WO2013141150A1

WO2013141150A1 - Interspinous implant

Info

Publication number: WO2013141150A1
Application number: PCT/JP2013/057367
Authority: WO
Inventors: 優畑
Original assignee: テルモ株式会社
Priority date: 2012-03-23
Filing date: 2013-03-15
Publication date: 2013-09-26

Abstract

This interspinous implant (1) is provided with a columnar shaft section (2), as well as a first anti-displacement member (3) and second anti-displacement member (4). The first anti-displacement member (3) and the second anti-displacement member (4) both expand and contract in the normal direction of a side surface section (2a) of the shaft section (2).

Description

Interspinous process implant

The present invention relates to an interspinous process implant placed between two spinous processes of a lumbar vertebra, for example, an interspinous process implant used for treating lumbar spinal canal stenosis.

Conventionally, the spinal canal may become narrow due to degeneration of intervertebral disc herniation, degenerative spondylosis or ligaments placed around the lumbar vertebrae with aging. When the spinal canal becomes narrow, the spinal cord and nerves passing through the spinal canal are compressed, causing a disease called lumbar spinal canal stenosis. In this lumbar spinal canal stenosis, the spinal cord and nerves are compressed, causing back pain, leg numbness, and the like.

One method of treating lumbar spinal canal stenosis is to place an implant between two spinous processes of adjacent vertebrae in the lumbar spine, keeping the distance between the two spinous processes at an appropriate distance, and to the spinal cord and nerves. Although there is a method of relieving the pressure of the implant, it is necessary to make a large incision in the vicinity of the spinous process in order to place the implant. Therefore, there is a need for a method for placing an implant between spinous processes with minimal invasiveness without burdening the patient.

As such a conventional interspinous process implant, for example, there is a spacer as described in Patent Document 1. The interspinous process implant described in Patent Document 1 includes a blocking member interposed between the spinous processes and a plurality of arms provided at both ends of the blocking member.

The plurality of arms have elasticity. In the state before being arranged between the spinous processes, the plurality of arms are folded along the axial direction of the blocking member, and the entire interspinous process implant has a substantially I-shape. When arranged between the spinous processes, the plurality of arms rotate around the end of the blocking member. Then, the entire interspinous process implant expands and expands in a substantially H shape.

This interspinous process implant is arranged in a tube-shaped member so-called cannula with a plurality of arms folded. Then, the cannula in which the interspinous process implant is disposed is inserted into a predetermined position, and the interspinous process implant is pushed out from the cannula between the spinous processes. In the interspinous process implant pushed out between the spinous processes, the plurality of arms rotate about the end of the blocking member at a substantially right angle, and expand and expand from the folded state. And the arm part arrange | positioned at the both sides of the interruption | blocking member clamps a spinous process. As a result, the interspinous process implant is placed at a predetermined position.

JP 2010-162358 A

However, in the technique described in Patent Document 1, the direction in which the arm rotates is determined in one direction. Therefore, in order to reliably place the interspinous process implant between the spinous processes, it is necessary to insert the interspinous process implant while paying attention to the direction in which the arm rotates.

Also, the arm portion was expanded and expanded by rotating around the end of the blocking member. Therefore, a large space is required for the arms to expand and expand. As a result, in the technique described in Patent Document 1, there is a risk that the tissue around the spinous process is damaged by the arm when the arm is deployed and expanded.

An object of the present invention is to provide a low-invasive interspinous process implant that can be inserted into a living body without considering the expansion direction of the interspinous process implant in consideration of the above-described problems. .

In order to solve the above-described problems and achieve the object of the present invention, an interspinous process implant of the present invention includes a columnar shaft portion inserted between two spinous processes of adjacent vertebrae, and a first slip prevention member. And a second misalignment prevention member. The first misalignment prevention member and the second misalignment prevention member are attached to the side surface portion of the shaft portion. The first misalignment prevention member and the second misalignment prevention member can be expanded and contracted in the normal direction of the side surface portion of the shaft portion.

According to the interspinous process implant of the present invention, the interspinous process implant can be inserted between the spinous processes without considering the expansion direction of the first misalignment preventing member and the second misalignment preventing member. Furthermore, the space for expanding the first misalignment prevention member and the second misalignment prevention member can be reduced, and the invasiveness can be reduced.

1 is a perspective view showing a first embodiment of an interspinous process implant of the present invention. It is a perspective view which shows the state which the 1st deviation prevention member in the 1st Example of the interspinous process implant of this invention and the 2nd deviation prevention member expanded. FIG. 3A is a schematic diagram of the lumbar vertebra, FIG. 3A is a diagram showing the lumbar vertebra in the living body, FIG. 3B is an enlarged view of a main part of the lumbar vertebra, and FIG. FIG. 4A is a schematic diagram of a puncture device used to introduce an interspinous process implant into a living body, FIG. 4A is a diagram showing an inner needle constituting the puncture device, and FIG. 4B is a diagram showing an outer cylinder constituting the puncture device; FIG. 4C is a cross-sectional view showing a state in which the inner needle is inserted into the outer cylinder. FIG. 5A is a diagram for explaining a procedure for placing an interspinous process implant in a living body, FIG. 5A is a diagram illustrating a state before the puncture device of FIG. 4 is punctured into a living body, and FIG. It is a figure which shows the state made to puncture. It is a figure for demonstrating the procedure which indwells the implant between spinous processes in the biological body, and is a figure which shows the state which inserted the insertion tube between spinous processes. It is the side view which looked at the state shown in FIG. 6 from the side surface of the lumbar vertebra. It is sectional drawing to which the principal part shown in FIG. 6 was expanded. FIG. 9A is a diagram for explaining a procedure for placing an interspinous process implant in a living body, FIG. 9A is an explanatory diagram showing a process of pushing the interspinous process implant from an insertion tube, and FIG. It is explanatory drawing which shows the state detained in the position. It is the side view which looked at the state shown in Drawing 9B from the side of the lumbar vertebra. It is a front view which shows the state which indwelled the implant between spinous processes between spinous processes. It is a front view which shows the 2nd example of embodiment of the implant between spinous processes of this invention. It is a perspective view which shows the 3rd Embodiment of the implant between spinous processes of this invention. It is a front view which shows the example of 4th Embodiment of the implant between spinous processes of this invention. FIG. 15A shows a fifth embodiment of the interspinous process implant of the present invention, FIG. 15A is a front view showing a state in which the first deviation preventing member and the second deviation preventing member are expanded, and FIG. It is a front view which shows the state which the displacement prevention member of this and the 2nd deviation prevention member reduced. FIG. 16A shows a fifth embodiment of the interspinous process implant of the present invention, FIG. 16A is a side view showing a state where the first deviation preventing member and the second deviation preventing member are expanded, and FIG. It is a side view which shows the state which the displacement prevention member of this and the 2nd deviation prevention member reduced. It is a principal part enlarged view in the 5th Example of the implant between spinous processes of this invention. It is a front view which shows the 6th example of embodiment of the implant between spinous processes of this invention.

Hereinafter, embodiments of the interspinous process implant of the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure. The present invention is not limited to the following form.

1. First Embodiment 1-1. Configuration Example of Interspinous Process Implant Next, a configuration example of a first embodiment of the interspinous process implant of the present invention (hereinafter referred to as “this example”) will be described with reference to FIGS. 1 and 2. .
1 and 2 are perspective views showing the interspinous process implant of this example.

An interspinous process implant 1 shown in FIG. 1 is an implant that is used, for example, for the treatment of lumbar spinal canal stenosis and is placed between the spinous processes of adjacent vertebrae in the lumbar spine. The interspinous process implant 1 includes a shaft portion 2, a first displacement prevention member 3, and a second displacement prevention member 4. The interspinous process implant 1 is inserted into a living body by a puncture device 8 described later (see FIG. 4).

The shaft portion 2 is formed in a substantially cylindrical shape. Note that the shape of the shaft portion 2 is not limited to a substantially cylindrical shape. As the shape of the shaft portion 2, for example, in addition to a rectangular column such as a quadrangular column or a hexagonal column, a central portion in the axial direction such as a shape in which the central portion in the axial direction swells or a shape in which the central portion in the axial direction is recessed It is preferable to be bilaterally symmetric, and the shape is not limited thereto. A first misalignment prevention member 3 and a second misalignment prevention member 4 are attached to the side surface portion 2 a of the shaft portion 2.

The first misalignment prevention member 3 is disposed on one side in the axial direction of the shaft portion 2, and the second misalignment prevention member 4 is disposed on the other side in the axial direction of the shaft portion 2. The first misalignment prevention member 3 and the second misalignment prevention member 4 are arranged at a predetermined interval in the axial direction of the shaft portion 2.

The first misalignment prevention member 3 and the second misalignment prevention member 4 are formed by spiral springs in which a belt-like body 6 having elasticity is wound spirally in the same plane. One end portion 6 a on the center side in the winding direction of the belt-like body 6 is fixed to the side surface portion 2 a of the shaft portion 2. Further, the other end portion 6b outside the winding direction in the strip 6 is a free end. In the contracted state, the first misalignment prevention member 3 and the second misalignment prevention member 4 are arranged so that the strips 6 positioned in the radially outward direction and the radially inward direction are in contact with each other against the elastic force. 2 is wound around the side surface portion 2a.

As shown in FIG. 2, the first deviation preventing member 3 and the second deviation preventing member 4 are in the direction of the radius of winding, that is, the normal line of the side surface portion 2a in the shaft portion 2, from the contracted state shown in FIG. Expand in the direction. At this time, the first misalignment prevention member 3 and the second misalignment prevention member 4 extend substantially uniformly in the normal direction of the side surface portion 2a. Therefore, it is not necessary to consider the direction for expanding the first misalignment prevention member 3 and the second misalignment prevention member 4.

Furthermore, the first misalignment prevention member 3 and the second misalignment prevention member 4 expand and contract in the same plane extending substantially vertically from the side surface portion 2a. Therefore, the space for expanding and contracting the first misalignment preventing member 3 and the second misalignment preventing member 4 can be made smaller than the conventional interspinous process implant in which the arm portion rotates.

Examples of the material of the belt-like body 6 constituting the first deviation preventing member 3 and the second deviation preventing member 4 include steel, Si—Mn steel, Mn—Cr steel, Mn—Cr—V steel, and Mn—CR. -B steel, Si-Mn-Cr steel, Mn-Cr-Co steel, Cr-Ni steel, Cr-Ni-Cu steel, Cr-Ni-Al steel, C-Cr steel, carbon steel, beryllium steel, brass, Phosphor bronze, nickel white, Cu—Ni steel, Cu—Ni—Zn steel, Cu—Sn steel, Cu—Zn—Al steel, Cu—Ni—Sn steel, Cu—Be steel, Cu—Be— Co steel, Ni—Co steel, Ni alloy, stainless steel, Ti alloy, Ti—Pd steel, Ni—Ti steel, Ni—Al steel, In—Ti steel, In—Cd steel, Ti—Ni—Cu steel, T— Ni-Fe steel, Cu-Zn steel, carbon fiber, glass fiber, ceramic, PSZ, Silicon carbide, shape memory alloy, Ag-Cd steel, Au-Cd steel, Cu-Al-Ni steel, Cu-Au-Zn steel, metal matrix composite (FRM), polymer matrix composite (FRP), ceramic matrix A composite material (FRC), glass fiber reinforced plastic (GFRP), rubber, epoxy resin, stainless steel, or the like can be used.

Furthermore, the following treatment may be applied to the surface of the strip 6. For example, plating of copper, nickel, chromium, zinc, cadmium, etc. Even if chemical conversion treatment such as phosphate coating, iron oxide coating, etc., and coating of rust preventive oil, zinc rich, graphite primer, phthalate black paint, epoxy resin, grease, bonderube lubricating coating, molybdenum lubricating coating, etc. Good.

Further, the material of the shaft portion 2 is not particularly limited as long as it can withstand various operations such as external pressure accompanying the movement of the spinous process 105 and insertion and removal operations. As a material of the shaft portion 2, for example, in addition to the same material as that of the band-shaped body 6 described above, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, cobalt chrome or cobalt chrome alloy, Polyamide resins such as vinyl, polyurethane, polyurethane elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), ethylene vinyl acetate copolymer (EVA), nylon And polyester resins such as polyamide elastomers, poly (ethylene terephthalate) (PET) and polyester elastomers, olefin resins such as polyethylene, rubber, silicone elastomers, fluororubbers, fluororesins, ethylene-tetraph Oroechiren copolymer (ETFE), polyurethane, and various soft materials such as polyether nylon resin may be used.

Furthermore, the size of the shaft portion 2 is appropriately set according to the state between the spinous processes 105 where the interspinous process implant 1 is placed. For example, the axial length of the shaft portion 2 is set in the range of 1 cm to 10 cm, and the diameter of the shaft portion 2 is set in the range of 0.5 cm to 1.7 cm.

The sizes of the first misalignment prevention member 3 and the second misalignment prevention member 4 are appropriately set according to the state of the spinous process 105 in which the interspinous process implant 1 is placed. For example, the thickness of the strip 6 constituting the first misalignment prevention member 3 and the second misalignment prevention member 4 is set to 0.01 cm to 0.9 cm, and the length in the width direction is 0.1 cm. Set to ~ 4 cm. Further, the length of the strip 6 in the longitudinal direction is set, for example, in the range of 0.6 cm to 240 cm.

Further, in the contracted state shown in FIG. 1, the number of turns wound around the shaft portion 2 in the first misalignment prevention member 3 and the second misalignment prevention member 4 is set in a range of 1 to 40 revolutions, Is set to 0.3 cm to 3.0 cm, more preferably 0.52 cm to 1.9 cm. Further, in the expanded state as shown in FIG. 2, the number of turns of the first deviation preventing member 3 and the second deviation preventing member 4 is set in a range of 1 to 39 rotations, and the diameter at that time is 0 It is set to be 6 cm to 12 cm.

1-2. Configuration of Lumbar Spine Here, the lumbar spine of the human body where the interspinous process implant having the above-described configuration is installed will be described with reference to FIGS.
3A to 3C are explanatory diagrams showing the lumbar spine.

As shown in FIGS. 3A to 3C, the lumbar vertebra 101 located on the back of the living body 100 is configured by connecting a plurality of vertebrae 102. The vertebra 102 includes a substantially cylindrical vertebral body 103, a vertebral arch 104, a spinous process 105, a transverse process 106, an upper joint process 107, and a lower joint process 108.

The vertebral arch 104 extends in an arc from the rear of the vertebral body 103. The spinous process 105 is formed at a substantially central portion of the vertebral arch 104 and extends backward. The transverse processes 106 are formed at both ends of the vertebral arch 104 in the left-right direction, and protrude and extend in the left-right direction. The upper joint process 107 is formed in a pair at the upper end of the vertebral arch 104 and extends upwardly. The lower joint process 108 is formed in a pair at the lower end of the vertebral arch 104 and extends downwardly.

A vertebral hole 109 that is partitioned by a vertebral body 103 and a vertebral arch 104 and penetrates in a vertical direction is formed at a substantially central portion of the vertebra 102. Since adjacent vertebrae 102 are connected via an intervertebral disc 110, a tubular spinal canal 111 having a vertebral hole 109 in each vertebra 102 communicated is formed in the lumbar vertebra 101. The spinal canal 111 includes a spinal cord and nerve (not shown) passing through the spinal canal 111, and the rear wall of the spinal canal 111 is composed of a yellow ligament.

Lumbar spinal canal stenosis is a narrowing of the spinal canal 111 due to diseases such as thickening of the ligamentum flavum on the posterior wall of the spinal canal with age, degenerative spondylosis, and degenerative spondylolisthesis. It is a disease caused by nerve pressure.

1-3. Puncture tool Next, the puncture tool 8 used in the procedure for placing the interspinous process implant 1 in the living body 100 will be described with reference to FIGS. 4A to 4C.
4A to 4C are explanatory views showing the puncture device 8. FIG.

As shown in FIGS. 4A and 4B, the puncture device 8 has an inner needle 81 and an outer cylinder 85 into which the inner needle 81 is inserted. As shown in FIG. 4A, the inner needle 81 has a main body portion 84 provided with a needle portion 82 at the distal end portion. A base end portion of the main body portion 84 is fixed to an inner needle gripping portion 83 having a substantially rectangular cross section. The main body 84 is formed to be bent at a predetermined angle. The inner needle gripping portion 83 is gripped by the practitioner when the inner needle 81 is inserted into the outer cylinder 85 or when the inner needle 81 is removed from the outer cylinder 85.

As shown in FIG. 4B, the outer cylinder 85 has an outer cylinder gripping portion 86 and a cylindrical portion 88. The outer cylinder gripping portion 86 has a substantially rectangular cross section. The base end portion of the cylindrical portion 88 in the axial direction is fixed to the outer cylinder gripping portion 86. The cylindrical portion 88 is formed to be bent at a predetermined angle, like the main body portion 84 of the inner needle 81. The main body portion 84 of the inner needle 81 passes through the tube portion side insertion hole 87 which is a tube hole of the tube portion 88 so as to be able to be inserted and removed. Further, a grip part side insertion hole 86 a communicating with the cylinder part side insertion hole 87 is formed at a substantially central part in the longitudinal direction of the outer cylinder grip part 86. An insertion hole 89 is formed by the communicating cylinder side insertion hole 87 and gripping part side insertion hole 86a.

When the practitioner punctures the living body 100 (see FIG. 5B) with the puncture device 8, the main body portion 84 of the inner needle 81 is inserted into the insertion hole 89 of the outer cylinder 85, as shown in FIG. 4C. The needle portion 82 of the inner needle 81 is exposed from the tip portion of the cylindrical portion 88 of the outer cylinder 85.

The material of the puncture device 8 is not particularly limited, and both the inner needle 81 and the outer cylinder 85 may be a metal material such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, cobalt chrome or cobalt chrome alloy, or ethylene- Various soft materials such as tetrafluoroethylene copolymer (ETFE), polyurethane, and polyether nylon resin can be used.

Also, the length of the outer cylinder 85 in the longitudinal direction is set in the range of 2.5 cm to 30 cm, and more preferably in the range of 3.0 cm to 20 cm. The length in the longitudinal direction of the main body portion 84 in the inner needle 81 is set in the range of 3.0 cm to 35 cm, more preferably in the range of 3.5 cm to 25 cm. Further, the diameter of the main body 84 is set in the range of 0.35 cm to 3.0 cm, more preferably in the range of 0.5 cm to 2.0 cm. The inner diameter of the outer cylinder 85 is set in the range of 0.4 cm to 3.5 cm, more preferably in the range of 0.6 cm to 2.1 cm.

1-4. Example of Procedure Next, an example of a procedure for placing the interspinous process implant 1 in the living body 100 will be described with reference to FIGS. 1 and 5 to 11.
5A, 5B, and 6 are views for explaining a procedure for placing the interspinous process implant 1 in the living body 100. FIG.

First, as shown in FIG. 5A, the main body portion 84 of the inner needle 81 is inserted into the insertion hole 89 of the outer cylinder 85, and the needle portion 82 of the inner needle 81 is exposed from the distal end portion of the cylindrical portion 88 of the outer cylinder 85. The puncture device 8 is prepared. Next, as shown in FIG. 5B, the puncture device 8 is punctured into the living body 100, and the distal end portion of the puncture device 8 is disposed at a predetermined position between the spinous processes 105. Thereby, a passage from the outside of the living body 100 to a predetermined position between the spinous processes 105 is formed.

Next, the inner needle 81 is extracted from the insertion hole 89 of the outer cylinder 85 and extracted from the living body 100.

Next, the hollow insertion tube 10 is inserted into the insertion hole 89 of the outer cylinder 85. The interspinous process implant 1 is housed inside the insertion tube 10 on the side to be inserted into the living body in advance. At this time, the first misalignment prevention member 3 and the second misalignment prevention member 4 are further wound around the shaft portion 2 against the elastic force from the expanded state. That is, the first deviation preventing member 3 and the second deviation preventing member 4 are accommodated in the insertion tube 10 in a contracted state.

The length of the insertion tube 10 is set, for example, in the range of 2.0 cm to 150 cm, and more preferably in the range of 3.0 cm to 25 cm. The diameter is set in the range of 0.3 to 3.0 cm, more preferably in the range of 0.5 cm to 2.0 cm.

Next, the insertion tube 10 is pushed forward between the two spinous processes 105 of the adjacent vertebra 102 through the passage formed by puncturing the puncture device 8. Then, the distal end portion of the insertion tube 10 is disposed at a predetermined position between the spinous processes 105. The outer cylinder 85 may be used as the insertion tube 10.

7 and 8 are enlarged views of the main part shown in FIG.
At this time, as shown in FIG. 7, the interspinous process implant 1 housed in the insertion tube 10 is disposed between the two spinous processes 105. Further, as shown in FIG. 8, a spinous process 105 is located between the first misalignment preventing member 3 and the second misalignment preventing member 4 in the interspinous process implant 1.

9A and 9B are views showing a state in which the interspinous process implant 1 is pushed out from the insertion tube 10.
Next, as shown in FIG. 9A, a pusher is inserted into the cylindrical hole of the insertion tube 10. Then, the interspinous process implant 1 is pushed out from the insertion tube 10 by the pusher 9 and the insertion tube 10 is pulled out from between the spinous processes 105. When the first deviation preventing member 3 in the interspinous implant 1 is pushed out of the insertion tube 10, the bias of the first deviation preventing member 3 by the insertion tube 10 is released. Therefore, the first deviation preventing member 3 expands in the direction outside the radius of winding, that is, the normal direction of the side surface portion 2a of the shaft portion 2 by its own elastic force.

Further, as shown in FIG. 9B, the insertion tube 10 is further pulled out and the interspinous process implant 1 is completely pushed out of the insertion tube 10. As a result, the second misalignment prevention member 4 that has been contracted by the insertion tube 10 also expands in the same manner as the first misalignment prevention member 3.

The first misalignment prevention member 3 and the second misalignment prevention member 4 are disposed so as to sandwich the two spinous processes 105 therebetween. Thereby, it can prevent that the axial part 2 arrange | positioned between the spinous processes 105 shifts | deviates from the predetermined position between the spinous processes 105 by a motion of a human body. Furthermore, since the first displacement preventing member 3 and the second displacement preventing member 4 can be expanded in a small space, the burden on the living body can be reduced, and the interspinous process implant 1 can be placed in a minimally invasive manner. It becomes possible.

FIG. 10 is a side view of the state shown in FIG. 9B as viewed from the side of the lumbar vertebra.
As shown in FIGS. 7 and 10, the first misalignment prevention member 3 and the second misalignment prevention member 4 are expanded substantially equally from the contracted state toward the radially outward direction. Therefore, the operation of housing the interspinous process implant 1 in the insertion tube 10 and the operation of inserting the insertion tube 10 between the spinous processes 105 are performed in the extending direction of the first displacement preventing member 3 and the second displacement preventing member 4. Can be done without consideration. This makes it possible to simplify the procedure.

The expanded first misalignment prevention member 3 and second misalignment prevention member 4 are arranged such that the strip 6 is swirled around the shaft 2 a plurality of times. Therefore, the contact area between the first misalignment prevention member 3 and the second misalignment prevention member 4 and the spinous process 105 can be increased, and the interspinous process implant 1 can be firmly fixed. In addition, since the first misalignment prevention member 3 and the second misalignment prevention member 4 are shaped so as to be swirled, they flexibly change so as to follow the operation of twisting the waist. Stable placement of the interprotrusion implant 1 is possible.

FIG. 11 is a front view showing a state in which the interspinous process implant 1 is placed between the spinous processes 105.
As shown in FIG. 11, the interspinous process implant 1 is deformed as a whole from a substantially I shape to a substantially H shape by expanding the first misalignment prevention member 3 and the second misalignment prevention member 4. Thereby, the procedure of placing the interspinous process implant 1 between the two spinous processes 105 of the adjacent vertebrae 102 is completed.

Also, before placing the interspinous implant 1 in place, a dumbbell-shaped or H-shaped confirmation balloon is inserted, and this confirmation balloon is expanded with a contrast medium or the like. And you may perform the procedure which confirms the state of the confirmation balloon expanded under X-ray fluoroscopy, and selects the implant 1 between spinous processes according to an expanded state.

2. Second Embodiment Next, a second embodiment of the interspinous process implant of the present invention will be described with reference to FIG.
FIG. 12 is a front view of an interspinous process implant according to a second embodiment.

The interspinous process implant 21 shown in the second embodiment is different from the interspinous implant 1 according to the first embodiment in that an interference member is provided in the shaft portion. In the following description of the second embodiment, components that are the same as those in the first embodiment are denoted by the same reference numerals and description thereof is omitted.

As shown in FIG. 12, the interspinous process implant 21 includes a shaft portion 2, a first displacement prevention member 3, a second displacement prevention member 4, and an interference member 25. The first misalignment prevention member 3 and the second misalignment prevention member 4 are arranged at a predetermined interval in the axial direction of the shaft portion 2.

The interference member 25 is provided between the first deviation prevention member 3 and the second deviation prevention member 4 in the shaft portion 2. When the interspinous process implant 21 is placed in the living body 100, the interference member 25 is disposed so as to face the spinous process 105. As the interference member 25, for example, a spiral spring or the like is applied in the same manner as the first misalignment prevention member 3 and the second misalignment prevention member 4, in addition to an elastic rubber material or a cushion material such as sponge. .

When a spiral spring is applied as the interference member 25, the size of the band-shaped body constituting the interference member 25 is set in the same range as the first displacement prevention member 3 and the second displacement prevention member 4, and The interference member 25 in the contracted state is set to have a winding number of, for example, 1 to 40 rotations, and the diameter of the interference member 25 is set to a range of 0.4 cm to 2.9 cm, and more preferably 0.52 cm to The range is set to 1.9 cm. When the interference member 25 is expanded, the number of turns is set in the range of 1 to 39 rotations, and the diameter is set in the range of 0.5 cm to 4.0 cm, more preferably 0.6 cm to 2.0 cm. Is set in the range.

By providing the interference member 25, when the living body 100 moves, the spinous process 105 and the shaft portion 2 can be prevented from coming into contact with each other and damaging the spinous process 105. Further, by applying a spiral spring as the interference member 25, the interference member 25 can exhibit a function as a member that expands the interval between the two spinous processes 105.

Other configurations are the same as those of the interspinous process implant 1 according to the first embodiment described above, and thus the description thereof is omitted. Also by such an interspinous process implant 21, the same operation and effect as the interspinous process implant 1 according to the first embodiment described above can be obtained.

3. Third Embodiment Next, a third embodiment of the interspinous process implant of the present invention will be described with reference to FIG.
FIG. 13 is a perspective view of an interspinous process implant according to a third embodiment.

The difference between the interspinous process implant 31 according to the third embodiment and the interspinous process implant 1 according to the first embodiment is the configuration of the shaft portion. For this reason, the shaft portion will be described here, and the same reference numerals are given to the components common to the first embodiment, and the description thereof will be omitted.

As shown in FIG. 13, the interspinous process implant 31 includes a shaft portion 32 formed in a columnar shape, and a first displacement prevention member 3 and a second displacement prevention member 4 attached to the shaft portion 32. I have.

The shaft portion 32 includes a rod-shaped core member 32a and a plate member 32b wound around the core member 32a in a spiral shape. The plate member 32 b has elasticity, and is a spiral spring, like the strips 6 of the first misalignment prevention member 3 and the second misalignment prevention member 4. In addition, you may form the axial part 32 by winding the board | plate material 32b spirally, without providing the core material 32a. The shaft portion 32 expands together with the first misalignment prevention member 3 and the second misalignment prevention member 4 when the interspinous process implant 31 is pushed out from the insertion tube 10 (see FIGS. 9A and 9B).

The shaft portion 32 itself can follow the movement of the spinous process 105 by making the shaft portion 32 a spiral spring. Therefore, the impact force generated when the shaft portion 32 and the spinous process 105 abut can be absorbed by the shaft portion 32, and the spinous process 105 can be prevented from being damaged.

Further, when the interspinous process implant 31 is placed in the living body 100, the shaft portion 32 is further wound and contracted against its elastic force. Thereby, the diameter of the axial part 32 becomes small. As a result, the diameter of the puncture device 8 that punctures the living body 100 can be reduced, the burden on the patient can be further reduced, and the invasion can be reduced.

Further, the size of the plate member 32b constituting the shaft portion 32 is set, for example, such that the length in the longitudinal direction is in the range of 0.6 cm to 240 cm, and the plate thickness is set in the range of 0.01 cm to 0.9 cm. The length of the plate 32b in the width direction is set in the range of 1 cm to 10 cm. That is, the axial length of the shaft portion 32 is set in the range of 1 cm to 10 cm.

Furthermore, in the contracted state, the number of turns of the shaft portion 32 is set in the range of 1 to 45 rotations, and the diameter thereof is set in the range of 0.1 cm to 1.7 cm. In the expanded state, the number of turns of the shaft portion 32 is set in a range of 1 to 44 rotations, and the diameter thereof is set to be 0.2 cm to 1.9 cm.

In the interspinous process implant 31 according to the third embodiment, the example in which the shaft portion 32 is a spiral spring has been described, but the present invention is not limited to this. As the shaft portion 32, for example, a balloon that can be deformed from a contracted state to an expanded state by injecting a filler may be used. Even when a balloon is applied as the shaft portion 32, the size of the shaft portion 32 can be reduced and the size of the puncture device 8 can be reduced when placed in the living body 100, like the spiral spring. It becomes.

In the interspinous process implant 31 according to the third embodiment, as in the interspinous process implant 21 according to the second embodiment, the first deviation preventing member 3 and the second deviation are also provided. An interference member 25 may be provided between the prevention members 4.

Other configurations are the same as those of the interspinous process implant 1 according to the first embodiment described above, and thus the description thereof is omitted. Also by such an interspinous process implant 31, the same operation and effect as the interspinous process implant 1 according to the first embodiment described above can be obtained.

4). Fourth Embodiment Next, a fourth embodiment of the interspinous process implant of the present invention will be described with reference to FIG.
FIG. 14 is a front view of an interspinous process implant according to a fourth embodiment.

As shown in FIG. 14, the interspinous process implant 41 according to the fourth embodiment is obtained by covering the first deviation preventing member 3 and the second deviation preventing member 4 with a cover member 47. For this reason, the same reference numerals are assigned to configurations common to the first embodiment, and the description thereof is omitted.

The cover member 47 is formed of a flexible member that can be expanded or contracted. By covering the first misalignment prevention member 3 and the second misalignment prevention member 4 with the cover member 47, the tissue of the living body 100 such as a ligament or muscle enters into the gap between the band-like body 6 wound in a spiral shape. Can be prevented. Therefore, like the interspinous process implant 51 according to a fifth embodiment to be described later, the ligament is formed in the gap between the band-like bodies 6 when the first displacement preventing member 3 and the second displacement preventing member 4 are contracted. It is possible to prevent the tissue of the living body 100 from being damaged by pinching the muscles or the like. Thereby, it becomes possible to make invasiveness lower.

Furthermore, when the first misalignment prevention member 3 and the second misalignment prevention member 4 are expanded and deployed, the gap of the belt-like body 6 can be covered with the cover member 47, so that the first misalignment prevention member 3 and The contact area between the second deviation preventing member 4 and the spinous process 105 can be further increased. Thereby, the interspinous process implant 41 can be placed between the spinous processes 105 more firmly.

Further, by injecting a fluid into the cover member 47, the interspinous process implant 41 can be placed in a state of following the surface shape of the spinous process 105. At this time, when fluid is injected into an implant having only a cover member, that is, a balloon-like implant as in the conventional example, the implant may be displaced in the axial direction with respect to the spinous process 105. Therefore, by using the interspinous process implant 41 of the present invention, it is possible to prevent a shift during fluid injection.

Moreover, as an embodiment for injecting fluid into the cover member 47, a fluid injection tube is connected to the proximal end side of the shaft portion 2 of the spinous process implant 41, and the fluid injection tube, the shaft portion 2 and the cover are connected. The members 47 are communicated with each other.

Of course, the entire shaft portion 2 may be covered with the cover member 47.

5. Fifth Embodiment Next, a fifth embodiment of the interspinous process implant of the present invention will be described with reference to FIGS.
15A and 15B are front views showing an interspinous process implant according to a fifth embodiment, and FIGS. 16A and 16B are side views showing an interspinous process implant according to a fifth embodiment. is there. FIG. 17 is an enlarged view of a main part of an interspinous process implant according to a fifth embodiment.

In the interspinous process implant 51 according to the fifth embodiment, the first misalignment prevention member 3 and the second misalignment prevention member 4 are expanded in the interspinous process implant 1 according to the first embodiment. A mechanism for returning to a contracted state is provided. Therefore, here, a mechanism for returning the first misalignment prevention member 3 and the second misalignment prevention member 4 from the expanded state to the contracted state will be described, and the same reference numerals will be used for configurations common to the first embodiment. A description thereof will be omitted.

As shown in FIGS. 15A and 16A, the interspinous process implant 51 includes a shaft portion 52, and a first displacement prevention member 3 and a second displacement prevention member 4 attached to the shaft portion 52. Yes. The other end of the shaft portion 52 in the axial direction is open. An insertion hole 55 is provided at the other axial end of the shaft portion 52. On the inner surface of the insertion hole 55, a thread groove 55a is formed. A collection jig 56 is inserted into the insertion hole 55.

The recovery jig 56 is provided with a screw portion 56a that is screwed into a screw groove 55a provided in the insertion hole 55. Then, when the recovery jig 56 and the insertion hole 55 are coupled and the recovery jig is rotated, the shaft portion 52 rotates around its axis.

In addition, although the example which applied the screwing of the thread groove 55a and the screw part 56a was demonstrated as a connection method of the collection | recovery jig | tool 56 and the axial part 52, it is not limited to this. As a coupling method, an engagement claw, an engagement receiving portion that engages with the engagement claw, and other various coupling methods such as fitting can be applied. That is, as a coupling method, it is only necessary that the recovery jig 56 and the shaft portion 52 are coupled and the shaft portion 52 can rotate when the recovery jig 56 is rotated.

Also, a holding tool 58 is fixed to each of the other end portions 6b outside the windings of the first misalignment prevention member 3 and the second misalignment prevention member 4. As shown in FIG. 17, the holder 58 is formed with a slit 58a. The band-shaped body 6 wound around the inner side in the radial direction from the outermost periphery of the band-shaped body 6 passes through the slit 58a. In this example, the belt-like body 6 in the second round from the outermost circumference passes.

The slit 58 a provided in the holder 58 is opened larger than the cross section of the strip 6. The width of the opening of the slit 58a is set to 0.11 cm to 4.01 cm, and the height of the opening is set to a range of 0.1 cm to 3.9 cm.

The holder 58 and the shaft portion 52 are connected by a connecting thread 59. The connecting thread 59 and the holding tool 58 define the expansion radius of the first deviation preventing member 3 and the second deviation preventing member 4. Thereby, the expansion state of the 1st deviation prevention member 3 and the 2nd deviation prevention member 4 can be adjusted. In addition, although the example which provided the holder 58 and the connection thread | yarn 59 was demonstrated as an example of the connection member which connects the axial part 52 and the other end part 6b of the strip | belt-shaped body 6, a connection thread | yarn was provided without providing the holder 58. You may fix 59 to the other end part 6b of the outer side of the winding in the strip | belt-shaped body 6 directly.

15B and 16B, the connecting thread 59 is wound around the side surface portion 52a of the shaft portion 52 as the shaft portion 52 rotates. Therefore, when the connection thread 59 is wound around the shaft portion 52, the belt-like body 6 constituting the first displacement prevention member 3 and the second displacement prevention member 4 is also wound around the shaft portion 52.

Thereby, the first misalignment prevention member 3 and the second misalignment prevention member 4 are deformed from the expanded state shown in FIGS. 15A and 16A to the contracted state shown in FIGS. 15B and 16B. As a result, the interspinous process implant 51 can be made small, and the interspinous process implant 51 placed in the living body 100 can be easily recovered without placing a burden on the living body 100.

It should be noted that the direction in which the belt-like body 6 is wound in the first misalignment prevention member 3 and the second misalignment prevention member 4 and the direction in which the screw groove 55a and the screw portion 56a are screwed are set to the same direction. Therefore, when the belt-like body 6 is wound around the shaft portion 52, there is no possibility that the screw groove 55a and the screw portion 56a are unscrewed.

The length of the connecting yarn 59 is set in the range of 0.2 cm to 10 cm, and the length exceeding the radius of the first deviation preventing member 3 and the second deviation preventing member 4 is wound around the shaft portion 52. Adjusted in

Further, when the frictional force between the first misalignment prevention member 3 and the second misalignment prevention member 4 and the ligament or muscle is large, the first misalignment prevention member 3 and the second misalignment even when the shaft portion 52 rotates. The rotation of the other end 6b in the prevention member 4 is suppressed by the ligament or muscle. In this case, the first misalignment prevention member 3 and the second misalignment prevention member 4 are deformed from the expanded state to the contracted state by rotating the shaft portion 52 without providing the holder 58 and the connecting thread 59. Is possible.

In the interspinous process implant 51 according to the fifth embodiment, the first misalignment prevention member 3 and the second misalignment prevention member are the same as the interspinous process implant 41 according to the fourth embodiment. 4 may be provided. Thereby, when contracting the first misalignment prevention member 3 and the second misalignment prevention member 4, it is possible to prevent the surrounding tissue from being caught between the strips 6.

Furthermore, similarly to the interspinous process implant 21 according to the second embodiment, even when the interference member 25 made of a spiral spring is provided, the interference member 25 may be provided with the holder 58 and the connecting thread 59. . Thereby, like the 1st deviation prevention member 3 and the 2nd deviation prevention member 4, the interference member 25 can be changed from an expansion state to a contraction state.

Further, when the shaft portion 32 is a spiral spring like the interspinous process implant 31 according to the third embodiment, the first displacement preventing member 3 and the second displacement preventing member 4 are also disposed on the shaft portion 32. Similarly, a mechanism for deforming from the expanded state to the contracted state may be provided. That is, a holder is provided at the outer end of the winding in the plate member 32b, and a connecting thread that connects the holder 58 and the core member 32a is provided. As a result, not only the first deviation preventing member 3 and the second deviation preventing member 4 but also the shaft portion can be deformed from the expanded state to the contracted state. The implant can be removed.

Other configurations are the same as those of the interspinous process implant 1 according to the first embodiment described above, and thus the description thereof is omitted. Also by such an interspinous process implant 51, the same operation and effect as the interspinous process implant 1 according to the first embodiment described above can be obtained.

6). Sixth Embodiment Next, a sixth embodiment of the interspinous process implant of the present invention will be described with reference to FIG.
FIG. 18 is a front view showing an interspinous process implant according to a sixth embodiment.

The interspinous process implant 61 according to the sixth embodiment differs from the interspinous process implant 1 according to the first embodiment in that the first misalignment prevention member and the second misalignment prevention member are different. It is a configuration. Therefore, here, the first misalignment prevention member and the second misalignment prevention member will be described, and the same components as those in the first embodiment will be denoted by the same reference numerals and description thereof will be omitted.

As shown in FIG. 18, the interspinous process implant 61 includes a shaft portion 2, and a first displacement prevention member 63 and a second displacement prevention member 64 attached to the shaft portion 2. The first misalignment prevention member 63 and the second misalignment prevention member 64 are arranged without a gap in the axial direction of the shaft portion 2.

The first misalignment prevention member 63 and the second misalignment prevention member 64 are composed of a belt-like body 66 having elasticity. The first deviation preventing member 63 and the second deviation preventing member 64 are formed by winding the belt-like body 66 in a substantially conical shape. The first misalignment prevention member 63 and the second misalignment prevention member 64 are disposed so that the centers of the turns serving as the apexes of the cone are adjacent to each other. That is, the first misalignment prevention member 63 and the second misalignment prevention member 64 are provided so as to be symmetrical in the axial direction of the shaft portion 2.

Other configurations are the same as those of the interspinous process implant 1 according to the first embodiment described above, and thus the description thereof is omitted. Also by such an interspinous process implant 61, the same operation and effect as the interspinous process implant 1 according to the first embodiment described above can be obtained. Furthermore, as compared with the other embodiments, the first misalignment member 3 and the second misalignment member 4 are in wide contact with the spinous process 105, so that the interspinous process implant 1 can be placed more stably. Is possible.

The present invention is not limited to the embodiment described above and shown in the drawings, and various modifications can be made without departing from the scope of the invention described in the claims. For example, in the embodiment described above, an example in which a spiral spring is applied as the first misalignment prevention member and the second misalignment prevention member has been described. However, as the first misalignment prevention member and the second misalignment prevention member, Alternatively, a sponge-like member having elasticity, a leaf spring, or the like may be used.

1,21,31,41,51,61 ... interspinous implant, 2,32,52 ... shaft, 2a, 52a ... side, 3,63 ... first misalignment prevention member, 4,64 ... second Slip prevention member, 6, 66 ... strip, 8 ... puncture tool, 9 ... pusher, 10 ... insertion tube, 25 ... interference member, 32a ... core material, 32b ... plate material, 47 ... cover member, 55 ... insertion hole , 55a ... thread groove, 56 ... recovery jig, 56a ... threaded part, 58 ... holder, 58a ... slit, 59 ... connecting thread (connecting member) 81 ... inner needle, 85 ... outer cylinder, 100 ... living body, 101 ... Lumbar vertebra, 102 ... vertebra, 105 ... spinous process, 111 ... vertebral canal

Claims

A columnar shaft inserted between two spinous processes of adjacent vertebrae;
A first misalignment prevention member and a second misalignment prevention member attached to the side surface portion of the shaft portion,
The interspinous process implant, wherein the first misalignment prevention member and the second misalignment prevention member are expandable and contractible in a normal direction of the side surface portion of the shaft portion.
The first misalignment prevention member and the second misalignment prevention member are:
2. The interspinous process implant according to claim 1, comprising a spiral spring in which a band having elasticity is wound in a spiral shape, and one end on the center side of the winding in the band is fixed to the shaft portion.
When the shaft portion is rotated in the winding direction of the first deviation prevention member and the second deviation prevention member, the first deviation prevention member and the second deviation prevention member are in an expanded state. The interspinous process implant according to claim 2, wherein the implant is deformed into a contracted state.
The interspinous process implant according to claim 3, further comprising a connecting member that connects the shaft portion and the other end outside the winding in the belt-like body.
The first misalignment prevention member and the second misalignment prevention member are arranged at an interval in the axial direction of the shaft portion,
The interspinous process implant according to claim 1, wherein an interference member is provided between the first misalignment prevention member and the second misalignment prevention member.
The interspinous process implant according to claim 1, wherein the shaft portion includes a balloon that is deformable from an unexpanded state to an expanded state.
The interspinous process implant according to claim 1, wherein the shaft portion includes a spiral spring in which an elastic band is wound in a spiral shape.
The interspinous process implant according to claim 1, wherein the shaft portion, the first deviation preventing member, and the second deviation preventing member are covered with a cover member.