puncturing assisting tool. In addition, a method of treating or diagnosing a living body using such a puncture method includes, for example, a step of inserting a catheter into a blood vessel of the living body using such a puncture method.

In the following, the case of percutaneously puncturing a human jugular vein with a puncture needle will be described as an example, but the case is not limited to such a site and the type of living body. Further, the case where the puncture assist tool of Example 18 is used as the puncture assist tool will be described as an example, but the present invention is not limited thereto.

FIG. 7 is a diagram schematically showing the running of the main veins to be punctured when performing central vein puncture around the human neck. As described above, in the central vein puncture, the internal jugular vein 105 shown in FIG. 7 is generally punctured. Further, among the internal jugular vein 105, it is common to puncture in the direction indicated by the arrow 106 from the apex of the supraclavicular fossa triangle 104. Hereinafter, the case where the internal jugular vein 105 is punctured in the direction indicated by the arrow 106 from the apex of the supraclavicular fossa triangle 104 will be described as an example, but the present invention is not limited thereto.

In the step (i) above, the running of the internal jugular vein 105 in the body and the depth from the skin surface are confirmed using an ultrasonic probe. Then, in the step (ii), based on this confirmation result, as shown in FIG. 8A, a mark 109 indicating a traveling line assumed on the skin surface along the traveling of the internal jugular vein 107 and a mark 109 in the living body. A mark 110 indicating a planned puncture position of a blood vessel is attached to the skin surface with a pen or the like. As shown in FIG. 8A, the common carotid artery runs parallel to the vein 107. In the step (iii), as shown in FIG. 8B, after the

marks

109 and 110 are attached to the skin surface, the above-mentioned puncture assisting tool is moved straight along the traveling line direction of the puncture needle and the puncturing assisting tool goes straight. The skin surface assumed from the planned puncture position of the internal jugular vein 107 (the position on the internal jugular vein 107 corresponding to the intersection of the mark 109 and the mark 110) so that the direction of the direction regulating portion 82a is parallel. The puncture aid is fixed to the skin surface by a fixing means in the vicinity of the puncture position. Although the illustration of the fixing means of the puncture assisting tool is omitted, the above-mentioned various fixing means can be adopted. In the step (iv), the puncture needle is punctured into the internal jugular vein 107 along the straight-ahead direction restricting portion 82a of the puncture assisting tool 8B. Since the puncture assisting tool 8B has the advancing angle regulating portion 72b, the entire surface of the inclined portion 83 of the advancing angle regulating portion 82b or both ends of the inclined portion 83 in the traveling line direction for fine adjustment to a desired angle. The puncture needle is advanced along the one end while being in contact with the one end. This puncture may be performed experimentally with a test puncture needle having a small outer diameter and then with a treatment puncture needle having a desired outer diameter larger than that of the test puncture needle, or may be performed from the beginning with a treatment puncture needle. You may perform puncture using. When the landmark method is used, it is common to perform a trial puncture and then perform a main puncture with a treatment puncture needle. When the puncture is performed under ultrasonic guidance, the main puncture may be performed without the trial puncture, or both punctures may be performed. Further, when the landmark method is performed, the advancing angle of the puncture needle with respect to the skin is generally 30 ° to 45 °, and when puncturing under ultrasonic guidance, the advancing angle is 60 °. Therefore, the inclination angle of the inclined portion 83 of the puncture aid is selected according to them. Since the inclination angle α of the puncture aid is 60 °, it is suitable for puncturing under ultrasonic guidance. When the landmark method is used, for example, a puncture aid or the like having an inclination angle β of 45 ° is preferable. FIG. 9 is an explanatory diagram schematically showing a situation in which puncture is performed under ultrasonic guidance. The direction of the arrow 106 in FIG. 7, that is, the syringe 113 having the puncture needle 112 attached to the tip of the human neck 116 of the subject from the head side is held by the right hand 115, and the ultrasonic probe 111 is held by the left hand 114. , The state when the puncture needle 112 is punctured into the internal jugular vein along the gap of the regulation portion 82 of the puncture assisting tool is shown. By using such a puncture aid that can be directly fixed to the skin, puncture can be performed regardless of the type of ultrasonic probe. In addition, the puncture needle can be advanced along the traveling line direction by the regulating portion having a predetermined configuration. Therefore, it is possible to effectively suppress erroneous puncture of the common carotid artery running in parallel with the regulation portion. Even when it is possible to regulate the traveling angle of the puncture needle with respect to the skin as in the puncture aid shown in FIG. 9, fine adjustment by the operator is easy because the puncture needle is locked from the skin side. Therefore, erroneous puncture can be suppressed more effectively.

When the tip of the puncture needle 112 is inserted into the internal jugular vein in this way, it is aspirated by the syringe 113 to confirm that it is venous blood. In this way, the internal jugular vein is punctured with a puncture needle. At this point, the puncture aid may be removed. When the catheter is inserted into the internal jugular vein as described later after the puncture of the internal jugular vein is completed, the puncture aid may be removed at an appropriate time depending on the situation.

After the puncture needle is punctured in the internal jugular vein, a catheter is inserted from the route percutaneously secured in the internal jugular vein from the skin, and treatment or diagnosis is performed using the catheter. Catheter insertion is performed according to a standard method. For example, after inserting a guide wire into the internal jugular vein from the lumen of the puncture needle, the puncture needle is removed leaving the guide wire, and a dilator is inserted along the guide wire to expand the route. After removing the dilator leaving the guide wire, insert the catheter along the guide wire and remove the guide wire. After confirming that there is regurgitation of venous blood from the catheter, fill the lumen of the catheter with heparin saline and fix the base end of the catheter to the skin by a predetermined method, and the insertion and placement of the catheter are completed. Various treatments or diagnoses are performed using the indwelling catheter. By performing puncture using the puncture aid as described above, quick and accurate puncture is possible, so that the burden on the patient can be minimized and subsequent treatment and diagnosis using a catheter become possible. ..

9A, 9B, 10A, 10B: Puncture aid; 6b, 6c, 7b, 8a, 8b: Main body; 38, 65, 72, 82: Regulator; 38a, 65a, 72a, 82a: Straight direction regulator; 52b, 52d, 77, 87: Supports; 51, 76, 86: Recesses; 36, 37, 63, 64, 70, 71, 80, 81: Walls; 55, 61: Bottoms; 38b, 65b, 72b, 82b: Progress Angle regulation part; 39, 66, 73, 83: Inclined part; 40, 67, 74, 84: V-shaped cross section (recess); 36a: End portion of wall surface 36 orthogonal to the traveling line direction; 36b:

Wall surface

36f, 36g: a surface opposite to the wall surface 36; 37a: an end orthogonal to the traveling line direction of the wall surface 37; 37b: along the traveling line direction of the wall surface 37. Parallel ends; 37f, 37g: surface opposite to wall surface 37; 43, 69, 75, 85: display surface; 43a, 69a, 75a, 85a: display line; 52c, 53, 53a: protrusion; 54, 54a, 78, 88, 100, 102, 103: Notch; 79, 89: Space; 90, 97, 101: Fixing means; 91, 95: Tape body; 92: Outer coating; 93, 96 : Skin side covering film; 94: Single-sided tape; 104: Subclavian fossa triangle; 105, 107: Internal jugular vein; 106: Arrow indicating puncture direction; 108: Common carotid artery; 109: Mark indicating running line; 110 : Mark indicating the planned puncture position of a blood vessel in the living body; 111: Ultrasonic probe; 112: Puncture needle; 113: Injection device; 114: Left hand; 115 Right hand; 116: Neck; α, β: Tilt of inclined part with respect to skin angle

Claims

It is a puncture aid for percutaneously puncturing a blood vessel of a living body.
A puncture assisting tool including a main body having a regulating portion that regulates the traveling direction of the puncture needle with respect to a blood vessel, and a fixing means for fixing the main body to the skin of a living body.
The puncture assisting tool according to claim 1, wherein the regulating portion has a straight-moving direction regulating portion that regulates the straight-ahead direction of the puncture needle with respect to the traveling line direction of a blood vessel assumed on the skin surface.
The straight-ahead direction regulating portion has a locking portion provided so as to abut and lock with the side surface of the puncture needle from both sides in a direction orthogonal to the traveling direction of the puncture needle, at least in a portion separated in the traveling line direction. The puncture aid according to claim 2.
3. The claim 3 in which the locking portion has at least one selected from a wall surface that is continuous along the traveling line direction, a wall surface that is discontinuous along the traveling line direction, and a columnar body that can make point contact with the puncture needle. The puncture aid described in.
The puncture assisting tool according to claim 3 or 4, wherein the locking portion has wall surfaces that continuously face each other along the traveling line direction.
The puncture aid according to claim 5, wherein the locking portion has a portion in which the distance between the facing wall surfaces becomes narrower as the locking portion approaches the skin side in a direction orthogonal to the traveling direction of the puncture needle.
The puncture aid according to any one of claims 1 to 6, wherein the regulating unit has a traveling angle regulating unit that regulates the traveling angle of the puncture needle with respect to the skin.
The restricting portion has a locking portion provided so as to abut and lock with the side surface of the puncture needle from both sides in a direction orthogonal to the progress of the puncture needle, at least in a portion separated in the traveling line direction.
The advancing angle regulating portion is provided between the locking portions on the traveling line, and the advancing angle of the puncture needle with respect to the skin can be adjusted to a preset angle by contacting the puncture needle from the skin side and locking. The puncture aid according to claim 7, which is provided as possible.
The puncture according to claim 8, wherein the advancing angle regulating portion has an inclined portion that continuously inclines so that the height from the skin surface decreases as the puncture position on the skin approaches the puncture position on the skin along the traveling line direction. Auxiliary tool.
The puncture aid according to claim 9, wherein the inclined portion has at least one shape selected from a straight line, a convex folding line, and a convex curve as a shape on the traveling line.
In the fixing means, a joint portion that is detachably joined to the skin, a connecting portion that connects to the main body, and the joint portion are fixed to one surface, and the connecting portion is fixed to the surface on the opposite side. The puncture aid according to any one of claims 1 to 10, further comprising a sheet-shaped base material portion.
The puncture aid according to any one of claims 1 to 11, wherein the main body has a support portion for supporting the regulation portion on a side close to the skin.
The puncture aid according to claim 12, wherein the fixing means is fixed to at least a part of the support portion.
The support portion has a plate-shaped portion extending toward the puncture position, and the plate-shaped portion is provided with a through hole or a notch portion through which a puncture needle can puncture the skin, according to claim 12 or 13. The described puncture aid.
The puncture aid according to any one of claims 1 to 14, wherein a concave portion and / or a convex portion is formed on the outer surface of the main body except the skin side along the traveling line.
The puncture aid according to claim 9 or 10, wherein the shape of the inclined portion on the traveling line is also formed on the outer side between the advancing angle regulating portions on the main body.
A puncture method in which a puncture needle is percutaneously punctured into a blood vessel of a living body by using the puncture assisting tool according to any one of claims 1 to 16, and a blood vessel to be punctured using an ultrasonic probe. In the process of confirming the running in the living body and the depth from the skin surface, a mark indicating a running line assumed on the skin surface along the running of the blood vessel and a mark indicating the planned puncture position of the blood vessel in the living body are provided. Assumed from the process of attaching to the skin surface, the straight direction along the running line direction of the puncture needle and the direction of the straight direction restricting portion of the puncture aid so as to be parallel and from the planned puncture position of the blood vessel in the living body. A step of fixing the puncture assisting tool to the skin surface by the fixing means in the vicinity of the puncturing position of the skin surface to be punctured, and a step of puncturing the blood vessel with the puncture needle along the straight-ahead direction regulating portion of the puncturing assisting tool. Including, puncture method.