Corneal endothelial protection device and main body and attachment part thereof

By designing a corneal endothelial protective device including the main part and the attached part, the problem of prone to rupture and damage of the existing device is solved, and effective protection and convenient operation of the corneal endothelial in ophthalmic surgery is achieved.

CN110974531BActive Publication Date: 2025-08-12BEIJING AIER INTECH EYE HOSPITAL LTD
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Patent Information

Application Number
CN202010000802.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2020-01-02
Publication Date
2025-08-12
Estimated Expiration
2040-01-02

AI Technical Summary

Technical Problem

Existing corneal endothelial protective devices are prone to rupture during surgery, difficult to remove from small incisions in the cornea limb, and are not soft enough may damage corneal endothelial cells.

Method used

A corneal endothelial protective device is designed, including a main body portion and an attachment portion, the main body portion is shaped upwardly narrowed, the attachment portion is used to pull the main body portion for easy insertion and removal, the attachment portion can be made of surgical material or polymer material, and the lower part of the main body portion can be thickened and formed a channel or edge structure to enhance protection.

Benefits of technology

It provides additional protection for the corneal endothelium, avoids damage, is easy to operate and does not affect the surgical field of view, and is convenient for insertion and removal. It is suitable for ophthalmic surgeries such as cataract, iris-related surgery, and corneal transplantation.

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Abstract

The present application relates to a protective device for corneal endothelium, which includes a main body portion and an attachment portion, wherein the attachment portion extends away from the main body portion, and the main body portion is generally formed into a shape that gradually narrows upward (such as a dome shape), and the attachment portion is used to pull the main body portion.
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Description

Technical Field

[0001] The present application relates to corneal endothelial protection devices and their main and attached portions, particularly for assisting in providing protection within the eye and / or removal from the eye. Background Art

[0002] The success of intraocular surgery depends particularly on avoiding damage to the corneal endothelium. For example, for this reason, a viscoelastic fluid may be administered into the anterior chamber of the eye between the iris and cornea through a small incision made in the limbus. Through this incision, surgical instruments and the like can also be moved in and out of the eye to perform the desired surgery.

[0003] During such surgical procedures, the pupil may be dilated, and the physician views, for example, the lens of the eye through the cornea and the dilated pupil. Physicians are generally required to be careful to avoid contact with the delicate interior of the cornea, as such damage may be irreversible.

[0004] In some cases, a specialized device can be inserted into the anterior chamber to protect the corneal endothelium, and once the surgical procedure is complete, the device can be removed from the eye. For example, US5951565 describes a flexible, transparent corneal endothelium protection device having a thin protective barrier portion and a thicker edge surrounding the barrier portion. The protection device is foldable for easy insertion through a surgical incision; the protection device is resilient so that it can spring back into shape once placed in the eye; and the protection device is flexible enough to be easily removed through the incision in the eye near the completion of the procedure.

[0005] The device requires an opening in at least one of its central portion and thicker edge portion to allow access for surgical instruments during surgery. However, the device's design does not adequately address the issue of device removal. Its thin, flexible central portion, combined with the thicker edge portion and the incision therein, makes the device particularly susceptible to breakage during removal from the small incision made in the limbus. Summary of the Invention

[0006] In view of this, the main purpose of this application is to provide a protective device for the corneal endothelium, which is transparent and does not affect the operation, soft and does not damage the corneal endothelial cells, and is easy to take and place, convenient to operate, and also provides additional beneficial protection for the corneal endothelium during surgery.

[0007] To achieve the above-mentioned objectives, the present application provides a device for protecting the corneal endothelium, the device comprising a main body portion and an attachment portion extending away from the main body portion, the main body portion being formed into a shape that gradually narrows upward, such as a dome or a dome or an umbrella, and the attachment portion being configured to pull the main body portion. The device is particularly suitable for protecting corneal endothelial cells during cataract surgery, especially in late-stage hard-nuclear cataracts, cataracts with low endothelial cell density, etc. It can also be used for other intraocular surgeries, such as iris-related surgeries, anterior chamber foreign body removal, and other intraocular surgeries. It can also be used in various corneal transplant surgeries, to protect the lens from damage, and to prevent vitreous loss in aphakic eyes.

[0008] In one embodiment of the present application, the attachment portion comprises a thread-like structure. Preferably, the attachment portion is a thread. The thread-like structure is formed from a surgical material, such as a plant material such as linen or cotton, an animal material such as silk or catgut, a polymeric material such as nylon, polyester, PGA, PGLA, PLA, or nitinol. Optionally, the attachment portion is integrally formed with the main body portion and optionally includes a securing portion, such as a hole or thread-like structure, to assist a physician in grasping the attachment portion to remove the device from the eye.

[0009] According to one aspect of the present application, the uppermost portion of the main body is a flat portion. According to one aspect of the present application, the main body comprises an upper section and a lower section, wherein the lower section comprises a structure suitable for holding and / or absorbing viscoelastic material, such as an outer layer having a hair-like structure or a pit-like structure.

[0010] According to another aspect of the present application, the main body portion includes a lower, thickened edge structure extending along the lower periphery of the main body portion. Preferably, the edge structure includes a channel therethrough, through which the attachment portion extends; more preferably, the linear structure of the attachment portion is at least partially free to move within the channel, and preferably completely free to move. In another embodiment, the edge structure is at least partially overmolded onto the linear structure of the attachment portion.

[0011] According to one aspect of the present application, the edge structure is formed integrally with the main body. According to another aspect of the present application, the edge structure is formed by an additional material surrounding the lower edge of the main body. The additional material is the same material as the rest of the main body, or a material with a higher Shore hardness than the rest of the main body. The additional material is selected from conventional intraocular lens materials, such as silicone gel, hydrogel, acrylate such as polymethyl methacrylate (PMMA), polycarbonate, polysiloxane, or any other biocompatible hydrophilic / hydrophobic material suitable for the eye.

[0012] According to one aspect of the present application, the protective device is designed so that pulling the attachment portion causes the main body portion to fold. Preferably, the lower edge of the main body portion, or if an edge structure is provided, 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 portion.

[0013] According to one aspect of the present 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 a terminal end (38) formed on the main body portion (98), extends from the terminal end (38) along the lower side of the main body portion, and then extends away from the main body portion in a proximal direction toward the incision through a hole (40) formed on the proximal side of the main body portion (relative to the eye incision).

[0014] According to one aspect of the present application, a spiral tear line is formed on the main body. According to one aspect of the present application, the main body has a distal anchor (35d) and a proximal anchor (35p). Preferably, the proximal anchor can also form or constitute a hinge portion (27) of the protective device, and the attachment portion extends away from the main body through the hinge portion (27).

[0015] The present application also provides a method for protecting corneal endothelium, the method comprising:

[0016] The protective device of the present application is inserted and arranged in the anterior chamber of the eye through an incision, wherein

[0017] When the protection device is deployed in the anterior chamber, at least a portion of the attachment portion extends through the incision to remain outside of the anterior chamber.

[0018] According to one aspect of the present application, placing the protective device of the present application in the anterior chamber of the eye includes injecting viscoelastic fluid to cause the protective device to unfold to a placement state, and may further include injecting additional viscoelastic fluid between the cornea and the protective device.

[0019] According to one aspect of the present application, the step of removing the protective device from the anterior chamber comprises pulling the portion of the attachment portion remaining outside the anterior chamber. Preferably, pulling the attachment portion causes the main body portion to at least partially fold into a retracted state that is more compact than the deployed state.

[0020] According to one aspect of the present application, the method includes inserting a catheter through the incision to a proximal end of the main body portion and then pulling the attachment portion to retrieve the protective device, wherein at least partially folding the main body portion includes forcing the main body portion against the distal end of the catheter while pulling the attachment portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Exemplary embodiments of the present application are shown in the accompanying drawings. The drawings are intended to be illustrative and not restrictive. The present invention (both in its structure and method of operation) and its objects, features, and advantages may be best understood when read and referred to the following detailed description in conjunction with the accompanying drawings, in which:

[0022] Figure 1 schematically illustrates a schematic cross-sectional view of a general human eye and an exemplary embodiment of a protective device of the present invention positioned within the anterior chamber of the eye to protect the corneal endothelium;

[0023] Figure 2A and 2B Schematically showing a side view and a side top view of an embodiment of the present invention; Figure 2C and 2D Schematically showing a side view and a side top view of another embodiment of the present invention;

[0024] Figures 3A to 3C Schematically showing a cross-sectional view, a bottom view and a side view of an embodiment of the present invention;

[0025] Figure 4A and 4B Schematically showing a top view and a cross-sectional view of an embodiment of the present invention; Figure 4C A side plan view and a partially enlarged view of the embodiment are schematically shown;

[0026] Figure 5A and 5B Schematically showing a top view and a side view of an embodiment of the present invention;

[0027] Figure 6A and 6B Schematically showing a top view and a cross-sectional view of an embodiment of the present invention;

[0028] Figure 7A Schematically shows a top view of one embodiment of the present invention; Figure 7B The embodiment is schematically shown in a folded state when taken out of the incision; Figure 7C is the top view of the folded state; Figure 7D A cross-section along line AA is shown;

[0029] Figure 8A Schematically shows a top view of one embodiment of the present invention; Figure 8B The embodiment is schematically shown in a folded state;

[0030] Figures 9A to 9CSchematically illustrating a top view, a side view, and a schematic diagram of a state in which the device is torn along a tear line and gradually forms a long and thin strip according to an embodiment of the present invention;

[0031] Figure 10A Schematically shows a top view of one embodiment of the present invention; Figure 10B shows a possible folded state of the device when the attachment portion of the device is pulled; Figure 10C A cross-sectional view along line BB of the folded state is shown;

[0032] Figure 11A and 11B A top view and a side view of an embodiment of the present invention are schematically shown respectively.

[0033] It is to be understood that for simplicity and clarity of illustration, the elements shown in the figures are not necessarily drawn to scale, and that features shown in each embodiment may be combined with features shown in other embodiments. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Furthermore, where deemed appropriate, reference numerals may be repeated in the figures to indicate similar elements. DETAILED DESCRIPTION

[0034] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are intended to be exemplary and illustrative, and not to limit the scope of the invention.

[0035] In one embodiment, a device for protecting the corneal endothelium is provided. The device includes a main body portion and an attachment portion extending away from the main body portion. The main body portion is generally shaped to taper upward. The specific shape is not particularly limited, but preferably has a curvature substantially consistent with the curvature of the cornea to provide necessary protection for the cornea, and is sized to be placed in an animal (preferably a human) eye. The main body portion is, for example, generally shaped like a dome, a dome, or an umbrella, and the attachment portion is configured to pull the main body portion.

[0036] Typically, when the protective device is arranged in the anterior chamber of the eye, the upwardly tapered shape of the main body portion is configured 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 touching the corneal endothelium) to provide sufficient surgical space underneath it.

[0037] The attachment portion is configured to pull the main body 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, wherein such pulling typically occurs near the end of a surgical procedure in the eye, wherein the protective device is used to assist in protecting the corneal endothelium during the procedure.

[0038] The attachment portion can, in principle, take any suitable shape, provided it does not interfere with the surgical field of view or the operation of the surgical instrument. In one embodiment, the attachment portion comprises a thread-like structure. Such a thread-like structure can be arranged to surround the lower edge of the main body portion, possibly via a channel formed in the lower edge, or can be arranged to extend upwardly to a portion of the main body portion.

[0039] In one embodiment, the uppermost portion of the main body portion is a flat portion. Such a generally flat upper portion can provide space (or additional space) between the main body portion of the protection device and the endothelium for receiving a viscoelastic gel that may be administered into the anterior chamber during surgery to help protect the endothelium.

[0040] In one embodiment, the protective device is designed so that pulling on the attachment portion causes the main body portion 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.

[0041] The specific embodiments of the present invention will be further described below with reference to the accompanying drawings.

[0042] Please see Figure 1 , which schematically shows a human eye 10. The eye has a cornea 12 and an anterior chamber 14 located between an iris 16 and the innermost surface of the cornea, the endothelium 121. An exemplary embodiment of a protective device 8 of the present invention is shown, which occupies the anterior chamber. The protective device has a main body portion 9 (here generally shaped as a dome) that occupies the anterior chamber in this example, and an attachment portion 7 that extends from the main body portion to the exterior of the anterior chamber through an incision 20 that may be formed in the limbus.

[0043] The incision 20 can be appropriately formed to provide access for surgical procedures performed on the eye. Such surgical procedures may include moving surgical tools, etc., into and out of the anterior chamber through the incision. In a broad aspect of the present invention, the various protective device embodiments described herein can be used, for example, to protect the corneal endothelium during such surgical procedures.

[0044] Such a protective device 8 can be inserted through an incision to place the main body portion 9 within the anterior chamber, while a portion of the attachment portion 7 of the device remains extended outside the anterior chamber, in a position more easily accessible to the surgeon performing the surgery.

[0045] In various embodiments disclosed herein, the main body of the device can assume a folded state suitable for insertion into and / or removal from the anterior chamber. Once within the anterior chamber, the main body can preferably self-expand (e.g., by elastically springing into position) to assume a deployed state suitable for protecting the endothelium. This deployed state includes forming a cavity 5 beneath the main body of the device.

[0046] In various embodiments disclosed herein, the attachment portion 7 of the retention device extends outside the anterior chamber and can be used by the physician to remove the protection device from the anterior chamber near the completion of the surgical procedure.

[0047] In the descriptions provided herein, features and aspects disclosed in the context of a certain embodiment may be combined alone, or may be combined with other features in that particular embodiment, or with one or more features or aspects described in other embodiments. Figure 2D The "flat" upper portion of the main body portion disclosed in the can be suitably applied to any of the other protective device embodiments described herein. In a further example, the linear attachment portion and / or hinge portion, such as Figure 3C What is disclosed in the foregoing may be appropriately applied (alone or in combination) to other protection device embodiments.

[0048] Now let's see Figures 2A to 2D , which shows the main body portions 91, 92 of various protector 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 comprising a first lower section 1 that generally follows the contour of a base that tapers upwardly (such as a dome), followed by a second upper section 2 that deviates from such a contour, for example being generally "squashed".

[0049] Such a second portion 2 is suitable for providing a space 3 (and / or additional "volume" and / or "chamber") below the contour of the upper portion where there would otherwise be a dome (or other upwardly tapering shape). Figure 2C The dotted line shows the outline of where such an upper portion (here, the dome) should exist. The space 3 formed below the corneal endothelium is suitable for receiving a larger volume / amount of viscoelastic fluid during surgery to provide further protection for the endothelium.

[0050] Come and see Figures 3A to 3C, which shows an embodiment of a protective device 83 comprised of a main body portion 93 and an attachment portion 73. The main body portion 93 shown in this example includes a lower, thickened edge structure 18 that extends along the lower periphery of the main body portion. The edge 18 includes a through-going peripheral channel 19 that extends around the lower edge of the main body portion. In this example, the attachment portion 73 is formed as a linear member that extends through the channel 19.

[0051] In some cases, the thread of attachment portion 73 can be freely movable within channel 19, while in other cases, the attachment portion can be formed substantially integrally within rim 18, for example by at least partially overmolding rim 18 onto the thread of attachment portion 73. Providing relative movement between the thread of attachment portion and channel 19 can, in some cases, reduce the risk of tearing of the protective device (e.g., near the rim) when the attachment portion is pulled to remove the device from the anterior chamber of the eye.

[0052] As non-limiting examples, such a wire attachment portion 73 may be formed from surgical materials such as nylon, polymeric materials, and in some cases, Nitinol.

[0053] The device of the protective device 83 can 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 can be funnel-shaped, narrowing in a direction away from the main body portion. The thickening at the hinge portion can be used to strengthen the protective device at this location to reduce the possibility of damage (e.g., tearing) to the device when the device is pulled out of the anterior chamber of the eye by the attachment portion.

[0054] Please see Figures 4A to 4C , which shows an embodiment of a protection device 84 formed at its main portion 94 by two sections 11, 22. The first lower section 11 forms the base of an upwardly narrowing shape (e.g., a dome), and the second upper section 22 forms an upper subsequent part which continues to narrow upwardly, for example, following the contour of the dome.

[0055] The first segment 11, generally located at the periphery of the main body portion, includes an outer layer 30 adapted to retain, maintain, and / or absorb the viscoelastic material. To this end, the outer layer 30 may include a roughened structure, such as a hair-like structure, a dimple-like structure, etc., to increase the surface area of the main body portion within the segment. Thus, the roughened outer layer 30 can reduce the transparency of the main body portion while increasing the affinity for the viscoelastic material and / or the presence of the viscoelastic material within the segment to protect the endothelium.

[0056] The second section 22, which is located more centrally relative to the optical axis O of the main body portion, can be made more transparent, for example, by including a more transparent material, a smoother outer structure, etc. This transparency can be used to provide a physician with a substantially unobstructed view through the cornea and the second section 22 of the main body portion to observe, for example, the lens of the eye.

[0057] Please see Figure 5A and 5B , which shows an embodiment of a protection device 85 including a body portion 95 having distal and proximal anchors 35d, 35p. Opposing distal and proximal directions are defined relative to the distance from an incision (not shown) through which such a protection device is introduced into the anterior chamber and relative to the incision when the protection device is positioned within the anterior chamber, specifically, distal anchor 35d distal to the incision and proximal anchor 35p adjacent to the incision. A deployment axis PD is defined as extending along these directions.

[0058] Thus, the protective device 85 is adapted to be inserted through an incision into the anterior chamber of the eye generally along axis PD, with the distal anchor 35d leading the way, and to be removed from the incision generally along axis PD, with the proximal anchor 35p leading the way. The anchors 35d, 35p can be formed as bulging members that are positioned to abut and contact the inner surface of the anterior chamber, perhaps generally near the limbus. The proximal anchor 35p can also form or constitute the hinge portion 27 of the protective device, through which the attachment portion 75 extends away from the main body portion.

[0059] Please see Figure 6A and 6B , which schematically illustrates an embodiment of a protective device 86 comprising an additional material 36 formed around the lower edge of the device's main body portion 96, the additional material being the same material as the remainder of the main body portion 96 or a material having a higher Shore durometer than the remainder of the main body portion 96 (possibly overmolded onto the lower edge of the main body portion). The additional material 36 may additionally (or alternatively) be defined as having a higher "elongation at break" than the remainder of the main body portion 96. The additional material may be selected, for example, from conventional intraocular lens materials such as silicone gel, hydrogel, acrylates such as polymethylmethacrylate (PMMA), polycarbonate, polysiloxane, or any other biocompatible hydrophilic / hydrophobic material suitable for use in the human eye.

[0060] The remaining material of the main body portion 96 can generally be formed of a relatively soft material, such as conventional intraocular lens materials such as silicone gel, which may be more susceptible to damage such as tearing when, for example, the device is pulled out of the anterior chamber of the eye via the attachment portion 76. The presence of the additional material 36 helps to strengthen the protective device, making it less susceptible to damage and facilitating its removal by pulling it out.

[0061] Please see Figures 7A to 7D , which shows a protection device embodiment 87 formed with proximal and distal interruptions 37p, 37d. Figure 7B The distal and proximal directions are defined by the distance from the incision 20 shown in FIG. 1 and the distance from the incision when the protection device is located in the anterior chamber. The deployment axis PD is defined as extending along these directions.

[0062] Thus, protection device 87 is adapted to be introduced through incision 20 into the anterior chamber of the eye, generally along deployment axis PD, generally with distal interruption 37d leading, and to be removed from the incision, generally along deployment axis PD, generally with proximal interruption 37p leading.

[0063] Preferably on relatively hard materials (e.g. Figure 6A and 6B The provision of such interruptions 37p, 37d in the additional material 36 discussed above facilitates the creation of flexure points (e.g., living hinge-type flexures) around which the main body portion 97 of the device can be folded to facilitate its introduction into and / or removal from the anterior chamber of the eye. This folding typically occurs about axis PD. Because the material of the remainder of the main body portion (e.g., hydrogel) is relatively soft, the presence of these flexure points provides greater flexibility in the folding of the main body portion, allowing for easier hinge formation and facilitating folding of the device.

[0064] Please see Figure 8A and 8B , which schematically illustrates a protective device embodiment 88 showing a thread-like attachment portion 78, wherein the thread extends to a terminal end 38 formed on a device body portion 98. Thus, in this example, the thread of the attachment portion does not necessarily extend in a loop around the periphery of the device body portion.

[0065] Here, the thread of the attachment portion extends from the distal end 38 along the underside of the main body portion (see dashed line) and then extends away from the main body portion in a proximal direction toward the incision through a hole 40 formed on the proximal side of the main body portion (relative to the eye incision). Figure 8B As shown, by pulling the thread of the attachment portion 78, the main body portion is caused to first fold inward at the end 38 and then further curl, thereby folding the protective device to facilitate pulling out.

[0066] Please see Figures 9A to 9C , which shows a protective 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 localized reduced thickness, and the attachment portion 79 of the pulling device is adapted to cause the main body portion to tear along the tear line and gradually form an elongated strip (see Figure 9C ), which can be easily moved out of the anterior chamber of the eye through an incision.

[0067] Please see Figures 10A to 10C , which shows a protective device embodiment 890 that includes at least one slit 390, here a plurality of slits 390, formed in a main body portion 990 of the device. In this example, the slits are shown to be formed transversely (e.g., perpendicularly) and / or parallel to an axis PD extending in a proximal and distal direction (where the distal and proximal directions are defined relative to the distance from the incision). Such slits 390 can help fold the main body portion of the device, for example, when pulling on the attachment portion 790 of the device to remove the device from the eye.

[0068] Please see Figure 11A and 11B , which schematically illustrates a protective device embodiment 8900 including an attachment portion 7900 integrally formed with a main body portion 9900 of the protective device. The attachment portion 7900 may include (not shown) a securing portion, such as a hole, a thread, or the like, to assist a physician in grasping the attachment portion to remove the device from the eye.

[0069] With reference to this exemplary embodiment, removing or extracting the protective device from the anterior chamber of the eye may include first placing a straw-like catheter 47 on a portion of the attachment portion located outside the anterior chamber. The catheter 47 (the attachment portion serving as a so-called guide) may then be pushed to position its distal end 471 proximal to the main body portion of the device.

[0070] Once the catheter is in place, the attachment portion can be pulled proximally while the catheter 47 is essentially held in place, the catheter acting as a guide member to help the main body of the protective device further curl into a compact state within the catheter for removal from the anterior chamber through the corneal incision without damaging the incision.

[0071] In the specification and claims of this application, each verb "comprise", "include" and "have" and their variations are used to indicate that one or more objects of the verb do not necessarily fully list the members, components, elements or parts of the one or more subjects of the verb.

[0072] Furthermore, while the present application or technology has been illustrated and described in detail in the drawings and foregoing description, such illustration and description should be considered illustrative or exemplary rather than restrictive; therefore, the invention is not limited to the disclosed embodiments. Variations to the disclosed embodiments may be understood and effected by those skilled in the art practicing the claimed technology through a study of the drawings, the technology, and the claims.

[0073] In the claims, the word "comprising" does not exclude other elements or steps and a reference without a number does not exclude a plurality. The mere 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.

[0074] The present invention should also be understood to include specific terms, features, values, or ranges, etc., if such terms, features, values, or ranges, etc. are referred to herein in conjunction with words such as "about, approximately, substantially, generally, at least," etc. In other words, "about 3" should also include "3" or "substantially perpendicular" should also include "perpendicular." Any reference signs in the claims should not be construed as limiting the scope.

[0075] Although the embodiments of the present invention have been described in some detail, it will be appreciated that various changes and modifications can be made without departing from the scope of the invention as claimed.

Claims

1. A protective device for corneal endothelium, the device comprising a main body portion and an attachment portion extending away from the main body portion, the main body portion being formed into a shape tapering upward, and the attachment portion being configured to pull the main body portion; The attachment portion includes a linear structure; The main body portion includes a lower thickened edge structure extending along a lower periphery of the main body portion; The edge structure is at least partially overmolded onto the linear structure of the attachment portion; The edge structure includes a through peripheral channel extending around a lower edge of the main body portion; the attachment portion is formed as a linear member extending through the channel; The device is formed with a thickened hinge portion at which the attachment portion projects away from the main body portion.

2. The protection device according to claim 1, characterized in that The main body portion is shaped like a dome.

3. The protection device according to any one of claims 1 or 2, characterized in that: The attachment portion is a wire.

4. The protection device according to any one of claims 1 or 2, characterized in that: The wire-like structure is formed of a surgical material or Nitinol.

5. The protection device according to any one of claims 1 or 2, characterized in that: The attachment portion is integrally formed with the main body portion and includes a securing portion in the form of a hole or wire structure for assisting a physician in grasping the attachment portion to remove the device from the eye.

6. The protection device according to any one of claims 1 or 2, characterized in that: The uppermost portion of the main body portion is a flat portion.

7. The protection device according to any one of claims 1 or 2, characterized in that: The main body portion includes an upper section and a lower section, the lower section including structure suitable for retaining and / or absorbing viscoelastic material.

8. The protection device according to claim 7, characterized in that: The lower section includes an outer layer formed with hair-like structures or pit-like structures.

9. The protection device according to claim 1, characterized in that: The thread-like structure of the attachment portion is partially free to move within the channel.

10. The protection device according to claim 1, characterized in that: The edge structure is integrally formed with the main body portion.

11. The protection device according to claim 1, characterized in that: The edge structure is formed of additional material around the lower edge of the main body portion, the additional material being the same material as the remainder of the main body portion or a material having a higher Shore hardness relative to the remainder of the main body portion.

12. The protection device according to claim 11, characterized in that The additional material is selected from conventional intraocular lens materials or any other biocompatible hydrophilic / hydrophobic materials suitable for eyes.

13. The protection device according to claim 1, characterized in that The edge structure includes one or more interruptions.

14. The protection device according to any one of claims 1 or 2, characterized in that: The protective device is designed so that pulling on the attachment portion causes the main body portion to fold.

15. The protection device according to any one of claims 1 or 2, characterized in that: The body portion has one or more slits formed therein.

16. The protection device according to any one of claims 1 or 2, characterized in that: The attachment portion extends away from a lower edge of the main body portion.

17. The protection device according to any one of claims 1 or 2, characterized in that: The linear structure of the attachment portion extends to a terminal end formed on the main body portion, extends from the terminal end along the lower side of the main body portion, and then extends away from the main body portion in a proximal direction toward the incision through a hole formed on the proximal side of the main body portion, wherein the proximal side is relative to the eye incision.

18. The protection device according to any one of claims 1 or 2, characterized in that: A spiral tear line is formed on the main body portion.

19. The protection device according to any one of claims 1 or 2, characterized in that: The body portion has a distal anchor and a proximal anchor.

20. The protection device according to claim 19, characterized in that The proximal anchor forms or constitutes a hinge portion of the protective device through which the attachment portion extends away from the main body portion.

Citation Information

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