WO2014045870A1

WO2014045870A1 - Insertion instrument assembly

Info

Publication number: WO2014045870A1
Application number: PCT/JP2013/073750
Authority: WO
Inventors: 北川ともみ; 本間康之
Original assignee: テルモ株式会社
Priority date: 2012-09-24
Filing date: 2013-09-04
Publication date: 2014-03-27

Abstract

An insertion instrument assembly (10A) is provided with: an insertion instrument (12) having a circular arc-shaped outer needle (22) and a circular arc-shaped inner needle (26); a base section (14) brought into contact with the skin of a patient; a connection means (15) capable of rotating relative to the base section (14); a height adjustment mechanism (16); a pair of X-ray impermeable markers (18a, 18b); and a marker support means (20) for connecting the height adjustment mechanism (16) and the pair of markers (18a, 18b). The curvature radius (R) of the circular arc shape of the insertion instrument (12) and the distance (D) between the straight line (L) which connects the pair of markers (18a, 18b) to each other and the center of rotation of the connection means (15) are the same.

Description

Puncture assembly

The present invention relates to a puncture device assembly including a puncture device for inserting a spacer placed between bones.

Lumbar spinal canal stenosis is a disease in which the spinal canal is constricted due to retrograde degeneration of the intervertebral disc or ligament, and causes symptoms such as low back pain, leg pain, and intermittent claudication. The mainstream of treatment for lumbar spinal canal stenosis is an operation that removes a part of the spine where the spinal canal is narrowed (laminectomy) or an operation that fixes the spine (spine fusion). On the other hand, as a relatively minimally invasive technique compared to laminectomy or spinal fusion, a metal spacer has recently been placed between the spinous processes to release the spinal nerve and nerve root compression. It has been developed. However, this method requires the incision of the back muscles and ligaments in order to place the spacer, so that the degree of invasiveness to the patient is still high, and hospitalization is also prolonged.

In response to such a problem, another method has been proposed in which a spacer is inserted between spinous processes and placed in a less invasive manner. In the other method, an expandable balloon is used as a spacer. After the balloon is folded, the balloon is percutaneously inserted between the spinous processes and placed, and then the balloon is filled with a filler such as bone cement. Is expanded and placed between the spinous processes. Since the filler is cured after filling the balloon, the balloon can be kept in a semi-permanent state.

Incidentally, US Patent Application Publication No. 2011/0093013 discloses an apparatus (hereinafter referred to as “puncture device”) for inserting and placing a hard spacer between spinous processes. The puncture device has an arc-shaped needle. The arc-shaped needle is inserted into a patient's skin and muscle, and a spacer attached to the tip of the needle is inserted between the spinous processes.

However, in the puncture device disclosed in US Patent Application Publication No. 2011/0093013, since the needle has an arc shape, it is difficult to accurately grasp the position where the needle is punctured, that is, the position where the spacer is placed. It is.

Even if the puncture depth is determined after measuring the depth from the skin in advance, the skin will be deformed by the pressure from the puncture device during puncture, and the puncture device will sink into the skin. It is difficult to puncture exactly at the position.

In addition, it is necessary to check whether the needle is inserted parallel to the intersection of the frontal surface of the patient and the horizontal plane by X-ray imaging from the lateral direction of the patient's body (X-ray imaging of the sagittal plane). As mentioned above, it is necessary that the X-ray imaging is accurately performed from the side of the patient's body. However, with the puncture device disclosed in US Patent Application Publication No. 2011/0093013, it is not possible to confirm whether X-ray imaging is performed accurately from the side of the patient's body.

The present invention has been made in consideration of such problems. The position where the spacer is placed can be accurately recognized before the needle is punctured, and the puncture is accurately performed at the position and depth aimed at the arc-shaped needle. An object of the present invention is to provide a puncture device assembly that can be used.

In order to achieve the above object, a puncture device having a hollow arc-shaped outer needle, and an inner needle that can be inserted through the outer needle and is formed in an arc shape having the same curvature as the outer needle, and a patient's A base part to be brought into contact with the skin; a connecting means that is fixed to the puncture tool and is rotatable with respect to the base part around the center of curvature of the arc shape of the puncture tool; and the base at the rotation center A height adjusting mechanism that adjusts the height relative to the portion, a pair of markers that are radiopaque and that are spaced apart from each other within a plane including the arc shape of the puncture device, and the puncture Marker support means for connecting the height adjusting mechanism and the pair of markers so that the radius of curvature of the arc shape of the tool, and the distance between the straight line connecting the pair of markers and the rotation center are equal, Characterized by comprising

According to the above configuration, the puncture target position can be accurately punctured by puncturing after aligning the position where the pair of markers overlap with the puncture target position based on the X-ray fluoroscopic image. Therefore, the puncture position of the puncture device can be accurately known before puncturing, and the spacer can be accurately placed at the target position. In addition, even if the skin is sunk or deformed at the time of puncturing, the target position can be accurately punctured without being affected. Furthermore, by using a pair of markers, it can be easily confirmed that X-ray imaging is performed from the side of the patient.

In the puncture device assembly, the pair of markers may be arranged on opposite sides with respect to the extending direction of the base portion with respect to the rotation center of the connecting means.

In the above puncture device assembly, the pair of markers may be arranged outside both ends of the base portion in the extending direction.

In the puncture device assembly, the marker support means may include a plurality of support arms for each of the pair of markers. According to this configuration, it is possible to stably maintain a state in which the radius of curvature of the arc shape of the puncture tool and the distance between the straight line and the rotation center of the connecting means coincide with each other, accurately with respect to the target position, Puncture of the puncture device and placement of the spacer can be performed.

In the puncture device assembly described above, the marker support means may be configured to be extendable and contractable in a direction in which a mutual interval between the pair of markers is changed. According to this structure, the space | interval of markers can be adjusted appropriately according to a patient's body shape.

In the puncture device assembly, the marker support means may be separable from the height adjustment mechanism. According to this configuration, in the puncture operation of the puncture tool and the insertion operation of the spacer, the marker support means and the marker do not get in the way, and these operations can be performed smoothly.

In the puncture device assembly described above, each of the pair of markers may include a frame body and a marker body having radiopacity disposed inside the frame body. According to this configuration, since the marker main body and the frame do not overlap in the X-ray fluoroscopic image, the contrast between the marker main body and the other portions increases, and the marker main body can be easily identified.

In the above puncture device assembly, the frame may be made of a material that transmits X-rays.

In the puncture device assembly, the marker body may be formed in a cross shape.

In the puncture device assembly, a position relative to the base portion can be fixed, the puncture device has a curvature that is substantially the same as the curvature of the arc shape of the puncture device, and contacts the outside of the arc shape of the outer needle. You may provide the guide part which guides so that an outer needle may draw circular arc track | orbits and may move. According to this configuration, when the puncture device is punctured into the patient, the outer needle of the puncture device is inserted while being in contact with the guide portion, so the direction of the force applied from the proximal end side of the puncture device is corrected in the needle tip direction. Is done. As described above, the force applied to the puncture device is appropriately transmitted in the traveling direction of the needle, so that the puncture of the patient with the puncture device can be performed easily and accurately.

According to the puncture device assembly of the present invention, the position where the spacer is placed can be accurately recognized before the needle is punctured, and the puncture device can be accurately punctured at the position and depth aimed at the arc-shaped needle.

It is a whole perspective view of the puncture device assembly which concerns on 1st Embodiment of this invention. 2A is a longitudinal sectional view taken along line IIA-IIA in FIG. 1, and FIG. 2B is a longitudinal sectional view showing a state in which the connecting means is rotated to the rotation restricting position. It is a top view of the puncture device assembly shown in FIG. FIG. 4A is a first diagram for explaining how to use the puncture device assembly, and FIG. 4B is a second diagram for explaining how to use the puncture device assembly. FIG. 5A is a third diagram illustrating a method of using the puncture device assembly, and FIG. 5B is a fourth diagram illustrating a method of using the puncture device assembly. FIG. 6A is a fifth diagram illustrating a method of using the puncture device assembly, and FIG. 6B is a sixth diagram illustrating a method of using the puncture device assembly. It is a top view of the puncture device assembly which concerns on a 1st modification. It is a perspective view of the puncture device assembly which concerns on a 2nd modification. It is a perspective view of the puncture device assembly which concerns on a 3rd modification. It is a whole perspective view of the puncture device assembly which concerns on 2nd Embodiment of this invention. It is a whole perspective view of the puncture device assembly which concerns on 3rd Embodiment of this invention.

Hereinafter, preferred embodiments of the puncture device assembly according to the present invention will be described with reference to the accompanying drawings.

[First Embodiment]
FIG. 1 is an overall perspective view of a puncture device assembly 10A according to the first embodiment, and FIG. 2A is a longitudinal sectional view taken along line IIA-IIA in FIG. The puncture device assembly 10A is provided in the puncture device 12 that is punctured into a living body, a base portion 14 that comes into contact with the patient's skin, a connecting means 15 that is rotatably supported by the base portion 14, and the base portion 14. The height adjusting mechanism 16, a pair of

markers

18a, 18b having radiopacity, and a marker support means 20 for supporting the pair of

markers

18a, 18b are provided.

The puncture device 12 is used to insert and place a spacer 62 (see FIG. 6A, etc.) between bones. The site where the spacer 62 is inserted is, for example, between the spinous processes, the shoulder joint, or the intervertebral disc. The spacer 62 inserted between the bones contracts in an initial state and expands when a filler is injected.

The puncture device 12 includes a hollow arc-shaped outer needle 22, a hub 24 fixed to the proximal end of the outer needle 22, and an inner needle 26 formed in an arc shape that can be inserted through the outer needle 22. FIG. 1 shows a state in which the inner needle 26 is inserted into the hollow portion of the outer needle 22 as far as possible.

The outer needle 22 is a member having a hollow structure that is open at both ends and has a hollow portion into which the inner needle 26 can be inserted. The hub 24 fixed to the proximal end of the outer needle 22 has a larger outer diameter than the outer needle 22 and is provided in a flange shape.

The inner needle 26 is a rod-like member that is inserted into the hollow portion of the outer needle 22 and curved in an arc shape having a sharp needle tip at the tip. When the inner needle 26 is inserted to the maximum with respect to the outer needle 22 (when the inner needle 26 is inserted into the outer needle 22 to the position where the connecting portion 42 and the hub 24 are in contact), the tip of the inner needle 26 is positioned at the outer needle. The length of the inner needle 26 is set so as to protrude from the tip of 22 by a predetermined length. The inner needle 26 may be either a solid structure or a hollow structure.

The constituent material of the outer needle 22 and the inner needle 26 is not particularly limited as long as it is a hard material having an appropriate strength that is not damaged or deformed when puncturing the living body. For example, stainless steel, aluminum alloy, Examples thereof include metals such as copper alloys, and hard resins such as polyvinyl chloride and polyethylene. The constituent material of the hub 24 is not particularly limited, but the hard material exemplified above can be adopted as the material of the outer needle 22 and the inner needle 26. An X-ray impermeable marker may be provided on at least a part of the distal end side of the outer needle 22 or the inner needle 26 so as to be recognized under X-ray fluoroscopy.

The base portion 14 includes a plate-like contact plate 28 and a pair of guide columns 34 protruding upward from the approximate center in the longitudinal direction of the contact plate 28. In this embodiment, the contact plate 28 includes a base 30 constituting one end side in the longitudinal direction of the contact plate 28 (right side in FIG. 2A), and a center portion and the other end side in the longitudinal direction of the contact plate 28 (left side in FIG. 2A). ), Extending from the base 30 toward the other end side, and extending portions 32 extending in parallel to each other at intervals.

The contact plate 28 is not limited to a flat plate shape, and may be configured in a curved shape or a wave shape so as to match the shape of the skin when placed on the patient's skin. A plurality of small protrusions are provided on the lower surface of the contact plate 28 so that the contact plate 28 is stabilized when the contact plate 28 is placed on the patient's skin so that the contact plate 28 and the skin are in point contact at a plurality of positions. You may comprise. Further, a gel-like sheet may be attached to the contact portion of the contact plate 28 with the skin in order to change and adhere to fit the shape of the body.

The guide pillars 34 are provided in each of the pair of extending portions 32 and face each other in parallel. Each guide column 34 is provided with a slider 36 that can move in the vertical direction along the guide column 34 and can be fixed at an arbitrary position. With this configuration, the height of the rotation center (rotation fulcrum) of the connecting means 15 with respect to the base portion 14 can be adjusted. That is, in the present embodiment, the slider 36 constitutes the height adjusting mechanism 16 that adjusts the height of the rotation fulcrum of the connecting means 15 with respect to the base portion 14.

In the present embodiment, the slider 36 is provided with a fixing screw 38 for fixing the position of the slider 36 with respect to the guide column 34. When the fixing screw 38 is screwed to the outer surface of the slider 36 and the fixing screw 38 is loosened, the tip of the fixing screw 38 is separated from the guide column 34, so that the slider 36 moves relative to the guide column 34. Can do. On the other hand, when the fixing screw 38 is tightened and the tip of the fixing screw 38 is in contact with the guide column 34, the slider 36 is prevented from moving relative to the guide column 34, and the height of the slider 36 can be fixed at that position. . Thus, the fixing screw 38 functions as means for adjusting the height of the slider 36 steplessly.

The steplessly adjusting means for adjusting the height of the slider 36 is not limited to the fixing screw 38, but is based on fitting between the slider 36 and the guide pillar 34 or other physical engaging means. Also good. Further, the means for adjusting the height of the slider 36 is not limited to the stepless adjustment, and may be adjusted with a small pitch.

The connecting means 15 has the puncture device 12 fixed to one end side and is rotatable with respect to the base portion 14 with the arcuate center of curvature of the puncture device 12 as the center of rotation. In the present embodiment, the connecting means 15 includes a pair of arm portions 40 that are rotatably connected to the base portion 14 (specifically, the slider 36) via the shaft portion 41 and extend in parallel, and the connecting means 15. And a connecting portion 42 that connects the pair of arm portions 40 on the opposite side of the rotation center (shaft portion 41). The proximal end of the inner needle 26 is fixed to the central portion of the connecting portion 42. The connecting portion 42 functions as a handle that is gripped and operated by the user when the puncture device 12 is punctured into a patient.

In this embodiment, the connecting portion 42 has a shape extending linearly in a direction orthogonal to the arm portion 40. Instead, the connecting portion 42 has a shape in which the tips of the arm portions 40 are curved and connected to each other. The whole means 15 may be configured to be U-shaped or V-shaped.

In FIG. 1, the arm portion 40 is rotatably connected to the inside of the pair of sliders 36, but instead of such a configuration, the arm portion 40 may be rotatably connected to the outside of the pair of sliders 36. Good.

The puncture device assembly 10A is further provided with a stopper 44 that regulates the puncture length of the puncture device 12. In the present embodiment, the stopper 44 is provided so as to protrude from the inner side surfaces of the pair of sliders 36. As shown in FIG. 2B, when the connecting means 15 rotates and the arm portion 40 contacts the stopper 44, further rotation of the connecting means 15 is prevented. Therefore, the puncture length with respect to the living body of the puncture device 12 fixed to the connecting means 15 is appropriately limited.

It should be noted that a stopper having a different configuration (not shown) may be moved up and down along the guide pillar 34, for example. In this case, the puncture length of the puncture device 12 may be regulated by adjusting the position of the stopper having the other configuration in accordance with the vertical position adjustment of the slider 36.

The

markers

18a, 18b are radiopaque and are disposed opposite to each other at positions spaced parallel to each other in a plane S (see FIGS. 1 and 3) including the arc shape of the puncture device 12. . More specifically, as shown in FIG. 2A, the arrangement positions of the two

markers

18a and 18b are opposite to each other with respect to the extending direction (left-right direction) of the contact plate 28 with respect to the rotation center of the connecting means 15. Yes, it is a position outside the both ends of the extending direction of the contact plate 28.

As shown in FIG. 1, in this embodiment, each

marker

18a, 18b has a frame body 50 and a marker main body 52 having radiopacity arranged inside the frame body 50. The frame 50 is made of a material that easily transmits X-rays, for example, a synthetic resin. In the illustrated example, the frame 50 is formed in a circular ring shape, but may be formed in another shape, for example, an ellipse or a polygon.

The marker main body 52 is made of a radiopaque material such as gold, platinum, or tungsten. Alternatively, the marker body 52 is not entirely composed of an X-ray opaque material, but is partially configured of an X-ray opaque material, for example, an X-ray opaque material in a synthetic resin. May be mixed. The marker body 52 in the illustrated example is formed in a cross shape. Note that the two marker bodies 52 need not have the same shape. Further, the shape of the marker body 52 is not limited as long as the overlap between the two marker bodies 52 can be clearly grasped in the X-ray fluoroscopic image from the side of the patient.

As shown in FIG. 2A, the arcuate radius of curvature R of the puncture device 12, the distance D between the straight line L connecting the pair of

markers

18a and 18b and the rotation center of the connecting means 15 (the straight line from the rotation center of the connecting means 15). The length of the perpendicular line down to L) is equal. In this embodiment, the radius of curvature R of the arc shape is the radius of curvature of the arc drawn by the central axis a of the outer needle 22, and the straight line L is the center of the two

markers

18a and 18b (specifically, This is a straight line connecting the cross-shaped intersections of the two marker bodies 52.

Since the

markers

18a and 18b are arranged in this way, the lowest point of the puncture trajectory of the puncture tool 12 is positioned on a straight line connecting the

markers

18a and 18b (see FIG. 2B). Therefore, when X-ray imaging is performed from the side of the patient, the puncture position and depth of the puncture device 12 can be easily confirmed before puncturing by observing the overlap of the two

markers

18a and 18b.

The marker support means 20 has a height adjustment mechanism so that the arcuate radius of curvature R of the puncture device 12 and the distance D between the straight line L connecting the pair of

markers

18a and 18b and the rotation center of the connecting means 15 are equal. 16 is connected to a pair of

markers

18a and 18b.

In the present embodiment, the marker support means 20 has two support arms 54 that support the pair of

markers

18a and 18b, respectively. One support arm 54 extends from one slider 36 in one of the left and right directions (left direction in the drawing), is displaced downward toward the one side, and includes a plane S (including the arc shape of the puncture device 12 in the middle. (Refer to FIG. 1 and FIG. 3). The other support arm 54 extends from the other slider 36 to the other side in the left-right direction (right direction in the figure), is displaced downward toward the other side, and on the plane S including the arc shape of the puncture device 12 in the middle. It is bent so as to approach, and is connected to the other marker 18b.

The support arm 54 constituting the marker support means 20 is formed in a shape that avoids the operating area of the puncture device 12 and the connection means 15. With this configuration, the marker support means 20 does not interfere with the puncture tool 12 and the connection means 15, and the rotation operation of the puncture tool 12 and the connection means 15 is not hindered. In the example shown in the figure, one support arm 54 is connected to one slider 36 and the other support arm 54 is connected to the other slider 36. The structure in which the two support arms 54 are connected to only one of them may be used.

The support arm 54 constituting the marker support means 20 may be separable from the slider 36 constituting the height adjustment mechanism 16. When the support arm 54 is separable from the slider 36, the support arm 54 and the marker 18a are separated by separating the support arm 54 from the slider 36 after determining the puncture target position and depth using the

markers

18a and 18b. 18b does not get in the way, and the subsequent puncture operation and the insertion operation of the spacer 62 are facilitated.

Each member constituting the puncture device assembly 10A is not particularly limited as long as it is a hard material having an appropriate strength that does not break or substantially deform when the puncture device 12 is punctured into a living body. , Metals such as stainless steel, aluminum alloy and copper alloy, or hard resins such as polyvinyl chloride and polyethylene.

The puncture device assembly 10A according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.

Here, with reference mainly to FIGS. 4A to 6B, a procedure for percutaneously inserting and placing the spacer 62 between adjacent spinous processes in the living body using the puncture device assembly 10A described above will be described. 4A to 6B, the reference symbol B is a vertebra, and the reference symbol B1 is a spinous process formed in the rear part of the vertebra B.

First, after confirming the lesioned part with an X-ray fluoroscope, MRI, ultrasonic diagnostic apparatus, etc., the patient P is placed in the prone position. Next, as shown in FIG. 4A, the puncture device assembly 10A is placed on the back of the patient P in the prone position. At this time, the puncture device assembly 10A is placed so that the separating direction (direction of the straight line L) of the

markers

18a and 18b in the puncture device assembly 10A is parallel to the line of intersection between the frontal surface of the patient P and the horizontal plane. Thereby, a pair of

marker

18a, 18b will be in the state arrange | positioned on the both sides of the patient P. FIG.

Next, X-ray imaging is performed from the side of the patient P, and the X-ray apparatus is moved to a position where the two

markers

18a and 18b just overlap in the fluoroscopic image. At this time, the separating direction (direction of the straight line L) of the

markers

18a and 18b in the puncture device assembly 10A is parallel to the line of intersection between the frontal surface of the patient P and the horizontal plane, and 2 in the fluoroscopic image. Since the two

markers

18a and 18b overlap each other, X-ray imaging is performed from the side of the patient P. Therefore, it can be confirmed accurately and easily that X-ray imaging is performed from the side of the patient P. In the case of the present embodiment, the

markers

18a and 18b have a configuration in which the marker main body 52 is disposed inside the frame body 50, and the marker main body 52 and the frame body 50 do not overlap in the X-ray fluoroscopic image. The contrast between the main body 52 and other parts increases, and the marker main body 52 can be easily identified.

Next, under X-ray fluoroscopy from right next to the patient P, the puncture device assembly 10A for the patient P so that the positions of the

markers

18a and 18b coincide with the indwelling target position of the spacer 62 (between the spinous processes to be treated). And the height of the slider 36 of the puncture device assembly 10A (the height of the rotation center of the connecting means 15) are adjusted. The distance from the skin on the back of the patient P to the spinous process to be treated differs for each patient P, but is adjusted to a height suitable for the target patient P by the above adjustment. Therefore, the puncture depth of the puncture device 12 can be easily adjusted according to the body shape of the patient P, and there is no need to prepare the puncture device assembly 10A individually set for each puncture depth.

Next, the patient P is punctured with the puncture device 12 with the inner needle 26 inserted into the outer needle 22 under fluoroscopy. As described above, the puncture device 12 rotates on the basis of the rotation center (shaft portion 41) of the connecting means 15, and the position of the rotation center can be fixed. For this reason, when the puncture device 12 is punctured into the living body, the puncture operation can be performed accurately and smoothly by rotating the puncture device 12 with the fixed rotation center as a reference. Further, since the connecting means 15 to which the puncture device 12 is fixed is supported by the pair of guide columns 34 via the slider 36, the puncture device 12 is stably rotated when the puncture device 12 is punctured into the living body. Can be made.

4B, the interspinous ligament between adjacent spinous processes is penetrated in the direction perpendicular to the axial direction of the spine by the outer needle 22 and the inner needle 26 of the puncture device 12. In this case, the tip of the puncture device 12 is punctured to a position beyond a predetermined length between the spinous processes. Since the puncture device assembly 10A according to the present embodiment includes the stopper 44 that regulates the puncture length of the puncture device 12, the puncture length of the puncture device 12 is appropriately regulated, and the puncture device 12 has a desired puncture length. Can be punctured into a living body.

As described above, the connecting means 15 includes the pair of arm portions 40 extending in parallel and the connecting portion 42 that connects the pair of arm portions 40 on the side opposite to the rotation fulcrum, and thus the pair of arm portions. A gap having a predetermined size is formed between 40 (see FIG. 1). Further, in the contact plate 28 of the base portion 14, a gap having a predetermined size is formed between the pair of extending portions 32. For this reason, the outer needle 22 and the inner needle 26 of the puncture device 12 are positioned between the pair of arm portions 40 and the pair of extension portions 32 in the plan view of the puncture device assembly 10A. To do.

With this configuration, when the puncture length (puncture depth) of the puncture device 12 is confirmed by irradiating X-rays from above the puncture device assembly 10A, the X-ray irradiation source and the puncture device 12 are The arm part 40 and the extension part 32 do not exist between the outer needle 22 and the inner needle 26. Therefore, since the gap provided between the arm portions 40 and between the extending portions 32 becomes a space through which the X-rays pass, the X-rays are not attenuated by the structure of the puncture device assembly 10A. A fluoroscopic image can be suitably obtained.

After the puncture device 12 has been punctured to a desired length, the inner needle 26 is then removed from the outer needle 22 while the position of the outer needle 22 is maintained, that is, while the outer needle 22 is pierced by the patient P, and the outer needle 22 is removed. In place.

Next, as shown in FIG. 5A, an expansion device 60 having a spacer 62 at the tip is inserted into the hollow portion of the outer needle 22. 5A to 6B, a part of the inner needle 26 and a part of the expansion device 60 are not shown. The expansion device 60 includes an expandable spacer 62 and a flexible tube 64 connected to the proximal side of the spacer 62. The illustrated spacer 62 is configured as a balloon and is a tubular body when contracted, and has a structure in which a pair of bulging portions 62a are connected via a constricted portion 62b when expanded (see FIG. 6A). When the spacer 62 is expanded in a dumbbell shape, a wheel shape (H shape), or the like, the pair of bulging portions 62a disposed on both sides of the constricted portion 62b inserted into the interspinous ligaments defines the spinous process B1. This is preferable because it is sandwiched.

The material of the spacer 62 is particularly limited as long as the material can be expanded by being injected with a filler, and can withstand the external pressure associated with the movement of the vertebral body and tissues such as the spinous processes B1 and interspinous ligaments surrounding the spacer 62. For example, vinyl chloride, polyurethane elastomer, nylon, PET and the like can be mentioned.

The tube 64 connected to the spacer 62 feeds the filler to the spacer 62, and a filler supply source such as a syringe or a pump is connected to the base end side. The spacer 62 and the tube 64 are detachably connected. The connection structure between the spacer 62 and the tube 64 is, for example, a screwed structure. When a predetermined torque or more is applied to the spacer 62 and the tube 64, the screw 62 is disengaged so that the spacer 62 and the tube 64 are connected. It comes to separate.

The connection structure between the spacer 62 and the tube 64 includes the above-described screwed structure, a structure in which the spacer 62 and the tube 64 are detachably connected by physical engagement (fitting, hooking, etc.), and some physical action (thermal action). , A chemical action, etc.) may be adopted so as to be detachably connected.

As shown in FIG. 5A, in the step of inserting the expansion device 60 into the hollow portion of the outer needle 22, the expansion is performed so that the axial center of the spacer 62 is positioned at the center of the interspinous ligament between adjacent spinous processes. Device 60 is inserted. After the expansion device 60 is inserted to a predetermined position of the outer needle 22, next, as shown in FIG. 5B, the outer needle 22 is retracted in the proximal direction while maintaining the position of the spacer 62. In this case, the outer needle 22 is retracted to a position where the entire length of the spacer 62 is exposed in the body.

Next, as shown in FIG. 6A, the spacer 62 is expanded by operating a filler supply source (not shown) and injecting the filler into the spacer 62 through the tube 64. The filler is either a fluid at the time of injection, and a material that hardens after injection (eg, bone cement, acrylic resin, two-component mixed cross-linked polymer, etc.) or a material that is a fluid at the time of injection and maintains the fluid after injection. Can also be applied.

The expanded spacer 62 has a shape in which a pair of bulging portions 62a are connected via a constricted portion 62b. The constricted portion 62b penetrates an interspinous ligament between spinous processes, and a pair of bulging portions on both sides thereof. An interspinous ligament is located between 62a. Thereby, the space | interval between spinous processes is expanded by the expanded constriction part 62b, and the spacer 62 will be in the state which the removal | extraction from the interspinous ligament between spinous processes was prevented.

After the spacer 62 is expanded, the tube 64 is then detached from the spacer 62 as shown in FIG. 6B. When the connection structure between the spacer 62 and the tube 64 is a screwed structure, when the tube 64 is rotated around its axis, the spacer 62 inserted in the interspinous ligament between adjacent spinous processes does not rotate, and the tube 64 is rotated. Only the rotation causes the spacer 62 and the tube 64 to be disengaged. Thereby, the tube 64 can be detached from the spacer 62.

In addition, when the filler is a material that is a fluid at the time of injection and is cured after the injection, the spacer 62 and the tube 64 are preferably separated after the filler is cured. In addition, when the filler is a material that maintains the fluid even after injection, a backflow prevention structure (check valve) may be provided at the inlet of the spacer 62.

When the tube 64 is detached from the spacer 62, the tube 64 is removed from the outer needle 22, and the outer needle 22 is completely removed from the patient P. As a result, the spacer 62 is placed between the spinous processes.

As described above, according to the puncture device assembly 10A according to the present embodiment, the lowest point of the puncture trajectory of the puncture device 12 is located on the straight line L connecting the

markers

18a and 18b. Thus, the puncture tool 12 is punctured after the position where the pair of

markers

18a and 18b overlap with the puncture target position, so that the puncture can be accurately performed at the target position and depth. Therefore, the puncture position and the puncture depth of the puncture device 12 can be accurately known before puncturing, and as a result, the spacer 62 can be accurately placed at the targeted position and depth.

Further, the arcuate radius of curvature R of the puncture device 12, the distance D between the straight line L connecting the pair of

markers

18a and 18b and the rotation center of the connecting means 15 are always the same, and therefore, due to deformation of the skin during puncture. Even if there is a sink, it can be accurately punctured with the targeted puncture depth without being affected by it.

Furthermore, the puncture device assembly 10A is placed on the patient P with the direction of separation of the

markers

18a and 18b facing the patient P's body, and the

markers

18a and 18b overlap each other in the fluoroscopic image. By moving the X-ray apparatus in this manner, X-ray imaging can be performed from the side of the patient P. In other words, it can be easily confirmed that an X-ray image is taken from the side of the patient P.

FIG. 7 is a plan view of the puncture device assembly 10a according to the first modification. The marker support means 20a of the puncture device assembly 10a has two support arms 54 for each of the

markers

18a and 18b. That is, one marker 18 a is fixed to the tip of a pair of support arms 54 that respectively extend in one direction (left direction in the illustrated example) from the pair of sliders 36, and the other marker 18 b extends from the pair of sliders 36 to the other. It is fixed to the tip of a pair of support arms 54 extending in the direction (right direction in the illustrated example).

Thus, since the marker support means 20a is configured to be supported by a plurality (two) of the support arms 54 for each of the

markers

18a and 18b, sufficient rigidity can be obtained. As a result, it is possible to stably maintain a state in which the arcuate radius of curvature R of the puncture device 12 and the distance D between the straight line L and the rotation center of the connecting means 15 coincide with each other, and accurately with respect to the target position. The puncture of the puncture device 12 and the placement of the spacer 62 can be performed. In FIG. 7, two support arms 54 are provided for each

marker

18a, 18b, but three or more support arms 54 may be provided for each

marker

18a, 18b.

In the embodiment shown in FIG. 1 and the like, the support arm 54 has a curved shape so as to be displaced downward as it moves away from the slider 36, but the marker support of the puncture device assembly 10b according to the second modification shown in FIG. The support arm 72 constituting the means 20b may be bent at a right angle along the way. Specifically, the support arm 72 extends from the slider 36 in parallel with the contact plate 28, bends at a right angle downward at a position outside the contact plate 28, and is connected to the

markers

74a and 74b, respectively. .

In the puncture device assembly 10A shown in FIG. 1 and the like, the

markers

18a and 18b have a configuration in which the marker main body 52 is arranged inside the frame 50, but like the

markers

74a and 74b shown in FIG. A configuration in which

marker bodies

78 a and 78 b having radiopacity are provided on the surface of the plate-like substrate 76 may be adopted. In FIG. 8, the base body 76 has a disk shape, one marker body 78a has a circular ring shape (donut shape), and the other marker body 78b has an outer diameter substantially the same as the inner diameter of one marker body 78a. It has a circular shape.

In addition, the shape of the base body 76 is not limited to a disk shape, and may be another shape such as an ellipse or a polygon. Instead of the circular ring-shaped marker main body 78a and the circular marker main body 78b, a cross-shaped marker main body may be provided on the surface of each base 76, or a marker main body having another shape in which the overlap can be clearly seen may be provided. . The marker support means 20b shown in FIG. 8 may be combined with the

markers

18a and 18b shown in FIG.

FIG. 9 is a perspective view of a puncture device assembly 10c according to a third modification. The puncture device assembly 10c is a further modification of the puncture device assembly 10b according to the second modification described above, and the marker support means 20c can be expanded and contracted in a direction in which the mutual interval between the pair of

markers

74a and 74b is changed. It is configured. Each support arm 80 constituting the marker support means 20c has a linear portion 82 extending from the slider 36 in parallel with the extending direction (longitudinal direction) of the contact plate 28. The straight portion 82 is configured to be extendable and contractible. Specifically, the linear portion 82 is connected to the first portion 84 coupled to the slider 36 and is displaceable in the extending direction of the first portion 84 (the direction of the straight line L) with respect to the first portion 84. And a second portion 86. In the illustrated example, the second portion 86 is slidably inserted into the first portion 84.

According to this configuration, when the puncture device assembly 10c is used for a patient whose body width is relatively small, the linear portion 82 is shortened and the interval between the

markers

74a and 74b is set to be small. 74a and 74b do not get in the way. Further, when the puncture device assembly 10c is used for a patient having a relatively large body width, the pair of

markers

74a, 74a, 74b, 74b can be securely placed on both sides of the patient's torso. That is, the interval between the

markers

74a and 74b can be appropriately adjusted according to the patient's body shape.

Instead of the circular ring-shaped marker main body 78a and the circular marker main body 78b, a cross-shaped marker main body may be provided on the surface of each base 76, and a marker main body having another shape in which the overlap can be clearly seen is provided. Also good. The marker support means 20c shown in FIG. 9 may be combined with the

markers

18a and 18b shown in FIG.

[Second Embodiment]
FIG. 10 is an overall perspective view of a puncture device assembly 10B according to the second embodiment of the present invention. In the puncture device assembly 10B according to the second embodiment, the same or similar components as those of the puncture device assembly 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.

The puncture device assembly 10B includes a guide portion 90 capable of fixing the position relative to the base portion 14 with respect to the puncture device assembly 10A described above, a guide body 92 formed with the guide portion 90, the base portion 14 and the guide body. 92 and a guide rail 94 that couples to 92.

The guide portion 90 has substantially the same curvature as that of the arc shape of the outer needle 22 and the inner needle 26, and contacts the outside of the arc shape of the outer needle 22 so that the outer needle 22 moves while drawing an arc trajectory. It is a guide. In the present embodiment, the guide portion 90 is configured by a hole having an inner diameter through which the outer needle 22 can be inserted. The inner diameter of the guide portion 90 should be slightly larger than the outer diameter of the outer needle 22 or substantially the same as the outer diameter of the outer needle 22 so that the outer needle 22 moves along an accurate circular arc trajectory. .

Since the guide portion 90 is provided, when the puncture device 12 is punctured into the patient, the outer needle 22 of the puncture device 12 is inserted while being in contact with the guide portion 90, and therefore, from the proximal end side of the puncture device 12. The direction of the applied force is corrected in the direction of the needle tip, and the puncture tool 12 can be moved so as to draw an arc trajectory having the same center of curvature and radius of curvature as the outer needle 22. Thereby, the puncture device 12 can be punctured easily and accurately with respect to the patient.

Further, when the outer needle 22 is retracted after the puncture device 12 is punctured to the patient, the outer needle 22 is guided so as to draw an arc orbit by the action of the guide portion 90, so that the outer needle 22 is smoothly moved backward. It can be carried out. In place of the guide portion 90 in the form of a hole, a concave (groove-shaped) guide portion extending in an arc shape may be employed.

The guide portion 90 is formed on the guide body 92. Specifically, the guide body 92 is a block-shaped member, and both ends of the guide portion 90 are opened on the upper and lower surfaces thereof. The guide body 92 is formed with two slide holes 93 penetrating in the vertical direction, and a guide rail 94 is inserted into the slide hole 93. Therefore, the height of the guide body 92 can be adjusted along the guide rail 94. In FIG. 10, the middle portion of the support arm 54 is bent outward so that the support arm 54 provided on the guide body 92 side and the guide body 92 do not interfere with each other.

The guide rail 94 supports the guide body 92 so that the position of the guide body 92 can be changed up and down. In the present embodiment, the guide rail 94 projects upward in parallel from the end of the extending portion 32 opposite to the contact plate 28. ing.

In order to fix the position of the guide body 92 with respect to the guide rail 94, a fixing screw 96 is provided on the side surface of the guide body 92. When the fixing screw 96 is loosened, the guide body 92 can move with respect to the guide rail 94. When the fixing screw 96 is tightened, the guide body 92 is prevented from moving relative to the guide rail 94, and the height of the guide body 92 is increased. It can be fixed in that position. Thus, the fixing screw 96 functions as a means for adjusting the height of the guide body 92 steplessly.

Note that means for steplessly adjusting the height of the guide body 92 with respect to the base portion 14 is not limited to the fixing screw 96, but by fitting the guide body 92 and the guide rail 94, or other physical It may be due to the engaging means. In addition, the means for adjusting the height of the guide body 92 with respect to the base portion 14 is not limited to the stepless adjustment, and may be adjusted with a small pitch.

In the puncture device assembly 10B, instead of the marker support means 20 and the

markers

18a and 18b, the marker support means 20a to 20c shown in FIGS. 7 to 9 and the

markers

74a and 74b may be freely combined. .

Of course, in the puncture device assembly 10B, the same operations and effects as those of the puncture device assembly 10A can be obtained with respect to the components common to the puncture device assembly 10A.

[Third Embodiment]
FIG. 11 is an overall perspective view of a puncture device assembly 10C according to the third embodiment of the present invention. In the puncture device assembly 10C according to the third embodiment, the same or similar components as those of the

puncture device assemblies

10A and 10B according to the first and second embodiments are denoted by the same reference numerals, and detailed description thereof will be given. Omitted.

The puncture device assembly 10C corresponds to a modification of the puncture device assembly 10B. Instead of the guide rail 94 and the guide body 92 in the second embodiment described above, the third embodiment includes a pressing member 100 and a pair of connecting arms 102.

The pressing member 100 suppresses the deformation of the skin at the insertion point and the repulsive force from the skin by contacting the patient's skin. In order to increase the contact area with the skin of the pressing member 100, a portion that contacts the skin is formed in a round shape. As shown in FIG. 11, the width W <b> 1 of the pressing member 100 is smaller than the interval W <b> 2 between the extending portions 32 of the contact plate 28. For this reason, in a state where the puncture device assembly 10 </ b> C is placed on the patient, the pressing member 100 can enter between the pair of extending portions 32 and contact the patient's skin.

The pressing member 100 is provided with an arcuate guide portion 90. Therefore, when inserting the puncture device 12 into the patient, the puncture device 12 can be moved so as to draw an arc trajectory having the same center of curvature and radius of curvature as the outer needle 22 by the guide action of the guide portion 90, and puncture the patient. The puncture of the tool 12 can be easily performed. Further, when the outer needle 22 is retracted after the puncture device 12 is punctured to the patient, the outer needle 22 is guided so as to draw an arc orbit by the action of the guide portion 90, so that the outer needle 22 is smoothly moved backward. It can be carried out.

The lower end of the guide portion 90 is formed so as to face the contact surface of the pressing member 100 with the skin. In place of the guide portion 90 in the form of a hole, a concave (groove-shaped) guide portion extending in an arc shape may be employed.

The distal end side of the connecting arm 102 is connected to the pressing member 100, and the proximal end side of the connecting arm 102 is rotatably connected to the slider 36 via the shaft portion 41. The connecting arm 102 and the arm part 40 are rotatable about the same axis. Therefore, the pressing member 100 fixed to the tip of the connecting arm 102 is rotatable around the rotation center (shaft portion 41) of the connecting means 15. The guide portion 90 provided on the pressing member 100 is rotatable at the same rotation center and rotation radius as the rotation center and rotation radius of the puncture device 12.

In the case of the puncture device assembly 10B according to the second embodiment described above, it is necessary to adjust the height of the guide body 92 according to the height of the rotation fulcrum of the connecting means 15. On the other hand, in the case of the puncture device assembly 10C according to this embodiment, if the height of the rotation center of the connecting means 15 is changed, the angle of the guide portion 90 provided on the pressing member 100 changes in conjunction with this change. In addition, it is not necessary to adjust the angle of the pressing member 100 independently of the adjustment of the height of the rotation center of the connecting means 15, and it is easy to use.

The outer needle 22 and the inner needle 26 of the puncture device 12 are positioned between the pair of arm portions 40, the pair of extending portions 32, and the pair of connecting arms 102 with respect to the separating direction of the pair of guide columns 34. With this configuration, when the puncture length (puncture depth) of the puncture device 12 is confirmed by irradiating X-rays from above the puncture device assembly 10C, the X-ray irradiation source and the puncture device 12 Since the arm part 40, the extension part 32, and the connection arm 102 do not exist between the outer needle 22 and the inner needle 26, an X-ray fluoroscopic image can be suitably obtained. That is, the gaps provided between the arm portions 40, between the extending portions 32, and between the connecting arms 102 serve as a space through which X-rays pass as they are, so that the X-rays are attenuated by the structure of the puncture tool assembly 10C. There is no.

In the puncture device assembly 10C, instead of the marker support means 20 and the

markers

18a and 18b, the marker support means 20a to 20c shown in FIGS. 7 to 9 and the

markers

74a and 74b may be freely combined. .

Of course, in the puncture device assembly 10C, the same functions and effects as those of the

puncture device assemblies

10A and 10B can be obtained with respect to the components common to the

puncture device assemblies

10A and 10B.

In the above description, the present invention has been described with reference to preferred embodiments and modifications. However, the present invention is not limited to the above embodiments and modifications, and various modifications can be made without departing from the scope of the present invention. Needless to say, it is possible.

Claims

A puncture device having a hollow arc-shaped outer needle (22) and an inner needle (26) that can be inserted through the outer needle (22) and is formed in an arc shape having the same curvature as the outer needle (22). (12)
A base (14) in contact with the patient's skin;
The puncture device (12) is fixed, and connecting means (15) rotatable with respect to the base portion (14) with the arcuate center of curvature of the puncture device (12) as a rotation center;
A height adjustment mechanism (16) for adjusting the height of the rotation center relative to the base portion (14);
A pair of markers (18a, 18b, 74a, 74b) that are radiopaque and spaced apart from each other in a plane including the arc shape of the puncture device (12);
The arcuate radius of curvature (R) of the puncture device (12) and the distance (D) between the rotation center and the straight line (L) connecting the pair of markers (18a, 18b, 74a, 74b) are equal. And a marker support means (20, 20a to 20c) for connecting the height adjustment mechanism (16) and the pair of markers (18a, 18b, 74a, 74b),
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10A to 10C, 10a to 10c) according to claim 1,
The pair of markers (18a, 18b, 74a, 74b) are arranged on opposite sides with respect to the extending direction of the base portion (14) with respect to the rotation center of the connecting means (15).
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10A to 10C, 10a to 10c) according to claim 2,
The pair of markers (18a, 18b, 74a, 74b) are arranged outside both ends in the extending direction of the base portion (14).
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10a) according to claim 1,
The marker support means (20a) has a plurality of support arms (54) for each of the pair of markers (18a, 18b).
A puncture device assembly (10a) characterized by the above.
The puncture device assembly (10c) according to claim 1,
The marker support means (20c) is configured to be extendable and contractable in a direction in which a mutual interval between the pair of markers (74a, 74b) is changed.
A puncture device assembly (10c).
The puncture device assembly (10A to 10C, 10a to 10c) according to claim 1,
The marker support means (20, 20a to 20c) is separable from the height adjustment mechanism (16).
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10A to 10C, 10a) according to claim 1,
Each of the pair of markers (18a, 18b) includes a frame (50) and a marker main body (52) having radiopacity disposed inside the frame (50).
A puncture device assembly (10A to 10C, 10a) characterized by the above.
The puncture device assembly (10A to 10C, 10a) according to claim 7,
The frame (50) is made of a material that transmits X-rays.
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10A to 10C, 10a to 10c) according to claim 7,
The marker body (52) is formed in a cross shape.
A puncture device assembly (10A to 10C, 10a to 10c) characterized by the above.
The puncture device assembly (10B, 10C) according to claim 1,
The position with respect to the base portion (14) can be fixed, has the same curvature as that of the arc shape of the puncture device (12), and contacts the outside of the arc shape of the outer needle (22). A guide portion (90) for guiding the outer needle (22) to move along an arcuate path;
A puncture device assembly (10B, 10C) characterized by the above.