JP7589437B2 - Intraocular lens insertion device - Google Patents

Description

This disclosure relates to an intraocular lens insertion device for inserting an intraocular lens into the eye.

Conventionally, as one of the methods of cataract surgery, a technique of inserting a foldable soft intraocular lens into the eye instead of the crystalline lens is commonly used. Here, an intraocular lens insertion device for inserting an intraocular lens into a patient's eye is known (for example, Patent Document 1). In the intraocular lens insertion device according to Patent Document 1, an intraocular lens is pre-filled in the internal space of a cylindrical main body. The main body is provided with an injection port that connects the outside of the main body with the internal space. When a user (for example, an operator or a caregiver) uses the intraocular lens insertion device according to Patent Document 1, a liquid lubricant is injected from the outside of the main body into the internal space through this injection port. Then, the user pushes out the intraocular lens with a pushing member that advances toward the tip side in the internal space, and the intraocular lens folded small in the nozzle is ejected from the tip to the outside and inserted into the eye. As a result, the intraocular lens coated with the lubricant passes smoothly through the nozzle in a folded state and is ejected.

Patent No. 6540000

The intraocular lens insertion device described above has one injection port on the main body. On the other hand, there are various types of lubricants. For example, lubricants include high-viscosity viscoelastic substances, low-viscosity viscoelastic substances, and ocular irrigation fluid (low viscosity). High-viscosity and low-viscosity lubricants tend to flow (spread) differently after being injected into the internal space of the main body, and even if the same amount is injected from the same injection port, it is not applied properly to the intraocular lens or the path of the intraocular lens, which may lead to poor tacking and clogging of the nozzle. For this reason, the viscosity of the lubricant applicable to the intraocular lens insertion device has been limited. However, there is a demand for different lubricants with different viscosities depending on the surgical content, surgical method, corneal endothelium of the patient's eye, and other eye conditions. For this reason, an intraocular lens insertion device that can smoothly eject an intraocular lens even when a lubricant with a wider range of viscosities is injected is desired.

Therefore, the present disclosure has been made to solve the above-mentioned problems, and aims to provide an intraocular lens insertion device that can be used with multiple types of viscosity.

An intraocular lens insertion device provided by a typical embodiment of the present disclosure is an intraocular lens insertion device that inserts an intraocular lens pre-filled in an internal space of a cylindrical main body into an eye, the main body having a plurality of injection ports for injecting at least a lubricant of a first viscosity and a lubricant of a second viscosity, respectively, in order to inject liquid lubricant from the outside of the main body into the internal space, the lubricant of the first viscosity having a higher viscosity than the lubricant of the second viscosity, the injection port for the first viscosity being located relatively forward and the injection port for the second viscosity being located relatively rearward, and a configuration that changes a method of injecting the lubricant into the internal space based on the viscosity of the lubricant to be injected into the internal space via the plurality of injection ports, the intraocular lens insertion device further comprising an injection method changing means that changes an injection position depending on the viscosity of the lubricant, and the injection method changing means has outer circumferential shapes different from each other for the injection port for the first viscosity and the injection port for the second viscosity .

The intraocular lens insertion device disclosed herein can provide an intraocular lens insertion device that can be used with multiple types of viscosity.

1 is a plan view showing an entire intraocular lens insertion instrument. FIG. 2 is a left side view showing the entire intraocular lens insertion instrument. FIG. 2 is a partial perspective view showing an enlarged view of a portion of the intraocular lens insertion instrument. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. 2 is an enlarged partial plan view of part V in FIG. 1 with a top plate portion of the main body removed. FIG. 6 is a partial plan view showing a main body portion by enlarging a portion VI in FIG. 1 . FIG. 2 is a cross-sectional view taken along line VII-VII of FIG. 1. FIG. 2 is a plan view of an intraocular lens. FIG. 2 is a right side view of the intraocular lens. 1 is a partial plan view showing how a viscoelastic material of medium viscosity spreads when a specified amount of the material is injected into a medium viscosity injection port. 1 is a partial plan view showing how a viscoelastic material of high viscosity spreads when a specified amount of the material is injected into a medium viscosity injection port. 1 is a partial plan view showing how a viscoelastic material with low viscosity spreads when a specified amount of the material is injected into a medium viscosity injection port. 1 is a partial plan view showing how a specified amount of high-viscosity viscoelastic material spreads when injected into a high-viscosity injection port. FIG. 1 is a partial plan view showing how a low-viscosity viscoelastic material spreads when a specified amount of the low-viscosity viscoelastic material is injected into a low-viscosity injection port. FIG. FIG.

＜Overview＞
The intraocular lens insertion device exemplified in the present disclosure is an intraocular lens insertion device that inserts an intraocular lens pre-filled into the internal space of a cylindrical main body into the eye, the main body having an injection port for injecting liquid lubricant from outside the main body into the internal space, and an injection method changing means (in other words, an injection method determining means) that changes the method of injecting the lubricant into the internal space based on the viscosity of the lubricant to be injected into the internal space through the injection port.

The intraocular lens insertion device of the present disclosure changes the method of injecting the lubricant into the internal space based on the viscosity of the lubricant, so that the lubricant can be suitably applied to the intraocular lens. This makes it possible to provide an intraocular lens insertion device that can be used with multiple types of viscosities.

The intraocular lens insertion device may be configured to include a plurality of the injection ports. By providing a plurality of injection ports, the degree of freedom in changing the method of injecting the lubricant into the internal space can be increased based on the viscosity of the lubricant.

The main body in the intraocular lens insertion device may have an installation section connected to the front end side of the main body tube section formed in a cylindrical shape extending in the front-rear direction and having the internal space, the installation section main body being a box-shaped member with an opening at the top, and a flat top plate section covering the top opening, and at least two of the multiple injection ports are provided in the top plate section. Thus, by providing at least two injection ports in the top plate section, it is easy to select when injecting lubricants of different viscosities.

In addition, at least one of the multiple injection ports in the intraocular lens insertion device may be configured to be located at a different position in the front-to-rear direction. This allows the way in which lubricants of different viscosities are spread into the internal space of the main body to be changed.

The intraocular lens insertion device may be configured to selectively use one or more of the multiple injection ports depending on the viscosity of the lubricant. This allows for even greater freedom in the injection method depending on the viscosity of the lubricant.

The injection method change means in the intraocular lens insertion device may be configured to be capable of changing the injection position depending on whether a viscoelastic substance is used as the lubricant or whether an irrigation fluid is used. Since an irrigation fluid can be used as the lubricant in addition to a viscoelastic substance, it is possible to accommodate lubricants of a wide range of viscosities depending on the type of surgery, the surgical method, the corneal endothelium of the patient's eye, and other eye conditions.

The injection method change means in the intraocular lens insertion device may have multiple injection ports as a configuration for changing the injection position, and each of the injection ports may have a different outer circumferential shape. This makes it easier to grasp the injection position, since each of the multiple injection ports has a different outer circumferential shape.

The injection method change means in the intraocular lens insertion device may be configured to change the injection position based on an induction indicator corresponding to the viscosity of different lubricants. This makes it even easier to grasp the appropriate injection position using the induction indicator corresponding to the viscosity of different lubricants.

First Embodiment
A first embodiment, which is one of typical embodiments of the present disclosure, will be described below with reference to Fig. 1 to Fig. 15. In the following description, the directions shown in each figure are defined as the direction toward the tip of the nozzle 180 side of the main body 100 of the intraocular lens insertion instrument 10 (left side of the paper in Fig. 1) and the direction toward the pressing part 370 of the plunger 300 (right side of the paper in Fig. 1) as the rear of the intraocular lens insertion instrument 10. The upper side of the paper in Fig. 1 is defined as the right side of the intraocular lens insertion instrument 10, and the lower side of the paper in Fig. 1 is defined as the left side of the intraocular lens insertion instrument 10. The front side of the paper in Fig. 1 is defined as the top of the intraocular lens insertion instrument 10, and the rear side of the paper in Fig. 1 is defined as the bottom of the intraocular lens insertion instrument 10.

<Overall composition>
The overall configuration of an intraocular lens insertion instrument 10 of the first embodiment will be described with reference to Figures 1 to 7. The intraocular lens insertion instrument 10 is used to insert a deformable intraocular lens 1 (see Figures 8 and 9, details will be described later) into the eye. The intraocular lens insertion instrument 10 includes a main body 100 and a plunger 300. The main body 100 is substantially cylindrical, and the intraocular lens 1 is inserted into the eye through a passage inside the main body 100. The plunger 300 is a rod-shaped member, and can move in the front-rear direction (direction along the extrusion axis A) through the passage inside the main body 100. The plunger 300 moves forward along the extrusion axis (axis of the passage) A to push out the intraocular lens 1 filled inside the main body 100.

The main body 100 and plunger 300 of the first embodiment are formed from a resin material. The intraocular lens insertion device 10 may be formed by injection molding, cutting by scraping out resin, or the like. By forming the intraocular lens insertion device 10 from a resin material, a user (e.g., a surgeon or a caregiver) can easily dispose of the used intraocular lens insertion device 10.

In the first embodiment, a lubricating coating is applied to the inner wall of the main body 100 in order to smoothly insert the adhesive soft intraocular lens 1 into the eye. In addition, the intraocular lens insertion device 10 of the first embodiment is formed to be colorless transparent or colorless translucent. Therefore, the user can easily visually check the deformation state of the intraocular lens 1 filled inside the intraocular lens insertion device 10 from the outside of the intraocular lens insertion device 10.

<Main body 100>
The main body 100 will now be described. The main body 100 includes, from the rear to the front, a cylindrical main body portion 110, an installation portion 130, and a nozzle 180.

The main body tube portion 110 is formed in a cylindrical shape that extends in the front-rear direction. The main body tube portion 110 is located on the rear end side of the main body portion 100. A flange portion 111 that protrudes outward from the outer peripheral surface is provided at a position on the rear end side in the longitudinal direction of the main body tube portion 110. When using the device, the user holds it by hooking their fingers on the flange portion 111.

The installation section 130 is connected to the front end side of the main body tube section 110. The installation section 130 includes an installation section main body 134 and a top plate section 132. The installation section main body 134 is a box-shaped member with an open top. Before being pushed out by the plunger 300, the intraocular lens 1 is pre-installed (filled) in the internal space of the installation section main body 134 by having the outer peripheral edge section 2C (see Figures 8 and 9) held by the holding section 131 provided on the installation section main body 134 (see Figure 7).

The top plate 132 is a lid member that is disposed across the nozzle 180 and the installation body 134 and covers the upper openings of these. The top plate 132 may be formed by injection molding using a resin material (e.g., polypropylene), cutting processing by cutting out the resin, or the like. The top plate 132 of the first embodiment is flat and is formed to cover the nozzle 180 and the openings of the installation body 134. The top plate 132 also has a pressing portion 133 at a position corresponding to the holding portion 131 of the installation body 134. The intraocular lens 1 is placed (filled) in the internal space of the installation part 130 with the outer peripheral edge portion 2C sandwiched between the holding portion 131 and the pressing portion 133 (see FIG. 7). The configuration of the injection port provided in the top plate 132 will be described later.

The nozzle 180 is connected to the front end side of the installation part 130. The passage area in the nozzle 180 becomes smaller toward the front in order to deform the intraocular lens 1 into a smaller shape in the process of pushing the intraocular lens 1 forward. In other words, the nozzle 180 has an internal cavity shape in which the passage through which the intraocular lens 1 passes becomes narrower toward the tip. A cylindrical insertion part 182 is provided at the front end of the nozzle 180. The insertion part 182 is inserted into the eye. An insertion port 183, which is an opening for discharging the intraocular lens 1 forward from the internal passage, is formed at the front end of the insertion part 182. The insertion port 183 has a notch (bevel) cut at an angle at the tip. The internal passage of the main body part 100 (see Figures 1 to 3) penetrates from the rear end of the main body tube part 110 (see Figure 1) to the insertion port 183 at the front end of the nozzle 180.

<Plunger 300>
The outline of the configuration of the plunger 300 (see FIGS. 1 and 4) will be described. The plunger 300 of the first embodiment includes a pushing member 310, a shaft base portion 350, and a pressing portion 370.

The pressing portion 370 is formed at the rear end of the plunger 300. The pressing portion 370 is a plate-shaped member extending in a direction perpendicular to the extrusion axis A (see FIG. 1). The pressing portion 370 is the portion that comes into contact with the user's finger when the user pushes the plunger 300 forward.

The shaft base 350 is a rod-shaped member extending forward from the front end side of the pressing portion 370. In the first embodiment, the shaft base 350 is formed so that the cross section perpendicular to the extrusion axis A has a substantially H-shaped shape. The shaft base 350 is inserted into the main body tube portion 110, which has a substantially rectangular cross section perpendicular to the extrusion axis A, thereby suppressing the circumferential rotation of the extrusion axis A of the plunger 300 relative to the main body portion 100. When the plunger 300 moves forward and reaches a position where the insertion of the intraocular lens 1 into the eye is completed, the inclined surface at the lower front end of the shaft base 350 comes into contact with an inclined surface formed at a predetermined location on the main body portion 100 and stops. As a result, the front end of the plunger 300 is prevented from excessively protruding from the insertion port 183.

The pusher member 310 (see FIG. 4) is a rod-shaped member that extends forward from the front end of the shaft base 350 along the axial direction of the pusher axis A. The pusher member 310 is formed so that the cross section perpendicular to the pusher axis A has a substantially circular shape. The pusher member 310 is also thick enough to pass through the insertion port 183 of the main body 100. The pusher member 310 moves forward along the pusher axis A within the passage of the main body 100, thereby deforming the intraocular lens 1 slightly and expelling the intraocular lens 1 from the insertion port 183 into the eye.

<Intraocular lens 1>
An example of an intraocular lens 1 inserted into the eye by an intraocular lens insertion device 10 will be described with reference to Figs. 8 and 9. The intraocular lens 1 includes an optical part 2 and a support part 3. The intraocular lens 1 of the first embodiment is a so-called one-piece type intraocular lens in which the optical part 2 and the support part 3 are integrally molded. The intraocular lens 1 used in the first embodiment is integrally molded with the optical part 2 and a pair of support parts 3, that is, a front support part 3A and a rear support part 3B. The intraocular lens 1 can employ various soft resin materials as the soft material, such as simple substances such as BA (butyl acrylate) and HEMA (hydroxyethyl methacrylate), and composite materials of acrylic acid ester and methacrylic acid ester. Although the so-called one-piece type intraocular lens 1 is exemplified in the first embodiment, at least a part of the technology exemplified in the present disclosure can also be applied to a so-called three-piece type intraocular lens in which the optical part 2 and the support part 3 are formed of separate members.

The optical part 2 provides a predetermined refractive power to the patient's eye. The optical part 2 is disc-shaped. The optical axis L of the optical part 2 passes through the center of the optical part 2 and extends in the vertical direction. The support part 3 supports the optical part 2 inside the eye. As an example, the intraocular lens 1 of the first embodiment is provided with a front support part 3A and a rear support part 3B as a pair of support parts 3. The front support part 3A and the rear support part 3B extend radially outwardly from the outer peripheral edge part 2C of the optical part 2 in a curved manner, and are formed in a position that is point-symmetrical with respect to the optical axis L, which is the center of the optical part 2. The front support part 3A has a root part 6A connected to the outer peripheral edge part 2C of the optical part 2 via the connection part 4A, has a loop shape curved in the circumferential direction, and has an open tip part 8A. (That is, the tip part 8A is a free end). The rear support part 3B has a base part 6B connected to the outer peripheral edge part 2C of the optical part 2 via a connection part 4B, and has a circumferentially curved loop shape with an open tip part 8B (i.e., the tip part 8B is a free end). The optical part 2 has, as an end face in the optical axis L direction, a first surface 2A that faces the top plate part 132 of the installation part 130 as described below, and a second surface 2B that is opposite the first surface 2A and contacts the bottom surface of the installation part 130.

<Lubricant D (viscoelastic material, irrigation fluid)>
The lubricant D used in the first embodiment is a viscoelastic substance (liquid) and an irrigation liquid (liquid). In this embodiment, the lubricant D refers to a liquid that is pushed by the plunger 300 and assists the sliding of the intraocular lens 1 that moves from the base end side to the tip end side in the internal space of the main body tube part 110. Viscoelastic substances (OVD: Ophthalmic Viscoelastic Devices) are sometimes used to maintain the anterior chamber of the patient's eye and protect the corneal endothelium during cataract surgery. Viscoelastic substances come in various forms from low viscosity to high viscosity, and their characteristics differ depending on, for example, the difference in viscosity or the difference in cohesiveness. A viscoelastic substance with a high viscosity tends to be, for example, excellent in the retention of the anterior chamber in the eye, easy to remove, and easy to inject. A viscoelastic substance with a low viscosity tends to be, for example, excellent in retention, has a high protective effect on the corneal endothelium in the eye, and even if it remains, has a low risk of increasing intraocular pressure. The irrigation solution is a liquid used for intraocular irrigation and intraocular cleaning of a patient's eye during, for example, cataract surgery. Therefore, the lubricant D may be selected depending on the type of surgery, the surgical method, the condition of the corneal endothelium of the patient's eye, other eye conditions, and the like.

The intraocular lens insertion device 10 of this embodiment has three viscosity classifications (viscosity ranges) as the viscosity ranges of the usable viscoelastic substance. In this embodiment, the viscoelastic substance is classified into the following viscosity classes. The low-viscosity viscoelastic substance D1 (first viscosity range) has a zero shear viscosity (Pa·s) of 20 or less at a temperature of 24°C. The medium-viscosity viscoelastic substance D2 (second viscosity range) has a zero shear viscosity (Pa·s) of more than 20 and less than 80 at a temperature of 24°C. The high-viscosity viscoelastic substance D3 (first viscosity range) has a zero shear viscosity (Pa·s) of 80 or more and 300 or less at a temperature of 24°C. As the viscoelastic substance, for example, sodium hyaluronate, sodium chondroitin sulfate, etc. may be used. As the perfusion fluid, for example, oxyglutathione solution, etc. may be used, and the viscosity is equivalent to that of water. For example, the viscosity of the perfusion fluid is exemplified as a zero shear viscosity (Pa·s) of 20 or less at a temperature of 24°C. Note that this embodiment is merely an example, and two or more classifications may be provided according to the viscosity. For example, there may be two or four viscosity classifications (viscosity range divisions). Note that some of the viscosity ranges may overlap.

<Injection port of top plate portion 132>
1, 2, 5, and 6, the top plate 132 in the installation section 130 has an injection method change means for changing the injection position of the lubricant D based on the viscosity of the liquid lubricant D to be injected from the outside of the main body section 100 into the internal space. Specifically, the injection method change means has a plurality of injection ports as a configuration for changing the injection position. In addition, the protrusions of the injection ports have different outer circumferential shapes, and are disposed at different positions on the top plate (a part of the wall forming the cylindrical installation section 130, or a part of the main body tube section 110 facing the intraocular lens 1 (see FIGS. 8 and 9)). Here, the injection method change means in the first embodiment is exemplified by a mode having three injection ports, a high viscosity injection port 140, a medium viscosity injection port 150, and a low viscosity injection port 160. In the first embodiment, all the injection ports are provided on the wall facing the front side of the intraocular lens 1. This makes it easy for a user (e.g., an operator or a caregiver) to find the injection ports, for example. However, for example, at least one of the multiple injection ports may be provided on the rear surface side of the intraocular lens 1 .

<High viscosity injection port 140>
3 and 6, the high viscosity injection port 140 has a protrusion 142 protruding upward from the plate surface of the top plate portion 132. The upper surface of the protrusion 142 has a conical recess 144. A hole 146 is provided that opens in a crank shape from the bottom of the recess 154 toward the thickness direction of the top plate portion 132. The protrusion 142 has an outer periphery that is a square prism.

<Medium viscosity injection port 150>
3 and 6, the medium viscosity injection port 150 has a protrusion 152 protruding upward from the plate surface of the top plate portion 132. The upper surface of the protrusion 152 has a conical recess 154. A hole 156 is provided that opens in a crank shape from the bottom of the recess 154 toward the thickness direction of the top plate portion 132. The protrusion 152 has an outer periphery that is a triangular prism.

<Low viscosity injection port 160>
3 and 6, the low-viscosity injection port 160 has a protrusion 162 protruding upward from the plate surface of the top plate portion 132. The upper surface of the protrusion 162 has a conical recess 164. A hole 166 is provided that opens in a crank shape from the bottom of the recess 154 toward the thickness direction of the top plate portion 132. The protrusion 162 has a cylindrical outer circumferential shape.

Here, the high viscosity injection port 140, the medium viscosity injection port 150, and the low viscosity injection port 160 are all configured in a crank shape that opens in the thickness direction of the top plate portion 132, so that the injection needle 210 (see FIG. 3) of the injector 200 such as a syringe does not reach the internal space, and the injection needle 210 does not come into contact with the intraocular lens 1. Note that the injection port is not limited to a crank shape (opening in a crank shape in the thickness direction of the top plate portion 132), but may be a shape that penetrates the wall surface of the top plate portion 132 so that the injection needle 210 of the injector 200 reaches the internal space.

<Position of medium viscosity injection port 150>
The position where the medium-viscosity injection port 150 is provided will be described with reference to FIG. 10. When the installation section 130 filled with the intraocular lens 1 is viewed from the front side of the paper surface of FIG. 10, the medium-viscosity injection port 150 is provided at a position adjacent to the outer peripheral edge portion 2C of the optical portion 2 of the intraocular lens 1 pre-filled in the installation section 130, forward of the optical axis L, and adjacent to the left side wall 136. The medium-viscosity viscoelastic material D2 is unlikely to exert an effect such as pushing the front support portion 3A, etc. forward, and is unlikely to be affected by the attitude (vertical direction) of the main body portion 100 because it has moderate viscosity and cohesiveness. Therefore, for example, by arranging it near the center (optical axis L) of the intraocular lens 1, it is easy to suppress the amount of the medium-viscosity viscoelastic material D2 used. In addition, the medium-viscosity viscoelastic material D2 is easy to spread over the entire optical portion 2 of the intraocular lens 1 in the internal space of the installation section 130. In addition, the medium-viscosity injection port 150 is located adjacent to the left side wall 136, so that the injected medium-viscosity viscoelastic material D2 can easily flow into the optical part 2. In addition, the medium-viscosity injection port 150 is located outside the outer peripheral edge portion 2C in order to facilitate the flow of the medium-viscosity viscoelastic material D2 on both the first surface 2A facing the top plate portion 132 and the second surface 2B (see FIG. 9 ) opposite the first surface 2A. The medium-viscosity injection port 150 may be located adjacent to the outer peripheral edge portion 2C of the optical part 2, rearward of the optical axis L, and adjacent to the right side wall 137 (position point-symmetrical with respect to the optical axis L with respect to the above-mentioned medium-viscosity injection port 150), but is preferably located forward of the optical axis L and adjacent to the left side wall 136 in order to fill the intraocular lens 1 with the medium-viscosity viscoelastic material D2 from the front side.

With reference to FIG. 11, the issues that arise when a high-viscosity viscoelastic material D3 is injected into the medium-viscosity injection port 150 will be described. The high-viscosity viscoelastic material D3 has a high cohesiveness and therefore tends to spread in a circular shape around the hole 156 after being injected through the medium-viscosity injection port 150. As a result, the tip portion 8A of the front support portion 3A is pushed forward by the flow of the high-viscosity viscoelastic material D3, making it easy for tacking defects to occur. FIG. 11 shows both the shape of the front support portion 3A before deformation and the shape of the front support portion 3A after deformation, and the front support portion 3A is deformed in the direction of the arrow in FIG. 11 by the high-viscosity viscoelastic material D3.

With reference to FIG. 12, the following describes the issues that may arise when a low-viscosity viscoelastic material D1 is injected into the medium-viscosity injection port 150. The low-viscosity viscoelastic material D1 flows more easily than the medium-viscosity viscoelastic material D2 and the high-viscosity viscoelastic material D3. Therefore, for example, when the nozzle 180 faces downward, the low-viscosity viscoelastic material D1 flows biased toward the front side of the optical axis L of the optical part 2 of the intraocular lens 1, and does not spread easily toward the rear side. In other words, the low-viscosity viscoelastic material D1 is easily affected by gravity due to its low viscosity. Note that when the nozzle 180 faces upward, the viscoelastic material D1 flows biased toward the rear side of the medium-viscosity injection port 150, and does not spread easily toward the front side.

<Position of high viscosity injection port 140>
The position where the high-viscosity injection port 140 is provided will be described with reference to FIG. 13. When the installation section 130 filled with the intraocular lens 1 is viewed from the front side of the paper surface of FIG. 13, the high-viscosity injection port 140 is located outside (on the front side) of the root portion 6A of the front support portion 3A of the intraocular lens 1 pre-filled in the installation section 130. The high-viscosity injection port 140 is provided at the position of the root portion 6A in consideration of the direction in which the high-viscosity viscoelastic material D3 spreads in a circular shape around the hole portion 146 and the direction in which the front support portion 3A extends are aligned (the same). This makes it possible to make the attitude of the front support portion 3A less susceptible to the flow of the high-viscosity viscoelastic material D3 injected from the high-viscosity injection port 140. Here, the high-viscosity viscoelastic material D3 has a high cohesiveness and therefore tends to spread in a circular shape around the hole portion 146 after being injected through the high-viscosity injection port 140. Here, if the high-viscosity injection port 140 is provided on the rear side (right side of the paper in FIG. 13 ) of the optical axis L, which is the center of the optical part 2, it is considered that the high-viscosity viscoelastic material D3 is unlikely to flow sufficiently to the front of the intraocular lens 1. If the high-viscosity viscoelastic material D3 is not sufficiently applied to the front support part 3A side of the intraocular lens 1 and is pushed out by the pushing member 310 (see FIG. 4 ), there is a concern that the intraocular lens 1 will be clogged in the nozzle 180. In addition, if the high-viscosity injection port 140 is provided on the tip part 8A side, which is the free end of the front support part 3A, as described above using FIG. 11 , the tip part 8A of the front support part 3A is pushed forward and deformed by the flow of the high-viscosity viscoelastic material D3, which makes it easy for tacking defects to occur. Therefore, the position where the high-viscosity injection port 140 in this embodiment is provided is desirable. The high-viscosity injection port 140 may be provided directly above the root portion 6A (at a position facing the root portion 6A), but is preferably provided outside the root portion 6A in consideration of facilitating the flow of the high-viscosity viscoelastic material D3 on both the first surface 2A facing the top plate portion 132 and the second surface 2B (see FIG. 9) opposite the first surface 2A. The high-viscosity injection port 140 may be provided between the root portion 6A and the outer peripheral edge portion 2C of the optical portion 2 (at a position below the position facing the root portion 6A, in other words, at the side of the front support portion 3A), but is preferably provided outside the root portion 6A in consideration of preventing the front support portion 3A from being pushed forward.

<Position of low viscosity injection port 160>
The position where the low-viscosity injection port 160 is provided will be described with reference to Fig. 14. When the installation section 130 filled with the intraocular lens 1 is viewed from the front side of the paper surface of Fig. 14, the low-viscosity injection port 160 is located outside (rear side) of the root portion 6B of the rear support portion 3B of the intraocular lens 1 pre-filled in the installation section 130. Furthermore, the rear side of the low-viscosity injection port 160 is provided at a corner position adjacent to the rear wall 135 and the left side wall 136 that form the internal space of the installation section 130. Therefore, the low-viscosity injection port 160 is formed at a position where the low-viscosity viscoelastic material D1 is less likely to flow rearward than the intraocular lens 1. The low-viscosity viscoelastic material D1 has a property of flowing more easily (spreading more easily) than the medium-viscosity viscoelastic material D2 and the high-viscosity viscoelastic material D3, and therefore the flow direction is easily unstable due to the influence of the posture of the main body section 100 during injection. Therefore, the low-viscosity injection port 160 is located outside (rear side) of the root portion 6B of the rear support portion 3B, and is provided at a corner position adjacent to the rear wall 135 and the left side wall 136 on the rear side of the low-viscosity injection port 160. Therefore, the specified amount of low-viscosity viscoelastic material D1 is spread rearward, and even if the main body portion 100 is tilted in the front-rear direction, it can be made to flow only forward. As a result, the low-viscosity viscoelastic material D1 flows in one direction, the forward direction. In addition, since the low-viscosity injection port 160 is located outside (rear side) of the root portion 6B of the rear support portion 3B, even if the low-viscosity viscoelastic material D1 flows in one direction, the low-viscosity viscoelastic material D1 is likely to come into contact with the intraocular lens 1.

<Guiding indicators>
The intraocular lens insertion device 10 is provided with guidance indicators corresponding to different viscosities of the lubricant D when selecting one of three injection ports, the high-viscosity injection port 140, the medium-viscosity injection port 150, and the low-viscosity injection port 160, as an injection method changing means. A user (e.g., an operator or an assistant) can change the injection position based on the guidance indicators. As the guidance indicators, for example, a marking on a case or packaging container that contains the intraocular lens insertion device 10, a marking on an instruction manual enclosed in a packaging container of the intraocular lens insertion device 10, a marking directly on the intraocular lens insertion device (for example, a marking on the main body tube part 110 of the main body part 100), etc. can be applied. In the first embodiment, the guidance indicators are written in the instruction manual enclosed in the packaging container together with the intraocular lens insertion device 10. For example, the marking method may be as shown in FIG. 15. That is, in this embodiment, the instruction manual enclosed in the packaging container together with the intraocular lens insertion device 10 and indicating the guidance indicator (for example, FIG. 15) is included in the injection method changing means for changing the injection method of the lubricant into the internal space based on the viscosity of the lubricant. Note that the indication of the guidance indicator (FIG. 15) in the instruction manual is one example, and for example, the guidance indicator (FIG. 15) may be indicated on the outer wall of the main body tube portion 110. FIG. 15 shows, as an example of indication of the guidance indicator, a first viscosity range (20 Pa·s or less) that can be injected into the low viscosity injection port 160, a second viscosity range (20-80 Pa·s) that can be injected into the medium viscosity injection port 150, and a third viscosity range (80 Pa·s or more and 300 Pa·s or less) that can be injected into the high viscosity injection port 140. Note that FIG. 15 shows the relationship between the viscosity and the corresponding injection port as the guidance indicator, but is not limited thereto. For example, in FIG. 15, instead of indicating the viscosity range, the product name of the lubricant D corresponding to each viscosity range may be indicated. It can be said that the trade name of lubricant D substantially indicates the viscosity of lubricant D. Of course, the viscosity range and the trade name of lubricant D may be listed together.

<How to use>
The intraocular lens insertion device of the first embodiment is manufactured by integrally molding the main body tube portion 110, the installation portion main body 134, and the nozzle 180, and assembling the top plate portion 132 and the plunger 300 which are formed separately. When assembling the intraocular lens insertion device 10 of the first embodiment, the installation portion main body 134 is filled with the intraocular lens 1 in advance and closed with the top plate portion 132. That is, in the first embodiment, a so-called preset type intraocular lens insertion system is constructed by the intraocular lens insertion device 10 and the intraocular lens 1 loaded in advance in the intraocular lens insertion device 10. The preset type intraocular lens insertion system can be used promptly at the site of use.

The intraocular lens insertion device 10 filled with the intraocular lens 1 is housed in a case made by deforming a synthetic resin sheet into an uneven shape, and a flexible sheet that allows sterilizing gas to pass through is attached to the opening of the case to seal it. The case sealed with the flexible sheet is then sterilized, and the case is sealed in a packaging container with an instruction manual and other documents enclosed.

At the site of use, the user (e.g., the surgeon or the caregiver) removes the case from the packaging container, peels off the flexible sheet of the case, and removes the intraocular lens insertion device 10 from the case. The user understands the correspondence between the three injection ports (high viscosity injection port 140, medium viscosity injection port 150, low viscosity injection port 160) and the viscosity of the lubricant D by the guidance indicator in the instruction manual enclosed in the packaging container. After the user decides the lubricant D to be used during surgery, he or she changes the injection port corresponding to the viscosity of the lubricant D based on the guidance indicator. In this embodiment, as an example, the viscosity of the lubricant D is described in the instruction manual enclosed in the packaging container of the lubricant D, and the user understands the viscosity of the lubricant D by reading the instruction manual. The user holds the injector 200, such as a syringe filled with the lubricant D, and inserts the injection needle 210 of the injector 200 into the injection port of the top plate portion 132. Next, the user discharges the lubricant D filled in the injector 200 from the tip of the injection needle 210 and injects the lubricant D into the internal space of the intraocular lens insertion device 10. When the user has completed the injection of the lubricant D, he or she removes the injection needle 210 from the intraocular lens insertion device 10.

As a result, the intraocular lens 1 in the mounting section 130 of the main body 100 is suitably coated with the lubricant D. Furthermore, the lubricant D makes it difficult for the intraocular lens 1 in the mounting section 130 to shift from its initial position, or for the front support section and rear support section to move. As a result, the intraocular lens insertion device 10 presses the pressing section 370 of the plunger 300, causing the pushing member 310 to push out the intraocular lens 1, making it ready for injection.

Thus, according to the intraocular lens insertion instrument 10 according to the first embodiment of the present disclosure, the main body 100 is provided with an injection port for injecting liquid lubricant D from outside the main body 100 into the internal space, and is provided with an injection method change means (high viscosity injection port 140, medium viscosity injection port 150, low viscosity injection port 160) for changing the injection method of lubricant D into the internal space based on the viscosity of the lubricant D injected into the internal space through the injection port. Since the intraocular lens insertion instrument 10 changes the injection method of lubricant D into the internal space based on the viscosity of the lubricant D, the lubricant D can be suitably applied to the intraocular lens 1. This makes it possible to provide an intraocular lens insertion instrument 10 that can be used in response to a plurality of types of viscosities.

In addition, the intraocular lens insertion device 10 is configured to have multiple injection ports (high viscosity injection port 140, medium viscosity injection port 150, and low viscosity injection port 160). By providing multiple injection ports, it is possible to increase the degree of freedom in changing the method of injecting the lubricant D into the internal space based on the viscosity of the lubricant D.

The main body 100 of the intraocular lens insertion device 10 has an installation section 130 that is connected to the front end of the main body tube 110, which is formed in a cylindrical shape extending in the front-rear direction, and has an internal space. The installation section 130 is a box-shaped member with an opening at the top, and a flat top plate 132 that covers the top opening. At least two of the multiple injection ports are provided in the top plate 132. By providing at least two injection ports in the top plate 132, it is easy to select when injecting lubricants D of different viscosities.

The intraocular lens insertion device 10 is configured such that at least one of the multiple injection ports is located at a different position in the front-to-rear direction. This allows the spread of the lubricant D of different viscosities injected into the internal space of the main body 100 to be changed.

The intraocular lens insertion device 10 is configured to selectively use one or more of the multiple injection ports depending on the viscosity of the lubricant D. This allows for even greater freedom in the injection method depending on the viscosity of the lubricant D.

The high viscosity injection port 140, medium viscosity injection port 150, and low viscosity injection port 160, which are injection method change means, are configured to allow the injection position to be changed depending on whether a viscoelastic substance is used as the lubricant D or whether an irrigation fluid is used. Since the lubricant D can be an irrigation fluid other than a viscoelastic substance, it is possible to accommodate lubricant D with a wide range of viscosities depending on the type of surgery, the surgical method, the corneal endothelium of the patient's eye, and other eye conditions.

In addition, the high viscosity injection port 140, the medium viscosity injection port 150, and the low viscosity injection port 160, which are the injection method changing means, have multiple injection ports as a configuration for changing the injection position, and the outer circumferential shapes of the injection ports may be different from each other. In this way, since the outer circumferential shapes of the multiple injection ports are different from each other, it becomes easier to grasp the injection position.

In addition, the high viscosity injection port 140, the medium viscosity injection port 150, and the low viscosity injection port 160, which are the injection method changing means, may be configured to be able to change the injection position based on an induction indicator corresponding to the different viscosities of the lubricant D. This makes it even easier to grasp the appropriate injection position using the induction indicator corresponding to the different viscosities of the lubricant D.

Although the embodiment of the present disclosure has been described above, the intraocular lens insertion device of the present disclosure is not limited to the above embodiment and can be embodied in various other forms. For example, the main body part 100 in this embodiment 1 is exemplified as an integral body tube part 110, an installation part 130, and a nozzle 180 made of a resin material, but it can also be applied to a so-called cartridge type embodiment in which the main body tube part 110 and the installation part 130 (the nozzle 180 is integral with the installation part) are separated. In this embodiment, the shape of the protrusions (142, 152, 162) is made different to correspond to the viscosity, but this is not limited to this. For example, as an injection method changing means, a letter for identifying the corresponding viscosity may be placed near the protrusion. For example, the letter H (meaning high viscosity) may be formed near the high viscosity injection port 140, the letter M (meaning medium viscosity) may be formed near the medium viscosity injection port 150, and the letter L (meaning low viscosity) may be formed near the low viscosity injection port 160.

In this embodiment, the injection needle 210 of the injector 200 may penetrate and reach the internal space of the installation part 130. In this embodiment, one of the multiple injection ports is selected according to the viscosity, but a mechanism for sliding the position of the injection port may be provided, and the position of the injection port for the first viscosity and the second viscosity may be changed (moved) by having the user operate this slide mechanism in a predetermined manner after looking at an instruction indicator (such as an instruction manual). Each of such an instruction indicator and slide mechanism is included in the injection method change means. This makes it possible to reduce the number of injection ports, and for example, it is easy to prevent the user from using the wrong injection port. Also, only one injection port (for example, only the medium viscosity injection port 150) may be provided on the side of the main body part 100, and the user may select whether to inject from the insertion port 183 or the medium viscosity injection port 150 according to the viscosity of the lubricant by the instruction indicator (injection method change means).

In addition, in this embodiment, the position of the injection port is changed according to the viscosity, but this is not limited to this, and for example, the injection amount of the lubricant into the injection port 150 for medium viscosity may be changed according to the viscosity of the lubricant. In this case, for example, the relationship between the viscosity and the injection amount for each viscosity (viscosity range) may be indicated in the instruction manual (injection method change means) enclosed in the packaging container of the intraocular lens insertion device. In other words, by indicating the injection amount corresponding to each viscosity as a guidance indicator (injection method change means) in the instruction manual, it is possible to deal with low viscosity to high viscosity with only one injection port. In addition, the injection amount into the first injection port and the injection amount into the second injection port may be changed according to the viscosity. Also, for example, the instruction manual (injection method change means) may be used to inject only into the first injection port at the first viscosity, and to inject into the first injection port and the second injection port at the second viscosity. In other words, the injection method of the lubricant D may be changed according to the viscosity.

1 Intraocular lens 2 Optical portion 2A First surface 2B Second surface 2C Outer peripheral edge portion 3 Support portion 3A Front support portion 4A Connection portion 6A Base portion 8A Tip portion 3B Rear support portion 4B Connection portion 6B Base portion 8B Tip portion 10 Intraocular lens insertion device 100 Main body portion 110 Main body tube portion 111 Flange portion 130 Installation portion 132 Top plate portion 134 Installation portion main body 140 High viscosity injection port (injection method change means)
150 Medium viscosity injection port (injection method change means)
160 Low viscosity injection port (injection method change means)
180 Nozzle 182 Insertion portion 183 Insertion port 300 Plunger 310 Pushing member 350 Shaft base portion 370 Pressing portion A Pushing shaft D Lubricant D1 Low viscosity viscoelastic material D2 Medium viscosity viscoelastic material D3 High viscosity viscoelastic material L Optical axis

Claims (7)

An intraocular lens insertion device for inserting an intraocular lens, which is preloaded in an internal space of a cylindrical main body, into an eye, comprising:
the main body portion includes a plurality of injection ports for injecting at least a lubricant having a first viscosity and a lubricant having a second viscosity into the internal space from the outside of the main body portion;
The lubricant of the first viscosity has a higher viscosity than the lubricant of the second viscosity, the injection port for the first viscosity is located relatively forward and the injection port for the second viscosity is located relatively rearward,
a lubricant injection method change means for changing an injection position according to a viscosity of the lubricant injected into the internal space through the plurality of injection ports;
The injection method changing means is an intraocular lens insertion device in which the injection port for the first viscosity and the injection port for the second viscosity have different outer circumferential shapes. An intraocular lens insertion device for inserting an intraocular lens, which is preloaded in an internal space of a cylindrical main body, into an eye, comprising:
the main body portion includes a plurality of injection ports for injecting at least a lubricant having a first viscosity and a lubricant having a second viscosity into the internal space from the outside of the main body portion;
The lubricant of the first viscosity has a higher viscosity than the lubricant of the second viscosity, the injection port for the first viscosity is located relatively forward and the injection port for the second viscosity is located relatively rearward,
a lubricant injection method change means for changing an injection position according to a viscosity of the lubricant injected into the internal space through the plurality of injection ports;
The injection method changing means is an intraocular lens insertion device that provides induction indicators corresponding to the different viscosities of the lubricants at the injection port for the first viscosity and the injection port for the second viscosity, and enables the injection position to be changed based on the induction indicators. The intraocular lens insertion device according to claim 1 or 2,
The main body portion is
The installation section is connected to a front end side of a main body tubular portion formed in a cylindrical shape extending in the front-rear direction and has the internal space. The installation section has a main body that is a box-shaped member and has an opening at the top, and a flat top plate portion that covers the opening at the top,
An intraocular lens insertion device, wherein at least two of the plurality of injection ports are provided on the top plate portion. 4. The intraocular lens insertion device according to claim 3 ,
When the installation portion filled with the intraocular lens is viewed in a plan view,
An intraocular lens insertion device, wherein at least one of the multiple injection ports is provided at a position outside the base portion of a front support portion or a rear support portion of the intraocular lens pre-loaded in the installation portion. The intraocular lens insertion device according to any one of claims 1 to 4 ,
An intraocular lens insertion device that selectively uses one or more of the plurality of injection ports depending on the viscosity of the lubricant. The intraocular lens insertion device according to any one of claims 1 to 5 ,
The injection method changing means is configured to be able to change the injection position depending on whether a viscoelastic substance is used as the lubricant or whether an irrigation fluid is used. An intraocular lens insertion device for inserting an intraocular lens, which is preloaded in an internal space of a cylindrical main body, into an eye, comprising:
the main body portion includes a plurality of injection ports for injecting a liquid lubricant from an outside of the main body portion into the internal space, at least one of the plurality of injection ports being disposed at a different position in a front-rear direction;
a lubricant injection method change means for changing an injection position according to a viscosity of the lubricant injected into the internal space through the plurality of injection ports,
The main body portion is
The installation section is connected to a front end side of a main body tubular portion formed in a cylindrical shape extending in the front-rear direction and has the internal space. The installation section has a main body that is a box-shaped member and has an opening at the top, and a flat top plate portion that covers the opening at the top.
At least two of the plurality of injection ports are provided in the top plate portion,
When the installation portion filled with the intraocular lens is viewed in a plan view,
an intraocular lens insertion device, wherein at least one of the multiple injection ports is provided at a position adjacent to the outer peripheral edge of the optical portion of the intraocular lens pre-filled in the installation section, is perpendicular to the extrusion axis along the front-to-back direction, is forward of the optical axis extending in the up-down direction at the center of the optical portion, and is adjacent to the left side wall.

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