Introduction head, implantation device, method for loading intraocular lens and related assembly

Abstract

The invention provides an introduction head, an implantation device and the like which are simple and convenient to operate. To achieve this, according to one aspect of the invention, there is provided an introduction head comprising: a tubular body having a circumferential side wall, a first end and a second end opposite in a longitudinal direction, and a through lumen extending from the first end to the second end in the longitudinal direction; the second U-shaped notch is located in the bottom wall, used for forming an intraocular lens loading area, of the circumferential side wall, the second U-shaped notch extends from the first end to the second end, and when the intraocular lens enters the through inner cavity through the second U-shaped notch from the lower portion of the leading-in head from bottom to top, the second U-shaped notch extends from the first end to the second end. The second U-shaped notch enables the two side edges of the intraocular lens to be bent in the direction opposite to the arch face of the optical part of the intraocular lens.

Description

Technical Field

[0001] The present invention relates to an introduction head capable of providing folding control of an intraocular lens. The present invention also relates to an implantation device comprising the introduction head. The present invention also relates to a method for loading an intraocular lens into the introduction head. The present invention also relates to an assembly comprising an implantation device and an intraocular lens. Background Art

[0002] A phakic intraocular lens (PR-IOL) is an artificial lens that is surgically placed in the posterior chamber of the eye (between the iris and the front surface of the natural lens) to improve the patient's postoperative corrected vision. The implanted PR-IOL remains in the patient's eye along with the natural lens.

[0003] Since the PR-IOL is located between the iris and the front surface of the natural lens after implantation, and the front surface of the natural lens is a convex shape that is approximately spherical or aspherical, and the implanted PR-IOL is not allowed to contact the front surface of the natural lens (Note: Once the PR-IOL contacts the front surface of the natural lens, there is a great chance that the natural lens will develop cataracts), the PR-IOL is usually designed as follows: Figure 1 The shape shown. Specifically, the PR-IOL is a thin sheet of intraocular lens. When observing the shape of the PR-IOL from the front, it consists of a circular optical part in the center and a peripheral support loop. When observing the shape of the PR-IOL from the side, it presents a unilateral arch upward structure, with the circular optical part in the center of the arch. In simple terms, the PR-IOL is a thin sheet of intraocular lens with a unilateral arch upward, a circular optical part in the center of the arch, and support loops around the arch. The unilateral upward arch structure can ensure that the implanted PR-IOL will not contact the front surface of the natural lens even under the pressure of the iris. PR-IOL can be made of a variety of soft materials, such as silicone elastomers, hydrogels, acrylics, etc. PR-IOL made of soft materials can be implanted into the patient's eye through a smaller surgical incision.

[0004] Implanting a PR-IOL into a patient's eye requires making a surgical incision in the patient's cornea, and then using a dedicated implantation instrument to complete the operation of implanting the PR-IOL into the patient's eye through the surgical incision. Currently, an intraocular lens implantation device is commonly used to complete the operation of implanting a PR-IOL into a patient's eye. An intraocular lens implantation device usually consists of an introduction head and a thruster. The introduction head usually includes a tubular body. The tubular body has a through inner cavity, which defines an intraocular lens loading area. When in use, the distal end of the tubular body of the introduction head will pass through the surgical incision to introduce the PR-IOL into the patient's eye. The thruster is used to provide a driving force for pushing the PR-IOL during the introduction process. Since the PR-IOL is made of soft materials and the through inner cavity of the introduction head has a specific cross-sectional design, the PR-IOL will be folded or curled to reduce its volume during the process of introducing the PR-IOL into the patient's eye through the introduction head, so that it can be introduced into the eye through a smaller surgical incision (the incision size is, for example, about 3 mm). After entering the eye, the folded or curled PR-IOL will unfold and return to its original free state due to the characteristics of the soft material.

[0005] Typically, PR-IOLs are provided to doctors in a separate package, and the PR-IOLs in the package are in an unfolded, original free state. Before implantation, doctors usually need to use implantation forceps or similar devices to take the PR-IOL out of the package and load it into the intraocular lens loading area of ​​the introduction head. The PR-IOL can be folded or curled before, during, or after being loaded into the intraocular lens loading area of ​​the introduction head. Thereafter, the introduction head loaded with the PR-IOL is assembled to the pusher. The pusher provides a push-in driving force so that the PR-IOL enters the patient's eye through a surgical incision in a folded or curled state. The PR-IOL that enters the eye will unfold and return to its original free state that is not folded or curled. Since the PR-IOL made of soft materials is a small, thin, and precise product, the PR-IOL needs to enter the patient's eye in the correct folded or curled state. If the PR-IOL enters the patient's eye in an incorrectly folded or curled state, the PR-IOL will unfold in the wrong way, which may require the PR-IOL to be removed from the patient's eye or further adjusted in the eye, causing trauma to the tissues around the eye. It can be seen that the folding or curling of the PR-IOL in the correct and predictable direction in the introduction head is the key to the success of the PR-IOL implantation operation.

[0006] The correct way to place the PR-IOL in the inserter is to make the central circular optical arch of the PR-IOL face upward (along the positive direction of the Z axis), and the long axis centerline of the PR-IOL is consistent with the long axis centerline of the inserter (note: consistent with the Y axis). In this article, please refer to the description of the direction of the coordinate axis. Figure 2 As shown. The correct way to fold or curl the PR-IOL is to fold or curl the two sides of the optical zone in the X direction (i.e., the short axis) in the opposite direction to the optical arch (i.e., the negative direction of the Z axis) toward the center line of the PR-IOL long axis (i.e., the Y axis direction). After folding or curling, the central circular optical arch of the PR-IOL faces upward (along the positive direction of the Z axis) and is not folded in the intraocular lens. The PR-IOL folded or curled in this way can be more easily and conveniently unfolded and restored to the initial state of the intraocular lens. If the PR-IOL is folded or curled in the opposite direction to the correct direction mentioned above, the optical arch will be folded in the curled PR-IOL. On the one hand, the PR-IOL squeezed into the patient's eye in this curling manner is not easy to unfold. On the other hand, after unfolding, it is likely that the central optical arch is always in a curled and squeezed state and is not easy to recover to the original free state or may be in an extruded and deformed state, so further adjustment and treatment are required, which increases the risk of causing trauma to the patient's eye tissue.

[0007] There are two main types of inserters that can be used for PR-IOL implantation. The main difference between the two inserters is the structure of the lens loading area, but the method of placing the PR-IOL in the lens loading area of ​​the inserter is basically the same, which is described in detail below.

[0008] The lens loading area of ​​an introduction head is a folding clip structure, see Figure 3 and Figure 4 . Figure 3 and Figure 4From U.S. Patent No. 5,494,484. When using this type of introduction head to load PR-IOL, the operator needs to hold the folding clip introduction head (folding clips 70 and 72 are in the open state) with one hand, and hold the PR-IOL with the other hand in the long-axis direction, and check and confirm that the arch surface of the central optical part of the PR-IOL faces upward (along the positive direction of the Z axis). Then, the operator places the two side edges of the PR-IOL in the short-axis direction in the two semicircular grooves 74 and 78 in the center of the folding clip opened by the introduction head. Then, slowly close the folding clip of the introduction head. In order to ensure that the PR-IOL is located in the circular inner cavity of the introduction head formed by the closed folding clip in the correct folded or curled state, the operator is usually required to close the folding clip while manually using the implantation forceps to adjust the folding or curling state of the PR-IOL. Another purpose of manual adjustment is to prevent the closed folding clip from clamping the optical part or support haptic of the PR-IOL. The closed folding clip will be assembled with the outer tube component of the pusher as the positioning part of the introduction head. During assembly, the folding clip is usually placed on the thruster outer tube with the folding clip facing upward and the circular inner cavity formed by the folding clip closing facing downward. For details, please refer to Figure 4 .

[0009] Another type of introduction head has a positioning structure outside the lens loading area. This positioning structure is used to determine the loading direction of the introduction head and confirm whether the introduction head is loaded in place when the introduction head is assembled with the outer tube component of the pusher. For this introduction head, when the positioning structure is facing upward, the lens loading area is a semi-enclosed cavity structure with an open groove on the upper part. For details, please refer to Figure 5 . When using this type of introduction head to load the PR-IOL, the operator needs to hold the introduction head in one hand (with the positioning structure or the open groove at the top of the lens loading area facing upwards), and hold the implantation forceps in the other hand to clamp the PR-IOL along the long axis direction of the PR-IOL. It is necessary to check and confirm that the arch surface of the central optical part of the PR-IOL is facing upwards, and at the same time, the long axis direction of the PR-IOL is consistent with the long axis direction of the introduction head. Then, the operator places the PR-IOL into the lens loading area from the open groove at the top of the lens loading area along the long axis direction, so that the arch surface of the central optical part of the PR-IOL faces upwards (along the positive direction of the Z axis) and the two side edges of the PR-IOL in the short axis direction are placed inside the side walls of the lens loading area. In order to complete the above action, the operator usually needs to first place one long side of the PR-IOL from the open slot at the top of the lens loading area into the side wall of the lens loading area, and then the operator manually rolls the PR-IOL with the implantation forceps to make the other long side of the PR-IOL rotate from the open slot at the top of the lens loading area into the side wall on the opposite side of the lens loading area. At this time, the state of the PR-IOL in the introduction head is shown in the figure below. Figure 6Next, in order to ensure that the PR-IOL is folded or curled in the expected correct direction during the movement of the PR-IOL toward the distal end of the tubular portion of the introducer, the operator still needs to manually use implantation forceps to fold the two long edges of the PR-IOL toward the long axis of the PR-IOL to adjust the position of the PR-IOL in the introducer. During assembly, the introducer is usually loaded onto the outer tube component of the pusher with the introducer positioning structure facing upward and the lens loading area facing downward.

[0010] As described above, in the operation of this structure, the operator is required to first place one long side of the PR-IOL from the open groove at the top of the lens loading area into the side wall of the lens loading area, and then the operator manually rolls up the PR-IOL with the implantation forceps so that the other long side of the PR-IOL is rotated from the open groove at the top of the lens loading area into the side wall on the opposite side of the lens loading area. Such operation is relatively cumbersome. Summary of the invention

[0011] To this end, the object of the present invention is to provide an introduction head, an implantation device, etc. that are relatively easy to operate. To achieve this object, according to one aspect of the present invention, an introduction head is provided, the introduction head comprising: a tubular body, the tubular body having a circumferential side wall, a first end and a second end opposite to each other in the longitudinal direction, and a through inner cavity extending from the first end to the second end in the longitudinal direction; a second U-shaped recess, located on the bottom wall of the circumferential side wall for forming an intraocular lens loading area, the second U-shaped recess extending from the first end toward the second end, when the intraocular lens enters the through inner cavity from the bottom to the top through the second U-shaped recess from below the introduction head, the second U-shaped recess causes the two side edges of the intraocular lens to bend in a direction opposite to the arch surface of its optical part.

[0012] With the above structure, since a second U-shaped notch is provided on the bottom wall forming the artificial lens loading area, when the operator places the artificial lens into the artificial lens loading area, the operator only needs to pass the artificial lens through the second U-shaped notch. At this time, the second U-shaped notch on the bottom wall causes the two side edges of the short axis of the artificial lens to bend in the direction opposite to the arch surface of its optical part, without the need for the operator to operate the two long sides of the artificial lens separately. In other words, there is no need to "first place one long side of the PR-IOL from the open groove at the top of the lens loading area into the side wall of the lens loading area, and then the operator manually rolls up the PR-IOL with the implantation forceps so that the other long side of the PR-IOL is rotated from the open groove at the top of the lens loading area into the side wall on the opposite side of the lens loading area" as in the prior art, so the operation is simple.

[0013] According to one aspect of the present invention, there is provided an introduction head for a phakic intraocular lens. The introduction head comprises a tubular body, the tubular body having a circumferential side wall, a first end and a second end opposite in a longitudinal direction, and a through inner cavity extending from the first end to the second end in a longitudinal direction. The introduction head further comprises a first U-shaped recess in the circumferential side wall, the first U-shaped recess extending from the first end toward the second end. The introduction head further comprises a second U-shaped recess in the circumferential side wall, the second U-shaped recess being opposite to the first U-shaped recess in a circumferential direction, the second U-shaped recess extending from the first end toward the second end. The introduction head further comprises a sheet-shaped positioning portion, the sheet-shaped positioning portion extending radially outward from the circumferential side wall between the first U-shaped recess and the second end, the longitudinal direction of the sheet-shaped positioning portion being parallel to the longitudinal direction of the tubular body, and the first U-shaped recess being aligned with the sheet-shaped positioning portion in a circumferential direction when viewed from the first end toward the second end.

[0014] In one embodiment, the edges of the first U-shaped recess have rounded corners.

[0015] In one embodiment, the edge of the second U-shaped recess has rounded corners.

[0016] In one embodiment, the maximum width of the second U-shaped notch is 4.0 mm.

[0017] In one embodiment, the second U-shaped recess is symmetrical about a longitudinal centerline of the tubular body.

[0018] In one embodiment, the second U-shaped recess has a non-uniform width in the longitudinal direction.

[0019] In one embodiment, the first U-shaped notch has a minimum width of 2.5 mm and a minimum length of 6 mm, and the first U-shaped notch can be used to observe the loaded phakic intraocular lens.

[0020] According to another aspect of the present invention, a device for implanting a phakic intraocular lens is provided. The implanting device comprises the above-mentioned introduction head and a pusher. The pusher is used to provide a driving force for pushing the phakic intraocular lens, and the pusher comprises an outer tube and a push-injection driving mechanism, wherein the first end of the outer tube comprises a groove, and the second end of the outer tube is engaged with the push-injection driving mechanism. The sheet-shaped positioning portion of the introduction head can be received in the groove of the first end of the outer tube, so that the introduction head and the pusher are assembled together.

[0021] According to another aspect of the present invention, a method for loading a phakic intraocular lens into an introduction head according to the present invention is provided, the method comprising the following steps: (a) making the sheet-shaped positioning portion of the introduction head face upward; (b) clamping the phakic intraocular lens along the long axis direction of the phakic intraocular lens using implantation forceps, so that the central optical portion arch of the phakic intraocular lens faces upward and the long axis direction of the phakic intraocular lens is parallel to the longitudinal direction of the tubular body of the introduction head; (c) placing the phakic intraocular lens at the lower end of the introduction head; and (d) placing the phakic intraocular lens at the lower end of the introduction head. (d) passing the front portion of the phakic intraocular lens through the second U-shaped recess of the introduction head from bottom to top, thereby placing the front portion of the phakic intraocular lens in the through-going inner cavity of the introduction head, so that the two side edges of the phakic intraocular lens in the short-axis direction are placed in the circumferential side wall of the tubular body; (e) pushing the phakic intraocular lens in the direction toward the second end of the tubular body of the introduction head, so that the phakic intraocular lens is completely located in the through-going inner cavity of the introduction head; and (f) withdrawing the implantation forceps from the introduction head.

[0022] In one embodiment, the width of the second U-shaped notch of the introduction head is smaller than the width of the phakic intraocular lens, and the step (d) further comprises: bending the two side edges of the short axis of the phakic intraocular lens when the phakic intraocular lens passes through the second U-shaped notch.

[0023] Compared with the existing introduction heads, the advantages of the introduction head and / or implantation device according to the present invention include avoiding the need for the operator to manually use implantation forceps to adjust the position or folding state of the PR-IOL in order to fold or curl the PR-IOL in the desired direction. Another advantage of the introduction head and / or implantation device according to the present invention is that compared with the existing folding clip type introduction head discussed above, it avoids the risk of damaging the lens by clamping certain features of the lens (such as the optical part or the support haptic) during the closing of the folding clip.

[0024] Definition of terms

[0025] Unless otherwise specified, the following definitions apply to the terms used in this specification.

[0026] The term "optical portion" used in the present application refers to a portion of a PR-IOL that has optical properties so as to achieve the main function of adjusting the diopter of the PR-IOL.

[0027] The term "haptic" used in this application refers to a portion connected to the optical portion of the PR-IOL that supports the optical portion and transmits the contraction force generated by the contraction and varicose contraction of the ciliary muscle to the optical portion.

[0028] In addition, unless otherwise defined, the meaning of all technical terms used herein is consistent with that commonly understood by those skilled in the art to which the present invention belongs. If there is any inconsistency, the present specification and its included definitions shall prevail. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Schematic diagram of a phakic intraocular lens (PR-IOL).

[0030] Figure 2 The coordinate axes of the PR-IOL used herein are shown.

[0031] Figure 3 A prior art introduction head is shown.

[0032] Figure 4 yes Figure 3 A schematic diagram of the assembly of the introduction head and the outer tube component of the thruster is shown.

[0033] Figure 5 Another introduction head of the prior art is shown.

[0034] Figure 6 shows the PR-IOL being loaded into Figure 5 The lens loading area of ​​the introducer is shown.

[0035] Figure 7 A schematic perspective view of an introduction head according to one embodiment of the present invention is shown.

[0036] Figure 8 A schematic perspective view of an implant device according to one embodiment of the present invention is shown.

[0037] Figures 9 to 12 The process of loading a PR-IOL into an introduction head according to an embodiment of the present invention is schematically shown. DETAILED DESCRIPTION

[0038] The following specific examples are only used to further explain the present invention, but the present invention is not limited to the following specific embodiments. Any changes based on these embodiments, as long as they comply with the spirit and scope of the principles of the present invention, will fall within the scope of protection of the present invention.

[0039] The present invention relates to an introduction head for a PR-IOL. In one embodiment, Figure 7 As shown, the introduction head 100 according to the present invention comprises a tubular body 120. The tubular body 120 has a circumferential side wall 121, a longitudinal direction ( Figure 7The first and second ends 122 and 123 are opposite in the circumferential direction (in the Y-axis direction) and a through inner cavity 124 extending from the first end 122 to the second end 123 in the longitudinal direction. The introduction head 100 according to the present invention also includes a first U-shaped recess 125 located in the circumferential side wall 121. The first U-shaped recess 125 extends from the first end 122 toward the second end 123. The introduction head 100 according to the present invention also includes a second U-shaped recess 126 located in the circumferential side wall 121. The second U-shaped recess 126 is opposite to the first U-shaped recess 125 in the circumferential direction. In other words, the first U-shaped recess 125 and the second U-shaped recess 126 are in opposite positions in the circumferential side wall 121. The second U-shaped recess 126 extends from the first end 122 toward the second end 123. The introduction head 100 according to the present invention also includes a sheet-shaped positioning portion 130. The sheet-shaped positioning portion 130 extends radially outward from the circumferential side wall 121 between the first U-shaped recess 125 and the second end 123. The longitudinal direction of the sheet-shaped positioning portion 130 is parallel to the longitudinal direction of the tubular body. Figure 7 When viewed from the first end 122 toward the second end 123, the first U-shaped recess 125 is aligned with the sheet-shaped positioning portion 130 in the circumferential direction. Figure 7 In the figure, the first U-shaped notch 125 is shown as being located at the upper portion of the circumferential side wall 121, and the sheet-shaped positioning portion 30 is shown as extending radially upward (i.e., along the positive direction of the Z axis) from the circumferential side wall 121. When the introduction head 100 is assembled with a pusher (such as the pusher 200 discussed below), the sheet-shaped positioning portion 130 is received in the groove of the pusher, so that the introduction head 100 and the pusher are assembled together.

[0040] In one embodiment, the edge of the first U-shaped notch 125 may have rounded corners. In one embodiment, the edge of the second U-shaped notch 126 may have rounded corners. The rounded corners of the edges of the first U-shaped notch 125 and / or the second U-shaped notch 126 can better reduce or avoid damage to the surface of the PR-IOL during the process of loading the PR-IOL into the introduction head 100.

[0041] In one embodiment, the maximum width of the second U-shaped notch 126 may be 4.0 mm.

[0042] In one embodiment, the second U-shaped notch 126 may be symmetrical about the longitudinal centerline of the tubular body 120 .

[0043] In one embodiment, the second U-shaped recess 126 may have a non-uniform width in the longitudinal direction of the tubular body 120 .

[0044] In one embodiment, the minimum width of the first U-shaped notch 125 may be 2.5 mm, and the minimum length may be 6 mm. The first U-shaped notch 125 can be used to observe the loaded phakic intraocular lens, such as Fig.11 and Fig.12 shown.

[0045] The present invention also provides a phakic intraocular lens implantation device 10. In one embodiment, Figure 8 As shown, the implantation device 10 may include the introduction head 100 discussed above and may also include a pusher 200 as described below. The pusher 200 is used to provide a driving force for pushing the intraocular lens. The pusher 200 may include an outer tube 210 and a push drive mechanism 220. The outer tube 210 is used for hand-held operation by an operator. The first end of the outer tube 210 is used to engage with the introduction head 100, and the second end of the outer tube 210 is used to engage with the push drive mechanism 220. The first end of the outer tube 210 of the pusher 200 may include a groove 240. The sheet-shaped positioning portion 130 of the introduction head 100 can be received in the groove 240 of the outer tube 210 of the pusher 200, so that the introduction head 100 and the pusher 200 are assembled together. During assembly, the introduction head 100 loaded with the PR-IOL is inserted from the front end opening of the outer tube 210 of the pusher 200. After being inserted into place, the introduction head is rotated to a certain angle so that the sheet-shaped positioning portion 130 of the introduction head 100 is received in the groove 240 of the outer tube 210 of the propeller 200, thereby completing the action of assembling the introduction head 100 to the propeller 200. Figure 8 shown.

[0046] Figures 9 to 12 The process of loading a PR-IOL into the above-mentioned introduction head 100 is schematically shown. When loading a PR-IOL with the introduction head 100 according to the present invention, the operator needs to hold the introduction head 100 with one hand and make the sheet-shaped positioning part 130 face upward (at this time, the first U-shaped notch 125 is located at the upper part of the circumferential side wall 121 and the second U-shaped notch 126 is located at the lower part of the circumferential side wall 121), and hold the PR-IOL along the long axis direction with the implantation forceps with the other hand, and at the same time, check and confirm that the central optical part arch of the PR-IOL faces upward (along the positive direction of the Z axis), and the long axis direction of the PR-IOL is consistent with the longitudinal direction of the tubular body 120 of the introduction head 100 (i.e. parallel). Then, the operator places the PR-IOL into the through inner cavity 124 of the introduction head 100 along the long axis direction, so that the central optical part arch of the PR-IOL faces upward (along the positive direction of the Z axis) and the two side edges of the short axis direction of the PR-IOL are placed in the circumferential side wall 121 of the tubular body 120. In order to complete the above-mentioned operation, the operator first needs to hold the implantation forceps along the long axis direction of the PR-IOL and place it under the introduction head 100 (such as Fig. 9Then, the front portion of the PR-IOL is passed from bottom to top (along the positive direction of the Z axis) through the second U-shaped notch 126 of the introduction head 100 (as shown in FIG. Fig.10 ), thereby placing the front portion of the PR-IOL in the through lumen 124 of the introduction head 100 (as shown in FIG. Fig.11 As shown). Since the width of the second U-shaped notch 126 of the introduction head 100 is smaller than the width of the PR-IOL, the two side edges of the short axis of the PR-IOL will bend when passing through the second U-shaped notch 126. After passing through the second U-shaped notch 126, due to the material properties and its own arched surface structure, the PR-IOL has a tendency to unfold and return to the free state before bending, but the cross-sectional size of the through lumen 124 of the introduction head 100 makes the PR-IOL after unfolding just in the expected folded or curled state. Finally, the operator pushes the PR-IOL whose front portion is already located in the through lumen 124 of the introduction head 100 in the direction toward the second end 123 of the tubular body 120 of the introduction head 100, so that the PR-IOL is completely located in the through lumen 124 of the introduction head 100. In this process, the through lumen 124 of the introduction head 100 causes the PR-IOL to further fold or curl in the expected direction (as shown). Fig.12 After the PR-IOL is placed in the through inner cavity 124 of the introduction head 100 in the expected folding or curling direction, the operator withdraws the implantation forceps from the introduction head 100, and the entire PR-IOL loading operation is completed.

[0047] When the implantation is performed, the sheet-shaped positioning portion 130 of the introduction head 100 faces upward. At this time, because the folding or curling trend of the PR-IOL in the introduction head 100 is determined, the subsequent PR-IOL will only continue to fold or curl to reduce the volume of the PR-IOL during the movement from the second end 123 to the first end 122 in the introduction head 100, but the folding direction or trend will not change, so that the PR-IOL is finally implanted in the patient's eye in a curled state that the operator can predict, and unfolds in a predictable unfolding direction to restore to an unfolded free state. Since the edge of the second U-shaped notch 126 of the introduction head 100 has rounded corners, and the PR-IOL is a thin sheet product of soft material, the PR-IOL itself will not be scratched when the PR-IOL passes through the second U-shaped notch 126 of the introduction head 100 from bottom to top. The first U-shaped notch 125 of the introduction head 100 is used to facilitate the operator to observe the movement state of the PR-IOL during the movement of the PR-IOL from the second end 123 to the first end 122 of the introduction head 100. If the movement or curling state of the PR-IOL deviates, the operator can make adjustments in time.

[0048] Compared with the existing introduction heads, the advantages of the introduction head 100 and / or the implantation device 10 according to the present invention include avoiding the need for the operator to manually use implantation forceps to adjust the position or folding state of the PR-IOL in order to fold or curl the PR-IOL in the desired direction. Another advantage of the introduction head 100 and / or the implantation device 10 according to the present invention is that compared with the existing folding clip type introduction head discussed above, it avoids the risk of damaging the lens by clamping certain features of the lens (such as the optical part or the support haptic) during the closing of the folding clip.

[0049] Although the present invention has been described with reference to (one or more) exemplary embodiments, it will be understood by those skilled in the art that the present invention is not limited to the exact structure and components described herein, and that various modifications, changes and variations can be understood from the foregoing description without departing from the spirit and scope of the present invention as defined in the appended claims. The present invention is not limited by the illustrated order of steps, as some steps can be performed in different orders and / or simultaneously with other steps. Therefore, the present invention is not limited to the disclosed (one or more) specific embodiments, but will include all embodiments falling within the scope of the appended claims.

Claims

1. An introduction head, comprising: a tubular body having a circumferential sidewall, a first end and a second end opposite in a longitudinal direction, and a through lumen extending in the longitudinal direction from the first end to the second end; The second U-shaped recess is located on the bottom wall of the circumferential side wall for forming an artificial lens loading area, and the second U-shaped recess extends from the first end toward the second end. When the artificial lens passes through the second U-shaped recess from bottom to top under the introduction head and enters the through inner cavity, the second U-shaped recess causes the two side edges of the artificial lens to bend in a direction opposite to the arch surface of its optical part.

2. The introduction head according to claim 1, wherein: The cross-sectional dimension of the through inner cavity perpendicular to the longitudinal direction is set so that the artificial lens after unfolding is just in the expected folding or curling state.

3. The introduction head according to claim 1, wherein: It also includes a first U-shaped notch located on the circumferential side wall, wherein the first U-shaped notch is used to facilitate an operator to observe the movement state of the artificial lens during the movement of the artificial lens from the second end to the first end of the introduction head.

4. The introduction head according to claim 3, wherein: The first U-shaped recess is located at an upper portion of the circumferential side wall, and the first U-shaped recess extends from the first end toward the second end; the second U-shaped recess is opposite to the first U-shaped recess in the circumferential direction.

5. The introduction head according to claim 3 or 4, wherein: It also includes a positioning part, which is used to determine its loading direction and whether it is loaded in place when the introduction head is assembled.

6. The introduction head according to claim 5, wherein: The positioning portion extends radially outward from the circumferential side wall between the first U-shaped recess and the second end.

7. The introduction head according to claim 6, wherein: The positioning portion is a sheet-like positioning portion, the longitudinal direction of which is parallel to the longitudinal direction of the tubular body, and when viewed from the first end toward the second end, the first U-shaped recess is aligned with the sheet-like positioning portion in the circumferential direction.

8. The introduction head according to claim 3 or 4, wherein: The edge of the first U-shaped recess has rounded corners.

9. The introduction head according to any one of claims 1 to 4, wherein: The edge of the second U-shaped recess has rounded corners.

10. The introduction head according to any one of claims 1 to 4, wherein: The maximum width of the second U-shaped notch is 4.0 mm.

11. The introduction head according to any one of claims 1 to 4, wherein: The second U-shaped recess is symmetrical about a longitudinal centerline of the tubular body.

12. The introduction head according to any one of claims 1 to 4, wherein: The second U-shaped recess has a non-uniform width in the longitudinal direction.

13. The introduction head according to any one of claims 1 to 4, wherein: The width of the second U-shaped notch is smaller than the short-axis width of the intraocular lens.

14. The introduction head according to any one of claims 1 to 4, wherein: The intraocular lens is a thin sheet-like intraocular lens with a unilateral arch surface facing upward, an optical part in the center of the arch surface, and support haptics around the arch surface.

15. The introduction head according to claim 14, wherein: The artificial lens is placed in the introduction head in such a manner that the optical arch surface of the artificial lens faces upward, and the long axis centerline of the artificial lens is consistent with the long axis centerline of the introduction head.

16. The introduction head according to any one of claims 1 to 4, wherein: The artificial lens is folded or curled in such a way that both sides of the short axis direction of the artificial lens are folded or curled toward the center line of its long axis in the direction opposite to the arch surface of its optical part.

17. The introduction head according to any one of claims 1 to 4, wherein: The second notch extends in the longitudinal direction for a length that is smaller than the length of the intraocular lens in the long-axis direction.

18. The introduction head according to claim 3 or 4, wherein: The second notch extends over a length in the longitudinal direction that is smaller than the first notch extends over a length in the longitudinal direction.

19. The introduction head according to any one of claims 1 to 4, wherein: The second U-shaped notch causes the two side edges of the short axis of the intraocular lens to bend in a direction opposite to the arch surface of the optical part thereof.

20. An implant device, comprising: An introduction head according to any one of claims 1 to 19; and A pusher is used to provide a driving force for pushing the artificial lens. The pusher includes an outer tube and a pushing drive mechanism. The introduction head is assembled at the first end of the outer tube, and the second end of the outer tube is engaged with the pushing drive mechanism.

21. The implant device according to claim 20, wherein: The first end of the outer tube includes a groove, wherein the positioning portion of the introduction head can be received in the groove of the first end of the outer tube to enable the introduction head and the pusher to be assembled together.

22. A method for loading an intraocular lens into an inserter according to any one of claims 1 to 19, the method comprising at least the following steps: (c) placing the intraocular lens below the introduction head; (d) Passing the front portion of the artificial lens from bottom to top through the second U-shaped recess of the introduction head, thereby placing the front portion of the artificial lens in the through inner cavity of the introduction head, so that the two side edges of the artificial lens are placed in the circumferential side wall of the tubular body.

23. The method according to claim 22, wherein: The method further comprises the following steps before step (c): (a) the sheet-shaped positioning portion of the introduction head is facing upward; (b) Using implantation forceps to clamp the intraocular lens along the long axis direction of the intraocular lens, so that the central optical part arch of the intraocular lens faces upward and the long axis direction of the intraocular lens is parallel to the longitudinal direction of the tubular body of the introduction head.

24. The method according to claim 23, wherein: After step (d), the method further comprises the following steps: (e) pushing the intraocular lens in a direction toward the second end of the tubular body of the introduction head so that the intraocular lens is completely located in the through inner cavity of the introduction head; and (f) withdrawing the implantation forceps from the introduction head.

25. The method according to claim 22, wherein: The width of the second U-shaped notch of the introduction head is smaller than the width of the artificial lens, and wherein the step (d) further comprises: when the artificial lens passes through the second U-shaped notch, the two side edges of the short axis of the artificial lens are bent in a direction opposite to the arch surface of its optical part.

26. A component comprising an artificial lens and an implantation device for implanting the artificial lens into a human eye, comprising an artificial lens, an introduction head and a pusher, wherein the introduction head is the introduction head as described in any one of claims 1 to 19, and the pusher is used to provide a driving force for pushing the artificial lens, and the pusher comprises an outer tube and a pushing drive mechanism, the artificial lens is placed in the introduction head, the introduction head is assembled at the first end of the outer tube, and the second end of the outer tube is engaged with the pushing drive mechanism.

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