CN104334092A - 穿孔植入物 - Google Patents

穿孔植入物 Download PDF

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CN104334092A
CN104334092A CN201380023464.8A CN201380023464A CN104334092A CN 104334092 A CN104334092 A CN 104334092A CN 201380023464 A CN201380023464 A CN 201380023464A CN 104334092 A CN104334092 A CN 104334092A
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implant
elongate body
hole
bone
longitudinal axis
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理查德·加勒特·莫尔丁
斯科特·A·耶比
马克·赖利
布雷特·施耐德
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SI Bone Inc
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SI Bone Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61B17/7055—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1697—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans specially adapted for wire insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • 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
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • A61F2002/30995—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for sacro-iliac joints

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Abstract

本发明一般涉及在诸如骨固定或骨融合的医疗程序中使用的植入物。更具体地，该申请涉及使用骨固定或骨融合的穿孔植入物。

Description

穿孔植入物
相关申请的交叉引用
该申请要求题为“FENESTRATED IMPLANT(穿孔植入物)”并且于2012年5月4日提交的第61/642,681号美国临时申请的优先权，为了所有目的，其通过引用以其整体并入本文。
通过引用并入
在本说明书中提及的所有公布及专利申请均通过引用并入本文，以如同每个单个的公布或专利申请被具体地和单独地表示为通过引用并入的相同的程度。例如，该申请将第2011/0087294号美国专利公布和第2011/0118785号美国专利公布通过引用以其整体并入。
领域
本申请一般涉及在诸如骨固定或骨融合的医疗程序中使用的植入物。更具体地，该申请涉及在骨固定或骨融合中使用的穿孔植入物。
背景
许多类型的硬件对于骨折的骨头的固定以及待融合的(关节固定的)骨头的固定均是可用的。
例如，人体骨盆带由三个相对固定的关节联结的三块大骨头组成。这些骨中的一块称为骶骨并且其位于腰脊柱的底部处，在这里骶骨与L5椎骨相连。另外的两块骨头通常称为“髋骨”并且专业上称为右髂骨和左髂骨。骶骨与两块髋骨在骶髂关节(简称，SI-关节)处连接。
SI-关节在将力从脊柱传递到下肢的过程中起作用，并且反之亦然。SI-关节被描述为对于高达22％的下背疼痛的疼痛发生源。
为了减轻SI关节所产生的疼痛，骶髂关节融合通常需要进行手术治疗，例如，用于退行性骶髂关节炎、炎症骶髂关节炎、骶髂关节的医源不稳定性、致密性髂骨炎或骨盆的创伤性骨折脱位。目前，螺钉和带板的螺钉用于骶髂融合。
为了促进骨头生长到植入物中以及加强植入物与骨头的融合，可以在植入物中创建促进骨头生长到植入物中的凹坑或通道。然而，这些凹坑或通道可能削弱了植入物的结构完整性，植入物也可被要求承受大的应力。因此，提供一种具有凹坑或通道以促进骨头生长同时大体上保持植入物的结构完整性的植入物将是期望的。
发明概述
本发明一般涉及在例如骨固定或骨融合的医疗程序中使用的植入物。更具体地，该申请涉及在骨固定或骨融合中使用的穿孔植入物。
在一些实施方案中，提供了一种用于骨固定术的植入物。该植入物可以包括具有纵向轴线和横向于该纵向轴线的由直线围成的横截面(rectilinear cross section)的长形主体、多个面、联结该多个面的多个顶端、沿该长形主体的纵向轴线延伸的中央内腔，以及具有该多个面上的开口的多个孔，其中该孔与中央内腔流体连通。
在一些实施方案中，孔是圆形的。在一些实施方案中，孔是椭圆形的。在一些实施方案中，孔以每个面上的单一纵列布置。在一些实施方案中，孔以每个面上的多个纵列布置。
在一些实施方案中，长形主体涂覆有生物助剂。
在一些实施方案中，孔具有约等于中央内腔的直径的直径。在一些实施方案中，孔具有在面的宽度的约0.2至0.5之间的直径。
在一些实施方案中，提供了一种用于骨固定的植入物。该植入物可以包括具有纵向轴线以及横向于该纵向轴线的由直线围成的横截面的长形主体、多个面、联结该多个面的多个顶端、沿该长形主体的纵向轴线延伸的中央内腔，以及沿该多个面中的每一个的一部分延伸的多个侧部凹坑，其中该侧部凹坑具有不延伸至中央内腔的深度。
在一些实施方案中，该多个面中的每一个具有仅一个侧部凹坑。在一些实施方案中，侧部凹坑中的每一个在该面中的每一个上居中。在一些实施方案中，侧部凹坑具有在面的宽度的约0.2至0.8之间的宽度以及在面的长度的约0.5至0.9之间的长度。
在一些实施方案中，植入物还包括位于侧部凹坑内的多个孔，其中这些孔与中央内腔流体连通。
在一些实施方案中，提供了一种用于骨固定的植入物。该植入物可包括具有纵向轴线和横向于该纵向轴线的由直线围成的横截面的长形主体、多个面、联结该多个面的多个顶端，以及沿该长形主体的纵向轴线延伸的中央内腔，其中，该多个顶端中的每一个包括沿顶端的长度延伸的凹槽。
在一些实施方案中，提供了一种用于骨固定的植入物。该植入物可以包括具有纵向轴线和横向于该纵向轴线的由直线围成的横截面的长形主体、多个面、联结该多个面的多个顶端，以及沿该长形主体的纵向轴线延伸的中央内腔，其中，该多个顶端中的每一个包括位于沿每一顶端的长度的离散点处的多个凹坑。
在一些实施方案中，提供了一种用于骨固定术的植入物。该植入物可包括具有纵向轴线、远端、近端以及横向于该纵向轴线的由直线围成的横截面的长形主体；多个面，每个面由具有厚度上在约2mm至3mm之间的厚度的壁形成；以及布置在每个面上的多个穿孔。
在一些实施方案中，长形主体的远端形成为一个或多个切割边缘。
在一些实施方案中，由直线围成的横截面具有三个侧部。在一些实施方案中，由直线围成的横截面具有四个侧部。
在一些实施方案中，穿孔位于长形主体的配置为被植入患者的骶骨内的远端部分上，而长形主体的配置为被植入髂骨内的近端部分没有穿孔。
在一些实施方案中，穿孔以交错型式布置。
在一些实施方案中，植入物还包括长形主体的近端上的盖子，该盖子具有大小适合接纳导销的孔。
在一些实施方案中，长形主体具有多孔的内表面和外表面。在一些实施方案中，长形主体具有粗糙化的内表面和外表面。在一些实施方案中，长形主体具有涂覆等离子体的内表面和外表面。在一些实施方案中，长形主体具有涂覆有生物助剂的内表面和外表面。在一些实施方案中，生物助剂是骨形态生成蛋白。
附图简述
以下权利要求书中特别地陈述了本发明的新颖特征。通过参照陈述使用本发明的原理的示例性实施方案的以下详细说明，将获得本发明的特征和优点的更好理解，并且其附图为：
图1A-1V示出了具有不同穿孔的植入物结构的各种实施方案。
图2A-2D是根据本发明的一个实施方案的骨中的钻孔的形成的侧视截面图。
图2E和图2F示出了用于放置在导丝之上的软组织保护器系统的组件。
图3和图4分别为包括骶骨和髋骨(右髂骨和左髂骨)的人体骨盆带的前部解剖图和后部解剖图，骶骨与两块髋骨在骶髂关节(简称，SI-关节)处连接。
图5至图7A和图7B是解剖视图，分别示出了植入前透视图、植入后透视图、植入后前部视图和植入后头尾截面图，用于固定SI-关节的三个植入物结构的植入使用穿过髂骨、SI-关节并进入骶骨中的侧向入路。
图8A和图8B示出了具有穿孔的植入物结构的另一个实施方案。
图9A和图9B示出了具有穿孔的植入物结构的另一个实施方案。
详细描述
如图1A所示的长形的长形、茎状的植入物结构20使以微创方式固定SI-关节(图3和图4分别以前部视图和后部视图示出)成为可能。可通过使用侧向手术方法有效地植入这些植入物结构20。该过程期望被辅助以常规的侧向和/或前-后(A-P)可视化技术，例如，使用如C形臂或荧光镜的X射线图像增强器以生成TV屏幕上显示的实时图像馈送。
在一些实施方案中，植入物结构20可包括允许骨移植材料被并入植入物结构中的凹坑、通路、空腔、开口、穿孔、通道和/或凹部。这些骨移植材料可以促进骨生长到植入物结构中和/或围绕植入物结构生长，这可减少植入物结构稳定地与骨头成为一体所花费的时间。骨移植材料可在植入之前施加到植入物结构和/或注入植入物结构中，或植入之后通过将骨移植材料注入近端插管或其它导管中来施加。在一些实施方案中，植入物结构20的表面可以是粗糙化的或纹理化的，以促进骨生长和骨移植材料的依附。内表面和/或外表面可通过机械方法来被粗糙化或纹理化，或可被喷涂有粗糙化材料。
骨移植材料可以是液体、凝胶、浆体、糊状物、粉末或其它形式，并且可包括生物助剂，该生物助剂可促进和/或增强骨向内生长、组织修复和/或减少炎症、感染和疼痛。例如，生物助剂可包括：例如骨形态生成蛋白(BMP)的生长因子；例如液体或浆体载体中的羟基磷灰石；脱矿骨；自体或同种异体颗粒骨；减少炎症、感染或疼痛的诸如镇痛剂、抗生素和类固醇的药物。在一些实施方案中，例如，生长因子可以是例如hr-BMP-2和/或hr-BMP-7的人类重组生长因子，或BMP的任意其它人类重组形式。例如，生物助剂的载体可以是液体或凝胶，如盐溶液或胶原凝胶。生物助剂也可被封装或包含在控释制剂中，使得在较长期间内在植入物部位处将生物助剂释放到患者。例如，控释制剂可以配置为在数天或数周或数月的过程中释放生物助剂，并且可配置为植入物部位痊愈将花费的估计时间内释放生物助剂。可使用多种技术控制递送到植入物结构的生物助剂的量，例如控制或改变施加到植入物的涂层材料的量和/或控制或改变包含到涂层材料中的生物助剂的量。在一些实施方案中，控制递送的生物助剂的量可能是重要的，因为过量使用某些生物助剂例如可导致如神经根疼痛的负面效果。
通常，植入物结构中的任意凹坑、通路、空腔、开口、穿孔、通道和/或凹部都可能削弱其结构强度，包括例如弯曲强度和剪切强度。以下植入物结构的例子是图1A的实体三角形植入物结构20的变型，图1A的实体三角形植入物结构20具有单一中心的纵向定向的内腔或插管，以接纳导丝或导销。相对弯曲强度和剪切强度可与图1A的被插入插管但以其他方式插入的实体植入物结构20进行比较，该实体植入物结构20可被分配1.00的弯曲强度和1.00的剪切强度。通过改变凹坑、通路、空腔、开口、穿孔、通道和/或凹部的大小、数量、间距、位置、取向和形状，相对弯曲强度和剪切强度可为了结构强度和促进骨移植的能力被改变或优化。虽然本文说明的实施方案示出了三角形植入物结构，但是具有不同的由直线围成的形状的植入物结构(例如矩形或正方形)都可以被使用或代替三角形植入物结构。
图1B-1D说明了三角形植入物结构100的实施方案，该三角形植入物结构100具有中央内腔101和植入物结构100的每一面103上的一系列孔102，该一系列孔102到达中央内腔101并且提供中央内腔101的入口。孔102可在面103上居中且以大体上垂直于或正交于植入物结构100的面103的角度向内延伸。在一些实施方案中，每个顶端104可被倒角或倒圆。在一些实施方案中，植入物结构100的远端105可以成锥形以便于植入到骨头中。在一些实施方案中，孔102的直径可以等于或大体上等于中央内腔101的直径。在其它实施方案中，孔102的直径可大于或小于中央内腔101的直径。在一些实施方案中，图1B-1D所示的植入物结构100具有约为0.82的相对弯曲强度和约为0.66的相对剪切强度。在一些实施方案中，为了用骨移植材料注入或装入植入物结构100，可阻塞或密封中央内腔101的远端孔106，使得骨移植材料的流动填充中央内腔101并且从侧孔102退出。
在一些实施方案中，孔102可具有植入物结构100的面103的宽度(W1)的约0.3的直径(D1)。在一些实施方案中，孔102可具有大于植入物结构100的面103的宽度的约0.3的直径。在一些实施方案中，孔102可具有小于植入物结构100的面103的宽度的约0.3的直径。在一些实施方案中，孔102可具有植入物结构的面103的宽度的约0.2至0.5之间的直径。在一些实施方案中，孔102可与相邻的孔102以孔直径的约2/3的距离隔开，其中，通过孔102的圆周之间的距离测定分隔距离(S1)。在一些实施方案中，孔102可与相邻孔102以小于孔直径的约2/3的距离隔开。在一些实施方案中，孔102可与相邻孔102以大于孔直径的约2/3的距离隔开。在一些实施方案中，孔102可与相邻孔102以孔102直径的约0.5至约2倍或约0.5至约1倍的距离隔开。在一些实施方案中，相对弯曲强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可在约0.5至0.9之间。在一些实施方案中，相对剪切强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可在约0.5至0.9之间。
图1E-1G示出了植入物结构110的另一个实施方案，该植入物结构110具有中央内腔111和植入物结构110的每个面113上的一系列狭槽112，该狭槽112到达中央内腔111并提供中央内腔111的入口。狭槽112可以在面113上居中且以大体上垂直于或正交于植入物结构110的面113的角度向内延伸。在一些实施方案中，每个顶端104可被倒角或倒圆。在一些实施方案中，植入物结构110的远端115可以成锥形以便于植入到骨头中。在一些实施方案中，狭槽的宽度可等于或大体上等于中央内腔111的直径。在其它实施方案中，狭槽的宽度可大于或小于中央内腔111的直径。在一些实施方案中，图1E-1G说明的植入物结构110具有约为0.82的相对弯曲强度和约为0.66的相对剪切强度。在一些实施方案中，为了用骨移植材料注入或装入植入物结构110，可阻塞或密封中央内腔111的远端孔116，使得骨移植材料的流动填充并离开狭槽112。
在一些实施方案中，狭槽112可具有植入物结构110的面113的宽度(W2)的约0.3的宽度(W3)。在一些实施方案中，狭槽112可具有大于植入物结构110的面113的宽度的约0.3的宽度。在一些实施方案中，狭槽112可具有小于植入物结构110的面113的宽度的0.3的宽度。在一些实施方案中，狭槽112可具有植入物结构110的面113的宽度的约0.2至约0.6之间的宽度。在一些实施方案中，狭槽112可具有面113的长度(L2)的约0.15的长度(L3)。在一些实施方案中，狭槽112可具有小于面113的长度的约0.15的长度。在一些实施方案中，狭槽112可具有大于面113的长度的0.15的长度。在一些实施方案中，狭槽112可具有面113的长度的约0.1至0.4之间或约0.1至0.25之间的长度。在一些实施方案中，狭槽112与相邻狭槽112以狭槽112的宽度的约2/3的距离隔开(S2)。在一些实施方案中，狭槽112与相邻狭槽112以大于狭槽112的宽度的约2/3的距离隔开。在一些实施方案中，狭槽112与相邻狭槽112以小于狭槽112的宽度的约2/3的距离隔开。在一些实施方案中，狭槽112可与相邻狭槽112以狭槽112宽度的约0.5倍至约2倍或约0.5倍至约1倍的距离隔开。在一些实施方案中，相对弯曲强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可为约0.5至0.9。在一些实施方案中，相对剪切强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可在约0.5至0.9之间。
图1H-1J示出了植入物结构120的另一个实施方案，该植入物结构120具有中央内腔121和植入物结构120的每个面123上的侧部凹坑122。侧部凹坑122可以是在面123上居中的具有宽度、长度和深度的凹陷部、空腔、凹槽或狭槽。在一些实施方案中，侧部凹坑122较浅，使得其不延伸到中央内腔121。在一些实施方案中，每个顶端104可被倒角或倒圆。在一些实施方案中，植入物结构120的远端125可以成锥形以便于植入到骨头中。在一些实施方案中，图1H-1J所示的植入物结构120具有约为0.77的相对弯曲强度和约为0.72的相对剪切强度。在一些实施方案中，为了用骨移植材料装入植入物结构120，在植入之前将骨移植材料施加到侧部凹坑122。在其它实施方案中，在植入期间施加骨移植材料，如题为TissueDilator and Protector(组织扩张器和保护器)的美国专利申请61/609,043进一步描述的，该专利申请在此通过引用以其整体并入，且可以应用到其它植入物。
在一些实施方案中，侧部凹坑122可具有植入物结构120的面123的宽度(W5)的约0.5的宽度(W4)。在一些实施方案中，侧部凹坑122可具有大于植入物结构120的面123的宽度的约0.5的宽度。在一些实施方案中，侧部凹坑122的宽度可具有小于植入物结构120的面123的宽度的约0.5的宽度。在一些实施方案中，侧部凹坑122可具有植入物结构120的面123的宽度的约0.2至约0.8之间的宽度。在一些实施方案中，侧部凹坑122可具有面123的长度(L5)的约0.75的长度(L4)。在一些实施方案中，侧部凹坑122可具有小于面123的长度的约0.75的长度。在一些实施方案中，侧部凹坑122可具有大于面123的长度的约0.75的长度。在一些实施方案中，侧部凹坑122可具有面123的长度的约0.5至0.9之间的长度。在一些实施方案中，侧部凹坑122可具有约0.2mm和5mm之间或约0.2mm和2mm之间或约0.2mm和1mm之间的深度。在一些实施方案中，侧部凹坑122可具有约0.25mm、0.5mm、0.75mm、1mm或2mm之间的深度。在一些实施方案中，相对弯曲强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可在约0.5至0.9之间。在一些实施方案中，相对剪切强度可以为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可在约0.5至0.9之间。
图1K-1M示出了植入物结构130的另一个实施方案，该植入物结构130具有中央内腔131和植入物结构130的每个面133上的侧部凹坑132，以及位于侧部凹坑132内的多个孔134。图1K-1M所示实施方案中的侧部凹坑132可以与先前在上文描述的并且在图1H-1J中示出的侧部凹坑122相同或类似。同样，图1K-1M所示的孔134可以与先前在上文描述的并且在图1B-1D中示出的孔102相同或类似。在一些实施方案中，如图1K-1M所示，孔134具有小于中央内腔131的直径的直径。在其他实施方案中，孔134具有等于或大于中央内腔131的直径的直径。在一些实施方案中，每个顶端135可被倒角或倒圆。在一些实施方案中，植入物结构130的远端136可以成锥形以便于植入到骨头中。在一些实施方案中，图1K-1M所示的植入物结构130具有约为0.74的相对弯曲强度和约为0.62的相对剪切强度。在一些实施方案中，为了用骨移植材料装入植入物结构130，可在植入之前将骨移植材料注入和/或施加到侧部凹坑132和孔134。在其它实施方案中，可将骨移植材料注入中央内腔131中，中央内腔131可具有封堵的或堵塞的远端开口137，使得骨移植材料填充中央内腔131且从孔134退出，孔134与中央内腔131流体连通。当骨移植材料从孔134退出时，骨移植材料可涂覆和填充孔134和侧部凹坑132两者。该注入过程可以在植入之前、植入期间或者植入之后进行。
在一些实施方案中，图1K-1M所示侧部凹坑132具有与图1H-1J所示并且在上文描述的侧部凹坑122相同或相似的尺寸。在一些实施方案中，孔134可具有侧部凹坑132的宽度(W6)的约0.4的直径(D2)。在一些实施方案中，孔134可具有约大于或小于侧部凹坑132的宽度的约0.4倍的直径。在一些实施方案中，可以以孔134的直径的约1.5倍的距离将孔134隔开(S3)。在一些实施方案中，可以以大于或小于孔134的直径的约1.5倍的距离将孔134隔开。在一些实施方案中，相对弯曲强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可在约0.5至0.9之间。在一些实施方案中，相对剪切强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可在约0.5至0.9之间。
图1N-1P示出了植入物结构140的另一个实施方案，该植入物结构140具有中央内腔141和围绕中央内腔141的多个外围内腔142。外围内腔142可纵向定向并且可位于中央内腔141与每个顶端143之间。如所示，植入物结构140是三角形的并且具有三个顶端143和围绕中央内腔141的三个外围内腔142。在一些实施方案中，中央内腔141与外围内腔142两者都可以贯穿植入物结构140的纵向长度延伸。在其它实施方案中，外围内腔142没有贯穿植入物结构140的长度延伸，并且而是，外围内腔142在植入物结构140的远端144之前终止。另外，多个侧孔145可被包括在植入物结构140中。每个外围内腔142可以与多个侧孔145交叉，其中每个侧孔145在植入物结构的两个面146之间延伸，两个面146中的每一个上具有侧孔开口147。侧孔145可以与面146的表面成约60度的角度横向地延伸穿过植入物结构140。在一些实施方案中，每个顶端143可被倒角或倒圆。在一些实施方案中，植入物结构140的远端144可以成锥形以便于植入到骨头中。在一些实施方案中，图1N-1P中所示的植入物结构140具有约为0.63的相对弯曲强度和约为0.66的相对剪切强度。在一些实施方案中，为了用骨移植材料装入植入物结构140，骨移植材料被注入到外围内腔142中，其中骨移植材料填满外围内腔并从侧孔145退出。骨移植材料的注入可在植入之前、植入期间或植入之后发生。在外围内腔142完全延伸穿过植入物结构140的一些实施方案中，可以在骨移植材料注入之前阻塞或堵塞外围内腔142的远端。
在一些实施方案中，外周内腔142具有植入物结构的面146的宽度(W7)的约0.2倍的直径(D3)。在一些实施方案中，外围内腔142具有大于或小于植入物结构的面146的宽度的约0.2倍的直径。在一些实施方案中，外围内腔142可具有比中央内腔141小的直径。在其它实施方案中，外围内腔142可具有等于或大于中央内腔141的直径的直径。在一些实施方案中，侧孔145具有等于或大体上等于外围内腔142的直径的直径(D4)。在其它实施方案中，侧孔145具有小于或大于外围内腔142的直径的直径。在一些实施方案中，相对弯曲强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可在约0.5至0.9之间。在一些实施方案中，相对剪切强度可为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可在约0.5至0.9之间。
图1Q-1S示出了具有中央内腔151的植入物结构150的另一个实施方案。每个顶端152可被倒角或倒圆并且可具有位于沿着顶端152的长度的离散点处的多个凹坑或空腔153。这些凹坑153从顶端152并且朝向中央内腔151延伸，但未到达中央内腔151。在一些实施方案中，凹坑153具有弯曲切槽形状，其可在形状上对应于圆柱体的一部分。在一些实施方案中，植入物结构140的远端154可以成锥形以便于植入到骨头中。在一些实施方案中，图1Q-1S中所示的植入物结构150具有约为0.89的相对弯曲强度和约为0.86的相对剪切强度。在一些实施方案中，为了用骨移植材料装入植入物结构150，在植入之前或植入期间该骨植入材料被从外部施加至植入物结构150。除了接纳这些骨移植材料，凹坑153还用来消除或减少拐角晕圈效应。
在一些实施方案中，凹坑153可具有顶端152的长度(L7)的约0.06的长度(L6)或直径。在一些实施方案中，凹坑153可具有大于或小于顶端152的长度的约0.06的长度或直径。在一些实施方案中，凹坑153可与相邻凹坑153以凹坑长度或直径的约2/3的距离隔开(S4)。在一些实施方案中，凹坑153可与相邻凹坑153以大于或小于孔直径的约2/3的距离隔开。在一些实施方案中，相对弯曲强度可以为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对弯曲强度可以在约0.5至0.95之间。在一些实施方案中，相对剪切强度可以为至少约0.5、0.6、0.7、0.8或0.9。在一些实施方案中，相对剪切强度可以在约0.5至0.95之间。
图1T-1V示出了具有中央内腔161的植入物结构160的另一个实施方案。每个顶端162具有沿顶端162的长度延伸的凹槽163。在一些实施方案中，植入物结构160的远端164可以成锥形以便于种植到骨头中。在一些实施方案中，图1T-1V中所示的植入物结构160具有约为0.87的相对弯曲强度和约为0.88的相对剪切强度。在一些实施方案中，为了用骨移植材料装入植入物结构160，在植入之前或植入期间骨移植材料被从外部施加到植入物结构160。除了接纳骨植入材料，凹槽163还用来消除或减少拐角晕圈效应。
在一些实施方案中，凹槽163可以是沿顶端162延伸的圆形切槽，该凹槽163具有面165的宽度的约0.25的直径(D5)以及面165的宽度的约0.28的弧长。在一些实施方案中，凹槽163可具有大于或小于面165的宽度的约0.25的直径。在一些实施方案中，凹槽163可具有大于或小于面165的宽度的约0.28的弧长。
在侧向入路的一个实施方案中(见图5、图6和图7A/7B)，一个或多个植入物结构20被穿过髂骨、SI-关节侧向地引入到骶骨中。图6和图7A/7B中最清楚地示出了该路径和植入物结构20的产生的放置。在所示的实施方案中，以这种方式放置三个植入物结构20。而且，在所示的实施方案中，植入物结构20是由直线构成的横截面并且在这种情况下为三角形，但应当理解的是，可以使用植入物结构20的其它横截面。另外，上述所公开的植入物结构中的任何一种都可用于本文的植入过程中。
在进行侧向植入过程之前，医生使用例如Fortin手指测试、大腿骨推力试验、FABER(外展、外旋并屈曲)、骶髂关节扭转试验(Gaenslen’s)、压缩、牵张、以及诊断SI关节注射来鉴定待固定或融合(关节固定)的SI-关节段。
辅以侧向、入口和出口C形臂视图，并且患者处于俯卧位，医生对齐坐骨大切迹和然后翼状部(使用侧向可视化)以提供真实的侧向位置。以与骶管的后皮质对准开始做出3cm的切口，然后将钝性组织与髂骨分离。从侧向视图看，导销38(具有套筒(未示出))(例如，斯坦曼钉)开始时在低于骶骨终板和骶管正前方的位置处置于髂骨上。在出口视图中，导销38应以前部的浅角平行于骶骨终板(例如，如图7B所示偏离水平方向15至20度)。在侧向视图中，导销38应位于骶骨前壁的后部。在入口视图中，导销38不应妨碍骶骨小孔。这大体对应于图2A和2B中示意性地示出的顺序。在移去导销套(未示出)之前，软组织保护器(未示出)期望地在导销38之上滑动并紧紧贴着髂骨。
如图2C中示意性地所示，在导销38之上(并穿过软组织保护器)，先导孔42以前述的方式被钻出。先导孔42穿过髂骨、SI-关节并且延伸到骶骨中。随后移去打孔钻头40。
成形拉刀44在导销38之上(并穿过软组织保护器)被掘进先导孔42中，以形成具有植入物结构20所期望的轮廓的拉削孔48，该轮廓在所示的实施方案中是三角形的。这大体对应于图2D示意性地示出的顺序。在图5中也示出了拉削孔48的三角形轮廓。
图2E和图2F示出了软组织保护器或扩张器或递送套筒200的组件的实施方案，该组件具有钻头套筒202、导销套筒204和手柄206。在一些实施方案中，钻头套筒202与导销套筒204可插入软组织保护器200内以形成软组织保护器组件210，该软组织保护器组件210可以在导销208之上滑动直至实现骨接触。该软组织保护器200可以是本文所公开的软组织保护器或扩张器或递送套筒中的任意一种。在一些实施方案中，如本文所公开的可张开的扩张器或递送套筒200可以代替常规的软组织扩张器使用。在使用可张开扩张器的情况下，在一些实施方案中，在钻头套筒202和/或导销套筒204插入可张开的扩张器之前，可张开的扩张器可在导销之上滑动并且然后张开。在其它实施方案中，将钻头套管202和/或导销套筒204插入可张开的扩张器内可以用于张开可张开的扩张器。
在一些实施方案中，在将软组织保护器组件210在导销之上滑动之前，可使用扩张器打开穿过组织的通道。例如，使用多个连续较大的扩张器或使用可张开的扩张器，一个或多个扩张器可被放置在导销上。穿过组织的通道形成之后，可以移去该一个或多个扩张器，且软组织保护器组件可在导销上滑动。在一些实施方案中，可张开的扩张器在张开后可作为软组织保护器。例如，张开后，可将钻头套筒和导销套筒插入可张开的扩张器中。
如图5和图6所示，三角形植入物结构20现可被穿过软组织保护器在导销38之上并穿过髂骨、穿过SI-关节并且被掘进骶骨中，直至植入物结构20的近端靠着髂骨的外侧壁齐平(也参见图7A和7B)。拔出导销38和软组织保护器，将植入物结构20留在拉削通道内，与髂骨的外侧壁齐平(见图7A和7B)。在所示实施方案中，如图6清楚地所示，以这种方式植入了两个另外的植入物结构20。在其它实施方案中，植入物结构20的近端仍然突出于髂骨的外侧壁，使得它们在髂骨外延伸1mm、2mm、3mm或4mm。这确保了植入物1020接合髂骨的硬皮质部分而不是仅接合较软的松质骨部分，如果没有硬皮质骨的结构支撑，植入物1020可能穿过松质骨部分迁移。该硬皮质骨还可承载通常由植入物1020施加在骨头上的负荷或力。
植入物结构20可根据局部解剖结构确定大小。对于SI-关节，代表性的植入物结构20可取决于局部解剖结构在大小上变化，在长度上从约35mm至约70mm以及约7mm的内切直径(即，具有约10.5mm的高度以及约12mm的底边的三角形)。通过使用人体骨骼解剖学的教科书并结合他们对患部及其病症或损伤的知识，医学专业人员可大体了解局部结构的形态。另外，基于使用例如平片X射线、荧光镜X射线或MRI或CT扫描对目标骨形态所进行的在先分析，医生也能够确定植入物结构20的尺寸。
使用侧向入路，一个或多个植入物结构20可以以微创性方式穿过SI-关节单独插入，如已经描述的。常规的组织进入工具、闭塞器、插管和/或钻头可用于该目的。可选择地，也可以使用上文以及题为“TISSUEDILATOR AND PROTECTER(组织扩张器和保护器)”且于2012年3月9日提交的共同待决的第61/609,043号美国申请中描述的新型组织进入工具。在插入路径形成之前或植入物结构20插入之前，不需要关节准备、移除软骨或进行刮擦，因此可形成大小近似等于或约等于植入物结构20最大外直径的微创性插入路径。
植入物结构20可避免对自体骨移植材料、另外的螺钉和/或杆、中空的模块化的锚固螺钉、插管的压缩螺钉、关节内的螺纹架或骨折固定螺钉的需要。另外，根据医生的判断，骨移植材料和其它固定装置可以与植入物结构20结合使用。
在代表性的过程中，根据患者的大小和植入物结构20的大小，可以使用一至六个或可能多达八个植入物结构20。移植之后，患者将被建议在融合发生时防止或减少装入SI-关节。根据患者的健康状况和他或她对术后协议的遵守情况，这可能为约六至十二周的时间段或更长。
植入物结构20使与传统开放手术相比更少侵入性、没有大范围软组织剥离的手术技术成为可能。SI-关节的侧向入路提供了一种补充微创手术技术的简单的手术方法。植入物结构20的轮廓和设计最小化了或减少了转动和微移动。钛合金制成的刚性植入物结构20提供了即时术后SI关节稳定性。包括不规则表面上的多孔等离子体涂层的骨向内生长区域24支持稳定的骨固定/融合。植入物结构20和手术方法使设计为以最大化术后承重能力的较大的融合表面区域的放置成为可能，并提供专门设计为使重负载SI-关节稳定的生物力学上严格的植入物。
在一些实施方案中，如图8A和图8B所示，植入物结构800可以具有由多个壁802形成的直线围成的横截面轮廓，该多个壁802具有近似为2mm至3mm，或1mm至5mm，或小于近似5mm、4mm、3mm或2mm的厚度。在一些实施方案中，由直线围成的横截面轮廓可以是三角形、正方形或矩形。在一些实施方案中，植入物结构800可以具有大体上直线围成的横截面轮廓，该横截面轮廓由被多个壁联结在一起的多个顶端形成。薄壁植入物结构800可几乎不需要骨准备而穿过骨头。例如，在一些实施方案中，植入物结构800可以不用预先形成形状类似于植入物结构800的孔而被驱动到骨头中。在一些实施方案中，植入物结构800的远端804可被变锋利和/或具有类似凿子的切割边缘以便于在植入物结构800前进时切割骨头。在一些实施方案中，植入物结构800插入骨头中之前可以使用骨凿以切割骨头。例如，题为“SYSTEMS AND METHODS FORREMOVING AN IMPLANT(用于移除植入物的系统和方法)”且于2013年3月15日提交的美国临时申请61/800,966(其为了所有目的通过引用以其整体并入本文)中描述的骨凿可适合于预切割骨头以便于插入植入物结构800而不用形成完整的孔。在一些实施方案中，可以如上所述形成孔，并且然后可将植入物结构800插入孔中。
在一些实施方案中，如图8A和图8B所示，形成植入物结构800的多个壁802的远端部分具有穿孔806。例如，植入物结构800的配置为嵌入骶骨或第二骨段中的远端部分可被穿孔，而植入物结构800的配置为嵌入髂骨或第一骨段中的近端部分可不含穿孔。在其它实施方案中，植入物结构800的近端部分可被穿孔，而植入物结构800的远端部分可不含穿孔。另一些实施方案中，如图9A和图9B以及本文所述的其它实施方案所示，穿孔可以穿过植入物结构每个壁或侧部的整个面分布。在一些实施方案中，穿孔的集中度或数量可以在植入物结构的一部分中高于植入物结构的其他部分。
在一些实施方案中，如图8A和图8B所示，这些穿孔806可以是椭圆形的或圆形的或曲线形的，使得穿孔806不具有角部。在一些实施方案中，穿孔806可以交错、随机排列或以其它方式以不对齐型式穿过每个壁802分布。例如，在一些实施方案中，每个纵列的穿孔可以与相邻纵列的穿孔交错或偏移。在一些实施方案中，穿孔可以可选择地或另外地沿植入物结构800的纵向轴线交错。这种不对齐布置的穿孔可为植入物结构提供改进的结构强度。
在一些实施方案中，植入物结构800的大小可以如本文所述的任何其它植入物结构。在一些实施方案中，如图8B所示，可将植入物结构800的大小设置成使得植入物结构800具有内切具有约为8mm或在约4mm至12mm之间的直径的圆的壁。在一些实施方案中，可将植入物结构800的大小设置成使得壁内切具有等于或约等于导销的直径的直径的圆。在一些实施方案中，植入物结构800可具有带圆形开口812的盖子810的近端808，该圆形开口812允许导销的路径。
在一些实施方案中，如图9A和图9B所示，植入物结构900可以类似于图8A和图8B所述的实施方案，除了穿孔902均匀地穿过植入物结构的面分布。图9B示出了骨头在植入物结构900的穿孔902和内腔内生长和/或穿过植入物结构900的穿孔902和内腔生长。在一些实施方案中，显示在植入物结构900的内腔内的骨头可以是植入物结构900前进到骨中后保留的原来的骨头，即自移植植入物。在一些实施方案中，图9A和图9B所示的植入物结构900的内腔以及本文所述的其它植入物结构可以填充有骨材料和/或生物助剂，例如颗粒骨、同种异体移植骨、自体移植骨、羟磷灰石、骨形态生成蛋白及类似物，以促进在植入物结构900内的骨向内生长。当植入物结构900被插入孔中时，这可能是适合的，使得在植入以后，植入物结构900的内腔是空的或大体上是空的并且可填充有骨生长促进材料。另外，如上所述，例如利用等离子体涂层工艺可以粗糙化和/或涂覆植入物结构的内表面和/或外表面，以提供多孔或粗糙化的表面。
术语“约”和“近似”及类似术语可表示在设定的值或范围的10％、20％或30％内。
本文公开的装置和方法的变化和修改将对本领域技术人员是显而易见的。同样，应当理解的是，前述的详细说明和附图旨在用于清楚和理解的目的，而不意在限制本发明的由在此所附权利要求所界定的范围。本文描述的任何一个实施方案中描述的任何特征可与其他实施方案中的任何一种中的任何其他特征组合，无论是否是优选的。
应当理解的是，本文所述的示例与实施方案仅仅是为了说明的目的，并且根据其的各种修改和变化将被建议给本领域所属技术人员，并将包括在该申请的精神和范围内以及所附权利要求的范围内。本文引用的所有公布、专利和专利申请为了所有目的在此通过引用并入。

Claims (27)

1.一种用于骨固定的植入物，所述植入物包括：
长形主体，其具有纵向轴线和横向于所述纵向轴线的由直线围成的横截面；多个面；多个顶端，其联结所述多个面；中央内腔，其沿所述长形主体的所述纵向轴线延伸；以及多个孔，其具有在所述多个面上的开口，其中所述孔与所述中央内腔流体连通。
2.根据权利要求1所述的植入物，其中所述孔是圆形的。
3.根据权利要求1所述的植入物，其中所述孔是椭圆形的。
4.根据权利要求1所述的植入物，其中所述孔布置在每个面上的单一纵列上。
5.根据权利要求1所述的植入物，其中所述孔布置在每个面上的多个纵列上。
6.根据权利要求1的植入物，其中所述长形主体涂覆有生物助剂。
7.根据权利要求1所述的植入物，其中所述孔具有大约等于所述中央内腔的直径的直径。
8.根据权利要求1所述的植入物，其中所述孔具有在所述面的宽度的约0.2至0.5之间的直径。
9.一种用于骨固定的植入物，所述植入物包括：
长形主体，其具有纵向轴线和横向于所述纵向轴线的由直线围成的横截面；多个面；多个顶端，其联结所述多个面；中央内腔，其沿所述长形主体的所述纵向轴线延伸；以及多个侧部凹坑，其沿所述多个面中的每一个的一部分延伸，其中所述侧部凹坑具有不延伸至所述中央内腔的深度。
10.根据权利要求9所述的植入物，其中所述多个面中的每一个具有仅一个侧部凹坑。
11.根据权利要求9所述的植入物，其中所述侧部凹坑中的每一个在所述面中的每一个上居中。
12.根据权利要求9所述的植入物，其中所述侧部凹坑具有在所述面的宽度的约0.2至0.8之间的宽度以及在所述面的长度的约0.5至0.9之间的长度。
13.根据权利要求9所述的植入物，还包括位于所述侧部凹坑内的多个孔，其中所述孔与所述中央内腔流体连通。
14.一种用于骨固定的植入物，所述植入物包括：
长形主体，其具有纵向轴线和横向于所述纵向轴线的由直线围成的横截面；多个面；多个顶端，其联结所述多个面；以及中央内腔，其沿所述长形主体的所述纵向轴线延伸，其中，所述多个顶端中的每一个包括沿所述顶端的长度延伸的凹槽。
15.一种用于骨固定的植入物，所述植入物包括：
长形主体，其具有纵向轴线和横向于所述纵向轴线的由直线围成的横截面；多个面；多个顶端，其联结所述多个面；以及中央内腔，其沿所述长形主体的所述纵向轴线延伸，其中，所述多个顶端中的每一个包括位于沿每个顶端的长度的离散点处的多个凹坑。
16.一种用于骨固定的植入物，所述植入物包括：
长形主体，其具有纵向轴线、远端、近端以及横向于所述纵向轴线的由直线围成的横截面；多个面，每个面由具有厚度上在约2mm至3mm之间的厚度的壁形成；以及多个穿孔，其布置在每个面上。
17.根据权利要求16所述的植入物，其中所述长形主体的所述远端被形成为一个或多个切割边缘。
18.根据权利要求16所述的植入物，其中所述由直线围成的横截面具有三个边。
19.根据权利要求16所述的植入物，其中所述由直线围成的横截面具有四个边。
20.根据权利要求16所述的植入物，其中所述穿孔位于所述长形主体的配置为被植入患者骶骨内的远端部分上，而所述长形主体的配置为被植入髂骨内的近端部分没有穿孔。
21.根据权利要求16所述的植入物，其中所述穿孔以交错的型式布置。
22.根据权利要求16所述的植入物，还包括所述长形主体的所述近端上的盖子，所述盖子具有孔，所述孔的大小适于接纳导销。
23.根据权利要求16所述的植入物，其中所述长形主体具有多孔的内表面和外表面。
24.根据权利要求16所述的植入物，其中所述长形主体具有粗糙化的内表面和外表面。
25.根据权利要求16所述的植入物，其中所述长形主体具有等离子体涂覆的内表面和外表面。
26.根据权利要求16所述的植入物，其中所述长形主体具有涂覆有生物助剂的内表面和外表面。
27.根据权利要求26所述的植入物，其中所述生物助剂是骨形态生成蛋白。
CN201380023464.8A 2012-05-04 2013-05-06 穿孔植入物 Pending CN104334092A (zh)

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