CN116785025A - Eye implant and delivery system thereof - Google Patents

Eye implant and delivery system thereof Download PDF

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Publication number
CN116785025A
CN116785025A CN202310600223.0A CN202310600223A CN116785025A CN 116785025 A CN116785025 A CN 116785025A CN 202310600223 A CN202310600223 A CN 202310600223A CN 116785025 A CN116785025 A CN 116785025A
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China
Prior art keywords
ocular implant
catheter
delivery system
flexible substrate
cannula
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Pending
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CN202310600223.0A
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Chinese (zh)
Inventor
郑浩
张嘉漪
颜彪
姜春晖
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Fudan University
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Fudan University
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Priority to CN202310600223.0A priority Critical patent/CN116785025A/en
Publication of CN116785025A publication Critical patent/CN116785025A/en
Pending legal-status Critical Current

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Abstract

The invention discloses an ocular implant and a delivery system thereof, comprising: a flexible substrate; a plurality of nanowire arrays disposed on the flexible substrate; an elastic ring disposed along a circumferential edge of the flexible substrate, the elastic ring having elastic memory capable of returning to a pre-deformation natural shape after deformation; and two opposing apertures disposed at the flexible substrate proximate the edge. The nanowire array of the ocular implant can be formed by splicing a plurality of materials, and the materials with different effects and different wave bands and light sensitivity can be selected for splicing, so that the personalized ocular implant can be customized according to different conditions of a patient so as to achieve the purpose of being matched with the fundus condition of the patient; and the design of the folding and hole sites in the ocular implant of the present invention, as well as the nature of the elastomeric ring to impart overall self-expansion, allows it to be adapted for positioning and minimally invasive implantation with a delivery system.

Description

Eye implant and delivery system thereof
Technical Field
The present invention is in the field of ocular medical treatment, and more particularly, the present invention relates generally to an ocular implant and delivery system therefor.
Background
Artificial retina is a high-tech medical product implanted under the retina of a blind person to achieve a certain efficacy and tolerance. The principle of such an implanted device is to operate with miniature cameras, transmitters and miniature wireless computers on glasses. The external view is captured by a camera on the patient's glasses, and then the image is transmitted to the artificial retina on the surface of the patient's eyeball through a wireless transmitter and converted into an electric pulse signal. Electrodes on the artificial retina then stimulate the retinal optic nerve and continue to transmit signals along the optic nerve to the brain.
The traditional technology adopts technical paths similar to artificial cochlea, cardiac pacemaker and brain pacemaker. Three types of small-sized active implantable medical instruments drive an electrode array implanted in fundus to achieve multipoint electrical stimulation. However, this technique has the drawbacks of limited clinical verification resolution and poor patient recovery and also has the risk of water short-circuiting due to the presence of the battery and chip on the intracorporal implant.
In recent years, a split type artificial retina is developed abroad through a semiconductor MEMS technology, an in-vivo implant is a passive silicon photocell array, and energy and information are transmitted to the in-vivo implant through an in-vitro machine (glasses). While this technique circumvents the complex design of in vivo implants, currently there is a minimum volume limitation for a single silicon photocell due to MEMS technology limitations, and resolution cannot be improved to a satisfactory level. Meanwhile, the electrode array and the artificial retina of the MEMS process are not flexible enough, and can not be minimally invasive during implantation.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provide an eye implant which has enough flexibility and can be minimally invasive when implanted and a delivery system thereof.
In a first aspect, the present invention provides an ocular implant comprising:
a flexible substrate;
a plurality of nanowire arrays disposed on the flexible substrate;
an elastic ring disposed along a circumferential edge of the flexible substrate, the elastic ring having elastic memory capable of returning to a pre-deformation natural shape after deformation; and
two opposing apertures disposed at the flexible substrate proximate the edge.
In a preferred embodiment of the present invention, the flexible substrate may be selected from at least one of Polydimethylsiloxane (PDMS), polyvinyl alcohol (PVA), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), and Polyimide (PI), preferably polydimethylsiloxane.
In a preferred embodiment of the present invention, the size of the plurality of nanowire arrays may each be independently selected from 0.01mm 2 To 2mm 2 Preferably 0.1mm 2 To 1mm 2 And the spacing between adjacent ones of the plurality of nanowire arrays may be 0.01mm to 1mm, preferably 0.05mm to 0.5mm.
In a preferred embodiment of the present invention, the shape of the plurality of nanowire arrays may each independently be polygonal, elliptical or circular, preferably square, rectangular, diamond, triangular or hexagonal.
In a preferred embodiment of the present invention, the plurality of nanowire arrays may be composed of a plurality of nanowire arrays having different efficacy and/or different wavelength band light sensitivity.
In a preferred embodiment of the present invention, the elastic ring may be selected from a metal alloy wire or an organic wire, wherein the metal alloy wire is preferably at least one of a nichrome wire, a platinum iridium wire, a inconel wire, an iron-chromium-aluminum alloy, an aluminum-platinum alloy wire, and a nickel-titanium alloy wire, preferably a nichrome wire.
In a second aspect, the present invention also provides a delivery system for implanting an ocular implant according to the above in an eye of a subject, comprising:
a cannula comprising a tubular portion and a head portion for receiving the ocular implant;
a catheter which is capable of passing through the tubular portion of the sleeve and is movable along a length direction of the tubular portion and rotatable about the length direction as an axis, and
a guide wire capable of passing through the catheter and movable along a length direction of the catheter and rotatable about the length direction,
wherein, one end of the catheter is provided with a first bending part, one end of the guide wire is provided with a second bending part, which are respectively used for coupling with the orifice of the ocular implant.
In a preferred embodiment of the invention, the head of the cannula may be arranged to receive the ocular implant prior to delivery of the ocular implant and to hold the ocular implant in a folded state.
In a preferred embodiment of the present invention, the catheter may have a length longer than the tubular portion of the cannula, and the guide wire may have a length longer than the catheter.
In a preferred embodiment of the invention, the first and second bends may be configured to move the ocular implant into or out of the head of the cannula by relative movement of the catheter and the guidewire with the cannula.
In a preferred embodiment of the present invention, the first and second bends may be configured to stretch the ocular implant by relative movement of the catheter and the guidewire.
In a third aspect, the present invention also provides an ocular implant kit comprising an ocular implant as described above and a delivery system as described above.
Compared with the prior art, the ocular implant and the delivery system thereof have at least the following outstanding advantages:
(1) The eye implant has the flexible substrate, the biocompatibility can be improved to a certain extent, and the flexible and foldable characteristics enable the eye implant to be curled and folded;
(2) The design of folding and hole sites in the ocular implant and the characteristic of the integral self-unfolding imparted by the elastic ring enable the elastic ring to be matched with a delivery system for positioning and minimally invasive implantation;
(3) The ocular implant can be repeatedly unfolded and folded, for example, the ocular implant can be in an unfolded state during processing and manufacturing, can be folded and compressed into a delivery system, can be matched with the delivery system to be repeatedly folded and unfolded during implantation operation, and can be taken out by a patient implanted with the ocular implant as required in special conditions, and can be folded and taken out again by using an elastic ring, a hole site and a taking-out system;
(4) The nanowire array of the ocular implant can be formed by splicing a plurality of materials, and can select different effects and different wave band light-sensitive materials for splicing, so that the personalized ocular implant can be customized according to different conditions of a patient so as to achieve the purpose of being matched with the fundus condition of the patient; and
(5) The delivery system of the present invention can ensure that the customized implant is implanted at the desired angle and location, ensuring compliance with the fundus condition of the patient.
Drawings
The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate the invention and together with the description serve to explain, without limitation, the invention. In the drawings:
fig. 1 is a schematic diagram showing components in an ocular implant 1 according to one embodiment of the present invention, including a flexible substrate 2, a plurality of nanowire arrays 3, an elastic ring 4, and an orifice 5, prior to assembly;
fig. 2 is a schematic diagram showing the combination of components in an ocular implant 1 according to one embodiment of the present invention;
fig. 3 is a schematic view showing an ocular implant 1 according to one embodiment of the present invention in a folded state;
fig. 4 is a schematic diagram showing the components of the delivery system 6, including the flexible sleeve 7, catheter 8 and guidewire 9, prior to combination, according to one embodiment of the invention;
fig. 5 is a schematic diagram showing the combination of components in the delivery system 6 according to one embodiment of the invention;
fig. 6 is a schematic diagram illustrating an ocular implant 1 and a delivery system 6 coupled in accordance with one embodiment of the present invention;
fig. 7 is a schematic view showing the curvature of the delivery system 6 to bring the ocular implant 1 to a natural state according to one embodiment of the present invention;
fig. 8 is a schematic diagram showing the curvature of the delivery system 6 with the ocular implant 1 in tension, according to one embodiment of the present invention;
fig. 9 is a schematic diagram showing after performing step S3 according to an embodiment of the present invention;
fig. 10 is a schematic view showing the process after performing step S4 according to an embodiment of the present invention;
fig. 11 is a schematic view showing after performing step S5 according to an embodiment of the present invention;
fig. 12 is a schematic diagram showing after performing step S6 according to an embodiment of the present invention;
fig. 13 is a schematic view showing a process after performing step S7 according to an embodiment of the present invention;
fig. 14 is a schematic view showing after performing step S8 according to an embodiment of the present invention;
fig. 15 is a schematic diagram showing after step S9 is performed according to an embodiment of the present invention.
Reference numerals:
an ocular implant-1; a flexible substrate-2; a nanowire array-3; an elastic ring-4; an orifice-5; a delivery system-6; a sleeve-7; a catheter-8; guide wire-9; a first curved portion-10; and a second curved portion-11.
Detailed Description
The following describes specific embodiments of the present invention in detail. It should be understood that the detailed description and specific examples, while indicating and illustrating the invention, are not intended to limit the invention.
The endpoints and any values of the ranges disclosed herein are not limited to the precise range or value, and are understood to encompass values approaching those ranges or values. For numerical ranges, one or more new numerical ranges may be found between the endpoints of each range, between the endpoint of each range and the individual point value, and between the individual point value, in combination with each other, and are to be considered as specifically disclosed herein.
In one aspect, the present invention provides an ocular implant 1 comprising:
a flexible substrate 2;
a plurality of nanowire arrays 3 disposed on the flexible substrate 2;
an elastic ring 4 disposed along a circumferential edge of the flexible substrate 2, the elastic ring 4 having elastic memory capable of returning to a pre-deformation natural shape after deformation; and
two opposite apertures 5 provided at the near edges of the flexible substrate 2.
Referring to fig. 1 and 2, wherein fig. 1 is a schematic view showing components in an ocular implant 1 according to one embodiment of the present invention before being combined, and fig. 2 is a schematic view showing components in an ocular implant 1 according to one embodiment of the present invention after being combined.
The ocular implant 1 of the present invention comprises a flexible substrate 2, a plurality of nanowire arrays 3, an elastic ring 4, and an aperture 5, wherein the plurality of nanowire arrays 3, the elastic ring 4, and the aperture 5 are all disposed on the flexible substrate 2. In order to enable the ocular implant of the present invention to better fold and conform to the eye, the present invention employs the flexible substrate 2 as the substrate of the ocular implant, and the specific choice of material for the flexible substrate 2 may be adapted according to actual needs, e.g. may be selected from any flexible material common in the art. More specifically, in one embodiment of the present invention, the flexible substrate may be selected from at least one of Polydimethylsiloxane (PDMS), polyvinyl alcohol (PVA), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), and Polyimide (PI), preferably, but not limited thereto. Furthermore, in a preferred embodiment of the present invention, the flexible substrate may have small pores or a porous structure that allows moisture and nutrients to permeate the flexible substrate, increasing oxygen permeability.
For the plurality of nanowire arrays 3, in order to meet the high requirement in terms of flexibility, the present invention gives up the use of a single complete nanowire array in the conventional art, and instead adopts a plurality of small nanowire arrays arranged at intervals, which not only ensures the high flexibility of the ocular implant of the present invention, but also allows the permeation of water vapor and nutrients further, thereby maintaining circulation. As shown in fig. 1 and 2, the nanowire arrays 3 of the present invention may be arranged and combined arbitrarily, and the material, shape, size, spacing, etc. of each nanowire array in the nanowire arrays 3 are not particularly limited, and may be adjusted according to practical situations (for example, different photoreceptive capacities, densities, etc. of photoreceptive cells based on different parts of eyes, and different degradation degrees of cells of different patients, etc.), and particularly, the personalized ocular implant may be customized according to different situations of patients through preoperative examination, so as to achieve the purpose of better matching with the fundus situation of the patient.
Alternatively, for example, in one embodiment of the present invention, the size of the plurality of nanowire arrays 3 may each be independently selected from 0.01mm 2 To 2mm 2 Preferably 0.1mm 2 To 1mm 2 (e.g. 0.2mm 2 、0.5mm 2 Or 0.8mm 2 Etc.), and the spacing between adjacent ones of the plurality of nanowire arrays 3 may be 0.01mm-1mm, preferably 0.05mm-0.5mm (e.g., 0.1mm, 0.2mm, 0.25mm, 0.3mm, etc.). In another embodiment of the present invention, the shape of the plurality of nanowire arrays 3 may be, but not limited to, a polygon, preferably a square, a rectangle, a diamond, a triangle, or a hexagon, each independently of the square shown in the drawings. In another embodiment of the present invention, the plurality of nanowire arrays 3 may be composed of a plurality of nanowire arrays having different effects and/or different wavelength band light sensitivity.
As for the elastic ring 4, since the ocular implant 1 is adapted to be delivered to the eye of a patient in a folded state, in order to enable the ocular implant 1 of the present invention to be unfolded after being delivered to the eye of a patient, the elastic ring 4 is further provided at the circumferential edge of the flexible substrate 2 of the ocular implant 1, and the elastic ring 4 has elastic memory capable of returning to an inherent shape before deformation after being deformed, so that the self-unfolding of the ocular implant 1 after being delivered to the eye of a patient in a folded state can be achieved. In one embodiment of the present invention, the elastic ring may be selected from a metal alloy wire or an organic wire, wherein the metal alloy wire is preferably at least one of a nichrome wire, a platinum iridium alloy wire, a inconel wire, an iron chromium aluminum alloy, an aluminum platinum alloy wire, and a nickel titanium alloy wire, preferably a nichrome wire.
For the aperture 5, it is used to couple with a delivery system, so that the delivery system can facilitate pushing, pulling, moving, etc. of the ocular implant 1 during a surgical procedure.
Further, referring to fig. 3, fig. 3 is a schematic view showing an ocular implant 1 according to an embodiment of the present invention in a folded state, wherein a flexible substrate 2 is folded inward toward a face provided with a plurality of nanowire arrays 3, thereby wrapping the plurality of nanowire arrays 3 inside, and exposing an orifice 5 so as to facilitate operation of a delivery system, i.e., being folded inward along a straight line where two orifices 5 are located. As described above, the ocular implant 1 of the present invention is adapted to be delivered to the eyes of a patient in a folded state, which not only can reduce surgical trauma, but also can protect the delicate nanowire arrays 3 inside the flexible substrate 2 from collision and friction with a delivery system or the eyes of the patient during minimally invasive implantation, and after the delivery is completed, the folded ocular implant 1 will self-expand from the folded state to the original shape under the elastic memory of the elastic ring 4.
In a second aspect, the present invention provides a delivery system 6 for implanting an ocular implant according to the above in an eye of a subject, comprising:
a cannula 7 comprising a tubular portion and a head portion for receiving the ocular implant;
a catheter 8 which is capable of passing through the tubular portion of the sleeve and is movable along the length direction of the tubular portion and rotatable about the length direction as an axis, and
a guide wire 9 which is capable of passing through the catheter and is movable along the longitudinal direction of the catheter and rotatable about the longitudinal direction,
wherein one end of the catheter 8 is provided with a first bend 10 and one end of the guide wire 9 is provided with a second bend 11 for coupling with the aperture 5 of the ocular implant 1, respectively.
Referring to fig. 4 and 5, wherein fig. 4 is a schematic diagram illustrating components in the delivery system 6 according to one embodiment of the present invention before being combined, and fig. 5 is a schematic diagram illustrating components in the delivery system 6 according to one embodiment of the present invention after being combined.
In one embodiment of the present invention, the head of the sleeve 7 may be provided in a cylindrical shape having a larger diameter than the tubular portion, and a funnel-shaped connection portion is provided with the tubular portion to communicate with the tubular portion through the connection portion. In addition to this, the head of the cannula 7 of the invention may also be provided with other shapes, such as conical, cuboid, etc., as long as it is able to function to house the ocular implant 1. Further, as described above, the ocular implant 1 of the present invention is desirably in a folded state before implantation, and thus the head of the cannula 7 may be sized according to the size of the ocular implant 1. For example, in a preferred embodiment of the invention, the head of the cannula may be configured to receive the ocular implant prior to delivery of the ocular implant and to maintain the ocular implant in a folded state.
As shown in fig. 6, with the catheter 8 and the guide wire 9, which are disposed inside the sleeve 7 in use, and by rotating the catheter 8 and the guide wire 9 about the longitudinal direction as the axis, the first bending portion 10 and the second bending portion 11, which are respectively disposed at the ends of both, can be coupled with the two orifices 5 of the ocular implant 1, so that the ocular implant 1 can be subjected to operations such as movement and stretching by moving the catheter 8 and the guide wire 9 in the longitudinal direction. Further, in order to facilitate rotation and movement of the catheter 8 and the guide wire 9 provided inside the cannula 7, in a preferred embodiment of the present invention, the catheter may have a length longer than the tubular portion of the cannula, and the guide wire may have a length longer than the catheter. In this case, the catheter 8 still exposes a portion after passing through the cannula 7, and similarly the guide wire 9 still exposes a portion after passing through the catheter 8, so that the user can perform operations such as moving and stretching the ocular implant 1 by manipulating the exposed portion of the catheter 8 and the exposed portion of the guide wire 9 so that the catheter 8 and the guide wire 9 can be rotated to couple or decouple the first curved portion 10 and the second curved portion 11 with the two orifices 5 of the ocular implant 1, or so that relative movement occurs between the cannula 7, the catheter 8, and the guide wire 9.
More specifically, the state of the ocular implant 1 may be changed by adjusting the relative distance of the first and second curves, wherein fig. 7 and 8 show illustrations of the curves of the delivery system 6 in a natural state and a stretched state, respectively, of the ocular implant 1 according to an embodiment of the present invention. Additionally, in a preferred embodiment of the present invention, the first and second bends may be configured to move the ocular implant into or out of the head of the cannula by relative movement of the catheter and the guidewire with the cannula. In another preferred embodiment of the present invention, the first and second curved portions may be capable of stretching the ocular implant by relative movement of the catheter and the guidewire.
In a third aspect, the present invention also provides an ocular implant kit comprising an ocular implant 1 as described above and a delivery system 6 as described above. For specific features of the ocular implant 1 and the delivery system 6, reference may be made to the relevant descriptions above, which are not repeated here to avoid unnecessary redundancy.
In a fourth aspect, the present invention also provides a method of delivering an ocular implant to an eye of a patient by the delivery system described above, which may comprise the steps of:
s1: removing the first bend of the catheter and the second bend of the guidewire from the head of the cannula and coupling with the ocular implant;
s2: stretching the ocular implant through the first and second bends and folding the ocular implant under the influence of an external force, and then drawing the ocular implant into the head of the cannula by pulling the catheter and the guidewire;
s3: the retina is lifted by the usual means of ophthalmology, and the head of the cannula is inserted into the lower cavity of the retina, as shown in fig. 9;
s4: pushing the catheter and guidewire to gradually push the ocular implant out of the cannula's head, the ocular implant gradually self-expanding under elastic memory, as shown in fig. 10;
s5: the ocular implant completes extrusion from the cannula as shown in fig. 11;
s6: the sleeve is withdrawn, the catheter is pushed forward, the guide wire is withdrawn, the push-pull force applied to the two ends of the ocular implant is gradually withdrawn, and the implant is restored to the original shape under elastic memory, as shown in fig. 12;
s7: decoupling the curvature of the catheter and guidewire from the ocular implant by rotating the catheter and guidewire, as shown in fig. 13;
s8: the guide wire catheter is firstly received in the sleeve, finally the sleeve is withdrawn, and the implant is implanted at the subretinal position, as shown in fig. 14; and
s9: the patient's subretinal space subsides and the retina clings to the implant, thereby completing the implantation of the ocular implant, as shown in fig. 15.
The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solution of the present invention within the scope of the technical concept of the present invention, and all the simple modifications belong to the protection scope of the present invention.
In addition, the specific features described in the above embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, various possible combinations are not described further.
Moreover, any combination of the various embodiments of the invention can be made without departing from the spirit of the invention, which should also be considered as disclosed herein.

Claims (12)

1. An ocular implant, comprising:
a flexible substrate;
a plurality of nanowire arrays disposed on the flexible substrate;
an elastic ring disposed along a circumferential edge of the flexible substrate, the elastic ring having elastic memory capable of returning to a pre-deformation natural shape after deformation; and
two opposing apertures disposed at the flexible substrate proximate the edge.
2. The ocular implant of claim 1, wherein the flexible substrate is selected from at least one of Polydimethylsiloxane (PDMS), polyvinyl alcohol (PVA), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), and Polyimide (PI), preferably polydimethylsiloxane.
3. The ocular implant of claim 1, wherein the size of the plurality of nanowire arrays are each independently selected from 0.01mm 2 To 2mm 2 Preferably 0.1mm 2 To 1mm 2 And the spacing between adjacent ones of the plurality of nanowire arrays is 0.01mm to 1mm, preferably 0.05mm to 0.5mm.
4. The ocular implant of claim 1, wherein the shape of the plurality of nanowire arrays is each independently polygonal, elliptical or circular, preferably square, rectangular, diamond, triangular or hexagonal.
5. The ocular implant of claim 1, wherein the plurality of nanowire arrays consists of a plurality of nanowire arrays having different efficacy and/or different wavelength band light sensitivity.
6. The ocular implant of claim 1, wherein the elastic ring is selected from metal alloy wires or organic wires, wherein the metal alloy wires are preferably at least one of nichrome wires, platinum iridium wires, inconel wires, iron chromium aluminum alloys, aluminum platinum alloy wires, and nickel titanium alloy wires, preferably nichrome wires.
7. A delivery system for implanting the ocular implant of any one of claims 1 to 6 into the eye of a subject, comprising:
a cannula comprising a tubular portion and a head portion for receiving the ocular implant;
a catheter which is capable of passing through the tubular portion of the sleeve and is movable along a length direction of the tubular portion and rotatable about the length direction as an axis, and
a guide wire capable of passing through the catheter and movable along a length direction of the catheter and rotatable about the length direction,
wherein, one end of the catheter is provided with a first bending part, one end of the guide wire is provided with a second bending part, which are respectively used for coupling with the orifice of the ocular implant.
8. The delivery system of claim 7, wherein the head of the cannula is configured to receive the ocular implant and hold the ocular implant in a collapsed state prior to delivery of the ocular implant.
9. The delivery system of claim 7, wherein the catheter has a length longer than the tubular portion of the cannula and the guidewire has a length longer than the catheter.
10. The delivery system of claim 7, wherein the first and second bends are configured to move the ocular implant into or out of the head of the cannula by relative movement of the catheter and guidewire with the cannula.
11. The delivery system of claim 7, wherein the first and second bends are configured to stretch the ocular implant by relatively moving the catheter and the guidewire.
12. An ocular implant kit comprising the ocular implant of any one of claims 1-6 and the delivery system of any one of claims 7-11.
CN202310600223.0A 2023-05-25 2023-05-25 Eye implant and delivery system thereof Pending CN116785025A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310600223.0A CN116785025A (en) 2023-05-25 2023-05-25 Eye implant and delivery system thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310600223.0A CN116785025A (en) 2023-05-25 2023-05-25 Eye implant and delivery system thereof

Publications (1)

Publication Number Publication Date
CN116785025A true CN116785025A (en) 2023-09-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202310600223.0A Pending CN116785025A (en) 2023-05-25 2023-05-25 Eye implant and delivery system thereof

Country Status (1)

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