WO2014162470A1

WO2014162470A1 - Medical device

Info

Publication number: WO2014162470A1
Application number: PCT/JP2013/059969
Authority: WO
Inventors: 康之本間
Original assignee: テルモ株式会社
Priority date: 2013-04-01
Filing date: 2013-04-01
Publication date: 2014-10-09

Abstract

This medical device (10) has a main body (30), an arcuate curved needle (20), a light emitting unit (40), a detection unit (50) and a control unit (60). The light emitting unit (40) is provided in the main body (30) and emits a visible guide light (L1). The detection unit (50) detects the inclination angle θ of the main body (30). The control unit (60) causes the light emitting unit (40) to change the emission angle α of the guide light (L1) depending on the detected inclination angle θ. A user determines as the irradiation target position (F) the intersection point between the body surface (130) and the perpendicular line (V) passing through the puncture target position (P) inside of the body. The user grasps the main body (30) and inserts the curved needle (20), piercing the body. At that time, by moving the main body (30) so as to maintain the state in which the guide light (L1) is irradiating the irradiation target position (F), the needle tip (21) can be simply and quickly guided to the puncture target position (P).

Description

Medical instruments

The present invention relates to a medical instrument having a curved puncture portion.

As a medical instrument capable of puncturing a living body, such as a guide needle for introducing various introduction media and members into a living body, a suture needle, a surgical knife, and a knife, a treatment instrument having an outer shape curved to a predetermined curvature (For example, refer to Patent Documents 1 and 2).

In the procedure of puncturing a living body with a treatment tool, a puncture route from a predetermined puncture position on the surface of the living body toward a puncture target position set in the living body is determined prior to the puncturing operation. Next, the treatment tool is moved to the puncture target position in the living body along the puncture route.

In the procedure performed using the treatment tool as described above, the puncture operation is performed by the operator performing an operation of pushing the needle tip from the proximal side toward the distal end side while grasping a grasping portion provided with the needle. It is advanced. When the outer shape of the needle is formed in a linear shape, the direction in which the gripping unit is pushed in and the direction in which the needle moves forward are the same or parallel to each other, so the operator can sense the position and moving direction of the needle tip. Can be recognized. Therefore, it is not so difficult to move the needle tip along the puncture route, and the needle tip can be guided relatively easily to the puncture target position in the living body.

On the other hand, when using a treatment instrument having a curved outer shape, the puncture path is curved according to the outer shape of the treatment tool. In the procedure using the curved treatment tool, the puncture operation is advanced by the operator pushing the gripping part or the like on the hand side as in the case of using the straight treatment tool.

Special table 2008-529737 JP 2007-275175 A

However, in the procedure using the curved treatment tool, unlike the procedure using the treatment tool formed in a linear shape, the direction in which the grip portion is pushed in does not match the direction in which the distal end portion of the treatment tool moves, It will not be parallel. For this reason, in order to accurately move the treatment tool along the puncture path in a conventional technique using a curved treatment tool, an image diagnostic apparatus such as an X-ray diagnostic apparatus is used during the procedure. It was necessary to check the direction and position of the tip. As a result, there is a problem that the time required for the procedure becomes long due to the time and effort required for the procedure, and a minimally invasive procedure cannot be realized.

Therefore, the present invention has been invented to solve the above-described problems, and enables a puncture operation using a medical instrument having a curved puncture portion to be performed easily and quickly, thereby achieving a minimally invasive procedure. An object is to provide a medical device that can be realized.

The present invention can be achieved by any of the following means (1) to (6).

(1) A curved puncture part capable of puncturing a living body, a grippable main body part provided with the puncture part, and an irradiation target position provided on the main body part and set at an arbitrary position on the surface of the living body A light emitting unit that emits visible guide light, a detection unit that detects an inclination state of the main body with respect to the surface of the living body into which the puncture unit is inserted, and a control unit that performs operation control of the light emitting unit And when the main body is operated such that the tip of the puncture unit moves along a puncture path passing through the puncture target position in the living body, By controlling the operation of the light emitting unit based on the detection result of the detecting unit, the emission angle of the guide light is changed so that the irradiation of the guide light to the irradiation target position is maintained. Medical equipment.

(2) The puncture unit has an arcuate outer shape in which a movement locus drawn when the distal end of the puncture unit moves makes a circle, and the control unit includes the radius of the circle, the irradiation An arithmetic processing unit that calculates a displacement of the emission angle of the guide light before and after the operation of the main body based on a distance from a target position to the center of the circle and a detection result of the detection unit; The medical instrument according to (1), wherein the emission angle of the guide light is changed according to the displacement of the emission angle calculated by the processing unit.

(3) The main body includes an input receiving unit that receives input of first data related to a radius of the circle and second data related to a distance from the puncture target position to the irradiation target position, and the arithmetic processing unit includes: The medical instrument according to (2), wherein a distance from the irradiation target position to the center of the circle is calculated based on the first data and the second data.

(4) Any one of the above (1) to (3), characterized in that it has an auxiliary light emitting part that is provided in the main body part and emits visible guide light toward the tip of the puncture part. Medical device described in one.

(5) The medical device according to any one of (1) to (4) above, wherein the main body has a shape confirmation part on which a graphic representing the outer shape of the puncture part is written.

(6) The puncture unit is configured by a curved needle whose tip is a needle tip, the puncture target position is a predetermined part between adjacent spinous processes, and the irradiation target position is the puncture target The medical instrument according to any one of (1) to (5) above, wherein the virtual perpendicular extending from the target position to the biological surface side intersects the biological surface.

According to the invention described in (1) above, when the distal end portion of the curved puncture portion is moved along the predetermined puncture path to the puncture target position set in the living body, the light is emitted from the light emitting portion. By confirming the position where the guide light is irradiated, it is possible to appropriately determine whether or not the distal end portion of the puncture portion is moving along the puncture route. If it is confirmed that the tip of the puncture part is displaced from the puncture path during the puncture operation, the moving direction of the tip of the puncture part can be easily corrected based on the irradiation position of the guide light. It becomes possible. For this reason, it is possible to easily and quickly perform a puncturing operation using a medical instrument having a curved puncturing unit, and a minimally invasive procedure can be realized.

According to the invention described in (2) above, it is possible to easily and quickly perform a procedure using a medical instrument having a puncture portion curved in an arc shape. Moreover, since the emission direction of the guide light can be controlled with high accuracy in accordance with the displacement of the emission angle calculated by the calculation processing unit provided in the control unit, the puncture portion is displaced from the puncture route during the puncture operation. Can be suitably prevented.

According to the invention described in (3) above, when performing a procedure using a medical instrument, by inputting various data to the input receiving unit provided in the main body unit, the emission direction of the guide light is controlled. The necessary numerical value can be calculated by the arithmetic processing unit. For this reason, even when a medical instrument is diverted between procedures with different puncture target positions, or when the main body is diverted between procedures using puncture sections with different lengths and curvatures, a predetermined amount is required before starting the procedure. It is possible to set the operation of the light emitting unit by a simple operation of simply inputting data.

According to the invention described in (4) above, since the guide light emitted from the auxiliary emitting portion is configured to be irradiated to the distal end portion of the puncture portion, the distal end portion of the puncture portion during the procedure Can be easily confirmed, and the puncturing operation can be performed more easily and quickly.

According to the invention described in (5) above, it is possible to grasp the amount of insertion of the puncture unit into the living body and the direction in which the puncture unit faces by visually observing the shape confirmation unit during the procedure. It becomes. Therefore, the puncturing operation with the medical instrument can be performed more easily and safely.

According to the invention described in (6) above, a medical instrument is provided that can easily and quickly guide the tip of a curved needle to an arbitrary puncture target position set between adjacent spinous processes in a living body. can do.

It is a general-view perspective view which shows the medical device which concerns on 1st Embodiment of this invention. It is a side view of the guide member used with a medical instrument. It is a side view of a medical device. It is a side view which shows the state which assembled | attached the guide member to the medical device. It is a top view of a medical device. It is a figure which expands and shows the input reception part with which a medical instrument is provided. It is a block diagram which shows the whole structure of the control part with which a medical instrument is provided. It is a figure which illustrates the living body used as the object of the procedure using a medical instrument. It is a figure which shows typically the lumbar spine which exists in the living body. It is a figure for demonstrating the control procedure of the emission direction of guide light, Comprising: It is a figure which shows typically the state by which the puncture part was inserted in the biological body. It is a figure for demonstrating the effect | action of a medical device, Comprising: It is a figure which shows typically the state before starting the puncture to the biological body by a medical device. It is a figure for demonstrating the effect | action of a medical device, Comprising: It is a figure which shows typically the state which moved the puncture part along the puncture path | route from the state shown in FIG. It is a figure for demonstrating the effect | action of a medical device, Comprising: It is a figure which shows typically the state which the front-end | tip part of the puncture part shifted | deviated from the puncture path | route at the time of a puncture operation. It is a figure for demonstrating the effect | action of a medical device, Comprising: It is a figure which shows typically the state which moved the puncture part along the puncture path | route from the state shown in FIG. It is a figure for demonstrating the effect | action of a medical instrument, Comprising: It is a figure which shows typically the state which moved the puncture part along the puncture path | route from the state shown in FIG. It is a figure which shows typically the state which has arrange | positioned the implant between adjacent spinous processes. It is a figure which shows typically the state which expanded the implant arrange | positioned between adjacent spinous processes. It is a figure which shows typically a mode that the expanded implant was detained between adjacent spinous processes. It is a block diagram which shows the whole structure of the control part with which the medical device which concerns on 2nd Embodiment of this invention is provided.

Hereinafter, the present invention will be described through embodiments with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
1 to 7 are diagrams for explaining the configuration of the medical device according to the present embodiment. 8 and 9 are diagrams for explaining a living body that is a target of a procedure using a medical instrument. FIG. 10 to FIG. 18 are diagrams for explaining examples of use and operation of the medical instrument.

With reference to FIG. 1, the medical device 10 according to the present embodiment can be summarized as a curved puncture unit 20 that can puncture a living body 120, a graspable main body unit 30 provided with the puncture unit 20, and a main body unit. 30 and a light emitting unit 40 for emitting visible guide light toward an irradiation target position F set at an arbitrary position on the biological surface 130, and a main body for the biological surface 130 into which the puncture unit 20 is inserted It has the detection part 50 which detects the inclination state of the part 30, and the control part 60 which performs operation | movement control of the light-projection part 40. Then, as shown in FIGS. 10 to 15, the control unit 60 operates the main body 30 so that the distal end portion 21 of the puncture unit 20 moves along the puncture route passing through the puncture target position P in the living body. When this is done, by controlling the operation of the light emitting unit 40 based on the detection result of the detecting unit 50, the emission angle of the guide light is changed so that the irradiation of the guide light to the irradiation target position F is maintained. .

This embodiment exemplifies a form in which the present invention is applied as a medical instrument used for introducing an implant between adjacent spinous processes in a living body. First, with reference to FIG. 8, FIG. 9, FIG. 18, a spinous process of a living body in which the implant 80 is placed and a disease to be treated will be briefly described.

FIG. 8 is a diagram schematically showing a perspective view of the lumbar vertebra from the back side of the living body, and FIG. 9 is a view of the living body in a direction orthogonal to the arrangement direction of spinous processes (the extending direction of the spine) as a part of the lumbar vertebra. FIG. 18 is a diagram schematically showing a peripheral portion of the spinous process of FIG. 8. The X axis shown in each figure indicates the direction orthogonal to the arrangement direction of the spinous processes, the Y axis shows the arrangement direction of the spinous processes, and the Z axis shows the thickness direction of the living body.

A plurality of lumbar vertebrae 126 are arranged on the back 121 of the living body 120 along the extending direction of the spine (see FIG. 18). The lumbar vertebra 126 has a configuration in which an anterior half vertebral body 125 and a latter half vertebral disc 127 are connected via a pedicle 128 (see FIGS. 8 and 9). On the lamina 127, various processes such as a spinous process 123, a rib (lateral) process, an upper joint process, and a lower joint process are formed. The lumbar vertebra 126 is normally lightly bent toward the front side of the living body 120. The adjacent lumbar vertebra 126 is connected via an intervertebral disc (intervertebral disc) 129, and a certain lumbar vertebra and the lumbar vertebra adjacent to the lumbar vertebra are present between the intervertebral disc 129 and the upper and lower joint processes. Therefore, it is prevented from being displaced by the facet joint or the like (see FIG. 18).

For example, when a load is repeatedly applied to the lumbar vertebra 126 in sports or the like and a fatigue fracture or the like occurs, lumbar sequestration in which the vertebral body 125 and the lamina 127 are separated at the pedicle 128 portion, Deformation of the intervertebral joints and degeneration of the intervertebral disc 129 may make it difficult to fix the lumbar vertebra 126 located on the upper side, and may cause lumbar degenerative slippage that causes a shift. These lumbar spondylosis, lumbar spondylolisthesis, and ligaments placed around the lumbar vertebrae degenerate with age, causing the spinal canal to narrow and cause intermittent claudication that is a symptom of lumbar spinal canal stenosis There is. As a treatment method for such lumbar spinal canal stenosis, there is a treatment method for suppressing spinal canal stenosis by placing an implant 80 that can function as a spacer between adjacent spinous processes 123 (see FIG. 18). In the present embodiment, the medical instrument 10 is used for an indwelling procedure for placing the implant 80. FIG. 8 illustrates the orientation of the medical device 10 with respect to the back 121 of the living body 120 before the puncturing operation.

Next, each configuration of the medical instrument 10 will be described.

As shown in FIGS. 1, 3, and 4, the puncture unit 20 included in the medical device 10 can be configured by a curved needle whose outer shape is curved with a predetermined curvature. The medical instrument 20 is formed such that the diameter gradually decreases from the base end side attached to the main body portion 30 toward the distal end side, and the distal end portion 21 is formed in a thin and sharp shape. The tip 21 constitutes the needle tip of the curved needle. In the following description, the puncture portion will be described as a curved needle 20 and the tip portion of the puncture portion will be described as a needle tip 21.

The curved needle 20 is configured to be detachable from the main body 30 by a mechanical connection form by screwing or fitting. For this reason, when performing a procedure, it is possible to select and use the curved needle 20 having an arc length and a curvature corresponding to a puncture target position P and a puncture route that are set in advance before performing the procedure. It has become.

The material constituting the curved needle 20 is not particularly limited as long as it is a material that can be punctured into a living body. For example, SUS, titanium, magnesium, chromium, cobalt, nickel, aluminum, gold, silver, copper, iron, And resin materials such as polyetheretherketone (PEEK), polycarbonate (PC), polycarbonate urethane (PCU), reinforced polyphenylene (SRP), carbon or glass fiber reinforced polymer.

When performing various procedures using the medical instrument 10, various treatment members can be used in combination according to the contents of the procedure. When the medical device 10 is used for implant placement, for example, a guide member 70 as shown in FIG. 2 can be used.

The guide member 70 is formed on the body 71 curved with the same curvature as the curved needle 20 of the medical device 10, the opening 73 a formed on the distal end side of the body 71, and the proximal end side of the body 71. It has an opening 73b, a connection part 75 provided on the proximal end side of the body part 71 and connectable / detachable to the main body part 30 of the medical instrument 10, and a lumen 77 formed inside the body part 71. It can be constituted as follows.

As shown in FIG. 4, the curved needle 20 can be inserted into the lumen 77 of the guide member 70. The length of the guide member 70 is formed shorter than the length of the curved needle 20. For this reason, in a state where the curved needle 20 is inserted into the lumen 77, the needle tip 21 of the curved needle 20 is exposed from the opening 73a on the distal end side of the guide member 70 by a predetermined length. By setting the curved needle 20 in the lumen 77, the guide member 70 and the main body 30 of the medical device 10 can be assembled via the connection portion 75 provided on the guide member 70. .

The connecting portion 75 of the guide member 70 is configured to be mechanically connected to the connecting portion 37 provided on the main body portion 30 of the medical instrument 10 by fitting, for example. The configuration is not particularly limited as long as the configuration is separable.

As the material constituting the body 71 of the guide member 70, for example, the same material as that of the curved needle 20 of the medical instrument 10 described above can be used.

The function of the guide member 70 will be described. Guide member 70 is used to introduce implant 80 between adjacent spinous processes 123. As shown in FIG. 15, in the procedure of introducing the implant 80 into the living body, an operation of puncturing the curved needle 20 is performed in a state where the medical instrument 10 and the guide member 70 are assembled. Then, after the needle tip 21 of the curved needle 20 reaches a predetermined position between the adjacent spinous processes 123, the curved needle 20 is removed from the guide member 70 as shown in FIG. By performing this operation, the inside of the lumen 77 of the guide member 70 is emptied, and therefore, between the adjacent spinous processes 123 located near the opening 73a on the distal end side of the guide member 70 via the lumen 77. The implant 80 can be introduced into a predetermined site.

As shown in FIG. 1, the main body 30 of the medical instrument 10 is configured as a housing that can accommodate predetermined components such as a control unit 60 and a detection unit 50 therein. A curved needle 20 is attached to the distal end side of the main body 30. A power switch 39 for switching the supply state of the drive current to the control unit 60 to ON / OFF can be disposed on the base end side of the main body unit 30. A groove or the like that functions as a slip stopper when the main body 30 is gripped can be provided on the lower surface side of the main body 30. It should be noted that the outer shape and outer dimensions of the main body 30 are not limited to the illustrated configurations, and it is sufficient that the user using the medical instrument 10 can hold the hand 30 with his / her hands (left hand, right hand, or both hands). It can be changed according to the specifications.

As a material constituting the main body 30, a metal material generally used for a hard cover of an electronic device, a hard plastic material, or the like can be used.

As shown in FIG. 7, the control unit 60 included in the medical instrument 10 stores a calculation processing unit that performs predetermined calculation processing, a ROM that stores various programs related to calculation, calculation results calculated by the calculation processing unit, and the like. It can be configured to include a possible RAM, an EEPROM capable of storing data relating to the curvature of the bending needle 20, the length of the arc, and the like, and a control circuit that controls the overall operation of the control unit 60 in an integrated manner. Each component which comprises the control part 60 is mutually connected via predetermined | prescribed BUS for performing a control command and data transfer.

Although the detection part 50 with which the medical instrument 10 is provided is comprised by the well-known gyro sensor, if the inclination state of the main-body part 30 can be detected, the kind will not be specifically limited, For example, a magnetic sensor etc. A known angle detection sensor can also be used. The position where the detection unit 50 is installed in the main body unit 30 is not particularly limited. For example, the detection unit 50 can be accommodated and arranged in the main body unit 30 in the same manner as the control unit 60.

The light emitting unit 40 included in the medical instrument 10 is configured by a known light emitting LED that can emit visible light used as visible guide light, but can emit visible light that can function as guide light. If so, the type is not particularly limited. Although not shown, the light emitting unit 40 is provided with a direction control mechanism that allows the guide light to be emitted in an arbitrary direction. As this direction control mechanism, for example, a mechanism including an optical lens system configured to be rotatable around a plurality of axes can be used. The change of the guide light emission direction is performed by the control unit 60 controlling the operation of the direction control mechanism.

As the guide light, for example, light having a wavelength in a range of 360 nm to 830 nm, which is a general visible light wavelength, can be selected, and more preferably, red light having a wavelength of 400 nm to 760 nm is used. When the guide light is red light, the guide light can be easily visually recognized, so that the guide function by the guide light can be improved. Moreover, although the form which irradiates guide light continuously in the shape of a beam is employ | adopted, the form which irradiates guide light intermittently, leaving a time difference, for example can also be employ | adopted. In each figure, the guide light is indicated by a two-dot chain line L1.

For example, as shown in FIG. 1, the light emitting unit 40 is arranged so that a part thereof is exposed on the outer surface of the main body 30, and the other part is accommodated in the main body 30. The exposed portion of the light emitting unit 40 functions as an emitting end that guides guide light to the outside of the main body 30. In the present embodiment, in order to facilitate the calculation of the displacement of the emission angle, which will be described later, the emission end of the light emission unit 40 moves along the movement locus R formed by the needle tip 21 of the curved needle 20. In addition, the arrangement of the light emitting portion 40 is designed (see FIG. 10).

As shown in FIGS. 5 and 6, the main body unit 30 is provided with an input receiving unit 31 that receives input of various data necessary for controlling the operation of the light emitting unit 40 by the control unit 60.

The input receiving unit 31 can be arranged inside the main body unit 30. Further, for example, the input receiving unit 31 can be covered with an openable / closable slide-type lid 33 provided in the main body unit 30. The positions where the input receiving unit 31 and the lid 33 are provided are not limited to the illustrated positions, and can be provided at arbitrary positions according to product specifications. Moreover, it is possible to employ | adopt the thing of structures other than the slide-type lid | cover 33 as a member which covers the input reception part 31, and installation of such a lid | cover 33 can also be abbreviate | omitted.

As shown in FIG. 6, the input receiving unit 31 is configured by a known liquid crystal display, but the type thereof is not particularly limited as long as the user can check the input content. For example, a dial input type or a voice input type can be used for the input receiving unit 31. The input receiving unit 31 can be added with a known capacitive touch panel function or the like.

Next, an overall control flow by the control unit 60 will be described with reference to FIG.

Each data input via the input receiving unit 31 is transmitted to the control unit 60. This transmission can be performed by, for example, a known lead wire or electric wire used for data transmission, and can also be performed by wireless communication as will be described in an embodiment described later.

When the main body 30 is operated in order to puncture the living body with the curved needle 20, data regarding the tilted state of the main body 30 is updated. The updated data is sequentially transmitted from the detection unit 50 to the arithmetic processing unit of the control unit 60. The arithmetic processing unit included in the control unit 60 calculates a numerical value necessary for operation control using each data. Then, the control circuit controls the operation of the light emitting unit 40 based on the data. The transmission of data and the like between the detection unit 50 and the control unit 60 can be performed in the same manner as the transmission method between the input reception unit 31 and the control unit 60.

Next, preparation work before performing a procedure using the medical instrument 10 will be described.

First, an operation of setting a puncture target position P that is a target for reaching the needle tip 21 of the curved needle 20 is performed.

The puncture target position P can be arbitrarily set according to the content of the procedure using the medical instrument 10, but in this embodiment, as shown in FIGS. A puncture target position P is set between the spinous processes 123 to be performed.

Referring to FIG. 10, after setting puncture target position P, a distance from living body surface 130 to puncture target position P (hereinafter also referred to as “distance D1”) is measured. As a measurement method, for example, measurement can be performed based on an image acquired using a known medical apparatus such as an X-ray fluoroscopic apparatus, MRI, or an ultrasonic diagnostic imaging apparatus. Further, for example, the distance D1 may be measured by photographing a measuring instrument with a scale indicating the length together with a living body and reading the scale. In addition, the living body surface 130 in this embodiment means the outer surface of the living body's epidermis.

When the puncture target position P is set between the adjacent spinous processes 123, the irradiation target position F of the guide light is, for example, a virtual perpendicular V extending from the puncture target position P toward the living body surface 130, and the living body surface 130. Can be set at the intersection. When set in this way, as will be described later, the puncture operation is performed in a state where the guide light is irradiated immediately above the puncture target position P, and the puncture target position P can be easily visually grasped. Therefore, it becomes easy to perform the procedure smoothly.

Next, the curved needle 20 used for the procedure is selected.

As described above, the curved needle 20 has an arcuate outer shape in which the movement locus drawn by the needle tip 21 of the curved needle 20 forms a circle R. For this reason, in order to enable the needle tip 21 of the curved needle 20 to reach the puncture target position P, the curved needle 20 is selected so that the radius r of the circle R that is the movement locus is at least the distance D1. Is done. The movement locus drawn by the needle tip 21 when the curved needle 20 is used is naturally determined by the length of the arc of the curved needle 20 and the curvature of the curved needle 20. In the drawing, a circle which is a movement locus of the needle tip 21 of the curved needle 20 is indicated by a symbol R.

In the procedure in the present embodiment, the puncture route passing through the puncture target position P is set so as to overlap with a part of the circle R that is the movement locus. That is, when the needle tip 21 of the curved needle 20 moves along the circle R, the needle tip 21 moves along the puncture route passing through the puncture target position P. In FIG. 10, the puncture route is indicated by an arrow W.

Next, an operation of inputting predetermined data to the control unit 60 of the medical instrument 10 is performed.

The data input operation is performed via an input receiving unit 31 provided in the main body unit 30. FIG. 6 shows a display example of the input receiving unit 31 when data is input. The user performs an input operation via the displayed numerical keys and the like, and performs a needle radius (first data regarding the radius of the circle R) and a distance D1 (a first distance regarding the distance from the puncture target position P to the irradiation target position F). 2 data). The radius of the needle is the radius r of the circle R drawn by the needle tip 21 (not shown in FIG. 6). In order to facilitate understanding of the numerical value to be input to the user, for example, In the input receiving unit 31, the radius of the needle can be displayed.

Since the radius of the needle to be input is different for each selected curved needle, for example, the numerical value is attached to the curved needle 20 in advance so that the user can easily check the numerical value during the data input operation. The numerical value can be added in advance to a case for storing the curved needle 20 or the like.

Next, an operation for setting the irradiation target position F of the guide light is performed. This setting can be performed by the following procedure.

As shown in FIG. 11, the main body 30 is positioned so that the guide light is irradiated from the vertical direction with respect to the irradiation target position F. The curved needle 20 is disposed so that the needle tip 21 of the curved needle 20 overlaps a part of a circle R that is a movement locus. This positioning operation is performed by referring to the known radius of the curved needle 20 so that the proximal end side of the curved needle 20 is located at a position away from the puncture target position P by a distance corresponding to the diameter thereof. This is done by adjusting the orientation and position.

After arranging the medical instrument 10 as described above, guide light is emitted from the light emitting unit 40. The position on the living body surface 130 where the guide light is irradiated becomes the irradiation target position F. Thus, the irradiation target position F is set at a position where the virtual perpendicular V extended from the puncture target position P intersects the living body surface 130. When the medical instrument 10 is used for implant placement between adjacent spinous processes, the irradiation target position F and the puncture target position P can be set, for example, on the midline M of the living body (FIG. 8). reference).

Then, the puncturing operation is performed by operating the main body 30 so that the movement locus drawn by the needle tip 21 of the curved needle 20 becomes a circle R as shown in FIG. As described above, by operating the main body 30 in this manner, the needle tip 21 of the curved needle 20 can be moved along the puncture path passing through the puncture target position P.

As described above, before performing the puncturing operation, operations such as determination of the puncture target position P, selection of the curved needle, data input to the input receiving unit, and determination of the irradiation target position F are performed.

Next, an example of operation control of the light emitting unit 40 by the control unit 60 will be described.

Referring to FIG. 10, when the main body 30 is operated in the puncturing operation, the inclined state of the main body 30 with respect to the biological surface 130 changes. The amount of change in the tilt state is represented by the tilt angle θ formed by the virtual perpendicular V and the tilt of the main body 30.

The control unit 60 controls the operation of the light emitting unit 40 to change the emitting direction of the guide light when the tilt state of the main body unit 30 changes (see FIG. 7). The angle for changing the guide light emission angle is calculated by an arithmetic processing unit included in the control unit 60. The arithmetic processing unit includes a radius r of the circle R drawn by the movement locus of the needle tip 21, a distance D2 from the irradiation target position F to the center O of the circle R (hereinafter also referred to as “distance D2”), and the detection unit 50. Based on the detection result, the displacement of the emission angle of the guide light before and after the operation of the main body 30 is calculated. Note that the detection result of the detection unit 50 means the inclination angle θ of the main body 30 after the operation.

An example of a calculation formula for calculating the displacement of the emission angle will be described.

Referring to FIG. 10, the displacement of the emission angle is a length corresponding to the line segment a (distance D2) from the irradiation target position F to the center O of the circle R and the radius of the circle R drawn by the movement locus of the needle tip 21. The cosine function can be applied to the virtual triangle T formed by the line segment b and the line segment c (distance D3) from the light emitting unit 40 to the irradiation target position F. In the figure, the internal angle formed by the line segment b and the line segment c is denoted by α, the internal angle formed by the line segment a and the line segment c is denoted by β, and the internal angle formed by the line segment a and the line segment b is denoted by γ. Show. The object to be calculated is an internal angle α that is a displacement of the emission angle of the guide light when the main body 30 is at the inclination angle θ. In the following mathematical formulas, in order to facilitate understanding, the length of each line segment is indicated by symbols a, b, and c representing the line segment, respectively.

First, let the following formula 1 regarding the cosine theorem of the virtual triangle T be a basic formula.

Next, based on the cosine theorem, the above formula 1 is changed to the following formula 2 which is a trigonometric function formula for the interior angle α.

The values of the length D2 of the line segment a and the length r of the line segment b are numerical values given as a precondition for the calculation. On the other hand, the length D3 of the line segment c is a numerical value that changes according to the amount of operation of the main body 30. For this reason, the line segment c is removed from Equation 2 above, and the following Equation 3 expressed by a trigonometric function related to the interior angle α is obtained.

Then, the above Equation 3 is represented by the following Equation 4 represented by an inverse trigonometric function with respect to the interior angle α.

As a calculation example by the above formula 4, for example, the radius r of the circle R that is the movement locus is 60 mm, the distance D1 from the puncture target position P to the living body surface 130 is 40 mm, and the inclination angle θ of the main body 30 is 30 °. When the value of the inner angle α (displacement of the outgoing angle) is calculated, it is obtained as follows.

The distance D2 of the line segment a is 20 mm which is a value obtained by subtracting the distance D1 from the radius r. Since the inner angle γ is the amount of change in the inclination angle θ from the virtual perpendicular, it is 150 °, which is a value obtained by subtracting the inclination angle θ from 180 °. When calculation is performed by substituting a (distance D2), b (radius r), and interior angle γ into Equation 4, the interior angle α is determined to be 7.37 °. Therefore, when the main body 30 is inclined by 30 ° from the initial state, the control unit 60 controls the operation of the light emitting unit 40 so that the emission angle of the guide light emitted from the light emitting unit 40 is changed by 7.37 °. Is done.

The above calculation is performed by an arithmetic processing unit included in the control unit 60. Therefore, when performing a procedure using the medical instrument 10, a change in the tilted state of the main body 30 can be performed simply by inputting the value of the radius r and the value of the distance D1 into the input receiving unit 31 provided in the main body 30. Accordingly, the displacement α of the emission angle is automatically calculated, and the emission angle of the guide light is automatically corrected based on the result.

Next, the auxiliary light emitting unit 45 and the shape confirmation unit 35 provided in the medical instrument 10 will be described.

As shown in FIG. 1, an auxiliary light emitting unit that emits visible guide light (hereinafter referred to as “auxiliary guide light”) toward the needle tip 21 of the curved needle 20 on the main body 30 of the medical instrument 10. 45 can be provided. The operation of the auxiliary light emitting unit 45 is controlled by the control unit 60 (see FIG. 7). During the procedure using the medical instrument 10, the control unit 60 performs operation control so that the auxiliary guide light emitted from the auxiliary light emitting unit 45 is applied to the needle tip 21 of the curved needle 20 (FIG. 10 to FIG. 10). FIG. 15). In each figure, auxiliary guide light is indicated by a two-dot chain line L2.

Control of the emission direction of the auxiliary guide light is executed based on a program stored in advance in a ROM provided in the control unit 60. However, since the emission direction of the auxiliary guide light is maintained in a constant direction regardless of the operation of the main body 30, the process of correcting the emission angle as in the light emission unit 40 is not necessary. For this reason, it is not necessary to provide the auxiliary light emitting unit 45 with the direction control mechanism provided in the light emitting unit 40.

The auxiliary light emitting unit 45 is configured by a known light emitting LED that can emit visible light used as visible guide light, as with the light emitting unit 40, for example, but visible light that can function as guide light. The type is not particularly limited as long as it is possible to irradiate light. Further, as the auxiliary guide light, for example, light having a wavelength in the range of 360 nm to 830 nm, more preferably in the range of 400 nm to 760 nm can be selected, and the auxiliary guide light is continuously irradiated in the form of a beam. It is the same as the light emitting unit 40 in that it can be configured to be irradiated intermittently with an arbitrary time difference.

The position where the auxiliary light emitting portion 45 is installed is not particularly limited as long as it is a position where guide light from the main body portion 30 to the needle tip 21 of the curved needle 20 is possible. For example, as shown in FIGS. It can be installed on the lower side of the main body 30 than the emitting part 40.

As shown in FIG. 1, a main body portion 30 of the medical instrument 10 can be provided with a shape confirmation portion 35 on which a graphic representing the outer shape of the curved needle 20 is written. The shape confirmation unit 35 is used for confirming a standard of how much the curved needle 20 is inserted into the living body and in which direction the needle tip 21 is directed when performing the puncturing operation. Yes (see FIG. 12). The position where the shape confirmation unit 35 is installed is not particularly limited as long as it is a position that can be viewed by the user during the puncturing operation. For example, the shape confirmation unit 35 may be installed on the side surface of the main body 30 as shown in FIG. it can. When installed at such a position, it is possible to easily view even when the medical instrument 10 is held.

In the medical instrument 10, since the puncture part is constituted by the curved needle 20, the pattern written on the shape confirmation part 35 is also a curved needle. However, when other members are used as the puncture part Each time, it is possible to change the symbol attached to the shape confirmation unit 35. Moreover, in order to be able to change a design, the shape confirmation part 35 can be comprised with the member which can be affixed etc. with respect to the main-body part 30, for example. Further, for example, a liquid crystal display or the like can be used for the shape confirmation unit 35 so that various shapes can be displayed.

Next, referring to FIGS. 5, 6 and 11 to 18, an example of use of the medical instrument 10 and its operation will be described.

First, as shown in FIG. 5, the power switch 39 provided in the medical instrument 10 is turned on. Then, as shown in FIG. 6, predetermined data such as first data related to the radius of the curved needle 20 and second data related to the distance from the puncture target position P to the irradiation target position F via the input receiving unit 31 included in the main body 30. Enter the data. Further, the curved needle 20 and the guide member 70 are connected to each other so that both members are assembled.

As shown in FIG. 11, the user grasps the main body 30 and confirms that the guide light is irradiated to the irradiation target position F. Also, it is confirmed that the auxiliary guide light is applied to the needle tip 21 of the curved needle 20. In the procedure, the guide light is emitted toward the irradiation target position F, but it is not necessary to actually irradiate the living body surface 130 directly. For example, when a patient to be treated wears clothes or the like, the guide function of puncture by guide light is not impaired even if the clothes or the like are irradiated.

Next, as shown in FIG. 12, the main body 30 is operated so that the needle tip 21 moves on a circle R that overlaps the puncture path passing through the puncture target position P. In this way, the medical instrument 10 is operated to insert the needle tip 21 of the curved needle 20 into the living body. In the figure, the state where the auxiliary guide light is irradiated so as to reach the inside of the living body is illustrated, but this is illustrated for easy understanding of the irradiation position of the auxiliary guide light. There is no need for the auxiliary guide light to reach the inside of the living body.

The control unit 60 controls the operation of the light emitting unit 40 in accordance with the change in the tilt state of the main body unit 30 to correct the emission angle of the guide light. By this correction, irradiation of the guide light to the irradiation target position F is maintained. Therefore, the user using the medical instrument 10 confirms that the needle tip 21 of the curved needle 20 has moved in an appropriate direction by confirming that the guide light is irradiated to the irradiation target position F. can do. When the curved needle 20 is moved in the direction opposite to the puncture direction during the puncture operation, or when the curved needle 20 is removed from the living body after the puncture operation is completed, the irradiation position of the guide light is confirmed. The curved needle 20 can be easily and smoothly moved through the punctured path.

Here, for example, as shown in FIG. 13, when the main body 30 is operated so that the needle tip 21 of the curved needle 20 moves out of the circle R, the irradiation of the guide light to the irradiation target position F is maintained. Not. For this reason, the user can grasp | ascertain that the curved needle 20 has shifted | deviated from the puncture path | route during the procedure only by confirming the irradiation position of guide light visually.

When such a deviation occurs, the inclination and position of the main body 30 are adjusted so that the guide light is irradiated to the irradiation target position F while visually confirming the irradiation position of the guide light. By this operation, the needle tip 21 of the curved needle 20 can be directed in an appropriate direction. While the procedure is being performed, positional displacement may occur in a direction perpendicular to the paper surface, but the puncture operation is performed with the user looking down from the upper side of the medical instrument 10 as a whole. Therefore, the positional deviation in the direction orthogonal to the paper surface can be easily corrected visually.

As shown in FIG. 14, the main body 30 is operated so that the needle tip 21 moves toward the puncture target position P while confirming the irradiation position of the guide light.

As shown in FIG. 15, after at least the needle tip 21 of the curved needle 20 reaches the puncture target position P, the puncture operation is finished.

As described above, the needle tip 21 can be easily and quickly guided to the puncture target position P by performing the puncture operation while confirming the position where the guide light is irradiated. While performing the puncturing operation, it is possible to perform the puncturing operation more easily and quickly by visually recognizing the irradiation position of the auxiliary guide light or visually recognizing the shape confirmation unit 35.

Subsequent to the puncture operation, a procedure for placing the implant 80 functioning as an interspinous process spacer around the puncture target position P will be described. In addition, since the following procedure becomes the treatment content after using the medical instrument 10, it demonstrates simply.

As shown in FIG. 16, after the puncturing operation is completed, the guide member 70 and the medical instrument 10 are separated and the medical instrument 10 is removed from the living body. Next, the implant 80 is introduced into the living body through the lumen 77 of the guide member 70.

The type and configuration of the implant 80 are not particularly limited. For example, a flexible balloon (container) that can be expanded and deformed by introducing a filler therein can be used. Further, as the implant 80, for example, an implant configured so that both

end portions

81a and 81b project and deform in the arrangement direction of the spinous processes 123 after expansion and the outer shape thereof becomes an H shape or a dumbbell shape is used. be able to. By using such an implant 80, it is possible to place the spinous process 123 with both

end portions

81a and 81b of the implant 80 interposed therebetween, and thus it is preferable to prevent the implant 80 from being displaced. (See FIG. 18).

As the filler, solid or fluid (gas, liquid, gel), bone cement that causes a hardening reaction after introduction, or the like can be used. For introducing the filler into the implant 80, a known fluid supply device 90 such as a syringe pump capable of pumping fluid or the like can be used. The implant 80 and the fluid supply device 90 can be connected in advance by a known tube member 91 or the like through which a fluid or fluid can flow. The implant 80 and the tube member 91 can be detachably connected by fitting, screwing, excision, or the like.

As shown in FIG. 17, the guide member 70 is removed, and the implant 80 is exposed from the guide member 70. Then, the fluid supply device 90 and the tube member 91 are connected by fitting or screwing, and a predetermined filler is introduced and expanded into the implant 80 via the tube member 91 by the fluid supply device 90. After expansion, the tube member 91 is separated from the implant 80 and removed from the living body. The implant 80 can be provided with a seal member, a valve, or the like that prevents the filler from leaking from a position where the implant 80 and the tube member 91 are connected.

As shown in FIG. 18, the implant 80 is placed in an expanded state between adjacent spinous processes 123. By placing the implant 80, the interval between the adjacent spinous processes 123 can be maintained at a predetermined size, and a therapeutic effect on the symptoms of lumbar spinal canal stenosis can be obtained.

As described above, according to the medical instrument 10 according to the present embodiment, when the needle tip 21 of the curved needle 20 is moved along the predetermined puncture path to the puncture target position P set in the living body, By confirming the position where the guide light emitted from the emitting unit 40 is irradiated, it is possible to appropriately determine whether the needle tip 21 of the curved needle 20 is moving along the puncture route. When it is confirmed that the needle tip 21 of the curved needle 20 is shifted from the puncture path during the puncturing operation, the movement direction of the needle tip 21 of the curved needle 20 is simply determined based on the irradiation position of the guide light. It becomes possible to correct. For this reason, the puncture operation using the medical instrument 10 including the curved needle 20 can be performed easily and quickly, and a minimally invasive procedure can be realized.

Further, the curved needle 20 has an arcuate outer shape, and the arithmetic processing unit provided in the control unit 60 is configured to calculate the displacement of the guide light emission angle based on the outer shape of the curved needle 20. Therefore, a procedure using the medical instrument 10 including the curved needle 20 can be performed easily and quickly. In addition to this, since the emission direction of the guide light can be controlled with high accuracy in accordance with the displacement of the emission angle calculated by the calculation processing unit provided in the control unit 60, the curved needle 20 from the puncture route during the puncture operation. It is possible to suitably prevent the deviation from occurring.

In addition, an input receiving unit 31 that receives input of data for calculating the emission angle of the guide light is provided in the main body unit 30, and the arithmetic processing unit is configured to execute various calculations based on the input data. Therefore, when performing a procedure using the medical instrument 10, it is necessary to control the emission direction of the guide light by inputting various data to the input receiving unit 31 provided in the main body unit 30. Numerical values can be calculated. For this reason, even when the medical instrument 10 is diverted between procedures with different puncture target positions P, or when the main body 30 is diverted between procedures using the curved needle 20 having a different arc length or curvature, the procedure is not limited. The operation setting of the light emitting unit 40 can be performed by a simple operation of inputting predetermined data before starting.

Further, since the auxiliary light emitting portion 45 for irradiating auxiliary emitted light to the needle tip 21 of the curved needle 20 is provided in the main body portion 30, the position of the needle tip 21 of the curved needle 20 can be easily set during the procedure. It can be confirmed, and the puncturing operation can be performed more easily and quickly.

Moreover, since the main body part 30 is provided with the shape confirmation part 35 showing the external shape of the curved needle 20, the amount of insertion of the curved needle 20 into the living body can be determined by observing the shape confirmation part 35 during the procedure. In addition, it is possible to grasp the direction in which the puncture unit is facing. Therefore, the puncturing operation with the curved needle 20 can be performed more easily and safely.

Further, the puncture portion is configured by a curved needle 20 whose tip portion forms the needle tip 21, the puncture target position P is set at a predetermined site between adjacent spinous processes, and the irradiation target position F is: Since the virtual perpendicular V extending from the puncture target position P toward the living body surface 130 and the living body surface 130 are set to intersect, any puncture target position P set between adjacent spinous processes in the living body is set. The needle tip 21 of the curved needle 20 can be guided easily and quickly.

Second Embodiment
Next, a medical instrument according to a second embodiment of the present invention will be described. The same members as those described in the first embodiment are denoted by the same reference numerals, and the description thereof is omitted.

Although the medical instrument 10 according to the first embodiment is configured to be able to input various types of data via the input receiving unit 31 provided in the main body unit 30, for example, various data input operations are performed. It is also possible to carry out via an external input device provided separately from the main body 30. The medical instrument according to the second embodiment is different from the medical instrument according to the first embodiment in that data input via an external input device is possible. In addition, since each structure except the control part 60 can be comprised similarly to the medical device which concerns on 1st Embodiment, description is abbreviate | omitted about structures other than the control part 60. FIG.

FIG. 19 shows an overall configuration of the control unit 60 included in the medical instrument according to the second embodiment. The external input device is configured by a PC or the like which is another device different from the medical instrument. The first data related to the radius of the circle R input to the external input device and the second data related to the distance from the puncture target position P to the irradiation target position F are, for example, publicly known information such as a wireless LAN or Bluetooth (registered trademark). The data is transmitted to a data receiving unit (corresponding to the input receiving unit 31) included in the control unit 60 by wireless communication means. After receiving the data, the control unit 60 causes the arithmetic processing unit to execute various calculations according to the same procedure as the medical instrument 10 according to the first embodiment.

Even when the medical instrument according to the present embodiment is used, it is possible to perform the puncturing operation easily and quickly by controlling the emission direction of the guide light emitted from the light emitting unit 40. This is the same as the medical device 10 according to the embodiment. In addition, since data input using an external input device is possible, it is possible to provide a medical instrument with further improved convenience.

<Modification example>
The medical instrument according to the first and second embodiments described above employs a configuration that allows the curved needle 20 to be removed from the main body 30, and when using the medical instrument, the curvature according to the purpose of the procedure, A curved needle 20 having an arc length can be used. For example, as a modification of the medical instrument, a configuration in which the curved needle 20 is integrally attached to the main body 30 can be adopted. In the case of such a configuration, the first data regarding the radius of the circle R is stored in advance in a ROM or the like provided in the control unit 60, thereby eliminating the need to input radius data as an initial setting when performing a procedure. . The arithmetic processing unit calculates the displacement of the emission angle of the guide light based on the second data regarding the distance from the puncture target position P to the irradiation target position F, which is input as an initial condition, and the first data stored in advance. Further, irradiation / non-irradiation switching of the guide light and the auxiliary guide light may be performed by a switch or the like separately provided in the main body 30. Thereby, it becomes possible to prevent unnecessary irradiation while the medical instrument 10 is not used.

As described above, the medical instrument according to the present invention has been described through a plurality of embodiments and modified examples. However, the present invention relates to a medical instrument having a curved puncture unit, and the puncture unit has a function of Guide light serving as a guide for guiding the movement is irradiated toward an arbitrary irradiation target position on the surface of the living body so that the movement path of the distal end portion can be moved along the puncture path passing through the puncture target position. While the puncture unit is moving along the puncture route, it can be changed as long as the irradiation of the guide light to the irradiation target position can be maintained by the operation control of the control unit. For example, the configuration of the entire medical instrument, the control method by the control unit, the calculation method by the arithmetic processing unit, and the like can be changed within a range in which the above-described object can be achieved.

Further, in the description of the embodiment, a form in which a curved needle having a needle structure is used as a curved puncture part is shown. However, the puncture part is formed in a curved shape with a predetermined curvature, and a living body Any device can be used as long as it can be inserted into at least a part. For example, in addition to a needle, a scalpel, a reamer, a treatment tool used for sampling a tissue, excision of an affected part, and the like can be used as a puncture unit. Even in the case where the puncture portion is constituted by a needle, the use of the needle is not limited, and for example, a suture needle, a biopsy needle, or the like can be used.

Also, the treatment performed using a medical instrument is not limited to the procedure for introducing the implant between the spinous processes, and can be changed according to the use of the puncture part used. Similarly, the puncture target position, puncture route, guide light irradiation target position, and the like can be appropriately changed according to the configuration of the puncture unit, the content of treatment, and the like.

10 medical devices,
20 curved needle (puncture),
21 Needle tip (tip),
30 body part,
31 Input reception part,
35 Shape confirmation part,
40 light emitting part,
45 Auxiliary light emitting part,
50 detector,
60 control unit,
80 implants,
120 living body,
123 Spinous processes,
130 biological surface,
F irradiation target position,
P Puncture target position,
V Virtual perpendicular,
L1 guide light,
L2 Auxiliary guide light.

Claims

A curved puncture part capable of puncturing a living body;
A graspable main body provided with the puncture portion;
A light emitting part that is provided in the main body part and emits visible guide light toward an irradiation target position set at an arbitrary position on the surface of the living body;
A detection unit for detecting an inclination state of the main body with respect to the surface of the living body into which the puncture unit is inserted;
A medical device having a control unit for controlling the operation of the light emitting unit,
When the main body is operated so that the tip of the puncture unit moves along a puncture path that passes through the puncture target position in the living body, the control unit is configured based on the detection result of the detection unit. By controlling the operation of the light emitting section, the medical instrument is configured to change the emission angle of the guide light so that the irradiation of the guide light to the irradiation target position is maintained.
The puncture part has an arcuate outer shape in which a movement locus drawn when the tip of the puncture part moves makes a circle,
The controller is
An arithmetic processing unit that calculates a displacement of the emission angle of the guide light before and after the operation of the main body based on the radius of the circle, the distance from the irradiation target position to the center of the circle, and the detection result of the detection unit; The medical instrument according to claim 1, further comprising: changing the emission angle of the guide light according to the displacement of the emission angle calculated by the arithmetic processing unit.
The main body includes an input receiving unit that receives input of first data related to a radius of the circle and second data related to a distance from the puncture target position to the irradiation target position,
The medical instrument according to claim 2, wherein the arithmetic processing unit calculates a distance from the irradiation target position to the center of the circle based on the first data and the second data.
The medical instrument according to any one of claims 1 to 3, further comprising: an auxiliary light emitting portion that is provided in the main body portion and emits visible guide light toward a distal end portion of the puncture portion. .
The medical device according to any one of claims 1 to 4, wherein the main body portion includes a shape confirmation portion on which a graphic representing the outer shape of the puncture portion is written.
The puncture portion is constituted by a curved needle whose tip portion forms a needle tip,
The puncture target position is a predetermined site between adjacent spinous processes,
The medical instrument according to any one of claims 1 to 5, wherein the irradiation target position is a position where a virtual perpendicular extending from the puncture target position toward the living body surface and a living body surface intersect.