CN1026754C - 眼球内压消除装置及其植入方法 - Google Patents
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Abstract
本发明涉及一种多孔装置,供植入眼巩膜组织中以降低青光眼的眼球内压,并涉及手术植入该装置的方法。
Description
本发明涉及眼病治疗过程中眼房水从眼中的排除。具体地说,本发明涉及一种植入装置,这种装置永久固定或者说植入到眼中的特定部位时能在比迄今所能达到的更长的时间内有效地起上述排液的作用;总之,能消除和防止(或至少能延迟)青光眼极端有害的后果。
眼球由三个基本层组成:(1)巩膜,(2)中层和(3)视网膜。
巩膜是眼球的外层,它由支撑眼构架组织用的坚韧白组织组成。巩膜在眼睛的前部延伸到清彻透明的角膜,光线即通过角膜进入眼中。角膜台面是一个小空间,即前房,其中含有清彻水样的流体,叫做眼房水。
中间层由三部分构成:(1)脉络膜,(2)睫状肌,和(3)虹膜。脉络膜在眼球后面两侧,形成中层大约80%的部分,它含有滋养眼睛的大部分血管。
脉络膜趋向眼球前面的部分成睫状肌。睫状肌由纤维连接到晶状体,使晶状体保持就位并控制着晶状体的形状。
中层的最前端形成虹膜,这是晶状体前面薄薄的由组织组成的屏障。虹膜中的圆孔叫做瞳孔,其大小由虹膜中的肌群控制。
简单说来,角膜使光通过前房再通过瞳孔这个眼睛的入口孔折射到晶状体上。晶状体用来使光通过含玻璃液的玻璃体腔折射到视网膜,即眼睛的后表面上。
在正常的情况下,眼内的流体,即眼房水,是由睫状体产生的,通过瞳孔流入前房,即角膜后面的小空间。房水从前房流过小梁网络(trabecular meshwork)进入形成结膜底下集液管的房水脉中,结膜覆盖住眼球前部,但不盖住角膜。
如前所述,当房水的流动不足以消除眼球内压的升高时就产生青光眼。眼压的这种升高通常是由于小梁网络中有一处或多处阻塞引起的。如果不加以控制,这种与青光眼有关的高压终究会导致视神经的永久性损伤,而视神经是由许多敏感的视网膜纤维形成的。
本发明的目的是提供一种能永久、简单、有效植入眼中,使房水从前房基本上正常流出,从而防止眼球内压不正常升高的装置。另一个目的是以这样的方式进行植入,使得经植入后还可以避免房水过量流出而导致前房因并发症而萎陷。
1984年7月3日颁发给A.C.B.Molteno的美国专利4,457,757涉及使用至少两个脊状体,用两个管状延伸体固定到巩膜上,一个管体通过巩膜连通到前房,以将房水排出眼球外。
1988年6月14日颁发给A.C.B.Molteno的美国专利4,750,901承认其早先(在美国专利4,457,757中所述)的器件有问题。早先的那种器件在插入后的头几天使眼压降到“可能会产生导致破坏视觉的手术并发症”的不能容许的水平。这种眼压的下降是由于病人的眼球筋膜(Tenon capsule)过量吸收房水所致。眼球筋膜是与眼连接时遮住巩膜板的一个光滑层。后一个专利公开了在巩膜板上部表面中使用辅助脊条的作法,由此连同一部分眼球筋膜形成小小的空腔,房水开始时即排到该空腔中,从而使房水只为眼球筋膜露出的小表面部分地吸收。
1987年元月六日颁发给P.S.Binder的美国专利4,634,418涉及将水凝胶hydrogel制成的泄液线植入眼前房中缓和眼球内压的作法。泄液线一经植入就起灯芯的作用,将房水从前房转移到结膜底下的空腔而不致使细菌入侵眼中。植入是在除去角膜矩形段、苏瓦尔伯(Schalbe)线和一部分小梁网络之后进行的。
1988年2月2日颁发给S.Schocket的美国专利4,722,724涉及使用一种包括两根连接管或一根与一个带相连接的管的植入件。一根管安置在前房中,另一根管或带安置在眼眶周围。为防止眼压过低,管端安置有一可破坏的阀,连同内室一起插入,以控制从前房流出的房水的压力。
1988年11月29日颁发给P.S.Bindar的美国专利4,787,885是批准为美国专利4,634,418这一申请的部分继续申请的继续申请。该专利,与其前身一样,也涉及除去矩形角膜段、苏瓦尔伯线和一部分小梁网络以装设泄液线的作法,该泄液线使房水可以从前房流到结膜底下的部位(眼睛外皮)。
在上述两专利中,发明人都达到了使房水流到巩膜外侧,进入结膜和附在结膜上覆盖住巩膜板的眼球筋膜底下形成的空间(即眼睛本体外侧)的目的。鉴于这些部位是治疗过程中特别过分地起作用的部位,眼球内压在短时间内降低;结膜和眼球筋膜底下的空间往往会萎陷,妨碍房水继续从前房流出,从而使眼压升高,这恰恰正是青光眼的病症。
本发明的目的是提供治疗青光眼眼球内压过高的病症的一种装置和方法,该装置和方法采取的方式使自身不致在连续的治疗过程中失效,也就是说,其疗效持续若干年之久。另一个目的是防止其它问题的产生,例如,前房萎陷,瘢痕组织渗遍整个小梁网络,这在现有技术公开的一般青光眼手术(小梁网切开)刚施完手术的术后期间是常常发生的。
本发明涉及一种植入装置,这种植入装置与眼组织生物体相适应,且使房水可以从前房流入巩膜的粗编纤维层中,从而将阻塞的小梁网络旁路,但房水流出后并不离开眼体,而是进入眼球外层,即巩膜中。巩膜中正常的房水压力是用来以这样的方式控制房水从前房的流出,即要使前房灾难性的萎陷可以避免。此外,由于没有在结膜和有关的眼球筋膜底下形成房水收集空间,这些部位的过分治疗作用在过高眼球内压在前房中再形成时就不会发生。
从根本上说,本发明涉及在几乎靠近有毛病的小梁网部位处,即靠近巩膜与角膜的交界处,安置一种多孔材料,这些材料的小孔尺寸类似于或者大于健康小梁网的网孔。这样就把植入装置中有许多孔径较小的细孔的部分安置在巩膜的较大孔的部分中。
具体地说,该眼内压降压装置包括一本体部分和若干基本上呈六面体的体壁部分,至少该体壁部分是由与生物体相适应的多孔水凝胶材料构成的。该装置适宜植入眼巩膜组织内,此装置的至少一个边缘处在前房靠近巩膜移入眼睛清彻角膜的孔口,但不伸入该孔口中。本体部分的细孔,其大小和数量达到这样的程度,使得房水可以从前房流到巩膜组织而又不致使前房萎陷。诸体壁部分的至少一个体壁上起码有一个延伸部分,用以将装置牢牢固定部位。
植入装置由水凝胶或其它与眼组织这个生物体相适应的材料制成。这类水凝胶材料的含水量可以在大约30%至大约80%的范围。一般说来,这类材料包括硅树脂、丙烯酸类聚合物和/或碳氟聚合物等。植入装置的形状应当使装置一经植入眼内就能固定就位,且能形成足以容纳有节制流入的房水的表面积,即房水的流动量足以降低眼球内压但不足以使前房萎陷。
参看附图和下列说明即可更清楚地了解本发明的内容。
图1是眼睛的剖视图,示出了本发明一个实施例的植入装置植入眼内的情况。
图2是本发明这一实施例的植入装置的侧视图。
图3是该实施例的正视图。
图4是该实施例的平面图或顶视图。
图5是本发明另一实施例的侧视图。
图6是该另一实施例的正视图。
图7是该另一实施例的平面图。
在第一实施例中,装置11的外形呈截面基本上为矩形的六面体结构,如图1所示,长约6毫米,宽约3毫米,高约1/2毫米。装置11系设计成准备放入巩膜12中如图1中所示按下述方式
制取的囊中的。在巩膜中距眼睛边缘2毫米处开个切口。揭起矩形巩膜膜片直到清彻的角膜13,该巩膜片的总厚度约1/3毫米。按同样的切口技术在先前切取的膜片下将巩膜12的另一切片揭起,直到清彻的角膜13。然后将这块巩膜切除,一直到前房14的前述伤口边缘15(即巩膜12变为清彻角膜13处)。这时房水就会通过长41/2毫米、宽1毫米、高1/2毫米的孔16进入该空间中(由于角膜呈弧形,因而经切开的组织从侧面看起呈三角形)。
这时把植入装置11安置在巩膜12中形成的那个囊中,装置的前部固定在原先在清彻角膜14中形成的多层架17中。应该指出的是,装置不伸入前房而固定在多层架中可以避免它沿角膜内表面与内皮细胞18接触。这个接触会导致这些细胞死亡,并失去角膜的功能。
在巩膜12后壁、间壁和侧壁作1毫米大小的分层小解剖。采用装有突边的装置的实施例时,突边19(或与装置构成一个整体的延伸部分)就安置在这些层状解剖部分中,使装置11向前滑动,就可以使其牢牢固定在原先制备的角膜多层架17中。必要时还可以将装置缝接固定,确保其保持就位。然后将头一个巩膜片缝回原位。植入装置11就位后的巩膜12,其厚度大致上与加入装置之前相同。
于是房水就会从前房14通过膜片底下的切口流到所植入的装置11。植入装置11则由于其内部20多孔而可以使房水通到巩膜的三个垂直壁中。于是垂直切开的巩膜12的粗编纤维层就可以让房水流出,进入巩膜12的组织21中。
图5、6和7所示的其它实施例也包括类似的基本植入装置11,该装置的尺寸也与上述类似,但植入装置底部周围的四边上都有一个薄突边19(1/8毫米)。该突边只在那些会与巩膜接触的各边伸出1毫米,而形成抬升边缘的边则伸出大约1/2毫米。此抬升边缘是在与巩膜接触处以植入装置垂直壁的1毫米伸长部分22的形式形成。该抬升边缘约1/8毫米厚。突边19即垂直附在该抬升边缘上。附着点处在突边的中段。突边厚1/8毫米,宽2毫米。后段长7毫米,而两边为21/2毫米。
本实施例的植入方式与先前所述的植入装置类似,只是有下列改变。1.初始的巩膜片为1/2毫米。2.不切出巩膜块。3.在膜片底部进行约1毫米的多层解剖。4.开出通入前房的孔口之后,将后突边滑入由多层解剖部分在先形成的空间中,使植入装置安置就位。然后将巩膜片放回其原先位置,并是在上突边底下。该上突边会将切口叠置入巩膜中,以便在各边形成1毫米的膜片,但最远的前方例外(该部分由于设有插入得象结膜那样远因而不会为眼球筋膜所覆盖)。然后通过上突边将巩膜片缝入就位。
这个实施例的器件有助于防止眼球筋膜向内长入切口中,而且会牢牢固定就位。此外本实施例也可以使房水按与上述实施例相同的方式通到巩膜垂直切开的边缘。
本发明的装置的另一种改进方案涉及房水从前房流到巩膜的特殊方法。这个改进方案利用了一种纤维网使房水快速流过各纤维之间的空间。纤维网是由与生物体相适应的材料制成的因而适应性强。纤维网使房水可以流到植入装置的垂直切开边缘和巩膜。
另一种达到多孔性的方法是在植入装置中设通过其中的沟道系。要使房水通过植入装置流到垂直切开的边缘可在其中切出各种形式的沟道。列如,可以采用扇形的钻孔系或从前到后的栅板式钻孔或从边到边钻成的联锁通孔形式等。应达到这样的目的和这样的设计,即,使房水可以如上所述那样通过,而且植入装置不致因施加到其上的压力而萎陷。
插入本发明最佳实施例的植入装置的操作过程一般如下:进行眼球后麻醉之后,将上直肌放在四零级丝质系带缝线(bribal Suture)上。然后将结膜片提起,从上直肌开始,朝前开到边缘,然后将其折回角膜上。用烙器止血并大致确定安置植入装置的位置。用64号毕夫手术刀片(Beaver blade)划出5毫米×3毫米矩形表面的轮廓。在巩膜侧开一个小槽,其深度为巩膜厚度的一半。抓住巩膜的一角,然后在前面剖开膜片,直到该矩形膜片完全揭到清彻的角膜为止。这时用75号刀片刺入眼睛前房中,然后一并切开1毫米×1毫米的角膜和小梁网。使用分层解剖刀解剖矩形膜片层,在膜片底部向后剖开大约0.5毫米。然后把植入装置放入该膜片层中就位,使下后膜片安置在刚在膜
片层后部上形成的小槽中。前部分直接与前房连通。然后把巩膜片放在该植入装置上,并将其一端塞入现有的前突边底下。必要时,可切开巩膜片的一部分,使巩膜平稳地覆在植入装置上。然后用10-0号尼龙缝线通过上突边上的孔将植入装置缝接到巩膜上。最后再用6-0肠缝线将结膜组织缝合在一起恢复原状。
Claims (5)
1、一种降低眼球内压用的装置,该装置包括一本体部分,该本体部分由与生物体相适应的多孔材料构成;其特征在于,该装置适宜植入眼巩膜组织内,使装置的至少一个边缘处在前房的一个孔口,并靠近巩膜移入眼睛清彻角膜的区域,但不伸入前房中;本体部分的细孔,其大小和数量达到这样的程度,使得房水可以从前房流到巩膜组织而又不致使前房萎陷。
2、如权利要求1所述的装置,其特征在于,本体的一面倾斜复在通到前房的孔上,以便将房水从前房引入装置的本体部分。
3、如权利要求1所述的装置,其特征在于,该装置顶部表面的至少一边被伸长,供将装置固定就位之用。
4、如权利要求1所述的装置,其特征在于,该装置顶部表面的三个边缘,不包括在前房孔口处的边缘在内被伸长,供将装置固定就位之用。
5、如权利要求1所述的装置,其特征在于,有一个薄突边从装置底部的四个边伸出,该突边是在装置的后部边上被所述装置的垂直壁延伸部分抬起并使其固定就位。
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US437,840 | 1982-10-29 | ||
US07/437,840 US4946436A (en) | 1989-11-17 | 1989-11-17 | Pressure-relieving device and process for implanting |
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CN1052253A CN1052253A (zh) | 1991-06-19 |
CN1026754C true CN1026754C (zh) | 1994-11-30 |
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CN90109295A Expired - Fee Related CN1026754C (zh) | 1989-11-17 | 1990-11-16 | 眼球内压消除装置及其植入方法 |
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US (1) | US4946436A (zh) |
EP (1) | EP0454838B1 (zh) |
JP (1) | JP3044238B2 (zh) |
KR (1) | KR100187526B1 (zh) |
CN (1) | CN1026754C (zh) |
AT (1) | ATE115388T1 (zh) |
CA (1) | CA2045178C (zh) |
DE (1) | DE69015161T2 (zh) |
DK (1) | DK0454838T3 (zh) |
ES (1) | ES2066416T3 (zh) |
GR (1) | GR3015276T3 (zh) |
IL (1) | IL96242A (zh) |
RU (1) | RU2107481C1 (zh) |
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US10952898B2 (en) | 2018-03-09 | 2021-03-23 | Aquesys, Inc. | Intraocular shunt inserter |
US11135089B2 (en) | 2018-03-09 | 2021-10-05 | Aquesys, Inc. | Intraocular shunt inserter |
CN108524096A (zh) * | 2018-06-28 | 2018-09-14 | 吴莺 | 一种巩膜内固定房水引流装置 |
US11672701B2 (en) | 2018-10-25 | 2023-06-13 | Amo Groningen B.V. | Bleb control glaucoma shunts |
DE102019216248B3 (de) * | 2019-10-22 | 2020-12-24 | Burkhard Awe | Implantat und Implantatsystem zur Vermeidung der Verwachsung und/oder Vernarbung eines mittels Trabekulektomie geschaffenen Skleradeckels |
WO2022150684A1 (en) | 2021-01-11 | 2022-07-14 | Ivantis, Inc. | Systems and methods for viscoelastic delivery |
WO2024209469A1 (en) | 2023-04-03 | 2024-10-10 | Glaucure Ltd | Devices for adjusting the intraocular pressure |
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US3915172A (en) * | 1970-05-27 | 1975-10-28 | Ceskoslovenska Akademie Ved | Capillary drain for glaucoma |
US4037604A (en) * | 1976-01-05 | 1977-07-26 | Newkirk John B | Artifical biological drainage device |
US4457757A (en) * | 1981-07-20 | 1984-07-03 | Molteno Anthony C B | Device for draining aqueous humour |
US4521210A (en) * | 1982-12-27 | 1985-06-04 | Wong Vernon G | Eye implant for relieving glaucoma, and device and method for use therewith |
US4787885A (en) * | 1984-04-06 | 1988-11-29 | Binder Perry S | Hydrogel seton |
US4634418A (en) * | 1984-04-06 | 1987-01-06 | Binder Perry S | Hydrogel seton |
NZ215409A (en) * | 1986-03-07 | 1989-02-24 | Anthony Christopher Be Molteno | Implant for drainage of aqueous humour in glaucoma |
US4722724A (en) * | 1986-06-23 | 1988-02-02 | Stanley Schocket | Anterior chamber tube shunt to an encircling band, and related surgical procedure |
US4936825A (en) * | 1988-04-11 | 1990-06-26 | Ungerleider Bruce A | Method for reducing intraocular pressure caused by glaucoma |
-
1989
- 1989-11-17 US US07/437,840 patent/US4946436A/en not_active Ceased
-
1990
- 1990-10-26 WO PCT/US1990/006216 patent/WO1991007195A1/en active IP Right Grant
- 1990-10-26 AT AT91900637T patent/ATE115388T1/de not_active IP Right Cessation
- 1990-10-26 EP EP91900637A patent/EP0454838B1/en not_active Expired - Lifetime
- 1990-10-26 JP JP3500779A patent/JP3044238B2/ja not_active Expired - Lifetime
- 1990-10-26 ES ES91900637T patent/ES2066416T3/es not_active Expired - Lifetime
- 1990-10-26 KR KR1019910700757A patent/KR100187526B1/ko not_active IP Right Cessation
- 1990-10-26 DK DK91900637.9T patent/DK0454838T3/da active
- 1990-10-26 DE DE69015161T patent/DE69015161T2/de not_active Expired - Fee Related
- 1990-10-26 RU SU5001487A patent/RU2107481C1/ru active
- 1990-10-26 CA CA002045178A patent/CA2045178C/en not_active Expired - Fee Related
- 1990-11-05 IL IL9624290A patent/IL96242A/en not_active IP Right Cessation
- 1990-11-16 CN CN90109295A patent/CN1026754C/zh not_active Expired - Fee Related
- 1990-11-16 ZA ZA909225A patent/ZA909225B/xx unknown
-
1995
- 1995-03-03 GR GR940404176T patent/GR3015276T3/el unknown
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100415190C (zh) * | 2005-10-17 | 2008-09-03 | 西安交通大学 | 一种青光眼房水引流装置 |
Also Published As
Publication number | Publication date |
---|---|
JP3044238B2 (ja) | 2000-05-22 |
GR3015276T3 (en) | 1995-06-30 |
EP0454838B1 (en) | 1994-12-14 |
KR100187526B1 (ko) | 1999-06-01 |
IL96242A0 (en) | 1991-08-16 |
CA2045178A1 (en) | 1991-05-18 |
IL96242A (en) | 1996-10-31 |
WO1991007195A1 (en) | 1991-05-30 |
ES2066416T3 (es) | 1995-03-01 |
AU642498B2 (en) | 1993-10-21 |
AU7786691A (en) | 1991-06-13 |
KR920700710A (ko) | 1992-08-10 |
CA2045178C (en) | 2002-12-31 |
DE69015161D1 (de) | 1995-01-26 |
DE69015161T2 (de) | 1995-05-11 |
EP0454838A4 (en) | 1992-03-18 |
CN1052253A (zh) | 1991-06-19 |
JPH04503767A (ja) | 1992-07-09 |
EP0454838A1 (en) | 1991-11-06 |
ATE115388T1 (de) | 1994-12-15 |
US4946436A (en) | 1990-08-07 |
DK0454838T3 (da) | 1995-05-15 |
RU2107481C1 (ru) | 1998-03-27 |
ZA909225B (en) | 1991-09-25 |
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