WO2021135979A1

WO2021135979A1 - Protective device for corneal endothelium, and main body part and attached part thereof

Info

Publication number: WO2021135979A1
Application number: PCT/CN2020/137475
Authority: WO
Inventors: 李绍伟
Original assignee: 北京爱尔英智眼科医院有限公司
Priority date: 2020-01-02
Filing date: 2020-12-18
Publication date: 2021-07-08
Also published as: CN110974531A; DE202020107486U1

Abstract

Disclosed is a protective device (8) for the corneal endothelium, the device comprising a main body part (9) and an attached part (7), wherein the attached part (7) extends away from the main body part (9), the main body part (9) is substantially shaped in an upwardly tapered shape (such as a dome), and the attached part (7) is used for pulling the main body part (9).

Description

Corneal endothelial protective device and its main part and attachment part

Technical field

This application relates to a corneal endothelial protection device and its main body and attachment parts, especially for assisting in providing protection in and/or removing from the eye.

Background technique

The success of intraocular surgery depends in particular on avoiding damage to corneal endothelial cells. For example, for this reason, it is possible to apply viscoelastic fluid into the anterior chamber of the eye between the iris and the cornea through a small incision made in the limbus. Through this incision, surgical instruments and the like can also be moved into and out of the eye to perform the required operation.

During this surgical procedure, the pupil may be dilated, and the physician looks at, for example, the lens of the eye through the cornea and the dilated pupil. Physicians are usually required to be cautious to avoid contact with the fragile interior of the cornea, as this damage may be irreversible.

In some cases, a dedicated device can be inserted into the anterior chamber to protect corneal endothelial cells, and once the surgical procedure is over, the device can be removed from the eye. For example, US5951565 describes a flexible and transparent corneal endothelial protective device, which has a thin protective barrier portion and a thicker edge surrounding the barrier portion. The protective device is foldable for easy insertion through a surgical incision; the protective device is elastic so that it can be popped up once placed in the eye, and the protective device is flexible enough to make it close to the completion of the operation It can be easily removed through an incision in the eye.

The device is required to form an opening in at least one of its central part and a thicker edge part as an entrance for surgical instruments during surgery. However, the design of the device did not fully consider the removal of the device. Its thin and flexible central part, thicker edges, and incisions make the device particularly susceptible to rupture when removed from the small incision made in the limbus.

Summary of the invention

In view of this, the main purpose of this application is to provide a protective device for corneal endothelium, which is transparent and does not affect surgery, is soft and does not damage corneal endothelial cells, is easy to take and place, and is convenient to operate. It is also corneal endothelium during surgery. Provide additional beneficial protection.

To achieve the above object, the present application provides a device for protecting the corneal endothelium. The device includes a main body part and an attachment part extending away from the main body part. The main body part is shaped into an upwardly narrowing shape, such as a dome shape. Or a dome or umbrella shape, and the attachment part is configured to pull the main body part. The device is particularly suitable for protecting corneal endothelial cells during cataract surgery, especially for advanced hard nuclear cataracts, cataracts with low endothelial cell density and the like. It can also be used for other internal eye surgery, such as iris-related surgery, anterior chamber foreign body removal and other internal eye surgery. It can also be used in various corneal transplant operations to protect the lens from damage, and aphakia to prevent vitreous prolapse.

In an embodiment of the present application, the attachment portion includes a linear structure. In a preferred case, the attachment part is a wire. The linear structure is formed of surgical materials such as plant materials such as flax or cotton, animal materials such as silk or catgut, and polymer materials such as nylon, polyester, PGA, PGLA, PLA, or Nitinol. Optionally, the attachment part is formed integrally with the main body part, and optionally includes a fixing site such as a hole or a thread-like structure for helping the physician grasp the attachment part to remove the device from the eye .

According to an aspect of the present application, the uppermost part of the main body part is a flat part. According to one aspect of the present application, the main body portion includes an upper section and a lower section, and the lower section includes a structure suitable for holding and/or absorbing a viscoelastic material, such as an outer layer formed with a hair-like structure and a pit-like structure.

According to another aspect of the present application, the main body portion includes a lower thickened edge structure that extends along the lower periphery of the main body portion. Preferably, the edge structure includes a channel penetrating therethrough, and the attachment portion extends through the channel; more preferably, the linear structure of the attachment portion moves at least partially freely in the channel, preferably completely free To move. In another case, the edge structure is at least partially overmolded on the linear structure of the attachment portion.

According to one aspect of the present application, the edge structure is integrally formed with the main body part. According to another aspect of the present application, the edge structure is formed of an additional material surrounding the lower edge of the main body part. The additional material is the same material as the rest of the body part, or a material with a higher Shore hardness relative to the rest of the body part. The additional material is selected from conventional intraocular lens materials, such as silicone gel, hydrogel, acrylic ester such as polymethylmethacrylate (PMMA), polycarbonate, polysiloxane, or any other biological materials suitable for the eye Compatible hydrophilic/hydrophobic materials.

According to one aspect of the present application, the protection device is designed such that pulling on the attachment part causes the main body part to fold. Preferably, the lower edge of the main body part, or if there is an edge structure, the edge structure includes one or more interruptions, such as a proximal interruption and a distal interruption. Also preferably, one or more slits are formed in the main body part.

According to an aspect of the application, the attachment portion extends away from the lower edge of the main body portion. According to another aspect of the present application, the linear structure of the attachment portion extends to the end (38) formed on the main body portion (98), extends from the end (38) along the underside of the main body portion, and then A hole (40) formed on the proximal side of the main body portion (relative to the eye incision) extends through the hole (40) away from the main body portion in the proximal direction toward the incision.

According to one aspect of the present application, a spiral tear line is formed on the main body part. According to one aspect of the application, the main body part has a distal anchor (35d) and a proximal anchor (35p). Preferably, the proximal anchor can also form or constitute a hinge part (27) of the protection device, and the attachment part extends away from the main body part through the hinge part (27).

This application also provides a method for protecting the corneal endothelium, the method comprising:

The protective device of the present application is inserted through the incision and placed in the anterior chamber of the eye, where

When the protective device is arranged in the anterior chamber, at least part of the attachment portion extends through the incision and remains outside the anterior chamber.

According to one aspect of the present application, arranging the protective device of the present application in the anterior chamber of the eye includes injecting viscoelastic fluid to promote the deployment of the protective device to the deployed state, and may further include injecting additional between the cornea and the protective device. The viscoelastic fluid.

According to an aspect of the present application, the step of removing the protective device from the anterior chamber includes: pulling the part of the attachment part remaining outside the anterior chamber. Preferably, pulling the attachment portion causes the main body portion to be at least partially folded into a retracted state that is more compact than the arranged state.

According to one aspect of the present application, the method includes inserting a catheter through the incision into a proximal position of the main body portion, and then pulling the attachment portion to retrieve the protective device. Wherein, the at least partial folding of the main body part includes urging the main body part against the distal end of the catheter while pulling the attachment part.

Description of the drawings

An exemplary embodiment of the present application is shown in the drawings. The drawings are intended to be illustrative, not restrictive. When reading and referring to the following specific embodiments in conjunction with the accompanying drawings, one can best understand the present invention (no matter its structure or method of operation) and its purpose, features and advantages, among which:

Fig. 1 schematically shows a general schematic cross-sectional view of the human eye, and an exemplary embodiment of the protective device of the present invention, which is located in the anterior chamber of the eye to protect the corneal endothelium;

2A and 2B respectively schematically show a side view and a side plan view of an embodiment of the present invention; FIGS. 2C and 2D respectively schematically show a side view and a side plan view of another embodiment of the present invention;

3A to 3C respectively schematically show a cross-sectional view, a bottom view, and a side plan view of an embodiment of the present invention;

4A and 4B respectively schematically show a top view and a cross-sectional view of an embodiment of the present invention; FIG. 4C schematically shows a side plan view and a partial enlarged view of this embodiment;

5A and 5B respectively schematically show a top view and a side plan view of an embodiment of the present invention;

6A and 6B respectively schematically show a top view and a cross-sectional view of an embodiment of the present invention;

Fig. 7A schematically shows a top view of an embodiment of the present invention; Fig. 7B schematically shows the folded state when the embodiment is taken out of the incision; Fig. 7C is a top view of the folded state; Fig. 7D shows Sectional view along the line AA;

Fig. 8A schematically shows a top view of an embodiment of the present invention; Fig. 8B schematically shows a folded state of this embodiment;

9A to 9C respectively schematically show a top view, a side view, and a schematic diagram of a state where it is torn along the tear line and gradually formed into an elongated strip;

Fig. 10A schematically shows a top view of an embodiment of the present invention; Fig. 10B shows a possible folded state of the device when the attachment part of the device is pulled; Fig. 10C shows a cross-section of the folded state along line BB Figure;

Figures 11A and 11B schematically show a top view and a side plan view of an embodiment of the present invention, respectively.

It is desirable to understand that for simplicity and clarity of the illustration, the elements shown in the figures are not necessarily drawn to scale, and the features shown in each embodiment can be combined with the features shown in other embodiments. For example, for clarity, the size of some elements may be exaggerated relative to other elements. In addition, where deemed appropriate, reference numerals will be repeated in the drawings to indicate similar elements.

Detailed ways

The following embodiments and various aspects thereof are described and illustrated in combination with systems, tools, and methods. These systems, tools, and methods are intended to be exemplary and illustrative, and do not limit the scope of the present invention.

In one embodiment, a protective device for corneal endothelium is provided. The device includes a main body portion and an attachment portion extending away from the main body portion. Subject to special restrictions, it is preferred that its curvature is substantially the same as the curvature of the cornea, so as to provide necessary protection for the cornea, and its size is suitable for being placed in the eyes of animals (preferably humans). The body part is, for example, substantially shaped like a dome or dome or umbrella, and the attachment part is provided for pulling the body part.

Generally, when the protective device is placed in the anterior chamber of the eye, the upwardly narrowing shape of the main body part is set to extend upward toward the cornea in a direction away from the lens of the eye, so as to be as close to the cornea as possible (but not to touch the corneal endothelium), So as to provide enough operating space below it.

The attachment portion is configured to pull the main part of the device out of the anterior chamber of the eye through an incision, through which the device was previously introduced into the anterior chamber, where this pulling usually occurs in surgical procedures adjacent to the eye At the end, the protective device is used to help protect the corneal endothelium during surgery.

The attachment part can take any suitable shape in principle, as long as it does not affect the surgical field of view or the operation of surgical instruments. In one embodiment, the attachment portion includes a linear structure. Such a thread may be arranged to surround the lower edge of the main body part, which may be achieved via a channel formed in the lower edge, or may be arranged to extend upward to a part of the main body part.

In one embodiment, the uppermost part of the main body part is a flat part. Such a substantially flat upper part can provide a space (or another space) between the main body part of the protective device and the endothelium for receiving possible viscoelastic gel into the anterior chamber during surgery to help protect Endothelium.

In one embodiment, the protection device is designed such that pulling on the attachment part causes the main body part to fold. This folding can be further assisted in various ways, such as using a catheter when pulling out from the anterior chamber, and/or forming slits or grooves in the main body portion.

The specific embodiments of the present invention will be further described below in conjunction with the accompanying drawings.

Please look at FIG. 1, which schematically shows the human eye 10. The eye has a cornea 12 and an anterior chamber 14 located between the iris 16 and the innermost surface of the cornea and the endothelium 121. An exemplary embodiment of the protection device 8 of the invention is shown, which occupies the anterior chamber. The protective device has a main body portion 9 (here generally shaped as a dome/dome shape) that occupies the anterior chamber in this example, and an attachment portion 7 which is removed from the limbus through an incision 20 that may be formed in the limbus. The main part extends to the outside of the anterior chamber.

The incision 20 may be appropriately formed to provide a passage for surgical procedures applied to the eye. Such surgical procedures may include moving surgical tools and the like into and out of the anterior chamber through an incision. In the broad aspects of the invention, the various protection device embodiments described herein can be used to protect the corneal endothelium, for example, during such surgical procedures.

Such a protective device 8 can be inserted through an incision to arrange the main body portion 9 in the anterior chamber, while a part of the attachment portion 7 of the device remains extended to the outside of the anterior chamber, in a position that is more accessible to the surgeon performing the surgery .

In various embodiments disclosed herein, the main body portion of the device may adopt a folded state suitable for insertion into and/or removal from the anterior chamber. Once inside the anterior chamber, the main body portion can preferably adopt a deployed state suitable for protecting the endothelium by self-expansion (for example, by elastically popping into position). This arrangement includes forming a cavity 5 below the main body portion of the device.

In the various embodiments disclosed herein, the attachment portion 7 of the leaving device extends outside the anterior chamber and can be used by the physician to remove the protective device from the anterior chamber near the completion of the surgical procedure.

In the description provided herein, the features and aspects disclosed in the context of a certain embodiment can be combined individually, or can be combined with other features in the specific embodiment, or with one or more features described in other embodiments Or aspect combination. For example, the "flat" upper portion of the main body portion disclosed in FIG. 2D can be suitably applied to any of the other protection device embodiments described herein. In a further example, the linear attachment portion and/or the hinge portion, such as disclosed in FIG. 3C, can be applied to other protection device embodiments as appropriate (alone or in combination).

Turn now to Figures 2A to 2D, which show the main body portions 91, 92 of various protection device embodiments (81, 82, respectively). As can be seen, the main body portion 91 is generally shaped as a dome/dome, while the main body portion 92 embodies an embodiment that includes a first lower section 1 which generally follows upwards The base profile of a tapered shape (such as a dome), while the subsequent second upper section 2 deviates from this profile, for example being substantially "squashed".

Such a second part 2 is suitable for providing a space 3 (and/or another "volume" and/or "chamber") below the contour of the upper part of the dome (or other upwardly narrowing shape) that would otherwise exist. . In FIG. 2C, the dotted dashed line represents the outline of such an upper part (here, a dome) where it should exist. The space 3 formed under the corneal endothelium is suitable for receiving a larger volume/amount of viscoelastic fluid during a surgical operation, so as to provide further protection for the endothelium.

Turning to FIGS. 3A to 3C, there are shown an embodiment of a protection device 83 composed of a main body portion 93 and an attachment portion 73. As shown in FIG. The body portion 93 shown in this example includes a lower thickened edge structure 18 that extends along the lower periphery of the body portion. The edge 18 includes a through peripheral channel 19 that extends around the lower edge of the main body portion. In this example, it can be seen that the attachment portion 73 is formed as a linear member extending through the channel 19.

In some cases, the thread of the attachment portion 73 can move freely in the channel 19, while in other cases, the attachment portion may be substantially integrally formed in the edge 18, for example, by The edge portion 18 is at least partially overmolded on the thread 73. When pulling the attachment part in order to remove the device from the anterior chamber of the eye, the relative movement between the thread providing the attachment part and the channel 19 can reduce the protective device in some cases (for example, near the edge ) Risk of tearing.

As a non-limiting example, such a linear attachment portion 73 may be formed of surgical materials such as nylon, polymer materials, and in some cases, Nitinol.

The device of the protection device 83 may be formed with a thickened hinge portion 27 where the attachment portion 73 extends away from the main body portion 93. The hinge portion 27 may be funnel-shaped, which narrows in a direction away from the main body portion. The thickening at the hub can be used to strengthen the protective device at this location, so as to reduce the possibility of damage (e.g., tearing) of the device when the device is pulled out of the anterior chamber of the eye through the attachment portion .

Please look at FIGS. 4A to 4C, which show an embodiment of a protection device 84 formed by two

sections

11, 22 at its main body portion 94. As shown in FIG. The first lower section 11 forms the base of an upwardly narrowing shape (for example, a dome), and the second upper section 22 forms an upper subsequent part, which continues to gradually narrow upwards, for example, along the contour of the dome.

The first section 11, which is generally located at the periphery of the main body portion, includes an outer layer 30 suitable for holding, maintaining and/or absorbing a viscoelastic material. For this purpose, the outer layer 30 may include a rough structure, for example formed with a hair-like structure, a pit-like structure, etc., for increasing the surface area of the main body portion in the section. Therefore, the roughened outer layer 30 can reduce the transparency of the main body part, while increasing the affinity for the viscoelastic material and/or the presence of the viscoelastic material in this section to protect the inner skin.

The second section 22 located more centrally with respect to the optical axis O of the main body portion may be formed to be more transparent, for example, by including a more transparent material, a smoother outer structure, or the like. This transparency can be used to provide a substantially unobstructed field of vision for the physician to observe, for example, the lens of the eye through the cornea and the second section 22 of the main body portion.

Please look at Figures 5A and 5B, which show an embodiment of a protective device 85, which includes a main body portion 95 with distal and

proximal anchors

35d, 35p. The distance from the incision (not shown here) through which such a protective device is introduced into the anterior chamber relative to the distance, and the distance from the incision when the protective device is located in the anterior chamber, defines the opposite position In particular, the distal anchor 35d is away from the incision, and the proximal anchor 35p is adjacent to the incision. The deployment axis PD is defined as extending along these directions.

Therefore, the protective device 85 is adapted to enter the anterior chamber of the eye through the incision generally along the axis PD with the distal anchor 35d as a lead, and to be taken out from the incision generally along the axis PD with the proximal anchor 35p as the lead. The

anchors

35d, 35p may be formed as bulging members that are arranged to abut and contact the inner surface of the anterior chamber, possibly usually near the limbus. The proximal anchor 35p may also form or constitute the hinge part 27 of the protection device, and the attachment part 75 extends away from the main body part through the hinge part 27.

6A and 6B, which schematically show an embodiment of the protective device 86, the protective device 86 includes an additional material 36 formed around the lower edge of the main body portion 96 of the device, which is the same as the rest of the material of the main body portion 96 Or a material with a higher Shore hardness relative to the rest of the body part 96 (may be overmolded on the lower edge of the body part). The additional material 36 may additionally (or alternatively) be defined as having a higher "elongation at break" than the rest of the material of the body portion 96. The additional material is selected from, for example, conventional intraocular lens materials such as silicone gel, hydrogel, acrylic ester such as polymethylmethacrylate (PMMA), polycarbonate, polysiloxane, or any other suitable Biocompatible hydrophilic/hydrophobic materials for the human eye.

The remaining material of the body portion 96 may generally be formed of a relatively soft material, such as conventional intraocular lens materials such as silicone gel, which may be easier for example when pulled out of the anterior chamber of the eye through the attachment portion 76 of the device Suffer damage such as tearing. The presence of the additional material 36 helps to strengthen the protection device so that it is not easy to be damaged, and is convenient for pulling out.

Please look at Figures 7A to 7D, which show an embodiment 87 of a protection device formed with proximal and

distal interruptions

37p, 37d. Relative to the distance through which such a protective device is introduced into the anterior chamber of the incision (see here the incision 20 shown in Figure 7B) and is when the protective device is located in the anterior chamber, the distance from the The distance of the incision to define the distal and proximal direction. The deployment axis PD is defined as extending along these directions.

Therefore, the protective device 87 is adapted to usually enter the anterior chamber of the eye through the incision 20 along the deployment axis PD usually with the distal interruption 37d as a lead, and to be removed from the incision usually along the deployment axis PD with the proximal interruption 37p as the lead. .

It is preferable to provide

such interruptions

37p, 37d in a relatively hard material (for example, the additional material 36 discussed with reference to FIGS. 6A and 6B), so as to help create a bending point (for example, a living hinge type bending point) around the bending point The main body portion 97 of the device can be folded to facilitate its introduction and/or removal from the anterior chamber of the eye. This fold is usually around the axis PD. Since the material of the rest of the main body part (for example, hydrogel, etc.) is relatively soft, the presence of these bending points makes the main body part more flexible and foldable, and it is easy to form a hinge, which facilitates the folding of the device.

Please look at Figures 8A and 8B, which schematically illustrate a protective device embodiment 88, which shows a thread-like attachment portion 78 in which the thread extends to an end 38 formed on the device body portion 98. As shown in FIG. Therefore, in this example, the thread of the attachment portion does not necessarily extend in a loop around the periphery of the main body portion of the device.

Here, the thread of the attachment part extends from the end 38 along the underside of the main body part (see the dashed line), and then passes through the hole 40 formed on the proximal side of the main body part (relative to the eye cut) away from the main body part Extend in the direction toward the proximal end of the incision. As shown in Fig. 8B, by pulling the thread of the attachment portion 78, the main body portion is urged to fold inward at the end 38 and further curled, thereby folding the protective device for easy pulling out.

9A to 9C, which show a protection device embodiment 89, which includes a main body portion 99 on which a spiral tear line 39 is formed. The tear line 39 forms a line of local thickness reduction, and the attachment portion 79 of the pulling device is adapted to cause the main body part to tear along the tear line and gradually form an elongated strip (see FIG. 9C), which can be easily removed through the incision. Remove the anterior chamber of the eye.

Please look at Figures 10A to 10C, which show a protection device embodiment 890, which includes at least one slit 390, here a plurality of slits 390, which are formed in the body portion 990 of the device. In this example, it is shown that the slit is transversely (e.g., perpendicular) and / along the axis PD extending along the proximal and distal directions (where the distal and proximal directions are defined relative to the distance from the incision) and/ Or formed in parallel directions. Such slits 390 can help to fold the main body portion of the device, for example when pulling the attachment portion 790 of the device to remove the device from the eye.

Please look at Figures 11A and 11B, which schematically illustrate a protection device embodiment 8900, which includes an attachment portion 7900 integrally formed with a main body portion 9900 of the protection device. The attachment portion 7900 may include (not shown), for example, a fixing part formed as a hole, thread, etc., for helping the physician grasp the attachment portion to remove the device from the eye.

With reference to this exemplary embodiment, removing or removing the protective device from the anterior chamber of the eye may include first placing the straw tube 47 on a part of the attachment portion located outside the anterior chamber. Then, the catheter 47 (the attachment portion serves as a so-called guide) can be pushed to position its distal end 471 near the proximal side of the device body portion.

Once the catheter is in place, it is possible to pull the attachment portion in the proximal direction while keeping the catheter 47 substantially fixed in its position. The catheter acts as a lead-out member to help the main body of the protective device stay in the catheter. The inside is further crimped into a compact state, so that it can be easily removed from the anterior chamber through the corneal incision without damaging the incision.

In the specification and claims of this application, each verb "include", "include" and "have" and their conjugations are used to indicate that one or more objects of the verb do not necessarily fully list the verbs. A member, component, element, or part of one or more subjects.

In addition, although the present application or technology has been illustrated and described in detail in the accompanying drawings and the foregoing description, such description and description should be regarded as illustrative or exemplary rather than restrictive; therefore, the present invention is not limited to all Disclosure of implementation. By studying the drawings, technology, and claims, those skilled in the art who practice the claimed technology can understand and implement the variants of the disclosed embodiments.

In the claims, the word "comprising" does not exclude other elements or steps, and reference without a number does not exclude a plurality. The fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

The present invention should also be understood to include exact terms, features, values or ranges, etc., if such terms, features, values or ranges are used in conjunction with such terms as "about, about, substantially, substantially, at least," etc. to refer to if. In other words, "about 3" should also include "3" or "substantially vertical" should also include "vertical". Any reference signs in the claims should not be considered as limiting the scope.

Although the embodiments of the present invention have been described in detail to a certain extent, it should be understood that various changes and modifications can be made without departing from the scope of protection claimed by the present invention.

Claims

A protective device for the corneal endothelium, the device comprising a main body part and an attachment part extending away from the main body part, the main body part being shaped into an upwardly narrowing shape, and the attachment part being configured to pull the main part.
The protection device according to claim 1, wherein the main body part is shaped as a dome.
The protection device according to claim 1, wherein the attachment portion includes a linear structure.
The protection device according to any one of claims 1 to 3, wherein the attachment part is a wire.
The protection device according to claim 3, wherein the linear structure is formed of surgical material or Nitinol.
The protection device according to any one of claims 1 to 3, wherein the attachment part is formed integrally with the main body part, and optionally includes a fixing part adopting a hole or a linear structure, and the fixing The site is used to help the physician grasp the attachment part to remove the device from the eye.
The protection device according to any one of claims 1 to 3, wherein the uppermost part of the main body part is a flat part.
The protection device according to any one of claims 1 to 3, wherein the main body part includes an upper section and a lower section, and the lower section includes a structure suitable for holding and/or absorbing viscoelastic materials.
The protection device according to claim 8, wherein the lower section comprises an outer layer formed with a hair-like structure or a pit-like structure.
The protection device according to any one of claims 1 to 3, wherein the main body part comprises a thickened lower edge structure, which extends along the lower periphery of the main body part.
The protection device according to claim 10, wherein the edge structure includes a passage therethrough, the attachment portion extends through the passage, and the linear structure of the attachment portion can be in the passage Move partly or completely freely.
The protection device according to claim 10, wherein the edge structure is at least partially overmolded on the linear structure of the attachment portion.
The protection device according to claim 10, wherein the edge structure is integrally formed with the main body part.
The protection device according to claim 10, wherein the edge structure is formed by an additional material surrounding the lower edge of the main body part, and the additional material is the same material as the rest of the main body part, or is opposite The rest of the material in the main body has a higher Shore hardness.
The protective device according to claim 14, wherein the additional material is selected from conventional intraocular lens materials or any other biocompatible hydrophilic/hydrophobic materials suitable for eyes.
The protection device according to claim 10, wherein the edge structure includes one or more interruptions.
The protection device according to any one of claims 1 to 3, wherein the protection device is designed such that pulling on the attachment portion causes the main body portion to fold.
The protection device according to any one of claims 1 to 3, wherein one or more slits are formed in the main body part.
The protection device according to any one of claims 1 to 3, wherein the attachment portion extends away from the lower edge of the main body portion.
The protection device according to any one of claims 1 to 3, wherein the linear structure of the attachment portion extends to the end (38) formed on the main body portion (98), from the end (38) ) Extends along the underside of the main body portion, and then passes through a hole (40) formed on the proximal side of the main body portion and extends away from the main body portion in the proximal direction toward the incision, the proximal side being relative to the eye incision .
The protection device according to any one of claims 1 to 3, wherein a spiral tear line is formed on the main body part.
The protection device according to any one of claims 1 to 3, wherein the main body part has a distal anchor (35d) and a proximal anchor (35p).
The protection device according to claim 22, characterized in that the proximal anchor forms or constitutes a hinge part (27) of the protection device, and the attachment part extends away from the hinge part (27) through the hinge part (27). The main part.
A method for protecting corneal endothelium, the method comprising:

The protective device according to any one of claims 1 to 23 is inserted and arranged in the anterior chamber of the eye through an incision, wherein

When the protective device is arranged in the anterior chamber, at least part of the attachment portion extends through the incision and remains outside the anterior chamber.
The method according to claim 24, wherein the step of removing the protective device from the anterior chamber comprises: pulling the part of the attachment part remaining outside the anterior chamber.
The method of claim 25, wherein pulling the attachment portion causes the main body portion to be at least partially folded into a retracted state that is more compact than the deployed state.
The method according to claim 26, comprising the steps of inserting a catheter into a proximal position of the main body part through the incision, and then pulling the attachment part to retrieve the protective device.
The method of claim 27, wherein the at least partial folding of the main body portion includes pulling the attachment portion while urging the main body portion against the distal end of the catheter.