Intraocular lens inserter, intraocular lens, and intraocular lens insertion method
The intraocular lens inserter addresses the challenge of cumbersome operation by integrating a rotatable knob and locking mechanism for simultaneous folding and cap removal, enhancing user convenience and reducing lens damage risk.
Patent Information
- Application Number
- PCT/JP2025/014168
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-13
- Filing Date
- 2025-04-09
- Publication Date
- 2025-11-20
AI Technical Summary
Existing intraocular lens inserters are cumbersome and difficult to operate, requiring separate folding and cap removal operations which can risk damage to the lens and impair user convenience.
An intraocular lens inserter with a rotatable knob that integrates a movement mechanism, cap member, and locking mechanism, allowing simultaneous folding and cap removal, enhancing user convenience and operability.
The intraocular lens inserter provides improved convenience and operability by enabling seamless folding and cap management, reducing the risk of lens damage during insertion.
Smart Images

Figure JP2025014168_20112025_PF_FP_ABST
Abstract
Description
Intraocular lens inserter, intraocular lens, and intraocular lens insertion method
[0001] The present invention relates to an intraocular lens inserter, an intraocular lens, and an intraocular lens insertion method.
[0002] In cataract surgery, after the opacified crystalline lens is extracted, an intraocular lens is inserted into the lens capsule in place of the crystalline lens. An intraocular lens inserter is used to insert the intraocular lens.
[0003] One invention relating to an intraocular lens cartridge is configured such that when a cap is removed, a nozzle is exposed and the intraocular lens moves and folds within the housing (see, for example, Patent Document 1).
[0004] Special Publication No. 2022-545417
[0005] Users of intraocular lens inserters (physicians, etc.) may sometimes desire to fold the intraocular lens and remove the cap at separate times (e.g., with a time lag). For example, after completing a pre-insertion procedure (e.g., lens removal), they may find it cumbersome to set up the intraocular lens inserter from scratch, and may therefore choose to keep the intraocular lens folded in advance. However, the intraocular lens inserter configured as described above is difficult to accommodate such situations, and is not necessarily convenient for users. While it is conceivable to perform the folding of the intraocular lens and the removal of the cap as separate operations, this would impair user operability. When folding the lens by pulling out the cap, caution is required due to the risk of impact or damage to the intraocular lens depending on the user's operation, and in this respect, it is not necessarily easy to operate.
[0006] The present invention provides a technique that can achieve excellent convenience and operability when using an intraocular lens inserter.
[0007] A first aspect of the present invention is an intraocular lens inserter comprising: an inserter body having a hollow cylindrical portion capable of containing an intraocular lens and configured to be able to release the intraocular lens contained in the hollow cylindrical portion to the outside through a lens release port; a movement mechanism portion that moves the intraocular lens inside the hollow cylindrical portion along the cylindrical axis direction of the hollow cylindrical portion; a rotation knob portion that is attached to the inserter body so as to be rotatable around the cylindrical axis of the hollow cylindrical portion; and a cap member that is attached to the inserter body so as to cover at least the lens release port, wherein the movement mechanism portion moves the intraocular lens in conjunction with rotation of the rotation knob portion, and the cap member is configured to be attachable and detachable to the inserter body when the rotation knob portion is in a predetermined rotation position.
[0008] A second aspect of the present invention is the intraocular lens inserter according to the first aspect, wherein the moving mechanism has an engaging piece that protrudes outside the hollow cylindrical portion, and the engaging piece engages with an engaging groove formed in the rotating knob portion, thereby linking the rotating knob portion and the moving mechanism portion.
[0009] A third aspect of the present invention is the intraocular lens insertion device according to the second aspect, wherein the movement mechanism includes a slider mechanism that moves the intraocular lens within the hollow cylindrical portion.
[0010] A fourth aspect of the present invention is the intraocular lens insertion device according to the third aspect, wherein the engagement groove in the rotation knob portion is formed so as to extend spirally in the axial direction of the hollow cylindrical portion.
[0011] A fifth aspect of the present invention is the intraocular lens inserter described in the first aspect, wherein the cap member has a tacking pin arranged to protrude into the hollow tubular portion when attached, and a pin support portion that supports the tacking pin, and is configured such that when the cap member is removed from the inserter body, the tacking pin retracts from the hollow tubular portion due to deformation of the pin support portion.
[0012] A sixth aspect of the present invention is the intraocular lens insertion device described in the fifth aspect, wherein the cap member has, in addition to the tacking pin and the pin support portion, a guide portion that causes deformation of the pin support portion in response to relative movement between the cap member and the hollow cylindrical portion in the axial direction of the cylinder.
[0013] A seventh aspect of the present invention is the intraocular lens insertion device according to the second aspect, wherein the movement mechanism includes a push-out mechanism that pushes out the intraocular lens from the lens release port.
[0014] An eighth aspect of the present invention is the intraocular lens insertion device according to the seventh aspect, further comprising: a locking mechanism that restricts the pushing-out operation of the pushing-out mechanism to push out the intraocular lens.
[0015] A ninth aspect of the present invention is the intraocular lens insertion device according to the eighth aspect, wherein the locking mechanism is configured to release the restriction on the pushing-out operation in conjunction with rotation of the rotary knob.
[0016] A tenth aspect of the present invention is an intraocular lens inserter for use with an intraocular lens including an optical portion and an outer edge, wherein the inserter body defines an outer shape and a direction of lens advancement and includes a hollow tubular portion, an intraocular lens storage area, a nozzle, and a transition area between the intraocular lens storage area and the nozzle; the plunger is movable within the inserter body distally in the direction of lens advancement relative to the inserter body and includes an end face configured to engage with and push the intraocular lens as the plunger moves distally; the lens folding device is movable distally in the direction of lens advancement relative to the inserter body and the plunger and configured to fold the intraocular lens during distal movement of the lens folding device; and a rotatable knob portion associated with the inserter body exterior and operably connected to the lens folding device, and the lens folding device moves distally in the direction of lens advancement in response to rotation of the rotatable knob portion.
[0017] An eleventh aspect of the present invention is the intraocular lens inserter according to the tenth aspect, further comprising: a cap member removably fixed to the inserter body over the nozzle.
[0018] A twelfth aspect of the present invention is the intraocular lens inserter according to the eleventh aspect, wherein the rotation knob portion is rotatable relative to the cap member.
[0019] A thirteenth aspect of the present invention is an intraocular lens inserter according to the eleventh or twelfth aspect, wherein the cap member includes a first cap lock having a locked state that prevents the cap member from being removed from the inserter body and an unlocked state that allows the cap member to be removed from the inserter body, and the lens folding device is configured to transition the first cap lock from the locked state to the unlocked state during distal movement of the lens folding device.
[0020] A fourteenth aspect of the present invention is the intraocular lens inserter according to the thirteenth aspect, wherein the inserter body includes a latch opening, and the first cap lock includes a latch that extends through the latch opening when the first cap lock is in a locked state, and the lens folding device includes a surface that moves the latch relative to the latch opening when the lens folding device transitions the first cap lock from the locked state to the unlocked state.
[0021] A fifteenth aspect of the present invention is an intraocular lens inserter according to any one of the tenth to fourteenth aspects, further comprising: a second cap lock having a locked state that prevents the cap member from being removed from the inserter body, and an unlocked state that allows the cap member to be removed from the inserter body; and a rotation of the rotation knob portion that causes the second cap lock to transition from the locked state to the unlocked state.
[0022] A sixteenth aspect of the present invention is the intraocular lens inserter according to the fifteenth aspect, wherein the second cap lock includes a pin and a slot in which the pin is disposed.
[0023] A seventeenth aspect of the present invention is the intraocular lens inserter according to the sixteenth aspect, wherein the cap member defines an inner surface, the pin is on the inner surface of the cap member, the slot is located on the rotation knob portion and includes a circumferentially extending portion and a distally extending portion having an end connected to the circumferentially extending portion and an open end, and when the rotation knob portion is fully rotated, the pin and the distally extending portion of the slot are aligned.
[0024] An eighteenth aspect of the present invention is an intraocular lens inserter according to any one of the tenth to seventeenth aspects, wherein the lens folding device comprises a slider including an end surface configured to engage the outer edge of the intraocular lens, a hinge, and a lens holder connected to the hinge that extends distally over the intraocular lens optic beyond the outer edge.
[0025] A nineteenth aspect of the present invention is an intraocular lens inserter according to any one of the tenth to eighteenth aspects, wherein the hollow tubular portion defines a circumference and a central axis, and the rotation knob portion extends completely around the circumference of a portion of the hollow tubular portion and is rotatable around the central axis.
[0026] A twentieth aspect of the present invention is the intraocular lens inserter according to the nineteenth aspect, wherein the hollow tubular portion includes a cylindrical wall and at least one longitudinally extending slot extending through the cylindrical wall, the rotation knob portion includes an inner surface with a helical thread, and the lens folding device includes at least one post extending through the at least one longitudinally extending slot into the helical thread.
[0027] A twenty-first aspect of the present invention is an intraocular lens inserter according to the twentieth aspect, wherein the hollow cylindrical portion includes first and second longitudinally extending slots extending through the cylindrical wall, and the lens folding device includes first and second posts extending through the first and second longitudinally extending slots, respectively, into the helical thread.
[0028] A twenty-second aspect of the present invention is an intraocular lens inserter according to any one of the eleventh to twenty-first aspects, further comprising a removable plug that prevents rotation of the rotation knob portion.
[0029] A 23rd aspect of the present invention is the intraocular lens inserter according to the 22nd aspect, wherein the cap member includes a cylindrical wall and an opening therethrough configured to receive a removable plug, the rotation knob portion includes a recess configured to receive a portion of the removable plug, and the cap member, the rotation knob portion, and the plug are constructed and arranged such that the plug prevents rotation of the rotation knob portion when the cap member is secured to the inserter body and the plug is positioned within the opening in the cap member and the recess in the rotation knob portion, respectively.
[0030] A 24th aspect of the present invention is an intraocular lens inserter according to any one of the 10th to 23rd aspects, wherein the plunger lock has a locked state that prevents the plunger from moving in the distal direction and an unlocked state that allows the plunger to move in the distal direction, and wherein the plunger lock transitions from the locked state to the unlocked state by rotation of the rotation knob portion.
[0031] A twenty-fifth aspect of the present invention is the insertion device according to any one of the tenth to twenty-fourth aspects, further comprising an intraocular lens stored in the lens storage area.
[0032] A twenty-sixth aspect of the present invention is a method of inserting an intraocular lens into an eye using an intraocular lens insertion device comprising an inserter body defining an exterior and a lens advancement direction and including a hollow tubular portion, an intraocular lens storage region, a nozzle, and a transition region between the intraocular lens, the inserter body including the intraocular lens storage region and the nozzle, the intraocular lens in the lens storage region, a plunger movable within the inserter body distally in the lens advancement direction relative to the inserter body and including an end face configured to engage and push the intraocular lens, and a rotatable knob portion associated with the exterior of the inserter body as the plunger moves in the distal direction, the method comprising the steps of: folding the intraocular lens without moving the plunger in the distal direction by rotating the rotatable knob portion; and after the intraocular lens is folded, pushing the intraocular lens through the nozzle and into the eye by moving the plunger in the distal direction.
[0033] A 27th aspect of the present invention is an intraocular lens insertion method according to the 26th aspect, wherein the intraocular lens insertion device includes a lens folding device that is movable distally in the lens advancement direction relative to the inserter body and the plunger and configured to fold the intraocular lens during distal movement of the lens folding device, and the rotatable knob portion is operably connected to the lens folding device such that the lens folding device moves distally in the lens advancement direction in response to rotation of the rotatable knob portion.
[0034] A 28th aspect of the present invention is an intraocular lens insertion method according to the 26th or 27th aspect, wherein the intraocular lens insertion device includes a cap member on the inserter body that covers the nozzle, and a cap lock that is locked to prevent the cap member from being removed from the inserter body, and the method further includes the following steps: during the folding step, transitioning the cap lock to an unlocked state that allows it to be removed from the inserter body, and removing the cap member before the pushing step.
[0035] A 29th aspect of the present invention is an intraocular lens insertion method according to any one of the 26th to 28th aspects, wherein the intraocular lens insertion device includes a plunger lock in a locked state that prevents the plunger from moving in a distal direction, and the method further includes a step of transitioning the plunger lock to an unlocked state that allows the plunger to move in the distal direction during the folding step.
[0036] A 30th aspect of the present invention is an intraocular lens insertion method according to any one of the 26th to 29th aspects, wherein the hollow tubular portion defines a circumference and a central axis, the rotatable knob portion extends completely around a portion of the hollow tubular portion and is rotatable around the central axis, and the step of rotating the rotatable knob portion includes the step of rotating the rotatable knob portion around the central axis.
[0037] According to the present invention, excellent convenience and operability can be achieved when using an intraocular lens insertion device.
[0038] Fig. 1 is an external perspective view showing an example of the configuration of an intraocular lens inserter according to one embodiment of the present invention. Fig. 2 is an exploded perspective view showing an example of the configuration of each component of the intraocular lens inserter of Fig. 1. Fig. 3 is a side sectional view showing an example of the internal configuration of the intraocular lens inserter of Fig. 1. Fig. 4 is an explanatory diagram showing an example of a specific aspect when using the intraocular lens inserter of Fig. 1, where (a) is a diagram showing stopper removal, (b) is a diagram showing rotation of a rotation knob portion, and (c) is a diagram showing cap removal. Fig. 5 is an explanatory diagram showing an example of the operation of unlocking the intraocular lens inserter of Fig. 1. Fig. 6 is an explanatory diagram showing an example of the operation of retracting a tacking pin in the intraocular lens inserter of Fig. 1.
[0039] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
[0040] (1) Configuration Example of Intraocular Lens Inserter First, a configuration example of an intraocular lens inserter according to this embodiment will be described.
[0041] (Overall Configuration) The intraocular lens inserter described in this embodiment is used when inserting an intraocular lens into the eye. In this embodiment, an example of an intraocular lens is a one-piece type made of a soft material such as silicone elastomer or soft acrylic, and is configured to have a circular optical section that performs optical functions and a pair of support sections extending from the outer periphery of the optical section. Note that, since intraocular lenses are well known, further description will be omitted here.
[0042] To insert such an intraocular lens into the eye, the intraocular lens inserter described in this embodiment is configured as shown in Figures 1 to 3. In the following description, when describing the relative positional relationships and operating directions of each part of the intraocular lens inserter, as shown in Figure 1, one side of the X-axis direction is defined as the X1 direction, the other side as the X2 direction, one side of the Y-axis direction is defined as the Y1 direction, the other side as the Y2 direction, one side of the Z-axis direction is defined as the Z1 direction, the other side as the Z2 direction, the X1 direction is defined as the leading end (forward), the X2 direction is defined as the trailing end (rear), the Y1 direction is defined as the left side (left), the Y2 direction is defined as the right side (right), the Z1 direction is defined as the upper side (upward), and the Z2 direction is defined as the lower side (downward). Of these, the X-axis direction (X1 direction and X2 direction) corresponds to the length direction of the intraocular lens inserter 1, the Y-axis direction (Y1 direction and Y2 direction) corresponds to the width direction of the intraocular lens inserter 1, and the Z-axis direction (Z1 direction and Z2 direction) corresponds to the height direction of the intraocular lens inserter 1.
[0043] As shown in Figures 1 to 3, the intraocular lens inserter 1 according to this embodiment is broadly composed of an inserter main body 2 and a cap member 3. The inserter main body 2 is composed of at least a body section 10, a slider mechanism section 20, a push-out mechanism section 30, and a lock mechanism section 40. Furthermore, a rotation knob section 50 is attached to the inserter main body 2. Each of these components is preferably formed from a molded product made of a resin material.
[0044] These components will be described in detail below.
[0045] (Body portion) The body portion 10 functions as the trunk portion of the inserter main body 2 and is formed in a hollow cylindrical shape capable of containing an intraocular lens. In other words, the inserter main body 2 has the body portion 10 as a hollow cylindrical portion capable of containing an intraocular lens. More specifically, the body portion 10 has a base portion 11 formed in a cylindrical shape and having an opening at its rear end, a nozzle portion 12 attached to the tip side of the base portion 11 so as to communicate with the interior of the base portion 11, and a flange portion 13 formed near the rear end of the base portion 11. These are all preferably formed from a light-transmitting resin material so that the interior of the cylinder can be seen through.
[0046] The base portion 11 has a lens housing portion 14 provided within its cylinder, which has an intraocular lens installation stand and is configured to accommodate the intraocular lens on the installation stand. By having such a lens housing portion 14 in the body portion 10, the intraocular lens inserter 1 according to this embodiment can function as a preload type in which the intraocular lens is installed in the inserter main body 2 in advance.
[0047] The base portion 11 is provided with an oval slit 15 in a portion thereof (e.g., both left and right side wall portions) extending along the cylindrical axis direction (X-axis direction) of the body portion 10. A slider engagement piece 22 of a slider mechanism 20 (described later) is adapted to engage with this slit 15. Furthermore, the base portion 11 is provided with a guide hole 16 extending along a portion of the circumference of the body portion 10 in a portion other than the slit 15 (e.g., a portion closer to the flange portion 13 than the slit 15). A lock engagement piece 42 of a lock mechanism 40 (described later) is adapted to engage with this guide hole 16. The functions of the slit 15 and the guide hole 16 will be described in detail below. In the following description, the cylindrical axis direction of the body portion 10 may also be simply referred to as the "X-axis direction."
[0048] The nozzle portion 12 is for folding the intraocular lens housed in the lens housing portion 14 in the body portion 10 into a small size and guiding the intraocular lens into the eye when inserting the intraocular lens into the eye. To this end, the nozzle portion 12 has a lens release port 18 for releasing the intraocular lens at its tip side (i.e., the cylindrical end of the body portion 10), and is configured so that the cross-sectional area of the internal space gradually narrows from the body portion 10 side toward the lens release port 18.
[0049] The nozzle part 12 has a transition part 19 at a predetermined position in its internal space for folding the intraocular lens being moved from the lens housing part 14. In other words, the nozzle part 12 is configured to be able to pre-fold the intraocular lens being moved to the transition part 19, which is the predetermined position, by taking advantage of the gradual narrowing of the cross-sectional area of the internal space.
[0050] A tacking pin 71, which will be described later, protrudes into the internal space of the nozzle part 12 through a through-hole (not shown) formed in a part of the nozzle part 12 (for example, the lower side wall part) so as to correspond to the transition part 19, which is a predetermined position. The tacking pin 71 is used to enable proper pre-folding of the intraocular lens (particularly folding of the anterior support part of the intraocular lens).
[0051] The flange portion 13 is provided for the fingers of the operating hand of the person using the intraocular lens inserter 1 (for example, a doctor performing cataract surgery; hereinafter simply referred to as the "operator") to rest on when operating the extrusion mechanism 30. Therefore, the flange portion 13 is not limited to a specific shape or configuration as long as it can ensure the operability of the extrusion mechanism 30.
[0052] (Slider mechanism) The slider mechanism 20 functions as one of the movement mechanisms that move the intraocular lens inside the body 10 along the X-axis direction. That is, the movement mechanism includes the slider mechanism 20 that moves the intraocular lens inside the body 10. More specifically, the slider mechanism 20 is arranged inside the body 10 so as to be movable along the X-axis direction, and is configured to thereby move the intraocular lens housed in the lens housing section 14 to the transition section 19, which is a predetermined position. When the slider mechanism 20 moves the intraocular lens, the intraocular lens is pre-folded in the internal space of the body 10.
[0053] In order to move the intraocular lens, the slider mechanism 20 has a lens support member 21 that applies a pressing force to the intraocular lens for movement, and a slider engagement piece 22 formed to connect to the lens support member 21. The slider engagement piece 22 is formed to protrude outside the cylinder of the body part 10 through the slit hole 15. The slider engagement piece 22 formed in this way is movable along the X-axis direction within the range of the slit hole 15, so that the slider mechanism 20 is configured so that the lens support member 21 moves in conjunction with the slider engagement piece 22, thereby moving the intraocular lens.
[0054] (Push-out mechanism) The push-out mechanism 30 functions as another of the moving mechanisms that move the intraocular lens in the body part 10 along the X-axis direction. That is, the moving mechanism includes the push-out mechanism 30 that pushes the intraocular lens from the lens release port 18. More specifically, the push-out mechanism 30 is configured to press the intraocular lens that has moved to the transition part 19 from the rear end side along the X-axis direction, thereby pushing the intraocular lens from the lens release port 18 of the body part 10 to the outside (for example, into the eye).
[0055] Known examples of the extrusion mechanism 30 that extrudes the intraocular lens to the outside include push-type mechanisms that extrude the intraocular lens by pushing a plunger or the like, screw-type mechanisms that extrude the intraocular lens by rotating a rotating member or the like, and mechanisms that are compatible with both the push-type and screw-type mechanisms. Hereinafter, the present embodiment will be described with reference to an example in which the extrusion mechanism 30 is of the push-type. However, the extrusion mechanism 30 is not limited to the push-type mechanism, and may be of the screw type or compatible with both the push-type and screw-type mechanisms.
[0056] The push-type extrusion mechanism 30 is a movable body that can move along the X-axis direction within the body 10, and is configured to have at least a rod-shaped rod 31 that extends along the X-axis direction and a plunger end 32 provided on the rear end side of the rod 31. A part of the rod 31 and the plunger end 32 are arranged to protrude from the rear end of the body 10, and the other part of the rod 31 is arranged to be contained within the body 10.
[0057] The rod portion 31 is shaped so that the tip side thereof abuts against and presses against the intraocular lens. The pressing force applied to the plunger end 32 is transmitted to the intraocular lens, thereby pushing the intraocular lens out of the body portion 10.
[0058] The plunger end 32 is for an operator to press in. For this purpose, the plunger end 32 is configured in a shape that allows the operator to apply a pressing force to the rear end side of the plunger end 32 with his / her hand.
[0059] In this way, a portion of the rod portion 31 and the plunger end 32 protrude from the rear end of the body portion 10, allowing the operator to perform a pushing operation on them. In other words, the portion protruding from the rear end of the body portion 10 (i.e., the portion of the rod portion 31 and the plunger end 32) functions as an operating member used by the operator to perform a pushing operation. When the operating member is pushed, the protruding portion of the rod portion 31 is pushed into the body portion 10 in conjunction with this, and the tip of the rod portion 31 presses against the intraocular lens inside the body portion 10 to eject it to the outside.
[0060] In the push-out mechanism 30 configured as described above, a rib 33 extending along the X-axis direction is provided on a portion of the rod 31. The function of the rib 33 on the rod 31 will be described in detail below. Furthermore, in the push-out mechanism 30, a slider 34 shaped to fit inside the cylindrical base 11 of the body 10 may be provided on a portion of the rod 31, and an O-ring 35 may seal the gap between the outer circumferential surface of the slider 34 and the cylindrical inner surface of the base 11. This configuration can prevent leakage of the viscoelastic substance (OVD), which will be described later, after filling. Furthermore, the sliding resistance of the O-ring 35 can be used to control the ejection force of the intraocular lens so that it does not become excessive.
[0061] (Locking Mechanism) The locking mechanism 40 is configured to restrict the pushing-out operation of the intraocular lens by the push-out mechanism 30 as needed. The pushing-out operation is restricted by restricting the operation of the operating member (i.e., the plunger end 32 and a portion of the rod 31). In other words, the locking mechanism 40 can restrict the pushing operation of the operating member (hereinafter simply referred to as the "restricted state") and can release the restriction to enable the operating member to be operated (hereinafter simply referred to as the "operable state"). The locking mechanism 40 is configured to be able to switch between the restricted state and the operable state as needed. As a result, for example, in the restricted state, the operating member cannot be pushed in, which restricts the pushing-out operation of the intraocular lens by the push-out mechanism 30. Furthermore, in the operable state, for example, the intraocular lens can be pushed out by the pushing-out operation of the operating member.
[0062] In order to switch between the restricted state and the operable state, the locking mechanism 40 has a locking member 41 disposed inside the body 10 .
[0063] The locking member 41 is contained within the base portion 11 of the body portion 10 so as to be positioned in an area where the guide hole 16 is formed in the base portion 11, and is configured to be rotatable around the cylindrical axis of the body portion 10 within the cylindrical portion of the base portion 11. Furthermore, the locking member 41 is provided with a lock engagement piece 42 that is formed to protrude outside the cylindrical portion of the base portion 11 through the guide hole 16. Because this lock engagement piece 42 is movable within the range of the guide hole 16, a rotational force is applied to the locking member 41 within the cylindrical portion of the base portion 11, and the rotational position is controlled.
[0064] The locking member 41 is configured so that the rod 31 of the push-out mechanism 30 passes through a portion thereof near the center of rotation and so that the relative position in the X-axis direction with respect to the rod 31 can be displaced. Furthermore, the locking member 41 is formed with a guide groove 43 that fits into the rib 33 of the rod 31 and extends along the X-axis direction.
[0065] By using the locking member 41 configured as described above, the locking mechanism 40 switches between a restricted state and an operable state depending on the rotational position of the locking member 41. Specifically, when the locking member 41 is in a rotational position where the rib 33 of the rod portion 31 fits into the guide groove 43 of the locking member 41, the rod portion 31 is displaceable in the X-axis direction, and the operating members including the rod portion 31 are in an operable state. On the other hand, when the locking member 41 is in any other rotational position, the rib of the rod portion 31 does not fit into the guide groove of the locking member 41, and this interference restricts the displacement of the rod portion 31 in the X-axis direction, resulting in the operating members including the rod portion 31 being in the restricted state.
[0066] The locking mechanism 40, which limits the pushing operation of the operating member, is made up of the locking member 41, the locking engagement piece 42 provided on the locking member 41, the rib 33 of the rod 31, and the guide groove 43 of the locking member 41. The guide hole 16 provided in the body 10 may also be included as a component of the locking mechanism 40.
[0067] (Insertor Main Body) The inserter main body 2, which includes the body portion 10, slider mechanism 20, push-out mechanism 30, and lock mechanism 40 described above, is configured so that after the lock mechanism 40 switches from the restricted state to the operable state, the slider mechanism 20 first moves the intraocular lens in the lens housing portion 14 to the transition portion 19, which is a predetermined position, to reliably fold the intraocular lens into a predetermined shape, and then the push-out mechanism 30 further pushes the intraocular lens to fold it even smaller, and in that state, the intraocular lens is released from the lens release port 18 and can be inserted into the eye. In this way, the inserter main body 2 is configured to contain an intraocular lens and to release the contained intraocular lens to the outside from the lens release port 18. The inserter main body 2 then moves the intraocular lens in the lens advancement direction (X-axis direction) in two stages, first via the slider mechanism 20 and then the push-out mechanism 30, so that the intraocular lens can be folded into a predetermined shape and released to the outside.
[0068] In addition, with regard to the body portion 10, slider mechanism portion 20 and push-out mechanism portion 30 that constitute the inserter main body 2, apart from the points described here, they may be constructed using publicly known technology (see, for example, Patent Publication No. 5413918, Patent Publication No. 6276619, etc.).
[0069] (Rotating Knob) The rotating knob 50 is attached to the inserter main body 2 so as to be rotatable around the X-axis (i.e., circumferential direction) of the body 10. The rotating knob 50 can be rotated manually by an operator. Note that the rotating knob 50 is rotatable around the X-axis relative to the body 10, but does not move in the X-axis direction. The specific configuration (mechanism) for making the rotating knob 50 rotatable may be any one realized using known technology, and is not limited to a specific embodiment.
[0070] The rotation knob portion 50 is formed in a cylindrical shape for attachment to the inserter body 2. A slider engagement groove 51 and a lock engagement groove 52 are provided inside the cylinder.
[0071] The slider engagement groove 51 is a concave groove formed on the cylindrical inner surface of the rotary knob portion 50 and is configured to engage with the slider engagement piece 22 of the slider mechanism portion 20 (particularly, the portion of the body portion 10 that protrudes outward from the cylinder). More specifically, the slider engagement groove 51 is formed to extend spirally in the X-axis direction, and has a groove width and depth that allow the slider engagement piece 22 to move along the groove when fitted in the groove. When the slider engagement piece 22 is fitted into such a slider engagement groove 51, the rotary knob portion 50 and the slider mechanism portion 20 are engaged with each other. As a result, the slider mechanism portion 20 moves the intraocular lens in conjunction with the rotation of the rotary knob portion 50, as will be described in detail below.
[0072] Similar to the slider engagement groove 51, the lock engagement groove 52 is a recessed groove formed on the cylindrical inner surface of the cap member 3. However, unlike the slider engagement groove 51, the lock engagement groove 52 is configured to engage with the lock engagement piece 42 of the lock mechanism 40 (particularly, the portion of the body 10 that protrudes outward from the cylinder). More specifically, the lock engagement groove 52 is formed to extend partially around the X-axis of the body 10 (i.e., the circumferential direction), and is formed with a groove width and depth that allow the lock engagement piece 42 to move along the groove when fitted in the groove. When the lock engagement piece 42 is fitted into the lock engagement groove 52, the rotary knob 50 and the lock member 41 of the lock mechanism 40 engage with each other. As a result, as will be described in detail later, the lock engagement piece 42 moves within the groove of the lock engagement groove 52 in conjunction with the rotation of the rotating knob portion 50, and the lock member 41 of the lock mechanism portion 40 rotates according to the movement position, thereby switching between a restricted state and an operable state by the lock mechanism portion 40.
[0073] Furthermore, the rotary knob 50 has a fitting portion 53 on the tip side (X1 side) of the body 10 that fits into an opening of the cap member 3, which will be described later. The fitting portion 53 is provided with a cap engagement groove 54.
[0074] The cap engagement groove 54 is a recessed groove formed on the outer peripheral surface of the fitting portion 53 and is configured to engage with a knob engagement piece (not shown) of the cap member 3, which will be described later. More specifically, the cap engagement groove 54 includes a rotational groove 55 extending in a portion of the circumferential direction of the outer peripheral surface of the fitting portion 53, and an insertion / removal groove 56 extending linearly from one end of the rotational groove 55 along the X-axis direction to the edge of the rotatable knob portion 50. The rotational groove 55 and the insertion / removal groove 56 are formed with groove widths and depths that allow the knob engagement piece to move along the grooves when fitted into the grooves. The knob engagement piece of the cap member 3 engages with the rotational groove 55 and the insertion / removal groove 56, which form the cap engagement groove 54, thereby engaging the cap member 3 and the rotatable knob portion 50 in the attached state. As a result, as will be described in detail below, when the rotation knob portion 50 is in a predetermined rotation position, the cap member 3 becomes detachable from the inserter main body 2, and the cap member 3 can be removed from the body portion 10 along the axial direction of the body portion 10.
[0075] (Cap Member) The cap member 3 is attached to the body portion 10 of the inserter main body 2 so as to cover the side of the lens ejection port 18 of the inserter main body 2. More specifically, the cap member 3 is formed in a cylindrical shape with an opening at at least one end and is configured to fit into the fitting portion 53 of the rotary knob portion 50 attached to the body portion 10 through the opening at that end. For example, if the outer shapes of the fitting portion 53 of the body portion 10 and the rotary knob portion 50 are circular in cross section, the cap member 3 is formed in a cylindrical shape that fits into the fitting portion 53. The fitting depth of the cap member 3 relative to the fitting portion 53 (i.e., the cylindrical length within which the fitting portion 53 can fit) is set so that it reaches at least the position where the cap engagement groove 54 is formed in the fitting portion 53 and can cover it. Note that as long as the cap member 3 has an opening at at least one end, the other end may be open or sealed. In the following description, a cap member 3 configured with the other end sealed will be used as an example.
[0076] The cap member 3 is configured to have one end open and the other end sealed, so that when attached to the body portion 10 (hereinafter sometimes simply referred to as the "attached state"), it can seal at least the lens release port 18 of the inserter main body 2. As a result, when the cap member 3 is attached, the lens release port 18 of the inserter main body 2 is protected from external forces even when the inserter main body 2 is not stored in a case or the like. In addition, because the lens release port 18 is covered by the cap member 3, it is also very useful in preventing foreign matter from entering the body portion 10 of the inserter main body 2.
[0077] The cap member 3 attached to the body portion 10 is configured so that the operator can manually remove it from the body portion 10. In other words, the cap member 3 is configured so that it can be attached and detached to and from the body portion 10. However, as will be described in detail later, the cap member 3 can be attached and detached to and from the inserter main body 2 only when the rotation knob portion 50 is in a predetermined rotation position.
[0078] The cap member 3 is also provided with a knob engagement piece and a tacking assist portion 70 .
[0079] The knob engagement piece is formed on the cylindrical inner surface of the cap member 3 so as to protrude toward the center of the cylindrical axis of the cap member 3. The knob engagement piece formed in this manner is movable within the cap engagement groove 54 in the fitting portion 53 of the rotatable knob portion 50, so that the cap member 3 can be attached and detached when the rotatable knob portion 50 is in a predetermined rotation position, but attachment and detachment to and from the inserter main body 2 is restricted when the rotatable knob portion 50 is in a rotation position other than the predetermined rotation position.
[0080] The tacking assisting unit 70 uses a tacking pin 71 to assist in pre-folding of the intraocular lens so that the slider mechanism 20 can properly perform the pre-folding. For this purpose, the tacking assisting unit 70 is configured to have a tacking pin 71, a pin support unit 72, and a guide unit 73 attached to the cap member 3.
[0081] The tacking pin 71 is arranged so as to protrude into the cylinder of the body part 10 through a through-hole (not shown) of the nozzle part 12 when the cap member 3 is attached. By having the tacking pin 71 protrude into the cylinder of the body part 10, the posture of a part of the intraocular lens (for example, the support part on the front side) in the body part 10 is controlled by abutment with the tacking pin 71 when the intraocular lens is moved by the slider mechanism part 20, thereby ensuring appropriate pre-folding.
[0082] The pin support portion 72 is rod-shaped and supports the tacking pin 71. The tip of the rod supports the tacking pin 71, and the rod-shaped portion is configured to be elastically deformable. As a result, the tacking pin 71 supported by the pin support portion 72 is arranged to protrude into the cylindrical body portion 10 when the cap member 3 is attached, but when the cap member 3 is removed from the body portion 10, the tacking pin 71 is retracted from the cylindrical body portion 10 due to the elastic deformation of the pin support portion 72.
[0083] The guide portion 73 is formed by an inclined surface provided on the rod-shaped tip side of the pin support portion 72, and causes elastic deformation of the pin support portion 72 in response to relative movement in the X-axis direction when the cap member 3 is removed from the body portion 10. In other words, the guide portion 73 guides the tacking pin 71 to retract by using the inclined surface that causes deformation in the pin support portion 72.
[0084] The tacking assist portion 70, which is composed of the tacking pin 71, the pin support portion 72, and the guide portion 73, is provided as a part of the cap member 3. However, the tacking assist portion 70 may be formed as a separate piece from the main body portion that forms the outer shape of the cap member 3.
[0085] As shown in FIGS. 1 and 2, the cap member 3 having the above-described structure is preferably provided with a stopper member 4 in addition to the above-described structure.
[0086] The stopper member 4 is formed in a shape that fits into dedicated through-holes 4a, 4b provided on both the attached cap member 3 and the body portion 10 of the inserter main body 2 to which the cap member 3 is attached. The stopper member 4 is also configured so that it can be removed from the fitted state in the through-holes 4a, 4b by holding it with one hand and pulling it out.
[0087] If the stopper member 4 having such a configuration is provided, the following functions are realized when the cap member 3 is attached.
[0088] For example, when the stopper member 4 is fitted into the through-holes 4a and 4b, it protrudes into the internal space of the body portion 10, thereby functioning to prevent misalignment of the intraocular lens (unintended movement of the intraocular lens) in the lens housing portion 14 within the body portion 10. The stopper member 4 is not limited to a specific shape or configuration, as long as it is configured to achieve the above-mentioned function. The stopper member 4 may be provided with a through-hole (not shown) that communicates the inside and outside of the body portion 10 when fitted into the through-holes 4a and 4b. If a through-hole is provided, a viscoelastic substance (OVD) such as sodium hyaluronate can be injected into the internal space of the body portion 10 through the through-hole. In this case, the through-hole is preferably tapered to facilitate the introduction of an OVD injection needle and facilitate the injection operation. However, the OVD injection may be performed by other methods than using the through-hole in the stopper member 4.
[0089] (2) Usage of Intraocular Lens Inserter Next, an example of a specific usage of the intraocular lens inserter 1 having the above-described configuration will be described with reference to FIGS.
[0090] When using the intraocular lens inserter 1, the intraocular lens inserter 1 is supplied sealed in a sterilized bag. Hereinafter, the state in which the intraocular lens inserter 1 is stored in a sterilized bag, or the state in which the intraocular lens inserter 1 has been removed from the sterilized bag without any operations being performed, will be referred to as the initial state before use. Note that the initial state of the intraocular lens inserter 1 is one in which the inserter body 2 already contains an intraocular lens. However, this is not limited to this, and an intraocular lens may be placed in the inserter body 2 in conjunction with or before the OVD injection, which will be described later, for an inserter body 2 that does not yet contain an intraocular lens.
[0091] In the initial state of the intraocular lens inserter 1, the cap member 3 is attached to the body portion 10 of the inserter main body 2, and the stopper member 4 is fitted to these. Therefore, in the initial state, the stopper member 4 restricts movement of the relative positions of the inserter main body 2 and the cap member 3, and therefore the cap member 3 cannot be removed from the inserter main body 2.
[0092] Furthermore, in the initial state of the intraocular lens inserter 1, the lens pushing-out operation is limited by the locking mechanism 40. Specifically, the rotational position of the locking member 41 constituting the locking mechanism 40 within the base 11 is set so that the operating member (i.e., the plunger end 32 and a portion of the rod 31) is in a restricted state. This rotational position is a position where the rib 33 of the rod 31 and the guide groove 43 of the locking member 41 interfere with each other without engaging with each other. More specifically, this position is a position where the locking engagement piece 42 provided on the locking member 41 is positioned within the guide hole 16 of the base 11 and is offset toward one end of the guide hole 16. By arranging the locking member 41 and the locking engagement piece 42 in this rotational position, the locking mechanism 40 places the operating member in a restricted state. Therefore, even when the cap member 3 does not entirely cover the inserter main body 2 and the operating member protrudes from the rear end of the body 10, the pushing operation of the operating member is limited. That is, there is no risk of the operating member being pressed in by mistake.
[0093] These facts mean that, in the initial state, if the cap member 3 is attached, there is no need for a case to house the entire intraocular lens inserter 1. In other words, the cap member 3 can be used as a substitute for the case. This makes it possible to simplify the configuration of the intraocular lens inserter 1, which is desirable in terms of lowering product costs through the reduction in resin material that accompanies simplification, and is also desirable in terms of environmental issues such as waste plastic.
[0094] When using such an intraocular lens inserter 1, that is, when inserting an intraocular lens into the eye using the intraocular lens inserter 1, first, the OVD is injected into the internal space of the body portion 10 that houses the intraocular lens, for example, by using the through-hole of the stopper member 4 to fill the internal space. This is one of the preparatory steps required for using the intraocular lens inserter 1.
[0095] After the OVD is filled, the stopper member 4 is removed by manually pulling it out as shown in FIG. 4(a) (see arrow A in the figure).
[0096] This releases the stopper member 4 from restricting the positional displacement of the intraocular lens inside the body portion 10. Therefore, the intraocular lens inside the body portion 10 can be expelled to the outside by the pushing operation of the pushing mechanism portion 30. This, along with the injection of the OVD, is one of the preparatory steps required for use of the intraocular lens inserter 1.
[0097] Even if the stopper member 4 is removed, the cap member 3 cannot be immediately removed from the inserter body 2 by pulling it out linearly along the X-axis direction. This is because the movement of the cap member 3 in the X-axis direction is restricted by the engagement between the knob engagement piece of the cap member 3 and the cap engagement groove 54 of the fitting portion 53 of the rotation knob portion 50.
[0098] After removing the stopper member 4, the rotary knob 50 is then rotated by hand in one direction (e.g., counterclockwise when viewed from the tip) as shown in Figure 4(b) (see arrow B in the figure). Note that during rotation, the rotary knob 50 does not move in the X-axis direction. In other words, the rotation around the cylindrical axis of the body 10 and the movement in the X-axis direction (the cylindrical axis direction of the body 10) represent different actions, and are not performed simultaneously.
[0099] At this time, the slider engagement piece 22 of the slider mechanism 20 protrudes from the slit hole 15 of the body part 10 of the inserter main body 2 to the outside of the cylinder of the body part 10 through the slit hole 15. The protruding portion of the slider engagement piece 22 engages with the slider engagement groove 51 of the rotary knob part 50 so as to be positioned within the groove of the slider engagement groove 51. Therefore, the slider engagement piece 22 is movable within the opening range of the slit hole 15, and the slider engagement groove 51 that engages with the slider engagement piece 22 extends spirally, so that when the rotary knob part 50 rotates, the engagement position of the slider engagement piece 22 with the slider engagement groove 51 is guided by the slit hole 15 and gradually moves toward the tip side.
[0100] As a result, inside the body 10, the slider mechanism 20 moves the intraocular lens in conjunction with the rotation of the rotary knob 50. The rotary knob 50 continues to rotate until the slider mechanism 20 moves the intraocular lens from the lens housing section 14 to the transition section 19. In other words, the shapes and positions (particularly the groove end positions) of the slit hole 15 in the body 10 and the slider engagement groove 51 in the rotary knob 50 are set so that the intraocular lens reaches the transition section 19 in conjunction with the rotation of the rotary knob 50. In this way, when the slider mechanism 20 moves the intraocular lens in conjunction with the rotation of the rotary knob 50, the movement speed of the intraocular lens depends on the number of rotations of the rotary knob 50. This means that the movement speed of the intraocular lens by the slider mechanism 20 can be adjusted by setting the number of rotations of the rotary knob 50. Similarly to setting the number of rotations, the moving speed of the intraocular lens can also be adjusted by setting the slider engagement groove 51 (for example, by setting the helical pitch).
[0101] When the intraocular lens moves to the transition section 19, the cap member 3 is in an attached state, and the tacking pin 71 of the tacking assist section 70 provided on the cap member 3 protrudes into the cylindrical body section 10. Moreover, even if the rotation knob section 50 rotates, the protruding position of the tacking pin 71 into the body section 10 does not change. Therefore, when the intraocular lens reaches the transition section 19, the posture of the intraocular lens is controlled by the abutment between the intraocular lens and the tacking pin 71. In other words, the tacking pin 71 can ensure appropriate pre-folding of the intraocular lens.
[0102] Furthermore, in the initial state before the rotary knob 50 is rotated, the lens pushing-out operation is restricted by the locking mechanism 40. Specifically, the rotational position of the locking member 41 within the base 11 is set so that the operating member is in the restricted state, and the lock engagement piece 42 is positioned toward one end of the guide hole 16. At this time, as shown in FIG. 5 , the tip of the lock engagement piece 42 protrudes outside the barrel of the base 11 through the guide hole 16. However, even though the lock engagement piece 42 protrudes outside the barrel of the base 11, the protruding portion of the lock engagement piece 42 is engaged with the lock engagement groove 52 of the rotary knob 50 so as to be positioned within the lock engagement groove 52. Therefore, even though the lock engagement piece 42 protrudes outside the barrel of the base 11, the presence of the lock engagement groove 52 does not hinder rotation of the rotary knob 50 from the initial state.
[0103] However, as the rotary knob 50 continues to rotate, one end of the lock engagement groove 52 reaches the position of the lock engagement piece 42, and further rotation of the rotary knob 50 causes one end of the lock engagement groove 52 to apply a pressing force to the lock engagement piece 42. As a result, the lock engagement piece 42 moves while being guided by the guide hole 16. As the lock engagement piece 42 moves, the lock member 41 of the lock mechanism 40 rotates within the base 11. In other words, in conjunction with the rotation of the rotary knob 50, the lock member 41 of the lock mechanism 40 also rotates in the same direction as the rotary knob 50.
[0104] 5, the locking member 41 rotates until the guide groove 43 formed in the locking member 41 moves and reaches the position where the rib 33 is formed on the rod portion 31 that passes through the locking member 41. When the guide groove 43 reaches the rib 33, they are positioned so that they can fit together. This causes the locking mechanism 40 to switch the state of the operating member from the restricted state to the operable state.
[0105] It is preferable that such state switching by the locking mechanism 40 (i.e., the arrival of the guide groove 43 at the rib 33 as the locking member 41 rotates) be timed to coincide with the timing of the intraocular lens reaching the transition portion 19. In other words, the shapes and formation positions (particularly the groove end positions) of the guide hole 16 in the body portion 10 and the lock engagement groove 52 in the rotary knob portion 50 are set so that the guide groove 43 reaches the rib 33 as the locking member 41 rotates in conjunction with the rotation of the rotary knob portion 50, coinciding with the arrival of the intraocular lens at the transition portion 19, thereby switching the state of the locking mechanism 40 from the restricted state to the operable state.
[0106] When the locking mechanism unit 40 switches from a restricted state to an operable state, the restriction imposed by the locking mechanism unit 40 is released, and the plunger end 32 and rod unit 31 that constitute the pushing mechanism unit 30 become movable along the X-axis direction.
[0107] Furthermore, as the rotary knob portion 50 rotates, the knob engagement piece of the cap member 3 moves within the rotation direction groove 55 in the fitting portion 53 of the rotary knob portion 50, and reaches the formation position of the insertion / removal direction groove 56. As a result, the knob engagement piece of the cap member 3 becomes movable in the X-axis direction within the insertion / removal direction groove 56, and the movement restriction imposed by the engagement with the cap engagement groove 54 is released, allowing the cap member 3 to be removed from the body portion 10.
[0108] In other words, when the rotatable knob portion 50 rotates to a position (hereinafter referred to as the "predetermined rotation position") where the guide groove 43 of the locking member 41 reaches the rib 33 of the rod portion 31 and the knob engagement piece of the cap member 3 reaches the insertion / removal direction groove 56 of the rotatable knob portion 50, the cap member 3 becomes detachable from the body portion 10 at that predetermined rotation position and can be removed from the body portion 10.
[0109] After the intraocular lens reaches the transition section 19, the restriction imposed by the locking mechanism section 40 is released, and the cap member 3 can be removed, the attached cap member 3 is then manually pulled out toward the tip side, as shown in Figure 4 (c), to remove the cap member 3 from the inserter body 2 (see arrow C in the figure).
[0110] When the cap member 3 is removed, the relative positions of the cap member 3 and the inserter main body 2 change. This change in relative position causes elastic deformation of the pin support portion 72 in the tacking assist portion 70 attached to the cap member 3, as shown in FIG. 6 . Specifically, the change in relative position causes the guide portion 73 to abut against the side wall surface of a through hole (not shown) provided corresponding to the tacking pin 71, and as the guide portion 73 moves further, it is pressed along the inclined surface, thereby elastically deforming the pin support portion 72 in a direction in which the tacking pin 71 retracts from the cylindrical interior of the body portion 10. Therefore, even if the tacking pin 71 protrudes into the cylindrical interior of the body portion 10, the tacking pin 71 retracts from the cylindrical interior of the body portion 10 due to elastic deformation of the pin support portion 72, and therefore does not interfere with the removal operation of the cap member 3.
[0111] As described above, in this embodiment, the operator performs two steps of operations with different directions on the intraocular lens inserter 1 in the initial state: rotating the rotary knob unit 50 and removing the cap member 3. These operations may be performed consecutively as a series of operations (i.e., as one continuous step), or may be performed at their own timing (e.g., with a time lag). In either case, by performing these operations, it becomes possible to operate the slider mechanism unit 20 in conjunction with the operation of the rotary knob unit 50.
[0112] Furthermore, in this embodiment, when the intraocular lens inserter 1 is in its initial state, the operator can perform two operations with different directions, namely, rotating the rotary knob portion 50 and removing the cap member 3, which releases the restriction imposed by the locking mechanism portion 40 in conjunction with the operation of the rotary knob portion 50, thereby switching the state of the operating member from a restricted state to an operable state.
[0113] As a result, it becomes possible to perform a pushing operation of the operating member after removing the cap member 3. Then, when the operating member is pushed, the pushing mechanism 30 pushes out the intraocular lens, and the intraocular lens is released from the lens release port 18.
[0114] At this time, because the slider mechanism 20 is interlocked with the operation of the rotary knob 50, the intraocular lens pushed out by the push-out mechanism 30 is one that has been pre-folded by the slider mechanism 20. Therefore, by simply pressing the operating member after removing the cap member 3, the intraocular lens can be released from the lens release port 18 in a small folded state, thereby preventing improper folding when the intraocular lens is released. In other words, because the rotary knob 50 and the slider mechanism 20 are interlocked, the intraocular lens can be successfully released from the lens release port 18 by simply pressing the operating member.
[0115] Furthermore, the operation of the rotary knob 50 is linked not only to the slider mechanism 20 but also to the state switching of the operating member. Specifically, when the operating member is in an operable state, the rib 33 of the rod 31 is guided by the guide groove 43 of the locking member 41, thereby enabling the rod 31 to move along the X-axis direction and push out the intraocular lens. At this time, the rod 31 is prevented from rotating relative to the body 10 by the presence of the rib 33, and always contacts the intraocular lens in a fixed position. Therefore, even when the intraocular lens is pushed out by pressing with the tip of the rod 31, a stable pushing operation in a fixed position is possible, which also contributes to the satisfactory release of the intraocular lens from the lens release port 18.
[0116] (3) Effects of this Embodiment According to this embodiment, one or more of the following effects can be obtained.
[0117] (a) In the intraocular lens inserter 1 according to this embodiment, the slider mechanism 20 moves the intraocular lens in conjunction with the rotation of the rotary knob 50. However, the movement of the intraocular lens is not linked to the attachment and detachment of the cap member 3 (i.e., movement in the X-axis direction). Therefore, a user of the intraocular lens inserter 1 (such as a physician) must perform the rotation of the rotary knob 50 (i.e., pre-folding the intraocular lens) and the removal of the cap member 3 as two steps with different directions of movement. These steps may be performed consecutively (i.e., as one continuous step) or at separate times (e.g., with a time lag). For example, this can accommodate cases where a user finds it cumbersome to set up the intraocular lens inserter 1 after completing a pre-insertion procedure (such as crystalline lens removal) and therefore prefers to keep the intraocular lens folded in advance. In other words, this intraocular lens inserter 1 is extremely convenient for users. Furthermore, because the rotation knob portion 50 of the intraocular lens inserter 1 according to this embodiment is located near the cap member 3, it is possible to prevent the user's operability of the intraocular lens inserter 1 from being impaired. Moreover, unlike, for example, when folding a lens by pulling out a cap, there is no risk of the intraocular lens being impacted or damaged by the user's operation, and the user does not need to take any special precautions when operating the intraocular lens. As described above, the intraocular lens inserter 1 according to this embodiment can achieve excellent convenience and operability.
[0118] (b) In the intraocular lens inserter 1 according to this embodiment, the cap member 3 is attached to the body portion 10 of the inserter main body 2 so as to cover the lens release port 18 side. Removing the cap member 3 from the body portion 10 enables the intraocular lens inserter 1 to be used (i.e., to release the intraocular lens from the lens release port 18). Therefore, compared to when the intraocular lens inserter 1 needs to be removed from a case housing the entire device, simply removing the cap member 3 is sufficient. This eliminates the inconvenience to the operator using the intraocular lens inserter 1 (e.g., a physician performing cataract surgery), resulting in superior operability (convenience) for the operator. Furthermore, covering the lens release port 18 side with the cap member 3 ensures minimal protection while simplifying the configuration compared to a case housing. This simplification reduces the amount of resin material used, which is advantageous in terms of reducing product costs and also in terms of environmental issues such as waste plastic. In other words, this embodiment allows the intraocular lens inserter 1 to achieve superior convenience through a simplified configuration.
[0119] (c) The intraocular lens inserter 1 according to this embodiment is configured so that the rotation knob portion 50 is rotatable around the cylindrical axis of the body portion 10, and the cap member 3 is detachable from the body portion 10 at a predetermined rotation position. In other words, when the cap member 3 is attached, it cannot be removed from the body portion 10 by simply pulling the cap member 3 in the X-axis direction. However, by rotating the rotation knob portion 50 to a predetermined rotation position, it can be removed from the body portion 10. Therefore, according to this embodiment, when the inserter main body 2 is partially protected by the cap member 3, it is possible to achieve excellent operability (convenience) for the operator using the intraocular lens inserter 1 while ensuring the necessary and sufficient protective function.
[0120] (d) In the intraocular lens inserter 1 according to this embodiment, the rotary knob portion 50 and the slider mechanism portion 20 of the inserter main body 2 are interlocked, and the slider mechanism portion 20 moves the intraocular lens in response to rotation of the rotary knob portion 50. Therefore, when the rotary knob portion 50 is rotated to remove the cap member 3, the intraocular lens in the body portion 10 moves to the transition portion 19, which is a predetermined position. In other words, when using the intraocular lens inserter 1, by performing the series of operations of rotating the rotary knob portion 50 and removing the cap member 3 as one continuous step, it is possible to insert an intraocular lens into the eye using the inserter main body 2. Therefore, for the operator using the intraocular lens inserter 1, the operability (convenience) is significantly superior to that of an intraocular lens inserter housed in a case, and use is not cumbersome. Furthermore, because the slider mechanism 20 is operated by rotating the rotary knob 50, unlike when the operator directly operates the slider mechanism 20 to move it in a linear manner, the possibility of an operator making an operational error can be reduced, which is preferable in terms of preventing the intraocular lens from being folded improperly. More specifically, when the operator directly operates the slider mechanism 20 to move it in a linear manner, depending on the operation method, an unintended usage mode may occur, or the usage mode itself may vary (it is difficult to perform the exact same operation every time), which may result in a negative impact on the lens release performance. However, according to this embodiment, the operator does not need to directly operate the slider mechanism 20, which reduces operational errors, variation in usage mode, and the like.
[0121] (e) The intraocular lens inserter 1 according to this embodiment is configured to interlock the rotary knob unit 50 and the slider mechanism unit 20 by utilizing the engagement between the slider engagement groove 51 formed on the cylindrical inner surface of the rotary knob unit 50 and the slider engagement piece 22 of the slider mechanism unit 20. In other words, the interlocking of the rotary knob unit 50 and the slider mechanism unit 20 can be achieved with a very simple configuration. Therefore, this embodiment is very preferable in terms of achieving excellent operability (convenience) with a simplified configuration.
[0122] (f) In the intraocular lens inserter 1 according to this embodiment, a tacking pin 71 is attached to the cap member 3, and is arranged so that the tacking pin 71 protrudes into the cylindrical body portion 10 of the inserter main body 2 when the cap member 3 is attached. Therefore, when moving the intraocular lens within the cylindrical body portion 10, the tacking pin 71 can be used to ensure appropriate pre-folding of the intraocular lens. Moreover, the tacking pin 71 only needs to be provided in association with the cap member 3, and does not need to be provided as a component separate from the inserter main body 2 and the cap member 3, so the configuration of the intraocular lens inserter 1 is not complicated.
[0123] Furthermore, when the cap member 3 is removed from the body portion 10 of the inserter main body 2, the tacking pin 71 attached to the cap member 3 is retracted from the cylindrical interior of the body portion 10 due to elastic deformation of the pin support portion 72. Therefore, the tacking pin 71 does not interfere with the removal operation of the cap member 3, and the cap member 3 can be easily removed from the body portion 10 of the inserter main body 2. In this respect, too, the intraocular lens inserter 1 offers excellent operability (convenience) for the operator.
[0124] As described above, according to this embodiment, the tacking pin 71 can be used to properly pre-fold the intraocular lens, while still achieving excellent convenience for the intraocular lens insertion device 1 with a simplified configuration.
[0125] (g) In the intraocular lens inserter 1 according to this embodiment, the intraocular lens pushing-out operation by the pushing-out mechanism 30 of the inserter main body 2 is restricted by the locking mechanism 40. Therefore, even if the cap member 3 does not cover the entire inserter main body 2 and a part of the rod portion 31 and the plunger end 32 that constitute the pushing-out mechanism 30 are exposed, the lens pushing-out operation by the pushing-out mechanism 30 is restricted, and the lens pushing-out operation will not be performed by mistake.
[0126] Furthermore, the locking mechanism 40 is configured to release the restriction on the pushing-out operation by the pushing-out mechanism 30 in conjunction with the rotation of the rotating knob 50. Therefore, when using the intraocular lens inserter 1, simply rotating the rotating knob 50 releases the restriction by the locking mechanism 40, meaning that the restriction is released in one step of operating the rotating knob 50, eliminating the need to perform a separate operating step to release the restriction.
[0127] As described above, according to this embodiment, the restriction by the locking mechanism 40 and the release of that restriction are linked to the cap member 3, which provides excellent operability (convenience) for the operator using the intraocular lens insertion device 1.
[0128] (4) Modifications, etc. Although the embodiments of the present invention have been described above, the above disclosure shows exemplary embodiments of the present invention. In other words, the technical scope of the present invention is not limited to the exemplary embodiments described above, and various modifications are possible within the scope of the gist of the present invention.
[0129] In the above embodiment, the inserter main body 2 includes the slider mechanism 20 and the locking mechanism 40, but the present invention is not limited to this. That is, the inserter main body 2 can release the intraocular lens as long as it includes at least the body 10 and the push-out mechanism 30. In this case, if the cap member 3 is detachably attached to the inserter main body 2, the excellent convenience of the intraocular lens inserter 1 can be achieved with a simplified configuration.
[0130] Furthermore, in the above embodiment, the extrusion mechanism 30 that releases the intraocular lens is of a push type that pushes out the intraocular lens by pushing the plunger end 32, etc., but the present invention is not limited to this. For example, the extrusion mechanism 30 is not limited to the push type, but may be of a screw type, or may be compatible with both the push type and the screw type.
[0131] In the above embodiment, when the slider mechanism 20 is provided, an example has been given in which the rotary knob 50 and the slider mechanism 20 are configured to move in conjunction with each other, but the present invention is not limited to this. For example, the slider mechanism 20 may be configured to move the intraocular lens independently of the rotary knob 50. However, if the rotary knob 50 and the slider mechanism 20 are moved in conjunction with each other as in the above embodiment, the operability (convenience) is excellent, which is preferable in terms of preventing the intraocular lens from being folded improperly.
[0132] In the above embodiment, when the rotary knob unit 50 and the slider mechanism unit 20 are interlocked, the interlocking is achieved by the engagement between the slider engagement piece 22 and the slider engagement groove 51. However, the present invention is not limited to this. For example, the interlocking between the slider mechanism unit 20 and the rotary knob unit 50 may be achieved by other configurations, mechanisms, etc.
[0133] Furthermore, in the above-described embodiment, an example was given in which the slider mechanism 20, which functions as one of the movement mechanisms, is linked to the rotation of the rotary knob 50, but the present invention is not limited to this. For example, the push-out mechanism 30, which functions as another of the movement mechanisms, may be configured to be linked to the rotation of the rotary knob 50. In other words, the present invention is only required to be configured such that the movement mechanism that moves the intraocular lens inside the body 10 is linked to the rotation of the rotary knob 50.
[0134] In the above embodiment, when the locking mechanism 40 is provided, the locking mechanism 40's restriction and release are linked to the rotary knob 50. However, the present invention is not limited to this. For example, the locking mechanism 40 may be configured to restrict and release the restriction independently of the rotary knob 50. In this case, the locking mechanism 40 may be configured to restrict and release the restriction in conjunction with, for example, another operating means operable by the operator of the intraocular lens insertion device 1. This means that the locking mechanism 40, which corresponds to the state switching of the operating member, does not necessarily require the rotary knob 50, and may be configured to restrict the extrusion operation of the extrusion mechanism 30 even without the rotary knob 50.
[0135] Furthermore, in the above embodiment, when the lock mechanism 40 and the rotary knob 50 are interlocked, the interlocking is achieved by the engagement between the lock engagement piece 42 and the lock engagement groove 52, but the present invention is not limited to this. For example, the interlocking between the lock mechanism 40 and the rotary knob 50 may be achieved by other configurations, mechanisms, etc.
[0136] Furthermore, in the above-described embodiment, the locking mechanism 40 includes a locking member 41 that is rotatable about the cylindrical axis of the body 10, and when the locking member 41 rotates to a predetermined rotational position, the locking mechanism 40 switches from a restricted state to an operable state. However, the present invention is not limited to this. For example, if the rod 31 of the push-out mechanism 30 is configured to be rotatable about the cylindrical axis of the body 10, a lock engagement piece 42 may be provided on the rod 31, and the state may be switched between the restricted state and the operable state depending on the rotational position of the rod 31. In this case, the locking member 41 is not required, thereby simplifying the configuration of the locking mechanism 40. However, a configuration that includes the locking member 41 allows the rod 31 to perform a stable push-out operation with the intraocular lens in a fixed position without rotating, which is highly preferable for successfully releasing the intraocular lens.
[0137] Furthermore, in the above embodiment, the locking mechanism 40 restricts and releases the restriction by utilizing the rotation of the locking member 41 and whether the rib 33 of the rod 31 and the guide groove 43 of the locking member 41 engage with or interfere with each other, but the present invention is not limited to this. For example, the restriction and release of the restriction by the locking mechanism 40 may be achieved by other configurations or mechanisms. For example, one such mechanism is a so-called latch mechanism that restricts by abutting against a protrusion and releases the restriction by passing over the protrusion.
[0138] In the above embodiment, the components of the intraocular lens inserter 1 are described as being formed from molded resin parts, but the present invention is not limited to this and the components may be formed from metal parts such as stainless steel or titanium.
[0139] In the above embodiment, the tacking pin 71 is retracted by elastic deformation of the pin support portion 72, but the present invention is not limited to this. For example, the deformation for retracting the tacking pin 71 may be plastic deformation.
[0140] (5) Technical Ideas in This Specification Taking into account the contents of the embodiments described above, it can be said that this specification discloses the following technical ideas.
[0141] [Supplementary Note 1] An intraocular lens inserter comprising: an inserter body having a hollow cylindrical portion capable of containing an intraocular lens, and configured to be able to release the intraocular lens contained in the hollow cylindrical portion to the outside through a lens release port; a movement mechanism portion that moves the intraocular lens inside the hollow cylindrical portion along the cylindrical axis direction of the hollow cylindrical portion; a rotation knob portion attached to the inserter body so as to be rotatable around the cylindrical axis of the hollow cylindrical portion; and a cap member attached to the inserter body so as to cover at least the lens release port, wherein the movement mechanism portion moves the intraocular lens in conjunction with rotation of the rotation knob portion, and the cap member is configured to be detachable from the inserter body when the rotation knob portion is in a predetermined rotation position.
[0142] [Appendix 2] The intraocular lens insertion device described in Appendix 1, wherein the moving mechanism has an engaging piece that protrudes outside the hollow cylindrical portion, and the engaging piece engages with an engaging groove formed in the rotating knob portion, thereby linking the rotating knob portion and the moving mechanism portion.
[0143] [Supplementary Note 3] The intraocular lens insertion device according to Supplementary Note 2, wherein the movement mechanism includes a slider mechanism that moves the intraocular lens within the hollow cylindrical portion.
[0144] [Supplementary Note 4] The intraocular lens insertion device according to Supplementary Note 3, wherein the engagement groove in the rotation knob portion is formed so as to extend spirally in the cylindrical axis direction of the hollow cylindrical portion.
[0145] [Appendix 5] The intraocular lens inserter described in Appendix 1, wherein the cap member has a tacking pin arranged to protrude into the hollow cylindrical portion when attached, and a pin support portion that supports the tacking pin, and is configured such that when the cap member is removed from the inserter body, the tacking pin retracts from the hollow cylindrical portion due to deformation of the pin support portion.
[0146] [Supplementary Note 6] The intraocular lens insertion device described in Supplementary Note 5, wherein the cap member has, in addition to the tacking pin and the pin support portion, a guide portion that causes deformation of the pin support portion in response to relative movement between the cap member and the hollow cylindrical portion in the cylindrical axis direction.
[0147] [Supplementary Note 7] The intraocular lens insertion device according to Supplementary Note 2, wherein the movement mechanism includes a pushing mechanism that pushes the intraocular lens out of the lens release port.
[0148] [Supplementary Note 8] The intraocular lens insertion device according to Supplementary Note 7, further comprising a locking mechanism that restricts the pushing-out operation of the intraocular lens by the pushing-out mechanism.
[0149] [Supplementary Note 9] The intraocular lens insertion device according to Supplementary Note 8, wherein the locking mechanism is configured to release the restriction on the pushing-out operation in conjunction with rotation of the rotary knob.
[0150] [Supplementary Note 10] An intraocular lens inserter for use with an intraocular lens including an optical portion and an outer edge, wherein the inserter body defines an outer shape and a direction of lens advancement, and includes a hollow tubular portion, an intraocular lens storage area, a nozzle, and a transition area between the intraocular lens storage area and the nozzle; the plunger is movable within the inserter body in a distal direction relative to the inserter body in the direction of lens advancement, and includes an end surface configured to engage with and push the intraocular lens as the plunger moves distally; the lens folding device is movable distally in the direction of lens advancement relative to the inserter body and the plunger, and is configured to fold the intraocular lens during distal movement of the lens folding device; and a rotatable knob portion associated with the inserter body exterior and operably connected to the lens folding device, and the lens folding device moves distally in the direction of lens advancement in response to rotation of the rotatable knob portion.
[0151] [Supplementary Note 11] The intraocular lens inserter according to Supplementary Note 10, further comprising: the cap member being removably fixed to the inserter body over the nozzle.
[0152] [Supplementary Note 12] The intraocular lens inserter according to Supplementary Note 11, wherein the rotation knob portion is rotatable relative to the cap member.
[0153] [Supplementary Note 13] The intraocular lens inserter according to Supplementary Note 11 or Supplementary Note 12, wherein the cap member includes a first cap lock having a locked state that prevents the cap member from being removed from the inserter body and an unlocked state that allows the cap member to be removed from the inserter body, and the lens folding device is configured to transition the first cap lock from the locked state to the unlocked state during distal movement of the lens folding device.
[0154] [Supplementary Note 14] The intraocular lens inserter of Supplementary Note 13, wherein the inserter body includes a latch opening, and the first cap lock includes a latch that extends through the latch opening when the first cap lock is in a locked state, and the lens folding device includes a surface that moves the latch relative to the latch opening when the lens folding device transitions the first cap lock from the locked state to the unlocked state.
[0155] [Supplementary Note 15] An intraocular lens inserter according to any one of Supplementary Notes 10 to 14, further comprising: the second cap lock has a locked state that prevents the cap from being removed from the inserter body, and an unlocked state that allows the cap to be removed from the inserter body; and the second cap lock transitions from the locked state to the unlocked state by rotation of the rotary knob portion.
[0156] [Supplementary Note 16] The intraocular lens inserter according to Supplementary Note 15, wherein the second cap lock includes a pin and a slot in which the pin is disposed.
[0157] [Supplementary Note 17] The intraocular lens inserter of Supplementary Note 16, wherein the cap member defines an inner surface, the pin is on the inner surface of the cap member, the slot is located on the rotatable knob portion and includes a circumferentially extending portion and a distally extending portion having an end connected to the circumferentially extending portion and an open end, and when the rotatable knob portion is fully rotated, the pin and the distally extending portion of the slot are aligned.
[0158] [Supplementary Note 18] The intraocular lens inserter according to any one of Supplementary Notes 10 to 17, wherein the lens folding device comprises a slider including an end face configured to engage an outer edge of the intraocular lens, a hinge, and a lens holder connected to the hinge that extends distally over the intraocular lens optic beyond the outer edge.
[0159] [Supplementary Note 19] An intraocular lens inserter according to any one of Supplementary Notes 10 to 18, wherein the hollow cylindrical portion defines a circumference and a central axis, and the rotation knob portion extends completely around the circumference of a portion of the hollow cylindrical portion and is rotatable around the central axis.
[0160] [Supplementary Note 20] The intraocular lens inserter of Supplementary Note 19, wherein the hollow tubular portion includes a cylindrical wall and at least one longitudinally extending slot extending through the cylindrical wall, the rotatable knob portion includes an inner surface with a helical thread, and the lens folding device includes at least one post extending through the at least one longitudinally extending slot and into the helical thread.
[0161] [Supplementary Note 21] The intraocular lens inserter of Supplementary Note 20, wherein the hollow cylindrical portion includes first and second longitudinally extending slots extending through the cylindrical wall, and the lens folding device includes first and second posts extending through the first and second longitudinally extending slots, respectively, and into the helical thread.
[0162] [Supplementary Note 22] An intraocular lens inserter according to any one of Supplementary Notes 11 to 21, further comprising a removable plug that prevents rotation of the rotation knob portion.
[0163] [Supplementary Note 23] The intraocular lens inserter of Supplementary Note 22, wherein the cap member includes a cylindrical wall and an opening therethrough configured to receive a removable plug; the rotatable knob portion includes a recess configured to receive a portion of the removable plug; and the cap member, rotatable knob portion, and plug are constructed and arranged such that when the cap member is secured to the inserter body and the plug is positioned within the opening in the cap member and the recess in the rotatable knob portion, respectively, the plug prevents rotation of the rotatable knob portion.
[0164] [Supplementary Note 24] An intraocular lens inserter according to any one of Supplementary Notes 10 to 23, wherein the plunger lock has a locked state that prevents the plunger from moving in the distal direction and an unlocked state that allows the plunger to move in the distal direction, and wherein the plunger lock transitions from the locked state to the unlocked state by rotating the rotation knob portion.
[0165] [Supplementary Note 25] The insertion device according to any one of Supplementary Notes 10 to 24, further comprising an intraocular lens stored in the lens storage area.
[0166] [Supplementary Note 26] A method for inserting an intraocular lens into an eye using an intraocular lens insertion device including an inserter body defining an exterior and a lens advancement direction and including a hollow tubular portion, an intraocular lens storage region, a nozzle, and a transition region between the intraocular lens, the inserter body including the intraocular lens storage region and the nozzle, the intraocular lens in the lens storage region, a plunger movable within the inserter body distally in the lens advancement direction relative to the inserter body and including an end face configured to engage and push the intraocular lens, and a rotatable knob portion associated with the exterior of the inserter body as the plunger moves in the distal direction, the intraocular lens insertion method comprising the following steps: folding the intraocular lens by rotating the rotatable knob portion without moving the plunger in the distal direction, and pushing the intraocular lens into the eye through the nozzle by moving the plunger in the distal direction after the intraocular lens is folded.
[0167] [Supplementary Note 27] The intraocular lens insertion method according to Supplementary Note 26, wherein the intraocular lens insertion device includes a lens folding device that is movable distally in the lens advancement direction relative to the inserter body and the plunger and configured to fold the intraocular lens during distal movement of the lens folding device, and the rotatable knob portion is operably connected to the lens folding device such that the lens folding device moves distally in the lens advancement direction in response to rotation of the rotatable knob portion.
[0168] [Supplementary Note 28] The intraocular lens insertion method according to Supplementary Note 26 or Supplementary Note 27, wherein the intraocular lens insertion device includes a cap member on the inserter body that covers the nozzle, and a cap lock that is locked to prevent the cap member from being removed from the inserter body, and the method further includes the steps of: transitioning the cap lock to an unlocked state that allows it to be removed from the inserter body during the folding step; and removing the cap member before the pushing step.
[0169] [Supplementary Note 29] An intraocular lens insertion method according to any one of Supplements 26 to 28, wherein the intraocular lens insertion device includes a plunger lock in a locked state that prevents the plunger from moving in a distal direction, and the method further includes a step of transitioning the plunger lock to an unlocked state that allows the plunger to move in a distal direction during the folding step.
[0170] [Supplementary Note 30] The intraocular lens insertion method according to any one of Supplements 26 to 29, wherein the hollow tubular portion defines a circumference and a central axis; the rotatable knob portion extends completely around a portion of the hollow tubular portion and is rotatable around the central axis; and the step of rotating the rotatable knob portion includes the step of rotating the rotatable knob portion around the central axis.
[0171] DESCRIPTION OF SYMBOLS 1...intraocular lens inserter, 2...inserter body, 3...cap member, 4...stopper member, 10...body portion, 11...base portion, 12...nozzle portion, 13...flange portion, 14...lens storage portion, 15...slit hole, 16...guide hole, 18...lens release port, 19...transition portion, 20...slider mechanism portion, 21...lens support member, 22...slider engagement piece, 30...push-out mechanism portion, 31...rod portion, 32...plunger end, 40...lock mechanism portion, 41...lock member, 42...lock engagement piece, 50...rotation knob portion, 51...slider engagement groove, 52...lock engagement groove, 53...fitting portion, 54...cap engagement groove, 55...rotation direction groove, 56...insertion / removal direction groove, 70...tacking support portion, 71...tacking pin, 72...pin support portion, 73...guiding guide portion
Claims
1. An intraocular lens inserter comprising: an inserter body having a hollow cylindrical portion capable of containing an intraocular lens and configured to be able to release the intraocular lens contained in the hollow cylindrical portion to the outside through a lens release port; a movement mechanism portion that moves the intraocular lens inside the hollow cylindrical portion along the cylindrical axis direction of the hollow cylindrical portion; a rotation knob portion attached to the inserter body so as to be rotatable around the cylindrical axis of the hollow cylindrical portion; and a cap member attached to the inserter body so as to cover at least the lens release port, wherein the movement mechanism portion moves the intraocular lens in conjunction with rotation of the rotation knob portion, and the cap member is configured so as to be attachable to and detachable from the inserter body when the rotation knob portion is in a predetermined rotation position.
2. An intraocular lens inserter according to claim 1, wherein the movement mechanism has an engagement piece that protrudes outside the hollow cylindrical part, and the engagement piece engages with an engagement groove formed in the rotation knob part, thereby linking the rotation knob part and the movement mechanism part.
3. An intraocular lens inserter according to claim 2, wherein the movement mechanism includes a slider mechanism that moves the intraocular lens within the hollow cylindrical portion.
4. An intraocular lens inserter according to claim 3, wherein the engagement groove in the rotary knob portion is formed so as to extend spirally in the axial direction of the hollow cylindrical portion.
5. An intraocular lens inserter as described in claim 1, wherein the cap member has a tacking pin arranged to protrude into the hollow cylindrical portion when attached, and a pin support portion that supports the tacking pin, and is configured so that when the cap member is removed from the inserter body, the tacking pin retracts from the hollow cylindrical portion due to deformation of the pin support portion.
6. An intraocular lens inserter according to claim 5, wherein the cap member has, in addition to the tacking pin and the pin support portion, a guide portion that causes deformation of the pin support portion in response to relative movement between the cap member and the hollow cylindrical portion in the axial direction of the cylinder.
7. An intraocular lens inserter according to claim 2, wherein the movement mechanism includes a push-out mechanism that pushes out the intraocular lens from the lens release port.
8. An intraocular lens inserter according to claim 7, further comprising a locking mechanism that restricts the pushing-out operation of the intraocular lens by the pushing-out mechanism.
9. An intraocular lens inserter according to claim 8, wherein the locking mechanism is configured to release the restriction on the pushing-out operation in conjunction with the rotation of the rotary knob.
10. An intraocular lens inserter for use with an intraocular lens including an optic and an outer rim, wherein the inserter body defines an outer shape and a direction of lens advancement and includes a hollow tubular portion, an intraocular lens storage region, a nozzle, and a transition region between the intraocular lens storage region and the nozzle; a plunger movable within the inserter body distally relative to the inserter body in a direction of lens advancement and including an end face configured to engage and push the intraocular lens as the plunger moves distally; a lens folding device movable distally relative to the inserter body and the plunger in the direction of lens advancement and configured to fold the intraocular lens during distal movement of the lens folding device; and a rotatable knob portion associated with the inserter body exterior and operably connected to the lens folding device, and wherein rotation of the rotatable knob portion causes the lens folding device to move distally in the direction of lens advancement.
11. An intraocular lens inserter according to claim 10, further comprising: a cap member removably secured to the inserter body over the nozzle.
12. An intraocular lens inserter according to claim 11, wherein the rotation knob portion is rotatable relative to the cap member.
13. An intraocular lens inserter according to claim 11 or 12, wherein the cap member includes a first cap lock having a locked state that prevents the cap member from being removed from the inserter body and an unlocked state that allows the cap member to be removed from the inserter body, and wherein the lens folding device is configured to transition the first cap lock from the locked state to the unlocked state during distal movement of the lens folding device.
14. An intraocular lens inserter as defined in claim 13, wherein the inserter body includes a latch opening, and the first cap lock includes a latch that extends through the latch opening when the first cap lock is in a locked state, and the lens folding device includes a surface that moves the latch relative to the latch opening when the lens folding device transitions the first cap lock from the locked state to the unlocked state.
15. An intraocular lens inserter according to any one of claims 10 to 14, further comprising: a second cap lock having a locked state that prevents the cap member from being removed from the inserter body, and an unlocked state that allows the cap member to be removed from the inserter body; and wherein the second cap lock transitions from the locked state to the unlocked state by rotation of the rotary knob portion.
16. An intraocular lens inserter according to claim 15, wherein the second cap lock comprises a pin and a slot in which the pin is disposed.
17. An intraocular lens inserter as defined in claim 16, wherein the cap member defines an inner surface, the pin is on the inner surface of the cap member, the slot is located on the rotatable knob portion and includes a circumferentially extending portion and a distally extending portion having an end connected to the circumferentially extending portion and an open end, and wherein upon full rotation of the rotatable knob portion, the pin and the distally extending portion of the slot are aligned.
18. An intraocular lens inserter according to any one of claims 10 to 17, wherein the lens folding device comprises a slider including an end face configured to engage the outer edge of the intraocular lens, a hinge, and a lens holder connected to the hinge that extends distally over the intraocular lens optic beyond the outer edge.
19. An intraocular lens inserter according to any one of claims 10 to 18, wherein the hollow cylindrical portion defines a circumference and a central axis, and the rotation knob portion extends completely around the circumference of a portion of the hollow cylindrical portion and is rotatable around the central axis.
20. An intraocular lens inserter according to claim 19, wherein the hollow tubular portion includes a cylindrical wall and at least one longitudinally extending slot extending through the cylindrical wall, the rotatable knob portion includes an inner surface with a helical thread, and the lens folding device includes at least one post extending through the at least one longitudinally extending slot and into the helical thread.
21. An intraocular lens inserter as defined in claim 20, wherein the hollow cylindrical portion includes first and second longitudinally extending slots extending through the cylindrical wall, and the lens folding device includes first and second posts extending through the first and second longitudinally extending slots, respectively, and into the helical thread.
22. An intraocular lens inserter according to any one of claims 11 to 21, further comprising a removable plug that prevents rotation of the rotation knob portion.
23. An intraocular lens inserter according to claim 22, wherein the cap member includes a cylindrical wall and an opening therethrough configured to receive a removable plug; the rotation knob portion includes a recess configured to receive a portion of the removable plug; and the cap member, rotation knob portion, and plug are constructed and arranged such that when the cap member is secured to the inserter body and the plug is positioned within the opening in the cap member and the recess in the rotation knob portion, respectively, the plug prevents rotation of the rotation knob portion.
24. An intraocular lens inserter according to any one of claims 10 to 23, wherein the plunger lock has a locked state that prevents the plunger from moving in the distal direction and an unlocked state that allows the plunger to move in the distal direction, and wherein the plunger lock transitions from the locked state to the unlocked state by rotating the rotation knob portion.
25. An insertion device according to any one of claims 10 to 24, further comprising an intraocular lens stored in the lens storage area.
26. A method of inserting an intraocular lens into an eye using an intraocular lens insertion device comprising an inserter body defining an exterior and a lens advancement direction and including a hollow tubular portion, an intraocular lens storage region, a nozzle, and a transition region between the intraocular lens, the inserter body including the intraocular lens storage region and the nozzle, an intraocular lens in the lens storage region, a plunger movable within the inserter body distally in the lens advancement direction relative to the inserter body and including an end face configured to engage and push the intraocular lens, and a rotatable knob portion associated with the exterior of the inserter body as the plunger moves distally, the method comprising the steps of: folding the intraocular lens without moving the plunger distally by rotating the rotatable knob portion; and, after the intraocular lens is folded, pushing the intraocular lens through the nozzle into the eye by moving the plunger distally.
27. A method of inserting an intraocular lens as defined in claim 26, wherein the intraocular lens insertion device includes a lens folding device that is movable distally in the direction of lens advancement relative to the inserter body and plunger and configured to fold the intraocular lens during distal movement of the lens folding device, and the rotatable knob portion is operably connected to the lens folding device such that the lens folding device moves distally in the direction of lens advancement in response to rotation of the rotatable knob portion.
28. An intraocular lens insertion method according to claim 26 or 27, wherein the intraocular lens insertion device includes a cap member on the inserter body that covers the nozzle, and a cap lock that is locked to prevent the cap member from being removed from the inserter body, and the method further includes the following steps: during the folding step, transitioning the cap lock to an unlocked state in which it can be removed from the inserter body; and removing the cap member before the pushing step.
29. An intraocular lens insertion method according to any one of claims 26 to 28, wherein the intraocular lens insertion device includes a plunger lock in a locked state that prevents the plunger from moving in a distal direction, and the method further includes the step of transitioning the plunger lock to an unlocked state that allows the plunger to move in a distal direction during the folding step.
30. A method of inserting an intraocular lens according to any one of claims 26 to 29, wherein the hollow cylindrical portion defines a circumference and a central axis; the rotatable knob portion extends completely around a portion of the hollow cylindrical portion and is rotatable about the central axis; and the step of rotating the rotatable knob portion includes the step of rotating the rotatable knob portion about the central axis.
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