Piercing instruments

Abstract

The present invention provides a puncture device capable of delivering (supplying) a drug solution. The puncture device comprises: a puncture top portion (2); a first tubular body (3) connected to the puncture top portion (2) at a distal end; and an outer tubular body (5) covering at least a portion of the first tubular body (3), wherein the first tubular body (3) is formed to be rotatable around an axis along the length direction, the outer diameter of the first tubular body (3) is smaller than the inner diameter of the outer tubular body (5), and a drug solution supply passage (5a) is provided on the outer side of the first tubular body (3).

Description

[0001] This application is a divisional application with an international application date of January 31, 2018 (date of entry into the Chinese national phase: July 31, 2019), an international application number of PCT / JP2018 / 003178 (national application number: 201880009503.1), and an invention name of “Puncture instrument and puncture device”. Technical Field

[0002] The present invention relates to a puncture device. Background Art

[0003] In the past, a bone marrow puncture needle was manually inserted into the ilium to extract bone marrow fluid. In this device, an inner needle is inserted and installed in a guide tube, and the tip of the inner needle protrudes from the guide tube to form a bone marrow puncture needle. In addition, in recent years, a device such as Patent Document 1 has been proposed, that is, a drill is formed at the tip of the inner needle, and the inner needle is rotated by an electric drill to perform excavation and perforation (excavation puncture) in a short time. However, for any bone marrow puncture needle, in order to extract sufficient bone marrow hematopoietic stem cells, a large amount of bone marrow fluid containing peripheral blood is required, and efficient stem cell extraction is not achieved.

[0004] However, since the extracted bone marrow (hereinafter also referred to as "bone marrow fluid") coagulates immediately, an anticoagulant is supplied to the inner needle for extracting the bone marrow fluid so that the bone marrow fluid and the anticoagulant are mixed. In Patent Document 1, a supply port for the anticoagulant is also connected near the root of the inner needle, and the anticoagulant is supplied to the inner needle from the supply port.

[0005] In addition, according to the histological structure of the bone marrow tissue, the bone marrow fluid does not flow from the surroundings into the puncture peripheral portion (puncture hole peripheral portion) formed immediately after a certain amount of bone marrow fluid has been extracted, but the peripheral blood is mainly supplied to the puncture peripheral portion during repeated extraction. Therefore, in the past, the position and angle of the outer needle were changed several times without changing the hole made in the skin, and the outer needle was re-inserted into the ilium to repeat the above-mentioned treatment. In addition, if a certain treatment is completed for one hole made in the skin, a hole is made in a different part of the skin and the same treatment is performed.

[0006] As a result, the number of holes in the skin is, for example, 2 to 6 in total, but the number of sites where the outer needle is inserted into the cortical bone of the ilium reaches 100 to 200 or more.

[0007] The reason for extracting from many parts as described above is that the amount of bone marrow fluid extracted from one part is limited to 3mL to 5mL. At this time, since there is no method to confirm the position of the inside of the ilium and the tip of the puncture needle inside the ilium from the outside, the extraction site often overlaps. In other words, since the position of the extraction site could not be confirmed from the outside in the past, it was necessary to adopt a method such as randomly changing the extraction site over a wide range to increase the probability of extracting the required amount of bone marrow fluid.

[0008] Prior art literature

[0009] Patent Literature

[0010] Patent Document 1: Japanese Patent No. 4808961 Summary of the invention

[0011] Problem that the invention aims to solve

[0012] However, in Patent Document 1, an opening is provided in the side wall near the tip of the inner needle, and the bone marrow fluid extracted from the opening is sucked by a suction device. Therefore, there is a problem that the anticoagulant supplied from the supply port near the root of the inner needle does not reach the vicinity of the opening and coagulates before reaching the supply port from the opening.

[0013] It is also considered to insert the tube for supplying the anticoagulant into the inner needle, but this is not ideal because the hollow part of the inner needle, which becomes the suction path of the bone marrow fluid, is blocked by the tube. In addition, when the outer diameter of the inner needle is increased in combination with the supply tube, the perforation (puncture hole) formed by the inner needle becomes too large, which is not ideal.

[0014] In addition, in addition to the case of extracting bone marrow fluid, the above-mentioned problem also occurs when a predetermined drug solution is administered (supplied) to body tissue while advancing a puncture needle or the like into the body.

[0015] Therefore, the first object of the present invention is to provide a puncture instrument capable of administering (supplying) a drug solution, for example, a puncture instrument or a puncture device that does not enlarge the perforation (puncture hole) formed in body tissue beyond the necessary level and can reliably administer (supply) a drug solution.

[0016] Furthermore, any bone marrow puncture needle requires a large amount of bone marrow fluid containing peripheral blood in order to extract sufficient bone marrow hematopoietic stem cells, and efficient stem cell extraction is not achieved.

[0017] Furthermore, when the tip of the inner needle formed with a drill is sharpened as in Patent Document 1, there is a hidden danger that the sharp tip may puncture (perforate) from the bone marrow cavity to the outside, causing a serious accident. In addition, when the opening for sucking bone marrow fluid is formed on the side of the tubular body connected to the inner needle as in Patent Document 1, the opening will be away from the tip of the inner needle that digs the hole (digs and punctures). Moreover, the opening direction of the opening becomes a direction orthogonal to the puncture direction of the tip of the inner needle. Therefore, it is difficult to efficiently suck the bone marrow fluid, and sometimes blockage occurs depending on the situation.

[0018] Therefore, the second object of the present invention is to provide a bone marrow puncture device capable of efficiently aspirating bone marrow fluid. The second object of the present invention is also to provide a bone marrow puncture device in which the tip of the puncture direction does not puncture (perforate) from the bone marrow cavity to the outside (e.g., the possibility of puncture is reduced).

[0019] Furthermore, in the method of Patent Document 1, since the angle of the outer needle and the direction in which the inner needle is to be inserted have to rely on the operator's intuition, the inner needle may sometimes enter the same site as the site where bone marrow extraction was performed once, resulting in poor efficiency of bone marrow extraction.

[0020] Furthermore, if the suction speed is too slow, blood will be over-sucked, whereas if the suction speed is too fast, the amount of bone marrow fluid extracted will be reduced. In order to maintain the quality of bone marrow fluid extraction, the inner needle needs to be inserted at an appropriate speed, but in the past, the extraction speed had to rely on the operator's intuition.

[0021] In order to solve the above problems, it is also considered to use an ultrasonic device to confirm the inside of the ilium and the positions of the outer needle and the inner needle in the ilium from the outside. However, the attenuation of ultrasound is large inside the bone, and it is very difficult to use an ultrasonic device for extracting bone marrow fluid from a deeper part.

[0022] Furthermore, in addition to the case of extracting bone marrow fluid, the above-mentioned problem also exists when a predetermined treatment is performed on body tissue while a puncture needle or the like is advanced in the body.

[0023] Therefore, the third object of the present invention is to provide a puncture device that can maintain a constant treatment quality without relying on the experience of the operator. The third object of the present invention is also to provide a puncture device that can improve the efficiency of treatment on body tissue and shorten the time required for treatment.

[0024] Solutions for solving problems

[0025] In order to achieve the above-mentioned first purpose, the first puncture instrument or the first puncture device of the present invention is characterized in that it comprises: a puncture top end portion; a first tubular body connected to the above-mentioned puncture top end portion at a distal end; and an outer tubular body, which covers at least a portion of the above-mentioned first tubular body, the above-mentioned first tubular body is formed to be rotatable around an axis along the longitudinal direction, the outer diameter of the above-mentioned first tubular body is smaller than the inner diameter of the above-mentioned outer tubular body, and a liquid medicine supply passage is provided on the outside of the above-mentioned first tubular body.

[0026] In order to achieve the above-mentioned second purpose, the bone marrow puncture instrument or bone marrow puncture device of the present invention allows at least the top end to be inserted into the bone marrow cavity to extract bone marrow fluid. The bone marrow puncture instrument or bone marrow puncture device is characterized in that it comprises: a tubular body, which has a distal end and an opening on the distal end surface; a top rotating part, which is arranged at a position closer to the distal side than the distal end surface of the above-mentioned tubular body, and the top rotating part rotates together with the above-mentioned tubular body to perforate (puncture) the tissue in the bone marrow cavity; and a connecting part, which connects the above-mentioned tubular body and the above-mentioned top rotating part.

[0027] In order to achieve the third object, the second puncture device of the present invention is characterized in that it comprises: a puncture section having a puncture tip and a tubular body connected to the puncture tip, the puncture section performing a predetermined treatment on body tissue while moving in the body; and a moving speed calculation section for calculating the moving speed of the puncture section.

[0028] Effects of the Invention

[0029] The first puncture device or puncture apparatus of the present invention can be used to administer a liquid medicine. In addition, the first puncture device or puncture apparatus of the present invention can be used to deliver a liquid medicine to the outer surface of the first tubular body through a liquid medicine supply passage provided on the outer side of the first tubular body. The liquid medicine delivered to the outer surface of the first tubular body is delivered to the puncture tip side, for example, and mixed with tissues extracted from the puncture tip, such as bone marrow fluid, etc. In addition, since the outer diameter of the first tubular body is, for example, smaller than the inner diameter of the outer tubular body, the first tubular body can rotate around an axis along the length direction, so the liquid medicine delivered to the outer surface of the first tubular body is delivered to the puncture tip side by the rotation of the first tubular body, and the bone marrow fluid, etc., just extracted from the puncture tip, is mixed with the liquid medicine. Therefore, the first puncture device or puncture apparatus of the present invention can reliably prevent the coagulation of the bone marrow fluid, etc., when an anticoagulant is used as the liquid medicine, for example. In addition, since the first tubular body for conveying the drug solution is, for example, housed in the outer tubular body, the perforation (puncture hole) for extracting the bone marrow fluid, etc. will not be enlarged beyond the required level, and the suction path of the bone marrow fluid, etc. can be fully ensured. More specifically, the first puncture tool or puncture device of the present invention can convey the drug solution even if, for example, no additional member for conveying the drug solution is provided with respect to the first tubular body and the outer tubular body. The puncture tool or puncture device of the present invention can provide, for example, a puncture tool (for example, a bone marrow puncture tool) or a puncture device (for example, a bone marrow puncture device) that can reliably deliver the drug solution without enlarging the perforation (puncture hole) formed in the body tissue beyond the required level. That is, the first puncture tool or puncture device of the present invention can reduce the size (for example, the diameter) of the puncture tool or puncture device, for example, and thus reduce the perforation (puncture hole) formed in the body tissue.

[0030] The bone marrow puncture instrument or bone marrow puncture device of the present invention can efficiently aspirate bone marrow fluid. Specifically, the bone marrow puncture instrument or bone marrow puncture device of the present invention can efficiently aspirate bone marrow fluid from the tissue in the bone marrow cavity perforated (punctured) by the top rotating part that rotates together with the tubular body, for example, and an opening is provided on the distal end surface of the tubular body connected from the top rotating part by the connecting part.

[0031] With the second puncture device of the present invention, when the position of the puncture portion moving in the body is moved, the moving speed of the puncture portion is calculated by the moving speed calculation unit. Therefore, with the second puncture device of the present invention, the moving speed of the puncture portion can be kept within an appropriate range by referring to the calculated moving speed of the puncture portion, and the quality of treatment can be kept constant without relying on the experience of the operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a diagram schematically showing a bone marrow puncture system according to one embodiment of the present invention.

[0033] Figure 2 This is a block diagram showing the structure of a bone marrow puncture system.

[0034] Figure 3 It is a cross-sectional view schematically showing a bone marrow puncture portion of a bone marrow puncture device.

[0035] Figure 4 is a diagram showing a guide tube, Figure 4 (A) is a plan view showing the entire guide tube in which the inner needle is inserted into the outer needle. Figure 4 (B) is Figure 4 A cross-sectional view of (A), Figure 4 (C) is a top view showing the inner needle. Figure 4 (D) is a top view showing the outer needle. Figure 4 (E) is Figure 4 (D) is a cross-sectional view of .

[0036] Figure 5 It is a perspective view showing the puncture tip.

[0037] Figure 6 It is a side view showing the puncture tip.

[0038] Figure 7 It is a top view showing the puncture tip portion.

[0039] Figure 8 It is a front view showing the puncture tip.

[0040] Fig. 9 The figure shows the puncture mark when the bone marrow puncture part of the embodiment is used for puncture in the simulation using the plastic block having the same hardness as the cortical bone and spongy bone of the human iliac bone. Fig. 9 (A) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 5 degrees. Fig. 9 (B) is a diagram showing the puncture marks when the puncture is performed at an incident angle of 10 degrees. Fig. 9 (C) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 15 degrees.

[0041] Fig.10 It is a side view showing a part of the first tubular body in an enlarged manner.

[0042] Fig.11 It is a cross-sectional view of a modified example of the first tubular body.

[0043] Fig.12 It is a front view of a modified example of the first tubular body.

[0044] Fig.13 It is a cross-sectional view schematically showing a bone marrow puncture portion of a bone marrow puncture device.

[0045] Fig.14 It is a top view showing the guide tube.

[0046] Fig.15 The figure schematically shows a bone marrow puncture system.

[0047] Fig.16 This is a block diagram showing the structure of a bone marrow puncture system.

[0048] Fig.17 This is a diagram for explaining navigation of a bone marrow puncture system.

[0049] Fig.18 This is a diagram for explaining navigation of a bone marrow puncture system.

[0050] Fig.19 This is a diagram for explaining navigation of a bone marrow puncture system.

[0051] Fig. 20 The diagram shows puncture marks when puncturing using the bone marrow puncture part of the comparative example in a simulation using a plastic block having a hardness equivalent to that of the cortical bone and spongy bone of the human iliac bone. Fig. 20 (A) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 5 degrees. Fig. 20 (B) is a diagram showing the puncture marks when the puncture is performed at an incident angle of 10 degrees. Fig. 20 (C) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 20 degrees.

[0052] Fig.21 It is a diagram schematically showing a modified example of the bone marrow puncture system of the present invention.

[0053] Fig. 22 It is a block diagram showing the structure of a modified example of the bone marrow puncture system.

[0054] Fig.23 It is a perspective view showing a modified example of the bone marrow puncture device.

[0055] Fig.24 yes Fig.23 Cross-sectional view along the A-A' direction.

[0056] Fig.25 yes Fig.23 An enlarged view of a modified example of the bone marrow puncture portion. DETAILED DESCRIPTION

[0057] In the description of the first puncture instrument or puncture device of the present invention, the "distal end" in this specification refers to the end of the first tubular body that is farther away when viewed from the surgeon's side when the surgeon punctures the puncture tip of the puncture device (puncture instrument) toward the surgical part.

[0058] In the description of the first puncture instrument or puncture device of the present invention, the "proximal end" in this specification refers to the end of the first tubular body that is closer when viewed from the surgeon's side when the surgeon punctures the puncture tip of the puncture device (puncture instrument) toward the surgical part.

[0059] In the description of the bone marrow puncture instrument or bone marrow puncture device of the present invention, the "distal end" of the present specification refers to the end of the tubular body that is farther from the side observed from the operator's side when the operator inserts the top end of the bone marrow puncture device (bone marrow puncture instrument) into the bone marrow cavity. In the description of the bone marrow puncture instrument or bone marrow puncture device of the present invention, the "distal side" of the present specification refers to the side farther from the distal end face of the tubular body when viewed from the operator's side. In the description of the bone marrow puncture instrument or bone marrow puncture device of the present invention, the "proximal side" of the present specification refers to the closer side of the tubular body when viewed from the operator's side.

[0060] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

[0061] (Structure of bone marrow puncture system)

[0062] The structure of the bone marrow puncture system 100 will be described with reference to the drawings. Figure 1 FIG. 1 is a diagram schematically showing a bone marrow puncture system 100 according to an embodiment of the present invention. Figure 2 is a block diagram showing the structure of the bone marrow puncture system 100. Figure 1 , Figure 2 The part related to the navigation described later is omitted.

[0063] like Figure 1 and Figure 2 As shown, the bone marrow puncture system 100 includes: a bone marrow puncture device 10, a container 110, a control unit 120, a vacuum generator 130, a switch unit 140, a syringe pump 150 and a personal computer (hereinafter referred to as PC) 190.

[0064] A bone marrow puncture device 10 as an example of a puncture device includes a housing 10a, and a bone marrow puncture unit 1 described below and a drive unit including a motor (not shown) are provided inside the housing 10a. A handle 10b is formed on the housing 10a to facilitate operation by an operator.

[0065] like Figure 1As shown in FIG. 1 , an outer sheath (outer tubular body) 5 covering the first tubular body 3 and the second tubular body 4 of the bone marrow puncture part 1 described later protrudes from the housing 10a, and a puncture tip portion 2 is installed at the tip of the first tubular body 3 covered by the outer sheath 5. The length of the protruding portion protruding from the housing 10a, including the first tubular body 3, the second tubular body 4, the outer sheath 5 and the puncture tip portion 2, is L1. Figure 1 As shown by the middle dotted line, the first tubular body 3 and the outer sheath 5 covering the first tubular body 3 are flexible. The length of the flexible portion is L2. The first tubular body 3, the second tubular body 4 and the puncture tip 2 covered by the outer sheath 5 can rotate counterclockwise or clockwise. The detailed description of the bone marrow puncture part 1 having the puncture tip 2, the first tubular body 3, the second tubular body 4 and the outer sheath 5 is described later.

[0066] The container 110 is a container for storing bone marrow fluid aspirated by the bone marrow puncture device 10, and is connected to the bone marrow puncture device 10. In addition, the container 110 is connected to the suction control unit 125 of the control unit 120, and the suction control unit 125 controls the pressure value of the suction pressure of the container 110 and the bone marrow puncture device 10 connected to the container 110 and the on / off of the suction pressure.

[0067] The control unit 120 includes a CPU (Central Processing Unit), a ROM (Read only memory), and a RAM (Random access memory), etc. (not shown), and functions as a suction control unit 125 and an action control unit 126. The suction control unit 125 is connected to a vacuum generator 130 and a switch unit 140. The vacuum generator 130 as a suction device is used to generate a predetermined negative pressure. The predetermined negative pressure is, for example, greater than -90 kPa and less than 0 kPa.

[0068] The switch unit 140 is provided near the operator and includes a switch for turning on / off suction and a switch for turning on / off the motor. Figure 1 The switch unit 140 is omitted in the figure. In addition, the switch unit 140 can be independent of the bone marrow puncture device 10 or integrated with the bone marrow puncture device 10. When the switch unit 140 is configured independently of the bone marrow puncture device 10, it can be set as a foot switch, for example. When the switch unit 140 is configured as an integral part of the bone marrow puncture device 10, the switch unit 140 can be set on the handle 10b, for example.

[0069] The suction control unit 125 is provided with a valve not shown in the figure, and opens / closes the valve when receiving a suction opening / closing signal from the switch unit 140 according to the operation of the surgical operator. For example, an internal container connected to the vacuum generator 130 may be provided in the control unit 120, and the valve may be provided in the internal container. Thus, the opening / closing of the suction pressure of the bone marrow puncture device 10 can be controlled. In addition, a knob 120a is provided in the control unit 120, and the pressure value of the suction pressure can be adjusted by turning the knob 120a. The suction control unit 125 may also close the valve after a specified time when receiving a closing signal, for example. Thus, the suction control unit 125 can, for example, prevent the anticoagulant supplied to the bone marrow puncture unit 1 from leaking from the opening 20b of the tubular body 20.

[0070] The action control unit 126 is connected to the drive unit and the switch unit 140 of the bone marrow puncture device 10. When the motor on / off signal is received from the switch unit 140 according to the operation of the operator, the on / off signal is sent to the motor of the drive unit. In this way, the rotation and stop of the bone marrow puncture unit 1 of the bone marrow puncture device 10 can be controlled. The control unit 120 is provided with a knob 120b, and the rotation speed of the motor can be adjusted by turning the knob 120b. The rotation speed and torque of the motor are, for example, the rotation speed and torque that can puncture the tissue in the bone marrow cavity. The rotation speed is, for example, 60rpm to 150rpm. In addition, the torque is, for example, less than 500mN·m and less than 300mN·m. The propulsion force of the bone marrow puncture unit 1 is, for example, about 15N to 20N. The propulsion speed of the bone marrow puncture unit 1 is, for example, about 1mm / second. In this embodiment, as an example, the rotation speed is set to 120rpm, and the knob 120b can be set to, for example, 90rpm, 120rpm or 150rpm. In order to prevent, for example, perforation of the outer side of the cortical bone and damage to the first tubular body 3, the action control unit 126 may calculate the current of the motor of the driving unit according to the torque of the deformation limit of the first tubular body 3. In this case, the action control unit 126 may send a shutdown signal to the motor of the driving unit when an overload of a current greater than the above current value is required. That is, the action control unit 126 may also cut off the drive of the motor. In addition, in the case where an overload protection device such as a torque limiter is installed on the shaft of the motor of the driving unit, the action control unit 126 may also send a signal to suppress the rotation speed to the overload protection device. That is, the action control unit 126 may also mechanically cut off the overload of the motor of the driving unit through the overload protection device. In addition, the action control unit 126 may also inform the operator of the torque and current value of the motor of the driving unit according to, for example, the on and off of the light, the warning sound, etc. In addition, the action control unit 126 may also send an on signal to the motor of the driving unit to drive again when the overload is relieved.

[0071] The injection pump 150 is a pump for supplying an anticoagulant as a medical solution to the bone marrow puncture device 10. The injection pump 150 is connected to the bone marrow puncture device 10. The injection pump 150 is provided with a knob 150a, and the supply speed of the anticoagulant can be adjusted by turning the knob 150a. In the present embodiment, as an example, an anticoagulant such as heparin is supplied at a speed of 40μl / second (sec). Detailed description related to the supply system of the anticoagulant is described later. In the present embodiment, the anticoagulant is supplied using the injection pump 150, but the present invention is not limited to this. For example, other liquid supply components such as a ring pump can also be used for liquid supply.

[0072] PC190 is connected to the control unit 120, and can output commands to the control unit 120 and output setting data. PC190 includes, for example, a CPU, a main memory (ROM, RAM, etc.), an auxiliary storage device (hard disk, flash memory, etc., hereinafter also referred to as a "recording unit"), a video codec, an I / O (input-output) interface, etc., and uses a controller (system controller, I / O controller, etc.) to control the above-mentioned components so that they work together. PC190, for example, may also have input components (keyboards, etc.) and output components (displays such as liquid crystal displays, printers, etc.). In the present embodiment, PC190 is a personal computer, but it may also be a structure similar to a server computer, a workstation, etc. In addition, PC190 may also be composed of, for example, a portable terminal (smartphones, tablet computers, etc.), a smart speaker, etc.

[0073] Fig.21 FIG. 2 is a diagram schematically showing a bone marrow puncture system 200 according to a modified example. Fig. 22 2 is a block diagram showing the structure of a bone marrow puncture system 200 according to a modified example. Fig.21 , Fig. 22 The part related to the navigation described later is omitted.

[0074] like Fig.21 and Fig. 22 As shown, the bone marrow puncture system 200 has a filter device 210 in addition to the structure of the bone marrow puncture system 100. In addition, the control unit 120 has a liquid delivery control unit 127 in addition to the suction control unit 125 and the operation control unit 126. The syringe pump 150 is electrically connected to the control unit 120.

[0075] The filter device 210 is a device for filtering the bone marrow fluid sucked by the bone marrow puncture device 10, and is used to remove the spongy bone of the bone marrow fluid. The filter device 210 can use a commercially available filter, jacket, etc. The filter device 210 is connected to the bone marrow puncture device 10 and the container 110. As described above, the container 110 connected to the filter device 210 is connected to the suction control unit 125 of the control unit 120. Therefore, the suction control unit 125 is used to control the pressure value of the suction pressure of the container 110, the filter device 210, and the bone marrow puncture device 10 connected to the container 110 and the on / off of the suction pressure.

[0076] The control unit 120 functions as a suction control unit 125 , an operation control unit 126 , and a liquid supply control unit 127 .

[0077] The liquid supply control unit 127 is connected to the switch unit 140 and the syringe pump 150. When receiving the liquid supply on / off signal from the switch unit 140 according to the operation of the operator, the liquid supply control unit 127 sends the liquid supply on / off signal to the syringe pump 150. In this way, the start and stop of the liquid supply of the syringe pump 150 can be controlled. In this way, the liquid supply from the syringe pump 150 is controlled to be on / off synchronously with the on / off of the suction pressure of the bone marrow puncture device 10, so that the anticoagulant supplied to the bone marrow puncture unit 1 can be prevented from leaking from the opening 20b of the tube body 20. As mentioned above, the syringe pump 150 is provided with a knob 150a, and the supply speed of the anticoagulant can be adjusted by turning the knob 150a. However, the present invention is not limited to this, and for example, the liquid supply control unit 127 can also adjust the supply speed of the anticoagulant and other liquid medicines.

[0078] In the bone marrow puncture system 200 of the modified example, the suction control unit 125, the motion control unit 126, and the liquid supply control unit 127 are all connected to the switch unit 140, but the switch unit 140 may be connected to the motion control unit 126, and the motion control unit 126 may be connected to the suction control unit 125 and the liquid supply control unit 127. In this case, when the motion control unit 126 receives the motor on / off signal, the suction on / off signal, and the liquid supply on / off signal from the switch unit 140 according to the operation of the operator, the motion control unit 126 sends the suction on / off signal and the liquid supply on / off signal to the suction control unit 125 and the liquid supply control unit 127. In addition, the motion control unit 126 sends an on / off signal to the motor of the driving unit. The suction control unit 125 is used to control the on / off of the suction pressure of the bone marrow puncture device 10. The liquid supply control unit 127 is used to control the on / off of the liquid supply of the syringe pump 150. In addition, the control unit 120 of the bone marrow puncture system 100 may also be configured in the same manner.

[0079] (Structure of bone marrow puncture site)

[0080] The structure of the bone marrow puncture part 1 of the bone marrow puncture device 10 will be described with reference to the drawings. Figure 3 2 is a cross-sectional view schematically showing the bone marrow puncture section 1 of the bone marrow puncture device 10 according to the present embodiment. Figure 3 The figure schematically shows the bone marrow puncture part 1, and does not show the actual length, thickness or ratio.

[0081] like Figure 3 As shown, the bone marrow puncture part 1 of this embodiment includes: a puncture tip 2, a first tubular body 3, a second tubular body 4, an outer sleeve 5, a first shaft 6, a gear 7, a second shaft 8, and a container connection part 9. The puncture tip 2, the first tubular body 3, the second tubular body 4, and the outer sleeve 5 of the bone marrow puncture part 1 (hereinafter also referred to as "bone marrow puncture needle" or "puncture needle") can also be installed in the first shaft 6, the gear 7, and the second shaft 8 in a detachable manner. In addition, Figure 3 The magnetic sensor used for navigation described later is omitted.

[0082] The puncture tip portion 2 includes a tubular body 20, a disc-shaped portion 21 as a tip rotating portion, and a connecting portion 22. Figure 5 , Figure 7 and Figure 8 As shown, the tubular body 20 has an opening 20b. Here, the tubular body 20 forms a tubular body together with the first tubular body 3 and the second tubular body 4, and the opening 20b is provided on the distal end surface of the tubular body. The disc-shaped portion 21 has a radial central axis C1 consistent with the central axis C of the tubular body 20, which is located at the top of the puncture direction shown by the arrow Z. In addition, in this specification, "puncture direction" refers to the direction in which the puncture tip portion 2 of the bone marrow puncture device 10 for perforating (puncturing) the bone marrow moves in the bone marrow. The connecting portion 22 connects a part of the top end surface 20a (the distal end surface of the tubular body) of the tubular body 20 with the disc-shaped portion 21. The tubular body 20, the disc-shaped portion 21 and the connecting portion 22 of the puncture tip portion 2 are made of metals such as stainless steel, titanium alloy, noble metal alloy, cobalt alloy (hereinafter also referred to as "metals such as stainless steel"), and are formed integrally by cutting, etc. In addition, the disk-shaped portion 21 and the connecting portion 22 may be integrally formed by cutting or the like, and the connecting portion 22 may be joined to the tubular body 20. Alternatively, the tubular body 20, the disk-shaped portion 21, and the connecting portion 22 may be separately formed by cutting or the like, and they may be joined separately. The detailed description of the puncture tip portion 2 is described later.

[0083] The first tubular body 3 is a tubular body connected to the tubular body 20 of the puncture top end portion 2, and is formed to be rotatable around an axis along the length direction. The first tubular body 3, for example, can also be called a tubular body that can rotate around the axis in the length direction. The first tubular body is, for example, a spiral body of a round wire such as stainless steel, and is formed by winding the round wire into a spiral shape. The spiral body can also be formed by a metal other than stainless steel such as a titanium alloy, a precious metal alloy, a cobalt alloy, etc. In addition, the spiral body can also be a spiral body of a wire material other than a round wire such as a flat wire. The winding direction of the first tubular body 3 is consistent with the rotation direction of the first tubular body 3 (for example, a counterclockwise direction or a clockwise direction (CW)). Since the first tubular body 3 is formed in a spiral shape, it has flexibility, and is formed so that a liquid medicine such as an anticoagulant can penetrate from the gaps (for example, permeation holes) between the round wires. The outer diameter of the first tubular body 3 is formed to be smaller than the inner diameter of the outer sheath 5, and the first tubular body 3 can rotate in the outer sheath 5. In addition, a drug solution supply passage 5a is formed between the outer circumference of the first tubular body 3 and the inner circumference of the outer sheath 5. The first tubular body 3 and the portion of the outer sheath 5 covering the first tubular body 3 have a length L2, and the portion having the length L2 is Figure 1 The length L2 shown corresponds to the flexible portion.

[0084] The second tubular body 4 is a cylindrical tube that is a rigid body connected to the first tubular body 3, and is formed of, for example, a metal such as stainless steel. The outer diameter of the second tubular body 4 is formed to be smaller than the inner diameter of the outer sheath 5, and the second tubular body 4 can rotate together with the first tubular body 3 in the outer sheath 5. In addition, a drug supply passage 5a is formed between the outer circumferential surface of the second tubular body 4 and the inner circumferential surface of the outer sheath 5, and the drug supply passage 5a is formed continuously with the drug supply passage 5a formed between the outer circumferential surface of the first tubular body 3 and the inner circumferential surface of the outer sheath 5. The length of the second tubular body 4 is preferably a length that does not allow the second tubular body 4 to protrude from the distal end of the guide tube when the bone marrow puncture needle is moved toward the distal end in the guide tube described later. That is, Figure 3 The length L5 in the middle is preferably as described below. Figure 4 The length L5 may be less than the length L4 shown in the figure. The length L5 may also be referred to as the length of the region of the second tubular body 4 that protrudes from the first shaft 6 and is excluding the connection portion connected to the first tubular body 3 in the longitudinal direction. Thus, the puncture tip portion 2 can be pressed out along the axial direction of the guide tube by the second tubular body 4, so that the puncture direction of the puncture tip portion 2 of the bone marrow puncture portion 1 is consistent with the axial direction of the guide tube, for example. Therefore, by setting the length of the second tubular body 4 to the above-mentioned structure, for example, the puncture direction of the bone marrow puncture device 10 can be easily set.

[0085] The outer sheath 5 is a cylindrical tube formed of plastics, resins, etc., such as PTFE (polytetrafluoroethylene), and has a length covering the entire first tubular body 3 and a part of the second tubular body 4. The outer sheath 5 is flexible. As described above, the inner diameter of the outer sheath 5 is formed to be larger than the outer diameter of the first tubular body 3 and the outer diameter of the second tubular body 4. The first tubular body 3 and the second tubular body 4 can rotate inside the outer sheath 5. In addition, a liquid medicine supply passage 5a is formed between the inner circumferential surface of the outer sheath 5 and the outer circumferential surface of the first tubular body 3 and between the inner circumferential surface of the outer sheath 5 and the outer circumferential surface of the second tubular body 4. One end of the outer sheath 5 contacts the end surface of the tubular body 20 of the puncture tip 2 to a degree that does not hinder the rotation of the puncture tip 2, and the other end of the outer sheath 5 is inserted into the first shaft 6. That is, the outer sheath 5 is configured to not rotate itself. By configuring in this way, the generation of friction caused by the rotation of the outer sheath 5 can be prevented, and the generation of heat caused by friction and the increase of the rotation load can be prevented.

[0086] The length of the portion of the second tubular body 4 protruding from the first shaft 6, the portion of the outer sleeve 5 covering the first tubular body 3, and the puncture tip portion 2 is L1. Figure 1 The protrusion of length L1 shown corresponds to this.

[0087] The first shaft 6 is a non-rotating body formed of metal such as stainless steel, plastic, resin, etc., and is mounted on the outer periphery of the second tubular body 4 via a bearing 60. In addition, an O-ring 61 is installed between the first shaft 6 and the second tubular body 4 to ensure the airtightness between the first shaft 6 and the second tubular body 4 with respect to the bearing 60 side. The first shaft 6 is formed with a supply port 6a for a drug solution such as an anticoagulant. Figure 1 and Figure 2 The syringe pump 150 as the drug supply unit is supplied to the supply port 6a along the direction of arrow B. A drug supply passage 6b is formed between the inner periphery of the first shaft 6 near the supply port 6a and the outer periphery of the second tubular body 4, and the drug supply passage 6b is continuous with the above-mentioned drug supply passage 5a. Therefore, the drug supplied from the supply port 6a is transported to the outer periphery of the first tubular body 3 via the drug supply passage 6b and the drug supply passage 5a, and penetrates into the first tubular body 3 from the gaps between the circular lines of the first tubular body 3.

[0088] The gear 7 is formed of metal such as carbon steel, stainless steel, plastic, resin, etc., and is engaged with the second tubular body 4. The rotational force of the motor not shown in the figure is transmitted to the gear 7 by means of a pinion not shown in the figure, so that the second tubular body 4 is rotated. As a result, the first tubular body 3 and the puncture tip portion 2 rotate together with the second tubular body 4. In the present embodiment, as an example, the rotation speed of the second tubular body 4, the first tubular body 3 and the puncture tip portion 2 is set to 120 rpm. The gear ratio of the gear 7 is not particularly limited and can be appropriately set according to the setting method of the drive unit.

[0089] The second shaft 8 is a non-rotating body formed of metal such as stainless steel, plastic, resin, etc., and is mounted on the outer periphery of the second tubular body 4 via a bearing 80. In addition, an O-ring 81 is installed between the second shaft 8 and the second tubular body 4 to ensure the airtightness between the second shaft 8 and the second tubular body 4 with respect to the bearing 80 side. A communication hole 8a is formed inside the second shaft 8 and communicates with the rear end opening 4a of the second tubular body 4.

[0090] The container connection part 9 is formed of, for example, plastic, resin, etc., and is mounted on the second shaft 8. An O-ring 90 is provided between the container connection part 9 and the second shaft 8 to ensure airtightness between the container connection part 9 and the second shaft 8. A communication hole 9a is formed inside the container connection part 9 to communicate with the communication hole 8a of the second shaft 8. Figure 1 as well as Figure 2 The container 110 is connected to the container 110. Figure 1 and Figure 2 The vacuum generator 130 is shown.

[0091] When the vacuum generator 130 generates negative pressure as the suction pressure, negative pressure is also generated in the container, the communicating hole 9a of the container connecting portion 9, the hollow part of the second tubular body 4, and the hollow part of the first tubular body 3. In addition, by rotating the second tubular body 4, the first tubular body 3, and the puncture tip portion 2 while the bone marrow puncture portion 1 as a whole moves in the puncture direction, the puncture tip portion 2, the outer cover 5, and the first tubular body 3 covered by the outer cover 5 move in the bone marrow cavity punctured by the puncture tip portion 2. In this process, the bone marrow fluid is sucked in the direction of arrow A through the opening 20b of the puncture tip portion 2, the hollow part of the first tubular body 3, the hollow part of the second tubular body 4, and the communicating hole 9a of the container connecting portion 9 under the action of the above-mentioned negative pressure, and is aseptically stored in the container 110 without being exposed to the outside of the bone marrow puncture device 10 during this transfer process. Furthermore, since the anticoagulant is supplied to the bone marrow fluid just sucked from the opening 20 b of the puncture distal end portion 2 via the first tubular body 3 , the bone marrow fluid is stored in the container 110 without being coagulated.

[0092] In the present embodiment, the bone marrow puncture needle may be, for example, in a state where the opening 20b, the rear opening 4a, and the connection portion connecting the drug supply passage 5a and the drug supply passage 6a are detached from the first shaft 6, the gear 7, and the second shaft 8, and the opening 20b, the rear opening 4a, and the connection portion connecting the drug supply passage 5a and the drug supply passage 6a are sealed or covered by a sealing member such as a cap, or a cover member such as a cover. Thus, the bone marrow puncture needle can be sterilized, for example, so that the inside of the bone marrow puncture needle can be made sterile, and the sterility of the bone marrow puncture system 100 can be maintained. In addition, the opening of the container 110 may also be sealed or covered by a sealing member such as a cap, or a cover member such as a cover. Thus, the container 110 can be sterilized, for example, so that the inside of the container 110 and the cover surface can be made sterile, and after the bone marrow fluid is extracted, it can be covered with a cover and transferred to a processing facility in a sterile state.

[0093] Reference Fig.23 , Fig.24 , Fig.25 A bone marrow puncture device 10 including a bone marrow puncture section 1 ′ according to a modified example will be described. Fig.23 It is a perspective view of the bone marrow puncture device 10 . Fig.24 yes Fig.23 Cross-sectional view along the A-A' direction.

[0094] Fig.25 yes Fig.23 The enlarged view of the bone marrow puncture section 1' in FIG. Fig.23 , Fig.24 , Fig.25 The magnetic sensor used for navigation described later is omitted.

[0095] like Fig.23 , Fig.24 As shown, the bone marrow puncture device 10 includes a housing 10a, and a bone marrow puncture part 1' and a driving part 71 including a motor 71a and the like are provided inside the housing 10a. In order to facilitate the operation by the operator, a handle part 10b is formed on the housing 10a. A switch part 140 is provided on the handle part 10b. A detachable upper cover 10c is installed on the upper part of the housing 10a. In a state where the upper cover 10c is removed from the housing 10a, the bone marrow puncture part 1' can be installed and removed in the housing 10a. As a result, when the bone marrow puncture device 10 is clogged in the first tubular body 3 or the second tubular body 4 of the bone marrow puncture part 1', the bone marrow puncture part 1' can be easily replaced.

[0096] like Fig.24As shown, the driving unit 71 includes: a motor 71a, a motor fixing portion 71b, a joint 71c, a gear 71d and a radial bearing 71e. The motor 71a is fixed to the motor fixing portion 71b formed of plastic, resin, etc. using a fixing member such as a screw. The shaft of the motor 71a and the shaft of the gear 71d are connected using a joint 71c. The gear 71d is fixed in an axially tightening manner using its fixing portion, and the shaft end is accommodated in the radial bearing 71e. As a result, when the motor 71a rotates, the rotational force is transmitted to the gear 71d via the joint 71c. The gear 71d is engaged with the gear 7 of the bone marrow puncture unit 1', and the rotational force transmitted from the motor 71a is transmitted to the gear 7.

[0097] like Fig.25 As shown, the bone marrow puncture part 1' comprises: a second tubular body 4, an outer sleeve 5, a puncture connection part 62, a first bearing unit 63 corresponding to the first shaft 6, a gear 7, a second bearing unit 82 corresponding to the second shaft 8, and a container connection part 9. In addition, since the puncture tip part 2 and the first tubular body 3 of the bone marrow puncture part 1' have the same structure as the puncture tip part 2 and the first tubular body 3 of the bone marrow puncture part 1, they are not shown in the figure.

[0098] The puncture connection part 62 is formed of, for example, plastic, resin, etc., and is detachably mounted on the first bearing unit 63. An O-ring 64 is provided between the second tubular body 4, the puncture connection part 62, and the first bearing unit 63 to ensure airtightness among the second tubular body 4, the puncture connection part 62, and the first bearing unit 63. In other words, the liquid tightness of the drug supply passage 6b is ensured. A connecting hole 62a is formed in the puncture connection part 62 to connect the supply port 6a of the drug such as the anticoagulant and the hollow part of the puncture connection part 62. The drug such as the anticoagulant is supplied from the puncture connection part 62 to the hollow part of the puncture connection part 62. Figure 1 and Figure 2 The syringe pump 150 as the drug supply unit is shown to supply the drug to the communicating hole 62a via the supply port 6a in the direction of arrow B. A drug supply passage 6b is formed between the inner periphery of the puncture connection portion 62 near the communicating hole 62a and the outer periphery of the second tubular body 4, and the drug supply passage 6b is continuous with the above-mentioned drug supply passage 5a. Therefore, the drug supplied from the supply port 6a is transported to the outer periphery of the first tubular body 3 via the communicating hole 62a, the drug supply passage 6b, and the drug supply passage 5a, and penetrates into the first tubular body 3 from the gaps between the circular lines of the first tubular body 3.

[0099] The first bearing unit 63 includes a first bearing shell 63a, a first radial bearing 60a, and a bearing holding portion 631. The first bearing shell 63a is a non-rotating body formed of, for example, plastic, resin, etc., and is mounted on the outer periphery of the second tubular body 4 covered by a protective sheath 4a as a protective member of the tube wall, with the first radial bearing 60a interposed therebetween. The first radial bearing 60a is held in the first bearing shell 63a by the adjacent bearing holding portion 631. A supply port 6a is formed in the first bearing shell 63a, and the supply port 6a is connected to the syringe pump 150 via a connecting connector 65 such as a roll joint connector. An O-ring 66 is provided between the supply port 6a and the connecting connector 65 to ensure airtightness between the first bearing shell 63a and the connecting connector 65. For example, in order to disperse the surface pressure, a gasket or the like may be arranged between the first bearing shell 63a and the first radial bearing 60a, and between the first radial bearing 60a and the bearing holding portion 631.

[0100] The gear 7 is made of metal such as carbon steel, stainless steel, plastic, resin, etc., and is fitted to the outer periphery of the second tubular body 4 covered by the protective sheath 4a to protect the tube wall. The rotational force of the motor 71a is transmitted to the gear 7 via the gear 71d of the driving unit 71, so that the second tubular body 4 rotates.

[0101] The second bearing unit 82 includes a second bearing shell 82a, a thrust bearing 80b, a second radial bearing 80c, and a bearing retaining portion 821. The second bearing shell 82a is a non-rotating body formed of, for example, plastic, resin, etc., and is mounted on the outer periphery of the second tubular body 4 covered by the protective sheath 4a via the second radial bearing 80c. In addition, a thrust bearing 80b is arranged in the second bearing shell 82a. The thrust bearing 80b and the second radial bearing 80c are retained in the second bearing shell 82a by the adjacent bearing retaining portion 821. For example, in order to disperse the surface pressure, a washer or the like may be arranged between the second bearing shell 82a and the second radial bearing 80c, between the second radial bearing 80c and the bearing retaining portion 821, and between the thrust bearing 80b and the gear 7.

[0102] The container connection part 9 is formed of, for example, plastic, resin, etc., and is detachably mounted on the second bearing unit 82. An O-ring 91 is provided between the second tubular body 4, the container connection part 9, and the second bearing unit 82 to ensure airtightness between the container connection part 9 and the second bearing unit 82. A communication hole 9a is formed inside the container connection part 9 to communicate with the second tubular body 4. The container connection part 9 and the second bearing unit 82 are connected. Figure 1 as well as Figure 2 The container 110 is connected. Figure 1 and Figure 2 The vacuum generator 130 is shown.

[0103] The bone marrow puncture part 1' includes: a first radial bearing 60a, a gear 7, a thrust bearing 80b, and a second radial bearing 80c. Therefore, the first radial bearing 60a, the gear 7, and the second radial bearing 80c indirectly mounted on the second tubular body 4 bear the resistance of the bone marrow puncture part 1' relative to the axial rotation in the rotation direction. In addition, the thrust bearing 80b bears the resistance of the bone marrow puncture part 1' relative to the propulsion force. Therefore, by using the bone marrow puncture part 1', the bone marrow puncture part 1' can bear various resistances during the puncture process, and the operation and puncture can be performed more safely. The method of using the bone marrow puncture part 1' is the same as the method of using the bone marrow puncture part 1.

[0104] Different bearings are provided for the bone marrow puncture part 1' to bear the resistance from the rotation direction (radial direction) and the resistance from the propulsion direction (axial direction) generated during puncture, but the present invention is not limited thereto, and one bearing may be used to bear the resistance from the rotation direction and the resistance from the propulsion direction. In addition, a lubricating bearing or the like may be used as the bearing.

[0105] In the bone marrow puncture part 1', the rotational force of the driving part 71 is transmitted to the second tubular body 4 via the gear 7, but the present invention is not limited thereto, and the rotational force of the driving part 71 may be directly transmitted to the second tubular body 4. As a specific example, the motor 71a may also directly rotate the second tubular body 4.

[0106] Each opening and connection of the bone marrow puncture part 1' may be sealed or covered by a sealing member such as a cap or a cover member such as a cover. Thus, the bone marrow puncture needle can be sterilized, so that the bone marrow puncture needle can be sterile and the sterility of the bone marrow puncture system 100 can be maintained.

[0107] (Structure of guide tube)

[0108] The structure of the guide tube 30 will be described with reference to the drawings. Figure 4 is a diagram showing a guide tube, Figure 4 (A) is a plan view showing the entire guide tube in which the inner needle is inserted into the outer needle. Figure 4 (B) is Figure 4 A cross-sectional view of (A), Figure 4 (C) is a top view showing the inner needle. Figure 4 (D) is a top view showing the outer needle. Figure 4 (E) is Figure 4 In addition, Figure 4 The magnetic sensor used for navigation described later is omitted.

[0109] In the bone marrow puncture system 100 of this embodiment, the guide tube 30 is first inserted into the ilium or the like from the skin of the donor, and then the protruding portion of the bone marrow puncture unit 1 having a length L1 is inserted into the hollow portion of the guide tube 30 to perform bone marrow puncture.

[0110] like Figure 4 (A) Figure 4 As shown in (B), the guide tube 30 is formed by combining an inner needle 31 and an outer needle 32. The material of the guide tube 30 can be, for example, pseudo-austenitic stainless steel. However, as the material of the guide tube 30, non-magnetic metal or high-tensile steel can also be used. In addition, as the material of the guide tube 30, non-metal can also be considered.

[0111] like Figure 4 (B) Figure 4 As shown in (C), the inner needle 31 includes: an inner needle portion 31a, a ring portion 31b, and an inner needle holding portion 31c. The inner needle portion 31a is a rod-shaped body with a sharp tip portion, which is supported by the inner needle holding portion 31c. The ring portion 31b is rotatably mounted on the inner needle holding portion 31c, and the inner needle 31 can be mounted on the outer needle 32 and removed from the outer needle 32 by rotating the ring portion 31b.

[0112] like Figure 4 (B) Figure 4 (D) Figure 4 As shown in (E) of FIG. 1 , the outer needle 32 includes an outer needle portion 32a and an outer needle holding portion 32b. The outer needle holding portion 32b includes a hollow portion, and the outer needle portion 32a is supported in the hollow portion. The outer needle portion 32a is a hollow cylindrical body.

[0113] When assembling the guide tube 30, first Figure 4 The inner needle 31a is inserted into the opening 32c at the rear end of the outer needle holding part 32b and the opening 32d at the rear end of the outer needle 32a shown in (E). Next, the outer needle holding part 32b is tightened by the inner needle holding part 31c by rotating the ring part 31b, and the guide tube 30 in which the outer needle 32 and the inner needle 31 are integrated is assembled.

[0114] When puncturing the bone marrow, first, the guide tube 30, which is composed of an outer needle 32 and an inner needle 31, is inserted from the donor's skin into the ilium or the like. The rotation speed of the inner needle 31 when inserting the guide tube 30 is, for example, about 1000 rpm at most. The part inserted into the ilium or the like is Figure 4 Next, the inner needle 31 is removed from the outer needle 32 by rotating the ring portion 31b, thereby loosening the tightening of the inner needle holding portion 31c to the outer needle holding portion 32b. As a result, the outer needle 32 is left in a state of piercing the ilium or the like. The portion piercing the ilium or the like is Figure 4In this state, the protruding portion of the bone marrow puncture part 1 having a length L1 is inserted from the opening 32d at the rear end of the outer needle part 32a into the hollow part of the outer needle part 32a to puncture the bone marrow.

[0115] In this embodiment, as described later, the guide tube 30 inserted into the same puncture hole (hole opened in the skin) can be inserted into the bone marrow puncture part 1 at various angles to perform bone marrow puncture and bone marrow fluid extraction. In addition, in this embodiment, the guide tube 30 can be inserted (punctured) into the same puncture hole (hole punctured into the cortical bone (opened in the cortical bone)) again at various angles to perform new bone marrow puncture and bone marrow fluid extraction.

[0116] (Structure of the puncture tip)

[0117] Next, the detailed structure of the puncture distal end portion 2 will be described with reference to the drawings. Figure 5 It is a perspective view showing the puncture distal end portion 2 . Figure 6 It is a side view showing the puncture distal end portion 2. Figure 7 It is a plan view showing the puncture distal end portion 2. Figure 8 It is a front view showing the puncture distal end portion 2. Fig. 9 The diagram shows puncture marks when puncturing is performed using the bone marrow puncture portion 1 of the present embodiment in a simulation using a plastic block having a hardness equivalent to that of the cortical bone and spongy bone of the human iliac bone. Fig. 9 (A) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 5 degrees. Fig. 9 (B) is a diagram showing the puncture marks when the puncture is performed at an incident angle of 10 degrees. Fig. 9 (C) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 15 degrees.

[0118] As described above, the puncture tip portion 2 includes: a tubular body 20, a disc-shaped portion 21, and a connecting portion 22. The tubular body 20 is a hollow cylinder. Figure 6 As shown in FIG. 1 , the angle θ formed by the top end surface 20a of the tube body 20 and the central axis C of the tube body 20 is set to an acute angle. In the present embodiment, the angle θ is set to, for example, 50 to 60 degrees. Figure 5 , Figure 7 and Figure 8As shown, the top end surface 20a is provided with an opening 20b intersecting with the central axis C of the tube body 20. In this way, since the opening 20b is formed on the top end surface 20a at which the angle θ formed with the central axis C of the tube body 20 is an acute angle, the opening 20b can be larger than when the opening is formed on the top end surface perpendicular to the central axis C. As a result, the bone marrow fluid can be efficiently extracted. In addition, since the opening 20b is formed larger in the puncture top end portion 2 and the opening is formed in one place, when the spongy bone punctured by the puncture top end portion 2 is sucked into the tube body 20, the negative pressure can be concentrated on the opening 20b, and the spongy bone can be prevented from being blocked in the opening 20b. As a result, the bone marrow fluid can be efficiently extracted.

[0119] In addition, if Figure 5 As shown, an opening 20d is formed in the rear end surface 20c of the tubular body 20. Therefore, the bone marrow fluid passes through the relatively large opening 20b and is sucked toward the first tubular body 3 via the hollow portion of the tubular body 20 and the opening 20d.

[0120] The disc-shaped portion 21 has a radial center axis C1 that is consistent with the center axis C of the tube body 20. That is, the disc-shaped portion 21 has a radial (Z-direction) center axis C1 of the disc-shaped portion 21 on the center axis C of the tube body 20, and the disc-shaped portion 21 is located at the top end of the puncture direction indicated by the arrow Z. The tube body 20 rotates around the center axis C, for example, in a counterclockwise direction or a clockwise direction, but because the radial center axis C1 of the disc-shaped portion 21 is consistent with the center axis C of the tube body 20, it can rotate smoothly without eccentricity. In addition, the tissue (spongy bone, etc.) in the bone marrow cavity is perforated due to the rotation of the disc-shaped portion 21, but due to the non-eccentric rotation of the disc-shaped portion 21, a hole is formed that is consistent with the center axis C of the tube body 20. Figure 5 The diameter R of the disc-shaped portion 21 shown in the figure is corresponding to the required minimum perforation (puncture hole). And the periphery of the disc-shaped portion 21 that becomes the top of the puncture direction is arc-shaped, does not have sharp position. As a result, even if the disc-shaped portion 21 arrives cortical bone, the cortical bone can not be damaged yet, and the disc-shaped portion 21 that becomes the top of the puncture direction can be prevented from puncturing (perforating) to the outside from the medullary cavity. In addition, because the disc-shaped portion 21 can be by spongy bone perforation (puncture), therefore adopt the puncture top portion 2, for example, also can efficiently reclaim bone marrow fluid from spongy bone. At the periphery of the disc-shaped portion 21, the face of the disc of the disc-shaped portion 21 and the side of the disc intersect with orthogonal direction, but the present invention is not limited thereto, the periphery of the disc-shaped portion 21 can also be to have round chamfer, and namely the periphery of the disc-shaped portion 21 is a curved surface. Thus, the disc-shaped portion 21 can maintain permeability, and since there is no sharp part on the peripheral portion of the disc-shaped portion 21, even if the disc-shaped portion 21 reaches the cortical bone, the cortical bone will not be damaged, and the disc-shaped portion 21 at the top of the puncture direction can be more effectively prevented from puncturing (perforating) from the bone marrow cavity to the outside.

[0121] In addition, the disc-shaped portion 21 as the top rotating portion is not limited to the shape formed by cutting a part of a disc, as long as the shape of the top of the puncture direction is arc-shaped, it can be a shape formed by cutting a part of an elliptical plate, or it can be a shape formed by combining a disc or an elliptical plate with a plate of other shapes. The top rotating portion can also take various shapes in addition, but in order to prevent the damage of cortical bone, the top (distal end) surface is preferably a curved surface, and in order to improve the permeability (puncture performance) of the tissue in the bone marrow cavity, it is preferably a thin plate-like shape in the direction perpendicular to the central axis C1.

[0122] And, if Figure 7 As shown in the figure, the diameter R of the disk-shaped portion 21 is formed to be larger than the width W of the tubular body 20 in the direction orthogonal to the central axis C, that is, in the Y direction. Therefore, the tubular body 20, the outer sleeve 5, and the first tubular body 3 covered by the outer sleeve 5 can smoothly move in the perforation (puncture hole) formed by the disk-shaped portion 21. For example, the size of the diameter R can be appropriately set according to the inner diameter of the guide tube described later. The size of the diameter R is, for example, about 8G (Gauge).

[0123] The tubular body 20 is the top end of the tubular body which is continuously formed with the second tubular body 4 and the first tubular body 3. Figure 5 , Figure 6 , Figure 7 , Figure 8 As shown, an opening 20b is provided at a top end surface 20a located at a distal end surface of the tubular body.

[0124] It is known that the bone marrow fluid in the bone marrow hole can be extracted only from the part very close to the suction point. In the present embodiment, since the bone marrow fluid is sucked from the opening 20b of the top end surface (distal end surface) 20a of the tubular body arranged behind the top rotating part (disk-shaped part 21), the bone marrow fluid can be efficiently extracted from the wide area of ​​the perforation (puncture).

[0125] In addition, the angle θ formed by the top surface 20a and the central axis C of the tube body 20 is set to be not perpendicular but acute, so the opening 20b does not intersect the central axis of the tubular body (20, 3, 4) orthogonally. In this embodiment, the angle θ is set to, for example, 50 to 60 degrees.

[0126] Thus, since the opening is formed on the top face 20a at an acute angle rather than perpendicular to the central axis C of the tubular body (20, 3, 4), the opening 20b can be larger than when the opening is formed on the top face perpendicular to the central axis C. As a result, bone marrow fluid can be efficiently extracted.

[0127] In addition, if Figure 5As shown, an opening 20d is formed in the rear end surface 20c of the tubular body 20. Therefore, the bone marrow fluid passes through the relatively large opening 20b and is sucked toward the first tubular body 3 via the hollow portion of the tubular body 20 and the opening 20d.

[0128] like Figure 5 and Figure 7 As shown, a groove 22a continuous with the opening 20b of the tubular body 20 is formed in the connecting portion 22. Therefore, the bone marrow punctured by the disk-shaped portion 21 is guided from the groove 22a to the opening 20b and is sucked to the first tubular body 3 side due to the negative pressure generated in the tubular body 20.

[0129] Fig. 9 The figure shows the puncture marks when a plastic block having the same hardness as the cortical bone and spongy bone of the human iliac bone is punctured using the bone marrow puncture part 1 of this embodiment. Fig. 9 (A)~ Fig. 9 In (C), the plastic block has a foamed portion 200 corresponding to the bone marrow and a laminated plate portion 201 corresponding to the cortical bone. Fig. 9 (A)~ Fig. 9 As shown in (C), it can be seen that when the incident angle is any angle between 5 degrees and 15 degrees, the puncture mark 203 does not invade the laminated plate-like portion 201 equivalent to the cortical bone and is formed in the foaming portion 200. Fig. 9 As shown in (C), it can be seen that when the incident angle is 15 degrees, the puncture mark 203 advances toward the laminated plate-like portion 201 at an angle that intrudes into the laminated plate-like portion 201, but bends near the laminated plate-like portion 201 and advances along the surface of the laminated plate-like portion 201. The reason is that there is no sharp part on the periphery of the circular plate-like portion 21 that becomes the top end of the puncture direction, and the first tubular body 3 is formed in a spiral shape and has flexibility.

[0130] Fig. 20 Expressing Fig. 9 The puncture marks obtained when the same plastic block was punctured using the bone marrow puncture part of the comparative example. Fig. 20 (A) is a diagram showing a puncture mark when puncturing is performed at an incident angle of 5 degrees. Fig. 20 (B) is a diagram showing the puncture marks when the puncture is performed at an incident angle of 10 degrees. Fig. 20 (C) is a diagram showing a puncture mark when puncturing at an incident angle of 20 degrees. The bone marrow puncture portion of the comparative example has a sharp puncture tip portion and the tubular body continuous with the puncture tip portion is formed entirely of a rigid body.

[0131] like Fig. 20As shown in (A), it can be seen that when the incident angle is 5 degrees, the puncture mark 203 does not invade the laminated plate-like portion 201. Fig. 20 (B) Fig. 20 As shown in (C), it can be seen that when the incident angle is 10 degrees and 20 degrees, the puncture mark 203 does not bend and advances toward the laminated plate-like portion 201. Therefore, when the bone marrow puncture portion of the comparative example advances in this state, it can be understood that there is a risk that the top end of the puncture direction invades the laminated plate-like portion 201.

[0132] As above, according to the present embodiment, the puncture top end 2 of the bone marrow puncture part 1 of the bone marrow puncture device is provided with the following components to constitute: the tubular body 20 having the opening 20b at the top end face 20a, the disc-shaped part 21 at the top end of the puncture direction, and the connecting part 22 that connects a part of the top end face 20a and the disc-shaped part 21. As a result, the bone marrow puncture device that can efficiently aspirate bone marrow fluid can be provided without puncturing (perforating) from the bone marrow cavity etc. by the top end of the puncture direction. In addition, in the present embodiment, the 1st tubular body 3 of the bone marrow puncture device (bone marrow puncture needle) is flexible. Therefore, according to the present embodiment, even if the puncture top end 2 contacts with cortical bone in the bone marrow cavity, the 1st tubular body 3 also can bend, so the damage risk of cortical bone such as puncturing (perforating) from the bone marrow cavity etc. by the top end of the puncture direction can be reduced.

[0133] Alternatively, an opening independent of the opening 20b may be provided on the side wall of the tube body 20. However, in this case, other openings provided on the side wall are easily clogged due to a decrease in negative pressure in the tube body 20, and therefore, from the perspective of properly aspirating the bone marrow fluid, it is preferred that only the opening 20b be used as an opening for extracting the bone marrow fluid.

[0134] (Structure of the First Tubular Body and Structure of the Drug Solution Supply Path)

[0135] Next, the structure of the first tubular body 3 and the structure of the drug solution supply passage 5a will be described in detail. Fig.10 It is a side view showing a part of the first tubular body 3 in an enlarged manner.

[0136] like Fig.10 As shown in the figure, the first tubular body 3 is formed by winding a round wire made of stainless steel or the like into a spiral shape, and the winding direction of the round wire is consistent with the rotation direction of the first tubular body 3. Therefore, when the first tubular body 3 rotates, the spiral round wire rotates in the tightening direction, and the outer diameter of the first tubular body 3 does not increase due to the rotation. As a result, the first tubular body 3 ensures the drug solution supply passage 5a between it and the outer sheath 5 and can rotate well in the outer sheath 5.

[0137] In this embodiment, Figure 1The supply port 6a of the first shaft 6 shown is connected to Figure 1 and Figure 2 The syringe pump 150 shown in the figure supplies an anticoagulant such as heparin at a rate of, for example, 40 μl / sec. The anticoagulant supplied from the supply port 6a is passed through the drug supply passage 6b and the drug supply passage 5a to the Fig.10 The liquid is transported in the direction of the arrow Z shown and supplied to the surface of the first tubular body 3 .

[0138] like Fig.10 As shown by the middle arrow C, the anticoagulant supplied to the surface of the first tubular body 3 enters the gaps between the round wires and is transported in the direction of the arrow Z along the winding direction of the round wires wound into a spiral shape. In addition, a portion of the anticoagulant enters the hollow portion of the first tubular body 3 from the gaps between the round wires and mixes with the bone marrow fluid sucked in the hollow portion. In addition, the anticoagulant transported in the direction of the arrow Z enters the hollow portion of the first tubular body 3 from the gaps between the round wires near the connection portion where the first tubular body 3 is connected to the tubular body 20 and mixes with the bone marrow fluid just sucked from the opening 20b of the tubular body 20. In addition, by causing the first tubular body 3 to rotate in a spiral shape, the bone marrow fluid just sucked and the bone marrow fluid sucked into the first tubular body 3 after suction are efficiently mixed with the anticoagulant, so that the coagulation of the bone marrow fluid can be reliably prevented.

[0139] As described above, according to the present embodiment, since the first tubular body 3 is formed of a round wire wound in a spiral shape, the anticoagulant as a medical solution can penetrate from the surface of the first tubular body 3 into the hollow portion of the first tubular body 3. As a result, the anticoagulant can be reliably supplied to the hollow portion of the first tubular body 3 that serves as the suction path of the bone marrow fluid without providing a tube for supplying the medical solution or the like. Therefore, the coagulation of the bone marrow fluid can be reliably prevented while the perforation (puncture hole) for extracting the bone marrow fluid is not increased beyond the necessary level and the suction path of the bone marrow fluid is sufficiently ensured.

[0140] Furthermore, according to the present embodiment, since the outer diameter of the first tubular body 3 is made smaller than the inner diameter of the outer sheath 5, the first tubular body 3 can rotate inside the outer sheath 5, and the anticoagulant can be delivered to the vicinity of the tubular body 20 along the winding direction of the spirally wound round wire. As a result, the bone marrow fluid just sucked from the opening 20b of the tubular body 20 can be mixed with the anticoagulant, and coagulation of the bone marrow fluid can be reliably prevented.

[0141] Furthermore, according to the present embodiment, since the outer diameter of the first tubular body 3 is made smaller than the inner diameter of the outer sheath 5, a drug supply passage 5a can be provided between the outer peripheral surface of the first tubular body 3 and the inner peripheral surface of the outer sheath 5, and the anticoagulant can be reliably supplied to the surface of the first tubular body 3.

[0142] Furthermore, according to the present embodiment, the outer sheath 5 also covers a portion of the second tubular body 4 of the rigid body connected to the first tubular body 3, and the outer diameter of the second tubular body 4 is smaller than the inner diameter of the outer sheath 5. As a result, a drug liquid supply passage 5a can be provided between the outer peripheral surface of the second tubular body 4 and the inner peripheral surface of the outer sheath 5, and the anticoagulant supplied from the supply port 6a can be reliably supplied to the surface of the first tubular body 3 from the drug liquid supply passage 5a.

[0143] Furthermore, as described above, since negative pressure is generated in the hollow portion of the first tubular body 3 by the pump, the anticoagulant does not leak out from the opening 20 b of the tubular body 20 to the outside.

[0144] Furthermore, by forming the first tubular body 3 with a round wire wound in a spiral shape, the rotational force received from the second tubular body 4 can be reliably transmitted to the tubular body 20, and the required torque can be generated in the tubular body 20. Furthermore, in the present embodiment, the bone marrow puncture part 1 is inserted into a guide tube called a trocar (not shown), and the structure is such that only the first tubular body 3, the portion of the outer sleeve 5 covering the first tubular body 3, and the puncture tip portion 2 protrude from the tip opening of the trocar. Therefore, the portion of the bone marrow puncture part 1 inserted into the bone marrow cavity has flexibility due to the first tubular body 3 formed with a round wire wound in a spiral shape, so that as shown in FIG. Fig. 9 This can prevent the puncture tip 2 from perforating the cortical bone or the like.

[0145] In addition, in the present embodiment, an example of forming the first tubular body 3 with a round wire wound into a spiral shape is described, but the present invention is not limited to such an example. As long as the material is permeable to the liquid medicine and can reliably transmit torque to the tubular body 20, other structures may be used, for example, a structure in which a round wire is braided, or a member having a permeable hole in a part. However, if it is formed into a spiral shape as in the present embodiment, it can assist the transportation of the liquid medicine to the top region, so it is more ideal.

[0146] In addition, in this embodiment, an example in which an anticoagulant is used as a drug solution is described, but the present invention is not limited to such an example. Other drug solutions other than an anticoagulant may be used as necessary.

[0147] Furthermore, in the present embodiment, an example in which the first tubular body 3 and the outer sheath 5 formed of a spirally wound round wire are applied to a bone marrow puncture device is described, but such a first tubular body 3 and the outer sheath 5 may also be applied to other devices. For example, the first tubular body 3 and the outer sheath 5 may be provided inside a catheter or the like for blood extraction to supply a liquid medicine such as an anticoagulant.

[0148] In addition, in the present embodiment, the outer sleeve 5 covers a portion of the first tubular body 3 and the second tubular body 4, but the present invention is not limited to this mode, and for example, it may be a mode that covers only a portion of the first tubular body 3. However, from the point that the drug solution can be efficiently supplied to the treatment area of ​​the puncture tip portion 2, it is preferable that the outer sleeve 5 extends to the vicinity of the puncture tip portion 2.

[0149] Furthermore, in the present embodiment, the drug supply passage 5a is a path having a ring-shaped cross section in a direction perpendicular to the length direction of the first tubular body 3 and formed by the gap between the outer sleeve 5 and the first tubular body 3, but it is not limited to this. Although the structure becomes complicated, it can also be, for example, a straight drug supply passage provided in the outer sleeve 5.

[0150] Fig.11 It is a cross-sectional view showing a modified example of the first tubular body 3 . Fig.12 2 is a front view showing a modified example of the first tubular body 3. Fig.11 and Fig.12 As shown in FIG. 1 , an inner sleeve 50 made of plastic such as PTFE, resin, etc. is provided on the inner periphery of the first tubular body 3. The inner sleeve 50 is, for example, a flexible cylindrical tube. In this case, the first tubular body 3 and the inner sleeve 50 constitute the first tubular body of the present invention. In the case of such a configuration, as long as Fig.11 and Fig.12 As shown, openings 50a are formed at multiple locations of the inner sleeve 50. In this case, it is also possible to reliably prevent the coagulation of the bone marrow fluid without increasing the perforation (puncture hole) for extracting the bone marrow fluid to a desired degree or more and fully ensuring the suction path of the bone marrow fluid. In addition, an example of a case where the inner sleeve 50 is provided on the inner periphery of the first tubular body 3 is cited, but the inner sleeve 50 can also be provided as the first tubular body 3 instead of the spiral first tubular body 3. In this case, the distal end of the inner sleeve 50 is connected to the tubular body 20, for example. In addition, the space between the outer peripheral surface of the inner sleeve 50 and the inner peripheral surface of the outer sleeve 5 becomes the drug liquid supply passage 5a.

[0151] In the present embodiment, a liquid medicine supply passage 5a is provided on the outer periphery of the first tubular body 3, but the present invention is not limited thereto, and the liquid medicine supply passage 5a may not be provided. In this case, the first tubular body 3 preferably has a drug disposition portion on its inner periphery, for example. The drug disposition portion is provided with a mixture of a sustained-release substance such as a gel or a polymer and drugs such as an anticoagulant. The drug disposition portion may also be coated with the above-mentioned mixture, for example. With such a structure, since drugs such as anticoagulants can be released from the drug disposition portion when the bone marrow fluid is aspirated, the drug supply passages 5a, 6a, 6b and the injection pump 150 may be omitted, for example. Therefore, the structure of the bone marrow puncture device 10 can be simplified.

[0152] Table 1 is a table showing the results of extracting bone marrow fluid from the iliac bone of a pig using the bone marrow puncture device 10 having the bone marrow puncture part 1 and the drug supply passage 5a of the present embodiment. In Table 1, the conventional method is to insert a ready-made puncture needle through the hole opened in the iliac bone and to aspirate the bone marrow fluid from the tip of the puncture needle, but not to aspirate the bone marrow fluid while advancing the puncture tip as in the present embodiment.

[0153] In Table 1, the ratio of cells in the CD34+ and CD45dim regions is a value obtained by finding the ratio of cells in the CD34+ and CD45dim regions in the lymphocyte and monocyte fraction (MNC fraction) in the extracted bone marrow fluid using flow cytometry. It can be seen from this that the bone marrow puncture section 1 and method of the present embodiment can increase the ratio of cells in the CD34+ and CD45dim regions that are markers of hematopoietic stem cells. In other words, the bone marrow puncture section 1 and method of the present embodiment can increase the ratio of hematopoietic stem cells required for bone marrow transplantation, and efficient extraction can be achieved. Therefore, the bone marrow puncture section 1 and method of the present embodiment, for example, can shorten the extraction time, and can reduce the number of perforations (punctures), so that the invasiveness caused to the donor can be greatly reduced, and local anesthesia can be used for bone marrow fluid extraction.

[0154]

Table 1

[0155]

[0156] In addition, the amount of bone marrow fluid, total white blood cell count (WBC), and total CD34+ and CD45dim cell counts obtained from the iliac bones of one pig using the conventional method and the method of this embodiment were compared using the same method as in Table 1. The results are shown in Table 2.

[0157]

Table 2

[0158]

[0159] In cell therapy, hematopoietic stem cell transplantation requires bone marrow fluid volume and stem cell count. The number of CD34+, CD45dim hematopoietic stem cells contained in 120 mL to 140 mL of bone marrow fluid extracted by the extraction method using the bone marrow puncture device 10 having a bone marrow puncture section 1 and a liquid medicine supply passage 5a is equivalent to the average value of 927 ± 163 mL of human iliac bone marrow fluid extracted by the conventional method and the average value of 89.6 ± 76.1 (×10 6). By using a bone marrow puncture device 10 having a bone marrow puncture section 1 and a liquid medicine supply passage 5a, hematopoietic stem cells required for hematopoietic stem cell transplantation can be extracted with a much smaller amount of bone marrow fluid than in the past. In addition, by using a bone marrow puncture device 10 having a bone marrow puncture section 1 and a liquid medicine supply passage 5a, the amount of bone marrow fluid obtained by one puncture is 15mL to 20mL, with less fluctuation. Therefore, by adjusting the number of punctures, the amount of bone marrow fluid extracted can be adjusted. In addition, the time required for extraction is about two minutes, and the extraction is completed in an extremely short time of 17 minutes to 20 minutes by puncturing 8 to 10 times on both sides of the ilium.

[0160] Next, the bone marrow fluid obtained in Table 2 was subjected to CFU-F (colony forming unit-fibroblast) measurement. The results are shown in Table 3 below.

[0161]

Table 3

[0162]

[0163] As shown in Table 3, the bone marrow fluid extracted by the extraction method using the bone marrow puncture device 10 showed 6 to 13 times the number of CFU-F colonies compared to the bone marrow fluid extracted by the conventional method. Based on this result, it can be seen that the bone marrow fluid extracted by the extraction method using the bone marrow puncture device 10 contains not only a high concentration of hematopoietic stem cells, but also a high concentration of mesenchymal stem cells compared to the bone marrow fluid extracted by the conventional method.

[0164] (navigation)

[0165] Next, navigation will be described with reference to the accompanying drawings. Figures 13 to 19 is a diagram used to illustrate navigation. Fig.13 It is a cross-sectional view schematically showing the bone marrow puncture section 1 of the bone marrow puncture device 10 . Fig.14 It is a top view showing the guide tube 30 . Fig.15 1 is a diagram schematically showing a bone marrow puncture system 100 . Fig.16 is a block diagram showing the structure of the bone marrow puncture system 100 . Figure 17 to Figure 19 This is a schematic diagram for explaining the navigation operation of the bone marrow puncture system.

[0166] This embodiment is as Fig.13 As shown in FIG. 1 , the first magnetic sensor 40 is mounted on the second axis 8 of the bone marrow puncture section 1. Fig.14 As shown in FIG. 1 , the second magnetic sensor 41 is attached to the outer needle portion 32 a of the guide tube 30 .

[0167] Fig.15 and Fig.16The bone marrow puncture system 100 shown in the figure comprises: a tracking unit 160 connected to the first magnetic sensor 40 and the second magnetic sensor 41, a camera unit 170 and an MRI unit 180, and the above parts are connected to the first magnetic sensor 40 and the second magnetic sensor 41. Figure 1 and Figure 2 The bone marrow puncture system 100 shown is different. In addition, the camera unit 170 and the MRI unit 180 are omitted. Fig.15 In addition, Fig.15 and Fig.16 In the bone marrow puncture system 100 shown, the PC 190 functions as a display control unit 196 and a display unit 197 .

[0168] The tracking unit 160 is connected to the first magnetic sensor 40 installed on the bone marrow puncture device 10 and the second magnetic sensor 41 installed on the guide tube 30, and is used to receive the position and angle data output from the first magnetic sensor 40 and the second magnetic sensor 41. The tracking unit 160 converts the received position and angle data into position and angle data that can be displayed on the PC 190. The tracking unit 160 is connected to the PC 190 and sends the converted position and angle data to the PC 190.

[0169] The camera unit 170 is used to photograph the periphery of the iliac bone of the donor for bone marrow puncture. Marks are attached to, for example, three places around the iliac bone of the donor, and the site for bone marrow puncture is the site surrounded by the above-mentioned marks. The camera unit 170 photographs the above-mentioned marks and the site surrounded by the marks. The camera unit 170 is connected to the PC 190 and transmits the image data to the PC 190.

[0170] The MRI unit 180 creates a three-dimensional 3D model of the ilium, etc., based on an MRI image of the ilium, etc. of a donor undergoing bone marrow puncture, taken using magnetic resonance imaging. The MRI image is taken in a state where a marker is attached to the periphery of the ilium, etc. as described above, and the marker is also taken as an MRI image. The position of the marker can be confirmed in the 3D model of the ilium, etc. The MRI unit 180 is connected to the PC 190, and the 3D model data of the ilium, etc. is sent to the PC 190.

[0171] The PC 190 functions as an analysis unit 195, a display control unit 196, and a display unit 197. The analysis unit 195 functions as a position calculation unit that calculates the position of the puncture tip 2 based on the output of the first magnetic sensor 40. In addition, the analysis unit 195 functions as a prediction unit that predicts the trajectory of the puncture tip 2 and the contact position of the puncture tip 2 with the cortical bone based on the output of the second magnetic sensor 41. In addition, the analysis unit 195 functions as a moving speed calculation unit that calculates the moving speed of the puncture tip 2 based on the temporal change in the position of the puncture tip 2 calculated by the function of the position calculation unit. In addition, the analysis unit 195 functions as a recording unit that records the past trajectory of the puncture tip 2 based on the position of the puncture tip 2 calculated by the function of the position calculation unit.

[0172] The display control unit 196 displays the position of the puncture tip portion 2 calculated by the analysis unit 195 on the display unit 197 at any time. In addition, the display control unit 196 displays the past trajectory of the puncture tip portion 2 recorded by the analysis unit 195 functioning as a recording unit on the display unit 197. Furthermore, the display control unit 196 displays the trajectory of the puncture tip portion 2 predicted by the analysis unit 195 functioning as a prediction unit and the contact position of the puncture tip portion 2 with the cortical bone on the display unit 197. In addition, the display control unit 196 also functions as a moving speed notification unit that notifies the moving speed of the puncture tip portion 2 calculated by the analysis unit 195 functioning as a moving speed calculation unit.

[0173] The display unit 197 is a display such as a liquid crystal display, and is used to display the position of the puncture tip 2, the past trajectory, the predicted trajectory, the predicted contact position of the puncture tip 2 with the cortical bone, the moving speed of the puncture tip 2, and the like.

[0174] Next, the navigation of the bone marrow puncture system 100 of this embodiment is described. As an example, bone marrow is extracted from the iliac bone of a donor. The iliac bone of the donor is imaged by MRI in advance, and the above three markers are attached to the skin around the puncture site. The markers are mapped to the MRI image.

[0175] The MRI unit 180 creates a 3D model of the ilium from the MRI image of the ilium. The 3D model also includes the above-mentioned markers. The 3D model of the ilium is sent from the MRI unit 180 to the PC 190 in advance.

[0176] When bone marrow puncture is performed, the camera unit 170 is used to capture an image of a predetermined range including the portion to which the above-mentioned mark is attached, and the captured image is sent from the camera unit 170 to the PC 190. The analysis unit 195 of the PC 190 matches the previously received 3D model of the ilium with the image captured by the camera unit 170. When matching, the mark of the 3D model is made consistent with the mark of the image captured by the camera unit 170.

[0177] Next, the operator inserts the tip of the guide tube 30 in which the inner needle 31 and the outer needle 32 are integrated into the ilium from the skin at a predetermined position in the area surrounded by the mark, removes the inner needle 31, and leaves the outer needle 32 in the ilium. At this time, the tracking unit 160 converts the position and angle data sent from the second magnetic sensor 41 installed on the guide tube 30 into displayable position and angle data, and sends it to the PC 190. The analysis unit 195 of the PC 190 superimposes the image data of the guide tube 30 on the 3D model based on the received position and angle data of the guide tube 30. In addition, the analysis unit 195 creates image data of the predicted trajectory of the puncture tip 2 of the bone marrow puncture part 1 and image data of the predicted contact position of the puncture tip 2 with the cortical bone based on the position and angle data of the guide tube 30, and superimposes them on the above image data. The analysis unit 195 outputs the image data thus created to the display control unit 196. The display control unit 196 displays the image on the display unit 197 based on the input image data.

[0178] Fig.17 1 is a diagram showing an example of an image displayed on the display unit 197. Fig.17 3D model image G1 of the ilium, image G2 corresponding to the outer needle 32 of the guide tube 30, image G3 of the predicted trajectory of the puncture tip 2, and image G4 of the predicted contact position of the puncture tip 2 with the cortical bone are displayed.

[0179] Thus, according to the present embodiment, since the image G3 of the predicted trajectory of the puncture tip portion 2 is displayed on the 3D model image G1 of the ilium, the operator can confirm the predicted trajectory of the puncture tip portion 2 in the bone marrow cavity of the ilium, which is difficult to use an ultrasonic device. When the displayed predicted trajectory is not in the desired position, the operator changes the angle of the outer needle 32 of the guide tube 30 to display a new image G3 of the predicted trajectory of the puncture tip portion 2. Therefore, the operator can puncture the bone marrow with the desired trajectory by referring to the above-mentioned image.

[0180] When the operator confirms the predicted trajectory of the puncture tip 2 and decides to puncture the bone marrow along the predicted trajectory, the protruding portion of the length L1 of the bone marrow puncture device 10 is inserted into the hollow portion of the outer needle 32 of the guide tube 30. At this time, the tracking unit 160 converts the position and angle data sent from the first magnetic sensor 40 of the bone marrow puncture part 1 installed in the bone marrow puncture device 10 into displayable position and angle data, and sends it to the PC 190. The analysis unit 195 of the PC 190 superimposes the image data of the position of the puncture tip 2 of the bone marrow puncture part 1 on the 3D model based on the received position and angle data of the bone marrow puncture part 1. In this embodiment, the first magnetic sensor 40 is installed on the second shaft 8, but since the length from the installation position of the first magnetic sensor 40 to the puncture tip 2 is known, the position of the puncture tip 2 can be calculated based on the above position and angle data. The analysis unit 195 outputs the image data thus prepared to the display control unit 196. The display control unit 196 displays the image on the display unit 197 based on the input image data.

[0181] Fig.18 1 is a diagram showing an example of an image displayed on the display unit 197. Fig.18 In addition to displaying Fig.17 In addition to the image shown, image data G5 of the position of the puncture tip 2 is also displayed. In this way, according to the present embodiment, since the image G5 of the current position of the puncture tip 2 is displayed on the 3D model image G1 of the ilium, the surgeon can confirm the position of the puncture tip 2 in the bone marrow cavity of the ilium, which is difficult to use an ultrasonic device. Therefore, the surgeon can puncture the bone marrow in a desired trajectory by referring to the image. In addition, since the image G4 of the predicted contact position of the puncture tip 2 with the cortical bone is also displayed on the 3D model image G1 of the ilium as described above, the contact between the puncture tip 2 and the cortical bone can be prevented.

[0182] exist Fig.18 In the figure, the image G6 representing the past trajectory of the puncture tip 2 is also displayed on the 3D model image G1 of the ilium. The analysis unit 195 successively stores the current position of the puncture tip 2 and creates image data of the past trajectory based on the stored data. The analysis unit 195 outputs the created image data of the past trajectory to the display control unit 196, and the display control unit 196 displays the image G6 of the past trajectory on the display unit 197. Fig.18 In the example of FIG. 1 , three past trajectories are displayed as image G6 . Therefore, the operator can determine the trajectory for the next puncture while checking the past trajectories, thereby preventing duplication of the bone marrow puncture site.

[0183] Fig.19This is an example of a 3D model image G1 showing the ilium from the cross-sectional direction of arrow Z1. Fig.19 As shown in FIG. 1 , an image G4 of the predicted contact position of the puncture tip portion 2 with the cortical bone is shown when the outer needle 32 of the guide tube 30 is inserted at the position and angle shown in P1 and P2. However, when the outer needle 32 of the guide tube 30 is inserted at the position and angle shown in P3, an image of the predicted contact position of the puncture tip portion 2 with the cortical bone is not shown. The reason is that Figure 1 The length of the protruding portion of the bone marrow puncture portion 1 shown in the figure is L1, and the thickness of the bone marrow cavity of the ilium can also be calculated from the 3D model. Thus, according to the present embodiment, by selecting the trajectory of the image of the predicted contact position of the puncture tip portion 2 with the cortical bone without displaying the track, the bone marrow can be punctured safely.

[0184] In addition, the analysis unit 195 calculates the moving speed of the puncture tip 2 by calculating the temporal change of the position and angle data obtained from the first magnetic sensor 40. The analysis unit 195 outputs the calculated moving speed data to the display control unit 196, and the display control unit 196 displays the moving speed on the display unit 197. Therefore, the surgical operator can puncture the bone marrow while confirming the moving speed of the puncture tip 2. In order to maintain the extraction quality of the bone marrow fluid well, it is necessary to make the puncture tip 2 enter at an appropriate speed associated with the suction speed (suction pressure), but according to the present invention, since the moving speed of the puncture tip 2 can be confirmed, the extraction quality of the bone marrow fluid can be maintained well regardless of the surgical operator. Here, the moving speed of the puncture tip 2 can be a constant speed when the suction speed (suction pressure) is constant, and changes accordingly when the suction speed (suction pressure) is changed.

[0185] In the present embodiment, the display control unit 196 is used as a moving speed notification unit, but the present invention is not limited to such a mode. For example, a control unit for controlling the output of a sound of a buzzer or the like may be used as a moving speed notification unit. In this case, a mode can be considered in which a predetermined moving speed associated with the suction speed (suction pressure) and the moving speed of the puncture tip portion 2 are compared by a comparison unit (not shown), and a sound of a buzzer or the like is output when the moving speed of the puncture tip portion 2 is outside the range of an appropriate speed. In addition, the display of the moving speed may be not only a case where the value of the moving speed is directly displayed, but also a case where an indicator or the like is used to display the range of an appropriate speed. Alternatively, all or some of the above modes may be appropriately combined.

[0186] Furthermore, when the moving speed of the puncture distal end portion 2 is outside the appropriate speed range, a feedback signal may be sent from the PC 190 to the control unit 120 to stop driving the motor of the bone marrow puncture device 10 .

[0187] As described above, according to this embodiment, since the previous trajectory, predicted trajectory, and current position of the puncture tip 2 are displayed on the 3D model image of the ilium, it is possible to prevent the puncture tip 2 from entering the same site as the site where bone marrow extraction was performed once. In particular, since the previous trajectory, predicted trajectory, and current position of the puncture tip 2 in the bone marrow cavity inside the ilium or other bones where the use of ultrasonic devices is difficult can be notified to the operator, the present invention is extremely effective for bone marrow puncture. As a result, the efficiency of bone marrow extraction can be improved.

[0188] In particular, when the bone marrow puncture part 1 is inserted from the guide tube 30 inserted into the same puncture hole (a hole made in the skin or a hole made in the cortical bone), there is a high possibility that the previous trajectory will be passed, so the navigation of this embodiment is effective.

[0189] Furthermore, a warning such as a buzzer or the like may be output when the current position or predicted trajectory of the puncture tip portion 2 is on the recorded past trajectory or close to the past trajectory. This can be achieved, for example, by outputting a warning when several consecutive points (e.g., 5 points) of the current position being sampled and monitored are on or near a certain past trajectory, or when the predicted trajectory or the predicted contact position with the cortical bone is on or near the past trajectory.

[0190] Furthermore, according to the present embodiment, since duplication of bone marrow extraction sites can be reliably prevented, bone marrow fluid can be efficiently extracted in a short time, and bone marrow fluid of high quality can be extracted while reducing the burden on the donor.

[0191] Furthermore, since the bone marrow can be punctured while checking the moving speed of the puncture distal end portion 2, the quality of bone marrow fluid extraction can be kept good regardless of the operator.

[0192] In the above-mentioned embodiment, the case where the bone marrow is extracted from the iliac bone is described. However, the present invention can be applied to other sites besides the iliac bone in the same manner as described above.

[0193] In addition, for example, navigation movement speed control and control to a trajectory different from the previous trajectory can also be applied to other puncture devices that perform prescribed treatments on body tissues while traveling in the body. Here, the prescribed treatment includes tissue extraction, suction, tissue cauterization, and drug supply, but does not include simple photography that does not impart changes to body tissues.

[0194] In the above navigation, the first magnetic sensor and the second magnetic sensor are used, but the present invention is not limited thereto and position monitoring using ultrasonic waves etc. can also be used. However, in terms of miniaturization of the device and accuracy of position monitoring, it is preferable to use magnetic sensors.

[0195] Although the embodiments of the present invention have been described above, the present invention can be implemented in various forms as follows. In addition, the various forms can be combined and implemented.

[0196] The present invention is characterized in that, for example, it comprises: a puncture tip portion; a first tubular body connected to the puncture tip portion at a distal end; and an outer tubular body covering at least a portion of the first tubular body, wherein the first tubular body is formed to be rotatable around an axis along the length direction, the outer diameter of the first tubular body is smaller than the inner diameter of the outer tubular body, and a liquid medicine supply passage is provided on the outer side of the first tubular body. In the present invention, the first tubular body, for example, has a connecting portion that connects the liquid medicine supply passage and the hollow portion (interior) of the first tubular body. The connecting portion is, for example, formed on the puncture tip portion side of the first tubular body.

[0197] According to the present invention, for example, the drug liquid is delivered to the outer surface of the first tubular body via the drug liquid supply passage provided on the outer side of the first tubular body. The drug liquid delivered to the outer surface of the first tubular body is delivered to the puncture tip side and mixed with the tissue extracted from the puncture tip, such as bone marrow fluid, etc. In addition, the outer diameter of the first tubular body is smaller than the inner diameter of the outer tubular body, and the first tubular body can rotate around the axis along the length direction, so the drug liquid delivered to the outer surface of the first tubular body is delivered to the puncture tip side due to the rotation of the first tubular body, so that the bone marrow fluid, etc., which has just been extracted from the puncture tip, is mixed with the drug liquid. When an anticoagulant is used as the drug liquid, the coagulation of the bone marrow fluid, etc. can be reliably prevented. In addition, since the first tubular body for delivering the drug liquid is accommodated in the outer tubular body, the perforation (puncture hole) for extracting the bone marrow fluid, etc. will not be enlarged beyond the required degree, and the suction path of the bone marrow fluid, etc. can be fully ensured.

[0198] In another aspect of the present invention, the drug supply passage is formed into a ring shape in cross section on a plane perpendicular to the length direction of the first tubular body. The drug supply passage is formed into a ring shape in cross section on a plane perpendicular to the length direction of the first tubular body.

[0199] According to this aspect, since the cross section of the drug supply passage in a plane perpendicular to the longitudinal direction of the first tubular body is annular, for example, the drug is reliably delivered toward the puncture distal end portion over the entire outer surface of the first tubular body.

[0200] In another aspect of the present invention, the drug solution supply passage is included in a gap between the inner peripheral surface of the outer tubular body and the outer peripheral surface of the first tubular body, for example.

[0201] According to this aspect, since the drug solution supply passage is included in the gap between the inner peripheral surface of the outer tubular body and the outer peripheral surface of the first tubular body, it is not necessary to separately configure a tubular member for drug solution supply, and the outer diameter of the outer tubular body can be prevented from increasing.

[0202] In another aspect of the present invention, the drug solution supply passage is characterized in that it extends to, for example, the vicinity of the puncture distal end portion.

[0203] According to this aspect, since the drug supply channel extends to, for example, the vicinity of the puncture tip portion, the drug is supplied to the vicinity of the puncture tip portion and mixed with the bone marrow fluid or the like that has just been extracted.

[0204] In another aspect of the present invention, the first tubular body is rotatable, for example, inside the outer tubular body relative to the outer tubular body.

[0205] According to this aspect, since the first tubular body can rotate inside the outer tubular body relative to the outer tubular body, for example, torque can be reliably transmitted to the puncture distal end portion, and the drug solution supplied to the drug solution supply passage can be delivered by the force of rotation.

[0206] In another aspect of the present invention, a second tubular body, such as a rigid body, is connected to the proximal end of the first tubular body.

[0207] According to this mode, when the second tubular body of the rigid body is given a rotational force, for example, the rotational force is transmitted to the first tubular body connected to the distal end of the second tubular body, and then transmitted to the puncture tip connected to the first tubular body. In addition, by rotating the first tubular body, the drug solution is transported as described above.

[0208] Furthermore, in another aspect of the present invention, it is characterized in that the outer tubular body, for example, covers at least a portion of the second tubular body, the outer diameter of the second tubular body is smaller than the inner diameter of the outer tubular body, the second tubular body can rotate inside the outer tubular body together with the first tubular body, and the drug solution supply passage is continuous between the outer circumferential surface of the first tubular body and the inner circumferential surface of the outer tubular body, and is also provided between the outer circumferential surface of the second tubular body and the inner circumferential surface of the outer tubular body.

[0209] In this mode, the drug liquid supply passage is also provided between the outer peripheral surface of the second tubular body and the inner peripheral surface of the outer tubular body, and is continuous with the drug liquid supply passage provided between the outer peripheral surface of the first tubular body and the inner peripheral surface of the outer tubular body. Therefore, when the drug liquid is supplied to the outer peripheral surface of the second tubular body, the drug liquid is reliably supplied to the outer surface of the first tubular body via the drug liquid supply passage.

[0210] Furthermore, in another aspect of the present invention, the first tubular body is formed in a spiral shape, for example.

[0211] In this state, since the first tubular body is formed into a spiral shape, for example, the medicinal solution supplied to the outer surface of the first tubular body can freely penetrate into the hollow portion of the first tubular body and can be reliably delivered to the puncture tip portion side as the first tubular body rotates. In addition, by forming the first tubular body into a spiral shape, torque can be reliably transmitted to the puncture tip portion.

[0212] In another aspect of the present invention, the winding direction of the spiral first tubular body is, for example, consistent with the rotation direction of the first tubular body.

[0213] In this mode, since the winding direction of the spiral first tubular body is consistent with the rotation direction of the first tubular body, when the first tubular body rotates, the spiral first tubular body rotates in the tightening direction, and the outer diameter of the first tubular body does not increase. As a result, the above-mentioned drug solution supply path is ensured, and the first tubular body can be smoothly rotated in the outer sheath (outer tubular body).

[0214] In another aspect of the present invention, for example, a suction device for sucking the interior of the first tubular body is provided, and the first tubular body is formed so that the drug solution in the drug solution supply passage can penetrate into the interior thereof.

[0215] In this state, the bone marrow fluid etc. extracted by the puncture tip is sucked from the inside of the first tubular body by, for example, a suction device. At this time, since the drug in the drug supply channel can penetrate into the first tubular body, the drug and the bone marrow fluid etc. are mixed.

[0216] In another aspect of the present invention, the suction device is used to suction bone marrow fluid, and the drug supply passage is used to supply an anticoagulant.

[0217] According to this mode, the bone marrow fluid extracted by the puncture tip is sucked from the inside of the first tubular body by, for example, the suction device. At this time, the anticoagulant supplied by the drug supply passage is mixed with the bone marrow fluid. As a result, the coagulation of the extracted bone marrow fluid is prevented.

[0218] The present invention is, for example, a bone marrow puncture device, at least the tip of which is inserted into the bone marrow cavity to extract bone marrow fluid, and the bone marrow puncture device is characterized in that it comprises: a tubular body having a distal end and an opening on the distal end surface; a top rotating portion (for example, the puncture tip portion) disposed at a position on the distal side of the distal end surface of the tubular body, the top rotating portion rotates together with the tubular body to perforate (puncture) tissue in the bone marrow cavity; and a connecting portion connecting the tubular body and the top rotating portion. The bone marrow puncture instrument (bone marrow puncture device) of the present invention is characterized in that it comprises, for example: a tubular body having an opening; a top rotating portion, which rotates together with the tubular body and is capable of perforating (puncturing) tissue in the bone marrow cavity; and a connecting portion connecting the tubular body and the top rotating portion, the top rotating portion, the connecting portion, and the tubular body being disposed in the order of the top rotating portion, the connecting portion, and the tubular body. The connecting portion is connected to, for example, an opening surface (distal end surface) around the opening of the tubular body.

[0219] According to the present invention, for example, the tissue in the bone marrow cavity is perforated (punctured) by the top rotating portion that rotates together with the tubular body, and an opening is provided on the distal end surface of the tubular body connected from the top rotating portion by the connecting portion, so that bone marrow fluid can be efficiently sucked from the tissue in the bone marrow cavity perforated (punctured) by the top rotating portion.

[0220] In addition, in another aspect of the present invention, it is characterized in that the tubular body at least includes, for example: a tubular body, which is integrally formed with the top rotating part and the connecting part and has the opening; and a flexible first tubular body, which is arranged on the proximal side of the tubular body. Another aspect of the present invention is, for example, that the tubular body includes a tubular body having the opening and a flexible first tubular body, the tubular body is integrally formed with the top rotating part and the connecting part, and the top rotating part, the connecting part, the tubular body, and the first tubular body are arranged in the order of the top rotating part, the connecting part, the tubular body, and the first tubular body.

[0221] According to the above aspect, since the tubular body includes at least the flexible first tubular body and the tubular body having the opening, even if the distal rotating portion reaches the cortical bone, the cortical bone will not be damaged due to the flexibility of the first tubular body.

[0222] In another aspect of the present invention, the distal end rotating portion includes, for example, a disk-shaped portion having a radial central axis on a central axis extending along the longitudinal direction of the tubular body.

[0223] According to the above-mentioned state, since for example the top rotating part includes the disc-shaped part, there is no sharp part at the top, the top of the puncture direction will not puncture (perforate) to the outside from the medullary cavity, and the occurrence of major accidents can be prevented. In addition, since the radial central axis of the disc-shaped part is for example present on the central axis along the length direction of the tubular body, the disc-shaped part does not rotate eccentrically relative to the central axis of the tubular body, and the rotation is smoothly carried out, and the required minimum perforation (puncture hole) is formed.

[0224] In another aspect of the present invention, the connection portion is characterized in that, for example, a groove continuous with the opening is formed.

[0225] According to this aspect, for example, since a groove continuous with the opening is formed in the connection portion connecting the distal rotation portion and the tubular body having the opening, the bone marrow punched (punctured) by the distal rotation portion can be efficiently transported to the opening via the groove of the connection portion.

[0226] Furthermore, in another aspect of the present invention, it is characterized in that, for example, the distal end surface and the longitudinal direction of the tubular body are not orthogonal to each other.

[0227] In this aspect, since the distal end face is not perpendicular to the longitudinal direction of the tubular body, for example, the opening of the tubular body becomes larger than that of the case where the distal end face perpendicular to the longitudinal direction of the tubular body is provided with an opening (for example, an opening). As a result, the bone marrow obtained by perforation (puncture) by the distal rotating portion can be efficiently sucked through the opening.

[0228] In addition, in another aspect of the present invention, it is characterized in that, for example, the width of the distal end rotating portion in a direction perpendicular to the longitudinal direction of the tubular body is greater than the width of the tubular body in a direction perpendicular to the longitudinal direction of the tubular body.

[0229] In this aspect, the size of the perforation formed by rotating the distal rotating portion is, for example, larger than the width of the tubular body in a direction perpendicular to the longitudinal direction of the tubular body, so that the tubular body can smoothly advance in the perforation (puncture hole) formed by the distal rotating portion.

[0230] In another aspect of the present invention, a guide tube may also be provided, which guides the puncture tip portion (e.g., the tip rotating portion) and the tubular body by allowing the puncture tip portion (e.g., the tip rotating portion) and the tubular body (e.g., the first tubular body, the second tubular body) and / or the outer tubular body (jacket portion) to pass through. The tubular body includes, for example, a flexible first tubular body and a rigid second tubular body, and the length of the second tubular body is less than the length of the guide tube. The puncture tip portion, the first tubular body, and the second tubular body are, for example, arranged in the order of the puncture tip portion, the first tubular body, and the second tubular body from the distal end toward the proximal end. According to the present invention, for example, the puncture direction of the puncture tip portion and the tubular body can be controlled by using a guide tube.

[0231] The driving device of the tubular body of the present invention is characterized in that, for example, it comprises: a holding portion for holding the tubular body; a driving portion for rotating the tubular body; and a liquid medicine supply portion for supplying liquid medicine to the tubular body. The tubular body is, for example, the puncture device (puncture needle) or the bone marrow puncture device (bone marrow puncture needle) of the present invention. According to the present invention, for example, the rotation of the tubular body and the supply of liquid medicine can be implemented efficiently. The holding portion, the driving portion, and the liquid medicine supply portion can also be arranged in the housing, for example.

[0232] In another aspect of the present invention, it is preferred that the tubular body has a first liquid medicine supply passage for guiding the liquid medicine, and the liquid medicine supply portion is, for example, connected to the first liquid medicine supply passage of the tubular body. The liquid medicine supply portion has a second liquid medicine supply passage for guiding the liquid medicine, and the second liquid medicine supply passage is a space between the inner peripheral surface of the holding portion and the outer peripheral surface of the tubular body, and the second liquid medicine supply passage is connected to the first liquid medicine supply passage. According to the present invention, for example, the liquid medicine supplied from outside the driving device can be efficiently supplied to the tubular body.

[0233] In another aspect of the present invention, for example, a bearing portion of the tubular body is provided, and a retaining portion retains the tubular body by means of the bearing portion. Specifically, for example, a bearing portion is arranged on the outer periphery of the tubular body, and a retaining portion is arranged on the outer periphery of the bearing portion. The bearing portion, for example, has a first bearing portion for the resistance borne from the rotation direction (radial direction) and a second bearing portion for the resistance borne from the propulsion direction (axial direction, axial direction) of the tubular body. In another aspect of the present invention, for example, a protective portion (for example, a protective sheath) of the tubular body may also be provided. In this case, the retaining portion retains the tubular body by means of the protective portion and the bearing portion. Specifically, a protective portion is arranged on the outer periphery of the tubular body, the bearing portion is located on the outer periphery of the protective portion, and a retaining portion is arranged on the outer periphery of the bearing portion. According to the present invention, since, for example, a driving device can be used to absorb the resistance generated when the tubular body is driven, the driving device can be easily operated. In addition, according to the present invention, for example, the tubular body can be prevented from being damaged when rotating.

[0234] The present invention is characterized in that, for example, it comprises: a puncture section including a puncture tip and a tubular body connected to the puncture tip, the puncture section performing a predetermined treatment on body tissue while advancing in the body; and a moving speed calculation section for calculating the moving speed of the puncture section.

[0235] According to the present invention, when the position of the puncture part moving in the body is moved, the moving speed of the puncture part is calculated by the moving speed calculation unit. Therefore, according to the present invention, for example, by referring to the calculated moving speed of the puncture part, the moving speed of the puncture part can be kept within an appropriate range, and the quality of treatment can be kept constant regardless of the experience of the operator.

[0236] In another aspect of the present invention, for example, a comparing unit is provided that compares the moving speed calculated by the moving speed calculating unit with a predetermined moving speed.

[0237] In this state, since the calculated moving speed and the specified moving speed are compared by, for example, a comparison unit is used, the moving speed of the puncture part can be kept within an appropriate range by referring to the comparison result between the moving speed of the puncture part and the specified moving speed, and the quality of the treatment can be kept constant regardless of the experience of the surgeon.

[0238] In another aspect of the present invention, for example, a notification unit is provided for providing notification regarding the moving speed of the puncture section based on the comparison result of the comparison unit.

[0239] In this mode, since the notification unit, for example, performs notification related to the moving speed of the puncture unit based on the comparison result of the comparison unit, the operator can know the information related to the moving speed of the puncture unit relative to the prescribed moving speed. As a result, according to this mode, for example, the moving speed of the puncture unit can be set within an appropriate range, and the quality of treatment can be kept constant regardless of the operator's experience.

[0240] The present invention is characterized in that, for example, it comprises: a puncture section, which comprises a puncture tip and a tubular body connected to the above-mentioned puncture tip, and the puncture section performs a predetermined treatment on body tissue while moving in the body; a position calculation section, which is used to calculate the position of the above-mentioned puncture tip; and a recording section, which is used to record the previous trajectory of the above-mentioned puncture tip.

[0241] According to the present invention, when the position of the puncture portion moving in the body moves, for example, the position of the puncture tip portion is calculated by the position calculation unit. Therefore, according to the present invention, for example, duplication of the extraction site can be prevented based on the calculated position of the puncture tip portion, and the efficiency of treatment can be improved. In addition, according to the present invention, since the previous trajectory of the puncture tip portion is recorded by the recording unit, for example, the surgical operator can avoid duplication of the site for treatment because he knows the recorded previous trajectory, and the efficiency of treatment can be improved. In addition, according to the present invention, for example, the time required for treatment can be shortened by utilizing the improved efficiency of treatment.

[0242] Another aspect of the present invention is characterized by, for example, comprising a display control unit that displays the position of the puncture distal end portion at all times and displays the past trajectory recorded by the recording unit.

[0243] According to this aspect, since the recorded past trajectory is displayed by the display control unit, the operator can confirm the current position of the puncture tip while confirming the past trajectory. As a result, according to this aspect, for example, duplication of the treated part can be more effectively prevented, and the treatment efficiency can be improved. In addition, according to this aspect, for example, the time required for treatment can be shortened by improving the treatment efficiency.

[0244] Another aspect of the present invention is characterized in that, for example, a prediction unit is provided for predicting the trajectory of the puncture tip portion, and the display control unit further displays the trajectory of the puncture tip portion predicted by the prediction unit. Another aspect of the present invention is characterized in that, for example, a prediction unit is provided for predicting the trajectory of the puncture tip portion, and a display control unit is provided for displaying the trajectory of the puncture tip portion predicted by the prediction unit.

[0245] In this aspect, for example, the prediction unit predicts the trajectory of the puncture tip. For example, the display control unit displays the predicted trajectory of the puncture tip. Therefore, the operator can, for example, insert the puncture tip into the body while confirming the predicted trajectory of the puncture tip, thereby more effectively preventing the duplication of the treatment site and improving the treatment efficiency. In addition, according to this aspect, for example, the time required for treatment can be shortened by improving the treatment efficiency.

[0246] Another aspect of the present invention is characterized by, for example, comprising a notification unit that compares the movement trajectory of the puncture distal end portion with the past trajectory recorded by the recording unit and notifies when the trajectories are substantially the same or the same.

[0247] In this mode, for example, the notification unit notifies that the movement trajectory of the puncture tip portion and the recorded previous trajectory are substantially the same trajectory or the same trajectory. Therefore, according to this mode, for example, duplication of the treated part can be more effectively prevented, and the efficiency of the treatment can be improved. In addition, according to this mode, for example, the time required for the treatment can be shortened by utilizing the improved efficiency of the treatment.

[0248] Another aspect of the present invention is characterized by, for example, comprising a notification unit that compares the trajectory of the puncture distal end portion predicted by the prediction unit and the past trajectory recorded by the recording unit and notifies when the trajectories are substantially the same or the same.

[0249] In this mode, for example, the notification unit notifies that the predicted movement trajectory of the puncture tip and the recorded past trajectory are substantially the same trajectory or the same trajectory. Therefore, according to this mode, for example, duplication of the treated parts can be more effectively prevented, and the efficiency of the treatment can be improved. In addition, according to this mode, for example, the time required for the treatment can be shortened by utilizing the improved efficiency of the treatment.

[0250] Another aspect of the present invention is characterized by providing, for example, a first magnetic sensor attached to the puncture portion.

[0251] Another aspect of the present invention is characterized by comprising, for example: a guide tube that guides the puncture portion by allowing the puncture portion to penetrate therethrough; and a second magnetic sensor attached to the guide tube.

[0252] The present invention is characterized in that, for example, it comprises: a bone marrow puncture section, which comprises a puncture top portion and a tubular body connected to the above-mentioned puncture top portion, and the bone marrow puncture section aspirates bone marrow fluid while moving in the body; a guide tube, which is used to guide the above-mentioned bone marrow puncture section; and a moving speed calculation section, which is used to calculate the moving speed of the above-mentioned bone marrow puncture section that passes through the above-mentioned guide tube.

[0253] According to the present invention, when the position of the bone marrow puncture part moving in the body is moved, the moving speed of the bone marrow puncture part is calculated by the moving speed calculation unit. Therefore, according to the present invention, for example, by referring to the calculated moving speed of the bone marrow puncture part, the moving speed of the bone marrow puncture part can be kept within an appropriate range, and the quality of bone marrow extraction can be kept constant regardless of the experience of the operator.

[0254] Another aspect of the present invention is characterized by comprising, for example, a comparing unit that compares the moving speed calculated by the moving speed calculating unit with a predetermined moving speed associated with the suction speed of the bone marrow fluid.

[0255] In this mode, for example, the calculated moving speed is compared with a predetermined moving speed associated with the suction speed of the bone marrow fluid by the comparison unit. Therefore, by referring to the comparison result between the moving speed of the bone marrow puncture unit and the predetermined moving speed, the moving speed of the bone marrow puncture unit can be set within an appropriate range, and the quality of bone marrow extraction can be kept constant regardless of the experience of the operator.

[0256] The present invention is characterized in that, for example, it comprises: a bone marrow puncture section, which comprises a puncture tip and a tubular body connected to the above-mentioned puncture tip, and the bone marrow puncture section aspirates bone marrow fluid while moving in the body; a guide tube, which is used to guide the above-mentioned puncture section; a position calculation section, which is used to calculate the position of the above-mentioned puncture tip; and a recording section, which is used to record the previous trajectory of the above-mentioned puncture tip.

[0257] According to the present invention, when the position of the bone marrow puncture portion moving in the body moves, the position of the puncture tip is calculated by the position calculation unit. Therefore, according to the present invention, for example, the bone marrow extraction site can be prevented from being repeated based on the calculated position of the puncture tip, and the efficiency of bone marrow extraction can be improved. In addition, according to the present invention, since the previous trajectory of the puncture tip is recorded by the recording unit, the surgical operator can prevent the site of bone marrow extraction from being repeated because he knows the recorded previous trajectory, and the efficiency of bone marrow extraction can be improved. In addition, according to the present invention, for example, the time required for bone marrow extraction can be shortened by utilizing the improved efficiency of bone marrow extraction.

[0258] Another aspect of the present invention is characterized by, for example, comprising a display control unit that displays the position of the puncture distal end portion at all times and displays the past trajectory recorded by the recording unit.

[0259] According to this aspect, since the recorded past trajectory is displayed by the display control unit, for example, the operator can confirm the current position of the puncture tip while confirming the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent the duplication of the bone marrow extraction site, and improve the efficiency of bone marrow extraction. In addition, according to this aspect, for example, the time required for bone marrow extraction can be shortened by utilizing the improved efficiency of bone marrow extraction.

[0260] Another aspect of the present invention is characterized in that, for example, it is provided with a prediction unit for predicting the trajectory of the puncture tip and the contact position of the puncture tip with the cortical bone, and the display control unit further displays the trajectory of the puncture tip and the contact position predicted by the prediction unit. Another aspect of the present invention is characterized in that, for example, it is provided with: a prediction unit for predicting the trajectory of the puncture tip and the contact position of the puncture tip with the cortical bone; and a display control unit for displaying the trajectory of the puncture tip and the contact position predicted by the prediction unit.

[0261] According to this aspect, since the recorded past trajectory is displayed by the display control unit, for example, the operator can confirm the current position of the puncture tip while confirming the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent the duplication of the bone marrow extraction site, and improve the efficiency of bone marrow extraction. In addition, according to this aspect, for example, the time required for bone marrow extraction can be shortened by utilizing the improved efficiency of bone marrow extraction.

[0262] Another aspect of the present invention is characterized in that, for example, the display control unit displays the past trajectory of the puncture tip portion, which is inserted from the same puncture hole as the puncture hole through which the puncture portion penetrates. Another aspect of the present invention is characterized in that, for example, a display control unit is provided, which displays the past trajectory of the puncture tip portion, which is inserted from the same puncture hole as the puncture hole through which the puncture portion penetrates.

[0263] According to this aspect, since the recorded past trajectory is displayed by the display control unit, for example, the operator can confirm the current position of the puncture tip while confirming the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent the duplication of the bone marrow extraction site, and improve the efficiency of bone marrow extraction. In addition, according to this aspect, for example, the time required for bone marrow extraction can be shortened by utilizing the improved efficiency of bone marrow extraction.

[0264] Although the present invention has been described above with reference to the embodiments and various aspects, the present invention is not limited to the embodiments and various aspects described above. Various changes that can be understood by those skilled in the art can be made to the structure and details of the present invention within the scope of the present invention.

[0265] <Note>

[0266] A part or all of the above-mentioned embodiments and examples can be described as the following supplementary notes, but are not limited to the following contents.

[0267] (Note 1)

[0268] A puncture device, characterized in that:

[0269] The puncture device has:

[0270] Puncture the top part;

[0271] a first tubular body connected to the puncture tip at its distal end; and

[0272] an outer tubular body covering at least a portion of the first tubular body,

[0273] The first tubular body is formed to be rotatable around an axis along the longitudinal direction.

[0274] The outer diameter of the first tubular body is smaller than the inner diameter of the outer tubular body.

[0275] A drug solution supply passage is provided on the outer side of the first tubular body.

[0276] (Note 2)

[0277] The puncture device according to Supplementary Note 1, wherein:

[0278] The cross section of the drug solution supply passage on a plane perpendicular to the longitudinal direction of the first tubular body is formed in an annular shape.

[0279] (Note 3)

[0280] The puncture device according to Supplementary Note 1 or 2, wherein:

[0281] The drug solution supply passage includes a gap between the inner peripheral surface of the outer tubular body and the outer peripheral surface of the first tubular body.

[0282] (Note 4)

[0283] The puncture device according to any one of Supplementary Notes 1 to 3, wherein:

[0284] The drug solution supply passage extends to the vicinity of the puncture distal end portion.

[0285] (Note 5)

[0286] The puncture device according to any one of Supplementary Notes 1 to 4, wherein:

[0287] The first tubular body is rotatable inside the outer tubular body relative to the outer tubular body outside.

[0288] (Note 6)

[0289] The puncture device according to any one of Supplementary Notes 1 to 5, wherein:

[0290] A second tubular body which is a rigid body is connected to the proximal end of the first tubular body.

[0291] (Note 7)

[0292] The puncture device according to Supplementary Note 6, wherein:

[0293] The outer tubular body covers at least a portion of the second tubular body.

[0294] The outer diameter of the second tubular body is smaller than the inner diameter of the outer tubular body, and the second tubular body can rotate inside the outer tubular body together with the first tubular body.

[0295] The drug solution supply passage is continuous between the outer peripheral surface of the first tubular body and the inner peripheral surface of the outer tubular body, and is also provided between the outer peripheral surface of the second tubular body and the inner peripheral surface of the outer tubular body.

[0296] (Note 8)

[0297] The puncture device according to any one of Supplementary Notes 1 to 7, wherein:

[0298] The first tubular body is formed in a spiral shape.

[0299] (Note 9)

[0300] The puncture device according to Supplementary Note 8, wherein:

[0301] The winding direction of the spiral first tubular body coincides with the rotation direction of the first tubular body.

[0302] (Note 10)

[0303] The puncture device according to any one of Supplementary Notes 1 to 9, wherein:

[0304] The puncture device comprises a suction device for sucking the interior of the first tubular body.

[0305] The first tubular body is formed so that the drug solution in the drug solution supply passage can penetrate into the first tubular body.

[0306] (Note 11)

[0307] The puncture device according to Supplementary Note 10, wherein:

[0308] The above suction device is used to suck bone marrow fluid.

[0309] The drug solution supply passage is used to supply an anticoagulant.

[0310] (Note 12)

[0311] The puncture device according to any one of Supplementary Notes 1 to 11, wherein

[0312] The puncture tip has:

[0313] A tubular body having a distal end and an opening at the distal end surface;

[0314] a distal end rotating portion disposed at a position distal to the distal end surface of the tube body, the distal end rotating portion rotating together with the tube body to perforate (puncture) tissue in the bone marrow cavity; and

[0315] A connecting portion connects the above-mentioned tube body and the above-mentioned top rotating portion.

[0316] (Note 13)

[0317] The puncture device according to Supplementary Note 12, wherein:

[0318] The tube body having the opening is formed integrally with the top rotating portion and the connecting portion.

[0319] The first tubular body is flexible and is disposed on the proximal end side of the tubular body.

[0320] (Note 14)

[0321] The puncture device according to Supplementary Note 12 or 13, wherein:

[0322] The distal end rotating portion includes a disk-shaped portion having a radial central axis on a central axis extending along the longitudinal direction of the tube.

[0323] (Note 15)

[0324] The puncture device according to any one of Supplementary Notes 12 to 14, wherein

[0325] The connecting portion has a groove formed therein so as to be continuous with the opening.

[0326] (Note 16)

[0327] The puncture device according to any one of Supplementary Notes 12 to 15, wherein

[0328] The distal end surface is not orthogonal to the length direction of the tube body.

[0329] (Note 17)

[0330] The puncture device according to any one of Supplementary Notes 12 to 16, wherein

[0331] The width of the top rotating portion in a direction perpendicular to the length direction of the tube body is greater than the width of the tube body in a direction perpendicular to the length direction of the tube body.

[0332] (Note 18)

[0333] The puncture device according to any one of Supplementary Notes 1 to 17, wherein

[0334] The above-mentioned puncture instrument is a bone marrow puncture instrument.

[0335] (Note 19)

[0336] A puncture device, characterized in that:

[0337] The puncture device has:

[0338] The puncture device according to any one of Supplementary Notes 1 to 18; and

[0339] The moving speed calculation unit is used to calculate the moving speed of the puncture instrument.

[0340] (Note 20)

[0341] The puncture device according to Supplementary Note 19, wherein:

[0342] The puncture device includes a comparing unit that compares the moving speed calculated by the moving speed calculating unit with a predetermined moving speed.

[0343] (Note 21)

[0344] The puncture device according to Appendix 20, wherein:

[0345] The puncture device includes a notification unit configured to provide notification regarding a moving speed of the puncture device based on a comparison result of the comparison unit.

[0346] (Note 22)

[0347] The puncture device according to any one of Supplementary Notes 19 to 21, wherein:

[0348] The puncture device has:

[0349] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0350] The recording part is used to record the past trajectory of the puncture tip.

[0351] (Note 23)

[0352] The puncture device according to Appendix 22, wherein:

[0353] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0354] (Note 24)

[0355] The puncture device according to Appendix 23, wherein:

[0356] The puncture device includes a prediction unit for predicting the trajectory of the puncture tip portion.

[0357] The display control unit further displays the trajectory of the puncture distal end portion predicted by the prediction unit.

[0358] (Note 25)

[0359] The puncture device according to Appendix 24, wherein:

[0360] The puncture device includes a notification unit that compares the trajectory of the puncture distal end portion predicted by the prediction unit and the past trajectory recorded by the recording unit, and notifies when the trajectories are substantially the same or the same.

[0361] (Note 26)

[0362] The puncture device according to any one of Supplementary Notes 22 to 25, wherein:

[0363] The puncture device includes a notification unit that compares the movement trajectory of the puncture distal end portion with the past trajectory recorded by the recording unit and notifies when the trajectories are substantially the same or the same.

[0364] (Note 27)

[0365] The puncture device according to any one of Supplementary Notes 19 to 26, wherein:

[0366] The puncturing device includes a first magnetic sensor, and the first magnetic sensor is attached to the puncturing device.

[0367] (Note 28)

[0368] The puncture device according to Appendix 27, wherein:

[0369] The puncture device has:

[0370] a guide tube for guiding the puncture device by allowing the puncture device described in any one of Supplementary Notes 1 to 18 to pass therethrough; and

[0371] The second magnetic sensor is mounted on the guide tube.

[0372] (Note 29)

[0373] A puncture device, characterized in that:

[0374] The puncture device has:

[0375] The puncture device according to any one of Notes 1 to 18;

[0376] A guide tube, used for guiding the puncture instrument; and

[0377] A moving speed calculation unit is used to calculate the moving speed of the puncture tool that passes through the guide tube.

[0378] (Note 30)

[0379] The puncture device according to Appendix 29, wherein:

[0380] The puncture device includes a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed associated with the suction speed of the bone marrow fluid.

[0381] (Note 31)

[0382] A puncture device, characterized in that:

[0383] The puncture device has:

[0384] The puncture device according to any one of Notes 1 to 18;

[0385] A guide tube, used to guide the puncture instrument;

[0386] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0387] The recording part is used to record the past trajectory of the puncture tip.

[0388] (Note 32)

[0389] The puncture device according to Appendix 31, wherein:

[0390] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0391] (Note 33)

[0392] The puncture device according to Appendix 32, wherein:

[0393] The puncture device includes a prediction unit for predicting a trajectory of the puncture tip portion and a contact position of the puncture tip portion with the cortical bone.

[0394] The display control unit further displays the trajectory of the puncture distal end portion and the contact position predicted by the prediction unit.

[0395] (Note 34)

[0396] The puncture device according to any one of Supplementary Notes 31 to 33, wherein:

[0397] The display control unit displays a past trajectory of the puncture distal end portion inserted from the same puncture hole as the puncture hole through which the puncture instrument is inserted.

[0398] (Note 35)

[0399] A puncture instrument is a bone marrow puncture device that inserts at least the tip into the bone marrow cavity to extract bone marrow fluid, the puncture instrument is characterized in that:

[0400] The puncture device has:

[0401] a tubular body having a distal end and an opening at the distal end surface;

[0402] a distal rotating portion disposed at a position distal to the distal end surface of the tubular body, the distal rotating portion rotating together with the tubular body to perforate (puncture) tissue in the bone marrow cavity; and

[0403] A connecting portion connects the tubular body and the distal end rotating portion.

[0404] (Note 36)

[0405] The puncture device according to Supplementary Note 35, wherein:

[0406] The tubular body at least comprises:

[0407] a tubular body, which is formed integrally with the top rotating portion and the connecting portion and has the opening; and

[0408] The flexible first tubular body is arranged on the proximal end side of the above-mentioned tubular body.

[0409] (Note 37)

[0410] The puncture device according to Appendix 35 or 36, wherein:

[0411] The distal end rotating portion includes a disk-shaped portion having a radial central axis on a central axis extending along the longitudinal direction of the tubular body.

[0412] (Note 38)

[0413] The puncture device according to any one of Supplementary Notes 35 to 37, wherein:

[0414] The connecting portion has a groove formed therein so as to be continuous with the opening.

[0415] (Note 39)

[0416] The puncture device according to any one of Supplementary Notes 35 to 38, wherein:

[0417] The distal end surface and the longitudinal direction of the tubular body are not orthogonal.

[0418] (Note 40)

[0419] The puncture device according to any one of Supplementary Notes 35 to 39, wherein:

[0420] Regarding the width in a direction perpendicular to the longitudinal direction of the tubular body, the width of the distal end rotation portion is larger than the width of the tubular body.

[0421] (Note 41)

[0422] The puncture device according to any one of Supplementary Notes 35 to 40, wherein:

[0423] The above-mentioned puncture instrument is a bone marrow puncture instrument.

[0424] (Note 42)

[0425] A puncture device, characterized in that:

[0426] The puncture device has:

[0427] The puncture device according to any one of Supplementary Notes 35 to 41; and

[0428] The moving speed calculation unit is used to calculate the moving speed of the puncture instrument.

[0429] (Note 43)

[0430] The puncture device according to Appendix 42, wherein:

[0431] The puncture device includes a comparing unit that compares the moving speed calculated by the moving speed calculating unit with a predetermined moving speed.

[0432] (Note 44)

[0433] The puncture device according to Appendix 43, wherein:

[0434] The puncture device includes a notification unit configured to provide notification regarding a moving speed of the puncture unit based on a comparison result of the comparison unit.

[0435] (Note 45)

[0436] A puncture device, characterized in that:

[0437] The puncture device has:

[0438] The puncture device according to any one of Notes 35 to 41;

[0439] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0440] The recording part is used to record the past trajectory of the puncture tip.

[0441] (Note 46)

[0442] The puncture device according to Appendix 45, wherein:

[0443] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0444] (Note 47)

[0445] The puncture device according to Appendix 46, wherein:

[0446] The puncture device includes a prediction unit for predicting the trajectory of the puncture tip portion.

[0447] The display control unit further displays the trajectory of the puncture distal end portion predicted by the prediction unit.

[0448] (Note 48)

[0449] The puncture device according to Appendix 47, wherein:

[0450] The puncture device includes a notification unit that compares the trajectory of the puncture distal end portion predicted by the prediction unit and the past trajectory recorded by the recording unit, and notifies when the trajectories are substantially the same or the same.

[0451] (Note 49)

[0452] The puncture device according to any one of Supplementary Notes 45 to 48, wherein:

[0453] The puncture device includes a notification unit that compares the movement trajectory of the puncture distal end portion with the past trajectory recorded by the recording unit and notifies when the trajectories are substantially the same or the same.

[0454] (Note 50)

[0455] The puncture device according to any one of Supplementary Notes 42 to 49, wherein:

[0456] The puncture device includes a first magnetic sensor, and the first magnetic sensor is attached to the puncture portion.

[0457] (Note 51)

[0458] The puncture device according to Appendix 50, wherein:

[0459] The puncture device has:

[0460] a guide tube for guiding the puncture portion by allowing the puncture portion to pass therethrough; and

[0461] The second magnetic sensor is mounted on the guide tube.

[0462] (Note 52)

[0463] A puncture device, characterized in that:

[0464] The puncture device has:

[0465] The puncture device according to any one of Notes 35 to 41;

[0466] a guide tube for guiding the bone marrow puncture part; and

[0467] A moving speed calculation unit is used to calculate the moving speed of the bone marrow puncture unit that passes through the guide tube.

[0468] (Note 53)

[0469] The puncture device according to Appendix 52, wherein:

[0470] The puncture device includes a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed associated with the suction speed of the bone marrow fluid.

[0471] (Note 54)

[0472] A puncture device, characterized in that:

[0473] The puncture device has:

[0474] The puncture device according to any one of Notes 35 to 41;

[0475] A guide tube, used for guiding the puncture part;

[0476] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0477] The recording part is used to record the past trajectory of the puncture tip.

[0478] (Note 55)

[0479] The puncture device according to Appendix 54, wherein:

[0480] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0481] (Note 56)

[0482] The puncture device according to Appendix 55, wherein:

[0483] The puncture device includes a prediction unit for predicting a trajectory of the puncture tip portion and a contact position of the puncture tip portion with the cortical bone.

[0484] The display control unit further displays the trajectory of the puncture distal end portion and the contact position predicted by the prediction unit.

[0485] (Note 57)

[0486] The puncture device according to Appendix 55 or 56, wherein:

[0487] The display control unit displays a past trajectory of the puncture distal end portion that was inserted from the same puncture hole as the puncture hole through which the puncture portion penetrated.

[0488] (Note 58)

[0489] A puncture device, characterized in that:

[0490] The puncture device has:

[0491] a puncture section including a puncture tip and a tubular body connected to the puncture tip, the puncture section performing a predetermined treatment on body tissue while advancing in the body; and

[0492] The moving speed calculation unit is used to calculate the moving speed of the puncture unit.

[0493] (Note 59)

[0494] The puncture device according to Supplement 58, wherein:

[0495] The puncture device includes a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed.

[0496] (Note 60)

[0497] The puncture device according to Appendix 59, wherein:

[0498] The puncture device includes a notification unit configured to provide notification regarding a moving speed of the puncture unit based on a comparison result of the comparison unit.

[0499] (Note 61)

[0500] A puncture device, characterized in that:

[0501] The puncture device has:

[0502] a puncture section including a puncture tip and a tubular body connected to the puncture tip, the puncture section performing a predetermined treatment on body tissue while advancing in the body;

[0503] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0504] The recording part is used to record the past trajectory of the puncture tip.

[0505] (Note 62)

[0506] The puncture device according to Appendix 61, wherein:

[0507] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0508] (Note 63)

[0509] The puncture device according to Appendix 62, wherein:

[0510] The puncture device includes a prediction unit for predicting the trajectory of the puncture tip portion.

[0511] The display control unit further displays the trajectory of the puncture distal end portion predicted by the prediction unit.

[0512] (Note 64)

[0513] The puncture device according to Appendix 63, wherein:

[0514] The puncture device includes a notification unit that compares the trajectory of the puncture distal end portion predicted by the prediction unit and the past trajectory recorded by the recording unit, and notifies when the trajectories are substantially the same or the same.

[0515] (Note 65)

[0516] The puncture device according to any one of Supplementary Notes 61 to 64, wherein:

[0517] The puncture device includes a notification unit that compares the movement trajectory of the puncture distal end portion with the past trajectory recorded by the recording unit and notifies when the trajectories are substantially the same or the same.

[0518] (Note 66)

[0519] The puncture device according to any one of Supplementary Notes 58 to 65, wherein:

[0520] The puncture device includes a first magnetic sensor, and the first magnetic sensor is attached to the puncture portion.

[0521] (Note 67)

[0522] The puncture device according to Appendix 66, wherein:

[0523] The puncture device has:

[0524] a guide tube for guiding the puncture portion by allowing the puncture portion to pass therethrough; and

[0525] The second magnetic sensor is mounted on the guide tube.

[0526] (Note 68)

[0527] A puncture device, characterized in that:

[0528] The puncture device has:

[0529] A bone marrow puncture section, which includes a puncture tip and a tubular body connected to the puncture tip, and the bone marrow puncture section sucks bone marrow fluid while advancing in the body;

[0530] a guide tube for guiding the bone marrow puncture part; and

[0531] A moving speed calculation unit is used to calculate the moving speed of the bone marrow puncture unit that passes through the guide tube.

[0532] (Note 69)

[0533] The puncture device according to Appendix 68, wherein:

[0534] The puncture device includes a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed associated with the suction speed of the bone marrow fluid.

[0535] (Note 70)

[0536] A puncture device, characterized in that:

[0537] The puncture device has:

[0538] A bone marrow puncture section, which includes a puncture tip and a tubular body connected to the puncture tip, and the bone marrow puncture section sucks bone marrow fluid while advancing in the body;

[0539] A guide tube, used for guiding the puncture part;

[0540] a position calculation unit, which is used to calculate the position of the puncture tip; and

[0541] The recording part is used to record the past trajectory of the puncture tip.

[0542] (Supplementary Note 71)

[0543] The puncture device according to Appendix 70, wherein:

[0544] The puncture device includes a display control unit that displays the position of the puncture distal end portion at any time and displays the past trajectory recorded by the recording unit.

[0545] (Supplementary Note 72)

[0546] The puncture device according to Appendix 71, wherein:

[0547] The puncture device includes a prediction unit for predicting a trajectory of the puncture tip portion and a contact position of the puncture tip portion with the cortical bone.

[0548] The display control unit further displays the trajectory of the puncture distal end portion and the contact position predicted by the prediction unit.

[0549] (Note 73)

[0550] The puncture device according to Appendix 71 or 72, wherein:

[0551] The display control unit displays a past trajectory of the puncture distal end portion that was inserted from the same puncture hole as the puncture hole through which the puncture portion penetrated.

[0552] This application claims the benefit of priority based on Japanese Patent Application No. 2017-015764, Japanese Patent Application No. 2017-015767, and Japanese Patent Application No. 2017-015795, filed on January 31, 2017, the disclosures of which are incorporated herein in their entirety by reference.

[0553] Industrial Applicability

[0554] As described above, by using the first puncture tool or puncture device of the present invention, it is possible to administer a drug solution. In addition, by using the first puncture tool or puncture device of the present invention, for example, when an anticoagulant is used as a drug solution, coagulation of bone marrow fluid or the like can be reliably prevented. In addition, by using the first puncture tool or puncture device of the present invention, since the first tubular body used for conveying the drug solution is, for example, housed in the outer tubular body, the perforation for extracting the bone marrow or the like will not be enlarged beyond the required extent, and the suction path of the bone marrow or the like can be fully ensured. Therefore, it can be said that the present invention is an extremely useful technology in the medical fields of transplantation medicine, regenerative medicine, etc., for example.

[0555] Description of Reference Numerals

[0556] 1. Bone marrow puncture part; 2. Puncture top part; 3. First tubular body; 4. Second tubular body; 5. Outer sleeve; 5a. Drug supply passage; 10. Bone marrow puncture device; 20. Tube body; 20a. Top end surface; 20b. Opening; 21. Disc-shaped part; 22. Connecting part; 30. Guide tube; 40. First magnetic sensor; 41. Second magnetic sensor; 100. Bone marrow puncture system; 160. Tracking part; 195. Analysis part; 196. Display control part; 197. Display part.

Claims

1. A puncture instrument having a tip configured to be inserted into a bone marrow cavity to extract bone marrow fluid, the tip having: tubular body, The top rotating part, and The connecting portion, wherein The tubular body comprises: A distal end, wherein the distal end surface of the distal end is inclined relative to the length direction of the tubular body; and An opening, which is located at the distal end face, The distal end rotating portion is configured to puncture tissue in the bone marrow cavity while rotating together with the tubular body, and is disposed at a position distal to the distal end surface of the tubular body, and The connecting portion extends in a direction different from the inclination direction of the distal end surface in a manner inclined relative to the longitudinal direction of the tubular body, and is configured to connect the tubular body and the distal rotating portion. The distal end rotating portion includes a disk-shaped portion having a radial central axis on a central axis extending along the longitudinal direction of the tubular body.

2. The puncture device according to claim 1, wherein: The tubular body comprises: a tubular body, which is formed integrally with the top rotating portion and the connecting portion and has the opening; and The flexible first tubular body is arranged on the proximal end side of the above-mentioned tubular body.

3. The puncture device according to claim 2, wherein: The flexible first tubular body is formed in a spiral shape.

4. The puncture device according to claim 3, wherein: The winding direction of the spiral first tubular body coincides with the rotation direction of the first tubular body.

5. The puncture device according to any one of claims 1 to 4, wherein The connecting portion has a groove formed therein so as to be continuous with the opening.

6. The puncture device according to any one of claims 1 to 5, wherein The width of the distal rotating portion in a direction perpendicular to the longitudinal direction of the tubular body is greater than the width of the tubular body in a direction perpendicular to the longitudinal direction of the tubular body.

7. The puncture device according to claim 1 or 2, wherein: An angle θ between the distal end surface of the tubular body and a central axis extending along the longitudinal direction of the tubular body is an acute angle.

8. The puncture device according to claim 7, wherein: The angle θ is 50 to 60 degrees.

9. The puncture device according to claim 1 or 2, wherein: The outer edge of the distal rotating portion at the distal side is arc-shaped.

10. The puncture device according to claim 1 or 2, wherein: The side surface at the outer edge of the top rotating part is a curved surface.

11. The puncture device according to claim 1 or 2, wherein: The above-mentioned puncture instrument is a bone marrow puncture instrument.

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