JP2018126363A - Sample collection needle - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sample collection needle for a biopsy needle suitable for collecting a tissue slice of a thinner shape and a hard tissue slice as a sample.SOLUTION: A sample collection needle 1 includes a handle part 2, a sample collection part 3 having a spiral groove part 5 constituting a space for sample collection on the side face, and a conical tip projection part 4 projecting in the tip direction from the front end of the sample collection part. The sample collection part 3 includes a cutting blade 6 at the front end of the groove part 5, and the cutting blade 6 includes a notch part 7 forming a notch along the outer periphery of the sample collection part 3 with respect to an object tissue, and a scraping part 8 for scraping the inside of the notch in the object tissue and sending it to the groove part 5.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a sample collection needle that constitutes an inner needle of a biopsy needle for collecting a biological tissue used for collecting a sample for tissue diagnosis.

  In recent years, for lesions such as tumors in the deep part of the body such as the submucosa of the stomach and the mediastinum around the pancreas and heart, a biopsy needle for collecting biological tissue while confirming the lesion with an ultrasonic endoscope ( Hereinafter, an ultrasonic endoscopic puncture biopsy (EUS-FNA) in which a tissue piece as a specimen is collected and inspected simply by “biopsy needle”) has been developed and is generally used. Yes.

  According to this ultrasonic endoscopic puncture biopsy method, an accurate pathological diagnosis of a lesion site can be performed prior to the start of surgery or treatment with an anticancer agent. Based on the results of this pathological diagnosis, an accurate treatment policy can be adopted.

  As a biopsy needle used for such an ultrasonic endoscopic puncture biopsy, for example, in Patent Document 1, a sheath member formed in a tube shape and a needle that is passed through the sheath member so as to freely advance and retract A puncture needle having a member is described. On the distal end side of the needle member, a rotary blade for collecting tissue by rotation around the central axis of the needle member, and a spiral groove continuous to the rear thereof are provided.

  According to this, by pressing the puncture needle against the lesion site and rotating the needle member around the central axis, a string-like or sheet-like shape is formed in the space between the sheath member and the groove portion by a so-called screw pump action. Tissue pieces can be collected.

JP2015-85141A

  However, when using the puncture needle of the above-mentioned Patent Document 1 and attempting to collect a finer tissue piece by reducing the diameter of the needle member, the tissue piece may be broken by the rotary blade. In addition, when trying to collect highly fibrotic and hard tissue pieces, smooth cutting cannot be performed, which may make it difficult to collect tissue pieces efficiently.

  An object of the present invention is to provide a specimen collection needle for a biopsy needle that is suitable for collecting a tissue piece having a thinner shape or a hard tissue piece as a specimen in view of the problems of the prior art.

The specimen collecting needle of the first invention is
A specimen collection needle that is housed in an outer cylinder of a biopsy needle for collecting biological tissue used for collecting a specimen for tissue diagnosis from a target tissue and used as an inner needle,
The handle,
A sample collection portion having a spiral groove on the side surface that constitutes a sample collection space closed by the outer cylinder, and extending from the front end of the handle portion toward the distal end of the sample collection needle;
A cone-shaped tip protruding portion protruding in the tip direction from the front end of the specimen collecting portion;
The sample collection unit has a cutting blade that rotates at the front end of the groove portion to cut the target tissue by rotating the sample collection unit in the outer cylinder.
The cutting blade is
A notch part that forms a notch along the outer periphery of the specimen collection part for the target tissue;
It has a cutting part which cuts off the inside of the notch in the object organization, and sends it into the groove part.

  In using the sample collection needle of the first invention, the sample collection needle housed and guided in the outer cylinder of the biopsy needle for biological tissue collection (hereinafter simply referred to as “biopsy needle”) is the tip of the outer cylinder. In a state of slightly protruding from the outer cylinder, it is pressed together with the outer cylinder to the part of the target tissue where the specimen is collected. At this time, since the tip protruding portion of the sample collection needle pierces the site, the sample collection needle is reliably positioned with respect to the site.

  Thereafter, when the sample collection needle is rotated around its central axis, the part is cut by the cutting blade of the sample collection unit, and the sample collection needle is formed in the sample collection space formed by the groove of the sample collection unit. It is taken in as a tissue piece. Here, “cutting” includes thin cutting. During this time, the cutting direction of the cutting is reliably maintained by the tip protrusion of the sample collection needle.

  Further, during this time, at each cutting time or each cutting position of the part, after the cutting is formed by the cutting part of the cutting blade, the inside of the cutting is cut by the cutting part. For this reason, the tissue piece is taken into the sample collection space very smoothly and efficiently. Therefore, even when a thin tissue piece or a hard tissue piece is collected as a specimen, the tissue piece can be collected while minimizing damage to the tissue pieces.

  The sample collection needle of the second invention is characterized in that, in the first invention, the tip protruding portion has a conical shape having an apex angle in the range of 28 to 32 °.

  According to the second invention, the tip of the sample collection unit can be more reliably positioned with respect to the sample collection position in the target tissue.

The specimen collecting needle of the third invention is the first or second invention,
The tip protrusion has a tip-side conical portion and a base end side thereof,
The diameter of the rear end of the conical portion is 35 to 45% of the diameter of the side surface of the specimen collection part.

  According to the third aspect of the present invention, it is possible to achieve a high specimen collection efficiency while optimizing the dimensional ratio between the tip protrusion and the cutting blade and appropriately securing the positioning effect of the tip protrusion.

  The sample collection needle of a fourth invention is characterized in that, in the third invention, the base of the tip protrusion is narrower than the rear end of the conical portion of the tip protrusion.

  According to the fourth aspect of the present invention, when the specimen is collected, the portion of the target tissue that has been spread by the conical portion of the tip protrusion is slightly returned in the direction of the base when reaching the base of the tip protrusion, and then cut. Since cutting with a blade is performed, cutting with a cutting blade can be performed appropriately.

  In any one of the first to fourth inventions, the sample collection needle of the fifth invention has a width along the length direction of the sample collection unit with respect to the other part of the side surface of the sample collection unit with respect to the groove. The ratio is characterized in that it is 1: 2 to 1: 3.

  According to the fifth aspect, since the width of the groove is relatively large, the specimen collection space formed by the groove can be secured as a larger space, and the specimen collection efficiency can be improved.

It is a front view of the sample collection needle concerning one embodiment of the present invention. 2A is a front view of the distal end portion of the sample collection needle of FIG. 1, FIG. 2B is a plan view of the distal end portion, FIG. 2C is a left side view of the distal end portion, and FIG. It is the figure which looked at the front end side from 15 degrees diagonally downward on the back side. FIG. 2 is an explanatory diagram for explaining a method of collecting a specimen tissue piece using the specimen collecting needle of FIG. 1.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. As shown in FIG. 1, a sample collection needle 1 according to an embodiment of the present invention includes a handle portion 2 having a predetermined length and diameter, and a front end direction of the sample collection needle 1 (hereinafter referred to as the following) from the front end of the handle portion 2. The specimen collection section 3 extending simply in the “tip direction”) and a conical tip projection section 4 having an acute apex angle projecting in the distal direction from the front end of the specimen collection section 3 are provided. The handle part 2 and the specimen collecting part 3 have substantially the same diameter.

  The sample collection needle 1 is used as an inner needle of a biopsy needle 15 (see FIG. 3) that collects a sample for tissue diagnosis from a target tissue. That is, it is housed in the outer cylinder 16 (see FIG. 3) of the biopsy needle 15 and is guided by the outer cylinder 16 so as to be movable forward and backward and rotatable. As a material for the specimen collection needle 1, stainless steel, or an alloy such as nickel, chromium, or titanium can be used.

  When the sample collection needle 1 is used in ultrasonic endoscopic puncture biopsy (EUS-FNA), the sample collection needle 1 is used by being inserted into an ultrasonic endoscope. It has a length of about and a diameter of about 0.5 mm. Moreover, the sample collection part 3 has a length of about 20 mm.

  2A to 2C are a front view, a plan view, and a left side view of the distal end portion of the sample collection needle 1. FIG. 2D shows a state in which the distal end side of the distal end portion is viewed obliquely downward by 15 ° on the back side, that is, from the D direction in FIG. 2C.

  As shown in FIGS. 2A to 2D, the sample collecting unit 3 has a spiral groove 5 on the side surface. The groove portion 5 is closed by the outer cylinder of the biopsy needle and constitutes a sample collection space. A portion 12 other than the groove portion 5 on the side surface of the specimen collecting portion 3 corresponds to a land portion in the drill bit.

  The sample collection unit 3 has a cutting blade 6 at the front end of the groove 5 that rotates along with the rotation of the sample collection unit 3 in the outer cylinder of the biopsy needle to cut the target tissue. The cutting blade 6 has a cut portion (scribing blade) 7 that forms a cut with respect to the target tissue, and a scraping portion (rake blade) 8 that scrapes the inside of the cut in the target tissue.

  That is, the notch portion 7 follows the rotation trajectory of the outer end portion of the cutting blade 6 when the front end of the sample collecting portion 3 is pressed against the target tissue and the sample collecting portion 3 is rotated around its central axis. Has a function of forming a cut along the outer periphery of the specimen collection part in the target tissue. The scraping portion 8 has a function of scraping and feeding the inner portion of the cut in the target tissue in which the cut is formed by the cut portion 7 and feeding it into the groove portion 5. This facilitates smooth and efficient sample collection.

  In the length direction of the specimen collection unit 3, the position P1 of the cut portion 7 located on the most distal side is substantially the same position as the position P2 of the cutting portion 8 located on the most distal side. It is. Thereby, formation of unnecessary cuts in the target tissue is avoided as much as possible. Note that the position P1 may be a position slightly on the tip side with respect to the position P2.

  The clearance angle θ1 of the cutting portion 8 of the cutting blade 6 shown in FIG. 2B is about 4 °. Further, the angle θ2 of the cutting edge of the cutting portion 7 of the cutting blade 6 shown in FIG. 2D is about 50 °. The cutting blade 6 is of the right-handed right-handed type. Although the left blade may be twisted to the left, in that case, it is necessary to rotate the cutting blade 6 in the reverse direction.

  The distal protrusion 4 has an apex angle within a range of 28 to 32 °, and is constituted by a conical portion 9 on the distal end side and a base portion 10 on the proximal end side thereof. The rear end side of the base 10 is connected to the front end of the sample collection unit 3. The ratio of the diameter φy of the rear end of the conical portion 9 to the diameter φx of the side surface (land portion) of the sample collection unit 3 is preferably 35 to 45%.

  If this ratio is less than 35%, the positioning function to the target tissue by the tip protrusion 4 may be insufficient. On the other hand, when this ratio exceeds 45%, the cutting efficiency by the cutting blade 6 may be deteriorated. That is, by setting this ratio to 35 to 45%, it is possible to secure an appropriate cutting area by the cutting blade 6 while appropriately securing the positioning effect by the tip protrusion 4 and to improve the sampling efficiency of the specimen. .

  The base 10 of the distal protrusion 4 is slightly thinner than the rear end of the conical portion 9 and is connected to the front end of the sample collection unit 3. As a result, the portion of the target tissue that has been spread out by the conical portion 9 is slightly returned to its original position, so that the cutting efficiency by the cutting blade 6 is improved.

  The width ratio A: B along the length direction of the sample collection unit 3 for the other portion (land portion) with respect to the groove 5 on the side surface of the sample collection unit 3 is 1: 2 to 1: 3. preferable.

  When the value of this ratio A: B is larger than ½, the specimen collection space formed by the groove 5 is reduced, and the specimen collection efficiency is deteriorated. On the other hand, if the value of the ratio A: B is smaller than 1/3, the width of the groove part 5 becomes too large, and the strength of the specimen collecting part 3 may be deteriorated. That is, by adopting a value in the above range as the value of the ratio A: B, the width of the groove portion 5 is increased as much as possible to improve the sample collection efficiency.

  The diameter φz of the central portion 11 in the radial direction of the sample collection unit 3, that is, the portion corresponding to the bottom of the groove 5 is approximately 30% of the diameter φx of the side surface of the sample collection unit 3. The center portion 11 ensures a sufficient strength for the sample collection portion 3 while adopting the value of the ratio A: B of the other portion relative to the groove portion 5 described above.

  FIG. 3 shows a method of using the sample collection needle 1. FIG. 3 shows a state where a tissue piece of a tumor 14 generated in the pancreas 13 is collected as a specimen. As shown in FIG. 3, the sample collection needle 1 is guided in an outer cylinder 16 of the biopsy needle 15 so as to be movable forward and backward and rotatable.

  The biopsy needle 15 is used by being inserted into the ultrasonic endoscope 17 and protruding from the distal end portion of the ultrasonic endoscope 17. The ultrasonic endoscope 17 is provided with a forceps raising base 18, whereby the protruding direction of the biopsy needle 15 is controlled.

  An operator controls the rotation of the sample collection needle 1 around the axis of the outer cylinder 16 and the amount of protrusion from the distal end of the outer cylinder 16 on a needle base (not shown) provided at the proximal end of the biopsy needle 15. For this purpose, an operation unit (not shown) is provided. That is, the surgeon can control the biopsy needle 15 by the method described in Patent Document 1 (Japanese Patent Laid-Open No. 2015-85141).

  When collecting a specimen for performing an examination by an ultrasonic endoscopic puncture biopsy (EUS-FNA) for a tumor 14 generated in the pancreas 13, the operator orally uses the ultrasonic endoscope 17. The position and size of the tumor 14 in the pancreas 13 are confirmed while being inserted and observed with an endoscopic image or an ultrasonic image from the inside of the stomach 19.

  Then, the biopsy needle 15 is protruded from the distal end portion of the ultrasonic endoscope 17 and punctures the tumor 14 in the pancreas 13 through the stomach wall 20. At the time of this puncturing, the protruding direction of the biopsy needle 15 is controlled by the forceps raising base 18.

  Further, at the time of this puncturing, the distal end portion of the sample collection needle 1 is appropriately protruded from the distal end of the outer cylinder 16 of the biopsy needle 15. Therefore, this puncture is performed smoothly with respect to a desired position of the tumor 14 based on the function of the tip protrusion 4 of the sample collection needle 1, and the puncture position is reliably determined.

  In this state, the surgeon rotates the sample collection needle 1 while gradually feeding the biopsy needle 15 from the ultrasonic endoscope 17 while keeping the amount of projection of the sample collection needle 1 from the outer cylinder 16 constant. Thus, a tissue piece of the tumor 14 can be collected as a specimen.

  That is, when the sample collection needle 1 is rotated to the right, the cutting blade 6 is right-handed and right-handed, so that the tissue of the tumor 14 is scraped off by the cutting blade 6 and the scraped portion gradually becomes the sample collection needle. It is accommodated in the sample collection space between the one groove portion 5 and the outer cylinder 16.

  When the tissue is cut by the cutting blade 6, at each cutting progress time or each cutting depth, first, the cutting portion 7 of the cutting blade 6 forms a cut along the rotation locus of the outer end portion of the cutting blade 6. Next, the inside of the portion where the cut is formed is scraped off by the scraping portion 8. Thereby, even when the cutting target site is hard or the cutting radius is small, the tissue piece is collected very smoothly.

  Each part to be cut is expanded by the conical portion 9 of the tip protrusion 4 immediately before cutting, and then reaches the base 10 of the tip protrusion 4 when the base 10 side (tip protrusion) is reached. 4) and then cut by the cutting blade 6. For this reason, it is possible to obtain a tissue piece with less damage compared to a case where the tissue is cut while being expanded by the conical portion 9.

  The specimen tissue piece collected in this manner is subjected to an examination for accurately diagnosing what kind of tumor 14 is. As a result, an accurate pathological diagnosis can be obtained before surgery or anticancer drug treatment is performed on the tumor 14, and a correct treatment policy can be determined.

  As described above, according to the present embodiment, when the sample is collected from the target tissue such as the tumor 14, the sample collection needle 1 is moved to the position where the sample is collected by the tip protrusion 4 of the sample collection needle 1. While positioning reliably, the cutting direction by the sample collection needle 1 can be reliably maintained.

  Further, while the target tissue is being cut, a cut is formed by the cut portion 7 of the cutting blade 6, and the inside of the cut portion 8 is cut away by the cut portion 8, so that acquisition of the tissue piece proceeds. No tissue pieces can be acquired smoothly and efficiently.

  At this time, the portion of the target tissue that has been spread by the conical portion 9 of the tip protrusion 4 is slightly returned in the direction of the base 10 when reaching the base 10 of the tip protrusion 4, and then the cutting blade 6. Therefore, a tissue piece with less damage can be obtained.

  In addition, since the apex angle of the tip protruding portion 4 is an angle in the range of 28 to 32 °, the positioning effect of the sample sampling needle 1 on the target tissue by the tip protruding portion 4 can be reliably realized.

  Moreover, since the diameter of the base end part of the front-end | tip protrusion part 4 is 35 to 45% of the diameter of the sample collection part 3, the ratio of the dimension of the front-end | tip protrusion part 4 and the cutting blade 6 etc. is optimized, and a front-end | tip protrusion part. High sample collection efficiency can be realized while appropriately securing the positioning effect of 4.

  Further, since the ratio A: B of the width along the length direction of the other part (land part) to the groove part 5 on the side surface of the specimen collecting part 3 is 1: 2 to 1: 3, a larger specimen collecting space is obtained. Can be ensured, and the sampling efficiency of the specimen can be improved.

  Further, the position P1 of the portion of the cutting blade 6 located on the most distal direction side of the cut portion 7 is substantially the same position as the position P2 of the portion of the cutting blade 6 located on the most distal direction side. Therefore, when the cutting by the cutting unit 8 is completed, it is possible to prevent the cutting unit 7 from forming an unnecessary cut in the target tissue.

  As mentioned above, although embodiment of this invention was described, this invention is not limited to this. For example, the sample collection needle 1 may be used as an inner needle of a biopsy needle that directly punctures a diseased tissue without using the ultrasonic endoscope 17.

  Further, an inner cylinder having a sharpened tip portion may be provided between the outer cylinder 16 and the sample collection needle 1. In this case, the needle base is provided with an operation unit for separately controlling the positional relation between the outer cylinder 16 and the inner cylinder and between the inner cylinder and the sample collection needle 1 in the forward / backward direction and the axial direction. According to this, it is possible to facilitate the puncture of a lesion tissue that has been fibrotically strengthened or a lesion tissue that exists in a deeper position, and it is possible to improve the efficiency of collecting a tissue piece for such a lesion tissue.

  Further, the specimen collection needle 1 collects a specimen in the same manner as described above in order to perform an examination by the ultrasonic endoscopic puncture biopsy (EUS-FNA) for the submucosal tumor 21 of the stomach 19 in FIG. It may be used for purposes. Moreover, the front-end | tip protrusion part 4 is not restricted to a cone shape, Other cone-shaped things, such as a pyramid shape, may be sufficient.

  DESCRIPTION OF SYMBOLS 1 ... Sample collection needle, 2 ... Pattern part, 3 ... Sample collection part, 4 ... Tip protrusion part, 5 ... Groove part, 6 ... Cutting blade, 7 ... Cutting part, 8 ... Cutting part, 9 ... Conical part, DESCRIPTION OF SYMBOLS 10 ... Base part, 11 ... Center part, 12 ... Parts other than a groove part (land part), 13 ... Pancreas, 14 ... Tumor, 15 ... Biopsy needle, 16 ... Outer cylinder, 17 ... Ultrasound endoscope, 18 ... Forceps origin Upper stage, 19 ... stomach, 20 ... stomach wall, 21 ... submucosal tumor.

Claims (5)

A specimen collection needle that is housed in an outer cylinder of a biopsy needle for collecting biological tissue used for collecting a specimen for tissue diagnosis from a target tissue and used as an inner needle,
The handle,
A sample collection portion having a spiral groove on the side surface that constitutes a sample collection space closed by the outer cylinder, and extending from the front end of the handle portion toward the distal end of the sample collection needle;
A cone-shaped tip protruding portion protruding in the tip direction from the front end of the specimen collecting portion;
The sample collection unit has a cutting blade fixed to the front end of the groove, and rotated with the rotation of the sample collection unit in the outer cylinder to cut the target tissue.
The cutting blade is
A notch part that forms a notch along the outer periphery of the specimen collection part for the target tissue;
A specimen collection needle comprising: a scraping portion that scrapes the inside of the cut in the target tissue and feeds it into the groove portion.   2. The specimen collecting needle according to claim 1, wherein the tip protruding portion has a conical shape having an apex angle within a range of 28 to 32 °. The tip protrusion has a tip-side conical portion and a base end side thereof,
3. The sample collection needle according to claim 1, wherein a diameter φy of a rear end of the conical portion is 35 to 45% of a diameter φx of a side surface of the sample collection unit.   The specimen collecting needle according to claim 3, wherein a base portion of the tip protrusion is narrower than a rear end of a conical portion of the tip protrusion.   The ratio of the width along the length direction of the sample collection unit for the other portion of the sample collection unit with respect to the groove is 1: 2 to 1: 3. The specimen sampling needle according to any one of the above.

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