An ocular implant and delivery system therefor

Abstract

This invention discloses an ocular implant and its delivery system, comprising: a flexible substrate; multiple nanowire arrays disposed on the flexible substrate; an elastic ring disposed along the circumferential edge of the flexible substrate, the elastic ring having elastic memory and capable of returning to its original shape before deformation after deformation; and two opposing openings disposed near the edge of the flexible substrate. The nanowire array of the ocular implant of this invention can be composed of multiple materials spliced ​​together, and materials with different efficacies and photosensitive wavelengths can be selected for splicing. Therefore, personalized ocular implants can be customized according to different patient conditions to achieve a better match with the patient's fundus condition. Furthermore, the folding and opening design of the ocular implant of this invention, as well as the self-expanding property of the elastic ring, enable it to be adapted to a delivery system for positioning and minimally invasive implantation.

Description

Technical Field

[0001] This invention belongs to the field of ophthalmic medicine, and more specifically, this invention generally relates to an ophthalmic implant and its delivery system. Background Technology

[0002] An artificial retina is a high-tech medical device implanted under the retina of a blind person to achieve certain efficacy and tolerance. This implanted device works by using a miniature camera, transmitter, and miniature wireless computer on a pair of glasses. First, the camera on the patient's glasses captures the external scene. Then, the image is transmitted wirelessly to the artificial retina on the surface of the patient's eyeball, where it is converted into electrical pulse signals. Next, electrodes on the artificial retina stimulate the optic nerve in the retina, continuing to transmit the signals along the optic nerve to the brain.

[0003] Traditional techniques employ approaches similar to cochlear implants, cardiac pacemakers, and brain pacemakers. These techniques utilize three types of small, active, implantable medical devices to drive an electrode array implanted in the retina, achieving multi-point electrical stimulation. However, this technology suffers from drawbacks such as limited resolution in clinical trials, poor patient recovery outcomes, and the risk of short circuits due to water ingress because the implants contain batteries and chips.

[0004] In recent years, a split-type artificial retina has been developed abroad using semiconductor MEMS technology. The implant is a passive silicon photovoltaic array, and energy and information are transmitted to the implant through an external device (glasses). Although this technology avoids the complex design of implants, current limitations in MEMS technology restrict the minimum size of a single silicon photovoltaic cell, and the resolution cannot be improved to a satisfactory level. Furthermore, the electrode array and MEMS-based artificial retina lack flexibility, making minimally invasive implantation impossible. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide an ocular implant and its delivery system that are sufficiently flexible and can be implanted minimally invasively.

[0006] In a first aspect, the present invention provides an ocular implant comprising:

[0007] Flexible substrate;

[0008] Multiple nanowire arrays are disposed on the flexible substrate;

[0009] An elastic ring, disposed along the circumferential edge of the flexible substrate, the elastic ring having elastic memory, capable of returning to its original shape before deformation after deformation; and

[0010] Two opposing openings are provided near the edge of the flexible substrate.

[0011] 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.

[0012] In a preferred embodiment of the present invention, the size of each of the plurality of nanowire arrays can be independently selected from 0.01 mm. 2 Up to 2mm 2 0.1mm is preferred 2 Up to 1mm 2 Furthermore, the spacing between adjacent nanowire arrays can be 0.01mm-1mm, preferably 0.05mm-0.5mm.

[0013] In a preferred embodiment of the present invention, the shapes of the plurality of nanowire arrays can each be independently polygonal, elliptical or circular, and the polygonal is preferably square, rectangular, rhomboid, triangular or hexagonal.

[0014] In a preferred embodiment of the present invention, the plurality of nanowire arrays may be composed of a plurality of nanowire arrays with different functions and / or different wavelength band photosensitive.

[0015] In a preferred embodiment of the present invention, the elastic ring may be selected from metal alloy wire or organic wire, wherein the metal alloy wire is preferably at least one of nickel-chromium alloy wire, platinum-iridium alloy wire, chromium-nickel-iron alloy wire, iron-chromium-aluminum alloy, aluminum-platinum alloy wire and nickel-titanium alloy wire, with nickel-chromium alloy wire being preferred.

[0016] In a second aspect, the present invention also provides a delivery system for implanting the ocular implant according to the above description into the eye of a subject, comprising:

[0017] A cannula, comprising a tubular portion and a head for receiving the ocular implant;

[0018] A catheter that can pass through the tubular portion of the cannula and is movable along the length of the tubular portion, and rotatable about the length direction as an axis.

[0019] A guidewire that can pass through the catheter and is movable along the length of the catheter, and rotatable about the length direction as an axis.

[0020] The catheter has a first bend at one end and the guidewire has a second bend at one end, which are used to couple with the orifice of the ocular implant, respectively.

[0021] In a preferred embodiment of the invention, the head of the cannula may be configured to receive the eye implant before delivery of the eye implant and to keep the eye implant in a folded state.

[0022] In a preferred embodiment of the invention, the catheter may have a length longer than the tubular portion of the cannula, and the guidewire may have a length longer than the catheter.

[0023] In a preferred embodiment of the invention, the first bend and the second bend can be configured to move the ocular implant into or out of the head of the cannula by moving the catheter and the guidewire relative to the cannula.

[0024] In a preferred embodiment of the invention, the first bend and the second bend can be configured to stretch the ocular implant by moving the catheter relative to the guidewire.

[0025] In a third aspect, the present invention also provides an ocular implant kit, which includes the above-described ocular implant and the above-described delivery system.

[0026] Compared with the prior art, the ocular implant and delivery system of the present invention have at least the following outstanding advantages:

[0027] (1) The ocular implant of the present invention has a flexible base, which can improve biocompatibility to a certain extent, and its flexible and foldable characteristics make it rollable and foldable.

[0028] (2) The design of the folding and hole positions in the ocular implant of the present invention, as well as the elastic ring that gives the whole body the characteristic of self-expansion, make it adaptable to the delivery system for positioning and minimally invasive implantation.

[0029] (3) The eye implant of the present invention can be repeatedly unfolded and folded. For example, it can be unfolded during processing and manufacturing, folded and compressed into the delivery system, and can also be repeatedly folded and unfolded in conjunction with the delivery system during implantation surgery. Furthermore, if a patient with an implanted eye implant needs to remove the entire implant in special circumstances, the elastic ring, the hole and the removal system can be used to fold and remove it again.

[0030] (4) The nanowire array of the ocular implant of the present invention can be composed of multiple materials spliced ​​together. Materials with different effects and photosensitive wavelengths can be selected for splicing, thus allowing for customized ocular implants to better match the patient's fundus condition; and

[0031] (5) The delivery system of the present invention can ensure that the customized implant is inserted at the expected angle and position, ensuring the fit with the patient’s fundus condition. Attached Figure Description

[0032] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the following detailed description to explain the invention, but do not constitute a limitation thereof. In the drawings:

[0033] Figure 1 This is a schematic diagram showing the components of an ocular implant 1 according to an embodiment of the present invention before assembly, including a flexible substrate 2, a plurality of nanowire arrays 3, an elastic coil 4, and an opening 5;

[0034] Figure 2 This is a schematic diagram showing the assembly of the components in an ocular implant 1 according to an embodiment of the present invention;

[0035] Figure 3 This is a schematic diagram showing an ocular implant 1 in a folded state according to an embodiment of the present invention;

[0036] Figure 4 This is a schematic diagram showing the components of a delivery system 6 according to an embodiment of the present invention before assembly, including a flexible cannula 7, a catheter 8 and a guidewire 9;

[0037] Figure 5 This is a schematic diagram showing the assembly of the components in a delivery system 6 according to an embodiment of the present invention;

[0038] Figure 6 This is a schematic diagram showing the coupling of an ocular implant 1 and a delivery system 6 according to an embodiment of the present invention;

[0039] Figure 7 This is a schematic diagram showing the curved portion of the delivery system 6 according to an embodiment of the present invention, which places the ocular implant 1 in a natural state.

[0040] Figure 8 This is a schematic diagram showing the bending portion of the delivery system 6 according to an embodiment of the present invention, which causes the ocular implant 1 to be in a stretched state.

[0041] Figure 9 This is a schematic diagram showing the execution of step S3 according to an embodiment of the present invention;

[0042] Figure 10 This is a schematic diagram showing the execution of step S4 according to an embodiment of the present invention;

[0043] Figure 11 This is a schematic diagram showing the execution of step S5 according to an embodiment of the present invention;

[0044] Figure 12This is a schematic diagram showing the execution of step S6 according to an embodiment of the present invention;

[0045] Figure 13 This is a schematic diagram showing the execution of step S7 according to an embodiment of the present invention;

[0046] Figure 14 This is a schematic diagram showing the execution of step S8 according to an embodiment of the present invention;

[0047] Figure 15 This is a schematic diagram showing the execution of step S9 according to an embodiment of the present invention.

[0048] Figure label:

[0049] Ocular implant-1; Flexible substrate-2; Nanowire array-3; Elastic coil-4; Orifice-5; Delivery system-6; Sleeve-7; Catheter-8; Guide wire-9; First bend-10; Second bend-11. Detailed Implementation

[0050] The following provides a detailed description of specific embodiments of the present invention. It should be understood that the specific embodiments described herein are for illustrative and explanatory purposes only and are not intended to limit the scope of the invention.

[0051] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0052] In one aspect, the present invention provides an ocular implant 1, comprising:

[0053] Flexible substrate 2;

[0054] Multiple nanowire arrays 3 are disposed on the flexible substrate 2;

[0055] An elastic ring 4 is disposed along the circumferential edge of the flexible substrate 2. The elastic ring 4 has elastic memory and can return to its original shape before deformation after deformation.

[0056] Two opposing openings 5 ​​are provided near the edge of the flexible substrate 2.

[0057] refer to Figure 1 and Figure 2 ,in Figure 1 This is a schematic diagram showing the components of an ocular implant 1 according to an embodiment of the present invention before assembly. Figure 2 This is a schematic diagram showing the assembly of the components in an ocular implant 1 according to an embodiment of the present invention.

[0058] The ocular implant 1 of the present invention includes a flexible substrate 2, multiple nanowire arrays 3, elastic coils 4, and orifices 5, wherein the multiple nanowire arrays 3, elastic coils 4, and orifices 5 are all disposed on the flexible substrate 2. To enable the ocular implant of the present invention to fold better and conform to the eye, the present invention uses the flexible substrate 2 as the base of the ocular implant. The specific selection of the material of the flexible substrate 2 can be adjusted according to actual needs, for example, it can be selected from any flexible material commonly used in the art. More specifically, in one embodiment of the present invention, the flexible substrate can be selected from at least one of polydimethylsiloxane (PDMS), polyvinyl alcohol (PVA), polyethylene terephthalate (PET), polyethylene naphthalate (PEN), and polyimide (PI), preferably polydimethylsiloxane, but not limited thereto. Furthermore, in a preferred embodiment of the present invention, the flexible substrate can have a pore or porous structure, which allows water vapor and nutrients to permeate through the flexible substrate, improving oxygen permeability.

[0059] For multiple nanowire arrays 3, to meet the high requirements for flexibility, this invention abandons the use of a single complete nanowire array in traditional technology, and instead adopts multiple small nanowire arrays spaced apart. This not only ensures the high flexibility of the ocular implant of this invention, but the spacing also allows water vapor and nutrients to permeate, thereby maintaining circulation. Figure 1 and Figure 2 As shown, the multiple nanowire arrays 3 of the present invention can be arranged and combined arbitrarily, and the material, shape, size, spacing, etc. of each nanowire array in the multiple nanowire arrays 3 are not particularly limited. They can be adjusted according to the actual situation (e.g., based on the different photoreceptor abilities and density of photoreceptor cells in different parts of the eye, and the different degrees of cell degeneration in different patients). In particular, through preoperative examination, personalized ocular implants can be customized according to the different conditions of patients to achieve a better match with the patient's fundus condition.

[0060] As a different option, for example, in one embodiment of the invention, the size of each of the plurality of nanowire arrays 3 can be independently selected from 0.01 mm. 2 Up to 2mm 2 0.1mm is preferred 2 Up to 1mm 2 (e.g., 0.2mm) 2 0.5mm 2 or 0.8mm 2(etc.), and the spacing between adjacent nanowire arrays 3 can be 0.01mm-1mm, preferably 0.05mm-0.5mm (e.g., 0.1mm, 0.2mm, 0.25mm, or 0.3mm, etc.). In another embodiment of the invention, the shape of the plurality of nanowire arrays 3, in addition to the square shown in the figure, can also be independently a polygon, ellipse, or circle. The polygon is preferably a square, rectangle, rhombus, triangle, or hexagon, but is not limited thereto. In another embodiment of the invention, the plurality of nanowire arrays 3 can be composed of multiple nanowire arrays with different efficiencies and / or different wavelength band photosensitive properties.

[0061] Regarding the elastic ring 4, since the ocular implant 1 is suitable for delivery to the patient's eye in a folded state, an elastic ring 4 is also provided at the circumferential edge of the flexible base 2 of the ocular implant 1 in order to enable the ocular implant 1 of the present invention to unfold after delivery to the patient's eye. The elastic ring 4 has elastic memory and can return to its original shape before deformation after deformation, thereby enabling the ocular implant 1 to self-unfold after delivery to the patient's eye in a folded state. In one embodiment of the present invention, the elastic ring can be selected from metal alloy wire or organic wire, wherein the metal alloy wire is preferably at least one of nickel-chromium alloy wire, platinum-iridium alloy wire, chromium-nickel-iron alloy wire, iron-chromium-aluminum alloy, aluminum-platinum alloy wire and nickel-titanium alloy wire, preferably nickel-chromium alloy wire.

[0062] The orifice 5 is used to couple with the delivery system, thereby enabling the delivery system to easily perform push-pull or move operations on the ocular implant 1 during surgery.

[0063] Further, refer to Figure 3 , Figure 3 This is a schematic diagram illustrating an ocular implant 1 according to an embodiment of the present invention in a folded state. The flexible substrate 2 is folded inwards towards the side where multiple nanowire arrays 3 are disposed, thereby enclosing the multiple nanowire arrays 3 internally and exposing the orifices 5 to facilitate operation by the delivery system, which folds inwards along the line containing the two orifices 5 as the axis. As described above, the ocular implant 1 of the present invention is suitable for delivery to the patient's eye in a folded state. This not only reduces surgical trauma but also protects the fragile multiple nanowire arrays 3 within the flexible substrate 2, preventing collisions and friction with the delivery system or the patient's eye during minimally invasive implantation. After delivery, the folded ocular implant 1 will unfold from its folded state back to its initial shape under the elastic memory effect of the elastic coil 4.

[0064] In a second aspect, the present invention provides a delivery system 6 for implanting the ocular implant according to the above description into the eye of a subject, comprising:

[0065] The cannula 7 includes a tubular portion and a head for receiving the ocular implant;

[0066] The conduit 8 is capable of passing through the tubular portion of the cannula and is movable along the length of the tubular portion, and rotatable about the length direction as an axis.

[0067] Guide wire 9, which can pass through the catheter and is movable along the length of the catheter, and rotatable about the length direction as an axis.

[0068] The catheter 8 has a first bend 10 at one end and the guidewire 9 has a second bend 11 at one end, which are used to couple with the opening 5 of the ocular implant 1, respectively.

[0069] refer to Figure 4 and Figure 5 ,in Figure 4 This is a schematic diagram showing the components of a delivery system 6 according to an embodiment of the present invention before assembly. Figure 5 This is a schematic diagram showing the assembly of the components in a delivery system 6 according to an embodiment of the present invention.

[0070] In one embodiment of the present invention, the head of the cannula 7 may be configured as a cylinder with a larger diameter than the tubular portion, and a funnel-shaped connecting portion is provided between the cannula 7 and the tubular portion to communicate with the tubular portion. Alternatively, the head of the cannula 7 may be configured as other shapes, such as conical or cuboid, as long as it can accommodate the ocular implant 1. Further, as described above, the ocular implant 1 of the present invention is preferably in a folded state before implantation; therefore, the size of the head of the cannula 7 can be set according to the size of the ocular implant 1. For example, in a preferred embodiment of the present invention, the head of the cannula may be configured to accommodate the ocular implant before delivery and keep the ocular implant in a folded state.

[0071] like Figure 6As shown, the catheter 8 and guidewire 9 are disposed inside the cannula 7 during use. By rotating the catheter 8 and guidewire 9 about their length axis, the first bend 10 and the second bend 11 located at their respective ends can be coupled to the two openings 5 ​​of the ocular implant 1. This allows for operations such as movement and stretching of the ocular implant 1 by moving the catheter 8 and guidewire 9 along their length. Furthermore, to facilitate the rotation and movement of the catheter 8 and guidewire 9 disposed inside the cannula 7, in a preferred embodiment of the invention, the catheter may have a length longer than the tubular portion of the cannula, and the guidewire may have a length longer than the catheter. In this case, the catheter 8 can still be partially exposed after passing through the cannula 7, and similarly, the guide wire 9 can also be partially exposed after passing through the catheter 8. Therefore, the user can rotate the catheter 8 and the guide wire 9 by manipulating the exposed parts of the catheter 8 and the guide wire 9 to couple or decouple the first bend 10 and the second bend 11 with the two openings 5 ​​of the ocular implant 1, or to make relative movement between the cannula 7, the catheter 8 and the guide wire 9, thereby performing operations such as moving and stretching the ocular implant 1.

[0072] More specifically, the state of the ocular implant 1 can be changed by adjusting the relative distance between the first curved portion and the second curved portion, wherein Figure 7 and Figure 8 The illustrations show the ocular implant 1 in a natural state and a stretched state, respectively, with the curved portion of the delivery system 6 according to an embodiment of the present invention. Furthermore, in a preferred embodiment of the present invention, the first and second curved portions may be configured to move the ocular implant into or out of the head of the cannula by the relative movement of the catheter and the guidewire with respect to 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 the relative movement of the catheter and the guidewire.

[0073] In a third aspect, the present invention also provides an ocular implant kit, which includes the aforementioned ocular implant 1 and the aforementioned delivery system 6. For specific features of the ocular implant 1 and the delivery system 6, please refer to the relevant descriptions above, which will not be repeated here to avoid unnecessary length.

[0074] In a fourth aspect, the present invention also provides a method for delivering an ocular implant to a patient's eye using the aforementioned delivery system, which may include the following steps:

[0075] S1: Remove the first bend of the catheter and the second bend of the guidewire from the head of the cannula and couple them with the ocular implant;

[0076] S2: The ocular implant is stretched through the first and second bends and folded under external force, and then the ocular implant is pulled into the head of the cannula by pulling the catheter and guidewire.

[0077] S3: Using common ophthalmic techniques, the retina is lifted, and the tip of the cannula is inserted into the subretinal space, such as... Figure 9 As shown;

[0078] S4: Push the catheter and guidewire to gradually expel the ocular implant from the tip of the cannula. The ocular implant gradually unfolds itself under elastic memory, as... Figure 10 As shown;

[0079] S5: The ocular implant is successfully extruded from the cannula, as... Figure 11 As shown;

[0080] S6: Withdraw the cannula while simultaneously pushing the catheter forward and retracting the guidewire, gradually removing the push-pull force applied to both ends of the ocular implant. The implant recovers its initial shape due to elastic memory. Figure 12 As shown;

[0081] S7: By rotating the catheter and guidewire, the curved portions of the catheter and guidewire are decoupled from the ocular implant, such as... Figure 13 As shown;

[0082] S8: First, retract the guidewire catheter into the sleeve, then withdraw the sleeve. The implant is placed under the retina. Figure 14 As shown; and

[0083] S9: The subretinal cavity recedes, and the retina adheres tightly to the implant, thus completing the implantation of the eye. Figure 15 As shown.

[0084] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0085] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

[0086] Furthermore, various different embodiments of the present invention can be combined in any way, as long as they do not violate the spirit of the present invention, they should also be regarded as the content disclosed by the present invention.

Claims

1. An ocular implant comprising: Flexible substrate; Multiple nanowire arrays are disposed on the flexible substrate, and the multiple nanowire arrays are composed of multiple nanowire arrays with different functions and / or different wavelength band photosensitive. An elastic ring is provided along the circumferential edge of the flexible substrate. The elastic ring has elastic memory and can return to its original shape before deformation after deformation. as well as Two opposing apertures are provided near the edge of the flexible substrate, the two opposing apertures being used to couple with a delivery system to stretch the ocular implant.

2. The ocular implant according to 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).

3. The ocular implant according to claim 2, wherein, The flexible substrate is polydimethylsiloxane.

4. The ocular implant according to claim 1, wherein, The size of each of the multiple nanowire arrays is independently selected from 0.01 mm. 2 Up to 2mm 2 Furthermore, the spacing between adjacent nanowire arrays is 0.01 mm to 1 mm.

5. The ocular implant according to claim 4, wherein, The size of each of the multiple nanowire arrays is independently selected from 0.1 mm. 2 Up to 1mm 2 .

6. The ocular implant according to claim 4, wherein, The spacing between adjacent nanowire arrays is 0.05 mm to 0.5 mm.

7. The ocular implant according to claim 1, wherein, The shapes of the multiple nanowire arrays are each independently polygonal, elliptical, or circular.

8. The ocular implant according to claim 7, wherein, The polygon is a square, rectangle, rhombus, triangle, or hexagon.

9. The ocular implant according to claim 1, wherein, The elastic coil is selected from metal alloy wire or organic wire.

10. The ocular implant according to claim 9, wherein, The metal alloy wire is at least one of nickel-chromium alloy wire, platinum-iridium alloy wire, chromium-nickel-iron alloy wire, iron-chromium-aluminum alloy wire, aluminum-platinum alloy wire, and nickel-titanium alloy wire.

11. The ocular implant according to claim 10, wherein, The metal alloy wire is a nickel-chromium alloy wire.

12. A delivery system for implanting an ocular implant according to any one of claims 1 to 11 into the eye of a subject, comprising: A cannula, comprising a tubular portion and a head for receiving the ocular implant; A catheter that can pass through the tubular portion of the cannula and is movable along the length of the tubular portion, and rotatable about the length direction as an axis. A guidewire that can pass through the catheter and is movable along the length of the catheter, and rotatable about the length direction as an axis. The catheter has a first bend at one end and the guidewire has a second bend at one end, which are used to couple with the orifice of the ocular implant, respectively.

13. The delivery system according to claim 12, wherein, The head of the cannula is configured to receive the eye implant before delivery and to keep the eye implant folded.

14. The delivery system according to claim 12, wherein, The catheter has a length longer than the tubular portion of the cannula, and the guidewire has a length longer than the catheter.

15. The delivery system according to claim 12, wherein, The first bend and the second bend are configured to move the ocular implant into or out of the head of the cannula by moving the catheter and the guidewire relative to the cannula.

16. The delivery system according to claim 12, wherein, The first and second bends are configured to stretch the ocular implant by moving the catheter relative to the guidewire.

17. An ocular implant kit comprising an ocular implant according to any one of claims 1-11 and a delivery system according to any one of claims 12-16.

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