WO2012105649A1

WO2012105649A1 - Implement for surgery

Info

Publication number: WO2012105649A1
Application number: PCT/JP2012/052398
Authority: WO
Inventors: 冨永　芳恵; 武彦中島; 努森原; 恭男笹井; 奥原　信; 聡大村谷
Original assignee: Hoya株式会社; アルフレッサファーマ株式会社
Priority date: 2011-02-04
Filing date: 2012-02-02
Publication date: 2012-08-09
Also published as: JPWO2012105649A1; JP5952198B2

Abstract

An implement (1) for surgery is provided with a flexible pouch (2) and is used as follows: said pouch (2) is inserted into a cavity (911) in a vertebral body (91), and with the pouch inserted, the inside of the pouch (2) is filled with a filler (8A). The pouch (2) is provided with a bioabsorbable coarse-mesh part (24) and a non-bioabsorbable fine-mesh part (25) for which absorption into the body is inhibited or prevented. The present invention makes it possible to both prevent unintended leakage of the filler (8A) from inside the pouch (2) and allow the filler (8A) in the pouch (2) to selectively contact a desired area of the bone.

Description

Surgical tools

The present invention relates to a surgical tool.

As a treatment method for so-called vertebral body compression fractures, in which the vertebral body collapses due to trauma, osteoporosis, etc., the treatment method is to fill the crushed vertebral body with a filling material via the pedicle (via the vertebral arch). There is.

In this treatment method, first, the collapsed vertebral body is returned to its original shape, that is, a reduction operation is performed on the vertebral body. Thereafter, the cavity formed in the vertebral body is filled with a filler such as a bone grafting material by such an operation, and prior to that, a mesh-like bag body capable of storing the bone grafting material is inserted into the cavity. (For example, refer to Patent Document 1). Then, filling the bone filling material into the bag inserted into the cavity is performed.

However, in the bag described in Patent Document 1, the mesh openings are almost uniform, and depending on the size, it is conceivable that the bone prosthetic material leaks unintentionally from the bag. Further, it may be preferable that the bone filling material in the bag body is in contact with the bone as much as possible, but depending on the size of the opening, the bone filling material cannot be exposed from the pores of the mesh (bag body) and It is also possible that contact is impossible.

JP 2005-527295 Gazette

An object of the present invention is to provide a surgical tool that can prevent unintentional leakage of the filler from the bag body and that allows the filler in the bag to selectively contact a desired site of bone. It is in.

Such an object is achieved by the present inventions (1) to (10) below.
(1) A surgical tool that is provided with a flexible bag body, inserted into a bone defect portion or a portion in contact with bone, and filled with a filling material in the inserted state in the inserted state. Because
The bag is provided with a bioabsorbable portion having bioabsorbability at least in part, and a bioabsorbable portion in which absorption into the living body is suppressed or prevented.

Thereby, unintentional leakage of the filler from the bag body can be prevented, and the filler in the bag body can selectively contact a desired part of the bone.

(2) The surgical tool according to (1), wherein the bag body is configured by a braided body formed in a mesh shape by intersecting a plurality of linear bodies.

As a result, the size of the opening of the braided body can be set as appropriate, so that it is possible to reliably prevent unintentional leakage of the filler from the bag body, and the filler in the bag body A desired site can be reliably and selectively contacted.

(3) The surgical instrument according to (2), wherein the opening of the bioabsorbable portion increases with time in the use state of the bag.

Thereby, the contact area of the filler with the desired part of the bone increases with time, and the bonding force with the desired part of the bone also increases with time. Therefore, the surgical instrument filled with the filler is reliably stabilized in the bone defect portion.

(4) The surgical instrument according to (2) or (3), wherein at least one of the two linear bodies intersecting each other is made of a bioabsorbable material and functions as the bioabsorbable part.

Thereby, the contact area of the filler with the desired part of the bone increases with time, and the bonding force with the desired part of the bone also increases with time. Therefore, the surgical instrument filled with the filler is more reliably stabilized in the bone defect.

(5) Each of the linear bodies is composed of a stranded wire or a combined yarn obtained by twisting a plurality of strands,
The surgical instrument according to (2) or (3), wherein at least one of the plurality of strands is made of a bioabsorbable material and functions as the bioabsorbable portion.

For example, in the case where the bag body has a mesh shape, when the wire functioning as the bioabsorbable portion is absorbed in the living body, it contributes to an increase in the opening of the bag body. Thereby, a contact with the filler and bone | frame in a bioabsorption part is accelerated | stimulated.

(6) The bioabsorbable material is selected from the group consisting of polydioxanone, poly-L-lactide (PLLA), poly-D, L-lactide (PD, L-LA), polyglycolic acid, and polycaprolactone. The surgical instrument according to (4) or (5), which is at least one kind.
This ensures that the bioabsorbable part has bioabsorbability.

(7) The bone in which the bone defect portion is formed or the portion in contact with the bone has a contactable portion that is desired to be brought into contact with the filler as much as possible and a contact deterrent portion that is desired to be prevented from being brought into contact with the filler as much as possible. ,
The surgical instrument according to any one of (1) to (6), wherein the bioabsorbable portion is addressed to the contactable portion, and the bioabsorbable portion is addressed to the contact suppression portion.

Thereby, the filler can come into contact with the bone via the bioabsorbable part. As described above, in the surgical instrument of the present invention, the filler in the bag can surely and selectively come into contact with a desired part of the bone.

(8) Any of the above (1) to (7), wherein the bag body has a flat shape, the bioabsorbable portion is disposed on both sides thereof, and the bioabsorbable portion is disposed on the side surface side. The surgical tool according to 1.

As a result, for example, when the surgical instrument of the present invention is used for the vertebral body, the bioabsorbable portion can be reliably addressed to the target portion of the vertebral body, that is, the portion where the bioabsorbable portion is intended to be directed to the vertebral body. .

(9) The surgical tool according to any one of (1) to (8), wherein the bag body includes a marker portion that is visible under X-ray fluoroscopy.
Thereby, the installation state of the bag body in the bone defect part can be grasped under X-ray fluoroscopy.

(10) The surgical instrument according to (9), wherein the marker portion is disposed at a boundary portion between the living body absorbing portion and the living body non-absorbing portion.

This makes it easy to introduce the filler so that the inside of the bag is dense during surgery, and facilitates follow-up after surgery.

According to the present invention, by inserting the bag body into the bone defect portion and filling the bag body with the filler, the bioabsorbable portion is addressed to a desired site of the bone. Then, for a while after the operation, the filler is prevented or prevented from contacting the desired site, but after the bioabsorbable portion is absorbed, it can pass through the bag and contact the desired site. it can. Thus, in this invention, the filler in a bag body can contact | abut preferentially the said desired site | part. Thereby, a filler and the said desired site | part are united and a surgical tool is reliably stabilized within a bone defect part. In addition, unintentional leakage of the filler can be prevented at portions other than the bioabsorbable portion of the bag.

FIG. 1 is a perspective view showing a first embodiment of the surgical instrument of the present invention in a natural state (when not in use). FIG. 2 is a perspective view showing an example of a usage state of the surgical instrument shown in FIG. 3 is a cross-sectional view taken along line AA in FIG. 2 (a cross-sectional view showing a change over time in the usage state of the surgical instrument shown in FIG. 1). FIG. 4 is a cross-sectional view showing the change over time in the usage state of the surgical instrument of the present invention (second embodiment). FIG. 5 is a graph showing the particle size distribution of the filler filled in the surgical instrument shown in FIG. FIG. 6 is a diagram showing a change over time in the usage state of the linear body constituting the surgical instrument (third embodiment) of the present invention. FIG. 7 is a perspective view showing a fourth embodiment in a natural state (when not in use) of the surgical instrument of the present invention. FIG. 8 is a diagram for sequentially explaining a method of using the surgical instrument shown in FIG. FIG. 9 is a view for sequentially explaining a method of using the surgical instrument shown in FIG. FIG. 10 is a diagram for sequentially explaining a method of using the surgical instrument shown in FIG. FIG. 11 is a diagram for sequentially explaining a method of using the surgical instrument shown in FIG. 1. FIG. 12 is a diagram for sequentially explaining a method of using the surgical instrument shown in FIG. FIG. 13 is a diagram for sequentially explaining a method of using the surgical instrument shown in FIG. 1.

Hereinafter, the surgical instrument of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
<First Embodiment>
FIG. 1 is a perspective view showing a first embodiment of the surgical tool of the present invention in a natural state (when not in use), FIG. 2 is a perspective view showing an example of a usage state of the surgical tool shown in FIG. 2 is a cross-sectional view taken along line AA in FIG. 2 (cross-sectional view showing a change over time in the usage state of the surgical tool shown in FIG. 1), and FIGS. 8 to 13 are views of the surgical tool shown in FIG. It is a figure for demonstrating a usage method in order. 2 and FIGS. 8 to 13, the front side of the page is the “head side”, the back side of the page is the “leg side”, the upper side is the “belly side”, and the lower side is the “back side”.

As shown in FIG. 2, FIG. 12, and FIG. 13, the surgical instrument 1 is used by being inserted into a bone defect portion or a portion in contact with bone. Here, the bone defect refers to a bone cavity caused by a loss due to trauma, removal by removal surgery of a tumor or the like, a decrease in bone density due to osteoporosis or the like, or a combination of these factors. Moreover, the site | part which contact | connects a bone means the intervertebral etc. which are between vertebral bodies.

In addition, the surgical tool 1 is a craniofacial bone, intervertebral, clavicle, sternum, rib, carpal bone, metacarpal bone, hand phalange, sciatic bone, pubic bone, patella, tarsal bone, metatarsal bone, foot phalange. Vertebral body, iliac bone, scapula, humerus, ulna, radius, femur, tibia, and at least one type of bone selected from the group consisting of the ribs or a site in contact with the bone. . These bones are bones of relatively large size (dimensions), and the surgical instrument 1 can be used by efficiently filling the bone defect portion of such bones with the filling material 8A at a high filling rate. it can. The constituent material of the filler 8A is not particularly limited, and may be, for example, one or a combination of calcium phosphate compound, alumina, zirconia, polymer resin, and the like. The filler 8A may be in any form such as a granule, a block, or a paste.

Hereinafter, a case where the surgical tool 1 is applied to a technique for repairing a vertebral body when the vertebral body is crushed (vertebral body compression fracture reduction) will be described.

As shown in FIG. 1 (the same applies to FIGS. 2, 12, and 13), the surgical instrument 1 of the present embodiment has a flexible bag body 2 and a flexible body connected to the bag body 2. It is comprised with the tubular part 3 which has. This surgical tool 1 can insert the bag 2 into the cavity (bone defect) 911 of the vertebral body 91 (see FIG. 12). In the inserted state, the surgical tool 1 is used by filling the lumen portion (internal space) 21 of the bag body 2 with a biocompatible filler 8A (see FIG. 13). Hereinafter, a state in which the bag body 2 is filled with the filler 8A is referred to as a “filled state”.

First, the filler 8A will be described.
The filler 8A is a paste-like material having viscosity (fluidity) until the surgical tool 1 is filled. Thereby, the filling material 8A can be easily and reliably filled into the surgical instrument 1. For example, a syringe 10 can be used for filling the filler 8A as shown in FIG. Moreover, it does not specifically limit as 8 A of fillers, For example, what has the following physical properties (consistency) is preferable. In an environment of 25 ° C., 1 [g] of the pasty filler 8A is placed on the glass plate, and a 120 [g] glass plate is gently stacked thereon. Then, the length of the portion having the maximum width and the length of the portion having the minimum width of the filler 8A spread at this time are measured, and an average value thereof is calculated. The average value is preferably 10 to 40 [mm], more preferably 15 to 30 [mm].

Such a filler 8A is obtained by kneading a powder of a material used as a bone filling material (biological material) and a hardening liquid. The “powder” here is a broad concept including powders, granules, fine flakes, needles, etc., and the shape, form, manufacturing method, etc. are not particularly limited.

As such a powder, for example, a powder made of a calcium phosphate compound or the like is preferable. Calcium phosphate compounds can be stably present in a living body for a long period of time, and are particularly excellent as a biomaterial.

Examples of calcium phosphate compounds include hydroxyapatite (Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ ), TCP (Ca ₃ (PO ₄ ) ₂ ), Ca ₂ P ₂ O ₇ , Ca (PO ₃ ) ₂ , and Ca. ₁₀ (PO ₄ ) ₆ F ₂ , Ca ₁₀ (PO ₄ ) ₆ Cl ₂ , DCPD (CaHPO ₄ .2H ₂ O), Ca ₄ O (PO ₄ ) _2, etc., one or two of these The above can be mixed and used.

The average particle size of the powder is not particularly limited, but is usually preferably about 1 to 50 μm, more preferably about 4 to 30 μm.

Although it does not specifically limit as a liquid agent, For example, the water for injection etc. are mentioned. For example, additives such as sodium chondroitin sulfate, disodium succinate anhydride, sodium hydrogen sulfite and the like may be added to the liquid agent.

Then, by kneading the powder and the liquid, the kneaded product (kneaded product) is cured with time to become a cured product.

Next, the surgical tool 1 will be described.
The surgical tool 1 includes a bag body 2 and a tubular portion 3.

As shown in FIGS. 1 and 2, the bag body 2 is formed of a braided body formed in a mesh shape by intersecting a plurality of linear bodies 22. The weaving method (knitting method) is not particularly limited, and examples include plain weaving, twill weaving, satin weaving, leash weaving, imitation weaving, knitting, warp knitting, sleeves, stitches, or a combination of these. It is done.

And although this mesh-shaped bag body 2 is not an essential requirement in the present invention, it is preferable to have a large opening portion 24 and a small opening portion 25 having different opening degrees. That is, it is preferable that the arrangement density of the pores 23 formed between the linear bodies 22 has a “sparse” portion and a “dense” portion. The method for changing the size of the opening in the bag body 2 is not particularly limited. For example, the method for appropriately changing the above-described weaving method, the thickness of the linear body 22 is set smaller than that for the large opening portion 24. A method of changing between the mesh openings 25, a method of using a single mesh braid for the large mesh opening 24, and a method of using two mesh braids superimposed on the small mesh opening 25, etc. Is mentioned. The bag body 2 is not limited to a mesh shape, and may be a balloon shape.

Further, the bag body 2 has a flat shape in the natural state shown in FIG. 1, and even in the use state shown in FIG. 2, that is, in a state in which the filler 8 </ b> A is filled, the bag body 2 expands to the flat shape. maintain. In particular, the outer shape in the use state shown in FIG. 2 approximates the shape of the cavity 911 that is roughly determined in the vertebral body 91. Further, large opening portions 24 are arranged on both sides (vertical direction in FIG. 3) located in the thickness direction of the flat shape, and small opening portions 25 are arranged on the side surfaces (left and right direction in FIG. 3). Has been. With such an outer shape and the arrangement of each opening portion, the bag body 2 directs the large opening portion 24 described later to the target portion of the vertebral body 91, that is, the large opening portion 24 with respect to the vertebral body 91. The small opening portion 25 can be surely addressed to the desired portion, and the small opening portion 25 is surely directed to the other target portion of the vertebral body 91, that is, the portion where the small opening portion 25 is intended to be directed to the vertebral body 91. be able to.

The large opening portion 24 is a relatively large portion of the bag body 2 in the size of the opening, that is, the size of the pores 23. On the other hand, the small opening portion 25 is a portion having a relatively small opening size in the bag body 2, that is, a portion having a smaller opening than the large opening portion 24.

The size relationship between the opening (pore 23) of the large opening portion 24 and the opening (pore 23) of the small opening portion 25 is, for example, the opening of the large opening portion 24 in a state before use. The size of the (pore 23) is preferably 2 to 50 times the opening (pore 23) of the small opening portion 25, and more preferably 5 to 20 times. Specifically, the opening of the large opening portion 24 is preferably 0.05 to 9 mm, and more preferably 0.5 to 5 mm. The opening of the small opening portion 25 is preferably 0.005 to 5 mm, and more preferably 0.1 to 1 mm.

Since the size of each opening of the large opening portion 24 and the small opening portion 25 is set as described above, the filler 8A is made of the large opening portion 24 as shown in FIG. Then, the passage from each of the pores 23 is reliably permitted, and the passage through each of the pores 23 is reliably prevented (or suppressed) in the small opening portion 25. Thereby, in the use state, the filler 8 </ b> A can preferentially contact the vertebral body 91 at the large opening portion 24 rather than the small opening portion 25. In other words, in the use state, the contact area of the filler 8A with the vertebral body 91 at the large opening portion 24 is larger than the contact area with the vertebral body 91 at the small opening portion 25.

By the way, the vertebral body 91 includes end plate bones (disk-like bones) 912 positioned in the vertical direction in a state where the human body is upright, and a side wall that connects the two end plate bones 912 and connects them. There is a bone 913 that constitutes it. When performing vertebral body compression fracture reduction, each end plate bone 912 (contactable portion) is desired to be brought into contact with the filler 8A as much as possible, and the bone 913 (contact deterring portion) constituting the side wall is filled with the filler. I want to suppress contact with 8A as much as possible. The reason is that the bone 913 constituting the side wall is more likely to have a fracture line than the end plate bone, and when the fracture line is generated in the bone 913 constituting the side wall, the filler 8A leaked from the fracture line is This is because there is a risk of coming into contact with the spinal cord and nerve roots in the vicinity. Further, the reason for making contact between the end plate bone 912 and the filling material 8A is that if the contact is made, the filling material 8A and the end plate bone 912 are joined (healed), and the operation tool 1 in the filled state is obtained. This is because it can be stabilized in the cavity 911 of the vertebral body 91.

Therefore, the surgical tool 1 has the shape as described above, so that the filler 8A can be inserted into the cavity 911 of the vertebral body 91 and filled with the filler 8A. 2 is spread from the inside, and the large opening portion 24 is surely addressed (appears) to the end plate bone 912, and the small opening portion 25 is surely addressed to the bone 913 constituting the side wall. (See FIG. 13). The filler 8A passes through the pores 23 of the large opening portion 24 and comes into contact with the end plate bone 912. However, the small opening portion 25 is blocked from passing, and contact with the bone 913 constituting the side wall is prevented. This is prevented (see FIG. 3A). As described above, in the surgical instrument 1, the filler 8A in the bag body 2 preferentially contacts the end plate bone 912 of the vertebral body 91 and the end plate bone 912 (desired portion) of the bone 913 constituting the side wall. be able to. As a result, the filling material 8A and the end plate bone 912 are fused, and the surgical tool 1 in the filled state is reliably stabilized in the cavity 911 of the vertebral body 91. In addition, unintentional leakage of the filler 8A at the small openings 25 can be prevented. Thereby, it is possible to reliably prevent the filler 8A from coming into contact with the spinal cord in the bone (vertebral canal) constituting the side wall or the nerve root existing in the vicinity thereof.

Now, the surgical tool 1 of the present invention includes a bioabsorbable part and a non-bioabsorbable part. The size of the pores 23 may be substantially uniform over the entire bag body 2. In this case, the bioabsorbable portion becomes a large opening portion 24 over time by being absorbed by the living body. Since the pores 23 can be set small in the initial stage of application of the affected area by becoming the large opening portion 24 with time, when a paste-like material is used as the filler 8A, the period until the paste is cured The leakage of the paste to the outside of the bag body 2 can be prevented. After the paste is cured, the bioabsorbable part, which is a desired part of the bag body 2, is absorbed. The large opening portion 24 is made of a material having the whole (or at least 60% portion) having bioabsorbability (biodegradability), whereas the small opening portion 25 is made of the whole (or at least at least 60%). 60% portion) may be made of a material having non-biological absorbability that prevents or prevents absorption by the living body.

The material having bioabsorbability (hereinafter referred to as “first material”) is not particularly limited, and examples thereof include poly-L-lactide (PLLA), poly-D-lactide (PDLA), and poly-D, L. -Lactide (PD, L-LA), polyglycolic acid, polycaprolactone, polydioxanone, L-lactide / glycolide copolymer, D-lactide / glycolide copolymer, L- and D-lactide / glycolide From copolymer (P (LA / GA)), L-lactide / caprolactone copolymer, D-lactide / caprolactone copolymer, L- and D-lactide / caprolactone copolymer (P (LA / CL)) At least one selected from the group can be used. In this case, both (or one) of the two linear bodies 22 intersecting each other that knitting the large opening portion 24 can be formed of the first material. As a result, as shown in FIGS. 3A to 3C, in the state of use, each linear body 22 of the large opening portion 24 is decomposed and absorbed with time, and finally disappears. Further, in the middle of the process, the size of each pore 23 increases by the amount that each linear body 22 is decomposed and absorbed.

By providing the large opening portion 24 having such a configuration, the contact area of the filling material 8A with the end plate bone 912 of the vertebral body 91 increases with time, and accordingly, the vertebral body 91 has a contact area. The joining force with the end plate bone 912 also increases with time. As a result, the filled surgical instrument 1 is more reliably stabilized in the cavity 911 of the vertebral body 91.

In the vertebral body 91 subjected to vertebral body compression fracture reduction, it is preferable to leave the large opening portion 24 until the bone formation is performed, but the large opening portion 24 disappears after the bone formation. May be. It can be said that the large opening portion 24 is configured to satisfy such a demand.

Further, it can be said that the large opening portion 24 is a portion in the bag body 2 that also serves as a “bioabsorbing portion” that is absorbed by the living body (functions as a “bioabsorbing portion”).

Further, the change with time of the size of the opening of the large opening portion 24 is preferably increased at a rate of 0.1 to 5% / day, for example. Whether or not such a setting is made is determined by, for example, impregnating a sample of the “large opening portion 24” with a simulated body fluid (SBF (Simulated Body Fluid)) or physiological saline, and changing the opening of the sample. This can be confirmed by observation.

On the other hand, the material (hereinafter referred to as “second material”) that is inhibited or prevented from being absorbed by the living body is not particularly limited. For example, polyethylene, polypropylene, polyester, polyamide (eg, nylon 6, nylon 46, Nylon 66, Nylon 610, Nylon 612, Nylon 11, Nylon 12, Nylon 6-12, Nylon 6-66), or natural fibers such as wool, silk, linen and cotton yarn, one of these Or what combined 2 or more types can be used. In this case, both of the two linear bodies 22 intersecting each other that knitting the small opening portion 25 can be made of the second material. As a result, as shown in FIGS. 3A to 3C, each linear body 22 of the small opening portion 25 is decomposed with time like each linear body 22 of the large opening portion 24 even in use.・ It is surely prevented from being absorbed. As a result, the size of the pores 23 of the small openings 25 is kept constant, and thus the filler 8A is prevented from leaking unintentionally and coming into contact with the bone 913 constituting the side wall of the vertebral body 91. The state can persist.

As described above, the small opening portion 25 is a portion of the bag body 2 that also serves as a “living body non-absorbing portion” in which absorption into the living body is suppressed or prevented (functions as a “living body non-absorbing portion”). Can do.

In the bag body 2 configured as described above, an unintentional leakage of the filler 8A from the inside of the bag body 2 due to the synergistic effect of having a size in the opening and having bioabsorbability and non-bioabsorption. 8A can be reliably prevented, and the filler 8A in the bag body 2 can selectively and reliably contact the end plate bone 912 of the vertebral body 91.

1 and 2, the tubular portion 3 is connected to the small opening portion 25 of the bag body 2. The tubular portion 3 has a pipe line (hollow portion) 31 communicating with the lumen portion 21 of the bag body 2. The conduit 31 functions as a flow path through which the filler 8A passes when the lumen 8 of the bag 2 is filled with the filler 8A. Thereby, the bag 8 can be filled with the filler 8A easily and reliably.

Further, the tubular portion 3 has a mesh shape. The opening of the tubular portion 3 is set to be smaller than the opening of the small opening portion 25, and is preferably 0.1 to 1 times the opening of the small opening portion 25, for example. Thus, when filling the bag body 2 with the filler 8A, the filler 8A is reliably prevented from leaking out of the tubular portion 3, and can thus reliably reach the bag body 2.

The constituent material of the tubular portion 3 is not particularly limited, but for example, the same material as the constituent material of the small opening portion 25 can be used. Thereby, the bag body 2 and the tubular part 3 can be manufactured collectively with a knitting machine.

Next, an example of how to use the surgical tool 1 will be described with reference to FIGS.
[1] First, under X-ray fluoroscopy, as shown in FIG. 8, the perforator 20 is punctured toward the vertebral body 91 from the

vertebrae

92 and 92 of the vertebra 9 to which the vertebral body compression fracture reduction is performed. As a result, small-

diameter holes

93 and 93 are formed on the left and right sides of the vertebra 9 in FIG. Next, the inner diameter of each hole 93 is expanded using the reamer 30.

[2] Next, two curettes 40 having a curved tip are prepared. Then, as shown in FIG. 9, each curette 40 is inserted into each hole 93 and the vertebral body 91 is scraped.

[3] Next, as shown in FIG. 10, the rasp 50 is inserted into one hole 93 to clean the cavity 911 of the vertebral body 91 and reduce the vertebral body 91.

[4] Next, a syringe 60 preliminarily filled with physiological saline Q is prepared. Then, as shown in FIG. 11, the mouth 601 of the syringe 60 is inserted into one hole 93, and in this state, physiological saline Q is injected into the cavity 911 of the vertebral body 91. This injection operation is performed until the physiological saline Q is discharged from the other hole 93. Thereby, the cavity 911 of the vertebral body 91 is cleaned.

[5] Next, as shown in FIG. 12, the bag 2 of the surgical tool 1 is inserted into the cavity 911 of the vertebral body 91 from one hole 93 using, for example, an insertion guide rod 70. At this time, the tubular portion 3 of the surgical instrument 1 is positioned in the one hole 93.

[6] Next, a syringe 10 preliminarily filled with the filler 8A is prepared. And as shown in FIG. 13, the opening | mouth part 101 of the syringe 10 is inserted in the tubular part 3 of the surgical tool 1, and the surgical tool 1 is filled with the filler 8A in this state. This filling operation is performed until the large opening portion 24 of the bag body 2 is assigned to the end plate bone 912 of the vertebral body 91 and the small opening portion 25 is assigned to the bone 913 constituting the side wall. Thereby, the surgical instrument 1 filled with the filler 8A is placed in the vertebral body 91.

Second Embodiment
FIG. 4 is a cross-sectional view showing a change over time in the usage state of the surgical instrument of the present invention (second embodiment), and FIG. 5 shows the particle size distribution of the filler filled in the surgical instrument shown in FIG. It is a graph.

Hereinafter, the second embodiment of the surgical instrument of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the aspect of the filler is different.

As shown in FIG. 4, in the present embodiment, the filler 8 </ b> B is composed of a plurality of granules 81. Here, “granule” is a broad concept including powders, particles, fine flakes, blocks, needles, and the like, and the shape, form, production method, and the like are not particularly limited.

Further, each granule 81 is made of, for example, the same material as the powder constituting the filler 8A in the first embodiment.

The average particle diameter d of the granules 81 is not particularly limited, but is preferably 0.1 to 10 mm, for example, and more preferably 1 to 5 mm.

Further, the opening of the large opening portion 24 and the opening of the small opening portion 25 are each smaller than the average particle diameter d in a state before use. Specifically, the opening of the large opening portion 24 is preferably 0.5 to 0.9 times the average particle diameter d. The opening of the small openings 25 is preferably 0.05 to 0.5 times the average particle diameter d. By setting to such a numerical range, as shown in FIG. 5, the granules 81 in the region of “hatching inclined to the right side” in the figure are reliably captured by the large openings 24, that is, large. It can be seen that passage through the opening 24 is prevented. Further, it can be seen that the granules 81 in the region of “hatching inclined to the left” in FIG. 5 are reliably captured even by the small openings 25, that is, are prevented from passing through the small openings 25. .

Thereby, even if it is the filler 8B comprised by the some granule 81, in the large opening part 24, it contacts with the endplate bone 912 of the vertebral body 91, preventing the filler 8B from leaking out. Can do. Moreover, in the small opening part 25, it is prevented that the filler 8B leaks out and contact with the bone 913 which comprises the side wall of the vertebral body 91 is also suppressed (refer FIG. 4).

<Third Embodiment>
FIG. 6 is a diagram showing a change over time in the usage state of the linear body constituting the surgical instrument (third embodiment) of the present invention.

Hereinafter, the third embodiment of the surgical instrument of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
The present embodiment is the same as the first embodiment except that the configuration of the linear body is different.

As shown in FIG. 6, in the present embodiment, each linear body 22 in the large opening portion 24 is composed of a stranded wire formed by twisting a strand 221 and a strand 222. Alternatively, each linear body 22 may be a combined yarn including a bundle of a plurality of yarns that are not twisted. And the strand 221 is comprised with the 1st material (material which has bioabsorbability) mentioned above. Thereby, in the large opening part 24, the strand 221 functions as a bioabsorbing part, and contributes to the increase in opening. Moreover, the strand 222 is comprised with the 2nd material (material in which absorption to a biological body is suppressed or prevented).

In addition, although the number of the strands which respectively comprise each linear body 22 in the large opening part 24 is two in this embodiment, it is not limited to this, For example, three or more may be sufficient. In this case, at least one strand can be made of a bioabsorbable material.

<Fourth embodiment>
FIG. 7 is a perspective view showing a fourth embodiment in a natural state (when not in use) of the surgical instrument of the present invention.

Hereinafter, the fourth embodiment of the surgical instrument of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the bag body of the surgical tool is different.

As shown in FIG. 7, in the surgical instrument 1 of the present embodiment, the bag 2 is provided with a marker portion 26 that can be viewed under X-ray fluoroscopy. An installation form of the marker portion 26 is not particularly limited, and for example, a form in which a metal wire made of a Ni—Ti superelastic alloy is knitted into the linear body 22 is exemplified. Other forms include contrast agents such as barium sulfate, barium fluoride, and barium silicate, bismuth compounds, zirconium compounds, lanthanum compounds, thorium compounds, and rare earth metals, etc. There is also a form of knitting a method).

Thereby, the marker part 26 can be provided with contrast, and therefore the installation state of the bag body 2 in the cavity 911 of the vertebral body 91 can be grasped under X-ray fluoroscopy. As a result, at the time of surgery, it becomes easy to introduce the filler so that the inside of the bag body 2 is dense, and follow-up is facilitated after the surgery.

The arrangement position of the marker portion 26 is not particularly limited, but is preferably a boundary portion between the large opening portion 24 (biological absorption portion) and the small opening portion 25 (biological non-absorption portion), for example. This makes it possible to check whether the bag body 2 is installed at an appropriate position and direction in the body even during compensation and during follow-up after surgery. Moreover, the marker part 26 may be arrange | positioned in the whole bag body 2, and when it fills in an affected part, it will become an upper part, a center, a part which becomes a lower end, or front, center, back, or one of these. A position combining the above may also be used.

As mentioned above, although the surgical tool of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a surgical tool of the arbitrary structures which can exhibit the same function Can be substituted. Moreover, arbitrary components may be added.

Further, the surgical tool of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

Further, the bag may have a uniform opening throughout.
Moreover, the bag body may contain a substance that promotes bone fusion, such as hydroxyapatite, BMP, and TGF.

According to the present invention, by inserting the bag body into the bone defect portion and filling the bag body with the filler, the bioabsorbable portion is addressed to a desired site of the bone. Then, for a while after the operation, the filler is prevented or prevented from contacting the desired site, but after the bioabsorbable portion is absorbed, it can pass through the bag and contact the desired site. it can. Thus, in this invention, the filler in a bag body can contact | abut preferentially the said desired site | part. Thereby, a filler and the said desired site | part are united and a surgical tool is reliably stabilized within a bone defect part. In addition, unintentional leakage of the filler can be prevented at portions other than the bioabsorbable portion of the bag. Therefore, the present invention has industrial applicability.

Claims

A surgical tool comprising a flexible bag body, inserted into a bone defect portion or a site in contact with bone, and filled with a filler in the inserted state in the inserted state. ,
The bag is provided with a bioabsorbable portion having bioabsorbability at least in part, and a bioabsorbable portion in which absorption into the living body is suppressed or prevented.
2. The surgical instrument according to claim 1, wherein the bag body is configured by a braided body formed by meshing a plurality of linear bodies.
The surgical instrument according to claim 2, wherein the opening of the bioabsorbable portion increases with time in the use state of the bag.
The surgical instrument according to claim 2 or 3, wherein at least one of the two linear bodies intersecting each other is made of a bioabsorbable material and functions as the bioabsorbable part.
Each of the linear bodies is composed of a stranded wire or a combined yarn obtained by twisting a plurality of strands,
The surgical instrument according to claim 2 or 3, wherein at least one of the plurality of strands is made of a bioabsorbable material and functions as the bioabsorbable portion.
The bioabsorbable material is at least one selected from the group consisting of polydioxanone, poly-L-lactide (PLLA), poly-D, L-lactide (PD, L-LA), polyglycolic acid, and polycaprolactone. The surgical instrument according to claim 4 or 5, which is a seed.
The bone formed with the bone defect part or the part that contacts the bone has a contactable part that wants to make contact with the filler as much as possible and a contact deterrent part that wants to prevent contact with the filler as much as possible.
The surgical instrument according to any one of claims 1 to 6, wherein the bioabsorbable portion is assigned to the contactable portion, and the non-absorbable portion is assigned to the contact suppression portion.
The surgical tool according to any one of claims 1 to 7, wherein the bag body has a flat shape, the bioabsorbable portions are disposed on both sides thereof, and the bioabsorbable portions are disposed on side surfaces.
The surgical tool according to any one of claims 1 to 8, wherein the bag body includes a marker portion that is visible under X-ray fluoroscopy.
The surgical tool according to claim 9, wherein the marker portion is disposed at a boundary portion between the living body absorbing portion and the living body non-absorbing portion.