WO2016152496A1

WO2016152496A1 - Flexible needle for medical use

Info

Publication number: WO2016152496A1
Application number: PCT/JP2016/057097
Authority: WO
Inventors: 中島　弘明; 保臣田中; 英昭請関
Original assignee: メディキット株式会社
Priority date: 2015-03-23
Filing date: 2016-03-08
Publication date: 2016-09-29
Also published as: JPWO2016152496A1; JPWO2016152497A1; WO2016152497A1

Abstract

A flexible needle for introducing a catheter into a blood vessel is provided with: a tube section comprising a needle tip that can be used for puncturing, a surface onto which the catheter is slidably fit and guided, and a flow path that communicates with the needle tip and passes through the interior thereof; and a groove having a spiral shape that winds around the surface in at least one continuous loop, a plurality of grooves having spiral shapes that wind around the surface and that are discontinuous, or a plurality or grooves having arcuate shapes that wind around the surface without fully encircling same.

Description

Medical flexible needle

The present invention relates to a medical flexible needle, and more particularly to a flexible needle that is used in a needle assembly for introducing a catheter to facilitate a procedure.

A catheter may be introduced into a patient's blood vessel using a needle assembly for the purpose of infusion or dialysis. The catheter is put on the needle of the needle assembly, punctured into the patient's body together with the needle, and the catheter is left in the blood vessel by removing only the needle.

The needle of the needle assembly often has a hollow structure similar to an injection needle. When the needle is punctured into the blood vessel, reverse blood passes through the needle (flashback), but if this is pulled out to an appropriate part of the needle assembly and visually confirmed, it can be confirmed that the needle tip has captured the inside of the blood vessel. .

Unlike the injection, since the catheter is left in the patient's body for a certain period of time, it needs to be inserted deeper into the blood vessel than the injection needle. In addition, since the needle of the needle assembly is covered with the catheter, the outer diameter is necessarily smaller than the inner diameter of the catheter. That is, the needle of the needle assembly is often longer and thinner than the needle.

Patent Documents 1 and 2 disclose related techniques related to a needle assembly used for introducing a catheter.

JP 2008-173463 A JP 2014-073183 A

Since the needle of the needle assembly is extremely long compared to a normal injection needle, it is not an easy procedure for medical staff to accurately position the needle tip deep inside the blood vessel. The needle tip can penetrate the blood vessel and pierce unintended parts of the patient's body tissue. In order to overcome such a problem, it has been considered to be advantageous to increase the rigidity of the needle to prevent bending and thereby make it easier to grasp the position of the needle tip.

When the present inventors examined, contrary to the common sense as described above, a needle that flexes more flexibly than a rigid needle is more likely to bend along the blood vessel, and the needle tip is more easily positioned correctly in the blood vessel. I found out that The present invention has been made in view of such a discovery, and an object thereof is to provide a medical flexible needle that can easily introduce a needle tip into a blood vessel.

According to one aspect of the present invention, a flexible needle for introducing a catheter into a blood vessel includes a needle tip that can be used for puncturing, a surface on which the catheter is slidably fitted and guided, and the needle A pipe portion having a flow path that communicates first and penetrates the inside; a spiral that continuously circulates the surface one or more times; a plurality of discontinuous spirals that circulate around the surface; A plurality of arc-shaped grooves of less than one turn.

FIG. 1 is a perspective view of a needle assembly including a flexible needle according to one embodiment. FIG. 2A is an elevational view of a flexible needle according to one embodiment. FIG. 2B is an elevation view of a flexible needle according to another embodiment. FIG. 2C is an elevational view of a flexible needle according to yet another embodiment. FIG. 3A is an elevational view of a flexible needle according to a different embodiment. FIG. 3B is an elevational view of a flexible needle according to yet another embodiment. FIG. 4A is an elevation view illustrating a process of manufacturing a flexible needle according to one embodiment. FIG. 4B is an elevational view illustrating a process for manufacturing a flexible needle according to another embodiment. FIG. 4C is an elevational view illustrating a process for manufacturing a flexible needle according to yet another embodiment. FIG. 5A is an elevation view illustrating a spiral state when the flexible needle is bent. FIG. 5B is an elevation view illustrating a state where the flexible needle is bent in the flexible needle according to another embodiment. FIG. 6 is a schematic cross-sectional view showing how a catheter is guided into a blood vessel, and is a case where a rigid needle is used. FIG. 7 is a schematic cross-sectional view showing how a catheter is guided into a blood vessel, and is a case using a flexible needle.

Several exemplary embodiments of the present invention are described below with reference to the accompanying drawings.

The medical flexible needle according to an embodiment of the present invention is not necessarily limited to this, but is used by being incorporated into the needle assembly 1 shown in FIG. The needle assembly 1 generally comprises a handle 3 and a flexible needle 9 for puncture extending forward from the handle 3. The catheter 7 is put on the flexible needle 9 and introduced into the blood vessel by being punctured with the flexible needle 9 into the patient's body. In this example, the flexible needle 9 can be retracted by a spring mechanism after use, and the button 5 for operating the spring mechanism has its head looked into the side surface of the handle 3. Of course, the flexible needle 9 can be used for a manual retraction type or a fixed needle assembly.

2A to 2C, the flexible needle 9 is made of an appropriate metal such as stainless steel. Alternatively, an appropriate elastic material including a resin may be used instead of the metal. Examples of such a resin include polyether ketone (PEEK), polycarbonate (PC), polyphenylene sulfide (PPS), and a liquid crystal polymer.

The entire flexible needle 9 is generally a hollow tube, but the needle tip is sharply pointed so that it can be used for puncture. The catheter 7 is guided by being slidably fitted to the tube portion. The cavity inside the tube portion communicates with the needle tip and penetrates the entire tube portion, and acts as a flow path for flowing reverse blood when the needle tip catches a blood vessel.

Referring particularly to FIG. 2A, the surface of the tube portion of the flexible needle 9 includes a spiral groove 9S that goes around the surface one or more times. The groove 9S may reach the needle tip at the front and may reach the rear end at the rear. The groove 9S may draw a spiral with an equal pitch throughout the groove 9S, or may draw a spiral with a pitch different from that of the other part in a specific part 9P as referred to by reference numeral 9S ′ in FIG. 2B. . Or the pitch may change continuously. The pitch of the grooves 9S 'may be shorter or longer than the others. Furthermore, as shown in FIG. 2C, the groove 9S may be limited to a specific portion 9P '.

Flexibility depends on the pitch of the spiral, and the narrower the pitch, the easier it is to flex. Therefore, the ease of bending can be adjusted by the pitch of the spiral. When it is desired to further promote the bending at a specific part or to suppress the bending, the pitch can be changed at the specific part or the groove can be limited to the specific part as shown in FIGS. 2B and 2C.

Alternatively, the groove 9S is discontinuous and may be composed of a plurality of small spiral portions. FIG. 3A is an example thereof, and each spiral portion ends around the flexible needle 9 in one round. Each spiral portion may of course have one or more rounds or less than one round.

Further alternatively, the groove 9S is not a spiral, but may be an arc of less than one round surrounding the flexible needle 9, as illustrated in FIG. 3B. Each arc may be deviated in the circumferential direction with respect to the adjacent arc. In the example of FIG. 3B, each arc is deviated by 90 degrees, but the deviation may be an arbitrary angle.

Since the groove 9S is a portion that is easily deformed, the flexible needle 9 is urged to bend flexibly. If the groove 9S extends over the entire flexible needle 9 as shown in FIG. Will not concentrate.

The groove 9S may be a groove that does not penetrate toward the inside of the flexible needle, but may be a penetration groove. Such a through-groove may be always open, or may be normally closed and open only when the pipe portion is bent, and the surface thereof communicates with the internal flow path. In the latter case, the bending of the flexible needle is absorbed exclusively by the opening and closing of the through-groove, and the space between the spirals hardly needs to be deformed. Moreover, since a groove | channel opens by bending and a reverse blood oozes out from a groove | channel, it can confirm that the needle point has caught the inside of the blood vessel by visually confirming this.

The groove 9S as described above can be formed by utilizing machining, laser processing, water jet processing, etching, or the like. For example, in the case of laser processing, referring to FIG. 4A, rotation R and translational motion F are given to the flexible needle 9 while irradiating the flexible needle 9 with the laser beam L. A groove is formed at the irradiation point S, and the irradiation point S advances spirally on the surface of the flexible needle 9, so that a spiral groove 9S can be formed. At this time, a tension T may be applied to the flexible needle 9 as shown in FIG. 4B. When the tension T is removed after the processing, the flexible needle 9 tends to shrink like a spring, so that the open groove 9S is closed, so that the groove 9S can be formed only when the flexible needle 9 is bent. . Alternatively, as shown in FIG. 4C, a similar structure can be formed by winding the steel strip 19 in a spiral shape.

After forming the groove 9S, coating may be applied to the entire flexible needle 9 or limited to the groove 9S. After the open groove 9S is formed, it can be closed with a coating and can be opened only when the flexible needle 9 is bent. Alternatively, a coating may be applied for lubrication or other purposes.

Further alternatively, the flexible needle 9 may be made of a shape memory alloy or a shape memory resin. The groove 9S can be closed or opened by the shape memory effect.

When the flexible needle 9 bends, as shown in FIG. 5A, the groove 9S narrows on the inner periphery side of the bend, and the groove 9S expands or opens on the outer periphery side of the bend. Accordingly, the groove 9S prompts the flexible needle 9 to bend flexibly. Furthermore, since the bending is absorbed exclusively by the groove 9S, the other portions can easily maintain their shapes. This prevents the flexible needle 9 from being crushed in the radial direction, thereby preventing the internal cavity from becoming narrow.

Measures can be applied to the flexible needle 9 so that the groove does not spread excessively. For example, in the flexible needle 9A shown in FIG. 5B, the groove 9AS generally has a spiral shape, but may partially include an S-shaped or N-shaped structure 9AC. The structure 9AC engages with each other when the groove 9AS is about to spread and prevents the part from spreading.

Referring to FIG. 6, as already described, the catheter 7 is used by being put on the needle 9. The medical staff operates the needle assembly 1 with the finger 11 to puncture the needle 9 into the patient's body (arm) 13 and attempt to guide the needle tip into the blood vessel 15. If the medical staff is immature and the needle 9 is rigid, the needle tip may penetrate the blood vessel 15 and reach deeper into the patient's body 13.

Referring to FIG. 7, according to the flexible needle 9 according to the present embodiment, after puncturing, the flexible needle 9 is easily bent along the blood vessel 15, thereby preventing the needle tip from penetrating the blood vessel. The At this time, the spiral groove 9 </ b> S prompts the flexible needle 9 to bend flexibly, and prevents the internal flow path from becoming narrow. It is confirmed that the needle tip is caught in the blood vessel by being drawn out to an appropriate part of the needle assembly 1 without being blocked by the reverse blood passing through the flexible needle 9 or by seeping out from the groove 9S. To help.

Although the present invention has been described with reference to preferred embodiments, the present invention is not limited to the above embodiments. Based on the above disclosure, a person having ordinary skill in the art can implement the present invention by modifying or modifying the embodiment.

A flexible medical needle that is easy to bend and prevents the internal cavity from being narrowed even if it is bent is provided.

Claims

A flexible needle for introducing a catheter into a blood vessel,
A needle tip that can be used for puncture;
A tube portion having a surface on which the catheter is slidably fitted and guided, and a flow path communicating with the needle tip and penetrating through the inside;
A spiral that circulates continuously around the surface one or more times, a plurality of discontinuous spirals that circulate around the surface, or a plurality of arc-shaped grooves that circulate around the surface;
A flexible needle.
2. The flexible needle according to claim 1, wherein the groove includes a first portion that draws a spiral having an equal pitch and a second portion that draws a spiral having a pitch different from the equal pitch.
3. The flexible needle according to claim 1, wherein the groove is a closed through groove, and is a through groove that opens when the pipe portion is bent to allow the surface to communicate with the flow path. Flexible needle.
The flexible needle according to claim 1 or 2, wherein the groove reaches the needle tip.
5. The flexible needle according to claim 4, wherein the groove is a closed through groove, and is a through groove that opens when the pipe portion is bent to allow the surface and the flow path to communicate with each other. .