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    • 2. 发明公开
    • 척추원판의 핵의 적어도 일부를 대체하기 위한 하이드로겔기재의 보철 장치
    • 用于替代脊髓核的一部分的基于水凝胶的前置装置
    • KR1020050092762A
    • 2005-09-22
    • KR1020057013169
    • 2003-01-16
    • 리플리케이션 메디칼, 인크
    • 스토이,블라디미르,에이.
    • A61F2/44
    • A61F2/442A61F2002/30014A61F2002/30016A61F2002/30075A61F2002/30125A61F2002/30324A61F2002/30448A61F2002/30563A61F2002/30971A61F2002/444A61F2002/4495A61F2210/0061A61F2220/005A61F2230/0008A61F2250/0018A61F2250/0019A61F2250/0036A61F2310/00365
    • The present invention is a prosthetic for replacement of at least a part of the nucleus of a intravertebral disc. The prosthetic device is composed of at least two substantially parallel soft layers (13, 15, 17, 19) of an elastically deformable hydrogel and at least one more rigid layer (21, 23, 25), the more rigid layer having less compressibility than the soft layers, being adjacent to the soft layers, and firmly attached to them. In some embodiments, the soft layers have the same thickness and composition. Typically, the prosthesis has more than one more rigid layer and these more rigid layers have the same thickness and composition. The number of soft layers is usually one more than the number of more rigid layers, with, e.g., at least three soft layers. The invention also includes a method of prosthesis production, which involves prefabricating soft and more rigid layers; stacking at least two prefabricated soft and at least one prefabricated more rigid layer in a substantially parallel fashion into their final form, and, permitting the layers to firmly connect to one another by mutual interaction. In this method, at least one type of the layers is prefabricated in the dehydrated state, which is done by dehydrating stretched foil in an apparatus preventing its contraction and thereby decreasing its area. There is at least partial dehydration of the prosthesis under pressure applied in a direction tangent to the planes of the layers. In preferred embodiments, while in the state of almost full dehydration, the implant is sterilized using ionizing radiation or a gaseous chemical agent, after which it is partially rehydrated within a sterile wrapper using water vapor.
    • 本发明是用于替代椎间盘的核的至少一部分的假体。 所述假体装置由至少两个基本平行的可弹性变形的水凝胶和至少一个更刚性层(21,23,25)的软层(13,15,17,19)组成,所述刚性层的压缩性比 软层,与软层相邻,并牢固地附着在它们上。 在一些实施例中,软层具有相同的厚度和组成。 通常,假体具有多于一个的刚性层,并且这些更刚性的层具有相同的厚度和组成。 软层的数量通常比更刚性层的数量多一个,例如至少三个软层。 本发明还包括假体生产方法,其涉及预制柔性和更刚性的层; 将至少两个预制的软的和至少一个预制的更刚性的层以基本上平行的方式堆叠成其最终形式,并且允许层通过相互作用彼此牢固地连接。 在这种方法中,至少一种类型的层是在脱水状态下预制的,其通过在防止其收缩的装置中脱水拉伸的箔并因此减小其面积来实现。 在与层的平面相切的方向上施加压力的假体至少部分脱水。 在优选的实施方案中,在几乎完全脱水的状态下,使用电离辐射或气体化学试剂对植入物进行灭菌,然后使用水蒸气在无菌包装内部分地再水合。