JP2007152025A - Bone prosthetic material, cartridge and filling instrument set - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To obtain a high filling density by filling a bone prosthetic material into a proper position in an osseous defect site. <P>SOLUTION: A bone prosthetic material 10, shaped like a cylinder, has a guide hole 12 in the center. A filling instrument set 100 comprises: an external cylinder 104 inserted into an insertion opening 204 connected to an osseous defect site 400 of the vertebral body 200; a guide wire 102 to be inserted into a guide hole 12 after being passed through an inner hollow part of the external cylinder 104 with its end inserted into the osseous defect site 400; and an internal cylinder 106 inserted into the external cylinder 104 while surrounding the guide wire 102 and to push the bone prosthetic material 10 into the osseous defect site by moving forward. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a bone filling material for filling a bone defect due to osteoporosis or the like, a cartridge containing a plurality of the bone filling materials, and a filling device set for filling the bone defect with the bone filling material.

  In recent orthopedic osteoporosis treatment and fracture treatment, it is important to be minimally invasive to reduce the burden on patients, and percutaneous vertebroplasty (PVP (Percutaneous Vertebroplasty)) is performed. It has come to be. Examples of fillers that fill bones in percutaneous vertebroplasty include HA (hydroxy apatite) blocks, PMMA (polymethylmethacrylate), CPC (Calcium phosphate cement), and the like.

  Among these, since the HA block is solid, it is not necessary to wait until it is solidified after filling the bone defect portion as in the case of using the liquid, and the procedure can be completed in a short time. Moreover, since there is no fear of leaking to places other than bones, the procedure can be easily performed (see, for example, Patent Document 1).

JP 2005-168670 A

  By the way, since the conventional HA block is merely dropped with respect to the bone defect part, the insertion range is limited with respect to the bone defect part, and it is difficult to fill the bone defect part with a high density. is there. Therefore, when the filling density is insufficient, it is necessary to increase the density by pressing with an impactor after filling.

  The present invention has been made in consideration of such problems, and a bone prosthetic material capable of obtaining a high filling density by filling an appropriate position with respect to a bone defect, and a plurality of the bone prosthetic materials are accommodated. An object of the present invention is to provide a cartridge and a filling instrument set for filling a bone defect with a bone filling material.

  A bone prosthetic material according to the present invention is a bone prosthetic material to be filled in a bone defect part, and has a guide part that slidably penetrates a striatum introduced into the bone defect part. And

  By sliding such a bone prosthetic material along the striatum, it can be filled at an appropriate position of the bone defect, and a high filling density can be obtained.

  The guide part may be a through-hole having a diameter of 0.1 to 3 mm, and a groove having a width of 0.1 to 3 mm at a portion penetrating the linear body. Thereby, while being able to set the diameter to be penetrated through to a sufficient diameter, the outer diameter can be suppressed and the insertion port communicating with the bone defect portion can be made small.

  When the height in the sliding direction of the bone grafting material is set to 1 to 10 mm, sufficient strength can be obtained and the bone filling material can be appropriately filled according to the shape of the bone defect portion. Further, even when the striatum is curved, it can be slid according to the curved shape.

  On the surface orthogonal to the sliding direction, the outer surface may be a circle centered on a portion that penetrates the linear body in the guide portion. By doing in this way, when dealing with several bone grafting materials collectively, a guide part is connected to an axial direction and a filament is easy to be inserted.

  When the outer side surface is columnar, it can be easily stored and slid with respect to a predetermined cylinder. The outer surface may be conical depending on the design conditions and the shape of the bone defect.

  The outer side surface may be a curved surface in which the central portion in the sliding direction gently swells, or a plurality of convex portions and grooves extending in the sliding direction may be provided. According to the curved surface shape, the convex portion, or the groove, there is little friction with respect to the predetermined cylinder, and it is easy to slide.

  The bone prosthetic material may have a shape in which at least one end surface in the sliding direction bulges into a spherical shape, or may have a shape recessed in a spherical shape. Spherical shape parts of the bulge part and the dent part slide while maintaining the surface contact state, respectively, and the orientation of the adjacent bone prosthetic materials is shifted, resulting in a curved shape as a whole, according to the shape of the bone defect part Can be filled.

  These bone prosthetic materials may contain various ceramics such as polymer materials, alumina / zirconia, and calcium phosphate compounds as constituent components. These ceramics are less harmful to living organisms and can provide sufficient strength.

  Next, a cartridge according to the present invention is a cartridge including a plurality of bone grafting materials and a cylinder body that stores the bone filling material, and the bone grafting material is disposed in the cylinder body and the wire in the guide portion. It is characterized by being housed in a row so that the portions penetrating the strip are coaxial. Thereby, each guide part communicates with each other, and can efficiently pass the striatum through all the bone prosthetic materials at once.

  When the lid constituting at least one end of the cylindrical body is configured to be removable or breakable so that the linear body can be inserted, the bone prosthetic material is gathered without taking it out from the cylindrical body. The striate body can be inserted into the guide portion in a state.

  The filling instrument set according to the present invention is a filling instrument set for filling a bone defect with a bone filling material, and is an outer cylinder inserted into the bone defect from an insertion port communicating with the bone defect. A striated body that is inserted into the bone defect part through the inner cavity part of the outer cylinder and penetrates the guide part provided in the bone prosthetic material, and pierced into the striated body And an inner cylinder that is inserted into the outer cylinder and pushes the bone prosthetic material to the bone defect by moving forward.

  With this filling instrument set, the bone prosthetic material moves along the striatum, and is arranged at an appropriate position in the bone defect according to the operator's intention. As a result, the bone defect portion is filled with the bone grafting material at a high density and sufficiently reinforced. Moreover, by setting the outer cylinder, the inner cylinder, and the striatum to be appropriately long, the operator can perform remote operation away from the affected area, and the exposure dose to the operator of X-rays irradiated to the affected area is extremely reduced.

  The striated body is an elastic body such as a superelastic alloy such as a Ni-Ti alloy or Ni-Cr-Mo alloy, stainless steel, or various alloy materials such as a piano wire, and the tip of the striated body is curved. It may be. Since the distal end portion is curved, the operability is improved, and the bone prosthetic material can be disposed at an appropriate position with respect to the bone defect portion.

Further, the present invention is a filling method for filling a bone defect material with a bone grafting material,
Inserting an outer cylinder into the bone defect from an insertion port communicating with the bone defect;
Inserting the striatum through the lumen of the outer cylinder and inserting the tip into the bone defect;
A step of penetrating a guide portion provided in the bone prosthetic material for the striatum;
Inserting the inner cylinder into the outer cylinder by penetrating the striatum, and pushing the bone prosthetic material to the bone defect by moving forward;
It is characterized by having.

  In this case, in at least one step, it is preferable to perform filling while irradiating the bone defect portion with X-rays and confirming the distal end portion of the striatum in real time with an X-ray image.

  According to the bone filling material and the filling instrument set according to the present invention, since the bone filling material can be slid along the striatum, the bone filling portion is filled at an appropriate position to obtain a high filling density. be able to. In addition, by setting the outer cylinder, inner cylinder and striatum appropriately long, the operator can perform remote operation away from the affected area, and the exposure dose to the operator of X-rays irradiated to the affected area is suppressed to a very small amount. be able to.

  Further, according to the cartridge according to the present invention, since the bone prosthetic materials are housed in a row so that the guide portions are coaxial, the striatum is gathered for all the bone prosthetic materials at once. It can be passed through and is efficient.

  Further, according to the filling method according to the present invention, since the bone prosthetic material is slid along the striatum, it can be filled at an appropriate position with respect to the bone defect portion to obtain a high filling density.

  Hereinafter, embodiments of the bone prosthetic material according to the present invention, a cartridge containing a plurality of the bone prosthetic materials, and a filling device set for filling the bone prosthetic material into the defect part will be described, and attached FIGS. The description will be given with reference.

  First, the bone grafting material 10 according to the present embodiment and the bone grafting materials 10a to 10i which are modifications thereof will be described with reference to FIGS. In addition, in each Example and modification, the same code | symbol is attached | subjected to the same location, and the detailed description is abbreviate | omitted.

  As shown in FIG. 1, the bone grafting material 10 according to the present embodiment has a columnar shape, and a guide hole (guide portion) 12 penetrating vertically is provided at the center. The guide hole 12 is a hole for penetrating a guide wire (wire body) 102, which will be described later, and its diameter d1 is larger than the diameter d (see FIG. 18) of the guide wire 102 so that it can slide smoothly. The diameter is set to be slightly larger, preferably 0.1 to 3 mm, and more preferably 0.2 to 2 mm. From the viewpoint of ease of molding and strength, the bone prosthetic material 10 has an axial height H of 0.5 mm or more, and more preferably 1 mm or more. Further, the height H is desirably reasonably low so that it can be filled in accordance with the shape of the bone defect 400 (see FIG. 20), and is desirably 15 mm or less, and more desirably 10 mm or less. Further, from the viewpoint of adapting to the volume on filling efficiency and the diameter of the insertion port 204 (see FIG. 20), the outer diameter of the bone grafting material 10 is 1 to 10 mm, preferably 2 to 5 mm.

  The material of the bone grafting material 10 is preferably a material that is easy to mold and has an appropriate strength, and that has a high affinity for a living body. Specifically, ceramics such as hydroxyapatite, β-TCP, and / or polymer materials A porous body containing is desirable. Of the ceramic materials, hydroxyapatite has characteristics such as little irritation to the living body, excellent osteoconductivity, osteosynthesis, etc., and mild tissue reaction.

  As shown in FIG. 2, the bone grafting material 10 a according to the first modification has a substantially columnar shape, and the outer surface 14 has a curved surface in which the central portion in the axial direction is gently swollen. By having such a curved surface, the sliding area is reduced when sliding in the later-described cartridge 50 and outer cylinder 104, and smooth movement becomes possible.

  As shown in FIG. 3, the bone prosthetic material 10b according to the second modified example has a columnar shape, and the outer surface 14 is provided with a plurality of convex portions (or ribs) 16 extending in the axial direction. .

  As shown in FIG. 4, the bone grafting material 10 c according to the third modification has a cylindrical shape, and the outer surface 14 is provided with a plurality of grooves 18 extending in the axial direction. According to such bone prosthetic materials 10b and 10c, when sliding inside the cartridge 50 and the outer cylinder 104, the sliding area is reduced, and the projections 16 and the grooves 18 are provided in parallel with the sliding direction. Therefore, friction is reduced, and smoother movement is possible. The groove 18 may be, for example, a knurled shape or a spiral shape.

  As shown in FIG. 5, the bone prosthetic material 10d according to the fourth modified example has a cylindrical shape, and both the one end face 20 in the axial direction and the other end face 22 bulge into a spherical shape. . As shown in FIG. 6, the bone grafting material 10e according to the fifth modification has a columnar shape, and both one end surface 20 and the other end surface 22 are recessed in a spherical shape. According to such bone prosthetic materials 10d and 10e, by arranging them alternately, the spherical bulge is fitted into the spherical depression, and is stably stored in the cartridge 50, and is contained in the outer cylinder 104. Improves the stability of movement in Further, when the bone defect portion 400 is filled, as shown in FIG. 7, the spherical surfaces slide while maintaining a surface contact state, and the directions of the bone prosthetic material 10d and the bone prosthetic material 10e are shifted and curved as a whole. Thus, the shape can be filled in accordance with the shape of the bone defect 400. The bone prosthetic materials 10d and 10e may have a shape in which one end face 20 bulges into a spherical shape and the other end face 20 is recessed into a spherical shape.

  As shown in FIG. 8, the bone prosthetic material 10f according to the sixth modified example has a substantially cylindrical shape, and the outer side surface 14 has a curved surface in which the central portion in the axial direction gently swells. Has a shape bulging into a spherical surface. Similar to the bone grafting material 10a, such a bone grafting material 10f has a reduced sliding resistance with respect to the cartridge 50 and the outer cylinder 104, and like the bone grafting material 10d, stability to the bone grafting material 10e is improved. To do.

  As shown in FIG. 9, the bone grafting material 10g according to the seventh modification has a conical outer surface 14. Such a bone grafting material 10g is appropriately used according to the design conditions and the shape of the bone defect 400.

  As shown in FIG. 10, the bone grafting material 10 h according to the eighth modified example has a columnar shape, and is provided with a U-shaped groove (guide portion) 24 that opens to the end surface 20, the end surface 22, and the outer surface 14. Yes. The U-shaped groove 24 reaches from the outer surface 14 to the center O of the cylinder and forms an arc portion 24 ′ centered on the center O. The U-shaped groove 24 is a groove for penetrating the guide wire (striate body) 102, and its width w is set to be slightly larger than the diameter d of the guide wire 102 so that it can slide smoothly. 0.1 to 3 mm is preferable, and 0.2 to 2 mm is more preferable. The outer diameter of the 180 ° arc portion 24 ′ with respect to the center O is set equal to the width w. According to such a bone grafting material 10h, the guide wire 102 can be attached from the side.

  As shown in FIG. 11, the bone grafting material 10 i according to the ninth modification has a cylindrical shape, and is provided with a U-shaped groove 24 and a notch 26. The notch 26 has a shape that is cut from the side of the outer surface 14 where the U-shaped groove 24 opens toward the back, and is cut deeper than the U-shaped groove 24. Further, the side portions 28 of one U-shaped groove 24 as viewed from the notch 26 have chamfered tips 28a.

  According to such a bone grafting material 10i, it is possible to mount on the guide wire 102 from the side, and the tip 28a is cut into the notch 26 by mounting the adjacent bone grafting materials 10i in the opposite directions. Fit and fixed by moderate friction. Therefore, the attached bone prosthetic material 10i is prevented from inadvertently falling off from the guide wire 102.

  In addition, about the bone grafting material 10 and the bone grafting materials 10a-10i, it cannot be overemphasized that each characteristic shape part may be used in combination with each other.

  Next, the cartridge 50 according to the present embodiment and the modified cartridges 50a and 50b will be described with reference to FIGS.

  As shown in FIG. 12, the cartridge 50 includes a plurality of bone grafting materials 10 and a cylindrical body 52 that houses the bone grafting materials 10. The inner cavity portion of the cylindrical body 52 has a slightly larger diameter than the outer diameter of the bone grafting material 10, and the bone grafting material 10 is stored in a line so that the respective guide holes 12 communicate with each other. The length of the cylindrical body 52 is set to be substantially equal to the total length of the arranged bone grafting materials 10 and the gap is small, so that the bone grafting material 10 does not lie down or move unnecessarily inside. A plurality of ribs extending in the axial direction may be provided on the inner surface of the cylindrical body 52 in order to reduce the sliding resistance of the bone grafting material 10 when penetrating the guide wire 102.

  The number of bone prosthetic materials 10 accommodated in the cylindrical body 52 is set according to the area, volume, and the like of the bone defect portion 400. For example, the procedure for the vertebral body is 2 to 500, more preferably 3 to It is good that it is 100, more preferably 4-20. In this embodiment, the cartridge 50 contains six bone prosthetic materials 10.

  The bone filling material 10 has no directionality on the surface orthogonal to the axial direction because the outer surface 14 has a circular shape with the center O as a reference, and the guide hole 12 (or the arc portion 24 ′ of the U-shaped groove 24) has no directivity. Corresponding virtual circles 25 (locations penetrating the striatum, see FIGS. 10 and 11) inevitably communicate with each other.

  One end surface 54 of the cylindrical body 52 is integrally formed with the outer side portion to constitute the bottom portion. A cap 58 is attached to the other side of the cylinder body 52 to keep the inside of the cylinder body 52 airtight. The inside of the cartridge 50 is sterilized by emitting an electron beam or γ-ray in advance, and the sterilized state is maintained by attaching the cap 58.

  By configuring the insertion portion 58a of the cap 58 as an elastic body and making it lightly abut on the surface of the bone-implanting material 10 on the most entrance side, all the bone-implanting materials 10 inside can be fixed. It is preferable that the cylindrical body 52 be formed of a transparent resin or the like because the state of the internal bone grafting material 10 can be visually confirmed.

  The cartridge 50 configured in this way functions as a protection / storage container for the bone grafting material 10 and also functions as a penetrating jig for the guide wire 102. When inserting the bone grafting material 10 into the guide wire 102, after removing the cap 58, the opening of the cartridge 50 is directed substantially upward as shown in FIG. The end portion 102 a is inserted into the communicating portion of the guide hole 12. Thereafter, as shown in FIG. 13B, the opening of the cartridge 50 is directed substantially downward while the guide wire 102 is inserted into the communicating portion of the guide hole 12. Thereby, the bone grafting material 10 slides down along the guide wire 102 and is inserted.

  As shown in FIG. 14, the cartridge 50 a according to the first modification includes a plurality of bone grafting materials 10, a cylindrical body 60 that houses the bone grafting materials 10, and a thin film that covers both ends of the cylindrical body 60. 62. The diameter and length of the cylinder 60 are the same as those of the cylinder 52, and the bone grafting material 10 can be stably stored. The film 62 is affixed to both end faces of the cylindrical body 60, and the inside of the cylindrical body 60 is maintained in a sterilized state. Examples of the film 62 include a resin film, an aluminum foil, and paper.

  When penetrating the bone prosthetic material 10 into the guide wire 102 using the cartridge 50a, as shown in FIG. 15A, the rear end portion 102a of the guide wire 102 is pierced from one film 62 and all the bone prosthetic materials are inserted. 10 guide holes 12 are inserted, and the other film 62 is pierced and inserted to protrude from the cylindrical body 60.

  Next, as shown in FIG. 15B, the film 62 on the side where the guide wire 102 is first inserted is peeled off from the cylindrical body 60, and then the cylindrical body 60 is pulled out so that the bone prosthetic material 10 penetrates the guide wire 102. Be dressed. According to this cartridge 50a, it is possible to penetrate the bone grafting material 10 while maintaining the direction of the guide wire 102 constant. Moreover, since the film 62 once peeled off cannot be reattached, it can be confirmed that the sealed state (that is, sterilized state) is maintained by attaching the film 62.

  As shown in FIG. 16, the cartridge 50b according to the second modification is provided with a plurality of bone prosthetic materials 10, a cylindrical body 66 for housing the bone prosthetic materials 10, and in the vicinity of both end portions of the cylindrical body 66. The stopper 68 is provided. The stopper 68 is U-shaped having a gripping portion 68a and two bars 68b extending in the same direction from the vicinity of both ends of the gripping portion 68a, and is provided in the vicinity of both ends of the cylindrical body 66. Two U-shaped tip portions are inserted into the pair of holes 70a and 70b. The guide hole 12 of the bone grafting material 10 is exposed from the center portion surrounded by the two bars 68b of the stopper 68. The cartridge 50b is hermetically housed in a package (not shown) and is sterilized in advance.

  When penetrating the bone grafting material 10 into the guide wire 102 using the cartridge 50b, as shown in FIG. 17A, the rear end portion 102a of the guide wire 102 is placed between the two bars 68b of one stopper 68. Through the guide hole 12 and through the space between the two bars 68 b of the other stopper 68. Next, as shown in FIG. 17B, the stopper 68 on the side where the guide wire 102 is first inserted is removed from the cylindrical body 66, and then the cylindrical body 66 is pulled out so that the bone prosthetic material 10 penetrates the guide wire 102. To do. According to this cartridge 50b, it is possible to penetrate the bone grafting material 10 while keeping the direction of the guide wire 102 constant.

  In the above description, it has been described that the bone filling material 10 is housed in the cartridges 50, 50a, and 50b. However, the bone filling materials 10a to 10i can be similarly housed and inserted into the guide wire 102. Of course there is.

  Next, the filling instrument set 100 according to the present embodiment will be described with reference to FIG. The filling instrument set 100 is an instrument set for filling the bone defect material 10 into the bone defect using the cartridge 50. In the description of the filling instrument set 100, the arrow A1 direction in FIG. 18 is the front end direction, and the opposite arrow A2 direction is the rear end direction.

  As shown in FIG. 18, the filling instrument set 100 includes a guide wire 102, an outer cylinder 104, and an inner cylinder 106. The guide wire 102 is a long striate body for guiding the bone grafting material 10 to the bone defect portion 400. The guide wire 102 has an appropriate elasticity in the bending direction and can be elastically deformed, but is hard in the twisting direction, and the other end can be rotated in the same manner by rotating one end. .

  The diameter d of the guide wire 102 is smaller than the diameter d1 of the guide hole 12 of the bone grafting material 10, and the surface is formed smoothly. The bone grafting material 10 penetrating the guidewire 102 slides smoothly. Can do. The distal end portion 102 b of the guide wire 102 has a curved shape according to the shape of the bone defect portion 400. The tip portion 102b may be set in various shapes so that an appropriate shape can be selected for each patient. Depending on the shape of the bone defect 400, the tip 102b may be linear.

  The outer cylinder 104 is a cylinder through which the guide wire 102, the inner cylinder 106, and the bone grafting material 10 can be inserted. The long main cylinder 104a and the slightly large-diameter short introduction 104b provided at the rear end. And have. The main tube portion 104a and the introduction portion 104b are smoothly connected in a tapered shape. The lumen portion of the main cylinder portion 104a is slightly larger than the outer diameter of the bone grafting material 10, and is set to the same diameter as the inner diameter of the cylinder body 52 (see FIG. 12), for example. Further, in order to reduce the sliding resistance of the bone grafting material 10, a plurality of ribs extending in the axial direction may be provided on the inner surface of the main cylinder portion 104a, or an appropriate coating process may be performed.

  The outer cylinder 104 is preferably of such a length that it can be remotely operated from a position where the operator is not exposed to the X-rays irradiated to the affected area and does not impair the operability. Set to ~ 50 cm.

  If the outer cylinder 104 is made of a metal such as stainless steel or titanium, the outer cylinder 104 has sufficient strength so that it can be thinned, the outer diameter is reduced, and the outer cylinder 104 can be easily inserted into the bone defect 400. Further, if the outer cylinder 104 is a synthetic resin such as PP (polypropylene), PC (polycarbonate), etc., since the X-ray permeability is good, the bone filling material 10 in the lumen can be clearly confirmed in the image, Operation becomes easy. The outer cylinder 104 may have a curved shape according to the shape of the surrounding appliance.

  The inner cylinder 106 is a cylinder for extruding a plurality of bone filling materials 10 penetrating the guide wire 102. The inner cylinder 106 has flexibility and is hard in the compressing direction. The end of is also extruded.

  The inner diameter of the inner cylinder 106 is set to be larger than the outer diameter d of the guide wire 102 and smaller than the outer diameter of the bone grafting material 10, and is set to d 1 having the same diameter as the guide hole 12, for example. The outer diameter of the inner cylinder 106 is set larger than the inner diameter of the guide hole 12 and smaller than the inner diameter of the main cylinder portion 104a. The inner cylinder 106 is preferably set to be thin so as to have sufficient flexibility. Further, the inner cylinder 106 is set longer than the outer cylinder 104 and shorter than the guide wire 102. The inner cylinder 106 is provided with a lock projection 106a at the rear end portion and a stopper 106b slightly at the front end side from the rear end portion.

  The lock protrusion 106a is used when connecting a predetermined cap or tube according to the application. The stopper 106 b has a larger diameter than the introduction portion 104 b of the outer cylinder 104, and prevents the inner cylinder 106 from being excessively inserted into the outer cylinder 104.

  Next, a method of filling the bone grafting material 10 into the bone defect 400 as a percutaneous vertebroplasty using the filling device set 100 configured as described above will be described with reference to FIG. Hereinafter, the case where the bone grafting material 10 is filled into the bone defect portion 400 in the vertebral body (for example, the first lumbar vertebra) that is an affected part of the patient with osteoporosis will be described as an example.

  First, in step S1, as an initial treatment, an anesthesia for the patient and a treatment for exposing the vertebral body 200 of the affected part are performed.

  In step S2, as shown in FIG. 20, an insertion port 204 is opened in the vertebral body 200 using a puncture needle 202 made of metal (for example, stainless steel). The puncture needle 202 may be prepared with three different diameters (for example, φ3, 4, 5 mm), and the insertion port 204 may be gradually expanded in diameter from the smallest one. In this way, the insertion slot 204 is expanded and adjusted to match the outer diameter of the outer cylinder 104.

  Inside the vertebral body 200 is a bone defect 400 having a low cavity or low density, and the insertion opening 204 communicates with the bone defect 400. In addition, if necessary, a predetermined instrument is inserted from the insertion port 204 to reduce the vertebral body 200 to a normal position, and the inside of the bone defect 400 is shaped to facilitate insertion and filling of the bone prosthesis 10. . Note that a plurality of insertion ports 204 may be provided in the vertebral body 200 as necessary.

  In step S <b> 3, as shown in FIG. 21, the outer cylinder 104 is inserted into the insertion port 204, and an appropriate amount of the distal end portion is protruded into the bone defect portion 400.

  In step S4, as shown in FIG. 22, the X-ray apparatus 300 is operated to irradiate the affected area with X-rays. The X-ray apparatus 300 includes an X-ray irradiation unit 302, a detection unit 304, a processing unit 306 that processes the X-rays detected by the detection unit 304 as an image, and a monitor 308 that displays the obtained image in real time. Have Thereafter, the operator 310 can perform the procedure while viewing the image on the monitor 308. A radiopaque partition 312 is provided between the operator 310 and the affected area.

  As is apparent from FIG. 22, the outer cylinder 104 has an appropriate length and can be remotely controlled. The irradiation unit 302 irradiates only the affected part with X-rays, and further, the partition. Since 312 is provided, the hand and other parts of the operator 310 are not exposed. Therefore, even if the surgeon 310 performs this percutaneous vertebroplasty frequently, the exposure dose and the accumulated dose of X-rays are extremely small. Although the patient's affected area is directly irradiated with X-rays, since the patient himself does not frequently undergo percutaneous vertebroplasty, the accumulated amount of X-ray exposure is sufficiently small.

  In step S5, as shown in FIGS. 23 and 24, the inner cylinder 106 into which the guide wire 102 is inserted is inserted from the introduction portion 104b of the outer cylinder 104. Since the guide wire 102 has appropriate elasticity, the curved tip end portion 102 b extends linearly and is accommodated in the inner cylinder 106, and can be easily inserted into the outer cylinder 104. Thereafter, the surgeon 310 pinches the portion of the guide wire 102 that is in the inner cylinder 106 and pulls out only the inner cylinder 106 backward.

  In step S <b> 6, the operator 310 operates the guide wire 102 so that the distal end portion 102 b is disposed at an appropriate position of the bone defect portion 400 while viewing the image on the monitor 308. That is, the position and orientation of the distal end portion 102b are adjusted while performing the forward / backward operation and the rotation operation of the rear end portion 102a of the guide wire 102. For example, by the operation of pushing out the rear end portion 102a, the tip end portion 102b moves forward in the bone defect portion 400 and advances along the wall portion as indicated by a virtual line 103a in FIG. Further, by rotating the rear end portion 102a, the direction of the front end portion 102b can be changed as indicated by a virtual line 103b in FIG. As described above, by remotely operating the rear end portion 102 a of the guide wire 102, the position and orientation of the distal end portion 102 b in the bone defect portion 400 can be adjusted considerably freely according to the intention of the operator 310. These operations may be performed together with the inner cylinder 106 before the inner cylinder 106 is removed from the guide wire 102.

  In step S <b> 7, a plurality of bone prosthetic materials 10 are inserted into the rear end portion of the guide wire 102 using the cartridge 50. Since this procedure has already been described (see FIGS. 13A and 13B), the description thereof will be omitted.

  Note that the bone grafting material 10 that penetrates the guide wire 102 at a time is not limited to one cartridge 50 (that is, six), and two or more cartridges 50 may be used. Further, if necessary, the bone filling material 10h or 10i having the U-shaped groove 24 may be inserted from the side of the guide wire 102 and supplemented. The bone grafting material 10h or 10i can be exposed to the exposed guide wire 102 from the side if the inner tube 106 is not completely pulled out of the guide wire 102 but is pulled out so that the front end is behind the outer tube 104. Can be penetrated.

  The bone grafting material 10 moves by its own weight with the guide hole 12 penetrating the guide wire 102 and is naturally inserted into the outer tube 104 or inserted by an auxiliary operation of the operator 310.

  In step S8, the inner cylinder 106 is penetrated from the rear end portion 102a of the guide wire 102 and moved forward. Thereby, the plurality of bone grafting materials 10 disposed in the outer cylinder 104 or in the distal end portion 102b in a state of being penetrated through the guide wire 102 are pushed by the front end surface of the inner cylinder 106, as shown in FIG. Then, it is pushed out from the distal end portion 102b of the guide wire 102. The operation of pushing out the bone grafting material 10 by the inner cylinder 106 is relative to the guide wire 102. As shown in FIG. 27, the bone grafting material 10 is moved to the distal end portion 102b of the guide wire 102 by the inner cylinder 106. The bone prosthetic material 10 may be filled by extruding until the guide wire 102 is pulled out.

  At this time, since the position and orientation of the distal end portion 102b are appropriately adjusted in the above-described step S6, the bone grafting material 10 is filled in a place according to the intention of the operator 310. Further, since the height H in the axial direction of the bone grafting material 10 is moderately low, it can be smoothly moved along the curved shape of the distal end portion 102b, and densely filled in accordance with the shape of the bone defect 400. can do.

  In step S <b> 9, the operator 310 confirms whether or not the bone defect material 400 is sufficiently filled with the bone grafting material 10 while viewing the image on the monitor 308. If the filling is sufficient, the process proceeds to step S10. If the filling is insufficient, the process returns to step S6, and the filling of the bone grafting material 10 is continued.

  When the filling of the bone prosthetic material 10 is continued, the new bone prosthetic material 10 may be densely filled in line with the filled bone prosthetic material 10 with hatching in FIG. . When the new bone filling material 10 is filled, the guide wire 102 may be exchanged for one having a curved shape at the distal end portion 102b. Further, as a procedure for filling the bone grafting material 10, it is easy and efficient to perform the operation in order from the back to the near side as viewed from the insertion port 204.

  In step S10, as shown in FIG. 29, the filling instrument set 100 is removed from the insertion port 204, and the opened insertion port 204 is closed with a predetermined plug 208. For example, the plug 208 is made of the same material as the bone grafting material 10. In FIG. 29, the bone grafting material 10 is shown as being filled in a single layer in a two-dimensional manner, but it is needless to say that the bone filling material 10 may be filled in multiple layers according to the shape of the bone defect 400.

  In step S11, a predetermined post-treatment such as suturing the affected part is performed, and the percutaneous vertebroplasty is completed.

  As described above, when the percutaneous vertebroplasty is performed using the bone filling material 10 (or the bone filling materials 10a to 10i) and the filling device set 100 according to the present embodiment, the bone filling material 10 is a guide wire. It moves along 102, and is arrange | positioned in the suitable position in the bone defect part 400 according to the operator's 310 intention. As a result, the bone defect part 400 is filled with the bone filling material 10 at a high density, and the vertebral body 200 is sufficiently reinforced, and the symptoms of osteoporosis are considerably relieved. Since the bone prosthetic material 10 is arranged at a high density, it is not necessary to increase the density by pressing and compacting with an impactor or the like after filling, and a percutaneous vertebroplasty can be performed with few procedures.

  Moreover, since the bone grafting material 10 is solid, there is no fear of leaking out of the vertebral body 200 from the bone defect part 400 like a liquid. Percutaneous vertebroplasty using the bone grafting material 10 and the filling instrument set 100 is minimally invasive because the bone grafting material 10 is filled into the vertebral body 200 through the small diameter insertion port 204. , Less physical and mental burden for the patient.

  When percutaneous vertebroplasty is performed using the bone grafting material 10 (or bone grafting materials 10a to 10i) and the filling device set 100 according to the present embodiment, the outer cylinder 104 has an appropriate length. The operator 310 can perform remote operation away from the affected area, and the amount of X-rays irradiated to the affected person 310 is very small.

  On the other hand, according to the cartridges 50, 50a, and 50b according to the present embodiment, an appropriate number of bone filling materials 10 (or bone filling materials 10a to 10i) are accommodated in the guide wire 102 to be filled at a time. There is no need to count the bone grafting material 10 when it is inserted. In addition, since each bone filling material 10 is stored in a line so that the guide hole 12 (or the portion of the circle 25 of the U-shaped groove 24) is coaxial, all the bone filling materials 10 are provided. The guide wire 102 can be passed through at a time, which is efficient.

  The application target of percutaneous vertebroplasty using the bone filling material 10 and the filling instrument set 100 is not limited to the vertebral body 200 but can be applied to other bone defects.

  The bone prosthetic material according to the present invention is not limited to the above-described embodiment, and it is needless to say that various configurations can be adopted without departing from the gist of the present invention.

It is a perspective view of the bone grafting material which concerns on this Embodiment. It is a perspective view of the bone grafting material which concerns on a 1st modification. It is a perspective view of the bone grafting material which concerns on a 2nd modification. It is a perspective view of the bone grafting material which concerns on a 3rd modification. It is a partial cross section perspective view of the bone grafting material which concerns on a 4th modification. It is a partial cross section perspective view of the bone grafting material which concerns on a 5th modification. It is a schematic diagram which shows the state which the spherical surfaces of the bone grafting materials which concern on the 4th and 5th modification contact | abut, and become the shape curved as a whole. It is a perspective view of the bone grafting material which concerns on a 6th modification. It is a perspective view of the bone grafting material which concerns on a 7th modification. It is a perspective view of the bone grafting material which concerns on an 8th modification. It is a perspective view of the bone grafting material and guide wire which concern on a 9th modification. It is a perspective view of the cartridge which concerns on this Embodiment. FIG. 13A is a side view showing a state in which the rear end portion of the guide wire is inserted into the cartridge, and FIG. 13B is a side view showing a state in which the bone prosthetic material is inserted from the cartridge into the guide wire. It is a perspective view of the cartridge which concerns on a 1st modification. FIG. 15A is a side view showing a state where the rear end portion of the guide wire is inserted into the cartridge according to the first modification, and FIG. 15B is a drawing of the cylindrical body of the cartridge according to the first modification from the guide wire. It is a side view which shows the state. It is a perspective view of the cartridge which concerns on a 2nd modification. FIG. 17A is a side view showing a state in which the rear end portion of the guide wire is inserted into the cartridge according to the second modification, and FIG. 17B is a drawing of the cylindrical body of the cartridge according to the second modification from the guide wire. It is a side view which shows the state. It is a perspective view of the filling instrument set and cartridge which concern on this Embodiment. It is a flowchart which shows the procedure which fills a bone defect material with a bone grafting material using a filling instrument set. It is sectional drawing of the vertebral body which opened the insertion port with the puncture needle. It is sectional drawing of the vertebral body which inserted the outer cylinder in the insertion port. It is a schematic diagram which shows a mode that percutaneous vertebroplasty is performed using an X-ray apparatus and a filling instrument set. It is sectional drawing of the vertebral body in which the guide wire and the inner cylinder were inserted in the bone defect part via the outer cylinder. It is a partial cross section perspective view of the vertebral body in which the guide wire and the inner cylinder are inserted into the bone defect part via the outer cylinder. It is sectional drawing of the vertebral body which shows a mode that the front-end | tip of a guide wire is rotated inside a bone defect part. It is sectional drawing of the vertebral body which shows a mode that several bone substitute materials are extruded from a guide wire with an inner cylinder. It is sectional drawing of the vertebral body which shows a mode that a guide wire is pulled out in the state which pressed down the several bone grafting material with the inner cylinder. It is sectional drawing of the vertebral body which shows a mode that a predetermined number of bone prosthetic material is filled in series and parallelly. It is sectional drawing of the vertebral body which filled the bone defect part with the bone grafting material, and closed the insertion port with the plug.

Explanation of symbols

10, 10a to 10i ... Bone prosthesis material 12 ... Guide hole (guide part)
DESCRIPTION OF SYMBOLS 14 ... Outer surface 16 ... Convex part 18 ... Groove 20, 22 ... End surface 24 ... U-shaped groove (guide part) 50, 50a, 50b ... Cartridge 52, 60, 66 ... Cylindrical body 58 ... Cap 62 ... Film 100 ... Filling instrument Set 102 ... Guide wire 102a ... Rear end part 102b ... Tip part 104 ... Outer cylinder 106 ... Inner cylinder 200 ... Vertebral body 202 ... Puncture needle 204 ... Insertion port 300 ... X-ray device 308 ... Monitor 400 ... Bone defect part

Claims (17)

A bone filling material for filling a bone defect,
A bone prosthetic material comprising a guide portion that slidably penetrates the striatum introduced into the bone defect portion. In the bone grafting material according to claim 1,
The bone prosthetic material, wherein the guide part is a through hole having a diameter of 0.1 to 3 mm. In the bone grafting material according to claim 1,
The bone prosthetic material, wherein the guide portion is a groove having a width of 0.1 to 3 mm at a portion penetrating the linear body. In the bone grafting material according to any one of claims 1 to 3,
Bone prosthetic material characterized in that the height in the sliding direction is 1 to 10 mm. In the bone prosthetic material according to any one of claims 1 to 4,
A bone prosthetic material characterized in that an outer side surface is a circle centering on a portion where the linear body penetrates in the guide portion on a surface orthogonal to the sliding direction. In the bone substitute material according to any one of claims 1 to 5,
Bone prosthetic material characterized in that the outer surface is columnar. In the bone substitute material according to any one of claims 1 to 5,
Bone prosthetic material characterized in that the outer surface is conical. In the bone substitute material according to any one of claims 1 to 5,
A bone prosthetic material characterized in that the outer side surface is a curved surface in which the central part in the sliding direction is gently swollen. In the bone substitute material according to any one of claims 1 to 8,
A bone prosthetic material comprising a plurality of convex portions extending in a sliding direction on an outer surface. In the bone substitute material according to any one of claims 1 to 8,
A bone prosthetic material characterized in that a groove is provided on the outer surface. In the bone grafting material of any one of Claims 1-10,
A bone prosthetic material characterized in that at least one end surface in the sliding direction has a spherical shape. In the bone substitute material according to any one of claims 1 to 11,
A bone prosthetic material characterized in that at least one end surface in the sliding direction has a spherically recessed shape. In the bone grafting material according to any one of claims 1 to 12,
A bone prosthetic material comprising ceramics and / or polymer materials as constituent components. A plurality of bone grafting materials according to any one of claims 1 to 13,
A cylinder for storing the filling material;
A cartridge comprising:
The cartridge according to claim 1, wherein the bone prosthetic material is stored in a line in the cylindrical body so that a portion of the guide portion that penetrates the linear body is coaxial. The cartridge of claim 14, wherein
The cartridge which comprises at least one edge part of the said cylinder is comprised so that removal or a fracture | rupture is possible so that the said linear body can be penetrated. A filling device set for filling a bone defect material with a bone filling material,
An outer cylinder inserted into the bone defect from an insertion port communicating with the bone defect;
A striatum through which a distal end portion is inserted into the bone defect portion through the lumen portion of the outer cylinder, and a guide portion provided in the bone prosthetic material is inserted;
An inner cylinder that penetrates the striatum and is inserted into the outer cylinder and moves forward to push the bone prosthetic material to the bone defect,
A filling instrument set comprising: The filling device set according to claim 16,
The said linear body is an elastic body, and the front-end | tip part is curving, The filling instrument set characterized by the above-mentioned.

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