Vibrating needle device and method for operating 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 needle insertion method. This application claims priority to Japanese Patent Application No. 2020-101453, filed on June 11, 2020, the contents of which are incorporated herein by reference. [Background technology]

[0002] In medical practice, percutaneous needle punctures are sometimes used during medical examinations. For example, Patent Document 1 below discloses a puncturing unit that can reduce pain when a needle punctures the skin. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 5835944 Summary of the Invention [Problem to be solved by the invention]

[0004] There is a diagnostic method in which a needle is inserted through the skin into a tumor inside the body, and the tumor is then sampled, cauterized, and frozen. Diagnostic methods using needle puncture can reduce the burden on the patient compared to open surgery. However, with conventional techniques, the organ that is the target of needle puncture is not completely fixed inside the body and moves with the movement of the needle, making it extremely difficult to accurately puncture the target, such as an organ.

[0005] An object of the present invention is to provide a vibrating needle device and a needle insertion method that allow for easy needle insertion. [Means for solving the problem]

[0006] In order to solve the above problems, the vibrating needle device of the present invention comprises a main body portion extending in a first axial direction and having a groove formed on its outer surface around the entire circumferential direction around the first axis, a needle having a tip portion provided at one end of the main body portion and tapering as it moves away from the main body portion in the first axial direction, and a vibrating portion that vibrates the needle along the first axial direction and a second axial direction that intersects the first axial direction.

[0007] In the above configuration, the side surface of the groove on the base end side of the needle is inclined radially inwardly in a direction perpendicular to the first axis from the base end side toward the tip end side.

[0008] In order to solve the above problems, the vibrating needle device of the present invention comprises a needle having a main body extending in a first axial direction, a tip provided at one end of the main body and tapering as it moves away from the main body 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 vibration section vibrates the needle so as to produce a sawtooth and / or inverted sawtooth vibration waveform in at least one of the first axial direction and the second axial direction.

[0010] In the above configuration, the vibration section vibrates the needle in at least one of the first axial direction and the second axial direction so as to produce a rectangular vibration waveform.

[0011] In the above configuration, the frequency at which the vibrating section vibrates the needle is set so as 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 of the present invention is a needle insertion method using any of the vibrating needle devices described above, and includes a vibration step of vibrating the needle in the first axial direction and the second axial direction, and an insertion step of inserting the needle into an object while the needle is vibrated.

[0014] In order to solve the above problems, the insertion method of the present invention is a needle insertion method using the above vibrating needle device, and comprises a vibration step of vibrating the needle in at least one of the first axial direction and the second axial direction at a low frequency of 5 Hz to 15 Hz, and an insertion 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 needle insertion method that can easily insert a needle into a target object. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a schematic diagram of a vibrating needle device according to an embodiment; [Figure 2] FIG. 1 is a side view of a needle according to an embodiment. [Figure 3] FIG. 3 is an enlarged view of part III in FIG. 2. [Figure 4] FIG. 10 is a side view of a needle according to a modified example. [Figure 5] FIG. 5 is an enlarged view of a portion V in FIG. [Figure 6] FIG. 10 is a side view of a needle without grooves. [Figure 7] 10 is a graph showing changes in puncture force. [Figure 8] 10 is a graph comparing the primary peak of the puncture force for each vibration. [Figure 9] 10 is a graph comparing the secondary peak of the puncture force for each vibration. [Figure 10] 10 is a graph comparing the stable range of the puncture force for each vibration. [Figure 11] 10 is a graph comparing the plateau range of the puncture force for each needle and each vibration. [Figure 12] 10 is a graph showing the correlation between the secondary peak of the puncturing force and the puncturing speed for each vibration. [Figure 13] 10 is a graph showing the correlation between the total puncture force and the puncture speed for each vibration. [Figure 14] 10 is a graph showing the correlation between the secondary peak of the puncturing force and the puncturing speed in two-directional vibration. [Figure 15] 10 is a graph showing the correlation between the total puncture force and the puncture speed in two-directional vibration. [Figure 16] 10 is a graph showing the correlation between puncture force and needle displacement in the absence of vibration and in the presence of vibration in two directions. [Figure 17] FIG. 10 is a box plot diagram comparing the maximum puncture force between no vibration and square wave vibration. [Figure 18] 10 is a graph showing the correlation between the maximum puncturing force and the puncturing speed with no vibration and with each vibration. [Figure 19] 10 is a graph showing the correlation between the total puncture force and the puncture speed with no vibration and with each vibration. [Figure 20] FIG. 10 is a diagram showing the displacement of the second kidney model due to a single instantaneous puncture at each puncture acceleration. [Figure 21] 10 is a graph showing the correlation between the displacement of the puncture target and the puncture acceleration in the axial direction, and the correlation between the puncture depth and the puncture acceleration in the axial direction in the second kidney model. [Figure 22] FIG. 10 is a diagram showing the surface displacement of a pig kidney caused by a single instantaneous puncture at various puncture accelerations. [Figure 23] FIG. 10 is a box plot showing the correlation between the surface displacement of the puncture target and the axial puncture acceleration in a porcine kidney. DETAILED DESCRIPTION OF THE INVENTION

[0017] Hereinafter, an embodiment of a vibrating needle device 1 according to the present invention will be described with reference to the drawings. FIG. 1 is a schematic diagram of a vibrating needle device 1. As shown in Fig. 1, the vibrating needle device 1 comprises a needle 10, a vibration unit 20, a control unit 2, a vibration waveform generating unit 3, an observation unit 4, and a movement unit 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 (corresponds to "insertion" in the claims) the needle 10 into a patient's organ, which is the target. In this embodiment, a human organ such as a kidney, whose tissue is covered with a membrane, will be described as the target organ.

[0018] FIG. 2 is a side view of needle 10. FIG. 3 is an enlarged view of part III in FIG. 2 and 3, needle 10 is made of a metal material and has a cylindrical main body 11 extending in the direction of a first axis C1 (hereinafter simply referred to as the "axial direction"), a tip end 12 provided at one axial end of main body 11, and a base end 13 provided at the other axial end of main body 11. In the following description, a direction perpendicular to the "axial direction" is referred to as a "radial direction," and a direction around the "axial direction" is referred to as a "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 molded integrally with the main body portion 11. The tip portion 12 is formed in a conical shape that tapers as it moves away from the main body portion 11 in the axial direction. 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 peripheral surface 14 of the main body 11. A plurality of grooves 15 (14 in this embodiment) are formed in the axial direction from the distal end 12 to the proximal end 13 of the main body 11 at intervals of, for example, 3.0 mm. The grooves 15 are formed around the entire circumferential direction of the main body 11. The maximum depth S1 of the grooves 15 is, for example, 0.5 mm. The groove 15 closest to the proximal end 13 of the plurality of grooves 15 is formed at a position, for example, 39 mm in the axial direction from the distal end 12 to the proximal end 13 of the main body 11. The side surface of the groove 15 on the distal end 12 side is aligned along the radial direction. The side surface of the groove 15 on the proximal end 13 side is tapered, inclining radially inward as it moves from the proximal end 13 side to the distal end 12 side. In a cross-sectional view along the axial direction, the side surface of the groove 15 on the proximal end 13 side intersects with the side surface of the groove 15 on the distal end 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] FIG. 4 is a side view of needle 10A. FIG. 5 is an enlarged view of part V in FIG. The needle of the present invention is not limited to the needle 10 described above, but may be a needle 10A according to a modified embodiment. As shown in Figures 4 and 5, multiple (e.g., 46) grooves 15 of the needle 10A may be formed at intervals of, for example, 0.9 mm in the axial direction from the distal end 12 toward the proximal end 13. Of the multiple grooves 15, the groove 15 located closest to the proximal end 13 may be formed at a position, for example, 40.5 mm in the axial direction from the distal end 12 toward the proximal end 13 in the main body 11.

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

[0023] The control unit 2 is electrically connected to the piezoelectric actuator 22. The control unit 2 applies a voltage to the piezoelectric actuator 22 to vibrate the piezoelectric actuator 22. The control unit 2 is electrically connected to a vibration waveform generating unit 3. The vibration waveform generating unit 3 inputs a signal to the control unit 2. The signal from the vibration waveform generating unit 3 includes information on the vibration waveform of the voltage applied from the control unit 2 to the piezo actuator 22. The vibration waveform generating 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. A signal including information on the vibration waveform of the voltage output from the control unit 2 to the piezo actuator 22 is input from the control unit 2 to the observation unit 4. 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 in the axial direction and inserts the needle 10 into the object. The moving device 30 has a mounting portion 31, a ball screw 32, and a motor 33. The piezo actuator 22 is attached to the mounting portion 31. The ball screw 32 extends in the axial direction. The mounting portion 31 is attached to the ball screw 32 so that it can move in the axial direction by rotation of the ball screw 32. The motor 33 is, for example, a DC motor. The motor 33 is a drive source for the ball screw 32. The rotation speed of the motor 33 is, for example, 1400 rpm. The motor 33 is connected to the ball screw 32 by a gear head 34. The gear head 34 is a reducer. The gear head 34 transmits the driving force of the motor 33 to the ball screw 32 while reducing the speed. Gear head 34 can change the speed in the puncture direction of needle 10 attached to attachment portion 31 (hereinafter simply referred to as "puncture speed") by changing the gear ratio. Gear ratios of gear head 34 are, for example, 150, 75, and 30. The puncture speeds of needle 10 correspond to gear ratios of gear head 34 of 150, 75, and 30, and are, for example, 311 μm / s, 622 μm / s, and 1556 μm / s, respectively.

[0025] (Needle insertion method) A method for inserting the needle 10 using the vibrating needle device 1 will be described below. The puncturing method of the needle 10 includes a vibration step, a movement step, and a puncturing step. (vibration process) The vibration step is a step 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 a voltage based on the first and second signals to the piezoelectric actuator 22. The piezoelectric actuator 22 vibrates the needle 10 in the axial direction based on the first signal. The piezoelectric actuator 22 vibrates the needle 10 in the radial direction based on the second signal.

[0026] (Moving process) The moving step is a step of moving the needle 10 in the axial direction while vibrating the needle 10 until the tip 12 of the needle 10 comes into contact with the membrane of the organ. In the movement process, the motor 33 is driven. The driving force of the motor 33 is transmitted to the ball screw 32 via the gear head 34. This causes the ball screw 32 to rotate. The attachment part 31 moves along the axial direction toward the organ due to the rotation of the ball screw 32. Therefore, the needle 10, in a vibrated state, moves along the axial direction together with the attachment part 31 until it comes into contact with the membrane of the organ. (puncture process) The puncturing step is a step in which the needle 10 is punctured into the organ while being vibrated. In the puncture process, needle 10 is punctured into an organ while being vibrated. Tip 12 presses against the membrane while repeatedly coming into and out of contact with the membrane. Tip 12 then breaks through the membrane and passes through. Needle 10 punctures the tissue inside the organ while pressing against the membrane that is in contact with needle 10. The membrane then returns to its original shape due to elastic force. The tissue enters groove 15 of needle 10. The tissue returns to its original shape by entering groove 15 due to elastic force. Needle 10 then punctures the inside of the tissue. In this manner, needle 10 punctures the organ.

[0027] (Experimental results on vibrating needle device) The results of experiments on the vibrating needle device 1 will be described below. FIG. 6 is a side view of needle 10B without groove 15. 6, needle 10B differs from needles 10 and 10A in that no groove is provided on outer peripheral surface 14 of main body 11. Below, experiments 1 to 5 on vibrating needle device 1 were carried out using needles 10, 10A, and 10B.

[0028] As shown in FIG. 1, a kidney model 40 was created as an object to be punctured by needles 10, 10A, and 10B. The kidney model 40 has an agar gel 42 and silicone rubber 43. The kidney model 40 corresponds to an organ. The agar gel 42 is in a solidified state and is filled in 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, 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 direction of the needles 10, 10A, and 10B was aligned with the vertical direction of gravity. A kidney model 40 was placed at a position spaced below the tip 12 of the needles 10, 10A, and 10B. The silicone rubber 43 of the kidney model 40 was placed on the tip 12 side. The kidney model 40 was placed on an electronic balance 5. This made it possible to measure the puncture force of the needles 10, 10A, and 10B as they puncture the kidney model 40.

[0030] (Experiment 1) Experiment 1 was conducted to confirm the relationship between the created kidney model 40 and the puncture force. Specifically, Experiment 1 was attempted multiple times under the following conditions. The kidney model 40 was punctured without vibrating the needle 10B. The puncture speed of the needle 10B was 311 μm / s. Figure 7 is a graph showing changes 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 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 and reaches a primary peak P1. The primary peak P1 occurs between 10 seconds and 25 seconds. The puncture force at the primary peak P1 is approximately 100 gf to 400 gf. The puncture force decreases after the primary peak P1. After that, the puncture force increases again over time and reaches a secondary peak P2. The puncture force reaches its maximum value at the secondary peak P2. After passing the secondary peak P2, the puncture force decreases again. The secondary peak P2 occurs in the range of 30 seconds to 45 seconds. The puncture force at the secondary peak P2 is approximately 400 gf to 900 gf. The puncture force then reaches a stable region P3. The rate of change of the puncture force in the stable region P3 with respect to time is smaller than that before the puncture force reaches the secondary peak P2. The stable region P3 occurs after 45 seconds. The puncture force in the stable region 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. FIG. 8 is a graph showing the results of Experiment 2, comparing the primary peak P1 of the puncture force for each vibration. FIG. 9 is a graph showing the results of Experiment 2, comparing the secondary peak P2 of the puncture force for each vibration. FIG. 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 needle 10B was vibrated in the axial direction. The change in puncture force was measured when needle 10B was vibrated in a sine wave pattern (sin wave), when needle 10B was vibrated in a sawtooth pattern (ramp wave), when needle 10B was vibrated in an inverse sawtooth pattern (inverse ramp wave), and when needle 10B was vibrated in a square wave pattern (square wave). The sine wave vibration has a frequency of 10 Hz and an amplitude of 100 μm. The sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm. The inverse sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm. The 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 at each vibration were compared with those when the needle 10B was punctured without vibration (no vibration). 8 to 10, the primary peak P1, secondary peak P2, and stable region P3 are compared between the case where needle 10B is inserted without vibrating and the case where needle 10B is inserted while vibrating in the axial direction. For stable region P3 in Fig. 10, the comparison is made using the integrated value from 50 seconds to 60 seconds. 8 to 10, the vertical axis represents the values ​​[gf] of the primary peak P1, secondary peak P2, and stable region P3, respectively, and the horizontal axis represents the experimental conditions (vibration state).

[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 needle 10B is vibrated in a sawtooth, inverted sawtooth, and rectangular wave pattern and used for puncturing are reduced compared to the primary peak P1, secondary peak P2, and stable region P3 when needle 10B is not vibrated and used for puncturing. The primary peak P1 and stable region P3 when the needle 10B was vibrated in a sine wave pattern during puncture were larger than the primary peak P1 and stable region P3 when the needle 10B was not vibrated. The secondary peak P2 when the needle 10B was vibrated in a sine wave pattern during puncture was only slightly smaller than the secondary peak P2 when the needle 10B was not vibrated.

[0034] From the above, it can be said that when needle 10B is vibrated in a sawtooth, inverted sawtooth, or rectangular wave pattern to perform puncturing, the effect of reducing the puncturing force is achieved compared to when needle 10B is punctured without vibrating or when needle 10B is punctured by vibrating in a sine wave pattern (hereinafter simply referred to as the ``puncturing force reduction effect due to vibration'').

[0035] (Experiment 3) Experiment 3 was conducted to confirm the relationship between the groove 15, the type of vibration, and the puncture force. FIG. 11 is a graph showing the results of Experiment 3, comparing the stable region P3 of the puncture force for each of the needles 10, 10A, and 10B and each vibration. Experiment 3 differs from Experiment 1 in that the kidney model 40 was punctured by vibrating the needles 10 and 10A in the axial direction. Needle 10 has a plurality of grooves 15 formed at intervals of 3.0 mm on its outer circumferential surface 14. Needle 10A has a plurality of grooves 15 formed at intervals of 0.9 mm on its outer circumferential surface 14. 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 sine wave vibration has a frequency of 10 Hz and an amplitude of 100 μm, while the inverse sawtooth vibration has a frequency of 10 Hz and an amplitude of 89.6 μm.

[0036] The stable region P3 of the puncture force at each vibration was compared with that when the needle 10B was inserted without vibration (Normal needle / No vibration). In FIG. 11, the stable region P3 is compared in terms of integrated values ​​from 50 seconds to 60 seconds when needle 10B is inserted without being vibrated and when needles 10, 10A are inserted while being vibrated in the axial direction. In FIG. 11, the vertical axis represents the value [gf] of the stable region P3, and the horizontal axis represents the experimental conditions (groove / vibration state).

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

[0038] (Experiment 4) Experiment 4 was conducted to confirm the relationship between the puncture force and the puncture speed in each vibration in one direction (axial direction). FIG. 12 is a graph showing the results of Experiment 4, illustrating the correlation between the secondary peak P2 of the puncturing force and the puncturing speed for each vibration. FIG. 13 is a graph showing the results of Experiment 4, illustrating the correlation between the puncture speed and the value obtained by integrating the puncture force at each vibration from 0 s to 60 s (hereinafter simply referred to as "total puncture force"). Experiment 4 differs from Experiment 1 in that needle 10B was vibrated in the axial direction to puncture kidney model 40. Experiment 4 was specifically conducted under the following conditions. Below, explanations of conditions common to Experiment 1 above will be omitted as appropriate. In Experiment 4, only needle 10B was used. In Experiment 4, the change in puncture force over time 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 change in puncture force over time was measured at each puncture speed. When the puncture speed was 311 μm / s, the drive time of motor 33 was set to 60 s. When the puncture speed was 622 μm / s, the drive time of motor 33 was set to 30 s. When the puncture speed was 1556 μm / s, the drive time of motor 33 was set to 15 s. The secondary peak P2 of the puncture force and the total puncture force were measured at each puncture speed, and the secondary peak P2 and the total puncture force were compared.

[0039] The above-mentioned experiment 4 was conducted in two cases: when needle 10B was vibrated in the axial direction in a sine wave pattern (sin wave) and when needle 10B was vibrated in the axial direction in a square wave pattern (square wave). The sine wave vibration has a frequency of 10 Hz and an amplitude of 100 μm. The square wave vibration has a frequency of 10 Hz and an amplitude of 100 μm. The secondary peak P2 of the puncture force and the total puncture force at each vibration were compared with those when the needle 10B was punctured without vibration (no vibration).

[0040] In Fig. 12 and Fig. 13, the vertical axis represents the secondary peak P2 and the total puncture force value [gf], and the horizontal axis represents the puncture speed [mm / s]. 12, the secondary peak P2 of the puncturing force tends to increase as the puncturing speed increases, regardless of whether or not the needle 10B is vibrating. The difference in the secondary peak P2 of the puncturing force between when the needle 10B is punctured without vibrating and when the needle 10B is punctured with vibrating becomes smaller as the puncturing speed increases. 13, the total puncture force decreases inversely proportional to the puncture speed, regardless of whether or not the needle 10B is vibrating. However, the difference in the total puncture force between when the needle 10B is not vibrating and when the needle 10B is vibrating decreases as the puncture speed increases. From the above, it can be said that the effect of reducing the puncture force due to vibration decreases as the puncture speed increases when needle 10B is vibrated in only one direction (axial direction).

[0041] (Experiment 5) Experiment 5 was conducted to confirm the relationship between the puncture force and the puncture speed in two-directional (axial and radial) vibrations. FIG. 14 is a graph showing the results of Experiment 5, illustrating the correlation between the secondary peak P2 in the vibration in two directions and the puncture speed. FIG. 15 is a graph showing the results of Experiment 5, illustrating the correlation between the total puncturing force and the puncturing speed when vibrating in two directions. Experiment 5 was conducted using the same method as Experiment 4 described above. Experiment 5 differs from Experiment 4 in that needle 10B was vibrated not only in the axial direction but also in the radial direction to puncture 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 in which needle 10B was vibrated in a rectangular wave pattern in two directions, the axial direction and the radial direction, to perform 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 vibration and radial vibration were out of phase with each other by π / 2. This caused needle 10B to vibrate, repeatedly moving and stopping in a square pattern when viewed from the radial direction. The secondary peak P2 of the puncture force and the total puncture force at each vibration were compared with those when the needle 10B was punctured without vibration (no vibration).

[0042] In Fig. 14 and Fig. 15, the vertical axis represents the secondary peak P2 and the total puncture force value [gf], and the horizontal axis represents the puncture speed [mm / s]. 14, when the needle 10B is punctured without vibrating, the secondary peak P2 of the puncturing force increases as the puncturing speed increases. In contrast, when the needle 10B is punctured while vibrating in two directions, the secondary peak P2 of the puncturing force tends to be relatively independent of the puncturing 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 at which the total puncture force decreases remains constant, independent of the puncture speed. From the above, it can be said that the effect of reducing the puncture force due to vibration is constant and does not depend on the puncture speed when the needle 10B is vibrated in two directions (axial direction and radial direction).

[0043] In addition to Experiments 1 to 5 described above, Experiments 6 to 8 were also conducted. Hereinafter, explanations of conditions common to Experiments 1 to 5 will be omitted as appropriate. In Experiments 6 to 8, a needle (not shown) was used that did not have a groove on the outer circumferential surface 14, like the above-mentioned needle 10B. Note that the needle of the present invention is not limited to the above-mentioned needles 10 and 10A, and may be a needle that does not have a groove, like the needles 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 targets for needle puncture. The pig kidneys were freshly harvested early in the morning on the day of the experiment, allowing the experiment to be performed with the membrane still formed on the surface of the kidney. The second kidney model consists of a spherical collagen casing and agar gel. The collagen casing has an outer diameter of 17 mm. The inside of the collagen casing is hollow. The collagen casing is filled with agar gel. The concentration of the agar gel is 2.0%. The second kidney model was floated in a 50 mm cube container filled with a 3.0% sodium chloride solution, reproducing a kidney moving within body tissue.

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

[0046] (Experiment 6) Experiment 6 was conducted to confirm the effect of axial and radial vibrations on the puncture force at low frequencies between 5 Hz and 15 Hz. In Experiment 6, a pig kidney was selected as the puncture target. A needle with an outer diameter of 1.5 mm was used. The needle puncture speed was 311 μm / s. The tip of the needle was in contact with the target and the needle was inserted in the axial direction. Experiment 6 was performed in two cases: when the needle was inserted without vibration (No vibration) and when the needle was inserted while vibrating in square waves in both the axial and radial directions (Biaxial square waves). The axial and radial vibrations were out of phase with each other 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 when there is no vibration and when vibration is applied in two directions. In Figure 16, the vertical axis represents the puncture force [gf] and the horizontal axis represents the needle displacement [mm]. Graph G1 shows the case where the needle was punctured without vibration, and graph G2 shows the case where the needle was punctured while vibrating in a rectangular wave pattern in two directions, the axial direction and the radial direction. As can be seen from the graph in Figure 16, in the two cases above, the puncture force increased as the needle displacement increased, and tended to be maximum when the needle displacement was in the range of 9 mm to 18 mm. The maximum puncture force is caused by the elastic deformation of the pig kidney membrane. Furthermore, it was confirmed that when the needle was vibrated in a rectangular wave pattern in two directions, axially and radially, the puncture force could be reduced for all needle displacements compared to when the needle was not vibrated.

[0048] Next, Experiment 6 was repeated seven times (sample number n≧7), and box plots were created for the cases where the needle was punctured without vibration and where the needle was punctured with rectangular wave vibration in both the axial and radial directions. The 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 between no vibration and square wave vibration. In Figure 17, the vertical axis represents the maximum puncture force [gf], and the horizontal axis represents the experimental condition (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, top, and line segments between the bottom and top of the box represent the first, third, and second quartile lines, respectively, and the cross in the box represents the mean value.

[0050] As can be seen from Figure 17, there was no significant difference in the variation between when the needle was punctured by vibrating it in a square wave in two directions, axially and radially, and when the needle was punctured without vibrating it. However, when comparing the average values, the maximum puncture force was lower in the former case than in the latter case. 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 low as 0.01. In other words, a significant difference was observed between the mean values ​​of the former and latter. Therefore, the result that the former was able to reduce the puncture force compared to the latter was inevitable.

[0051] The only difference between the former and latter conditions is whether or not the needle vibrates. 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 when the needle is not vibrated.

[0052] (Experiment 7) Experiment 7 was conducted to confirm 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 while puncturing, the needle vibration frequency 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 speeds were 622 μm / s and 1556 μm / s, and in that kidney model 40 was used as the puncture target. The thickness of silicone rubber 43 of kidney model 40 in Experiment 7 was 600 mm or more and 700 mm or less.

[0053] Figure 18 is a graph showing the results of Experiment 7, illustrating the correlation between the maximum puncture force and the puncture speed for no vibration and for each vibration. 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, no vibration is labeled "No vibration," square wave vibration in the axial direction only is labeled "Axial square wave," square wave vibration in the radial direction only is labeled "Lateral square wave," and square wave vibration in both the axial and radial directions is 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 when there was no vibration. From this, it is thought that by vibrating the needle in at least one of the axial and radial directions at a frequency of 5 Hz to 15 Hz, the maximum puncture force can be reduced regardless of the puncture speed.

[0055] Furthermore, it was confirmed that the maximum puncture force increases as the puncture speed increases when the needle is not vibrated and when it is vibrated only in the axial or radial direction. In contrast, when the needle is vibrated in both the axial and radial directions, the maximum puncture force remains 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 of 5 Hz or more and 15 Hz or less, 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 with no vibration and with each vibration. 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, the total puncture force is the integrated value of all puncture forces applied to the target object during needle puncture.

[0057] As can be seen from Figure 19, it was confirmed that the total puncture force decreased as the puncture speed increased when there was no vibration and when the needle was vibrated in at least one of the axial and radial directions. Furthermore, when the needle was vibrated in only one of the axial and radial directions, it was confirmed that the rate of reduction in the 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 of 5 Hz or more and 15 Hz or less, the total puncture force can be reduced at a constant rate regardless of the puncture speed.

[0058] Experiment 7 confirmed that vibrating the needle at a low frequency of 5 Hz to 15 Hz reduces the puncture force. Furthermore, it was confirmed that vibrating the needle in both the axial and radial directions reduces the puncture force more effectively while maintaining a constant reduction in the puncture force, compared to vibrating the needle in only one of the axial and radial directions.

[0059] (Experiment 8) Experiment 8 was conducted to confirm 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. The tip of the needle was placed in contact with the target, and the needle was inserted with a 10 mm stroke in the axial direction. Furthermore, the needle was accelerated in the axial direction to perform a single, instantaneous puncture. The needle's acceleration in the puncture direction (axial direction) (hereinafter simply referred to as "puncture acceleration") was varied within a 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 targets for puncture.

[0060] First, a second kidney model was selected as the puncture target, and the above-mentioned Experiment 8 was performed. The needle puncture 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, sudden puncture at each puncture acceleration. In Figure 20, the needle and second kidney model after puncture are displayed, from left to right, in order of decreasing puncture acceleration: 0 m / s (when puncturing at a constant speed), 6.38 m / s, 18.3 m / s, 30.0 m / s, 40.7 m / s, 65.9 m / s, and 102 m / s. Note that only the second image from the left in Figure 20 (when the puncture acceleration is 6.38 m / s) also shows an afterimage of the second kidney model moving due to puncture.

[0062] As can be seen from Figure 20, when the puncture acceleration was 0 m / s2, the needle did not break the collagen casing, and the second kidney model sank by the amount of needle displacement, with the tip of the needle remaining in contact with the collagen casing. In contrast, when puncture acceleration was applied to the needle, the needle broke the collagen casing, and the kidney model sank as the needle punctured the inside of the second kidney model. As the puncture acceleration increased, the displacement of the second kidney model, which was the target of puncture, was suppressed, and the needle puncture depth became deeper. In order to quantitatively consider the results shown in FIG. 20, the data shown in FIG. 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 (in the figure, labeled "Object displacement") and the axial puncture acceleration, and the correlation between the puncture depth (in the figure, labeled "Puncture depth") and the axial puncture acceleration in the second kidney model. The displacement of the puncture target refers to the distance the second kidney model moves downward from its initial position due to the needle puncture, and the puncture depth refers to the length of the puncture target actually punctured by 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 remained almost constant at around 1 mm, confirming that the puncture target hardly moved when the needle was inserted.

[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. At puncture accelerations of 80 m / s2 or higher, the puncture depth remained almost constant at around 8 mm, and it was confirmed that at least 80% or more of the length was punctured for a 10 mm stroke.

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

[0067] Next, a pig kidney was selected as the puncture target, and the above-mentioned Experiment 8 was performed. The needle puncture speed was also changed 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, sudden puncture at each puncture acceleration. In Figure 22, the needle and the surface of the pig kidney before and after puncture are displayed side by side, from left to right, in order of increasing puncture acceleration: 0 m / s (when puncturing at a constant speed), 48.4 m / s, and 110 m / s. In Figure 22, the top shows the state before puncture, and the bottom shows the state after puncture. As can be seen from Figure 22, when the puncture acceleration was 0 m / s2, the needle did not break the membrane of the pig's kidney, and the tip of the needle remained in contact with the membrane, causing the membrane to deform in the puncture direction by the displacement of the needle. In contrast, when puncture acceleration was applied to the needle, the needle broke the membrane of the pig's kidney, and the membrane deformed in the puncture direction as the needle punctured the inside of the pig's kidney. As the puncture acceleration increased, the surface displacement of the pig's kidney, which was the target of puncture, was suppressed. In order to quantitatively consider the results shown in FIG. 22, the data shown in FIG. 23 was obtained.

[0069] Figure 23 is a graph showing the results of Experiment 8, and is a box plot diagram showing 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 moves downward from its initial position due to needle puncture. Figure 23 is a box plot diagram created using the same method as Figure 17, with sample number n being n>7. In Figure 23, the vertical axis represents the "surface displacement of the puncture target per 10 mm stroke" [mm] / 10 [mm], and the horizontal axis represents the experimental condition (puncture acceleration).

[0070] In Experiment 8 using pig kidneys, the puncture accuracy was determined to be low when the surface displacement of the puncture target was large relative to a 10 mm stroke, and high when the surface displacement of the puncture target was small. In other words, the "surface displacement of the puncture target relative to a 10 mm stroke" was used as an index of puncture accuracy.

[0071] As can be seen from Figure 23, there was no significant difference in variation when puncturing at a constant speed (when the puncturing acceleration was 0 m / s²), when the puncturing acceleration was 48.4 m / s², and when the puncturing acceleration was 110 m / s². In contrast, when comparing the average values, the puncturing accuracy index decreased as the puncturing acceleration increased. In other words, it can be said that the puncturing accuracy improved as the puncturing 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 low as 0.01. That is, there was a significant difference 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 the puncture accuracy improved as the puncture acceleration increased was inevitable.

[0072] The only difference in conditions between the three cases shown in Fig. 23 is the difference in puncture acceleration. Considering this, it is thought that puncture accuracy can be improved by increasing the puncture acceleration.

[0073] Experiment 8 confirmed that increasing the axial puncture acceleration during single punctures can improve puncture accuracy, whether the target is a second kidney model or a pig kidney. Here, the higher the puncture acceleration, the more the single puncture resembles a single puncture using square wave vibration. This square wave vibration can be considered a low-frequency vibration in the axial direction of 5 Hz to 15 Hz. In other words, the results of Experiment 8 suggest that when the needle is vibrated in the axial direction at a low frequency of 5 Hz to 15 Hz, making the needle vibration waveform square-shaped can improve puncture accuracy.

[0074] In Experiment 8, if a single puncture is considered to be an approximation of a single puncture using square wave vibration, a stroke of 10 mm can be considered to be the amplitude of the square 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 needle vibration waveform square wave.

[0075] In the above-mentioned experiments 6 to 8, when the needle was vibrated, the frequency of the needle vibration was set to 10 Hz, but similar results were obtained when the frequency of the needle vibration was set to 5 Hz or 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 section 20 that vibrates the needle 10 in the axial and radial directions. According to this configuration, the needle 10 can be inserted into an organ while being vibrated in the axial and radial directions by the vibration unit 20. The tip 12 of the needle 10 passes through the membrane of the organ while repeatedly coming into and out of 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 coming into contact with the membrane can be shortened. After the needle 10 passes through the membrane of the organ, the needle 10 is punctured into the tissue inside the organ in a vibrated state. Therefore, the needle 10 punctures the tissue while repeatedly coming into contact with and not coming into contact with the membrane. As a result, the membrane pressed against the tissue by the needle 10 returns to its original shape due to elastic force when it is not in contact with the needle 10. Therefore, the puncture resistance when the needle 10 punctures the tissue can be reduced compared to when the needle 10 punctures the organ without vibrating the needle 10. Therefore, the puncture force required for the needle 10 to puncture the tissue can be reduced. The needle 10 punctures the tissue inside the organ while vibrating. Therefore, the needle 10 punctures the tissue while repeatedly coming into contact with the tissue and not contacting it. As a result, the tissue pressed by the needle 10 returns to its original shape due to elastic force when it is not in contact with the needle 10. Therefore, the puncture resistance when the needle 10 punctures the tissue can be reduced compared to when the needle 10 punctures an organ without vibrating the needle 10. Therefore, the puncture force required for the needle 10 to puncture the tissue can be reduced.

[0077] The vibration unit 20 vibrates the needle 10 in the axial direction and in the radial direction intersecting the axial direction. This configuration allows the needle 10 to puncture the organ while widening the hole made in the organ by the needle 10 in the axial and radial directions. This reduces the puncture force required for the needle 10 to pass through the membrane of the organ and the puncture force required for the needle 10 to puncture the tissue inside the organ, compared to when the needle 10 is vibrated in only one direction.

[0078] A groove 15 is formed on the outer peripheral surface 14 of the main body 11 of the needle 10 over the entire circumference. With this configuration, the portion of the tissue that is pressed by the puncture of needle 10 enters groove 15. This causes needle 10 to be caught in the tissue, preventing needle 10 from being pushed out of the organ by the elastic force of the tissue. Therefore, the organ can be prevented from moving due to the resistance from needle 10. The portion of the tissue that is pressed by the puncture of needle 10 enters groove 15, reducing the elastic force of the tissue acting on outer surface 14 of needle 10. This reduces the puncture force required for needle 10 to puncture the inside of an organ.

[0079] As described above, the puncture force required for the needle 10 to puncture the membrane of an organ and the puncture force required for the needle 10 to puncture the inside of the organ can be reduced. This prevents organs that are not completely fixed inside the body from moving with the movement of the needle, making it easier to puncture the organ. Therefore, the needle can be accurately punctured at the desired location in the organ, such as diseased tissue that has developed in the organ.

[0080] The side surface of the groove 15 on the side of the base end 13 of the needle 10 is inclined radially inward in a direction perpendicular to the axial direction from the base end 13 side toward the tip end 12 side. According to this configuration, when needle 10 is inserted into an organ in the axial direction, needle 10 can be inserted into the organ while gradually expanding the organ in the radial direction, thereby allowing needle 10 to be inserted into the organ smoothly.

[0081] The vibration unit 20 vibrates the needle 10 in the axial and radial directions so as to produce a rectangular 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 when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually, such as a sine wave. This increases the load that the needle 10 applies to the membrane, allowing the tip 12 of the needle 10 to pass through the membrane more easily. This further reduces the puncture force required for the tip 12 to pass through the membrane. As a result, the time it takes for the tip 12 of the needle 10 to pass through the membrane after coming into contact with the membrane can be shortened. When the needle 10 is vibrated with a rectangular vibration waveform, the puncture acceleration can be increased compared to when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually. This increases the load that the needle 10 applies to the membrane of the organ, so that after the needle 10 passes through the membrane, the membrane that has come into contact with the needle 10 can be more reliably separated from the needle 10 by the vibration of the needle 10. Therefore, the membrane pressed against the tissue by the needle 10 can return to its original position more quickly due to its elastic force when it is not in contact with the needle 10. This further reduces the puncture resistance when the needle 10 punctures the tissue. This further reduces the puncture force required for the needle 10 to puncture the tissue. As a result, the time it takes for the membrane pressed against the tissue by the needle 10 to return to its original position can be further shortened. When the needle 10 is vibrated with a rectangular vibration waveform, the puncture acceleration can be increased compared to when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually. This increases the load that the vibration of the needle 10 imparts to the tissue inside the organ, so that after the needle 10 has returned to its original position, the tissue that has come into contact with the needle 10 can be more reliably separated from the needle 10 by the vibration of the needle 10. Therefore, the tissue pressed by the needle 10 can be more reliably restored by its elastic force when it is not in contact with the needle 10. This further reduces the puncture resistance when the needle 10 punctures the tissue. This further reduces the puncture force required for the needle 10 to puncture the tissue.

[0082] The frequency at which the vibrating unit 20 vibrates the needle 10 is set so as 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 increase the amplitude of vibration of the needle 10 compared to when it is set so as not to resonate with the natural frequency of the needle 10. As a result, even in situations where the vibration of the needle 10 is restricted, the amplitude of vibration of the needle 10 can be controlled by changing the vibration setting of the vibrating unit 20. Therefore, the effect of the vibrating needle device 1 in reducing the puncture force can be maintained.

[0083] The first axis C1 and the second axis C2, which are axes of the vibration direction of the needle, are perpendicular to each other. According to this configuration, needle 10 can be punctured into an organ while vibrating in two perpendicular directions. This allows needle 10 to puncture the organ while significantly expanding it, compared to when needle 10 is punctured into an organ while vibrating in two intersecting directions without being perpendicular. Therefore, the puncture force required for needle 10 to pass through the membrane of the organ and the puncture force required for needle 10 to puncture tissue inside the organ can be reduced.

[0084] The puncturing method of the needle 10 includes a vibration step of vibrating the needle 10 in the axial and radial directions, and an insertion step of inserting the needle 10 into the organ while the needle 10 is vibrated. According to this configuration, the needle 10 can be punctured into an organ while being vibrated in the axial and radial directions by the vibration unit 20. The tip 12 of the needle 10 passes through the membrane of the organ while repeatedly coming into and out of contact with the membrane. This reduces the puncture resistance when the tip 12 passes through the membrane compared to when the organ is punctured 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 coming into contact with the membrane can be shortened. After the needle 10 passes through the membrane of the organ, the needle 10 is punctured into the tissue inside the organ in a vibrated state. Therefore, the needle 10 punctures the tissue while repeatedly coming into contact with and not coming into contact with the membrane. As a result, the membrane pressed against 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, the puncture resistance when the needle 10 punctures the tissue can be reduced compared to when the needle 10 punctures an organ without vibrating the needle 10. Therefore, the puncture force required for the needle 10 to puncture the tissue can be reduced. As a result, the time it takes for the membrane pressed against the tissue by the needle 10 to return to its original position can be shortened. The needle 10 is punctured into the tissue inside the organ while vibrating. Therefore, the needle 10 punctures the inside of the tissue while repeatedly coming into contact with the tissue and not contacting it. As a result, the tissue pressed by the needle 10 returns to its original shape due to elastic force when it is not in contact with the needle 10. Therefore, the puncture resistance when the needle 10 punctures the tissue can be reduced compared to when the needle 10 punctures an organ without vibrating the needle 10. Therefore, the puncture force required for the needle 10 to puncture the tissue can be reduced.

[0085] In the vibration step, the needle 10 is vibrated in the axial direction and in the radial direction intersecting the axial direction. This configuration allows the needle 10 to puncture the organ while widening the hole made in the organ by the needle 10 in the axial and radial directions. This reduces the puncture force required for the needle 10 to pass through the membrane of the organ and the puncture force required for the needle 10 to puncture the tissue inside the organ, compared to when the needle 10 is vibrated in only one direction.

[0086] The vibrating needle device 1 includes a vibrating section 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. With this configuration, it was confirmed that vibrating the needle at a low frequency of 5 Hz or more and 15 Hz or less along at least one of the axial and radial directions can reduce the puncture force applied to the object being punctured by the needle.

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

[0088] It was confirmed that when the needle is vibrated at a low frequency of 5 Hz or more and 15 Hz or less, the puncture accuracy can be further improved by making the needle vibration waveform rectangular.

[0089] As described above, the puncture force required for the needle 10 to puncture the membrane of an organ and the puncture force required for the needle 10 to puncture the inside of the organ can be reduced. This prevents organs that are not completely fixed inside the body from moving with the movement of the needle, making it easier to puncture the organ. Therefore, the needle can be accurately punctured at the desired location in the organ, such as diseased tissue that has developed in the organ.

[0090] In the above-described embodiment, the object to be punctured is an organ such as a human kidney, but this is not limiting. The organ to be punctured may be an organ of an animal other than a human.

[0091] In the above-described embodiment, the vibrating needle device 1 is used to insert the needle 10 into a patient's organ during medical treatment, for example, but is not limited to this. The vibrating needle device 1 may also be used to assist in vaccinations, insulin injections for diabetic patients, etc. As described above, the vibrating needle device 1 can reduce the puncturing force and improve puncturing accuracy. This allows even unskilled personnel to easily administer vaccinations. Furthermore, for example, when a diabetic patient injects insulin themselves, it becomes possible to insert the injection needle with less pain and with high accuracy.

[0092] In the above-described embodiment, the first axis C1 direction coincides with the axial direction and the second axis C2 direction coincides with the radial direction, but this is not limited thereto. The second axis C2 direction may intersect with the first axis C1 direction.

[0093] In the above-described embodiment, the second axis C2 direction is perpendicular to the first axis C1 direction, but this is not limiting. The second axis C2 direction may be any direction as long as it intersects with the first axis C1 direction.

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

[0095] In the above-described embodiment, the vibration unit 20 has the piezo actuator 22, but this is not limited to this. The vibration unit 20 may be anything that vibrates the needle 10, and may be, for example, a leaf spring.

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

[0097] For example, the vibration unit 20 may vibrate the needle 10 in at least one of the axial and radial directions to produce a sawtooth and / or inverted sawtooth vibration waveform. This configuration allows for a greater acceleration of the needle 10 in the puncture direction compared to when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually, such as a sine wave. This increases the load that the vibration of the needle 10 imparts to the membrane, allowing the tip 12 of the needle 10 to pass through the membrane more easily. This further reduces the puncture force required for the tip 12 to pass through the membrane. As a result, the time it takes for the tip 12 of the needle 10 to pass through the membrane after coming into contact with the membrane can be shortened. When the needle 10 is vibrated with a sawtooth or / and inverted sawtooth vibration waveform, the puncture acceleration can be increased compared to when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually. This increases the load that the needle 10 applies to the membrane of the organ, so that after the needle 10 passes through the membrane, the membrane that has come into contact with the needle 10 can be more reliably separated from the needle 10 by the vibration of the needle 10. Therefore, the membrane pressed against the tissue by the needle 10 can return to its original position more quickly due to its elastic force when it is not in contact with the needle 10. This further reduces the puncture resistance when the needle 10 punctures the tissue. This further reduces the puncture force required for the needle 10 to puncture the tissue. As a result, the time it takes for the membrane pressed against 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 inverted sawtooth vibration waveform, the puncture acceleration can be increased compared to when the needle 10 is vibrated with a vibration waveform whose amplitude changes gradually. This increases the load that the vibration of the needle 10 imparts to the tissue inside the organ, so that after the needle 10 has returned to its original position, the tissue that has come into contact with the needle 10 can be more reliably separated from the needle 10 by the vibration of the needle 10. Therefore, the tissue pressed by the needle 10 can more reliably return to its original position due to its elastic force when it is not in contact with the needle 10. This further reduces the puncture resistance when the needle 10 punctures the tissue. This further reduces the puncture force required for the needle 10 to puncture the tissue.

[0098] In addition, within the scope of the spirit of the present invention, it is possible to replace the components in the above-described embodiments with well-known components as appropriate, and the above-described embodiments may be combined as appropriate. [Industrial Applicability]

[0099] TECHNICAL FIELD The present invention relates to a vibrating needle device and a needle insertion method, and more particularly to a vibrating needle device and a needle insertion method that can easily insert a needle into a target 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...Vibration part C1…1st axis C2…Second axis

Claims

1. a needle having a main body portion extending in a first axial direction and a tip portion provided at one end of the main body portion and tapering as it moves away from the main body portion in the first axial direction; a vibration 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 a second axis direction intersecting the first axis direction; A vibrating needle device comprising: The vibrating section vibrates the needle in at least one of the first axial direction and the second axial direction to produce a sawtooth or inverted sawtooth vibration waveform.

2. The vibrating needle device according to claim 1 , wherein the vibrating section vibrates the needle so as to produce a sawtooth or inverted sawtooth vibration waveform in both the first axial direction and the second axial direction.

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

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

5. 2. A method of operating the vibrating needle device of claim 1, comprising: a vibration step of vibrating the needle in at least one of the first axial direction and the second axial direction at a low frequency of 5 Hz to 15 Hz; a moving step of moving the tip of the needle in the first axial direction while vibrating the needle; Equipped with In the vibration step, the needle is vibrated in at least one of the first axial direction and the second axial direction to produce a sawtooth or inverted sawtooth vibration waveform.

6. 6. The method for operating a vibrating needle device according to claim 5, wherein the vibration step vibrates the needle so as to produce a sawtooth or inverted sawtooth vibration waveform in both the first axial direction and the second axial direction.

Images