HK40007987B - Puncturing instrument and puncturing device - Google Patents

Description

Puncture instruments and puncture devices

Technical Field

The present invention relates to a puncture tool and a puncture device.

Background Art

In the past, a bone marrow puncture needle was manually inserted into the iliac bone 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 is made to protrude 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 using 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.

However, since the extracted bone marrow (hereinafter also referred to as "bone marrow fluid") coagulates immediately, an anticoagulant is supplied into the inner needle used to extract the bone marrow fluid to mix the bone marrow fluid and the anticoagulant. Patent Document 1 also discloses a supply port for the anticoagulant connected near the base of the inner needle, through which the anticoagulant is supplied into the inner needle.

Furthermore, due to the histological structure of bone marrow tissue, bone marrow fluid does not flow from the surrounding area into the periphery of the perforation (the periphery of the puncture hole) immediately after a certain amount of bone marrow fluid has been extracted. Instead, during repeated extractions, this periphery is primarily supplied with peripheral blood. Therefore, conventionally, the outer needle position and angle are changed several times without changing the perforation in the skin, and the outer needle is reinserted into the ilium, repeating the aforementioned process. Furthermore, once a specific treatment has been completed for a single perforation in the skin, a different perforation is then made and the same treatment is repeated.

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

The reason for extracting bone marrow fluid from so many locations is that the amount of bone marrow fluid extracted from a single location is limited to 3 to 5 mL. Because there is no external method for confirming the position of the needle tip inside the iliac bone and inside the iliac bone, overlapping extraction sites often occur. In other words, because the location of the extraction site cannot be externally confirmed, the method of randomly changing the extraction site over a wide range has been used to increase the probability of extracting the required amount of bone marrow fluid.

Prior art literature

Patent Literature

Patent Document 1: Japanese Patent No. 4808961

Summary of the Invention

Problems to be solved by the invention

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 through the opening is sucked by a suction device. Consequently, there is a problem in that the anticoagulant supplied from the supply port near the base of the inner needle does not reach the vicinity of the opening and coagulates before reaching the supply port from the opening.

Inserting a tube for supplying the anticoagulant into the inner needle is also conceivable, but this is not ideal because the hollow portion of the inner needle, which serves as the path for aspirating the bone marrow fluid, would be blocked by the tube. Furthermore, if the outer diameter of the inner needle is increased in conjunction with the supply tube, the perforation (puncture hole) formed by the inner needle would become excessively large, which is also not ideal.

Furthermore, 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.

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

Furthermore, any bone marrow aspiration needle requires a large amount of bone marrow fluid containing peripheral blood to extract sufficient bone marrow hematopoietic stem cells, and thus efficient stem cell extraction is not achieved.

Furthermore, when the tip of the inner needle with a drill is sharpened, as in Patent Document 1, there is a risk that the sharp tip will puncture (perforate) the bone marrow cavity, etc., to the outside, causing a serious accident. Furthermore, when the opening for aspirating 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 is excavating the perforation (excavating and puncturing). Furthermore, the opening direction of the opening is perpendicular to the puncture direction of the tip of the inner needle. Therefore, it is difficult to efficiently aspirate bone marrow fluid, and depending on the situation, blockage may sometimes occur.

Therefore, a second object of the present invention is to provide a bone marrow puncture device capable of efficiently aspirating bone marrow fluid. A second object of the present invention is also to provide a bone marrow puncture device in which, for example, the tip of the puncture direction does not puncture (perforate) the bone marrow cavity to the outside (for example, the possibility of puncture is reduced).

Furthermore, in the method of Patent Document 1, since the angle of the outer needle and the direction of entry of the inner needle must rely on the operator's intuition, the inner needle may sometimes enter the same site as the site of previous extraction, resulting in poor bone marrow extraction efficiency.

Furthermore, if the suction speed is too slow, excessive blood will be sucked out, while 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, this extraction speed had to rely on the operator's intuition.

To address the above issues, one approach is to use an ultrasound device to confirm the interior of the ilium and the positions of the outer and inner needles within the ilium from the outside. However, ultrasound attenuation is significant within the bone, making it difficult to use ultrasound devices to extract bone marrow fluid from deep within the bone.

Furthermore, in addition to the case of extracting bone marrow fluid, the above-mentioned problem also occurs when a puncture needle or the like is advanced in the body to perform a predetermined treatment on body tissue.

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

Solutions for solving problems

To achieve the first object, the first puncture device or apparatus of the present invention is characterized by comprising: 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 rotatable about an axis extending along its longitudinal 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.

To achieve the second object, the bone marrow puncture instrument or device of the present invention is configured to insert at least the distal end into the bone marrow cavity to extract bone marrow fluid. The bone marrow puncture instrument or device is characterized by comprising: a tubular body having a distal end and an opening at the distal end surface; a distal rotating portion disposed distally of the distal end surface of the tubular body, the distal rotating portion rotating together with the tubular body to perforate (puncture) tissue within the bone marrow cavity; and a connecting portion connecting the tubular body and the distal rotating portion.

To achieve the third object, the second puncture device of the present invention is characterized by comprising: 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 advancing within the body; and a movement speed calculation section for calculating the movement speed of the puncture section.

Effects of the Invention

The first puncture instrument or puncture device of the present invention can be used to administer a medicinal solution. Furthermore, using the first puncture instrument or puncture device of the present invention, for example, a medicinal solution is delivered to the outer surface of the first tubular body via a medicinal solution supply passage provided on the outside of the first tubular body. The medicinal solution delivered to the outer surface of the first tubular body is delivered toward the puncture tip, for example, and mixed with tissue extracted from the puncture tip, such as bone marrow fluid. Furthermore, because 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 about an axis along its length. Therefore, the medicinal solution delivered to the outer surface of the first tubular body is delivered toward the puncture tip by the rotation of the first tubular body, and the bone marrow fluid, etc., just extracted from the puncture tip, mixes with the medicinal solution. Therefore, using the first puncture instrument or puncture device of the present invention, for example, when using an anticoagulant as the medicinal solution, coagulation of the bone marrow fluid, etc., can be reliably prevented. Furthermore, because the first tubular body for delivering the medical solution is housed within the outer tubular body, for example, the perforation (puncture hole) for extracting bone marrow fluid, etc., does not increase beyond the necessary size, and a sufficient aspiration path for the bone marrow fluid, etc., can be ensured. More specifically, the first puncture instrument or puncture device of the present invention enables delivery of the medical solution even without providing a separate component for delivering the medical solution relative to the first tubular body and the outer tubular body. The puncture instrument or puncture device of the present invention can provide a puncture instrument (e.g., a bone marrow puncture instrument) or puncture device (e.g., a bone marrow puncture device) that, for example, does not increase the perforation (puncture hole) formed in body tissue beyond the necessary size and can reliably deliver the medical solution. That is, the first puncture instrument or puncture device of the present invention can reduce the size (e.g., diameter) of the puncture instrument or puncture device, thereby reducing the perforation (puncture hole) formed in body tissue.

The bone marrow puncture instrument or bone marrow puncture device of the present invention enables efficient aspiration of bone marrow fluid. Specifically, the bone marrow puncture instrument or bone marrow puncture device of the present invention utilizes, for example, a distal rotating portion that rotates together with the tubular body to perforate (puncture) tissue within the bone marrow cavity, and an opening is provided on the distal end surface of the tubular body connected to the distal rotating portion by a connecting portion. Therefore, bone marrow fluid can be efficiently aspirated from tissue within the bone marrow cavity perforated (punctured) by the distal rotating portion.

With the second puncture device of the present invention, the movement speed calculation unit calculates the movement speed of the puncture portion as it moves within the body. Therefore, with the second puncture device of the present invention, the movement speed of the puncture portion can be kept within an appropriate range by referring to the calculated movement speed of the puncture portion, thereby maintaining consistent treatment quality without relying on the operator's experience.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a diagram schematically showing a bone marrow puncture system according to one embodiment of the present invention.

FIG2 is a block diagram showing the configuration of a bone marrow puncture system.

FIG3 is a cross-sectional view schematically showing a bone marrow puncture portion of a bone marrow puncture device.

Figure 4 is a diagram showing a guide tube, Figure 4 (A) is a top view of the entire guide tube with an inner needle inserted into an outer needle, Figure 4 (B) is a sectional view of Figure 4 (A), Figure 4 (C) is a top view of the inner needle, Figure 4 (D) is a top view of the outer needle, and Figure 4 (E) is a sectional view of Figure 4 (D).

FIG5 is a perspective view showing the puncture tip portion.

FIG6 is a side view showing the puncture tip portion.

FIG7 is a plan view showing the puncture tip portion.

FIG8 is a front view showing the puncture tip portion.

FIG9 is a diagram showing puncture marks made using a bone marrow puncture unit according to an embodiment of the present invention in a simulation using a plastic block having a hardness equivalent to that of the cortical bone and spongy bone of a human iliac bone. FIG9(A) shows the puncture mark made at an incident angle of 5 degrees, FIG9(B) shows the puncture mark made at an incident angle of 10 degrees, and FIG9(C) shows the puncture mark made at an incident angle of 15 degrees.

FIG10 is a side view showing a part of the first tubular body in an enlarged manner.

FIG11 is a cross-sectional view of a modified example of the first tubular body.

FIG12 is a front view of a modified example of the first tubular body.

FIG13 is a cross-sectional view schematically showing a bone marrow puncture portion of a bone marrow puncture device.

FIG14 is a plan view showing the guide tube.

FIG. 15 is a diagram schematically showing a bone marrow puncture system.

FIG16 is a block diagram showing the configuration of a bone marrow puncture system.

FIG. 17 is a diagram for explaining navigation of the bone marrow puncture system.

FIG. 18 is a diagram for explaining navigation of the bone marrow puncture system.

FIG. 19 is a diagram for explaining navigation of the bone marrow puncture system.

FIG20 shows puncture marks made using a bone marrow puncture unit of a 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. FIG20(A) shows the puncture mark made at an incident angle of 5 degrees, FIG20(B) shows the puncture mark made at an incident angle of 10 degrees, and FIG20(C) shows the puncture mark made at an incident angle of 20 degrees.

FIG. 21 is a diagram schematically showing a modified example of the bone marrow puncture system of the present invention.

FIG22 is a block diagram showing the configuration of a modified example of the bone marrow puncture system.

FIG23 is a perspective view showing a modified example of the bone marrow puncture device.

FIG24 is a cross-sectional view taken along the line AA’ in FIG23 .

FIG. 25 is an enlarged view of a modified example of the bone marrow puncture portion in FIG. 23 .

DETAILED DESCRIPTION

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 operator's side when the operator punctures the puncture tip of the puncture device (puncture instrument) toward the surgical site.

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 to the end when the surgeon punctures the puncture tip of the puncture device (puncture instrument) toward the surgical site when the surgeon is viewing it from the side of the surgeon.

In the description of the bone marrow puncture instrument or bone marrow puncture device of the present invention, the term "distal end" herein refers to the end of the tubular body that is farther from the distal end of the tubular body when the operator inserts the tip of the bone marrow puncture instrument (bone marrow puncture instrument) into the bone marrow cavity, as 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 term "distal side" herein refers to the side farther from the distal end 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 term "proximal side" herein refers to the closer side of the tubular body when viewed from the operator's side.

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

(Structure of bone marrow puncture system)

The structure of the bone marrow puncture system 100 will be described with reference to the accompanying drawings. FIG1 schematically illustrates the bone marrow puncture system 100 according to one embodiment of the present invention. FIG2 is a block diagram illustrating the structure of the bone marrow puncture system 100. Note that portions related to navigation, which will be described later, are omitted in FIG1 and FIG2.

As shown in FIG1 and FIG2 , a 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 .

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

As shown in Figure 1, an outer sleeve (outer tubular body) 5, which covers the first tubular body 3 and the second tubular body 4 of the bone marrow puncture section 1 (described later), protrudes from the housing 10a. The puncture tip 2 is attached to the tip of the first tubular body 3 covered by the outer sleeve 5. The length of the protruding portion from the housing 10a, including the first tubular body 3, the second tubular body 4, the outer sleeve 5, and the puncture tip 2, is L1. As shown by the dotted line in Figure 1, the first tubular body 3 and the outer sleeve 5 covering the first tubular body 3 are flexible. The length of this flexible portion is L2. The first tubular body 3, the second tubular body 4, and the puncture tip 2 covered by the outer sleeve 5 can rotate counterclockwise or clockwise. A detailed description of the bone marrow puncture section 1, including the puncture tip 2, the first tubular body 3, the second tubular body 4, and the outer sleeve 5, will be described later.

Container 110 is a container for storing bone marrow fluid aspirated by bone marrow puncture device 10 and is connected to bone marrow puncture device 10. Container 110 is also connected to aspiration control unit 125 of control unit 120. Aspiration control unit 125 controls the aspiration pressure value and on/off switching of container 110 and bone marrow puncture device 10 connected thereto.

The control unit 120 includes a CPU (Central Processing Unit), ROM (Read Only Memory), and RAM (Random Access Memory), among other components (not shown), and functions as a suction control unit 125 and an operation control unit 126. The suction control unit 125 is connected to a vacuum generator 130 and a switch unit 140. The vacuum generator 130, serving as a suction device, generates a predetermined negative pressure. This predetermined negative pressure is, for example, not less than -90 kPa and less than 0 kPa.

The switch unit 140 is located near the operator and includes a switch for turning suction on/off and a switch for turning the motor on/off. The switch unit 140 is not shown in FIG1 . Furthermore, the switch unit 140 can be independent of the bone marrow puncture device 10 or integrated with the device 10. If the switch unit 140 is independent of the device 10, it can be provided as a foot switch, for example. If the switch unit 140 is integrated with the device 10, it can be provided on the handle 10b, for example.

The suction control unit 125 is equipped with a valve (not shown) that opens and closes the valve when it receives a suction on/off signal from the switch unit 140 according to the operator's operation. For example, an internal container connected to the vacuum generator 130 may be provided within the control unit 120, and the valve may be provided in the internal container. In this way, the suction pressure of the bone marrow puncture device 10 can be controlled to be on/off. In addition, the control unit 120 is provided with a knob 120a, and by turning the knob 120a, the pressure value of the suction pressure can be adjusted. For example, the suction control unit 125 may close the valve after a specified time when it receives a closing signal. In this way, 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.

The motion control unit 126 is connected to the drive unit and switch unit 140 of the bone marrow puncture device 10. Upon receiving a motor on/off signal from the switch unit 140 in response to an operator's operation, the unit transmits an on/off signal to the drive unit's motor. This allows the rotation and stopping of the bone marrow puncture unit 1 of the bone marrow puncture device 10 to be controlled. The control unit 120 is provided with a knob 120b, which can be turned to adjust the motor speed. The motor speed and torque, for example, are those required to puncture tissue within the bone marrow cavity. The speed is, for example, 60 rpm to 150 rpm. Furthermore, the torque is, for example, less than 500 mN·m or less than 300 mN·m. The propulsion force of the bone marrow puncture unit 1 is, for example, approximately 15 N to 20 N. The propulsion speed of the bone marrow puncture unit 1 is, for example, approximately 1 mm/second. In this embodiment, as an example, the speed is set to 120 rpm, and knob 120b can be used to adjust the speed to, for example, 90 rpm, 120 rpm, or 150 rpm. To prevent, for example, perforation of the outer side of the cortical bone or damage to the first tubular body 3, the motion control unit 126 can calculate the current of the driver's motor based on the torque at the deformation limit of the first tubular body 3. In this case, the motion control unit 126 can also send a shutdown signal to the driver's motor when an overload current exceeding the specified current value is required. In other words, the motion control unit 126 can also cut off the motor's drive. Furthermore, if an overload protection device such as a torque limiter is installed on the shaft of the driver's motor, the motion control unit 126 can also send a signal to the overload protection device to suppress the rotational speed. In other words, the motion control unit 126 can also mechanically cut off the overload of the driver's motor through the overload protection device. Furthermore, the motion control unit 126 can inform the operator of the torque and current values of the driver's motor by, for example, turning on and off a light or sounding a warning. Furthermore, when the overload is relieved, the motion control unit 126 can send a signal to the driver's motor to resume driving.

The syringe pump 150 is a pump for supplying an anticoagulant as a medical solution to the bone marrow puncture device 10. The syringe pump 150 is connected to the bone marrow puncture device 10. A knob 150a is provided on the syringe pump 150, and by turning the knob 150a, the supply rate of the anticoagulant can be adjusted. In this embodiment, as an example, an anticoagulant such as heparin is supplied at a rate of 40μl/second (sec). Detailed description related to the supply system of the anticoagulant is described later. In this embodiment, the anticoagulant is supplied using the syringe 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.

PC190 is connected to the control unit 120, and can output commands to the control unit 120 and output data for settings. 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 can work together. PC190 may also have, for example, input components (keyboard, etc.) and output components (displays such as liquid crystal displays, printers, etc.). In this 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 (smartphone, tablet computer, etc.), a smart speaker, etc.

Fig. 21 schematically shows a modified bone marrow puncture system 200. Fig. 22 is a block diagram showing the configuration of a modified bone marrow puncture system 200. In Figs. 21 and 22, portions related to navigation, which will be described later, are omitted.

As shown in Figures 21 and 22 , bone marrow puncture system 200 includes a filter device 210 in addition to the components of bone marrow puncture system 100. Furthermore, control unit 120 includes a liquid delivery control unit 127 in addition to suction control unit 125 and motion control unit 126. Syringe pump 150 is electrically connected to control unit 120.

Filter device 210 is used to filter the bone marrow fluid aspirated by bone marrow puncture device 10, thereby removing spongy bone from the bone marrow fluid. Filter device 210 can use, for example, a commercially available filter or jacket. Filter device 210 is connected to bone marrow puncture device 10 and container 110. As previously mentioned, container 110 connected to filter device 210 is connected to suction control unit 125 of control unit 120. Therefore, suction control unit 125 controls the suction pressure value and on/off switching of container 110, filter device 210, and bone marrow puncture device 10 connected to container 110.

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

The liquid delivery control unit 127 is connected to the switch unit 140 and the syringe pump 150. Upon receiving a liquid delivery on/off signal from the switch unit 140 in response to an operation by the operator, the liquid delivery control unit 127 transmits a liquid delivery on/off signal to the syringe pump 150. This allows the start and stop of liquid delivery by the syringe pump 150 to be controlled. By controlling the on/off of liquid delivery from the syringe pump 150 in synchronization with the on/off of the suction pressure of the bone marrow puncture device 10, it is possible to prevent the anticoagulant supplied to the bone marrow puncture unit 1 from leaking from the opening 20b of the tube body 20. As described above, the syringe pump 150 is provided with a knob 150a, and by turning the knob 150a, the anticoagulant supply rate can be adjusted. However, the present invention is not limited to this; for example, the liquid delivery control unit 127 may also be capable of adjusting the supply rate of a liquid medical solution such as an anticoagulant.

In the modified bone marrow puncture system 200, the suction control unit 125, motion control unit 126, and liquid supply control unit 127 are all connected to the switch unit 140. However, 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 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 in response to the operator's operation, the motion control unit 126 transmits 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. Furthermore, the motion control unit 126 transmits the on/off signal to the motor of the drive unit. The suction control unit 125 controls the on/off of the suction pressure of the bone marrow puncture device 10. The liquid supply control unit 127 controls the on/off of the liquid supply of the syringe pump 150. Furthermore, the control unit 120 of the bone marrow puncture system 100 may also be configured in the same manner.

(Structure of the bone marrow puncture site)

The structure of the bone marrow puncture section 1 of the bone marrow puncture device 10 will be described with reference to the accompanying drawings. FIG3 is a schematic cross-sectional view of the bone marrow puncture section 1 of the bone marrow puncture device 10 according to this embodiment. FIG3 is a schematic view of the bone marrow puncture section 1 and does not represent the actual length, thickness, or proportions.

As shown in FIG3 , the bone marrow puncture section 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 portion 9. The puncture tip 2, first tubular body 3, second tubular body 4, and outer sleeve 5 of the bone marrow puncture section 1 (hereinafter also referred to as the "bone marrow puncture needle" or "puncture needle") can also be detachably mounted within the first shaft 6, gear 7, and second shaft 8. The magnetic sensor used for navigation, described later, is omitted in FIG3 .

The puncture tip portion 2 comprises: a tubular body 20, a disc-shaped portion 21 as a top rotating portion, and a connecting portion 22. As shown in Figures 5, 7, and 8 described later, the tubular body 20 comprises 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 located on the distal end face 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, and is located at the top end 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 the bone marrow (puncture) moves in the bone marrow. The connecting portion 22 connects a portion of the top end face 20a (the distal end face of the tubular body) of the tubular body 20 to the disc-shaped portion 21. The tubular body 20, the disc-shaped portion 21 and the connecting portion 22 of the puncture top 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 disc-shaped portion 21 and the connecting portion 22 can also be formed integrally by cutting etc., and the connecting portion 22 and the tubular body 20 can be joined together. Alternatively, the tubular body 20, the disc-shaped portion 21, the connecting portion 22 can also be formed respectively by cutting etc., and they can be joined together respectively. The detailed description of the puncture top portion 2 is described later.

The first tubular body 3 is connected to the tubular body 20 of the puncture tip portion 2 and is configured to rotate about an axis extending along its longitudinal direction. The first tubular body 3 can also be referred to as a tubular body capable of rotating about its longitudinal axis. The first tubular body is, for example, a helix of round wire, such as stainless steel, formed by winding the round wire into a spiral. The helix can also be formed from metals other than stainless steel, such as titanium alloys, precious metal alloys, and cobalt alloys. Furthermore, the helix can also be a helix of wire materials other than round wire, such as flat wire. The winding direction of the first tubular body 3 coincides with the direction of rotation of the first tubular body 3 (e.g., counterclockwise or clockwise (CW)). Since the first tubular body 3 is formed into a helical shape, it is flexible and allows for a liquid medicine, such as an anticoagulant, to penetrate through the gaps (e.g., permeation holes) between the round wires. The outer diameter of the first tubular body 3 is smaller than the inner diameter of the outer sleeve 5, allowing the first tubular body 3 to rotate within the outer sleeve 5. Furthermore, a drug solution supply passage 5a is formed between the outer circumferential surface of the first tubular body 3 and the inner circumferential surface 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 this portion having the length L2 corresponds to the flexible portion having the length L2 shown in FIG.

The second tubular body 4 is a rigid cylindrical tube connected to the first tubular body 3, formed, for example, from a metal such as stainless steel. The outer diameter of the second tubular body 4 is smaller than the inner diameter of the outer sheath 5, allowing the second tubular body 4 to rotate within the outer sheath 5 together with the first tubular body 3. Furthermore, 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. This drug supply passage 5a is continuous 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 such that, when a bone marrow puncture needle is moved toward the distal end within a guide tube (described later), the second tubular body 4 does not protrude from the distal end of the guide tube. Specifically, the length L5 shown in FIG. 3 is preferably less than the length L4 shown in FIG. 4 (described later). The length L5 can also be referred to as the longitudinal length of the region of the second tubular body 4 that protrudes from the first shaft 6 and excluding the connection with the first tubular body 3. Thus, the puncture tip 2 can be pushed out along the axial direction of the guide tube by the second tubular body 4. Therefore, the puncture direction of the puncture tip 2 of the bone marrow puncture unit 1 is aligned with the axial direction of the guide tube, for example. Therefore, by setting the length of the second tubular body 4 to the above configuration, for example, the puncture direction of the bone marrow puncture device 10 can be easily set.

The outer sleeve 5 is a cylindrical tube formed from a plastic such as PTFE (polytetrafluoroethylene), a resin, or the like, and has a length sufficient to cover the entire first tubular body 3 and a portion of the second tubular body 4. The outer sleeve 5 is flexible. As described above, the inner diameter of the outer sleeve 5 is larger than the outer diameters of the first tubular body 3 and the second tubular body 4. The first and second tubular bodies 3 and 4 can rotate within the outer sleeve 5. Furthermore, a drug supply passage 5a is formed between the inner circumferential surface of the outer sleeve 5 and the outer circumferential surface of the first tubular body 3, and between the inner circumferential surface of the outer sleeve 5 and the outer circumferential surface of the second tubular body 4. One end of the outer sleeve 5 contacts the end surface of the tubular body 20 of the puncture tip 2 to an extent that does not hinder the rotation of the puncture tip 2, while the other end of the outer sleeve 5 is inserted into the first shaft 6. In other words, the outer sleeve 5 is designed to be non-rotatable. This design prevents the generation of friction caused by the rotation of the outer sleeve 5, thereby preventing the generation of heat and increase in rotational load caused by friction.

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 combined is L1. The portion having the length L1 corresponds to the protruding portion of the length L1 shown in FIG.

The first shaft 6 is a non-rotating body formed of a metal such as stainless steel, plastic, or resin, and is mounted on the outer periphery of the second tubular body 4 via a bearing 60. An O-ring 61 is installed between the first shaft 6 and the second tubular body 4 to ensure airtightness between the first shaft 6 and the second tubular body 4 with respect to the bearing 60. A supply port 6a for a medical solution such as an anticoagulant is formed in the first shaft 6. The anticoagulant is supplied to the supply port 6a in the direction indicated by arrow B from a syringe pump 150, serving as the medical solution supply unit, shown in Figures 1 and 2. A medical solution supply passage 6b is formed between the inner periphery of the first shaft 6 and the outer periphery of the second tubular body 4 near the supply port 6a. The medical solution supply passage 6b is continuous with the aforementioned medical solution supply passage 5a. Therefore, the drug solution supplied from the supply port 6a is transported to the outer periphery of the first tubular body 3 via the drug solution supply passage 6b and the drug solution supply passage 5a, and penetrates into the first tubular body 3 from the gaps between the circular lines of the first tubular body 3.

Gear 7 is formed of, for example, a metal such as carbon steel or stainless steel, plastic, or resin, and is engaged with second tubular body 4. The rotational force of a motor (not shown) is transmitted to gear 7 via a pinion (not shown), thereby rotating second tubular body 4. As a result, first tubular body 3 and puncture tip portion 2 rotate together with second tubular body 4. In this embodiment, as an example, the rotational speed of second tubular body 4, first tubular body 3, and puncture tip portion 2 is set to 120 rpm. The gear ratio of gear 7 is not particularly limited and can be appropriately set according to the installation method of the drive unit.

The second shaft 8 is a non-rotating member formed of a metal such as stainless steel, plastic, or resin, and is mounted on the outer periphery of the second tubular body 4 via a bearing 80. Furthermore, an O-ring 81 is interposed between the second shaft 8 and the second tubular body 4 to ensure airtightness between the second shaft 8 and the second tubular body 4 with respect to the bearing 80. A communication hole 8a is formed within the second shaft 8, communicating with the rear end opening 4a of the second tubular body 4.

The container connection portion 9 is formed of, for example, plastic or resin and is attached to the second shaft 8. An O-ring 90 is provided between the container connection portion 9 and the second shaft 8 to ensure airtightness between the container connection portion 9 and the second shaft 8. A communication hole 9a is formed within the container connection portion 9, which communicates with the communication hole 8a of the second shaft 8. The container connection portion 9 is connected to the container 110 shown in Figures 1 and 2, and the vacuum generator 130 shown in Figures 1 and 2 is connected to the container 110.

When negative pressure, acting as suction pressure, is generated by vacuum generator 130, negative pressure is also generated within the container, communication hole 9a of container connecting portion 9, the hollow portion of second tubular body 4, and the hollow portion of first tubular body 3. Furthermore, by rotating the second tubular body 4, first tubular body 3, and puncture tip 2 while advancing the entire bone marrow puncture portion 1 in the puncture direction, the puncture tip 2, outer sleeve 5, and first tubular body 3 covered by outer sleeve 5 advance within the bone marrow cavity punctured by the puncture tip 2. During this process, bone marrow fluid is suctioned in the direction of arrow A through opening 20b of puncture tip 2, the hollow portion of first tubular body 3, the hollow portion of second tubular body 4, and communication hole 9a of container connecting portion 9 under the action of the negative pressure. For example, during this transfer, bone marrow fluid is sterilely stored within container 110 without being exposed to the outside of bone marrow puncture device 10. Furthermore, since the anticoagulant is supplied to the bone marrow fluid immediately after being aspirated 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 coagulation.

In this embodiment, the bone marrow puncture needle may be, for example, detached from the first shaft 6, gear 7, and second shaft 8, such that the opening 20b, rear end opening 4a, and the connection between the drug supply passage 5a and the drug supply passage 6a are sealed or covered with a sealing member such as a cap or a cover member such as a hood. This allows the bone marrow puncture needle to be sterilized, for example, thereby maintaining the sterility of the bone marrow puncture system 100. Furthermore, the opening of the container 110 may also be sealed or covered with a sealing member such as a cap or a cover member such as a hood. This allows the container 110 to be sterilized, for example, thereby maintaining the interior of the container 110 and the surface of the cap. This allows the container 110 to be sterilized, for example, thereby maintaining the sterility of the container 110 while still covered with the hood after bone marrow fluid extraction.

A bone marrow puncture device 10 including a modified bone marrow puncture unit 1' will be described with reference to Figures 23, 24, and 25. Figure 23 is a perspective view of the bone marrow puncture device 10. Figure 24 is a cross-sectional view taken along the line A-A' in Figure 23. Figure 25 is an enlarged view of the bone marrow puncture unit 1' in Figure 23. The magnetic sensor used for navigation, described later, is omitted in Figures 23, 24, and 25.

As shown in Figures 23 and 24, the bone marrow puncture device 10 includes a housing 10a. The housing 10a houses a bone marrow puncture unit 1' (described later) and a drive unit 71 including a motor 71a. To facilitate operation by the operator, the housing 10a is provided with a handle 10b. A switch 140 is provided on the handle 10b. A removable upper cover 10c is attached to the upper portion of the housing 10a. With the upper cover 10c removed from the housing 10a, the bone marrow puncture unit 1' can be installed and removed from the housing 10a. This facilitates replacement of the bone marrow puncture unit 1' in the event of a blockage within the first tubular body 3 or the second tubular body 4 of the bone marrow puncture unit 1'.

As shown in Figure 24, the drive 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 by the joint 71c. The gear 71d is fixed in an axially tightened manner using its fixing portion, and the shaft end is housed 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 engages with the gear 7 of the bone marrow puncture unit 1', transmitting the rotational force transmitted from the motor 71a to the gear 7.

As shown in FIG25 , the bone marrow puncture section 1′ includes a second tubular body 4, an outer sleeve 5, a puncture connection portion 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 portion 9. The puncture tip portion 2 and first tubular body 3 of the bone marrow puncture section 1′ have the same structure as the puncture tip portion 2 and first tubular body 3 of the bone marrow puncture section 1 and are therefore not shown.

The puncture connection 62 is made of, for example, plastic or resin and is detachably mounted to the first bearing unit 63. An O-ring 64 is provided between the second tubular body 4, the puncture connection 62, and the first bearing unit 63, ensuring a tight seal between the three. This ensures the liquid-tightness of the drug supply passage 6b. The puncture connection 62 is formed with a communication hole 62a that connects the supply port 6a for a drug solution, such as an anticoagulant, with the hollow portion of the puncture connection 62. The anticoagulant, such as a drug solution, is supplied to the communication hole 62a from the syringe pump 150 (shown in Figures 1 and 2) serving as the drug solution supply unit, via the supply port 6a in the direction indicated by arrow B. A drug supply passage 6b is formed between the inner periphery of the puncture connection 62 near the communication hole 62a and the outer periphery of the second tubular body 4. This drug supply passage 6b is continuous with the aforementioned drug supply passage 5a. Therefore, the drug solution supplied from the supply port 6a is transported to the outer periphery of the first tubular body 3 via the communication hole 62a, the drug solution supply passage 6b, and the drug solution supply passage 5a, and penetrates into the first tubular body 3 from the gaps between the circular lines of the first tubular body 3.

The first bearing unit 63 includes a first bearing housing 63a, a first radial bearing 60a, and a bearing retaining portion 631. The first bearing housing 63a is a non-rotating member formed, for example, from plastic or resin. It is attached to the outer circumference of the second tubular body 4, which is covered by a protective sheath 4a, which serves as a protective member for the tubular wall, via the first radial bearing 60a. The first radial bearing 60a is retained within the first bearing housing 63a by the adjacent bearing retaining portion 631. A supply port 6a is formed in the first bearing housing 63a, which is connected to the syringe pump 150 via a connector 65, such as a roll connector. An O-ring 66 is provided between the supply port 6a and the connector 65 to ensure airtightness between the first bearing housing 63a and the connector 65. For example, to disperse surface pressure, washers or the like may be disposed between the first bearing housing 63a and the first radial bearing 60a, and between the first radial bearing 60a and the bearing retaining portion 631.

Gear 7 is formed of a metal such as carbon steel or stainless steel, plastic, or resin, and is fitted onto the outer periphery of second tubular body 4, which is covered by protective sheath 4a to protect the tubular wall. The rotational force of motor 71a is transmitted to gear 7 via gear 71d of drive unit 71, thereby rotating second tubular body 4.

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, or the like, and is mounted on the outer periphery of the second tubular body 4, which is covered by the protective sheath 4a, via the second radial bearing 80c. Furthermore, the thrust bearing 80b is disposed within the second bearing shell 82a. The thrust bearing 80b and the second radial bearing 80c are retained within the second bearing shell 82a by adjacent bearing retaining portions 821. For example, to disperse surface pressure, washers or the like may be disposed between the second bearing shell 82a and the second radial bearing 80c, between the second radial bearing 80c and the bearing retaining portion 821, or between the thrust bearing 80b and the gear 7.

The container connection portion 9 is formed of, for example, plastic or resin and is detachably attached to the second bearing unit 82. An O-ring 91 is provided between the second tubular body 4, the container connection portion 9, and the second bearing unit 82 to ensure airtightness between the container connection portion 9 and the second bearing unit 82. A communication hole 9a is formed within the container connection portion 9, communicating with the second tubular body 4. The container connection portion 9 is connected to the container 110 shown in Figures 1 and 2. The vacuum generator 130 shown in Figures 1 and 2 is connected to the container 110.

The bone marrow puncture section 1' includes a first radial bearing 60a, a gear 7, a thrust bearing 80b, and a second radial bearing 80c. Therefore, the resistance to axial rotation of the bone marrow puncture section 1' relative to the rotational direction is borne by the first radial bearing 60a, gear 7, and second radial bearing 80c, which are indirectly attached to the second tubular body 4. Furthermore, the thrust bearing 80b bears the resistance to the propulsive force of the bone marrow puncture section 1'. Therefore, using the bone marrow puncture section 1' allows the entire section to withstand various resistances encountered during the puncture process, enabling safer operation and puncture. The method of using the bone marrow puncture section 1' is the same as that of the bone marrow puncture section 1.

The bone marrow puncture section 1' is provided with different bearings to respectively withstand the resistance in the rotational direction (radial direction) and the resistance in the propulsion direction (axial direction) generated during puncture. However, the present invention is not limited to this. A single bearing may be used to withstand the resistance in the rotational direction and the resistance in the propulsion direction. In addition, a lubricating bearing or the like may also be used as the bearing.

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 to this, 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.

Each opening and connection of the bone marrow puncture part 1' can also 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 inside of the bone marrow puncture needle can be made sterile, and the sterility of the bone marrow puncture system 100 can be maintained.

(Structure of the guide tube)

The structure of the guide tube 30 is described with reference to the accompanying drawings. Figure 4 illustrates the guide tube. Figure 4(A) is a top view of the entire guide tube with the inner needle inserted into the outer needle. Figure 4(B) is a cross-sectional view of Figure 4(A). Figure 4(C) is a top view of the inner needle. Figure 4(D) is a top view of the outer needle. Figure 4(E) is a cross-sectional view of Figure 4(D). The magnetic sensor used for navigation, described later, is omitted in Figure 4.

In the bone marrow puncture system 100 of this embodiment, the guide tube 30 is first inserted through the donor's skin into the iliac bone, etc., 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.

As shown in FIG4(A) and FIG4(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, semi-austenitic stainless steel. However, non-magnetic metals or high-tensile steel can also be used as the material of the guide tube 30. Furthermore, the use of non-metals as the material of the guide tube 30 is also conceivable.

As shown in Figures 4(B) and 4(C), the inner needle 31 comprises an inner needle portion 31a, a ring portion 31b, and an inner needle retaining portion 31c. The inner needle portion 31a is a rod-shaped body with a sharp tip and is supported by the inner needle retaining portion 31c. The ring portion 31b is rotatably mounted to the inner needle retaining portion 31c. Rotating the ring portion 31b allows the inner needle 31 to be attached to and detached from the outer needle 32.

As shown in Figures 4(B), 4(D), and 4(E), 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 within the hollow portion. The outer needle portion 32a is a hollow cylindrical body.

When assembling the guide tube 30, first, the inner needle 31a is inserted through the rear opening 32c of the outer needle holder 32b and the rear opening 32d of the outer needle 32a, as shown in FIG4(E). Next, the ring 31b is rotated to secure the outer needle holder 32b with the inner needle holder 31c, thereby assembling the guide tube 30 with the outer needle 32 and inner needle 31 integrated.

When puncturing the bone marrow, the guide tube 30, which is composed of an outer needle 32 and an inner needle 31, is first inserted into the ilium or the like through the skin of the donor. The rotation speed of the inner needle 31 when inserting the guide tube 30 is, for example, a maximum of about 1000 rpm. The portion that penetrates the ilium or the like is the portion of length L3 shown in Figure 4 (A). Next, by rotating the ring portion 31b, the tightening of the outer needle holding portion 32b by the inner needle holding portion 31c is loosened, and the inner needle 31 is removed from the outer needle 32. As a result, the outer needle 32 is retained in a state of penetrating the ilium or the like. The portion that penetrates the ilium or the like is the portion of length L4 shown in Figure 4 (D). In this state, the protruding portion of the bone marrow puncture portion 1 having a length of L1 is inserted from the opening 32d at the rear end of the outer needle portion 32a into the hollow portion of the outer needle portion 32a to puncture the bone marrow.

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

(Structure of the puncture tip)

Next, the detailed structure of the puncture tip portion 2 will be described with reference to the accompanying drawings. FIG5 is a perspective view of the puncture tip portion 2. FIG6 is a side view of the puncture tip portion 2. FIG7 is a top view of the puncture tip portion 2. FIG8 is a front view of the puncture tip portion 2. FIG9 is a diagram showing puncture marks when puncturing 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 ilium. FIG9 (A) is a diagram showing puncture marks when puncturing at an incident angle of 5 degrees, FIG9 (B) is a diagram showing puncture marks when puncturing at an incident angle of 10 degrees, and FIG9 (C) is a diagram showing puncture marks when puncturing at an incident angle of 15 degrees.

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. As shown in Figure 6, the angle θ formed by the top surface 20a of the tubular body 20 and the central axis C of the tubular body 20 is set to an acute angle. In this embodiment, the angle θ is set to, for example, 50 to 60 degrees. As shown in Figures 5, 7, and 8, the top surface 20a is provided with an opening 20b that intersects with the central axis C of the tubular body 20. In this way, since the opening 20b is formed on the top surface 20a where the angle θ formed with the central axis C of the tubular body 20 is an acute angle, the opening 20b can be larger than when the opening is formed on the top surface perpendicular to the central axis C. As a result, bone marrow fluid can be efficiently extracted. Furthermore, since opening 20b is formed larger and located in one place in puncture tip 2, negative pressure can be concentrated at opening 20b when the spongy bone punctured by puncture tip 2 is aspirated into tubular body 20, thereby preventing the spongy bone from clogging opening 20b. As a result, bone marrow fluid can be efficiently extracted.

5 , an opening 20d is formed in the rear end surface 20c of the tubular body 20. Therefore, 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.

Disc-shaped portion 21 has the central axis C1 in the radial direction consistent with the central axis C of tubular body 20. That is to say, disc-shaped portion 21 has the central axis C1 in the radial direction (Z direction) of disc-shaped portion 21 on the central axis C of tubular body 20, and this disc-shaped portion 21 is positioned at the top of the puncture direction shown in the arrow Z. Tubular body 20 for example rotates counterclockwise or clockwise around central axis C, but because the central axis C1 in the radial direction of disc-shaped portion 21 is consistent with the central axis C of tubular body 20, therefore can not rotate smoothly eccentrically. In addition, tissue (spongy bone etc.) in the medullary cavity is perforated due to the rotation of disc-shaped portion 21, but forms the required minimum perforation (puncture hole) corresponding to the diameter R of disc-shaped portion 21 shown in Figure 5 due to the rotation without eccentricity of disc-shaped portion 21. And, the periphery of the disc-shaped portion 21 that becomes the top of puncture direction is arc-shaped, does not have sharp position. As a result, even if disc-shaped portion 21 arrives cortical bone, cortical bone can not be damaged yet, and the disc-shaped portion 21 at the top that can prevent puncture direction from puncturing (perforation) to outside from the medullary cavity.In addition, because disc-shaped portion 21 can be with spongy bone perforation (puncture), therefore adopt puncture top portion 2, for example, also can reclaim bone marrow fluid efficiently from spongy bone.At the peripheral portion of disc-shaped portion 21, the face of the disc of disc-shaped portion 21 and the side of disc intersect with orthogonal direction, but the present invention is not limited to this, and the peripheral portion of disc-shaped portion 21 can also be to have round chamfer, and promptly the peripheral portion of disc-shaped portion 21 is a curved surface.Thus, disc-shaped portion 21 can keep perforation, and owing to there is no sharp position at the peripheral portion of disc-shaped portion 21, even if therefore disc-shaped portion 21 arrives cortical bone, cortical bone can not be damaged yet, and the disc-shaped portion 21 at the top that can more effectively prevent puncture direction from puncturing (perforation) to outside from the medullary cavity.

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

Furthermore, as shown in FIG7 , the diameter R of the disc-shaped portion 21 is formed to be larger than the width W of the tubular body 20 in the direction perpendicular to the central axis C, i.e., 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 pass through the perforation (puncture hole) formed by the disc-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. For example, the size of the diameter R is approximately 8G (Gauge).

The tubular body 20 is the distal end portion of a tubular body continuously formed with the second tubular body 4 and the first tubular body 3 , and as shown in FIG5 , FIG6 , FIG7 , and FIG8 , has an opening 20 b at a distal end surface 20 a located at the distal end of the tubular body.

It can be seen that bone marrow fluid can only be extracted from the area very close to the aspiration point in the bone marrow pore. In this embodiment, since aspiration is performed from the opening 20b of the distal end surface (distal end surface) 20a of the tubular body arranged behind the distal rotating portion (disk-shaped portion 21), bone marrow fluid can be efficiently extracted from a wide area of the perforation (puncture).

Furthermore, the angle θ formed between the top surface 20a and the central axis C of the tubular body 20 is set to be not perpendicular but acute, so that the opening 20b does not intersect the central axis of the tubular body (20, 3, 4) at right angles. In this embodiment, the angle θ is set to, for example, 50 to 60 degrees.

In this manner, since the opening is formed on the top surface 20a at an acute angle rather than a perpendicular angle θ formed with the central axis C of the tubular body (20, 3, 4), the opening 20b can be made larger than when the opening is formed on the top surface perpendicular to the central axis C. As a result, bone marrow fluid can be efficiently extracted.

5 , an opening 20d is formed in the rear end surface 20c of the tubular body 20. Therefore, 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.

As shown in Figures 5 and 7 , a groove 22a is formed in the connecting portion 22, which is continuous with the opening 20b of the tubular body 20. Therefore, the bone marrow perforated (punctured) by the disc-shaped portion 21 is guided from the groove 22a to the opening 20b and is drawn toward the first tubular body 3 due to the negative pressure generated within the tubular body 20.

Figure 9 shows puncture marks resulting from puncturing a plastic block having a hardness comparable to the cortical and cancellous bones of the human iliac bone using the bone marrow puncture unit 1 of this embodiment. In Figures 9(A) to 9(C), the plastic block comprises a foamed portion 200 corresponding to the bone marrow and a laminated plate portion 201 corresponding to the cortical bone. As shown in Figures 9(A) to 9(C), puncture marks 203 do not intrude into laminated plate portion 201 corresponding to the cortical bone and form within foamed portion 200 at any angle of incidence between 5 and 15 degrees. In particular, as shown in Figure 9(C), at an angle of incidence of 15 degrees, puncture marks 203 advance toward laminated plate portion 201 at an angle that intrudes, but curve just in front of laminated plate portion 201 and proceed along the surface of laminated plate portion 201. This is because there is no sharp portion on the periphery of the disk-shaped portion 21 serving as the distal end in the puncture direction, and the first tubular body 3 is formed in a spiral shape and has flexibility.

FIG20 shows puncture marks obtained when the same plastic block as in FIG9 was punctured using a bone marrow puncture unit according to a comparative example. FIG20(A) shows the puncture mark obtained when the puncture was performed at an incident angle of 5 degrees, FIG20(B) shows the puncture mark obtained when the puncture was performed at an incident angle of 10 degrees, and FIG20(C) shows the puncture mark obtained when the puncture was performed at an incident angle of 20 degrees. The bone marrow puncture unit of the comparative example used a bone marrow puncture unit having a sharp puncture tip and a tubular body continuous with the puncture tip formed entirely of a rigid body.

As shown in Figure 20(A), at an incident angle of 5 degrees, puncture mark 203 does not intrude into laminated plate portion 201. However, as shown in Figures 20(B) and 20(C), at incident angles of 10 and 20 degrees, puncture mark 203 does not bend but instead advances toward laminated plate portion 201. Therefore, if the bone marrow puncture unit of the comparative example is advanced in this state, it can be understood that there is a risk that the tip of the puncture direction may intrude into laminated plate portion 201.

As above, according to present embodiment, the puncture top portion 2 of the bone marrow puncture part 1 of bone marrow puncture device is provided with following member and constitute: the tubular body 20 that possesses opening 20b at top end face 20a, the disc-shaped portion 21 at the top end of puncture direction, the connecting portion 22 that a part of top end face 20a and the disc-shaped portion 21 are connected.As a result, the bone marrow puncture device that can not puncture (perforation) to outside and can efficiently aspirate bone marrow fluid from the top end of puncture direction can be provided.In addition, in present embodiment, the 1st tubular body 3 of bone marrow puncture device (bone marrow puncture needle) is flexible.Therefore, according to present embodiment, even owing to puncture top portion 2 contacts with cortical bone in bone marrow cavity, the 1st tubular body 3 also can bend, therefore can reduce the damage risk of cortical bone such as puncturing (perforation) to outside from the top end of puncture direction from the bone marrow cavity etc.

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

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

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 is a side view showing a portion of the first tubular body 3 in an enlarged manner.

As shown in Figure 10 , the first tubular body 3 is formed by spirally winding a round wire, such as stainless steel, with the winding direction of the wire coinciding with the rotation direction of the first tubular body 3. Therefore, when the first tubular body 3 rotates, the spiral wire rotates in a 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 secures a drug solution supply passage 5a between it and the outer sheath 5 and can rotate smoothly within the outer sheath 5.

In this embodiment, the syringe pump 150 shown in Figures 1 and 2 is connected to the supply port 6a of the first shaft 6 shown in Figure 1, and an anticoagulant such as heparin is supplied at a rate of, for example, 40 μl/second (sec) from the syringe pump 150. The anticoagulant supplied from the supply port 6a is transported in the direction of arrow Z shown in Figure 10 via the drug supply passage 6b and the drug supply passage 5a, and is supplied to the surface of the first tubular body 3.

As shown in arrow C among Figure 10, the anticoagulant supplied to the surface of the first tubular body 3 enters the gaps between the round wires and is transported in the arrow Z direction along the winding direction of the spirally wound round wire. 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 that has been aspirated in the hollow portion. In addition, the anticoagulant transported in the arrow Z direction 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 that has just been aspirated from the opening 20b of the tubular body 20. In addition, by causing the first tubular body 3 to spirally rotate, the bone marrow fluid that has just been aspirated and the bone marrow fluid that has been aspirated into the first tubular body 3 after aspiration are efficiently mixed with the anticoagulant, thereby reliably preventing the coagulation of the bone marrow fluid.

As described above, according to this embodiment, since the first tubular body 3 is formed from a helically wound round wire, the anticoagulant, serving 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, which serves as the aspiration path for the bone marrow fluid, without providing a tube or the like for supplying the medical solution. Therefore, it is possible to reliably prevent the coagulation of the bone marrow fluid while ensuring a sufficient aspiration path for the bone marrow fluid without increasing the size of the perforation (puncture hole) for extracting the bone marrow fluid beyond what is necessary.

Furthermore, according to this embodiment, since the outer diameter of the first tubular body 3 is smaller than the inner diameter of the outer sleeve 5, the first tubular body 3 can rotate within the outer sleeve 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 aspirated from the opening 20b of the tubular body 20 can be mixed with the anticoagulant, thereby reliably preventing the coagulation of the bone marrow fluid.

Furthermore, according to this embodiment, since the outer diameter of the first tubular body 3 is 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.

Furthermore, according to this embodiment, the outer sheath 5 also covers a portion of the rigid second tubular body 4 that is 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 circumferential surface of the second tubular body 4 and the inner circumferential 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 through the drug liquid supply passage 5a.

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 .

Furthermore, by forming the first tubular body 3 from a helically wound round wire, the rotational force received from the second tubular body 4 can be reliably transmitted to the tubular body 20, thereby generating the desired torque in the tubular body 20. Furthermore, in this embodiment, the bone marrow puncture unit 1 is inserted into a guide tube (not shown) called a trocar, 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 2 protrude from the distal end opening of the trocar. Therefore, the portion of the bone marrow puncture unit 1 inserted into the bone marrow cavity is flexible due to the first tubular body 3 formed from a helically wound round wire. Therefore, as shown in FIG9 , it is possible to prevent the puncture tip 2 from perforating cortical bone or the like.

Furthermore, while this embodiment describes an example in which the first tubular body 3 is formed from a helically wound round wire, the present invention is not limited to this example. As long as the material is permeable to the medical solution and can reliably transmit torque to the tubular body 20, other structures are possible, such as a structure incorporating a round wire or a member having a permeable hole in a portion. However, a helical shape, as in this embodiment, is preferred because it assists in transporting the medical solution to the distal region.

In addition, in this embodiment, an example in which an anticoagulant is used as a drug solution has been described, but the present invention is not limited to such an example, and other drug solutions besides an anticoagulant may be used as needed.

Furthermore, in this embodiment, the first tubular body 3 and the outer sheath 5 formed of a helically wound round wire are described as being applied to a bone marrow puncture device. However, such a first tubular body 3 and the outer sheath 5 can also be applied to other devices. For example, the first tubular body 3 and the outer sheath 5 can be provided inside a catheter used for blood collection to supply a liquid medicine such as an anticoagulant.

Furthermore, in this 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 embodiment. For example, it may cover only a portion of the first tubular body 3. However, from the perspective of being able to efficiently supply the medical solution 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.

Furthermore, in the present embodiment, the drug supply passage 5a is formed by the gap between the outer sleeve 5 and the first tubular body 3, and is a path having a circular cross-section in a direction perpendicular to the longitudinal direction of the first tubular body 3, but 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.

Figure 11 is a cross-sectional view showing a modified example of the first tubular body 3. Figure 12 is a front view showing a modified example of the first tubular body 3. As shown in Figures 11 and 12, an inner sleeve 50 made of a plastic such as PTFE or a resin may be provided on the inner circumference of the first tubular body 3. The inner sleeve 50 may be, 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. With this configuration, it is sufficient to form openings 50a at multiple locations in the inner sleeve 50, as shown in Figures 11 and 12. In this case, the perforation (puncture hole) for extracting bone marrow fluid can be prevented from solidifying while ensuring a sufficient aspiration path for the bone marrow fluid without increasing the size beyond the necessary size. While the example of providing the inner sleeve 50 on the inner circumference of the first tubular body 3 is described, the inner sleeve 50 may also be provided as the first tubular body 3 in place of the spiral-shaped first tubular body 3. In this case, the distal end of the inner sheath portion 50 is connected to, for example, the tubular body 20. Furthermore, the space between the outer peripheral surface of the inner sheath portion 50 and the inner peripheral surface of the outer sheath portion 5 serves as a drug solution supply passage 5a.

In this embodiment, a drug 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 drug supply passage 5a may also be omitted. In this case, the first tubular body 3 preferably has a drug placement portion on its inner periphery, for example. The drug placement portion is provided with a mixture of a sustained-release substance, such as a gel or polymer, and a drug, such as an anticoagulant. The drug placement portion may also be coated with the above-mentioned mixture. With this structure, since drugs such as anticoagulants can be released from the drug placement portion during aspiration of the bone marrow fluid, for example, the drug supply passages 5a, 6a, 6b and the syringe pump 150 can be omitted. Consequently, the structure of the bone marrow puncture device 10 can be simplified.

Table 1 shows the results of extracting bone marrow fluid from the iliac bone of a pig using a bone marrow puncture device 10 having a bone marrow puncture section 1 and a drug supply passage 5a according to this embodiment. In Table 1, the conventional method involves inserting a pre-existing puncture needle through a hole in the iliac bone and aspirating bone marrow fluid from the tip of the needle. This does not involve aspirating bone marrow fluid while advancing the puncture tip, as in this embodiment.

In Table 1, the ratio of cells in the CD34+ and CD45dim regions is a value obtained by calculating 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 unit 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 unit 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 unit 1 and method of the present embodiment can, for example, shorten the extraction time and reduce the number of perforations (punctures), thereby significantly reducing the invasiveness caused to the donor and enabling bone marrow fluid extraction to be performed using local anesthesia.

【Table 1】

Furthermore, 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 approximately 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.

【Table 2】

In cell therapy, hematopoietic stem cell transplantation requires particularly high bone marrow fluid volume and stem cell count. Using a bone marrow puncture device 10 with a bone marrow puncture section 1 and a drug supply passage 5a, 120-140 mL of bone marrow fluid extracted using an extraction method contains CD34+, CD45dim hematopoietic stem cells, equivalent to the average values of 927±163 mL and 89.6±76.1 (×10 ⁶ ) of human iliac bone marrow fluid extracted using conventional methods. Using the bone marrow puncture device 10 with a bone marrow puncture section 1 and a drug supply passage 5a, the hematopoietic stem cells required for hematopoietic stem cell transplantation can be extracted using significantly smaller amounts of bone marrow fluid compared to conventional methods. Furthermore, using the bone marrow puncture device 10 with a bone marrow puncture section 1 and a drug supply passage 5a, the volume of bone marrow fluid obtained from a single puncture is 15-20 mL, with minimal fluctuation. Therefore, the amount of bone marrow fluid extracted can be adjusted by adjusting the number of punctures. Furthermore, the extraction process takes approximately two minutes, and the extraction can be completed in an extremely short time of 17 to 20 minutes by puncturing the iliac bones 8 to 10 times on both sides.

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.

【Table 3】

As shown in Table 3, bone marrow fluid extracted using the bone marrow puncture apparatus 10 exhibited 6 to 13 times the number of CFU-F colonies compared to bone marrow fluid extracted using conventional methods. These results demonstrate that bone marrow fluid extracted using the bone marrow puncture apparatus 10 contains higher concentrations of not only hematopoietic stem cells but also mesenchymal stem cells compared to bone marrow fluid extracted using conventional methods.

(navigation)

Next, navigation will be described with reference to the accompanying drawings. Figures 13 to 19 are diagrams used to illustrate navigation. Figure 13 is a cross-sectional view schematically showing the bone marrow puncture section 1 of the bone marrow puncture apparatus 10. Figure 14 is a top view showing the guide tube 30. Figure 15 is a diagram schematically showing the bone marrow puncture system 100. Figure 16 is a block diagram showing the structure of the bone marrow puncture system 100. Figures 17 to 19 are schematic diagrams used to illustrate the operation of navigation in the bone marrow puncture system.

In this embodiment, as shown in Fig. 13 , a first magnetic sensor 40 is attached to the second shaft 8 of the bone marrow puncture unit 1. Furthermore, as shown in Fig. 14 , a second magnetic sensor 41 is attached to the outer needle portion 32a of the guide tube 30.

The bone marrow puncture system 100 shown in Figures 15 and 16 includes 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. These differences from the bone marrow puncture system 100 shown in Figures 1 and 2 are noted. The camera unit 170 and the MRI unit 180 are omitted from Figure 15 . Furthermore, in the bone marrow puncture system 100 shown in Figures 15 and 16 , the PC 190 functions as a display control unit 196 and a display unit 197.

The tracking unit 160 is connected to the first magnetic sensor 40 mounted on the bone marrow puncture device 10 and the second magnetic sensor 41 mounted on the guide tube 30, and is configured to receive position and angle data outputted 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 transmits the converted position and angle data to the PC 190.

Camera unit 170 is used to capture images of the surrounding area of the donor's iliac bone, etc., for bone marrow aspiration. Markers are placed, for example, at three locations around the donor's iliac bone, etc., and the area to be aspirated is the area surrounded by these markers. Camera unit 170 captures these markers and the area surrounded by these markers. Camera unit 170 is connected to PC 190 and transmits the captured image data to PC 190.

MRI unit 180 creates a three-dimensional model of the ilium, etc., based on MRI images of the ilium, etc., of a donor undergoing bone marrow aspiration, taken using magnetic resonance imaging (MRI). MRI images are captured with markers attached to the periphery of the ilium, etc., as described above. The markers are also captured in the MRI image. The positions of the markers can be confirmed in the 3D model of the ilium, etc. MRI unit 180 is connected to PC 190 and transmits the 3D model data of the ilium, etc. to PC 190.

PC 190 functions as an analysis unit 195, a display control unit 196, and a display unit 197. Analysis unit 195 functions as a position calculation unit that calculates the position of puncture tip 2 based on the output of first magnetic sensor 40. Furthermore, analysis unit 195 functions as a prediction unit that predicts the trajectory of puncture tip 2 and the contact position of puncture tip 2 with cortical bone based on the output of second magnetic sensor 41. Furthermore, analysis unit 195 functions as a movement speed calculation unit that calculates the movement speed of puncture tip 2 based on the temporal changes in the position of puncture tip 2 calculated by the position calculation unit. Furthermore, analysis unit 195 functions as a recording unit that records the past trajectory of puncture tip 2 based on the position of puncture tip 2 calculated by the position calculation unit.

The display control unit 196 constantly displays the position of the puncture tip 2 calculated by the analysis unit 195 on the display unit 197. Furthermore, the display control unit 196 displays the past trajectory of the puncture tip 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 2 and the contact position of the puncture tip 2 with the cortical bone, predicted by the analysis unit 195, functioning as a prediction unit, on the display unit 197. Furthermore, the display control unit 196 also functions as a moving speed notification unit that notifies the user of the moving speed of the puncture tip 2 calculated by the analysis unit 195, functioning as a moving speed calculation unit.

The display unit 197 is a display such as a liquid crystal display, and displays 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.

Next, the navigation of the bone marrow puncture system 100 according to this embodiment will be described. As an example, assume that bone marrow is being extracted from a donor's iliac bone. An MRI scan of the donor's iliac bone is performed beforehand, and the three markers described above are affixed to the skin surrounding the puncture site. These markers are mapped onto the MRI image.

The MRI unit 180 creates a 3D model of the ilium from the captured MRI image. This 3D model also includes the aforementioned markers. The 3D model of the ilium is sent from the MRI unit 180 to the PC 190 in advance.

When bone marrow puncture is performed, the camera unit 170 captures an image of a predetermined area including the area where the marker is affixed, and the captured image is sent from the camera unit 170 to the PC 190. The analysis unit 195 of the PC 190 compares the previously received 3D model of the ilium with the image captured by the camera unit 170. During the comparison, the markers on the 3D model are aligned with the markers on the image captured by the camera unit 170.

Next, the operator inserts the tip of the guide tube 30, which integrates the inner needle 31 and outer needle 32, through the skin into the ilium at a specified location within the area surrounded by the marker. The inner needle 31 is then removed, leaving the outer needle 32 in place in the ilium. At this point, the tracking unit 160 converts the position and angle data transmitted from the second magnetic sensor 41 attached to the guide tube 30 into displayable position and angle data, which is then transmitted to the PC 190. The analysis unit 195 of the PC 190 overlays the image data of the guide tube 30 on the 3D model based on the received position and angle data. Furthermore, the analysis unit 195 creates image data of the predicted trajectory of the puncture tip 2 of the bone marrow puncture section 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 overlays these data on the image data. The analysis unit 195 outputs the generated image data 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.

FIG17 is a diagram showing an example of an image displayed on the display unit 197. FIG17 shows a 3D model image G1 of the ilium, an image G2 corresponding to the outer needle 32 of the guide tube 30, an image G3 showing the predicted trajectory of the puncture tip 2, and an image G4 showing the predicted contact position of the puncture tip 2 with the cortical bone.

Thus, according to this embodiment, by displaying the image G3 of the predicted trajectory of the puncture tip 2 on the 3D model image G1 of the ilium, the surgeon can confirm the predicted trajectory of the puncture tip 2 within the bone marrow cavity of the ilium, which is difficult to use with ultrasound equipment. If the displayed predicted trajectory is not in the desired position, the surgeon can change 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 2. Thus, by referring to the above image, the surgeon can puncture the bone marrow along the desired trajectory.

After the operator confirms the predicted trajectory of the puncture tip 2 and decides to puncture the bone marrow along this predicted trajectory, they insert the protruding portion of the bone marrow puncture device 10, length L1, into the hollow portion of the outer needle 32 of the guide tube 30. At this point, the tracking unit 160 converts the position and angle data transmitted from the first magnetic sensor 40 mounted on the bone marrow puncture section 1 of the bone marrow puncture device 10 into displayable position and angle data and transmits it to the PC 190. Based on the received position and angle data of the bone marrow puncture section 1, the analysis unit 195 of the PC 190 overlays image data showing the position of the puncture tip 2 of the bone marrow puncture section 1 on the 3D model. In this embodiment, the first magnetic sensor 40 is mounted on the second shaft 8. Since the length from the mounting 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 this position and angle data. The analysis unit 195 outputs the generated image data to the display control unit 196. The display control unit 196 displays an image on the display unit 197 based on the input image data.

FIG18 is a diagram showing an example of an image displayed on the display unit 197. FIG18 also displays image data G5 showing the position of the puncture tip 2 in addition to the image shown in FIG17. Thus, according to this embodiment, since the image G5 showing the current position of the puncture tip 2 is displayed on the 3D model image G1 of the ilium, the operator can confirm the position of the puncture tip 2 within the bone marrow cavity of the ilium, which is difficult to use with an ultrasonic device. Thus, by referring to this image, the operator can puncture the bone marrow along the desired trajectory. Furthermore, 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, contact between the puncture tip 2 and the cortical bone can be prevented.

In FIG18 , 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 sequentially 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, which displays image G6 of the past trajectory on the display unit 197. In the example of FIG18 , three past trajectories are displayed as image G6. Thus, the operator can determine the next puncture trajectory while confirming the past trajectories, thereby preventing duplication of bone marrow puncture sites.

Figure 19 shows an example of a 3D model image G1 of the ilium, viewed from the cross-sectional direction indicated by arrow Z1. As shown in Figure 19, an image G4 is displayed showing the predicted contact position of the puncture tip 2 with the cortical bone when the outer needle 32 of the guide tube 30 is inserted at the positions and angles indicated by P1 and P2. However, when the outer needle 32 of the guide tube 30 is inserted at the position and angle indicated by P3, the image of the predicted contact position of the puncture tip 2 with the cortical bone is not displayed. This is because the length L1 of the protruding portion of the bone marrow puncture portion 1 shown in Figure 1 and other figures is known, and the thickness of the bone marrow cavity of the ilium can also be calculated based on the 3D model. Thus, according to this embodiment, by selecting a trajectory that does not display the image of the predicted contact position of the puncture tip 2 with the cortical bone, bone marrow puncture can be performed safely.

In addition, the analysis unit 195 calculates the moving speed of the puncture tip 2 by calculating the temporal changes in 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 quality of bone marrow fluid extraction well, it is necessary to make the puncture tip 2 enter at an appropriate speed related to the suction speed (suction pressure), but according to the present invention, since the moving speed of the puncture tip 2 can be confirmed, the quality of bone marrow fluid extraction can be maintained well regardless of the surgeon. Here, the moving speed of the puncture tip 2 can be a constant speed when the suction speed (suction pressure) is constant, and can change accordingly when the suction speed (suction pressure) is changed.

In this embodiment, the display control unit 196 is used as a moving speed notification unit, but the present invention is not limited to this configuration. For example, a control unit for controlling the output of a sound such as a buzzer may be used as the moving speed notification unit. In this case, a configuration is conceivable in which a comparison unit (not shown) compares a predetermined moving speed associated with the suction speed (suction pressure) with the moving speed of the puncture tip 2, and outputs a sound such as a buzzer when the moving speed of the puncture tip 2 is outside the appropriate speed range. Furthermore, the display of the moving speed may not only directly display the value of the moving speed, but may also display the appropriate speed range using an indicator or the like. Alternatively, all or some of the above configurations may be appropriately combined.

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 .

As described above, according to this embodiment, the past trajectory, predicted trajectory, and current position of the puncture tip 2 are displayed on the 3D model image of the ilium. This prevents the puncture tip 2 from entering the same area where bone marrow aspiration has been performed. In particular, since the operator can be informed of the past trajectory, predicted trajectory, and current position of the puncture tip 2 within the medullary cavity of bones such as the ilium, where ultrasound equipment is difficult to use, the present invention is extremely effective for bone marrow puncture. Consequently, the efficiency of bone marrow aspiration can be improved.

In particular, when the bone marrow puncture part 1 is inserted from the guide tube 30 inserted into the same puncture hole (a hole in the skin or a hole in the cortical bone), there is a high possibility of passing through the previous trajectory. Therefore, the navigation of this embodiment is effective.

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

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

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 high regardless of the operator.

Furthermore, in the above-described embodiment, the case where the bone marrow is extracted from the iliac bone has been described. However, the present invention can also be applied to other sites besides the iliac bone in the same manner as described above.

Furthermore, navigation-based movement speed control and control to a trajectory different from the previous one, for example, can also be applied to other puncture devices that perform predetermined treatments on body tissue while traveling within the body. Here, predetermined treatments include tissue extraction, aspiration, cauterization, and the administration of a drug solution, but do not include simple imaging that does not alter the body tissue.

Furthermore, in the above-mentioned navigation, the first and second magnetic sensors are used, but the present invention is not limited thereto and position monitoring using ultrasonic waves can also be used. However, in terms of miniaturization of the device and accuracy of position monitoring, the use of magnetic sensors is more ideal.

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.

The present invention is characterized by, for example, comprising: 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 rotatable about an axis extending along its length, the outer diameter of the first tubular body is smaller than the inner diameter of the outer tubular body, and a drug solution 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 connecting the drug solution 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.

According to the present invention, for example, a medicinal solution is delivered to the outer surface of the first tubular body via a medicinal solution supply passage provided outside the first tubular body. The medicinal solution delivered to the outer surface of the first tubular body is transported toward the puncture tip and mixed with tissue, such as bone marrow fluid, extracted from the puncture tip. Furthermore, because 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 about its longitudinal axis, the medicinal solution delivered to the outer surface of the first tubular body is transported toward the puncture tip due to the rotation of the first tubular body, causing the bone marrow fluid, etc., just extracted from the puncture tip, to mix with the medicinal solution. When an anticoagulant is used as the medicinal solution, coagulation of the bone marrow fluid, etc., can be reliably prevented. Furthermore, because the first tubular body, which delivers the medicinal solution, is housed within the outer tubular body, the perforation (puncture hole) for extracting the bone marrow fluid, etc., does not increase beyond its necessary size, and a sufficient aspiration path for the bone marrow fluid, etc., can be ensured.

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

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 spreads over the entire outer surface of the first tubular body and is reliably delivered toward the puncture distal end portion.

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.

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, there is no need to separately provide a tubular member for drug solution supply, and the outer diameter of the outer tubular body can be prevented from increasing.

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

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

Furthermore, 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.

According to this aspect, since the first tubular body can rotate relative to the outer tubular body on the inside of the outer tubular body, for example, torque can be reliably transmitted to the puncture tip portion, and the drug solution supplied to the drug solution supply passage can be transported by utilizing the rotational force.

Furthermore, 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.

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

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.

In this embodiment, the drug supply passage is also provided, for example, between the outer circumferential surface of the second tubular body and the inner circumferential surface of the outer tubular body, and is continuous with the drug supply passage provided between the outer circumferential surface of the first tubular body and the inner circumferential surface of the outer tubular body. Therefore, when the drug is supplied to the outer circumferential surface of the second tubular body, the drug is reliably supplied to the outer surface of the first tubular body via the drug supply passage.

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

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

Furthermore, in another aspect of the present invention, a winding direction of the spiral first tubular body is, for example, consistent with a rotation direction of the first tubular body.

In this embodiment, since the winding direction of the helical first tubular body coincides with the rotation direction of the first tubular body, the helical first tubular body rotates in a tightening direction when the first tubular body rotates, 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 rotated smoothly within the outer sleeve (outer tubular body).

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.

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 inside of the first tubular body, the drug and the bone marrow fluid etc. are mixed.

Furthermore, in another aspect of the present invention, for example, the suction device is used to aspirate bone marrow fluid, and the drug supply passage is used to supply an anticoagulant.

According to this mode, the bone marrow fluid extracted by the puncture tip is sucked from the interior of the first tubular body by, for example, a suction device. At this time, the anticoagulant supplied by the liquid medicine supply passage mixes with the bone marrow fluid. As a result, the coagulation of the extracted bone marrow fluid is prevented.

The present invention, for example, is a bone marrow puncture device, at least the tip of which is inserted into the bone marrow cavity to extract bone marrow fluid. The bone marrow puncture device is characterized by comprising: a tubular body having a distal end and an opening on the distal end surface; a distal rotating portion (e.g., the puncture tip portion) disposed distally of the distal end surface of the tubular body, the distal rotating portion rotating together with the tubular body to perforate (puncture) tissue within the bone marrow cavity; and a connecting portion connecting the tubular body and the distal rotating portion. The bone marrow puncture instrument (bone marrow puncture device) of the present invention is characterized by comprising, for example: a tubular body having an opening; a distal rotating portion rotating together with the tubular body and capable of perforating (puncturing) tissue within the bone marrow cavity; and a connecting portion connecting the tubular body and the distal rotating portion, the distal rotating portion, the connecting portion, and the tubular body being disposed in the order of the distal 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.

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. Therefore, bone marrow fluid can be efficiently aspirated from the tissue in the bone marrow cavity perforated (punctured) by the top rotating portion.

In another aspect of the present invention, the tubular body is characterized in that, for example, the tubular body includes at least: a tubular body integrally formed with the distal rotating portion and the connecting portion and having the opening; and a flexible first tubular body disposed on the proximal side of the tubular body. In another aspect of the present invention, for example, the tubular body includes the tubular body having the opening and the flexible first tubular body, the tubular body being integrally formed with the distal rotating portion and the connecting portion, and the distal rotating portion, the connecting portion, the tubular body, and the first tubular body being disposed in this order.

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 flexibility of the first tubular body will not damage the cortical bone.

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

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

Furthermore, in another aspect of the present invention, a groove continuous with the opening is formed in the connecting portion, for example.

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

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 perpendicular to each other.

In this embodiment, since the distal end face is not perpendicular to the longitudinal direction of the tubular body, for example, the opening of the tubular body is larger than in a case where the distal end face is provided with an opening perpendicular to the longitudinal direction of the tubular body (e.g., an opening). As a result, bone marrow obtained by perforation (puncture) by the distal rotating portion can be efficiently aspirated through the opening.

In another aspect of the present invention, 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.

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

In another aspect of the present invention, a guide tube may also be provided, which guides the above-mentioned puncture tip portion (e.g., top rotating portion) and the above-mentioned tubular body (e.g., the first tubular body, the second tubular body) and/or the outer tubular body (outer sleeve) by passing through the above-mentioned puncture tip portion (e.g., top rotating portion) and the above-mentioned tubular body. The above-mentioned tubular body, for example, includes 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 above-mentioned puncture tip portion, the first tubular body, and the second tubular body are, for example, arranged in the order of the above-mentioned 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 above-mentioned puncture tip portion and the above-mentioned tubular body can be controlled by using a guide tube.

The tubular body drive device of the present invention is characterized by, for example, comprising: a retaining portion for retaining the tubular body; a driving portion for rotating the tubular body; and a drug solution supply portion for supplying drug solution to the tubular body. The tubular body is, for example, the puncture instrument (puncture needle) or bone marrow puncture instrument (bone marrow puncture needle) of the present invention. According to the present invention, for example, the tubular body can be rotated and the drug solution can be supplied efficiently. The retaining portion, driving portion, and drug solution supply portion can also be disposed within a housing.

In another aspect of the present invention, the tubular body preferably has a first liquid medicine supply passage for guiding 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 liquid medicine, the second liquid medicine supply passage being a space between the inner circumferential surface of the retaining portion and the outer circumferential 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, liquid medicine supplied from outside the drive device can be efficiently supplied to the tubular body.

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 with the aid 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 has, for example, 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 with the aid 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, the resistance generated when the tubular body is driven can be absorbed by the driving device, the driving device can be operated simply. In addition, according to the present invention, for example, the tubular body can be prevented from being damaged during rotation.

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 movement speed calculation section for calculating the movement speed of the puncture section.

According to the present invention, for example, when the position of the puncture section moves while advancing within the body, the moving speed of the puncture section 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 section, the moving speed of the puncture section can be adjusted to be within an appropriate range, thereby maintaining a constant treatment quality regardless of the operator's experience.

Another aspect of the present invention is characterized by including, for example, a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed.

In this state, since the calculated moving speed is compared with the specified moving speed using, for example, a comparison unit, 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 operator.

Furthermore, in another aspect of the present invention, for example, a notification unit is provided that provides notification regarding the moving speed of the puncture section based on the comparison result of the comparison unit.

In this embodiment, the notification unit provides notification of the puncture unit's moving speed based on the comparison result of the comparison unit, for example. This allows the operator to be informed of information regarding the puncture unit's moving speed relative to the prescribed moving speed. Consequently, this embodiment allows the operator to maintain the puncture unit's moving speed within an appropriate range, for example, and maintain consistent treatment quality regardless of the operator's experience.

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, wherein the puncture section performs a predetermined treatment on body tissue while advancing in the body; a position calculation section for calculating the position of the puncture tip; and a recording section for recording the past trajectory of the puncture tip.

According to the present invention, for example, when the position of the puncture tip moves while advancing within the body, the position calculation unit calculates the position of the puncture tip. Therefore, according to the present invention, for example, the calculated position of the puncture tip can be used to prevent duplication of the extraction site, thereby improving treatment efficiency. Furthermore, according to the present invention, for example, the recording unit records the past trajectory of the puncture tip. Therefore, the surgeon, knowing the recorded past trajectory, can prevent duplication of the treatment site, thereby improving treatment efficiency. Furthermore, according to the present invention, for example, the improved treatment efficiency can be used to shorten the treatment time required.

Another aspect of the present invention is characterized by comprising, for example, 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.

According to this aspect, for example, the display control unit displays the recorded past trajectory, allowing the operator to confirm the current position of the puncture tip while simultaneously reviewing the past trajectory. Consequently, according to this aspect, for example, overlapping treatment sites can be more effectively prevented, thereby improving treatment efficiency. Furthermore, according to this aspect, for example, the improved treatment efficiency can shorten the treatment time required.

Another aspect of the present invention is characterized by, for example, comprising a prediction unit for predicting the trajectory of the puncture tip portion, and the display control unit further displaying the trajectory of the puncture tip portion predicted by the prediction unit. Another aspect of the present invention is characterized by, for example, comprising: a prediction unit for predicting the trajectory of the puncture tip portion; and a display control unit for displaying the trajectory of the puncture tip portion predicted by the prediction unit.

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. Thus, the operator can, for example, confirm the predicted trajectory of the puncture tip while inserting the puncture tip into the body. This effectively prevents overlapping treatment sites and improves treatment efficiency. Furthermore, this aspect can, for example, shorten the treatment time by utilizing the improved treatment efficiency.

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

In this mode, for example, the notification unit notifies the user that the movement trajectory of the puncture tip and the previously recorded trajectory are substantially the same or identical. Therefore, this mode can more effectively prevent overlapping treatment areas, thereby improving treatment efficiency. Furthermore, this improved treatment efficiency can shorten treatment time, for example.

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

In this mode, for example, the notification unit notifies the user that the predicted trajectory of the puncture tip and the recorded previous trajectory are substantially the same or identical. Therefore, this mode can more effectively prevent overlapping treatment areas, improving treatment efficiency. Furthermore, this improved treatment efficiency can shorten treatment time, for example.

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

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 pass therethrough; and a second magnetic sensor attached to the guide tube.

The present invention is characterized in that, for example, it comprises: a bone marrow puncture section comprising a puncture tip and a tubular body connected to the puncture tip, wherein the bone marrow puncture section aspirates bone marrow fluid while advancing in the body; a guide tube for guiding the bone marrow puncture section; and a movement speed calculation section for calculating the movement speed of the bone marrow puncture section advancing through the guide tube.

According to the present invention, for example, when the position of the bone marrow puncture unit is moved while traveling within the body, the movement speed of the bone marrow puncture unit is calculated by the movement speed calculation unit. Therefore, according to the present invention, for example, by referring to the calculated movement speed of the bone marrow puncture unit, the movement speed of the bone marrow puncture unit can be kept within an appropriate range, thereby maintaining the quality of bone marrow extraction constant regardless of the operator's experience.

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 aspiration speed of the bone marrow fluid.

In this mode, for example, the calculated movement speed is compared by a comparator with a predetermined movement speed associated with the bone marrow fluid aspiration speed. Therefore, by referring to the comparison result between the movement speed of the bone marrow puncture unit and the predetermined movement speed, the movement speed of the bone marrow puncture unit can be kept within an appropriate range, thereby maintaining the quality of bone marrow extraction regardless of the operator's experience.

The present invention is characterized in that, for example, it comprises: a bone marrow puncture section comprising a puncture tip and a tubular body connected to the puncture tip, wherein the bone marrow puncture section aspirates bone marrow fluid while advancing in the body; a guide tube for guiding the puncture section; a position calculation section for calculating the position of the puncture tip; and a recording section for recording the past trajectory of the puncture tip.

According to the present invention, for example, when the position of the bone marrow puncture portion moves while traveling within the body, the position calculation unit calculates the position of the puncture tip. Therefore, according to the present invention, for example, the calculated position of the puncture tip can be used to prevent duplication of bone marrow extraction sites, thereby improving the efficiency of bone marrow extraction. Furthermore, according to the present invention, for example, the recording unit records the past trajectory of the puncture tip. Therefore, the operator, knowing the recorded past trajectory, can prevent duplication of bone marrow extraction sites, thereby improving the efficiency of bone marrow extraction. Furthermore, according to the present invention, for example, the improved efficiency of bone marrow extraction can be used to shorten the time required for bone marrow extraction.

Another aspect of the present invention is characterized by comprising, for example, 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.

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 simultaneously checking the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent overlap in the bone marrow extraction site, thereby improving the efficiency of bone marrow extraction. Furthermore, according to this aspect, for example, the improved efficiency of bone marrow extraction can shorten the time required for bone marrow extraction.

Another aspect of the present invention is characterized by, for example, comprising a prediction unit for predicting the trajectory of the puncture tip and the contact position of the puncture tip with the cortical bone, wherein 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 by, for example, comprising: 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.

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 simultaneously checking the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent overlap in the bone marrow extraction site, thereby improving the efficiency of bone marrow extraction. Furthermore, according to this aspect, for example, the improved efficiency of bone marrow extraction can shorten the time required for bone marrow extraction.

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

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 simultaneously checking the past trajectory. As a result, according to this aspect, for example, it is possible to more effectively prevent overlap in the bone marrow extraction site, thereby improving the efficiency of bone marrow extraction. Furthermore, according to this aspect, for example, the improved efficiency of bone marrow extraction can shorten the time required for bone marrow extraction.

While 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 modifications 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.

＜Note＞

A part or all of the above-mentioned embodiments and examples can be described as the following supplementary notes, but the present invention is not limited to the following contents.

(Note 1)

A puncture device, characterized in that:

The puncture device has:

Puncture the top part;

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

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

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

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

A drug solution supply passage is provided on the outside of the first tubular body.

(Note 2)

The puncture device according to Supplementary Note 1, wherein

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

(Note 3)

The puncture device according to Supplementary Note 1 or 2, wherein

The medical solution supply passage includes a space between the inner peripheral surface of the outer tubular body and the outer peripheral surface of the first tubular body.

(Note 4)

The puncture device according to any one of Supplementary Notes 1 to 3, wherein

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

(Note 5)

The puncture device according to any one of Supplementary Notes 1 to 4, wherein

The first tubular body is rotatable inside the outer tubular body relative to the outer tubular body.

(Note 6)

The puncture device according to any one of Supplementary Notes 1 to 5, wherein

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

(Note 7)

The puncture device according to Supplementary Note 6, wherein

The outer tubular body 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, and the second tubular body can rotate inside the outer tubular body together with the first tubular body.

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.

(Note 8)

The puncture device according to any one of Supplementary Notes 1 to 7, wherein

The first tubular body is formed in a spiral shape.

(Note 9)

The puncture device according to Supplementary Note 8, wherein

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

(Note 10)

The puncture device according to any one of Supplementary Notes 1 to 9, wherein

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

The first tubular body is formed so that the medical solution in the medical solution supply passage can penetrate into the interior of the first tubular body.

(Note 11)

The puncture device according to Supplementary Note 10, wherein

The above-mentioned suction device is used to aspirate bone marrow fluid.

The drug solution supply passage is used to supply an anticoagulant.

(Note 12)

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

The puncture tip has:

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

a distal rotating portion disposed at a distal side of 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

A connecting portion connects the tubular body and the top rotating portion.

(Note 13)

The puncture device according to Supplementary Note 12, wherein

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

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

(Note 14)

The puncture device according to Supplementary Note 12 or 13, wherein

The distal end rotating portion includes a disk-shaped portion having a radial central axis along a central axis extending in the longitudinal direction of the tube body.

(Note 15)

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

A groove continuous with the opening is formed in the connecting portion.

(Note 16)

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

The distal end surface and the longitudinal direction of the tube body are not perpendicular to each other.

(Note 17)

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

The width of the top rotating portion in a direction perpendicular to the longitudinal direction of the tube body is greater than the width of the tube body in a direction perpendicular to the longitudinal direction of the tube body.

(Note 18)

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

The above-mentioned puncture instrument is a bone marrow puncture instrument.

(Note 19)

A puncture device, characterized in that:

The puncture device has:

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

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

(Note 20)

The puncture device according to Supplementary Note 19, wherein:

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

(Note 21)

The puncture device according to Supplementary Note 20, wherein:

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

(Note 22)

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

The puncture device has:

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip.

(Note 23)

The puncture device according to Supplementary Note 22, wherein:

The puncture device includes 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.

(Note 24)

The puncture device according to Supplementary Note 23, wherein:

The puncture device includes a prediction unit for predicting the trajectory of the puncture tip.

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

(Note 25)

The puncture device according to Supplementary Note 24, wherein:

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.

(Note 26)

The puncture device according to any one of Supplementary Notes 22 to 25, wherein

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

(Note 27)

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

This puncture device includes a first magnetic sensor, and the first magnetic sensor is attached to the puncture device.

(Note 28)

The puncture device according to Supplementary Note 27, wherein:

The puncture device has:

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

The second magnetic sensor is mounted on the guide tube.

(Note 29)

A puncture device, characterized in that:

The puncture device has:

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

a guide tube for guiding the puncture instrument; and

A moving speed calculation unit is configured to calculate a moving speed of the puncture instrument advancing through the guide tube.

(Note 30)

The puncture device according to Supplementary Note 29, wherein

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 aspiration speed of the bone marrow fluid.

(Note 31)

A puncture device, characterized in that:

The puncture device has:

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

A guide tube, used to guide the puncture instrument;

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip.

(Note 32)

The puncture device according to Supplementary Note 31, wherein:

The puncture device includes 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.

(Note 33)

The puncture device according to Supplementary Note 32, wherein:

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

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

(Note 34)

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

The display control unit displays a past trajectory of the puncture distal end portion that was inserted through the same puncture hole as the puncture hole through which the puncture instrument was inserted.

(Note 35)

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:

The puncture device has:

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

a distal rotating portion disposed at a distal side of 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

A connecting portion connects the tubular body and the distal rotating portion.

(Note 36)

The puncture device according to Supplementary Note 35, wherein

The tubular body at least comprises:

a tubular body integrally formed with the distal rotating portion and the connecting portion and having the opening; and

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

(Note 37)

The puncture device according to Supplementary Note 35 or 36, wherein

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

(Note 38)

The puncture device according to any one of Supplementary Notes 35 to 37, wherein

A groove continuous with the opening is formed in the connecting portion.

(Note 39)

The puncture device according to any one of Supplementary Notes 35 to 38, wherein

The distal end surface and the longitudinal direction of the tubular body are not perpendicular to each other.

(Note 40)

The puncture device according to any one of Supplementary Notes 35 to 39, wherein

Regarding the width in a direction perpendicular to the longitudinal direction of the tubular body, the width of the distal rotating portion is larger than the width of the tubular body.

(Note 41)

The puncture device according to any one of Supplementary Notes 35 to 40, wherein

The above-mentioned puncture instrument is a bone marrow puncture instrument.

(Note 42)

A puncture device, characterized in that:

The puncture device has:

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

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

(Note 43)

The puncture device according to Supplementary Note 42, wherein:

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

(Note 44)

The puncture device according to Supplementary Note 43, wherein:

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

(Note 45)

A puncture device, characterized in that:

The puncture device has:

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

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip.

(Note 46)

The puncture device according to Supplementary Note 45, wherein

The puncture device includes 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.

(Note 47)

The puncture device according to Supplementary Note 46, wherein

The puncture device includes a prediction unit for predicting the trajectory of the puncture tip.

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

(Note 48)

The puncture device according to Supplementary Note 47, wherein

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.

(Note 49)

The puncture device according to any one of Supplementary Notes 45 to 48, wherein

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

(Note 50)

The puncture device according to any one of Supplementary Notes 42 to 49, wherein

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

(Note 51)

The puncture device according to Supplementary Note 50, wherein:

The puncture device has:

a guide tube for guiding the puncture portion by allowing the puncture portion to pass through; and

The second magnetic sensor is mounted on the guide tube.

(Note 52)

A puncture device, characterized in that:

The puncture device has:

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

a guide tube for guiding the bone marrow puncture portion; and

A moving speed calculation unit is configured to calculate a moving speed of the bone marrow puncture unit that advances through the guide tube.

(Note 53)

The puncture device according to Supplementary Note 52, wherein:

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 aspiration speed of the bone marrow fluid.

(Note 54)

A puncture device, characterized in that:

The puncture device has:

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

a guide tube, used for guiding the puncture portion;

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip.

(Note 55)

The puncture device according to Supplementary Note 54, wherein:

The puncture device includes 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.

(Note 56)

The puncture device according to Supplementary Note 55, wherein:

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

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

(Note 57)

The puncture device according to Supplementary Note 55 or 56, wherein:

The display control unit displays a past trajectory of the puncture distal end portion that was inserted through the same puncture hole as the puncture portion.

(Note 58)

A puncture device, characterized in that:

The puncture device has:

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

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

(Note 59)

The puncture device according to Supplementary Note 58, wherein:

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

(Note 60)

The puncture device according to Supplementary Note 59, wherein:

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

(Note 61)

A puncture device, characterized in that:

The puncture device has:

a puncture section comprising 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;

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip portion.

(Note 62)

The puncture device according to Supplementary Note 61, wherein

The puncture device includes 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.

(Note 63)

The puncture device according to Supplementary Note 62, wherein:

The puncture device includes a prediction unit for predicting the trajectory of the puncture tip.

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

(Note 64)

The puncture device according to Supplementary Note 63, wherein:

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.

(Note 65)

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

The puncture device includes a notification unit that compares the movement trajectory of the puncture distal end portion with the previous trajectory recorded by the recording unit and provides notification when the trajectory is substantially the same or the same.

(Note 66)

The puncture device according to any one of Supplementary Notes 58 to 65, wherein

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

(Note 67)

The puncture device according to Supplementary Note 66, wherein:

The puncture device has:

a guide tube for guiding the puncture portion by allowing the puncture portion to pass through; and

The second magnetic sensor is mounted on the guide tube.

(Note 68)

A puncture device, characterized in that:

The puncture device has:

a bone marrow puncture section comprising a puncture tip and a tubular body connected to the puncture tip, the bone marrow puncture section being configured to aspirate bone marrow fluid while advancing in the body;

a guide tube for guiding the bone marrow puncture portion; and

A moving speed calculation unit is configured to calculate a moving speed of the bone marrow puncture unit that advances through the guide tube.

(Note 69)

The puncture device according to Supplementary Note 68, wherein:

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 aspiration speed of the bone marrow fluid.

(Note 70)

A puncture device, characterized in that:

The puncture device has:

a bone marrow puncture section comprising a puncture tip and a tubular body connected to the puncture tip, the bone marrow puncture section being configured to aspirate bone marrow fluid while advancing in the body;

a guide tube, used for guiding the puncture portion;

a position calculation unit for calculating the position of the puncture tip; and

The recording portion is used to record the past trajectory of the puncture tip.

(Supplementary Note 71)

The puncture device according to Supplementary Note 70, wherein:

The puncture device includes 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.

(Supplementary Note 72)

The puncture device according to Supplementary Note 71, wherein

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

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

(Supplementary Note 73)

The puncture device according to Supplement 71 or 72, wherein:

The display control unit displays a past trajectory of the puncture distal end portion that was inserted through the same puncture hole as the puncture portion.

This application claims the benefit of priority based on Japanese Patent Application Nos. 2017-015764, 2017-015767, and 2017-015795, filed on January 31, 2017, the disclosures of which are incorporated herein in their entirety by reference.

Industrial applicability

As described above, the first puncture device or puncture apparatus of the present invention can be used to administer a medical solution. Furthermore, the first puncture device or puncture apparatus of the present invention can reliably prevent the coagulation of bone marrow fluid, for example, when an anticoagulant is used as the medical solution. Furthermore, since the first tubular body used to deliver the medical solution is housed within the outer tubular body, the perforation for extracting bone marrow, etc., does not become larger than necessary, and a sufficient aspiration path for the bone marrow, etc., can be ensured. Therefore, the present invention can be said to be an extremely useful technology in medical fields such as transplantation medicine and regenerative medicine.

Description of Reference Numerals

1. Bone marrow puncture section; 2. Puncture top section; 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 section; 22. Connecting section; 30. Guide tube; 40. First magnetic sensor; 41. Second magnetic sensor; 100. Bone marrow puncture system; 160. Tracking section; 195. Analysis section; 196. Display control section; 197. Display section.

Claims (34)

1. A puncture device, characterized in that, The puncture instrument has the following features: Puncture the tip; A first tubular body, whose distal end is connected to the aforementioned puncture tip; and An outer tubular body that covers at least a portion of the first tubular body. The first tubular body described above is configured to rotate about an axis along its length. The outer diameter of the first tubular body is smaller than the inner diameter of the outer tubular body. A drug supply passage is provided on the outside of the first tubular body. The first tubular body is formed to allow the drug solution in the drug solution supply passage to permeate into the interior of the first tubular body. 2. The puncture device according to claim 1, wherein, The cross-section of the surface of the above-mentioned drug supply passage that is perpendicular to the length direction of the first tubular body is formed into a ring shape. 3. The puncture device according to claim 1 or 2, wherein, The aforementioned drug supply passage is contained in the gap between the inner circumferential surface of the outer tubular body and the outer circumferential surface of the first tubular body. 4. The puncture device according to claim 1 or 2, wherein, The aforementioned drug supply pathway extends to the vicinity of the aforementioned puncture tip. 5. The puncture device according to claim 1 or 2, wherein, The first tubular body is capable of rotating inside the outer tubular body relative to the outer tubular body. 6. The puncture device according to claim 1 or 2, wherein, A rigid second tubular body is connected to the proximal end of the first tubular body. 7. The puncture device according to claim 6, wherein, The aforementioned outer tubular body covers at least a portion of the aforementioned second tubular body. 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 together with the first tubular body inside the outer tubular body. The aforementioned drug supply passage is continuously connected between the outer peripheral surface of the first tubular body and the inner peripheral surface of the outer tubular body, and is also located between the outer peripheral surface of the second tubular body and the inner peripheral surface of the outer tubular body. 8. The puncture device according to claim 1 or 2, wherein, The first tubular body mentioned above is formed in a spiral shape. 9. The puncture device according to claim 8, wherein, The winding direction of the spiral-shaped first tubular body is consistent with the rotation direction of the first tubular body. 10. The puncture device according to claim 1 or 2, wherein, The puncture instrument has a suction device for aspirating the interior of the first tubular body. 11. The puncture device according to claim 10, wherein, The aforementioned aspiration device is used to aspirate bone marrow fluid. The aforementioned drug supply pathway is used to supply anticoagulant. 12. The puncture device according to claim 1 or 2, wherein, The aforementioned puncture tip has: A tube body having a distal end and an opening on the distal end face; A ferrule, positioned distal to the distal end face of the tube body, rotates together with the tube body to perforate the tissue within the medullary cavity; and The connecting part connects the tube body and the rotating part at the top. 13. The puncture device according to claim 12, wherein, The tube body having the aforementioned opening is integrally formed with the aforementioned top rotating portion and the aforementioned connecting portion. The first tubular body is flexible and is disposed on the proximal side of the aforementioned tubular body. 14. The puncture device according to claim 12, wherein, The aforementioned top rotating portion includes a circular plate-shaped portion, which has a radial central axis extending along the central axis of the tube body along its length. 15. The puncture device according to claim 12, wherein, A groove that is continuous with the opening is formed in the connecting part. 16. The puncture device according to claim 12, wherein, The aforementioned distal end face and the aforementioned tube body are not orthogonal in length direction. 17. The puncture device according to claim 12, wherein, The width of the aforementioned top rotating part in the direction orthogonal to the length direction of the aforementioned tube is greater than the width of the aforementioned tube in the direction orthogonal to the length direction of the aforementioned tube. 18. The puncture device according to claim 1 or 2, wherein, The aforementioned puncture instruments are bone marrow aspiration instruments. 19. A puncture device, characterized in that, The puncture device has the following features: The puncture device according to any one of claims 1 to 18; and The moving speed calculation unit is used to calculate the moving speed of the aforementioned puncture instrument. 20. The puncture device according to claim 19, wherein, The puncture device includes a comparison unit that compares the moving speed calculated by the moving speed calculation unit with a predetermined moving speed. 21. The puncture device according to claim 20, wherein, The puncture device includes a notification unit that provides information related to the moving speed of the puncture device based on the comparison result of the comparison unit. 22. The puncture device according to any one of claims 19 to 21, wherein, The puncture device has the following features: Position calculation unit, which is used to calculate the position of the aforementioned puncture tip; and The recording section is used to record the previous trajectory of the aforementioned puncture tip. 23. The puncture device according to claim 22, wherein, The puncture device includes a display control unit that displays the position of the puncture tip at all times and the previous trajectory recorded by the recording unit. 24. The puncture device according to claim 23, wherein, The puncture device includes a prediction unit for predicting the trajectory of the aforementioned puncture tip. The aforementioned display control unit also displays the trajectory of the aforementioned puncture tip predicted by the aforementioned prediction unit. 25. The puncture device according to claim 24, wherein, The puncture device includes a notification unit that compares the trajectory of the puncture tip predicted by the prediction unit with the previous trajectory recorded by the recording unit, and provides notification when the trajectories are approximately the same or identical. 26. The puncture device according to claim 22, wherein, The puncture device includes a notification unit that compares the movement trajectory of the puncture tip with the previous trajectory recorded by the recording unit, and provides notification when the trajectories are approximately the same or identical. 27. The puncture device according to any one of claims 19 to 21, wherein, The puncture device is equipped with a first magnetic sensor, which is installed in the puncture device. 28. The puncture device according to claim 27, wherein, The puncture device has the following features: A guide tube, which guides the puncture device through which the puncture instrument of any one of claims 1 to 18 passes; and The second magnetic sensor is installed in the aforementioned guide tube. 29. A puncture device, characterized in that, The puncture device has the following features: The puncture device according to any one of claims 1 to 18; A guide tube, used to guide the aforementioned puncture instrument; and The moving speed calculation unit is used to calculate the moving speed of the puncture instrument as it moves through the guide tube. 30. The puncture device according to claim 29, wherein, The puncture device includes a comparison unit that compares the movement speed calculated by the movement speed calculation unit with a predetermined movement speed associated with the aspiration speed of bone marrow fluid. 31. A puncture device, characterized in that, The puncture device has the following features: The puncture device according to any one of claims 1 to 18; A guide tube, used to guide the aforementioned puncture instrument; Position calculation unit, which is used to calculate the position of the aforementioned puncture tip; and The recording section is used to record the previous trajectory of the aforementioned puncture tip. 32. The puncture device according to claim 31, wherein, The puncture device includes a display control unit that displays the position of the puncture tip at any time and the previous trajectory recorded by the recording unit. 33. The puncture device according to claim 32, wherein, The puncture device includes a prediction unit for predicting the trajectory of the puncture tip and the contact position of the puncture tip with the cortical bone. The aforementioned display control unit also displays the trajectory of the aforementioned puncture tip and the aforementioned contact position predicted by the aforementioned prediction unit. 34. The puncture device according to claim 32 or 33, wherein, The aforementioned display control unit displays the previous trajectory of the aforementioned puncture tip, which was inserted through the same puncture hole as the puncture instrument.