WO2011029267A1

WO2011029267A1 - Epithelial knife under guiding of corneal topographic map

Info

Publication number: WO2011029267A1
Application number: PCT/CN2010/001329
Authority: WO
Inventors: 卢先领; 褚仁远; 张宝华; 周行涛; 戴锦辉; 周浩; 王斌
Original assignee: 无锡市康明医疗器械有限公司
Priority date: 2009-09-04
Filing date: 2010-09-01
Publication date: 2011-03-17
Also published as: CN101690686B; CN101690686A

Abstract

An epithelial knife under guiding of a corneal topographic map includes a control box (1), a tool bit (2), a separating piece (3); a double-motor assembly (5), a sucking ring (6), a moisture separator (7) and a foot switch (8). The control box (1) is provided with an interface (10) for inputting topographic map, a microprocessor is provided in the control box (1), and a color monitor (11) is provided on the surface of the control box (1), the color monitor (11) showing a simulated cornea topographic map. The microprocessor includes a channel scanning processor (CPU1), a picture microprocessor (12) and a separating capacity stabilizing microprocessor (CPU2). The interface (10) for inputting topographic map is connected with the channel scanning processor (CPU1) and the picture microprocessor (12) in the control box (1) respectively, and the channel scanning processor (CPU1) is connected with the separating capacity stabilizing microprocessor (CPU2) and the picture microprocessor (12). The picture microprocessor (12) is connected to the color monitor. The separating capacity stabilizing microprocessor (CPU2) is also connected serially with a vacuum pump and a sampling sensor provided in the control box (1), the separating capacity stabilizing microprocessor (CPU2) is also connected with the first motor (16) and the second motor (17) of the double-motor assembly (5) respectively, the first motor (16) and the second motor (17) being connected with the separator and a separating piece (3) respectively, and the separating capacity stabilizing microprocessor (CPU2) is connected with a control device.

Description

Epithelial knife guided by corneal topography

Technical field:

The present invention relates to a medical device for ophthalmic refractive laser surgery, and more particularly to an epithelial knife guided by a corneal topography.

Background Art:

In the past 20 years, ophthalmic excimer laser corneal refractive surgery has experienced rapid development from PRK, LASIK to LASEK and Epi-LASIK. The revision of surgical procedures has always centered on improving predictability while reducing complications. LASIK has been widely used in accordance with the anatomical and physiological characteristics of the cornea, the incidence of Haze is small, and the regression is light. It has been widely used, but the adhesion between the corneal stroma layers is weak due to the cross-shaped layer and the external force. It is prone to cracking and dislocation. In the clinical, there was a soldier who had been treated for 10 years after LASIK. During the training, the eye was accidentally hit, the wound between the original cornea was split, and the corneal flap was dislocated. Therefore, Epi-LASIK is the future development direction of LASIK, because its flap thickness is only 50-70um. When the thickness of the corneal stromal bed is more than 300um, more corneal tissue can be cut with excimer laser, which can correct more. High myopia, followed by a relatively uniform thickness of the corneal epithelial flap, so that the laser can better maintain the original aspheric curvature of the cornea, so that better visual quality after surgery. In addition, after the excimer laser hand, the epithelial flap directly and the corneal stroma tissue adhered to the cornea with higher strength and greater impact resistance. Therefore, Epi-LASIK is the future direction of excimer laser correction refractive surgery.

To make the epithelial flap, it is necessary to make a living epithelial flap, so that the epithelial basement membrane remains intact on the epithelium, so that the epithelial flap is active, which not only makes the surgery recover quickly but also rarely appears Haze, but to make it The living epithelial flap should make the epithelial separation ability of the epithelial knife constant, which is the epithelial separation ability created by our company in the second prize of the 2006 National Technology Invention Award, "Key Technology and Application of Myopia Surgical Microkeratome System". The formula M = N * V1/F * V2, M (representing the separation ability of the separation epithelium) should be constant, because the surface of the eyeball is a rugged surface similar to our earth, the separation piece should be "alpine" during the separation process. Or "squatting" should be pressed on a plane to advance, so that the positive pressure N acting on the separation piece decreases with the increase of "mountain" with the "squatting". To make the M value constant, it is necessary to adjust the straight line of the separation piece in time. Line speed VI and separation piece forward center point rotation linear velocity V2, which is why in the corneal topography

1

Confirmation The reason for guiding the separation of the epithelium.

Summary of the invention:

SUMMARY OF THE INVENTION It is an object of the present invention to provide an automatic epithelial knife with a safety device for separating the corneal epithelium under the guidance of a corneal topography, that is, Epi-LASIK guided by a corneal topography.

In order to achieve the above object, the present invention adopts the following technical solutions:

An epithelial knife guided by a corneal topography, comprising a control box, a cutter head, a separation piece, a dual motor assembly, a suction ring, a water gas separator, a foot switch, the control box is provided with a topographic map input interface, and a control box A microprocessor is disposed therein, and a surface of the control box is provided with a color display that displays a simulated corneal topography.

The microprocessor includes a channel scan processor, a graphics microprocessor, and a separation capability stable microprocessor. The topographic map input interface is respectively connected with the channel scanning processor and the graphic microprocessor in the control box, the channel scanning processor is respectively connected with the separation capability stable microprocessor and the graphic microprocessor, and the graphic microprocessor is connected to the color display. The separation capability stabilization microprocessor is also sequentially connected with the vacuum pump and the sampling sensor provided in the control box, and the separation capability is stabilized. The first motor and the second motor of the dual motor assembly are respectively connected to the microprocessor, and the first motor and the second motor are respectively respectively The separator and separator are connected, and the separation function is stabilized. The control switch is also connected to the microprocessor.

A strip is disposed on the side wall of the separator adjacent to the cutting edge, and the distance between the strip and the edge of the separator is 60 μm to 120 μm.

5mm〜0. 5mm。 The width of the curved groove is 0. 25mm~0. 5mm

Advantageous Effects: The present invention increases the topographic map input interface interface and the microprocessor, and processes the corneal topographic map input through the U disk; the corneal topographic map 6 allows a wide channel scan to record the positive pressure between the corneal epithelium on the septum According to the formula of M=N * V1/F « V2, the channel changes linearly with the linear velocity VI of the separator with the change in the positive pressure N between the corneal epithelium and the rotational center velocity V2 of the separation center.

According to the software programming, the separation ability stable microprocessor implements the control of the width of the motor pulse to control the linear velocity of the separation piece VI, the separation piece (the machine), the forward center point rotation linear velocity V2 speed.

The separator of the present invention has a flexible property after being grooved, so that the mathematical model Μ = Ν · Vl / F * V2 is also observed when separating the upper flap, in the above formula: M: represents the separation ability of the isolated epithelium: the requirement is a relatively constant constant value;

N: represents the positive pressure between the epithelium of the septum. Unit: Newton;

F: separation piece bluntness (sharpness) Unit: Newton;

VI: linear linear velocity of the separator. Unit: m/Sec;

V2: Separation piece (machine) forward center point rotation linear velocity Unit: m/Sec.

From the corneal topography, the corneal surface of the human eye can be clearly seen. It is not a smooth spherical surface, but a high and low undulating terrain like a mountain. The separation piece of the corneal epithelial knife is flattened and separated from the epithelium on this uneven terrain. The positive pressure N is different when the positive pressure of the separation piece separates the epithelium along the uneven terrain. =N · V1/F · V2 (N is the positive pressure, VI is the moving speed of the separator, F is the sharpness of the separator, and V2 is the speed of the cutter head that drives the separator, that is, the speed at which the separator separates the epithelium) The separation ability M is made constant, and as the positive pressure changes, the linear velocity VI of the separator and the forward center point rotation linear velocity of the separator are constantly adjusted.

The invention refers to the principle of "ballistic missile", scans the corneal topography of the patient through the corneal map instrument, and inputs it into the control box of the epithelial knife through the U disk; in the control box of the epithelial knife, the input is through software programming. The topographic map was scanned on the corneal topography of the 6 mm wide track on the epithelial knife separation trajectory by recreating the patient's corneal topography on the color display of the control box and scanning the separation piece on a 6 mm wide channel. The highland and the depression are converted into positive pressure according to the color and the darkness, and the variation of the positive pressure is used as the variation of the separation ability M=N*V1/F·V2 of the separation epithelium, thereby changing the linear velocity VI of the separation piece and The separation piece (machine) advances the center point rotation linear velocity V2, because the separation piece is indefinite (sharpness) F is determined to be constant, and the linear velocity VI of the separation piece is adjusted by the principle that the separation ability M of the separation epithelium is constant Separation piece (device) The forward center point rotates the linear velocity V2.

The corneal epithelial blade of the present invention is designed to have a clear requirement for the length of the arcuate groove of the separator, the distance of the bar from the edge of the separator, and the control performance of the control box, thereby ensuring that the epithelial keratome can be completely Separating the epithelial flap with the basement membrane and separating the strip on the sheet increases the rigidity of the septum and limits the increment of the positive pressure N of the septum between the corneal epithelium. The groove increases the flexibility of the septum; The new type completely separates the epithelial flap without damaging the stromal layer, while retaining the integrity of the corneal epithelial layer and the anterior elastic layer.

BRIEF DESCRIPTION OF THE DRAWINGS:

Figure 1 is a schematic view of the structure of the present invention; Figure 2 is a schematic structural view of a control box of the present invention;

3 is a schematic structural view of a separator with a strip of the present invention;

Figure 4 is a flow chart of the operation of the present invention;

Figure 5 is a corneal topography;

Figure 6 is a trajectory of the separation piece guided by the corneal topography.

detailed description:

The technical solution of the present invention will be described in detail below with reference to the accompanying drawings:

An epithelial knife guided by a corneal topography, comprising a control box 1, a cutter head 2, a separation piece 3, a dual motor assembly 5, a suction ring 6, a water gas separator 7, a foot switch 8, and the control box 1 is set There is a topographic map input interface 10, and a control unit 1 is provided with a microprocessor. The surface of the control box 1 is provided with a color display 11, and the color display 11 displays a corneal topographic map.

The microprocessor includes a channel scan processor CPU 1, a graphics microprocessor 12, and a separation capability stabilization microprocessor CPU2. ,

The topographic map input interface 10 is respectively connected to the channel scan processor CPU1 and the graphic microprocessor 12 in the control box 1, and the channel scan processor CPU1 is respectively connected with the separation capability stabilization microprocessor CPU2 and the graphic microprocessor 12, and the graphics The microprocessor 12 is connected to the color display 11, and the separation capability stabilization microprocessor CPU2 is also sequentially connected with the vacuum pump 13 and the sampling sensor 14 provided in the control box 1, and the separation capability is stabilized. The microprocessor 2 is also connected to the dual motor assembly 5 respectively. A motor 16 and a second motor 17, the first motor 16 and the second motor 17 are connected to the separator 18 and the separator 19, respectively. The separation capability stabilization microprocessor CPU2 is also connected to the control switch 15.

a strip 4 is disposed on the side wall of the separator 3 near the cutting edge,

The distance between the strip 4 and the edge of the separator 3 is 60 μ Π! ~ 120 μ m.

The width of the arc-shaped closed groove (9) is 0. 25πιπ! ~ 0. 5 discussion.

The working principle of the invention is as follows: the separating piece 3 is driven by the power of the dual motor assembly 5, and the main motor, that is, the first motor 16 is rapidly rotated, and the reciprocating linear motion is changed by the shank to obtain the power for separating the epithelium, and the sub motor is the first The second motor 17 drives the cutter head 2 assembly to rotate or linearly through the suction ring 6, so as to achieve the purpose of safety protection and flexibility when separating the upper skin. When the separation piece 3 separates the epithelium, the resistance bar 4 pushes the epithelial resistance to one end of the movement direction, and the barrier strip 4 blocks the separation piece 3 once the separation piece 3 is cut through the epithelium and penetrates into the matrix layer. Go deep down, the CPU calculates the treatment software with 1/1000 second real-time monitoring to monitor the change of the separation epithelial current consumption. The monitoring strip 4 prevents the separation piece 3 from deepening and causes the secondary motor current to start increasing. The current limit, once the current is increased, the dual motor assembly 5 will automatically stop, which will not hurt the pre-corneal elastic layer. When the separation piece 3 is separated from the epithelium, since the cornea is separated by the separation piece 3, since the separation piece 3 has an arc-shaped closed groove 9, the separation piece 3 will follow the separation piece along the upper and lower slopes of the cornea. The pressure is increased, and the arc-shaped groove 9 of the separating piece just exceeds the pressure too small, so that the cutting head 2 of the separating piece 3 is elastically deformed up and down. This upper and lower elastic deformation also relieves the positive pressure of the separating piece 3 during the up and down slope movement. The separation piece 3 is formed to be flexible when the epithelium is separated, and the purpose of flexible separation is achieved.

The control box 1 is a dual motor power source that not only drives the main and auxiliary motors, but also generates a vacuum to cause the suction ring 6 to absorb the eyeball. More importantly, the control box 1 automatically controls the flapping process to achieve a safe and reliable flap. There is a CPU treatment calculation software, 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.

In the specific working process, when the separation piece 3 contacts the surface of the cornea, the control box CPU knows the working current of the secondary motor through sampling, thereby tracking the current 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 prevention of the resistance of the resistance strip 4, 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 9 of the separating piece 3, the elasticity increases during the process of the lobes, and according to the separation force, the formula M=^ is used, and since the cutting edge contacts the surface of the cornea, the positive pressure N is increased, and the straight line of the separating piece 3 is reduced. When the speed VI is lowered, the rotational linear velocity V2 of the separator 3 is also lowered, and the bluntness K of the separator 3 is also increased, so that the basic separation ability of the separator 3 is constant, ensuring safety and reliability in the separation process.

The invention refers to the principle of "ballistic missile", scans the corneal topography of the patient through the corneal map instrument, and inputs it into the control box 1 of the epithelial knife through the U disk; in the control box 1 of the epithelial knife, through software programming, The input topographic map is scanned on the corneal topography of the 6 mm wide track on the epithelial knife separation track line by recreating the patient's corneal topography on the color display 11 of the control box 1 and scanning the separation piece on a 6 mm wide channel. The height and the squatting encountered are converted into positive pressure according to the color and the darkness, and the variation of the positive pressure is used as the variation of the separation ability M=N*V1/F*V2 of the separation epithelium, thereby changing the separation piece 3 The linear linear velocity VI and the separation piece (the machine) advance the center point rotation linear velocity V2, because the separation piece 3 is dull (sharpness) F is determined to be constant, and the separation line is adjusted by the principle that the separation ability M of the separation epithelium is constant. The linear velocity VI and the separation piece (the machine) advance the center point to rotate the linear velocity V2. The corneal epithelial knives of the present invention are designed to have clear requirements for 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. There is no problem of corneal flap complications after operation, and the application of EPi-LASIK in excimer laser surgery is promoted. The majority of patients bring safe and reliable medical equipment.

The above embodiments are merely illustrative of the invention, and are not intended to limit the scope of the invention, and various modifications and changes can be made without departing from the spirit and scope of the invention. Equivalent technical solutions are also within the scope of the protection of the invention.

Claims

Claim

1. An epithelial knife guided by a corneal topography, including 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), foot pedal (8), characterized in that: the control box (1) is provided with a topographic map input interface (10), a control box (1) is provided with a microprocessor, the surface of the control box (1) A color display (11) is provided, which displays a simulated corneal topography.

2. The epithelial knife guided by a corneal topography according to claim 1, wherein: said microprocessor comprises a channel scan processor (CPU1), a graphics microprocessor (12), and a separation capability stable microprocessor.

(CPU2).

3. The epithelial knife guided by a corneal topography according to claim 2, wherein: the topographic map input interface (10) and the channel scan processor (CPU1) and the graphic micro in the control box (1) respectively The processor (12) is connected, the channel scan processor (CPU1) is respectively connected to the separation capability stabilizing microprocessor (CPU2) and the graphic microprocessor (12), and the graphic microprocessor (12) is connected to the color display (11) The separation capability stabilization microprocessor (CPU2) is also sequentially connected with the vacuum pump (13) and the sampling sensor (14) provided in the control box (1), and the separation capability stabilization microprocessor (CPU2) is also connected to the dual motor respectively. The first motor (16) and the second motor (17) of the component (5), the first motor (16) and the second motor (17) are respectively connected to the cutter head (2) and the separator (3), and the separation capability is stable A control switch (15) is also connected to the processor (CPU2).

The epithelial knife guided by the corneal topography according to claim 1, characterized in that: the strip (4) is disposed on the side wall of the separating piece (3) near the cutting edge.

5. The epithelial knife guided by a corneal topography according to claim 4, wherein: the distance between the strip (4) and the edge of the separator (3) is 60 μ π! ~ 120 μ πι.

6. The epithelial blade guided by the corneal topography according to claim 1, characterized in that an arc-shaped closed groove (9) is formed in the separating piece (3) on the side of the bar (4) away from the cutting edge.

The width of the curved closed groove (9) is 0. 25mn! ~ 0. 5mm.