WO2012105647A1 - Instrument pour chirurgie - Google Patents
Instrument pour chirurgie Download PDFInfo
- Publication number
- WO2012105647A1 WO2012105647A1 PCT/JP2012/052396 JP2012052396W WO2012105647A1 WO 2012105647 A1 WO2012105647 A1 WO 2012105647A1 JP 2012052396 W JP2012052396 W JP 2012052396W WO 2012105647 A1 WO2012105647 A1 WO 2012105647A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- opening portion
- filler
- bone
- large opening
- bag body
- Prior art date
Links
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
- A61F2002/30588—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with solid particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
- A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
- A61F2002/30682—Means for preventing migration of particles released by the joint, e.g. wear debris or cement particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00203—Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00221—Ceramics or ceramic-like structures based on metal oxides containing calcia or calcium oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00239—Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00359—Bone or bony tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
Definitions
- the present invention relates to a surgical tool.
- the treatment method is to fill the crushed vertebral body with a filling material via the pedicle (via the vertebral arch). There is.
- the collapsed vertebral body is returned to its original shape, that is, a reduction operation is performed on the vertebral body.
- 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.
- a filler such as a bone grafting material
- a mesh-like bag body capable of storing the bone grafting material is inserted into the cavity.
- 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.
- 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.
- 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 filler in the inserted state in the inserted state. Because The bag body has a mesh shape, and has a large opening portion having a large opening, and a small opening portion having a smaller opening than the large opening portion. .
- the filler is composed of a plurality of granules, The surgical instrument according to (1), wherein the opening of the large opening portion and the opening of the small opening portion are each smaller than an average particle diameter of the plurality of granules.
- the filler and the bone can be in contact with each other at the large opening portion, and the contact between the filler and the bone can be suppressed or prevented at the small opening portion.
- the opening of the large opening portion is 0.5 to 0.9 times the average particle size, and the opening of the small opening portion is 0.05 to 0. 0 of the average particle size.
- the surgical instrument according to (3) which is 5 times.
- the bone can be preferentially contacted with the bone.
- the opening of the large opening part is 0.05 to 9 mm, and the opening of the small opening part is 0.005 to 5 mm.
- the filler is more reliably allowed to pass through the large opening portion and more reliably prevented or suppressed from passing through the small opening portion. It is possible to contact the bone more preferentially at the opening of the mesh.
- 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 filler in the bag can surely and selectively come into contact with a desired part of the bone.
- the large opening portion can be reliably applied to the target portion of the vertebral body, that is, the portion where the large opening portion is desired to be directed to the vertebral body
- the small opening portion can be reliably applied to another target portion of the vertebral body, that is, the portion where the small opening portion is desired to be directed to the vertebral body.
- a large opening portion is obtained by inserting a bag into a bone defect or a portion in contact with bone (hereinafter, typically referred to as “bone defect”) and filling the bag with a filler.
- first part a desired part of the bone
- second part another desired part of the bone
- the filler passes through the large opening portion and comes into contact with the first portion, but the passage is restricted at the small opening portion, and contact of the second portion is prevented or suppressed.
- the filler in a bag body can contact
- unintentional leakage of the filler at the small openings can be prevented.
- 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.
- 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.
- 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)
- 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”.
- the surgical instrument 1 is used by being inserted into a bone defect portion or a portion in contact with bone.
- 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.
- connects a bone means the vertebral body between the vertebral bodies, etc.
- 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.
- 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.
- 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).
- 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).
- a state in which the bag body 2 is filled with the filler 8A is referred to as a “filled state”.
- 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.
- a syringe 10 can be used for filling the filler 8A as shown in FIG.
- 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.
- 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.
- a powder of a calcium phosphate compound 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 ⁇ m, more preferably about 4 to 30 ⁇ m.
- liquid agent for example, the water for injection etc. are mentioned.
- additives such as sodium chondroitin sulfate, disodium succinate anhydride, sodium hydrogen sulfite and the like may be added to the liquid agent.
- the kneaded product (kneaded product) is cured with time to become a cured product.
- the surgical tool 1 includes a bag body 2 and a tubular portion 3.
- 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 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.
- this mesh-shaped bag body 2 has the large opening part 24 and the small opening part 25 from which the degree of opening differs, ie, the pore 23 formed between the linear bodies 22 mutually.
- the arrangement density has a “sparse” part and a “dense” part.
- the method for changing the size of the opening in the bag body 2 is not particularly limited.
- 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.
- the bag body 2 is not limited to a mesh shape, and may be a balloon shape.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the filler 8A 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.
- 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.
- 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.
- 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).
- the filler 8A in the bag body 2 is selectively used only for 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. You can touch. As a result, the filler 8A and the end plate bone 912 are joined, and the filled surgical tool 1 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.
- the large opening portion 24 has a bioabsorbability (biodegradability) as a whole (or at least 60%).
- bioabsorbability biodegradability
- the entire small opening portion 25 or at least a 60% portion is inhibited or prevented from being absorbed into the living body.
- the material having bioabsorbability 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.
- PLLA poly-L-lactide
- PDLA poly-D-lactide
- L-LA L. -Lactide
- P (LA / GA) L-l
- 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.
- each linear body 22 of the large opening portion 24 is decomposed and absorbed with time, and finally disappears.
- the size of each pore 23 increases by the amount that each linear body 22 is decomposed and absorbed.
- 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.
- the large opening portion 24 is configured to satisfy such a demand.
- 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”).
- 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.
- a simulated body fluid Simulated Body Fluid
- the material (hereinafter referred to as “second material”) that is inhibited or prevented from being absorbed by the living body is not particularly limited.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- a syringe 10 preliminarily filled with the filler 8A is prepared. And as shown in FIG. 13, the opening
- 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.
- the filler 8 ⁇ / b> B is composed of a plurality of granules 81.
- 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.
- 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.
- 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.
- 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.
- 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. .
- 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.
- 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.
- 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.
- each linear body 22 may be a combined yarn including a bundle of a plurality of yarns that are not twisted.
- the strand 221 is comprised with the 1st material (material which has bioabsorbability) mentioned above.
- the strand 221 functions as a bioabsorbing part, and contributes to the increase in opening.
- the strand 222 is comprised with the 2nd material (material in which absorption to a biological body is suppressed or prevented).
- 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.
- 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.
- This embodiment is the same as the first embodiment except that the configuration of the bag body of the surgical tool is different.
- the marker 2 that can be visually recognized under X-ray fluoroscopy is provided on the bag body 2.
- 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).
- the marker part 26 can be provided with contrast, and thus the installation state of the bag body 2 in the cavity 911 of the vertebral body 91 can be grasped under X-ray fluoroscopy.
- 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.
- the marker part 26 may be arrange
- the surgical tool of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
- the bioabsorbable portion and the bioabsorbable portion can be omitted. That is, the whole bag body may be comprised with the 1st material, and the whole bag body may be comprised with the 2nd material.
- the bag body may contain a substance that promotes bone fusion, such as hydroxyapatite, BMP, and TGF.
- the large opening portion is assigned to the first portion of the bone, The opening will be directed to the second part of the bone.
- the filler passes through the large opening portion and comes into contact with the first portion, but the passage is restricted at the small opening portion, and contact of the second portion is prevented or suppressed.
- the filler in a bag body can contact
- unintentional leakage of the filler at the small openings can be prevented. Therefore, the present invention has industrial applicability.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Neurology (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Abstract
L'invention porte sur un instrument (1) pour chirurgie qui comporte une poche souple (2) et est utilisé comme suit : ladite poche (2) est introduite dans une cavité (911) dans un corps vertébral (91), et la poche étant introduite, l'intérieur de la poche (2) est rempli d'une charge (8A). La poche (2) comprend une maille et a une partie à mailles grossières (24), où les trous dans la maille sont de grande dimension, et une partie à mailles fines (25), où les trous dans la maille sont plus petits que ceux dans la partie à mailles grossières (24). La présente invention permet d'empêcher une fuite involontaire de la charge (8A) depuis l'intérieur de la poche (2) et permet à la charge (8A) dans la poche (2) de venir en contact de manière sélective avec une région désirée de l'os.
Priority Applications (1)
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JP2012555952A JP5909197B2 (ja) | 2011-02-04 | 2012-02-02 | 手術用具 |
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JP2011022332 | 2011-02-04 | ||
JP2011-022332 | 2011-02-04 |
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WO2012105647A1 true WO2012105647A1 (fr) | 2012-08-09 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/JP2012/052396 WO2012105647A1 (fr) | 2011-02-04 | 2012-02-02 | Instrument pour chirurgie |
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JP (1) | JP5909197B2 (fr) |
WO (1) | WO2012105647A1 (fr) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104905868A (zh) * | 2015-06-23 | 2015-09-16 | 上海凯利泰医疗科技股份有限公司 | 一种非均匀孔径的骨填充囊袋 |
JP2015532167A (ja) * | 2012-10-19 | 2015-11-09 | ツナミ,エス.アール.エル | 椎骨固定デバイスおよびシステム |
CN106214241A (zh) * | 2016-08-15 | 2016-12-14 | 江苏常美医疗器械有限公司 | 一种一体式可扩张球囊囊袋装置 |
JP2019076533A (ja) * | 2017-10-26 | 2019-05-23 | 芳朗 武者 | 生体留置用袋体 |
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JP2015532167A (ja) * | 2012-10-19 | 2015-11-09 | ツナミ,エス.アール.エル | 椎骨固定デバイスおよびシステム |
CN104905868A (zh) * | 2015-06-23 | 2015-09-16 | 上海凯利泰医疗科技股份有限公司 | 一种非均匀孔径的骨填充囊袋 |
CN106214241A (zh) * | 2016-08-15 | 2016-12-14 | 江苏常美医疗器械有限公司 | 一种一体式可扩张球囊囊袋装置 |
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JP7114828B2 (ja) | 2017-10-26 | 2022-08-09 | 芳朗 武者 | 生体留置用袋体 |
Also Published As
Publication number | Publication date |
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JP5909197B2 (ja) | 2016-04-26 |
JPWO2012105647A1 (ja) | 2014-07-03 |
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