WO2014132366A1 - Spacer - Google Patents

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Publication number
WO2014132366A1
WO2014132366A1 PCT/JP2013/055213 JP2013055213W WO2014132366A1 WO 2014132366 A1 WO2014132366 A1 WO 2014132366A1 JP 2013055213 W JP2013055213 W JP 2013055213W WO 2014132366 A1 WO2014132366 A1 WO 2014132366A1
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WO
Grant status
Application
Patent type
Prior art keywords
balloon
spacer
portion
10a
10b
Prior art date
Application number
PCT/JP2013/055213
Other languages
French (fr)
Japanese (ja)
Inventor
中川雄司
伊藤祐貴
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor

Abstract

A spacer (10A) comprises: a balloon (18) capable of expanding consequent to the introduction of a filler; and an expansion restraining unit (20) which is disposed inside the balloon (18), which partially restrains the expansion of the balloon (18), and the restraint of which is released after the balloon (18) has been filled with a designated amount of the filler.

Description

Spacer

The present invention is placed between the bones, to a spacer for extending the distance between the bone.

Lumbar spinal stenosis is a disease spinal canal by retraction degeneration of such discs and ligaments is stenosis, back pain, leg pain, causing symptoms such as intermittent claudication. Treatment of lumbar spinal stenosis, spinal partially resection surgery of the portion to narrow the spinal canal (laminectomy) or surgery for fixing the spinal (spinal fusion) is the mainstream. On the other hand, the relatively minimally invasive surgical procedure as compared to the laminectomy and spinal fusion, in recent years, a metal spacer was placed between the spinous processes, a method of releasing the compression of spinal nerves and nerve roots It has been developed. However, the method for placing a spacer, invasiveness to the patient because it is necessary to incise the back muscles and ligaments still high, hospitalization becomes long.

In order to solve such a problem, by inserting a spacer implant between spinous processes less invasive, alternative methods of placement have been proposed. As the alternative, for example, in U.S. Patent Application Publication No. 2009/0118833, uses a puncturable puncture device in a living body, and an expandable balloon, folded balloon through the barrel of the puncture tool inserted between percutaneously spinous processes while, after placement, by filling a filler such as bone cement into the balloon to expand the balloon, the method of placement between spinous processes is disclosed. Fillers, for cured after filling of the balloon, the balloon can be semi-permanently hold the expanded state.

If placing a spacer between the spinous processes, it is necessary to position the center of the width direction of the interspinous ligament between adjacent spinous processes of the center in the axial direction of the spacer. However, when filled with filler spacer disposed between the spinous processes, the displacement the spacer is against the spinous process (slipping) to the center in the axial direction of the spacer is deviated from the center in the width direction of the interspinous ligament it may become.

Expansion This spacers or unfolded asymmetrically in the axial direction, the spacer is surrounding tissue (bone, muscle, ligaments, etc.) by or hit, the either the front end side and rear end side of the spacer previously It generated by.

That is, for example, when the front end side of the spacer is expanded first, reaction force spine distal end side of the spacer in a state where the rear end of the spacer is not in contact with the spinous process contacts the spinous process pushes the spacer distally to act a protrusion on the spacer, the spacer will be relatively displaced distally relative spinous process.

Similarly, for example, when the rear end of the spacer is expanded first, the distal end side of the spacer contacts the spacer rear end spinous process in a state not in contact with the spinous process on the rear end side spacer since the reaction force pushing is applied from the spinous process spacer, the spacer will be relatively displaced to the rear end side of the spinous process.

Such positional deviation becomes remarkable when the spacer is uneven, such as a so-called H-type or dumbbell shape is large. Then, by the positional displacement, the axial center of the spacer deviates greatly from the center in the width direction of the interspinous ligament, there may be a case where the spacer will be removed from the interspinous.

The present invention has such a problem has been made in consideration of, and to provide a spacer that can prevent the occurrence of positional deviation of the spacer at the time of filling the filling material into the spacer.

To achieve the above object, the present invention is placed between the bones, a spacer for extending the distance between the bone, the expandable balloon with the introduction of the filler, in the balloon provided, extends partially restrict the balloon, the filling material into the balloon, characterized in that it comprises a extension regulating portion regulating is released after being filled with a predetermined amount.

According to the above construction, when the filler is introduced into the balloon, after the balloon has a primary expansion may be filled with the locations extension regulating portion is not provided within the balloon, regulations released by expansion restricting portion is the balloon is secondary extended. Therefore, by appropriately setting the site and order to expand the balloon, one of the distal side and the proximal side of the balloon it can be prevented from expanding above. Therefore, it is possible to prevent the occurrence of positional deviation at the time of expansion of the spacer.

In this case, in the said balloon, non-regulated portions can flow to the filler prior to regulation by the expansion restricting portion is released, may extend in the longitudinal direction of the balloon. According to this configuration, upon introduction of the filling material into the balloon, for non-regulated portion is a passage of filler, over the balloon in a predetermined range in the longitudinal direction can be primary extension.

The expansion restricting portion is at least may be provided on both sides of the longitudinal center of the balloon. According to this configuration, among the balloon portion which contacts laterally the bone, to extend later than other portions (both end portions or the longitudinal center). Therefore, since the portion that extends above functions as a stopper, it is possible to prevent displacement of the balloon effectively.

The expansion restricting portion further longitudinal center of the balloon, or may be provided on the distal side and the proximal side of the balloon. According to this construction, since the longitudinal center of the balloon also temporally delayed secondary expansion, it is possible to prevent displacement of the balloon more effectively. Alternatively, by delaying the secondary expansion of the distal side and the proximal side of the balloon, it is possible to prevent displacement of the balloon more effectively.

The balloon, when expanded, has a shape having a constricted portion, and a protruding portion provided on both sides of the constricted portion, the extension restricting portion, at least the constricted portion-side portion of the bulged portion it may be provided. According to this configuration, among the balloon portion which contacts laterally the bone, to extend later than other portions (both end portions or the longitudinal center). Therefore, since the portion that extends above functions as a stopper, it is possible to prevent displacement of the balloon effectively. Further, since a shape having a bulging portion on both sides of the constricted portion, indwelling position in vivo of the spacer is stably held.

In this case, the expansion restricting portion further the constricted portion, or may be provided in a portion corresponding to a distal end and a proximal end of the balloon of the bulging portion. According to this structure, since the constricted portion of the balloon also temporally delayed secondary expansion, it is possible to prevent displacement of the balloon more effectively. Alternatively, by delaying the secondary expansion of the distal side and the proximal side of the balloon, it is possible to prevent displacement of the balloon more effectively.

Within the balloon, said longitudinal tube member disposed along a is provided in the balloon, in a deflated state of the balloon, in communication and a distal side and a proximal side of the balloon through the tube member it may be. According to this arrangement, since the passage of the filler is ensured by a tube member, with the introduction of the filler into the balloon, it is possible to reliably primary expand the balloon over a predetermined range in the longitudinal direction.

In the spacer, the balloon is in the deflated state, are folded in the circumferential direction of the plurality of locations may be the expansion restricting portion is provided on the inner surface of each portion folded in the balloon. According to this configuration, it is possible to effectively restrict the expansion of the balloon structure which is a folded and deflated condition.

In the spacer, the extension regulating portion may be configured by the fusion part or bonding areas. According to this arrangement, by pressing at the time of introduction of the filler, the fused portion or the contact portion by peeling, extended regulation for the balloon is released. Thus, with a simple configuration, with the introduction of the filling material, and a primary expansion and secondary expansion of the balloon can be reliably performed.

In the spacer, the extension regulating portion may be present in the square-shaped or dot-shaped. According to this configuration, it is possible to prevent the can be easily set weak pressure for secondary expansion, injection pressure of the filler material to support the expansion of the balloon is too high.

It is a partially omitted side view of an implant assembly with spacers according to the first embodiment of the present invention. 2A is a schematic longitudinal sectional view of the spacer shown in FIG. 1, FIG. 2B is a cross-sectional view taken along line IIB-IIB in FIG. 2A, FIG. 2C, IIC-IIC line in FIG. 2A is a cross-sectional view taken along. 3A is a first diagram illustrating a method of manufacturing the spacers, FIG. 3B is a second diagram illustrating a manufacturing method of the spacer, Fig. 3C, a third for explaining a manufacturing method of the spacer it is a diagram. 4A is a diagram showing another presence pattern of the expansion restricting portion, FIG. 4B is a diagram showing still another presence pattern of the expansion restricting portion. 5A is an explanatory view of insertion steps in a method of placement inserting a spacer between the spinous processes, FIG. 5B is an explanatory view of the insertion steps in a method of placement inserting a spacer between the spinous processes. 6A is an explanatory view of the outer cylinder retraction steps in a method of placement inserting a spacer between the spinous processes, FIG. 6B is a sectional view taken along line VIB-VIB in FIG. 6A. 7A is an explanatory view of a primary expansion step in the method of placement and inserting a spacer between the spinous processes, FIG. 7B is an explanatory view of a secondary expansion step in the method of placement and inserting a spacer between the spinous processes . 8A is an explanatory view showing a state where the spacer is expanded at a desired position between the spinous processes, 8B is an explanatory view of a detachment steps in a method of placement inserting a spacer between the spinous processes. It is a schematic longitudinal sectional view of a spacer according to a second embodiment of the present invention. 10A is a schematic longitudinal sectional view of a spacer according to a third embodiment of the present invention, FIG. 10B is a cross-sectional view taken along line XB-XB in FIG. 10A, FIG. 10C, in Figure 10A it is a cross-sectional view along the XC-XC line. 11A is a schematic longitudinal sectional view of a spacer according to a fourth embodiment of the present invention, FIG. 11B is a cross-sectional view taken along XIB-XIB line in FIG. 11A, FIG. 11C, in Figure 11A it is a cross-sectional view taken along XIC-XIC line.

Hereinafter, like the preferred embodiment for the spacer according to the present invention will be described with reference to the accompanying drawings.

First Embodiment
Figure 1 is a fragmentary side view of the implant assembly 12 which includes a spacer 10A according to the first embodiment of the present invention. The implant assembly 12 comprises a spacer 10A provided at the tip, the catheter tube 14 connected to the proximal end side of the spacer 10A (hereinafter, referred to as "tube 14") and.

The spacer 10A, which functions as an implant to be inserted into the indwelling (spacer implants), expandable configured by the filler 40 therein (see FIG. 7A) is filled. Site in the body where the spacer 10A is inserted, for example, between the spinous processes, the shoulder joint, an intervertebral disc. The spacer 10A is initially are contracted as shown by the solid line in FIG. 1. On the other hand, the filling material 40 to the spacer 10A through the tube 14 is injected, the spacer 10A is caused to expand as indicated by the phantom line in FIG.

Upon expansion of the shape of the spacer 10A, for example, as shown in FIG. 1, it may be a pair of bulging portions 16 are connected through the constricted portion 15 shaped. Upon expansion shape such dumbbell spacers 10A, When it is wheeled (H-type) or the like, a pair of bulging portions 16 arranged on both sides of the constricted portion 15 inserted through the interspinous ligament spinous since the shape to sandwich the B1 (see FIG. 8B), preferably. The shape of the spacer 10A may be of other shapes of the cylindrical or the like.

Figure 2A is a schematic longitudinal sectional view of the spacer 10A. As shown in FIG. 2A, the spacer 10A is provided with an expandable balloon 18 with the introduction of the filler 40, and an expansion restricting portion 20 provided in the balloon 18.

The balloon 18, constitutes a body portion of the spacer 10A, is configured in a bag shape, in contracted state, it is one that exhibits an elongated tubular folded in the circumferential direction. When the filling material 40 into the balloon 18 is introduced, folded portion is expanded, as shown by the phantom lines in FIG. 1, it is extended to a preset shape and size.

The material of such balloons 18, filler material 40 is injected can be extended, and the spinous process is a tissue surrounding the balloon 18, there a material that can withstand the external pressure due to the movement of the tissue and vertebral such interspinous ligament It is not particularly limited as, for example, vinyl chloride, polyurethane elastomers, nylon, PET, and the like.

Expanded restriction portion 20 extends partially regulations balloon 18, the filler 40 into the balloon 18 is configured to regulate after being filled with a predetermined amount is canceled. Therefore, when the filler 40 is introduced into the balloon 18, after being filled with filler material 40 at a position extended restricting portion 20 is not provided balloon 18 has primary extended (see FIG. 7A) in the balloon 18, extend is released restriction by the restricting portion 20 balloon 18 is secondary extended (see FIG. 7B).

2A, in the present embodiment, expansion restricting portion 20 is provided with a portion corresponding to the constricted portion 15, the portion corresponding to one constricted portion 15 side of the bulging portion 16, to. In FIG. 2A, extends the region regulating portion 20 is provided, but with cross hatching shows schematically, in the balloon 18 deflated i.e. folded state, specifically 2B, 2C extension regulating portion 20 is provided as.

2B, 2C, respectively, cross-sectional view taken along line IIB-IIB in FIG. 2A, a cross-sectional view taken along the IIC-IIC line in FIG. 2A. The balloon 18 is folded in the circumferential direction in the circumferential direction of the plurality of locations, expansion restricting portions 20 are provided on the inner surface of each portion folded. Thus, extension regulating portion 20 is provided in the circumferential direction of the plurality of locations of the balloon 18. When more pressure given is applied by introduction of the filling material 40 into the balloon 18, extension regulating portion 20 can be peeled off.

Such extension regulating portion 20, for example, can be constituted by the fusion part 21 or the adhesive portion 22. If the expansion restricting portion 20 is constituted by the fusion part 21, the fusion part 21, folded portion of the balloon 18 is heated and pressed, heat sealing the inner surfaces of the portion is formed by fixing it is. The heat seal is formed of a thermoplastic resin which serves as a weak seal enough to be peeled off when the above pressure given is applied by introduction of the filling material 40 into the balloon 18.

In this case, the balloon 18 itself composed of a thermoplastic resin, heating the folded portion of the balloon 18 by pressing, it may form the fused portion 21 to the inner surface of the portion. Alternatively, separately provided layer of thermoplastic resin on the inner surface of the balloon 18, heat the folded portion of the balloon 18, melting the layer of thermoplastic resin is pressed, by solidifying, forms the fused portion 21 it may be.

As the thermoplastic resin, such as polyethylene, polypropylene, polyvinyl chloride, ethylene - vinyl acetate copolymer, polyamide, polyvinylidene chloride, polyvinyl fluoride, poly trifluoroethylene trichlorethylene, polyethylene terephthalate, polyester, polyolefin resin and their It includes mixtures and laminates of.

If the expansion restricting portion 20 is constituted by bonding portion 22, the bonding portion 22 is applied to the inner surface of the folded portion of the balloon 18, a cured adhesive. The adhesive functions as a weak seal enough to be peeled off when the above pressure given is applied by introduction of the filling material 40 into the balloon 18.

As shown in FIGS. 2A ~ Figure 2C, the balloon 18, on the inner side of the extension regulating portion 20, non-regulated portions 24 to allow flow into the filler material 40 before the regulation by extension regulating portion 20 is released , extending longitudinally of the balloon 18 (the axial direction). The non-regulated portion 24 is a portion extended restricting portion 20 is not provided, the flow path of the filling material 40 upon introduction of the filling material 40 into the balloon 18.

Method for manufacturing such a spacer 10A, especially for the case extension regulating portion 20 is fused portion 21 will be described mainly with reference to FIGS. 3A ~ Figure 3C.

First, a predetermined shape upon expansion (e.g., shape shown in phantom in FIG. 1) a bag-like balloon 18 to be formed by thermoplastic resin (see FIG. 3A). Next, the circumferential direction of the plurality of locations of the resulting balloon 18 (four positions in the illustrated example), the portion 19 of the inner surface of the respective portions are folded so as to contact, radially protruding in the circumferential direction of the plurality of locations in the transverse plane a shape having (see Figure 3B). In this case, it folded as little space remains in the central portion of the balloon 18.

Then, sandwiched folded each portion was of the balloon 18 from the outside, the heating, by pressing the inner surface of each portion folded to form a fused portion 21 (heat sealing) (see FIG. 3C). If the range shown in FIG. 2A provided the expansion restricting portion 20, the heating range for pressing includes a constricted portion 15 of the balloon 18, only both side portions of the constricted portion 15.

After forming the fused portion 21, bent portions 19 projecting radially of the balloon 18 in the circumferential direction, FIG. 2B, the folded in circumferential direction as shown in FIG. 2C. Thus, the spacer 10A can be obtained with enhanced regulating portion 20 constituted by the fusion part 21.

Incidentally, expansion restricting portion 20, as shown in FIG. 4A, may be present in the square shape, or, as shown in FIG. 4B, may be present in the form of dots. 4A and 4B, the range extension regulating portion 20 is provided is the same as the extension regulating portion 20 shown in Figure 2A.

In Figure 1, the tube 14 connected to the proximal side of the balloon 18 is feeding the filler 40 to the balloon 18 (supplied). Specifically, the tube 14 is a member of small diameter in elongated, having a lumen 14a which serves as a flow path of the filler supplied to the balloon 18 communicated with the interior (lumen) of the balloon 18. Bore 14a communicates from the distal end of the tube 14 to the proximal end.

Tube 14 has an appropriate flexibility so that it can be inserted into the puncture device 30 is curved will be described later (see FIG. 5A). As the constituent material of the tube 14, for example, polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene - propylene copolymer, ethylene - vinyl acetate copolymer, ionomer, or mixtures of two or more of them, etc.), polyvinyl chloride , polyamides, polyesters, polyester elastomers, polyamide elastomers, polyurethanes, polyurethane elastomer, polyimide, polymer material such as fluorine resin or a mixture thereof.

The spacers 10A and the tube 14 are detachably connected via the connection structure 25. Connecting structure 25 is, for example, a screwing structure, when a predetermined or more torque to the tube 14 and the spacer 10A is applied is that the screwing is released, so that the tube 14 and the spacer 10A is separated there.

Connecting structure 25, other engagement structure described above, the physical engagement (fitting, caught, etc.) structure and linked to be separated by some kind of physical action members (thermal effects, chemical effects, etc.) It may employ a structure connected separably by dividing by.

The proximal end of the tube 14, hub 26 of the hollow structure for holding the base end is provided. The hub 26 is composed of, for example, a hard resin having a lumen 26a which communicates with the lumen 14a of the tube 14, syringe proximal end thereof is not shown, connectable to the structure and the filler supply source such as a pump ing.

The implant assembly 12 which includes a spacer 10A according to this embodiment, which is basically constructed as described above, will be described below the operation and effects.

Here, mainly with reference to FIGS. 5A ~ FIG 8B, by using the puncture device 30 will be described procedure to insert a percutaneously spacer 10A between adjacent spinous processes in vivo indwelling. In FIG. 5A ~ FIG 8B, reference numeral B is the vertebra, reference numeral B1 is a spinous process, which is formed in the rear of the vertebrae B.

In Figure 5A, the piercing device 30 includes an outer tube 32 of hollow arcuate shape, a hub 34 fixed to the proximal end of the outer tube 32 is insertable into the outer tube 32 of the same curvature as the outer tube 32 arc having inner needle 36 formed into a shape, and a handle 38 fixed to the proximal end of the inner needle 36. In Figure 5A, it shows the state where the inserted fully down the inner needle 36 to the hollow portion of the outer tube 32.

The outer tube 32, both ends open, a member of the hollow structure having an insertable hollow portion inner needle 36. Hub 34 fixed to the proximal end of the outer tube 32 has a larger outer diameter than the outer tube 32, is provided in a flange shape.

Inner needle 36 is inserted into the hollow portion of the outer cylinder 32, a rod-like member curved in an arc shape having a sharp needle tip 36a at the tip. Upon insertion of the inner needle 36 up against the outer tube 32, the tip of the inner needle 36 protrudes from the distal end of the outer tube 32 by a predetermined length. Inner needle 36 is solid structure may be any of a hollow structure. Handle 38 provided at the proximal end of the needle 36 functions as a grip for a user of the puncture device 30 is gripped.

The distal end side of the at least a portion in the X-ray opaque marker to allow recognition under X-ray fluoroscopy of the outer tube 32 or the inner needle 36 may be installed.

Incidentally, puncture tool 30 for use with the implant assembly 12 is not limited to the puncture device 30 having the configuration shown in FIG. 5A, for example, puncture device straight type with straight outer tube and the inner needle may be used .

In surgery placing a spacer 10A in the living body, first, X-rays fluoroscope, MRI, after determining the lesion by the ultrasonic diagnostic apparatus or the like, to the patient P in the prone position. Next, as shown in FIG. 5A, under X-ray fluoroscopy, for insertion to a predetermined depth the puncture device 30 in the state in which the inner needle 36 is inserted into the outer tube 32 relative to the patient P (insertion step).

In the insertion step, more specifically, in the outer tube 32 and the inner needle 36 of the puncture device 30, passing the interspinous ligament L between adjacent spinous processes in a direction crossing the axial direction of the spine. In this case, to be puncture to a position where the tip portion of the puncture device 30 has exceeded a between predetermined length spinous process.

After the puncture device 30 desired length insertion, and then, while maintaining the position of the outer cylinder 32, i.e. while stabbed outer tube 32 to the patient P, and withdrawing the inner needle 36 from the outer tube 32 (inner needle removal step). Thus, it is placed in a state where the outer cylinder 32 is stuck on the living body.

Next, as shown in FIG. 5B, the hollow portion of the outer tube 32, inserts the implant assembly 12 having a spacer 10A of the contracted state to the distal end (insertion step). In this insertion step, specifically, as shown in Figure 5B, the spacer 10A is positioned within the distal end of the outer tube 32, and a central axial direction of the spacer 10A is, interspinous ligament between adjacent spinous processes L so as to be positioned at the center of (see FIG. 6B), the inserting the implant assembly 12. Thus, the implant assembly 12 is inserted to a predetermined position in the outer tube 32.

Next, as shown in FIG. 6A, as the total length of the spacer 10A is exposed in the body, it is retracted only the outer tube 32 (and the hub 34) in the proximal direction (the outer cylinder retraction step). Here, FIG. 6B is a sectional view taken along line VIB-VIB in FIG. 6A. In Figure 6B, the spacer 10A is at a position corresponding to the constricted portion 15 of the balloon 18, it extends through the interspinous ligament L. Both end portions of the extension regulating portion 20 provided in the balloon 18 is positioned outside the interspinous.

If either of these conditions to place the spacer 10A, then the filling material supply source (not shown) connected to the hub 26 (see FIG. 1), by operating the filler supply, the balloon 18 via the tube 14 by injecting the filler material 40, as shown in FIG. 7A, it causes the spacers 10A primarily expanded (primary expansion step). Specifically, in this primary expansion step and through the tube 14 for introducing the filling material 40 into the balloon 18, preferentially filler 40 is gradually filled in the portion where expansion restricting portion 20 is not provided. That is, places where expansion restricting portion 20 is provided, until a predetermined pressure is applied not peeled off, to prevent expansion of the balloon 18 (expansion), locations extension regulating portion 20 is not provided is first Expand.

In this case, in the present embodiment, since the constricted portion 15 and its opposite side portions (constricted portion 15-side portion of the bulged portion 16) in the expansion restricting portion 20 of the balloon 18 is provided, at the time of primary expansion, bone (spinous processes B1 ) extended sites capable of contacting the lateral direction is restricted, the reaction force pushing the spacer 10A on the distal side or proximal side does not act from the spinous processes B1 to the spacer 10A. Therefore, causing no positional deviation of the spacer 10A when the primary expansion.

Then, by further injecting the filling material 40 into the balloon 18, to release the extended restriction by extension regulating portion 20 causes the balloon 18 to the secondary expansion (secondary expansion step). Specifically, after the primary expansion, further introducing a filler material 40 into the balloon 18, the pressure in the balloon 18, when a higher pressure than the regulating force of the expansion restricting portion 20, extension regulating portion 20 is peeled off, expanded restriction of the balloon 18 is released by the expansion restricting portion 20. When extended regulation by extension regulating portion 20 is released, by the filling material 40 flows to the expansion has been restricted portion, as shown in FIG. 7B, the balloon 18 expands to a predetermined size and shape. In this case, the portion which has been extended forward to during the primary expansion, to function as a stopper, never spacer 10A is dislocated during a secondary expansion.

Filler 40 is in fluid during injection, the material hardens after injection (e.g., bone cement, an acrylic resin, a two-liquid mixing crosslinked polymer) in fluid during, or injection, after injection also of material that maintains fluid both can be applied. As shown in FIGS. 7B and 8A, expanded spacer 10A (balloon 18) exhibits a connecting shape through a pair of bulging portions 16 are constricted portion 15, neck portion 15, spine interspinous passes between ligament L, interspinous ligament L is positioned between the pair of the bulging portions 16 on both sides thereof. Thus, the spacing between the spinous processes is extended by extended constriction 15, the spacer 10A is in a state of omission is prevented from interspinous ligament L interspinous.

Once fully dilates the spacer 10A, then, as shown in FIG. 8B, thereby separating the spacers 10A and the tube 14 (separation step). If the connection structure 25 of the spacer 10A and the tube 14 is threaded structure, rotating the tube 14 about its axis, a spacer 10A which is inserted into the interspinous ligament L between adjacent spinous processes is not rotated, by only tube 14 is rotated, it disengages engagement between the spacer 10A and the tube 14. Thus, it is possible to separate the spacer 10A and the tube 14.

The filling material 40 is, in the fluid during injection, when a material that hardens after injection, the separation between the spacer 10A and the tube 14, it is preferable to after the filling material 40 is cured. Also, the filler 40, if the post-injection also of material that maintains fluid may be provided with backflow preventing structure to the inlet of the spacer 10A (check valve).

When allowed to separate and the spacer 10A and the tube 14, as well as removing the tube 14 from the outer tube 32, is completely withdrawn outer tube 32 from the patient P. Thus, a state where the spacer 10A is placed between the spinous processes.

As described above, according to the spacer 10A according to this embodiment, when the filler 40 is introduced into the balloon 18, first, the filler 40 at a position extended restricting portion 20 is not provided in the balloon 18 is is filled balloon 18 is primary expansion, then it is released regulated by expansion restricting portion 20 the balloon 18 is secondary expansion. Therefore, by appropriately setting the extended sites and the order of the balloon 18, one of the distal side and the proximal side of the balloon 18 can be prevented from expanding above. Therefore, it is possible to effectively prevent displacement during expansion of the spacer 10A.

In this case, the balloon 18, non-regulated portions 24 to allow flow into the filler material 40 before the regulation by extension regulating portion 20 is released (see FIG. 2A) extending in the longitudinal direction of the balloon 18. According to this configuration, upon introduction of the filling material 40 into the balloon 18, for non-regulated portions 24 as a flow path of the filler 40, thereby effectively primary extended over the balloon 18 in a predetermined range in the longitudinal direction be able to.

Extended restricting portion 20, at least, since it is provided on both sides of the longitudinal center of the balloon 18, of the balloon 18, a portion in contact laterally on the bone, later than other portions (both end portions or longitudinal central) Expand. Therefore, since the portion that extends above functions as a stopper, it is possible to prevent displacement of the balloon 18 effectively.

Further, in this embodiment, extension regulating portion 20, since also provided at the center in the longitudinal direction of the balloon 18, to the longitudinal center also temporally delayed secondary expansion of the balloon 18. Therefore, it is possible to prevent displacement of the balloon 18 more effectively.

According to this embodiment, the balloon 18 is in the contracted state, the circumferential direction of the plurality of locations is folded, the inner surface of each portion of the folded fusion part 21 or the adhesive portion 22 of the extension regulating portion 20 is provided . According to this arrangement, by pressing at the time of introduction of the filler 40, the fusion portion 21 or the adhesive portion 22 by peeling, extended restrictions on the balloon 18 is released. Thus, with a simple configuration, with the introduction of the filler 40, and a primary expansion and secondary expansion of the balloon 18 can be reliably performed.

In this embodiment, since the expansion restricting portions 20 on the inner surface of each portion which is folded in the balloon 18 is provided, it can be expanded effectively regulate the unfolded configuration is the contracted condition the balloon 18.

Incidentally, expansion restricting portion 20, when present in the square shape (see FIG. 4A) or dot-shaped (see FIG. 4B), can be set appropriately weak pressure for secondary expansion, second balloon 18 primary it is possible to suppress the injection pressure of the filling material 40 to support the expansion is too high.

Second Embodiment
Figure 9 is a schematic longitudinal sectional view of the spacer 10B according to the second embodiment of the present invention. Spacer 10B according to the second embodiment, in that the tube member 42 is provided within the balloon 18, unlike the spacer 10A according to the first embodiment described above, other configurations are the same as the first embodiment.

Specifically, the tube member 42 is disposed inside the extension regulating portion 20 along the longitudinal direction of the balloon 18, having a lumen 42a penetrating from one end 43 to the other 44. One end 43 of the tube member 42 faces the front end side of the space of the balloon 18, the other end 44 of the tube member 42, facing the space on the base end side of the balloon 18. Thus, in a contracted state of the balloon 18, through the tube member 42, the distal side and the proximal side of the balloon 18 communicates. Such tube member 42 may be configured, for example, by one or more materials selected from the materials exemplified as the material of the tube 14.

According to the configuration of the present embodiment, since the passage of the filling material 40 is ensured by a tube member 42, when introducing the filling material 40 into the balloon 18, a filling material 40 which is introduced into the proximal side of the balloon 18 , it can be reliably introduced into the distal end side of the balloon 18 through the tube member 42. Accordingly, reliably over a balloon 18 in the longitudinal direction of the overall length can be primary extension.

Third Embodiment
Figure 10A is a schematic longitudinal sectional view of a spacer 10C according to a third embodiment of the present invention. Figure 10B is a cross-sectional view taken along line XB-XB in FIG. 10A, FIG. 10C is a cross-sectional view along the XC-XC line in FIG 10A. In the third embodiment, for the first embodiment and the same or similar components are denoted by the same reference numerals, and detailed description thereof will be omitted.

Spacer 10C according to the third embodiment, in that the expansion restricting portions 20 are provided at positions corresponding to the bulge portion 16 of the balloon 18 is different from the spacer 10A according to the first embodiment. Specifically, in the spacer 10C, there is no expansion restriction portion 20 at positions corresponding to the constricted portion 15, from both sides of that portion (constricted portion 15 corresponding to the two bulging portions 16, the distal end side of the balloon 18 and exists only expansion restricting portion 20 in range) up to the base end side.

As shown in FIGS. 10A and 10B, extension regulating portion 20 is provided in the circumferential direction of the plurality of locations. Inside than extension regulating portion 20 of the balloon 18 deflated, the longitudinal direction of the non-regulated part 24 (space) balloon 18 to allow flow into filler material 40 before the regulation by extension regulating portion 20 is released extending.

The spacer 10C configured as described above, the introduction of filling material 40 via a tube 14, first, preferentially filler 40 is gradually filled in the portion where expansion restricting portion 20 is not provided. That is, places where expansion restricting portion 20 is provided, until a predetermined pressure is applied not peeled off, to prevent expansion of the balloon 18 (expansion), locations extension regulating portion 20 is not provided is first Expand.

In this case, in the present embodiment, since the expansion restricting portions 20 at positions corresponding to the bulge portion 16 of the balloon 18 is provided, at the time of primary expansion, expansion of sites capable of contacting the laterally bone (spinous processes B1) is restricted, the reaction force pushing the spacer 10C distally or proximal side does not act from the spinous process B1 the spacer 10C. Therefore, causing no positional deviation of the spacer 10C when the primary expansion.

Further, after the primary expansion, further introducing a filler material 40 into the balloon 18, the pressure in the balloon 18, when a higher pressure than the regulating force of the expansion restricting portion 20, extension regulating portion 20 is separated, extended restricting portion 20 extension regulation of the balloon 18 is released by. When extended regulation by extension regulating portion 20 is released, by the filling material 40 flows to the expansion has been restricted portion, the balloon 18 expands to a predetermined size and shape (secondary expansion). In this case, the portion which has been extended forward to during the primary expansion, to function as a stopper, never spacer 10C is positional deviation at the time of a secondary expansion.

In the spacer 10C, extension regulating portion 20, similar to the configuration of FIG. 4A or FIG. 4B, it may be present in the square-shaped or dot-shaped.

In a third embodiment, the same or similar components as the first embodiment, the same or similar effects as the first embodiment can be obtained as a matter of course.

Fourth Embodiment
Figure 11A is a schematic longitudinal sectional view of a spacer 10D according to a fourth embodiment of the present invention. Figure 11B is a cross-sectional view taken along XIB-XIB line in FIG. 11A, FIG. 11C is a cross-sectional view taken along XIC-XIC line in FIG 11A. In the fourth embodiment, for the first embodiment and the same or similar components are denoted by the same reference numerals, and detailed description thereof will be omitted.

Spacer 10D according to the fourth embodiment, in that the expansion restricting portions 20 are provided at positions corresponding to the constricted portion 15 and the bulge portion 16 of the balloon 18 is different from the spacer 10A according to the first embodiment. Specifically, extension regulating portion 20 in the spacer 10D is provided from the front end side of the balloon 18 to the proximal end side. As shown in FIGS. 11A ~ FIG 11C, extension regulating portion 20 is provided in the circumferential direction of the plurality of locations. Inside than extension regulating portion 20 of the balloon 18 deflated, the longitudinal direction of the non-regulated part 24 (space) balloon 18 to allow flow into filler material 40 before the regulation by extension regulating portion 20 is released extending.

A spacer 10D configured as described above, the introduction of filling material 40 via a tube 14, first, preferentially filler 40 at a position extended restricting portion 20 is not provided will be filled (primary expansion ). That is, places where expansion restricting portion 20 is provided, until a predetermined pressure is applied not peeled off, to prevent expansion of the balloon 18 (expansion), locations extension regulating portion 20 is not provided is first Expand.

In this case, in the present embodiment, since the extension regulating portion 20 is provided from the front end side of the balloon 18 to the proximal end side, at the time of primary expansion, expansion of sites capable of contacting the laterally bone (spinous processes B1) is regulated , is not the reaction force pushing the spacer 10D on the tip side or base end side is applied from the spinous process B1 the spacer 10D. Therefore, causing no positional deviation of the spacer 10D when the primary expansion.

Further, after the primary expansion, further introducing a filler material 40 into the balloon 18, the pressure in the balloon 18, when a higher pressure than the regulating force of the expansion restricting portion 20, extension regulating portion 20 is separated, extended restricting portion 20 extension regulation of the balloon 18 is released by. When extended regulation by extension regulating portion 20 is released, by the filling material 40 flows to the expansion has been restricted portion, the balloon 18 expands to a predetermined size and shape (secondary expansion). In this case, the portion which has been extended forward to during the primary expansion, to function as a stopper, never spacer 10D is positioned displaced during a secondary expansion.

In the spacer 10D, extension regulating portion 20, similar to the configuration of FIG. 4A or FIG. 4B, it may be present in the square-shaped or dot-shaped.

In the fourth embodiment, the same or similar components as the first embodiment, the same or similar effects as the first embodiment can be obtained as a matter of course.

Has been shown and described by way of preferred embodiments for the present invention, the present invention is not limited to the above embodiments, without departing from the scope of the present invention, it possible that various modifications may needless to say There.

Claims (10)

  1. Is detained between bone spacer to extend the distance between the bone (10A, 10B, 10C, 10D) a,
    And expandable balloon (18) with the introduction of the filler (40),
    Provided in the balloon (18) within the extension, extends partially restrict the balloon (18), said filler to said balloon (18) in (40) is restricted after being filled with a predetermined amount is canceled includes regulating portion (20), a
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  2. Claim 1, wherein the spacer (10A, 10B, 10C, 10D) in,
    The said balloon (18) within the non-regulated portions can flow to the filling material (40) prior to regulation by extension regulating portion (20) is released (24), longitudinal of the balloon (18) to extend in a direction,
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  3. Claim 2 wherein the spacer (10A, 10B, 10C, 10D) in,
    The expansion restricting portion (20) is at least provided on both sides of the longitudinal center of the balloon (18),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  4. Claim 3 wherein the spacers (10A, 10B, 10C, 10D) in,
    The expansion restricting portion (20) is further provided in the longitudinal center, or distal side and the proximal side of the balloon (18) of the balloon (18),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  5. Claim 2 wherein the spacer (10A, 10B, 10C, 10D) in,
    Said balloon (18), at the time of expansion, a shape having a constricted portion (15), bulging portions provided on both sides of the constricted portion (15) and (16),
    The expansion restricting portion (20) is provided on at least part of said constricted portion (15) side of the bulged portion (16),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  6. Spacer of claim 5 wherein (10A, 10B, 10C, 10D) in,
    The expansion restricting portion (20) further includes a constricted portion (15), or is provided in a portion corresponding to the distal end side and the proximal side of the balloon (18) of said bulged portion (16),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  7. In the spacer (10B) according to claim 2,
    Wherein the balloon (18), longitudinally disposed along the tube member (42) is provided in the balloon (18),
    In a contracted state of the balloon (18), a distal end and a proximal end side of the through said tube member (42) the balloon (18) communicates,
    Spacer, characterized in that (10B).
  8. The spacer according to any one of claims 1 ~ 7 (10A, 10B, 10C, 10D) in,
    Said balloon (18), in a contracted state, are folded in the circumferential direction of the plurality of locations,
    The expansion restricting portion (20) provided on the inner surfaces of the portions folded in the balloon (18),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  9. According to claim 8 of the spacer (10A, 10B, 10C, 10D) in,
    The expansion restricting portion (20) is composed of a fused portion (21) or adhesive portion (22),
    Spacer, characterized in that (10A, 10B, 10C, 10D).
  10. The spacer according to any one of claims 1 ~ 7 (10A, 10B, 10C, 10D) in,
    The expansion restricting portion (20) is present in square shape or dot shape,
    Spacer, characterized in that (10A, 10B, 10C, 10D).
PCT/JP2013/055213 2013-02-27 2013-02-27 Spacer WO2014132366A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/055213 WO2014132366A1 (en) 2013-02-27 2013-02-27 Spacer

Publications (1)

Publication Number Publication Date
WO2014132366A1 true true WO2014132366A1 (en) 2014-09-04

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080300687A1 (en) * 2007-05-30 2008-12-04 Kwan-Ku Lin Medical implantation device for spine
US20090118833A1 (en) * 2007-11-05 2009-05-07 Zimmer Spine, Inc. In-situ curable interspinous process spacer
US20090216274A1 (en) * 2008-02-21 2009-08-27 Zimmer Gmbh Expandable interspinous process spacer with lateral support and method for implantation
JP2009534163A (en) * 2006-04-24 2009-09-24 ウォーソー・オーソペディック・インコーポレーテッド Expandable device and its usage instructions for inserting into between anatomy
JP2010158914A (en) * 2007-08-10 2010-07-22 Autoliv Development Ab Airbag device
US20110054532A1 (en) * 2007-07-03 2011-03-03 Alexandre De Moura Interspinous mesh
JP2011521746A (en) * 2008-06-02 2011-07-28 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Inflatable interspinous spacer
US20120022590A1 (en) * 2010-07-26 2012-01-26 Kyphon SÀRL Injectable flexible interspinous process device system
WO2012108531A1 (en) * 2011-02-11 2012-08-16 テルモ株式会社 Interspinous process spacing device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009534163A (en) * 2006-04-24 2009-09-24 ウォーソー・オーソペディック・インコーポレーテッド Expandable device and its usage instructions for inserting into between anatomy
US20080300687A1 (en) * 2007-05-30 2008-12-04 Kwan-Ku Lin Medical implantation device for spine
US20110054532A1 (en) * 2007-07-03 2011-03-03 Alexandre De Moura Interspinous mesh
JP2010158914A (en) * 2007-08-10 2010-07-22 Autoliv Development Ab Airbag device
US20090118833A1 (en) * 2007-11-05 2009-05-07 Zimmer Spine, Inc. In-situ curable interspinous process spacer
US20090216274A1 (en) * 2008-02-21 2009-08-27 Zimmer Gmbh Expandable interspinous process spacer with lateral support and method for implantation
JP2011521746A (en) * 2008-06-02 2011-07-28 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Inflatable interspinous spacer
US20120022590A1 (en) * 2010-07-26 2012-01-26 Kyphon SÀRL Injectable flexible interspinous process device system
WO2012108531A1 (en) * 2011-02-11 2012-08-16 テルモ株式会社 Interspinous process spacing device

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