WO2007019748A1 - Microkératome multifonction - Google Patents

Microkératome multifonction Download PDF

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Publication number
WO2007019748A1
WO2007019748A1 PCT/CN2006/000234 CN2006000234W WO2007019748A1 WO 2007019748 A1 WO2007019748 A1 WO 2007019748A1 CN 2006000234 W CN2006000234 W CN 2006000234W WO 2007019748 A1 WO2007019748 A1 WO 2007019748A1
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WO
WIPO (PCT)
Prior art keywords
motor
microkeratome
vacuum pump
blade
multifunctional
Prior art date
Application number
PCT/CN2006/000234
Other languages
English (en)
French (fr)
Inventor
Renyuan Chu
Baohua Zhang
Original Assignee
Wuxi Kangming Medical Device Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wuxi Kangming Medical Device Co., Ltd. filed Critical Wuxi Kangming Medical Device Co., Ltd.
Publication of WO2007019748A1 publication Critical patent/WO2007019748A1/zh

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Classifications

    • 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
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0133—Knives or scalpels specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00544—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated pneumatically

Definitions

  • the invention relates to an ophthalmic surgical instrument, in particular to a multifunctional microkeratome.
  • the microkeratome is used to make the corneal flap and the epithelial flap to match the excimer laser surgery to correct the refractive error.
  • the cornea Because the cornea has no rejection, it can be used for the treatment of corneal diseases, corneal plate grafting, limbal transplantation, corneal epithelial transplantation and corneal stem cell transplantation, thus expanding the application range of the keratome, making the original complex
  • the operation of keratopathy has become simpler and has greatly improved the success rate and effect of the operation.
  • our corneal transplant knife has undergone corneal transplantation surgery in various hospitals across the country, and our equipment has been further improved from the clinical perspective. More use, widely used. Providing hospitals with a wider range of medical instruments with better surgical results, so that patients get better gospel.
  • Two different types of operations can be performed using the same system, by replacing individual counterparts (knife heads, blades or suction rings), including Molecular laser in situ corneal infarction, corneal lamellar transplantation, direct mechanical separation of epithelium, corneal epithelial transplantation, limbal transplantation, corneal stem cell transplantation, various ophthalmic corneas and other surgical types.
  • the technical solution of the present invention is a multifunctional microkeratome, comprising a control system and a body of a keratome, and a vacuum pump, the lancet body comprising a dual motor composed of a first motor and a second motor
  • the control system comprises: an input device, selecting a type of surgical operation according to a user's needs; a control device for controlling start and stop of the vacuum pump and feeding and retracting of the lancet body; sampling device, The vacuum pressure of the vacuum pump and the operating current of the first motor are sampled, and the sampled value is provided to the central processing unit for determination; the output device, Outputting a video signal of the vacuum pressure of the vacuum pump and a determination result to perform an audio alarm; the central processing unit, according to the type of operation determined by the input device, simultaneously determining whether the vacuum pump provides a normal working vacuum pressure according to the selected operation, and the control station The work of the first and second motors is described.
  • the keratome body further comprises: a suction ring assembly comprising a suction ring with a handle, a circumferential groove is formed on an inner side surface of the suction ring, and an eyebrow groove is opened at a suction opening of the suction ring a cutter head including a cutter head body and a blade, the blade being chucked in a cutter body structure, the cutter head body including a connection portion detachably and connectable with the dual motor assembly, the connection portion The opposite side is a blade holder, and the two ends of the blade holder respectively extend along the connecting portion to form an extending portion, and a bracket for the blade is disposed on the blade seat between the extending portions.
  • the type of surgical operation includes a first type of operation and a second type of operation.
  • the first type of operation is for surgery including excimer laser in situ corneal ablation, corneal transplantation, limbal transplantation, and corneal stem cell transplantation.
  • the second type of operation is for surgery including mechanical subcutaneous flap excimer laser in situ grinding and epithelial transplantation.
  • the rotation speed of the first motor is inversely proportional to the bluntness of the blade
  • the rotation speed of the second motor and the unit normal pressure on the cornea of the blade In an inverse relationship, the product of the rotational speed of the second motor and the unit normal normal pressure of the blade on the cornea is proportional to the product of the rotational speed of the first motor and the bluntness of the blade.
  • the suction ring has a circular shape, and an arcuate opening centered on the center point is formed on the circular body.
  • the cutter head is a dock type flexible cutter head.
  • the cutter head body further includes: a crystal glass piece disposed between the extensions of the front plane of the separation cutter body.
  • control device is a three-position foot switch, comprising: a vacuum control position for controlling the start and stop of the vacuum pump and self-locking; and an infeed control position for controlling the advancement of the microkeratome Knife; retraction control position, used to control the retraction of the sacral keratome.
  • Figure 1 is a schematic view showing the structure of the present invention
  • FIG. 2 is a block diagram showing the composition of the control system of the present invention.
  • FIG. 3 is a flow chart showing the operation of the CPU of the present invention.
  • Figure 4 is an exploded perspective view of the main body of the corneal knife of the present invention.
  • Figure 5 (a), 5 (b) are schematic diagrams of the cutter head for the first type of operation and the cutter head for the second type of operation;
  • Figure 6 (a) is a schematic view of the structure of a suction ring
  • Figure 6 (b) shows a schematic view of the structure of the suction ring including the corneal stem cell transplantation.
  • the multifunctional microkeratome of the present invention is shown in FIG. 1.
  • the composition of the keratome comprises two parts of the control box 1 and the keratome body 2 which are connected to each other.
  • a portion of the control box 1 in which the vacuum pump 105, the CPU 101 as a control system, and a battery (not shown) as a pump power source are disposed are disposed in the control box 1.
  • FIG. 2 including a central processing unit (hereinafter referred to as CPU) 101, an input device 102, a control device 103, a sampling device 104, a vacuum pump 105, a suction ring 106, and a first motor (also referred to as a vice Motor) 107, a second motor (also referred to as a main motor) 108, an output device 109, a tool tip body 110, and a blade 111.
  • CPU central processing unit
  • the input device 102 is selected by the operator to perform the first operation type, which is also referred to as the L operation or the second operation type, and is also referred to as the E operation.
  • the L procedure here is used for surgery including LASIK, corneal transplantation, limbal transplantation, and corneal stem cell transplantation.
  • the E procedure here is for surgery including Epi-LASIK and epithelial transplantation.
  • the signal of the selected operation is transmitted to the CPU 101.
  • a three-position foot switch is adopted, and the three gear positions respectively correspond to three pedal positions, respectively: a vacuum control position for controlling the start and stop of the vacuum pump 105, and the requirement is Self-locking structure; Infeed control position, used to control the feeding of the microkeratome; Retraction control position, used to control the retraction of the microkeratome.
  • the above three different control signals are transmitted to the CPU 101.
  • the sampling device 104 compares the magnitude of the vacuum pressure of the vacuum pump 105 with the operating current of the first motor 107, and supplies the sampled value to the CPU 101 for judgment.
  • the output device 109 is for outputting a video signal of the vacuum pressure of the vacuum pump and the judgment result to perform an audio alarm.
  • the first motor 107 is configured to control the movement of the cutter body 110 along the center line of the cutter head, and the second motor 108 is used to control the movement of the blade 111 perpendicular to the centerline of the cutter head.
  • the operation of both motors 107, 108 is controlled by the CPU 101.
  • the vacuum pump 105 communicates with the suction ring 106 through the air passage, and is also connected to the sample device 104 through the air passage.
  • step S1 initialization of the entire system is performed, the process including setting two predetermined vacuum ranges of the operation, and setting a predetermined value of the blocking current stopped by the first motor 107;
  • Step S2 receiving an input signal, which is an L operation or an operation determined by the operator through the input device 102;
  • Step S3 determining whether the vacuum is activated, the determination is determined by the CPU 101 receiving the signal of the vacuum control position of the control device 103;
  • Step S4 if the CPU 101 receives the signal of the vacuum control bit of the control device 103, indicating that the control device 103 has selected the vacuum control gear position, the vacuum pump is in the working state, and then outputs the current vacuum pressure value to the display interface through the output device 109 for operation. If the result of the determination in step S3 is that the vacuum is not activated, return to step S3, continue to judge and wait for the selection of the control device 103;
  • Step S5 determining whether the sampling vacuum falls within a predetermined range, which is a vacuum range corresponding to the L operation and the E operation in the step S1;
  • Step S6 if the vacuum air pressure at this time falls within the corresponding operating range that meets the requirements, an alarm is given to the operator through the output device 109, indicating that the surgical vacuum requirement is met at this time;
  • step S7 the infeed is performed.
  • the CPU 101 controls the second motor 108 to drive the blade 111 according to the nl rotation speed to reciprocate according to the linear velocity v1, and also controls the first motor 107 to drive the knife according to the rotation speed of ⁇ 2.
  • the head body 110 moves forward along the suction ring 106 according to the linear velocity v2;
  • step S8 it is determined whether the sampling current is greater than a preset value, that is, the sampling current of the first motor 107 is sampled by the sampling device 104, and the sampling current value is compared with the set current value of the first motor in the initialization of step S1. ;
  • Step S9 if the sampling current is greater than the preset current value, indicating that the feed resistance is too large, in order to prevent the forced feed from injuring the patient's cornea, the feed is stopped; if the sampling current is less than the preset current value, returning to step S8 , continue to sample;
  • Step S10 the control performs the retraction, specifically, the CPU 101 controls the cutter head body 110 through the first motor 107;
  • step S11 it is determined whether the vacuum pump 105 is closed. Once the operator selects the retracting control position to close the vacuum pump 105 through the control device 103 during the retracting process, the vacuum pump 105 is determined by the vacuum sample value, and if it is closed, the entire process is ended. If the vacuum pump 105 is not turned off, the process returns to step S7, indicating that the surgical operation is not completed, and the infeed operation is continued.
  • the keratome body 2 shown in Fig. 4 includes a dual motor assembly 5, which further includes a first motor 107 and a second motor 108, and a cutter body 110 and a blade 111 which are respectively driven by the two motors.
  • the suction ring assembly 4 which is connected to the front end of the cutter head body 110, is formed by the suction ring assembly 4 and is movably connected to the cutter head body 110. It should be noted that, for the E operation, the blunt blade 111 is combined with the cutter head 110 to form the cutter head assembly 3; for the L operation, the sharp blade 111 is combined with the cutter head 110 to form the cutter head assembly 3.
  • It consists of a mating cutter head assembly 3, a suction ring assembly 4 with a handle, and a dual motor assembly 5, wherein the cutter head assembly 3 includes a cutter head body 110 and a blade 111.
  • Figure 5 (a) shows the structure of the cutter head body in the cutter head assembly 3 in the E operation
  • the body 65 includes a joint portion 61 detachably and connectable with the double motor assembly 5, the opposite side of the joint portion 61 It is a blade holder 64, and the front end forms symmetrical head body extensions 631, 632.
  • Figure 5 (b) shows the structure of the cutter head body of the cutter head assembly 3 in the L operation. The difference from FIG. 5(a) is that the cutter head body 66 in the L operation is characterized in that the front plane is provided with the crystal glass 62; and the cutter head body 65 in the E operation in FIG. 5(a) is open. Visible, no front plane.
  • Figure 6 (a) shows the structure of the conventional surgical suction ring 106, and the improvement of the two authorized invention patents (ZL01143742. ZL01279997. 1) of the present applicant in 2001 is that the inner side of the suction ring assembly 4 is disposed.
  • the circumferential groove 12 and the eyebrow groove 14 are added at the suction opening 13, thereby ensuring that the vacuum line of the suction ring assembly 4 is unobstructed, and the stability of the vacuum creates a necessary condition for the smooth operation of the operation.
  • Fig. 6(b) shows a suction ring structure including a corneal stem cell transplantation operation, which is different from Fig. 6(a) in that the suction ring body is not circular but has a circular structure in a circle.
  • the shape of the main body is centered on the center point, and an arcuate opening 21 is provided.
  • the eyeball is not exposed from the entire circle during the operation, but is exposed from the curved opening 21 of the one-month curved shape.
  • two motors 107 and 108 need to be selected according to the working rate, wherein: the velocity v2 of the first motor 108 is inversely related to the blunt K of the separation piece 111, The rate v1 of the second motor 107 is inversely proportional to the unit normal positive pressure N of the separator 111 on the cornea. In addition, it is necessary to consider a proportional relationship between LX v2 and NX vl.
  • the epithelial separation is preferably separated from the basement membrane and the front elastic layer.
  • the epithelium is relatively thin, about 60 ⁇ less, and the thickness of each epithelium is different.
  • the hardness is softer than that of the front elastic layer.
  • the basement membrane is about 2 ⁇ , soft and hard between the two; therefore, the bluntness of the separation must be ensured to cut into the epithelium including the basement membrane but not to damage the front elastic layer. This is the value required for separation. Determined by the following mathematical model -
  • the fixed value M of the separated epithelium is inversely proportional to the bluntness of the separator, and is proportional to the positive pressure of the separator on the cornea, proportional to the linear velocity of the separation of the separator, and the rotational speed of the separator is separated from the separator. In inverse proportion.
  • N is at the minimum value
  • VI and V2 are at a fixed value
  • K is always a constant value during the whole separation process, because once the separation piece is determined, the K value is determined accordingly. It will change again, this is the setting of the dullness of the separation piece.
  • the principle of the range of M is the minimum value of the epithelium that can be separated from the basement membrane, leaving the epithelium without damaging the maximum value of the anterior elastic layer.
  • K is a fixed value
  • N is a variable value. It is a curved variable value map 1 from the beginning to the end, and V2 in VI and V2. Once selected, it is also a fixed value like the K value. It requires that the separation process be evenly distributed throughout the separation process so that it is on a smooth separation surface.
  • VI is a variable opposite to N. Only the relative changes of N and VI can balance the M value.
  • the range of M is that after the K and V2 are basically determined, the relative changes of N and VI will be guided. M is stable.
  • the positive pressure N value is the positive pressure on the contact length of the unit separator, for the separator, the starting point is brought into contact with the longest length of the contact, and the contact positive pressure is also from the beginning to the middle to the middle. It is necessary to flatten the cornea with a height of nearly 2 mm. This is a variable value, which exceeds the value of the VI variable. This is a difficult point we have encountered in balancing these factors. Another difficulty is that the separation of the epithelium is separated from the basement membrane and the front elastic layer. How to ensure The separator does not damage the front elastic layer as the positive pressure changes, which requires the separator to be "dock floating" in the separator, and the separator is intelligent.
  • the separator When the separator enters the basement membrane at the beginning, the separator hits the harder front elastic layer and intelligently pushes up gradually under the push of the front elastic layer, and the normal positive pressure component of the separator on the cornea gradually increases. After the center, the upward thrust of the front elastic layer is gradually reduced, the positive pressure is gradually reduced, the normal positive pressure component is gradually reduced, and the unit positive pressure is gradually reduced.
  • the value of V2 should be such that the smart dock-type separator has a separation.

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Description

多功能微型角膜刀 技术领域
本发明涉及一种眼科手术器械， 尤其是一种多功能微型角膜刀。
背景技术
微型角膜刀用以制作角膜瓣和上皮瓣来配合准分子激光手术校正屈光不正，本申 请人于 2003年 11月 19日申请国家发明专利 "一种角膜瓣无压力退刀装置" 申请号 200310108685. 3, 有效地解决了制作超薄角膜瓣的难题； 又于 2004年 5月 26日申请 了 "自动眼角膜上皮分离装置"专利号： ZL 20040023091. 2， 有效地解决了不再用酒 精浸泡而用机械力直接分离上皮的机械法上皮瓣下准分子激光角膜原位磨削术（以下 简称 Epi-LASIK) , 准分子激光角膜原位磨削术 （以下简称 LASIK) ， 使准分子激光 屈光手术更趋完善。 从这些基本手术中， 本发明人就自然联想到角膜移植， 二者的差 别仅仅是有否瓣的蒂。 正是由于角膜没有排异性， 因而在医治角膜病时， 可以进行角 膜板层移植、 带角膜缘移植、 角膜上皮移植和角膜干细胞移植， 这样就把角膜刀的应 用范围扩大了，使原先复杂的角膜病手术变为较为简单而且大大提高了手术的成功率 和效果， 近年来由于我公司的角膜移植刀在全国各家医院进行角膜移植手术， 从临床 上又进一步改进了我们的器械， 使一刀多用、 广用。 为医院提供应用更为广泛、 手术 效果更加好的医疗仪器， 使患者得到更好的福音。
发明内容
本发明的目的在于提供一种机械力切割角膜或分离角膜上皮的装置， 能用同一 套系统进行两种不同类型的操作， 通过更换个别对应部件（刀头、 刀片或吸环）， 完成 包括准分子激光角膜原位磨削术、 角膜板层移植、 直接用机械力来分离上皮的方法、 角膜上皮移植、 带角膜缘移植、 角膜干细胞移植多种眼科角膜等多种手术类型。
为了实现上述目的， 本发明的技术方案为， 一种多功能微型角膜刀， 包括 控制系统和角膜刀主体两部分， 以及真空泵， 所述角膜刀主体包括由第一、 第 二电机组成的双电机组件， 其中所述控制系统包括： 输入装置， 根据用户需要 选择手术操作类型； 控制装置， 用于控制所述真空泵的启动和停止和所述角膜 刀主体的进刀和退刀； 采样装置， 对所述真空泵的真空压力大小以及所述第一 电机的工作电流进行采样，将采样值提供给中央处理单元进行判断；输出装置， 输出所述真空泵的真空压力大小的视频信号和判断结果进行音频报警； 中央处 理单元， 根据所述输入装置确定的操作类型， 同时判断所述真空泵是否根据选 定操作提供正常工作真空气压， 控制所述第一、 第二电机的工作。
比较好的是， 所述角膜刀主体进一步包括： 吸环组件， 包括一带手柄的吸 环，在所述吸环的内侧面开设有圆周槽沟，在所述吸环的吸口处开设有眉毛槽； 刀头， 包括刀头本体和刀片， 所述刀片卡设在刀头本体结构中， 所述刀头本体 包括与所述双电机组件之间可拆卸与连接的连接部，所述连接部的相对侧是刀 片座， 所述刀片座的两端沿连接部为对称中心分别伸出形成延伸部， 在该延伸 部之间的刀片座上幵设有卡设刀片的卡座。
比较好的是， 所述手术操作类型包括第一操作类型和第二操作类型。
比较好的是，所述第一操作类型用于包括准分子激光角膜原位磨削、角膜 移植、 带角膜缘移植和角膜干细胞移植在内的手术。
比较好的是，所述第二操作类型用于包括机械法上皮瓣下准分子激光角膜 原位磨削手术和上皮移植在内的手术。
比较好的是， 选择第二操作类型时， 所述第一电机的转速与所述刀片的钝 度为反比关系，所述第二电机的转速与所述刀片在角膜上的单位法向正压力为 反比关系，且所述第二电机的转速与所述刀片在角膜上的单位法向正压力之积 与所述第一电机的转速与所述刀片钝度之积为正比关系。
比较好的是， 所述吸环呈圆形状， 在在圆形主体的上开设一以中心点为圆 心的弧形开口。
比较好的是， 选择第二操作类型时， 所述刀头为一船坞式柔性刀头。
比较好的是， 选择第一操作类型时， 所述刀头本体进一步包括： 水晶玻璃 片， 设置在所述分离刀头本体前平面的延伸部之间。
比较好的是，所述控制装置是一个三档位的脚踏开关，包括：真空控制位， 用于控制真空泵的启动和停止和自锁； 进刀控制位， 用于控制微型角膜刀的进 刀； 退刀控制位， 用于控制徼型角膜刀的退刀。
附图说明
下面， 参照附图， 对于熟悉本技术领域的人员而言， 从对本发明方法的详细描 述中， 本发明的上述和其他目的、 特征和优点将显而易见。 图 1是本发明的构成示意图；
图 2是本发明控制系统的组成框图；
图 3是本发明的 CPU的工作流程图；
图 4是本发明的角膜刀主体分解示意图；
图 5 ( a) 、 5 (b)分别是是用于第一操作类型时的刀头和用于第二操作类型时的 刀头结构示意图；
图 6 ( a) 是一吸环的结构示意图； 图 6 (b)给出包括用于角膜干细胞移植手术的 吸环结构示意图。
具体实施方式
本发明的多功能微型角膜刀如图 1所示，结合图 2所示的控制系统的框图可以看 出， 该角膜刀的组成包括互相连接的控制箱 1和角膜刀主体 2两部分， 在该控制箱 1 中装设有真空泵 105和作为控制系统的 CPU101以及作为泵动力源的蓄电池 （未图示 出） 等部分均设置在控制箱 1中。
请参见附图 2所示的控制系统框图， 包括中央处理器 （以下简称 CPU) 101、 输 入装置 102、 控制装置 103、 采样装置 104、 真空泵 105、 吸环 106、 第一电机 （又称 为副电机） 107、 第二电机 （又称为主电机） 108、 输出装置 109、 刀头本体 110以及 刀片 111。
在上述组成中， 输入装置 102， 是由操作者选择进行第一操作类型， 又称为 L操 作或第二操作类型， 又称为 E操作。 这里的 L操作用于包括 LASIK、 角膜移植、 带角 膜缘移植和角膜干细胞移植在内的手术。这里的 E操作用于包括 Epi-LASIK和上皮移 植在内的手术。
一旦选定其中一种操作类型， 将该选定操作的信号传送给 CPU101。 在具体实现 控制装置 103时， 采用的是一个三档位的脚踏开关， 三个档位分别对应三个踏板位， 分别是： 真空控制位， 用于控制真空泵 105的启动和停止， 要求为自锁结构； 进刀控 制位， 用于控制微型角膜刀的进刀； 退刀控制位， 用于控制微型角膜刀的退刀。 上述 三种不同的控制信号传送给 CPU101。采样装置 104, 对真空泵 105的真空压力大小以 及第一电机 107的工作电流进行釆样， 将采样值提供给 CPU101进行判断。 输出装置 109用于输出真空泵的真空压力大小的视频信号和判断结果进行音频报警。
其中， 第一电机 107用于控制刀头本体 110沿刀头中心线方向运动， 第二电机 108用于控制刀片 111垂直于刀头中心线方向运动。 两电机 107、 108的工作过程均 受到 CPU101的控制。
此外， 真空泵 105通过气路与吸环 106相连通， 同时还是通过气路与釆样装置 104相连。
下面结合图 3， 说明 CPU101的工作流程情况。
在步骤 S1中， 进行整个系统的初始化， 此过程包括设定^ E操作的两种预定真 空范围， 以及设定第一电机 107停止的阻断电流的预定值；
步骤 S2，接收输入信号，该输入信号是操作者通过输入装置 102所确定的进行 L 操作或 E搡作中哪一种；
步骤 S3， 判断真空是否启动， 这个判断是通过 CPU101收到控制装置 103真空控 制位的信号来确定；
步骤 S4， 如果 CPU101收到控制装置 103真空控制位的信号， 表明控制装置 103 选定了真空控制档位， 真空泵处于工作状态， 继而通过输出装置 109将当前真空压力 数值输出在显示界面上供操作者参考； 如果步骤 S3的判断结果为真空未启动， 返回 步骤 S3， 继续判断并等待控制装置 103的选择；
步骤 S5， 判断采样真空是否落入预定的范围内， 该预定的范围是对应于步骤 S1 中 L操作和 E操作所设定的真空范围；
步骤 S6， 如果此时的真空气压落入符合要求的对应操作范围内， 通过输出装置 109向操作者进行报警提示， 表明此时满足手术真空要求；
步骤 S7， 执行进刀， 具体来说， 此时 CPU101控制第二电机 108按照 nl转速带 动刀片 111， 使其按照线速度 vl进行往复平动， 同时还控制第一电机 107按照 π2的 转速带动刀头本体 110按照线速度 v2沿吸环 106向前运动；
步骤 S8, 判断采样电流是否大于预设值， 即由釆样装置 104对第一电机 107的 工作电流进行采样， 并将采样电流值与步骤 S1初始化中的第一电机的设定电流值进 行对比；
步骤 S9, 如果采样电流大于预设的电流值， 表明进刀阻力过大， 为防止强制进 刀对患者角膜产生伤害， 则停止进刀； 如果采样电流小于预设的电流值， 则返回步骤 S8, 继续进行采样；
步骤 S10,控制执行退刀，具体是由 CPU101通过第一电机 107控制刀头本体 110; 步骤 Sll，判断真空泵 105是否关闭，一旦操作者在退刀过程中通过控制装置 103 选择退刀控制位关闭真空泵 105， 此时通过真空釆样值确定是否关闭真空泵 105， 如 果关闭， 则结束整个流程， 如果真空泵 105未关闭， 返回步骤 S7， 表明手术操作并 未完成， 继续执行进刀操作。
图 4给出的角膜刀主体 2包括双电机组件 5， 该双电机组件 5中进一步包括了第 一电机 107和第二电机 108， 以及分别由两电机驱动的刀头本体 110和刀片 111。 此 外，连接在刀头本体 110前端的由吸环 106构成的吸环组件 4与刀头本体 110为活动 连接。 需要说明的是， 对于 E操作时， 采用钝性刀片 111与刀头 110组合形成刀头组 件 3; 对于 L操作时， 釆用锋利刀片 111与刀头 110组合形成刀头组件 3。
由互相配合的刀头组件 3、 一带手柄的吸环组件 4和双电机组件 5组成， 其中的 刀头组件 3包括刀头本体 110和刀片 111两部分。
图 5 ( a) 给出了 E操作中刀头组件 3中刀头本体的结构， 该本体 65包括一与 双电机组件 5之间可拆卸与连接的连接部 61， 该连接部 61的相对侧是一刀片座 64， 前端形成对称的刀头本体延伸部 631、 632。 图 5 ( b ) 是 L操作中刀头组件 3的刀头 本体结构。 与图 5 (a)的区别之处在于， L操作中的刀头本体 66的特点是其前平面上 镶有水晶玻璃 62; 而图 5 ( a)中 E操作中的刀头本体 65是敞开式可视，没有前平面。
图 6 ( a) 为普通手术用吸环 106的结构， 与本申请人于 2001年两个授权发明 专利 ( ZL01143742. ZL01279997. 1 ) 的改进之处在于， 在吸环组件 4的内侧面设置 了圆周沟槽 12， 并在吸口处 13添加了一眉毛槽 14， 从而保证了吸环组件 4的真空管 路畅通无阻， 真空的稳定可靠为手术的顺利进行创造了必要条件。
图 6 (b)给出包括用于角膜干细胞移植手术的吸环结构，有别于图 6 ( a)之处在 于， 该吸环主体并非呈圆环状， 而是呈圆形结构， 在圆形主体的上以中心点为圆心， 设有一弧形开口 21， 由此， 手术时眼球不是从整圆中暴露出来， 而是从一个月弯型 的弧形开口 21中暴露出来。
此外， 还需要说明的是， 在该角膜刀的设计过程中， 需要根据工作速率选择两电 机 107、 108， 其中： 第一电机 108的速率 v2与分离片 111的钝度 K呈反比关系， 第 二电机 107的速率 vl与分离片 111在角膜上的单位法向正压力 N呈反比关系，此外， 还需要考虑 L X v2与 N X vl之间保持正比关系。
上述关系可以从如下的分离过程中得到理解。 在进刀的过程中， 由真空泵 105 产生的真空通过吸环 106吸附眼球， 同时眼球又有自身的眼内压， 故对分离片 111有 反作用力， 从而形成分离片 111在角膜上的单位法向正压力 N。
根据角膜结构的要求，上皮分离最好是从基底膜与前弹力层分离，上皮是比较薄 的， 约 60 μ不到， 各个人的上皮均有厚度的差异， 硬度与前弹力层相比较软， 基底 膜约 2 μ， 软硬介于二者之间； 因而分离的钝度要保证能切入上皮包括基底膜但又切 不可伤及前弹力层， 这就是分离要求的定值 Μ， 此值由以下数学模型决定-
Λ , N ' Vl
M=
K - V2
上述表达式说明了分离上皮的定值 M与分离片的钝度成反比， 与分离片在角膜 上的正压力成正比， 与分离片的分离直线线速度成正比， 与分离器片分离旋转速度成 反比。
当分离片接触上皮开始分离上皮时， N是处于最小值， VI、 V2均处于定值， K 在整个分离过程中一直是一个定值， 因为分离片一旦确定， K值也就随之确定不会再 改变了， 这就是制作分离片的钝度的定值。
M的取值范围原则就是能从基底膜上分离开上皮的最小值， 分离开上皮又不伤 及前弹力层的最大值。
M值相关的 、 N、 VI、 V2四个值中， K是一个定值， 而 N是一个变值， 随 起始到结束它是一个带弧形变值图一， 而 VI、 V2中 V2—旦选定也和 K值一样是一 个定值。 它要求分离片整个分离过程是均速的， 这样才在一个平滑的分离面。 只有 VI是一个与 N相反的变值， 只有 N、 VI的相对变化才能平衡 M值， 当然 M取值范 围是在已有 K和 V2基本确定后， 才会有 N、 VI的相对变化导之 M的稳定。 由于正 压力 N值取值是单位分离片接触长度上正压力，对分离片来说，把起始位置点接触到 中间最长长度的接触， 而接触正压力也从起始近于 0到中间要把近 2mm高度角膜压 平。 这是一个变量值， 这个变量值超过 VI的变量值， 这是我们平衡这几个因素关系 遇到的一个难点， 另一个难点是分离片分离上皮是从基底膜与前弹力层分离， 如何保 证分离片随着正压力变化而不伤及前弹力层， 这就要求分离片在分离器中是 "船坞浮 动的"， 分离片是智能的。 当分离片一开始进入基底膜， 分离片碰到较硬的前弹力层 就智能地在前弹力层推动下逐步向上转，分离片在角膜上的法向正压力分量就逐步增 大了。 过中心后随着前弹力层的向上推力逐步减少， 正压力逐步减小， 法向正压力分 量逐步减小， 单位正压力逐步减小。 V2的取值应是使智能船坞式分离片在分离中有 足够时间向上转， 向下转的反应时间， 而 VI则应在 N最大值区域要减小分离片的分 离线速度， 所以主电机的力矩不能是"钢"性的， 需要在一定负载下不一定"软"性， 而这 "钢"性变 "软"性值不能太大， 只要填补 N的变化量， 使 M值相对稳定这就是 N最大区域与 VI "软"性的平衡。 至此分离上皮的基本数学模型公式就建立起来了。
根据前述的数学模型 M在制瓣过程中
Figure imgf000009_0001
保持恒定， 这样把角膜上皮从基底膜与前弹力层分离开来。
前面提供了对较佳实施例的描述， 以使本领域内的任何技术人员可使用或利用 本发明。对这些实施例的各种修改对本领域内的技术人员是显而易见的， 可把这里所 述的总的原理应用到其他实施例而不使用创造性。 因而， 本发明将不限于这里所示的 实施例， 而应依据符合这里所揭示的原理和新特征的最宽范围。

Claims

权利要求
1、 一种多功能微型角膜刀， 包括控制系统和角膜刀主体两部分， 以及真空 泵， 所述角膜刀主体包括由第一、 第二电机组成的双电机组件， 其中所述控制 系统包括：
输入装置， 根据用户需要选择手术操作类型；
控制装置， 用于控制所述真空泵的启动和停止和所述角膜刀主体的进刀和 退刀；
采样装置， 对所述真空泵的真空压力大小以及所述第一电机的工作电流进 行釆样， 将釆样值提供给中央处理单元进行判断；
输出装置， 输出所述真空泵的真空压力大小的视频信号和判断结果进行音 频报警；
中央处理单元， 根据所述输入装置确定的操作类型， 同时判断所述真空泵 是否根据选定操作提供正常工作真空气压， 控制所述第一、 第二电机的工作。
2、 根据权利要求 1所述的多功能微型角膜刀， 其特征在于， 所述角膜刀 主体进一步包括：
吸环组件， 包括一带手柄的吸环， 在所述吸环的内侧面开设有圆周槽沟， 在所述吸环的吸口处开设有眉毛槽；
刀头， 包括刀头本体和刀片， 所述刀片卡设在刀头本体结构中， 所述刀头 本体包括与所述双电机组件之间可拆卸与连接的连接部，所述连接部的相对侧 是刀片座， 所述刀片座的两端沿连接部为对称中心分别伸出形成延伸部， 在该 延伸部之间的刀片座上开设有卡设刀片的卡座。
3、 根据权利要求 2所述的多功能微型角膜刀， 其特征在于， 所述手术操 作类型包括第一操作类型和第二操作类型。
4、 根据权利要求 3所述的多功能微型角膜刀， 其特征在于， 所述第一操 作类型用于包括准分子激光角膜原位磨削、 角膜移植、 带角膜缘移植和角膜干 细胞移植在内的手术。
5、 根据权利要求 3所述的多功能微型角膜刀， 其特征在于， 所述第二操 作类型用于包括机械法上皮瓣下准分子激光角膜原位磨削手术和上皮移植在 内的手术。
6、 根据权利要求 5所述的多功能微型角膜刀， 其特征在于，
选择第二操作类型时，所述第一电机的转速与所述刀片的钝度为反比关系， 所述第二电机的转速与所述刀片在角膜上的单位法向正压力为反比关系，且所 述第二电机的转速与所述刀片在角膜上的单位法向正压力之积与所述第一电 机的转速与所述刀片钝度之积为正比关系。
7、 根据权利要求 2或 4或 5所述的多功能微型角膜刀， 其特征在于， 所述吸环呈圆形状，在在圆形主体的上开设一以中心点为圆心的弧形开口。
8、 根据权利要求 5所述的多功能微型角膜刀， 其特征在于， 选择第二操作 类型时， 所述刀头为一船坞式柔性刀头。
9、 根据权利要求 4所述的多功能微型角膜刀， 其特征在于， 选择第一操作 类型时， 所述刀头本体进一步包括- 水晶玻璃片， 设置在所述分离刀头本体前平面的延伸部之间。
10、根据权利要求 8或 9所述的多功能微型角膜刀， 其特征在于， 所述控 制装置是一个三档位的脚踏开关， 包括：
真空控制位， 用于控制真空泵的启动和停止和自锁；
进刀控制位， 用于控制微型角膜刀的进刀；
退刀控制位， 用于控制微型角膜刀的退刀。
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