Multi-puncture assembly

Abstract

The present invention relates to a multi-puncture assembly comprising: a cannula assembly with a sheath to be inserted into an abdominal cavity; and a puncture needle assembly that is provided with puncture needles inserted into the cannula assembly to puncture the abdominal cavity and that advances the sheath into the abdominal cavity, wherein the sheath has a distal end portion that has a bent form and is inserted into the abdominal cavity, the distal end portion being unfolded by the insertion of the puncture needles and returning to the bent form when the puncture needle is withdrawn, and when inserted into the sheath, the puncture needles are rotated at a designated alignment angle for insertion.

Description

Multiple venous puncture assembly

[0001] The present invention relates to a paracentesis assembly for removing ascites from the abdominal cavity.

[0002] A paracentesis is a procedure in which the abdominal cavity is punctured with a needle inserted into a cannula to check for ascites or amniotic fluid, the needle is withdrawn, and a drainage tube is connected to drain the ascites.

[0003] Figure 1 illustrates a conventional paracentesis. Figure 1 depicts a cannula (3) being inserted into the abdominal cavity through a puncture needle to drain ascites. As the drainage progresses, the ascites in the abdominal cavity drains, and the internal organs (31) are attached to the peritoneum. As the drainage progresses with a conventional paracentesis catheter, the internal organs (31) come into contact with the sharp end of the cannula (3), which may cause injury to the organ or inflammation, which may lead to a medical accident.

[0004] To address these issues, a pigtail-type puncture assembly is provided in which the sheath end area of ​​the cannula is rolled up to prevent damage even when it comes into contact with the internal organs (31). A related technology is U.S. Patent No. 7,736,336. Fig. 2 illustrates an example of a puncture assembly having a pigtail-type sheath (310). Referring to Fig. 2, it can be seen that the sheath end (310) of the cannula (31) for sucking ascites is rolled up. The rolled-up end (310) of the sheath has a gentle contact surface so as not to damage the internal organs even when they come into contact during the drainage process of ascites.

[0005] However, the conventional pigtail-type cannula (31) requires an additional configuration to prevent the puncture needle (33) from penetrating and piercing the rounded sheath during the process of puncturing the cannula (31). In the embodiment of Fig. 2, a configuration of a needle cover (333) is disclosed that is additionally inserted into the tip (330) of the puncture needle (33) to make the end blunt.

[0006] Fig. 3 shows the actual use appearance of a commercialized product of the pigtail-type multiple puncture assembly according to Fig. 2. Fig. 3(a) shows the puncture needle (33) with the needle cover (333) attached entering the sheath end (310) of the cannula, Fig. 3(b) shows the puncture needle (33) being fully inserted while unfolding the rolled sheath end (310), and Fig. 3(c) shows the catheter just before preparation for the abdominal puncture procedure by removing the needle cover (333) of the puncture needle (33).

[0007] In summary, the conventional pigtail-type multiple puncture needle assembly had the following problems. A separate needle cover was required to insert the needle so that the sheath could be unfolded without damaging the rolled sheath. The needle cover had to be inserted through the tip hole of the long, thin needle, making assembly difficult and posing a risk of pricking during the fastening process. Furthermore, the conventional pigtail-type multiple puncture needle assembly required the cumbersome preparatory work of fastening and detaching the cover.

[0008] In addition, the conventional pigtail-type multiple puncture needle assembly has a design issue that prevents the outer diameter of the needle and sheath from being formed to be less than 2 mm. If the outer diameter of the needle becomes thinner, the needle cover must also be formed thinner. Even if the needle cover covers the needle tip at an outer diameter of less than 2 mm, the rolled sheath may not unfold and may be pierced and discharged. The thinner the rolled sheath is, the higher the risk of piercing, so the pigtail-type multiple puncture needle assembly has a design disadvantage of being composed of a larger outer diameter and a thicker sheath than the conventional straight sheath assembly.

[0009] The purpose of the present invention is to provide a puncture assembly that simplifies the preparation process for a puncture without separate components, and allows the outer diameter of the needle and sheath to be designed to be sufficiently small as in a conventional straight sheath puncture, while allowing the puncture needle to be inserted without penetrating the banded sheath, and preventing damage to organs within the abdominal cavity after the puncture needle is removed by banding the sheath.

[0010] The present invention relates to a puncture assembly, comprising: a cannula assembly having a sheath inserted into an abdominal cavity; and a puncture needle assembly having a puncture needle inserted into the cannula assembly to puncture the abdominal cavity and to advance the sheath into the abdominal cavity; wherein the sheath has a banded distal end that is inserted into the abdominal cavity, the distal end is spread when the puncture needle is inserted, and when the puncture needle is withdrawn, the distal end is returned to the banded shape, and the puncture needle is inserted by being rotated at a designated alignment angle when inserted into the sheath.

[0011] In one embodiment, the needle tip of the puncture needle may be cut at an acute angle greater than 0° and less than 90°, and the alignment angle may be set to an entry angle such that the cut cross-section of the puncture needle is aligned in a direction opposite to the direction in which the distal end of the sheath is banded.

[0012] In one embodiment, the cannula assembly comprises a sheath having a restored shape at the distal end;

[0013] It may include a support fixed to prevent the above-mentioned shis from rotating; and a tube hub connected to the support and having a first connector to which a drainage tube is connected and a second connector having a valve formed into which the puncture needle is inserted.

[0014] In one embodiment, the sheath may be formed with an outer diameter greater than 0 mm and less than or equal to 2 mm.

[0015] In one embodiment, the sheath may have a banded end that is 'J' shaped.

[0016] In one embodiment, when the sheath is bent in a semicircular shape by bending in a direction perpendicular to the longitudinal direction (x-axis) and the direction perpendicular to the y-axis, the position of the end point, which is the banded end, may be a 'J' shape that does not exceed the axis on the vertical line of the starting point of the banding.

[0017] In one embodiment, the needle assembly may include a needle having a length longer than the sheath; and a needle hub to which the needle is secured.

[0018] In one embodiment, the cannula assembly may include a first marker, and the puncture needle assembly may include a second marker, such that the first marker may indicate a specified alignment angle of the sheath, and the second marker may indicate a specified alignment angle of the puncture needle.

[0019] In one embodiment, the first marker may indicate the direction in which the distal end of the sheath is banded, and the second marker may indicate the position along the axis (x-axis) of the aligned cross-section, which is opposite to the cut cross-section of the puncture needle.

[0020] In one embodiment, the cannula assembly may have the first marker formed on a tube hub into which the puncture needle is inserted, and the puncture needle assembly may have the second marker formed on a needle hub to which the puncture needle is fixed.

[0021] The present invention allows a puncture needle to be inserted into a sheath at a designated alignment angle through a first marker and a second marker. At this time, the puncture needle is inserted with the structural shape of a needle tip having an acute angle so that the alignment cross-section, which is the opposite side of the cutting cross-section, is aligned in the bending direction of the sheath, and the distal end of the sheath is formed with a banding structure that can be uniformly and low-torquely unfolded at each entry point of the needle, so that the needle can be inserted without damaging the sheath and unfolding the banded distal end without requiring a separate needle tip protector.

[0022] According to the disclosure of the present invention, a puncture assembly is provided that can protect internal organs during puncture without separate configuration or preparatory work due to the structural dynamics of the needle tip and the banded sheath. Furthermore, the present invention enables the performance of puncture without requiring skin incision by forming the needle tip and the inner diameter of the sheath to be 2 mm or less.

[0023] Figure 1 shows a conventional multiple puncture procedure.

[0024] Figure 2 shows a conventional pigtail-type multiple puncture assembly.

[0025] Figure 3 shows the actual use of a commercialized product of the multiple-point assembly of Figure 2.

[0026] Figure 4 illustrates a needle assembly according to an embodiment of the present invention.

[0027] Figure 5 illustrates a cannula assembly according to an embodiment of the present invention.

[0028] Figure 6 illustrates a needle assembly according to an embodiment of the present invention.

[0029] Figure 7 is a cross-sectional side view of a needle according to an embodiment of the present invention entering a sheath at a specified alignment angle.

[0030] Figure 8 shows a needle attached to a cannula assembly at an alignment angle specified by the first marker and the second marker of the multiple puncture needle assembly.

[0031] Fig. 9 shows an embodiment of a banding structure at the sheath end of a cannula assembly.

[0032] The various embodiments described in this document are exemplified for the purpose of clearly explaining the technical concepts of the present invention and disclosure, and are not intended to limit them to specific embodiments. The technical concepts of the present invention and disclosure include various modifications, equivalents, alternatives, and embodiments selectively combined from all or part of the embodiments described in this document. Furthermore, the scope of the technical concepts of the present invention and disclosure is not limited to the embodiments presented below or the specific descriptions thereof.

[0033] Terms used in this document, including technical or scientific terms, unless otherwise defined, may have the meaning commonly understood by one of ordinary skill in the art to which the present invention and disclosure pertain.

[0034] The expressions "includes," "may include," "comprises," "may have," "have," and "may have" used in this document imply the presence of a function, operation, or component as the target feature, and do not exclude the presence of other additional features. In other words, such expressions should be understood as open-ended terms that imply the possibility of including other embodiments.

[0035] The singular forms used in this document may include the plural form unless the context clearly indicates otherwise, and this also applies to the singular forms set forth in the claims.

[0036] As used herein, the expressions "A, B, and C," "A, B, or C," "A, B, and / or C," or "at least one of A, B, and C," "at least one of A, B, or C," "at least one of A, B, and / or C," "at least one selected from A, B, and C," "at least one selected from A, B, or C," "at least one selected from A, B, and / or C," and the like can mean each of the listed items or all possible combinations of the listed items. For example, "at least one selected from A and B" can refer to (1) A, (2) at least one of A, (3) B, (4) at least one of B, (5) at least one of A and at least one of B, (6) at least one of A and B, (7) at least one of B and A, and (8) both A and B.

[0037] The expression "based on" as used in this document is used to describe one or more factors that influence the decision, act of judgment, or action described in the phrase or sentence containing the expression, and this expression does not exclude additional factors that influence the decision, act of judgment, or action.

[0038] As used herein, the expression that a component (e.g., a first component) is “connected” or “connected” to another component (e.g., a second component) may mean that the component is directly connected or connected to the other component, as well as connected or connected via a new other component (e.g., a third component).

[0039] The expression "configured to" used in this document can have the meanings of "set to do", "having the ability to do", "changed to do", "made to do", and "capable of doing" depending on the context, and is distinct from the meaning of "consist".

[0040] Hereinafter, various embodiments of the present disclosure will be described with reference to the attached drawings. In the attached drawings and the description of the drawings, identical or substantially equivalent components may be assigned the same reference numerals. Furthermore, in the description of various embodiments below, duplicate descriptions of identical or corresponding components may be omitted, but this does not mean that the corresponding components are not included in the embodiments.

[0041] Fig. 4 shows a multiple-point assembly (1) according to an embodiment of the present invention.

[0042] Referring to FIG. 4, the ascites puncture assembly (1) may include a cannula assembly (10) and a puncture needle assembly (20). The ascites puncture assembly (1) is a type of drain catheter for draining ascites after abdominal puncture. The ascites puncture assembly (1) is used by puncturing the abdomen with the puncture needle assembly (20) inserted into the cannula assembly (10), removing the puncture needle assembly (20), and then connecting a tube and a collection container for ascites drainage to the cannula assembly (10).

[0043] When performing a puncture, the cannula assembly (10) is inserted into the abdominal cavity to suction ascites. However, if the inserted sheath is in a straight shape, there is a risk that the sharp end of the sheath may come into contact with the internal organs during the drainage process, which may cause damage to the internal organs. According to the present embodiment, the cannula assembly (10) discloses a configuration of a sheath with a banded end, and the banded sheath can be unfolded and the puncture needle can be inserted by fastening according to the specified alignment angle of the banded shape and the puncture needle, and can be provided as a product with an outer diameter of 2 mm or less. Each configuration will be described in detail below.

[0044] Figure 5 shows a cannula assembly (10) according to an embodiment of the present invention.

[0045] The cannula assembly (10) refers to a member provided with a sheath (11) that is inserted into the abdominal cavity. In the present embodiment, the cannula assembly (10) may include a sheath (11), a support (13), a tube hub (14), and a drainage tube (140). A second connector (15) provided with a valve (150) may be connected to the tube hub (14).

[0046] The sheath (11) has a banded shape at the distal end (100) that is inserted into the abdominal cavity, and when the distal end (100) is unfolded, a puncture needle (21) is inserted, and when the puncture needle (21) is withdrawn, the distal end (100) returns to the banded shape. The sheath (11) is provided as a hollow biocompatible tube, and the distal end (100) is processed to have a restored shape through a heat treatment process during manufacturing. In the present embodiment, the sheath (11) may be provided as PEBAX, a medical tube material, and may be provided by being coated with a hydrophilic material.

[0047] In this embodiment, the sheath (11) can be formed with an outer diameter of more than 0 mm and less than 2 mm. Preferably, the sheath (11) can be configured with an outer diameter of 1.3 mm to 1.8 mm. The reason why the design of the minimized outer diameter is possible in this embodiment is because no additional components for unfolding the banded portion, such as a stylet or needle cover, are required, and the bent portion of the banded sheath is designed to unfold simply by inserting the puncture needle. To this end, the shape and degree of the banding and the entry angle of the puncture needle must be taken into consideration.

[0048] In this embodiment, the sheath (11) may have a banded distal end (100) in a 'J' shape. The distal end (100) refers to a banded area at the distal end of the sheath (11). The distal end (100) may have a plurality of small holes formed along the length direction for sucking in ascites.

[0049] The support (13) secures the sheath (11) so that it does not rotate. The sheath (11) according to the present embodiment must be aligned at a specified alignment angle when the puncture needle (21) is fastened. Therefore, the sheath (11) is fixedly connected to the support (13) so that it does not rotate. The support (13) is formed with a support plate having a predetermined area, and supports it by making contact with the abdomen when the cannula is sufficiently inserted.

[0050] The tube hub (14) may be connected to the support (13) and may include a first connector to which a drainage tube (140) is connected and a second connector (15) having a valve (150) formed so that a puncture needle (21) is inserted. The second connector (15) has a through hole formed along the longitudinal axis of the sheath (11), and a puncture needle (21) inserted through the valve (150) may enter the interior of the sheath (11) along the same axis. The valve (150) may be provided as an elastic valve to prevent backflow. In one embodiment, the valve (150) is provided with a synthetic rubber material and has a cut portion formed therein for the puncture needle to be inserted. The puncture needle is inserted through the cut portion, and when the puncture needle is withdrawn, the cut portion closes to prevent backflow of the drainage.

[0051] In this embodiment, the cannula assembly (10) may include a first marker (17). The first marker (17) indicates a designated alignment angle of the sheath (11). The first marker (17) indicates a direction in which the distal end of the sheath (11) is bent. More specifically, the first marker (17) indicates a direction in which the distal end (100) is bent and rolled up.

[0052] In this specification, the alignment angle means the aligned position of the sheath (11) and the puncture needle (21) so that the distal end (100) of the sheath (11) can be unfolded without being penetrated when the puncture needle (21) is inserted. To this end, the sheath (11) must be prepared in a designated direction, and the puncture needle (21) must also be inserted in a designated direction based on the prepared position of the sheath (11). The first marker (17) indicates the designated direction of the sheath (11). The first marker (17) may be formed on the support (13), the tube hub (14), or the second connector (15). The first marker (17) refers to a marking means that can be visually confirmed by a user, and this may be a marking mark or a mark by a protruding structure.

[0053] Figure 6 shows a needle assembly (20) according to an embodiment of the present invention.

[0054] The puncture needle assembly (20) refers to a member that is provided with a puncture needle (21) inserted into the cannula assembly (10) to puncture the abdominal cavity and to introduce the sheath (11) into the abdominal cavity. In the present embodiment, the puncture needle assembly (20) may include a puncture needle (21) and a needle hub (22). The puncture needle (21) may be inserted by rotating at a designated alignment angle when inserted into the sheath (11). Here, the designated alignment angle of the puncture needle (21) means a rotation angle of the puncture needle.

[0055] The puncture needle (21) is formed to be longer than the sheath (11). The puncture needle (21) can be formed to have an outer diameter (H1, Fig. 7) of 0.9 mm to 1 mm. The puncture needle (21) is cut at an acute angle of more than 0° and less than 90° with the needle tip (200), and the alignment angle indicates a state in which the cut cross-section (210) of the puncture needle (21) is aligned in the opposite direction to the direction in which the distal end (100) of the sheath (11) is banded. The needle hub (22) fixes the puncture needle (21).

[0056] Referring to Fig. 6, the shape of the illustrated needle tip (200) will be described. The needle tip (200) is not cut on both sides (upper and lower) of the tip, but is cut in the opposite direction based on one side so that the inner angle of the tip forms an acute angle. The designated angle of the puncture needle (21) is a state in which the direction of the cut end surface (210) is aligned so that it faces the opposite direction to the direction in which the distal end (100) of the sheath (11) is bent. In the present specification, for the convenience of explanation, the opposite side of the cut end surface (210) is referred to as the aligned end surface (220).

[0057] If the designated angle of the needle (21) is expressed differently, the upper side forming an acute angle at the needle tip (200) is called the alignment section (220), and the alignment section (220) can be understood as a rotation angle that aligns the distal end (100) of the sheath (11) to be positioned in the direction in which it is bent.

[0058] In this embodiment, the puncture needle assembly (20) may include a second marker (27). The puncture needle assembly (20) may have the second marker (27) formed on the needle hub (22) to which the puncture needle (21) is fixed. The second marker (27) refers to a marking means that can be visually confirmed by a user, and may be a marking mark or a marking using a protruding structure.

[0059] The second marker (27) indicates a designated alignment angle of the puncture needle (21). The second marker (27) can indicate the axial (longitudinal) position of the alignment section (220), which is the opposite side of the cut section (210) of the puncture needle (21). The second marker (27) indicates the direction in which the alignment section (220) of the puncture needle (21) is located on the needle hub (22). In other words, at the position of the second marker (27), the alignment section (220), not the cut section (210), is located on the same axial line in the longitudinal direction of the puncture needle (21).

[0060] Fig. 7 is a side cross-sectional view showing a needle (21) according to an embodiment of the present invention entering a sheath (11) at a specified alignment angle. Referring to Fig. 7, assuming that the horizontal and vertical axes of Fig. 7 are the x-axis and the y-axis, respectively, when the sheath (11) is bent in a direction perpendicular to the longitudinal direction (x-axis) and the y-axis to be curved into a semicircular shape at the distal end (100), the position of the end point (103), which is the bent end, may be a 'J' shape that does not exceed the axis on the vertical line of the starting point (101) where the banding started. In Fig. 7, the position of the end point (103) is exemplified as a state in which it coincides with the axis on the vertical line of the starting point (101) where the banding started.

[0061] The distal end (100) of the sheath (11) is composed of a starting point (101), a banding portion (102), and an end point (103). The starting point (101) refers to the part where the banding begins. The banding portion (102) forms a gently curved surface and refers to the surface that comes into contact with the internal organs during multiple punctures. The end point (103) refers to the end of the sheath (11).

[0062] The distal end (100) of the sheath (11) is banded so that the end point (103) does not exceed the range of the y-axis on the vertical line of the starting point (101). The position at which the end point (103) is banded affects the torque at which the banding portion (102) unfolds. If the end point (103) is rolled inward beyond the range of the y-axis on the vertical line of the starting point (101), when the needle tip (200) of the puncture needle (21) enters the area of ​​the banding portion (102), a strong torque is formed to unfold the banding portion (102), and a puncture may occur where the needle tip (200) penetrates the banding portion (102). The 'J'-shaped banding to the extent that the end point (103) is positioned on the vertical axis of the starting point (101) minimizes the torque so that the distal end (100) can be unfolded when the needle tip (200) is invasive without damaging the internal organs by the banding portion (102).

[0063] In particular, at this time, based on FIG. 7, the needle tip (200) enters the distal end (100) with the alignment cross-section (220) facing upward. As the acute-angled distal end of the needle tip (200) matches the inclined direction of the banding portion (102), the needle tip (200) can be inserted to the end point (103) while unfolding the banding portion (102) without a separate cover member. This banding design of the needle tip (200) and the sheath (11) enables a needle (H1) of 1 mm or less and a sheath (H2) of 2 mm or less.

[0064] Fig. 8 shows a state in which a puncture needle (21) is fastened to a cannula assembly (10) at an alignment angle designated by a first marker (17) and a second marker (27) of a multiple puncture assembly. Referring to Fig. 8, the alignment corresponding to Fig. 7 is achieved by a first marker (17) indicating a designated direction in which a sheath is banded and a second marker (27) designating the direction of a needle tip (200). A user can easily align the alignment angle corresponding to Fig. 7 by checking the first marker (17) and the second marker (27), and no separate preparatory work is required for inserting the puncture needle (21) into the cannula.

[0065] Fig. 9 illustrates an embodiment of a banding structure of a distal end (100) of a sheath (11) of a cannula assembly (10). Fig. 9 exemplifies a banding portion (102) having different curvatures (D1, D2, D3). The cases of D1, D2, and D3 are banded so that the end point (103) described above in Fig. 7 does not cross the y-axis on the vertical line of the starting point (101), and the difference is the curvature of the banding portion (102).

[0066] In this embodiment, the curvatures of D1, D2, and D3 are described based on the bending angle. The bending angle is defined as the angle formed by a straight line passing through the center point of the bending portion (102) that is bent from the starting point (101) with respect to the x-axis, which is the longitudinal direction of the sheath (11). In the case of D1, the bending angle is 65°, in the case of D2, the bending angle is 45°, and in the case of D3, the bending angle is 20°.

[0067] In this embodiment, when the bending angle is 65° or more, the torque required to unfold the bending portion (102) from the starting point (101) increases. Conversely, when the bending angle is 20° or less, the torque at the starting point (101) is low, but the torque when passing through the center of the bending portion (102) increases. When the bending angle is too large or too small, the sheath may be damaged when the needle tip (200) penetrates the area where the torque is high at the distal end (100).

[0068] Preferably, the range of the bending angle is set to a range where a uniform torque is formed at the starting point (101), the bending portion (102), and the end point (103). In a preferred embodiment, the bending angle can be designed to be 45° (with a margin of error of ±5°), which is the case of D2. In addition, it is preferable that the bending portion (102) be designed in a semicircular shape rather than a semi-elliptical shape.

[0069] While the technical concept of the present invention and disclosure has been illustrated by the embodiments described above, the technical concept of the present invention encompasses various substitutions, modifications, and variations that can be made within the scope understandable to those of ordinary skill in the art. Furthermore, it should be understood that such substitutions, modifications, and variations are encompassed within the scope of the appended claims.

[0070]

[0071] 1: Multiple lancet assembly

[0072] 10: Cannula assembly

[0073] 11: Shes

[0074] 101: Starting Point

[0075] 102: Banding section

[0076] 103: End point

[0077] 100: Terminal part

[0078] 13: Support

[0079] 14: Tube Hub

[0080] 140: Drainage tube

[0081] 15: Connector

[0082] 150: Valve

[0083] 17: First marker

[0084] 20: Needle assembly

[0085] 21: Acupuncture needle

[0086] 22: Needle Hub

[0087] 27: Second marker

[0088] 200: Needle tip

[0089] 210: Cutting cross section

[0090] 220: Alignment cross-section

[0091]

[0092] According to the disclosure of the present invention, a puncture assembly is provided that can protect internal organs during puncture without a separate configuration or preparatory work due to the structural dynamics of the needle tip and the banded sheath, thereby improving workability and convenience during the procedure and enabling the inner diameter to be designed sufficiently small, thereby enabling minimal scarring and rapid recovery after the procedure.

Claims

1. A cannula assembly having a sheath inserted into the abdominal cavity; and A puncture needle assembly is provided to puncture the abdominal cavity by inserting a puncture needle into the above cannula assembly, and the puncture needle assembly is provided to introduce the sheath into the abdominal cavity; The above-mentioned sheath has a banded shape at the end inserted into the abdominal cavity, and when the puncture needle is inserted, the end is spread out, and when the puncture needle is withdrawn, the end is returned to the banded shape. A multiple puncture assembly characterized in that the above puncture needle is inserted by rotating at a specified alignment angle when inserted into the above sheath.

2. In paragraph 1, The above needle is, The needle tip is cut at an acute angle greater than 0° and less than 90°, The above alignment angle is, A multiple puncture assembly characterized in that the cut cross-section of the above puncture needle is aligned at an entry angle opposite to the direction in which the distal end of the sheath is banded.

3. In paragraph 1, The above cannula assembly, A sheath having a restored shape at the distal end; A support to which the above-mentioned sheath is fixed so as not to rotate; and A tube hub comprising a first connector connected to the support and to which a drainage tube is connected, and a second connector having a valve formed into which the puncture needle is inserted; A multiple-point assembly characterized by including:

4. In paragraph 1, The above sheath is, A multiple-hole assembly characterized by being formed with an outer diameter of more than 0 mm and less than 2 mm.

5. In paragraph 1, The above sheath is, A multiple-point puncture assembly characterized by a banded distal end having a 'J' shape.

6. In paragraph 5, The above sheath is, A multiple-point assembly characterized in that when the distal end is bent in a direction perpendicular to the longitudinal direction (x-axis) and the direction (y-axis) to be curved into a semicircular shape, the position of the end point, which is the banded distal end, is a 'J' shape that does not exceed the axis on the vertical line of the starting point of the banding.

7. In paragraph 1, The above needle assembly is, A puncture needle having a length longer than the above-mentioned sheath; and A multiple needle aspiration assembly characterized by including a needle hub to which the above aspiration needle is fixed.

8. In paragraph 1, The above cannula assembly comprises a first marker, The above needle assembly includes a second marker, The above first marker indicates the specified alignment angle of the sheath, A multiple puncture assembly, wherein the second marker indicates a designated alignment angle of the puncture needle.

9. In paragraph 8, The above first marker is, The end of the above sheath indicates the direction in which it is banded, The second marker above is, A multiple needle acupuncture assembly characterized in that it indicates the axial (x-axis) position of the aligned cross-section, which is the opposite side of the cut cross-section of the above needle acupuncture needle.

10. In paragraph 8, The above cannula assembly, The first marker is formed on the tube hub into which the above-mentioned needle is inserted, The above needle assembly is, A multiple needle aspiration assembly characterized in that the second marker is formed on the needle hub to which the aspiration needle is fixed.

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