JP2009028253A - Needle assembly - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a needle assembly preventing the adhesion of gel to a needle when administering an injection into a patient's body using an ultrasonic imaging method. <P>SOLUTION: This needle assembly is provided with: a needle body having a proximal end and a distal end formed with a tip portion, and formed with a lumen communicating the proximal end with the distal end; a hub connected with the proximal end of the needle body; and a cap having a proximal end and a distal end covering at least the tip portion; and is further provided with an ultrasonic reflection means at the distal end of the needle body at least at the tip portion; and the cap is adapted to move at least the distal end of the cap relatively to the needle body, when the needle body punctures. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a needle assembly, and more particularly to a needle assembly used in a puncture assisting device using ultrasonic technology.

Conventionally, in the medical field, ultrasonic technology has been used as an image inspection method that allows non-destructive investigation of the internal state of an object by applying ultrasound to the object and visualizing the echo. Ultrasound imaging methods are used. A diagnostic method using ultrasonic waves can be used in various applications and methods by taking advantage of safety on the living body surface.
2. Description of the Related Art In general, an ultrasonic imaging apparatus for using an ultrasonic imaging method generally includes a probe having a mechanism for generating ultrasonic waves and receiving reflected ultrasonic waves, a processing unit for processing received data, and a display for displaying images. Consists of. When an ultrasonic wave is generated by applying a probe to an object to be inspected, the ultrasonic wave travels through the object in a short time and is reflected by a living tissue. Then, the reflected sound wave is measured by the probe, the distance is calculated from the time until the reflected sound returns, and the internal state is visualized. Therefore, the ultrasonic imaging method is widely used because it can observe the inside of the human body, which is the object of observation, in real time and obtain various information such as the blood flow velocity in the blood vessel.

  Such an ultrasonic imaging method may be used when a tissue in a region where an ultrasonic image is obtained is collected as a specimen. These tissue specimens are usually collected using a needle that is inserted percutaneously into the area of interest (a special needle consisting of a double structure with an inner needle on the outer jacket of the needle: usually called a biopsy needle). Is done. In this case, the doctor can collect tissue at an appropriate location while looking at the display of the ultrasonic imaging apparatus so that the tip of the sharp needle does not damage the blood vessel or nerve. In particular, a needle for puncturing an organ may be punctured using an ultrasonic imaging device because the needle needs to be punctured reliably at a predetermined part of the human body. For example, when a biopsy is performed by collecting a part of a tumor tissue by puncturing a needle, the tissue tissue infiltrated with a normal tissue and a tumor is different in cell density. In order to be able to reliably guide to the tumor tissue, where the inner needle of the needle can be removed and the tumor tissue can be aspirated, an ultrasound imaging method may be used.

Such an ultrasonic imaging method is generally performed by applying a gel to the skin where the probe is applied. This is because ultrasonic waves have the property of being easily attenuated in gas and being transmitted efficiently in liquids and solids. Therefore, when observing the inside of the human body using the ultrasonic imaging apparatus, the image inside the human body is not displayed on the display even if the probe is directly applied to the skin. Therefore, a gel-like material is applied to the skin, and a probe is brought into close contact with the gel to emit ultrasonic waves. This is because by applying the gel, the air between the probe and the skin can be blocked, and the image inside the human body can be displayed on the display.
As a needle used in an ultrasound imaging method using ultrasound, a technique is disclosed in which a bubble matrix is provided on the outer surface of a biopsy needle for collecting a tissue sample (see, for example, Patent Document 1). Since the reflectance is low with a single metal needle, the needle may be difficult to display on the display of the ultrasonic imaging apparatus. That is, the body tissue reflects ultrasound energy and is easily displayed clearly on the display of the ultrasound imaging apparatus. On the other hand, cylindrical metal appliances tend to dissipate ultrasonic energy that impinges on the appliances and are therefore substantially invisible on the display. Therefore, by providing a bubble matrix on the surface of the needle, ultrasonic energy can be reflected and the tip of the needle can be displayed on the display.

In recent years, such an ultrasonic imaging method is sometimes used not only for the use of a needle for the purpose of puncturing an organ but also for the purpose of puncturing a blood vessel. Usually, in the injection for the purpose of puncturing a blood vessel, the optimal site to puncture is specified based on vision and palpation. When it is difficult to specify the puncture site of the blood vessel, for example, when the blood vessel is thin or difficult to visually recognize, the blood vessel is punctured based on anatomical knowledge and experience. However, even if puncture is performed based on vision, palpation, experience, and the like, there is a possibility that puncture is performed accidentally at a site other than the blood vessel. In particular, patients who are erroneously punctured are often erroneously punctured due to the nature of their blood vessels.
Therefore, a patient who is afraid of puncture failure may wish to have a puncture performed by a doctor or health care worker who has long experience in each puncture, or a doctor who is familiar with the blood vessels of the patient. Even in such a case, by using the ultrasound imaging method for puncture for the purpose of puncturing a blood vessel, the blood vessel and the tip of the needle are displayed on the display of the ultrasound imaging apparatus, and the needle tip of the needle is Can lead to position.
As a result, the blood vessel can be accurately punctured even for patients with thin blood vessels, regardless of the experience of a doctor or medical staff.
Furthermore, Patent Literature 2 and Patent Literature 3 disclose a technique for covering the needle with a cap.

Japanese Patent Laid-Open No. 06-327671 Japanese Patent Laid-Open No. 2000-167054 JP 2001-340457 A

  As described above, in the ultrasonic imaging method, it is necessary to apply a gel to the skin where the probe is applied. A needle used for puncturing an organ has a long needle length, and can be percutaneously inserted into a region other than the skin to which a gel is applied to collect a body tissue. That is, a needle for puncturing an organ has a length longer than that of a needle used for puncturing a blood vessel because a target tissue collection site is inserted deeper than a blood vessel, and a probe is applied. It is possible to puncture from a part that is somewhat distant from the part. In addition, even when the needle is inserted percutaneously from the area where the gel is applied, the needle intended for puncturing the organ is provided with an inner needle and an outer needle, and is arranged inside the outer needle. The gel can be prevented from entering the hollow of the outer needle when passing through the gel layer by the inner needle.

However, the needle for puncturing a blood vessel is shorter than the needle for puncturing an organ, and the needle is inserted percutaneously from the region of the skin where the gel is applied. At this time, when the needle passes through the applied gel layer, the gel may adhere to the needle. Therefore, when the gel adheres to the needle, the gel may enter the needle from the tip.
The present invention has been made in view of the above points, and an object of the present invention is to provide a needle assembly that prevents a gel from adhering to and entering into a needle when injection is performed into a patient's body using an ultrasonic imaging method. And

Therefore, in the present invention, a needle body having a tip portion capable of reflecting ultrasonic waves,
A needle assembly comprising a cap covering the tip,
When the needle body is punctured into the patient, the tip of the needle body penetrates the cap, and when the needle body is withdrawn from the patient, the tip of the needle body is stored in the cap.
A needle assembly is provided.

According to the above configuration, since the tip of the needle body is covered with the cap, even if the gel is applied to the skin, the cap first comes into contact with the skin, and in this state the tip of the needle body is the cap. Therefore, it is possible to reliably prevent the gel from adhering to the needle body and entering the body of the patient.
In addition, since the pointed end of the needle body is housed in the cap after the needle body is pulled out, the contents are trapped by the cap even if the contents are in the needle body or in the syringe.
This content is blood, for example, when the needle body is for blood collection or dialysis. When the needle body is for infusion, it is an infusion solution.
In order to prevent the contents trapped by the cap from leaking from the cap, it is preferable to fill the opening portion side of the cap with the first leakage preventing member.
Moreover, it is preferable to arrange | position the 2nd leakage prevention member also in the front-end | tip part (part facing the pointed part of a needle body) of the cap part which the needle body penetrated.

Embodiments of the present invention will be described below in detail with reference to the drawings.
FIG. 1 is a side view showing a needle assembly according to the present embodiment. The needle assembly 10 includes a needle 11 that is a needle body, a hub 12, and a protective cap 13. The proximal end portion of the needle 11 is connected to the hub 12 of the syringe body. The other end of the needle 11 is a pointed portion 14 and has a cut portion 15 obtained by cutting a bevel portion. The needle 11 is formed with a lumen 16 through which a chemical solution, blood, and the like pass.
The base end side (lower part in the figure) of the cap 13 is opened so as to cover the needle 11 (opening portion 19). The opening portion 19 is filled with a first leakage prevention member 17 made of cotton. The cap 13 of this embodiment is reduced in diameter at the opening 19 to prevent the first leakage prevention member 17 from falling off.

The material of the first leakage preventing member 17 is not particularly limited as long as the first leakage preventing member 17 is slidable with respect to the needle 11, preferably maintaining the sealing performance against the cap contents. Polymer elastomers such as rubber can be employed. In addition, as a first leakage prevention member, a superabsorbent resin (Superabsorbent
Materials such as Acrylic Acid-Vinyl Alcohol Copolymer known as Polymer; SAP) can be used. In addition, fabrics such as woolen fabrics, non-woven fabrics, and the like can be used.
The distal end of the cap 13 also covers the tip 14 of the needle 11 and includes a skin engaging surface 18 for pressing the assembly 10 against the skin.
Reflecting means for reflecting ultrasonic waves is provided at the distal end portion of the needle 11 including the pointed portion 14 of the needle 11. Hereinafter, the ultrasonic reflection means will be described with reference to FIGS.

FIG. 2 is a side view showing the needle 11 according to the present embodiment. FIG. 3 is a view showing an example of ultrasonic reflection means of the needle 11.
The material of the needle 11 of the present embodiment is stainless steel, but the material of the needle 11 of the present invention may be other metals as long as it is used for a medical needle, and is limited to stainless steel. is not.
FIG. 2 (a) shows a needle having a smooth surface that has been conventionally used for puncture. FIG. 2B to FIG. 2E show the needle 11 provided with the ultrasonic wave reflection means used in the present embodiment.
FIG. 2B shows a needle in which an ultrasonic reflecting means is provided in the cut portion 15 of the needle 11, and FIG. 2C shows an ultrasonic reflection on the inner surface of the needle tube that is the surface of the lumen 16 formed in the needle 11. 2 (d) shows a needle provided with ultrasonic reflecting means at the end of the needle 11, and FIG. 2 (e) shows an ultrasonic reflecting means provided on the entire needle 11. Each needle shown is shown.

As shown in FIGS. 2 (b) to 2 (e), the ultrasonic wave reflecting means formed on the needle 11 which will be described later with reference to FIGS. 3 (a) to 3 (e) has at least the tip 14 of the needle 11. It is provided in the part including. In the medical method using the ultrasonic imaging apparatus, it is necessary to confirm the position of the needle on the display by detecting the difference in the acoustic impedance received by the probe without relying on the tip of the needle visually or by palpation. . Therefore, by applying ultrasonic reflection means, which will be described later, to the tip portion 14 of the needle 11, an image of the needle tip is displayed on the display of the ultrasonic imaging apparatus, and the site to be punctured and the tip of the needle are accurately Can be confirmed.
In FIG.2 (b), the ultrasonic reflection means is provided in the part 15 which cut the bevel part of the terminal part of a needle. In FIG. 2C, ultrasonic reflection means is provided on the surface of the lumen 16 of the needle. Mainly, when a needle is injected into a vein, the cut part is injected upward with respect to the affected part. Therefore, in order to reflect the ultrasonic energy transmitted from the probe and display the tip position of the needle on the display, in the case of a needle used for intravenous injection, at least the surface of the cut portion 15 or the lumen 16 is super It is preferable to provide a sound wave reflecting means.

  Further, in FIG. 2D, ultrasonic reflecting means is provided at the end of the needle. Mainly, when a needle is injected into an artery, the cut part is injected downward with respect to the affected part. Therefore, in order to reflect the ultrasonic energy transmitted from the probe and display the tip position of the needle on the display, in the case of a needle used for arterial injection, an ultrasonic reflection means is provided at the end including at least the tip. It is preferable to provide it.

Next, the ultrasonic reflecting means formed on the surface of the needle 11 will be described with reference to FIGS. 3 (a) to 3 (d).
3A shows a shape in which grooves are formed in the direction from the proximal end to the distal end by applying a hairline process to the surface of the needle 11, and FIG. 3B shows the shape shown in FIG. 3C shows a shape in which lattice-like grooves are formed on the surface of the needle 11 by adding cross lines, FIG. 3C shows a shape in which fine irregularities are formed on the surface of the needle 11, and FIG. 3 (e) shows the shape formed on the surface of the needle 11 singly or in combination with fine letters, numbers, and symbols. ing. In these processes, a concave portion is provided by polishing the surface of the needle, or a concave portion is provided on the surface of the needle by evaporating indium or the like.

As shown in FIGS. 3A to 3E, the ultrasonic energy can be reflected by providing an uneven portion such as a narrow groove on the surface of the needle or covering it with a reflective coating. Therefore, the ultrasonic wave transmitted from the probe is reflected by the ultrasonic wave reflection means, and the difference in acoustic impedance can be detected by the probe. As a result, a portion with a needle recess is clearly displayed on the display of the ultrasonic imaging apparatus.
In this embodiment, the needle having the shape shown in FIGS. 3A to 3E is used. However, the present invention is not limited to such a shape, and the difference in acoustic impedance is measured with a probe. Any shape can be used as long as it can be detected via the line. That is, by providing such a concavo-convex portion or covering with a reflective coating, the acoustic impedance is different from the original acoustic impedance of the needle. For this reason, the ultrasonic waves are reflected by the concave and convex portions and the reflective coating, and the reflected waves are transmitted in the reverse order of the ultrasonic transmission path to reach the probe. In this way, the measurement result of the ultrasonic reception signal reflected by the uneven portion or the reflective film is displayed on the display of the ultrasonic imaging apparatus.

FIG. 4A to FIG. 4C are side views showing an example in which the cap 13 is attached to the needle 11. In a state before the needle 11 is used for puncturing, the end portion of the cap 13 covers at least the pointed portion 14 of the needle 11.
FIG. 4A shows a needle assembly to which a cap 13 that covers the entire needle 11 is attached. A base end portion of the cap 13 covering the needle 11 is connected to the hub 12 via an O-ring 30. In a state before the needle 11 is used for puncturing, the end portion of the cap 13 covers the pointed portion 14 as indicated by a solid line.
The cap 13 does not move when the needle assembly passes through the gel layer applied to the skin. When the skin engaging surface 18 formed at the end of the cap 13 is pressed against the skin, the tip 14 of the needle 11 breaks through the skin engaging surface 18 and the tip 14 is injected into the skin. The skin engagement surface 18 is pressed against the skin by the length of the length of the distal end portion 14 in the body, the cap 13 contracts in a bellows shape, and the distal end portion of the cap 13 is indicated by a two-dot chain line. 11 toward the proximal end.

As described above, when the needle 11 passes through the gel layer, the cap 13 covers the entire needle 11, passes through the gel layer, and the skin engaging surface 18 of the cap 13 is pressed against the skin. 14 goes out of the cap 13. Therefore, the needle 11 does not touch the gel, the gel does not adhere to the surface of the needle 11, and the puncture can be performed without entering the gel from the lumen 16 of the needle 11.
When the needle 11 is removed from the body, the bellows portion 20 of the cap 13 returns to the original state, and the skin engaging surface 18 returns to the position covering the pointed portion 14 again.

As the material of the cap 13 of this embodiment, rubber is used because it is necessary to prevent leakage of contents from a hole formed in the cap 13 when the needle 11 of the example is pulled out from the cap 13 as described later. . However, the material of the cap of the present invention is not limited to rubber, and includes olefin polymers, allyl and higher compound polymers, halogenated olefin polymers, N-vinyl compound polymers, vinyl acetate and related compounds. Polymers, vinyl ether polymers, α, β-unsaturated aldehyde and α, β-unsaturated ketone polymers, acrylic acid / acid halide / ester and α, β-substituted polymers, polysulfonamides, polypeptides Polyamide, polyester, polyurea, polyurethane, polyanhydride, and other linear polymers may be used. Moreover, the water-repellent thing which processed natural plant fiber may be sufficient.
Further, the material of the cap 13 is preferably a transparent material so that the surface direction of the cut portion 16 of the needle tip 14 can be seen, but the cap 13 is made of a material in which the surface direction of the cut portion 16 cannot be seen. However, it is only necessary that the hub 12, the cap 13, and the like have a display or the like so that the surface direction of the cut portion 16 can be understood.

FIG. 4B shows a needle assembly to which a cap 13 covering half from the end of the needle 11 is attached.
The base end portion of the cap 13 covering the needle 11 is located at a substantially intermediate portion between the base end portion and the distal end portion of the needle 11. A first leakage prevention member 17 is provided at the base end portion of the cap 13. In a state before the needle 11 is used for puncturing, the end portion of the cap 13 covers the pointed portion 14 as indicated by a solid line.
The cap 13 does not move when the needle assembly passes through the gel layer applied to the skin. When the skin engaging surface 18 formed at the end of the cap 13 is pressed against the skin, the tip 14 of the needle 11 breaks through the skin engaging surface 18 and the tip 14 is injected into the skin. The skin engaging surface 18 is pressed against the skin by the length of the distal end portion 14 entering the body, and the cap 13 moves toward the proximal end portion of the needle 11 as indicated by a two-dot chain line.

Therefore, as in the needle assembly shown in FIG. 4A, the needle 11 does not touch the gel, the gel does not adhere to the surface of the needle 11, and the puncture does not enter the lumen 16 of the needle 11. Can be performed.
Since the skin engaging surface 18 is pressed against the skin even after the needle is punctured, the cap 13 may be further moved toward the proximal end of the needle 11 with a finger in order to remove the pressure.

When the needle 11 is pulled out, the cap 13 does not move naturally to the end of the needle 11. For this reason, while pulling out the needle, the cap 13 is pressed from the top of the liquor with a finger and moved toward the distal end, and the tip of the needle 11 is housed in the cap 13 (shown by the solid line). To do. Thereby, even if the contents (blood, medicine, etc.) exist in the needle 11, the contents are trapped by the cap 13 and stored in the cap 13.
The first leakage prevention member 17 maintains the sealing performance even after the needle 11 is removed from the first leakage prevention member 17 (that is, automatically closes the through hole of the needle 11) so that the contents of the cap 13 do not leak. Is preferred.
The hole opened in the cap 13 is closed immediately after the needle is pulled out, and leakage of blood, chemicals, etc. leaking into the cap 13 can be prevented.
The first leakage preventing member 17 moves smoothly on the surface of the needle 11.

  FIG. 4C shows a needle assembly to which a cap 13 that covers only the end portion of the needle 11 is attached. Except for the size of the cap 13, it is the same as the cap 13 shown in FIG. That is, the cap according to the present invention may be any size that can cover the end of the needle.

FIG. 5 shows an example of a cap according to another embodiment. The same elements as those in FIG. 4 are denoted by the same reference numerals, and the description thereof is omitted.
In FIG. 5A, the first leakage preventing member 17 described above is also disposed on the opening portion side of the cap 13 that covers the entire needle 11.
5B and 5C, the second leakage preventing member 117 is disposed at the tip of the cap 13 (the back side of the skin engaging surface 18). The second leakage prevention member 117 reliably prevents the contents of the cap 13 from leaking from the hole formed in the skin engaging surface 18 (formed by the penetration of the needle 11). The second leakage prevention member 117 can employ the same or the same material as the first leakage prevention member 17.
In the above, when the cap 13 is formed of a flexible material, the cap 13 is in contact with the needle 11 unlike the illustrated example (see FIGS. 4 and 5), and a space portion is formed between the needle 11 and the cap 13. May not be formed.

  The present invention is not limited to the description of the embodiments and examples of the invention described above. Various modifications may be included in the present invention as long as those skilled in the art can easily conceive without departing from the description of the scope of claims.

It is a side view which shows the needle assembly concerning embodiment of this invention. It is a side view which shows the needle concerning embodiment of this invention. It is a figure explaining the ultrasonic reflection means concerning embodiment of this invention. It is a figure which shows the example of the cap concerning embodiment of this invention. It is a figure which shows the example of the cap concerning other embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Needle assembly 11 Needle 12 Hub 13 Cap 14 Pointed part 15 Cut surface 16 Lumen 17 First leak prevention member 18 Skin engaging surface 19 Open part 20 Bellows part 30 O-ring

Claims (10)

A needle body having a tip portion capable of reflecting ultrasonic waves;
A needle assembly comprising a cap covering the tip,
When the needle body is punctured into the patient, the tip of the needle body penetrates the cap, and when the needle body is withdrawn from the patient, the tip of the needle body is stored in the cap.
A needle assembly characterized by that.   The cap is shorter than the needle main body, and an open portion thereof is filled with a first leakage preventing member, and the needle main body slidably penetrates the first leakage preventing member, and the first leakage preventing member 2. The needle assembly according to claim 1, wherein the cap prevents leakage of the contents of the cap from between the needle body and the cap.   3. The needle assembly according to claim 2, wherein a second leakage preventing member is disposed in a portion of the cap that faces the tip of the needle body.   The opening portion of the cap is fitted to a hub to which the proximal end portion of the needle body is connected, and the opening portion prevents the contents of the cap from leaking between the needle and the cap. The needle assembly according to claim 1, wherein one of the leakage prevention members is filled.   5. The needle assembly according to claim 4, wherein a second leakage preventing member is disposed in a portion of the cap that faces the tip of the needle body.   The needle assembly according to claim 1, wherein the cap is made of a flexible material.   The needle assembly according to any one of claims 1 to 6, wherein a surface of the tip portion of the needle body has an uneven shape so as to reflect ultrasonic waves.   The needle assembly according to any one of claims 1 to 6, wherein a reflective coating is formed on the surface of the tip portion of the needle body to reflect ultrasonic waves.   The needle assembly according to claim 7, wherein the uneven shape is formed of a plurality of narrow grooves.   9. The needle assembly according to claim 8, wherein the reflective coating is a fluorinated ethylene propylene polymer coating.

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