KR102417053B1 - Tool for separating tissue layer of cornea comprising oct sensor and apparatus for separating tissue layer of cornea comprising the same - Google Patents

Abstract

The present invention relates to a corneal layer separation tool and a corneal layer separation device comprising the same. For this purpose, the corneal layer separation tool for corneal layer separation in the corneal transplantation operation of the present invention includes a gripper extending in the longitudinal direction for the user's grip; a support part connected to the grip part and extending in the longitudinal direction; a blade part protruding from the other end of the support part at an angle different from the axis indicating the longitudinal direction of the support part; and an OCT sensor unit formed in a through hole formed through at least a portion of the support and the blade unit, emitting an optical signal in a downward direction of the blade unit, and collecting the reflected optical signal reflected from the lower part of the blade unit.

Description

TOOL FOR SEPARATING TISSUE LAYER OF CORNEA COMPRISING OCT SENSOR AND APPARATUS FOR SEPARATING TISSUE LAYER OF CORNEA COMPRISING THE SAME

The present invention relates to a corneal layer separation tool including an OCT sensor and a corneal layer separation device including the same, and more specifically, performs corneal layer separation in ophthalmic partial layer corneal transplantation surgery, but allows a user to monitor the corneal layer separation situation It relates to tools and devices that can be grasped in real time.

The cornea is a major transparent tissue constituting the anterior segment of the human eye and has an optical function to provide a constant refractive power to form an image on the retina. When a lesion or trauma occurs in the cornea due to intrinsic and extrinsic factors, the cornea may become cloudy or may impair uniform refractive power, and thus vision may be partially or entirely lost. Corneal transplantation exists as a surgical countermeasure for such corneal damage, and corneal transplantation is a surgical method for restoring the function of the cornea in the recipient's eye by transplanting the recipient's cornea to the recipient.

1 is a conceptual diagram schematically illustrating the structure of a cornea and types of partial-layer keratoplasty. 1, the cornea is a tissue composed of a corneal epithelial layer 11, Bowman's membrane 12, corneal stroma 13, Descemet's membrane 14, and corneal endothelial layer 15 , Corneal transplantation is divided into full-thickness corneal transplantation and partial-thickness corneal transplantation according to how many layers are included in the cornea. Here, partial-layer corneal transplantation is a surgical method in which only a portion requiring transplantation is selectively incised and transplanted. Partial-thickness keratoplasty includes procedures such as deep superficial keratoplasty and Descemet's membrane detachment corneal endothelial lamellar grafting. Such partial-layer keratoplasty is characterized by replacing only the abnormal layer in the recipient cornea in common.

Compared to the traditional transplantation in which the entire cornea is transplanted, the partial-layer transplantation method has the advantages of lower risk of rejection, better postoperative corneal characteristics, and faster recovery of vision. Accordingly, in developed countries such as the United States and Europe, partial-thickness corneal transplantation has become more common, and the frequency of its implementation is increasing compared to full-thickness transplantation.

However, the partial-thickness keratoplasty has a problem in that it requires a higher skill level for the surgeon than the full-thickness keratoplasty. In partial-thickness keratoplasty, the process of forming the corneas of the donor and recipient is essential, and this includes the process of separating a partial layer of the cornea from the corneas of the donor and recipient according to the surgical plan. Separation of the cornea is difficult because the total thickness of the cornea is only 0.4 to 0.6 mm, and the thickness of the partial layer to be removed and transplanted is very thin. Therefore, the surgeon must separate the corneal layers with high precision and then manipulate the separated corneal partial layers. In this process, as planned, the process of separating the partial layers of the cornea determines the success or failure of the whole, and the difficulty is the highest. Up to now, this process has mainly depended on the experience and sense of the surgeon. Therefore, there is a problem that high skill of the operating surgeon is required, the risk of failure is high, and the prediction of the surgical result is difficult.

Korea Patent Publication No. 2014-0104584

It is an object of the present invention to provide a corneal layer separation tool capable of increasing the success probability of a keratoplasty, specifically, a partial-layer keratoplasty, regardless of a user's skill level, and a corneal layer separation device including the same.

Another object of the present invention is to provide a corneal layer separation tool capable of assisting a corneal transplant operation by notifying a user of a corneal layer separation situation in real time, and a corneal layer separation device including the same.

The corneal layer separation tool for corneal layer separation in the corneal transplant surgery of the present invention for solving the above problems includes a gripper extending in the longitudinal direction for the user's grip; a support part connected to the grip part and extending in the longitudinal direction; a blade part protruding from the other end of the support part at an angle different from the axis indicating the longitudinal direction of the support part; and an OCT sensor unit formed in a through hole formed through at least a portion of the support and the blade unit, emitting an optical signal in a downward direction of the blade unit, and collecting the reflected optical signal reflected from the lower part of the blade unit.

In addition, the lower surface of the OCT sensor unit and the lower surface of the blade unit may coincide with each other.

In addition, an optical fiber connected to the OCT detection device is disposed in the through hole, the other end of the optical fiber and the upper surface of the OCT sensor unit are spaced apart, and the optical fiber transmits the optical signal generated by the OCT detection device to the OCT sensor unit, and in the OCT sensor unit The reflected light signal reflected from the lower portion of the collected blade may be transmitted to the OCT detection device.

In addition, the grip portion has a hollow structure, and the through hole may extend through the grip portion.

In addition, the OCT sensor unit, a lens spaced apart from the other end of the optical fiber; and a window disposed under the lens to protect the lens.

In addition, at least two of the four side surfaces of the blade unit may have a blade formed thereon.

In addition, when the blade unit is inserted into the incision region of the cornea and rotated through an operator's manipulation, the lower surface of the separation target layer among the plurality of layers included in the cornea may be caught on the upper surface of the blade unit.

In addition, the width between the two sides facing each other among the four side surfaces of the blade part may be gradually widened from the top to the bottom.

In addition, the lower surface of the blade unit may be flat, and each corner of the lower surface of the blade unit may have a curved shape.

In addition, the blade unit may protrude in a direction perpendicular to the longitudinal direction.

The corneal layer separation device of the present invention for solving the above problems is an OCT detection device; and a corneal layer separation tool connected to the OCT detection device through an optical fiber and used for corneal layer separation in a corneal transplant operation, wherein the corneal layer separation tool includes: a gripper extending in a longitudinal direction for gripping by a user; a support part connected to the grip part and extending in the longitudinal direction; a blade part protruding from the other end of the support part at an angle different from the axis indicating the longitudinal direction of the support part; and a through hole formed through at least a portion of the support and the blade unit, receives the optical signal generated by the OCT detection device through an optical fiber, radiates it downward, and receives the reflected optical signal reflected from the lower portion of the blade unit. It may include an OCT sensor unit that collects and transmits to the OCT detection device through an optical fiber.

In addition, the OCT detection apparatus may include an image processing unit to obtain a tomographic image of the cornea by image processing the reflected light signal.

In addition, by analyzing the tomography image, the OCT sensor unit may further include a thickness calculator that calculates the thickness between the end of the lower surface and the cornea.

Also, the image processing unit may include the thickness between the lower surface of the blade part and the end-to-end thickness of the cornea in at least a partial region of the tomography image.

Using the corneal layer separation tool and the corneal layer separation device including the same according to an embodiment of the present invention, the blade part is inserted into the gap of the pre-incised corneal tissue, and at this time, the OCT sensor part is adjacent to the corneal tissue anatomy on the lower surface of the blade part. It acquires enemy information and provides it to users in real time. The user manipulates the tissue separation device by hand through the gripper and can monitor in real time whether the blade has reached a planned depth in the cornea. When it is evaluated that the planned depth has been reached, the gripping part rotates and horizontally moves, and the blade part can perform layer separation with double-sided blades. Here, the OCT sensor unit is connected to an external OCT detection unit with an optical fiber to form an OCT sensor system, thereby composing OCT image information with the reflected light signal collected by the OCT sensor unit and providing it to the user, enabling the user to monitor in real time. .

As such, when using the tissue separation device provided by the present invention, the user can easily determine whether it is appropriate to perform layer separation by reaching the originally planned depth within the tissue into which the blade part is inserted during the operation, and performing the layer separation. It is possible to monitor in real time whether the expected layer separation is being performed smoothly through the tomographic image information presented by the OCT sensor unit. Accordingly, using the tissue separation device provided by the present invention can solve the difficulties of partial-layer corneal transplantation.

1 is a conceptual diagram schematically illustrating the structure of a cornea and types of partial-layer keratoplasty.
2A to 2D are conceptual views for explaining a general corneal separation method.
3 is a conceptual diagram of an apparatus for separating a corneal layer according to an embodiment of the present invention.
4A to 4D are views of a support part, a blade part, and an OCT sensor part among the corneal layer separation tool according to an embodiment of the present invention.
5 is a block diagram of an OCT detection apparatus according to an embodiment of the present invention.
6 is a view for explaining an example of a corneal layer separation process using the corneal layer separation device according to an embodiment of the present invention.
7A to 7D are conceptual views illustrating a corneal layer separation process using the corneal layer separation device according to an embodiment of the present invention.

The present invention will be described in detail with reference to the accompanying drawings as follows. Here, repeated descriptions, well-known functions that may unnecessarily obscure the gist of the present invention, and detailed descriptions of configurations will be omitted. The embodiments of the present invention are provided in order to more completely explain the present invention to those of ordinary skill in the art. Accordingly, the shapes and sizes of elements in the drawings may be exaggerated for clearer description.

Before the description of the present invention, the structure of the cornea will be described with reference to FIG. 1 to help the understanding of the present invention, and a general corneal separation method will be described with reference to FIGS. 2A to 2D .

As described above, the cornea 10 is a tissue composed of the corneal epithelial layer 11 , the Bowman's membrane 12 , the corneal stroma 13 , the Descemet's membrane 14 , and the corneal endothelial layer 15 . Of these layers, the corneal stroma layer 13 occupies the center of the cornea, and has several layers internally. In the following description, the term "a corneal layer" should be understood to include all of the above-described five layers and a plurality of layers included in the corneal stroma layer 13 .

The method of separating a part of the cornea is a process of incision in the depth direction of the cornea 10 using an incision knife 21, as shown in FIGS. 2A to 2D, and a tool 22 to separate the cornea. The process of securing the space 10a by injecting air into the anatomical interface, the process of circularly incising a part of the cornea from the corneal surface to the anatomical interface to be separated using the rotary knife 23, and circular incision It includes the process of completely separating the corneal piece (10b) from the cornea (10).

At this time, even if a space is secured by injecting air into the anatomical interface and the cornea is cut in a circular shape, the circularly cut corneal piece 10b may not be naturally separated from the cornea 10 . In order to completely separate the corneal piece 10b from the cornea 10, a process of physically separating it using a corneal layer separation tool is required.

However, as described above, partial-thickness keratoplasty requires a higher level of skill and precision for users than full-thickness keratoplasty. As planned, the process of separating the partial layers of the cornea determines the success or failure of the whole, but since the total thickness of the cornea is only 0.4 to 0.6 mm, even an experienced user can find the location of the corneal layer to be separated with high precision is not easy Accordingly, there is a need for a new surgical technique capable of increasing the success probability of partial-thickness keratoplasty regardless of the skill level of the operation.

The corneal layer separation tool and the corneal layer separation device including the same according to an embodiment of the present invention have been devised to solve the above-described problems, and are used to separate the corneal layer 10b from the cornea 10 . By using a tool, after partial incision of the cornea, it is characterized in that the user can be informed of the incision depth. Now, with reference to FIG. 3 , a description of the corneal layer separation apparatus 1000 according to an embodiment of the present invention is made.

3 is a conceptual diagram of an apparatus 1000 for separating a corneal layer according to an embodiment of the present invention. As shown in FIG. 3 , the corneal layer separation apparatus 1000 according to an embodiment of the present invention may include a corneal layer separation tool 100 and an optical coherence tomography (OCT) detection apparatus 200 . . Here, the corneal layer separation tool 100 functions to transmit a signal including information on the thickness of the cornea to the OCT detection apparatus 200 as well as an original function (ie, separation of a corneal piece). The OCT detection apparatus 200 analyzes the signal received from the corneal layer separation tool 100 to generate a tomographic image of the cornea, and calculates the thickness of the cornea based on the tomographic image of the cornea. In addition, the OCT detection apparatus 200 may assist the operation by providing the generated and calculated tomography image and thickness of the cornea to the user through the display unit 30 .

In order to perform the above function, the corneal layer separation tool 100 includes the gripper 110 , the support unit 120 , and the blade unit 130 used to separate the corneal piece, and a signal to be used for tomographic image and thickness calculation of the cornea It may be configured to include the OCT sensor unit 140 for detecting the. Here, the support part 120 and the blade part 130 are described as having their respective configurations divided according to their functions, but in reality, they may be formed integrally.

The grip part 110 is a configuration for the user's grip, and may have a hollow structure to surround at least a portion of the outer periphery of the support part 120 to be mentioned below. In addition, the gripper 110 may have a shape extending in the longitudinal direction as shown in FIG. 3 .

The support part 120 is connected to the grip part 110 and has a shape extending in the longitudinal direction. The support part 120 functions to support the blade part 130 mentioned below. In addition, one side of the support 120 may be connected to the OCT detection apparatus 200 . For example, the support 120 and the OCT detection apparatus 200 may be connected in a fixed form through one optical fiber. However, this is only an example, and a method in which a terminal is formed at one end of the support part 120 and the connection between the OCT detection apparatus 200 and the support part 120 is made through the terminal is also conceivable.

The blade unit 130 is inserted into the incision area where the incision is made with an incision knife (or surgical knife), etc., and rotates in the direction of the corneal piece to be separated, in the course of surgery through partial-layer corneal transplantation, and lifts the corneal piece. do. To this end, the blade part 130 is formed to protrude from the other end of the support part 120 at an angle different from the axis indicating the longitudinal direction of the support part. Here, the angle between the axis indicating the longitudinal direction of the support and the protruding portion of the blade unit 130 is for the ease of insertion into the incision region of the cornea and the rotational operation of the blade unit 130, which will be mentioned again below. It is preferable to make 90 degrees. Of course, this angle is only an example, and the angle between them may be formed in various angles.

As described above with reference to FIGS. 2A to 2D , it is important to insert the blade unit 130 into the anatomical interface to be separated, thereby separating the corneal piece existing on the upper part of the anatomical interface. However, in the case of the corresponding anatomical interface, there may be a situation in which the separation is not completely achieved even by air injection. Accordingly, it is preferable that the blade is formed on at least two side surfaces that can be inserted into the anatomical interface during rotation among the four side surfaces of the blade unit 130 . That is, as shown in FIGS. 4A to 4D , the blade unit 130 has two side surfaces in the longitudinal direction among the four side surfaces, and more preferably, the blade is formed in the lower part of the two side surfaces in the longitudinal direction among the four side surfaces. can be Here, the purpose of the blade is not to cut cells inside the cornea, but to perform layer separation by cutting between layers that can be easily separated anatomically. Accordingly, the blade included in the blade unit 130 does not need to be as sharp as a knife generally used for cutting.

The shape of the blade unit 130 according to an embodiment of the present invention will be described with reference to FIGS. 4A to 4D . 4A to 4D are a perspective view, a front view, a side view, and a bottom view, respectively, of the blade unit 130 according to an embodiment of the present invention. The blade unit 130 may be formed of a thin metal plate having a length (L) and a width (W). The upper surface and the lower surface of the blade unit 130 may have different areas, and the lower surface may be wider than the upper surface. Specifically, at least three of the four side surfaces of the blade unit 130 may have an inclined shape rather than a right angle to the lower surface of the blade unit 130 . In other words, the width between the two sides facing each other among the four side surfaces of the blade unit 130 may gradually increase from the top to the bottom. The characteristics of this shape of the blade unit 130 is that the blade unit 130 is inserted into the anatomical interface through rotation, which is made after the corneal layer separation tool 100 according to an embodiment of the present invention is placed on the incision area. This is to eliminate or minimize damage to the layers in the cornea by making the process more smooth and smooth.

Blade 130 is preferably made of a length of 0.5mm to 3.0mm, and a width of 0.2mm to 1.0mm in order to achieve the above-described object. Of course, a method of making the length of the blade unit 130 to be less than 0.5 mm or more than 3.0 mm is also conceivable. However, if the length of the blade unit 130 is 0.5 mm or less, it is difficult to operate to obtain a sufficiently large layer separation area, and on the contrary, if the length exceeds 3.0 mm, the information obtained from the OCT sensor unit 140 and the blade unit 130 A situation may arise where the actual situation of the terminations of the In addition, the width of the blade unit 130 is better as the strength is smaller within the allowable range, if the width is less than 0.2mm, there is a problem in that sufficient strength cannot be expected. Accordingly, the blade unit 130 preferably has a length of 0.5 mm to 3.0 mm, and a width of 0.2 mm to 1.0 mm. The thickness (T) of the blade unit 130 is sufficient if the level is smaller than the width, but it is not essential.

The lower surface of the blade unit 130 may be flat, and the edge thereof is preferably curved so as not to damage the lower part of the anatomical interface during rotation operation. For example, the edge of the lower surface of the blade unit 130 preferably has a curved shape with a radius of curvature of 0.05 mm or more.

Due to the shape characteristics of the blade unit 130 described above, when the corneal layer separation tool 100 is inserted into the incision area and then rotated through the operator's manipulation, the blade unit ( 130) is brought into contact with the lower surface of the layer to be separated. Accordingly, the layer to be separated is caught on the upper surface of the blade unit 130 , and the user can simply separate the layer to be separated by lifting the blade unit 130 .

In addition, the corneal layer separation tool 100 according to an embodiment of the present invention detects a signal to be used for calculating a tomography image and thickness of the cornea to a user as well as the above-described function, and transmits it to the OCT detection device 200 . function to To this end, the OCT sensor unit 140 may be included in the corneal layer separation tool 100 , and the OCT sensor unit 140 may be disposed in the corneal layer separation tool 100 . Here, OCT represents a medical imaging technology that provides an optical tomography image by applying the optical interference phenomenon.

The OCT sensor unit 140 may be disposed in a through hole formed through at least a portion of the support unit 120 and the blade unit 130 of the corneal layer separation tool 100 . In addition, referring to the right area of FIG. 3 showing an enlarged view of the area indicated by reference numeral A in FIG. 3 , the second optical fiber (of ₂ ) disposed on the OCT sensor unit 140 is further disposed in the through hole. can Here, the second optical fiber (of ₂ ) may be disposed inside the support unit 120 , and may be connected to the first optical fiber (of ₁ ) connected to the OCT detection apparatus 200 . The first optical fiber (of ₁ ) and the second optical fiber (of ₂ ) may be connected through a terminal, or may consist of one optical fiber.

Due to this structure, when the optical signal os is generated from the OCT detection apparatus 200 , the generated optical signal os passes through the OCT sensor unit 140 through the optical fibers of ₁ , of ₂ . After that, the optical signal os is reflected from the object, that is, the eyeball 40 and re-enters the OCT sensor unit 140 . The OCT sensor unit 140 functions to transmit the reflected light signal r_os reflected from the lower portion of the blade unit 130 back to the OCT detection device 200 through the optical fibers of ₂ , of ₁ .

The OCT sensor unit 140 may include a lens 141 and a window 142 . The lens 141 is disposed to be spaced apart from the other end of the second optical fiber of ₂ , and functions to determine the emission characteristics of the optical signal os transmitted to the second optical fiber of ₂ . Here, the lens may be a ball lens. The optical signal os emitted from the optical fiber of ₂ is coupled by the lens 141 and has appropriate beam characteristics and is radiated to the outside (ie, the lower part of the blade 130 ). In addition, the reflected optical signal r_os by the reflective surface 40 of the external sample proceeds in the same path in the opposite direction to be incident on the optical fiber of ₂ again.

The window 142 is a transparent glass film that is disposed under the lens 141 and serves to protect the lens 141 . In addition, in order to facilitate the measurement of the thickness of the cornea to be described again below, the OCT sensor unit 140 so that the lower surface of the OCT sensor unit 140, that is, the lower surface of the window 142 and the lower surface of the blade unit 130 coincide with each other. ) can be placed.

In the above description, the OCT sensor unit 140 has been referred to as a configuration including a lens 141 and a window 142 . However, this is only an example, and the OCT sensor unit 140 may be formed of a stepwise transitional core fiber optical system having a simpler structure without a lens or a window. This optical system has a form composed of only optical fibers, and the description thereof is described in the following references (Jangbeom Lee, Yugyeong Chae, Yeh-Chan Ahn, and Sucbei Moon, "Ultra-thin and flexible endoscopy probe for optical coherence tomography based on stepwise transitional") core fiber," Biomedical Optics Express, vol. 6, pp. 1782-1796, 2015), so a description thereof will be omitted. In addition, the optical fiber optical system of the step transition structure is a structure made by fusing optical fibers having different core sizes to each other, and can provide a microprobe optical system that replaces the function of a lens with an optical fiber optical system.

The OCT detection apparatus 200 receives the reflected optical signal r_os transmitted through the OCT sensor unit 140 and analyzes the received reflected optical signal r_os to obtain a tomographic image of the cornea, and measure the thickness of the cornea. can be calculated. The tomography image obtained and calculated in this way and the thickness of the cornea may be provided to the user through the display unit 30 . As shown in FIG. 3 , the reflective surface 40 of the sample spaced apart by z ₁ from the OCT sensor unit 140 is displayed at a position of Mz ₁ at a magnification M on the display unit 30 . The display unit 30 may provide a tomography image that changes with time to the user, and the user easily senses the change.

As described above, the corneal layer separation apparatus 1000 according to an embodiment of the present invention is characterized in that it assists partial-layer keratoplasty by using OCT technology. Of course, the OCT technology itself is a concept that already exists in the prior art. However, the OCT technology according to the prior art can be used only to look at the situation before or after surgery, but due to the structural problems of the OCT equipment, it is possible to monitor the surgical progress during the corneal layer separation process during the operation. Since it cannot be utilized for real-time monitoring, the conventional technique does not improve the point that the corneal layer separation must still be performed by the user's experience and senses.

On the other hand, in the corneal layer separation apparatus 1000 according to an embodiment of the present invention, the OCT sensor 140 is disposed on the user's surgical tool, that is, the corneal layer separation tool 100 , and the lower surface and the blade of the OCT sensor 140 . The lower surface of the part 130 coincides with each other, making it easier to calculate the thickness of the cornea. In addition, the OCT detection apparatus 200 according to an embodiment of the present invention uses a signal transmitted through the OCT sensor 140 disposed in the corneal layer separation tool 100 to provide a tomographic image and thickness of the cornea to the user in real time. can be provided, there is an advantage in that the success rate of the operation can be increased regardless of the skill level of the user performing the operation. Now, an OCT detection apparatus 200 according to an embodiment of the present invention will be described with reference to FIG. 5 .

5 is a block diagram of an OCT detection apparatus 200 according to an embodiment of the present invention. As shown in FIG. 5 , the OCT detection apparatus 200 according to an embodiment of the present invention includes an optical signal generator 210 , a signal detector 220 , an image processor 230 , and a thickness calculator 240 . can be configured. Here, the components are divided by function to help the understanding of the present invention, and in fact, may be implemented through one processing device such as a CPU, MPU, GPU, or the like.

The optical signal generating unit 210 functions to generate an optical signal and transmit it to the OCT sensor unit 140 . As described above, the optical signal is connected to the corneal layer separation tool 100 through a first optical fiber connected to the OCT detection device 200 , and the OCT sensor unit 140 through a second optical fiber in the corneal layer separation tool 100 . ) is transferred to Here, a method of configuring the first optical fiber and the second optical fiber as one optical fiber is also possible.

The optical signal is coupled to the lens included in the OCT sensor unit 140 , has appropriate beam characteristics, is radiated to the lower portion of the blade unit, is reflected by the reflective surface of the external sample, and is incident back to the OCT sensor unit 140 . The reflected light signal incident to the OCT sensor unit is transmitted to the OCT detection apparatus 200 again, and the signal detection unit 220 detects it.

The image processing unit 230 functions to obtain a tomographic image of the cornea by image processing the reflected optical signal. The tomographic image of the cornea obtained in this way is transmitted to the display unit 30, so that the tomography image of the cornea can be provided to the user in real time.

The thickness calculating unit 240 functions to calculate the thickness between the lower surface of the OCT sensor unit 140 and the end of the cornea by analyzing a tomographic image of the cornea. As described above, the corneal layer separation tool is inserted into the incision area where the incision is made with an incision knife or the like to separate the corneal layer. Here, in the case of partial-layer keratoplasty, it is very important to find the anatomical interface and separate only the layers above the anatomical interface. Accordingly, the thickness calculating unit 240 calculates the thickness between the lower surface of the OCT sensor unit 140 and the cornea on the basis of the current position of the OCT sensor unit 140 and calculates the depth of the incision region in addition thereto. can

The information on the thickness and depth may be included in, for example, at least a partial region of a tomography image of the cornea, and the image may be transmitted to the display unit 30 and provided to the user. By checking the display unit 30 , the user can intuitively and in real time grasp not only the tomographic image of the cornea, but also the incision depth for the incision area and the thickness of the cornea, to determine whether the incision is correct. If the incision depth does not reach the planned depth, the user may perform additional incision using an incision knife.

As such, when the corneal layer separation device 1000 including the OCT detection device 200 according to an embodiment of the present invention is used, the user can be helped by using the reflected light signal transmitted from the corneal layer separation tool 100 . Information that can be given can be provided in the form of an image. Accordingly, the user can find an anatomical boundary to be separated with high precision using the corresponding information, thereby further improving the success rate of surgery regardless of the operator's skill level.

6 is a view for explaining an example of a process of separating the cornea 10 through the corneal layer separating apparatus 1000 according to an embodiment of the present invention. Referring to FIG. 6 , the user holds the grip unit 110 and inserts the blade unit 130 into the incision portion of the cornea 10 . The lower surface of the blade unit 130 is in contact with the corneal tissue placed under the corneal layer separation tool 100 . When an optical signal is generated and transmitted by the OCT detection device 200 , the optical signal is radiated in a direction perpendicular to the lower surface of the blade unit 130 , and a reflected optical signal is formed in the corneal tissue. The reflected light signal is collected by the OCT sensor unit 140 and transmitted to the OCT detection device 200 again.

The user may monitor the anatomical structure or thickness of the corneal tissue of the lower surface of the blade unit 130 through the display unit 30 . When the magnification of the screen display is M, if the refractive index is n according to the principle of the OCT imaging method and the thickness of the cornea remaining under the blade part 130 is z ₂ , the image displayed on the display unit 30 is M-nz ₂ of will appear in thickness. The user may obtain the position information of the blade unit 130 with the image information or numerical information of the tissue thickness calculated from the image information and take appropriate measures. Since the refractive index of the tissue is well known, the user can accurately determine the position of the blade unit 130 in the cornea.

7A to 7D are conceptual views illustrating a corneal layer separation process using the corneal layer separation device according to an embodiment of the present invention. Here, the corneal layer separation process is sequentially illustrated in chronological order from FIG. 7A to FIG. 7D . In the following description, the orientation of the x, y, and z axes follows a right-hand Cartesian coordinate system, and unless otherwise specified, the z-axis is always the same as the axis of the layer separation device.

Referring to FIG. 7A , first, the corneal layer separation tool 100 according to an embodiment of the present invention is brought into contact with the epidermis of the cornea 10 to measure the thickness (z ₃ ) of the entire corneal layer. In this procedure, it is okay to measure the thickness of the cornea using other means, including an ultrasound device. The user can plan a subsequent surgical procedure based on the obtained information.

Thereafter, the process shown in FIG. 7B may be performed. In the process shown in FIG. 7B, an incision of an appropriate depth is performed in consideration of the measured thickness information. The incision of the cornea 10 may be performed by inserting a knife to a desired depth with an incision knife (or surgical knife) such as a diamond knife having an adjustable length. In FIG. 7B , the cutting knife horizontally moved along the y-axis direction to perform the incision to form an incision region 10c having an appropriate depth and length. However, this incision is a process that does not cut the entire cornea.

In the process shown in FIG. 7C , the blade part 130 of the corneal layer separation tool 100 according to an embodiment of the present invention is inserted into the incision region 10c of the cornea 10 to determine the thickness of the remaining tissue of the cornea or the remaining tissue. Investigate the anatomical characteristics of tissues. At this time, the blade part 130 is inserted so as to have a length along the incision direction, that is, the y-axis direction of FIG. In this state, through the reflected optical signal collected and transmitted by the OCT sensor unit 140 , the OCT detection apparatus 200 may obtain a tomographic image of the corneal tissue that is not cut in contact with the lower surface of the blade unit 130 . This OCT tomography image may be performed while the position of the OCT sensor unit 140 is fixed, or the user moves the corneal layer separation tool 100 little by little to perform a horizontal scan operation in which the OCT sensor unit 140 moves little by little. It can also be obtained in an additive manner.

On the other hand, by examining the tissue that has not been incised in this way and checking the depth of the incision site, the user can determine whether a sufficient incision has been made. If it is determined that the incision is not made to a sufficient depth, the incision may be re-incision using an incision knife to secure an additional incision depth. When it is determined that sufficient incision has been made, the inserted layer separation device is rotated about 90 degrees so that the blade unit placed in the y-axis direction is placed in the x-axis direction.

In the process shown in FIG. 7D , the blade unit 130 inserted and rotated in this way is gradually moved in parallel horizontally along the y-axis direction of the drawing, that is, the direction of incision, and the blade unit 130 separates the corneal layer. manipulate it to At this time, the position (z ₅ ) in the tissue of the blade unit 130 by the OCT sensor unit 140 may be monitored in real time. The user may operate the blade unit 130 to separate a predetermined corneal layer at a predetermined depth based on this information.

As suggested in the above description, the user holds the gripper 110 and rotates it about 90 degrees about its axis so that the blade 130 inserted into the tissue performs layer separation at a certain depth. Since the corneal tissue is generally flat in a narrow spatial region, the blade unit 130 must be perpendicular to the axis of rotation in order for the blade unit 130 to rotate while maintaining a constant depth therein. Therefore, the support unit 120 is placed on the same axis as the grip unit 110, and the blade unit 130 is required to have a structure orthogonal to this axis. However, this does not mean that the angle between the blade unit 130 and the axis of the tool 100 is exactly 90 degrees. In order to meet the above-mentioned purpose, if the angle of the blade unit 130 is able to maintain a constant height as a whole when the corneal layer separation tool 100 rotates, even if there is a slight deviation from the right angle, it is found that it does not deviate from the spirit of the present invention. put

On the other hand, the blade unit 130 is inserted into the tissue of the cornea to rotate and move in parallel to perform layer separation. In order to be inserted through a narrow incision, the blade unit 130 must have a width of 1 mm or less. On the other hand, both sides of the blade unit 130 must have sharp blades for rotation and parallel movement. Here, the blade is not for the purpose of cutting the cells inside the tightly coupled layer, but only to perform the layer separation by cutting between the sublayers that can be easily separated anatomically. Therefore, it is pointed out that the blade of the blade unit 130 does not need to be very sharp like a conventional cutting knife.

It is not preferable for the blade unit 130 to have sharp edges. In particular, it is preferable that both sides of the ends of the blade unit 130 do not have a sharp shape. Otherwise, the edge of the blade unit 130 may damage the corneal tissue due to unexpected deviation accompanying the rotation and parallel movement of the blade unit 130 . This damage is a problem that cannot be prevented because it cannot be detected by the OCT sensor unit 140 . Therefore, a preferred embodiment of the present invention may include that the blade unit 130 has a curved edge of a radius of curvature of 0.05 mm or more in the surface shape of its lower surface.

The teachings of the present principles may be implemented as a combination of hardware and software. In addition, the software may be implemented as an application program actually implemented on the program storage unit. The application program may be uploaded to and executed by a machine comprising any suitable architecture. Preferably, the machine may be implemented on a computer platform having hardware such as one or more central processing units (CPU), a computer processor, random access memory (RAM), and input/output (I/O) interfaces. . The computer platform may also include an operating system and microinstruction code. The various processes and functions described herein may be part of microinstruction code or part of an application program, or any combination thereof, which may be executed by various processing devices including a CPU. Additionally, various other peripheral devices such as additional data storage and printers may be connected to the computer platform.

It is noted that since some of the constituent system components and methods shown in the accompanying drawings are preferably implemented in software, the actual connections between system components or process functional blocks may vary depending on the manner in which the principles of the present invention are programmed. should be further understood. Given the teachings herein, one skilled in the relevant art will be able to contemplate these and similar implementations or configurations of the principles of the present invention.

Although exemplary embodiments have been described herein in connection with the accompanying drawings, the principles of the invention are not limited to these precise embodiments, and various changes and modifications can be made in the related art without departing from the scope or spirit of the principles of the invention. It should be understood that it can be performed by one of ordinary skill in the art. All such changes and modifications are intended to be included within the scope of the present principles as set forth in the appended claims.

100: corneal layer separation tool 110: grip portion
120: support 130: blade unit
140: OCT sensor unit 141: lens
142: window 200: OCT detection unit
1000: corneal layer separation device

Claims (14)

A corneal layer separation tool for corneal layer separation in corneal transplant surgery, comprising:
a gripper extending in the longitudinal direction for gripping by the user;
a support part connected to the grip part and extending in the longitudinal direction;
a blade part protruding from the other end of the support part at an angle different from an axis indicating a longitudinal direction of the support part; and
and an OCT sensor unit for emitting an optical signal in the lower direction of the blade unit and collecting the reflected light signal reflected from the lower side of the blade unit,
A through hole passing through at least a portion of the support and the blade is formed,
The OCT sensor unit is disposed inside the through hole,
A corneal layer separation tool in which the lower surface of the OCT sensor unit and the lower surface of the blade unit coincide with each other. delete According to claim 1,
An optical fiber connected to the OCT detection device is disposed in the through hole,
The other end of the optical fiber and the upper surface of the OCT sensor part are spaced apart,
The optical fiber transmits the optical signal generated by the OCT detection device to the OCT sensor unit, and transmits the reflected optical signal reflected from the lower portion of the blade unit collected by the OCT sensor unit to the OCT detection device. 4. The method of claim 3,
The gripper has a hollow structure, and the through hole extends through the gripper. 4. The method of claim 3,
The OCT sensor unit,
a lens spaced apart from the other end of the optical fiber; and
A corneal layer separation tool comprising a window disposed under the lens to protect the lens. According to claim 1,
At least two of the four side surfaces of the blade part have a knife blade formed thereon. 7. The method of claim 6,
When the blade unit is inserted into the incision region of the cornea and rotated through an operator's operation, the lower surface of the target layer to be separated among the plurality of layers included in the cornea is caught on the upper surface of the blade unit. According to claim 1,
A corneal layer separation tool in which the width between the two sides facing each other among the four side surfaces of the blade part gradually widens from the top to the bottom. According to claim 1,
The lower surface of the blade part is flat, and each corner of the lower surface of the blade part is a curved corneal layer separation tool. According to claim 1,
The blade part is a corneal layer separation tool that protrudes in a direction perpendicular to the longitudinal direction. OCT detection device; and
and a corneal layer separation tool connected to the OCT detection device through an optical fiber and used for corneal layer separation in a corneal transplant operation, wherein the corneal layer separation tool comprises:
a gripper extending in the longitudinal direction for gripping by the user;
a support part connected to the grip part and extending in the longitudinal direction;
a blade part protruding from the other end of the support part at an angle different from an axis indicating a longitudinal direction of the support part; and
OCT that receives the optical signal generated by the OCT detection device through the optical fiber, radiates it downward of the blade part, collects the reflected optical signal reflected from the lower part of the blade part, and transmits it to the OCT detection device through the optical fiber including a sensor unit,
A through hole passing through at least a portion of the support and the blade is formed,
The OCT sensor unit is disposed inside the through hole,
A corneal layer separation device in which the lower surface of the OCT sensor unit and the lower surface of the blade unit coincide with each other. 12. The method of claim 11,
The OCT detection device,
and an image processing unit configured to obtain a tomographic image of the cornea by image processing the reflected light signal. 13. The method of claim 12,
The corneal layer separation device further comprising a thickness calculator for calculating the thickness between the lower surface of the OCT sensor and the end-to-end thickness of the cornea by analyzing the tomography image. 14. The method of claim 13,
The image processing unit includes an end-to-end thickness of the lower surface of the blade unit and the cornea in at least a partial region of the tomography image.

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