Puncture needle

Abstract

To provide a puncture needle capable of obtaining sufficient ultrasonic reflection intensity without decreasing mechanical strength.SOLUTION: A puncture needle 100 comprises an outer needle 1 that has a blade surface formed at its tip, and an inner insertion body 2 in which an ultrasonic reflection structure 3 is formed. The inner insertion body 2 is arranged in a cylinder of the outer needle 1. The ultrasonic reflection structure 3 is housed in the cylinder of the outer needle 1, and exposed via an opening 19 of the outer needle 1.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a puncture needle.

Background Art

[0002] Patent Document 1 describes a puncture needle for ultrasound. In this puncture needle for ultrasound, a cutting edge is formed at the tip of a puncture needle body which is a needle tube body, and at a predetermined position of the puncture needle body, at least one corner cube mirror formed by a triangular pyramid-shaped depression is formed. The corner cube mirror is a triangular pyramid-shaped depression provided on the surface of the puncture needle body near the cutting edge. Since the ultrasonic wave oscillated from the ultrasonic probe is reflected by the corner cube mirror and returned to the ultrasonic probe, even when the angle formed by the irradiation path of the ultrasonic wave and the axis of the puncture needle is small, the reflected wave travels in the same direction as the incident direction of the ultrasonic wave and is surely returned to the ultrasonic probe. Note that the needle tube body may be an inner needle, an outer needle, a single tube structure, or other needles of a double needle. Patent Document 1 describes an example in which a corner cube mirror is formed on the outer surface of the outer needle, the cutting surface of the inner needle, or the inner circumferential surface of the outer needle.

[0003] Patent Document 2 describes an endoscopic access device including an outer cannula and a penetration stylet. In this endoscopic access device, the stylet has a surface structure with a recess for reflecting ultrasonic waves sufficient to project an ultrasonic image visualizing the inside of a patient's body by ultrasound, and realizes efficient cannula guidance by ultrasonic fluoroscopy inside the patient's body.

[0004] Patent Document 3 describes a medical needle provided with an ultrasonic reflector. The ultrasonic reflector is formed on the inner wall of a tube forming the medical needle. The case where the ultrasonic reflector is formed in a groove shape is illustrated.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

[0006] In conventional techniques, when an ultrasonic reflective structure is formed on the outer surface of a puncture needle, the echogenicity of the needle tip on the blade side may not be sufficient. When an ultrasonic reflective structure is formed on the inner surface of a puncture needle as a recess, indentation, or groove, it may reduce the mechanical strength of the puncture needle. When an ultrasonic reflective structure is formed on the tip blade, the ultrasonic reflective structure may cause resistance during puncture, or the needle may be damaged by the resistance during puncture.

[0007] This invention has been made in view of the above circumstances, and its purpose is to provide a puncture needle that can obtain sufficient ultrasonic reflection intensity without reducing mechanical strength. [Means for solving the problem]

[0008] The puncture needle according to the present invention, for achieving the above objective, A cylindrical section with a blade surface formed at the tip, It comprises an insert with an ultrasonic reflection structure formed on it, The insert is placed inside the cylinder of the cylindrical portion. The ultrasonic reflection structure is housed within the cylinder portion and exposed through the opening at the tip of the cylinder portion.

[0009] The puncture needle according to the present invention further, The ultrasonic reflection structure may be positioned closer to the base end than the blade surface.

[0010] The puncture needle according to the present invention further, The aforementioned interpolator has a flat portion, The ultrasonic reflection structure may be formed on the flat surface portion.

[0011] The puncture needle according to the present invention further The inner insert has a reflection portion on which the ultrasonic reflection structure is formed, and a base portion disposed on the proximal end side of the reflection portion. The base portion may be disposed on the proximal end side of the proximal end of the opening of the blade surface in the cylindrical portion.

[0012] The puncture needle according to the present invention further The reflection portion may be disposed on the distal end side of the proximal end of the blade surface.

[0013] The puncture needle according to the present invention further The base portion may close the inside of the cylinder.

[0014] The puncture needle according to the present invention further A space communicating the distal end side and the proximal end side inside the cylinder may be formed between the cylindrical portion and the base portion.

[0015] The puncture needle according to the present invention further The inner insert may be removable from inside the cylinder.

[0016] The puncture needle according to the present invention further The inner insert may be welded or adhered to the inner surface of the cylindrical portion of the cylinder.

[0017] The puncture needle according to the present invention further The inner insert may further include a restricting portion that restricts movement of the inner insert in the axial direction of the cylindrical portion.

[0018] The puncture needle according to the present invention further The ultrasonic reflection structure may be composed of a plurality of concave portions or convex portions.

[0019] The puncture needle according to the present invention further The inner insert may be formed of one or more selected from the group consisting of a metal material, a resin material, and a rubber-like material.

Advantages of the Invention

[0020] It is possible to provide a puncture needle that can obtain sufficient ultrasonic reflection intensity without reducing mechanical strength.

Brief Description of the Drawings

[0021] [Figure 1] It is a top view of the puncture needle. [Figure 2] It is a sectional view taken along the arrow II-II in Fig. 1. [Figure 3] It is a sectional view taken along the arrow III-III in Fig. 2. [Figure 4] It is a sectional view taken along the arrow IV-IV in Fig. 2. [Figure 5] It is a view showing the overall configuration of the puncture needle with the inner insert removed from the outer needle. [Figure 6] It is a view showing the overall configuration of the puncture needle during use. [Figure 7] It is a view showing an example of the ultrasonic reflection structure. [Figure 8] It is an explanatory view of the use of the puncture needle and ultrasonic diagnosis. [Figure 9] It is a view for explaining the reflection of ultrasonic waves in the ultrasonic diagnosis of the puncture needle. [Figure 10] It is a view for explaining the reflection of ultrasonic waves in the ultrasonic diagnosis of the puncture needle. [Figure 11] It is a sectional view along the axis of another puncture needle. [Figure 12] It is a sectional view taken along the arrow XII-XII in Fig. 11. [Figure 13] It is a top view of another puncture needle. [Figure 14] It is a sectional view along the axis of another puncture needle. [Figure 15] It is a sectional view taken along the arrow XV-XV in Fig. 14. [[ID=​​​​​​ [Figure 19] This is a cross-sectional view along the axis of a puncture needle having another regulatory section. [Figure 20] This is a cross-sectional view along the axis of a puncture needle having another regulatory section. [Figure 21] This is a cross-sectional view of another puncture needle, along its axis. [Modes for carrying out the invention]

[0022] A puncture needle according to an embodiment of the present invention will be described based on the drawings.

[0023] [First Embodiment] [Summary] First, an overview of the embodiments of the present invention will be described. As shown in Figures 1 and 2, the puncture needle 100 according to this embodiment comprises an outer needle 1 which is a cylindrical portion with a cutting surface 10 formed at its tip, and an insert 2 which has an ultrasonic reflection structure 3 formed thereon. Figure 1 is a top view of the puncture needle 100. Figure 2 is a cross-sectional view taken along the line II-II shown in Figure 1.

[0024] The insert 2 is positioned inside the barrel of the outer needle 1, as shown in Figures 1 to 4. The ultrasonic reflection structure 3 is housed inside the barrel of the outer needle 1 and exposed through the opening 19, which is the tip opening of the outer needle 1, as shown in Figures 1 to 3. Figure 3 is a cross-sectional view taken along the line III-III shown in Figure 2. Figure 4 is a cross-sectional view taken along the line IV-IV shown in Figure 2.

[0025] The puncture needle 100 is a needle that can be guided into blood vessels or body cavities to inject fluids such as drugs or nutrients into the body, and can also be used to extract bodily fluids such as blood or cell tissue from the body. The puncture needle 100 is used as a so-called injection needle, indwelling needle, biopsy needle, etc. The puncture needle 100 according to this embodiment has an ultrasonic reflection structure 3 that can be visualized with an ultrasound diagnostic device to confirm the position of the needle tip when a user such as a doctor punctures a subject such as a patient. For example, by using an ultrasound diagnostic device, the puncture needle 100 can be used to confirm the position of the blood vessel to be punctured and the position of the needle tip of the puncture needle 100 visualized based on the ultrasonic waves reflected from the ultrasonic reflection structure 3 while puncturing.

[0026] [Description of each part] As shown in Figure 5, the puncture needle 100 comprises a tubular outer needle 1 and an inner insert 2 inserted into the outer needle 1. Figure 5 shows the inner insert 2 removed from the outer needle 1.

[0027] In this embodiment, the puncture needle 100, as an example, as shown in Figure 5, further comprises an outer needle 1 and an inner tube 2, as well as an outer needle hub 8 that holds the proximal end of the outer needle 1 and guides the insertion of the inner tube 2 into the outer needle 1, and an inner tube hub 9 that holds the proximal end of the inner tube 2 and is connected to the outer needle hub 8 to fix the inner tube 2 inside the outer needle 1. As shown in Figure 6, the puncture needle 100 is used by inserting the inner tube 2 into the outer needle 1 and fixing the inner tube 2 relative to the outer needle 1 with the inner tube hub 9 and the outer needle hub 8.

[0028] As shown in Figures 1 and 2, the outer needle 1 is a tubular or cylindrical needle with a cutting surface 10 formed at its tip. The outer needle 1 may be made of a metal material such as stainless steel (for example, SUS304 or SUS316L), titanium, or a titanium alloy. In this embodiment, the base end of the outer needle 1 is supported by the outer needle hub 8 (see Figure 5).

[0029] As shown in Figure 3, the outer needle 1 has circular contours on both its outer and inner circumferential surfaces in cross-section. The radially inner portion of the cutting surface 10 forms an opening 19 that connects the inner and outer spaces of the outer needle 1. In this embodiment, the outer needle 1 is formed in a straight cylindrical shape as an example. The center of the cylinder of the outer needle 1 coincides with the axis G of the outer needle 1.

[0030] In the following explanation, when the extension direction of the outer needle 1 is mentioned, it is the same as the direction along the axis G, and these expressions are used interchangeably for the sake of explanation. The tip or tip side refers to the side of the outer needle 1 in the extension direction where the cutting surface 10 is formed. The base or base side refers to the side opposite to the side of the outer needle 1 in the extension direction where the cutting surface 10 is formed.

[0031] Hereinafter, in the extending direction of the outer needle 1, the tip portion of the outer needle 1 where the cutting surface 10 is formed, including the position of the base end 19a of the opening 19 and its tip side, will be referred to as the outer needle tip portion 12, and the portion of the outer needle tip portion 12 closer to the base end will be referred to as the outer needle base end portion 11.Hereinafter, the inside of the cylinder of the outer needle 1 and the inside of the cylinder of the outer needle base end portion 11 may be referred to as the inside of the outer needle 1 and the inside of the outer needle base end portion 11, respectively.

[0032] As shown in Figures 1 to 3, the insert 2 is a rod-shaped member inserted into the outer needle 1. In this embodiment, the base end of the insert 2 is supported by the insert hub 9 (see Figure 5). The insert 2 is sometimes referred to as the inner needle. The insert 2 may be positioned at the same location as the cutting surface 10 of the outer needle 1, or at the base end side of the cutting surface 10. In this embodiment, the tip surface of the insert 2 is positioned at the same location as the cutting surface 10 in the direction along the axis G, and the boundary between the tip surface of the insert 2 and the cutting surface 10 is approximately flush (see Figure 2). In the following description, "positioned at the base end side of the cutting surface 10" means that the entirety of a certain member (for example, the insert 2) is located at the base end side of the cutting surface 10, and no member protrudes beyond the virtual plane along the cutting surface 10 towards the tip. One example of a state in which a certain component does not protrude beyond a virtual plane along the blade surface 10 toward the tip is a state in which, when the tip portion where the blade surface 10 of the puncture needle 100 is formed is viewed from the side, the certain component cannot be seen, that is, the certain component is completely hidden by the outer needle 1.

[0033] The implant 2 may be formed from one or more materials selected from the group consisting of metal materials, resin materials, and rubber-like materials. Specifically, it may be formed from metal materials such as stainless steel (e.g., SUS304 or SUS316L), titanium, or titanium alloys; resin materials such as polypropylene, polyethylene, and polycarbonate; and rubber-like materials such as silicone rubber or isopropylene rubber. In this embodiment, the case in which the implant 2 is formed from a metal material will be described below as an example.

[0034] The implant 2 has a base portion 21 that is housed within the proximal end portion 11 of the outer needle 1, and a reflective portion 22 on which an ultrasonic reflection structure 3 is formed.

[0035] As shown in Figure 2, the base portion 21 is a rod-shaped part that is inserted into the proximal end portion 11 of the outer needle. The insert 2 is held inside the outer needle 1 with the base portion 21 supported by the proximal end portion 11 of the outer needle. The base portion 21 is positioned further proximal than the proximal end portion 19a of the opening 19. Furthermore, the tip of the base portion 21 is positioned further forward than the proximal end portion 10a of the blade surface 10. By positioning the base portion 21 further proximal than the proximal end portion 19a of the opening 19 and the tip of the base portion 21 further forward than the proximal end portion 10a of the blade surface 10 in this way, the area of ​​the flat portion 22a of the reflective portion 22 for providing the ultrasonic reflection structure 3, which will be described later, can be secured in the region exposed from the opening 19. In addition, since the base portion 21 can firmly support the reflective portion 22 near the opening 19, damage to the reflective portion 22 can be prevented. As mentioned above, Figure 2 is a cross-sectional view taken along the line II-II shown in Figure 1. However, in terms of its relationship with the base end 10a and base end 19a, Figure 2 is a cross-sectional view of the plane passing through the axis G, base end 19a, and base end 10a.

[0036] In this embodiment, as shown in Figures 2 and 4, the shape of the outer circumferential surface of the base 21 conforms to the shape of the inner circumferential surface of the outer needle proximal end 11. The base 21 closes off the inside of the tube of the outer needle proximal end 11. The statement that the inside of the tube of the outer needle proximal end 11 is closed off means not only that there is no space connecting the space on the tip side and the space on the proximal end side of the outer needle proximal end 11 when the base 21 is inserted, but also that water or blood cannot flow smoothly between the tip side and the proximal end side of the outer needle proximal end 11, that is, even if the opening 19 at the tip of the outer needle 1 is guided into a blood vessel or body cavity, fluids such as drug solutions or nutrients cannot be injected into the body, and bodily fluids such as blood or cell tissue cannot be removed from the body. For example, a very small clearance is provided between the inner surface of the proximal end 11 of the outer needle and the outer surface of the base 21 to allow the implant 2 to be removed from the outer needle 1. However, a state in which this clearance does not allow for the smooth flow of water or blood between the tip and proximal end of the proximal end 11 of the outer needle is included in the state in this embodiment where the base 21 is blocking the inside of the barrel of the proximal end 11 of the outer needle.

[0037] As described above, by occluding the inside of the proximal end 11 of the external needle, fluid is not allowed to accumulate inside the proximal end 11 except when necessary, preventing contamination inside the proximal end 11 and making it easier to maintain a clean environment. This is also beneficial when you want to avoid blood flashback during puncture.

[0038] As shown in Figures 2 and 3, the reflective portion 22 is the part of the insert 2 that is closer to the tip than the base portion 21. The reflective portion 22 is thinner than the base portion 21. The reflective portion 22 is located within the tip portion 12 of the outer needle. That is, the reflective portion 22 is located at the same position as the cutting surface 10 of the outer needle 1, or closer to the base end than the cutting surface 10. Furthermore, the tip of the reflective portion 22 is located closer to the tip than the base end portion 19a of the opening 19.

[0039] In this embodiment, the base end of the reflective portion 22 is positioned closer to the tip than the base end 10a of the blade surface 10. Furthermore, the base end of the reflective portion 22 is positioned closer to the base than the base end 19a of the opening 19. By positioning the base end of the reflective portion 22 between the base end 19a of the opening 19 and the base end 10a of the blade surface 10 in this way, a large area of ​​the flat portion 22a for providing the ultrasonic reflection structure 3, which will be described later, can be secured. In addition, the portion of the reflective portion 22 that cannot reflect ultrasonic waves with the ultrasonic reflection structure 3 can be minimized, thereby reducing the risk of damage to the reflective portion 22, which is thinner than the base portion 21.

[0040] In the reflective portion 22, the surface on the side separated from the inner circumferential surface of the outer needle 1 is formed as a flat portion 22a. An ultrasonic reflection structure 3, which will be described later, is formed on the flat portion 22a.

[0041] The surface of the outer needle 1 that is spaced apart from the inner circumferential surface is the surface of the reflective portion 22 that faces the opening 19 of the blade surface 10. In this embodiment, the flat portion 22a is the surface that aligns with the axis G and faces the opening 19. By making the surface of the reflective portion 22 that is spaced apart from the inner circumferential surface of the outer needle 1 a flat portion 22a, the degree of freedom in the processing shape when forming the ultrasonic reflection structure 3 is improved, making processing easier.

[0042] The planar portion 22a is preferably located on the opposite side of the axis G from the blade surface 10, and the reflective portion 22 is preferably not to overlap with the axis G. This makes it possible to secure a large area of ​​the planar portion 22a on which the ultrasonic reflection structure 3 can be provided. In this embodiment, as shown in Figures 2 and 3, the planar portion 22a is located on the opposite side of the axis G from the blade surface 10, and the reflective portion 22 is not to overlap with the axis G.

[0043] In this embodiment, the surface of the reflective portion 22 that is spaced apart from the blade surface 10, that is, the surface opposite to the flat portion 22a, is in contact with the inner circumferential surface of the outer needle tip portion 12, or is in close proximity to the inner circumferential surface of the outer needle tip portion 12 with a very small gap between them. As a result, even if physical stress is applied to the reflective portion 22, the reflective portion 22 is supported by the outer needle tip portion 12, which may prevent damage or deformation of the reflective portion 22.

[0044] As shown in Figures 1 to 3 and Figure 7, the ultrasonic reflection structure 3 is an acoustic structure suitable for reflecting ultrasonic waves, formed on the flat portion 22a. The ultrasonic reflection structure 3 is housed within the cylinder of the outer needle 1 and exposed through the opening 19 of the outer needle 1. "Exposed through the opening 19 of the outer needle 1" means that it is visible through the opening 19 (including when magnified and visible using a magnifying glass or microscope). "Hosted within the cylinder of the outer needle 1" means that it is located within the cylinder of the outer needle 1 and positioned on the proximal end side of the blade surface 10. For example, even if the reflection portion 22 or the flat portion 22a includes a portion that is in the same position as the blade surface 10 in the direction along the axis G, the ultrasonic reflection structure 3 is formed within the range of the flat portion 22a that is housed within the cylinder of the outer needle 1.

[0045] As shown in Figures 8 to 10, the ultrasonic reflection structure 3 allows the probe P of the ultrasound diagnostic device (so-called echo) to receive the reflected ultrasound waves R2 from the ultrasonic reflection structure 3 of the ultrasound W irradiated for exploration or visualization (contrast enhancement) with high intensity. This allows the user of the puncture needle 100 (see Figure 1), such as a physician, to accurately determine the position of the tip of the puncture needle 100. Details regarding the use and position determination of the puncture needle 100 will be described later.

[0046] The acoustic structure used as the ultrasonic reflection structure 3 is preferably one that can reflect reflected ultrasound along the angle of incidence of the incident ultrasound, in other words, one that can reflect reflected ultrasound with the strongest possible intensity relative to the probe P. This allows the probe P of the ultrasound diagnostic device to receive the reflected ultrasound with even greater intensity, enabling the user to reliably determine the tip position of the puncture needle 100.

[0047] In other words, the state in which the ultrasonic reflection structure 3 is exposed from the opening 19 of the outer needle 1, or the state in which the ultrasonic reflection structure 3 can be seen through the opening 19, means that ultrasonic waves W can be incident on the ultrasonic reflection structure 3 from outside the outer needle 1 through the opening 19, and that the ultrasonic reflection structure 3 can emit reflected waves R2 of ultrasonic waves W toward the probe P.

[0048] The ultrasonic reflection structure 3 may be formed as an uneven surface, as shown in Figures 1 to 3 and Figure 7. Specifically, a portion of the flat surface 22a may be recessed by etching, cutting, grinding, laser processing, etc., to form multiple recesses, and these multiple recesses, along with multiple protrusions formed relative to these recesses, may be used as the ultrasonic reflection structure 3. Alternatively, multiple protrusions may be constructed on the flat surface 22a by a three-dimensional printer, plating, vapor deposition, etc., and this may be used as the ultrasonic reflection structure 3. Furthermore, the ultrasonic reflection structure 3 may be constructed by pressing with a mold having a shape corresponding to the desired ultrasonic reflection structure 3 to form the uneven surface. In addition, a rough surface may be formed by blasting and this may be used as the ultrasonic reflection structure 3.

[0049] Specific examples of the uneven structure of the ultrasonic reflection structure 3 include corner cube shapes, unevenness created by the formation of through holes, striped patterns created by the formation of horizontal lines, and protrusions created by the formation of crosshatch patterns or dimple shapes.

[0050] The reflective portion 22, which serves as the implantation body 2, may be placed inside the outer needle tip portion 12 after the ultrasonic reflection structure 3 has been formed. Alternatively, the ultrasonic reflection structure 3 may be formed on the flat portion 22a after the reflective portion 22 has been placed inside the outer needle tip portion 12.

[0051] Figure 7 shows, as an example, a case where the ultrasonic reflection structure 3 is an aggregate of relatively convex portions 30. The convex portions 30 may be, for example, truncated square pyramidal shapes with a planar apex 31. The convex portions 30 can be formed as relatively convex portions by forming a first groove 32 along the axis G (see Figure 1) and a second groove 33 intersecting the first groove 32 in a cross-hatch pattern on the planar portion 22a of the reflection portion 22 (see Figures 1 to 3). In Figure 7, the inclined surface of the convex portion 30 formed by the first groove 32 is shown as the slope 32a. Also in Figure 7, the inclined surface of the convex portion 30 formed by the second groove 33 is shown as the slope 33a. Note that if only the first groove 32 or the second groove 33 is formed, the ultrasonic reflection structure 3 can be formed in a striped pattern.

[0052] The outer needle hub 8 shown in Figure 5 holds the base end of the outer needle 1, guides the insertion of the insert 2 into the outer needle 1, and serves as the connection interface with the insert hub 9. The outer needle hub 8 is a cylindrical space that penetrates in the direction along the extending direction of the outer needle 1, that is, in the direction along the axis G (see Figures 1 to 3), and has a space inside that communicates with the outer needle 1. A flange-shaped restricting portion 81 is formed on the base end side of the outer needle hub 8.

[0053] The implant hub 9 shown in Figure 5 is the part that holds the proximal end of the implant 2 and serves as the connection interface with the external needle hub 8. The implant hub 9 has a fitting portion 92 that is connected to and supports the proximal end of the implant 2, and a restricted portion 91 that is connected to the proximal end of the fitting portion 92 and has a larger outer diameter than the fitting portion 92. The fitting portion 92 can be fitted into the external needle hub 8 from the proximal end of the external needle hub 8, thereby enabling the implant hub 9 to be connected to the external needle hub 8.

[0054] [Instructions for use] The following describes how to use the puncture needle 100. When puncturing, the puncture needle 100 is used with the implant 2 inserted into the outer needle 1. That is, prior to use, the implant 2 is inserted into the outer needle 1 of the puncture needle 100. This insertion may be performed during the manufacturing of the puncture needle 100, or it may be performed by a doctor or nurse immediately before puncture. The implant hub 9 is fitted into the outer needle hub 8, and by this fitting, the implant 2 is held by the implant hub 9 while inserted into the outer needle 1. The implant hub 9 is fitted into the outer needle hub 8 and connected while the implant 2 is inserted into the outer needle 1.

[0055] The implant hub 9 may be connected to and fixed to the outer needle hub 8 by fitting its insertion portion 92 into the internal space of the outer needle hub 8 from the base end side, as shown in Figure 6, for example. In this embodiment, when the insertion portion 92 is fitted into the innermost part of the outer needle hub 8, that is, toward the tip of the outer needle hub 8, the tip of the restricted portion 91 comes into contact with the restricting portion 81, restricting the implant hub 9 from moving further toward the tip. In other words, the movement of the implant hub 2 in the direction along the axis G of the outer needle 1 is restricted by the restricting portion 81. This prevents displacement of the ultrasonic reflection structure 3, and ensures reliable position determination or detection (including detection when simply referred to as position determination) of the position of the outer needle tip 12 by the ultrasonic diagnostic device described later.

[0056] Next, referring mainly to Figures 8 to 10, we will explain how to determine the position of the puncture needle 100 within the body in relation to the use of the puncture needle 100. When using the puncture needle 100, it is important to determine the position of the tip of the puncture needle 100, that is, the outer needle tip 12 shown in Figures 9 and 10, when identifying the target for puncture, such as a blood vessel.

[0057] As shown in Figures 8 to 10, the position of the tip 12 of the external needle inside the subject's body is visualized using an ultrasound diagnostic device equipped with a probe P. In Figures 8 to 10, for ease of explanation, the puncture needle 100 is displayed enlarged compared to its actual size in relation to the display size of the probe P.

[0058] As shown in Figure 8, when using the puncture needle 100, the outer needle 1 is first inserted into the body (below the skin H) through the subject's skin H.

[0059] In the puncture needle 100 of this embodiment, the ultrasonic reflection structure 3 is formed not on the outer needle 1, but on the internal insert 2 which is inserted into the outer needle 1. Therefore, the mechanical strength of the outer needle 1, such as rigidity and toughness, is not reduced. As a result, the puncture needle 100 makes it easy to ensure the mechanical strength required during puncture. Rather, in the puncture needle 100, the internal insert 2 is inserted into the outer needle 1, and the internal insert 2 supports the outer needle 1 from the inside. Therefore, the overall mechanical strength of the puncture needle 100 is improved, the outer needle 1 is less likely to bend, breakage is avoided, and ease of use during puncture is improved.

[0060] Furthermore, in the puncture needle 100 of this embodiment, since the ultrasonic reflection structure 3 is housed inside the barrel of the outer needle 1, it does not cause resistance during puncture, and damage to the ultrasonic reflection structure 3 due to resistance during puncture can also be avoided.

[0061] After puncturing with the puncture needle 100, ultrasound echo gel L is applied to the skin H, and then the sensor surface Ps of the probe P is gently brought into contact with the skin H. Ultrasound W is then irradiated from the sensor surface Ps of the probe P, aiming at the tip of the puncture needle 100. Figure 8 illustrates the case where the sensor surface Ps of the probe P is in contact with the skin H. Ultrasound echo gel L is interposed in the gap between the sensor surface Ps and the skin H. In this embodiment, the concept of the sensor surface Ps being in contact with the skin H includes the case where ultrasound echo gel L is interposed in the gap between the sensor surface Ps and the skin H.

[0062] The position of the puncture needle 100 inside the body is detected by reflected ultrasonic waves R1 and R2, as shown in Figures 8 to 10, and displayed on the display unit of the echo device. Here, reflected wave R1 is the ultrasonic wave W reflected from the part of the outer needle 1 other than the ultrasonic reflection structure 3 toward the probe P. Reflected wave R2 is the ultrasonic wave W reflected from the ultrasonic reflection structure 3 toward the probe P. In this embodiment, the frequency of the ultrasonic wave W includes cases where it is at least 3 MHz to 14 MHz.

[0063] As shown in Figure 9, when the probe P is in contact with the skin H (see Figure 8) such that the sensor surface Ps is aligned with the axis G of the outer needle 1, the reflection of ultrasound W from the outer needle 1 becomes a highly directional reflection toward the probe P, so that the probe P can receive the reflected wave R1 with high intensity. Therefore, the ultrasound diagnostic device can sharply depict the outer needle 1 based on the reflected wave R1, and the user of the puncture needle 100 (e.g., a doctor) can accurately determine the position of the outer needle 1.

[0064] In this case, the ultrasonic reflection structure 3 (particularly the top portion 31 shown in Figure 7) provides highly directional reflection towards the probe P, allowing the probe P to receive the reflected wave R2 with high intensity. Therefore, the ultrasound diagnostic device can accurately depict the position of the opening 19 of the outer needle 1, i.e., the position of the outer needle tip 12, based on the reflected wave R2, and the user of the puncture needle 100 (e.g., a physician) can easily grasp the position of the outer needle tip 12.

[0065] As shown in Figure 10, if the sensor surface Ps is not aligned with the axis G of the outer needle 1, and the probe P is in contact with the skin H (see Figure 8) at an angle to the axis G of the outer needle 1, the reflection of ultrasound W from the outer needle 1 will be a reflection with low directivity directed towards the probe P, and the probe P may not be able to receive a reflected wave R1 of sufficient intensity. Therefore, the ultrasound diagnostic device may not be able to depict the outer needle 1 with sufficient sharpness based on the reflected wave R1.

[0066] As shown in Figure 10, even when the probe P is in contact with the skin H (see Figure 8) with the sensor surface Ps deviated from the axis G of the outer needle 1, for example, when the sensor surface Ps is tilted from 5° to 80° with respect to the axis G, one of the surfaces of the ultrasonic reflection structure 3 faces the sensor surface Ps to some extent. As a result, the ultrasonic reflection structure 3 reflects with high directivity toward the probe P, and the reflected wave R2 contains a relatively large specular component of the ultrasound W from the ultrasonic reflection structure 3 (particularly the inclined surface 33a shown in Figure 7). Therefore, the probe P can receive the reflected wave R2 with sufficient and necessary strength. Consequently, the ultrasound diagnostic device can depict the position of the opening 19 of the outer needle 1, i.e., the position of the tip 12 of the outer needle, with sufficient and necessary clarity based on the reflected wave R2, and the user of the puncture needle 100 (e.g., a doctor) can easily grasp the position of the tip 12 of the outer needle.

[0067] As described above, the puncture needle 100 provides sufficient ultrasonic reflection intensity for imaging with an ultrasound diagnostic device during puncture. Furthermore, as shown in Figures 1 to 3, since the ultrasonic reflection structure 3 is formed on the implant 2, the mechanical strength of the puncture needle 100, especially the outer needle 1, is not reduced. Therefore, damage to the puncture needle 100 during puncture can be suppressed.

[0068] Furthermore, with the puncture needle 100, the implant 2 may be removed after puncture, and a guidewire used for catheter treatment or other procedures may be inserted. Even in such a usage environment with a guidewire inserted, the outer needle 1 has sufficient mechanical strength, so the puncture needle 100 can withstand use without damage or other issues.

[0069] In other words, the puncture needle 100 of this embodiment allows for proper visualization using an ultrasound diagnostic device, improving ease of use and ensuring safety and security.

[0070] If, as in conventional technology, an ultrasonic reflection structure is formed on the inner surface of the outer needle 1 by recesses, indentations, or grooves, this may reduce the mechanical strength of the outer needle 1. Specifically, if the outer needle 1 is already formed with thin walls, and then further thinning is achieved by cutting or grinding to form the ultrasonic reflection structure 3, the mechanical strength of the outer needle 1 will decrease. In such cases, the risk of breakage during puncture increases. Furthermore, in the case of introducer needles used to insert a guidewire into a blood vessel, the risk of breakage during guidewire insertion also increases. In other words, it may become impossible to guarantee safe and secure use.

[0071] [Second Embodiment] As shown in Figures 11 and 12, the second embodiment differs from the first embodiment in the configuration of the reflective portion 22, but is otherwise the same. Below, the second embodiment will be described, focusing on the differences from the first embodiment.

[0072] In this embodiment, as shown in Figures 11 and 12, the surface of the reflective portion 22 that is separated from the blade surface 10 is separated from the inner circumferential surface of the outer needle tip 12. By separating the reflective portion 22 from the inner circumferential surface of the outer needle tip 12, it may be possible to prevent damage or deformation of the reflective portion 22 even if physical stress is applied to the outer needle tip 12 and distortion occurs. Figure 11 is a cross-sectional view of the puncture needle 100 in this embodiment, and is a cross-sectional view of the surface passing through the axis G, the base end 19a of the opening 19, and the base end 10a of the blade surface 10. In other words, Figure 11 is a cross-sectional view corresponding to Figure 2 shown in the first embodiment. Figure 12 is a cross-sectional view taken along the line XII-XII in Figure 11.

[0073] Even when the reflective portion 22 is spaced apart from the inner circumferential surface of the outer needle tip portion 12, it is preferable that the flat portion 22a is located on the opposite side of the axis G from the blade surface 10, and that the reflective portion 22 does not overlap with the axis G. In this embodiment, the distance between the flat portion 22a and the axis G is closer than in the first embodiment, but as in the first embodiment, the flat portion 22a is located on the opposite side of the axis G from the blade surface 10, and the reflective portion 22 does not overlap with the axis G.

[0074] Figure 13 shows a top view of the puncture needle 100 in this embodiment. As shown in Figures 11 and 13, the tip of the reflective portion 22 is located slightly closer to the base end compared to the first embodiment, but similar to the first embodiment, the reflective portion 22 is located inside the tip portion 12 of the outer needle. The reflective portion 22 may be located at the same position as the blade surface 10 of the outer needle 1, or closer to the base end than the blade surface 10, in the direction along the axis G. Figure 11 shows the case where the reflective portion 22 is located closer to the base end than the blade surface 10. The base end of the reflective portion 22 is located even closer to the base end 19a of the opening 19. The tip of the reflective portion 22 is located closer to the tip end than the base end 19a of the opening 19.

[0075] [Third Embodiment] The third embodiment differs from the first embodiment in that the base portion 21 does not block the inside of the cylinder of the outer needle base end portion 11, as shown in Figures 14 and 15, but is otherwise the same as the first embodiment.

[0076] Figure 14 is a cross-sectional view of the puncture needle 100 in this embodiment, and is a cross-sectional view of the plane passing through the axis G, the base end 19a of the opening 19, and the base end 10a of the cutting surface 10. In other words, Figure 14 is a cross-sectional view corresponding to Figure 2 shown in the first embodiment. Figure 15 is a cross-sectional view taken along the line XV-XV in Figure 14.

[0077] As shown in Figures 14 and 15, in this embodiment, a space S is formed within the outer needle base end 11 when the base 21 is inserted, connecting the space on the tip side of the outer needle base end 11 with the space on the base end side. In this embodiment, the space S is formed by removing the end of the base 21 of the first embodiment that is close to the base end 10a of the blade surface 10 in the radial direction of the outer needle 1, i.e., along the axis G of the outer needle 1, thereby forming a surface portion 21a that extends along the axis G. In other words, the space S is a space formed between the inner circumferential surface of the outer needle tip 12 and the surface portion 21a of the base 21.

[0078] The space S allows water and blood to flow smoothly between the space on the tip side and the space on the proximal side of the proximal end 11 of the outer needle. In other words, the opening 19 at the tip of the outer needle 1 is guided into a blood vessel or body cavity, allowing fluids such as drug solutions and nutrients to be injected into the body, and also allowing body fluids such as blood and cellular tissue to be extracted from the body.

[0079] In the puncture needle 100, the space S allows water and blood to flow smoothly between the space at the tip and the space at the proximal end of the outer needle 11, resulting in a blood flashback when puncturing a blood vessel. Therefore, users of the puncture needle, such as physicians, can recognize proper puncture by checking for the flashback in conjunction with the use of an ultrasound diagnostic device. This may improve the usability of the puncture needle 100 as a medical device.

[0080] [Fourth Embodiment] The fourth embodiment differs from the first embodiment in that, as shown in Figures 16 and 17, the insert 2 does not have a base 21, and consequently the reflective portion 22 is fixed to the inner surface of the outer needle 1; the ultrasonic reflection structure 3 is formed by constructing protrusions rather than forming a grooved structure; the insert hub 9 is not provided; and there is no operation to insert the insert 2 into the outer needle 1. Otherwise, it is the same as the first embodiment. Note that the choice of whether to form the uneven structure in the ultrasonic reflection structure 3 by forming grooves or by constructing protrusions is arbitrary, and the differences in the method of constructing the uneven structure shown in the first embodiment and the fourth embodiment are merely illustrative.

[0081] Figure 16 is a cross-sectional view of the plane passing through the axis G, the base end 19a of the opening 19, and the base end 10a of the cutting surface 10. In other words, Figure 15 is a cross-sectional view corresponding to Figure 2 shown in the first embodiment. Figure 17 is a cross-sectional view taken along the line XVII-XVII in Figure 16.

[0082] As shown in Figures 16 and 17, the interpolator 2 of this embodiment comprises only a reflective portion 22. The entire reflective portion 22 is positioned on the tip side of the base end 19a of the opening 19. The reflective portion 22 may be fixed to the inner surface of the outer needle tip portion 12 of the outer needle 1 by bonding with an adhesive or by welding. In this case, the reflective portion 22 may be one which has been pre-formed with an ultrasonic reflective structure 3 by metal powder injection molding (so-called MIM), or one which has been formed with an ultrasonic reflective structure 3 on a pre-formed resin molded product. Alternatively, the reflective portion 22 may be constructed on the inner surface of the outer needle tip portion 12 by a three-dimensional printer, plating, vapor deposition, etc. Note that, similar to the relationship between the outer needle 1 and the interpolator 2 in the first embodiment, the reflective portion 22 as the interpolator 2 is a separate entity from the outer needle 1.

[0083] In this embodiment, since the implant 2 is not inserted through the proximal end 11 of the outer needle, there is an advantage in that a guidewire used for catheters, etc., can be inserted through the proximal end 11 of the outer needle without removing the implant 2.

[0084] As described above, a puncture needle can be provided that provides sufficient ultrasonic reflection intensity without reducing mechanical strength.

[0085] [Another embodiment] (1) In the first and second embodiments described above, the shape of the outer circumferential surface of the base portion 21 conforms to the shape of the inner circumferential surface of the outer needle base end portion 11, and the case in which the base portion 21 closes the inside of the cylinder of the outer needle base end portion 11 was described. However, when closing the inside of the cylinder of the outer needle base end portion 11, it is sufficient to close only a part of the outer needle base end portion 11 in the direction of extension. In other words, it is not necessary to close the entire outer needle base end portion 11 in the direction of extension.

[0086] (2) In the fourth embodiment described above, the case in which the reflective portion 22, which is the insert 2, is made of a metal material was explained. However, as explained in the first embodiment, the insert 2 is not limited to being made of a metal material. In particular, in the fourth embodiment, by forming the reflective portion 22 of a resin material or rubber-like material that is more flexible than a metal material, it may be possible to avoid damage or peeling of the reflective portion 22 due to the guide wire coming into contact with the reflective portion 22 when the guide wire is inserted into the outer needle 1. Also, it may be possible to avoid damage or deformation of the guide wire due to the guide wire coming into contact with the reflective portion 22. That is, if the reflective portion 22 is fixed to the inner surface of the outer needle tip 12 and the reflective portion 22 is made of a flexible resin material or rubber-like material, the reflective portion 22 does not become an obstacle when inserting or removing the guide wire from the opening 19 (see Figure 16).

[0087] (3) In the first to third embodiments described above, the base portion 21 is positioned closer to the base end 19a of the opening 19 and the tip of the base portion 21 is positioned closer to the tip than the base end 10a of the blade surface 10. In other words, the base end of the reflecting portion 22 is positioned between the base end 19a of the opening 19 and the base end 10a of the blade surface 10. However, as shown in Figure 18, the effects of the present invention can be achieved even if the base end of the reflecting portion 22 is positioned further closer to the base end 10a of the blade surface 10.

[0088] As shown in Figure 18, if the base end of the reflecting portion 22 is positioned further to the base than the base end 10a of the blade surface 10, the base end of the ultrasonic reflection structure 3 may extend further to the base than the base end 10a. In this case, when the ultrasonic waves W from the probe P (see Figure 8) are incident on the reflecting portion 22 from the opening 19 at a large inclination with respect to the axis G, the reflected waves R2 can be reflected from the ultrasonic reflection structure 3 further to the base than the base end 10a. This is preferable because the ultrasonic diagnostic device can accurately depict the position of the opening 19 of the outer needle 1 based on the reflected waves R2, and the user of the puncture needle 100 (e.g., a doctor) can easily grasp the position of the outer needle 1.

[0089] (4) In the first to third embodiments described above, the case in which the movement of the outer needle 1 in the implant 2 in the direction along the axis G is restricted by the restricting portion 81 of the outer needle hub 8 was described. However, the restriction of the movement of the outer needle 1 in the implant 2 in the direction along the axis G is not limited to the case in which the restricting portion 81 is provided. For example, as shown in Figures 19 and 20, a projection 12a as a restricting portion may be formed on the inner circumferential surface of the outer needle 1, and the tip side of the implant 2 may be brought into contact with the base end side of the projection 12a to restrict the movement of the outer needle 1 in the implant 2 in the direction along the axis G. The projection 12a may be formed, for example, by recessing the outer needle 1 from the outer circumferential surface and making it protrude towards the inner circumferential surface (see Figure 19), or the outer needle 1 inside A protrusion 12a (see Figure 20) may be formed on the circumferential surface by bonding, welding, plating, etc.

[0090] (5) In the above embodiment, the case in which the flat portion 22a is aligned with the axis G and faces the opening 19 was described. However, as shown in Figure 21, the effects of the present invention can also be achieved even if the flat portion 22a intersects with the axis G. In Figure 21, the flat portion 22a is arranged parallel to the blade surface 10, but the flat portion 22a is positioned on the proximal end side of the blade surface 10 and is housed in the tip portion 12 of the outer needle. The ultrasonic reflection structure 3 is also housed in the tip portion 12 of the outer needle. That is, as in the above embodiment, the ultrasonic reflection structure 3 is housed inside the cylinder of the outer needle 1, so it does not cause resistance during puncture, and damage to the ultrasonic reflection structure 3 due to resistance during puncture can also be avoided.

[0091] (6) In the above embodiment, the surface of the reflective portion 22 that is spaced apart from the inner circumferential surface of the outer needle 1 is a planar flat portion 22a, and the case in which the ultrasonic reflection structure 3 is formed on this planar flat portion 22a has been described. However, it is not essential that the reflective portion 22 has a planar flat portion 22a. The ultrasonic reflection structure 3 may be formed on a non-planar surface of the reflective portion 22, and even in this case, the effects of the present invention can be achieved.

[0092] Furthermore, the configurations disclosed in the above embodiments (including other embodiments, the same applies hereinafter) can be applied in combination with configurations disclosed in other embodiments, as long as no inconsistencies arise. Moreover, the embodiments disclosed herein are illustrative, and the embodiments of the present invention are not limited thereto, and can be modified as appropriate without departing from the object of the present invention. [Industrial applicability]

[0093] This invention can be applied to puncture needles. [Explanation of symbols]

[0094] 1 Outer needle 10 Blade surface 100 puncture needle 10a Proximal end 11 Proximal end of outer needle 12 Outer needle tip 12a protrusion 19 Opening 19a Proximal end 2 inserts 21 Base 21a Surface part 22 Reflector 22a Flat part 3 Ultrasonic reflection structure 30 Convex part 31 Top 32 First groove 32a Slope 33 Second groove 33a slope 8. Outer needle hub 81 Regulatory Department 9 Insertion Hub 91 Regulatory Department 92 Inset part G-axis center L Ultrasound Echogel P probe Ps sensor surface R1 reflected wave R2 reflected wave S space W sound waves

Claims

1. a cylindrical portion having a cutting edge formed at its tip; an insert having an ultrasonic reflecting structure formed thereon; The insert is disposed within the cylindrical portion, The ultrasonic reflecting structure is housed within the cylindrical portion and is exposed through a tip opening of the cylindrical portion.

2. The puncture needle according to claim 1 , wherein the ultrasonic reflection structure is disposed closer to the proximal end than the blade surface.

3. The insert has a flat surface, The puncture needle according to claim 1 or 2, wherein the ultrasonic reflection structure is formed on the flat surface portion.

4. the insert has a reflecting portion in which the ultrasonic reflecting structure is formed and a base portion disposed on a base end side of the reflecting portion, The puncture needle according to claim 1 , wherein the base portion is located closer to the base end than the base end of the opening of the blade surface in the cylindrical portion.

5. The puncture needle according to claim 4 , wherein the reflecting portion is disposed closer to the tip end than the base end of the blade surface.

6. The puncture needle according to claim 4 or 5, wherein the base closes the inside of the cylinder.

7. The puncture needle according to claim 4 or 5, wherein a space communicating the distal end side and proximal end side inside the cylinder is formed between the cylindrical portion and the base portion.

8. The puncture needle according to claim 1 , wherein the insert is removable from the cylinder.

9. The puncture needle according to claim 1 , wherein the insert is welded or bonded to the inner surface of the cylindrical portion.

10. The puncture needle according to claim 1 , further comprising a restricting portion that restricts axial movement of the cylindrical portion of the insert.

11. The puncture needle according to claim 1 , wherein the ultrasound reflection structure is composed of a plurality of recesses or protrusions.

12. The puncture needle according to any one of claims 1 to 11, wherein the insert is made of one or more materials selected from the group consisting of metal materials, resin materials, and rubber-like materials.

Images