JP2015009154A - スペーサの製造方法およびそのための装置 - Google Patents
スペーサの製造方法およびそのための装置 Download PDFInfo
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- 125000006850 spacer group Chemical group 0.000 title claims abstract description 107
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- 238000005266 casting Methods 0.000 claims abstract description 144
- 239000002639 bone cement Substances 0.000 claims abstract description 69
- 239000004568 cement Substances 0.000 claims abstract description 36
- 238000000034 method Methods 0.000 claims description 42
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims description 33
- 239000004926 polymethyl methacrylate Substances 0.000 claims description 33
- 239000004744 fabric Substances 0.000 claims description 19
- 229910000831 Steel Inorganic materials 0.000 claims description 13
- 239000010959 steel Substances 0.000 claims description 13
- 239000012530 fluid Substances 0.000 claims description 9
- -1 polyethylene Polymers 0.000 claims description 8
- 229910001220 stainless steel Inorganic materials 0.000 claims description 8
- 239000010935 stainless steel Substances 0.000 claims description 8
- 239000004698 Polyethylene Substances 0.000 claims description 6
- 239000003242 anti bacterial agent Substances 0.000 claims description 6
- 229940088710 antibiotic agent Drugs 0.000 claims description 6
- 229920000573 polyethylene Polymers 0.000 claims description 6
- 239000003755 preservative agent Substances 0.000 claims description 6
- 239000013013 elastic material Substances 0.000 claims description 4
- 238000009489 vacuum treatment Methods 0.000 claims description 3
- 239000004952 Polyamide Substances 0.000 claims description 2
- 239000004743 Polypropylene Substances 0.000 claims description 2
- 230000003115 biocidal effect Effects 0.000 claims description 2
- 229920002647 polyamide Polymers 0.000 claims description 2
- 229920001155 polypropylene Polymers 0.000 claims description 2
- 230000002335 preservative effect Effects 0.000 claims description 2
- 238000009423 ventilation Methods 0.000 claims description 2
- 230000003014 reinforcing effect Effects 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 description 19
- 210000003127 knee Anatomy 0.000 description 15
- 208000015181 infectious disease Diseases 0.000 description 13
- 210000002303 tibia Anatomy 0.000 description 13
- 230000007547 defect Effects 0.000 description 8
- 230000002458 infectious effect Effects 0.000 description 8
- 238000010438 heat treatment Methods 0.000 description 7
- 238000011882 arthroplasty Methods 0.000 description 6
- 210000000988 bone and bone Anatomy 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
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- 229920001296 polysiloxane Polymers 0.000 description 3
- 238000011883 total knee arthroplasty Methods 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000001804 debridement Methods 0.000 description 2
- 230000009969 flowable effect Effects 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- 230000000379 polymerizing effect Effects 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000010526 radical polymerization reaction Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010028289 Muscle atrophy Diseases 0.000 description 1
- 241000906034 Orthops Species 0.000 description 1
- 238000002679 ablation Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
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- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
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- 230000000977 initiatory effect Effects 0.000 description 1
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- 230000020763 muscle atrophy Effects 0.000 description 1
- 201000000585 muscular atrophy Diseases 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/003—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
-
- 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
- A61F2/38—Joints for elbows or knees
- A61F2/389—Tibial components
-
- 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
- A61F2/3094—Designing or manufacturing processes
-
- 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
- A61F2002/30672—Features concerning an interaction with the environment or a particular use of the prosthesis temporary
-
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
-
- 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
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4653—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using cooling means
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
- A61F2240/004—Using a positive or negative model, e.g. moulds
-
- 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
- A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
- B29K2033/04—Polymers of esters
- B29K2033/12—Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Manufacturing & Machinery (AREA)
Abstract
Description
A)注型モールドの温度を第1の温度に制御するステップと、
B)温度制御された注型モールドの温度よりも低い温度のセメント生地を、当該温度制御された注型モールドに充填するステップと、
C)セメント生地を注型モールド内で硬化させてスペーサを形成するステップと、
D)スペーサの硬化後に、注型モールドをスペーサから分離するステップと、
をこの時間順で含む方法によって解決される。
2 内壁
3 外壁
4 ケーブル/管
5 接続端部
6 天井面
7 壁
8 モールドキャビティ/注型モールド内部
9 スプルー
10 ライザ
Claims (16)
- A)注型モールドの温度を第1の温度に制御するステップと、
B)前記温度制御された注型モールドの温度よりも低い温度のセメント生地を、当該温度制御された注型モールドに充填するステップと、
C)前記セメント生地を前記注型モールド内で硬化させてスペーサを形成するステップと、
D)前記スペーサの硬化後に、前記注型モールドを前記スペーサから分離するステップと、
をこの時間順で含む、
ことを特徴とする骨セメントからスペーサを製造する方法。 - ポリメチルメタクリレート製セメント生地、好ましくは、真空処理により脱気したポリメチルメタクリレート含有セメント生地をセメント生地として用い、それにより製造された前記スペーサはポリメチルメタクリレートからなる、請求項1記載の方法。
- 前記スペーサを製造するための少なくとも前記注型モールドの表面(1、2、6)は、90%以上、好ましくは99%以上が、非弾性材料、好ましくは、ポリエチレン、ポリプロピレン、ポリアミドおよび/またはステンレス鋼からなり、特に好ましくは、ステンレス鋼1.4401および/またはステンレス鋼1.4404を用いて構成されている、請求項1または2記載の方法。
- 前記セメント生地が、前記温度制御された注型モールドの第1の温度よりも10℃以上低い温度、好ましくは20℃以上低い温度、特に好ましくは20℃乃至50℃低い温度にある間に、前記セメント生地を前記温度制御された注型モールドに充填する、請求項1から3のいずれか1項記載の方法。
- 前記注型モールドを、40℃乃至65℃、好ましくは45℃乃至60℃、特に好ましくは50℃乃至55℃の第1の温度に温度制御する、請求項1から4のいずれか1項記載の方法。
- 前記注型モールドに充填されるセメント生地の温度は、−30℃乃至30℃、好ましくは−20℃乃至10℃、特に好ましくは−20℃乃至0℃である、請求項1から5のいずれか1項記載の方法。
- 前記セメント生地を前記注型モールドに充填する前に、前記セメント生地を前記温度制御された注型モールドの第1の温度よりも低い温度とする、請求項1から6のいずれか1項記載の方法。
- 前記注型モールドに充填される前記セメント生地の量は、前記モールドのキャビティよりも2体積%以上、好ましくは5体積%以上大きく、少なくとも前記骨セメントの硬化前に、前記注型モールドのスプルー(9)内に付加的な量が存在している、請求項1から7のいずれか1項記載の方法。
- 前記スペーサの補強のために、前記注型モールド内に少なくとも1つの鋼心を配置し、前記鋼心の温度は、前記温度制御された注型モールドの第1の温度よりも10℃以上低く、好ましくは30℃以上低い、請求項1から8のいずれか1項記載の方法。
- 前記注型モールドの内側表面(1、2、6)と前記鋼心の表面との間の距離が定められるようにセパレータによって前記少なくとも1つの鋼心を前記注型モールド内に適切に配置し、前記セパレータの温度は、前記温度制御された注型モールドの第1の温度よりも10℃以上低く、好ましくは30℃以上低い、請求項9記載の方法。
- 前記骨セメントは、少なくとも1種の抗生剤および/または防腐剤を含み、好ましくは2種の抗生剤および/または防腐剤を含み、特に好ましくは、3種の抗生剤および/または防腐剤を含む、請求項1から10のいずれか1項記載の方法。
- 請求項1から11のいずれか1項記載の方法を用いて骨セメントからスペーサを製造するための装置であって、
注型モールドと、前記注型モールドの温度を制御するための温度制御手段とを備えており、
前記注型モールドの内側表面(1、2、6)の80%以上が、製造されるスペーサの表面のネガ像を有している、
ことを特徴とする装置。 - 前記注型モールドは互いに対して可動な少なくとも2つの部分からなる、請求項12記載の方法。
- 骨セメントだめと、前記骨セメントだめに接続され、前記注型モールドを骨セメントで充填可能な補給孔とを備えている、請求項12または13記載の装置。
- 前記注型モールドは、過剰な骨セメントを取り出し可能な少なくとも1つのスプルー(9)を備えており、
前記注型モールドは、前記注型モールドの内側の通風のために、好ましくは少なくとも1つのライザ(10)、特に好ましくは複数のライザ(10)を、前記注型モールドの最上部領域に備えている、
請求項12から14のいずれか1項記載の装置。 - 前記温度制御手段は、前記注型モールドの壁(7)内に設けられた電気抵抗ヒータおよび/または流体ヒータ、および/または、前記注型モールドの壁(7)の外側に設けられた電気抵抗ヒータおよび/または流体ヒータを備えている、請求項12から15のいずれか1項記載の装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE102013010593.5 | 2013-06-26 | ||
DE102013010593.5A DE102013010593B4 (de) | 2013-06-26 | 2013-06-26 | Verfahren zur Herstellung von Spacern und Vorrichtung hierzu |
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JP2015009154A true JP2015009154A (ja) | 2015-01-19 |
JP2015009154A5 JP2015009154A5 (ja) | 2015-02-26 |
JP5822988B2 JP5822988B2 (ja) | 2015-11-25 |
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US (1) | US9895830B2 (ja) |
EP (1) | EP2818138B1 (ja) |
JP (1) | JP5822988B2 (ja) |
CN (1) | CN104248479B (ja) |
AU (1) | AU2014203307B2 (ja) |
CA (1) | CA2854115C (ja) |
DE (1) | DE102013010593B4 (ja) |
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JP7090186B2 (ja) * | 2020-03-20 | 2022-06-23 | ヘレウス メディカル ゲーエムベーハー | スペーサを製造するための装置及び方法 |
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CN101843920A (zh) * | 2010-06-17 | 2010-09-29 | 天津大学 | 自成孔磷酸钙骨水泥支架的制备方法 |
CN102028971A (zh) * | 2010-12-29 | 2011-04-27 | 安徽理工大学 | 生物固定型仿生关节及其制备方法 |
DE102011103005A1 (de) * | 2011-05-24 | 2012-11-29 | Heraeus Medical Gmbh | Form zur Herstellung einer Femurkomponente eines Kniegelenkspacers |
DE102011104808A1 (de) * | 2011-06-06 | 2012-12-06 | Heraeus Medical Gmbh | Form zur Herstellung einer Tibiakomponente eines Kniegelenkspacers |
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- 2014-06-18 AU AU2014203307A patent/AU2014203307B2/en active Active
- 2014-06-23 EP EP14173374.1A patent/EP2818138B1/de active Active
- 2014-06-24 US US14/312,817 patent/US9895830B2/en active Active
- 2014-06-26 CN CN201410294372.XA patent/CN104248479B/zh active Active
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Cited By (2)
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KR20200106338A (ko) * | 2019-03-04 | 2020-09-14 | 주식회사 지씨에스 | 음순간 패드 제조용 금형 |
KR102191148B1 (ko) * | 2019-03-04 | 2020-12-15 | 주식회사 지씨에스 | 음순간 패드 제조용 금형 |
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AU2014203307A1 (en) | 2015-01-22 |
US20150001765A1 (en) | 2015-01-01 |
EP2818138A3 (de) | 2015-03-11 |
AU2014203307B2 (en) | 2015-11-05 |
CA2854115A1 (en) | 2014-12-26 |
DE102013010593A1 (de) | 2014-12-31 |
US9895830B2 (en) | 2018-02-20 |
DE102013010593B4 (de) | 2015-12-03 |
CN104248479B (zh) | 2016-08-24 |
CA2854115C (en) | 2016-08-16 |
JP5822988B2 (ja) | 2015-11-25 |
EP2818138A2 (de) | 2014-12-31 |
EP2818138B1 (de) | 2017-03-08 |
CN104248479A (zh) | 2014-12-31 |
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