Puncture system, puncture aid, body surface irradiation laser mechanism, and puncture navigation system

Abstract

A puncture system (1) is provided with: a puncture aid (3) that has a holding part that is attached to and detached from a puncture needle (2) that punctures on the body surface of a subject (M) using a line (H) formed on the body surface of the subject (M) using a vertical plane that includes a target point (Q) and a puncture point (P) in the body of the subject (M); a sensor unit (32) capable of measuring the angle of the held puncture needle with respect to the vertical axis or the horizontal plane; a body surface laser irradiation mechanism (4) having a laser irradiation unit (42) for irradiating laser light to a vertical plane along a line (H) formed on the body surface of the subject, and a movement mechanism for moving the laser irradiation unit; and a puncture navigation system having a calculation unit for determining the irradiation position of the laser beam and the penetration angle of the puncture needle (2) on the basis of the target point (Q) and the penetration point in the body of the subject (M), and a control unit for controlling the laser beam irradiation unit.

Description

Technical Field

[0001] The present invention relates to a puncture assist device, a body surface laser irradiation mechanism, a puncture navigation system, and a puncture system suitable for performing biopsy, drainage, radiofrequency ablation therapy, cryo therapy, etc., which puncture a needle into a living tissue of the body by puncture under CT guidance, ultrasound guidance, MRI guidance, etc.

[0002] This application claims the priority of PCT / JP2023 / 002678 filed on January 27, 2023, and incorporates its content herein. Background Art

[0003] Conventionally, when inserting (piercing) a puncture needle into a puncture target point of a subject determined within a CT cross-section based on computed tomography (CT) for puncture, the puncture needle is arranged within the CT cross-section by irradiating a laser on the back surface of the traveling direction of the puncture needle (for example, refer to Patent Documents 1 and 2).

[0004] In addition, Patent Document 1 describes a technique for determining the insertion depth, lateral insertion angle, and cephalocaudal insertion angle of a needle inserted into the body from an insertion entry point to a target within the body, and irradiating the laser on the insertion entry point.

[0005] In addition, when an operator inserts a puncture needle into a subject, the angle of the puncture needle is prompted (for example, refer to Patent Documents 3 to 5).

[0006] In addition, there is also known a technique for detecting a target organ to be punctured by an ultrasonic probe, using the line laser from the ultrasonic probe for guidance, and inserting a puncture needle (for example, refer to Patent Document 6).

[0007] In addition, there is also known a technique for performing puncture by aligning the laser line generated by a CT scanner with the visible laser line of a line generation laser installed in a cover body integrally mounted with a line generation laser and a puncture needle (for example, refer to Patent Document 7).

[0008] Furthermore, there is known a technique for using the cross light from two laser planes to mark the guiding path of medical instruments such as a puncture needle and a catheter (for example, refer to Patent Document 8).

[0009] Prior Art Documents

[0010] Patent Documents

[0011] Patent Document 1: Japanese Patent Application Laid-Open No. 2002-511784

[0012] Patent Document 2: Japanese Patent Application Laid-Open No. 2000-070272

[0013] Patent Document 3: Japanese Patent No. 2009-523508

[0014] Patent Document 4: Chinese Patent Publication No. 1939234

[0015] Patent Document 5: International Publication No. 2017 / 070124

[0016] Patent Document 6: US Patent Application Publication No. 2010 / 0030082

[0017] Patent Document 7: US Patent Application Publication No. 2016 / 0296179

[0018] Patent Document 8: US Patent No. 5782842 SUMMARY OF THE INVENTION

[0019] PROBLEMS TO BE SOLVED BY THE INVENTION

[0020] In the device for irradiating a laser on the back side of the traveling direction of a puncture needle as described in Patent Documents 1 and 2, the laser is irradiated at one point from the entry point toward the target point, so it is very sensitive to position deviation. In particular, when performing puncture with a puncture needle, movement of the subject cannot be avoided, and it is difficult to perform laser re-correction at this time.

[0021] In addition, in order to irradiate a laser on the back side of the traveling direction of a puncture needle, a special puncture needle formed in this way on the back side is required. There are problems such as being unable to use an ablation needle having a cable, a liquid delivery tube, etc. provided at the rear end of the puncture needle, and a puncture needle used in cryotherapy.

[0022] In addition, since it is necessary to irradiate the laser from above, depending on the angle, it is sometimes difficult to irradiate the laser, the puncture range is limited, or the device becomes large-sized.

[0023] In addition, in Patent Document 1, the insertion depth of the needle, the lateral insertion angle, and the cephalocaudal insertion angle are determined, and the laser is irradiated toward the insertion entry point, which causes difficulties such as requiring the subject to be in an accurate position relative to the laser and being unable to perform correction when the subject moves.

[0024] In addition, in the instrument for indicating the angle of a puncture needle as described in Patent Documents 3 to 5, it is not guided by a laser, but is punctured at a specified angle by repeatedly taking images such as CT. Therefore, during CT imaging, the operator needs to continuously hold the instrument holding the puncture needle, so a large amount of X-ray radiation cannot be avoided. In addition, since images are repeatedly taken by CT or the like many times, not only the operator but also the subject cannot avoid being exposed to a large amount of X-ray radiation.

[0025] In addition, although the accurate puncture angle of the puncture needle is prompted, during the operation, sometimes the puncture needle is moved by the layer thickness of the CT image along the CT slice plane while maintaining the insertion angle, but an operation to cope with such a situation cannot be performed.

[0026] In Patent Document 6, a line laser is used as a guide for inserting the puncture needle. However, since it is emitted from the ultrasonic probe, it is impossible to avoid hand tremors, etc., and it is very difficult to accurately maintain the line laser guide. Therefore, it is very difficult to perform an accurate puncture. In addition, it is very difficult for the operator inserting the puncture needle to hold the ultrasonic probe and perform the puncture while displaying the correct line laser guide, and an assistant is required. In addition, since the line laser is irradiated from the ultrasonic probe, the degree of freedom of the laser is extremely low, and it is difficult to perform appropriate laser guidance.

[0027] Furthermore, the line laser from the ultrasonic probe pressed against the body surface of the subject is easily affected by the unconscious body movement of the subject, and the position of the line laser is likely to shift, making it extremely difficult to perform a safe puncture.

[0028] In addition, in Patent Document 7, the laser line generated by the CT scanner is aligned with the visible laser line of the line generator mounted on the cover body for puncture. However, the operator needs to hold the cover body by hand while operating, so it is difficult to keep the visible laser line in the same position as the laser generated by the CT scanner. In addition, since the line generator and the puncture needle are integrated, the burden on the operator is large and the usability is poor.

[0029] In addition, in Patent Document 8, the puncture needle is guided along the puncture path formed by the cross light from two laser planes. However, it is necessary to accurately form the two intersecting laser planes at the puncture position of the subject. Therefore, there are problems such as the device being prone to large size and the operator needing to perform the operation in a form that does not block the two laser beams. In addition, there is also a problem of being very sensitive to the movement of the subject.

[0030] The present invention has been completed in view of the above problems, and an object thereof is to provide a puncture system, a puncture assist device, a body surface irradiation laser mechanism, and a puncture navigation system that impose a small burden on the operator, can easily and accurately confirm the inclination angle of the puncture needle puncturing the subject, and can perform high-precision puncture.

[0031] Means for Solving the Problems

[0032] The puncture system of the present invention is characterized by having: a puncture assisting device having a holding portion and a sensor portion, the holding portion being detachable from and attachable to a puncture needle, the puncture needle being punctured along a line formed on the body surface of the subject by a vertical plane including a target point and a puncture point in the body of the subject, and the sensor portion being capable of measuring the angle of the held puncture needle with respect to the vertical axis or the horizontal plane; a body surface laser irradiation mechanism having a laser irradiation portion and a moving mechanism, the laser irradiation portion irradiating a laser along the line formed on the body surface of the subject to the vertical plane, and the moving mechanism moving the laser irradiation portion; and a puncture navigation system having a calculation portion and a control portion, the calculation portion determining the irradiation position of the laser and the puncture angle of the puncture needle based on the target point and the puncture point in the body of the subject, and the control portion controlling the laser irradiation portion.

[0033] The puncture assisting device of the present invention is characterized by being detachable from and attachable to a puncture needle, the puncture needle being punctured along a line formed on the body surface of the subject by a vertical plane including a target point and a puncture point in the body of the subject, and the puncture assisting device includes: a holding portion having a fixing portion for holding the puncture needle, a movable portion, and a fixing mechanism for holding and fixing the puncture needle by the fixing portion and the movable portion; a sensor portion capable of measuring the angle of the held puncture needle with respect to the vertical axis or the horizontal plane; and a prompting portion for prompting the angle, the fixing portion having a vertical plane perpendicular to the puncture needle when the puncture needle is fixed, and a scale being provided on the vertical plane.

[0034] The body surface laser irradiation mechanism of the present invention is characterized by having: a holding member; a laser irradiation portion installed via the holding member and irradiating a laser along the line formed on the body surface of the subject by a vertical plane including a target point and a puncture point in the body of the subject to the vertical plane; and a moving mechanism for moving the laser irradiation portion provided on the holding member.

[0035] The puncture navigation system of the present invention is characterized by having: a calculation portion that determines a puncture angle and a puncture length based on a target point and a puncture point in the body of the subject determined by at least any one of a CT, an MRI, and an ultrasonic probe, and calculates an angle between a plane including the target point and the puncture point and the body axis of the subject; and a control portion that controls the laser irradiation portion that irradiates a laser along the line formed on the body surface of the subject to the vertical plane based on the angle with respect to the body axis of the subject calculated by the calculation portion.

[0036] Advantages of the Invention

[0037] According to the puncture system, the puncture assisting device, the body surface laser irradiation mechanism, and the puncture navigation system of various aspects of the present invention, the burden on the operator is small, the inclination angle of the puncture needle puncturing the subject can be easily and accurately confirmed, and high-precision puncture can be performed. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a perspective view showing an overall outline of the puncture system according to the first embodiment.

[0039] Figure 2 is a perspective view showing a puncture assisting device holding a puncture needle.

[0040] Figure 3 is a perspective view showing a specific structure of the puncture assisting device.

[0041] Figure 4 is a perspective view showing a positional relationship between the puncture needle and the puncture assisting device during puncture.

[0042] Figure 5 is Figure 4 a side view of.

[0043] Figure 6 is a perspective view showing an overall structure of a body surface irradiating laser mechanism.

[0044] Figure 7 is showing Figure 6 a perspective view of a structure of a moving mechanism of the body surface irradiating laser mechanism shown in.

[0045] Figure 8 is a top view for explaining a calibration mechanism for making the coordinates of the puncture navigation system coincide with the coordinates of the CT device.

[0046] Figure 9 is a top view for explaining the puncture navigation system.

[0047] Figure 10 is a perspective view showing a specific structure of the puncture assisting device according to the third embodiment.

[0048] Figure 11 is a perspective view showing a positional relationship between the puncture needle and the puncture assisting device during puncture.

[0049] Figure 12 is showing Figure 11 a view of a vertical plane including the Nx axis in.

[0050] Figure 13 is showing Figure 11 a view of the Ny axis - Nz axis plane in.

[0051] Figure 14 is a view showing an outline of a puncture system using an ultrasonic probe in the puncture system according to the fifth embodiment.

[0052] Figure 15 is a view showing a structure of the puncture system according to the fifth embodiment.

[0053] Figure 16 This is a diagram showing the structure of the puncture system according to the fifth embodiment.

[0054] Figure 17 This is a diagram showing the structure of the adjustment mechanism of the body surface irradiation laser mechanism according to the sixth embodiment. Specific Embodiments

[0055] Refer to Figures 1 to 9 An example of the puncture system, puncture assistance device, body surface irradiation laser mechanism, and puncture navigation system according to the embodiments of the present invention will be described.

[0056] In addition, in this specification, there are expressions such as puncturing along a line and aligning positions, but these are not necessarily limited to being exactly the same, and can be understood to include the range of errors allowed in general surgeries.

[0057] (First Embodiment)

[0058] [Puncture System]

[0059] Figure 1 This is a perspective view showing the puncture system 1 of this embodiment, showing the state inside the gantry of a computed tomography (CT) device (not shown). As Figure 1 shown, the puncture system 1 is used to puncture the puncture needle 2 into the body of the subject M during puncture under CT guidance, puncture under ultrasonic guidance, puncture under MRI guidance, etc. In this first embodiment, an example of puncture under CT guidance is shown. That is, the puncture system 1 uses the surface marking line H to be displayed on the body surface Ma of the subject M by the body surface irradiation laser mechanism 4 for the surface including the puncture target point Q and the puncture insertion point P in the body of the subject M pre-determined by CT, so as to puncture the puncture needle 2 along the surface marking line H with high precision. In addition, the body surface Ma can be the chest side, the abdominal side, or the back side. Furthermore, Figure 1 O in this represents the body axis.

[0060] In addition, in the present invention, the body axis O refers to the normal body axis of the subject M analyzed from the subject M obtained by imaging (an axis that is approximately symmetric with respect to this axis, that is, the long axis from the tail to the head). Usually, the subject M is placed in the center of the operating table 40. In addition, since the movement of the subject M can be excluded, the central axis in the long axis direction of the operating table 40 can also be set as the body axis O of the subject. In addition, the body axis O is not limited to the above axis, and can also be a reference fixed axis (reference axis) set as a reference during the operation of the subject M, etc.

[0061] The puncture system 1 has a puncture assisting device 3 that is detachably mounted relative to the puncture needle 2, a body surface irradiation laser mechanism 4 that irradiates a laser beam R toward the body surface Ma of the subject M (see Figure 6 ), and a puncture navigation system 5 (see Figure 1 ) not shown in Figure 8 and Figure 9 ) that determines the position of the laser beam R.

[0062] As described above, the puncture system 1 uses the puncture target point Q in the body of the subject M determined by CT. The method of determining the puncture target point Q using CT will be described later in the puncture navigation system 5.

[0063] [Puncture Assisting Device]

[0064] As Figure 2 and Figure 3 shown, the puncture assisting device 3 is configured to be mounted on the puncture needle 2 and to indicate to the puncture operator the inclination angle (inclination angle θ) of the puncture needle 2 with respect to the vertical axis or the horizontal plane. The puncture assisting device 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 with respect to the vertical axis or the horizontal plane, and an inclination angle indication portion 33 that indicates the inclination angle θ of the puncture needle 2. Since the puncture assisting device 3 is used by being mounted on the puncture needle 2, it is preferably sterilized during use.

[0065] As Figure 3 shown, the sensor portion 32 of the puncture assisting device 3 has a fixing portion 34 and a movable portion 35 that is movably fixed to the fixing portion 34.

[0066] In addition, an example of fixing the puncture needle 2 by the fixing portion 34 and the movable portion 35 of the puncture assisting device 3 is shown below, but the fixing method of the puncture assisting device 3 for the puncture needle 2 is not limited to this. The puncture needle 2 can also be fixed by various methods such as sticking the puncture needle 2 to a specified position of the puncture assisting device 3. In addition, the position of fixing the puncture assisting device 3 to the puncture needle 2 is not limited to the puncture needle 2, and it can also be fixed to a member extending from the puncture needle 2.

[0067] The fixing part 34 is formed in a plate shape that is rectangular when viewed from above, and a three-axis acceleration sensor (not shown) is built therein. An inclination angle indication part 33 is provided on the outer surface 34a of the fixing part 34 opposite to the one surface (inner surface 34b) where the movable part 35 is provided. The short side part 34d of the fixing part 34 extends in the direction along the length direction of the puncture needle 2 held by the groove part 31 when viewed from above. The long side part 34e of the fixing part 34 extends in the direction orthogonal to the groove part 31 when viewed from above. The groove part 31 is formed such that when the puncture needle is fixed, the sensor axis of the acceleration sensor coincides with the length direction of the puncture needle 2. A movable part rotation axis 36 that supports the movable part 35 so as to be rotatable is provided at the middle part in the long side direction on the inner surface 34b of the fixing part 34. The axial direction of the movable part rotation axis 36 is along the direction of the short side part 34d.

[0068] As Figure 3 shown, the movable part 35 is formed in a substantially plate shape that is rectangular when viewed from above. The movable part 35 is arranged such that the inner surface 35b faces the inner surface 34b of the fixing part 34. The planar shape of the movable part 35 is substantially the same as that of the fixing part 34. That is, the short side part 35d of the movable part 35 extends in the direction along the length direction of the puncture needle 2 held by the groove part 31 when viewed from above. The long side part 35e of the movable part 35 extends in the direction along the long side part 34e of the fixing part 34 when viewed from above.

[0069] The rotation support part 35c at the middle part in the long side direction on the inner surface 35b of the movable part 35 is rotatably supported and connected to the movable part rotation axis 36 provided on the fixing part 34. The inner surface 35b of the movable part 35 has a clamping surface 35f on the tip side and a base end surface 35g on the base end side with respect to the rotation support part 35c. The clamping surface 35f is inclined so as to gradually approach the outer surface 35a from the rotation support part 35c toward the tip side. The base end surface 35g is inclined so as to gradually approach the outer surface 35a from the rotation support part 35c toward the base end side.

[0070] In addition, the above-mentioned groove part 31 having a V-shaped cross section is formed on the clamping surface 35f of the movable part 35.

[0071] In addition, when the long side part 34e of the puncture assisting device 3 is also made to coincide with the laser plumb plane A described later, when forming the scale 380 described later, when the puncture needle 2 is locked, the length direction of the puncture needle 2 is formed perpendicular to the surface of the long side part 34e of the fixing part 34 and the surface of the long side part 35e of the movable part 35. At this time, by locking the puncture needle 2 along the groove direction of the groove part 31, the orientation of the length direction of the puncture needle 2 is determined to be in the direction orthogonal to the long side part 35e of the movable part 35. That is, the orientation of the puncture needle 2 is determined to be in the direction orthogonal to the long side part 34e of the fixing part 34.

[0072] In addition, preferably, the groove portion 31, the fixed portion 34, and the movable portion 35 are configured such 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.

[0073] The movable portion 35 is rotatable about the movable portion rotation axis 36 in a swinging manner. The tip portion on the side of the groove portion 31 in the movable portion 35 is biased in a direction approaching the inner surface 34b of the fixed portion 34 by the biasing force of a biasing member such as a spring member (not shown). By pressing the proximal end side of the movable portion 35 in a direction approaching the fixed portion 34 against the biasing force of the above biasing member, the proximal end surface 35g approaches the inner surface 34b of the fixed portion 34, and the clamping surface 35f moves away from the inner surface 34b of the fixed portion 34. In the groove portion 31, it is possible to maintain a state in which the puncture needle 2 is clamped between the groove portion 31 and the inner surface 34b of the fixed portion 34. The groove portion 31 is set to have a groove shape and a groove depth that can press the puncture needle 2 when the puncture needle 2 is clamped between the groove portion 31 and the inner surface 34b of the fixed portion 34. Therefore, the groove shape of the groove portion 31 is not limited to a V-shaped groove as in the present embodiment.

[0074] In this way, the movable portion rotation axis 36, the biasing member, and the groove portion 31 in the groove portion 31 correspond to a locking mechanism that fixes the puncture needle 2 in a clamped manner.

[0075] As Figure 2 shown, the inclination angle prompting portion 33 is electrically connected to an acceleration sensor housed in the sensor portion 32, and numerically (digitally) displays, for example, the inclination angle θ of the puncture needle 2. The operator using the puncture assistance device 3 can visually recognize the angle of the puncture needle 2 held by the puncture assistance device 3 by looking at the inclination angle prompting portion 33 of the fixed portion 34.

[0076] In addition, the display form of the inclination angle θ of the inclination angle prompting portion 33 is not limited to digital display, and may also be a display such as a mark or color that allows the operator to visually recognize the inclination angle θ. In addition, it may be sound, vibration, etc. In addition, in digital display, it may be only the display of the numerical value of the inclination angle θ, or it may be a display with the unit "°" and a mark as in the present embodiment. In addition, the deviation from the set angle may be displayed. For example, if the deviation from the set angle is equal to or greater than a specified threshold value, a special display (flashing, sound, vibration, etc.) may be performed.

[0077] In addition, the display position of the inclination angle prompting portion 33 is not limited to the outer surface 34a of the fixed portion 34. For example, the inclination angle prompting portion 33 may be provided on the outer surface 35a of the movable portion 35, or the inclination angle prompting portion 33 may be provided on both the outer surface 34a of the fixed portion 34 and the outer surface 35a of the movable portion 35.

[0078] As the sensor built into the fixing part 34, a triaxial acceleration sensor is taken as an example. In the sensor part 32, it is set to measure the tilt angle θ with respect to the groove direction of the groove part 31, that is, the vertical direction or the horizontal direction (the vertical direction in this embodiment) of the puncture needle 2 held by the groove part 31 of the puncture assist device 3. In addition, if a triaxial can be detected, it is not limited to an acceleration sensor, and any sensor can be used.

[0079] In addition, the sensor housed in the sensor part 32 is not limited to a triaxial acceleration sensor. For example, a biaxial acceleration sensor can also be used. However, in the case of a biaxial acceleration sensor, different requirements from those of this embodiment need to be met, so it will be described in another embodiment (the second embodiment) described later.

[0080] Figure 4 It is a perspective view showing the positional relationship between the puncture needle 2 and the puncture assist device 3 during puncture. Figure 5 is Figure 4 a side view of Figure 4 and Figure 5 The laser beam R shown in and is irradiated from the body surface to the laser irradiation part 42 of the laser mechanism 4 described later. Figure 4 and Figure 5 The Ny axis shown in and is the axis (the first sensor axis) in the length direction (the puncture needle direction) of the puncture needle 2, the Nx axis is the first orthogonal axis (the second sensor axis) orthogonal to the axis (the Ny axis) in the puncture needle direction, and the Nz axis is the second orthogonal axis (the third sensor axis) orthogonal to both the axis (the Ny axis) in the puncture needle direction and the first orthogonal axis (the Nx axis). Here, Figure 4 and Figure 5 The symbol H in and represents the body surface marking line obtained by orthogonally projecting the straight line connecting the puncture insertion point P and the puncture target point Q onto the body surface.

[0081] The first sensor axis Ny of the sensor part 32 is set in the puncture needle direction of the puncture needle 2, the second sensor axis Nx is set in the direction perpendicular to the puncture needle 2, and the third sensor axis Nz is set in the direction perpendicular to both the axis Nx and the axis Ny. And at the tilt angle prompting part 33 of the puncture assist device 3, the tilt angle θ of the puncture needle 2 with respect to the vertical axis or the horizontal plane of the vertical direction Nxyz is prompted to the operator in such a way that the laser beam R showing the laser vertical plane A including the puncture insertion point P and the puncture target point Q irradiates the puncture needle 2 while holding the puncture needle 2 together with the puncture assist device 3.

[0082] For example, as Figure 5As shown, 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 in the laser plumb plane A with respect to the horizontal plane is calculated by the formula 90 - θvt, and is displayed on the inclination angle prompt section 33.

[0083] After determining the puncture route such that the puncture needle 2 does not damage important organs, etc. by the puncture navigation system 5 (refer to Figure 8 and Figure 9 ), a laser beam R is irradiated along the puncture route including the puncture target point Q and the puncture insertion point P to display the body surface marking line H (the line formed on the body surface Ma of the subject M by the plane including the puncture target point Q and the puncture insertion point P inside the body of the subject M). The operator aligns the tip 2a of the puncture needle 2 with the puncture insertion point P, and further aligns the longitudinal direction of the puncture needle 2 with the laser beam R (in a state where the line light formed by the laser beam R is displayed in the puncture needle direction of the puncture needle 2), and holds and punctures in such a way that the value of the inclination angle prompt section 33 is the set angle, so that the puncture target point Q can be safely reached.

[0084] [Body surface laser irradiation mechanism]

[0085] As Figure 6 shown, the body surface laser irradiation mechanism 4 includes a holding member 41 provided on the operating table 40 that supports the subject M, a laser irradiation unit 42 that is installed via the holding member 41 and irradiates a laser beam R that forms a line (body surface marking line H) on the body surface Ma of the subject M by the laser plumb plane A 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 movably arranges the laser irradiation unit 42 on the holding member 41.

[0086] The laser irradiation unit 42 forms the laser plumb plane A by irradiating a planar laser beam R downward. The laser irradiation unit 42 is provided above the subject M lying on the operating table 40. In the present embodiment, the operating table 40 is preferably arranged to be able to move forward and backward inside a CT gantry (not shown) or an MRI gantry, but if the puncture target point Q is determined by ultrasonic waves or the like, such an arrangement is not necessary. Preferably, the laser irradiation unit 42 is provided or moved to the side opposite to the operator and the CT gantry, so as to be in a position that does not interfere with the puncture operation of the operator. In addition, according to the situation, it can also be provided or moved to the same side as the operator.

[0087] As an example, the holding member 41 includes foot frames 411 that are erected from the left and right end portions 40a and 40b of the operating table 40 and are detachably provided, and a horizontal frame 412 that connects the upper ends of the foot frames 411 to each other. The holding member 41 removes the foot frames 411 from the operating table 40 when the subject M gets on and off the operating table 40, and installs the foot frames 411 after the subject M gets on the operating table 40. In addition, the position where the holding member 41 is installed on the operating table 40 can be arbitrarily changed.

[0088] In addition, in Figure 6 , the foot frames 411 are provided on both sides so as to straddle the subject M for the body surface irradiation laser mechanism 4, but they may also be provided only on one side, and the body surface irradiation laser mechanism 4 is held by the foot frames 411 on one side. In this case, the foot frame 411 can also be used as a base axis to enable the body surface irradiation laser mechanism 4 to rotate. Before the subject M gets on the operating table 40, it is shaped to face the body axis O direction, and after the subject M gets on the operating table 40, it is rotated and arranged so that the body surface irradiation laser mechanism 4 is located above a predetermined position of the subject M, and is fixed at this position using a fixing mechanism (not shown).

[0089] Auxiliary feet 413 that branch downward are provided on the foot frames 411. The foot frames 411 are provided so as to be telescopic, and the length can be adjusted. That is, the foot frame 411 includes a large-diameter tube 411A and a telescopic small-diameter tube 411B that is inserted into the upper end of the large-diameter tube 411A. By adjusting to an arbitrary length and fixing, the height of the horizontal frame 412 can be arbitrarily set. The horizontal frame 412 is provided so as to be telescopic, and the length can be adjusted. That is, as Figure 7 shown, the horizontal frame 412 includes a large-diameter tube 412A and telescopic small-diameter tubes 412B that are inserted into both ends of the large-diameter tube 412A. By adjusting to an arbitrary length and fixing, the length can be set to match the width dimension of the operating table 40. In addition, the cross-sectional shapes of the foot frames 411 and the horizontal frame 412 can also be a circular cross-section or a rectangular cross-section, and are not particularly limited.

[0090] The moving mechanism 43 includes a rotational moving mechanism 46 that holds the laser irradiation unit 42 so as to be rotatable about a vertical axis, and a linear moving mechanism 45 that holds the laser irradiation unit 42 so as to be movable in a linear direction along the horizontal frame 412.

[0091] As Figure 7As shown in the figure, the moving mechanism 43 includes a first fixed housing 441 and a second fixed housing 442 that are immovably arranged on both sides in the longitudinal direction of the horizontal frame 412, and a moving housing 443 that is arranged so as to be movable between the first fixed housing 441 and the second fixed housing 442 along the horizontal frame 412 in the longitudinal direction of the horizontal frame 412. A laser irradiation unit 42 is housed in the moving housing 443 so as to be able to irradiate a laser beam R downward.

[0092] Next, the linear moving mechanism 45 will be described. A linear drive unit 451 such as a stepping motor that rotates about a horizontal axis is housed in the first fixed housing 441, and is connected to a feed screw 452 that transmits the rotation of the linear drive unit 451. The feed screw 452 extends parallel to the extending direction of the horizontal frame 412, and the front end 452a of the screw is supported by a bearing 453 housed in the second fixed housing 442 so as to be rotatable.

[0093] A feed screw nut 454 that engages with the feed screw 452 and moves along the feed screw 452, and a fitting sliding cylinder 455 that fits and slides with the horizontal frame 412 are housed in the moving housing 443. The feed screw nut 454 moves the moving housing 443 along the horizontal frame 412 together with the laser irradiation unit 42. Thereby, the laser irradiation unit 42 moves in a direction perpendicular to the body axis O of the subject M.

[0094] The rotational moving mechanism 46 will be described. A rotational drive unit 461 such as a stepping motor that rotates about a vertical axis is housed in the moving housing 443. The rotational moving mechanism 46 is configured such that a first pulley 462 is shaft-supported by the rotational drive unit 461, a second pulley 463 is shaft-supported by the laser irradiation unit 42, and the first pulley 462 and the second pulley 463 are connected by a connecting belt 464, thereby transmitting the rotation of the rotational drive unit 461 to the laser irradiation unit 42.

[0095] As Figure 6 shown, the horizontal movement operation and rotational operation of the laser irradiation unit 42 in the body surface irradiation laser mechanism 4, and the switching operation of the laser beam R are controlled in a wired or wireless manner using the operation panel 47.

[0096] In addition, the overall size of the body surface irradiation laser mechanism 4 is preferably such that when the operating table 40 is moved in the state where it is set on the operating table 40, the whole of the body surface irradiation laser mechanism 4 can pass without interfering with the gantry of a CT or the like.

[0097] Each structure, dimension, shape, etc. of the holding member 41, the linear moving mechanism 45, and the rotational moving mechanism 46 in the body surface irradiation laser mechanism 4 Figure 6 and Figure 7An example is shown and can be appropriately changed. For example, the linear drive unit 451 and the rotational drive unit 461 are not limited to stepper motors and can also be general motors or other components capable of mechanical drive. In addition, the driving force transmission unit is not limited to pulleys and belts and can also be chains, gears, direct drive, or other units for transmitting driving force.

[0098] In addition, the body surface irradiation laser mechanism 4 is preferably separately provided from the line laser provided in the conventional gantry as shown in Figure 6 and Figure 7 However, it is not limited to this. The body axis laser or the line laser provided in the gantry can also have the function of the laser irradiation unit in the form of a moving mechanism or a rotational moving mechanism. The body axis laser provided in a general gantry is fixed with the laser plane as the body axis O, and the line laser is fixed with the line laser plane perpendicular to the body axis O. The body axis laser or the line laser can also be made movable and rotationally movable and used as the body surface irradiation laser mechanism of the present invention.

[0099] In addition, the body axis laser and the line laser provided in the conventional gantry are used as the reference of the body axis O and the reference for CT imaging. From the viewpoints of accuracy, versatility, etc., it is preferably in the form of using the body surface irradiation laser mechanism 4 as shown in Figure 6 and Figure 7 In addition, in the present embodiment, the laser irradiation unit 42 preferably forms a laser vertical plane A that irradiates the laser vertically as a laser plane that simplifies calculations, is clear, and is easily intuitively grasped by the operator.

[0100] However, depending on the body surface marking line H of the subject M, the laser irradiation unit 42 is not limited to irradiating the laser vertically and can also form a laser plane with a specified angle.

[0101] In addition, as shown in

[0102] etc., the linear movement mechanism 45 moves in a direction orthogonal to the body axis O, but it can also move in a direction other than the direction orthogonal to the body axis O, and such a structure can also be adopted. Figure 6 etc.

[0103] [Puncture Navigation System]

[0104] The puncture navigation system 5 determines the puncture target point Q in the body of the subject M based on CT-MPR (Multi Planar Reconstruction) images, MRI images, and ultrasonic images. As shown in Figure 8 and Figure 9As shown, the insertion route of the puncture needle 2 that can reach the puncture target point Q and avoid important organs and blood vessels is obtained. In the case where there are multiple insertion routes, there is a calculation unit (not shown), which selects the safest insertion route with a short insertion length to determine the puncture insertion point P, determines the plane including the puncture target point Q and the puncture insertion point P, and the puncture insertion point P, insertion angle, and insertion length at which the puncture needle 2 is inserted, and calculates the angle between the body axis O and the plane. In addition, the insertion angle, insertion length, and the angle between the body axis O and the plane can also be determined by reading from the CT-MPR image. Furthermore, the allowable insertion angle error, insertion length error, etc. for each insertion route can be calculated, and based on a specified determination criterion, the degree of safety of the insertion can be calculated. The puncture navigation system 5 also has a control unit (not shown), which, based on the determination and calculation of the calculation unit, uses the moving mechanism 43 to move the laser irradiation unit 42 in the laser vertical plane A as shown in Figure 6 The calculation unit and the control unit are composed of a known electronic circuit unit such as a CPU (not shown), a storage unit composed of storage elements such as ROM and RAM, and an interface circuit. 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), and automatically sets the rotation angle θh and the X-axis direction position Xj of the laser irradiation unit 42 through the control unit.

[0105] As Figure 8 shown, in the method of correcting the laser irradiation unit 42, first, the rotation angle of the laser beam R of the laser irradiation unit 42 is set to 0 degrees (perpendicular to the CT line laser Rc, in other words, along the direction of the body axis O), for example, aligned with the body axis O (usually the long dimension direction in the center of the medical bed) laser Ro of the CT, etc., and its X coordinate is set to Xc (in Figure 8 , the state where the laser (laser beam R) irradiated by the laser irradiation unit 42 on the body axis O overlaps with the laser Ro of the CT, etc. is shown). Then, the rotation angle of the laser beam R is rotated to 90 degrees (parallel to the CT line laser Zct) and made parallel to the CT line laser Rc. The interval Zjct between the laser of the laser irradiation unit 42 and the CT line laser Rc at this time is measured, and Zj is obtained.

[0106] As Figure 9 shown, specifically, in the case where the subject M is in the supine position, as an example of a method of aligning the laser beam R of 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 making the tip of the puncture needle 2 reach the target point coordinate T, taking the case of using CT as an example, two methods are described.

[0107] As a first method, the coordinates S of the puncture insertion point P (hereinafter referred to as the insertion point coordinates S) and the coordinates T of the puncture target point Q (hereinafter referred to as the target point coordinates T) are determined from the CT-MPR images, the insertion point coordinates S (Xs, Ys, Zs) and the target point coordinates T (Xt, Yt, Zt) are read, and the rotation angle θh of the laser plumb plane A containing the insertion point coordinates S and the target point coordinates T with respect to the body axis and the X coordinate Xj of the intersection of the laser plumb plane A and Zj are calculated, and the laser irradiation unit 42 is moved.

[0108] Furthermore, the inclination angle θv of the line segment ST in the laser plumb plane A with respect to the horizontal plane and the distance Dst between the insertion point coordinates S and the target point coordinates T corresponding to the puncture depth are calculated. The tip of the puncture needle 2 is aligned with the puncture point coordinates S, and the puncture needle 2 is inserted into the laser plumb plane A in such a way that the laser beam R is irradiated onto the entire puncture needle 2, and the puncture needle 2 is tilted so that the angle of the inclination angle presentation unit 33 is θv, and the puncture needle 2 is advanced by the depth Dst, so that the tip of the puncture needle 2 reaches the target point coordinates T.

[0109] The above θh, Xj (any one of the four formulas), θv, and Dst can be calculated by the following formulas (1) and (1′).

[0110] θh = arctan{(Xt - Xs) / (Zt - Zs)

[0111] Xj = Xs - (Zs - Zj) × tan(θh)

[0112] Xj = Xt - (Zt - Zj) × tan(θh)

[0113] Xj = Xs - (Xs - Xt) × (Zs - Zj) / (Zs - Zt)

[0114] Xj = Xt - (Xs - Xt) × (Zt - Zj) / (Zs - Zt)

[0115] Dxz = √{(Xt - Xs) 2 +(Zt - Zs) 2}

[0116] θv = arctan{(Yt - Ys) / Dxz} ···(1)

[0117] Dst = √{(Xt - Xs) 2 +(Yt - Ys) 2 +(Zt - Zs) 2} ···(1′)

[0118] In addition, as another method, that is, the second method, there is also a method of calculating only Xj without calculating θh, θv, and Dst as described above.

[0119] Rotate the CT-MPR sagittal plane around the vertical axis to determine the sagittal plane containing the coordinates S of the puncture point and the coordinates T of the target point. Read the rotation angle θh of the sagittal plane and the coordinates (Xs, Ys, Zs) of the puncture point or the coordinates (Xt, Yt, Zt) of the target point. Calculate the X coordinate Xj of the intersection point of the laser vertical plane A and Zj based on the rotation angle θh of the sagittal plane and the coordinates S of the puncture point or the coordinates T of the target point, and move the laser irradiation unit 42.

[0120] Furthermore, read the inclination angle θv of the line segment ST in the sagittal plane with respect to the horizontal plane, and the distance Dst between the coordinates S of the puncture point and the coordinates T of the target point corresponding to the puncture depth. Align the tip of the puncture needle 2 with the puncture point coordinates S, and insert the puncture needle 2 into the laser vertical plane A in such a way that the laser beam R irradiates the entire puncture needle 2. Tilt the puncture needle 2 so that the angle of the inclination angle display unit 33 is θv, and advance the puncture needle 2 by the depth Dst. Thus, the tip of the puncture needle 2 can also reach the target point coordinates T.

[0121] Regardless of which of the above methods or a combination of the two methods is used, the tip of the puncture needle 2 can reach the target point coordinates T guided by the laser beam R of the laser irradiation unit 42. Each method can perform the puncture surgery by using any method or a combination of methods according to the functions of devices such as CT used.

[0122] In addition, the puncture navigation system 5 may also include a correction unit for correcting the movement of the subject M during the surgery. During the surgery, sometimes the subject M moves, and the laser beam R of the laser irradiation unit 42 will deviate from the body surface marking line H determined to include the puncture point P.

[0123] To prevent this situation, the puncture system of the present invention may also include a marking element.

[0124] For example, a marking element that can be visually recognized for the determined puncture point P or the body surface marking line H may be arranged. For example, an attachable marking element or a drawable marking element may be arranged on the surface Ma of the body surface at the puncture point P or the body surface marking line H. Even when the laser beam R of the laser irradiation unit 42 deviates from the body surface marking line H due to the movement of the subject M, the marking element can be used to visually adjust the position and rotation of the laser beam R of the laser irradiation unit 42 again to align it with the body surface marking line H.

[0125] In addition, the puncture navigation system 5 may also have an imaging unit such as a camera to detect the marking element. Through the image analysis function, calculate the degree of deviation. Based on this, drive the body surface irradiation laser mechanism 4 through the control unit to automatically control the linear direction and rotation direction, and correct the laser beam R from the laser irradiation unit 42 so that it never deviates from the body surface marking line H.

[0126] [Surgical Steps Using a Puncture System]

[0127] Next, the operation steps of puncturing the puncture needle 2 at an accurate angle to the puncture target point Q of the subject M using the puncture assist device 3 will be described in detail.

[0128] First, as Figure 1 shown, the puncture target point Q indicating the position of a target such as a malignant tumor is read from a CT image or the like. In the preoperative plan, the operator determines the puncture direction and the puncture insertion point P that can safely puncture to the puncture target point Q. Through this determination, the straight line connecting the puncture target point Q and the puncture insertion point P is determined, and further, the straight line (body surface marking line H) in this straight line that is projected onto the body surface Ma of the subject M is determined. In addition, the inclination angle θ of the extension line of the straight line connecting the puncture target point Q and the puncture insertion point P with respect to the vertical axis or the horizontal plane is calculated. This inclination angle θ is the puncture angle of the puncture needle 2. Then, a laser beam R is irradiated from the laser irradiation unit 42 to form a laser vertical plane A passing through the body surface marking line H. The operations up to this point are performed by the control unit of the above-described puncture navigation system 5 in this embodiment.

[0129] Specifically, as Figure 6 shown, the following control is performed in the control unit: controlling the linear movement mechanism 45 and the rotational movement mechanism 46 of the laser irradiation mechanism 4 placed above the subject M, calculating and adjusting the position in the horizontal direction orthogonal to the body axis O and the angle of the rotational direction around the vertical axis when the laser irradiation unit 42 is viewed from above. It is also possible to take a photograph with the imaging unit and confirm whether the body surface marking line H is displayed at the correct position through image analysis.

[0130] In addition, even when the puncture navigation system 5 is not used, the operator or the like similarly determines the puncture insertion point P based on a CT image or the like, calculates or reads from a CT image or the like to obtain the position in the horizontal direction orthogonal to the body axis O and the angle of the rotational direction around the vertical axis when the laser irradiation unit 42 is viewed from above, and the operator or the like operates the operation panel 47 to adjust the position of the laser irradiation unit 42 to form the laser vertical plane A.

[0131] Next, the puncture of the puncture needle 2 is performed. First, the puncture assist device 3 is installed on the puncture needle 2. As Figure 3 shown, the puncture needle 2 is held in the groove portion 31 of the movable portion 35 and clamped between the groove portion 31 and the fixed portion 34, so that the sensor portion 32 with a built-in sensor is installed on the puncture needle 2.

[0132] After that, as Figure 4 and Figure 5As shown, the operator 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 plumb plane A contacts the entire puncture needle 2. Then, the puncture needle 2 is arranged within the plane of the laser plumb plane A, and while confirming the inclination angle indication unit 33 of the puncture assistance instrument 3, the inclination angle θ of the puncture needle 2 is adjusted. That is, the puncture needle 2 is inserted into the body at a predetermined inclination angle θ. During this puncture operation, the operator also observes and confirms the value (inclination angle) displayed on the inclination angle indication unit 33, and further, according to the situation, checks the insertion condition of the puncture needle 2 into the body by repeatedly obtaining CT images or the like.

[0133] [Effect]

[0134] As described above, the puncture assistance instrument 3 of the present embodiment is detachably provided with a puncture needle 2 that performs puncture along a line (body surface marking line H) formed on the body surface Ma of the subject M using a laser plane including the puncture target point Q and the puncture insertion point P in the body of the subject M. The puncture assistance instrument 3 has a groove portion 31 (holding portion) for holding the puncture needle 2, a sensor unit 32 capable of measuring the angle of the held puncture needle 2 relative to the plumb axis or the horizontal plane, and an inclination angle indication unit 33 for indicating the angle.

[0135] In the puncture assistance instrument 3 of the present embodiment, when the puncture needle 2 held by the groove portion 31 is oriented at a specified inclination angle along a line formed on the body surface Ma of the subject M using a laser plane including the puncture target point Q and the puncture insertion point P in the body of the subject M, the sensor unit 32 can measure the angle of the puncture needle 2 relative to the plumb axis or the horizontal plane, and the inclination angle indication unit 33 indicates the measured inclination angle as its value. Therefore, the operator can observe the inclination angle indication unit 33 and accurately confirm the inclination angle θ of the puncture needle 2 in real time. By simply adjusting the inclination angle of the puncture needle 2 while puncturing into the body of the subject M with high precision, the puncture target point Q can be safely reached.

[0136] For example, in CT-guided puncture, when puncturing within a CT section, the inclination angle of the puncture needle 2 relative to the plumb axis or the horizontal plane can be indicated to the operator during puncture from the start of puncture.

[0137] Therefore, in the present embodiment, the number of adjustments of the inclination angle of the puncture needle 2 during puncture can be reduced, and the operation time can be shortened. Therefore, in the case of CT-guided puncture, the X-ray radiation received by the operator and the subject M can be reduced. Further, in order to reduce X-ray radiation, even when the operator holds the puncture needle 2 using a puncture holder or the like and performs CT imaging, the inclination angle indication unit 33 can always indicate the inclination angle of the puncture needle to the operator, so that the change in the inclination angle of the puncture needle 2 can be suppressed.

[0138] In addition, in the present embodiment, when finely adjusting the inclination angle of the puncture needle during puncture, since the inclination angle of the puncture needle is always prompted, the inclination angle of puncture can be finely adjusted based on specific angle values. In addition, even when the operator is unskilled, the operator can receive an indication of the puncture angle from the instructor by specific angle values, and the unskilled operator can finely adjust the inclination angle of the puncture needle while referring to the angle prompt of the inclination angle prompt unit 33.

[0139] In addition, in the puncture assisting device 3 of the present embodiment, the holding portion is constituted by the groove portion 31, and has a fixing mechanism for holding and fixing the puncture needle 2 to the groove portion 31 by the fixing portion 34 and the movable portion 35.

[0140] In the present embodiment, the sensor unit 32 for prompting the inclination angle of the puncture needle 2 has a structure that can be clamped and fixed between the fixing portion 34 and the movable portion 35, and the sensor unit 32 can be simply attached to and detached from the existing puncture needle 2. Therefore, the sensor unit can be simply attached to the puncture needle 2 in a short time for puncture. Further, even when multiple punctures are required during one operation, after puncture, the sensor unit 32 can be detached and easily attached to other puncture needles 2, so that multiple punctures can be efficiently and cleanly performed at low cost.

[0141] The body surface irradiation laser mechanism 4 of the present embodiment has a holding member 41 provided on an operating table 40 for supporting a subject M, a laser irradiation unit 42 that is installed via the holding member 41 and irradiates a line formed on the body surface Ma of the subject M along a laser plane including a puncture target point Q and a puncture insertion point P in the body of the subject M, and a moving mechanism 43 for moving the laser irradiation unit 42 provided on the holding member 41.

[0142] In the present embodiment, a laser irradiation unit 42 different from the CT laser can be provided, and the laser irradiation unit 42 can irradiate a laser for forming a laser vertical plane A including the puncture target point Q and the puncture insertion point P in the body of the subject M. Therefore, by aligning the puncture needle 2 provided with the sensor unit 32 with the laser vertical plane A, the operator can make the orientation of the puncture needle 2 face along the line (body surface marking line H) formed on the body surface Ma in a top view, and while confirming the prompt of the inclination angle prompt unit 33 in a state where the puncture needle 2 is arranged within the laser vertical plane A, adjust the inclination angle θ of the puncture needle 2 to perform puncture.

[0143] In addition, in the present embodiment, the laser irradiation unit 42 provided on the holding member 41 can be moved to a specified position by the moving mechanism 43, so it has a very high degree of freedom. It can display the laser at a large range and any location on the body surface, at the position of the body surface marking line H, and can display the above-mentioned laser vertical plane A irradiated by the laser irradiation unit 42 at any position. It is possible to perform the puncture operation easily and with high precision in cooperation with the displayed laser.

[0144] In addition, the laser irradiation unit 42 does not need to be manually held by an assistant or the like, so there will be no hand tremors or the like. In addition, the laser irradiation unit 42 does not come into contact with the subject, so the laser can be stably displayed.

[0145] In addition, in the body surface laser irradiation mechanism 4 of the present embodiment, the moving mechanism 43 has a rotational moving mechanism 46 that holds the laser irradiation unit 42 so as to be rotatable.

[0146] In this case, the laser irradiation unit 42 can be adjusted by the rotational moving mechanism 46 in the rotational direction around the vertical axis. Therefore, the display position can be made more free, and the laser vertical plane A intersecting the CT section can be formed with high precision.

[0147] Moreover, in the body surface laser irradiation mechanism 4 of the present embodiment, the moving mechanism 43 has a linear moving mechanism 45 that holds the laser irradiation unit 42 so as to be movable in a linear direction.

[0148] In this case, the laser irradiation unit 42 can be adjusted by the linear moving mechanism 45 in a linear direction orthogonal to the body axis O of the subject M. Therefore, the laser vertical plane A and the body surface marking line H can be formed with high precision.

[0149] In the puncture navigation system 5 of the present embodiment, the puncture target point Q and the puncture insertion point P in the body of the subject M can be determined, and the laser plane including the puncture target point Q and the puncture insertion point P, the insertion angle, the insertion length, and the angle between the body axis O and the laser plane into which the puncture needle 2 is inserted can be automatically calculated with high precision by the control unit. Therefore, the efficiency of the puncture operation can be improved, and the angle correction can also be easily performed in a short time. Therefore, for example, even when the position of the subject M changes during the puncture, the puncture operation can be performed while adjusting the puncture needle 2 based on the angle calculated by the puncture navigation system 5.

[0150] In the puncture system 1 of the present embodiment, the control unit can use the moving mechanism 43 to move the laser irradiation unit 42 toward the laser vertical plane A.

[0151] According to the puncture system 1, puncture assisting device 3, body surface laser irradiation mechanism 4, and puncture navigation system 5 of the present embodiment, it is possible to easily and accurately confirm the inclination angle of the puncture needle 2 puncturing the subject M, and high-precision puncture can be performed.

[0152] [Other]

[0153] Next, the puncture system, puncture assisting device, body surface laser irradiation mechanism, and puncture navigation system of other embodiments will be described with reference to the drawings. In addition, the same or similar components and parts as those in the above-described first embodiment are denoted by the same reference numerals and their description is omitted, and the structures different from those of the first embodiment will be described.

[0154] (Second Embodiment)

[0155] In Figure 4 and Figure 5 a triaxial acceleration sensor is used, but a biaxial acceleration sensor can also be used in the same manner. In this case, the sensor unit constituted by the biaxial acceleration sensor can be realized by setting the first sensor axis Ny in the puncture needle direction of the puncture needle 2 and the second sensor axis Nx in a direction perpendicular to the puncture needle 2. At this time, the inclination angle θ of the puncture needle 2 measured by the sensor unit 32 is displayed on the inclination angle display unit 33 of the puncture assisting device. And, the puncture assisting device 3 is held so that the laser beam R of the laser vertical plane A including the puncture insertion point P and the puncture target point Q is irradiated perpendicular to Figure 3 the long side portion 34e of the fixing portion 34 in the length direction of the puncture needle 2 / the short side portion 34d of the fixing portion 34 extending in the direction along the length direction of the puncture needle 2, and the inclination angle θ of the puncture assisting device 3 with respect to the vertical axis or the horizontal plane of the vertical direction Nxy is presented to the operator. In addition, a scale for the biaxial 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 irradiated by the laser beam R.

[0156] (Third Embodiment)

[0157] Next, the puncture assisting device 3B of the third embodiment will be specifically described using Figures 10 to 13 .

[0158] Although there is a method of aligning the laser vertical plane A irradiated by the laser irradiation unit 42 (refer to Figure 1 ) with the puncture needle 2 as described above, as Figure 10 shows, the puncture assisting device 3B of the present third embodiment employs a method of aligning the scale 380 of the vertical plane 38a described later with the CT cross section Ac as the laser vertical plane A.

[0159] The puncture assisting device 3B has a vertical wall 38 having a vertical surface 38a perpendicular to the puncture needle 2 fixed to the fixing portion 34. The vertical wall 38 is fixed so that the vertical surface 38a is parallel to one long side of the fixing portion 34. The fixing portion 34 and the vertical wall 38 are formed into an L shape when viewed from the side. The vertical wall 38 is formed with a notch 38b that penetrates in the thickness direction and allows the puncture needle 2 to be inserted from the outer peripheral edge of the vertical wall 38.

[0160] A scale 380 is provided on the vertical surface 38a of the vertical wall 38. The scale 380 has Figures 11 to 13 The plane parallel scale 381 shown is aligned in a manner that the Nx axis is parallel to the laser vertical plane A (CT section Ac), and the offset angle scale 382 is set perpendicular to the plane parallel scale 381. A plurality of plane parallel scales 381 are displayed at a certain interval on the vertical plane 38a. A plurality of offset angle scales 382 are displayed at a certain interval on the vertical plane 38a. The intervals between the plane parallel scales 381 and the offset angle scale 382 are set to arbitrary intervals.

[0161] In addition, the display of the vertical surface 38a is not limited to Figure 10 Such a line display scale 380 may be, for example, a display in which a quadrilateral pattern arranged at a predetermined interval functions as a scale, or may be a display with a relatively wide scale. In addition, the intervals may not be equal, but may be intervals that take into account the allowable error.

[0162] Figure 11 It is a perspective view showing the positional relationship between the puncture needle 2 and the puncture assisting tool 3B during puncture. Figure 12 It means Figure 11 A diagram of a vertical plane Ah parallel to the laser vertical plane A (CT cross section Ac) including the Nx axis. Figure 13 Yes means Figure 11 The figure is the Ny axis-Nz axis plane. Figures 11 to 13 The CT line laser Rc or the laser beam R from the laser irradiation unit 42 is shown as irradiating the scale 380 and the tip of the puncture needle 2 . Figures 11 to 13 The Ny axis shown 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) orthogonal to the 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) orthogonal to the axis (Ny axis) in the puncture needle direction and the first orthogonal axis (Nx axis). The puncture assisting device 3B has a surface parallel scale 381 for identifying the vertical plane 38a parallel to the laser vertical plane A where the Nx axis is parallel to the laser vertical plane A.

[0163] The sensor unit 32 of the puncture assisting device 3B in the third embodiment uses a three-axis acceleration sensor. The first sensor axis Ny of the sensor unit 32 is set in the puncture needle direction of the puncture needle 2, the second sensor axis Nx is set in a direction perpendicular to the puncture needle 2, and the third sensor axis Nz is set in a direction perpendicular to both the axis Nx and the axis Ny. At this time, the inclination angle θ of the puncture needle 2 measured by the sensor unit 32 is displayed on the inclination angle prompting unit 33 of the puncture assisting device 3B. Then, the puncture assisting device 3B holds the sensor unit 32 by aligning the CT line laser Rc showing the laser plumb plane A including the puncture insertion point P or the laser beam R from the laser irradiation unit 42 with the plane parallel scale 381 of the vertical plane 38a, and prompts on the inclination angle prompting unit 33 either or both of the inclination angle θ of the puncture needle 2 projected onto the laser plumb plane A with respect to the plumb line and the inclination angle between the laser plumb plane A and the puncture needle 2.

[0164] For example, as Figure 12 shown, the inclination angle θct of the puncture needle 2 with respect to the plumb line projected onto the vertical plane Ah including the Nx axis parallel to the laser plumb plane A is obtained by the formula (6).

[0165] Nyz = √{(Ny) 2 +(Nz) 2}

[0166] θct = arctan(Nx / Nyz) ··· (6)

[0167] In addition, as Figure 13 shown, the inclination angle θts between the laser plumb plane A and the puncture needle 2 is obtained by the formula (7).

[0168] θts = arctan(Nz / Ny) ··· (7)

[0169] In addition, when the CT cross-section Ac is used as the laser plumb plane A, the inclination angle θct is consistent with the puncture needle angle in the CT image, and θts is consistent with arctan(Ds / Ls). Therefore, it is easy for the operator using CT to understand. Here, Ls represents the length of the puncture needle projected onto the CT image, and Ds represents the slice thickness of the CT image.

[0170] It is possible to prompt the operator from the start of puncture to during puncture the inclination angle of the puncture needle 2 projected onto the laser plumb plane A with respect to the plumb axis or the horizontal plane and the inclination angle of the puncture needle 2 with respect to the laser plumb plane A.

[0171] In addition, even when puncturing while deviating from the laser plumb plane A, it is possible to prompt the operator from the start of puncture to during puncture the inclination angle of the puncture needle 2 projected onto the CT line laser plumb plane A with respect to the plumb axis or the horizontal plane and the inclination angle of the puncture needle 2 with respect to the CT cross-section.

[0172] (Fourth Embodiment)

[0173] Figure 2 The puncture assistance device 3 described can also be configured such that the inclination angle prompting unit 33 can be separated from the sensor unit 32. The inclination angle prompting unit 33 is arranged to be able to communicate with the sensor unit 32 by wire or wirelessly, and display the inclination angle θ of the puncture needle 2 measured by the sensor unit 32 (in the case where the prompting method is sound, vibration, etc., for notification). That is, it is not limited to the sensor unit 32 and the inclination angle prompting unit 33 being integrally provided. In this case, it is also possible to perform only the sterilization treatment on the sensor unit 32, and use the inclination angle prompting unit 33 without sterilization by putting it into a sterilization bag.

[0174] The inclination angle prompting unit 33, for example, has a display mode switching button, a switch, and can switch the state of the sensor unit 32 mounted on the puncture needle 2 and the displayed inclination angle θ. In addition, it can also be configured such that the operation of the sensor unit 32 can be changed by the switching button or switch of the inclination angle prompting unit 33. In addition, a tablet terminal or the like can also be used as the inclination angle prompting unit 33.

[0175] (Fifth Embodiment)

[0176] The puncture system 1B of the fifth embodiment shows an example of a case where, instead of using the CT cross-section Ac guided by the CT cross-section laser, for example, CT, MRI, and an ultrasonic probe are used to determine the puncture target point Q, the puncture insertion point P, and the inclination angle θ of the puncture needle 2 in the body of the subject M.

[0177] Figure 14 It is a diagram showing an outline of the puncture system 1B using the ultrasonic probe 60. As Figure 14 shown, in the puncture system 1B, for example, the ultrasonic probe 60 with a spirit level is brought into vertical contact with the body surface Ma of the subject M along the vertical direction, the vertical depth D of the puncture target point Q from the body surface Ma is measured, and the target point mark Q1 is displayed on the body surface Ma directly above the puncture target point Q. In addition, Figure 14 shows an example of using the ultrasonic probe 60, but instead of the ultrasonic probe 60, the position of the puncture target point Q can also be measured by MRI.

[0178] Next, as Figure 15 shown, based on the puncture target point Q, the puncture insertion point P of the puncture needle 2 is determined, and the insertion point mark P1 is displayed on the body surface Ma. After that, for example, a length measuring instrument 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 the angle t of the straight line L with respect to the horizontal plane is measured. Then, the puncture angle of the puncture needle 2 is calculated based on the angle t.

[0179] After that, as shown in Figure 16 the laser beam R irradiated by the laser irradiation unit 42 shows a laser plumb plane A including the puncture insertion point P and the puncture target point Q, and aligns the puncture needle 2 or the sensor unit 32 of the puncture assist device 3 attached to the puncture needle 2 with the laser plumb plane A to make them coincide. Thus, from the start time of puncture to during puncture, the inclination angle prompt unit 33 can prompt the operator of the inclination angle of the puncture needle 2 with respect to the plumb axis or the horizontal plane.

[0180] (Sixth Embodiment)

[0181] Figure 17 FIG. is a diagram showing the structure of the adjustment mechanism 48 of the body surface irradiation laser mechanism 4A according to the sixth embodiment. As shown in Figure 17 the body surface irradiation laser mechanism 4A according to the sixth embodiment includes an adjustment mechanism 48 for the laser plumb plane. That is, the laser irradiation unit 42 is arranged to be able to rotate about each of the X-axis (first axis) in the linear direction along the horizontal frame 412 (feed screw 452) shown in Figure 7 , the Z-axis (second axis) orthogonal to the X-axis, and the Y-axis (third axis) constituting the irradiation axis of the laser irradiation unit 42. In addition, as described above, the X-axis is in the horizontal direction, and as shown in Figure 6 , it is arranged in a direction perpendicular to the body axis O of the subject M when viewed from above.

[0182] The adjustment mechanism 48 includes a first housing 481 that can move along the X-axis, a second housing 482 housed in the first housing 481, and a third housing 483 housed in the second housing 482 and fixing the laser irradiation unit 42. The first housing 481, the second housing 482, and the third housing 483 are each in a rectangular parallelepiped shape. In addition, the shapes of the respective housings 481, 482, 483 are not limited to rectangular parallelepipeds, and may be any shapes such as cubes and spheres.

[0183] The first housing 481 can be moved along the feed screw 452 extending in the X-axis direction by an operation of an operation panel 47 or the like (refer to Figure 6 ). The first housing 481 cannot rotate about the feed screw 452.

[0184] The second housing case 482 rotates relative to the first housing case 481 about the X-axis (in the direction of arrow E1) by operation of the operation panel 47 or the like, for example, by a rotation 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 rotatable relative to each other about the X-axis (in the direction of E1). For example, a structure can be adopted in which a first bearing (not shown) is provided on a wall surface of the first housing case 481 orthogonal to the X-axis, and the first pin 491 supported so as to be rotatable relative to the first bearing is fixed to the second housing case 482.

[0185] The third housing case 483 rotates relative to the second housing case 482 about the Z-axis (in the direction of arrow E2) by operation of the operation panel 47 or the like, for example, by a rotation 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 rotatable relative to each other about the Z-axis (in the direction of E2). For example, a structure can be adopted in which a second bearing (not shown) is provided on a wall surface of the second housing case 482 orthogonal to the Z-axis, and the second pin 492 supported so as to be rotatable relative to the second bearing is fixed to the third housing case 483.

[0186] The third housing case 483 is provided with an acceleration sensor (not shown). In the adjustment mechanism 48, the direction of gravity can be detected based on the output of the acceleration sensor provided in the third housing case 483, and the laser plumb plane A can be automatically corrected to be plumb. This correction is performed by automatic correction.

[0187] In addition, the rotation directions of the second housing case 482 and the third housing case 483 may be opposite. That is, a structure may also be adopted in which the second housing case 482 rotates relative to the first housing case 481 about the Z-axis (in the direction of E2), and the third housing case 483 rotates relative to the second housing case 482 about the X-axis (in the direction of E1).

[0188] In addition, the mounting positions of the bearings and the pins 491, 492 may be opposite.

[0189] In this way, in the body surface irradiating laser mechanism 4A of the sixth embodiment, even when Figure 6 the heights of the left and right pair of leg frames 411 of the holding member 41 are different as shown, the horizontal frame 412 (feed screw 452) is not horizontal, and the laser plumb plane A is not plumb, the posture of the laser irradiation unit 42 can be corrected by operating the adjustment mechanism 48 so that the laser plumb plane A is plumb.

[0190] As described above, the preferred embodiments of the present invention have been described, but the present invention is not limited to these embodiments, each modification example, and each example. Additions, omissions, substitutions, and other changes can be made without departing from the gist of the present invention.

[0191] In addition, the present invention is not limited by the foregoing description, but only by the appended claims.

[0192] In the present embodiment, the groove portion 31 (holding portion) is provided in the movable portion 35 of the puncture assisting instrument 3. However, the holding portion may be provided in the fixed portion 34, or may be configured to have the holding portion for fixing the puncture needle 2 in both the fixed portion 34 and the movable portion 35. Further, as the structure of the holding portion for holding the puncture needle 2 by the sensor portion 32, it is not limited to the groove portion 31, and other holding structures may be used.

[0193] In the above-described first embodiment, the structure of the body surface laser irradiation mechanism 4 and the puncture navigation system 5 provided with the support laser irradiation portion 42 is taken as an example. However, either one or both of the body surface laser irradiation mechanism 4 and the puncture navigation system 5 can be omitted.

[0194] Industrial Applicability

[0195] According to the puncture system, puncture assisting instrument, body surface laser irradiation mechanism, and puncture navigation system of the present invention, it can be applied to a puncture system, puncture assisting instrument, body surface laser irradiation mechanism, and puncture navigation system that can easily and accurately confirm the inclination angle of the puncture needle puncturing the subject and can perform high-precision puncture.

[0196] Description of Reference Numerals

[0197] 1, 1B Puncture system

[0198] 2 Puncture needle

[0199] 3, 3B Puncture assisting instrument

[0200] 4 Body surface laser irradiation mechanism

[0201] 5 Puncture navigation system

[0202] 31 Groove portion (holding portion)

[0203] 32 Sensor portion

[0204] 33 Inclination angle prompting portion

[0205] 34 Fixed portion

[0206] 35 Movable portion

[0207] 41 Holding member

[0208] 42 Laser irradiation portion

[0209] 43 Moving mechanism

[0210] 45 Linear moving mechanism

[0211] 46 Rotary moving mechanism

[0212] A Laser plumb plane

[0213] Ac CT cross-section

[0214] Ah Plumb plane

[0215] M Patient

[0216] Ma Body surface

[0217] P Puncture insertion point

[0218] Q Puncture target point

[0219] R Laser beam.

Claims

1. A puncture system, comprising: A puncture assisting device having a holding portion and a sensor portion, wherein the holding portion is detachable from and attachable to a puncture needle, the puncture needle being used to perform puncture along a line formed on the body surface of the subject by a vertical plane including a target point and a puncture point in the body of the subject, and the sensor portion being capable of measuring an angle of the held puncture needle with respect to a vertical axis or a horizontal plane; A body surface laser irradiation mechanism having a laser irradiation portion and a moving mechanism, wherein the laser irradiation portion irradiates a laser onto the vertical plane along the line formed on the body surface of the subject, and the moving mechanism moves the laser irradiation portion; and A puncture navigation system having a calculation portion and a control portion, wherein the calculation portion determines an irradiation position of the laser and a puncture angle of the puncture needle based on the target point and the puncture point in the body of the subject, and the control portion controls the laser irradiation portion.

2. The puncture system according to claim 1, wherein, the holding portion of the puncture assisting device includes a fixing portion, a movable portion, and a fixing mechanism for holding and fixing the puncture needle through the fixing portion and the movable portion.

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

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

5. The puncture system according to claim 1, wherein, the moving mechanism has a rotational moving mechanism for holding the laser irradiation portion so as to be rotatable.

6. The puncture system according to claim 1, wherein, the moving mechanism has a linear moving mechanism for holding the laser irradiation portion so as to be movable in a linear direction.

7. The puncture system according to claim 6, wherein, the laser irradiation portion is provided so as to be rotatable about a first axis along the linear direction, a second axis orthogonal to the first axis, and a third axis constituting an irradiation axis of the laser irradiation portion.

8. The puncture system according to claim 1, wherein, the calculation portion determines a puncture angle, a puncture length based on the target point and the puncture point, and calculates an angle between the vertical plane and the body axis of the subject.

9. The puncture system according to claim 1, wherein, the puncture system has at least any one of a CT, an MRI, and an ultrasonic probe for determining the target point in the body of the subject.

10. A puncture assisting device capable of being detached from and attached to a puncture needle, the puncture needle being used to perform puncture along a line formed on the body surface of the subject by a vertical plane including a target point and a puncture point in the body of the subject, the puncture assisting device comprising: a holding portion including a fixing portion for holding the puncture needle, a movable portion, and a fixing mechanism for holding and fixing the puncture needle through the fixing portion and the movable portion; a sensor portion capable of measuring an angle of the held puncture needle with respect to a vertical axis or a horizontal plane; and A prompting unit that prompts the angle. 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.

11. A body surface laser irradiation mechanism, comprising: A holding member; A laser irradiation unit that is installed via the holding member and irradiates laser light onto a vertical plane formed on the body surface of the subject along a line formed on the vertical plane that includes a target point and a puncture point in the body of the subject; and A moving mechanism that moves the laser irradiation unit provided on the holding member.

12. A puncture navigation system, comprising: A calculation unit that determines a puncture angle and a puncture length based on a target point and a puncture point in the body of the subject determined by at least any one of a CT, an MRI, and an ultrasonic probe, and calculates an angle between the vertical plane including the target point and the puncture point and the body axis of the subject; and A control unit that controls a laser irradiation unit that irradiates laser light onto the vertical plane along a line formed on the body surface of the subject based on the angle calculated by the calculation unit with respect to the body axis of the subject.

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