WO2014118941A1 - 骨癒合のための医療用線状部材 - Google Patents
骨癒合のための医療用線状部材 Download PDFInfo
- Publication number
- WO2014118941A1 WO2014118941A1 PCT/JP2013/052209 JP2013052209W WO2014118941A1 WO 2014118941 A1 WO2014118941 A1 WO 2014118941A1 JP 2013052209 W JP2013052209 W JP 2013052209W WO 2014118941 A1 WO2014118941 A1 WO 2014118941A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- linear member
- wires
- medical linear
- spiral body
- force
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/842—Flexible wires, bands or straps
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B1/00—Constructional features of ropes or cables
- D07B1/06—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core
- D07B1/0693—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core having a strand configuration
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B1/00—Constructional features of ropes or cables
- D07B1/06—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core
- D07B1/08—Ropes or cables built-up from metal wires, e.g. of section wires around a hemp core the layers of which are formed of profiled interlocking wires, i.e. the strands forming concentric layers
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B2201/00—Ropes or cables
- D07B2201/20—Rope or cable components
- D07B2201/2015—Strands
- D07B2201/2024—Strands twisted
- D07B2201/2029—Open winding
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B2201/00—Ropes or cables
- D07B2201/20—Rope or cable components
- D07B2201/2015—Strands
- D07B2201/2024—Strands twisted
- D07B2201/2029—Open winding
- D07B2201/203—Cylinder winding, i.e. S/Z or Z/S
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B2401/00—Aspects related to the problem to be solved or advantage
- D07B2401/20—Aspects related to the problem to be solved or advantage related to ropes or cables
- D07B2401/2005—Elongation or elasticity
-
- D—TEXTILES; PAPER
- D07—ROPES; CABLES OTHER THAN ELECTRIC
- D07B—ROPES OR CABLES IN GENERAL
- D07B2401/00—Aspects related to the problem to be solved or advantage
- D07B2401/20—Aspects related to the problem to be solved or advantage related to ropes or cables
- D07B2401/2005—Elongation or elasticity
- D07B2401/201—Elongation or elasticity regarding structural elongation
Definitions
- the present invention relates to a medical linear member for internal fixation used for fracture treatment.
- medical treatment that can apply a predetermined capsule pressure from the outer periphery to the inner side to the bound fractured part using the contraction force in the length direction and the expansion force in the diameter direction accumulated in the stretched medical linear member
- the present invention relates to a linear member.
- Patent Document 1 discloses a medical linear member as disclosed in Patent Document 1 and Patent Document 2.
- Patent Documents 1 and 2 have a smooth outer shape as compared with existing products. Therefore, it can be applied even to bones of children with low strength and bones of elderly people with insufficient bone mass and quality without damaging the bone to be fixed and surrounding tissues.
- Patent Documents 1 and 2 are medical linear members excellent in elongation and flexibility, it is necessary to fix a large bone such as a femur or a hip bone with a strong binding force. In some cases, the strength was insufficient.
- the present invention provides a medical linear member having stronger strength while maintaining elongation and flexibility.
- the medical linear member of the present invention is an inner spiral body in which a plurality of wires have a space portion on the inner side and are spirally wound with a gap portion between each wire in the axial direction, and a plurality of wires are disposed outside the inner spiral body.
- An outer spiral body in which a wire is spirally wound by providing a gap between the wires so that the spiral direction is opposite to the inner spiral body is arranged in a multilayer structure.
- the present invention uses a restoring force that attempts to return to a medical linear member that has been stretched in the long axis direction and contracted in the diametric direction as a binding force. That is, the contraction force accumulated in the length direction of the medical linear member and the expansion force with respect to the diameter direction are used as the capsule pressure to fix the fractured portion.
- the present invention since a gap is provided between the wires, there is no friction between the wires. Therefore, the force applied to the medical linear member is not reduced by the frictional force between the wires. Therefore, the restoring force of the stretched medical linear member is applied as a bone binding force without being reduced by the frictional force.
- the diameters of the wires forming the inner spiral body and the outer spiral body are the same or different, and the number of wires forming the outer spiral resistance is greater than the number of wires forming the inner spiral body. It is characterized by many.
- the wire of the inner spiral body of the medical linear member of Patent Document 1 uses a thinner wire than the wire of the outer spiral body.
- the wire forming the inner spiral body of the medical linear member of the present invention has the same thickness as the wire forming the outer spiral body, the strength is higher than that of the medical linear member of Patent Document 1. Yes.
- the medical linear member of the present invention is characterized in that the pitch of the outer spiral is longer than the pitch of the inner spiral.
- the tensile strength of the medical linear member can be increased because the pitch of the outer spiral is longer than the pitch of the inner spiral.
- the medical linear member of the present invention is characterized by using a shape memory alloy containing titanium in the wire.
- the metal member to be fixed in the body is preferably an alloy containing titanium from the viewpoint of biocompatibility and memorizing a certain spring property. Bone can be fixed with a stable binding force using a shape memory alloy that has been treated to return to its original length and diameter according to body temperature. By storing the spring property, the force applied to the medical linear member acts as a restoring force.
- the external view which shows the two-layer medical linear member of an Example The external view which shows the single layer medical linear member of a comparative example.
- FIG. 1 is an external view schematically showing a medical linear member of the present invention, in which (A) is a front view and (B) is an end view taken along the line II shown in (A). .
- the medical linear member 1 has a plurality of wires 2 arranged, and a gap 3 is opened between the wires and spirally wound at a pitch P1 and an outer diameter D1 to form an inner spiral body 4. At this time, the gaps 3 between the wires are designed to be uniform.
- the outer spiral body 6 is formed outside the inner spiral body 4 by spirally winding a plurality of wires 5 at a pitch P2 and an outer diameter D2 so that the spiral direction is opposite to that of the inner spiral body 4.
- a gap 7 is provided between the wire 5 forming the outer spiral body 6 and the adjacent wire 5.
- the gaps 7 are evenly provided between the wires in each spiral body, so that even when the medical linear member is stretched, the adjacent wires 5 are connected to each other. There is no contact and there is no friction between the wires. Further, a gap 8 is also provided between the inner spiral body 4 and the outer spiral body 6 so as to avoid friction caused by contact between the spiral bodies.
- the diameter of the wire 2 forming the inner spiral body 4 and the diameter of the wire 5 forming the outer spiral body 6 are the same, and the outer diameter D1 of the inner spiral body 4 is reduced by reducing the number of wires 2 forming the inner spiral body 4. Is designed to be smaller than the outer diameter D2 of the outer spiral body 6.
- the outer diameters D1 and D2 and the pitches P1 and P2 of the spiral body can be appropriately designed depending on the purpose of use, the application location, etc. of the medical linear member 1, but the pitch P1 is preferably shorter than the pitch P2. As described above, the tensile strength of the medical linear member can be increased because the pitch of the outer spiral body is longer than the pitch of the inner spiral body.
- the medical member of the example manufactured for comparing the strength and the like actually uses a titanium wire having a diameter of 0.14 mm as a wire, and the wire includes 12 inner spirals and 18 outer spirals.
- pitch P1 is 5.2 mm (inner spiral)
- pitch P2 is 6.9 mm (outer spiral)
- outer diameter D1 0.78 mm outer spiral outer diameter
- outer diameter D2 1.06 mm outer diameter of the spiral body.
- it has the structure where the space
- the diameter of the wire used, the number of wires forming the spiral body, the pitch, and the outer diameter are appropriately set in order to obtain the necessary physical properties such as strength depending on the fracture site to which the medical linear member of the present invention is applied. can do.
- FIG. 2A and 2B are external views schematically showing the medical linear member 11 of the comparative example, in which FIG. 2A is a front view and FIG. 2B is an end view taken along the line II shown in FIG. .
- a plurality of wires 12 are arranged, and a gap portion 13 is opened between the wires to form a spiral winding with a pitch P11 and an outer diameter D11.
- the gaps 13 between the wires are designed to be uniform.
- the spiral body is formed with the same pitch and outer diameter using the same wire as in the embodiment except that the spiral body is not a two-layer structure but a single layer.
- the wires used for the strength test and the like were manufactured by using 18 titanium wires having a diameter of 0.14 mm so that the pitch P11 was 6.9 mm and the outer diameter D11 was 1.06 mm.
- Fig. 3 shows how much elongation occurs when a certain force is applied to a linear member based on JIS Z-2241 using the medical linear member of the present invention and another company's product. is there.
- test force (N) on the vertical axis is applied to a medical linear member having a fixed length of 100 mm
- the elongation of the medical linear members of Examples A and B, which are products of other companies, is plotted. is there.
- Each other company's product is manufactured by twisting a thin titanium wire like a thread, there is no gap in the center as in the present invention, it has poor extensibility, and the surface is the medical of the present invention. It is not as smooth as a linear member.
- the product of Company A has a basic structure in which seven strands of 0.12 mm titanium wire are twisted like a thread, and this basic structure is further twisted, for a total of 49 Manufactured from wire.
- the diameter is 1.05 mm, which is approximately the same diameter as the medical linear members of the examples and comparative examples.
- the product of Company B has a basic structure of a 0.064 mm wire twisted like 7 threads, and is composed of 133 wires in which 19 basic structures are twisted together.
- the diameter is 0.84 mm.
- the medical linear member of the present invention stretches with a weak force, so that when the bone is fixed, it moves flexibly with a weak force and is very easy for an operator to handle.
- the medical linear member of the present invention can be applied to various places because it extends with a weak force and can bind a bone with good followability even if it is deformed.
- the medical linear member of company B shows that the medical linear member of company B was broken when a force of about 500 N was applied, the medical linear member of the example was about 610 N, and the medical linear member of company A was about 650 N.
- the medical linear member of the present invention is superior in strength as compared with the product of Company B. Although it is slightly weak in terms of strength as compared with the product of Company A, there is no problem when the bone is actually bound.
- the linear member of the example when a test force of about 50 N to about 570 N is applied, the linear member expands at a substantially constant rate. Therefore, the bone can be firmly fixed by applying a force of about 50 N to about 570 N and binding the fractured portion.
- the force is absorbed as the extension of the medical linear member. Therefore, even if a strong force is applied, the bone is not damaged.
- FIG. 4A is a comparison of the flexibility of the medical linear member of the present invention, the comparative example, and the products of other companies.
- the medical linear member has a hang end of 250 mm from one end and the other end is fixed.
- the relationship between the amount of hang (H) and the amount of deflection ( ⁇ ) when the hang end is bent by its own weight is plotted, and used as a measure of flexibility.
- the deflection amount ⁇ becomes a large value and the hang amount H becomes a small value.
- the comparative example is a single-layered spiral body, it is superior in terms of flexibility compared to the medical member having the two-layer structure of the example.
- the strength of the medical linear member of the comparative example is not sufficient for fastening large bones such as the hip bone and the femur.
- the medical linear member of the example is not as flexible as the product of Company B. However, as shown in FIG. 3, the medical linear member of the present invention has a very good elongation even when a weak force is applied when the bone is fastened while being stretched. The above is easy to handle.
- the medical linear member of the present invention is very flexible and easy to handle because it has excellent extensibility even when a weak force is applied.
- the force can be absorbed by stretching, and the bone is not damaged.
- the medical linear member 1 includes an inner helical contraction force f1a and an outer spiral contraction force f2a, and an expansion force f1b that attempts to return to the outer diameters D1 and D2. f2b is accumulated.
- the surgeon wraps the medical linear member 1 around the fractured portion, applies a tensile force F1 to extend the medical linear member 1 in the length direction, and extends the fractured portion with the expanded medical linear member 1. Secure by fastening.
- the medical linear member of the present invention can always apply a predetermined capsule pressure from the outer periphery to the center direction with respect to the fractured portion by the above-described contraction force and expansion force. Furthermore, since the spiral body has a two-layer structure, sufficient strength can be obtained and the fracture portion can be fixed with a strong binding force. However, since the gap portion is provided between the wires, the wire is extended with a weak force, so that it has flexibility.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
〔実施例〕
図1は、本発明の医療用線状部材を模式的に示す外観図であり、(A)は正面図、(B)は(A)に示したI-I線に沿った端面図である。
図2は比較例の医療用線状部材11を模式的に示す外観図であり、(A)は正面図、(B)は(A)に示したI-I線に沿った端面図である。
2、5、12・・・ワイヤ
3、7、8、13・・・間隙部
4・・・内側螺旋体
6・・・外側螺旋体
D1、D2・・・外径
P1、P2・・・ピッチ
Claims (4)
- 複数本のワイヤを内側に空間部を有し、且つ各ワイヤ間に軸線方向に間隙部を開けて螺旋巻きした内側螺旋体とし、
前記内側螺旋体の外側に複数本のワイヤを前記内側螺旋体と螺旋方向が逆方向になるように各ワイヤ間に間隙部を設けて螺旋巻きにした外側螺旋体を複層構造に配置することを特徴とする医療用線状部材。 - 請求項1に記載の医療用線状部材であって、
前記内側螺旋体と外側螺旋体を形成するワイヤの直径は同一又は異なるものであり、
外側螺旋体を形成するワイヤの本数が、内側螺旋体を形成するワイヤの本数より多いことを特徴とする医療用線状部材。 - 請求項1又は請求項2記載の医療用線状部材であって、
前記外側螺旋体のピッチが前記内側螺旋体のピッチに比べて長いことを特徴する医療用線上部材。 - 請求項1~請求項3いずれか1項記載の医療用線状部材であって、
ワイヤにチタンを含む金属を用いることを特徴とする医療用線状部材。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2014559433A JP6190994B2 (ja) | 2013-01-31 | 2013-01-31 | 骨癒合のための医療用線状部材 |
PCT/JP2013/052209 WO2014118941A1 (ja) | 2013-01-31 | 2013-01-31 | 骨癒合のための医療用線状部材 |
US14/764,053 US9913673B2 (en) | 2013-01-31 | 2013-01-31 | Linear member for medical use for bone union |
EP13874043.6A EP2952148B1 (en) | 2013-01-31 | 2013-01-31 | Linear member for medical use for bone union |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/JP2013/052209 WO2014118941A1 (ja) | 2013-01-31 | 2013-01-31 | 骨癒合のための医療用線状部材 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2014118941A1 true WO2014118941A1 (ja) | 2014-08-07 |
Family
ID=51261686
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2013/052209 WO2014118941A1 (ja) | 2013-01-31 | 2013-01-31 | 骨癒合のための医療用線状部材 |
Country Status (4)
Country | Link |
---|---|
US (1) | US9913673B2 (ja) |
EP (1) | EP2952148B1 (ja) |
JP (1) | JP6190994B2 (ja) |
WO (1) | WO2014118941A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2017130385A1 (ja) * | 2016-01-29 | 2018-11-22 | 株式会社シンテック | 医療用線状部材の製造方法 |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2952148B1 (en) * | 2013-01-31 | 2017-12-06 | Syntec Corporation | Linear member for medical use for bone union |
US10143506B2 (en) * | 2016-03-17 | 2018-12-04 | Arthrex, Inc. | Method and system for providing a suture wrap cerclage |
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- 2013-01-31 EP EP13874043.6A patent/EP2952148B1/en not_active Not-in-force
- 2013-01-31 US US14/764,053 patent/US9913673B2/en active Active
- 2013-01-31 JP JP2014559433A patent/JP6190994B2/ja active Active
- 2013-01-31 WO PCT/JP2013/052209 patent/WO2014118941A1/ja active Application Filing
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JPH02211164A (ja) * | 1989-02-10 | 1990-08-22 | Kobe Steel Ltd | 生体用ワイヤ |
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Also Published As
Publication number | Publication date |
---|---|
EP2952148B1 (en) | 2017-12-06 |
JP6190994B2 (ja) | 2017-09-06 |
EP2952148A4 (en) | 2016-08-31 |
US20150359577A1 (en) | 2015-12-17 |
US9913673B2 (en) | 2018-03-13 |
EP2952148A1 (en) | 2015-12-09 |
JPWO2014118941A1 (ja) | 2017-01-26 |
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