KR20160057564A

KR20160057564A - Biopsy needle assembly

Info

Publication number: KR20160057564A
Application number: KR1020140158174A
Authority: KR
Inventors: 서준범; 김남국; 이상민
Original assignee: 울산대학교 산학협력단
Priority date: 2014-11-13
Filing date: 2014-11-13
Publication date: 2016-05-24

Abstract

The present invention relates to a biopsy needle assembly, comprising sheath including a cannula, and an inner stylet including a needle part penetratingetrate inside the sheath, wherein the needle part is longitudinally bent. The biopsy needle assembly can extract needed tissues by a single insertion into various parts of the tissues needed for biopsy.

Description

Biopsy needle assembly {BIOPSY NEEDLE ASSEMBLY}

Disclosure relates generally to a needle-like device for tissue biopsy, and more particularly to a biopsy needle assembly in which the needle portion of the inner stylet is curved along the length direction.

Typically, when a nodule or mass in a human body is suspected of being a cancer, the disease is confirmed through tissue sampling called a tissue biopsy and pathological examination of the collected tissue. The histological biopsy can be divided into two types: a method of collecting tissue through surgery and a minimally invasive method using the latest image guiding equipment. Since the surgical biopsy has a large incision site, In recent years, a biopsy method based on a minimally invasive method has become popular because of its long, painful, complicated, and even more risky of death. An image - guided biopsy can be divided into two types: an aspiration biopsy to obtain cells only and a core biopsy to obtain more tissue.

Prior art for aspiration biopsy includes a number of patents such as U.S. Patent Nos. 3,938,505, 4,314,565, 5,199,441, 5,469,860, 6,872,185, 6,592,559. Prior art relating to core biopsy includes a number of patents including U.S. Patent Nos. 3,477,423, 4,600,014, 5,161,542, 5,236,334, 7,914,463. Aspiration biopsy can be performed when there is a pathologist at the biopsy site, when the likelihood of cancer is very high, if no immunologic or genetic testing is required, if the tumor is accompanied by extensive necrosis, In the case of using a core biopsy, it is necessary to diagnose cancer biopsy more precisely, to obtain genetic information of cancer, to have a benign tumor, or to diagnose a pathologist. . The biopsy needle for biopsy has a core biopsy needle and an aspiration biopsy needle, depending on the biopsy method.

Figure 1 shows an example of a core biopsy needle assembly structure. One example of the core biopsy needle assembly structure described in FIG. 1 is described in U.S. Patent No. 5,236,334, but the terminology and reference symbols have been changed for convenience of explanation. The core biopsy needle assembly consists of an inner stylet (10) and a sheath (20). The inner stylet 10 is composed of a needle portion 14 having a hub 11, a body 12 and a notch 13. The notch 13 is located near the distal end of the needle part 14 and is a space in which the cut tissue is stored. The distal end of the needle portion 14 has a pointed shape for the function of passing through the living body. The sheath 20 is composed of a hub 21 and a cannula 22.

Figure 2 shows an example of a method of using a core biopsy needle assembly. An example of a method of using the core biopsy needle assembly described in FIG. 2 is described in U.S. Patent No. 5,161,542, but the terminology and reference symbols have been changed for convenience of explanation. First, insert the inner stylet and sheath into the tissue (30) where harvesting is required (see 40). Thereafter, the notches 13 of the inner stylet are inserted into the tissue 30 (refer to 41). The cannula 22 of the sheath is then inserted into the tissue 30 (see 42) to cut the tissue entering the notch 13. Thereafter, the core biopsy needle assembly is pulled out from the living body with the cut tissue in the notch 13, and the tissue contained in the notch 13 is used for the examination.

Figure 3 shows an example of an aspiration biopsy needle assembly structure. One example of the structure of the aspiration biopsy needle assembly described in Fig. 3 is commonly used and is known as the Chiba needle. The chiba needles are composed of a sheath 50 and an inner stylet 60. The sheath 50 is composed of a hub 51 and a cannula 52. The inner stylet 60 is composed of a hub 61 and a needle 62. The major difference from the inner stylet 10 in the core biopsy needle assembly is that it does not have a notch 13, which is a space for collecting tissue and storing it.

Figure 4 shows an example of a method of using an aspirated biopsy needle assembly. First, the inner stylet 60 and the sheath 50 are joined (refer to 81), and then inserted into the tissue 30 to be harvested (see 82). Thereafter, the inner stylet 60 is separated from the sheath 50 (see 82). The syringe 70 is then coupled to the hub 51 of the sheath 50 (see 83). Then, a part of the tissue 30 is collected using the suction force of the syringe. Various methods other than the injector 70 can be used as a method of using the suction force. A vacuum machine may also be used. Generally, the outer diameter size of the sheath 50 of the suction biopsy needle assembly is smaller than the outer diameter size of the sheath 20 of the core biopsy needle assembly because the inner diameter of the sheath 50 is better to improve the suction force.

Figure 5 shows the problem of the biopsy needle assembly in the prior art.

The core biopsy needle assembly 90 in the prior art has a straight line in the longitudinal direction of the inner stylet 92.

In the case of the core biopsy needle assembly 90 in which the inner stylet 92 is a straight structure, when the core biopsy needle assembly 90 is used to collect various portions 31, 32, 33 of the tissue 30, Three inserts are required because they must be inserted in different paths. The precise insertion of a biopsy needle assembly into a tissue requiring harvest is a highly focused task for the practitioner. The patient also feels uncomfortable when inserting a biopsy needle assembly. Therefore, there is a problem in the core biopsy needle assembly 90 in which the inner stylet 92 has a straight structure when a plurality of portions are to be sampled in one tissue 30 as shown in FIG. Figure 5 shows only the core biopsy needle assembly, but has the same problem when the inner biopsy needle assembly is linear.

This will be described later in the Specification for Enforcement of the Invention.

SUMMARY OF THE INVENTION Herein, a general summary of the present disclosure is provided, which should not be construed as limiting the scope of the present disclosure. of its features).

According to one aspect of the present disclosure, there is provided a biopsy needle assembly comprising: a sheath having a cannula; And an inner stylet having a needle portion penetrating the inside of the sheath, wherein the shape of the needle portion is bent along the longitudinal direction.

1 shows an example of a core biopsy needle assembly structure,
Figure 2 shows an example of a method of using a core biopsy needle assembly,
Figure 3 shows an example of an aspiration biopsy needle assembly structure,
Figure 4 shows an example of a method of using a suction biopsy needle assembly,
Figure 5 shows a problem of the prior art core biopsy needle assembly,
6 is a view showing an example of a biopsy needle assembly according to the present disclosure,
FIG. 7 is a view showing a characteristic of a biopsy needle assembly according to the present disclosure when the tip shape of the needle part is beveled;
8 is a view showing an example of using the biopsy needle assembly according to the present disclosure,
9 is a view showing another example of a biopsy needle assembly according to the present disclosure;

The present disclosure will now be described in detail with reference to the accompanying drawings. However, the form of the disclosure is not limited to the description of the drawings.

6 is a view showing an example of a biopsy needle assembly according to the present disclosure;

The biopsy needle assembly 100 includes an inner stylet 110 and a sheath 120. The inner stylet 110 includes a hub 111 and a needle portion 112. The shape of the distal end 113 of the needle part 112 has a beveled shape so as to pass through the tissue to be collected for biopsy. The needle portion 112 includes a notch 114 that can hold the severed tissue. The sheath 120 includes a hub 121 and a cannula 122. Unlike the prior art shown in FIGS. 1 and 3, the needle portion 112 is bent in a predetermined direction along the longitudinal direction. Although not shown, it is preferable that the cannula 122 is bent along the longitudinal direction in the same direction as the needle portion 112. [ The cannula 122 is not bent when the needle portion 112 is not in the cannula 122 but is not bent when the needle portion 112 is inserted into the cannula 122, It is preferable to bend. The direction in which the needle portion 112 is bent along the longitudinal direction is related to the bevel shape in the shape of the distal end 113 of the needle portion 112, which is described in Fig.

FIG. 7 is a view showing the characteristics of the biopsy needle assembly according to the present disclosure when the shape of the needle tip is beveled. FIG.

Fig. 7 (a) shows only the vicinity of the distal end of the needle part 112 in Fig. When the shape of the distal end 113 of the needle part 112 is beveled, a portion of the distal end 113 receives a reaction force 115 from the tissue when the needle part 112 is inserted into a tissue requiring biopsy. When the material of the needle part 112 is soft due to the reaction force 115, the needle part 112 is bent in a certain direction. A technique of adjusting the direction of the needle part in vivo in the biopsy needle assembly using the biopsy needle assembly when the distal end of the biopsy needle assembly is beveled in the biopsy needle assembly is known in the art. A related prior art is U.S. Patent No. 7,822,458. That is, as shown in FIG. 7 (a), when the distal end 113 of the needle part 112 has a bevel shape and passes through the living tissue, the inclined surface corresponding to the bevel shape receives the reaction force 115. 7 (b) and 7 (c), when the material of the needle part 112 is soft, the direction in which the needle part 112 is bent in a certain direction and the direction in which the needle part 112 is bent is determined according to the direction of the beveled inclined surface.

8 is a view showing an example of using the biopsy needle assembly according to the present disclosure.

8 (a) shows a tissue 30 to be harvested for biopsy, a biopsy needle assembly 210, and an outsheath 200, which allows the biopsy needle assembly 210 to be placed near the tissue 30 Respectively. And three portions (31, 32, 33) are shown as portions to be collected from the tissue (30). There are three places to be sampled for convenience of explanation.

Fig. 8 (b) shows the harvesting of the middle portion 32 as a portion to be harvested. When collecting the middle portion 32, it is preferable to use the biopsy needle assembly 300 of the prior art in which the needle portion 310 is straight rather than the biopsy needle assembly according to the present disclosure. The needle portion 310 is first protruded from the outer sheath 200 toward the middle portion 31 in order to collect the middle portion 32. The cannula 320 protrudes from the outer sheath 200 along the longitudinal direction of the needle portion 310 to cut the tissue that has entered the notch 311 of the needle portion 310. [ 8 (b) shows only the final state of the cannula 320 after the needle part 310 is protruded, not shown in a stepwise manner. Refer to FIG. 2 for the steps. However, the outer sheath 200 is not shown in Fig. The use of the outer sheath 200 as an in vivo insertion pathway of the biopsy needle assembly during the biopsy procedure is readily apparent to those skilled in the art.

Fig. 8 (c) shows collecting the upper part 31 as a part to be harvested. The outer sheath 200 remains and is used by replacing the biopsy needle assembly inserted into the outer sheath 200. [ A straight conventional biopsy needle assembly can not be used to collect the upper portion 31. Accordingly, the biopsy needle assembly 400 according to the present disclosure is used. The bent needle portion 410 first protrudes from the outer sheath 200 toward the upper portion 31 in order to take the upper portion 31. The cannula 420 protrudes from the outer sheath 200 along the bent direction of the needle portion 410 to cut the tissue that has entered the notch 411 of the needle portion 410. [ It is preferable that the cannula 420 is bent in advance in a direction in which the needle 410 is bent so that the cannula 420 moves along the longitudinal direction of the bent needle 410. FIG. 8 (c) also shows only the final state of the cannula 420 after the needle part 410 is protruded, not showing it in a stepwise manner.

Figure 8 (d) shows the harvesting of the lower part 33 as the part to be harvested. The outer sheath 200 remains and is used by replacing the biopsy needle assembly inserted into the outer sheath 200. [ In order to collect the lower end portion 31, it is also not possible to use a conventional linear biopsy needle assembly. Accordingly, biopsy needle assembly 500 according to the present disclosure is used. The bent needle portion 510 protrudes from the outer sheath 200 toward the lower end portion 33 in order to collect the lower end portion 33. The cannula 520 protrudes from the outer sheath 200 along the bent direction of the needle portion 510 to cut the tissue that has entered the notch 511 of the needle portion 510. [ It is preferable that the cannula 520 is also bent in advance in the direction in which the needle 510 is bent so that the cannula 520 moves along the longitudinal direction of the bent needle part 510. [ FIG. 8 (d) shows only the final state of the cannula 520 after the needle part 510 is protruded, not showing it in a stepwise manner. By using the biopsy needle assembly (400, 500) and the outer sheath (200) according to the present disclosure, the patient feels only one needle insertion, but the operator can collect three tissues (31, 32, 33). When the needle portions 410 and 510 and the cannulas 420 and 520 of the biopsy needle assembly 400 and 500 according to the present disclosure are inserted into the outer sheath 200, 200). When the shape of the outer sheath 200 is linear and the needle portions 410 and 510 of the biopsy needle assembly 400 and 500 according to the present disclosure and the cannulas 420 and 520 are inside the outer sheath 200 The shapes of the needle portions 410 and 510 and the cannulas 420 and 520 are linear and protrude from the outer sheath 200 to have a predetermined curved shape. As described above, it is preferable to use a shape memory alloy as a material in order to have a predetermined shape under specific conditions. The shape memory alloy is, for example, a Ni-Ti alloy. Further, in order to improve bending in a predetermined shape while penetrating the tissue, the direction in which the needle portions 410 and 510 are bent along the longitudinal direction is the same as that of the needle portions 410 and 510 when the tissue is penetrated due to the bevel shape, 510 coincide with the bending direction. It is also necessary that the needle portions 410, 510 penetrate the tissue and momentarily strong forces are required for the cannula 420, 520 to cut the tissue. Biopsy guns using elastic members such as inner stylet and spring on the sheath are widely known to those skilled in the art. Although the biopsy needle assembly 400, 500 and the outer sheath 200 according to the present disclosure have been described separately, the biopsy needle assembly in a broad sense may include an outer sheath.

9 is a view showing another example of the biopsy needle assembly according to the present disclosure.

The biopsy needle assembly 600 according to the present disclosure includes a sheath 610 and an inner stylet 620. The inner stylet 620 includes a hub 621, a body 622, and a needle portion 623. The needle portion 623 is bent along the longitudinal direction. At this time, when the needle portion 623 is inserted into the living body, the direction in which the needle portion 623 is bent can not be seen from outside the living body. The direction in which the needle portion 623 is bent is important for inserting the needle portion 623 according to the position of the portion to be sampled as seen in Fig. Therefore, it is important that the indicator 624, which can recognize the direction in which the needle portion 623 is bent, can be seen from outside the living body. An indicator 624 may be provided on the hub 621. In addition to the hub 621, an indicator may be provided at a place where the inner stylet rotates together with the needle while it is outside the living body after being inserted into the living body. The direction of the needle 623 along the longitudinal direction of the inner stylet 620 is referred to as a proximal portion and the direction of the hub 621 is referred to as a distal portion.

6 to 9, only one example according to the present disclosure has been described for a core biopsy needle, but it can also be applied to an aspiration biopsy needle.

Hereinafter, various embodiments according to the present disclosure will be described.

(1) A biopsy needle assembly, comprising: a sheath having a cannula; And an inner stylet having a needle portion penetrating the inside of the sheath, wherein the shape of the needle portion is bent along the longitudinal direction.

(2) A biopsy needle assembly characterized in that the shape of the tip of the needle part is a bevel shape.

(3) The biopsy needle assembly as claimed in any one of the preceding claims, wherein the direction in which the shape of the needle portion is bent along the longitudinal direction coincides with the direction in which the needle portion is bent by the bevel shape as the needle passes through the tissue.

(4) A biopsy needle assembly characterized by a notch in the needle portion.

(5) The biopsy needle assembly according to any one of (1) to (4), wherein the cannula is bent along the longitudinal direction same as the shape of the needle part.

(6) an outer sheath.

(7) A biopsy needle assembly according to the shape of an outer sheath when the needle part is inside the outer sheath.

(8) A biopsy needle assembly characterized in that the material of the needle part is a shape memory alloy.

(9) The biopsy needle assembly as claimed in any one of the preceding claims, further comprising an indicator for detecting the direction in which the needle portion is bent near the distal end of the inner stylet.

According to the biopsy needle assembly according to the present disclosure, necessary tissue can be collected through one insertion into various parts of a tissue requiring biopsy. Thus, the convenience of the patient and the operator can be improved.

30: Organization
10, 60, 92, 110, 620: inner stylet
20, 50, 91, 120, 610:
14, 62, 112, 212, 320, 420, 520, 623:
22, 52, 122, 211, 310, 410, 510: cannula

Claims

In a biopsy needle assembly,
A sheath with a cannula; And
And an inner stylus having a needle portion penetrating into the sheath
Wherein the shape of the needle portion is curved along the longitudinal direction.

The method according to claim 1,
Wherein the shape of the distal end of the needle part is a bevel shape.

The method of claim 2,
Wherein a direction in which the shape of the needle portion is bent along the longitudinal direction coincides with a direction in which the needle portion is bent by the bevel shape when the needle portion passes through the tissue.

The method of claim 3,
Characterized in that the needle portion has a notch.

The method of claim 3,
Wherein the cannula is bent along the longitudinal direction same as the shape of the needle portion.

The method according to claim 1,
And an outer sheath.

The method of claim 6,
Wherein the shape of the needle part is dependent on the shape of the outer sheath when the needle part is inside the outer sheath.

The method of claim 7,
Wherein the material of the needle portion is a shape memory alloy.

The method of claim 3,
And an indicator that indicates the direction in which the needle portion is bent near the distal end of the inner stylet.

The method of claim 9,
Characterized in that the needle portion has a notch.

The method of claim 10,
And an outer sheath.