Puncture system

Abstract

A puncture system (1) comprises: a puncture assisting tool (3) which includes a holding portion that is attached to and detached from a puncture needle (2) for performing puncture using a line (H) that is formed on the body surface of a subject (M) by a vertical plane including a target point (Q) inside the body of the subject (M) and a piercing point (P), and a sensor unit (32) capable of measuring the angle of the puncture needle being held from a vertical axis or a horizontal plane; a body surface-irradiating laser mechanism (4) which includes a laser irradiation unit (42) for irradiating the vertical plane along the line (H) formed on the body surface of the subject with a laser, and a moving mechanism for moving the laser irradiation unit; and a puncture navigation system which includes a calculation unit that determines an irradiation position for the laser and a piercing angle of the puncture needle (2) on the basis of the target point (Q) inside the body of the subject (M) and the piercing point, and a control unit that controls the laser irradiation unit.

Description

Puncture system, puncture assisting device, body surface irradiating laser mechanism, and puncture navigation system

[0001] The present invention relates to a puncture assisting device, a body surface irradiating laser mechanism, a puncture navigation system, and a puncture system that are applied to biopsy, drainage, radiofrequency ablation, cryotherapy, etc., in which a needle is inserted into the body using CT-guided puncture, ultrasound-guided puncture, MRI-guided puncture, etc. This application claims priority to PCT / JP2023 / 002678, filed on January 27, 2023, the contents of which are incorporated herein by reference.

[0002] Conventionally, when a puncture needle is inserted (pierced) toward a puncture target point of a patient identified in a CT cross section by computed tomography (CT), the puncture needle is positioned in the CT cross section so that a laser is irradiated on the rear side of the puncture needle in the direction of travel (see, for example, Patent Documents 1 and 2).

[0003] Patent document 1 also describes determining the insertion depth, transverse insertion angle, and caudal insertion angle of a needle inserted into the body from an entrance point to a target within the body, and irradiating a laser toward the insertion entrance point.

[0004] Furthermore, when a practitioner inserts a puncture needle into a patient, the angle of the puncture needle is indicated (see, for example, Patent Documents 3 to 5).

[0005] Also known is a system that uses an ultrasound probe to detect a target organ to be punctured and then inserts a puncture needle using a line laser from the ultrasound probe as a guide (see, for example, Patent Document 6). Another system is known that uses a housing in which a line-generating laser and a puncture needle are integrally attached, and punctures the organ by aligning a laser line generated by a CT scanner with a visible laser line from the line-generating laser attached to the housing (see, for example, Patent Document 7). Another system is known that uses crossed light from two laser surfaces to mark a guide path for a medical instrument such as a puncture needle or catheter (see, for example, Patent Document 8).

[0006] Patent Document 1: JP 2002-511784 A, Patent Document 2: JP 2000-070272 A, Patent Document 2009-523508 A, Chinese Patent Publication No. 1939234, International Publication No. 2017 / 070124, U.S. Patent Publication No. 2010 / 0030082, U.S. Patent Publication No. 2016 / 0296179, U.S. Patent No. 5,782,842

[0007] Devices that irradiate a laser onto the back surface of the puncture needle in the direction of travel, such as those described in Patent Documents 1 and 2, irradiate the laser from the entrance point to the target point at a single point, making them highly susceptible to misalignment. In particular, when performing puncture with a puncture needle, the patient inevitably moves, making it difficult to readjust the laser. Furthermore, irradiating a laser onto the back surface of the puncture needle in the direction of travel requires a special puncture needle with a specifically shaped back surface. This creates problems, such as the inability to use cauterization needles or puncture needles used in cryotherapy, which require cables or fluid delivery tubes at the rear end of the puncture needle. Additionally, because the laser must be irradiated from above, depending on the angle, it can be difficult to irradiate the laser, limiting the puncture range and increasing the size of the device.

[0008] In addition, in Patent Document 1, the needle insertion depth, transverse insertion angle, and caudal insertion angle are determined, and a laser is irradiated toward the insertion entrance point, but difficulties arise, such as the need for the patient to be in an accurate position relative to the laser, and the inability to make corrections if the patient moves.

[0009] Furthermore, the instruments that indicate the angle of the puncture needle as described in Patent Documents 3 to 5 are not guided by a laser, but rather repeatedly capture images using CT or the like and insert the needle at a determined angle, and since the practitioner needs to continue holding the instrument that holds the puncture needle during CT imaging, a large amount of X-ray exposure is unavoidable, and since imaging is repeated multiple times using CT or the like, a large amount of X-ray exposure is unavoidable for not only the practitioner but also the patient. Furthermore, although the accurate puncture angle of the puncture needle is indicated, there are cases in which the puncture needle is moved by the slice thickness of the CT image along the CT slice plane while maintaining the insertion angle, and treatment that can accommodate such cases has not been possible.

[0010] In Patent Document 6, a line laser is used as a guide to insert a puncture needle. However, because it is emitted from an ultrasound probe, hand shake is unavoidable, making it difficult to accurately maintain the line laser guide, making accurate puncture extremely difficult. Furthermore, it is extremely difficult for the practitioner inserting the puncture needle to hold the ultrasound probe and perform the puncture while displaying an accurate line laser guide, requiring an assistant. Furthermore, because the line laser is emitted from the ultrasound probe, the degree of freedom of the laser is extremely low, making it difficult to perform appropriate laser guidance. Furthermore, the line laser from the ultrasound probe pressed against the patient's body surface is easily affected by the patient's unintended body movements, making the line laser position prone to shifting, making safe puncture extremely difficult. Furthermore, in Patent Document 6, the laser line generated by the CT scanner is aligned with the visible laser line of the line generating laser attached to the housing to perform the puncture. However, because the surgeon must manually hold the housing while operating it, it is difficult to maintain the visible laser line in the same position as the laser generated by the CT scanner. Furthermore, because the line generating laser and the puncture needle are integrated, it places a heavy burden on the surgeon and is difficult to use. In addition, in Patent Document 7, the puncture needle is guided to a puncture path formed by intersecting light from two laser surfaces, but since it is necessary to accurately form the two intersecting laser surfaces at the puncture position on the patient, there are problems such as the device being large and the operator having to perform the procedure in a way that does not block the two laser beams. There is also the problem that it is very sensitive to the movement of the patient.

[0011] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a puncture system, a puncture assisting device, a body surface irradiating laser mechanism, and a puncture navigation system that impose a small burden on the practitioner, enable the practitioner to easily and accurately check the inclination angle of the puncture needle that will puncture the subject, and enable the practitioner to perform puncture with high precision.

[0012] The puncture system of the present invention is characterized by comprising: a puncture assisting device having a holding part that is detachable from a puncture needle that punctures using a line formed on the body surface of the subject by a vertical plane including a target point and an insertion point inside the body of the subject; and a sensor part that can measure the angle of the held puncture needle from the vertical axis or the horizontal plane; a body surface irradiating laser mechanism having a laser irradiation part that irradiates a laser onto the vertical plane along the line formed on the body surface of the subject and a moving mechanism that moves the laser irradiation part; and a puncture navigation system having a calculation part that determines the irradiation position of the laser and the insertion angle of the puncture needle from the target point and the insertion point inside the body of the subject; and a control part that controls the laser irradiation part.

[0013] The puncture aid of the present invention is a puncture aid that can be attached and detached to a puncture needle that punctures using a line formed on the body surface of the subject, which is a vertical plane including a target point inside the body and an insertion point, and is characterized in that it comprises: a holding part that has a fixed part that holds the puncture needle, a movable part, and a fixing mechanism that holds and fixes the puncture needle with the fixed part and the movable part; a sensor part that can measure the angle of the held puncture needle from the vertical axis or horizontal plane; and a display part that displays the angle; the fixed part has a vertical plane that is perpendicular to the puncture needle when the puncture needle is fixed, and the vertical plane is provided with a scale.

[0014] The body surface irradiation laser mechanism of the present invention is characterized by having a holding member, a laser irradiation unit attached via the holding member and irradiating a laser onto a vertical plane including a target point and an insertion point inside the body of the subject along a line formed on the body surface of the subject, and a moving mechanism for moving the laser irradiation unit provided on the holding member.

[0015] The puncture navigation system of the present invention is characterized by comprising: a calculation unit that determines the insertion angle and insertion length from a target point and insertion point inside the body of a patient identified by at least one of CT, MRI, and an ultrasound probe, and calculates the angle from the body axis of the patient to a plane including the target point and insertion point; and a control unit that controls a laser irradiation unit that irradiates a laser onto a vertical plane along a line formed by the vertical plane on the body surface of the patient, based on the angle from the body axis of the patient calculated by the calculation unit.

[0016] The puncture system, puncture assisting device, body surface irradiating laser mechanism, and puncture navigation system according to each aspect of the present invention reduce the burden on the practitioner, enable the practitioner to easily and accurately check the inclination angle of the puncture needle that will puncture the patient, and enable highly accurate puncture.

[0017] 11 。 FIG. 11 is a perspective view showing an overall overview of the puncture system according to the first embodiment. FIG. 12 is a perspective view showing a puncture assisting device holding a puncture needle. FIG. 13 is a perspective view showing a specific configuration of the puncture assisting device. FIG. 14 is a perspective view showing the positional relationship between the puncture needle and the puncture assisting device during puncture. FIG. 15 is a side view of FIG. 4. FIG. 16 is a perspective view showing the overall configuration of the body surface irradiating laser mechanism. FIG. 17 is a perspective view showing the configuration of the movement mechanism of the body surface irradiating laser mechanism shown in FIG. 6. FIG. 18 is a plan view for explaining a calibration mechanism that matches the coordinates of the puncture navigation system with the coordinates of the CT device. FIG. 19 is a plan view for explaining the puncture navigation system. FIG. 19 is a perspective view showing a specific configuration of the puncture assisting device according to the third embodiment. FIG. 19 is a perspective view showing the positional relationship between the puncture needle and the puncture assisting device during puncture. FIG. 11 is a diagram showing a vertical plane including the Nx axis in FIG. 11. FIG. 19 is a diagram showing the Ny-Nz axis plane in FIG. 11. FIG. 19 is a diagram showing an overview of a puncture system using an ultrasound probe in a puncture system according to a fifth embodiment. FIG. 19 is a diagram showing the configuration of the puncture system according to the ... an adjustment mechanism for the body surface irradiating laser mechanism according to a sixth embodiment.

[0018] Examples of a puncture system, a puncture assisting device, a body surface irradiating laser mechanism, and a puncture navigation system according to embodiments of the present invention will be described with reference to Figures 1 to 9. Note that although expressions such as "puncturing along a line" and "aligning a position" are used in this specification, they are not necessarily limited to perfect alignment and are understood to include the range of error that is acceptable in general surgical procedures.

[0019] First Embodiment [Puncture System] FIG. 1 is a perspective view showing a puncture system 1 according to this embodiment, illustrating the interior of a gantry of a computed tomography (CT) device (not shown). As shown in FIG. 1, the puncture system 1 is used to insert a puncture needle 2 into the body of a subject M in CT-guided puncture, ultrasound-guided puncture, MRI-guided puncture, or the like. This first embodiment illustrates an example of using CT-guided puncture. Specifically, the puncture system 1 displays a body surface marker line H on the body surface Ma of the subject M, which includes a puncture target point Q and a puncture insertion point P, both of which are determined in advance by CT, using a body surface irradiating laser mechanism 4. The puncture needle 2 is then accurately inserted along the body surface marker line H. The body surface Ma may be the chest, abdomen, or back. Also, O in FIG. 1 represents the body axis. In the present invention, the body axis O refers to the normal body axis of the patient M (the long axis extending from the tail to the head, which is an axis that is approximately symmetrical with that axis) analyzed from the patient M obtained by imaging, but since the patient M is generally placed in the center of the treatment table 40 and movement of the patient M can be eliminated, the longitudinal central axis of the treatment table 40 may also be the patient's body axis O. The body axis O is not limited to the above, and may also be a fixed axis (reference axis) that the patient M or the like has determined as a reference when performing treatment.

[0020] The puncture system 1 includes a puncture assisting tool 3 that is detachably attached to the puncture needle 2, a body surface irradiating laser mechanism 4 (see FIG. 6 ) that irradiates laser light R toward the body surface Ma of the subject M, and a puncture navigation system 5 (see FIGS. 8 and 9 ), not shown in FIG. 1 , that determines the position of the laser light R.

[0021] As described above, the puncture system 1 uses the puncture target point Q inside the body of the patient M determined by CT. A method for determining the puncture target point Q using CT will be described later in the description of the puncture navigation system 5.

[0022] 2 and 3 , the puncture assisting tool 3 is attached to the puncture needle 2 and is configured to indicate to the puncture operator the inclination angle (inclination angle θ) of the puncture needle 2 from the vertical axis or horizontal plane. The puncture assisting tool 3 has a groove portion 31 (holding portion) that holds the puncture needle 2, a sensor portion 32 that can measure the inclination angle θ of the held puncture needle 2 from the vertical axis or horizontal plane, and an inclination angle indicating portion 33 that indicates the inclination angle θ of the puncture needle 2. Because the puncture assisting tool 3 is attached to the puncture needle 2 when in use, it is preferable to sterilize it before use.

[0023] 3 , the sensor unit 32 of the puncture assisting tool 3 has a fixed part 34 and a movable part 35 movably fixed to the fixed part 34. Note that, although an example will be shown below in which the puncture needle 2 is fixed by the fixed part 34 and movable part 35 of the puncture assisting tool 3, the method for fixing the puncture needle 2 to the puncture assisting tool 3 is not limited to this. The puncture needle 2 may be fixed by various methods, such as by attaching it to a predetermined position on the puncture assisting tool 3. Furthermore, the position at which the puncture assisting tool 3 is fixed to the puncture needle 2 is not limited to the puncture needle 2, and the puncture assisting tool 3 may also be fixed to a member extending from the puncture needle 2.

[0024] The fixed portion 34 is formed in a rectangular plate shape in a plan view and has a three-axis acceleration sensor (not shown) built in. The fixed portion 34 has an inclination angle indicating unit 33 on its outer surface 34a, opposite to the surface (inner surface 34b) on which the movable portion 35 is provided. The short side 34d of the fixed portion 34 extends in a direction along the length of the puncture needle 2 held by the groove 31 in a plan view. The long side 34e of the fixed portion 34 extends in a direction perpendicular to the groove 31 in a plan view. The groove 31 is formed so that the sensor axis of the acceleration sensor coincides with the length direction of the puncture needle 2 when the puncture needle is fixed. A movable portion rotation shaft 36 that rotatably supports the movable portion 35 is provided in a middle portion of the inner surface 34b of the fixed portion 34 in the long side direction. The axial direction of the movable portion rotation shaft 36 is along the short side 34d.

[0025] 3, the movable part 35 is formed in a generally rectangular plate shape in plan view. The movable part 35 is disposed with its inner surface 35b facing the inner surface 34b of the fixed part 34. The planar shape of the movable part 35 is substantially the same as that of the fixed part 34. That is, the short side 35d of the movable part 35 extends in a direction along the length of the puncture needle 2 held by the groove 31 in plan view. The long side 35e of the movable part 35 extends in a direction perpendicular to the long side 34e of the fixed part 34 in plan view.

[0026] A rotation support portion 35c at the middle of the inner surface 35b of the movable portion 35 in the long side direction is rotatably supported and connected to a movable portion rotation shaft 36 provided in the fixed portion 34. The inner surface 35b of the movable portion 35 has a clamping surface 35f on the distal side of the rotation support portion 35c and a base end surface 35g on the proximal side. The clamping surface 35f is inclined so as to approach the outer surface 35a from the rotation support portion 35c toward the distal side. The base end surface 35g is inclined so as to approach the outer surface 35a from the rotation support portion 35c toward the proximal side.

[0027] Furthermore, the above-mentioned V-shaped groove 31 is formed on the clamping surface 35f of the movable part 35. Furthermore, when the long side 34e of the puncture aid 3 is also aligned with the laser vertical plane A described below or when forming the scale 380 described below, the long side 34e is formed so that when the puncture needle 2 is locked, the length direction of the puncture needle 2 is perpendicular to the surface of the long side 34e of the fixed part 34 and the surface of the long side 35e of the movable part 35. At this time, by locking the puncture needle 2 along the groove direction of the groove 31, the length direction of the puncture needle 2 is determined in a direction perpendicular to the long side 35e of the movable part 35. In other words, the orientation of the puncture needle 2 is determined in a direction perpendicular to the long side 34e of the fixed part 34. Preferably, the groove portion 31, the fixed portion 34, and the movable portion 35 may be configured so that the longitudinal direction of the puncture needle 2 is parallel to the surface of the short side portion 34d of the fixed portion 34 and the surface of the short side portion 35d of the movable portion 35.

[0028] The movable part 35 is rotatable so as to swing around the movable part rotation axis 36. The tip of the movable part 35 on the groove 31 side is biased toward the inner surface 34b of the fixed part 34 by the biasing force of a biasing member (not shown), such as a spring member. By pushing the base end of the movable part 35 toward the fixed part 34 against the biasing force of the biasing member, the base end surface 35g approaches the inner surface 34b of the fixed part 34, and the clamping surface 35f moves away from the inner surface 34b of the fixed part 34. The groove 31 can hold the puncture needle 2 in a clamped state between the groove 31 and the inner surface 34b of the fixed part 34. The groove 31 has a groove shape and groove depth that allows it to press the puncture needle 2 when clamped between the groove 31 and the inner surface 34b of the fixed part 34. Therefore, the groove shape of the groove 31 is not limited to a V-groove as in this embodiment. In this way, the above-mentioned movable part rotation shaft 36 in the groove 31, the biasing member, and the groove 31 correspond to a locking mechanism that clamps and fixes the puncture needle 2.

[0029] 2 , the inclination angle display unit 33 is electrically connected to an acceleration sensor housed in the sensor unit 32, and displays, for example, a numerical (digital) value of the inclination angle θ of the puncture needle 2. A practitioner using the puncture assist tool 3 can visually check the inclination angle display unit 33 of the fixing part 34 to recognize the angle of the puncture needle 2 held by the puncture assist tool 3.

[0030] The display format of the tilt angle θ of the tilt angle indicator 33 is not limited to a digital display, and may be a display of symbols, colors, or the like that allow the practitioner to visually recognize the tilt angle θ. Sound, vibration, or the like may also be used. The digital display may simply display the numerical value of the tilt angle θ, or may display the unit "°" or symbols as in this embodiment. Deviation from the set angle may also be displayed. For example, if the deviation from the set angle exceeds a predetermined threshold, a special display (such as flashing, sound, or vibration) may be performed.

[0031] Furthermore, the display position of the inclination angle presenting unit 33 is not limited to the outer surface 34a of the fixed unit 34. For example, the inclination angle presenting unit 33 may be provided on the outer surface 35a of the movable unit 35, or the inclination angle presenting unit 33 may be provided on both the outer surface 34a of the fixed unit 34 and the outer surface 35a of the movable unit 35.

[0032] A three-axis acceleration sensor is used as an example of the sensor built into the fixed part 34. The sensor part 32 is set to measure the inclination angle θ based on the groove direction of the groove part 31, i.e., the vertical or horizontal direction (vertical direction in this embodiment) of the puncture needle 2 held in the groove part 31 of the puncture aid 3. Note that the sensor is not limited to an acceleration sensor, and any sensor that can detect three axes can be used.

[0033] The sensor housed in the sensor unit 32 is not limited to a three-axis acceleration sensor, and for example, a two-axis acceleration sensor can also be used. However, in the case of a two-axis acceleration sensor, different requirements are required from those of this embodiment, and therefore, this will be explained in another embodiment (second embodiment) described later.

[0034] FIG. 4 is a perspective view showing the positional relationship between the puncture needle 2 and the puncture assisting tool 3 during puncture. FIG. 5 is a side view of FIG. 4. The laser light R shown in FIGS. 4 and 5 is emitted from a laser irradiation unit 42 (described later) of the body surface irradiating laser mechanism 4. The Ny axis shown in FIGS. 4 and 5 is the axis (first sensor axis) in the length direction (puncture needle direction) of the puncture needle 2, the Nx axis is the first orthogonal axis (second sensor axis) perpendicular to the puncture needle direction axis (Ny axis), and the Nz axis is the second orthogonal axis (third sensor axis) perpendicular to both the puncture needle direction axis (Ny axis) and the first orthogonal axis (Nx axis). Here, the symbol H in FIGS. 4 and 5 indicates a body surface marker line obtained by planarly projecting onto the body surface a straight line connecting the puncture insertion point P and the puncture target point Q.

[0035] The sensor unit 32 has a first sensor axis Ny installed in the direction of the puncture needle 2, a second sensor axis Nx installed perpendicular to the puncture needle 2, and a third sensor axis Nz installed perpendicular to both the axes Nx and Ny. The puncture needle 2 is held together with the puncture assist tool 3 so that laser light R, which displays a laser vertical plane A including the puncture insertion point P and the puncture target point Q, irradiates the puncture needle 2, and the inclination angle display unit 33 of the puncture assist tool 3 displays to the practitioner the inclination angle θ of the puncture needle 2 from the vertical axis of the vertical direction Nxyz or the horizontal plane. For example, as shown in FIG. 5 , when the angle θvt between the first sensor axis Ny and the vertical direction Nxyz is arctan(Nxz / Ny), the inclination angle θ of the puncture needle 2 from the horizontal plane within the laser vertical plane A is calculated using the formula 90-θvt and displayed on the inclination angle display unit 33.

[0036] After a puncture line along which the puncture needle 2 will not damage vital organs or the like is determined by the puncture navigation system 5 (see FIGS. 8 and 9 ), which will be described later, is irradiated with laser light R along the puncture line including the puncture target point Q and the puncture insertion point P, and a body surface marker line H (a line formed on the body surface Ma of the patient M by a plane including the puncture target point Q and the puncture insertion point P inside the body of the patient M) is displayed. The practitioner aligns the tip 2 a of the puncture needle 2 with the puncture insertion point P, and aligns the length direction of the puncture needle 2 with the laser light R (a state in which a line of light created by the laser light R is displayed in the puncture needle direction of the puncture needle 2), and holds and punctures the puncture needle 2 so that the value of the inclination angle indicating unit 33 is the set angle, thereby safely reaching the puncture target point Q.

[0037] [Body surface irradiation laser mechanism] As shown in Figure 6, the body surface irradiation laser mechanism 4 includes a holding member 41 provided on a treatment table 40 that supports the patient M, a laser irradiation unit 42 attached via the holding member 41 and irradiating laser light R that forms a line (body surface marker line H) formed on the body surface Ma of the patient M by a laser vertical plane A that includes the puncture target point Q and the puncture insertion point P inside the body of the patient M, and a moving mechanism 43 that moves the laser irradiation unit 42 provided on the holding member 41.

[0038] The laser irradiation unit 42 forms a vertical laser plane A by emitting a planar laser beam R downward. The laser irradiation unit 42 is installed above the patient M lying on the treatment table 40. In this embodiment, the treatment table 40 is preferably provided so as to be movable forward and backward relative to the interior of a CT gantry (not shown) or MRI gantry, but this is not necessary if the puncture target point Q is determined using ultrasound or the like. The laser irradiation unit 42 is preferably installed or moved on the opposite side of the CT gantry from the practitioner so as not to interfere with the practitioner's puncture treatment. Depending on the situation, it may also be installed or moved on the same side as the practitioner.

[0039] As an example, the holding member 41 includes leg frames 411 that are detachably provided upright from both left and right end portions 40a, 40b of the treatment table 40, and a horizontal frame 412 that connects the upper ends of the leg frames 411. When the treatment recipient M gets on or off the treatment table 40, the leg frames 411 of the holding member 41 are removed from the treatment table 40, and the leg frames 411 are attached after the treatment recipient M gets on the treatment table 40. The attachment position of the holding member 41 to the treatment table 40 can be changed as desired. In addition, in FIG. 6, the leg frames 411 are provided on both sides so that the body surface irradiating laser mechanism 4 straddles the treatment recipient M, but the leg frames 411 may be provided on only one side, and the body surface irradiating laser mechanism 4 may be held by the leg frame 411 on one side. In this case, the body surface irradiation laser mechanism 4 can be rotated around the leg frame 411 as a base axis, and before the patient M steps onto the treatment table 40, it is oriented in the direction of the body axis O, and after the patient M steps onto the treatment table 40, it is rotated so that the body surface irradiation laser mechanism 4 is positioned above a predetermined position of the patient M, and can be fixed in that position using a fixing mechanism not shown.

[0040] The leg frame 411 is provided with auxiliary legs 413 branching downward. The leg frame 411 is extendable and adjustable in length. Specifically, the leg frame 411 includes a large-diameter tube 411A and a small-diameter tube 411B inserted into the upper end of the large-diameter tube 411A and is extendable and flexibly configured. The height of the horizontal frame 412 can be set arbitrarily by adjusting and fixing the tubes to any desired length. The horizontal frame 412 is extendable and adjustable in length. Specifically, as shown in FIG. 7 , the horizontal frame 412 includes a large-diameter tube 412A and a small-diameter tube 412B inserted into both ends of the large-diameter tube 412A and is extendable and flexibly configured. The length can be set to match the width of the treatment table 40 by adjusting and fixing the tubes to any desired length. The cross-sectional shapes of the leg frame 411 and the horizontal frame 412 may be circular or rectangular, and are not particularly limited.

[0041] The movement mechanism 43 includes a rotational movement mechanism 46 that holds the laser irradiation unit 42 rotatably around a vertical axis, and a linear movement mechanism 45 that holds the laser irradiation unit 42 so that it can move in a linear direction along the horizontal frame 412.

[0042] 7, the moving mechanism 43 includes a first fixed case 441 and a second fixed case 442 immovably provided on either side of the horizontal frame 412 in the longitudinal direction, and a moving case 443 movable along the horizontal frame 412 between the first fixed case 441 and the second fixed case 442 in the longitudinal direction of the horizontal frame 412. The laser irradiation unit 42 is housed in the moving case 443 so as to be able to irradiate laser light R downward.

[0043] The linear movement mechanism 45 will now be described. A linear drive unit 451, such as a stepping motor with a horizontal axis as its center of rotation, is housed in the first fixed case 441, and is connected to a feed screw 452 to which the rotation of the linear drive unit 451 is transmitted. The feed screw 452 extends parallel to the extension direction of the horizontal frame 412, and a screw tip 452a is rotatably supported by a bearing 453 housed in the second fixed case 442.

[0044] The moving case 443 accommodates a feed screw nut 454 that fits onto the feed screw 452 and moves along the feed screw 452, and a fitting sliding cylinder 455 that fits onto the horizontal frame 412 and slides. The feed screw nut 454 moves the moving case 443 along the horizontal frame 412 together with the laser irradiation unit 42. As a result, the laser irradiation unit 42 moves in a direction perpendicular to the body axis O of the patient M.

[0045] The rotational movement mechanism 46 will now be described. A rotational drive unit 461, such as a stepping motor with a vertical axis as its center of rotation, is housed in the movement case 443. The rotational movement mechanism 46 has a first pulley 462 journaled on the rotational drive unit 461, a second pulley 463 journaled on the laser irradiation unit 42, and rotation of the rotational drive unit 461 is transmitted to the laser irradiation unit 42 by a connecting belt 464 between the first pulley 462 and the second pulley 463.

[0046] 6, the horizontal movement and rotation of the laser irradiation unit 42 in the body surface irradiating laser mechanism 4, and the on / off operation of the laser light R, are controlled by wire or wirelessly using a control panel 47. The overall size of the body surface irradiating laser mechanism 4 is preferably such that when the treatment table 40 is moved while the body surface irradiating laser mechanism 4 is installed on the treatment table 40, the entire body surface irradiating laser mechanism 4 can pass through a gantry such as a CT scanner without interfering with the gantry.

[0047] 6 and 7 are merely examples of the configurations, dimensions, and shapes of the holding member 41, linear movement mechanism 45, and rotational movement mechanism 46 in the body surface irradiating laser mechanism 4, and can be modified as appropriate. For example, the linear drive unit 451 and the rotational drive unit 461 are not limited to stepping motors, but may be general motors or other mechanically driven devices. Furthermore, the drive force transmission means is not limited to pulleys and belts, and may be chains, gears, direct drives, or other devices for transmitting drive force.

[0048] Furthermore, the body surface irradiating laser mechanism 4 is preferably provided separately from the line laser provided in a conventional gantry, as shown in Figures 6 and 7, but is not limited thereto. The body axis laser or line laser provided in the gantry may be provided with the function of a laser irradiation unit in the form of a moving mechanism or a rotating mechanism. The body axis laser provided in a typical gantry is fixed so that the laser plane is aligned with the body axis O, and the line laser is fixed so that the line laser plane is perpendicular to the body axis O. The body axis laser or line laser may be made movable and rotatable to serve as the body surface irradiating laser mechanism of the present invention. Note that, from the viewpoints of accuracy, versatility, etc., it is preferable to use the body axis laser and line laser provided in a conventional gantry as a reference for the body axis O and for CT imaging, and to use the body surface irradiating laser mechanism 4 in combination with them, as shown in Figures 6 and 7.

[0049] In this embodiment, the laser irradiation unit 42 preferably forms a vertical laser plane A that irradiates the laser vertically, in order to simplify calculations and to provide a laser plane that is clear and easy for the practitioner to intuitively grasp. However, depending on the body surface marker line H of the treatment recipient M, the laser irradiation unit 42 is not limited to irradiating the laser vertically, and may instead use a laser plane at a predetermined angle.

[0050] Furthermore, although the linear movement mechanism 45 is shown in Figure 6 and other figures as moving in a direction perpendicular to the body axis O, it can also be made movable in a direction other than perpendicular to the body axis O, and such a configuration may be adopted.

[0051] [Puncture Navigation System] The puncture navigation system 5 identifies a puncture target point Q inside the body of the patient M from CT-MPR (Multi Planar Reconstruction) images, MRI images, and ultrasound images. As shown in FIGS. 8 and 9 , among the insertion lines of the puncture needle 2 that can reach the puncture target point Q, the system determines an insertion line that avoids important organs and blood vessels. If there are multiple insertion lines, the system selects the safest insertion line with the shortest insertion length to determine the puncture insertion point P. The system then determines a plane including the puncture target point Q and the puncture insertion point P, the puncture insertion point P where the puncture needle 2 will insert, the insertion angle, and the insertion length, and calculates the angle from the body axis O relative to the plane. The insertion angle, insertion length, and angle from the body axis O relative to the plane may be determined by reading them from the CT-MPR images. The system may also calculate the allowable insertion angle error and insertion length error for each insertion line, and calculate the degree of safety of the insertion based on predetermined criteria. The puncture navigation system 5 also has a control unit (not shown) that moves the laser irradiation unit 42 on the laser vertical plane A using a movement mechanism 43, as shown in Fig. 6, based on the determination and calculation by the calculation unit. The calculation unit and control unit are composed of a well-known electronic circuit unit or the like that includes a CPU (not shown), a storage unit composed of storage elements such as ROM and RAM, and an interface circuit, etc. The puncture navigation system 5 uses one of the determined and calculated coordinates of the puncture target point Q (target point coordinate T) and the coordinates of multiple puncture insertion points P (insertion point coordinate S) to automatically set the rotation angle θh and the X-axis position Xj of the laser irradiation unit 42 using the control unit.

[0052] As shown in FIG. 8 , the method of calibrating the laser irradiation unit 42 involves first setting the rotation angle of the laser light R emitted by the laser irradiation unit 42 to 0 degrees (perpendicular to the CT line laser Rc, in other words, in the direction along the body axis O) and aligning it with, for example, a laser Ro provided in a CT or the like, which is the body axis O (usually in the longitudinal direction of the center of the bed), and setting its X coordinate to Xc ( FIG. 8 shows a state in which the laser light R emitted by the laser irradiation unit 42 toward the body axis O and the laser Ro provided in the CT or the like, which irradiates the body axis O, overlap). Then, the rotation angle of the laser light R is set to 90 degrees (parallel to the CT line laser Zct) and rotated so that it is parallel to the CT line laser Rc. At this time, the distance Zjct between the laser of the laser irradiation unit 42 and the CT line laser Rc is measured, and Zj is calculated.

[0053] 9 , specifically, when the patient M is in a supine position, two methods will be described, using CT as an example, for aligning the laser light R from the laser irradiation unit 42 with the insertion point coordinate S and the target point coordinate T, inserting the puncture needle 2 from the insertion point coordinate S, and causing the tip of the puncture needle 2 to reach the target point coordinate T. In the first method, the coordinate S of the puncture insertion point P (hereinafter referred to as the insertion point coordinate S) and the coordinate T of the puncture target point Q (hereinafter referred to as the target point coordinate T) are determined from a CT-MPR image, the insertion point coordinate S (Xs, Ys, Zs) and the target point coordinate T (Xt, Yt, Zt) are read, and the rotation angle θh from the body axis of the laser vertical plane A containing the insertion point coordinate S and the target point coordinate T, and the X coordinate Xj of the intersection with Zj of the laser vertical plane A, are calculated, and the laser irradiation unit 42 is moved. Furthermore, the tilt angle θv of the line segment ST in the laser vertical plane A from the horizontal plane and the distance Dst between the insertion point coordinate S and the target point coordinate T, which correspond to the puncture depth, are calculated, the tip of the puncture needle 2 is placed at the puncture point coordinate S, the puncture needle 2 is placed in the laser vertical plane A so that the laser light R is irradiated onto the entire puncture needle 2, the puncture needle 2 is tilted so that the angle of the tilt angle display unit 33 is θv, and the puncture needle 2 is advanced to a depth Dst, so that the tip of the puncture needle 2 reaches the target point coordinate T. The above θh, Xj (any of the four equations), θv, and Dst can be calculated using the following equations (1) and (1'). θh=arctan{(Xt-Xs) / (Zt-Zs) Xj=Xs-(Zs-Zj)×tan(θh) Xj=Xt-(Zt-Zj)×tan(θh) Xj=Xs-(Xs-Xt)×(Zs-Zj) / (Zs-Zt) Xj=Xt-(Xs-Xt)×(Zt-Zj) / (Zs-Zt) Dxz=√{(Xt-Xs) ２ + (Zt-Zs) ２} θv=arctan{(Yt-Ys) / Dxz} ...(1) Dst=√{(Xt-Xs) ２ +(Yt-Ys) ２ + (Zt-Zs) ２} ... (1')

[0054] As an alternative second method, there is a method in which only Xj is calculated without calculating θh, θv, and Dst as described above. The CT-MPR sagittal plane is rotated around the vertical axis to determine a sagittal plane including the insertion point coordinate S and the target point coordinate T. The rotation angle θh of the sagittal plane and the insertion point coordinates (Xs, Ys, Zs) or the target point coordinates (Xt, Yt, Zt) are read, and the X coordinate Xj of the intersection with Zj of the laser vertical plane A is calculated from the rotation angle θh of the sagittal plane and the insertion point coordinate S or the target point coordinate T, and the laser irradiation unit 42 is moved. Furthermore, the inclination angle θv of the line segment ST in the sagittal plane from the horizontal plane and the distance Dst between the insertion point coordinate S and the target point coordinate T, which corresponds to the puncture depth, are read, the tip of the puncture needle 2 is placed at the puncture point coordinate S, the puncture needle 2 is placed in the laser vertical plane A so that the laser light R is irradiated onto the entire puncture needle 2, the puncture needle 2 is tilted so that the angle of the inclination angle indicating unit 33 becomes θv, and the puncture needle 2 is advanced to the depth Dst, whereby the tip of the puncture needle 2 can reach the target point coordinate T.

[0055] By using either of the above methods or by combining both methods, the tip of the puncture needle 2 can be guided by the laser light R from the laser irradiation unit 42 to reach the target point coordinates T. The puncture procedure can be performed by using either one of the methods or a combination of the methods, depending on the capabilities of the device such as CT to be used.

[0056] The puncture navigation system 5 may also include a calibration means for calibrating the movement of the patient M during the procedure. During the procedure, the patient M may move, causing the laser light R from the laser irradiation unit 42 to deviate from the determined body surface marker line H including the puncture insertion point P. To prevent this, the puncture system of the present invention may include a marking element. For example, a marking element may be provided that allows the determined puncture insertion point P or the body surface marker line H to be visually identified. For example, an adhesive marking element or a drawable marking element may be provided on the surface of the body surface Ma at the puncture insertion point P or the body surface marker line H. Even if the laser light R from the laser irradiation unit 42 deviates from the body surface marker line H due to the movement of the patient M, the marking element can be used to visually readjust the position and rotation of the laser light R from the laser irradiation unit 42 so that it aligns with the body surface marker line H. The puncture navigation system 5 may also have an imaging means such as a camera, detect the marking element, and use an image analysis function to calculate the degree of deviation. Based on this, the control unit may drive the body surface irradiation laser mechanism 4 and automatically control the linear direction and rotation direction, thereby calibrating the laser light R from the laser irradiation unit 42 so that it does not deviate from the body surface marker line H at all times.

[0057] [Procedure Using the Puncture System] Next, a detailed description will be given of the procedure for inserting the puncture needle 2 into the puncture target point Q of the patient M at an accurate angle using the puncture assisting tool 3. First, as shown in FIG. 1 , the practitioner reads the puncture target point Q, which indicates the location of a target such as a malignant tumor, from a CT image or the like, and determines, in a preoperative plan, a puncture direction and a puncture insertion point P that will allow safe puncture into the puncture target point Q. This determination determines a line connecting the puncture target point Q and the puncture insertion point P, and further determines a line (body surface marker line H) projected onto the body surface Ma of the patient M from this line. Furthermore, the inclination angle θ of the extension of the line connecting the puncture target point Q and the puncture insertion point P with the vertical axis or horizontal plane is calculated. This inclination angle θ becomes the puncture angle of the puncture needle 2. Then, laser light R is emitted from the laser irradiation unit 42, forming a laser vertical plane A that passes through the body surface marker line H. The operations up to this point are performed by the control unit of the puncture navigation system 5 described above in this embodiment.

[0058] Specifically, as shown in Fig. 6, the control unit controls the linear movement mechanism 45 and rotational movement mechanism 46 of the body surface irradiating laser mechanism 4 set above the patient M, and performs control to calculate and adjust the horizontal position perpendicular to the body axis O in a plan view of the laser irradiating unit 42 and the angle of the rotational direction around the vertical axis. Whether the laser irradiating unit 42 displays the body surface marker line H at the correct position may be confirmed by image analysis after capturing an image with an imaging means.

[0059] Even when the puncture navigation system 5 is not used, the practitioner determines the puncture insertion point P using a CT image or the like, and then calculates or reads from the CT image or the like the horizontal position of the laser irradiation unit 42 that is perpendicular to the body axis O in a planar view and the angle of rotation around the vertical axis, and then operates the operation panel 47 to adjust the position of the laser irradiation unit 42 so that a laser vertical plane A is formed.

[0060] Next, puncture is performed with the puncture needle 2. First, the puncture assisting tool 3 is attached to the puncture needle 2. As shown in Figure 3, the puncture needle 2 is held in the groove 31 of the movable part 35 and sandwiched between the movable part 35 and the fixed part 34, thereby attaching the sensor part 32 with a built-in sensor to the puncture needle 2.

[0061] 4 and 5 , the practitioner holds the puncture needle 2 equipped with the sensor unit 32 using a puncture holder or the like and brings the tip 2a of the puncture needle 2 close to the puncture insertion point P on the body surface Ma so that the laser vertical plane A hits the entire puncture needle 2. Then, the practitioner places the puncture needle 2 within the plane of the laser vertical plane A and adjusts the inclination angle θ of the puncture needle 2 while checking the inclination angle display unit 33 of the puncture assisting tool 3. That is, the practitioner inserts the puncture needle 2 into the body while pointing it at the predetermined inclination angle θ. Even during this puncture operation, the practitioner checks the numerical value (inclination angle) displayed on the inclination angle display unit 33 and, depending on the situation, may check the insertion status of the puncture needle 2 into the body by repeatedly acquiring CT images or the like.

[0062] [Effect] As described above, the puncture assisting tool 3 according to this embodiment is provided with a detachable puncture needle 2 that punctures using a line (body surface marker line H) formed on the body surface Ma of the subject M by a laser plane that includes the puncture target point Q and the puncture insertion point P inside the body of the subject M. The puncture assisting tool 3 has a groove section 31 (holding section) that holds the puncture needle 2, a sensor section 32 that can measure the angle of the held puncture needle 2 from the vertical axis or horizontal plane, and an inclination angle display section 33 that displays the angle.

[0063] In the puncture assisting device 3 according to this embodiment, when the puncture needle 2 held by the groove 31 is directed at a predetermined tilt angle along a line formed by the body surface Ma of the patient M, where the laser plane includes the puncture target point Q and the puncture insertion point P inside the body of the patient M, the angle of the puncture needle 2 from the vertical axis or the horizontal plane is measured by the sensor unit 32, and the measured value, that is, the tilt angle, can be displayed on the tilt angle display unit 33. Therefore, the practitioner can accurately check the tilt angle θ of the puncture needle 2 in real time by looking at the tilt angle display unit 33, and can safely reach the puncture target point Q simply by accurately puncturing the body of the patient M while adjusting the tilt angle of the puncture needle 2.

[0064] For example, in CT-guided puncture, when puncturing within a CT cross section, the angle of inclination of the puncture needle 2 with respect to the vertical axis or horizontal plane can be presented to the practitioner from the start of puncture through the puncture.

[0065] Therefore, in this embodiment, the number of times the inclination angle of the puncture needle 2 needs to be adjusted during puncture can be reduced, thereby shortening the treatment time. Therefore, in the case of CT-guided puncture, it is possible to reduce X-ray exposure of the practitioner and the patient M. Furthermore, even when the practitioner holds the puncture needle 2 with a puncture holder or the like to perform CT imaging in order to reduce X-ray exposure, the puncture needle inclination angle is always displayed to the practitioner on the inclination angle display unit 33, so fluctuations in the inclination angle of the puncture needle 2 can be suppressed.

[0066] In this embodiment, when the puncture needle inclination angle is finely adjusted during puncture, the puncture needle inclination angle is always displayed, so the puncture needle inclination angle can be finely adjusted based on a specific angle value. Furthermore, even if the practitioner is inexperienced, the practitioner can receive instructions on the puncture angle using a specific angle value from the practitioner's instructor, and the inexperienced practitioner can finely adjust the puncture needle inclination angle while referring to the angle displayed on the inclination angle display unit 33.

[0067] Furthermore, in the puncture assisting tool 3 according to this embodiment, the holding portion is made up of the groove portion 31 and includes a fixing mechanism that holds and fixes the puncture needle 2 in the groove portion 31 by the fixed portion 34 and the movable portion 35 .

[0068] In this embodiment, the sensor unit 32 for indicating the inclination angle of the puncture needle 2 has a structure that allows it to be fixed by being clamped between the fixed part 34 and the movable part 35, and the sensor unit 32 can be easily attached and detached to an existing puncture needle 2. Therefore, the sensor unit can be easily attached to the puncture needle 2 in a short time and can be used for puncturing. Furthermore, even if multiple punctures are required in one procedure, the sensor unit 32 can be removed after the puncture and easily attached to another puncture needle 2, so multiple punctures can be performed efficiently, cleanly, and at low cost.

[0069] The body surface irradiating laser mechanism 4 according to this embodiment includes a holding member 41 provided on a treatment table 40 that supports the subject M, a laser irradiation unit 42 that is attached via the holding member 41 and irradiates laser along a line formed by the body surface Ma of the subject M, the laser plane including the puncture target point Q and the puncture insertion point P inside the body of the subject M, and a moving mechanism 43 that moves the laser irradiation unit 42 provided on the holding member 41.

[0070] In this embodiment, a laser irradiation unit 42 separate from the CT laser can be provided, and this laser irradiation unit 42 can emit a laser that forms a laser vertical plane A that includes the puncture target point Q and the puncture insertion point P inside the body of the patient M. Therefore, by placing the puncture needle 2 equipped with the sensor unit 32 against the laser vertical plane A, the practitioner can orient the puncture needle 2 along a line (body surface marker line H) formed on the body surface Ma in a planar view, and can adjust the inclination angle θ of the puncture needle 2 while checking the display by the inclination angle display unit 33, while keeping the puncture needle 2 positioned within the laser vertical plane A. Furthermore, in this embodiment, the laser irradiation unit 42 provided on the holding member 41 can be moved to a predetermined position by the movement mechanism 43, providing an extremely high degree of freedom, allowing a laser to be displayed at the body surface marker line H location over a wide range and at any location on the body surface. The above-mentioned laser vertical plane A irradiated by the laser irradiation unit 42 can be displayed at any position, and the puncture procedure can be performed easily and accurately in accordance with the displayed laser. In addition, the laser irradiation unit 42 does not need to be held by the hand of an assistant or other person, so there is no risk of hand shake, etc. In addition, the laser irradiation unit 42 does not come into contact with the patient, so the laser can be displayed stably.

[0071] Furthermore, in the body surface irradiating laser mechanism 4 according to this embodiment, the moving mechanism 43 has a rotation moving mechanism 46 that rotatably holds the laser irradiating unit 42 .

[0072] In this case, the laser irradiation unit 42 can be adjusted in the rotational direction around the vertical axis using the rotational movement mechanism 46, allowing for greater freedom in the display position and making it possible to accurately form a laser vertical plane A that intersects with the CT cross section.

[0073] Furthermore, in the body surface irradiating laser mechanism 4 according to this embodiment, the moving mechanism 43 has a linear moving mechanism 45 that holds the laser irradiating unit 42 so that it can move in a linear direction.

[0074] In this case, the linear movement mechanism 45 can adjust the laser irradiation unit 42 in a linear direction perpendicular to the body axis O of the patient M, making it possible to form the laser vertical plane A and the body surface marker line H with high precision.

[0075] The puncture navigation system 5 according to this embodiment determines the puncture target point Q and the puncture insertion point P inside the body of the patient M, and the control unit can automatically and accurately calculate the laser plane including the puncture target point Q and the puncture insertion point P, the insertion angle at which the puncture needle 2 inserts, the insertion length, and the angle from the body axis O to the laser plane. This improves the efficiency of the puncture operation, and also makes it possible to easily calibrate the angle in a short time. Therefore, even if the position of the patient M changes during puncture, the puncture operation can be performed while adjusting the puncture needle 2 based on the angle calculated by the puncture navigation system 5.

[0076] In the puncture system 1 according to the present embodiment, the control unit can move the laser irradiation unit 42 to the laser vertical plane A using the movement mechanism 43 .

[0077] The puncture system 1, puncture assisting device 3, body surface irradiating laser mechanism 4, and puncture navigation system 5 according to this embodiment make it possible to easily and accurately confirm the inclination angle of the puncture needle 2 that will puncture the subject M, thereby enabling precise puncture.

[0078] [Others] Next, a puncture system, a puncture assisting device, a body surface irradiating laser mechanism, and a puncture navigation system according to other embodiments will be described with reference to the accompanying drawings. Note that the same or similar members and parts as those in the first embodiment described above will be designated by the same reference numerals, and their description will be omitted. Only configurations different from those in the first embodiment will be described.

[0079] Second Embodiment Although a three-axis acceleration sensor is used in Figures 4 and 5, a two-axis acceleration sensor can also be used. In this case, the sensor unit consisting of the two-axis acceleration sensor can be implemented by installing the first sensor axis Ny in the direction of the puncture needle 2 and the second sensor axis Nx perpendicular to the puncture needle 2. In this case, the inclination angle indicator 33 of the puncture aid displays the inclination angle θ of the puncture needle 2 measured by the sensor unit 32. The puncture aid 3 is held so that the laser light R, which displays the laser vertical plane A including the puncture insertion point P and the puncture target point Q, irradiates the long side 34e of the fixing part 34, which is perpendicular to the length direction of the puncture needle 2, and the short side 34d of the fixing part 34, which extends in the direction along the length direction of the puncture needle 2, in Figure 3, and displays the inclination angle θ of the puncture aid 3 from the vertical axis in the vertical direction Nxy or the horizontal plane to the practitioner. In addition, a scale for the two-axis acceleration sensor may be provided so that the laser can be easily aligned with the long side portion 34e and the short side portion 34d onto which the laser light R is irradiated.

[0080] Third Embodiment Next, a puncture assisting tool 3B according to a third embodiment will be described in detail with reference to Figures 10 to 13. The method is to apply the laser vertical plane A irradiated by the laser irradiation unit 42 (see Figure 1) as described above to the puncture needle 2, but as shown in Figure 10, the puncture assisting tool 3B of this third embodiment applies a scale 380 on a vertical plane 38a (described later) to the CT cross section Ac as the laser vertical plane A.

[0081] The puncture assisting tool 3B has a vertical wall 38 fixed to a fixing part 34, the vertical wall 38 having a vertical surface 38a perpendicular to the puncture needle 2. The vertical wall 38 is fixed so that the vertical surface 38a is parallel to one long side of the fixing part 34. The fixing part 34 and the vertical wall 38 are formed in an L shape when viewed from the side in a plan view. The vertical wall 38 has a notch 38b that penetrates in the thickness direction and into which the puncture needle 2 can be inserted from the outer periphery of the vertical wall 38.

[0082] A scale 380 is provided on the vertical surface 38a of the vertical wall 38. The scale 380 has a surface-parallel scale 381 that is aligned so that the Nx axis shown in FIGS. 11 to 13 is parallel to the laser vertical plane A (CT cross section Ac), and a deviation angle scale 382 that is provided perpendicular to the surface-parallel scale 381. A plurality of the surface-parallel scales 381 are displayed at regular intervals on the vertical surface 38a. A plurality of the deviation angle scales 382 are displayed at regular intervals on the vertical surface 38a. The respective intervals between the surface-parallel scale 381 and the deviation angle scale 382 are set to arbitrary intervals.

[0083] The markings on the vertical surface 38a are not limited to the linear scale 380 shown in Fig. 10, but may be, for example, a square pattern arranged at a predetermined interval that functions as a scale, or may be a thick scale. Also, the intervals do not have to be equal, and may be intervals that take into account allowable error.

[0084] FIG. 11 is a perspective view showing the positional relationship between the puncture needle 2 and the puncture aid 3B during puncture. FIG. 12 is a view showing a vertical plane Ah parallel to the laser vertical plane A (CT cross section Ac) including the Nx axis in FIG. 11. FIG. 13 is a view showing the Ny-axis-Nz-axis plane in FIG. 11. The CT line laser Rc or laser light R from the laser irradiation unit 42 shown in FIGS. 11 to 13 is irradiated onto the scale 380 and the tip of the puncture needle 2. The Ny axis shown in FIGS. 11 to 13 is the axis (first sensor axis) in the length direction (puncture needle direction) of the puncture needle 2, the Nx axis is the first orthogonal axis (second sensor axis) perpendicular to the puncture needle direction axis (Ny axis) in the vertical plane Ah parallel to the laser vertical plane A, and the Nz axis is the second orthogonal axis (third sensor axis) perpendicular to both the puncture needle direction axis (Ny axis) and the first orthogonal axis (Nx axis). The puncture assisting tool 3B has a plane parallel scale 381 on the vertical surface 38a that identifies the parallelism between the Nx axis and the laser vertical surface A.

[0085] A three-axis acceleration sensor is used for the sensor unit 32 of the puncture aid 3B of the third embodiment. The sensor unit 32 has a first sensor axis Ny installed in the direction of the puncture needle 2, a second sensor axis Nx installed perpendicular to the puncture needle 2, and a third sensor axis Nz installed perpendicular to both the axes Nx and Ny. At this time, the inclination angle display unit 33 of the puncture aid 3B displays the inclination angle θ of the puncture needle 2 measured by the sensor unit 32. The puncture aid 3B holds the sensor unit 32 so that the CT line laser Rc or the laser light R from the laser irradiation unit 42, which displays the laser vertical plane A including the puncture insertion point P, is aligned with the plane-parallel scale 381 on the vertical surface 38a, and displays either or both of the inclination angle θ of the puncture needle 2 projected onto the laser vertical plane A and the vertical line, and the inclination angle between the laser vertical plane A and the puncture needle 2, on the inclination angle display unit 33.

[0086] For example, as shown in Fig. 12, the inclination angle θct of the puncture needle 2 projected onto a vertical plane Ah containing the Nx axis parallel to the laser vertical plane A and the vertical line can be calculated by equation (6): Nyz = √{(Ny) ２ + (Nz) ２} θct=arctan(Nx / Nyz) (6) As shown in FIG. 13 , the tilt angle θts between the laser vertical plane A and the puncture needle 2 can be calculated using equation (7). θts=arctan(Nz / Ny) (7) When a CT cross section Ac is used for the laser vertical plane A, the tilt angle θct coincides with the puncture needle angle in the CT image, and θts coincides with arctan(Ds / Ls), making it easy for practitioners using CT to understand. Here, Ls indicates the puncture needle length projected on the CT image, and Ds indicates the slice thickness of the CT image. The tilt angle of the puncture needle 2 projected on the laser vertical plane A relative to the vertical axis or horizontal plane and the tilt angle of the puncture needle 2 from the laser vertical plane A can be presented to the practitioner from the start of puncture and throughout the puncture. Furthermore, even when the puncture is performed away from the laser vertical plane A, the inclination angle of the puncture needle 2 projected onto the CT line laser vertical plane A relative to the vertical axis or horizontal plane and the inclination angle of the puncture needle 2 from the CT cross section can be presented to the practitioner from the start of the puncture throughout the puncture.

[0087] (Fourth embodiment) The puncture assisting tool 3 shown in Fig. 2 may be configured such that the inclination angle indicating unit 33 is separable from the sensor unit 32. The inclination angle indicating unit 33 is provided to be able to communicate with the sensor unit 32 via wire or wirelessly, and displays the inclination angle θ of the puncture needle 2 measured by the sensor unit 32 (if the indication method is sound or vibration, it will notify the user). In other words, the sensor unit 32 and the inclination angle indicating unit 33 are not limited to being provided as a single unit. In this case, it is possible to sterilize only the sensor unit 32, and use the inclination angle indicating unit 33 in a sterilized bag without sterilization.

[0088] The inclination angle presenting unit 33 has, for example, a display mode switching button or switch, and can switch the state of the sensor unit 32 attached to the puncture needle 2 and the displayed inclination angle θ. The inclination angle presenting unit 33 may also be configured so that the operation of the sensor unit 32 can be changed using the switching button or switch. The inclination angle presenting unit 33 may also be a tablet terminal or the like.

[0089] (Fifth embodiment) The puncture system 1B of the fifth embodiment shows an example of determining the puncture target point Q, the puncture insertion point P, and the inclination angle θ of the puncture needle 2 inside the body of the subject M by using, for example, a CT, MRI, and ultrasound probe without using a CT cross section Ac obtained by a CT cross section guide laser.

[0090] Fig. 14 is a diagram showing an overview of a puncture system 1B using an ultrasonic probe 60. As shown in Fig. 14, in the puncture system 1B, for example, an ultrasonic probe 60 with a level is brought into vertical contact with the body surface Ma of the subject M, the vertical depth D of the puncture target point Q from the body surface Ma is measured, and a target point mark Q1 is displayed on the body surface Ma directly above the puncture target point Q. Note that Fig. 14 shows an example in which the ultrasonic probe 60 is used, but the position of the puncture target point Q may also be measured by MRI instead of the ultrasonic probe 60.

[0091] 15 , the puncture insertion point P of the puncture needle 2 is determined based on the puncture target point Q, and an insertion point mark P1 is displayed on the body surface Ma. After that, a length measuring device 61 such as a vernier caliper is used to measure the distance of the straight line L between the target point mark Q1 and the insertion point mark P1, and also to measure the angle t of the straight line L with respect to the horizontal plane. Then, the puncture angle of the puncture needle 2 is calculated based on the angle t.

[0092] Thereafter, as shown in FIG. 16 , a laser vertical plane A including the puncture insertion point P and the puncture target point Q is displayed by the laser light R emitted by the laser irradiation unit 42, and by bringing the sensor unit 32 of the puncture needle 2 or the puncture assisting tool 3 attached to the puncture needle 2 into contact with this laser vertical plane A and aligning it, the inclination angle of the puncture needle 2 from the vertical axis or the horizontal plane can be presented to the practitioner by the inclination angle presentation unit 33 from the start of puncture through the duration of the puncture.

[0093] Sixth Embodiment Fig. 17 is a diagram showing the configuration of an adjustment mechanism 48 of a body surface irradiation laser mechanism 4A according to a sixth embodiment. As shown in Fig. 17, the body surface irradiation laser mechanism 4A of the sixth embodiment includes a laser vertical adjustment mechanism 48. That is, the laser irradiation unit 42 is configured by the adjustment mechanism 48 to be rotatable about an X-axis (first axis) along the linear direction of the horizontal frame 412 (feed screw 452) shown in Fig. 7, a Z-axis (second axis) perpendicular to the X-axis, and a Y-axis (third axis) forming the irradiation axis of the laser irradiation unit 42. Note that the X-axis is horizontal as described above and is disposed perpendicular to the body axis O of the patient M when viewed from above, as shown in Fig. 6.

[0094] The adjustment mechanism 48 includes a first housing case 481 that is movable along the X axis, a second housing case 482 that is housed within the first housing case 481, and a third housing case 483 that is housed in the second housing case 482 and has the laser irradiation unit 42 fixed thereto. The first housing case 481, the second housing case 482, and the third housing case 483 each have a rectangular parallelepiped shape. Note that the shape of each of the cases 481, 482, and 483 is not limited to a rectangular parallelepiped, and may be any shape such as a cube or a sphere.

[0095] The first casing 481 can be moved along a feed screw 452 extending in the X-axis direction (see FIG. 6 ) by operating the operation panel 47 or the like. The first casing 481 cannot rotate around the feed screw 452.

[0096] By operating the operation panel 47 or the like, the second housing case 482 rotates around the X axis (in the direction of arrow E1) relative to the first housing case 481 by a rotary drive unit such as a stepping motor. The first housing case 481 and the second housing case 482 are supported by a first pin 491 along the X axis so as to be relatively rotatable around the X axis (in the direction of arrow E1). For example, a configuration can be employed in which a first bearing (not shown) is provided on a wall surface of the first housing case 481 that is perpendicular to the X axis, and the first pin 491, which is rotatably supported relative to the first bearing, is fixed to the second housing case 482.

[0097] By operating the operation panel 47 or the like, the third housing case 483 rotates around the Z axis (in the direction of arrow E2) relative to the second housing case 482 by a rotary drive unit such as a stepping motor. The second housing case 482 and the third housing case 483 are supported by a second pin 492 along the Z axis so as to be relatively rotatable around the Z axis (in the direction of arrow E2). For example, a configuration can be employed in which a second bearing (not shown) is provided on a wall surface of the second housing case 482 perpendicular to the Z axis, and the second pin 492 rotatably supported relative to the second bearing is fixed to the third housing case 483.

[0098] The third housing case 483 has an acceleration sensor (not shown). The adjustment mechanism 48 can detect the direction of gravity from the output of the acceleration sensor provided in the third housing case 483 and automatically calibrate the laser vertical plane A to be vertical. This calibration is performed automatically.

[0099] The rotation directions of the second housing case 482 and the third housing case 483 may be reversed. That is, the second housing case 482 may rotate around the Z axis (direction E2) relative to the first housing case 481, and the third housing case 483 may rotate around the X axis (direction E1) relative to the second housing case 482.

[0100] It is also possible to reverse the mounting positions of the bearings and the pins 491 and 492.

[0101] In this way, in the body surface irradiation laser mechanism 4A of the sixth embodiment, even if the heights of the pair of left and right leg frames 411 of the holding member 41 as shown in FIG. 6 are different and the horizontal frame 412 (feed screw 452) is not horizontal, and the laser vertical plane A is not vertical, the posture of the laser irradiation unit 42 can be calibrated by operating the adjustment mechanism 48 so that the laser vertical plane A is vertical, by adjustment or automatic calibration using the operation panel 47.

[0102] Although the preferred embodiments of the present invention have been described above, the present invention is not limited to these embodiments, modifications, or examples. Additions, omissions, substitutions, and other modifications of the configuration are possible within the scope of the present invention. Furthermore, the present invention is not limited by the above description, but is limited only by the scope of the appended claims.

[0103] In this embodiment, the movable part 35 of the puncture assisting tool 3 is provided with the groove 31 (holding part), but the fixed part 34 may be provided with a holding part, or both the fixed part 34 and the movable part 35 may have holding parts for fixing the puncture needle 2. Furthermore, the configuration of the holding part that holds the puncture needle 2 in the sensor part 32 is not limited to the groove 31, and other holding structures may be used.

[0104] In the first embodiment described above, a configuration is shown as an example in which a body surface irradiation laser mechanism 4 that supports the laser irradiation unit 42 and a puncture navigation system 5 are provided, but it is also possible to omit either or both of the body surface irradiation laser mechanism 4 and the puncture navigation system 5.

[0105] The puncture system, puncture assisting device, body surface irradiating laser mechanism, and puncture navigation system according to the present invention can easily and accurately confirm the inclination angle of the puncture needle that will puncture the subject, and can be applied to the puncture system, puncture assisting device, body surface irradiating laser mechanism, and puncture navigation system that can perform puncture with high precision.

[0106] REFERENCE SIGNS LIST 1, 1B Puncture system 2 Puncture needle 3, 3B Puncture assisting tool 4 Body surface irradiating laser mechanism 5 Puncture navigation system 31 Groove section (holding section) 32 Sensor section 33 Inclination angle indicating section 34 Fixed section 35 Movable section 41 Holding member 42 Laser irradiating section 43 Movement mechanism 45 Linear movement mechanism 46 Rotational movement mechanism A Laser vertical plane Ac CT cross section Ah Vertical plane M Patient Ma Body surface P Puncture insertion point Q Puncture target point R Laser light

Claims

1. A puncture assisting device comprising a puncture needle for puncturing a subject, a holding part for holding the puncture needle, and a sensor part capable of measuring an angle of the puncture needle held by the holding part with respect to a vertical axis or a horizontal plane, a body surface irradiation laser mechanism comprising a laser irradiation part for irradiating the subject with a line laser, and a moving mechanism for moving the laser irradiation part vertically downward to a position of a laser vertical plane including a target point and a puncture point in the body of the subject, and comprising the body surface irradiation laser mechanism irradiates the line laser on the laser vertical plane, while arranging the puncture needle in the laser vertical plane, punctures the puncture needle based on the angle of the puncture assisting device, a puncture system.

2. The holding part of the puncture assisting device comprises a fixing part, a movable part, and a fixing mechanism for holding and fixing the puncture needle with the fixing part and the movable part. The puncture system according to claim 1.

3. The fixing part has a vertical plane perpendicular to the puncture needle when the puncture needle is fixed, and a scale is provided on the vertical plane. The puncture system according to claim 2.

4. The scale on the vertical plane has a plane parallel scale parallel to the vertical plane, and a deviation angle scale provided perpendicular to the plane parallel scale. The puncture system according to claim 3.

5. The moving mechanism has a rotational moving mechanism for rotatably holding the laser irradiation part. The puncture system according to claim 1.

6. The moving mechanism has a linear moving mechanism for movably holding the laser irradiation part in a linear direction. The puncture system according to claim 1.

7. The laser irradiation part is rotatably provided around each of an axis along the linear direction, an axis perpendicular to the first axis, and an axis forming an irradiation axis of the laser irradiation part. The puncture system according to claim 6.

8. A puncture navigation system comprising a calculation unit for determining an irradiation position of the line laser and a puncture angle of the puncture needle from the target point and the puncture point in the body of the subject, and a control unit for controlling the laser irradiation part. The puncture system according to claim 1.

9. The calculation unit determines a puncture angle and a puncture length from the target point and the puncture point, and calculates an angle from the body axis of the subject with respect to the laser vertical plane. The puncture system according to claim 8.

10. The puncture system according to claim 1, having at least any one of a CT, an MRI, and an ultrasonic probe that specifies the target point in the body of the subject.