KR102475421B1 - Production Metohd of Aspiration needle for preventing detachment of biopsy tissue - Google Patents

Abstract

The present invention relates to a suction needle and a method for manufacturing the same, which prevent a sample tissue that has entered a lesion and is once inserted into the lumen of the needle from falling out when the suction needle is retrieved, and more particularly, is applied to and used in a flexible endoscope. It relates to a suction needle for preventing tissue dropout and a manufacturing method thereof, characterized in that a predetermined dropout prevention groove or a dropout prevention protrusion is formed in the lumen of the distal end of the suction needle.

Description

Manufacturing method of aspiration needle for preventing tissue detachment {Production Method of Aspiration needle for preventing detachment of biopsy tissue}

The present invention relates to a suction needle for preventing tissue detachment and a method for manufacturing the same, and more particularly, to suction that enters a lesion and prevents sample tissue once inserted into the lumen from falling out when the suction needle is retrieved. It relates to a needle and a manufacturing method thereof.

Conventionally, as a biopsy tool for a flexible endoscope, a forcep or an aspiration needle is used.

Forceps obtain tissue only from lesions on the surface of the gastrointestinal tract or bronchial tubes, so it is impossible to collect lesions on the inside of the surface, and since they are a method of grabbing and tearing tissue, it has the disadvantage of causing more damage to the tissue than necessary (Fig. see 1a).

A suction needle is a tool that allows tissue to be obtained by repeating the act of inserting and withdrawing a needle into the lesion to obtain tissue while negative pressure is applied to the opposite side (outside) of the empty needle (Fig. see 1b). According to this method, tissue can be obtained from lesions located deeper than the surface, but it is difficult to manipulate and damage tissue because the action of inserting and withdrawing the needle must be repeated several to dozens of times in order to insert the tissue into the lumen of the needle. In addition to this, it is difficult to make an accurate diagnosis because the tissue chart structure obtained through this causes a crushing effect. In addition, as shown in the drawing, a push rod pushing out the sample stuck inside the lumen is inserted into the lumen, and a catheter sheath is added to protect the inside of the flexible endoscope inserted from the tip of a sharp needle, increasing the diameter and increasing flexibility. Very low and very inconvenient to use.

Patent Publication No. 10-2004-0045779 (tissue biopsy needle) relates to a biopsy needle (see FIG. 1c) in which protruding protrusions are formed in a spiral shape in the inner space of the needle to prevent the collected bone tissue from being separated from the inner space of the needle. The above prior art is for percutaneous bone tissue collection, not a 'suction needle' that finely collects soft tissue.

US6,872,185 (double-action suction biopsy needle) relates to a suction needle (see Fig. 1d) having a sharp edge formed on the outer surface of the hollow needle with a closed tip and an opening communicating with the inside near the tip. . According to this, when the needle moves forward and backward, the tissue is scratched and pulled into the needle through the opening, preventing the tissue from escaping during recovery. There are inconveniences that you have to go through.

JP4950900 (Rotating Fine Needle for Core Tissue Sampling) is inserted into a flexible endoscope having a tubular covering member, a shaft member (= suction needle) inserted into the covering member, and a drive unit for axially moving and axially rotating the shaft member A biopsy device (see Fig. 1e) that is used is suggested. The prior art aims at minimizing tissue damage by allowing a suction needle to penetrate tissue while rotating, and there is no solution to preventing the sample inserted into the suction needle from being separated.

On the other hand, as illustrated in FIG. 1B, a suction needle is applied to a flexible endoscope equipped with an ultrasonic probe and is used to collect tissue of a lesion on the surface or inside of the lung or digestive tract. At this time, while checking the ultrasonic image of the suction needle from the outside through the ultrasonic probe, the exact position and the forward and backward movement of the suction needle are checked and controlled in real time. In order to obtain a clearer image, the suction needle is coated with a polymer or, as in Patent Registration 10-1049672, grooves for reflecting ultrasonic waves are formed on the surface of the suction needle (see FIG. 1f).

Patent Publication 10-2004-0045779 US6,872,185 JP4950900 Registered Patent 10-1049672

An object of the present invention is to provide a suction needle used in a flexible endoscope with improved usability and a manufacturing method thereof.

The present invention for achieving the above object is

In the suction needle applied and used in the flexible endoscope,

It is characterized in that a suction needle for preventing tissue dropout and a manufacturing method thereof, characterized in that a predetermined dropout prevention groove or a dropout prevention protrusion is formed in the lumen of the distal end of the suction needle.

As described above, according to the suction needle according to the present invention, the process of repeatedly inserting and withdrawing a conventional suction needle into a lesion can be reduced to one or two times, so that lesional tissue sampling can be performed more conveniently and safely than in the prior art.

In addition, according to the present invention, the tissue obtained can be obtained in an original state that is not crushed compared to conventional suction needles, which can help in accurate diagnosis.

Figure 1a is a conceptual diagram showing a process of collecting lesion tissue by biopsy forceps used by being inserted into the working channel of a conventional endoscope.
Figure 1b is a photograph showing a tip portion of a conventional suction needle for biopsy and a flexible endoscope to which it is applied.
Figure 1c is an example of a conventional biopsy needle for percutaneous bone tissue collection.
1d and 1e are examples of suction needles according to the prior art, respectively.
Figure 2 is a conceptual diagram showing a process of collecting biological lesion tissue using a suction needle.
Figure 3a is a conceptual cross-sectional view of the end of the suction needle in which a fall-out prevention groove or a fall-out prevention protrusion is formed according to the present invention.
Figure 3b is a conceptual cross-sectional view of the end of the suction needle according to the present invention in which a reflective groove is formed on the anti-falling protrusion.
Figure 4 is a flow chart by conceptual cross-sectional view showing the progress of the manufacturing method according to the present invention.
5a and 5b are views showing examples of internal molds used in the manufacturing method according to the present invention.

Hereinafter, the present invention will be described in more detail with reference to the accompanying drawings. However, the accompanying drawings are only examples for easily explaining the content and scope of the technical idea of the present invention, and thereby the technical scope of the present invention is not limited or changed. It will be obvious to those skilled in the art that various modifications and changes are possible within the scope of the technical spirit of the present invention based on these examples.

The suction needle 10 according to the present invention is adopted and used in a flexible endoscope. For this purpose, in addition to the structure of the distal end of the suction needle 10, which is a key component of the present invention, forward and backward movement of the suction needle 10 during the procedure, endoscope A predetermined mechanical configuration (hereinafter referred to as 'manipulator') for control and manipulation, such as coupling with, is formed at the exposed end exposed to the outside. Such a mechanical configuration for manipulation is not a key feature of the present invention, and since it can be borrowed from, for example, a conventional side cutting biopsy needle instrument shown in FIG. 1B, a detailed description thereof will be omitted.

On the other hand, as illustrated in FIG. 2, in order to obtain a tissue sample of the lesion using the suction needle 10, the process of inserting the suction needle 10 into the lesion and withdrawing it is repeated several times, and in this process, the tissue of the lesion A phenomenon of entering and exiting the lumen of the suction needle 10 occurs. Hereinafter, in order to prevent confusion, the entry and exit of the suction needle 10 into the lesion will be described as ' entry and withdrawal ', and the entry and exit of the tissue into the lumen of the suction needle 10 will be described as ' ingress and exit '.

(1) The present invention relates to a suction needle (10),

In the suction needle (10) applied to and used in the flexible endoscope, a predetermined anti-falling groove (11) or a falling-out prevention protrusion (12) is formed at the distal end of the lumen of the suction needle (10) to prevent tissue falling out. It relates to the suction needle 10 for. 3A illustrates a conceptual cutaway view of the end of the suction needle 10 having a circular anti-falling groove 11 (A in the drawing) or a partial anti-falling protrusion 12 (B in the drawing) according to the present invention. did In the drawing, A may also be seen as an anti-falling protrusion 12 between the anti-falling grooves 11.

The suction needle 10 according to the present invention has a structure that allows tissue to easily enter the lumen when the suction needle 10 enters the lesion and prevents tissue from entering the lumen when the suction needle 10 is retrieved. will have Therefore, it is preferable that the circular anti-falling groove 11 or the anti-falling protrusion 12 is formed perpendicularly to the entry and recovery path of the suction needle 10, and in the case of the partial anti-falling protrusion 12, the suction needle 10 It is preferable to have a gentle slope in the distal direction and a steep slope in the opposite direction in the entry and return path of. However, it is not limited thereto.

According to the present invention, the anti-falling groove 11 or the anti-falling protrusion 12 is formed on the inner surface (lumen), so that when the suction needle 10 enters the lesion, the sample tissue inserted into the lumen is prevented from falling out of the lumen. The groove 11 or the drop-out prevention protrusion 12 holds the sample tissue once entered and remains inside the suction needle 10 when the suction needle 10 is retrieved from the lesion. This means that tissue can be collected very easily by the suction needle 10 according to the present invention, compared to conventional suction needles 10 having a smooth lumen surface.

The suction needle 10 according to the present invention may have a predetermined ultrasonic reflection groove 13 formed on the surface of the distal end so that it is easy to check the exact position and forward and backward movement of the suction needle 10 in real time through an ultrasonic probe. have. At this time, the ultrasonic reflection groove 13 may be formed directly above the fall-out prevention protrusion 12 in the lumen, and this example is shown in FIG. 3B.

(2) Another present invention is a suction needle formed with the anti-falling protrusion 12 and the ultrasonic reflective groove 13 as illustrated in FIG. It relates to the manufacturing method of (10). 4 shows the progress of the manufacturing method according to the present invention as a conceptual cross-sectional view. In the drawings, for convenience of understanding, the thickness between the outer and inner surfaces of the suction needle 10 is exaggerated and expressed as thin.

In the present invention, the internal mold introduction step has an outer diameter in contact with the lumen of the suction needle 10, and has a groove 21 corresponding to the 'falling prevention protrusion 12' on the surface, and is connected to the groove 21 This step is to introduce the inner mold 20 having the separation keel 22 formed in the longitudinal direction into the lumen of the distal end of the suction needle 10.

A partial plan view, A-A' cross-sectional view, and B-B' cross-sectional view of the inner mold 20 are illustrated in FIG. 5A, and a C-C' partial cutaway perspective view are illustrated in FIG. 5B. In the drawing, one line of the groove 21 and the separation keel 22 are shown for simplicity, but it will be natural that a plurality of lines of the groove 21 and the separation keel 22 can be formed. The inner mold 20 is a rod circumscribed to the inner lumen of the suction needle 10, and as can be seen in the drawing, the groove 21 corresponding to the 'falling prevention protrusion 12' and the groove 21 are continuous. Thus, a separation keel 22 is formed in the longitudinal direction. The width and depth of the separation keel 22 are equal to or greater than those of the groove 21.

A cross-sectional view of a state in which the inner mold 20 is inserted into the lumen of the suction needle 10 is shown in (A) of FIG. 4 .

In the present invention, the protruding reflective groove forming step is sucked into the outer mold 30 having a protrusion 31 corresponding to the 'reflecting groove 13' formed at a position corresponding to the groove 21 of the inner mold 20. This step is to press the needle 10 to form the anti-falling protrusion 12 and the reflective groove 13 at the same time.

Cross-sectional views of a process in which the anti-falling protrusion 12 and the reflective groove 13 are formed by pressing the protrusion 31 of the external mold 30 are shown in (B) and (C) of FIG. 4 . As can be seen in the figure, when the protruding part 31 of the outer mold 30 is compressed at a position corresponding to the groove 21 of the inner mold 20, the corresponding part of the suction needle 10 is pressed and the lumen inside The anti-falling protrusion 12 corresponding to the groove 21 of the inner mold 20 is formed on the side, and the reflection groove 13 corresponding to the protrusion 31 of the outer mold 30 is formed on the outer surface at the same time.

In the mold separation step in the present invention, the inner mold 20 is relatively rotated so that the anti-falling protrusion 12 formed by separating the outer mold 30 is positioned on the separation keel 22, and then the inner mold 20 will separate The width and depth of the separation keel 22 formed long in the longitudinal direction of the inner mold 20 are the same as the width and depth of the groove 21 of the inner mold 20 - thus, the anti-falling protrusion 12 formed thereby equal or greater Therefore, even if the anti-falling protrusion 12 is formed in the lumen of the suction needle 10, it is not jammed, so that the inner mold 20 and the suction needle 10 can be separated.

10. Suction needle
11. Fall prevention groove 12. Fall prevention protrusion 13. Reflection groove
20. Inner mold
21. Piping groove 22. Separation keel
30. External mold
31. Overhang

Claims (4)

A method of manufacturing a suction needle for preventing tissue dropout, which is applied to a flexible endoscope and has a predetermined dropout prevention protrusion formed at the distal end of the suction needle lumen, the method comprising:
(A) Introducing an inner mold having an outer diameter in contact with the suction needle lumen, a groove corresponding to the 'fall-out prevention protrusion' on the surface, and a separation keel formed in the longitudinal direction in connection with the groove, into the lumen of the distal end of the suction needle Internal mold introduction step;
(B) a protruding reflective groove forming step of simultaneously forming an anti-falling protrusion and a reflective groove by pressing a suction needle with an outer mold having a protrusion corresponding to the 'reflecting groove' formed at a position corresponding to the groove of the inner mold;
(C) a mold separation step of separating the outer mold, rotating the inner mold so that the formed anti-falling protrusion is positioned on the separation keel, and then separating the inner mold;
A method for manufacturing a suction needle to prevent tissue loss. delete delete delete

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