WO2015001661A1

WO2015001661A1 - Medical assistance tool, medical tool, and method of measuring distance

Info

Publication number: WO2015001661A1
Application number: PCT/JP2013/068509
Authority: WO
Inventors: 康之本間
Original assignee: テルモ株式会社
Priority date: 2013-07-05
Filing date: 2013-07-05
Publication date: 2015-01-08

Abstract

[Problem] To provide a medical assistance tool, a medical tool, and a method of measuring distance with which, in the performance of a variety of techniques in which a puncture member provided with a predetermined radius of curvature is used, the preparatory work for these techniques can be performed with ease and precision on the basis of X-ray images, thus making it possible to implement the techniques in a minimally-invasive manner. [Solution] An assistance tool (10) has the following: a sheet-shaped main body (20) having flexibility; an X-ray imaging unit (30) that is provided to the main body and extends in a plane direction intersecting the thickness direction of the main body; and an insertion position display unit (40) that is provided to the main body at a predetermined distance from the X-ray imaging unit, and indicates a position for insertion of the puncture member into a living body, such position determined in accordance with the radius of curvature of the puncture member.

Description

Medical aid, medical instrument, and distance measurement method

The present invention relates to a medical aid, a medical instrument, and a distance measuring method.

As a medical instrument that can puncture a living body such as a guide needle for introducing various introduction media and members into a living body, a suturing needle used for suturing living tissue, a surgical knife and knife used for cutting skin, etc. A puncture member formed in an outer shape curved with a predetermined curvature may be used (see, for example, Patent Document 1).

In general, in a procedure using the puncture member as described above, first, a site to be treated by a living body, that is, a target site to reach the puncture member is set. Next, a puncture member having a radius of curvature that can reach the target site from the surface of the living body (skin surface layer) is selected. And the puncture path | route which goes to the target site | part set in the biological body from the predetermined puncture position on the biological body surface is set, and a puncture member is moved along the puncture path | route.

Each preparatory work before the puncture of the puncture member can be performed based on, for example, an X-ray image obtained by X-ray imaging of a subject (patient). As a specific work procedure, the technician refers to the photographed X-ray image and measures the distance from the living body surface to the target site. Next, a puncture member having an appropriate curvature radius corresponding to the measured distance is selected. Then, based on the curvature radius, a puncture path connecting the target site and the biological surface is set, and a position that is an intersection of the puncture path and the biological surface is set as the insertion position of the puncture member.

US Patent Application Publication No. 2011/0144697

As described above, the method for performing each preparation work based on the X-ray image may cause the following problems.

The surface of the living body into which the puncture member is inserted has lower X-ray contrast properties (higher X-ray permeability) than bones and organs existing inside the living body, and the surface of the living body is not clearly displayed on the X-ray image. Sometimes. For this reason, the position of the biological surface cannot be identified on the X-ray image, and the distance from the biological surface to the target site cannot be accurately measured based on the X-ray image. As a result, it is not possible to select a puncture member having an appropriate radius of curvature, and it is not possible to set a puncture route and a puncture position that are determined according to the radius of curvature of the puncture member. Therefore, in the conventional method, various preparatory work performed prior to the procedure using the puncture member becomes complicated, and a puncture member having an appropriate radius of curvature cannot be selected, which is minimally invasive. It is difficult to realize the procedure.

Therefore, the present invention makes it possible to easily and accurately perform the preparation of the procedure based on the X-ray image when performing various procedures using the puncture member having a predetermined radius of curvature, and is minimally invasive. It is an object of the present invention to provide a medical auxiliary tool, a medical instrument, and a distance measuring method capable of realizing a procedure.

The present invention can be achieved by any of the following means (1) to (10).

(1) A medical auxiliary tool used for assisting an operation of puncturing a living body with a puncture member having a predetermined radius of curvature, which is provided in a flexible sheet-like main body, and provided in the main body An X-ray contrast unit extending in a plane direction intersecting the thickness direction of the main body unit, and provided in the main body unit at a predetermined distance from the X-ray contrast unit, and having a radius of curvature of the puncture member And an insertion position display unit that indicates the insertion position of the puncture member into the living body determined accordingly.

(2) The X-ray contrast unit includes a length reference unit that serves as a reference for a length when measuring a length dimension based on an X-ray image taken from a side surface direction of the main body (1) ) Auxiliary device described in the above.

(3) The auxiliary tool according to (2), wherein the length reference portion includes a plurality of X-ray contrast marker portions that are spaced apart from each other in a direction in which the X-ray contrast portion extends.

(4) The auxiliary tool according to (2) or (3), wherein the length reference portion includes an X-ray contrast member having a predetermined thickness dimension along a thickness direction of the main body portion.

(5) The auxiliary tool according to (4), wherein the X-ray contrast member has at least a first X-ray contrast member and a second X-ray contrast member having different thickness dimensions.

(6) The X-ray contrast unit is arranged so that an outer shape of the main body when viewed in plan is a linear shape, and the insertion position display unit extends in parallel to the X-ray contrast unit. The auxiliary device according to any one of (1) to (5), which is arranged in a straight line shape.

(7) The insertion position display unit includes at least a first display unit and a second display unit that are disposed apart from each other in a direction away from the X-ray contrast unit. The auxiliary tool as described in one.

(8) The auxiliary device according to any one of (1) to (7), wherein the main body portion and the insertion position display portion have X-ray transparency.

(9) Via a predetermined position of the living body indicated by the assisting device according to any one of (1) to (8) above and the insertion position display unit provided in the main body of the assisting device A medical device having a puncture member that is percutaneously inserted into a living body and that is punctured toward a target site set around a spinous process of the living body.

(10) The direction of the side surface of the main body in a state where an auxiliary tool having a flexible sheet-like main body provided with an X-ray contrast unit extending in a plane direction intersecting the thickness direction is disposed on the living body. A distance measurement method for measuring a distance from a living body surface to a target site set at an arbitrary position in a living body based on an X-ray image of the X-ray contrast unit included in an X-ray plane image captured from .

According to the invention described in (1) above, X-ray imaging is performed on the surface of the living body together with the auxiliary tool in a state where the auxiliary tool is disposed on the surface of the living body. The position of the living body surface can be displayed on the line image so as to be identifiable. And by referring to the photographed X-ray image, it becomes possible to easily and accurately measure the distance between the target site set in the living body and the surface of the living body. The puncture member can be selected. As a result, since it is possible to set a puncture route and a puncture position according to the radius of curvature of the puncture member, various procedures using the puncture member can be performed in a minimally invasive manner.

According to the invention described in (2) above, when a predetermined distance is measured based on an X-ray image, the measurement can be performed easily and accurately by referring to the length reference portion of the X-ray contrast unit. Is possible.

According to the invention described in (3) above, a plurality of X-ray contrast marker portions included in the length reference portion are arranged apart from each other in the extending direction of the X-ray contrast portion, and therefore a predetermined distance is measured. It is possible to easily identify the length serving as a reference when visually checking, and it is possible to perform measurement more easily and accurately.

According to the invention described in (4) above, since the X-ray contrast member of the length reference portion has a predetermined thickness dimension, the thickness dimension of the X-ray contrast member is used as a reference when measuring a predetermined distance. By doing so, it becomes possible to perform measurement more easily and accurately. In addition, since an X-ray contrast member can be clearly projected on the X-ray image when an X-ray image is taken from the side of the main body, the measurement of a predetermined distance using the X-ray contrast member can be accurately performed. It becomes possible to do.

According to the invention described in (5) above, since the X-ray contrast member has the first X-ray contrast member and the second X-ray contrast member having different thickness dimensions, at least two lengths are measured when measuring a predetermined distance. It becomes possible to use the standard of the length, and the measurement can be performed more accurately. In addition, since the relative position of each contrast member can be easily identified visually on an X-ray image taken from the direction of the side surface of the main body of the assisting tool, the target set in the living body The positional relationship between the part and each part of the assisting tool can be easily grasped, and the insertion position for inserting the puncture member can be easily set.

According to the invention described in (6) above, since the insertion position display unit is arranged in a linear shape extending in parallel to the X-ray imaging unit arranged in a linear shape, the X-ray imaging unit and the insertion position The positional relationship of the display unit can be easily confirmed visually. For this reason, the operation | work which inserts a puncture member can be performed safely and rapidly.

According to the invention described in (7) above, since the insertion position display unit includes the first display unit and the second display unit that are arranged apart from each other, the puncture member having a different curvature radius is used. Even when the auxiliary tool is diverted between procedures, the insertion position of the puncture member can be determined easily and accurately.

According to the invention described in (8) above, since the main body portion and the insertion position display portion of the auxiliary tool have X-ray transparency, the main body portion and the X-ray image taken from the side surface of the main body portion The insertion position display unit is not projected on the X-ray contrast unit. For this reason, when measuring a distance based on an X-ray image, an X-ray contrast unit can be clearly identified.

According to the invention described in (9) above, it is possible to provide a medical instrument having a puncture member having a predetermined radius of curvature and an auxiliary tool that favorably assists a puncture operation for puncturing the living body with the puncture member. . According to the medical instrument, when performing various procedures using the puncture member, it is possible to accurately and easily measure the distance between the living body surface and the predetermined target site based on the X-ray image. The procedure can be performed quickly and minimally invasively.

According to the invention described in (10) above, there is provided a distance measuring method capable of easily and accurately measuring a distance between a target site set in a living body and a living body surface based on an X-ray image. Can be provided.

1A and 1B are diagrams showing an auxiliary tool according to a first embodiment of the present invention, in which FIG. 1A is a schematic perspective view of the auxiliary tool, and FIG. 1B is a plan view of the auxiliary tool. 2A and 2B are views showing the needle assembly according to the first embodiment, in which FIG. 2A is a side view of a treatment instrument provided with a puncture member, and FIG. 2B is a side view of a guide member used with the treatment instrument. (C) is a side view of a needle assembly configured by assembling a treatment instrument and a guide member. Drawing 3 is a figure for explaining an example of use of an auxiliary tool concerning a 1st embodiment, (A) is an outline perspective view showing a use condition, and (B) is a top view showing a use condition. It is a figure for demonstrating the effect | action of the auxiliary tool which concerns on 1st Embodiment, Comprising: It is a figure which expands and shows the auxiliary tool arrange | positioned on the back of the biological body. It is a figure for demonstrating the effect | action of the auxiliary tool which concerns on 1st Embodiment, Comprising: It is a figure which shows typically the X-ray image image | photographed from the side of the biological body in the state which has arrange | positioned the auxiliary tool on the back of the biological body. . It is a figure which shows typically an example of the procedure using an auxiliary tool and a puncture member, and is a figure which shows the mode before inserting a puncture member in a biological body. It is a figure which shows typically an example of the procedure using an auxiliary tool and a puncture member, and is a figure which shows a mode that the puncture member was punctured to the biological body. It is a figure which shows typically an example of the technique using an auxiliary tool and a puncture member, and is a figure which shows a mode that the puncture member punctured to the biological body is moved toward the peripheral part of the spinous process used as a target site | part. It is a figure which shows typically an example of the procedure using an auxiliary tool and a puncture member, and is a figure which shows the operation | work which arrange | positions a flexible container to a target site | part. It is a figure which shows typically an example of the procedure using an auxiliary tool and a puncture member, and is a figure which shows a mode that the flexible container arrange | positioned in the target site | part was expanded. It is a figure which shows a mode that the flexible container was detained in the target site | part. It is a figure which shows the modification of the auxiliary tool which concerns on 1st Embodiment, (A) is a general | schematic perspective view of the auxiliary tool which concerns on the modification 1, (B) is a general perspective view of the auxiliary tool which concerns on the modification 2. FIG. . It is a figure which shows the modification of the auxiliary tool which concerns on 1st Embodiment, (A) is a general | schematic perspective view of the auxiliary tool which concerns on the modification 3, (B) is a general perspective view of the auxiliary tool which concerns on the modification 4. . FIG. 14 is a view for explaining an auxiliary tool according to a second embodiment of the present invention, in which (A) is a schematic perspective view of the auxiliary tool, and (B) is a state in which the auxiliary tool is arranged on the back of a living body. It is a figure which shows typically the X-ray image image | photographed from the biological body side. It is a block diagram which shows simply the whole structure of the measurement system which concerns on 3rd Embodiment of this invention. It is a figure which shows the processing flow of the measurement system which concerns on 3rd Embodiment. It is a figure which shows the output example from which the measurement result of the measurement system which concerns on 3rd Embodiment was output.

<First Embodiment>
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.

FIGS. 1 to 5 are diagrams for explaining the configuration and operation of the auxiliary tool and the puncture member according to the present embodiment. FIGS. 6 to 11 are procedures using the auxiliary tool and the puncture member according to the present embodiment. It is a figure where it uses for description of an example.

First, an overview of a procedure performed using the assisting tool and the puncture member according to the present embodiment and a disease that is a target of the procedure will be described.

FIG. 3B schematically shows a state where the lumbar vertebra 126 is seen through from the back 121 side of the living body 120 of the subject (patient) 100. FIG. 4 shows a partially enlarged view of part of FIG. FIG. 6 schematically shows a cross section (transverse section) of the living body 120 in a direction intersecting with the arrangement direction of spinous processes 123 (a spine extending direction) that is a part of the lumbar vertebra 126. FIG. 11 shows an enlarged view of the peripheral portion of the spinous process 123 shown in FIG. The X axis shown in each figure indicates the direction intersecting with the arrangement direction of the spinous processes 123, the Y axis indicates the arrangement direction of the spinous processes 123, and the Z axis indicates the thickness direction of the living body 120. Yes.

As shown in FIGS. 4 and 11, a plurality of lumbar vertebrae 126 are arranged on the back 121 of the living body 120 of the subject 100 along the extending direction of the spine. As shown in FIG. 6, 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. 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. Further, as shown in FIG. 11, adjacent lumbar vertebra 126 are connected via an intervertebral disc (intervertebral disc) 129, and a lumbar vertebra 126 and lumbar vertebra 126 adjacent to lumbar vertebra 126 are intervertebral disc 129, It is prevented from being displaced by an intervertebral joint or the like existing between the upper joint process and the lower joint process (see also FIG. 5).

For example, when a load is applied to the lumbar vertebra 126 repeatedly during sports or the like and a fatigue fracture or the like occurs, the lumbar spondylolysis that causes the vertebral body 125 and the lamina 127 to separate at the pedicle 128 portion, The lumbar vertebra 126 located on the upper side becomes difficult to be fixed due to the deformation of the facet joint or the degeneration of the intervertebral disc 129, and lumbar degenerative spondylolisthesis may be caused in which a shift occurs. These lumbar spondylosis and lumbar spondylolisthesis occur, or the ligaments arranged around the lumbar vertebra 126 degenerate with age, causing the spinal canal to narrow and intermittent symptoms that are symptoms of lumbar spinal canal stenosis. Sexual claudication may be caused.

As a treatment method for the lumbar spinal canal stenosis as described above, two adjacent spinous processes 123 (the spinous process located on the upper side in FIG. 11 is referred to as a spinous process 123a, and the spinous process located on the lower side is referred to as the spinous process. 123b), a treatment method for suppressing stenosis of the spinal canal has been proposed by placing an implant that can function as a spacer for maintaining a gap between the two. In this embodiment, the flexible container 80 filled with the filler is placed between the adjacent

spinous processes

123a and 123b, and the auxiliary tool 10 and the puncture member 61 are used for implant placement using the container 80 as an implant. An example in which is applied will be described. However, the structure of the implant placed between adjacent spinous processes is not limited to the structure as described above, and for example, it is also possible to use a structure configured to expand and deform mechanically.

Referring to FIG. 5 and FIG. 6, a method of using the auxiliary tool 10 will be described.

When introducing the flexible container 80 to the living body 120, the auxiliary tool 10 measures the distance D1 from the living body surface (living body surface layer) 130 to an arbitrary target site p1 set in the living body 120. Can be used. As shown in FIG. 5, when X-ray imaging is performed from the side of the living body (for example, the direction of arrow C shown in FIG. 3) with the assisting tool 10 placed on the living body surface 130, the position of the living body surface 130 is assisted. The X-ray contrast unit 30 included in the tool 10 can be displayed in an identifiable manner. And since it becomes possible to confirm the position of the biological body surface 130 on an X-ray image, it becomes possible to measure the distance D1 from the biological surface 130 to the predetermined target site | part p1. As a result, it is possible to select the puncture member 61 having an optimal radius of curvature, and at the same time, the insertion position s for inserting the puncture member 61 into the living body surface 130 and the puncture member 61 as the target site in the living body 120. It is possible to set a puncture route w for moving to p1.

Describes the structure of the assistive device.

As shown in FIGS. 1 (A) and 1 (B), the assisting tool 10 assists in the work of puncturing the living body 120 with a puncture member 61 (see FIG. 2 (A)) having a predetermined radius of curvature. A sheet-like main body portion 20 having flexibility, and provided in the main body portion 20 in the thickness direction of the main body portion 20 (arrow a in FIG. 1A). X-ray contrast unit 30 extending in the plane direction intersecting with the X-ray contrast unit 30, and provided in the main body unit 20 at a predetermined distance from the X-ray contrast unit 30, and determined according to the radius of curvature of the puncture member 61 A puncture position display unit 40 that indicates a puncture position s of the puncture member 61 into the living body 120.

The main body 20 can be configured by a sheet-like member processed into a thin wall. The outer shape of the main body 20 can be formed in a rectangular shape including a front surface 21, a back surface 23 formed on the back side of the front surface 21, and a side surface 25 connected to the front surface 21 and the back surface 23, for example, as illustrated. . The outer shape of the main body 20 may be any shape as long as it can be arranged at a desired position on the living body surface 130. For example, the main body 20 can be formed in a shape such as a circle, an ellipse, or a rhombus.

When using the auxiliary tool 10, for example, the back surface 23 of the main body 20 is disposed so as to face the biological surface 130 (see FIG. 3A). The back surface 23 of the main body 20 can be provided with, for example, an adhesive or an adhesive layer for preventing the occurrence of displacement or the like after being disposed on the biological surface 130.

The dimensions of each part of the main body 20 can be formed such that the length of one side of the front surface 21 and the back surface 23 is 150 mm and 250 mm, and the thickness is 0.1 mm. However, the external dimensions (size) and thickness dimensions of the main body portion 20 can be changed as long as the flexibility of the main body portion 20 is not impaired, and is not limited to the above dimension example.

The material constituting the main body 20 is not particularly limited as long as it has flexibility. For example, a material made of a known resin material can be used. For example, polyurethane, polyester, polypropylene, polyethylene terephthalate, or the like can be used as the resin material constituting the main body 20. Moreover, the main-body part 20 can be comprised with a transparent resin material. By configuring in this way, it becomes possible to visually identify the living body surface 130 through the main body portion 20 when the assisting tool 10 is arranged on the living body surface 130, and thus the usability of the assisting tool 10 is further improved. It will be a thing.

The main body 20 can be configured to have X-ray transparency. Although it does not prevent the use of a material having radiopacity, etc., when the main body portion 20 is configured to have X-ray transparency, the work load when measuring a predetermined distance D1 described later is reduced. It becomes possible to reduce. Note that the main body portion 20 having X-ray transparency means that the main body portion 20 itself is configured to have X-ray permeability, and the X-ray contrast unit 30 provided in the main body portion 20 includes It does not mean that X-ray transparency is provided.

The X-ray contrast unit 30 is formed in a linear shape extending a predetermined length in a plane direction parallel to the front surface 21 and the back surface 23 of the main body unit 20. The X-ray contrast unit 30 includes, for example, Pt (platinum), Pt alloy, Au (gold), Au alloy, W (tungsten), W alloy, Pd (palladium), Pd alloy, Ta (tantalum), Ta alloy, and Ag. (Silver), Ag alloy, or other material having X-ray contrast properties can be embedded in the main body 20, or these materials can be bonded or adhered to the front surface 21 or the back surface 23 of the main body 20. .

The X-ray contrast unit 30 can be provided with a length reference unit 31 that serves as a length reference when measuring the length dimension based on an X-ray image taken from the direction of the side surface 25 of the main body unit 20. . In the auxiliary tool 10, the length reference portion 31 is configured by a plurality of X-ray contrast marker portions 33 that are spaced apart from each other in the direction in which the X-ray contrast portion 30 extends. As will be described later, when the distance between the X-ray contrast marker portions 33 and the length of each X-ray contrast marker portion 33 on the X-ray image shown in FIG. Can be used as a reference length (unit length).

In the assisting device 10 according to the present embodiment, the X-ray contrast unit 30 is configured by the X-ray contrast marker unit 33. Specifically, X-rays are obtained by a set of a plurality of X-ray contrast marker portions 33 formed by attaching a material having a predetermined X-ray contrast property to the main body portion 20 in a broken line shape (disconnected shape) as shown in the figure. An imaging unit 30 is configured.

The length of each X-ray contrast marker portion 33 can be formed to 2.0 mm, for example. Moreover, the distance between each X-ray contrast marker part 33 can be formed in 1.0 mm, for example. However, the length of the X-ray contrast marker portion 33 and the interval between the X-ray contrast marker portions 33 are not limited to the above dimensions. Further, for example, the X-ray contrast marker portion 33 may be configured to have a different length, or may be configured to include a plurality of sets in which a plurality of contrast marker portions 33 are formed with the same length. Also good. It is also possible to vary the contrast property for each contrast marker portion 33.

The insertion position display unit 40 only needs to be configured so that it can be visually identified when the auxiliary tool 10 is viewed from the outside. In this embodiment, the insertion position display unit 40 is formed by a predetermined ink attached to the surface 21 of the main body unit 20. The insertion position display unit 40 is configured. In this embodiment, the ink is made of a material having X-ray transparency. For this reason, the insertion position display unit 40 is configured to have X-ray transparency.

As shown in FIG. 1B, the X-ray contrast unit 30 can be arranged such that the outer shape when the main body 20 is viewed in plan is a linear shape. Further, the insertion position display unit 40 can be arranged in a linear shape extending in parallel with the X-ray contrast unit 30. Here, the plan view of the main body 20 means that the main body 20 is viewed from the direction orthogonal to the front surface 21 (or the back surface 23) of the main body 20 with the field of view directed. In the case where the X-ray contrast unit 30 is configured by a plurality of X-ray contrast marker units 33 as in the present embodiment, the X-ray contrast unit 30 is arranged in a linear shape as shown in the figure. It means that the outline of the X-ray contrast unit 30 is formed in a substantially straight line by arranging the line contrast marker part 33 in a straight line.

The insertion position display unit 40 can be configured to include a first display unit 41 and a second display unit 42 that are arranged apart from each other in a direction away from the X-ray contrast unit 30. The distance between each

display part

41 and 42 and the X-ray contrast part 30 can be set so that it may respond | correspond to the curvature radius of the puncture member 61 used for a procedure. In the illustrated example, the first display unit 41 is disposed 60 mm away from the X-ray contrast unit 30, and the second display unit 42 is disposed 80 mm away from the X-ray contrast unit 30.

In the auxiliary tool 10, in addition to the first display unit 41 and the second display unit 42, a third display unit 43 is provided. The third display unit 43 is arranged 100 mm away from the X-ray contrast unit 30. As shown in the present embodiment, the number of display units included in the insertion position display unit 40 is not particularly limited. Further, the distance between the X-ray contrast unit 30 and the

display units

41, 42, and 43 is not limited to the above-described dimension examples, and the relationship with the puncture member 61 used and the contents of the procedure are not limited. It can be changed accordingly. Also, for example, a display of a numerical value indicating the distance is attached to the main body unit 20 so that the distance between the X-ray contrast unit 30 and each

display unit

41, 42, 43 can be easily confirmed. Also good. Moreover, although the case where the main-body part 20 was one layer was demonstrated, it is not limited to this, You may be comprised by the multilayer of two or more layers. Furthermore, in this case, the X-ray contrast unit 30 and the insertion position display unit 40 may be disposed on the uppermost layer of the main body unit 20 or may be disposed between the layers.

Next, the puncture member will be described.

2A to 2C, a treatment instrument 60 including a puncture member 61, a guide member 70 used together with the treatment instrument 60, and a needle assembly 50 configured by combining the treatment instrument 60 and the guide member 70. Is shown. This needle assembly 50 can be used to introduce a flexible container 80 between adjacent

spinous processes

123a, 123b (see FIGS. 7-9).

As shown in FIG. 2A, the treatment instrument 60 has a puncture member 61 curved with a predetermined curvature and a gripping portion 63 provided on the proximal end side of the puncture member 61. The puncture member 61 may be used in combination with other members as described above. For example, the puncture member 61 may constitute a treatment instrument such as a curved needle or a puncture instrument by using only the puncture member 61. . In the present embodiment, a combination of the puncture member 61 and the auxiliary tool 10 is referred to as a medical instrument.

The puncture member 61 is configured such that the outer diameter gradually decreases from the proximal end side toward the distal end side, and a needle tip 65 is formed at the distal end. The gripping portion 63 of the treatment tool 60 is not limited to the illustrated structure as long as the user can grip the treatment tool 60 when using the treatment tool 60.

The puncture member 61 can be configured to be connectable / separable to the grip portion 63. For example, a configuration in which the proximal end of the puncture member 61 is mechanically connected to the grip portion 63 by screwing or fitting is adopted as a configuration that enables the puncture member 61 and the grip portion 63 to be connected and separated. it can.

The material constituting the puncture member 61 may be any material that can puncture the living body 120 and is not particularly limited. 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.

Although it does not specifically limit as a material which comprises the holding part 63, A predetermined | prescribed metal material, a hard plastic material, etc. can be used.

As shown in FIG. 2 (B), the guide member 70 includes an insertion portion 71 curved with substantially the same curvature as the puncture member 61 of the treatment instrument 60, and a distal end opening 73a formed on the distal end side of the insertion portion 71. A proximal end opening 73 b formed on the proximal end side of the insertion portion 71, a connection portion 75 provided on the proximal end side of the insertion portion 71 and connectable / detachable to the grasping portion 63 of the treatment instrument 60, It can be configured to have a lumen 77 formed inside the insertion portion 71.

As shown in FIG. 2C, the puncture member 61 of the treatment instrument 60 can be inserted into the lumen 77 of the guide member 70. The length of the insertion portion 71 of the guide member 70 is shorter than the length of the puncture member 61. For this reason, when the puncture member 61 is inserted into the lumen 77, the needle tip 65 of the puncture member 61 is exposed from the distal end opening 73a of the guide member 70 by a predetermined length.

In addition, when the puncture member 61 is inserted into the lumen 77, the treatment instrument 60 and the guide member 70 are connected via the connecting portion 67 provided on the treatment instrument 60 and the connection portion 75 provided on the guide member 70. Can be assembled. For example, the connecting portion 75 of the guide member 70 is configured to be mechanically connected to the connecting portion 67 of the treatment instrument 60 by fitting, but is configured to be connectable and detachable to the treatment instrument 60. If it is, the structure in particular is not limited.

As the material constituting the insertion portion 71 of the guide member 70, for example, the same material as that of the puncture member 61 of the treatment instrument 60 described above can be used.

Next, the radius of curvature of the puncture member 61 and the puncture route w for advancing the puncture member 61 to the target site p1 will be described.

As shown in FIGS. 4 and 6, in the procedure in which the flexible container 80 is placed between the adjacent

spinous processes

123a and 123b, the target site p1 to be treated is between the adjacent

spinous processes

123a and 123b. Can be set. When actually performing the procedure, after setting the target site p1, an operation of inserting the puncture member 61 from the back 121 of the living body 120 is performed. After inserting the puncture member 61, the puncture member 61 is moved so that the needle tip 65 of the puncture member 61 approaches the target site p1. Here, the puncture path w through which the puncture member 61 passes from the insertion position s on the living body surface 130 to the target site p1 set in the living body 120 is determined by the radius of curvature of the puncture member 61.

As shown in FIG. 6, when using a puncture member 61 having a predetermined radius of curvature, the puncture member 61 is operated such that the target site p1 overlaps the virtual circle r drawn by the puncture member 61. That is, the ideal puncture route w is set so as to overlap the virtual circle r. Therefore, the radius of curvature of the puncture member 61 is determined according to the length from the biological surface 130 to the target site p1. For example, by measuring the length from the biological surface 130 to the target site p1 on the X-ray image shown in FIG. 5, the distance D1 between the biological surface 130 and the target site p1 can be confirmed. Then, by selecting the puncture member 61 having a radius of curvature that is at least larger than the distance D1, the needle tip 65 of the puncture member 61 can be guided to the target site p1. The auxiliary tool 10 according to the present embodiment makes it possible to select a puncture member 61 having an appropriate curvature radius from among a plurality of puncture members 61 having different radii of curvature, and at the same time, the insertion position of the puncture member 61 Used to allow s and puncture path w to be defined.

Next, the flow of the entire procedure using the auxiliary tool 10 and the puncture member 61 will be described.

In starting the procedure, an X-ray image of the living body 120 of the subject 100 is taken. The target site p1 to be treated is clarified based on the photographed X-ray image. Note that imaging is performed from the side of the living body 120 (in the direction of arrow c shown in FIG. 3A) so that an X-ray image as shown in FIG. 5 is taken. An X-ray image can be captured using a known imaging apparatus such as an X-ray imaging apparatus, an X-ray CT apparatus, an MRI apparatus, or an ultrasonic diagnostic apparatus.

First, as shown in FIGS. 3A and 3B, the assisting tool 10 is placed on the back 121 of the living body 120.

The target site p1 is set between adjacent

spinous processes

123a and 123b as in the procedure described in the present embodiment, and the X-ray contrast unit 30 provided in the main body 20 of the assisting tool 10 is provided. When arranged in a straight line shape, the X-ray contrast unit 30 is preferably arranged on the midline M of the living body 120. By arranging in this way, the positional relationship between the arrangement direction of the

spinous processes

123a and 123b and the insertion position s of the puncture member 61 can be easily confirmed visually, so that the puncture member 61 is inserted. Can be performed more safely and quickly.

Next, an X-ray image is taken in a state where the auxiliary tool 10 is disposed on the biological surface 130. Photographing is performed from the side of the living body 120 so that the surface of the back 121 of the living body 120 and the side surface 25 of the main body 20 of the assisting device 10 are included in the photographing range.

As shown in FIG. 5, the outline of the biological surface 130 is shown on the photographed X-ray image by the X-ray contrast unit 30 provided in the auxiliary tool 10. The broken line in the figure is a line that virtually shows the living body surface 130 that was not identifiable on the X-ray image.

When taking an X-ray image, a predetermined indicator 95 such as a rod or forceps having X-ray contrast properties may be arranged on an extension line extending from the target site p1 set in the living body 120 to the auxiliary tool 10. . By using such an indicator 95, it is possible to confirm the approximate position of the target site p1 outside the living body 120, so that the work for insertion can be performed easily and quickly. Become. Further, when measuring the distance D1 from the living body surface 130 to the target site p1 based on the X-ray image, the distance D1 can be measured more accurately by confirming the position indicated by the pointing tool 95. It becomes possible.

Since the main body 20 is configured to have flexibility in the auxiliary tool 10, the main body 20 can be arranged in a deformed state along the surface shape of the living body surface 130. Therefore, even when the assisting tool 10 is used for a part having a curved outer shape such as the back 121, the distance D1 from the biological surface 130 to the target part p1 can be accurately measured.

Further, since the main body 20 and the insertion position display section 40 of the assisting tool 10 have X-ray transparency, the main body on the X-ray image taken from the direction of the side surface 25 of the main body 20 as shown in FIG. 20 and the insertion position display unit 40 are not projected on the X-ray contrast unit 30. Therefore, the X-ray contrast unit 30 can be clearly identified when measuring the distance D1 based on the X-ray image.

Next, the distance D1 from the target site p1 to the living body surface 130 is measured based on the photographed X-ray image. The measurement includes, for example, the length of each X-ray contrast marker unit 33 constituting the X-ray contrast unit 30, the interval between the X-ray contrast marker units 33, the target site p1 displayed on the X-ray image, and the living body. This is done by comparing the length with the surface 130. When taking an X-ray image, it is also possible to take a ruler with a scale as a reference for length together and measure the distance D1 with reference to the scale.

After measuring the distance D1, the puncture member 61 is selected. The puncture member 61 is selected so that its radius of curvature is at least larger than the distance D1. Then, as shown in FIG. 4, the insertion position s is set on the insertion position display unit 40 arranged at a position away from the position indicated by the pointing tool 95 than the length of the radius of curvature of the puncture member 61. When the X-ray contrast unit 30 is arranged on the midline M of the living body 120, the position shifted in the direction orthogonal to the direction in which the X-ray contrast unit 30 extends becomes the insertion position s. In the illustrated example, assuming that the distance D1 is measured to be 70 mm, the puncture member 61 having a curvature radius of 80 mm is selected, and the second display unit 42 disposed at a position 80 mm away from the X-ray contrast unit 30 is displayed. The insertion position s is set.

The preparatory work before performing the procedure using the puncture member 61 is advanced by the procedure as described above.

By using the auxiliary tool 10 according to the present embodiment, it becomes possible to easily and accurately measure the distance D1 between the predetermined target site p1 and the living body surface 130, and thus puncture with an appropriate radius of curvature. The member 61 can be selected, the insertion position s can be set, and the puncture route w can be set. Further, based on the X-ray image of the X-ray contrast unit 30 included in the X-ray plane image taken from the direction of the side surface 25 of the main body 20 of the auxiliary tool 10 with the auxiliary tool 10 disposed on the living body 120, A distance measuring method for measuring the distance D1 from the living body surface 130 to the target site p1 set at an arbitrary position in the living body 120 can be provided.

Next, the puncturing operation and the operation of placing the flexible container 80 will be described.

As shown in FIG. 6, in the following description, the puncture member 61 is represented by the radius of curvature of the puncture member 61 in order to facilitate the description of the puncture route w that advances the puncture member 61 to the target site p1. A state of moving along a perfect circular puncture path w is illustrated. As described above, when there is a difference between the distance D1 from the biological surface 130 to the target site p1 and the radius of curvature of the puncture member 61, the puncture path w passes through the target site p1 and the target site p1 to Z A circular arc centering on a virtual point separated by the length of the radius of curvature of the puncture member 61 in the axial direction is formed. In this case, the puncture path w can be changed so that the needle point 65 of the puncture member 61 passes at least the target site p1. Specifically, the insertion is performed while tilting the puncture member 61 so that the insertion angle when the puncture member 61 is inserted into the living body 120 becomes small. Then, a puncture route w is set such that the puncture member 61 is advanced at an inclination angle smaller than the perfect circle puncture route w.

As shown in FIG. 6, the needle assembly 50 is operated so that the needle tip 65 of the puncture member 61 moves toward the set insertion position s. Before performing the puncturing operation, the treatment instrument 60 and the guide member 70 are assembled in advance to prepare the needle assembly 50 (see FIG. 2C). The puncture member 61 inserted into the guide member 70 is shown in a simplified manner in the drawing.

As shown in FIG. 7, the needle tip 65 of the puncture member 61 is inserted into the living body 120. As shown in the figure, it is possible to perform the insertion operation with the auxiliary tool 10 placed on the biological surface 130. For example, after setting the insertion position s, a mark indicating the insertion position s is provided. By attaching to the living body surface 130, it is also possible to perform the operation of inserting the needle tip 65 of the puncture member 61 with the auxiliary tool 10 removed.

As shown in FIG. 8, the puncture member 61 is moved until the needle point 65 of the puncture member 61 reaches at least the target site p1. In this embodiment, since the flexible container 80 is disposed near the center position in the left-right direction of the spinous process 123a, the distal end opening 73a of the guide member 70 extends beyond the spinous process 123a on the distal side in the puncture direction (see FIG. The puncture member 61 is moved to a position reaching the left side in the middle.

After moving the puncture member 61 to a predetermined position, the treatment instrument 60 is separated from the guide member 70 and the puncture member 61 is removed from the lumen 77 of the guide member 70. Next, as shown in FIG. 9, the flexible container 80 is guided to the periphery of the target site p <b> 1 through the lumen 77 of the guide member 70.

The flexible container 80 is contracted in a state before the predetermined filler is injected, and is configured to expand and deform when the filler is injected. In addition, the flexible container 80 includes, for example, a trunk portion 81 disposed between adjacent

spinous processes

123a and 123b, and both

end portions

82a and 82b provided integrally with the trunk portion 81. A thing can be used (refer FIG. 10, FIG. 11).

As a material constituting the flexible container 80, for example, it has at least pressure resistance that can withstand external pressure received from the

spinous processes

123a and 123b and external pressure accompanying movement of the vertebral body 125, and There is no particular limitation as long as it can be expanded and deformed by injection. For example, vinyl chloride, polyurethane elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer It is preferable to use a thermoplastic elastomer such as coalescence (SEPS), a thermoplastic resin such as nylon or PET, or a thermosetting resin such as rubber or silicone elastomer, and a porous material such as nonwoven fabric, woven fabric, knitted fabric, or ePTFE It is particularly preferable to use Moreover, it is also possible to use these in combination as appropriate.

Next, the guide member 70 is pulled back in the proximal direction, and the flexible container 80 is exposed from the guide member 70. At this time, the tip of the guide member 70 may be punctured into the living body 120, or may be completely removed from the living body 120 as shown in FIG.

Next, as shown in FIG. 10, the filler is injected into the container 80 with the flexible container 80 exposed from the guide member 70. For injecting the filler into the flexible container 80, a known fluid supply device 90 such as a syringe pump capable of pumping a fluid or the like can be used.

The flexible container 80 and the fluid supply device 90 can be connected in advance by a known catheter tube 91 or the like through which fluid can flow. In addition, the flexible container 80 and the catheter tube 91 can be detachably connected by a method such as fitting, screwing, or excision.

As the filler to be injected into the flexible container 80, for example, solid or fluid (gas, liquid, gel), bone cement that causes a hardening reaction after introduction, or the like can be used. It is also possible to add a material (metal or the like) having contrast properties to the filler.

As shown in FIG. 9, for example, the distal end of the guide member 70 is proximal to the spinous process 123a (see FIG. The mandrel is inserted into the flexible container 80 in the state of being disposed on the right side of the inside, and the catheter tube 91 is pushed in the distal direction, so that the guide member 70 can be flexed without pulling back in the proximal direction. It is also possible for the sex container 80 to reach the periphery of the target site p1.

As shown in FIG. 10, after the flexible container 80 is expanded by injecting a filler into the flexible container 80, the catheter tube 91 is separated from the container 80, and the catheter tube 91 is examined. The person 100 is removed from the living body 120. The connecting portion between the flexible container 80 and the catheter tube 91 can be provided with a seal member, a valve, or the like that prevents the filler from leaking when the catheter tube 91 is separated.

As shown in FIG. 11, the flexible container 80 is left in a state of being filled with a filler. Both

end portions

82a and 82b of the flexible container 80 form a convex shape that protrudes when expanded, and the both

end portions

82a and 82b sandwich the

spinous processes

123a and 123b so that the flexible Misalignment of the container 80 is prevented. The trunk portion 81 of the flexible container 80 is expanded and deformed while maintaining a substantially linear shape, and supports the adjacent

spinous processes

123a and 123b and maintains a gap therebetween.

By placing the flexible container 80 in the above procedure, the interval between the adjacent

spinous processes

123a and 123b can be kept wide. This makes it possible to obtain an effective therapeutic effect on the symptoms of lumbar spinal canal stenosis.

As described above, according to the present embodiment, X-ray imaging of the biological surface 130 together with the auxiliary tool 10 in a state where the auxiliary tool 10 is disposed on the biological surface 130 is provided on the main body portion 20 of the auxiliary tool 10. The X-ray contrast unit 30 can project the position of the living body surface 130 on the X-ray image in an identifiable manner. Then, by referring to the photographed X-ray image, it becomes possible to easily and accurately measure the distance D1 between the predetermined target site p1 set in the living body 120 and the living body surface 130. The puncture member 61 having an appropriate radius of curvature can be selected. As a result, since it is possible to set the puncture route w and the puncture position s according to the radius of curvature of the puncture member 61, various procedures using the puncture member 61 can be performed in a minimally invasive manner.

Further, when measuring the predetermined distance D1 based on the X-ray image, it is possible to easily and accurately perform the measurement by referring to the length reference unit 31 included in the X-ray contrast unit 30.

Further, since a plurality of X-ray contrast marker portions 33 included in the length reference portion 31 are arranged apart from each other in the extending direction of the X-ray contrast portion 30, a length serving as a reference when measuring the predetermined distance D1 The thickness can be easily identified visually, and measurement can be performed more easily and accurately.

Further, since the insertion position display unit 40 is arranged in a linear shape extending in parallel to the X-ray imaging unit 30 arranged in a linear shape, the positional relationship between the X-ray imaging unit 30 and the insertion position display unit 40 Can be easily confirmed visually. For this reason, the operation | work which inserts the puncture member 61 can be performed safely and rapidly.

Moreover, since the insertion position display part 40 has the 1st display part 41 and the 2nd display part 42 which were arrange | positioned mutually spaced apart, since it is between the procedures performed using the puncture member 61 of a different curvature radius, it is the auxiliary tool 10. Even in the case of diverting, the insertion position s of the puncture member 61 can be determined easily and accurately.

Further, since the main body 20 and the insertion position display unit 40 of the assisting tool 10 have X-ray transparency, the main body 20 and the insertion position display on the X-ray image taken from the direction of the side surface 25 of the main body 20. The unit 40 is not projected on the X-ray contrast unit 30. Therefore, when measuring the predetermined distance D1 based on the X-ray image, the X-ray contrast unit 30 can be clearly identified.

Also, it is possible to provide a medical instrument having a puncture member 61 having a predetermined radius of curvature and an auxiliary tool 10 that suitably assists the puncture operation of puncturing the living body 120 with the puncture member 61. According to the medical instrument, when performing various procedures using the puncture member 61, the distance D1 between the living body surface 130 and the predetermined target site p1 can be accurately and easily measured based on the X-ray image. This enables the procedure to be performed quickly and safely.

Also, it is possible to provide a distance measuring method capable of easily and accurately measuring the distance D1 between the target site p1 set in the living body 120 and the living body surface 130 based on the X-ray image.

Next, a modification of the above-described first embodiment will be described. In the assisting tool according to each modification described below, the shape and arrangement of the X-ray contrast unit, the shape and arrangement of the insertion position display unit, and the like are different from the assisting tool 10 according to the first embodiment described above. . The same members as those described in the first embodiment are denoted by the same reference numerals, and description thereof is omitted.

In the auxiliary tool 210 according to the first modification shown in FIG. 12A, the configuration of the X-ray contrast unit 230 is different from that of the auxiliary tool 10 according to the above-described embodiment.

The X-ray contrast unit 230 is configured to have a first contrast marker unit 231 and a second contrast marker unit 232 having different lengths. Further, the number of second contrast marker portions 232 arranged between the first contrast marker portions 231 is different in each part of the X-ray contrast portion 230. By configuring the X-ray contrast unit 230 in this way, the X-ray contrast unit 230 can have more length references, so that measurement of the predetermined distance D and the like can be performed more easily and accurately. It becomes possible to do.

In the auxiliary tool 310 according to the modified example 2 shown in FIG. 12B, the X-ray contrast unit 330 is not formed in a broken line shape, but is formed in a continuous linear shape. In this respect, it is different from the auxiliary tool 10 according to the first embodiment.

Even if the X-ray contrast unit 230 is not formed in a broken line like the auxiliary tool 310 shown in the figure, the function of projecting the position of the living body surface 130 on the X-ray image is not impaired. Therefore, by using the assisting tool 310 according to the present modification, various procedures using the puncture member 61 can be favorably supported as in the case of using the assisting tool 10 according to the above-described embodiment. .

In the auxiliary tool 410 according to Modification 3 shown in FIG. 13A, the configuration of the X-ray contrast unit 430 is different from that of the auxiliary tool 10 according to the first embodiment.

The X-ray contrast unit 430 is configured to include first, second, and

third contrast units

431, 432, and 433 having different X-ray contrast properties. If comprised in this way, the distance from the 1st contrast part 431 to each

display part

41,42,43, the distance from the 2nd contrast part 432 to each

display part

41,42,43, each display from the 3rd contrast part 433 The distances to the

portions

41, 42, and 43 are different. When performing the procedure, for example, when the

contrast units

431, 432, and 433 are arranged on the midline M of the living body 120, the X-ray contrast unit is used in the case where the assisting device 10 formed in a simple linear shape is used. In comparison, the auxiliary tool 410 can be diverted to more puncture members 61 having different radii of curvature.

In the auxiliary tool 410 according to the present modification, the

contrast sections

431, 432, and 433 are configured to have different contrast properties. Therefore, each contrast section is displayed on the X-ray image taken from the direction of the side surface 25 of the main body section 20. 431, 432, and 433 can be individually identified. For this reason, in the case where the predetermined distance D1 is measured with any of the

contrast units

431, 432, 433 as a reference, the relative positional relationship between each of the

contrast units

431, 432, 433 and the target site p1 is grasped. Therefore, the predetermined distance D1 can be obtained by a procedure similar to the procedure described in the above-described embodiment.

In the auxiliary tool 510 according to the modified example 4 shown in FIG. 13B, the configurations of the X-ray contrast unit 530 and the insertion position display unit 540 are different from those of the auxiliary tool 10 according to the above-described embodiment.

In the auxiliary tool 510, each

display unit

541, 542, 543 and the X-ray contrast unit 530 included in the insertion position display unit 540 are configured to have an outer shape including a curved portion. Even when the auxiliary tool 510 is configured in this way, the position of the living body surface 130 can be displayed on the X-ray image in an identifiable manner by the X-ray contrast unit 530. In addition, the function of assisting the operation of setting the insertion position s according to the radius of curvature of the puncture member 61 with the insertion position display unit 540 is not impaired. Similar to the X-ray contrast unit 430 according to Modification 3 described above, the X-ray image captured from the direction of the side surface 25 of the main body unit 20 can be obtained by making the contrast of each part of the X-ray contrast unit 530 different. It is possible to configure so that each part of the X-ray contrast unit 530 can be identified.

As exemplified in each of the above-described modifications, the X-ray contrast unit provided in the assisting tool identifies the position of the living body surface 130 on an X-ray image taken with at least the assisting tool placed on the living body surface 130. Each component such as shape, size, number, etc. can be changed as long as it can be projected. In addition, the insertion position display unit provided in the assisting device functions as a guideline for setting the insertion position of the puncture member 61 by being provided at a predetermined distance from the X-ray contrast unit. As long as it is obtained, each component such as shape, size, number, etc. can be changed.

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

The assisting device 610 according to the second embodiment is different from the assisting device 10 according to the first embodiment in the configuration of the length reference unit 631 provided in the X-ray contrast unit 630.

As shown in FIGS. 14A and 14B, the length reference portion 631 provided in the auxiliary tool 610 includes an X-ray contrast member 633 having a predetermined thickness dimension along the thickness direction of the main body portion 620. Yes. The X-ray contrast member 633 includes a first X-ray contrast member 641 and a second X-ray contrast member 642 having different thickness dimensions. As shown in the figure, for example, the first X-ray contrast member 641 can be configured to have a prismatic outer shape, and the second X-ray contrast member 642 can be configured to have a cylindrical outer shape. .

The

X-ray contrast members

641 and 642 can be arranged linearly at intervals so that the X-ray contrast unit 630 has a linear shape, but as described in the above-described modification examples, The shape to be arranged is not limited to a linear shape but can be changed to a curved shape or the like.

The material constituting each of the

contrast members

641 and 642 is not particularly limited as long as it has X-ray contrast properties. For example, Pt (platinum), Pt alloy, Au (gold), W (tungsten), W alloy, Pd (palladium), Pd alloy, Ta (tantalum), Ta alloy, Ag (silver), and Ag alloy can be used. The X-ray contrast unit 30 can be configured by attaching a material obtained by molding these materials into a predetermined shape to the main body 620 by a known means such as adhesion or welding.

The first X-ray contrast member 641 can be formed with a length dimension of about 4.0 mm and a thickness dimension of about 4.0 mm, for example. The second X-ray contrast member 642 can be formed to have a length dimension of 2.0 mm and a thickness (outer diameter) dimension of approximately 2.0 mm, for example. In addition, each dimension of each

contrast member

641 and 642 is not limited to these illustrated dimensions, It can change suitably.

When using the auxiliary tool 610 according to the present embodiment, the predetermined length D1 can be measured with reference to the thickness dimension of each

X-ray contrast member

641, 642. Therefore, the distance D1 between the target site p1 and the living body surface 130 can be easily and accurately measured as in the case of using the auxiliary tool 10 according to the first embodiment. Further, when the outer shape is a columnar shape, the length of the auxiliary tool 610 when the X-ray image is taken from the direction of the side surface 25 of the main body 20 and a predetermined angle with respect to the photographing direction exists. Since the thickness of the reference portion 631 is constant in the entire circumferential direction, it can be used as a reference for an appropriate length. This makes it possible to perform more accurate measurement.

Further, since the X-ray contrast member 633 includes the first X-ray contrast member 641 and the second X-ray contrast member 642 having different thickness dimensions, at least two reference lengths are used when measuring the predetermined distance D1. Can do. Thereby, accurate measurement can be performed. Furthermore, since the relative positions of the

contrast members

641 and 642 can be easily identified visually on an X-ray image taken from the direction of the side surface 25 of the main body 20 of the assisting tool 10, The positional relationship between the target part p1 set in 120 and each part of the auxiliary tool 610 can be easily grasped, and the insertion position s for inserting the puncture member 61 can be easily set.

In the description of the second embodiment, an example in which the X-ray contrast member 633 is configured to include two types of contrast members, the first X-ray contrast member 641 and the second X-ray contrast member 642 has been described. It is also possible to configure with a kind of X-ray contrast member. Moreover, although the example arrange | positioned with the space | interval between each

contrast member

641 and 642 was shown in figure, it is also possible to arrange | position without space | interval. In addition, it is possible to appropriately combine each X-ray contrast marker portion described in the first embodiment and the modification thereof and the X-ray contrast member 633 described in the second embodiment, and provide the same auxiliary tool.

<Third Embodiment>
In the description of the first embodiment described above, an example in which a technician or the like measures a predetermined distance D1 based on an X-ray image has been described. For example, a predetermined measurement system is used to measure the distance D1. Can be automatically measured. In this embodiment, a measurement example using this measurement system will be described.

FIG. 15 is a block diagram showing the configuration of the measurement system 700. The measurement system 700 can be configured by, for example, a general PC (personal computer).

In summary, the measurement system 700 is a calculation unit 710 that performs predetermined calculation processing, an input unit 720 that receives input of predetermined information related to the measurement of the distance D1, and a predetermined value related to the measurement of the distance D1 from the captured X-ray image. A detection unit 730 that detects the information of the image information, and an output unit 740 that outputs predetermined information based on the measured distance D1 and the like together with the X-ray image.

FIG. 16 shows the flow of each process using the measurement system 700.

First, the auxiliary tool 10 is placed on the living body 120 of the subject 100, and an X-ray image is acquired (step 11). Acquisition of an X-ray image can be performed using, for example, a known imaging apparatus such as an X-ray imaging apparatus, an X-ray CT apparatus, an MRI apparatus, or an ultrasonic diagnostic apparatus. In addition, although this embodiment demonstrates the example which used the auxiliary tool 10 demonstrated in 1st Embodiment, it is also possible to use the auxiliary tool demonstrated in each modification mentioned above and 2nd Embodiment.

Next, the detection unit 730 of the measurement system 700 detects the lowest point p2 of the spinous process 123 based on the captured X-ray image (step 12). Here, the lowest point p2 is a surface portion of the spinous process 123 as shown in the output example of FIG. Next, the measurement system 700 plots and displays the indwelling target position p1 on the X-ray image based on the ideal distance input in advance via the input unit 720. The ideal distance is a distance between a position that the operator considers preferable as a position for placing the flexible container 80 and the lowest point p <b> 2 of the spinous process 123. This numerical value is appropriately determined by the operator based on the photographed X-ray image. In this embodiment, the ideal distance is 5 mm. The indwelling target position p1 is the target site p1 described in the above-described embodiment.

Next, the detection unit 730 of the measurement system 700 detects the living body surface 130 and the X-ray contrast unit 30 (step 13). Note that the order in which step 13 is executed and the order in which step 12 is executed may be reversed.

Next, based on the result detected in step 13, the distance D1 from the indwelling target position p1 to the living body surface 130 is measured (step 14). The measurement is performed by executing measurement software incorporated in advance in the calculation unit 710. Further, the measurement is performed with reference to a length reference unit 31 provided in the photographed X-ray contrast unit 30. In this embodiment, the length per one X-ray contrast marker portion 33 serving as a reference for the length is 0.5 mm.

And as shown in FIG. 17, each information, such as a measurement result, is output to the output part 740 (step 15). The output unit 740 can be configured by, for example, a monitor provided in the PC. As shown in the figure, for example, together with an X-ray image taken in advance, the virtual line b extending from the biological surface 130 to the indwelling target position p1 on this X-ray image, the length of the virtual line b (the biological surface 130 and the target site p1 Distance D1), the lowest point p2 of the spinous process 123, the distance D2 between the lowest point p2 of the spinous process 123 and the biological surface 130, and the like are displayed.

As described in the present embodiment, it is possible to construct a medical system that displays various types of information on an X-ray image by using the measurement system 700 for measuring the predetermined distance D1. . By using such a medical system, various procedures using the assisting tool 10 and the puncture member 61 can be performed more easily and smoothly. Note that the software used in step 14 of the above-described processing flow can be handled only by software independently of the measurement system 700, and can be diverted on a different measurement system (PC), for example.

As described above, the assisting device, the puncture member, the medical device including the assisting device and the puncture member according to the present invention have been described through a plurality of embodiments and modifications, but the present invention is configured as described in each embodiment and modification. The present invention is not limited to this, and various modifications can be made based on the description of the scope of claims.

For example, a procedure using an auxiliary tool or a puncture member is not limited to a procedure in which an implant is placed between adjacent spinous processes. For example, a procedure used for collecting a scalpel, reamer, tissue, or excising an affected part. The present invention can be applied to various procedures performed using a medical instrument having a predetermined radius of curvature, such as a tool, a suture needle for suturing a biological tissue, and a biopsy needle for tissue sampling. Further, the target site of the living body on which the assisting device is disposed is not limited to the back, but can be set to each part such as the arm, the leg, and the head according to the contents of the procedure and the living organ to be treated.

10, 210, 310, 410, 510, 610 auxiliary tools,
20 body part,
30 X-ray contrast unit,
31 Length reference part,
33 X-ray contrast marker part,
40 Insertion position display section,
41 1st display part 42 2nd display part,
43 3rd display part,
50 needle assembly,
60 treatment tool,
61 Puncture member,
70 guide members,
80 flexible container,
100 subjects,
120 living body,
121 back,
123, 123a, 123b spinous processes,
130 biological surface,
700 measuring system,
p1 target part (indwelling target position),
p2 The lowest point of the spinous process,
w Puncture route,
s Insertion position,
D1 Distance between the biological surface and the target site,
D2 Distance between the lowest point of the spinous process and the biological surface.

Claims

A medical aid used to assist the work of puncturing a living body with a puncture member having a predetermined radius of curvature,
A sheet-like main body having flexibility;
An X-ray contrast unit provided in the main body and extending in a plane direction intersecting the thickness direction of the main body;
A puncture position display unit that is provided in the main body unit at a predetermined distance from the X-ray contrast unit and indicates a puncture position of the puncture member into a living body that is determined according to a radius of curvature of the puncture member; Auxiliary tool having.
The said X-ray contrast part has a length reference | standard part used as the reference | standard of the length at the time of measuring a length dimension based on the X-ray image image | photographed from the direction of the side surface of the said main-body part. Auxiliary tool.
3. The auxiliary tool according to claim 2, wherein the length reference part has a plurality of X-ray contrast marker parts arranged apart from each other in a direction in which the X-ray contrast part extends.
The auxiliary tool according to claim 2 or 3, wherein the length reference portion includes an X-ray contrast member having a predetermined thickness dimension along a thickness direction of the main body portion.
The auxiliary tool according to claim 4, wherein the X-ray contrast member has at least a first X-ray contrast member and a second X-ray contrast member having different thickness dimensions.
The X-ray contrast unit is arranged so that the outer shape when the main body is viewed in plan is a linear shape,
The assisting tool according to any one of claims 1 to 5, wherein the insertion position display unit is arranged in a linear shape extending in parallel with the X-ray contrast unit.
7. The insertion position display unit according to any one of claims 1 to 6, wherein the insertion position display unit includes at least a first display unit and a second display unit that are disposed apart from each other in a direction away from the X-ray contrast unit. Auxiliary tool.
The auxiliary tool according to any one of claims 1 to 7, wherein the main body part and the insertion position display part have X-ray transparency.
The auxiliary tool according to any one of claims 1 to 8,
The body is percutaneously inserted into the living body via a predetermined position of the living body indicated by the insertion position display unit provided on the main body of the assisting device, and set around the spinous process of the living body. And a puncture member that is punctured toward a target site.
Photographed from the direction of the side surface of the main body with an auxiliary tool having a flexible sheet-like main body provided with an X-ray contrast unit extending in the surface direction intersecting the thickness direction disposed on the living body. A distance measuring method of measuring a distance from a living body surface to a target site set at an arbitrary position in the living body based on an X-ray image of the X-ray contrast unit included in the X-ray plane image.