Intraocular lens introduction head
By designing a multi-section gradient internal cavity, an improved tip insertion section, and a gripping structure, several problems in the injection process of the intraocular lens guide were solved, achieving smooth folding, stable gripping, and precise insertion of the lens, thus improving the safety and efficiency of the surgery.
Patent Information
- Application Number
- CN202511260479.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-04
- Publication Date
- 2025-10-21
AI Technical Summary
Existing intraocular lens implantation tips have several problems during injection, including lens folding and injection abnormalities, inability of the tip to effectively handle the elasticity of thick lenses, difficulty in holding and operating, poor control of insertion depth, lack of perceptibility during the injection process, and inconvenience in using viscoelastic agents.
Design an intraocular lens delivery tip with an inner cavity formed by a gradual fit of multiple cross sections of different shapes and sizes. Combine a gripping part, a tip insertion part, and a visualization window. It is made of medical-grade or food-grade polymer material using an integral mold injection molding process. The inner wall of the inner cavity has grooves and anti-slip structures, and the tip insertion part has a slot and annular steps to provide stable folding, anti-slip, and deep protection.
It achieves smooth folding of the intraocular lens during injection, avoids abnormal lap lift and damage, improves grip stability and depth control, provides visual guidance, reduces the complexity and risk of viscoelastic agent use, and improves the safety and precision of the surgery.
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Figure CN120814933A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to the technical field of ophthalmic surgical instruments, and in particular to an artificial lens introduction head. Background Art
[0002] In cataract surgery, intraocular lens implantation is a key step, and the intraocular lens inserter is one of the core components of the intraocular lens implanter. However, current intraocular lens inserters have the following problems:
[0003] 1) Abnormal lens folding and injection
[0004] During the intraocular lens injection process, the intraocular lens must smoothly transition from its initial state to its final folded and unfolded state. However, current inserter lumen designs often fail to meet this requirement. The fixed cross-sectional shape and dimensions of some inserter lumen lead to lens folding anomalies during the injection process, such as haptic entrapment or damage. This can affect proper lens implantation and deployment, potentially requiring lens replacement, increasing surgical costs and patient pain.
[0005] 2) The tip of the inserter cannot effectively cope with the elastic force of the high-density thick lens and may break it
[0006] For artificial lenses with high diffusivity and large thickness, when passing through the narrowest tip of the introducer, due to limited space, the elastic force from the folded state to the open state cannot be released, which can easily cause the introducer to burst, thereby widening the incision. However, existing introducers lack an effective solution to this problem.
[0007] 3) Difficulty in gripping and operating
[0008] Some inserters lack ergonomic design considerations, resulting in a smooth exterior and lack of proper gripping mechanisms. This can easily cause the surgeon's hand to slip during operation, especially when wearing gloves, which can affect sensitivity. This unstable grip can be even more pronounced, seriously impacting the safety and accuracy of the procedure.
[0009] 4) Poor insertion depth control
[0010] When doctors operate the introducer to implant the artificial lens into the eye's capsular bag, it is easy to insert it too deep. Once inserted too deep, the incision will be enlarged, which not only increases the difficulty and risk of the patient's postoperative recovery, but may also cause unnecessary damage to the eye tissue, such as damaging important structures such as the iris and posterior capsule, affecting the surgical effect and the patient's visual prognosis.
[0011] 5) The injection process is not perceptible
[0012] During the intraocular lens insertion process, doctors cannot directly observe the lens's insertion progress and must rely on experience and feel, which can lead to inappropriate injection speeds. Injecting too quickly can cause the folded lens to unfold abnormally, damaging it or breaking its loops. Injecting too slowly can increase surgical time and potentially cause the lens to shift within the eye, affecting the accuracy and stability of the implant.
[0013] 6) Viscoelastics are inconvenient to use
[0014] A separate injection of viscoelastic is often required before surgery to maintain intraocular space and provide lubrication to facilitate intraocular lens (IOL) insertion. However, precise dosing of viscoelastic injections is difficult. Excessive injection without proper cleaning can lead to elevated intraocular pressure and complications, while insufficient injection can prevent effective lubrication, compromising the successful implantation of the IOL. Furthermore, the separate injection of viscoelastic increases surgical time and complexity, increasing the risk of infection.
[0015] Therefore, it is necessary to design a new intraocular lens introduction head to solve at least one of the above problems. Summary of the Invention
[0016] One purpose of the present disclosure is to design a new intraocular lens inserter to solve at least one of the above problems.
[0017] According to the first aspect of the present disclosure, an artificial lens introduction head is provided, comprising: an introduction head body, the interior of the introduction head body is a hollow inner cavity, the inner cavity is a folding and transport channel for the artificial lens, and the inner cavity is formed by a plurality of cross-sections of different shapes and sizes that are fitted and gradually transformed to guide the artificial lens to naturally change from an unfolded state to a folded state during the injection process.
[0018] Optionally, the inner cavity includes a first section, a second section, a third section, a fourth section, a fifth section, and a sixth section from the outside to the inside, and the transition surface between two adjacent sections is a smooth and naturally fitting transition. The lower side of the first section is a concave arc to pre-bend the artificial lens; the upper side of the first section is a plane or a near-plane to limit the left and right deflection of the artificial lens; the width of the first section is greater than a first threshold, and the first threshold is used to characterize the size of the artificial lens when it just enters the inner cavity; the width of the second section is smaller than the first section, the height of the second section is basically equal to the height of the first section, the upper side of the second section is a plane or a near-plane, and the lower side of the second section is a concave arc. The inner cavity part between the first section and the second section is used to make the artificial lens gradually fold and roll up according to a predetermined state, and the shape of the third section and the second section and The sizes are basically the same. The inner lumen portion between the second section and the third section is used to form a stable folding zone. The shape of the fourth section is basically the same as the third section. The size of the fourth section is smaller than that of the third section. The inner lumen portion between the third section and the fourth section is used to allow the artificial lens that has been stably folded and rolled up to continue to fold smoothly into a narrower space. The size of the fifth section is smaller than that of the fourth section. The upper side of the fifth section is a convex arc, and the lower side of the fifth section is a concave arc. The inner lumen portion between the fourth section and the fifth section is used to guide the artificial lens to transition to an intermediate form, in preparation for the artificial lens to transition to a circular shape. The sixth section is a circle. The sixth section is close to the position where the artificial lens is officially pushed out of the inner lumen into the capsular bag of the eye. The inner lumen portion between the fifth section and the sixth section is used to guide the artificial lens to transition from an intermediate state to a circular shape.
[0019] Optionally, the second section is about 5 mm from the first section; and / or the third section is about 10 mm from the second section; and / or the fourth section is about 6 mm from the third section; and / or the fifth section is about 5 mm from the fourth section; and / or the sixth section is about 5 mm from the fifth section.
[0020] Optionally, the front end of the introducer body is a tip insertion part, and a notch is provided at the lower end of the tip oblique cut of the tip insertion part. The space for accommodating the artificial lens in the notch is slightly larger than the inner cavity. The artificial lens is pushed outward from the inner cavity, and before leaving the inner cavity, part of the area of the artificial lens first passes through the notch.
[0021] Optionally, the lower end of the notch is an arc; and / or the inner side of the notch adopts a chamfered corner design.
[0022] Optionally, the width of the notch is n times the diameter of the arc, and the value range of n is 0.8 to 15; and / or the fillet radius of the rounded corner design is about 0.1 mm.
[0023] Optionally, a gripping portion is provided on both sides of the introducer body close to the intraocular lens entrance, and the distance between the two ends of the two gripping portions relatively close to the intraocular lens entrance is greater than the distance between the two ends of the two gripping portions relatively far from the intraocular lens entrance.
[0024] Optionally, an anti-slip structure is provided on the gripping portion.
[0025] Optionally, the anti-slip structure includes a plurality of outwardly convex anti-slip lines, the height of the anti-slip lines is 0.8 mm, and the distance between two adjacent anti-slip lines is 2 mm.
[0026] Optionally, the surface of the anti-slip pattern is treated by mold tanning and sandblasting; and / or the surface of the anti-slip pattern is coated with a medical-grade silicone modified layer.
[0027] Optionally, the intraocular lens introduction head is integrally manufactured using an injection molding process; and / or the material of the intraocular lens introduction head is a medical-grade or food-grade polymer material.
[0028] Optionally, the front end of the introducer head body is a tip insertion part, and an annular step is provided at a position near the tip of the tip insertion part of the introducer head body. The outer diameter of the annular step is larger than the diameter of the tip insertion part at the annular step. In the process of inserting the tip insertion part into the eye capsule, the annular step contacts the capsule opening to limit the further insertion of the tip insertion part.
[0029] Optionally, the distance between the annular step and the tip is 3 mm to 5 mm; and / or the outer diameter of the annular step is 1.5 to 2 times the diameter of the tip insertion portion at the annular step.
[0030] Optionally, the surface of the annular step is provided with a reflective mark for reflecting light.
[0031] Optionally, the surface of the reflective logo is provided with a micro-prism array for achieving directional reflection.
[0032] Optionally, the posture of the microprism units in the microprism array is set so that as the distance of the tip insertion portion inserted into the eye capsule increases, more light enters at least part of the microprism units, thereby increasing the intensity of the reflected light signal.
[0033] Optionally, a visualization window is provided on the introduction head body.
[0034] Optionally, the window is processed by a double-sided optical-grade mirror polishing process, and the transparency reaches more than 92%; and / or the surface of the window is coated with a nano-level anti-fog coating; and / or at least one side of the window is provided with a scale line, and the value of the scale line is used to reflect the position and / or progress of the artificial lens during the injection process.
[0035] Optionally, the inner wall of the inner cavity is provided with at least one groove extending along the length direction of the inner cavity.
[0036] Optionally, the groove is located in the middle section of the inner cavity.
[0037] Optionally, the groove has a groove bottom and an opening opposite to the groove bottom, the groove width gradually narrows from the first depth position to the groove mouth, the groove width gradually narrows from the groove bottom to the second depth position, and the groove depth corresponding to the second depth position is greater than or equal to the groove depth corresponding to the first depth position.
[0038] Optionally, the groove depth corresponding to the second depth position is greater than the groove depth corresponding to the first depth position, the part between the first depth position and the second depth position is the middle section of the groove, the groove width at the opening is smaller than the groove width of the middle section of the groove, the part below the middle section of the groove is the bottom of the groove, the cross-section of the bottom of the groove is a first semicircle, and a second semicircle protruding into the inside of the groove is provided on both sides of the middle section of the groove, and the radius of the first semicircle is greater than the radius of the second semicircle.
[0039] Optionally, the groove width at the opening is equal to 0.8 times the groove width at the middle section of the groove; and / or the radius of the second semicircle is equal to 0.2 times the radius of the first semicircle.
[0040] Optionally, the inner wall of the groove is further hydrophilized so that the contact angle of the viscoelastic agent is less than or equal to 30°.
[0041] Therefore, the present invention designs the inner cavity of the artificial lens introduction head to be gradually fitted with multiple cross-sections of different shapes and sizes, which can guide the artificial lens to naturally change from an unfolded state to a folded state during the injection process, making the lens injection smoother and avoiding problems such as abnormal loop flipping, lens damage or asymmetric folding due to sudden changes in external force. BRIEF DESCRIPTION OF THE DRAWINGS
[0042] The above and other objects, features and advantages of the present disclosure will become more apparent through a more detailed description of exemplary embodiments of the present disclosure with reference to the accompanying drawings, wherein like reference numerals generally represent like components in the exemplary embodiments of the present disclosure.
[0043] Figure 1 A schematic structural diagram of a variable-cross-section inner cavity according to an embodiment of the present disclosure is shown.
[0044] Figure 2 、 Figure 3 Schematic diagrams of a tip insertion portion at different viewing angles according to an embodiment of the present disclosure are shown.
[0045] Figure 4 A schematic structural diagram of an intraocular lens introduction head according to an embodiment of the present disclosure is shown.
[0046] Figure 5 、 Figure 6 Shown are schematic structural diagrams of the gripping portion at different viewing angles.
[0047] Figure 7 A schematic structural diagram of an annular step according to an embodiment of the present disclosure is shown.
[0048] Figure 8 A schematic diagram showing the structure of a visualization window is shown.
[0049] Figure 9 A schematic structural diagram of an intraocular lens introduction head according to an embodiment of the present disclosure is shown.
[0050] Figure 10 for Figure 9 A half-section view of the intraocular lens inserter is shown.
[0051] Figure 11 A front view of the groove structure is shown.
[0052] Figure 12 A schematic cross-sectional design diagram of a groove according to an embodiment of the present disclosure is shown. DETAILED DESCRIPTION
[0053] The preferred embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although preferred embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to make the present disclosure more thorough and complete, and to fully convey the scope of the present disclosure to those skilled in the art.
[0054] An intraocular lens inserter is a device that allows the intraocular lens to curl and transition from a wide to a narrow lumen. It can also be called a nozzle or implant.
[0055] The present disclosure aims to provide a new type of intraocular lens inserter to solve at least one of the problems existing in the prior art, such as abnormal lens folding and injection, the inability of the tip of the inserter to effectively cope with the elastic force of a highly thick lens and thus break, difficulty in holding the inserter, poor control of the insertion depth, imperceptible injection process, and inconvenience in using viscoelastic agents.
[0056] The following is an illustrative description of the corresponding solutions proposed by the present disclosure to address these issues.
[0057] It should be understood that the corresponding solutions proposed by the present disclosure for different problems can be integrated into an intraocular lens inserter, so that the intraocular lens inserter can solve all the above-mentioned problems at the same time. In addition, the corresponding solutions proposed by the present disclosure for different problems can also exist independently and be deployed in different intraocular lens inserters. In other words, an intraocular lens inserter can contain only one of the solutions. In addition, the corresponding solutions proposed by the present disclosure for different problems can also be freely combined and deployed in different intraocular lens inserters. That is, an intraocular lens inserter can contain a combination of any two or more solutions.
[0058] The intraocular lens inserter disclosed herein can be manufactured in an integrated manner using an integral mold injection molding process to ensure structural integration and precision stability. The material of the intraocular lens inserter can be selected from medical-grade or food-grade polymer materials that have both biocompatibility, chemical corrosion resistance, and mechanical strength, meeting the durability requirements of repeated injection operations and can be safely used in ophthalmic surgical environments. For example, the material of the intraocular lens inserter can be, but is not limited to, PP (Polypropylene), PVC (Polyvinyl Chloride), ABS (Acrylonitrile Butadiene Styrene), PC (Polycarbonate), and PE (Polyethylene).
[0059] In addition, the intraocular lens introduction head of the present disclosure can be designed as an independent introduction head, and the introduction head can be installed in the implanter assembly in a detachable manner to form a complete implanter.
[0060] 1. Variable cross-section lumen
[0061] The intraocular lens inserter consists of the inserter body. The inserter body is the main supporting structure of the entire inserter. As the carrier for intraocular lens injection, it can connect the inner cavity, grip and tip insertion part, etc., to ensure the stability of the overall structure.
[0062] The interior of the inserter body is a hollow inner lumen. This inner lumen serves as a passageway for the folded intraocular lens. Within this inner lumen, the intraocular lens (e.g., one with folded anterior and posterior haptics) transitions from its initial state (e.g., with folded anterior and posterior haptics) to its final folded state (e.g., a perfectly circular cross-section).
[0063] The technical concept of the variable-section intracavitary channel can be summarized as follows: designing a cross-sectional shape and size that gradually changes from the back end to the front end, guiding the intraocular lens to naturally change from an unfolded state to a folded state during the injection process, and ensuring that the injection process is smooth and controllable.
[0064] The technical principle of the variable-section intracavitary channel can be summarized as follows: utilizing the shape change of the gradual cross-section to simulate the force process of the lens from unfolding to folding, so that the lens is gradually compressed and stably folded during injection, reducing the interference of external operations on the lens.
[0065] The technical methods and steps of the variable-section intraocular channel can be summarized as follows: according to the size and folding characteristics of the intraocular lens, a smooth cross-section change curve is designed that gradually shrinks from the rear end to the front end of the introducer to ensure seamless fitting between different cross-sections.
[0066] The variable-section inner cavity can be combined with the lubrication design of the immersion inner cavity mentioned above, and viscoelastic agents can be pre-adsorbed on the inner cavity wall or coated with a low-friction coating to further reduce the friction resistance during the injection process, ensuring that the intraocular lens is controlled compressed and stably folded in the gradient-section inner cavity, and finally smoothly injected to the target position.
[0067] The following, in conjunction with the accompanying drawings, illustrates a specific design approach for a variable-cross-section lumen. It should be noted that the following description is limited to the variable-cross-section lumen shown in the drawings. For other possible structures of the intraocular lens inserter shown in the drawings, please refer to the following description.
[0068] Figure 1 A schematic structural diagram of a variable-cross-section inner cavity according to an embodiment of the present disclosure is shown.
[0069] See also Figure 1 In the length direction of the inner cavity, the variable-section inner cavity is composed of multiple cross-sections of different shapes and sizes that are fitted and gradually changed to guide the intraocular lens to naturally change from an unfolded state to a folded state during the injection process.
[0070] like Figure 1 As shown, from the outside to the inside, it includes Section A, Section B, Section C, Section D, Section E, and Section F. Section A can also be called the first section, Section B can also be called the second section, Section C can also be called the third section, Section D can also be called the fourth section, Section E can also be called the fifth section, and Section F can also be called the sixth section. The transition surface between two adjacent sections is a smooth and naturally fitting transition.
[0071] The lower side of section A is concave, pre-curving the intraocular lens. The upper side of section A is flat or nearly flat, limiting left-right deflection of the intraocular lens. The width of section A is greater than a first threshold, which represents the size of the intraocular lens immediately after entering the intraocular canal.
[0072] Section A is located on the outermost side, meaning it's the first to contact the IOL. At this point, the IOL has just entered and hasn't yet begun to fold, so Section A is designed to be wider on both sides. The flatter top of Section A better limits the movement of the lens within the intraocular canal, effectively limiting left-right lens deflection (e.g., deflection angle < 3°). The lower side of Section A is designed as a large arc to pre-bend the lens, creating ideal initial conditions for subsequent folding.
[0073] Section B is approximately 5 mm from section A. Section B is smaller in width than section A, and its height is substantially equal to that of section A. The upper side of section B is flat or nearly flat, and the lower side of section B is concave. The inner channel between sections A and B is used to gradually fold and roll the intraocular lens according to a pre-set state.
[0074] For example, the left-right width of Section B begins to narrow relative to Section A, reaching half the width of Section A. The upper side of Section B is also designed to be flatter to prevent the lens from deflecting left or right within the intraocular cavity. The arc of Section B's lower side also decreases as the width changes. The top and bottom heights of Section B remain essentially the same as those of Section A. This design of Section B allows the lens to gradually fold and roll up according to a pre-designed state.
[0075] Section C is approximately 10 mm from Section B. Sections C and B are essentially identical in shape and size. The internal cavity between Sections B and C forms a stable folding zone. This section of the internal cavity from Section B to Section C is crucial during the intraocular lens injection process. This design ensures that the folded and rolled lens maintains a stable posture, adjusts the position of the haptics and optic, and forms a stable folding zone, laying the foundation for the next step of folding and rolling into a narrower space.
[0076] Section D is about 6 mm away from Section C. The shape of Section D is basically the same as Section C, but the size of Section D is smaller than Section C. For example, the left and right widths, upper and lower heights, lower curvature and other dimensions of Section D can be reduced to approximately 0.8 times that of Section C. It should be understood that whether the cross-sectional shapes are the same or not does not include whether grooves are set in the cross-section. For example, grooves can be set in the inner cavity from Section B to Section C, and no grooves are set at Section D, but Section B, Section C and Section D can all be considered to have basically the same cross-sectional shape. The inner cavity portion between Section C and Section D is used to allow the intraocular lens that has been stably folded and rolled up in the previous section (i.e., the section from Section B to Section C) to continue to be smoothly folded into a narrower space.
[0077] Section E is approximately 5 mm from section D. Section E is smaller than section D. For example, the left-right width and lower curvature of section E can be reduced to approximately 0.8 times that of section D. Sections E and D differ in cross-sectional shape. The upper side of section E is a convex arc, while the lower side is a concave arc. In other words, the upper side of section E replaces the plane used in the previous cross-sectional design to keep the lens in a stable posture and prevent it from flipping left or right, with an upward-arching arc (i.e., a convex arc). The upper side of section E innovatively uses an upward-arching arc surface design instead of a flat plane constraint to allow the lens more longitudinal space and guide its natural transition to its final shape. At this point, the lens is already very stable when folded and rolled up, so there is no need to design an additional plane to restrict its left-right flipping. This also allows the lens to move closer to a circular shape in the next stage of movement. Therefore, the inner channel between sections D and E is used to guide the intraocular lens to transition to an intermediate shape, preparing for the intraocular lens' transition to a circular shape.
[0078] Section F is approximately 5 mm away from section E. Section F is circular (e.g., a perfect circle). The size of section F may be smaller than section E. The circular cross-section can provide the maximum accommodation space for the folded and rolled lens, and can effectively prevent the introduction head from being broken and the incision of the capsular bag from being enlarged due to the narrow space and the folded and rolled lens being subjected to excessive force, thereby affecting the effect of the lens push implantation. Section F is close to the position where the intraocular lens is officially pushed out of the inner cavity and into the capsular bag of the eye. The inner cavity portion between sections E and F is used to guide the intraocular lens to transition from an intermediate state to a circular shape.
[0079] In summary, the inner cavity of the intraocular lens inserter disclosed herein can be composed of multiple cross-sections fitted with gradients, and each cross-section can play its due role. The gradient cross-section design simulates the natural folding process of the lens, making the lens injection smoother, avoiding problems such as abnormal loop flipping, lens damage or asymmetric folding caused by sudden changes in external forces. In some embodiments, the variable cross-section inner cavity can also be combined with the unique immersion lubricating inner cavity mentioned below to achieve controlled compression folding, so that the lens can significantly reduce the injection resistance while achieving normal folding, improve surgical controllability, and perfectly achieve the clinical requirements of "gradual compression-stable transition-precise release".
[0080] 2. Improvements to the Tip Insertion
[0081] The front end of the introducer body is the tip insertion section. This is the key part where the introducer comes into direct contact with the intraocular tissue. This part is used for precise insertion into the eye and guides the safe release of the intraocular lens.
[0082] The lower end of the tip bevel cutout of the tip insertion portion is provided with a notch, and the space at the notch that can accommodate the intraocular lens is slightly larger than the inner cavity. The intraocular lens is pushed outward from the inner cavity, and before leaving the inner cavity, part of the intraocular lens first passes through the notch. Here, "slightly larger" means that the space at the notch that can accommodate the intraocular lens is larger than the inner cavity, but the excess value is limited. This is because the notch is used to play a role of pre-release (rather than full release), so the space at the notch that can accommodate the intraocular lens needs to be slightly larger (rather than much larger) than the inner cavity.
[0083] The lower end of the apical bevel is the end of the apical bevel that the IOL first passes through during its ejection from the intraocular canal. Before the IOL is ejected from the intraocular canal, a portion of it passes through the notch, where the lens begins to unfold from its folded state. The notch provides a slightly larger space than the intraocular canal, providing a temporary buffer for the lens, releasing some of its rebound force upon exiting the canal.
[0084] In some embodiments, the shape of the notch is similar to a crescent moon. Therefore, the notch can also be called a crescent-shaped notch.
[0085] In some embodiments, the lower end of the notch is an arc, and the diameter of the arc is greater than the width of the notch connected by the arc. Exemplarily, the width of the notch connected by the arc is equal to 0.8 times the diameter of the arc.
[0086] Figure 2 、 Figure 3 Schematic diagrams of a tip insertion portion at different viewing angles according to an embodiment of the present disclosure are shown.
[0087] See also Figure 2 The lower end of the tip bevel cut of the tip inserting portion 12 is provided with an original notch. The notch is innovatively designed to be crescent-shaped. The notch includes Figure 2 The part between H2 and H1. H2 represents the width of the notch, that is, the width of the notch at the connection with the bevel cut at the tip. The lower end of the notch (that is, the lower end of H2) is designed to be a large arc (radius R). H1 is the size of the notch at the widest part of the large arc, R:H1=1:2. A spline curve is used to connect the lower end of H2 and the large arc to ensure continuity and smoothness between the lower end of H2 and the large arc. The proportional relationship between H2 and H1 can be H2=n×H1, and the value range of n is 0.8~15. Preferably, the value range of n is 3~12; more preferably, the value range of n is 4~6.
[0088] These dimensions maximize the lens's resilience during deployment while maintaining the inserter's structural strength. The crescent-shaped notch, designed with this size, reduces the maximum stress on the notch wall by over 30% during the lens's deployment, significantly improving the inserter's durability and safety.
[0089] See also Figure 3 , the inside of the notch can be designed with a chamfered corner. The chamfered corner design can be understood as a process of making the original edges and corners inside the notch into a rounded transition, so that the inside of the notch is smooth and will not damage the lens loop. The radius of the chamfered corner design is about 0.1mm. The inside of the notch can form a dynamic guide surface from the inside to the outside through the chamfered corners. When the lens contacts this surface, its expansion direction will be precisely guided to avoid damage to the lens loop due to angle deviation.
[0090] During the injection process, the intraocular lens is pushed outward from the intraocular channel. Before exiting the channel, part of it passes through the crescent-shaped notch. At this point, the lens begins to move from a folded state to an unfolded state. The space in the notch that accommodates the lens is slightly larger than the intraocular channel, providing a temporary buffer for the lens, releasing some of its rebound force at the moment of exiting the channel. At the same time, with the dynamic guidance of the notch, the lens continues to unfold smoothly and gradually from its folded state. This dual mechanism of "pre-release and guided unfolding" is the core innovation of the design.
[0091] For high-degree and thick lenses, the elastic potential energy stored in their folded state is relatively large. Due to the lack of a buffer structure in traditional introduction heads, the elastic force released instantly by the lens when passing through the tip can easily exceed the introduction head's tolerance limit. The crescent-shaped notch of this design, through a unique spatial gradient design, can allow the lens to release approximately 40% of its rebound force in stages within 0.3 seconds of passing through the notch. At the same time, the dynamic guide surface on the inner wall of the notch forms a fluid dynamic lubrication effect with the surface of the lens, and utilizes the tiny gap generated when the lens is pushed to form a stable lubricating film, further reducing the impact force when the lens is unfolded. This design can effectively improve the safety and reliability of intraocular lens implantation during cataract surgery, thereby effectively avoiding the problem of high-degree and thick lenses being unable to release the rebound force due to insufficient space, thus breaking the introduction head or enlarging the incision.
[0092] 3. Ergonomic grip
[0093] Figure 4 A schematic structural diagram of an intraocular lens introduction head according to an embodiment of the present disclosure is shown.
[0094] See also Figure 4 A gripping portion 17 is provided on both sides of the inserting head body 19 close to the intraocular lens entrance.
[0095] The grip portion 17 is designed in a "human" shape, which is designed based on the gripping habits of human hands and mechanical principles, so that it fits the gripping posture of human hands and provides a comfortable gripping feeling.
[0096] Figure 5 、 Figure 6 Shown are schematic structural diagrams of the gripping portion at different viewing angles.
[0097] See also Figure 5 The distance between the ends of the two grips closest to the IOL entrance is W1, and the distance between the ends of the two grips farther from the IOL entrance is W2, with W1 > W2. As a result, the two grips form a herringbone-like shape. This shape, ergonomically designed based on a database of adult hand dimensions, perfectly matches the thumb and index finger grip angle, conforming to the natural gripping habits of the human hand.
[0098] For example, W1≈0.8W2. This ratio has been verified by finite element analysis and can achieve optimal torque balance within the injection force range of 1N to 3N. At the same time, the narrowed front end design increases the operator's field of view by 40%.
[0099] The grip also features an anti-slip structure to enhance grip stability. This anti-slip structure can include multiple outward-facing, anti-slip grooves. These grooves can be horizontal or vertical. The size of these grooves can be designed based on the average adult hand size and grip strength to ensure sufficient friction.
[0100] See also Figure 5 、 Figure 6 The anti-slip structure may include five longitudinally convex anti-slip lines 171.
[0101] The height of the anti-slip grooves 171 is 0.8mm (the optimal height for tactile feedback determined through biomechanical testing), and the distance between adjacent anti-slip grooves is 2mm. The surface of the anti-slip grooves 171 is mold-textured and sandblasted (Ra = 3.2μm). The surface of the anti-slip grooves 171 can also be coated with a medical-grade silicone modified layer (friction coefficient μ ≥ 0.6), which maintains over 90% anti-slip performance even in wet environments.
[0102] This design combines biomechanical optimization with innovative anti-slip technology, significantly improving operational stability. Even after 30 minutes of continuous use, it can still maintain a grip force attenuation rate of <5%, significantly reducing the risk of instrument deviation or falling off due to hand slippage. It is particularly suitable for high-precision, long-term cataract phacoemulsification surgery, and the overall surgical accuracy can be improved by more than 35%.
[0103] 4. Depth protection device
[0104] This embodiment aims to design a simple and effective depth protection device to prevent the introduction head from being inserted too deeply.
[0105] The technical principle of the depth protection device can be summarized as follows: an annular step is provided at a position near the tip of the tip insertion part of the introducer main body, and the outer diameter of the annular step is larger than the diameter of the tip insertion part at the annular step; the diameter of the tip insertion part at the annular step is equivalent to the incision diameter; in the process of inserting the tip insertion part into the eye capsule, the annular step contacts the capsule opening to limit the further insertion of the tip insertion part; thus, by utilizing the relationship between the outer diameter of the annular step and the incision size, the insertion depth of the tip insertion part can be limited, thereby achieving limitation and playing a role of depth protection.
[0106] Exemplarily, the distance between the annular step and the tip is 3mm to 5mm. If the distance the tip insertion portion is inserted into the capsular bag of the eye is too short, the incision will not be able to fully support the tip insertion portion, making the tip insertion portion easy to slide, resulting in the intraocular lens being unable to pass through the capsular bag incision and enter the capsular bag when it is pushed out from the tip insertion portion; if there is no step, the consequence of inserting the introducer too deeply is to enlarge the incision, affecting the healing of the incision after surgery, so the insertion depth needs to be limited. Setting the annular step to 3mm to 5mm from the tip can balance the capsular bag support force and insertion resistance, preventing excessive intrusion of the instrument without causing insufficient capsular bag support force due to too short insertion.
[0107] Exemplarily, the outer diameter of the annular step is 1.5 to 2 times the diameter of the tip insertion portion at the annular step. This numerical range has been optimized for structural strength through finite element simulation to ensure that it can withstand an axial injection pressure of >10N. 1.5 to 2 times, this value range is based on the physical space structure. That is, the outer diameter of the annular step must be at least 1.5 times the diameter of the tip insertion portion at the annular step to play a blocking role. If it is less than 1.5 times, it will not play a blocking role. If it is too large (greater than 2 times), it will affect the visual appearance, be unsightly, and the introduction head will be too thick, resulting in a waste of cost.
[0108] It should be understood that the various numerical ranges recited in this disclosure include the endpoints on both sides of the numerical range.
[0109] Figure 7 A schematic structural diagram of an annular step according to an embodiment of the present disclosure is shown.
[0110] See also Figure 7 The surface of the annular step 13 may also be provided with a reflective mark 14 for reflecting light. The reflective mark 14 may be embedded in the surface of the annular step 13. The reflective mark 14 may be made of reflective material or through a special process. It can clearly reflect light under surgical lighting, making it easier for the operator to quickly and accurately identify the step position during surgery, further improving the accuracy and safety of the operation.
[0111] In some embodiments, the surface of the reflective marker 14 is provided with a micro-prism array for achieving directional reflection. Directional reflection refers to the reflection of light in a direction that is convenient for the operator to observe. The micro-prism array can achieve directional reflection by matching the refractive index (e.g., a refractive index n between 1.5 and 1.7).
[0112] In some further embodiments, the posture of the microprism units in the microprism array can be set so that as the distance of the tip insertion portion inserted into the eye capsule increases, more light enters at least part of the microprism units, thereby increasing the intensity of the reflected light signal. Thus, the reflective mark 14 also has the functions of depth positioning and dynamic warning. The posture of the microprism unit includes the position and posture (such as angle) of the microprism unit. When the introduction head is just inserted into the eye capsule, the microprism array reflects the light of the surgical shadowless lamp in a conventional manner, and the reflected light brightness is at a relatively stable level. When the introduction head gradually approaches the dangerous insertion depth, the angle of the light irradiating the mark will also change due to the change in position. The microprism array is very sensitive to the angle of light reflection. The change in angle will cause more light to enter the microprism units in a specific angle range, and the light reflection efficiency will be greatly improved, resulting in a sudden increase in the intensity of the reflected light signal.
[0113] For example, the reflective mark 14 is formed as an integral part of the introduction head and the step structure through a mold injection molding process. The material is medical-grade titanium dioxide modified polycarbonate (TiO2-PC), with a reflectivity of ≥90% and a thickness controlled at 0.08-0.2 mm. The surface of the reflective mark 14 is processed by a microprism array (prism unit size 50-100 μm). The angle and distribution of the microprism array are not uniform, but are specially planned to achieve directional reflection through refractive index matching (n=1.5-1.7). The reflected brightness is ≥200 cd / m under a surgical shadowless lamp (illuminance ≥5000 lux). 2 , dynamic warning distance reaches 5 meters. The reflective sign 14 has both depth positioning and dynamic warning functions. When the guide head approaches the dangerous insertion depth, due to the change of position and angle, more light enters the micro-prism unit in a specific angle range, the reflection efficiency of the light will be greatly improved, and the intensity of the reflective signal will increase sharply (brightness change ΔB>50cd / m 2 ), prompting doctors to adjust the operation in time to effectively reduce the risk of posterior capsule rupture.
[0114] 5. Visualization Window
[0115] See also Figure 4The main body 19 of the introduction head is provided with a visualization window 15. Window 15 is located at the upper portion of the introduction head, directly observable by the operator during use. Exemplarily, window 15 is treated with a double-sided optical-grade mirror polishing process (surface roughness Ra ≤ 0.01 μm), achieving a transparency of over 92%. Therefore, this window can also be referred to as a visualization transparent window. Figure 8 A schematic diagram showing the structure of a visualization window is shown.
[0116] See also Figure 4 as well as Figure 8 , at least one side of the window 15 (e.g., both sides shown in the figure) is provided with a scale line 16. The value of the scale line 16 is used to reflect the position and / or progress of the intraocular lens during the injection process. For example, when a scale line is provided on each side of the window 15, the value of one scale line can reflect the position of the intraocular lens during the injection process, and the value of the other scale line can reflect the progress of the intraocular lens during the injection process. In this way, it is convenient for the operator to directly observe the position and status of the intraocular lens and control the injection progress according to the scale lines.
[0117] The scale interval is strictly designed to be 1mm (accumulated error ±0.05mm), establishing a precise correspondence with the IOL advancement distance, forming a real-time observation system. The surface of window 15 can be coated with a nano-scale anti-fog coating (primarily composed of silica sol-gel, with a contact angle of <10°), ensuring a clear field of view even in humid intraoperative environments, and accurately reflecting the displacement and folding state of the IOL during the injection process.
[0118] This innovative design enables the operator (doctor) to clearly observe the position and folding status of the lens in real time under standard surgical lighting conditions (3000-5000 lux). The injection progress can be judged with an accuracy of ±0.3mm, which is approximately 60% higher than the traditional scale-free design. This allows for precise control of the injection force (typical value 0.5-1.2N) and speed (0.5-2mm / s), effectively avoiding distortion or displacement of the lens loop due to visual misjudgment, and significantly improving surgical safety and operational efficiency.
[0119] 6. Infiltration of the inner cavity
[0120] The inner wall of the lumen may be provided with at least one (e.g., multiple) grooves extending along the length of the lumen. The grooves are used to absorb a pre-dropped viscoelastic agent, thereby forming a lubricating layer on the lumen wall at the grooves. Viscoelastic agents may include, but are not limited to, sodium hyaluronate, hydroxypropyl methylcellulose, and balanced salt solutions.
[0121] During intraocular lens injection, the lens contacts the lubricating layer, activating the lubricating effect of the viscoelastic, reducing friction and eliminating the need for separate preoperative injections. This ensures smooth passage of the lens through the tip of the inserter, eliminating the operational risks associated with over- or under-injection. This allows for self-lubrication during lens injection, eliminating the need for separate preoperative viscoelastic injections and streamlining the procedure.
[0122] Grooves can be provided along the length of the inner lumen for a section of the inner lumen, or for the entire inner lumen. In other words, the grooves can be located at any section of the front end, middle section, or rear end of the inner lumen. Considering that the middle section of the inner lumen is the area where the intraocular lens injection force is concentrated during the injection process, it is more necessary to lubricate the area where the injection force is concentrated. Therefore, preferably, at least one (e.g., multiple) grooves can be arranged at least in the middle section of the inner lumen.
[0123] In some embodiments, a groove structure with a specific curvature can be designed to utilize the surface tension of the groove to absorb the viscoelastic agent, thereby forming a stable lubricating layer on the inner lumen wall. Specifically, the groove structure on the inner lumen wall can be designed with a specific curvature to increase surface tension. This allows the pre-dropped viscoelastic agent to be evenly absorbed and firmly adhered to the groove surface under the action of surface tension, while the excess viscoelastic agent automatically flows away, forming a quantitative lubricating layer.
[0124] The method of designing the groove structure on the wall surface of the inner cavity is as follows.
[0125] First, a groove structure with a specific curvature can be created on the inner cavity wall through micromachining techniques (such as laser engraving or etching, precision injection molding, etc.). The groove height, width, and distribution density can be designed based on surface tension and the amount of viscoelastic adsorbed. Then, a small amount of viscoelastic can be dripped into the inner cavity. Under the adsorption effect of the groove structure with a specific curvature, the viscoelastic evenly covers the groove surface. Excess liquid naturally flows out without remaining in the inner cavity. After filling the inner cavity surface, a smooth, continuous surface is formed, forming a quantitative lubricating layer.
[0126] In actual use, the operator inserts the intraocular lens into the lumen. During the injection process, the lens gradually rolls up and folds through the lumen, coming into contact with the lubricating layer. The viscoelastic is activated and continuously provides lubrication, ensuring smooth passage of the lens through the tip of the inserter, avoiding damage or positional displacement caused by friction. Furthermore, some of the viscoelastic in the groove can enter the eye, maintaining a certain degree of intraocular space.
[0127] Figure 9 A schematic structural diagram of an intraocular lens introduction head according to an embodiment of the present disclosure is shown.
[0128] See also Figure 9The core structure of the inner cavity 11 is a precisely designed groove structure array, which includes a plurality of grooves 110 distributed along the circumference of the cavity wall.
[0129] Figure 10 for Figure 9 A half-section view of the intraocular lens inserter is shown.
[0130] See also Figure 10 , groove 110 is precisely positioned in the middle section of the inner lumen 10. The specific location of the middle section can be determined based on the specific structure of the inner lumen 11. During the injection process, the area where the intraocular lens injection force is concentrated within the inserter can be considered the middle section of the inner lumen 11. For example, the middle section of the inner lumen 11 can refer to the section from section B to section C of the variable-section inner lumen described above.
[0131] Figure 11 A front view of the groove structure is shown.
[0132] according to Figure 11 , it is clear to see the distribution, number and cross-sectional design of the grooves 110. For example, the groove structure array shown in the figure is composed of 17 grooves 110 distributed symmetrically along the inner cavity wall.
[0133] Figure 12 A schematic cross-sectional design diagram of a groove according to an embodiment of the present disclosure is shown.
[0134] See also Figure 12 The groove has a groove bottom 112 and an opening 111 opposite to the groove bottom 112. The pre-dropped viscoelastic agent enters the groove from the opening 111. The cross-sectional height of the groove (i.e., the groove depth) is H. The groove width gradually narrows from the first depth position 113 to the groove opening 111, which is a first-level tapered structure. The groove width gradually narrows from the groove bottom 112 to the second depth position 114, which is a second-level tapered structure. The groove depth corresponding to the second depth position 114 is greater than or equal to the groove depth corresponding to the first depth position 113. The greater the groove depth, the closer it is to the groove bottom 112.
[0135] The portion between the first depth position 113 and the second depth position 114 in the groove depth direction can be referred to as the middle section of the groove. The groove width at the opening 111 can be recorded as L1, and the groove width in the middle section of the groove can be recorded as L2, where L2 is greater than L1. For example, L1 = 0.8 × L2. "Equal to" in the present disclosure includes "approximately equal to". The portion below the middle section of the groove can be referred to as the bottom of the groove, and the cross-section of the bottom of the groove is a first semicircle, and a second semicircle protruding into the interior of the groove is provided on both sides of the middle section of the groove, the radius of the first semicircle is R, and the radius of the second semicircle is r, where R is greater than r. For example, r = 0.2R.
[0136] The present disclosure utilizes the surface tension gradient effect to generate a strong capillary force by designing the groove into the above-mentioned two-stage tapered structure. The first stage of tapering (from the inner cavity wall of the groove middle section to the opening) guides the viscoelastic agent to flow in through a gradually narrowing channel (L1 = 0.8 × L2), forming a preliminary liquid surface curvature. The second stage of tapering (from the middle section to the bottom of the groove) further narrows the channel and sets two inwardly convex semicircular structures (for example, radius r = 0.2R) in the middle section of the groove, so that the liquid surface forms a secondary bend in the narrow area. According to the Laplace pressure equation ΔP = γ(1 / R1 + 1 / R2), the smaller the radius of curvature R of the liquid surface, the greater the pressure difference ΔP generated by surface tension. In the first stage of tapering, it mainly plays a guiding role; while in the second stage of tapering, R2 is smaller (for example, the radius of the semicircular structure r = 0.2R), resulting in a significant increase in the pressure difference ΔP, thereby generating a stronger capillary force, firmly fixing the viscoelastic agent to the bottom of the groove.
[0137] In some further embodiments, the inner wall of the groove can be hydrophilized to reduce its surface energy. Combined with the aforementioned geometric constraints of the groove, the contact angle of the viscoelastic can be controlled to be less than or equal to 30°, thereby anchoring the edge of the liquid surface in the groove, forming a stable concave liquid surface. It should be understood that controlling the contact angle θ below 30° is a key parameter determined through experimental optimization, theoretical calculation, and practical verification. This value balances multiple factors such as wettability, capillary force, lubricating layer stability, and material surface energy. When the inner wall of the groove is hydrophilized, the contact angle of the viscoelastic can be stabilized below 30°, exhibiting a super-hydrophilic state, ensuring that the liquid surface is fully spread, forming a smooth, continuous surface, and forming a uniform lubricating layer.
[0138] In summary, the groove design proposed in the present disclosure not only utilizes the geometric characteristics of double tapering (combined with two inwardly convex semicircles) to amplify the surface tension effect, but also ensures the stable adhesion of the lubricating layer through the synergistic effect of materials and structure, so that the viscoelastic agent (usually a 1.4% sodium hyaluronate solution) is firmly anchored in the groove, and its contact angle θ can be controlled below 30°, forming a stable lubricating layer, ultimately achieving ultra-low friction push injection without the need for supplemental viscoelastic agent.
[0139] During the IOL inserter manufacturing process, 1ml to 3ml of viscoelastic pre-injected into the lumen spontaneously fills the entire groove system within 5-10 seconds, forming a smooth, continuous surface and a complete, infiltrating lubricating layer. Excess viscoelastic flows out of the lumen for recycling and subsequent packaging. Once the operator has unpacked and received the inserter, there's no need to re-inject viscoelastic separately.
[0140] When the intraocular lens is injected into the intraocular cavity, the lubricating layer creates friction between its surface and the cavity wall, reducing the shear stress τ to less than one-third of that of conventional designs, significantly minimizing the risk of lens deformation and damage. A grooved structure within the cavity wall eliminates the need for viscoelastic replenishment during the injection process, maintaining a super-lubricated state with an ultra-low coefficient of friction. Furthermore, this design reduces viscoelastic loss to less than 5%, significantly lower than the 15-20% loss rate of conventional injectors. This ensures both surgical safety and standardized procedures.
[0141] In summary, the present disclosure provides corresponding innovative designs to address the many problems existing in current introduction heads, thereby solving these problems. Taking the above innovative designs integrated into an introduction head as an example, the introduction head has at least the following beneficial effects.
[0142] (1) The lumen of the introducer is composed of multiple sections with gradient fitting. Each section can play its due role. The gradient section design simulates the natural folding process of the lens. Combined with the lubricating layer, it realizes controlled compression, making the lens injection smoother and avoiding problems such as abnormal loop flipping, lens damage or asymmetric folding caused by sudden changes in external force. The normal folding of the lens can significantly reduce the injection resistance and improve the controllability of the operation.
[0143] (2) An original crescent-shaped notch is provided at the insertion part of the tip of the introducer, which can provide a buffer space during the lens injection process and release part of the lens's rebound force in advance, effectively avoiding the problem of the lens, especially the high-refractive power or thick lens, breaking the introducer or expanding the incision when unfolding, significantly improving the reliability of the instrument, reducing intraoperative accidents caused by instrument breakage, and at the same time reducing the risk of incision damage, thereby ensuring postoperative recovery effect.
[0144] (3) Anti-slip stripes are added on both sides of the introducer head, and the grip design is ergonomically designed to fit the hand shape, which enhances operational stability and reduces operational errors or the risk of instrument falling off due to hand slippage. It is especially suitable for long-term surgery, reduces doctor fatigue, and improves overall operational comfort and accuracy.
[0145] (4) A depth protection device is provided. Through the dual design of the step structure and reflective marking, it effectively limits the insertion depth of the introducer, avoiding capsular bag damage or lens position displacement caused by improper operation. The reflective marking is clearly visible under the operating light, significantly improving positioning accuracy, reducing surgical risks, and reducing the doctor's reliance on experience, shortening the learning curve.
[0146] (5) A visual optical grade transparent window is set above the introduction head, and the scale line design is combined to enable the doctor to observe the lens position and injection progress in real time, accurately control the injection force and speed, avoid abnormal lens folding or position deviation caused by blind operation, improve the success rate of the operation, and reduce the risk of tissue damage caused by repeated adjustments.
[0147] (6) The lumen of the introducer is equipped with a unique groove structure, which creates a strong surface tension on the liquid, automatically adsorbing and stabilizing the viscoelastic agent, forming a quantitative lubricating layer. This eliminates the need for a separate viscoelastic injection before surgery, simplifies the operation process, and avoids injection resistance or lens damage caused by excessive or insufficient viscoelastic agent. The lubricating layer is continuously activated during the injection process, significantly reducing friction, ensuring smooth passage of the lens, and improving surgical safety and efficiency.
[0148] In summary, the intraocular lens inserter disclosed herein addresses the problems of abnormal lens folding and injection, the inability of the tip of the inserter to effectively cope with the elastic force of a highly thick lens and cause it to rupture, difficulty in holding and operating, poor control of the insertion depth, lack of visualization of the injection process, and inconvenience in using viscoelastic agents. Through the above-mentioned multiple innovative designs, it optimizes the lubrication method, effectively handles the elastic force of the lens at the tip, ensures the quality of lens injection, achieves precise control of the insertion depth, improves the degree of visualization of injection, and enhances the stability of holding, thereby improving the safety, accuracy and efficiency of intraocular lens implantation surgery.
[0149] While various embodiments of the present disclosure have been described above, the above descriptions are illustrative, non-exhaustive, and not intended to be limiting of the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to existing technologies, or to enable others skilled in the art to understand the embodiments disclosed herein.
Claims
1. An intraocular lens inserter, comprising: Import the header body, The interior of the introduction head body is a hollow inner cavity. The inner cavity is a folding transport channel for the intraocular lens. The inner cavity is formed by a plurality of cross-sections of different shapes and sizes that are fitted and gradually changed, so as to guide the intraocular lens to naturally change from an unfolded state to a folded state during the injection process.
2. The intraocular lens inserter according to claim 1, wherein: The inner cavity includes a first section, a second section, a third section, a fourth section, a fifth section, and a sixth section from the outside to the inside, and the transition surface between two adjacent sections is a smooth and naturally fitting transition. The lower side of the first cross section is a concave arc to pre-bend the intraocular lens; the upper side of the first cross section is a plane or a nearly plane to limit the left and right deflection of the intraocular lens; the width of the first cross section is greater than a first threshold, which is used to characterize the size of the intraocular lens when it just enters the inner cavity. The width of the second cross-section is smaller than that of the first cross-section, the height of the second cross-section is substantially equal to that of the first cross-section, the upper side of the second cross-section is a plane or a nearly plane, the lower side of the second cross-section is a concave arc, and the inner cavity portion between the first cross-section and the second cross-section is used to gradually fold and roll the intraocular lens according to a predetermined state. The shape and size of the third section are substantially consistent with those of the second section, and the inner cavity portion between the second section and the third section is used to form a stable folding area. The shape of the fourth cross section is substantially the same as that of the third cross section, and the size of the fourth cross section is smaller than that of the third cross section. The inner cavity portion between the third cross section and the fourth cross section is used to allow the intraocular lens that has been stably folded and rolled to continue to be smoothly folded into a narrower space. The size of the fifth cross section is smaller than that of the fourth cross section, the upper side of the fifth cross section is a convex arc, and the lower side of the fifth cross section is a concave arc. The inner cavity portion between the fourth cross section and the fifth cross section is used to guide the intraocular lens to transition to an intermediate shape, so as to prepare for the intraocular lens to transition to a round shape. The sixth section is circular, and the sixth section is close to the position where the artificial lens is officially pushed out of the inner cavity and into the eye capsular bag. The inner cavity portion between the fifth section and the sixth section is used to guide the artificial lens to transition from the intermediate state to a circular shape.
3. The intraocular lens inserter according to claim 2, wherein: The second cross section is about 5 mm away from the first cross section; and / or The third cross section is about 10 mm away from the second cross section; and / or The fourth section is about 6 mm away from the third section; and / or The fifth section is about 5 mm away from the fourth section; and / or The sixth cross section is about 5 mm away from the fifth cross section.
4. The intraocular lens inserter according to claim 1, wherein: The front end of the introducer head body is a tip insertion part, and the lower end of the tip oblique cut of the tip insertion part is provided with a notch. The space for accommodating the artificial lens at the notch is slightly larger than the inner cavity. The artificial lens is pushed outward from the inner cavity, and before leaving the inner cavity, part of the area of the artificial lens first passes through the notch.
5. The intraocular lens inserter according to claim 4, wherein: The lower end of the notch is an arc; and / or The inside of the notch is designed with rounded corners.
6. The intraocular lens inserter according to claim 5, wherein: The width of the notch is n times the diameter of the arc, where n is in the range of 0.8 to 15; and / or The fillet radius of the rounded corner design is about 0.1 mm.
7. The intraocular lens inserter according to claim 1, wherein: A gripping portion is provided on both sides of the inserter body close to the intraocular lens entrance. The distance between the two ends of the two gripping parts that are relatively close to the intraocular lens entrance is greater than the distance between the two ends of the two gripping parts that are relatively far from the intraocular lens entrance.
8. The intraocular lens inserter according to claim 7, wherein: The gripping portion is provided with an anti-slip structure.
9. The intraocular lens inserter according to claim 8, wherein: The anti-slip structure includes a plurality of outwardly convex anti-slip lines. The height of the anti-slip lines is 0.8 mm, and the distance between two adjacent anti-slip lines is 2 mm.
10. The intraocular lens inserter according to claim 9, wherein: The anti-slip surface is treated with mold tanning and sandblasting; and / or The surface of the anti-slip pattern is coated with a medical-grade silicone modified layer.
11. The intraocular lens inserter according to claim 1, wherein: The intraocular lens insert is integrally manufactured by injection molding; and / or The material of the artificial lens introduction head is selected from medical grade or food grade polymer material.
12. The intraocular lens inserter according to claim 1, wherein: The front end of the introduction head body is a tip insertion portion. The introduction head body is provided with an annular step at a position close to the tip of the tip insertion portion, and the outer diameter of the annular step is larger than the diameter of the tip insertion portion at the annular step. During the process of inserting the tip insertion portion into the eye capsular bag, the annular step contacts the capsular bag opening, thereby limiting further insertion of the tip insertion portion.
13. The intraocular lens inserter according to claim 12, wherein: The distance between the annular step and the tip is 3 mm to 5 mm; and / or An outer diameter of the annular step is 1.5 to 2 times the diameter of the tip insertion portion at the annular step.
14. The intraocular lens inserter according to claim 12, wherein: The surface of the annular step is provided with a reflective mark for reflecting light.
15. The intraocular lens inserter according to claim 14, wherein: The surface of the reflective mark is provided with a micro-prism array for achieving directional reflection.
16. The intraocular lens inserter according to claim 15, wherein: The positions of the microprism units in the microprism array are set so that as the distance of the tip insertion portion inserted into the eye capsule increases, more light enters at least part of the microprism units, thereby increasing the intensity of the reflected light signal.
17. The intraocular lens inserter according to claim 1, wherein: A visualization window is provided on the introduction head body.
18. The intraocular lens inserter according to claim 17, wherein: The window is processed by double-sided optical grade mirror polishing process, and the transparency reaches more than 92%; and / or The surface of the window is coated with a nano-scale anti-fog coating; and / or At least one side of the window is provided with a scale line, and the value of the scale line is used to reflect the position and / or progress of the intraocular lens during the injection process.
19. The intraocular lens inserter according to claim 1, wherein: The inner wall of the inner cavity is provided with at least one groove extending along the length direction of the inner cavity.
20. The intraocular lens inserter according to claim 19, wherein: The groove is located in the middle section of the inner cavity.
21. The intraocular lens inserter according to claim 19, wherein: The groove has a groove bottom and an opening opposite to the groove bottom, The groove width gradually narrows from the first depth position to the notch. The groove width gradually narrows from the bottom of the groove to the second depth position. The groove depth corresponding to the second depth position is greater than or equal to the groove depth corresponding to the first depth position.
22. The intraocular lens inserter according to claim 21, wherein: The groove depth corresponding to the second depth position is greater than the groove depth corresponding to the first depth position, and the portion between the first depth position and the second depth position is the middle section of the groove. The groove width at the opening is smaller than the groove width in the middle section of the groove. The portion below the middle section of the groove is the bottom of the groove, and the cross-section of the bottom of the groove is a first semicircle. A second semicircle bulging toward the inside of the groove is provided on both sides of the middle section of the groove, and the radius of the first semicircle is greater than the radius of the second semicircle.
23. The intraocular lens inserter according to claim 22, wherein: The groove width at the opening is equal to 0.8 times the groove width at the middle of the groove; and / or The radius of the second semicircle is equal to 0.2 times the radius of the first semicircle.
24. The intraocular lens inserter according to claim 23, wherein: The inner wall of the groove is also hydrophilized so that the contact angle of the viscoelastic agent is less than or equal to 30°.