WO2010051690A1 - 带安全保护装置的自动柔性角膜上皮刀 - Google Patents

带安全保护装置的自动柔性角膜上皮刀 Download PDF

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Publication number
WO2010051690A1
WO2010051690A1 PCT/CN2009/070232 CN2009070232W WO2010051690A1 WO 2010051690 A1 WO2010051690 A1 WO 2010051690A1 CN 2009070232 W CN2009070232 W CN 2009070232W WO 2010051690 A1 WO2010051690 A1 WO 2010051690A1
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Prior art keywords
cutter head
separating piece
separator
lasik
motor assembly
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PCT/CN2009/070232
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English (en)
French (fr)
Inventor
卢先领
褚仁远
张宝华
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无锡市康明医疗器械有限公司
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Publication of WO2010051690A1 publication Critical patent/WO2010051690A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/013Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea

Definitions

  • the present invention relates to an ophthalmic surgical instrument, and more particularly to a safe and reliable, high-precision corneal epithelial knife for EPi-lasik surgery for refractive surgery. Background technique
  • excimer laser keratectomy Since the excimer laser used in refractive surgery in the 1980s, excimer laser keratectomy has continued to develop rapidly throughout the world. From excimer laser photorefractive keratectomy (PRK) to excimer laser in situ keratomileusis (LASIK) to excimer laser corneal epithelial keratomileusis (LASEK) to mechanical excimer laser cornea Subepithelial keratomileusis (EPi-LASIK), as well as the current hot spot ultra-thin LASIK surgery, have pushed the imaging level of excimer laser surgery to increase. Despite this, each procedure has its own advantages and disadvantages.
  • PRK excimer laser photorefractive keratectomy
  • LASIK excimer laser in situ keratomileusis
  • LASEK excimer laser corneal epithelial keratomileusis
  • EPi-LASIK mechanical excimer laser cornea Subepithelial keratomileusis
  • PRK is suitable for patients with low myopia, without the need to make a flap, but there is a risk of haze after surgery.
  • the advantage of LASIK is that postoperative visual recovery is fast, but there are corneal flap complications and large aberrations.
  • LASEK is particularly suitable for patients with thin corneal and high myopia. There is no risk of corneal flap complications and small aberrations, but postoperative stimuli are severe, vision recovery is slow, and haze may occur.
  • EPi-LASIK is also especially suitable for patients with corneal thin and high myopia. There is no risk of corneal flap complications and small aberrations. Postoperative stimuli are lighter than LASEK, vision recovery is faster than LASEK, and haze probability is lower than LASEK. .
  • EPi-LASIK surgery has the advantages of both, and overcomes the disadvantages of the two. It is the future development trend and has broader potential and development advantages.
  • the EPi-LASIK epithelial knife has a certain risk of flapping in the production of the epithelial flap, that is, sometimes the epithelial flap will have a little stromal layer, which will have certain adverse effects on postoperative visual acuity, although this probability is not very large.
  • it brings the risk of surgery and the fear of doctors.
  • To promote EPi-LASIK we must solve this risk. Summary of the invention
  • the invention comprises a control box, a cutter head, a separating piece, a double motor component, a suction ring, a water gas separator, a foot switch, a double motor component and a water gas separator respectively connected to the control box, and the cutter head is connected on the double motor component, a separating piece is disposed in the cutting head cavity of the cutter head; wherein: the separating piece is close to the cutting edge A resistance bar is added at a certain distance, and the width of the resistance bar is 1 mm, and the length is equivalent to the separation piece.
  • the distance between the barrier strip of the present invention and the edge of the separator is 60 ⁇ 120 ⁇ .
  • the strip of the invention is provided with an arc-shaped closed groove on the separating piece on the side far from the cutting edge.
  • the curved closed groove of the present invention has a width of 0.25 mm to 0.5 mm.
  • the working principle of the invention is as follows: under the action of the power of the dual motor assembly, the separating piece makes a rapid rotation of the main motor, and the reciprocating linear motion is changed by the shank to obtain the power of separating the epithelium, and the auxiliary motor drives the cutter head assembly to rotate through the suction ring. Or linear motion, to achieve the purpose of safety and flexibility when separating the epithelium.
  • the resistance bar pushes the epithelial resistance to one end of the movement direction, and once the separation piece is cut through the epithelium and penetrates into the matrix layer, the resistance bar prevents the separation piece from going deep down, and the CPU is calculated in real time by 1/1000 second.
  • the treatment software monitors the amount of change in the current consumption of the separated epithelium.
  • the monitoring strip prevents the separation piece from deepening and causes the secondary motor current to start increasing.
  • the current limit is increased as soon as the motor is set. Once the current is increased, the dual motor assembly will automatically stop. This will not hurt the pre-corneal elastic layer.
  • the arc-shaped groove of the separating piece just exceeds the pressure too small to elastically deform the upper and lower blades of the separating piece, and the upper and lower elastic deformations alleviate the positive pressure of the separating piece in the up-and-down slope movement, so that the separating piece forms when the upper skin is separated.
  • the present invention adopts the above technical solutions, and has the following advantages compared with the prior art:
  • the control box of the present invention disconnects the circuit when the current is steeply increased, stops the operation, and ensures that it does not cut into the front elastic layer, thereby greatly improving the safety during use.
  • the invention alleviates the positive pressure of the separation piece in the up and down slope movement, so that the separation piece forms flexibility when separating the epithelium, and achieves the purpose of flexible separation.
  • the present invention is capable of completely separating the epithelial flap without damaging the matrix layer, while retaining the integrity of the corneal epithelial layer and the anterior elastic layer.
  • Figure 1 is a schematic view showing the structure of the present invention.
  • FIG. 2 is a schematic view showing the structure of a dual motor assembly of the present invention.
  • Figure 3 is a schematic view showing the structure of the suction ring of the present invention.
  • Figure 4 is a schematic view showing the structure of the cutter head of the present invention.
  • Fig. 5 is a schematic view showing the structure of a separator having a barrier strip of the present invention.
  • FIG. 6 is a schematic view showing the structure of the barrier strip of the present invention. detailed description:
  • the present invention includes a control box 1, a cutter head 2, a separator 3, a dual motor assembly 5, a suction ring 6, a water gas separator 7, a foot switch 8, a dual motor assembly 5, and a water gas.
  • the separators 7 are respectively connected to the control box 1 , and the double motor assembly 5 is connected to the cutter head 2 .
  • the cutter head 2 is provided with a separating piece 3 in the cutter head cavity, and the cutter head 2 is connected with the suction ring 6; 3
  • a barrier strip 4 is provided on the side wall near the cutting edge, and the strip 4 has a width of 1 mm and a length equal to that of the separator 3.
  • the distance L2 between the barrier strip 4 of the present invention and the cutting edge of the separator 3 is 60 ⁇ n! ⁇ 120 ⁇ m.
  • the resisting strip 4 of the present invention is provided with a curved closing groove 9 on the separating piece 3 on the side far from the cutting edge.
  • the width L1 of the curved closed groove 9 of the present invention is 0.25 mm to 0.5 mm.
  • M represents the value of the separation epithelium: the requirement is a relatively constant constant value
  • N represents the bluntness of the separator. Unit: Newton;
  • F unit normal pressure on the cornea of the separator. Unit: Newton;
  • VI linear linear velocity of the separator. Unit: m/Sec;
  • V2 Separator (Motor) Forward center point rotation linear velocity Unit: m/Sec.
  • the control box is a dual motor power source that not only drives the main and auxiliary motors, but also creates a vacuum to attract the suction ring 6 to the eyeball. More importantly, the control box 1 automatically controls the flapping process to achieve a safe and reliable flap.
  • the main and auxiliary motors during operation are sampled in real time by the sampling circuit, and the auxiliary motor operating current is compared with the safety value by 1/1000 second. When the current is steeply increased, the circuit is disconnected and stopped. Work to ensure that it does not cut into the front elastic layer.
  • the control box CPU knows the working current of the secondary motor through sampling, thereby tracking the current magnitude in time. If the separation piece is cut into the front elastic layer, the secondary motor current must exceed the safe current range due to the blockage of the resistance, thereby cutting off the voltage of the dual motor and stopping the operation. At the same time, due to the effect of the arcuate groove of the separation piece, the elasticity increases during the process of the lobes, and according to the separation force, the formula is adopted, because the cutting edge contacts the surface of the cornea, and the positive pressure N is slowed down.
  • the corneal epithelial knives of the present invention are designed to have clear requirements on the length of the arcuate groove of the separator, the distance of the strip from the edge of the separator, and the control performance requirements of the control box, thereby ensuring that the epithelial keratome can be
  • the epithelial flap with basement membrane is completely separated, and the stromal layer is not damaged, ensuring the safety and reliability of the operation.
  • the barrier strip 4 of the present invention may be a biocompatible metal such as stainless steel or titanium alloy, or may be a biocompatible non-metal such as a crystal or an organic resin, and the shape may be square, rectangular or round, regardless of the connection method. It is glued or laser spliced.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Description

带安全保护装置的自动柔性角膜上皮刀 技术领域
本发明涉及一种眼科手术器械, 特别涉及一种屈光矫正手术用的安全可 靠、 高精确度的 EPi-lasik手术用的角膜上皮刀。 背景技术
自从上世纪八十年代准分子激光用于屈光矫正手术以来, 准分子激光角 膜屈光手术在全世界范围内一直持续快速地发展。 从准分子激光屈光性角膜 切削术 (简称 PRK) 到准分子激光原位角膜磨镶术 (简称 LASIK) 到准分子 激光角膜上皮瓣磨镶术 (简称 LASEK) 到机械法准分子激光角膜上皮瓣下磨 镶术(简称 EPi-LASIK), 以及目前热点超薄 LASIK手术, 推动准分子激光手 术的成像水平不断提高。 尽管如此, 各种手术各有其优缺点, PRK适用于低 度近视眼患者, 无需制作角膜瓣, 但术后有产生 haze的风险。 LASIK优点是 术后视力恢复快, 但存在角膜瓣并发症和像差大。 LASEK特别适用于角膜薄 和高度近视眼患者, 没有了角膜瓣并发症的风险和像差小, 但是术后剌激症 状重, 视力恢复慢, 且可能产生 haze。 EPi-LASIK也特别适用于角膜薄和高 度近视眼患者, 没有了角膜瓣并发症的风险和像差小, 术后剌激症较 LASEK 轻, 视力恢复较 LASEK快, 产生 haze概率也低于 LASEK。 其中 EPi-LASIK 手术相比较而言, 具备了两者的优势, 又克服了二者的劣势, 是今后的发展 的趋势, 具有更广阔的潜力和发展优势。 但 EPi-LASIK上皮刀在制作上皮瓣 存在一定的制瓣风险, 即有时上皮瓣会带有一点基质层, 这给术后的视力带 来一定的不利影响, 虽然这种概率不是很大, 但毕竟带来了手术风险和医生 的恐惧感, 为此要全力推广 EPi-LASIK, 必须要解决这一风险。 发明内容
本发明目的是提供一种安全性高、 分离片在分离时实现柔性分离、 很好 的保留角膜上皮层和前弹力层完整性的带安全保护装置的自动柔性 EPi-LASIK上皮刀。
本发明包括控制箱、 刀头、 分离片、 双电机组件、 吸环、 水气分离器、 脚踏开关, 双电机组件、 水气分离器分别与控制箱连接, 双电机组件上连接 刀头, 刀头的刀头腔内设置分离片; 其特征在于: 所述分离片靠近刃口处的 一定距离增加设置一阻条, 所述阻条的宽度为 1mm,长度与分离片等同。
本发明的阻条与分离片刃口之间的距离为 60 μ ηι〜120 μ ηι。
本发明的阻条远离刃口一侧的分离片上开设一条弧形封闭槽。
本发明的弧形封闭槽的宽度为 0.25mm〜0.5mm。
本发明的工作原理是: 分离片在双电机组件动力的作用下, 作出主电机 快速旋转, 经刀柄改为往复直线运动, 得到分离上皮的动力, 副电机通过吸 环带动刀头组件作旋转或直线运动, 达到分离上皮时具有安全保护和柔性的 目的。 分离片在分离上皮时阻条把上皮阻推到运动方向的一端, 而一旦分离 片切过上皮深入到基质层则阻条就阻止分离片深入下走, 以 1/1000秒实时监 控的 CPU计算治疗软件来监控分离上皮消耗电流的变化量, 监控阻条阻止分 离片深入而导致副电机电流启动增加, 按原先设定电机瞬间增加了电流限量, 增加电流一旦超过, 则双电机组件会自动停止, 这样就不会伤及角膜前弹力 层。 而分离片在分离上皮时由于角膜是靠分离片压平分离的, 由于分离片开 了一条弧形的封闭槽, 因而分离片就会随着分离片沿着角膜上下坡面增大减 小压力, 而分离片弧形槽正好超过随压力太小而使分离片的刀头上下弹性变 形, 这一上下弹性变形也就缓解了分离片在上下坡运动中正压力, 使分离片 在分离上皮时形成柔性, 达到柔性分离的目的。
本发明采用上述技术方案, 与现有技术相比具有如下优点:
1、 本发明的控制箱在电流陡增时会断开电路, 停止工作, 确保不会切入 前弹力层内, 大大提高了使用时的安全性。
2、 本发明缓解了分离片在上下坡运动中正压力, 使分离片在分离上皮时 形成柔性, 达到柔性分离的目的。
3、 本发明能够完全分离出上皮瓣而不会伤及基质层, 又保留了角膜上皮 层和前弹力层的完整性。 附图说明
图 1是本发明的一种结构示意图。
图 2是本发明双电机组件的结构示意图。
图 3是本发明吸环的结构示意图。
图 4是本发明刀头的结构示意图。
图 5是本发明带阻条的分离片的结构示意图。
图 6是本发明阻条的结构示意图。 具体实施方式:
下面结合附图对本发明的技术方案进行详细说明:
如图 1-6所示: 本发明包括控制箱 1、 刀头 2、 分离片 3、 双电机组件 5、 吸环 6、 水气分离器 7、 脚踏开关 8, 双电机组件 5、 水气分离器 7分别与控 制箱 1连接, 双电机组件 5上连接刀头 2, 刀头 2的刀头腔内设置分离片 3, 刀头 2上连接吸环 6; 其特征在于: 所述分离片 3靠近刃口处的侧壁上设置阻 条 4, 所述阻条 4的宽度为 1mm,长度与分离片 3等同。
如图 5所示, 比较好的是: 本发明的阻条 4与分离片 3刃口之间的距离 L2为 60 μ n!〜 120 μ m。
如图 5所示, 比较好的是: 本发明的阻条 4远离刃口一侧的分离片 3上 设置弧形封闭槽 9。
如图 5所示,比较好的是:本发明的弧形封闭槽 9的宽度 L1为 0.25mm〜 0.5mm。
本发明的分离片开槽后使分离片具有柔性特性, 使在分离上皮瓣时同样 遵循数学模型 M= , 上式中:
M: 代表分离上皮的定值: 要求是一个相对稳定的恒值;
N: 代表分离片的钝度 单位: 牛顿;
F: 分离片在角膜上的单位法向正压力 单位: 牛顿;
VI: 分离片的直线线速度 单位: m/Sec;
V2: 分离片 (器) 前进中心点旋转线速度 单位: m/Sec。
控制箱为双电机动力源, 不仅驱动主副电机, 且还产生真空使吸环 6 吸 附眼球。 更重要的是控制箱 1 对制瓣过程中的自动控制, 以实现安全可靠的 制瓣。 其内设有一 CPU 治疗计算软件, 通过采样电路对工作时的主副电机进 行实时采样, 并对副电机工作电流 1/1000秒与安全数值进行比较, 在电流陡 增时会断开电路, 停止工作, 确保不会切入前弹力层内。
在具体工作过程中, 当分离片 3接触角膜表面时, 控制箱 CPU通过采样 获知副电机工作电流, 从而及时跟踪电流大小。 如果分离片切入至前弹力层, 则由于阻条的阻止前进, 副电机电流必然超过安全电流范围, 从而切断双电 机的电压停止工作。 同时由于分离片的弧形槽的作用在制瓣过程中弹性增加, 根据分离力遵循公式 由于刃口接触角膜表面, 减缓了正压力 N增
Figure imgf000005_0001
大, 分离片的直线线速度 VI降低, 分离片的旋转线速度 V2也降低, 分离片 的钝度 K也增大, 因此分离片的基本分离能力不变, 确保了分离过程中的安 全可靠。
本发明的角膜上皮刀在设计上对分离片的弧形槽长宽、 阻条距离分离片 的刃口的距离、 以及控制箱的控制性能要求都有明确的要求, 从而确保该上 皮角膜刀可以完全分离出带基底膜的上皮瓣, 而且不会伤及基质层, 确保手 术的安全可靠, 术后不存在角膜瓣并发症的问题, 推动 EPi-LASIK手术在准 分子激光手术的应用, 为广大患者带来安全可靠的医疗器械。
本发明的阻条 4 可以是不锈钢、 钛合金等生物相容性的金属, 也可以是 水晶, 有机树脂等生物相容性非金属, 形状不论是方的、 长方, 圆的, 连接 方法不论是胶接或激光悍接的。
以上诸实施例仅供说明本发明之用, 而非对本发明的限制, 有关技术领 域的技术人员, 在不脱离本发明的精神和范围的情况下, 还可以作出各种变 换或变化, 因此所有等同的技术方案也应该属于本发明的各权利要保护范畴 内。

Claims

权 利 要 求 书
1、一种带安全保护装置的自动柔性 EPi-LASIK上皮刀,包括控制箱(1)、 刀头 (2)、 分离片 (3)、 双电机组件 (5)、 吸环 (6)、 水气分离器 (7)、 脚 踏开关 (8), 双电机组件 (5)、 水气分离器 (7) 分别与控制箱 (1) 连接, 双电机组件 (5) 上连接刀头 (2), 刀头 (2) 的刀头腔内设置分离片 (3), 刀头 (2) 可在吸环 (6) 的端平面上实施滑动切割; 其特征在于: 所述分离 片 (3) 靠近刃口处的侧壁上设置阻条 (4), 所述阻条 (4) 的宽度为 1mm,长 度与分离片 (3) 等同。
2、根据权利要求 1所述的带安全保护装置的自动柔性 EPi-LASIK上皮刀, 其特征在于: 所述阻条 (4) 与分离片 (3) 刃口之间的距离为 60 μη!〜 120 μ m。
3、根据权利要求 1所述的带安全保护装置的自动柔性 EPi-LASIK上皮刀, 其特征在于: 位于阻条 (4) 远离刃口一侧的分离片 (3) 上开设一条弧形封 闭槽 (9)。
4、根据权利要求 1所述的带安全保护装置的自动柔性 EPi-LASIK上皮刀, 其特征在于: 所述弧形封闭槽 (9) 的宽度为 0.25mm〜0.5mm。
PCT/CN2009/070232 2008-11-07 2009-01-21 带安全保护装置的自动柔性角膜上皮刀 WO2010051690A1 (zh)

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CN107837463B (zh) * 2017-10-31 2024-01-12 重庆京渝激光技术有限公司 带脚踏开关收纳功能的激光治疗仪

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