Vibrating needle device and method of operating the vibrating needle device

Abstract

To provide a vibrating needle device capable of easily punctuating a needle and a method for inserting the needle.SOLUTION: A vibrating needle device 1 includes: a needle 10 which has a body part 11 extending in a first axis C1 direction and a tip 12 provided at one end of the body part 11 and tapered as it goes away from the body part 11 in the first axis C1 direction; and a vibration part 20 which vibrates the needle 10 with low frequency between 5 Hz and 15 Hz along at least either the first axis C1 direction or a second axis C2 direction crossing the first axis C1 direction. The vibration part 20 vibrates the needle 10 so that there appears a vibration waveform of a sawtooth or reverse sawtooth at least either in the first axis direction C1 or in the second axis C2 direction.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a vibrating needle device and a method for inserting a needle. This application claims priority to Japanese Patent Application No. 2020-101453 filed on June 11, 2020, the content of which is incorporated herein by reference.

Background Art

[0002] In the medical field, percutaneous needle puncture may be used during medical treatment. For example, Patent Document 1 below discloses a puncture unit that can reduce pain during needle puncture into the skin.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, there is a medical treatment method of inserting a needle from the skin into a tumor in the body and collecting, cauterizing, or freezing the tumor. The medical treatment method by needle puncture can reduce the burden on the patient compared to open surgery. However, in the prior art, the organ that is the target of needle puncture is not completely fixed in the body and moves along with the movement of the needle. Therefore, it has been extremely difficult to accurately puncture the needle into the target object such as an organ.

[0005] An object of the present invention is to provide a vibrating needle device and a method for inserting a needle that can easily puncture the needle.

Means for Solving the Problems

[0006] To solve the above problems, the vibrating needle device according to the present invention comprises a needle having a main body portion extending in the first axial direction and having grooves formed on its outer circumferential surface over the entire circumference around the first axis, a tip portion provided at one end of the main body portion that tapers as it moves away from the main body portion in the first axial direction, and a vibrating unit that vibrates the needle along the first axial direction and a second axial direction intersecting the first axial direction.

[0007] In the above configuration, the side surface of the needle on the base end side in the groove is inclined inward in the radial direction perpendicular to the first axis as it moves from the base end side toward the tip end side.

[0008] To solve the above problems, the vibrating needle device according to the present invention comprises a needle having a main body portion extending in a first axial direction, a tip portion provided at one end of the main body portion that tapers as it moves away from the main body portion in the first axial direction, and a vibrating unit that vibrates the needle at a low frequency of 5 Hz to 15 Hz along at least one of the first axial direction and a second axial direction intersecting the first axial direction.

[0009] In the above configuration, the vibrating unit vibrates the needle such that the vibration waveform is sawtooth-shaped and / or inverse sawtooth-shaped in at least one of the first axial direction and the second axial direction.

[0010] In the above configuration, the vibrating unit vibrates the needle so that it produces a rectangular wave-shaped vibration waveform in at least one of the first axial direction and the second axial direction.

[0011] In the above configuration, the frequency at which the vibrating part vibrates the needle is set to resonate with the natural frequency of the needle.

[0012] In the above configuration, the second axis is perpendicular to the first axis.

[0013] In order to solve the above problems, the insertion method according to the present invention is a method for inserting a needle using any of the above vibrating needle devices, comprising: a vibrating step of vibrating the needle in the first axial direction and the second axial direction; and an inserting step of inserting the needle into an object while the needle is vibrating.

[0014] In order to solve the above problems, the insertion method according to the present invention is a method for inserting a needle using the above vibrating needle device, comprising: a vibrating step of vibrating the needle at a low frequency of 5 Hz or more and 15 Hz or less in at least one of the first axial direction and the second axial direction; and an inserting step of inserting the needle into an object while the needle is vibrating.

Effects of the Invention

[0015] Therefore, the present invention provides a vibrating needle device and a method for inserting a needle that can easily puncture an object.

Brief Description of the Drawings

[0016] [Figure 1] It is a schematic diagram of a vibrating needle device according to an embodiment. [Figure 2] [[ID=…]]It is a side view of a needle according to an embodiment. [Figure 3] [[ID=…]]It is an enlarged view of part III of FIG. 2. [Figure 4] [[ID=…]]It is a side view of a needle according to a modification. [Figure 5] [[ID=…]]It is an enlarged view of part V of FIG. 4. [Figure 6] [[ID=…]]It is a side view of a needle without a groove. [Figure 7] [[ID=…]]It is a graph showing the change in puncture force. [Figure 8] [[ID=…]]It is a graph comparing the primary peaks of the puncture force in each vibration. [Figure 9] [[ID=…]]It is a graph comparing the secondary peaks of the puncture force in each vibration. [Figure 10] [[ID=…]]It is a graph comparing the stable regions of the puncture force in each vibration. [Figure 11] [[ID=…]]It is a graph comparing the stable regions of the puncture force for each needle and each vibration. [Figure 12] It is a graph showing the correlation between the second peak of the puncture force and the puncture speed in each vibration. [Figure 13] It is a graph showing the correlation between the total puncture force and the puncture speed in each vibration. [Figure 14] It is a graph showing the correlation between the second peak of the puncture force and the puncture speed in the two - direction vibration. [Figure 15] It is a graph showing the correlation between the total puncture force and the puncture speed in the two - direction vibration. [Figure 16] It is a graph showing the correlation between the puncture force and the displacement of the needle in no - vibration and two - direction vibration. [Figure 17] It is a box - plot diagram comparing the maximum values of the puncture force between no - vibration and rectangular - wave vibration. [Figure 18] It is a graph showing the correlation between the maximum value of the puncture force and the puncture speed in no - vibration and each vibration. [Figure 19] It is a graph showing the correlation between the total puncture force and the puncture speed in no - vibration and each vibration. [Figure 20] It is a diagram showing the displacement of the second kidney model due to instantaneous single puncture for each puncture acceleration. [Figure 21] In the second kidney model, it is a graph showing the correlation between the displacement of the puncture target and the axial puncture acceleration, and the correlation between the puncture depth and the axial puncture acceleration. [Figure 22] It is a diagram showing the surface displacement of a pig's kidney due to instantaneous single puncture for each puncture acceleration. [Figure 23] In the pig's kidney, it is a box - plot diagram showing the correlation between the surface displacement of the puncture target and the axial puncture acceleration.

Embodiments for Carrying out the Invention

[0017] Hereinafter, an embodiment of the vibrating needle device 1 according to the present invention will be described with reference to the drawings. FIG. 1 is a schematic diagram of the vibrating needle device 1. As shown in Figure 1, the vibrating needle device 1 comprises a needle 10, a vibrating unit 20, a control unit 2, a vibration waveform generation unit 3, an observation unit 4, and a moving device 30. The vibrating needle device 1 is used, for example, as a medical instrument. The vibrating needle device 1 is used, for example, during medical treatment to puncture (correspond to "insertion" in the claim) the needle 10 into the target organ of a patient. In this embodiment, the target organ is described using a human organ such as the kidney, in which the tissue is covered by a membrane.

[0018] Figure 2 is a side view of the needle 10. Figure 3 is an enlarged view of part III of Figure 2. As shown in Figures 2 and 3, the needle 10 is formed from a metal material. The needle 10 has a cylindrical body portion 11 extending in the direction of the first axis C1 (hereinafter simply referred to as the "axial direction"), a tip portion 12 provided at one end of the body portion 11 in the axial direction, and a base portion 13 provided at the other end of the body portion 11 in the axial direction. In the following explanation, the direction perpendicular to the "axial direction" is called the "radial direction," and the direction around the "axial direction" is called the "circumferential direction."

[0019] The axial length of the main body 11 is, for example, 70 mm. The maximum outer diameter of the main body 11 is, for example, 5 mm. The tip portion 12 is integrally molded with the main body portion 11. The tip portion 12 is formed in a conical shape that tapers as it moves axially away from the main body portion 11. The apex angle θ1 of the tip portion 12 is, for example, 40 degrees. The base end portion 13 is integrally molded with the main body portion 11. The base end portion 13 is formed in a cylindrical shape with the same diameter as the maximum outer diameter of the main body portion 11.

[0020] Grooves 15 are formed on the outer circumferential surface 14 of the main body portion 11. Multiple grooves 15 (14 in this embodiment) are formed on the main body portion 11 at intervals of, for example, 3.0 mm in the axial direction from the tip portion 12 to the base portion 13. The grooves 15 are formed around the entire circumference of the main body portion 11 in the circumferential direction. The maximum depth S1 of the grooves 15 is, for example, 0.5 mm. Of the multiple grooves 15, the groove 15 located closest to the base portion 13 is formed at a position of, for example, 39 mm in the axial direction from the tip portion 12 to the base portion 13 on the main body portion 11. The side surface of the groove 15 on the tip portion 12 side is along the radial direction. The side surface of the groove 15 on the base portion 13 side is tapered, inclining radially inward as it moves from the base portion 13 side towards the tip portion 12 side. In a cross-sectional view along the axial direction, the side surface of the groove 15 on the base portion 13 side intersects with the side surface of the groove 15 on the tip portion 12 side at, for example, 60 degrees (angle θ2). The groove has a V-shape when viewed in cross-section along the axial direction.

[0021] Figure 4 is a side view of needle 10A. Figure 5 is an enlarged view of section V in Figure 4. The needle of the present invention is not limited to the needle 10 described above, but may also be a modified needle 10A of the embodiment. As shown in Figures 4 and 5, the grooves 15 of the needle 10A may be formed in multiple locations (for example, 46 grooves) at intervals of, for example, 0.9 mm in the axial direction from the tip portion 12 to the base portion 13. The groove 15 located closest to the base portion 13 among the multiple grooves 15 may be formed at a position of, for example, 40.5 mm in the axial direction from the tip portion 12 to the base portion 13 on the main body portion 11.

[0022] As shown in Figure 1, the vibrating unit 20 vibrates the needle 10 along the axial direction and the direction of a second axis C2 perpendicular to the axial direction. The direction of the second axis C2 coincides with the radial direction. The frequency at which the vibrating unit 20 vibrates the needle 10 is set to, for example, several tens of Hz, corresponding to the natural frequency of the needle 10. As a result, the frequency at which the vibrating unit 20 vibrates the needle 10 resonates with the natural frequency of the needle 10. In addition, when using an ultrasonic device that uses ultrasound vibrating at a frequency of, for example, 20 kHz or higher, interference between the vibrating needle device 1 and the ultrasonic device can be suppressed. The vibrating unit 20 vibrates the needle 10 in the axial and radial directions to produce an arbitrary vibration waveform. The vibrating unit 20 vibrates the needle 10 in both the axial and radial directions to produce a rectangular wave vibration waveform, for example. The vibrating unit 20 includes a support unit 21 and a piezo actuator 22. The support portion 21 is a cylindrical member. The base end portion 13 of the needle 10 is fixed to one end of the support portion 21. The support portion 21 is arranged coaxially with the needle 10. The other end of the support portion 21 is attached to the piezo actuator 22. The piezo actuator 22 vibrates the needle 10 in the axial and radial directions together with the support portion 21. The piezo actuator 22 generates vibrations in response to a voltage input from the control unit 2, which will be described later. The maximum amplitude of the piezo actuator 22 is, for example, 100 μm.

[0023] The control unit 2 is electrically connected to the piezo actuator 22. The control unit 2 applies a voltage to the piezo actuator 22 to cause it to vibrate. A vibration waveform generation unit 3 is electrically connected to the control unit 2. The vibration waveform generation unit 3 inputs a signal to the control unit 2. The signal from the vibration waveform generation unit 3 includes information about the vibration waveform of the voltage applied from the control unit 2 to the piezo actuator 22. The vibration waveform generation unit 3 is, for example, a function generator 3a. The function generator 3a has an input monitor 3b that displays the vibration waveform included in the signal input to the control unit 2. The control unit 2 is electrically connected to the observation unit 4. The observation unit 4 receives a signal from the control unit 2 that includes information about the vibration waveform of the voltage output from the control unit 2 to the piezo actuator 22. The observation unit 4 is, for example, an oscilloscope 4a. The oscilloscope 4a has an output monitor 4b that displays the vibration waveform of the voltage output from the control unit 2 to the piezo actuator 22.

[0024] The moving device 30 moves the needle 10 axially to puncture the target object with the needle 10. The moving device 30 has a mounting part 31, a ball screw 32, and a motor 33. A piezo actuator 22 is attached to the mounting part 31. The ball screw 32 extends axially. The mounting part 31 is attached to the ball screw 32 so as to be movable axially by the rotation of the ball screw 32. The motor 33 is, for example, a DC motor. The motor 33 is the drive source for the ball screw 32. The rotational speed of the motor 33 is, for example, 1400 rpm. The motor 33 is connected to the ball screw 32 by a gearhead 34. The gearhead 34 is a reduction gear. The gearhead 34 transmits the driving force of the motor 33 to the ball screw 32 while reducing its speed. The gearhead 34 can change the speed of the needle 10 attached to the mounting portion 31 in the puncture direction (hereinafter simply referred to as "puncture speed") by changing the gear ratio. The gear ratios of the gearhead 34 are, for example, 150, 75, and 30. The puncture speeds of the needle 10 correspond to the gear ratios of the gearhead 34 of 150, 75, and 30, and are, for example, 311 μm / s, 622 μm / s, and 1556 μm / s, respectively.

[0025] (Method of needle insertion) The following describes the method of needle puncture using the vibrating needle device 1. The method for puncturing with needle 10 comprises a vibration step, a movement step, and a puncture step. (vibration process) The vibration process is a process of vibrating the needle 10 in the axial and radial directions. In the vibration process, a signal is input from the function generator 3a to the control unit 2. The signal from the function generator 3a includes a first signal corresponding to the axial vibration of the needle 10 and a second signal corresponding to the radial vibration of the needle 10. The control unit 2 applies voltages based on the first and second signals to the piezo actuator 22. The piezo actuator 22 vibrates the needle 10 axially based on the first signal. The piezo actuator 22 vibrates the needle 10 radially based on the second signal.

[0026] (Moving process) The movement process involves moving the needle 10 axially while vibrating the needle 10 until the tip 12 of the needle 10 contacts the membrane of the organ. During the movement process, the motor 33 is driven. The driving force of the motor 33 is transmitted to the ball screw 32 via the gearhead 34. This causes the ball screw 32 to rotate. The mounting portion 31 moves axially toward the organ due to the rotation of the ball screw 32. Therefore, the needle 10 moves axially together with the mounting portion 31 in a vibrating state until it contacts the membrane of the organ. (Puncture process) The puncture process involves inserting the needle 10 into an organ while it is being vibrated. In the puncture process, the needle 10 is vibrated while being inserted into the organ. The tip 12 repeatedly presses against the membrane, alternating between contact and non-contact. The tip 12 then penetrates and passes through the membrane. The needle 10 punctures the tissue inside the organ while pressing against the membrane in contact with the needle 10. The membrane then recovers due to its elasticity. Tissue enters the groove 15 of the needle 10. The tissue recovers by entering the groove 15 due to its elasticity. The needle 10 then penetrates into the tissue. In this manner, the needle 10 punctures the organ.

[0027] (Experimental results regarding the vibrating needle device) The following describes the experimental results regarding the vibrating needle device 1. Figure 6 is a side view of the needle 10B without the groove 15. As shown in Figure 6, needle 10B differs from needles 10 and 10A in that a groove is not provided on the outer circumferential surface 14 of the main body 11. Experiments 1 to 5 were then conducted using needles 10, 10A, and 10B to address the vibrating needle device 1.

[0028] As shown in Figure 1, a kidney model 40 was prepared as the target for puncture with needles 10, 10A, and 10B. The kidney model 40 has an agar gel 42 and a silicone rubber 43. The kidney model 40 corresponds to an organ. The agar gel 42 is in a solidified state and fills a weighing dish 41. The concentration of the agar gel 42 is 2.0%. The agar gel 42 corresponds to the tissue inside the organ. The silicone rubber 43 covers the agar gel 42. The silicone rubber 43 is fixed to the agar gel 42 by means of, for example, a clip (not shown). The silicone rubber 43 corresponds to the membrane of the organ.

[0029] The vibrating needle device 1 was installed so that the axial directions of the needles 10, 10A, and 10B were aligned with the vertical direction of gravity. The kidney model 40 was placed at a position spaced below the tips 12 of the needles 10, 10A, and 10B. The silicone rubber 43 of the kidney model 40 is positioned on the tip 12 side. The kidney model 40 was placed on the electronic balance 5. This made it possible to measure the puncture force of the needles 10, 10A, and 10B when they puncture the kidney model 40.

[0030] (Experiment 1) Experiment 1 was conducted to confirm the relationship between the prepared kidney model 40 and the puncture force. Specifically, Experiment 1 was performed multiple times under the following conditions: The needle 10B was punctured into the kidney model 40 without vibration. The puncture speed of the needle 10B was 311 μm / s. Figure 7 is a graph showing the change in puncture force. In Figure 7, the vertical axis represents puncture force [gf], and the horizontal axis represents the time [s] it takes for needle 10B to puncture the kidney model 40. Figure 7 shows the results of multiple trials. As can be seen from the graph in Figure 7, the puncture force increases over time, reaching a primary peak P1. The primary peak P1 occurs in the range of 10s to 25s. The puncture force at the primary peak P1 is approximately 100gf to 400gf. The puncture force decreases after the primary peak P1. Subsequently, the puncture force increases again over time, reaching a secondary peak P2. The puncture force is at its maximum value at the secondary peak P2. After the secondary peak P2, the puncture force decreases again. The secondary peak P2 occurs in the range of 30s to 45s. The puncture force at the secondary peak P2 is approximately 400gf to 900gf. Subsequently, the puncture force reaches the stable zone P3. The rate of change of the puncture force in the stable zone P3 is smaller with respect to time compared to the rate of change until the secondary peak P2 is reached. The stable zone P3 occurs after 45 seconds. The puncture force in the stable zone P3 is approximately 100 gf to 300 gf.

[0031] (Experiment 2) Experiment 2 was conducted to confirm the relationship between the type of vibration and the puncture force. Figure 8 is a graph showing the results of Experiment 2, comparing the primary peak P1 of the puncture force in each vibration. Figure 9 is a graph showing the results of Experiment 2, comparing the secondary peak P2 of the puncture force in each vibration. Figure 10 is a graph showing the results of Experiment 2, comparing the stable region P3 of the puncture force for each vibration. Experiment 2 differs from Experiment 1 in that the needle 10B was vibrated in the axial direction. The change in puncture force was measured when the needle 10B was vibrated in a sine wave pattern (sin wave), when the needle 10B was vibrated in a sawtooth pattern (ramp wave), when the needle 10B was vibrated in an inverse sawtooth pattern (inverse ramp wave), and when the needle 10B was vibrated in a square wave pattern (square wave). A sine wave vibration has a frequency of 10 Hz and an amplitude of 100 μm. A sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm. An inverse sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm. A square wave vibration has a frequency of 10 Hz and an amplitude of 100 μm.

[0032] The primary peak P1, secondary peak P2, and stable region P3 of the puncture force were compared when needle 10B was inserted without vibration (no vibration) with each vibration. Figures 8 to 10 compare the primary peak P1, secondary peak P2, and stable region P3 when needle 10B is used for puncture without vibration and when needle 10B is used for puncture with axial vibration. In Figure 10, the stable region P3 is compared using the cumulative value from 50s to 60s. Figures 8 to 10 show the values ​​[gf] of the primary peak P1, secondary peak P2, and stable region P3 on the vertical axis, and the experimental conditions (vibration state) on the horizontal axis.

[0033] As can be seen from the graphs in Figures 8 to 10, the primary peak P1, secondary peak P2, and stable region P3 when the needle 10B is vibrated in a sawtooth, reverse sawtooth, and rectangular wave pattern during puncture are reduced compared to the primary peak P1, secondary peak P2, and stable region P3 when the needle 10B is not vibrated during puncture. When needle 10B was vibrated sinusoidally during puncture, the primary peak P1 and stable region P3 were increased compared to when needle 10B was not vibrated during puncture. The secondary peak P2 when needle 10B was vibrated sinusoidally during puncture was only slightly decreased compared to the secondary peak P2 when needle 10B was not vibrated during puncture.

[0034] Based on the above, it can be said that when the needle 10B is vibrated in a sawtooth, reverse sawtooth, or rectangular wave pattern during puncture, the puncture force can be reduced compared to when the needle 10B is not vibrated or when the needle 10B is vibrated in a sine wave pattern during puncture (hereinafter simply referred to as the "puncture force reduction effect by vibration").

[0035] (Experiment 3) Experiment 3 was conducted to confirm the relationship between groove 15, the type of vibration, and the puncture force. Figure 11 is a graph showing the results of Experiment 3, comparing the stable range P3 of the puncture force for each needle (10, 10A, 10B) and each vibration. Experiment 3 differs from Experiment 1 in that needles 10 and 10A were vibrated axially before puncturing the kidney model 40. Needle 10 has multiple grooves 15 formed on its outer surface 14 at intervals of 3.0 mm. Needle 10A has multiple grooves 15 formed on its outer surface 14 at intervals of 0.9 mm. The change in puncture force was measured when needle 10 was vibrated in an inverse sawtooth pattern (Grooved needle(coarse) / Inverse ramp wave), when needle 10 was vibrated in a sine wave pattern (Grooved needle(coarse) / Sin wave), when needle 10A was vibrated in an inverse sawtooth pattern (Grooved needle(fine) / Inverse ramp wave), and when needle 10A was vibrated in a sine wave pattern (Grooved needle(fine) / Sin wave). The sinusoidal vibration has a frequency of 10 Hz and an amplitude of 100 μm. The inverse sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm.

[0036] We compared the puncture force stability range P3 with that obtained when needle 10B was inserted without vibration (Normal needle / No vibration) and with that obtained with each vibration. Figure 11 compares the stability zone P3 as an integrated value from 50s to 60s when puncture is performed with needle 10B without vibration and when puncture is performed with needles 10 and 10A vibrated axially. Figure 11 shows the value of the stable region P3 [gf] on the vertical axis and the experimental conditions (groove / vibration state) on the horizontal axis.

[0037] As can be seen from the graph in Figure 11, the puncture force when needles 10 and 10A are vibrated is reduced compared to the puncture force when needle 10B is not vibrated. The puncture force when needle 10A is vibrated is reduced compared to the puncture force when needle 10 is vibrated. In particular, the puncture force is reduced the most when needle 10A is vibrated in a reverse sawtooth pattern compared to other cases. Based on the above, it can be said that the effect of vibration in reducing puncture force is amplified by the groove 15.

[0038] (Experiment 4) Experiment 4 was conducted to confirm the relationship between puncture force and puncture velocity in each vibration in one direction (axial direction). Figure 12 is a graph showing the results of Experiment 4, which illustrates the correlation between the secondary peak P2 of the puncture force and the puncture velocity in each vibration. Figure 13 is a graph showing the results of Experiment 4, which illustrates the correlation between the puncture force in each vibration, accumulated from 0s to 60s (hereinafter simply referred to as "total puncture force"), and the puncture speed. Experiment 4 differs from Experiment 1 in that the needle 10B was vibrated axially before puncturing the kidney model 40. Specifically, Experiment 4 was conducted under the following conditions. Conditions common to Experiment 1 described above will be omitted from explanation as appropriate. In Experiment 4, only needle 10B was used. In Experiment 4, the time change of puncture force was measured using the same method as in Experiment 1 described above. The puncture speed of needle 10B was changed to 311 μm / s, 622 μm / s, and 1556 μm / s, and the time change of puncture force was measured at each puncture speed. When the puncture speed was 311 μm / s, the motor 33 was driven for 60 seconds. When the puncture speed was 622 μm / s, the motor 33 was driven for 30 seconds. When the puncture speed was 1556 μm / s, the motor 33 was driven for 15 seconds. At each puncture speed, the secondary peak P2 of the puncture force and the total puncture force were measured, and the secondary peak P2 and total puncture force were compared.

[0039] Experiment 4 described above was performed when needle 10B was vibrated in a sinusoidal wave pattern in the axial direction (sin wave) and when needle 10B was vibrated in a square wave pattern in the axial direction (square wave). A sine wave vibration has a frequency of 10 Hz and an amplitude of 100 μm. A square wave vibration also has a frequency of 10 Hz and an amplitude of 100 μm. The secondary peak P2 and total puncture force were compared when needle 10B was used without vibration (no vibration) and when it was used with each vibration.

[0040] Figures 12 and 13 show the values ​​of the secondary peak P2 and total puncture force [gf] on the vertical axis, and the puncture speed [mm / s] on the horizontal axis. As can be seen from the graph in Figure 12, the secondary peak P2 of the puncture force tends to increase with increasing puncture speed, regardless of whether or not the needle 10B is vibrated. The difference in the secondary peak P2 of the puncture force between puncture with and without vibrating the needle 10B decreases with increasing puncture speed. As can be seen from the graph in Figure 13, the total puncture force decreases inversely proportional to the puncture speed, regardless of whether or not the needle 10B is vibrated. However, the difference in total puncture force between puncturing with and without vibrating the needle 10B decreases as the puncture speed increases. Based on the above, it can be said that the effect of vibration on reducing puncture force decreases as the puncture speed increases when the needle 10B is vibrating in only one direction (axial direction).

[0041] (Experiment 5) Experiment 5 was conducted to confirm the relationship between puncture force and puncture velocity in two directions (axial and radial). Figure 14 is a graph showing the results of Experiment 5, illustrating the correlation between the secondary peak P2 in two-directional vibration and the puncture velocity. Figure 15 is a graph showing the results of Experiment 5, illustrating the correlation between total puncture force and puncture velocity in two-directional vibration. Experiment 5 was conducted using the same method as Experiment 4 described above. Experiment 5 differed from Experiment 4 in that the needle 10B was vibrated radially as well as axially to puncture the kidney model 40. Specifically, Experiment 5 was conducted under the following conditions. Below, explanations of conditions common to Experiment 4 described above will be omitted as appropriate. Experiment 5 was conducted when needle 10B was vibrated in a rectangular wave pattern in both the axial and radial directions during puncture (square + square). The axial vibration had a frequency of 10 Hz and an amplitude of 100 μm. The radial vibration had a frequency of 10 Hz and an amplitude of 60 μm. The axial and radial vibrations were out of phase by π / 2. As a result, needle 10B vibrated by repeatedly moving and stopping in a square shape when viewed from the radial direction. The secondary peak P2 and total puncture force were compared when needle 10B was used without vibration (no vibration) and when it was used with each vibration.

[0042] Figures 14 and 15 show the values ​​of the secondary peak P2 and total puncture force [gf] on the vertical axis, and the puncture speed [mm / s] on the horizontal axis. As can be seen from the graph in Figure 14, when needle 10B is used for puncture without vibration, the secondary peak P2 of the puncture force increases with increasing puncture speed. In contrast, when needle 10B is used for puncture with vibration in two directions, the secondary peak P2 of the puncture force tends to be relatively independent of the puncture speed. As can be seen from the graph in Figure 15, the total puncture force decreases inversely proportional to the puncture speed, regardless of whether or not the needle 10B vibrates. The total puncture force is reduced at each puncture speed. The rate of reduction in total puncture force remains constant and does not depend on the puncture speed. Based on the above, it can be said that the effect of vibration on reducing puncture force is constant and independent of the puncture speed when the needle 10B is vibrating in two directions (axial and radial).

[0043] In addition to experiments 1 through 5 described above, experiments 6 through 8 were also conducted. In the following, explanations of conditions common to Experiments 1 through 5 described above will be omitted as appropriate. Experiments 6 to 8 used needles (not shown) that did not have grooves on their outer surface 14, similar to needle 10B described above. It should be noted that the needles of the present invention are not limited to needles 10 and 10A described above, and may also be needles without grooves, such as those used in Experiments 6 to 8.

[0044] In addition to the kidney model 40 described above, a pig kidney and a second kidney model different from the kidney model 40 described above were used as subjects for needle puncture. The pig kidneys used were fresh, collected early in the morning on the day of the experiment. Therefore, the experiment could be conducted with a film still formed on the surface of the pig kidneys. The second kidney model consists of a spherical collagen casing and an agar gel. The outer diameter of the collagen casing is 17 mm. The inside of the collagen casing is hollow. The agar gel is filled inside the collagen casing. The concentration of the agar gel is 2.0%. The second kidney model was suspended in a 50 mm cubic container filled with a 3.0% mass sodium chloride aqueous solution to simulate the movement of a kidney in body tissue.

[0045] The pig kidney and second kidney models are placed on the electronic balance 5, similar to the kidney model 40. A needle is inserted vertically downwards from above into the pig kidney and second kidney models placed on the electronic balance 5. This makes it possible to measure the puncture force of the needle as it penetrates the pig kidney and second kidney models.

[0046] (Experiment 6) Experiment 6 was conducted to investigate the effects of axial and radial vibrations on puncture force at low frequencies between 5 Hz and 15 Hz. In Experiment 6, a pig kidney was selected as the target for puncture. A needle with an outer diameter of 1.5 mm was used in Experiment 6. The needle puncture speed was 311 μm / s. The needle was inserted axially from a position where the tip of the needle was in contact with the target. Experiment 6 was performed under two conditions: puncture without needle vibration (No vibration) and puncture with the needle vibrated in a rectangular wave pattern in both the axial and radial directions (Biaxial square waves). The axial vibration and radial vibration were out of phase by π / 2. The axial vibration had a frequency of 10 Hz and an amplitude of 100 μm. The radial vibration had a frequency of 10 Hz and an amplitude of 60 μm.

[0047] Figure 16 is a graph showing the results of Experiment 6, illustrating the correlation between puncture force and needle displacement under both vibration-free and bidirectional vibration conditions. In Figure 16, the vertical axis represents puncture force [gf] and the horizontal axis represents needle displacement [mm]. Graph G1 represents the case where the needle was not vibrated, and graph G2 represents the case where the needle was vibrated in a rectangular wave pattern in both the axial and radial directions during puncture. As can be seen from the graph in Figure 16, in the two cases described above, the puncture force increased as the needle displacement increased, and tended to be maximum in the range of needle displacement between 9 mm and 18 mm. The maximum puncture force is caused by the elastic deformation of the membrane of the pig kidney. Furthermore, it was confirmed that vibrating the needle in a rectangular wave pattern in both the axial and radial directions during puncture reduced the puncture force for all needle displacements compared to puncture without needle vibration.

[0048] Next, Experiment 6 was repeated seven or more times (sample size n≧7), and box plots were created for both cases: when the needle was not vibrated during puncture, and when the needle was vibrated in a rectangular wave pattern in both the axial and radial directions during puncture. The created box plots are shown in Figure 17.

[0049] Figure 17 is a graph showing the results of Experiment 6, a box plot comparing the maximum puncture force under no vibration and square wave vibration conditions. In Figure 17, the vertical axis represents the maximum puncture force [gf], and the horizontal axis represents the experimental conditions (vibration state). The upper end of the line segment passing through the box represents the maximum value, and the lower end represents the minimum value. The bottom edge, top edge, and the line segment between the bottom and top edges of the box represent the first, third, and second quartile lines, respectively, while the "x" mark inside the box represents the mean value.

[0050] As can be seen from Figure 17, there was no significant difference in variability between puncturing with a needle vibrated in a rectangular wave pattern in both the axial and radial directions and puncturing without vibrating the needle. However, when comparing the average values, the maximum puncture force was reduced in the former case than in the latter. By performing a Student's t-test, it was confirmed that the p-value was below the significance level, even at a small significance level of 0.01. In other words, a significant difference was observed between the mean values ​​of the former and the latter. Therefore, the result that the former was able to reduce puncture force compared to the latter was an inevitable consequence.

[0051] The only difference between the former and the latter conditions is the presence or absence of needle vibration. Considering this point, it is thought that vibrating the needle in a rectangular wave pattern in two directions, axially and radially, can reduce the puncture force compared to puncturing without needle vibration.

[0052] (Experiment 7) Experiment 7 was conducted to investigate the effect of needle vibration on the relationship between puncture force and puncture speed at frequencies between 5 Hz and 15 Hz. Experiment 7 was conducted using the same needle and method as Experiment 6 described above. Therefore, in Experiment 7, when the needle was vibrated during puncture, the vibration frequency of the needle was 10 Hz. Experiment 7 differs from Experiment 6 in that measurements were taken not only when the needle puncture speed was 311 μm / s, but also when the needle puncture speed was 622 μm / s and 1556 μm / s, and a kidney model 40 was used as the target of puncture. The thickness of the silicone rubber 43 of the kidney model 40 in Experiment 7 was between 600 mm and 700 mm.

[0053] Figure 18 is a graph showing the results of Experiment 7, illustrating the correlation between the maximum puncture force and the puncture speed in the vibration-free and vibration-dependent states. In Figure 18, the vertical axis represents the maximum puncture force [gf] and the horizontal axis represents the puncture speed [mm / s]. In Figure 18, vibration-free states are labeled "No vibration," axial-only rectangular wave vibrations are labeled "Axial square wave," radial-only rectangular wave vibrations are labeled "Lateral square wave," and biaxial square wave vibrations in both axial and radial directions are labeled "Biaxial square waves."

[0054] As can be seen from Figure 18, when the needle was vibrated in at least one of the axial and radial directions, it was confirmed that the maximum puncture force was reduced at all puncture speeds compared to the case without vibration. From this, it is thought that by vibrating the needle in at least one direction, both axially and radially, at a frequency between 5 Hz and 15 Hz, the maximum puncture force can be reduced regardless of the puncture speed.

[0055] Furthermore, it was confirmed that the maximum puncture force increased as the puncture speed increased when comparing the case with no vibration and when the needle was vibrated in either the axial or radial direction only. In contrast, when the needle was vibrated in both the axial and radial directions, it was confirmed that the maximum puncture force remained constant in the range of approximately 500 gf to 600 gf at all puncture speeds. From this, it is thought that by vibrating the needle in two directions, axially and radially, at a frequency between 5 Hz and 15 Hz, the maximum puncture force can be maintained within a certain range, regardless of the puncture speed.

[0056] Figure 19 is a graph showing the results of Experiment 7, illustrating the correlation between total puncture force and puncture speed under both vibration-free and vibration-dependent conditions. In Figure 19, the vertical axis represents total puncture force [104 gf·s] and the horizontal axis represents puncture speed [mm / s]. In Experiment 7, total puncture force is the cumulative value of the total puncture force applied to the object during needle puncture.

[0057] As can be seen from Figure 19, it was confirmed that the total puncture force decreases as the puncture speed increases when comparing the case without vibration with the case where the needle is vibrated in at least one of the axial and radial directions. Furthermore, when the needle was vibrated in either the axial or radial direction only, it was confirmed that the rate of reduction in total puncture force decreased as the puncture speed increased. In contrast, when the needle was vibrated in both the axial and radial directions, it was confirmed that the total puncture force decreased at a constant rate as the puncture speed increased. From this, it is thought that by vibrating the needle in two directions, axially and radially, at a frequency between 5 Hz and 15 Hz, the total puncture force can be reduced by a constant percentage, regardless of the puncture speed.

[0058] Experiment 7 confirmed the effect of reducing puncture force by vibrating the needle at low frequencies between 5 Hz and 15 Hz. Furthermore, it was confirmed that vibrating the needle in both axial and radial directions allowed for a greater reduction in puncture force while maintaining a consistent level of reduction, compared to vibrating the needle in only one direction (axial or radial).

[0059] (Experiment 8) Experiment 8 was conducted to examine the effect of needle acceleration on puncture accuracy. In Experiment 8, a needle with an outer diameter of 1.5 mm and a length of 150 mm was used. With the tip of the needle in contact with the target for puncture, the needle was inserted with a 10 mm stroke in the axial direction. Furthermore, instantaneous single punctures were performed by accelerating the needle in the axial direction. The acceleration of the needle in the direction of puncture (axial direction) (hereinafter simply referred to as "puncture acceleration") was varied in the range of 0 m / s² to approximately 110 m / s², and the displacement of the target and the puncture depth were measured for each puncture acceleration. Both a second kidney model and a pig kidney were used as the target for puncture.

[0060] First, the second kidney model was selected as the target for puncture, and Experiment 8 described above was performed. The needle insertion speed was set to 311 μm / s. The results of Experiment 8 using the second kidney model are shown in Figures 20 and 21.

[0061] Figure 20 shows the results of Experiment 8, illustrating the displacement of the second kidney model due to a single, instantaneous puncture for each puncture acceleration. In Figure 20, the needle and the second kidney model after puncture are shown from left to right in order of increasing puncture acceleration: 0 m / s² (when punctured at a constant speed), 6.38 m / s², 18.3 m / s², 30.0 m / s², 40.7 m / s², 65.9 m / s², and 102 m / s². Note that only the second figure from the left in Figure 20 (when the puncture acceleration is 6.38 m / s²) also shows the afterimage of the second kidney model moving due to the puncture.

[0062] As can be seen from Figure 20, when the puncture acceleration was 0 m / s², the needle did not rupture the collagen casing, and the second kidney model sank by the amount of needle displacement while the tip of the needle remained in contact with the collagen casing. In contrast, when puncture acceleration was applied to the needle, the needle ruptured the collagen casing, and the kidney model sank as the needle penetrated into the interior of the second kidney model. As the puncture acceleration increased, the displacement of the second kidney model, which was the target of the puncture, was suppressed, and the needle penetration depth increased. To quantitatively analyze the results shown in Figure 20, the data shown in Figure 21 was obtained.

[0063] Figure 21 is a graph showing the results of Experiment 8, illustrating the correlation between the displacement of the puncture target (labeled "Object displacement" in the figure) and the axial puncture acceleration, as well as the correlation between the puncture depth (labeled "Puncture depth" in the figure) and the axial puncture acceleration in the second kidney model. The displacement of the puncture target refers to the distance the second kidney model moved downward from its initial position due to needle insertion, and the puncture depth refers to the actual length of the puncture target with a 10 mm stroke. In Figure 21, the vertical axis represents the displacement of the puncture target and the puncture depth [mm], and the horizontal axis represents the puncture acceleration [m / s²].

[0064] As can be seen from Figure 21, in the second kidney model, as the axial puncture acceleration increased, the displacement of the puncture target decreased, and the slope of the decrease in the displacement of the puncture target gradually decreased. When the puncture acceleration was 60 m / s² or higher, the displacement of the puncture target became almost constant at around 1 mm, confirming that the puncture target hardly moved due to needle insertion.

[0065] Furthermore, in the second kidney model, as the axial puncture acceleration increased, the puncture depth increased, and the slope of the increase in puncture depth gradually decreased. When the puncture acceleration was 80 m / s² or higher, the puncture depth remained almost constant at around 8 mm, and it was confirmed that at least 80% of the length of a 10 mm stroke was punctured.

[0066] In Experiment 8, using a second kidney model, a shallow puncture depth for a 10 mm stroke was considered low puncture accuracy, while a deep puncture depth was considered high puncture accuracy. In other words, "puncture depth for a 10 mm stroke" was used as an indicator of puncture accuracy. According to this indicator of puncture accuracy, as the puncture acceleration increases, the movement of the puncture target decreases, and puncture accuracy improves. Furthermore, at puncture accelerations of 80 m / s² or higher, the movement of the puncture target is suppressed to about 1 mm, and puncture accuracy improves to the point where the ratio of puncture depth to stroke approaches 100%.

[0067] Next, we selected a pig kidney as the target for puncture and performed Experiment 8 described above. We also changed the needle puncture speed to 3.0 mm / s. The results of Experiment 8 using a pig kidney are shown in Figures 22 and 23.

[0068] Figure 22 shows the results of Experiment 8, illustrating the surface displacement of a pig kidney due to a single, instantaneous puncture at different puncture accelerations. In Figure 22, the surface of the needle and the pig kidney before and after puncture are shown from left to right in order of increasing puncture acceleration: 0 m / s² (when punctured at a constant speed), 48.4 m / s², and 110 m / s². In Figure 22, the state before puncture is shown at the top, and the state after puncture is shown at the bottom. As can be seen from Figure 22, when the puncture acceleration was 0 m / s², the needle did not rupture the membrane of the pig kidney, and the membrane deformed in the direction of puncture only by the displacement of the needle while the tip of the needle remained in contact with the membrane. In contrast, when puncture acceleration was applied to the needle, the needle ruptured the membrane of the pig kidney, and the membrane deformed in the direction of puncture as the needle penetrated into the inside of the pig kidney. As the puncture acceleration increased, the surface displacement of the pig kidney being punctured was suppressed. To quantitatively analyze the results shown in Figure 22, the data shown in Figure 23 was obtained.

[0069] Figure 23 is a graph showing the results of Experiment 8, a box plot diagram illustrating the correlation between the surface displacement of the puncture target and the axial puncture acceleration in a pig kidney. The surface displacement of the puncture target refers to the distance the membrane of the pig kidney moved downward from its initial position due to needle puncture. Figure 23 is a box plot diagram created using the same method as in Figure 17, with a sample size n > 7. In Figure 23, the vertical axis is set to "Surface displacement of the puncture target for a 10 mm stroke" [mm] / 10 [mm], and the horizontal axis is set to the experimental conditions (puncture acceleration).

[0070] In Experiment 8, which used pig kidneys, a large surface displacement of the puncture target for a 10 mm stroke was considered indicative of low puncture accuracy, while a small surface displacement was considered indicative of high puncture accuracy. In other words, "surface displacement of the puncture target for a 10 mm stroke" was used as an indicator of puncture accuracy.

[0071] As can be seen from Figure 23, there was no significant difference in variability between puncture at a constant speed (puncture acceleration of 0 m / s²), puncture acceleration of 48.4 m / s², and puncture acceleration of 110 m / s². In contrast, when comparing the average values, the index of puncture accuracy decreased as the puncture acceleration increased. In other words, it can be said that puncture accuracy improved as the puncture acceleration increased. Furthermore, by performing a Student's t-test, it was confirmed that the p-value was below the significance level even when the significance level was as small as 0.01. In other words, significant differences were observed between the average value when puncturing at a constant speed and the average value when the puncture acceleration was 48.4 m / s², and between the average value when puncturing at a constant speed and the average value when the puncture acceleration was 110 m / s². Therefore, the result that puncture accuracy improved as the puncture acceleration increased was an inevitable consequence.

[0072] The only difference in the conditions across the three cases shown in Figure 23 is the difference in puncture acceleration. Considering this, it is thought that increasing puncture acceleration can improve puncture accuracy.

[0073] Experiment 8 confirmed that increasing the axial puncture acceleration during a single puncture improves puncture accuracy, regardless of whether the puncture target is a second kidney model or a pig kidney. Here, the higher the puncture acceleration, the more this single puncture approximates a single puncture with rectangular wave oscillation. This rectangular wave oscillation can be considered as a low-frequency oscillation between 5 Hz and 15 Hz in the axial direction. In other words, from the results of Experiment 8, it is considered that puncture accuracy can be improved by making the vibration waveform of the needle rectangular when the needle is vibrated axially at a low frequency between 5 Hz and 15 Hz.

[0074] Furthermore, in Experiment 8, if we approximate a single puncture as a single puncture using rectangular wave vibration, a 10 mm stroke can be considered to be the amplitude of the rectangular wave vibration. In other words, even with a relatively large amplitude of about 10 mm, it can be said that puncture accuracy can be improved by making the vibration waveform of the needle rectangular.

[0075] In experiments 6 through 8 described above, the frequency of the needle vibration was set to 10 Hz, but similar results were obtained when the needle vibration frequency was set to 5 Hz and 15 Hz.

[0076] According to the above-described embodiment, the following actions and effects can be obtained. The vibrating needle device 1 includes a vibrating unit 20 that vibrates the needle 10 along the axial and radial directions. With this configuration, the needle 10 can be vibrated axially and radially by the vibrating unit 20 while the needle 10 is inserted into an organ. The tip 12 of the needle 10 passes through the organ membrane while repeatedly alternating between contact and non-contact with the membrane. This reduces the puncture resistance when the tip 12 passes through the membrane compared to when the needle 10 is inserted into an organ without vibrating the needle 10. Therefore, the puncture force required for the tip 12 to pass through the membrane can be reduced. As a result, the time it takes for the tip 12 to pass through the membrane after contact can be shortened. After the needle 10 passes through the organ membrane, the needle 10 is vibrated as it penetrates the tissue inside the organ. As a result, the needle 10 penetrates the tissue while repeatedly alternating between contact and non-contact with the membrane. Consequently, the membrane, which is pressed toward the tissue by the needle 10, recovers due to elastic force when it is not in contact with the needle 10. Therefore, compared to penetrating the organ without vibrating the needle 10, the puncture resistance when the needle 10 penetrates the tissue can be reduced. Thus, the puncture force required for the needle 10 to penetrate the tissue can be reduced. The needle 10 penetrates the tissue inside the organ while vibrating. Therefore, the needle 10 penetrates the tissue while repeatedly alternating between contact and non-contact. As a result, the tissue compressed by the needle 10 recovers due to elastic force when it is not in contact with the needle 10. Thus, compared to penetrating an organ without vibrating the needle 10, the puncture resistance when the needle 10 penetrates the tissue can be reduced. Consequently, the puncture force required for the needle 10 to penetrate the tissue can be reduced.

[0077] The vibrating unit 20 vibrates the needle 10 along the axial direction and the radial direction intersecting the axial direction. With this configuration, the needle 10 can puncture the organ while widening the hole it has made in the organ in both the axial and radial directions. As a result, compared to when the needle 10 is vibrated in only one direction, the puncture force required for the needle 10 to pass through the organ membrane and the puncture force required for the needle 10 to penetrate the tissue inside the organ can be reduced.

[0078] A groove 15 is formed on the outer circumferential surface 14 of the main body 11 of the needle 10, extending around its entire circumference. In this configuration, the portion of the tissue pressed by the needle 10 enters the groove 15. This causes the needle 10 to catch on the tissue, preventing it from being pushed out of the organ by the tissue's elastic force. Therefore, it is possible to prevent the organ from moving due to the resistance force from the needle 10. The portion of the tissue compressed by the needle 10 punctures into the groove 15, thereby reducing the elastic force of the tissue acting on the outer surface 14 of the needle 10. Consequently, the puncture force required for the needle 10 to penetrate the inside of the organ can be reduced.

[0079] As described above, the puncture force required for the needle 10 to penetrate the organ membrane and the puncture force required for the needle 10 to penetrate the inside of the organ can be reduced. This suppresses the movement of organs that are not completely fixed in the body along with the movement of the needle, so the needle can be easily inserted into the organ. Therefore, it is possible to accurately puncture the target area of ​​the organ, such as lesion tissue in the organ.

[0080] The side surface of the needle 10 on the base end 13 side in the groove 15 is inclined radially inward, perpendicular to the axial direction, as it moves from the base end 13 side toward the tip end 12 side. With this configuration, when inserting the needle 10 into an organ from the axial direction, the needle 10 can be inserted into the organ while gradually expanding it radially. This allows the needle 10 to be inserted into the organ smoothly.

[0081] The vibrating unit 20 vibrates the needle 10 in the axial and radial directions so that it produces a rectangular wave-shaped vibration waveform. With this configuration, the acceleration of the needle 10 in the puncture direction (hereinafter simply referred to as "puncture acceleration") can be increased compared to the case where the needle 10 is vibrated with a vibration waveform whose amplitude changes slowly, such as a sine wave. As a result, the load that the needle 10 applies to the membrane can be increased, so that the tip 12 of the needle 10 can easily pass through the membrane. Therefore, the puncture force required for the tip 12 to pass through the membrane can be further reduced. As a result, the time it takes from when the tip 12 of the needle 10 contacts the membrane until it passes through the membrane can be shortened. When the needle 10 vibrates with a rectangular wave-shaped vibration waveform, the puncture acceleration can be increased compared to when the needle 10 vibrates with a vibration waveform that changes amplitude gradually. This increases the load that the needle 10 applies to the organ membrane, so that after the needle 10 passes through the membrane, the vibration of the needle 10 can more reliably separate the membrane that was in contact with the needle 10 from the needle 10. Therefore, the membrane that has been pressed toward the tissue by the needle 10 can recover more quickly due to elastic force when it is not in contact with the needle 10. Consequently, the puncture resistance when the needle 10 penetrates the tissue can be further reduced. This further reduces the puncture force required for the needle 10 to penetrate the tissue. As a result, the time it takes for the membrane that has been pressed toward the tissue by the needle 10 to return to its original position can be further shortened. When the needle 10 vibrates with a rectangular wave-shaped vibration waveform, the puncture acceleration can be increased compared to when the needle 10 vibrates with a vibration waveform that changes amplitude gradually. This increases the load that the vibration of the needle 10 exerts on the tissue inside the organ, so that after the needle 10 is restored, the tissue that was in contact with the needle 10 due to the vibration can be more reliably separated from the needle 10. Therefore, the tissue that has been pressed by the needle 10 can be restored more reliably by elastic force when it is not in contact with the needle 10. Consequently, the puncture resistance when the needle 10 penetrates the tissue can be further reduced. This further reduces the puncture force required for the needle 10 to penetrate the tissue.

[0082] The frequency at which the vibrating unit 20 vibrates the needle 10 is set to resonate with the natural frequency of the needle 10. With this configuration, the frequency at which the vibrating unit 20 vibrates the needle 10 can be set to a larger amplitude compared to the case where the frequency is set without resonating with the natural frequency of the needle 10. As a result, even in situations where the vibration of the needle 10 is limited, the amplitude of the vibration of the needle 10 can be controlled by changing the vibration setting of the vibrating unit 20. Therefore, the puncture force reduction effect of the vibrating needle device 1 can be maintained.

[0083] The first axis C1 and the second axis C2, which are the axes of the needle's vibration direction, are orthogonal to each other. This configuration allows the needle 10 to be vibrated in two orthogonal directions while puncturing an organ. This allows the needle 10 to be inserted while significantly expanding the organ, compared to when the needle 10 is vibrated in two intersecting directions rather than orthogonally. Therefore, the puncture force required for the needle 10 to pass through the organ membrane and the puncture force required for the needle 10 to penetrate the tissue inside the organ can be reduced.

[0084] The needle 10 puncture method comprises a vibration step of vibrating the needle 10 in the axial and radial directions, and an insertion step of inserting the needle 10 into an organ while the needle 10 is vibrating. With this configuration, the needle 10 can be vibrated axially and radially by the vibrating unit 20 while puncturing an organ. The tip 12 of the needle 10 passes through the organ membrane while repeatedly alternating between contact and non-contact with the membrane. This reduces the puncture resistance when the tip 12 passes through the membrane compared to when the needle 10 is punctured without vibration. Therefore, the puncture force required for the tip 12 to pass through the membrane can be reduced. As a result, the time it takes for the tip 12 to pass through the membrane after contact can be shortened. After the needle 10 passes through the organ membrane, it punctures the tissue inside the organ while vibrating. As a result, the needle 10 repeatedly enters the tissue while in contact with and not in contact with the membrane. Consequently, the membrane, which has been pressed toward the tissue by the needle 10, returns to its original position due to elastic force when it is not in contact with the needle 10. Therefore, compared to puncturing the organ without vibrating the needle 10, the puncture resistance when the needle 10 penetrates the tissue can be reduced. Thus, the puncture force required for the needle 10 to penetrate the tissue can be reduced. As a result, the time it takes for the membrane, which has been pressed toward the tissue by the needle 10, to return to its original position can be shortened. The needle 10 penetrates the tissue inside the organ while vibrating. As a result, the needle 10 penetrates the tissue while repeatedly alternating between contact and non-contact. Consequently, the tissue compressed by the needle 10 recovers due to elastic force when it is not in contact with the needle 10. Therefore, compared to puncturing the organ without vibrating the needle 10, the puncture resistance when the needle 10 penetrates the tissue can be reduced. Thus, the puncture force required for the needle 10 to penetrate the tissue can be reduced.

[0085] In the vibration process, the needle 10 is vibrated along the axial direction and the radial direction intersecting the axial direction. With this configuration, the needle 10 can puncture the organ while widening the hole it has made in the organ in both the axial and radial directions. As a result, compared to when the needle 10 is vibrated in only one direction, the puncture force required for the needle 10 to pass through the organ membrane and the puncture force required for the needle 10 to penetrate the tissue inside the organ can be reduced.

[0086] The vibrating needle device 1 includes a vibrating unit 20 that vibrates the needle at a low frequency of 5 Hz to 15 Hz along at least one of the axial and radial directions. This configuration confirmed that vibrating the needle at a low frequency of 5 Hz to 15 Hz along at least one of the axial and radial directions reduces the puncture force applied to the object being punctured.

[0087] When vibrating the needle at a low frequency of 5 Hz to 15 Hz, it was confirmed that vibrating the needle in both the axial and radial directions further reduces the puncture force compared to vibrating the needle in only one of the axial or radial directions. By vibrating the needle in two directions, axial and radial, it was confirmed that the effect of reducing puncture force through low-frequency vibrations between 5 Hz and 15 Hz can be maintained at a constant rate regardless of speed.

[0088] It was confirmed that puncture accuracy can be further improved by making the needle's vibration waveform a rectangular wave when vibrating the needle at a low frequency of 5 Hz to 15 Hz.

[0089] As described above, the puncture force required for the needle 10 to penetrate the organ membrane and the puncture force required for the needle 10 to penetrate the inside of the organ can be reduced. This suppresses the movement of organs that are not completely fixed in the body along with the movement of the needle, so the needle can be easily inserted into the organ. Therefore, it is possible to accurately puncture the target area of ​​the organ, such as lesion tissue in the organ.

[0090] In the embodiments described above, human organs such as kidneys were used as examples of objects to be needle-punctured, but the invention is not limited to these. The target organ may also be an organ of an animal other than a human.

[0091] In the embodiments described above, the vibrating needle device 1 was used, for example, to insert a needle 10 into a patient's organ during medical treatment, but it is not limited to this. The vibrating needle device 1 may also be used to assist with, for example, vaccination or insulin injections for diabetic patients. As described above, the vibrating needle device 1 can reduce the puncture force and improve puncture accuracy. Therefore, even inexperienced individuals can easily administer vaccinations. Furthermore, for example, when a diabetic patient administers an insulin injection themselves, it becomes possible to insert the injection needle with less pain and greater accuracy.

[0092] In the embodiments described above, the direction of the first axis C1 coincides with the axial direction and the direction of the second axis C2 coincides with the radial direction, but this is not limited to this. The direction of the second axis C2 only needs to intersect with the direction of the first axis C1.

[0093] In the embodiment described above, the direction of the second axis C2 was assumed to be perpendicular to the direction of the first axis C1, but this is not the only possible configuration. The direction of the second axis C2 only needs to intersect with the direction of the first axis C1.

[0094] In the embodiment described above, the maximum outer diameter of the main body 11 was set to, for example, 5 mm, but it is not limited to this. The maximum outer diameter of the main body 11 may be 2 mm or more and less than 5 mm.

[0095] In the embodiment described above, the vibrating part 20 is assumed to have a piezo actuator 22, but it is not limited to this. The vibrating part 20 can be anything that vibrates the needle 10, and may be, for example, a leaf spring.

[0096] In the embodiment described above, the vibrating unit 20 vibrates the needle 10 so that it produces a rectangular wave vibration waveform in the axial and radial directions, but it is not limited to this. For example, the vibrating unit 20 may vibrate the needle 10 so that it produces a rectangular wave vibration waveform in at least one of the axial and radial directions.

[0097] For example, the vibrating unit 20 may vibrate the needle 10 such that the vibration waveform is sawtooth-shaped and / or inverse sawtooth-shaped in at least one of the axial and radial directions. With this configuration, the acceleration of the needle 10 in the puncture direction can be increased compared to when the needle 10 is vibrated with a vibration waveform that changes amplitude slowly, such as a sine wave. As a result, the load that the vibration of the needle 10 places on the membrane can be increased, so that the tip 12 of the needle 10 can easily pass through the membrane. Therefore, the puncture force required for the tip 12 to pass through the membrane can be further reduced. As a result, the time it takes from when the tip 12 of the needle 10 contacts the membrane until it passes through the membrane can be shortened. When the needle 10 vibrates with a sawtooth and / or inverse sawtooth vibration waveform, the puncture acceleration can be increased compared to when the needle 10 vibrates with a vibration waveform that changes amplitude gradually. This increases the load that the needle 10 places on the organ membrane, so that after the needle 10 has passed through the membrane, the vibration of the needle 10 can more reliably separate the membrane that was in contact with the needle 10 from the needle 10. Therefore, the membrane that has been pressed toward the tissue by the needle 10 can recover more quickly due to elastic force when it is not in contact with the needle 10. Consequently, the puncture resistance when the needle 10 penetrates the tissue can be further reduced. This further reduces the puncture force required for the needle 10 to penetrate the tissue. As a result, the time it takes for the membrane that has been pressed toward the tissue by the needle 10 to return to its original position can be further shortened. When the needle 10 is vibrated with a sawtooth and / or inverse sawtooth vibration waveform, the puncture acceleration can be increased compared to when the needle 10 is vibrated with a vibration waveform that changes amplitude gradually. This increases the load that the vibration of the needle 10 places on the tissue inside the organ, so that after the needle 10 is restored, the tissue that was in contact with the needle 10 can be more reliably separated from the needle 10 by the vibration. Therefore, the tissue pressed by the needle 10 can be restored more reliably by elastic force when it is not in contact with the needle 10. Consequently, the puncture resistance when the needle 10 penetrates the tissue can be further reduced. This further reduces the puncture force required for the needle 10 to penetrate the tissue.

[0098] Furthermore, without departing from the spirit of the present invention, the components in the embodiments described above may be replaced with well-known components, and the embodiments described above may be combined as appropriate. [Industrial applicability]

[0099] The present invention relates to a vibrating needle device and a method for inserting a needle. According to the present invention, it is possible to provide a vibrating needle device and a method for inserting a needle that can easily puncture an object. [Explanation of symbols]

[0100] 1...Vibrating needle device 10...needle 11...Main body 12...Tip 13...Proximal end 14...Outer surface 15...Groove 20…Vibrating part C1…1st axis C2…Second axis

Claims

1. A needle having a main body extending in the first axial direction, and a tip provided at one end of the main body that tapers as it moves away from the main body in the first axial direction, A vibrating unit that vibrates the needle at a low frequency of 5 Hz to 15 Hz along at least one of the first axis direction and the second axis direction intersecting the first axis direction, A vibrating needle device comprising, The vibrating part is a vibrating needle device that vibrates the needle so that it produces a sawtooth or inverse sawtooth vibration waveform in at least one of the first axial direction and the second axial direction.

2. The vibrating needle device according to claim 1, wherein the vibrating part vibrates the needle so that the vibration waveform is sawtooth-shaped or inverse sawtooth-shaped in both the first axial direction and the second axial direction.

3. The vibrating needle device according to claim 1 or 2, wherein the frequency at which the vibrating part vibrates the needle is set to resonate with the natural frequency of the needle.

4. The vibrating needle device according to claim 1 or 2, wherein the second axis is perpendicular to the first axis.

5. A method for operating the vibrating needle device according to claim 1, A vibration step in which the needle is vibrated at a low frequency of 5 Hz to 15 Hz in at least one of the first axial direction and the second axial direction, A movement step of moving the tip of the needle in the first axial direction while the needle is being vibrated, Equipped with, A method for operating a vibrating needle device, wherein the vibration step involves vibrating the needle so that it produces a sawtooth or inverse sawtooth vibration waveform in at least one of the first axial direction and the second axial direction.

6. The method of operating a vibrating needle device according to claim 5, wherein in the vibration step, the needle is vibrated so that the vibration waveform is sawtooth-shaped or inverse sawtooth-shaped in both the first axial direction and the second axial direction.

Images