CN1194817A - 半月板修复装置 - Google Patents
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
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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
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B17/083—Clips, 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
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0419—H-fasteners
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/0618—Sutures elastic, e.g. stretchable
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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
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
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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
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
Abstract
一种对组织进行外科手术用的H型紧固器,该紧固器具有一中央偏压元件。该偏压件具有第一端部和第二端部。两锚定件安装在每一端部。
Description
本发明涉及的技术领域是一些用于使组织接近弥合的医疗装置,特别是用于使软组织接近弥合的医疗装置。
近来在以最低侵入程度的外科技术方面例如内镜检查、腹腔镜检查和关节镜检查正在取得进展,这使得能以对组织最少破坏和切开的方式进行复杂的外科手术。利用各种类型的观察镜完成这些技术使外科医生能通过显像观察手术区。使设计的各种观察镜和仪器穿过套针式插管,所述插管定位在利用套针式手术刀或封堵器进行手术的区域。当将套针式封堵器插入到体腔或缝中时,仅产生极小的穿孔。通常利用可适合生物体的气体或液体例如二氧化碳或无菌盐水溶液吹入体腔或接缝使之扩展,以便为外科医生提供进行外科手术的空间。
在大多数外科手术中,必须使组织接近以便修复伤口和撕裂处以及弥合切口。为了使组织弥合有很多公知的方法和器具。这些器具包含外科用针、外科用缝合线、卡钉之类。采用外科用钉或其它紧固器也是公知的。一种持定类型的紧固器称为“H形”紧固器。H型紧固器及使用方法公开在No.4006747和No.4586502的美国专利中,本案引用该文献做为参考。该H型紧固器通常具有一中央连接部分,其两个相对端的每端上安装组织锚定件。非医用的H型紧固器和紧固系统常用于服装的附加标签和卡片。
H型紧固器在某些最小侵入操作技术方面比常规紧固器具有一些优点。特别是,在关节镜检查技术方面例如在No 5320633美国专利中所公开的半月板修复方面使用H型紧固器的优点是公知的。已发现如果使半月板的撕裂处接近弥合,对于半月板的损伤例如破裂或撕裂是可以修复的。有一个时期,流行的操作是这样的,即通过外科手术将受伤的半月板的撕裂断面部分除去,导致最终由于骨骼与骨骼接触引起在骨缝处的骨骼受到伤害。然而,最近已经发现,为了有效地修复半月板,必须使撕裂的或破裂的半月板的两相对表面接近弥合,令两表面维持在紧密接触的状态中。
确认H型紧固器在半月板修复方面是有效的,是由于它们利用常规装置易于穿入,这种常规装置具有末端插管式针,其中该针具有一纵向槽口。将H型紧固器的一个短脚或组织锚定件装入最好具有一槽口的插管式针中。将针刺透撕裂的半月板的两侧,并将一个短脚或锚定件由针中推出置于撕裂处的一侧。然后将针由半月板中取出,另一对侧的短脚或锚定件就地留在撕裂处的另一对侧,因此,使半月板撕裂处接近弥合。
采用已有的H型紧固器使半月板中的撕裂处接近弥合存在一些相应的缺点。一个缺点是为了选择适当尺寸的H型紧固器在穿入H型紧固器之前,外科医生必须精确地测量半月板。需要精确地测量是由于紧固器尺寸必须适合,以使撕裂处的相对两侧或表面彼此接近并产生压力。本技术领域的技术人员都会感到在使用观察镜进行关节镜检查或实施最少侵入手术的过程中要得到这样的测量结果是困难的。即使能精确测量和使用适当尺寸的H型紧固器,也难于实现组织恰当地接近,这是由于通常不可能使针在体内精确地在半月板中到位,特别是在关节镜观察的手术过程中更是这样。因而,半月板经常呈现为欠接近的不适当的面对面接触,或者呈现为过接近的不适当的面对面接触。此外,在作手术时,外科医生一般仅能得到有限数量尺寸的H型紧固器,另外要在修复半月板时使组织适当接触,使外科手术复杂化。如上所述,外科医生必须精确地选择H型紧固器的尺寸。如果外科医生选择的H型紧固器太大,组织将不能接近。如果H型紧固器太小,组织可能褶绉和堆拢,可能使撕裂处的边缘或表面扭曲,使得它们不能彼此适当接触,因此,仅局部有效或不能适当地修复。
为了克服与现有技术的H型紧固器相关的缺点,需要改进用于使组织接近弥合的H型紧固器。
本发明的目的是提供一种具有形成偏压部分的H型紧固器,当其穿过身体组织的两个相邻断面部分时,使该组织的两侧边缘或表面彼此压靠。
本发明的另一个目的是提供一种H型紧固器,其不再或极少需要在插入使用前对组织进行精确的体内测量。
本发明的再一个目的是提供一种用H型紧固器通过外科手术使组织接近弥合的方法,所述紧固器具有一形成偏压的部分,所述偏压部分提供偏压作用力,以便使在撕裂处附近的组织的边缘或表面维持接近弥合。
因此,本发明提供一种H型紧固器,该H型紧固器具有一带有第一端部和第二端部的细长的中央偏压件。第一组织锚定件安装在偏压件的第一端部。第二组织锚定件安装在偏压件的第二端部。细长的偏压件具有一静置位置并且可以弹性变形达到一延伸位置。在延伸位置,偏压件产生一偏压作用力。偏压件具有各种静置位置结构形状,包括锯齿形、正弦波形、螺旋形、弧形、抛物线形,直线和曲线部分的组合等。组织锚定件可以类似地具有各种结构形状,例如可以是杆形,盘形、球形等。
根据本发明的另一个方面,提供一种H型紧固器,其具有一带有第一端部和第二端部的细长中央连接元件。第一偏压组织锚定件安装在中央元件的第一端部。第二偏压组织锚定件安装在连接元件的第二端部。偏压组织锚定件具有第一静置形态和第二弹性变形的形态。当产生弹性变形时,该组织锚定件产生偏压作用力。
根据本发明的再一个方面是提供一种利用本发明的组织接近弥合装置使组织接近弥合的方法。该方法包含将本发明具有中央偏压部分的H型紧固器穿入组织中。接着,使一个组织锚定件移动到在该组织中或附近的第一位置处,以及将第二锚定件移动到在该组织中或附近的第二位置处,使偏压部分由它的静置位置弹性移动到一延伸位置,因此使两锚定件之间的组织接近,产生一偏压作用力作用在该组织处。
根据本发明的再一个方面,提供一种利用本发明的组织接近弥合装置使组织接近弥合的方法。该方法包含将本发明的具有偏压组织锚定件和一非偏压中央元件的H型紧固器穿入组织。接着,将一个偏压组织锚定件移动到在该组织中或附近的第一位置,以及将第二个偏压组织锚定件移动到在该组织中或附近的第二位置,使这两个偏压组织锚定件由它们的静置位置弹性移动到延伸位置,因此使两锚定件之间的组织接近弥合并且产生偏压作用力作用在该组织上。偏压锚定件可以具有各种形状,包含V形,X形等。
根据如下的介绍和附图使本发明的这些和其它特点变得更加清楚。
图1是本发明的具有半圆形偏压部分的H型紧固器的透视图。
图1A是图1所示H型紧固器的侧视图。
图2是本发明的具有螺旋形偏压部分的H型紧固器的透视图。
图2A是图2所示H型紧固器的侧视图。
图3是本发明的具有带锯齿结构的偏压部分的H型紧固器的透视图。
图3A是图3所示H型紧固器的透视图。
图4是本发明的具有正弦波形偏压部分的H型紧固器的透视图。
图4A是图4所示H型紧固器的侧视图。
图5是本发明的具有带90°弧形结构的偏压部分的H型紧固器的透视图。
图5A是图5所示H型紧固器的侧视图。
图6是本发明的具有90°弧形结构的偏压部分以及两端部锚定件的H型紧固器的透视图,该两端部锚定件,彼此相对旋转90°。
图6A是图6所示H型紧固器的侧视图。
图7是本发明的一种H型紧固器的透视图,其中的偏压部分具有形状重复的正弦波形结构以及还具有沿着纵向轴线彼此平行的组织锚定件。
图7A是图7所示H型紧固器的侧视图。
图8是本发明的H型紧固器的透视图,其中的偏压部分具有两个平行的由一中间开孔隔开的锯齿形结构元件。
图8A是图8所示的H型紧固器的侧视图。
图9是本发明的一种H型紧固器的透视图,其中的偏压部分具有两个连接的环路。
图9A是图9所示H型紧固器的侧视图。
图10是本发明的H型紧固器的另一实施例的透视图,具有常规的直形中央连接部分和安装在二端部的V形偏压组织锚定件。
图10A是图10所示H型紧固器的侧视图。
图11是本发明的一种H型紧固器的透视图,其中的中间偏压件呈抛物线状。
图11A是图11所示H型紧固器的侧视图。
图12是本发明的一种H型紧固器的透视图,其中一个组织锚定件为盘形,另一个锚定件为杆形;偏压件有弧形部分和直线部分。
图12A是图12所示H型紧固器的侧视图。
图13是本发明的具有圆形结构形状的H型紧固器的偏压部分的断面图。
图14是本发明的具有椭圆形结构形状的H型紧固器的偏压部分的断面图。
图15是本发明的具有矩形结构形状的H型偏压器的偏压部分的断面图。
图16是本发明的一种H型紧固器的偏压部分的断面图,它的结构形状包含两个方形,在一拐角处以对顶角方式连接在一起。
图17是本发明的一种H型紧固器的偏压部分的断面图。它的结构形状为两个相切连接的圆。
图18是本发明的一种H型紧固器的偏压部分的断面图,它的结构形状为一个在两端各有一个圆的杆。
图19是本发明的一种具有方形结构形状的H型紧固器偏压部分的断面图。
图20是本发明的一种具有十字形结构形状的H型紧固器偏压部分的断面图。
图21是产生撕裂的半月板顶视图。
图22是沿图21中的观察线22-22所取的半月板断面图。
图23表示邻近图21中的半月板放置的关节镜式测量装置。
图24表示已就位的半月板的断而图,其中已安置就位一带有安装在穿刺针中的H型紧固器的穿刺针。
图25表示图24中所示在H型紧固器已由穿刺针中展开后的状态,穿刺针仍置于半月板中。
图26表示在取出穿刺针后图25中所示半月板的状态,H型紧固器已充分展开围绕在半月板中的撕裂处就位,使得在邻近紧固器的撕裂处周围的组织由于紧固器的中央偏压部分产生的偏压作用力的作用而接近弥合。
图27是图26所示半月板的顶视图,表示通过半月板围绕撕裂处已展开使用的紧固器以及使撕裂处局部接近的情况。
图28是图27所示半月板的顶视图,是表示在通过半月板围绕撕裂处已展开使用后的多个H型紧固器,因此使围绕撕裂处的组织接近的情况。
图29是图26所示半月板的断面图,表示利用位于起初穿入的紧固器上方的附加辅助H型紧固器使撕裂处沿三维更加接近的情况。
图30表示安装在穿刺针内的本发明的H型紧固器。
图31表示图30中所示穿针的侧视图。
本发明的H型紧固器可以用很多种常规的适合于生物体的聚合物制成。这些适合于生物体的聚合物材料或者是常规的不可吸收的适合于生物体的聚合材料,或者是常规的可吸收的或可重新吸收的适合于生物体的材料,可以采用的不可吸收且适合生物体的材料包含聚丙烯、尼龙、聚乙烯、聚酯、聚烯烃以及它们的等效物。可以用于制造本发明的H型紧固器的常规的可吸收和可重新吸收的适应生物体的聚合材料包括:聚二噁烷酮、聚半乳酸聚乳酸,聚己酸内酯,一些共聚物以及它们的等效物。这些聚合物可以和骨骼生长增强材料例如羟磷灰钙石(alcium hydroxyapatite)之类混合。某些上述材料的实例包含在No.4052988和No.5252701的美国专利中。虽然不是特别优选,但是本技术领域的熟练人员会理解,本发明的H型紧固器可以由其它常规类的可适合生物体的材料制造,例如由不锈(钢)弹簧钢、镍-钛合金、陶瓷、某些复合物以及它们的等效物制造。本发明的H型紧固器可以利用常规的制造方法制造。例如当制造本发明的紧固器时除了其它的方法之外还可以采用如下的方法,注射塑模、嵌模、挤压成形、热粘合、溶剂粘接、退火、热处理、机械变形、热熔、焊接、机械切削等。
下面参阅图2,说明本发明的H型紧固器10的一个优选实施例。可以看出紧固器10具有一带第一端14和第二端16的中央螺旋型偏压部分12。还可以看出,偏压件12具有中心纵向轴线13。二个组织锚定件20固定在偏压件12的端部14和16上。由图2可以看出,组织锚定件20基本是杆形件,它的两端22呈圆形,不过,锚定件20可以为其它结构形状,例如球形、盘形、杆状等。锚定件20的端部可以是尖的、平的、圆锥形、棱锥形等。可以看出该组织锚定件20具有纵向轴线21。将组织锚定件20这样固定在偏压件12的端面14和16上,即令组织锚定件20的纵向轴线21垂直于偏压件12的纵向轴线13。锚定件20对中地固定在该端部14和16上。两轴线21可以是平行的、或者彼此旋转成一定角度。当将装置10置入组织中和使偏压件12拉长时,偏压件12由通常的静置位置拉长到延长位置,将由锚定件20形成作用在组织上的偏压作用力,由于偏压件12作用于锚定件20上的偏压作用力的作用,在两锚定件20之间的组织受到压力。
在图1和1A中表示本发明的H型紧固器的另一实施例。图1和1A中所示的H型紧固器30具有一沿纵向轴线33的中央偏压件32。该中央偏压件32呈近于180°弧形的半圆形结构,不过也可以使用更小幅度的弧形。偏压件32具有纵向轴线33和第一端34以及第二端36。两个组织锚定件40固定在偏压件32的第一端34和第二端36。组织锚定件40基本为杆形件,具有圆形端面42和纵向轴线43。两杆形锚定件40对中地固定在该端部34和36上,使锚定件的纵向轴线43在端部34和36与偏压件32的纵向轴线33相垂直。如果需要,可以按这样一种方式固定杆形组织锚定件40,即令它们的纵向轴线43彼此成一定角度(例如45°),或着彼此相对旋转(例如90°),这样两个组织锚定件40的轴线43不处在同一平面内。
图3和3A表示本发明的H型紧固器的再一实施例。紧固器50具有该分别带第一端部54和第二端部56的中央偏压部分52。偏压件52具有纵向轴线57。两杆形组织锚定件60固定在偏压件52的第一端部54和第二端部56上。二个组织锚定件60为杆形件,分别在中心处固定在端部54和56上,锚定件60的纵向轴线63垂直于偏压件52的纵向轴线57。偏压件52具有锯齿形结构形状。
图4和图4A表示本发明的H型紧固器的再一实施例。由图4可以看出,H型紧固器70具有一为正弦波形状的中央偏压部分72。中央偏压件72分别具有第一端74和第二端76以及纵向轴线77。杆形锚定件80固定在元件72的端部74和76。杆形组织锚定件80具有纵向轴线83和圆形端部82。组织锚定件80固定在偏压件72的第一端部74和第二端部76,令锚定件80的纵向轴线83垂直于偏压件72的纵向轴线。如前所述,锚定件可以按彼此成一定角度或彼此相对旋转的方式固定。
在图5、5A、6和6A中表示本发明的H型紧固器的再一实施例。参阅图5,锚定件90具有一分别带有第一端部94和第二端部96的中央偏压部分92。中央偏压件92呈曲线结构形状,例如呈90°圆弧形。由图5A看出,组织锚定件100对中地固定到偏压件92的端部94和96,从而使纵向轴线103和纵向轴线107处在同一平面内,当然也可以彼此成一定角度。在图6和6A中表示H型装置90的一种变化方案,其中一个组织锚定件100相对另一个旋转一定角度,使得两个组织锚定件100的纵向轴线103不再处于一个平面内。
图7中表示本发明的H型紧固器的再一实施例。紧固器110具有一带有第一端部114和第二端部116的偏压部分112。偏压部分112具有重复出现的正弦波形的结构形状。两个组织锚定件120为杆形件,具有圆形端部122,其纵向轴线为123,二锚定件120的中心固定在该端部114和116上,令锚定件120的中心轴线123垂直于该端部114和116。
图8表示本发明的H型紧固器的再一实施例。该H型装置130具有中央偏压件131,其具有第一端部132和第二端部133以及纵向轴线134。中央偏压件131具有两个相对的锯齿形元件135以及将两锯齿形元件135隔开的中央开孔136。具有纵向轴线138和圆形端部139的两杆形元件137固定在偏压件131的端部132和133。两个组织锚定件137可以垂直于纵向轴线134固定,并且可以在同一平面内或者彼此相对旋转从而不在一个平面内。两个锚定件137可以彼此成一定角度。
图9和9A表示本发明的H型紧固器的再一实施例。紧固器140具有中央偏压部分141,其具有双环部分145和146以及纵向轴线148。偏压件141具有端部142和143。具有轴线155的杆形组织锚定件150的中心处固定在该端部142和143。锚定件150与该端部142和143以及纵向轴线148相垂直,不过也可以彼此成一定角度。两个组织锚定器150可以在一平面内,或者可以围绕轴线148旋转,使得它们不在一个平面内。
图10和10A表示本发明的H型紧固器的再一实施例。紧固器160具有一带有端部162和163的中压偏压部分161。偏压件161具有直线部分164、中央弯曲部分165以及邻近端部163的弯曲部分166。具有不同形状的两个组织锚定件固定到端部162和163。杆形组织锚定件170固定在端部163,而盘形件175在中心处固定到端部162。
图11和11A表示本发明的H型紧固器的再一实施例。紧固器180具有一呈抛物线形状的偏压部分181,其具有第一端部182和第二端部183以及纵向轴线184。具有曲线形端部187和纵向轴线188的杆形组织锚定件186按前述的方式固定在该端部182和183。
图12和12A表示本发明的H型紧固器的再一实施例。紧固器190具有并不是作为偏压件的中央连接部分。连接部分190具有第一端部191和第二端部192以及纵向轴线195。连接部分190最好具有圆形截面,不过也可以具有包括如在图13-20中所表示的各种截面。二个形成偏压的组织锚定件200以居中的方式安装在该端部192和193。锚定件200具有彼此成一定角度的且在顶端205处连接形成V形结构的二个支脚202和203。两支脚202和203朝元件190向内形成一定角度,不过也可以按相反的方向形成一定角度。两锚定件200可以围绕轴线195旋转或者处在同一平面内或者处在不同的平面内。两支脚202和203从第一位置达到一被伸展的或弹性变形的位置向外远离元件192形成的偏转,将对在两锚定件200之间约束的组织上产生偏压作用力。其它形状包括U形、多个向外伸展的支脚或附件、倒圆锥形、圆柱形、X形以及如上所述适于用作非偏压型组织锚定件的其它结构形状。
熟悉本领域的技术人员会认识到,对于本发明的H型紧固器中的中央偏压件选择的结构形状取决于几种因素,其中包括(但不局限于):所需偏压作用力的大小,需使之接近的组织的类型,需使之接近的组织或器官在人体内的位置、组织中撕裂或切开的尺寸、用于制造该装置的材料是可吸收的还是不可吸收的材料、构件的材料以及外科手术的类型等。本领域的技术人员在权衡这些因素之后在其权限范围内选择最终的设计结构。
如由图13-20可以看出,本发明的H型紧固器中的中央偏压件可以具有各种断面。参阅图13,其中作为一种优选实施例的断面是从断面210中看到的圆形断面。在图14中所示的为椭圆形断面215。在图15中表示适用于本发明的H型紧固器中的偏压件的矩形断面。在图16中表示的断面220包含两个分别具有对角线227和228的方形断面223和222,它们在顶角224和225处沿对角线227和228连接。图17中表示由两个圆232和233组成的断面,这两个圆在点234沿它们的圆周相切固定。
图18表示的断面具有一带有端部243和244的中央矩形部分242以及由端部244和243延伸的圆形部分247和246。图19表示矩形断面,而图20表示具有交叉支脚269的十字形或X形断面。本领域的技术人员会认识到可以选择适合于该偏压件的各种等效的断面。如在图12中所示的本发明的具有形成偏压的锚定件中的锚定件上的中央连接件如果需要可以具有相似的断面。
常用于本发明的H型紧固器上的组织锚定件可以具有各种结构形状包括:杆形、盘形、圆锥形、球形之类以及它们的等效形状。组织锚定件还可以由类似的其中具有开孔的结构元件,例如X形元件或具有辐条的环形元件、或工形柱、T形柱等以及它们的等效物构成。此外,虽然,将锚定件以固定方式固定在偏压件或连接件上是优选的,但锚定件可以旋转方式利用常规的安装构件例如球与座式连接件、铆钉、销、扣环、轴、套筒之类以及它们的等效物进行安装。
本发明的H型紧固器可以用在很多类型的外科手术中,用以使各种(哺乳)动物的组织接近弥合。可以接近弥合的各种组织的类型包含(但不局限于)韧带、软骨、骨部组织、肠部组织、肌肉(包括骨骼肌肉、心脏肌肉、不随意运动的肌肉)、骨骼、皮肤、神经组织、血管以及连接组织。本发明的H型装置对于使软骨接近弥合是特别适用的。特别是对在例如包含在膝部半月板中的软骨的撕裂很有效。本发明中的H型紧固器通常按如下的方式使用。参阅图21-29,可以看出半月板300具有撕裂处310。由图22可以看出,该撕裂处310由半月板300的顶部302延伸到底部303。如图23所示,利用带有等级测量器322的常规骨骼镜半月板测量装置320可以测量半月板300的尺寸。一旦外科医生测量到半月板300的尺寸,他就能选择本发明的H型紧固器,通过在撕裂处310的两侧组织上施加偏压作用力使撕裂处310适当地接近弥合。例如,在图30和31中所示,将如图6和6A所示的本发明的紧固器90装入常规的H型紧固器用穿刺针式输送装置400。如图可以看出,该装置400包含一具有通道415、与通道415连通的槽口417和一末端穿刺针尖412的末端针式插管410。一经选择的定位器套420安装在插管410的近端419上。该套420具有槽口422和钩形件425。近端支脚锁定元件440从远端419附近延伸并由间隔441所隔开。每个支脚具有构成一活动铰接的远端基体部分445和近端舌片形件446。装置400通过将元件440向内按压并使近端舌片形件插入通道510以及将舌片形件446锁定在插管500中包含的孔口520中而安装到插入用插管500上。通过向内按压锁定用支脚元件440并因此使舌片形件446从孔口520中脱出,使该装置可以按相似的方式由插管500中取出。推杆530可滑动地安装在插管500的通道510中。通过将一个组织锚定件100装入插管通道415中,和将相对端的锚定件100装入钩形元件425,使偏压形成部分92由槽口417和422伸出,而将H型紧固器90装入装置400。一旦将装置90装入输送装置400中的远端插管410,于是外科医生将穿刺针尖412穿过半月板,使针式插管410行进通过半月板和撕裂处310。然后外科医生操作推杆530,以便推动组织锚定器100通过插管410,使其位于半月板300的表面305附近。其后外科医生抽出针式插管410,因此使另一锚定件100脱开锚定件套上的钩425,并且还使偏压件92由插管410移位,以及使另一锚定件100位于半月板300的表面307附近。被延伸的偏压件92对两锚定件100产生偏压作用力,因此使两锚定件100彼此相对向内移动,借此使撕裂处310附近的组织接近弥合。重复该手术插入另外一些H型元件90,直到整个撕裂处310接近弥合,如图27-29所示。利用本发明的具有形成偏压的组织锚定件(例如图12和12A所示)的H型紧固器可以相似的方式进行相似的外科手术。
下面介绍一个实例,说明本发明的原理和实践。
实例
准备对一个病人做外科手术,并利用常规操作进行麻醉。按照常规的关节观察操作将套针插管刺入围绕病人其中一个膝部的包囊中,并使盐水流动注入接缝处。将一常规的关节观察镜插入一插管中以便显影目测在病人半月板中的撕裂处。在利用常规的半月板测量装置测量半月板后,将适当尺寸的本发明的H型紧固器装入针式插管中,并插入套针式插管。针尖穿过半月板,再抽回针,因此将紧固器置于围绕撕裂处的半月板组织中,使撕裂处断面接近弥合。按照相同的方式将两个或更多个紧固器置入半月板中,因此,修复半月板撕裂处。然后将插管由病人膝部取出,并按常规方式使套针针孔伤口接近弥合。
本发明的H型紧固器具有很多优点。该固定器便于按照最小侵入方式的外科手术例如关节镜检察、内诊镜检查和腹腔镜检查术使组织接近弥合。本发明的紧固器对组织施加偏压作用力,有利于痊愈。紧固器在使组织接近弥合特别是使例如半月板软骨的组织接近弥合方面是特别有用的。
虽然是按照本发明的各详细实施例表示和说明本发明的,但本技术领域的技术人员会认识到,在不脱离权利要求所限定的本发明的构思和范围的前提下可以对它的结构细节进行各种改变。
Claims (24)
1、一种对组织进行外科手术用的H型紧固器,包含
中央偏压件,所述元件具有第一端部、第二端部和一定断面,所述元件能由第一松弛静置位置到第二延伸位置产生弹性变形;
第一锚定件,安装到偏压件的第一端;及
第二锚定件,安装到偏压件的第二端。
2、如权利要求1所述的紧固器,其中的偏压件具有锯齿形结构。
3、如权利要求1所述的紧固器,其中的偏压件具有半圆形结构。
4、如权利要求1所述的紧固器,其中的偏压件具有螺旋结构。
5、如权利要求1所述的紧固器,其中的偏压件包含正弦波形结构。
6、如权利要求1所述的紧固器,其中的编压件包含方形波形结构。
7、如权利要求1所述的紧固器,其中的偏压件包含圆弧形结构。
8、如权利要求1所述的紧固器,其中的偏压件包含至少一个直线段和至少一个曲线段结构。
9、如权利要求1所述的紧固器,其中的偏压件断面为一个圆。
10、如权利要求1所述的紧固器,其中所述的断面为一椭圆。
11、如权利要求1所述的紧固器,其中所述的断面为矩形。
12、如权利要求1所述的紧固器,其中所述的断面为方形。
13、如权利要求1所述的紧固器,其中所述的断面为X形。
14、如权利要求1所述的紧固器,其中所述的断面为T形。
15、如权利要求1所述的紧固器,其中所述的断面为工形。
16、如权利要求1所述的紧固器,其中所述的断面包含一对方形部分,每个方形部分具有顶角和对角线,两方形部分在一顶角处沿对角线连接。
17、如权利要求1所述的紧固器,其中所述的断面包含一对圆形部分,在它们的圆周公共的一点处相连。
18、如权利要求1所述的紧固器,其中所述的断面包含一具有第一端部和第二端部的矩形部分以及从每一端部延伸出的圆形部分。
19、如权利要求1所述的紧固器,其中的偏压件具有一纵向轴线。
20、如权利要求1所述的紧固器,其中第一和第二偏压件为一具有两圆形相对端的细长圆柱形元件。
21、一种使组织接近弥合的方法,所述方法包含的步骤有:
a)将一H型紧固器穿入组织,所述组织具有相对的第一和第二断面部分,其中的H型紧固器包含:
中央偏压件,所述元件具有第一端、第二端和一定断面,所述元件能够从第一松弛静置位置到第二沿纵向轴线延伸的位置产生弹性变形,并且所述元件具有一定结构形状;
第一组织锚定件,安装在偏压件的第一端,以及
第二组织锚定件,安装在偏压件的第二端,
b)将第一组织锚定件设置在该组织的其中一个断面之内或附近;
c)使中央偏压件变形达到延伸位置;
d)将第二组织锚定件设置在第二组织断面之内或附近;
因此,对位于第一和第二组织锚定件之间的组织施加偏压作用力。
22、一种用于对组织进行外科手术用的H型紧固件,包含:
一细长的中央连接件,所述元件具有第一端部、第二端部以及一定断面;
第一锚定件,安装在偏压件的第一端,所述元件能够由第一松弛静置位置到第二延伸位置产生弹性变形;以及
第二锚定件,安装在偏压件的第二端,所述元件能够从第一松弛静置位置到第二延伸位置产生弹性变形。
23、如权利要求21所述的紧固器,其中的两锚定件为V形结构,其包含两个在顶点连接成一定角度的支脚,以及其中每个锚定件的安装顶点安装在细长的中央连接件的一端。
24、一种使组织接近弥合的方法,所述方法包含的步骤有:
a)将H型紧固器穿人组织,其中该H型固定器包含:
一细长的中央连接件,所述元件具有第一端部、第二端部和一定断面;
第一锚定件,安装到偏压件的第一端,所述锚定件能由第一松弛静置位置到第二延伸位置产生弹性变形;
第二锚定件,安装到偏压件的第二端,所述锚定件能由第一松弛静置位置到第二延伸位置产生弹性变形;
b)将第一组织锚定件设置在该组织的其中一个断面部分之内或附近,并且使第一锚定件变形达到延伸位置;
c)将第二组织锚定件设置在该组织中的相对断面部分之内或附近;
因此,对位于第一和第二组织锚定件之间的组织施加偏压作用力。
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US766,535 | 1991-09-27 | ||
US76653596A | 1996-12-11 | 1996-12-11 |
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CN97125244A Pending CN1194817A (zh) | 1996-12-11 | 1997-12-11 | 半月板修复装置 |
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EP (1) | EP0847727B1 (zh) |
JP (1) | JPH10179598A (zh) |
CN (1) | CN1194817A (zh) |
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- 1997-12-10 AU AU48296/97A patent/AU735951B2/en not_active Ceased
- 1997-12-10 DE DE69727772T patent/DE69727772T2/de not_active Expired - Fee Related
- 1997-12-11 BR BR9705514-0A patent/BR9705514A/pt not_active IP Right Cessation
- 1997-12-11 JP JP9361694A patent/JPH10179598A/ja active Pending
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CN105662658A (zh) * | 2011-03-08 | 2016-06-15 | 新特斯有限责任公司 | 替换受损半月板组织的方法和植入物 |
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CN103957819A (zh) * | 2011-10-03 | 2014-07-30 | 史密夫和内修有限公司 | 半月板根部附着点修复 |
CN106419982A (zh) * | 2015-08-10 | 2017-02-22 | 李胜文 | 一种生物可吸收缝合组件 |
CN109363743A (zh) * | 2018-11-29 | 2019-02-22 | 广州科荟泽生物科技有限公司 | 手术缝合线、缝合装置及心脏瓣膜或血管缝合装置 |
CN109363743B (zh) * | 2018-11-29 | 2024-02-06 | 广州科荟泽生物科技有限公司 | 手术缝合线、缝合装置及心脏瓣膜或血管缝合装置 |
Also Published As
Publication number | Publication date |
---|---|
AU4829697A (en) | 1998-06-18 |
DE69727772D1 (de) | 2004-04-01 |
CA2224366C (en) | 2006-10-31 |
CA2224366A1 (en) | 1998-06-11 |
US6152935A (en) | 2000-11-28 |
BR9705514A (pt) | 1999-12-07 |
EP0847727B1 (en) | 2004-02-25 |
DE69727772T2 (de) | 2004-12-09 |
EP0847727A1 (en) | 1998-06-17 |
US6156044A (en) | 2000-12-05 |
AU735951B2 (en) | 2001-07-19 |
JPH10179598A (ja) | 1998-07-07 |
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