TWI458462B - A stable system that is permanently or temporarily implanted into an implant in a human or animal body - Google Patents
A stable system that is permanently or temporarily implanted into an implant in a human or animal body Download PDFInfo
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- TWI458462B TWI458462B TW099106103A TW99106103A TWI458462B TW I458462 B TWI458462 B TW I458462B TW 099106103 A TW099106103 A TW 099106103A TW 99106103 A TW99106103 A TW 99106103A TW I458462 B TWI458462 B TW I458462B
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- 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
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
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- 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
- A61F2/28—Bones
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- 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
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- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
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- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
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- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
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- 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
- A61B17/86—Pins or screws or threaded wires; nuts therefor
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- 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
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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- 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
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
- A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
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- 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
- A61F2002/30565—Special structural features of bone or joint prostheses not otherwise provided for having spring elements
- A61F2002/30571—Leaf springs
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30777—Oblong apertures
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
- A61F2002/30787—Plurality of holes inclined obliquely with respect to each other
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Description
本發明係有關一種具永久或暫時植入人體或動物體內之植入器的穩固系統,藉由一脊椎固定器、椎間圓盤替代物或螺紋部裝置的連接桿形成一穩固系統。
在現代醫學普遍使用植入器來代替人類骨骼因生病、受傷或老化所造成的損壞部位,按習用固定器用於如脊椎骨斷裂或脊柱被腫瘤所侵害的部位,如歐洲專利EP0268115B1。
類似的方法,椎間圓盤可由適當的固定器替代,如專利案DE4323034C1所述,該固定器實際為一圓柱形管狀結構,該結構須能承擔軸向擠壓力,如此脊柱上的擠壓力才能消除,所以,該固定器必須有足夠的強度。
此外,為了使固定器具有彈性,而讓脊柱能彎曲或扭轉,習用脊椎固定器或椎間圓盤固定器結合了強度及移動性兩種功能,特別是在軸向擠壓力方向的強度和相對旋轉軸的彎曲度方面,如歐洲專利DE10337088A1和WO2005/039454A2專利案,該固定器於中段部分設有一彈性區段,該彈性區段可為彈性材質製成或由適當的結構達成,專利案WO2005/039454A2,著重於螺旋形狹縫,該狹縫使得主體中段彈性部分具彈簧特質。
WO2005/039454A2專利案,更進一步指出其他植入器如螺紋部裝置的連接桿或類似的穩固系統,除了能傳送擠壓力外,還具有一定程度的彈性,該彈性來自於螺旋形狀。
雖然這些解決方法產生不錯的結果,然而,因為旋轉軸或彎曲軸等結構的不確定,使得承受軸向擠壓力的強度和程度不夠。
本發明之目的,著重於彈性或移動性以及強度或承重能力的改善,使得該植入器或固定器於手術時容易植入,並且易於製造。
藉由一具有申請專利範圍第1項所述之特徵的植入器,及具有申請專利範圍第21項所述之特徵的固定器,具有申請專利範圍第24項所述之特徵的椎間圓盤替代物,具有申請專利範圍第27項所述之特徵的螺紋部裝置的連接桿,和由前述裝置組成而具有申請專利範圍第29項所述之特徵的穩固系統,達到前面所述之目的。
本發明著手進行改善彈性或移動性及強度或承重能力的平衡關係,藉由轉動關節的傳送負載的能力,如在縱軸負載方向,且幫助相對於旋轉軸的旋轉,使得植入器得以彎曲。
當該轉動關節與該植入器一體成形,較佳實施例為該轉動關節為一薄片鉸鏈,該薄片鉸鏈為一薄的薄片部、韌帶部或體壁部,經由尺寸的設計,而達到具彈性及旋轉能力,即使該體壁或韌帶是由跟其他部份相同材質所製成。
本發明具有至少一該轉動關節,來達到傾斜植入器的兩端,或至少能往一方向彎曲,較佳實施例為設置有數個轉動關節,該數個轉動關節沿著主負載軸設置在不同平面,且繞著主負載軸旋轉,一較佳結構為不同旋轉軸設置在不同平面且互相錯開成90度,如此該植入器可向任何方向彎曲。
此外,將植入器設計成管狀,尤其是圓柱形管狀是可幫助達到效果,該主體由數個圓盤或圓環狀之環形件所組成,該環形件互相疊著且由對應的轉動關節或薄片鉸鏈連接,但每兩相鄰的環形件間留有空間,該空間可供相對於轉動關節旋轉時的活動空間。
較佳實施例為,每一該轉動關節設置於各個環形件的等分線上,一簍空部設置於薄片鉸鏈兩旁,以供活動所需的空間。
兩相鄰環形件間之簍空部或空間,從轉動關節或薄片鉸鏈開始變小,最後於邊緣處只剩一狹縫空間,當軸向擠壓力沿著植入器的主負載軸產生時,該狹縫空間可供相鄰環形件互相傾斜,同時也可當潛在的接觸面,結果,當軸向擠壓力沿著植入器的主負載軸產生,由轉動關節或薄片鉸鏈承擔該擠壓力,由於該環形件被設計成由薄片鉸鏈連接,環形件的高度因為較大簍空部的原因,於薄片鉸鏈附近變短,當該軸向擠壓力更進一步增加,導致該環形件彈性變形或彎曲,直到該狹縫空間消失,一但該環形件的狹縫部互相接觸,該管狀主體結構的邊緣部分也可承擔擠壓力,如此,相對的強度就會產生即使有很大的軸向擠壓力。同時由於狹縫簍空部的設置,使得被擠壓及與主負載軸成直角的旋轉或彎曲的細微動作變得可能,且可避免鄰近的體節負載過大,而與固定器的兩端薄板快速的密合,因為該固定器可稍微活動,而不會使兩端薄板斷裂。
同時,該固定器兩端的薄板或環形件設置連接元件,該連接元件幫助與毗鄰的身體部分連接且與其密合,或可與其他植入器構件連接,為達此目的,該連接元件設有鈍鋸齒部、凹陷部、簍空部及其他的形狀,尤其,該連接元件具有可輕易調整長度的特徵。
該薄片鉸鏈,較佳實施例為,由韌帶從環形件間的管狀主體的外圍壁面向內做放射狀的延伸所構成,亦可被橫向的薄板連接到該環形件;該韌帶或薄片鉸鏈由兩相對的薄片構成,並於中心區域分隔,如此一連貫的中空部沿著中心軸產生,該中空部可設計成不同形狀和結構,例如四葉苜蓿葉形、十字形或其他形狀。
該一體成形主體的材質,即環形件的材質可選用不同的材料,尤其,各種生物相容的材質、合金和聚合物材質皆可,由於本發明之該主體結構設計成有彈性及移動性,實質上非常堅硬的材質亦可使用,自然地,具有某種程度的彈性的材質亦可使用。
請參閱第一圖所示,係本發明第一實施例的立體圖,顯示植入器為一脊椎固定器之形態。
該固定器(1)為一圓柱管狀主體,該主體是由6個圓盤或圓環狀之環形件(2)(3)(4)(5)(6)(7)所組成,該環形件(2)(3)(4)(5)(6)(7)沿著縱軸(L)方向延伸逐一相互連接,該縱軸(L)同時也是主要負載軸(L),在環形件(2)和(7)的自由端各有連接元件(8)(9)(10),該連接元件(8)(9)(10)分別為鈍鋸齒部(8)、鑽石形或是三角形簍空部(9)和鋸齒狀突部間的三角形凹陷部(10),該連接元件(8)(9)(10)是用來與毗鄰的組織、軟骨或脊椎骨連接固定並且密合,藉由該連接元件(8)(9)(10),該固定器(1)得以穩固的固定在脊柱上。
每兩相鄰環形件(2)(3)(4)(5)(6)(7)之間設有兩條韌帶,該兩條韌帶由環形件(2)(3)(4)(5)(6)(7)呈放射狀地向內延伸至負載軸(L)或是一條與負載軸平行的中心軸之附近,並於中心軸形成一貫穿孔,此部分會於後面描述。該韌帶於環形件(2)(3)(4)(5)(6)(7)連接處形成薄片鉸鏈(11)(12)(13)(14)(15),該薄片鉸鏈(11)(12)(13)(14)(15)與負載軸(L)平行。另外,該韌帶的寬度相當於該主體或環形件(2)(3)(4)(5)(6)(7)的厚度。
此外該薄片鉸鏈(11)(12)(13)(14)(15)互相錯開成90度,即薄片鉸鏈(11)與薄片鉸鏈(12)成直角、薄片鉸鏈(12)與薄片鉸鏈(13)成直角,依此類推。
該環形件(2)(3)(4)(5)(6)(7)中的每兩相鄰環形件由對應的薄片鉸鏈(11)(12)(13)(14)(15)連接,該薄片鉸鏈(11)(12)(13)(14)(15)將對應的環形件(2)(3)(4)(5)(6)(7)之間的兩個半圓形簍空部分隔,該簍空部的厚度於薄片鉸鏈(11)(12)(13)(14)(15)延著負載軸(L)延伸方向處比遠離該薄片鉸鏈處厚。其中,該環形件(2)(3)(4)(5)(6)(7)之間的每一簍空部被分成兩部分,第一部分的橫切面形成三角形簍空部(17),該三角形簍空部(17)的厚度由薄片鉸鏈(11)(12)(13)(14)(15)沿著負載軸(L)延伸方向漸漸變薄,最後於環形件(2)(3)(4)(5)(6)(7)之間形成第二部分之薄狹縫簍空部(18),該三角形簍空部(17)的邊緣為圓形,不會形成壓迫尖端。
藉由薄片鉸鏈(11)(12)(13)(14)(15)旁的簍空部(17)(18)的設置,使得該固定器(1)可以依照旋轉軸(D)及旋轉箭頭所指示的方向彎曲,該旋轉軸(D)與該薄片鉸鏈(11)(12)(13)(14)(15)上的韌帶平行。
由於薄片鉸鏈(11)(13)(15)和薄片鉸鏈(12)(14)對應偏離成90度,使得固定器(1)可以該縱軸(L)為中心向任何方向彎曲,彎曲角度可以達到5度。
請參閱第二、三圖所示,係本發明另兩個具體實施例,固定器(1’)和(1”),其中,相同元件設定相同編號。
該固定器(1’)的縱軸(L)可以承受拉力和擠壓力,該固定器(1’)由4個圓盤或圓環狀之環形件(2’)(3’)(4’)(5’)組成,該環形件(2’)(3’)(4’)(5’)之間由轉動關節或薄片鉸鏈(11)(12)(13)連接,每兩個環形件連接處形成一個旋轉軸(D),該旋轉軸(D)與縱軸(L)成直角。
該薄片鉸鏈(11)(12)(13)上的韌帶兩旁設有三角形簍空部(17),該三角形簍空部(17)隨著遠離薄片鉸鏈(11)(12)(13)逐漸變尖,最後形成薄狹縫簍空部(18)。
該負載軸(L)的兩端分別為環形件(2’)和(5’),該環形件(2’)和(5’)的兩端分別有連接元件用來與毗鄰的脊椎骨、軟骨或組織連接固定,如第一圖之具體實施例所述,該連接元件包含有鈍鋸齒部(8)、三角形凹陷部(10)和三角形簍空部(9’),而不包含鑽石形簍空部,因為第二圖中的固定器(1’)的連接元件頂端比第一圖中的固定器(1)的連接元件頂端短。
請參閱第三圖所示,係本發明之另一實施例,固定器(1”)的連接元件只包含鈍形頂部(8”)和梯形凹陷部(10”)。
如前面所述,4個圓盤環形件(2”)(3”)(4”)(5”)藉由薄片鉸鏈(11)(12)(13)連接在一起,該薄片鉸鏈(11)(12)(13)互相錯開成90度,其中,該環形件(2”)(3”)(4”)(5”)之間形成簍空部(17)(18),該環形件(2”)(3”)(4”)(5”)間的距離於三角形簍空部(17)處比狹縫簍空部(18)處的距離大,如其他實施例一樣,該環形件圓周約有一半為狹縫簍空部,而另一半則有較大距離介於兩環形件間。
請參閱第四至七圖所示,用固定器(1)和(1”)再一次說明本發明之植入器的設計原理。第四圖和第五圖為固定器(1)的側面圖,圖五為固定器(1)繞著縱軸(L)旋轉90度,由圖四和圖五可清楚地看出該薄片鉸鏈(11)(13)(15)在一端,而該薄片鉸鏈(12)(14)在另一端,而且該薄片鉸鏈(11)(12)(13)(14)(15)對應的旋轉軸(D)亦互相旋轉成90度,藉由狹縫簍空部(18)的裝置,相對於各自的旋轉軸(D)彎曲。
請參閱第六、第七圖所示,前面所述亦適用於固定器(1”),該固定器(1”)包含較少數量的環形件、薄片鉸鏈(11)(12)(13)和旋轉軸(D)。
請參閱第八、九圖所示,圖八為固定器(1”)的平面俯視圖,圖九為固定器(1)的平面俯視圖,該固定器(1”)和(1)包含一圓柱管狀主體,該主體是由對應的圓盤或圓環狀之環形件所組成,由該平面圖可清楚地看出,例如該薄片鉸鏈(11)(12)由韌帶於環形件向內作放射狀延伸而構成,如第八圖所示,並於中心部分形成一中空部(19),該中空部(19)沿著該縱軸(L)貫穿整個固定器(1”)。
該薄片鉸鏈(11)(12)(13)(14)(15)的韌帶只與環形件(2)(3)(4)(5)的外壁連接,該韌帶於環形件(2)(3)(4)(5)內部形成四個中空部(20)(21)(22)(23),該中空部(20)(21)(22)(23)與負載軸(L)平行,且貫穿整個固定器(1),形成一個四葉苜蓿葉形的中空部(19)(20)(21)(22)(23)。
另外,該薄片鉸鏈(11)(12)(13)(14)(15)的韌帶亦可由對應的薄板(16)支撐(請參閱第一圖),或依附於對應的環形件(2)(3)(4)(5)(6)(7)上,如果該薄板(16)為三角形,該平面圖會是一貫穿整個固定器(1)的十字形中空部(24),該薄片鉸鏈(11)(12)(13)(14)(15)的韌帶設置於虛線(25)上,如第九圖所示。
請參閱第十、十一圖所示的機構,顯示本發明之結構運作的狀態。
由第十圖中的圖a) b) c)可明顯地看出,該薄片鉸鏈例如薄片鉸鏈(12)或對應的韌帶被沿著負載軸(L)方向的力量壓縮,其中,該環形件(3)和(4)於其結構最脆弱的部分即韌帶的附近變形或彎曲,直到環形件(3)和(4)於狹縫簍空部(18)的地方互相接觸。圖b)顯示,該軸向擠壓力不僅被薄片鉸鏈(12)的韌帶承擔,同時亦被環形件(3)(4)相互接觸的邊緣所承擔,如此,該軸向擠壓力的承載力就會增加。圖c)顯示,如果軸向壓力,亦即擠壓力更進一步地增加,該環形件(3)(4)的狹縫簍空部(18)被擠壓得更靠近,而承擔大部分的壓力,因為此時該接觸面比薄片鉸鏈(12)的韌帶的橫切面大。
在彎曲負載方面,如第十一圖顯示,藉由該薄片鉸鏈(12)的薄韌帶設置,使得環形件相對於旋轉軸(D)旋轉,如此,該環形件(3)和(4)的邊緣於狹縫簍空部(18)處的一端接觸,且彎曲該固定器(1)或傾斜該固定器(1)的兩端,該環形件(3)和(4)於狹縫簍空部(18)處相接觸,如第十一圖的b)圖顯示,導致該狹縫簍空部(18)承受擠壓力,如此,進一步的傾斜可同時被防止,隨著擠壓力越大,產生越大的接觸區,如第十一圖的c)圖顯示,而使其更加穩固。
從第十、十一圖可明顯地看出,由於環形件(3)和(4)之間的簍空部(17)(18)的設置,得以協助調節傾斜或彎曲區域,並且增加整個植入器的穩定性及強度。如果狹縫區域變大,會產生越大的強度,因為接觸區域變大;如果狹縫距離變大,亦即該環形件(3)和(4)之間的距離變大,彎曲力越大。
第十二圖更加詳細地顯示出,該環形件(2)和(3)之間的狹縫,亦即狹縫簍空部(18),決定該環形件(2)和(3)之間的移動性或傾斜度,該狹縫距離越大,該環形件(2)(3)相對於薄片鉸鏈(11)的旋轉能力越好,再者,於該狹縫簍空部(18)區的可能接觸面大小決定能承受軸向擠壓力或相對彎曲的大小,環形件(2)於該區域(34)的結構決定該環形件(2)的彎曲能力和負載軸(L)延伸方向的彈性。
請參閱第十三至十六圖所示,係為本發明之植入器不同的運用範圍,第十三圖為固定器(1)與螺紋部裝置配合使用,藉由栓入脊椎骨的螺紋部(30),及一連接桿(32)套接該螺紋部(30)於套接頭(31),發揮穩固的功用,在本實施例中,該連接桿(32)由彈性材質做成半彈性桿體。
請參閱第十四圖所示,該固定器(1)的使用情況與第十三圖所示相同,差別在於將半彈性連接桿(32)換成彈性連接桿(33),該連接桿(33)的彈性來自中心件外面設置螺旋狀;該連接桿(33)亦可為本發明之圓盤結構,而由轉動關節連接。
請參閱第十五、十六圖所示,係本發明之另一實施例,其顯示該固定器(1”)可單獨使用(如第十五圖),亦可配合穩定裝置使用(如第十六圖),由於該固定器(1”)的高度較矮,於本實施例該固定器(1”)係當椎間圓盤使用;亦可與螺紋部裝置配合使用,該螺紋部裝置包含螺紋部(30)、套接頭(31)和彈性連接桿(33),該螺紋部(30)和連接桿(33)套接於套接頭(31)。
請參閱第十七圖所示,一彈性連接桿(100)於中段部分設有一主體,該主體的結構與固定器(1)相似,係設有絞接式的環形件(200)(300)(400),該環形件(200)(300)(400)由轉動關節連接,該接頭互相錯開成90度。
其中,該關節由薄片鉸鏈(120)所構成,亦即由環形件(200)(300)(400)之間的連接韌帶所構成,該韌帶的寬度相當於該環形件(200)(300)(400)的厚度。
該連接桿(100)的兩端設有連接件(80),該連接件(80)供螺紋部(30)的套接頭(31)套接,如第十七圖所示的實施例中,該連接件(80)的橫切面比連接桿上具有關節之部位的橫切面小,因此,該連接桿(100)的橫切面維持不變是可能的。
第十八圖為第十七圖的局部放大圖,其顯示該環形件(200)和(300)只由對應的薄片鉸鏈(120)連接,該環形件(200)和(300)之間形成一瓶子形狀的簍空部(170)(180),該簍空部包括一較寬的簍空部(170)和一狹縫簍空部(180),該簍空部(170)(180)的形狀,尤其是狹縫簍空部(180)的厚度限定該連接桿(100)的壓縮力及傾斜或彎曲的程度。
第十九圖係為第十七、十八圖之該連接桿(100)的剖面圖,由此圖可清楚地看出該連接件(80)與主體一體成形,然而,亦可使用適當方法,將該連接件(80)與該主體結構分離,如使用相當的螺絲連接器。
請參閱第二十圖所示,為該彈性連接桿(100)的立體圖,顯示該圓柱形管狀的主體結構是由環形件(200)(300)(400)所構成,該環形件(200)(300)(400)由薄片鉸鏈(120)連接,每兩相鄰環形件間的薄片鉸鏈(120)互相成90度。
請參閱第二十一圖所示,係本發明之另一實施例,顯示該固定器(1)和該彈性連接桿(100)的螺紋部裝置配合使用,而形成一穩固系統,該彈性連接桿(100)的連接件(80)套接於套接頭(31),而將栓入脊椎骨的該螺紋部(30)連接,該固定器(1)設置於脊椎骨間,經由固定器(1)的彈性結構和彈性連接桿(100)的配合,可如第二十一圖中的箭頭所指的方向,於壓縮固定器(1)的同時使彈性連接桿(100)伸展,反之亦然,此外,該彈性連接桿(100)和固定器(1)皆可使其兩末端彎曲或傾斜,如此,可達到強度的加強和具有彈性之目的。
(1)(1’)(1”)...固定器
(2)(3)(4)(5)(6)(7)...環形件
(2’)(3’)(4’)(5’)...環形件
(2”)(3”)(4”)(5”)...環形件
(8)...鋸齒部
(9)...簍空部
(10)...三角形凹陷部
(9’)...三角形簍空部
(8”)...頂部
(10”)...梯形凹陷部
(11)(12)(13)(14)(15)...薄片鉸鏈
(16)...薄板
(17)(18)...簍空部
(19)...中空部
(20)(21)(22)(23)...中空部
(24)...十字形中空部
(25)...虛線
(34)...區域
(L)...負載軸
(D)...旋轉軸
(30)...螺紋部
(31)...套接頭
(32)...連接桿
(33)...彈性連接桿
(80)...連接件
(100)...彈性連接桿
(120)...薄片鉸鏈
(170)(180)...簍空部
(200)(300)(400)...環形件
第一圖係本發明之立體示意圖。
第二圖係本發明之第二實施例立體示意圖。
第三圖係本發明之第三實施例立體示意圖。
第四圖係本發明相對於第一圖之側面圖。
第五圖係本發明相對於第四圖旋轉90度之側面圖。
第六圖係本發明相對於第三圖之側面圖。
第七圖係本發明相對於第六圖旋轉90度之側面圖。
第八圖係本發明相對於第三圖之平面俯視圖。
第九圖係本發明相對於第一圖之平面俯視圖。
第十圖中之附圖a)至c)係本發明之固定器於不同負載情況之局部側面圖。
第十一圖中之附圖a)至c)係本發明之固定器於不同負載情況之局部側面圖。
第十二圖係本發明相對於第一圖之局部放大圖。
第十三圖係本發明相對於第一圖之固定器與螺紋部裝置配合使用之概要側面圖。
第十四圖係本發明相對於第一圖之固定器與另一種螺紋部裝置配合使用之概要側面圖。
第十五圖係本發明相對於第三圖之固定器使用情況之概要側面圖。
第十六圖係本發明相對於第三圖之固定器與螺紋部裝置配合使用之概要側面圖。
第十七圖係本發明連接桿之概要側面圖。
第十八圖係本發明相對於第十七圖之連接桿局部剖面圖。
第十九圖係本發明相對於第十七、十八圖之連接桿剖面圖。
第二十圖係本發明相對於第十七至十九圖之連接桿之立體示意圖。
第二十一圖係本發明相對於第一圖之固定器與相對於第二十圖之連接桿配合使用之概要側面圖。
(1)...固定器
(2)(3)(4)(5)(6)(7)...環形件
(8)...鋸齒部
(9)...簍空部
(10)...三角形凹陷部
(11)(12)(13)(14)(15)...薄片鉸鏈
(16)...薄板
(17)(18)...簍空部
(L)...負載軸
(D)...旋轉軸
Claims (25)
- 一種穩固系統,包括多個構件,該多個構件的固定器及/或椎間圓盤替代物及連接桿,其中該多個構件是多個植入器供永久或暫時植入人體或動物體內的植入器,該植入器包括一供連接分離的身體部位及/或其他植入器構件的主體,該植入器具有一供傳送主要的拉力及/或擠壓力的負載軸(L),及至少一相對該負載軸橫伸的旋轉軸(D),該旋轉軸便於該主體彎曲,該至少一旋轉軸被一轉動關節(11,12,13,14,15)所界定,該轉動關節與該主體一體成形。
- 依據請求項1所述之穩固系統,其中,該旋轉軸便於沿著該負載軸延伸之該主體的兩端彎曲。
- 依據請求項1所述之穩固系統,其中,該轉動關節(11,12,13,14,15)及數個環形件被提供於一該植入器,每兩相鄰該環形件以一該轉動關節相連接,該數個轉動關節各自有一該旋轉軸,並設置在不同的平面上,且該旋轉軸相對該負載軸(L)橫伸。
- 依據請求項1或3所述之穩固系統,其中,有數個該植入器被提供於一該固定器,該轉動關節相對於該負載軸(L)互相轉動。
- 依據請求項1所述之穩固系統,其中,有數個該轉動關節(11,12,13,14,15)被提供於一該植入器,各自有一該旋轉軸並位在不同的平面上,且該旋轉軸相對該負載軸(L)成直角。
- 依據請求項1所述之穩固系統,其中,有數個該轉動關節(11,12,13,14,15)沿著該負載軸設置於不同平面上,且互相疊著,該數個轉動關節互相錯開成90度。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,該轉動關節(11,12,13,14,15)係成一薄片鉸鏈之形態者。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,該轉動關節(11,12,13,14,15)由兩個沿著該旋轉軸而呈相對的韌帶所形成,該韌帶延伸的平面與該負載軸(L)平行。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,該轉動關節(11,12,13,14,15)由兩個沿著該旋轉軸相對的韌帶所形成,該韌帶自該主體外圍壁面沿著一與該負載軸平行的該主體之中心軸延伸。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,有多數個該轉動關節均成一薄片鉸鏈之形態。
- 依據請求項10所述之穩固系統,其中,該薄片鉸鏈由該環形件之間的連接韌帶所形成,該韌帶的寬度相當於該環形件的厚度。
- 依據請求項1所述之穩固系統,其中,該主體具有至少一個簍空部,該簍空部位在一與該負載軸(L)成直角的平面上,該平面設有一該轉動關節,該簍空部設置於該轉動關節兩旁,使得該主體得以傾斜。
- 依據請求項12所述之穩固系統,其中,該簍空部(17,18)自該轉動關節(11,12,13,14,15)起開始逐漸變細,且至少在該主體壁處。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,該轉動關節(11,12,13,14,15)沿著該主體的等分線上設置。
- 依據請求項1所述之穩固系統,其中,該主體具有至少3個環形件(2,3,4,5,6,7)。
- 依據請求項1所述之穩固系統,其中,該主體具有數個環形件(2,3,4,5,6,7),該環形件的數量可為2至10個。
- 依據請求項1所述之穩固系統,其中,該轉動關節(11,12,13,14,15)的數量為1至5個。
- 依據請求項1或3或6之任一項所述之穩固系統,其中,該主體具有奇數個該轉動關節(11,12,13,14,15),及偶數個環形件(2,3,4,5,6,7)。
- 依據請求項1所述之穩固系統,其中,該主體係為可彈性變形,且與該負載軸平行。
- 依據請求項1所述之穩固系統,其中,該主體係為可壓縮且與該負載軸平行。
- 依據請求項3或15或16之任一項所述之穩固系統,其中,環形件(2,3,4,5,6,7)被該主體圍繞,當軸向負載沿著該負載軸產生,該主體可彈性變形,且在該轉動關節附近彎曲。
- 依據請求項3或15或16之任一項所述之穩固系統,其中,環形件(2,3,4,5,6,7)被該主體圍繞,使得該主體可在該轉動關節附近彎曲。
- 依據請求項1所述之穩固系統,其中,該主體係為一具有各式橫切面形狀的管狀體。
- 依據請求項1所述之穩固系統,其中,該主體沿著該負載軸兩端具有連接元件(8,9,10)。
- 依據請求項1所述之穩固系統,其中,該主體沿著該負載軸兩端具有連接元件(8,9,10),該連接元件(8,9,10)由凹陷部、簍空部、凸出部及/或鋸齒部構成,用來與毗鄰的身體組織連接或密合。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP05110043A EP1779814B1 (de) | 2005-10-26 | 2005-10-26 | Implantat mit einstückigem Drehgelenk |
Publications (2)
Publication Number | Publication Date |
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TW201034618A TW201034618A (en) | 2010-10-01 |
TWI458462B true TWI458462B (zh) | 2014-11-01 |
Family
ID=36061662
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TW099106103A TWI458462B (zh) | 2005-10-26 | 2006-10-25 | A stable system that is permanently or temporarily implanted into an implant in a human or animal body |
TW095139300A TWI341191B (en) | 2005-10-26 | 2006-10-25 | Implant with one-piece swivel joint |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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TW095139300A TWI341191B (en) | 2005-10-26 | 2006-10-25 | Implant with one-piece swivel joint |
Country Status (8)
Country | Link |
---|---|
US (1) | US8152849B2 (zh) |
EP (3) | EP1779814B1 (zh) |
JP (1) | JP5025221B2 (zh) |
KR (1) | KR101288232B1 (zh) |
CN (2) | CN102895023B (zh) |
DE (1) | DE502005006888D1 (zh) |
ES (2) | ES2322072T3 (zh) |
TW (2) | TWI458462B (zh) |
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Also Published As
Publication number | Publication date |
---|---|
TW201034618A (en) | 2010-10-01 |
DE502005006888D1 (de) | 2009-04-30 |
EP1943986A2 (de) | 2008-07-16 |
TW200716053A (en) | 2007-05-01 |
US8152849B2 (en) | 2012-04-10 |
EP1943987B1 (de) | 2012-04-18 |
CN102895023B (zh) | 2018-02-06 |
CN1954786A (zh) | 2007-05-02 |
JP2007117735A (ja) | 2007-05-17 |
EP1779814B1 (de) | 2009-03-18 |
US20070093904A1 (en) | 2007-04-26 |
KR101288232B1 (ko) | 2013-07-24 |
ES2322072T3 (es) | 2009-06-16 |
EP1943987A2 (de) | 2008-07-16 |
EP1943987A3 (de) | 2009-01-14 |
TWI341191B (en) | 2011-05-01 |
EP1943986B1 (de) | 2012-04-25 |
CN102895023A (zh) | 2013-01-30 |
CN1954786B (zh) | 2012-11-14 |
EP1779814A1 (de) | 2007-05-02 |
ES2385618T3 (es) | 2012-07-27 |
KR20070045128A (ko) | 2007-05-02 |
EP1943986A3 (de) | 2008-10-01 |
JP5025221B2 (ja) | 2012-09-12 |
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